Q2 2024 Travere Therapeutics Inc Earnings Call

Speaker Change: Good day and welcome to the Travere Therapeutics 2nd Quarter 2024 Financial Results in Corporate Update Conference Call.

Unknown Executive: Piotic, Second Quarter, 2024, Financial Results, Incorporate Update Conference Call. Today's call is being recorded.

Operator: At this time, I would like to turn the conference call over to the Vice President of Corporate Investor Relations, Nivi Naira. Please go ahead.

Nivi Nehra: At this time, I would like to turn the conference call over to the Vice President of Corporate Communications and Investor Relations, Nivi Nehra. Please go ahead, Nivi.

Speaker Change: Today's call is being recorded. At this time, I would like to turn the conference call over to the Vice President of Corporate Communications and Investor Relations, Nivi Naira. Please go ahead, Nivi.

Unknown Executive: Thank you, Rachel.

Unknown Executive: Good afternoon and welcome to Travere Therapeutics, Second Quarter, 2024, Financial Results, Incorporate Update Call. Thank you all for joining.

Nivi Nara: Thank you, Rachel. Good afternoon, and welcome to Tribune Therapeutic's second quarter 2024 financial results and corporate update call. Thank you all for joining.

Eric Dube: Today's call will be led by our President and Chief Executive Officer, Dr. Eric Dube. Eric will be joined in the prepared remarks by Dr. Jula Inrig, or Chief Medical Officer, Peter Heerma, or Chief Commercial Officer, and Chris Cline, or Chief Financial Officer.

Speaker Change: Today's call will be led by our President and Chief Executive Officer, Dr. Eric Dube.

Speaker Change: Eric will be joined in the prepared remarks by Dr. Jula Inrig, our Chief Medical Officer.

Speaker Change: Peter Heerma, our Chief Commercial Officer, and Chris Cline, our Chief Financial Officer. Dr. Bill Roat, Senior Vice President of Research and Development, will join us for the Q&A session.

Unknown Executive: Dr. Bill Rote, Senior Vice President, Every search and development will join us for the Q&A session.

Unknown Executive: Before we begin, I'd like to remind everyone that statements made during this call regarding matters that are not historical facts are forward-looking statements within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not guarantees of performance; 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 forward-looking statements. Please see the forward-looking statement disclaimer in the company's press release issued earlier today, as well as the risk factors section in our Forms 10-Q and 10-K, filed with the SEC. Thank you, Nibi. And good afternoon, everyone.

Unknown Executive: Before we begin, I'd like to remind everyone that statements made during this call regarding matters that are not historical facts are forward-looking statements within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not guarantees of performance. They involve known and unknown risks, uncertainties, and assumptions that may cause actual results, performance, and achievements to differ materially from those expressed or implied by the statement.

Speaker Change: Before we begin, I'd like to remind everyone that statements made during this call regarding matters that are not historical facts are forward-looking statements within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

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

Unknown Executive: Please say the forward-looking statements disclaimer on the company's press release issued earlier today, as well as the risk factor section in our forms, 10-Q, and 10-Js, filed with the SQP.

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

Unknown Executive: In addition, any forward-looking statements represent our views only as of the date such statements are made, August 1, 2024. The interview specifically explains any obligations to update such statements to reflect future information, events, or circumstances.

Speaker Change: In addition, any forward-looking statements represent our views only as of the date such statements are made, August 1, 2024, and Travere 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?

Eric Dube: Thank you, Divi, and good afternoon, everyone. In the second quarter, we continued to make significant progress on our key priorities. At the center of our growth is Phil Spari, which is becoming a foundational therapy for IJNF property, giving patients hope for a better future. Our launch performance continues to strengthen. During the second quarter, we set new highs in demand and revenue, and we are on track to outperform benchmark launches in year two. Phil Spari is the only rare arena launch to consistently deliver quarter-over-quarter growth in new patient start forms through the first six quarters of launch, which speaks to high demand from physicians and patients, and our ability to achieve our goals.

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

Eric Dube: In the second quarter, we continue to make significant progress on our key priorities, Bill Sparry is becoming a foundational therapy for hygiene and property, giving patients hope for a better life. And we are on track to outperform benchmark launches this year. Bill Sparry is the only rare renal launch to consistently deliver quarter-over-quarter growth in new patient start forms through the first six quarters of launch, which speaks to high demand from physicians and patients and our ability to achieve This strength is being driven by positive trends in all of our key growth factors.

Eric Dube: Thank you, Divy, and good afternoon, everyone. In the second quarter, we continue to make significant progress on our key priorities. At the center of our growth is Philspori, which is becoming a foundational therapy for hygiene and property, giving patients hope for a better future.

Speaker Change: Our launch performance continues to strengthen. During the second quarter, we set new highs in demand and revenue, and we are on track to outperform benchmark launches in year two.

Speaker Change: Vilspari is the only rare renal launch to consistently deliver quarter-over-quarter growth in new patient start forms through the first six quarters of launch, which speaks to high demand from physicians and patients and our ability to achieve our goals.

