Q1 2025 Travere Therapeutics Inc Earnings Call

Unknown Attendee: A forward-looking statement within the safe hardware provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not guarantees of performance. They involve known and unknown risks, uncertainties, and assumptions that may cause actual results, performance, and achievement to differ materially from those expressed or implied by the statement.

Within the Safe Harbor provisions of the private Securities Litigation Reform Act of 1995.

Forward looking statements are not guarantees of performance they involve known and unknown risks uncertainties and assumptions that may cause actual results performance and achievements to differ materially from those expressed or implied by the statements.

Unknown Attendee: Please see the forward-looking statement disclaimer on the company's press release issued earlier today as well as risk factors section in our forms 10-Q and 10-K filed with the SEC.

Please see the forward looking statement disclaimer on the company's press release issued earlier today as well as risk factors section in our forms 10-Q, and 10-K filed with the FCC.

Unknown Attendee: In addition, any forward-looking statements represent our views only as of the date such statements are made, May 1, 2025, and Travere specifically disclaims any obligation to update such statements to reflect future information, events, or circumstances.

In addition, any forward looking statements represent our views only as of the date such statements I made my first 2025.

<unk>, specifically disclaims any obligation to update such statements to reflect future information events or circumstances.

Eric Dube: With that, let me now turn the call over to Eric.

Eric: With that let me now turn the call over to Eric.

Eric Dube: Thank you, Victoria, and good afternoon, everyone. We entered the year determined to solidify FILSPARI's foundational positioning in IJ nephropathy, unlock additional growth for FILSPARI to a potential new indication in FSGS, and continue advancing toward restarting enrollment in our pivotal harmony study of pegdobatinase in HCU. And I'm pleased to report that we are making great progress with strong results in each of these three areas.

Eric: Thank you Victoria and good afternoon, everyone.

Eric: We entered the year determined to solidify feels far as foundational positioning and Iga nephropathy.

Eric: Unlock additional growth for fill storage rate potential new indication and SGS.

Eric: Advancing toward restarting enrollment in our pivotal harmony study has talked about <unk> and <unk>.

Eric: And I'm pleased to report that we are making great progress with strong results in each of these three areas.

Eric Dube: Let me begin with Philsipari and Igan. Following its full approval last fall, we saw momentum continue throughout the first quarter. Net sales at Philsipari grew 182% year over year and 13% versus the prior quarter, which reflects continued demand and strong uptake. We also continue to see high compliance rates, a growing patient base, and an expanding group of prescribing physicians, which illustrates the positive Philsipari experience. This strengthens our confidence in the durability and long-term trajectory of growth. At a time of continued evolution in the IGAN treatment landscape, Philsipari remains uniquely positioned as the only fully approved non immunosuppressive kidney targeted therapy that has shown superiority over the historical standard of care.

Eric: Let me begin with so far again.

Eric: Following its full approval last fall we saw momentum continued throughout the first quarter net sales of <unk> grew 182% year over year, and 13% versus the prior quarter, which reflects continued demand and strong uptake.

Eric: We also continue to see high compliance rates, a growing patient base and an expanding group of prescribing physicians, which illustrates the positive <unk> experience. This strengthens our confidence in the durability and long term trajectory of growth.

Eric: At a time of continued evolution in the <unk> treatment landscape <unk> remains uniquely positioned as the only fully approved non immunosuppressive kidney targeted therapy.

Eric: That has shown superiority over the historical standard of care.

Eric Dube: Recent market research continues to validate this positioning as nephrologists regularly highlight Philsipari's strong clinical data, real world effectiveness and safety profile for chronic use, all of which underscores its role as a foundational therapy for IGAN. We continue to believe that Fils-Pari can become foundational care outside of the U.S. as well. Recently, the European Commission and MHRA in the U.K. converted Fils-Pari's conditional approvals to full approvals for the treatment of adults with Igan, an important milestone that will enable our partner CSLV4 to expand access to patients across Europe and the U.K. Our partner, Rinalys, also continues to make good progress, and they remain on track to report top-line data in the second half of this year from their pivotal study in IGAN to support a regulatory submission in Japan.

Eric: Recent market research continues to validate this positioning as Nephrologist regularly highlight feels very strong clinical data real world effectiveness and safety profile for chronic use all of which underscores its role as a foundational therapy for IGN.

Eric: We continue to believe that <unk> can become foundational care outside of the U S. As well recently, the European Commission and the NHRA in the U K converted feels far east conditional approval to full approvals for the treatment of adults with IGN and important milestone that will enable our partner CSL V for two <unk>.

Eric: Spanned access to patients across Europe, and the U K.

Eric: Our partner analysis also continues to make good progress and they remain on track to report topline data in the second half of this year from their pivotal study again to support a regulatory submission in Japan.

Eric Dube: Turning to FSGS, we have made excellent progress towards our role of bringing Philspori to a community that currently has no approved medication. After aligning with the FDA on our plan to submit an SNDA for an FSGS indication, we completed our submission in March. This reflects our team's dedication to a community that has been waiting for decades. We expect to receive notification of the FDA's acceptance of this filing later this month. If we are granted priority review as expected, Fils-Phari could be approved and ready to launch in FSGS as early as September. This would mark a historic milestone.

Eric: Turning to <unk>, we have made excellent progress towards our goal of bringing <unk> to a community that currently has no approved medications.

Eric: After aligning with the FDA on our plan to submit an <unk> for an <unk> indication we completed our submission in March. This reflects our team's dedication to a community that has been waiting for decades.

Eric: We expect to receive notification of the Fda's acceptance of this filing later this month.

Eric: If we are granted priority review as expected thus far it could be approved and ready to launch and <unk> as early as September This would mark a historic milestone thus far he would become the first and only approved medication indicated for patients with <unk>. We continue to believe that the opportunity in <unk>.

Eric Dube: Fils-Phari would become the first and only approved medication indicated for patients with FSGS. We continue to believe that the opportunity in FSGS is potentially even larger than that in IGAN given the urgent unmet need in this disease. Our team is advancing preparations to execute a successful launch so we can deliver Fillsparry to the FSGS community quickly if approved.

Eric: <unk> is potentially even larger than that and again given the urgent unmet need in this disease. Our team is advancing preparations to execute a successful launch. So we can deliver <unk> to the <unk> community quickly if approved.

Eric Dube: We also remain very enthusiastic about PEGdibatinase, or PEG-T, our investigational therapy for classical homocystinuria, or HCU. PEG-T has the potential to be the first disease modifying treatment for HCU, and we continue to make strong progress towards restarting patient enrollment in the Phase 3 Harmony Study next year. We remain committed to the HCU community and believe PEG-T has the potential to significantly improve the lives of these patients in the future. Looking ahead, we remain confident in our strategy with strong fundamentals and a clear focus on executing our key priorities.

Eric: We also remained very enthusiastic about pegged about nacer pay T. Our investigational therapy for classical home assistant area or HCA you pegged. It has the potential to be the first disease modifying treatment for <unk> and we continue to make strong progress towards restarting patient enrollment in the phase III Harmony study next year.

Eric: We remain committed to the HCM community and believe <unk> has the potential to significantly improve the lives of these patients in the future.

Eric: Looking ahead, we remain confident in our strategy with strong fundamentals and a clear focus on executing our key priorities. Let me now hand, the call over to Julie for a clinical update Julian.

Jula Inrig: Let me now hand the call over to Jula for a clinical update. Thank you, Eric. Across our programs, we continue to deliver on our mission of transforming care for people living with rare kidney and metabolic diseases. We are making strong, steady progress toward our goal of establishing Fils-Phari as a foundational treatment for patients with IGN nephropathy across the full disease continuum. from early diagnosis through post kidney transplant. as the only available medicine that optimally blocks two critical pathways, endothelin one and angiotensin two in a single pill. Vilspari offers unrivaled efficacy and convenience for preserving kidney function for patients with IgA nephropathy and with a safety profile comparable to herbicartin.

Julie: Thank you Eric across our programs, we continue to deliver on our mission of transforming care for people living with rare kidney and metabolic diseases.

Speaker Change: We are making strong steady progress toward our goal of establishing <unk> as a foundational treatment for patients with Iga nephropathy across the full disease continuum from.

Julie: From early diagnosis through post kidney transplant.

Julie: As the only available medicine that optimally block two critical pathways Endothelin, one an angiotensin II and a single pill.

Julie: Sorry offers unrivaled efficacy and convenience for preserving kidney function for patients with Iga nephropathy and.

Julie: And with a safety profile comparable to Irbesartan.

Jula Inrig: At the National Kidney Foundation Spring Clinical Meeting, we were pleased to receive highly encouraging feedback on the foundational role of Fils-Pare for treating patients with IgA nephropathy. Physicians reported earlier diagnosis of their patients with IGAN driven by referrals and biopsies earlier in the disease process. Importantly, more clinicians are now prescribing Fils-Bari earlier in the disease course and treating to lower targeted proteinuria thresholds. This is based on data demonstrating that reducing proteinuria to the recommended draft KDGO treatment thresholds of less than 0.5 grams per day, or ideally 0.3 grams per day, preserve kidney function and results in better kidney survival in patients with IGAM.

Julie: At the National Kidney Foundation spring clinical meeting we were pleased to receive highly encouraging feedback on the foundational role I feel sorry for treating patients with Iga nephropathy.

Julie: Physicians reported earlier diagnosis of their patients with ICANN, driven by referrals and biopsies earlier in the disease process.