Eric Dube: This strength is being driven by positive trends in all of our key growth factors, including increasing breadth and depth of prescribers, strong payer coverage, and continuing improvements in our pull-through process.

Speaker Change: This strength is being driven by positive trends in all of our key growth factors, including increasing breadth and depth of prescribers, strong payer coverage, and continuing improvements in our pull-through process.

Eric Dube: From a regulatory perspective, our S&DA review process for full approval in IJN continues this plan, and we are eagerly preparing for full potential approval next month. To date, our educational and promotional focus has been on the rapid and profound impact on protein urea and the results from our interim readout from Protect. We are excited about the opportunity to build further momentum in the launch that an updated label would provide, including the ability to educate on two-year data from the most rigorous study conducted in IJNF. We anticipate that a broader label would enable us to reach more - Patience.

Speaker Change: From a regulatory perspective, our S&DA review process for full approval in IGAN continues as planned, and we are eagerly preparing for full potential approval next month.

Eric Dube: Today, our educational and promotional focus has been on the rapid and profound impact on proteinuria and the results from our interim readout from PROTECT. We are excited about the opportunity to build further momentum in the launch that an updated label would provide, including the ability to educate on two-year data from the most rigorous study conducted in India, could nearly double over time from the current level. And the two-year data should build even more conviction in prescribing Fils-Bari since it will potentially provide an opportunity for a, We plan to engage with regulators later this year and to provide an update following those meetings. As we outlined at the start of the year, 2024 is a year of, Thank you, Eric.

Speaker Change: To date, our educational and promotional focus has been on the rapid and profound impact on proteinuria and the results from our interim readout from PROTECT.

Speaker Change: We are excited about the opportunity to build further momentum in the launch that an updated label would provide, including the ability to educate on two-year data from the most rigorous study conducted in IGAN.

Speaker Change: We anticipate that a broader label would enable us to reach more patients.

Eric Dube: Specifically, we estimate Phil Spari's addressable eye-gam patient population in the future could nearly double over the time from the current level. And the two-year data should build even more conviction in prescribing Phil Spari, since it will potentially provide an opportunity for our teams to clearly highlight long-term, durable, preliminary reduction, long-term kidney function preservation, and two-year safety data, and our teams are ready. We also continue to make progress in bringing Phil Spari to eye-gam patients in other parts of the world. Our partner in Europe, CSLB4, is preparing for the first launch of Phil Spari in that region very soon.

Speaker Change: Specifically, we estimate Filspari's addressable IgAN patient population in the future could nearly double over the time from the current level.

Speaker Change: And the two-year data should build even more conviction in prescribing Fils-Bari, since it will potentially provide an opportunity for our teams to clearly highlight long-term durable proteinuria reduction, long-term kidney function preservation, and two-year safety data.

Speaker Change: and our teams are ready.

Speaker Change: We also continue to make progress in bringing Fils-Pari to Igant patients in other parts of the world. Our partner in Europe , CSLV4, is preparing for the first launch of Fils-Pari in that region very soon.

Eric Dube: In Japan, Rinalis recently dosed the first patient in their pivotal study, which is expected to have results in the second half of 2025, and the support of submission to Japanese regulators for approval. As for the additional priorities to expand our growth, we are encouraged by the ongoing work regarding FSGS endpoints by the Parasol group, and we remain hopeful that we will be able to identify a regulatory path to bring Phil Spari to patients diagnosed with FSGS.

Rinalis: In Japan, Rinalis recently dosed the first patient in their pivotal study, which is expected to have results in the second half of 2025, and to support a submission to Japanese regulators for approval.

Rinalis: As for the additional priorities to expand our growth, we are encouraged by the ongoing work regarding FSGS endpoints by the Paracel Group, and we remain hopeful that we will be able to identify a regulatory path to bring Fils-Pare to patients diagnosed with FSGS.

Eric Dube: We plan to engage with regulators later this year and to provide an update following those discussions. And finally, take the baton. Ace continues enrollment activities in furtherance of a planned top line readout in 2026.

Rinalis: We plan to engage with regulators later this year and to provide an update following those discussions. And finally, PEG to BATNAYS continues enrollment activities in furtherance of a planned top-line readout in 2026.

Eric Dube: As we outlined at the start of the year, 2024 is a year of execution for trivia. As we move into the second half of the year, I am proud of our teams and how they have continued to execute exquisitely across our priorities, all while keeping the needs of patients front of mind.

Rinalis: As we outlined at the start of the year, 2024 is a year of execution for Travere.

Rinalis: As we move into the second half of the year, I am proud of our teams and how they have continued to execute exquisitely across our priorities, all while keeping the needs of patients front of mind. I'll now turn the call over to Jula for an update on our development activities. Jula?

Jula Inrig: Well, now I'll turn the call over to Jula for an update on our development activities. Jula.