Julie: Importantly, more clinicians are now prescribing <unk> earlier in the disease course, and training to lower targeted proteinuria thresholds.

Julie: This is based on data demonstrating that reducing proteinuria to the recommended draft K Diego treatment thresholds.

Julie: Less than 0.5 grams per day, or ideally 0.3 grams per day.

Julie: Preserved kidney function and result in better kidney survival in patients with ICANN.

Jula Inrig: It is important to remember that Filspari is the only non-immunosuppressive kidney-targeted therapy indicated for adult patients at risk of IgM progression, regardless of their proteinuria level. And we are increasingly hearing from nephrologists that they're observing consistently positive results across the wide range of patients with IgAN that they treat. some of which were presented in real world case series at NKF. We also presented additional data from the SPARTAN study, which adds further depth to Philsipari's clinical story. In Spartan, Tilspari is being evaluated as a first line treatment. The data reported at NKF showed that treatment with Delspare resulted in approximately 70% proteinuria reduction from baseline and stabilization of EGFR over 24 weeks.

Julie: It is important to remember that <unk> is the only non immunosuppressive kidney targeted therapy indicated for adult patients at risk of <unk> progression, regardless of their proteinuria level.

Julie: And we are increasingly hearing from nephrologist that they are observing consistently positive results across the wide range of patients with ICANN that they treat.

Julie: Some of which were presented in real World case series at MKS.

Julie: We also presented additional data from the Spartan study, which adds further depth to fill <unk> clinical story.

Julie: And Spartan Pillsbury is being evaluated as a first line treatment.

Julie: The data reported at <unk> showed that treatment with Pillsbury resulted in approximately 70% proteinuria reduction from baseline.

Julie: And stabilization of Egfr over 24 weeks.

Jula Inrig: Additionally, nearly 60% of patients achieved complete proteinuria remission during the treatment period. We also presented the first evidence in humans of Filspare's anti-inflammatory effect. Specifically a 50% reduction in urinary soluble CD163 over 24 weeks in newly diagnosed treatment naïve patients with Igam. This data resonated with nephrologists as psilocybin not only addresses the kidney damage, but has the potential to also reduce immune system response and inflammation in the kidney that contributes to progression of IgAN and without the need for systemic immunosuppression. We expect to share additional exciting data from this ongoing study later this year. Recognizing that nephrologists are data driven, we are generating additional evidence to support the use of Fils-Pare across the full continuum of disease, including in recurrent disease after kidney transplantation.

Julie: Additionally, nearly 60% of patients achieved complete proteinuria remission during the treatment period.

Julie: We also presented the first evidence in humans of <unk> anti inflammatory effects.

Julie: Specifically, a 50% reduction in urinary soluble CD 163 over 24 weeks and newly diagnosed treatment naive patients with IGN.

Julie: This data resonated with Nephrologist as still spring not only addresses the kidney damage that has the potential to also reduce immune system response and inflammation in the kidney that contributes to progression of <unk> and <unk>.

Julie: Without the need for systemic immunosuppression.

Julie: We expect to share additional exciting data from this ongoing study later this year.

Julie: Recognizing that nephrologist or data driven we are generating additional evidence to support the use of <unk> across the full continuum of disease, including in recurrent disease after kidney transplantation.

Jula Inrig: This remains an area of high unmet need, and our upcoming studies present a critical opportunity to generate data that will help physicians evaluate Fils-Pare as a potentially beneficial, non-immunosuppressive treatment option. We are currently in study startup for these studies and plan to provide further updates in the future. For a safety update, we are pleased with the progress of our submitted SNDA for modification of the liver monitoring frequency, as well as removal of the embryo fetal toxicity range. Notably, as patient exposure to Filspare increases, we have not seen any cases of Hyde's Law. And we now have enough exposure data to rule out a potential risk of drug-induced liver injury of one in 1,000.

Julie: This remains an area of high unmet need and our upcoming studies presents a critical opportunity to generate data that will help physicians evaluate until sorry, as a potentially beneficial non immunosuppressive treatment option.

Julie: We are currently in study startup for these studies and plan to provide further updates in the future.

Julie: For a safety update we are pleased with the progress of our submitted NDA for modification of the liver monitoring frequency.

Julie: As well as removal of the embryo fetal toxicity rents.

Julie: Notably as patient exposure to fill sparry increases.

Julie: We have not seen any cases of highs law.

Julie: And we now have enough exposure data to rule out a potential risk of drug induced liver injury of one and 1000.

Jula Inrig: We remain on track for our August 28th PDUFA date for this submission and look forward to providing further updates as they become available. Now turning to FSGS, DOSPARI continues to be the only potential treatment in development with data showing efficacy across patients with either biopsy proven or genetic FSGS. Importantly, the FOSPARI data have shown remarkable consistency in reducing proteinuria across all FSGS subtypes studies. Particularly important for difficult-to-treat populations, including primary and genetic forms of FSGS, as well as in pediatric patients. Data supportive of this broad efficacy is even more critical in FSGS than in IGAN due to the heterogeneity and complexity of the disease.

Julie: We remain on track for our August 28, <unk> date for this submission and look forward to providing further updates as they become available.

Julie: Now turning to <unk>.

Julie: <unk> continues to be the only potential treatment in development with data showing efficacy across patients with either biopsy proven or genetic FX, yes.

Julie: Importantly, the sparring data have shown remarkable consistency in reducing proteinuria across all <unk> sub types of studies.

Julie: Particularly important for difficult to treat populations, including primary and genetic forms of <unk> as well as in pediatric patients.

Julie: Data is the data supportive of this broad efficacy is even more critical in <unk> than in <unk> due to the heterogeneity and complexity of the disease.

Jula Inrig: At NKS, we presented new analyses from the FSGS duplex study, which demonstrated that patients achieved partial and complete remission of proteinuria earlier and more often with Philspori versus Herbicartin. And importantly, those patients who achieved partial or complete proteinary remission in the study had 67 to 77 percent lower risk of kidney failure, respectively. These important findings are the first randomized clinical trial analyses to validate the observational data from Parasol and further support the Parasol recommendation of proteinuria as a surrogate endpoint in FSGS. Following our SNDA submission for FSGS, our interactions with the FDA have been productive and consistent with the experience we had during the IGAN process.

Julie: And N chaos, we presented new analyses from the <unk> duplex study, which demonstrated that patients achieved partial and complete remission of proteinuria earlier and more often with Phil sorry versus irbesartan.

Julie: And importantly, those patients who achieved partial or complete proteinuria remission. In this study had 67% to 77% lower risk of kidney failure, respectively.

Julie: These important findings are the first randomized clinical trial analyses to validate the observational data from parasol and further support the parasol recommendation of proteinuria as a surrogate endpoint and FX, yes.

Julie: Following our <unk> submission for <unk>, our interactions with the FDA have been productive and consistent with the experience we had during the <unk> process.

Jula Inrig: As Eric highlighted earlier, we anticipate notification of our acceptance of our application later this month, and if granted priority review, we expect potential approval this fall.

Julie: As Eric highlighted earlier, we anticipate notification of our acceptance of our application later this month.

Julie: And if granted priority review, we expect potential approval this fall.

Jula Inrig: Finally, our PEG-T program continues to make good progress, and we are on track to restart enrollment in our Phase 3 Harmony Study next year.

Julie: Finally, our <unk> program continues to make good progress and we are on track to restart enrollment in our phase III Harmony study next year.

Jula Inrig: We are also pleased to share that our Phase I-II Composed Study Manuscript has been accepted for publication in the top tier peer reviewed journal Genetics and Medicine. This publication will further reaffirm PEG-T's potential to become the first disease-modifying therapy for the HCU community.

Julie: We're also pleased to share that our phase one to compose study manuscript has been accepted for publication in a top tier peer reviewed journal genetics in medicine.

Julie: This publication will further reaffirmed pegged <unk> potential to become the first disease modifying therapy for the HCM community.

Jula Inrig: In summary, the first quarter marked another strong period of clinical and scientific advancement. Our programs are maturing in ways that deliver not only improved clinical outcomes, but real meaningful change in how physicians approach these chronic and complex diseases.

Julie: In summary, the first quarter marked another strong period of clinical and scientific advancement.

Our programs are maturing in ways that deliver not only improved clinical outcomes.

Julie: Real meaningful change in how physicians approach these chronic and complex diseases.

Jula Inrig: We are excited for what lies ahead and look forward to keeping you updated as we move through the rest of the year.

We are excited for what lies ahead and look forward to keeping you updated as we move through the rest of the year I'll now turn the call over to Peter for a commercial update Peter.

Peter Heerma: I'll now turn the call over to Peter for a commercial update. Peter. Thank you, Jula. The first quarter marked a strong start to the year for our commercial team and Phil Sparrow. We saw continued momentum following full FDA approval in IgA nephropathy, which resulted in approximately 56 million in net breast sales of Hillsbury in the first quarter. This reflects further growth driven by an increasing prescriber base and deepening penetration amongst experienced prescribers. We received 703 new patient start forms in the first quarter, a robust continuation of the heightened demand we have seen since full approval.

Peter: Thank you Joel.

Peter: The first quarter marked a strong start to the year for our commercial team until sorry.

Peter: We saw continued momentum following full FDA approval, and Iga nephropathy, which resulted in approximately $56 million and that's what appeals oilfield fiery in the first quarter.

Peter: This reflects further growth driven by an increasing prescriber base and deepening penetration amongst experienced prescribers.

Peter: We received 703, new patients start forms in the first quarter the robust continuation of the heightened demand we have seen since full approval.

Peter Heerma: Importantly, we saw consistent month over month growth throughout the quarter, culminating in March being our strongest month since launch.

Peter: Importantly, we saw consistent month over month growth throughout the quarter, culminating in March being our strongest months since launch.

Peter Heerma: and Jemaine D'Enable continued this. This highlights the beliefs physicians have in Phil Sparis' efficacy profile as the only kidney-targeted therapy to demonstrate rapid and sustained proteolytic reduction and benefit in kidney function preservation. with efficacy superior to that of a maximally dosed active comparator and a safety profile that is comparable over two years. The expansion of Phil Spary's label to more patients with IHG and nephropathy, regardless of their proteinuria levels, has also amplified physicians' confidence in choosing Phil Spary for the broad spectrum of their patients. In fact, what we are seeing is a meaningful shift in prescribing behavior.

Peter: And demand in April continued this trend.

Peter: This highlights the beliefs inflation path until salaries of efficacy profile as the <unk>.

Peter: Kidney targeted therapy to demonstrate rapid and sustained profitability and a reduction in benefit in kidney function preservation.

Peter: With the efficacy superior to that of a maximum dose.

Peter: Active comparator and a safety profile that is comparable over two years.

Peter: The expenses will fuel <unk> label to more patients with Iga nephropathy, regardless of that both on Yulia levels is also amplified physicians' confidence in choosing fuels Bobby for the broad spectrum of their patients.

Peter: In fact, what we are seeing is a meaningful shift in prescribing behavior.

Peter Heerma: The median proteinuria levels at initiation continue to trend below 1.5 gram per gram and many existing prescribers are now initiating treatment in patients with proteinuria levels below 1 gram per gram. This change reflects growing alignment with the updated draft Cadego guidelines, which recommend earlier intervention and more ambitious treatment goals to optimize long term outcomes. From an access and fulfillment standpoint, patient experience remains strong. We have maintained broad coverage across players, with criteria easing across the board following the label expansion at full approval. Most notably, this has resulted in the removal of paternalia thresholds in multiple payer plans.

Peter: The median proteinuria levels at initiation continue to trend below one five gram per gram and many existing prescribers are now initiating feed within patients with possibly lower levels below one gram per gram.

Peter: This is James reflects growing alignments with the update of drastic illegal guidelines with recommended lulea intervention and more ambitious treatment goals to optimize long term outcomes.

Peter: Former excesses fulfillment standpoint patient experience remains strong.

Peter: We have maintained broad coverage across sprayers.

Peter: The area easy across the board following the label expansion a full approval.

Peter: Most notably this has resulted in the removal of patent yoga thresholds and multiple pay airplanes.

Peter Heerma: These developments are making Philspiring more accessible, more quickly to the patients who need it, which pairs nicely with the efficiencies we continue to realize in our fulfillment process. Also, our patient services are highly valued as evidenced by survey responses indicating that 90% of the Philspari patients are highly satisfied with the services provided through Travere Total Care. Patient compliance and persistence rates continue to be higher than benchmark. further reflecting the convenience, durability, and efficacy of Philspari as an indicator of patients being highly satisfied with their Philspari experience.

These developments are making feels pottery barn accessible more quickly to the patients who need it which fits nicely with the efficiencies we continued to realize in our fulfillment process.

Peter: Also our patient services are highly valued as evidenced by survey responses indicated 90% of the <unk> patients are highly satisfied with the service provider suite drove total care.

Peter: Patient compliance and persistence rates continued to be higher than benchmarks.

Peter: Further, reflecting the convenience portability and efficiency, you'll feel sorry the index.

Peter: Indicate those patients being highly satisfied with their fuel spiry experience.

Peter Heerma: Looking ahead, we are well positioned to upgrade the historical state of care of AIDS inhibitors and ARBs, which will drive continued revenue growth in 2025. As the only non-immune suppressor therapy that is fully approved for the adult IgA nephropathy patients at risk of progression, independent of proteinuria levels, Philspari continues to see broad uptake across some groups of patients. We expect Philspari will remain the leading choice for upgrading foundational care. And we anticipate the largest segment of patient uptake to continue coming from those with UPCR levels below 1.5 gram per gram, which we estimate represents roughly 70 percent of the 70,000 addressable patients.

Peter: Looking ahead.

Peter: We are well positioned to upgrade to the historical standard of care of Ace inhibitors, and <unk>, which will drive continued revenue growth in 2025.

Peter: And the only known immune suppressive therapy that is fully approved for the <unk> Iga nephropathy patients at risk of progression independent of proteinuria levels fuel salary continues to see broad uptake across subgroups of patients.

Peter: We expect <unk> will remain the leading choice for upgrading foundational care and we anticipate the largest technical stations updates to continue coming from those with <unk> levels below one five gram per Gram, which we estimate represents roughly 70% of the 70000 addressable patients.

Peter: <unk>.

Peter Heerma: The expected upcoming finalization and publication of the Key Diego guidelines will likely reinforce the shift to earlier and more ambitious treatment. consistent with the Phil Spari label and prescribed interest. Our latest market research shows that approximately 75% of nephrologists are now targeting proteinuria below 0.5 gram per gram, with nearly a third targeting even more conditioned goals of 0.3 gram per gram, meaning complete remission.

Peter: The expected upcoming Finalization and publication of the <unk> guidelines will likely reinforces shifts resilience and more ambitious treatments.

Peter: Consistent with the <unk> label and prescribing trends.

Peter: Our latest market research shows that approximately 75% of Nephrologist now targeting proteinuria below <unk> five gram per gram with nearly a third targeting even more.

Peter: <unk> goals of three Gram per gram, meaning complete remission.

Peter Heerma: Our market research and feedback from the fraud. also indicates that the REMS requirements do not have a meaningful impact on the intention to prescribe. That said, potential future modifications to the ramps would further enhance the product convenience, particular for newly diagnosed or lower risk patients.

Peter: Our market research and feedback from those royalties.

Peter: Also indicates that the rems requirements do not have a meaningful impact on the intention to prescribed.

Peter: That's a potential future modifications to the Rems and further enhance the potash convenience particular for newly diagnosed or lower risk patients.

Peter Heerma: Turning to FFDS, we are preparing our commercial organization to be ready for a successful second launch in anticipation of a potential new indication. with up to 30,000 addressable patients, FSGF is the most progressive and symptomatic glomerular disease. If approved, TILS-PARI could be an important new treatment option for a community with no approved medicines today, representing a significant opportunity, potentially even greater than in IgA nephropathy.

Peter: Turning to <unk>, yes, we are preparing our commercial organization to be ready for a successful second loans in anticipation of a potential new indication.

Peter: With up to 30000 addressable patients <unk> is the most progressive and symptomatic glomerular disease.

Peter: If approved so far it could be an important new treatment option for a community with no approved medicines today, we presented significant opportunity potentially even greater than in <unk>.

Peter: Then in Iga nephropathy.

Peter Heerma: We are in the early stages of expanding our commercial team, building upon our existing infrastructure. Given the significant overlap between the prescriber basis for FSDS and IgA nephropathy, we are confident that we can efficiently and effectively deliver Fils-Pare to FSDS patients from the outset.

Speaker Change: We are in early stages of expanding our commercial team Bill.

Bill: Building upon our existing infrastructure.

Bill: Given the significant overlap between the prescriber base for <unk> and Iga nephropathy, we are confident that we can efficiently and effectively deliver fuel salary to <unk> patients from the outset is approved.

Peter Heerma: It's approved. I am pleased with our progress and we will be well prepared for potential approval later this year.

Bill: I am pleased with our progress and we will be well prepared for a potential approval later this year.

Peter Heerma: In summary, our performance in the first quarter clearly demonstrates the strength and effectiveness of our commercial team. Phil Fari is delivering on its promise, and our team is building strong, sustainable momentum heading into the rest of the year.

Bill: In summary.

Bill: Our performance in the first quarter, clearly demonstrates the strength and effectiveness of our commercial team.

Bill: So far is delivering on its promise and our team is building strong sustainable momentum heading into the rest of the year.

Peter Heerma: Positioning us for significant growth in IGN property and preparing the organization for successful launch is approved for FSDM.

Bill: Listening us for significant growth in Iga nephropathy, and preparing the organization for successful loans approved for Ssds.

Christopher Cline: Let me now turn the call over to Chris for the financial update. Thank you, Peter, and good afternoon, everyone. As you heard from the rest of the team, we are pleased to report another quarter of grade X. was driven by continued momentum in the ongoing FOSPARI launch and leveraging our strong financial foundation to strategically invest in the key priorities that are delivering growth now and in the future. I'll start with revenue, where we generated net product sales of $75.9 million in the first quarter, representing 90% growth over the same period last year, as well as continued sequential growth over last quarter.

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

Bill: Yes.

Chris: Thank you Peter and good afternoon, everyone. As you heard from the rest of the team. We are pleased to report another quarter of great execution. This was driven by continued momentum in the ongoing <unk> launch and leveraging our strong financial foundation to strategically invest in the key priorities that are delivering growth now and in the future.

Chris: I'll start with revenue, where we generated net product sales of $75 $9 million in the first quarter, representing 90% growth over the same period last year as well as continued sequential growth over last quarter.