Jula Inrig: Thank you, Eric. From a medical perspective, we continue to be focused on achieving full approval of Phil Spari, and providing the education and support to enable Phil Spari to replace rat inhibitors as foundational care for igianopropathy. I am very pleased with the progress that we have made on both of these priorities during the quarter. We have long held the belief that the future of treatment and igianopropathy will be combination therapy designed to address the over activation in both the kidney and the immune system. Phil Spari is unique in being a single pill that directly blocks two harmful pathways: endothelan and angiotensin, which are over activated in the kidney and lead to kidney injury and igianopropathy.

Eric Dube: From a medical perspective, we continue to be focused on achieving full approval of Fils-Phari and providing the education and support to enable Fils-Phari to replace RAS inhibitors as foundational care for IgA nephropathy. We have long held the belief that the future of treatment for IgA nephropathy will be combination therapy designed to address the overactivation in both the kidney and the immune system. Endothelin and Angiotensin, which are overactivated in the kidney and lead to kidney injury and IgA nephropathy.

Jula Inrig: Thank you, Eric. From a medical perspective, we continue to be focused on achieving full approval of Filscari and providing the education and support to enable Filscari to replace RAS inhibitors as foundational care for IgA nephropathy.

Jula Inrig: I am very pleased with the progress that we have made on both of these priorities during the quarter.

Jula Inrig: We have long held the belief that the future of treatment in IGA nephropathy will be combination therapy designed to address the overactivation in both the kidney and the immune system.

Jula Inrig: So SPARI is unique in being a single pill that directly blocks two harmful pathways, endothelin and angiotensin, which are over activated in the kidney and lead to kidney injury and IgA nephropathy.

Jula Inrig: And we believe that Phil Spari, with its superior clinical profile, addressing the over-activation in the kidney and providing long-term nephroprotection, will ultimately replace the use of rat inhibitors, which have been a standard for addressing the damage in the kidney for decades. We are seeing tangible signs of this evolution and a growing excitement within the nephrology community and among patients with IgA nephropathy. We recently attended an igianopropathy patient and caregiver conference and heard hope and inspiration through personal stories from patients on Phil Spari, who now feel they have better control of their disease and a brighter outlook for the future.

Eric Dube: And we believe that Filspari, with its superior clinical profile, addressing the overactivation in the kidney and providing long-term nephroprotection. We are seeing tangible signs of this evolution and growing excitement within the nephrology community and among patients with IgA nephropathy. We recently attended an IJ Neuropathy Patient and Caregiver Conference and heard hope and inspiration through personal stories from patients on Philspori who now feel they have better control of their disease and a brighter outlook for the future. We've seen a substantial shift this year in how nephrologists are speaking about and using Fils-Pare for patients with IJ nephropathy.

Jula Inrig: And we believe that Filspari, with its superior clinical profile, addressing the over-activation in the kidney, and providing long-term nephroprotection,

Jula Inrig: will ultimately replace the use of RAS inhibitors, which have been the standard for addressing the damage in the kidney for decades.

Jula Inrig: We are seeing tangible signs of this evolution and a growing excitement within the nephrology community and among patients with IgA nephropathy.

Speaker Change: We recently attended an IJNephropathy patient and caregiver conference and heard hope and inspiration through personal stories from patients on Philspari who now feel they have better control of their disease and a brighter outlook for the future.

Jula Inrig: We've seen a substantial shift this year in how nephrologists are speaking about and using Phil Sparry for patients with hygiene and property. We hear more nephrologists referencing Phil Sparry as foundational care in their practice, including initiating treatment with Phil Sparry as a first-line therapy. At the heart of this momentum is our data. We have incredibly strong results from the most rigorous phase three study completed in IGAN, one in which Phil Sparry demonstrated superior results over an active comparator arm that significantly outperformed the placebo arm in other studies. And we've continued to generate additional data showing that if treated early with Phil Sparry, patients can achieve protonary reductions of about 80 percent and stabilization of EGFR, and that Phil Sparry can be used safely in combination with SGLT2 inhibitors.

Speaker Change: We've seen a substantial shift this year in how nephrologists are speaking about and using Feel Sorry for patients with IGN nephropathy.

Speaker Change: We hear more nephrologists referencing Fils-Pare as foundational care in their practice, including initiating treatment with Fils-Pare as a first-line therapy.

Eric Dube: At the heart of this momentum is our data, one in which Vilspari demonstrated superior results over an active comparator arm that significantly outperformed the placebo arm in other studies, and we've continued to generate additional data and Stabilization of EGFR, and that Zolfari can be used safely in combination with SGLT2 inhibitors. This is why we're seeing physicians continue to upgrade their patients from RAS inhibitors to Telspari. This is aligned with the increasing recommendations and treatment guidelines and algorithms to replace RAS inhibitor therapy with DOSPARI in patients who remain at risk for progression.

Speaker Change: At the heart of this momentum is our data.

Speaker Change: We have incredibly strong results from the most rigorous Phase 3 study completed in IGAN, one in which FOSPARI demonstrated superior results over an active comparator arm that significantly outperformed the placebo arm in other studies.

Speaker Change: And we've continued to generate additional data showing that if treated early with Dilspari, patients can achieve protein area reductions of about 80% and stabilization of EGFR.

Speaker Change: And that Zofari can be used safely in combination with SGLT2 inhibitors.