Christopher Cline: Philsipari maintained great momentum in the first quarter, generating $55.9 million in net product sales. We achieved this despite gross-to-net discounts being higher as a result of the typical insurance coverage changes in the beginning of the new year and the implementation of the Part D redesign. As we outlined at the beginning of the year, we continue to anticipate that we will have higher gross-to-net discounts for Philsipari in 2025. With that continued momentum and demand, high compliance and persistence will drive significant growth in Philsipari sales throughout the year. Thiola and Thiola EC also contributed $20 million in net product sales for the first quarter.

Chris: Thus far we maintain great momentum in the first quarter generating $55 $9 million and net product sales.

Chris: This despite gross to net discounts being higher as a result of the typical insurance coverage changes at the beginning of the new year and the implementation of the part D redesign.

Chris: As we outlined at the beginning of the year. We continue to anticipate that we will have higher gross to net discounts for Phil sorry in 2025 that continued momentum and demand high compliance and persistence will drive significant growth thus far sales throughout the year.

Chris: Viola entitle you see also contributed $20 million and net product sales for the first quarter. We continue to anticipate more generic competition for <unk> EC in the coming quarters, and we continue to be pleased with the performance thus far.

Christopher Cline: We continue to anticipate more generic competition for Thiola and Thiola EC in the coming quarters, but we continue to be pleased with the performance thus far. During the quarter, we also recognized $5.9 million of license and collaboration revenue, which results in total revenue of $81.7 million reported for the first quarter of 2025. Of note, during the quarter, we sold drug product to our partner, CSLV4, as they continue their launch of PhilSparAid Europe. This activity accounted for $3.8 million of the license and collaboration revenue, and a nearly proportional increase in cost of goods sold for the quarter.

Chris: During the quarter, we also recognized $5 $9 million of license and collaboration revenue.

Chris: <unk> total revenue of $81 $7 million reported for the first quarter of 2025.

Chris: Of note during the quarter, we saw drug product to our partner CSL before as they continue their launch thus far in Europe.

Chris: This activity accounted for $3 $8 million of the license and collaboration revenue and a nearly proportional increase in cost of goods sold for the quarter.

Christopher Cline: Turning to operating expenses, our research and development expenses for the first quarter of 2025 were $46.9 million compared to $49.4 million for the same period in 2024. The decrease in R&D is largely attributable to reduced costs associated with the development of FOSFARI as our Phase 3 programs advance towards completion. On a non-GAAP-adjusted basis, R&D expenses were $42.2 million compared to $45.8 million for the same period in 2024. Selling general and administrative expenses for the first quarter were $72.8 million, compared to $64.2 million for the same period in 2024. The increase in SG&A is largely attributable to increased investment in the Fils Barre launch following full approval, as well as increased amortization expense related to Fils Barre royalty.

Chris: Turning to operating expenses research and development expenses for the first quarter of 2025 or $46 9 million compared to $49 4 million for the same period in 2024.

Chris: The decrease in R&D is largely attributable to reduced cost associated with the development that thus far as our phase III programs advanced towards completion.

Chris: On a non-GAAP adjusted basis, R&D expenses were $42 $2 million compared to $45 8 million for the same period in 2024.

Chris: Selling general and administrative expenses for the first quarter were $72 8 million compared to $64 2 million for the same period in 2024.

Chris: The increase in SG&A was largely attributable to increased investment in the <unk> launch following full approval as well as increased amortization expense related to first foray royalties.

Christopher Cline: On a non-GAAP-adjusted basis, SG&A expenses were $53.3 million for the first quarter, compared to $48.2 million from the same period in 2024. Total other income net for the first quarter of 2025 was $1.5 million compared to $3.5 million in the same period of 2024. The difference is largely attributable to lower interest income during the period. Net loss for the first quarter of 2025 was $41.2 million, or $0.47 per basic share, compared to $136.1 million, or $1.76 per basic share, for the same period in 2024. On a non-GAAP-adjusted basis, net loss for the first quarter of 2025 was $16.9 million, or $0.19 per basic share, compared to $116.2 million, or $1.51 per basic share, for the same period in 2020.

Chris: On a non-GAAP adjusted basis, SG&A expenses were $53 3 million for the first quarter compared to $48 $2 million from the same period in 2024.

Chris: Total other income net for the first quarter of 2025 was $1 5 million compared to $3 $5 million in the same period in 2020 for the.

Chris: The difference is largely attributable to lower interest income during the period.

Chris: Net loss for the first quarter of 2025 was $41 2 million or 47 per basic share compared to $136 1 million or $1 76 per basic share for the same period in 2024.

Chris: On a non-GAAP adjusted basis net loss for the first quarter of 2024 type was $16 $9 million or <unk> 19 per basic share compared to $116 2 million or $1 51 per basic share for the same period in 2024.

Christopher Cline: As of March 31, 2025, we had cash, cash equivalents, and marketable securities totaling $322.2 million. We expect to receive a $17.5 million milestone payment from CSLV4 during the second quarter as a result of the recent conversion of conditional approval of FOSFARI to full approval in Europe. We also anticipate additional milestone payments tied to key market access achievements later this year and sales-based achievements in the future, which should further enhance our financial flexibility. As we look to the remainder of the year and beyond, we expect continued strong demand for Fils Fari and IGA nephropathy, with net product sales projected to grow meaningfully this year and maintaining a pace well above benchmark launch.

Chris: As of March 31, 2025, we had cash cash equivalents in marketable securities totaling $322 $2 million.

Chris: We expect to receive a $17 $5 million milestone payment from CSL before during the second quarter as a result of the recent conversion of conditional approval first foray to full approval in Europe.

Chris: We also anticipate additional milestone payments tied to key market access achievements later this year and sales based achievements in the future, which should further enhance our financial flexibility.

Chris: As we look to the remainder of the year and beyond we expect continued strong demand for <unk> and Iga nephropathy with net product sales projected to grow meaningfully this year and maintaining a pace well above benchmark launches.

Christopher Cline: Continuing to thoughtfully invest in both near-term execution and longer-term growth drivers. This includes supporting the further success of the IGNeproperty launch, advancing launch readiness for potential FSGS approval, and enabling the restart of enrollment in the Pivotal Pectobatinase program. Like many others, we are continuing to monitor legislative developments and geopolitical uncertainties. Based upon what we know today, if tariffs are extended more broadly to pharmaceutical products, we believe the impact to Tilspari would not be material. Importantly, with a strong balance sheet, a clear set of priorities, and continued strong execution, we're well positioned to fund our strategic initiatives and drive sustainable growth.

Chris: We're continuing to thoughtfully invest in both near term execution and longer term growth drivers. This includes supporting the further success of the Iga nephropathy launch advancing launch readiness for a potential <unk> approval and enabling the restart of enrollment in the pivotal effect about next program.

Chris: Like many others, we are continuing to monitor legislative developments and geopolitical uncertainties based upon what we know today if tariffs are extended more broadly to pharmaceutical products. We believe the impact thus far would not be material importantly, with a strong balance sheet, a clear set of priorities and continued strong execution, we are well positioned to fund our strategic initiatives.

Chris: And drive sustainable growth.

Eric Dube: With that, I'll turn the call over to Eric for his closing comments.

Chris: That I will turn the call over to Eric for his closing comments.

Eric Dube: Eric? Thank you, Chris. In closing, I'm proud of our strong start to 2025. Our teams continue to demonstrate solid execution, and we are confident in our ability to maintain this momentum throughout the year. We look forward to keeping you updated as we achieve key milestones in the quarters ahead.

Eric: Thank you Chris in closing I'm proud of our strong start to 2025, our teams continue to demonstrate solid execution and we are confident in our ability to maintain this momentum throughout the year. We look forward to keeping you updated as we achieve key milestones in the quarters ahead now let me turn the call over to Victoria for Q&A.

Unknown Attendee: Now, let me turn the call over to Victoria for Q&A. Victoria? Thank you, Eric.

Chris: Victoria.

Victoria: Thank you Eric.

Unknown Attendee: Operator, we can now open the line up for the Q&A. Thank you.

Victoria: We can now open the lineup for the Q&A.

Victoria: Thank you at this time, if you would like to ask a question simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question. Please press the pound key thank you.

Unknown Attendee: At this time, if you would like to ask a question, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, please press the pound key. Thank you.

Victoria: Yeah.

Tyler Buren: Our first question comes from the line of Tyler Van Buren from PDK. When your line is open, Hey guys, thanks very much and congratulations on the progress. Can you just elaborate on any interactions with the agency you've had since you filed the SNDA for FSGS and how those have gone? And is the FDA feedback that's been publicized by competitor Dimerix consistent with your experience with the agency?

Speaker Change: Our first question comes from the line of Tyler Van brand for MTBE Cowen Your line is open.

Speaker Change: Hey, guys, thanks, very much and congratulations on the progress.

Speaker Change: Can you just elaborate on any interactions with the agency you've had since you filed the NDA for <unk> and how those have gone in and as the FDA feedback has been publicized by competitor dime Eric's consistent with your experience with the agency.

Speaker Change: Okay.

William Rote: Father, thanks for the question. I'll turn that one over to Bill. Yeah, thanks. Thanks, Tyler. Well, we're we're seeing the same headlines that that everyone else is and it's clearly a dynamic situation. With that said, as we look at the reviewers for our FSGS SNDA, we see consistency there and our FDA interactions have been progressing as we expected. As we continue to anticipate the PDUFA date for the potential REMS toward the end of the summer and our continued review on the SNDA for FSGS, I can report that the interactions that we have are very similar to what we've experienced in the prior year with the IGAN indication at this stage in the process.