Jula Inrig: This is why we're seeing physicians continue to upgrade their patients from RAS inhibitors to Phil Sparry. And for those that need an additional treatment, they're combining Phil Sparry with an SGLT2 inhibitor or steroids. This is aligned with the increasing recommendations in treatment guidelines and algorithms to replace RAS inhibitor therapy with Phil Sparry and patients who remain at risk for progression. We believe the future for effective treatment of IGAN will call for diagnosing patients earlier and treating them with the goal of getting them into complete remission of their disease. This will require simultaneous therapy addressing both the overactivation in the kidney and the immune system.

Speaker Change: This is why we're seeing physicians continue to upgrade their patients from RAS inhibitors to Filspari.

Speaker Change: And for those that need an additional treatment, they're combining Silsipare with an SGLT2 inhibitor or a steroid.

Speaker Change: This is aligned with the increasing recommendations in treatment guidelines and algorithms to replace RAS inhibitor therapy with DILSPARI in patients who remain at risk for progression.

Eric Dube: We believe the future for effective treatment of IGAN will call for diagnosing patients earlier and treating them with the goal of getting them into complete remission of their disease. This will require simultaneous therapy addressing both the overactivation in the kidney and the immune system.

Speaker Change: We believe the future for effective treatment of IGAN will call for diagnosing patients earlier and treating them with the goal of getting them into complete remission of their disease.

Speaker Change: This will require simultaneous therapy addressing both the over activation in the kidney and the immune system.

Jula Inrig: We expect Phil Sparry will be part of the foundational kidney-targeted therapy in that algorithm.

Eric Dube: We expect SILFARI will be part of the foundational kidney-targeted therapy in that algorithm. From a regulatory perspective, the SNDA process has been collaborative, and it's moving according to our expectations. This would be grounded in the two-year PROTECT data that showed significant and durable reductions in proteinuria, kidney function preservation, including the slowest EGFR decline seen in a phase 3 study, as well as robust safety data seen in our PROTECT study. Providing further context and conviction for a nephrologist to prescribe Tilsipari to more of their patients. There was considerable variability, so the EGFR endpoint was not achievable.

Speaker Change: We expect SOFARI will be part of the foundational kidney-targeted therapy in that algorithm.

Jula Inrig: From a regulatory perspective, the SNDA process has been collaborative and is moving according to our expectations. We are pleased with the interactions, and we look forward to our fidufit date early next month. Upon full approval, we would anticipate a broader label for Phil Sparry. This would be grounded in the two-year Protect data that showed significant and durable reductions in prognaria, kidney function preservation, including the slowest EGFR clients seen in a phase 3 study and in a cruel of EGFR benefits, as well as robust safety data seen in our Protect study. Tending full approval, we believe these data will only further reinforce the never protective effects of Phil Sparry, providing further context and conviction for nephrologists to prescribe Phil Sparry to more of their patients and to continue our progress towards Phil Sparry achieving foundational care.

Speaker Change: From a regulatory perspective, the SNDA process has been collaborative and is moving according to our expectations.

Speaker Change: We are pleased with the interactions and we look forward to our PDUFA date early next month.

Speaker Change: Upon full approval, we would anticipate a broader label for Philspari.

Speaker Change: This would be grounded in the two-year PROTECT data that showed significant and durable reductions in proteinuria, kidney function preservation, including the slowest EGFR decline seen in a Phase III study, and an accrual of EGFR benefits.

Speaker Change: as well as robust safety data seen in our PROTECT study.

Speaker Change: Tending full approval, we believe these data will only further reinforce the necroprotective effects of Fils-Phari.

Speaker Change: Providing further context and conviction for a nephrologist to prescribe Dilsipari to more of their patients and to continue our progress towards Dilsipari achieving foundational care.

Jula Inrig: Now let me briefly discuss our efforts at that SGS. As a reminder, in our phase 3 duplex trial, Sparry sentence demonstrated a statistically significant difference on the modified partial remission prognaria endpoint and clinically meaningful improvements in kidney function and the composite kidney failure endpoints compared to Herbicertain. And while we demonstrated a 0.9 mils per minute per year favorable treatment effect on chronic EGFR slope, there was considerable university, so the EGFR endpoint was not achievable. These data are important because of benefit on EGFR can't be statistically shown within a reasonable time frame and sample size in a phase three FSGS trial, then another endpoint, such as Protenuria, needs to be proposed and validated.

Speaker Change: Now let me briefly discuss our efforts with FSGS.

Speaker Change: As a reminder, in our phase three duplex trial,

Speaker Change: Sparsentine demonstrated a statistically significant difference on the modified partial remission proteinuria endpoint and clinically meaningful improvements in kidney function and the composite kidney failure endpoints compared to herbicartin.

Speaker Change: And while we demonstrated a 0.9 mils per minute per year favorable treatment effect on chronic EGFR slope, there was considerable variability, so the EGFR endpoint was not achievable.