Speaker Change: Got it thanks for the question I'll turn that one over to Bill.

Speaker Change: Yeah. Thanks, Thanks Tyler.

Speaker Change: We're seeing the same headlines that everyone else is and it is clearly a dynamic situation.

Speaker Change: With that said as we look at the reviewers for our <unk>.

Speaker Change: S. NDA, we see consistency there and our FDA interactions have been progressing as we expected.

Speaker Change: We continue to anticipate that the <unk> date for the potential rems towards the end of the summer and our continued review on on the NDA for <unk> I can report that the interactions that we have are very similar to what we've experienced.

Speaker Change: In the prior year with the IGN indication at this stage in the process.

William Rote: So, you know, the experience that we're seeing on the other side of the table matches what we would expect and what we've been used to in the past.

Speaker Change: No.

Speaker Change: The experience that we're seeing on the other side of the table matches.

Speaker Change: What we would expect and what we've been used to in the past with respect to your other comment it was pleasing to see the confirmation.

William Rote: With respect to your other comment, it was pleasing to see the confirmation from the FDA with a different product that there was consistent feedback supporting the use of proteinuria as an approval-based endpoint for FSGS.

Speaker Change: From the FDA.

Speaker Change: With a different product.

Speaker Change: There was consistent feedback supporting the use of proteinuria.

Speaker Change: As a an approval based endpoint.

Speaker Change: <unk>.

Speaker Change: Okay.

Unknown Attendee: Okay, Operator, do we have any other questions?

Speaker Change: Okay, operator, do we have any other questions.

Unknown Attendee: Yes.

Unknown Attendee: As a reminder, we ask that you limit yourself to one question. If you have another question, please rejoin the queue.

Speaker Change: Yes, as a reminder, we ask that you limit yourself to one question. If you have another question. Please rejoin the queue. Our next question comes from the line of Vimeo Durban from Guggenheim. Your line is open.

Vamil Divan: Our next question comes from the line of Vamil Divan from Guggenheim. Your line is open. Okay, great.

Vamil Divan: Maybe just if I just have one question, I'll keep it on the FSGS side. And just, again, tied to the regulatory discussions and the label, you mentioned the, you know, the data is supported across a broad range of patients with FSGS, might be a little bit early for you to comment on this. I'm just trying to get a sense of what you think the label would look like. Do you think it would just be literally for all patients with FSGS? Or do you think there might be some restrictions in how the indication is defined?

Vimeo Durban: Okay, Great maybe just if I just have one question I'll keep it on the <unk> side, and just again tied to the regulatory discussions in the label you mentioned.

Vimeo Durban: The data is supportive across a broad range of patients with FCS maybe a little bit early for you to comment on this but I'm just trying to get a sense of what you think the label would look like do you think it would just be.

Vimeo Durban: Literally for all patients with FCS or do you think there might be some restrictions and how the.

Vimeo Durban: So the indication is defined.

William Rote: Pavel, thanks for the question. I'll turn that one over to Bill as well. Yeah, I mean, my expectation is that the indication statement would be for the treatment of FSGS in patients ages eight and up, because that matches what we studied. The inclusion criteria for the duplex study was broad. And we also know from post-study analysis, we have a very good description of the patient types based on their histology and their genetic makeup for many of those patients, where we can segregate their causes. And what we can conclude from that is that we recruited a population of primary FSGS, genetic FSGS, and saw consistent effects across all of those subgroups.

Vimeo Durban: Pavel Thanks for the question I'll turn that one over to bill as well.

Bill: Yeah I'm in my expectation is that the indication statement and it would be for the treatment of F. S. T S.

Bill: In patients ages, aten up because that matches what we studied.

Bill: The inclusion criteria for the duplex study was broad and we also know from post study analysis, we have a very good description of the patient types based on their histology.

Bill: And there are genetic makeup for many of those patients.

Bill: Where we can segregate their causes and what we can conclude from that is that we recruited a population of primary SSG Jeanette.

Bill: Kinetic F S T S.

Bill: And saw consistent effects across all of those subtypes. So I think that when we think about <unk> as a <unk>.

William Rote: So I think that, you know, when we think about FSGS as a podopsychopathy. The injury and the cause may come from different sources. But ultimately, FSGS is a damage to the podocyte. And treatment with sparsentin, blocking angiotensin and endothelin, it's a common disease pathway that's beneficial, independent of the heterogeneity that's part and parcel of the FSGS diagnosis.

Bill: The injury and cause may come from different sources, but ultimately <unk> is a damage to the prototype and treatment with sports center and blocking angiotensin and Endothelin. It's a common disease pathway, that's beneficial independent of the of the heterogeneity.

Bill: Eddie.

Bill: Part and parcel of the <unk> diagnosis.

Bill: Okay. Thanks.

Bill: Okay.

Joseph Schwartz: Our next question comes from the line of Joseph Schwartz from Lincoln, South Carolina. Great. Hi, everyone. This is Will Hunford-Jo. Congrats on a strong quarter in progress here.

Joseph Schwartz: Our next question comes from the line of Joseph Schwartz from Leerink. Your line is open.

Joseph Schwartz: Great Hi, everyone. This is will on for Joe Congrats on a strong quarter and progress here. So I guess, one from us with the recent approval or accelerated approval with Novartis is second therapy.

Peter Heerma: So I guess one from us, with the recent approval or accelerated approval of Novartis' second therapy in Hygiene, can you provide a bit more color on what your sales reps are seeing in the field? Is there some counter-detailing that's ongoing? And what are the main types of questions your reps are getting? And then maybe piggybacking off of this, it seems like the nephrologist's more extensive experience with Phil Sparry and buying up the EGFR data on the label might make it a preferred choice for a new patient. Is that something you're seeing in the field, or is it a bit early to tell?

Speaker Change: Could you provide a bit more color on what your sales reps are seeing in the field is there some counter detailing that's ongoing and one of the main types of questions. Your reps are getting and then maybe piggybacking off of this it seems like the nephrologist more extensive experience with feldspar.

Speaker Change: Combined with the Egfr data on our label might make it a preferred choice for a new patient is that something youre seeing in the field or is it a bit early to tell.

Peter Heerma: Thank you.

Peter Heerma: Well, thanks so much for the questions. And I will turn that over to Peter. Yeah, I think so. Well, it's very early. It's one month now that Arthur Stoneman has been I think, first of all, it's good for patients to have more medicine in the market. And I think especially as IGA and Frappuccino is a market in development that historically was seen as a relatively benign disease. And now there's much more recognition that those patients should be treated earlier and more effectively. I think more companies raising that importance, I think is good for the market.

Speaker Change: Well, thanks, so much for the questions and I will turn that over to Peter.

Peter: Yeah. Thanks, Bill well, it's very early it's one month now that the opposite one has been approved.

Peter: I think first of all it's good for patients to have more medicine in the market and I think especially is Iga nephropathy is a market in development that historically was seen as a relatively benign disease and nowadays mismo recognition that those patients should be treated earlier and more aggressively.

Peter: More companies raising.

That importance I think is good for the market to have endothelium headwind in the markets. We will also further amplify the importance of.

Peter Heerma: To have an endothelium inhibitor in the market will also further amplify the importance of inhibiting endothelium as part of foundational care. So I think in that respect, it will help us to further grow the market and in particular grow the market for endothelium. With regards to, like, competition and what we have heard, it's very early. We haven't really heard so far too much in the marketplace. But what I mentioned in the call is that we have seen continued growing demand this year so far, and that growth continued in the month of April, which was the first month that Arthur Santana was in the market.

Peter: Inhibiting endothelin as part of foundational data. So I think in that respect it will help us to further grow the market in particular grow the market for endothelium.

Peter: With regards to like competition and what we have heard it's very early we haven't really heard so far two months in the marketplace, but what I mentioned in the call is that we have seen continued growing demand. This year, so far and that growth continued in the month of April was what the first month's debt offer some thought it was in the market and I think that speaks to the confidence that physicians have.

Peter Heerma: And I think that speaks to the confidence that physicians have on the profile that Phil Sparey has. And I think Jula mentioned in her prepared remarks, data matters for nephrologists. They have seen that Phil Sparey has long-term kitten preservation data and unprecedented proteinuria reduction that's sustained over a long period of time. Which is really the consistency of inhibiting two receptors that result in efficacy benefits as well as convenience benefits for patients. One pill, one co-pay. So I'm confident in the profile of Phil Sparey. And yeah, I welcome other modalities coming to the market because I think that further reinforces the importance for patients to be treated earlier and more.

Speaker Change: On the profiled our fuels fiery has and I think you had mentioned in her prepared remarks data matters for Nephrologist.

Speaker Change: I have seen that <unk> has long term kidney preservation data and unprecedented proteinuria reduction that's sustained over long periods of time, which is really the consistency of inhibiting two receptors that result in a secrecy benefits as well as convenience benefit for patients Lumpier, one copay, so I'm going.

Speaker Change: Two months in the profile of Pillsbury.

Speaker Change: Yeah I welcome automobiles is coming to the market because I think that's sort of reinforces the importance for patients to be treated earlier and more aggressively.

Unknown Attendee: Great, thank you so much.

Speaker Change: Great. Thank you so much.