Eric Dube: These data are important because if benefit on EGFR can't be statistically shown within a reasonable time frame and sample size in a Phase III FSGS trial, then another endpoint, such as proteinuria, needs to be proposed and validated. We plan to engage with the FDA once the Parasol results are available and expect to provide an update on our program later this year. We are excited about our potential to deliver PEG-tobatinase as the first disease-modifying therapy for classical HCU.

Speaker Change: These data are important because if benefit on EGFR can't be statistically shown within a reasonable time frame and sample size in a Phase III FSGS trial, then another endpoint, such as proteinuria, needs to be proposed and validated.

Jula Inrig: With this background, Ness Kier, the FDA, EMA, and academia created an initiative called Parasol, with the goal of defining a better pathway to bring medicines to people living with FSGS. In order to accomplish this, Parasol is compiling and analyzing datasets to define what should be the right endpoint in FSGS for regulatory approval. We are grateful for the work this group is taking on, and we continue to be optimistic that we can identify a path to approval for Phil Sparry in FSGS. We plan to engage with the FDA once the Parasol results are available, and expect to provide an update on our program later this year.

Speaker Change: With this background, Nefcare, the FDA, EMA, and academia created an initiative called Parasol with the goal of defining a better pathway to bring medicines to people living with FSGS.

Speaker Change: In order to accomplish this, Parasol is compiling and analyzing datasets to define what should be the right endpoint in FSGS for regulatory approval.

Speaker Change: We are grateful for the work this group is taking on, and we continue to be optimistic that we can identify a path to approval for Filspare in FSGS.

Speaker Change: We plan to engage with the FDA once the Parasol results are available and expect to provide an update on our program later this year.

Jula Inrig: Briefly, let me discuss our PEG-to-Batinase program for patients with HCU. We are excited about our potential to deliver PEG-to-batinase as the first disease-modifying therapy for a classical HCU. Our team recently attended an HCU patient summit and consistently heard encouragement and hope from patients and their caregivers around the PEG-to-Batinase program. We remain on track with our enrollment targets to enable top-line data in 2026. In parallel, we continue to work on manufacturing scale-up to support the Seoul Phase 3 program and commercial launch.

Speaker Change: Briefly, let me discuss our PEG-to-Vatnase program for patients with HCU.

Speaker Change: We are excited about our potential to deliver PEG-tobatinase as the first disease-modifying therapy for classical HCU.

Eric Dube: Our team recently attended an HCU patient summit and consistently heard encouragement and hope from patients and their caregivers about the PEG2BAT NACE program. Let me now turn it over to Peter for a commercial update.

Speaker Change: Our team recently attended an HCU patient summit and consistently heard encouragement and hope from patients and their caregivers around the PEG-to-BAT NACE program.

Speaker Change: We remain on track with our enrollment targets to enable top-line data in 2026.

Speaker Change: In parallel, we continue to work on manufacturing scale-up to support the full Phase III program and commercial launch.

Peter Heerma: Let me now turn it over to Peter for a commercial update. Peter?

Speaker Change: Let me now turn it over to Peter for a commercial update. Peter?

Peter Heerma: Thank you, Noah, and good afternoon, everyone. In the first half of this year, we have been focused on delivering strong execution in FSGS. And I'm very proud of the progress that our teams have made across the board. We continue to see strong demand from physicians and their patients. In the second quarter, we again achieved quarter-over-quarter growth programs, generated 521 new patient-star forms, or ESFs. We have now demonstrated continued growth in new PSFs each and every quarter since the beginning of our launch.

Peter Heerma: In the first half of this year, we have been focused on delivering strong execution on prosperity loans, and I'm very proud of the progress that our teams have made across the board. We have now demonstrated continued growth in new PSFs each and every quarter since the beginning of our launch, as well as rapid and sustained production in the Potomac area with a well-tolerated safety profile.

Peter: Thanks everyone, and good afternoon everyone.

Peter: In the first half of this year, we have been focused on delivering strong execution on cross-party loans. And I'm very proud of the progress that our teams have made across the board.

Speaker Change: We continue to see strong demands from physicians and their patients.

Speaker Change: In the second quarter, we again achieved quarter-over-quarter growth and generated 521 new patient stock forms, or PSFs.

Peter: We have now demonstrated continued growth in new PSFs each and every quarter since the beginning of our launch.

Peter Heerma: And we are continuing to build momentum as we have towards our early September to do the day, so full of approval, which we believe will further accelerate field-spire growth. Motively, new PSFs have generated both by a broadening of the prescriber base, as well as by further deepening of prescriptions by nephrologists. By the end of the second quarter, approximately 2,400 nephrologists will run certified. And we are exceeding reasons ran nephrology benchmark for the number of total prescribers after 18 years. We believe one of the key drivers of this continued growth is that we are continuing to hear from society prescribers that their patients are experiencing what we saw in clinical trials.

Peter: And we are continuing to build momentum as we head towards our early September PDUBA days for full approval.

Peter: which we believe will further accelerate sales power growth.

Peter: Notably, new PSFs were generated both by a broadening of the prescriber base as well as by further deepening of prescriptions by nephrologists.

Peter: By the end of the second quarter, approximately 2,400 morphologists were RAM-certified.

Peter: And we are exceeding Reason's Rare Nephrology Benchmark for the number of total prescribers after 18 months.

Peter: We believe one of the key drivers of this continued growth is that we are continuing to hear from society's drivers that their patients are experiencing what we saw in clinical trials.

Peter Heerma: The rapid and sustained reduction in Potomaria was a well-tolerated safety profile. As monophrologists adopt short-spire, they are having this positive experience with their patients. And we are pleased that they then become advocates for using short-spire with their peers. Eric Exxys in Reimbursement is strong, with 96% of the US lives having a pathway to first-party reimbursement, and we are very pleased with the claims approval rates we are seeing, also reflecting the strong authorization criteria for first-party and Bayer plans and formularies. We're also driving additional efficiencies in our post-through process, which is supporting our increasing prescribing rates and the growing number of patients initiating therapy, having positive experience with third-party.

Peter: A rapid and sustained reduction in potameria with a well-tolerated safety profile.

Peter: As monophrologists adopt FOSPARI, they are having this positive experience with their patients, and we are pleased that they then become advocates for using FOSPARI with their peers.

Peter: Public access and reimbursement is strong, with 96% of the U.S. lives having a pathway to first-party reimbursement.

Peter: And we are very pleased with the claims approval rates we are seeing, also reflecting the strong authorization criteria for FISPAR in payer plans and formularies.

Peter: We are also driving additional efficiencies in our pull-through process, which is supporting our increasing prescriber base and the growing number of patients initiating therapy, having a positive experience with soul sparring.

Peter Heerma: All of these efforts have resulted in 27.1 million dollars of net third-party sales in the second quarter, an increase of 37% over the first quarter. I am really pleased with this inflection in Reimbursement, as a position to outperform the reasons Reimbursement for the Reimbursement March in the second year of loans, especially the strong catalysts ahead of us.

Peter: All of these efforts have resulted in $27.1 million of net prosperity sales in the second quarter, an increase of 37% over the first quarter.

Speaker Change: I am really pleased with this inflection in revenue, and it positions us to outperform recent revenue for all the revenue benchmarks in the second year of loans.

Peter Heerma: As we look ahead, the most important catalyst is our upcoming Padova date next month. As you are mentioned, we are preparing for a full approval with a broadening of the Piosperry label, which, if granted, we believe will allow for an acceleration of demand based on two factors. We believe that a potential wider indication statement, coupled with our further data initiatives and the largest evolution towards earlier treatment of eigenpatients, will have the potential over time to increase the addressable eigenpatient population from approximately 30 to 50,000 patients to up to 70,000 patients. Alongside this, with the full approval and updated label, we would expect to finally be able to educate physicians on our exciting two-year data, from the most rigorous, pivotal trial conducted in IgM's rapidity to date.

Peter: especially the strong catalyst Hadamard.

Peter: As we look ahead, the most important catalyst is our upcoming PDUVA date next month.

Peter: As Juha mentioned, we are preparing for full approval with some broadening of the FIOSPARI label, which, if granted, we believe will allow for an acceleration of demand based on two factors.

Jula Inrig: We believe that a potential wider indication statement, coupled with our further data initiatives and nephrologists' evolution towards earlier treatment of IgM patients, will have the potential over time to increase the addressable IgM patient population from approximately 30,000 to 50,000 patients to up to 70,000 patients.

Peter Heerma: Alongside this, with full approval and an updated label, we would expect to finally be able to educate physicians on our exciting two-year data from the most rigorous pivotal trial conducted in IgA nephropathy to date. We are ready, prepared, and fully energized to leverage this anticipated milestone to elevate Salisbury. Preparations are underway to position our teams to engage with patients and physicians to amplify the profile of psoriasis once full approval is obtained. Additionally, we anticipate that the new Cadillo Guidelines will become available soon. The timing is potentially lining up quite nicely.

Jula Inrig: Alongside this, with the full approval and updated label, we would expect to finally be able to educate physicians on our exciting two-year data, from the most rigorous pivotal trial conducted in hygiene and therapy to date.

Peter Heerma: To form, our optic has been largely driven by the results from the interim analysis, so we expected two-year confirmatory data to further support foundation on universal fourth-party and daily practice. We are ready. We are prepared and fully energized to leverage this anticipated milestone, to elevate self-sparry. Preparations are underway to position our teams and gate stations and physicians to amplify the profile of third-party on full approval. Additionally, we anticipate that the new Cedillo guidelines will become available soon, timing that is potentially line up quite nicely. We anticipate that for the first time, there will be true self-sparry as part of the treatment paradigm, and that they will emphasize the urgency to diagnose and treat IgM-phroxytation screeninger with some more ambitious partner-oriented treatment orders.

Jula Inrig: Thus far, our uptake has been largely driven by the results from the interim analysis, so we expect the two-year confirmatory data will further support foundational results for aspiring and daily practice.

Jula Inrig: We are ready, prepared, and fully energized to leverage this anticipated milestone to elevate Salisbury.