Anupam Rama: Our next question comes from the line of Anupam Rama from J.P. Morgan. Your line is open. Hey guys, thanks so much for taking the question.

Speaker Change: Our next question comes from the line of <unk> from Rodman from JP Morgan Your line is open.

Speaker Change: Hey, guys. Thanks, so much for taking the question.

Christopher Cline: I was wondering if you could expand a little bit on your gross net comments in your opening remarks, you know, maybe helping us understand the type of impact you saw in one cue and give us a little color here about if looking to the balance of the year gross net is actually a tailwind with the reversal of the impact that you saw in one cue. Thanks so much. Thanks, Anupam.

Speaker Change: I was wondering if you could.

Speaker Change: Expand a little bit on your gross to net comments in your opening remarks, maybe helping us understand the type of impact you saw in <unk> and <unk>.

Speaker Change: Give us a little color here about if looking to the balance of the year <unk> actually a tailwind with the reversal of the impact that you saw in Q. Thanks, so much.

Christopher Cline: Chris, why don't you take that question? Yeah, thanks for the question, Anupam. And I think it's probably easiest to compare it back to what we saw last year versus this year, where last year, we had growth to net, really in the mid to high teens. And what we experienced there was the highest discount at the beginning of the year, and then it eased through the balance of the year. This year, we're guiding to growth to nets that are going to be in the low 20s. And with the changes to, you know, just the insurance coverage, as well as with Part D redesign, we did see that increase in the first quarter, as we normally would expect.

Speaker Change: Thanks, Ana Paula Chris why don't you take that question.

Speaker Change: Yes. Thanks for the question on the bonds and I think it's probably easiest compare it back to what we saw last year versus this year, where last year, we had gross to net.

Chris: In the mid to high teens, and what we experienced there was the highest discount at the beginning of the year and then it is through the balance of the year. This year, we're guiding to gross to nets that are going to be in the low twenties and with the changes to.

Chris: Just the insurance coverage as well as with part D. Redesign, we did see that increase in the first quarter as we normally would expect but we also anticipate with the part D redesign and also.

Christopher Cline: But we also anticipate with the Part D redesign, and also, you know, the coverage that comes along with that or exposure to the catastrophic coverage going forward, we're going to see at least that portion of our growth to net be a bit stickier than it was last year. So it'll probably be a little bit more even than it was last year. But we do expect at least for the fundamental pieces of growth to net to be the highest.

Chris: The coverage that comes along with that our exposure to the catastrophic coverage going forward, we're going to see at least that portion of our growth in FTE a bit stickier than it was.

Chris: Last year, so it'll probably be a little bit more even than it was last year, but we do expect at least for the fundamental pieces of gross to net to be the highest in Q1.

Chris: Thanks, so much for taking my question.

Laura Chico: Our next question comes from the line of Laura Chico from Wetbush Securities. Your line is open. Thank you very much. Good afternoon. One question for you on the cadence of patient start form. It was interesting to see the number tick up a little bit over the prior quarter. And Eric, I think you had made some comments prior to this about expectations around maybe the rate of growth here.

Chico: Our next question comes from the line of Florida, Chico from Wedbush Securities. Your line is open.

Chico: Thank you very much good afternoon. One question for you on the cadence of patient start form it was interesting to see the number tick up a little bit over the prior quarter and Eric I think you made some comments prior to this about expectations around maybe the rate of growth here. So just wondering if you could.

Laura Chico: So just wondering if you can have any comments or thoughts on the sustainability of this kind of metric and where this might go over the course of 2025. Thank you.

Chico: Have any comments or thoughts on the sustainability of this kind of metric and where this might go over the course of 2025. Thank you.

Peter Heerma: Sure, Laura, thanks for the question. And Peter, why don't you take Yeah, thanks, Derek. And thanks, Laura, for that question. What I would say is that we have seen significant acceleration of growth with the broader label after full approval. And we continue that growth trajectory with 703 new patient start forms in the first quarter. I think most importantly is that you have to realize that fill sparing is a chronic treatment and we continue to see very strong compliance and persistence. So we built upon a very robust and healthy revenue base. And it gives me confidence that we will see a continuation of meaningful revenue growth moving forward.

Chico: Sure Laura Thanks for the question and Peter why don't you take this one.

Chico: Yeah. Thank you Eric and thanks, Laura for the question.

Peter: What I would tell you is that we have seen significant acceleration of growth with the broader label. After full approval and we continue that growth trajectory with 703, new patient start forms in the first quarter.

Peter: I think most importantly is that you have to realize that fills fiery is a chronic treatment and we continue to see very strong compliance and persistence rates.

Peter: We built upon a very robust and healthy revenue base and it gives me confidence that we will see it continue.

Peter: Continuation of meaningful revenue barrels moving forwards.

Eric Dube: Thank you, Peter. Laura, the other thing that I would add is, as we look at the patients that we believe are in need of an upgraded therapy, essentially those patients that are on RAS inhibitors that are not at the new Cadego guidelines, Peter alluded to this in his prepared comments, that this is where we're seeing the majority of the new growth coming from. Physicians are looking earlier for patients to be, you know, upgraded from the RAS inhibitor to Filspari. And that really is a sustainable source of growth moving forward because there are so many patients that are not yet at that guideline of 0.5 or 0.3.

Speaker Change: Thank you Peter Laura the other thing that I would add is as we look at the patients that we believe are in need of of an upgraded therapy essentially those patients that are on Ras inhibitors that are not at the new <unk> guidelines Peter alluded to this in his prepared comments that this is where we are.

Speaker Change: Seeing the majority of the new growth coming from physicians are looking earlier for patients to be upgraded from the Ras inhibitor to phil's forehead and that really is a sustainable source of growth moving forward because theres. So many patients that are not yet at that guideline of 0.5 or three.

Laura Chico: And so we expect that that is going to continue to be a major driver of our PSF growth moving forward. And as Peter also mentioned, you know, not many of the other therapies have that broader indication or the support of the guidelines to be able to reach those patients. So I think that's one of the key drivers as we think about the sustainable, you know, addition of new patients to Filspari. That's helpful. Thank you.

Speaker Change: And so we expect that that is going to continue to be a major driver of our PSS growth moving forward.

Speaker Change: As Peter also mentioned not many of the other therapies have that broader indication or the support of the guidelines to be able to reach those patients. So I think that's one of the key drivers as we think about the sustainable.

Speaker Change: The addition of new patients to fill sorry.

Speaker Change: That's helpful. Thank you.

Lisa Bakel: Our next question comes from the line of Lisa Bakel from Evercore. Your line is open. Hi there. Thanks for taking the question. This is a couple for me. I was wondering if you could just break out. I know we talked about this a little bit, but what percentage of prescriptions are you seeing that are below 1.5 grams now that you have label expansion versus above 1.5 grams? And then are you seeing any change in sort of new patient ads now that we have Acroxantin? I mean, in some ways, having another player there can grow the market and grow awareness.

Speaker Change: Our next question comes from the line of Lisa <unk> from Evercore. Your line is open.

Lisa: Hi, there. Thanks for taking my question just a couple from me I was wondering if you could just break out I know you talked about this a little bit but.

Speaker Change: What percentage of prescriptions are you seeing that are below one five gram now that you have label expansion versus above one five Gram and then are you seeing any change.

Speaker Change: In sort of new patient adds another way of ACA Santana I mean in some ways, having another player there can grow the market and grow awareness.

Lisa Bakel: You know, in some cases, you see kind of new patient ads sort of stabilize or even drop off a little bit. I'm just wondering what kind of early trends you're seeing there.

Speaker Change: And some in some cases, you see kind of new patient add sort of stabilize or even drop off a little bit I'm. Just wondering what kind of early trends youre seeing there and I think that's it for for me. Thanks.

Lisa Bakel: And I think that's it for me. Thanks.

Peter Heerma: All right, Lisa, thanks so much for the questions. And Peter, why don't you take those? Yeah, let me yeah, so it's two questions that you're asking. The first one is with regards to like, what is the breakdown of different levels of toponeuria? We haven't broken it down specifically, but what we are seeing is that the median trend of proteinuria levels are going down and is now well below 1.5 gram per gram. And in particular, with experienced prescribers, we see that there is a meaningful amount of physicians that are now prescribing below 1 gram per gram.

Speaker Change: Alright, Lisa Thanks, so much for the questions and Peter why don't you take those.

Speaker Change: Yes.

Peter Laura: Yeah, Let me so it's two questions that you're asking the first one is with regards to like what is the breakdown of the different levels of proteinuria.

Peter Laura: We haven't broken it down specifically, but what we are seeing is that the median threat of patent yulia levels are going down and is now well below one five gram per gram and in particular with experienced prescribers. We see that there is a meaningful amount of physicians that are now prescribing below one gram per gram as well I think that is the most.

Peter Heerma: I think that is the most important takeaway. And to Erich's earlier point, that allows for a sustainable growth opportunity over time since Tilsperi is the only non-immunosuppressive treatment that is fully approved without a proteinuria limitation. With regards to your second question on ATRA and what trends we are seeing, well, the trends that we are seeing is very consistent to what we have seen so far. And that's a continued demand growth that continued in April as well. So we haven't seen any impact. And to your point, I mean, I mentioned that earlier, there is a market improvement with more companies talking about like the urgency to trade.

Speaker Change: The important takeaway here is really a point that allows for a sustainable growth opportunity over time since <unk> is the only.

Peter Laura: Not only in the Mr vessels.

Peter Laura: And that is fully approved without a proteinuria.

Peter Laura: Limitation.

Dominion: With regards to your second question on <unk> and what trends, we are seeing well the trends that we're seeing is very consistent with what we have seen so far and thats. A continued demand growth that continued in April as well. So we haven't seen any impact and to your point Dominion I mentioned earlier there is some.

Dominion: Market improvement with more companies talking about like the urgency to treat and now in particular with more companies talking about the importance of endothelial. So so far the trends that we have seen a positive.

Peter Heerma: And now, in particular, with more companies talking about the importance of entertaining. So, so far, the trends that we have seen are positive and continue on very strong growth trend.

Dominion: There was strong growth trajectory.

Dominion: Yeah.

Dominion: Okay.

Dominion: Yeah.

Dominion: Yes.

Unknown Attendee: Operator, operator, can we go to the next question, please?

Speaker Change: Operator, operator can we go to the next question. Please.

Greg Harrison: Yes, our next question comes from the line of Greg Harrison from Scotiabank. Your line is open. Hey, good afternoon, guys. And thanks for taking the question. I'm wondering about your assessment of the impact that the removal of the REMS program could have on the trajectory of new patient starts in Igan. Is it maybe on the level of the inflection you saw since you were granted full approval compared to the period before that? Or just trying to get a sense of, you know, the.

Speaker Change: Yes. Our next question comes from the line of Greg Harrison from Scotiabank. Your line is open.

Greg Harrison: Hey, good afternoon, guys and thanks for taking the question.

Wondering about.

Greg Harrison: Your assessment of the.

Greg Harrison: Impact.

Greg Harrison: The removal of the Rems program could have on the trajectory of new patient starts again.

Greg Harrison: Is it maybe on the level.

Greg Harrison: Of the inflection you saw.

Greg Harrison: You were granted full approval compared to the period before that or.

Greg Harrison: I'm just trying to get a sense of you know.

Greg Harrison: The Ah <unk>.

Peter Heerma: the additional patient flow that you you may see if that's granted Greg, thanks for the question. And for context, we are on track with the PDUFA date to modify that the REMS in August, late August.

Greg Harrison: The additional patient.

Greg Harrison: Slow that you may see a.

Greg Harrison: If that is granted.

Greg Harrison: Greg Thanks for the question and for context, we are on track with a <unk> date to modify that the rems.

Greg Harrison: In August late August and Peter why don't you talk about your view on what that impact could have.

Peter Heerma: And Peter, why don't you talk about your your view on what that impact could have? Yeah, happy to do it, Eric. And Greg, thanks for that question. I would say first and foremost, RAMS has not been an obstacle in our In fact, Phil Sparey is being the most successful of the four most recent rare nephrology launches. All of the comparators actually did not include RAN. So, with the ramps, we were able to kind of like set a best-in-class benchmark. Having said that, and two earlier points, we want to provide the best in-class treatment option. And we want to do that in the most convenient way for patients and physicians.

Speaker Change: Yeah, Eric and Greg Thanks for the question.

Greg Harrison: I would say first and foremost rent has not been an obstacle in our performance.

Greg Harrison: In fact fuel salary is being the most successful of the for most reasons ran nephrology launches.

Greg Harrison: All of the comparator is actually did not conclude a rems.

Greg Harrison: So with the labs, we were able to kind of like set a best in class benchmarks, having said that and Eric earlier points, we want to provide the best in class III auction and we want to do that in the most convenient way for patients and physicians and we are therefore looking forward to the modification we anticipate late late August.

Unknown Attendee: And we are, therefore, looking forward to the modification we anticipate in later.

Greg Harrison: Yeah.

Greg Harrison: Yeah.

Sadia Rahman: Our next question comes from the line of Mohit Bansal from Wells Fargo. Your line is open. Hi, this is Sadia Rahman on for MOHIT. Thanks for taking our question. So I have a question on FSGS on the Dimeric. Recently, there was a partnership announced for US commercialization of that asset. How are you thinking about the benefit of that drug versus Farcentin and FSGS? And do you think they could still be significantly further behind from launching in the US based on their enrollment status and how long it took for duplex to enroll? Thanks. All right, thank you for the questions.

Greg Harrison: Our next question comes from the line of Mohit Bansal from Wells Fargo. Your line is open.

Speaker Change: Hi, this is body armor.

Hi, Thanks for taking our question.

Speaker Change: So I have a question on SSG us on the gay marriage recently, there was a partnership announced for U S commercialization of that asset.

Speaker Change: And how are you thinking about the benefit of bad drug versus our Sunshine in Appalachia.

Speaker Change: And do you think they could still be significantly further behind from launching in the U S based on their.

Speaker Change: Their enrollment status and how long it took for duplex turnaround. Thanks.

Speaker Change: Yeah.

Speaker Change: Alright, Thank you for the questions Juba I'll pass those to you.

Jula Inrig: Jula, I'll pass those to you. Yeah, thanks for the question. I would say the important takeaway is that we're very pleased to see the alignment with the FDA on Paracel, that proteinuria can be an endpoint for full approval at two years in FSGS. When you look at their data, we really don't have a lot of data, we have some phase two data from Dimeric's 200. And it's going to be many years before we see their full two year proteinuria data, because, as they've stated, they're still enrolling, they hope to finish by the end of this year, but to be determined when they complete that enrollment.

Speaker Change: Yes. Thanks for the question I would say the important takeaway is that we're very pleased to see the alignment with the FDA on parasol that proteinuria can be an endpoint for full approval at two years and <unk>, yes.

Speaker Change: When you look at their data, we really don't have a lot of data and we have some phase two data from <unk> 200, and it's going to be many years before we see their full two year proteinuria data because as they stated they are still enrolling and hope to finish by the end of this year, but to be determined when they complete that enrollment, but I would also add that the MLR.

Jula Inrig: But I would also add that the MOA of DMX-200 of CCR2 antagonism is certainly complimentary for Fils Barre if it becomes available in the future.

Speaker Change: Way of game next 200 of <unk> antagonism, certainly complementary FERC, sorry, if it becomes available in the future.

Speaker Change: Yeah.

Maurice Raycroft: Our next question comes from the line of Maurice Raycroft from Jefferies. Your line is open. Hi, thanks for taking my question.

Speaker Change: Our next question comes from the line of Maury Raycroft from Jefferies. Your line is open.

Maury Raycroft: Hi, Thanks for taking my question.

Peter Heerma: I'm wondering just for Phil Spirey and I again, what the split is between new versus repeat prescribers? Can you provide more granularity on what you're seeing on compliance and persistence rates? I guess what's the average amount of time that patients are staying on treatment?

Maury Raycroft: Wondering just for full Sperry and again, what the split is between new versus repeat prescribers can you provide more granularity on what youre seeing on compliance and persistence rates I guess whats the average amount of time that patients are staying on treatment.

Peter Heerma: All right, Maura, thanks for the questions. Peter, we'll hand that one over to you. Yeah, this split is slightly more skewing to experienced prescribers, but with a very healthy continuation of new prescribers. So that was the first part of your question. Second part of your question. Comply. Compliance. Yeah, and I mentioned that in the prepared remarks as well.

Peter Laura: Alright, thanks for the questions Peter I'll hand that one over to you.

Peter Laura: Yes, the split is slightly more skewed into experienced prescribers with very with a very healthy continuation of new prescribers as well.

Peter Laura: So that was the first part of your question.

Peter Laura: The second part of your question.

Peter Laura: Compliance.

Peter Laura: Compliance yes.

Peter Laura: And I mentioned that in the prepared remarks as well if you compare just feels far is compliance and persistence to compared to benchmarks.

Peter Heerma: If you compare the Fils-Paris compliance and persistence to compare to benchmarks, chronic disease, non non symptomatic disease, it's at a very high end, we haven't given what this exactly, but it's at a very high end, which We speak to the confidence and the satisfaction of patients.

Peter Laura: Chronic disease long term genetic disease at the very high and we haven't given call. This exactly but it's at the very high end, which you would expect.

Peter Laura: Got it I will speak to the governance and <unk>.

Peter Laura: The satisfaction of patients as well.

Prakhar Agrawal: Our next question comes from the line of Prakhar Agrawal from Kantor, your line is open. Hi, thank you for taking my questions and congrats on the quarter. So on the FSGS and the expectations for the launch, just wanted to get some color there. Among the 15 to 30,000 addressable patients for FSGS in the U.S., how many of these are currently managed by Fillspari top prescribers? And any thoughts on how you expect the launch to be when approved? And if I can just follow up here on the pair discussions on FSGS pricing, wondering if you got any feedback there given the possibility of double the Eigen pricing and whether that's feasible here.

Speaker Change: Our next question comes from the line of from time, Sorry. Your line is open.

Peter Laura: Yeah.

Speaker Change: Alright, Thank you for taking my questions and congrats on the quarter. So only SSG is and the expectations for the launch just wanted to get some color there among the 15 to 30000 addressable patients for SSG is in the U S.

Speaker Change: Many of these are currently managed by from Sperry top prescribers.

Speaker Change: And any thoughts on how you expect the launch to be when approved and if I can just follow up here on the pair discussions on SSG is pricing wondering if you've got any feedback there.

Speaker Change: The possibility of double the IGON pricing and whether that's reasonable here. Thank you.

Eric Dube: Thank you. Sure.