Jula Inrig: Preparations are underway to position our teams to engage with patients and physicians to amplify the profile of psilocybin on full approval.

Jula Inrig: Additionally, we anticipate that the new CEDELO guidelines will become available soon, timing that is potentially lining up quite nicely.

Speaker Change: We anticipate that for the first time they will include Phil Sparry as part of the treatment paradigm, that they will emphasize the urgency to diagnose and treat IGA nephropathy patients earlier with a more ambitious pontineuria treatment target.

Peter Heerma: This will provide some opportunity to broaden the addressable patient population.

Jula Inrig: This provides an opportunity to broaden the addressable patient population.

Peter Heerma: I didn't be more proud to the progress of our talented and dedicated teams have made in the first half of this year. These accomplishments provide the sole spring board to strengthen the first-party profile and broaden the addressable patient population in the second half of the year. We are driven by the prospects of serving even more patients moving forward by establishing fourth-party as defundation therapy for high-diated fourth-party patients.

Peter Heerma: I couldn't be more proud of the progress that our talented and dedicated teams have made in the first half of this year. We are driven by the prospect of serving even more patients moving forward by establishing Philospari as the foundation therapy for IgA defrobity patients. Now, we go over to Chris for the financial update.

Jula Inrig: I couldn't be more proud of the progress that our talented and dedicated teams have made in the first half of this year.

Jula Inrig: These accomplishments provide a solid springboard to strengthening the philosophy profile and broadening the addressable patient population in the second half of the year.

Jula Inrig: We are driven by the prospect of serving even more patients moving forward by establishing Futura Aspari as the foundation therapy for IgA deformity patients.

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

Unknown Executive: Ritz. Thank you, Peter.

Chris: Thank you, Peter. And good afternoon, everyone. During the second quarter, we continue to have strong operational performance led by a significant increase in net product sales and reduced operating cash. During the quarter, we also recognized $1.9 million of license and collaboration revenue, which results in $54.1 million in total revenue reported for the period, compared to $32.2 million in the same period in 2023. Research and development expenses for the second quarter of 2024 were $54.3 million, compared to $66.5 million for the same period in

Christopher Cline: Good afternoon, everyone. During the second quarter, we continued to have strong operation performance led by a significant increase in net product sales and reduced operating cashews. Net product sales for the second quarter of 2024 grew to $52.2 million compared to $29.5 million for the same period in 2023. This increase of approximately 77 percent is a tribute to growth in net product sales and reduced operating cashews. Net product sales for the second quarter of 2024 grew to $52.2 million compared to $29.5 million for the same period in 2023. Net product sales from the ongoing U.S. launch of Filsbari and IGNF property.

Chris: Thank you Peter and good afternoon everyone. During the second quarter we continue to have strong operational performance led by a significant increase in net product sales and reduced operating cash use.

Chris: Net product sales for the second quarter of 2024 grew to $52.2 million, compared to $29.5 million for the same period in 2023. This increase of approximately 77% is attributable to growth in net product sales from the ongoing U.S. launch of Phosphoryl and IgA nephropathy.

Christopher Cline: During the quarter, we also recognized $1.9 million of licensing collaboration revenue, which results in $54.1 million in total revenue reported for the period compared to $32.2 million in the same period in 2023. Research and development expenses for the second quarter of 2024 were $54.3 million compared to $66.59 million for the same period in 2023. On a non-gap adjusted basis, our expenses were $50.6 million. For the second quarter of 2024, compared to $59.5 million for the same period in 2023. Selling, general, and administrative expenses for the second quarter of 2024 were $64.8 million compared to $68.2 million for the same period in 2023.

Jula Inrig: During the quarter, we also recognized $1.9 million of license and collaboration revenue, which results in $54.1 million in total revenue reported for the period, compared to $32.2 million in the same period in 2023.

Jula Inrig: Research and development expenses for the second quarter of 2024 were $54.3 million compared to $66.5 million for the same period in 2023. On a non-GAAP adjusted basis, R&D expenses were $50.6 million for the second quarter of 2024 compared to $59.5 million for the same period in 2023.

Chris: On a non-GAAP adjusted basis, R&D expenses were $50.6 million for the second quarter of 2024, compared to $59.5 million for the same period in 2023. Selling general and administrative expenses for the second quarter of 2024 were $64.8 million, compared to $68.2 million for the same period in 2023. The decline in year-over-year operating expenses is attributable to the restructuring enacted at the end of 2023 and a reduced clinical expense as this first sentence-based restudy advanced towards completion. Total other expense net for the second quarter of 2024 was $1.9 million compared to total other income net of $2.1 million in the same period of 2023.

Jula Inrig: Selling general and administrative expenses for the second quarter of 2024 were $64.8 million, compared to $68.2 million in the same period in 2023.

Christopher Cline: On a non-gap adjusted basis, SGN expenses were $48.3 million for the second quarter of 2024, compared to $49.7 million for the same period in 2023. The decline in Eurovere operating expenses is attributable to the restructuring and active at the end of 2023. In a reduced clinical expense, as this far sentence-based study is advanced towards completion. Total other expense net for the second quarter of 2024 was $1.9 million compared to total other income net of $2.1 million in the same period of 2023. The difference is largely attributable to a $3.4 million non-cash charged other expense related to the Rinalis collaboration announced earlier this year.