Peter Heerma: Prakash, thanks for the question. I'll take the one on pricing and outlook, and Peter can talk about the overlap and, you know, where these patients are being treated. So, our overall pricing strategy for FSGS is very similar to IGAN in that we want to make sure that there is broad access to full SPARI, which is really critical for us in establishing it as a foundational therapy where, you know, a broad swath of the community should have access to full SPARI. We have mentioned that it's likely that it would be double the price for adult patients at the target dose given double the dose, and we believe that given the unmet need and the more rapid progression that FSGS patients have to kidney failure, that that higher price certainly would come with high benefit for these patients.

Speaker Change: Sure.

Greg Harrison: Okay. Thanks for the question I'll take the one on pricing and I'm looking at Peter can talk about the overlap and where these patients are being treated.

Greg Harrison: Our overall pricing strategy for <unk> is very similar to <unk> in that we want to make sure that there is broad access to <unk>, which is really critical for us in establishing it as a foundational therapy, where a broad.

Greg Harrison: Swath of the community should have access to to fill sorry.

Greg Harrison: We have mentioned that it's likely that it would be double the price for adult patients at the target dose given double the dose.

Greg Harrison: And we believe that given the unmet need.

Greg Harrison: And the more rapid progression that <unk> patients have to kidney failure that that higher price certainly.

Greg Harrison: Wood wood.

Peter Heerma: With regard to the outlook for the launch, we certainly expect that that uptake could be quite rapid and certainly more rapid than what we've seen in FSGS because of the high unmet need, but also because of the high awareness and experience, the success that Peter's team has had in IJ nephropathy.

Greg Harrison: Some with high benefit for these patients.

Greg Harrison: With regard to the outlook for the launch we certainly expect that that uptake could be quite rapid and certainly more rapid than what we've seen in F. S. Jess.

Greg Harrison: Because of the <unk>.

Greg Harrison: High unmet need, but also because of the high awareness and experience. The success that Peter's team has had in Iga nephropathy and with that I'll have Peter talk about what that overlap is in prescribers and where these 30000 patients are.

Peter Heerma: And with that, I'll have Peter talk about what that overlap is in prescribers and where these 30,000 patients are. Excellent. Well, thanks, Eric. And I think you covered quite a lot of the questions already. To your point, and depending on the label, we see that there's up to 30,000 patients that could be addressable for Fils-Pare. I think to Eric's other point, I think that there may be an even bigger opportunity in FSGS compared to IgA nephropathy, because in IgA nephropathy, and I was alluding to that earlier, we really have to establish the urgency to treat and change treatment.

Greg Harrison: Excellent well. Thank you again I think you covered.

Greg Harrison: There's a lot of the questions already.

Greg Harrison: To your point and depending on the label, we see that there's up to 30000 patients that could be addressable fulfills Barry.

Greg Harrison: I think to Eric's other points I.

Greg Harrison: I think maybe an even bigger opportunity in <unk> compared to Iga nephropathy, because in Iga nephropathy.

Greg Harrison: Alluding to that earlier.

Greg Harrison: We really have to establish the urgency to treat and changed treatments.

Peter Heerma: With FSDS, every nephrologist is convinced about the high progressive rate of those patients and also the symptomatic nature of the disease. So we don't have to establish the early treatment. Physicians are really well aware of that. To your other points, we have already very strong brand awareness with basically the same prescriber base for FSDS as for IgA nephropathy, with many of the prescribers already having the experience in IgAs. I think that that allows for a much more rapid uptake. And one additional aspect, building on your pricing question, TILS-PARI is already well established in payer plans and formularies.

Speaker Change: Yes every nephrologist is convinced about the high progressive rate of those patients and also the symptomatic nature of the disease. So we don't have to establish the urgency to treat.

Greg Harrison: A really well aware of that.

Greg Harrison: Two other points, we have already a very strong brand awareness with basically the same prescriber base for <unk> as for Iga nephropathy with many of the prescribers already having the experience.

Greg Harrison: In Iga, So I think that allows for a much more rapid uptake and one additional aspect building on your pricing question to expiry is already well established and payer plans and formulary. So all the heavy lifting that you do normally in the first 12 to 18 months, we have done that already for Iga nephropathy.

Peter Heerma: So all the heavy lifting that you do normally in the first 12 to 18 months, we have done that already for IgA nephropathy, and this gives me confidence that we will see a rapid uptake for this patient population that has been underserved for so long and is really waiting for the first approved medicine that could be salisbury.

Greg Harrison: And this gives me confidence that we will see a rapid uptake for this patient population.

Greg Harrison: Has been.

Greg Harrison: So for so long and its really waiting for the first approved medicine.

Greg Harrison: Could be some filings.

Greg Harrison: Okay.

Jason Zemansky: Our next question comes from the line of Jason Zemansky from Bank of America. Your line is open. Good afternoon. Congratulations on the progress and really appreciate you taking our question. I wanted to ask a follow up regarding some of your earlier comments regarding dynamics as far as the updated Cadego guidelines go. But do you have a sense of what overall fraction of the community has started to embrace treating more aggressively? You know, is it overall meaningful? Should we expect a significant inflection when these are finalized? Or, you know, is it going to be something more like a trickle effect thereafter?

Speaker Change: Our next question comes from the line of Jason <unk> from Bank of America. Your line is now open.

Speaker Change: Good afternoon, congratulations on the progress and really appreciate you taking our question I.

Speaker Change: Wanted to ask a follow up regarding some of your earlier comments regarding dynamics.

Speaker Change: As far as the updated <unk> guidelines go but do you have a sense of what overall fraction of the community has started to embrace.

Speaker Change: Treating more aggressively.

Speaker Change: Is it overall meaningful should we expect a significant inflection when these are finalized or or.

Speaker Change: Is it going to be something more like a trickle effect thereafter, just trying to get a gauge of near term.

Jason Zemansky: Just trying to get a gauge of near-term impact of the different growth levers.

Speaker Change: <unk> of the different growth levers.

Peter Heerma: Yeah, Peter, do you want to take that? And then Jula, you know, you've engaged quite a bit with nephrology experts. Maybe you can share what you're hearing as well. Yeah, Jason, I'm happy to take that question. First of all, I think there is quite an impact already. And ASN was only six weeks after the draft Cadego guideline was published. And I heard from multiple, in particular, academic physicians already about like how they are being more aggressive, in particular, by doing earlier biopsies in a patient population that I wouldn't have done it in the past. And I spoke with a few physicians, for example, that actually started doing biopsies in pupillary levels of like 0.3, 0.4, and actually found sclerosis and thought that patient would be a candidate for Philz-Var.

Speaker Change: Yes, Peter do you want to take that and then July.

Speaker Change: You've engaged quite a bit with.

Speaker Change: The nephrology experts maybe you can share what you are hearing as well.

Speaker Change: Yes.

Speaker Change: To take that question.

Speaker Change: First of all I think there is quite an impact already and yes animals only six weeks. After the draft guideline was published and I heard from the multiple in particular academic physicians already about like how they are being more aggressive in particular by doing earlier biopsies.

Speaker Change: In a patient population that I wouldn't have done it in the past and I spoke with a few physicians for example that actually started doing biopsies and public unit levels, three four and actually found sclerosis and pocket the basically would be a candidate fulfilled sorry.

Jula Inrig: I think with the full publication, you have more of a trickling down effect. With the publication, it's in the broader domain as well. So I think you will have a continuation of adaptation there. And as I mentioned in my prepared remarks, 75% of the nephrology community is now targeting 0.5 as the new treatment target. So I think there is a meaningful impact. But I think with the full publication, you will see a continuation and trickling down.

Speaker Change: I think it was the full publication you have more of a trickling down effect.

Speaker Change: With the publication of the broader domain as well. So I think you will have a continuation of penalties in there and as I mentioned in my prepared remarks, 75% of the nephrology community is now targeting five as the new treatment targets I think there is a meaningful impact, but I think it was the full publication you will see a continuation and crude.

Speaker Change: The wind down.

Unknown Attendee: Do anything you'd like to add. Perfect. Thanks for the color.

Hello.

Speaker Change: Ed.

Speaker Change: Yeah, I'll Echo what Peter said, it's taken data from the radar publication as well as they can't do their guidelines for physicians really to change their mindset.

Speaker Change: And it wasn't benign disease, and we can let them smelled or along with higher ranges of proteinuria as they get exposure to that data and the guidelines. There is an awareness that they need to bring their patients back treat them treat them more aggressively and to lower targets and they are starting to.

Speaker Change: Further understand exactly how to do that and upgrade their asthma. Thus far you can get more patients to lower range of that proteinuria and that's starting to resonate I think that to Peter's point. The publication of the <unk> guidelines will further help cement and educate because there'll be continued education around the importance of getting pay.

<unk> kilowatt ranges, but it certainly is starting to think and what we've done historically isn't good enough for this patient population.

Speaker Change: Perfect. Thanks for the color.

Unknown Attendee: Ladies and gentlemen, this concludes the question and answer session of today's conference call. I'll hand the call back over to Victoria. Thank you, Chloe. And thank you, everyone, for joining today's call.

Victoria: Ladies and gentlemen. This concludes the question and answer session of today's conference call hand, the call back over to Victoria.

Victoria: Thank you Corey and thank you everyone for joining today's call have a great rest of your day.

Unknown Attendee: Have a great rest of your day. This concludes today's conference call.

Victoria: This concludes today's conference call.