Jula Inrig: On a non-GAAP-adjusted basis, SG&E expenses were $48.3 million for the second quarter of 2024, compared to $49.7 million for the same period in 2023. The decline in year-over-year operating expenses is attributable to the restructuring inactive at the end of 2023 and a reduced clinical expense as this first sentence phase three study's advanced towards completion.

Jula Inrig: Total other expense net for the second quarter of 2024 was $1.9 million compared to total other income net of $2.1 million in the same period of 2023. The difference is largely attributable to a $3.4 million non-cash charge to other expense related to the Reynolds Collaboration announced earlier this year.

Eric Dube: The difference is largely attributable to a $3.4 million non-cash charge for other expenses related to the Reynolds collaboration announced earlier this year. As of June 30, 2024, the company had cash equivalents and marketable securities of $325.4 million. Cash used during the second quarter included approximately $71 million of previously disclosed milestone payments and approximately $45 million of operating cash. Importantly, operating cash use declined by approximately $20 million in the quarter, and further declines in the second half of the year are expected, as well as throughout 2025 and beyond.

Christopher Cline: Net laws, including from discontinued operations for the second quarter of 2024, was $70.4 million for 91 cents per basic share, compared to a net loss of $8.6 million or $1.13 cents per basic share for the same period in 2023. On a non-adjusted basis, net loss, including from the discontinued operations for the second quarter of 2024, was $50.1 million for 65 cents per basic share, compared to a net loss of $60.1 million for 79 cents per basic share for the same period in 2023. As of June 30, 2024, the company cashed cash equivalents and marketable securities at $325.4 million. Cash used during the second quarter included approximately $71 million, the previously disclosed milestone payments, and approximately $45 million of operating cash used.

Jula Inrig: Net loss, including from discontinued operations for the second quarter of 2024, was $70.4 million, or $0.91 per basic share, compared to a net loss of $85.6 million, or $1.13 per basic share, for the same period of 2023.

Jula Inrig: On a non-adjusted basis, net loss, including from discontinued operations from the second quarter of 2024, was $50.1 million, or $0.65 per basic share, compared to a net loss of $60.1 million, or $0.79 per basic share for the same period of 2023.

Jula Inrig: As of June 30, 2024, the company cashed cash equivalents and marketable securities at $325.4 million. Cash used during the second quarter included approximately $71 million of previously disclosed milestone payments and approximately $45 million of operating cash use.

Christopher Cline: Importantly, operating cash used declined by approximately $20 million in the quarter, and further declines in the second half of the year are expected, as well as throughout 2025 and beyond. This is driven by expected growth until Sparray sales, continued contributions from Tyola, and declining R&D investments per cent in over time as the supporting studies complete. We also anticipate multiple incoming milestone payments from CSLV4 upon conversion of field sparray to full approval in Europe and market access achievements.

Jula Inrig: Importantly, operating cash use declined by approximately $20 million in the quarter, and further declines in the second half of the year are expected, as well as throughout 2025 and beyond.

Speaker Change: This is driven by expected growth in FILS-PARE sales, continued contribution from FIOLA, and declining R&D investments per cent in overtime as the supporting studies complete. We also anticipate multiple incoming milestone payments from CSLV4 upon conversion of FILS-PARE to full approval in Europe and market access achievements.

Christopher Cline: With these elements, we continue to believe that our balance sheet can support current operations into 2021. I'll add one administrative note alongside the filing of our 10-Q today; we're also filing a new shelf registration statement with the SEC. This is a housekeeping measure, as our current shelf registration statement is set to expire on September 3rd.

Eric Dube: With these elements, we continue to believe that our balance sheet can support current operations into 2028. I'll add one administrative note. Alongside the filing of our 10-Q today, we're also filing a new shelf registration statement with the SEC. This is a housekeeping measure, as our current shelf registration statement is set to expire on September 3rd. With that, I'll now turn it back to Eric for his closing comments.

Jula Inrig: With these elements, we continue to believe that our balance sheet can support current operations into 2028.

Speaker Change: I'll add one administrative note. Alongside the filing of our 10-Q today, we're also filing a new shelf registration statement with the SEC. This is a housekeeping measure, as our current shelf registration statement is set to expire on September 3rd. With that, I'll now turn it back to Eric for his closing comments. Eric?

Eric Dube: With that, I'll now turn it back to Eric for his closing comments. Eric?

Eric Dube: Thank you, Chris. Through the first half of 2024, we've delivered meaningful growth in Sylspari, continued the collaborative engagements with regulators and payers, and it made meaningful progress in bringing both Sylspari and Pagdebatnase to patients. We know that they are waiting for us.

Operator: Thank you, Chris. Through the first half of 2024, we've delivered meaningful growth in Philspari. We know that they are waiting for you. It's for this reason that I and my colleagues at Travere have worked with focus and passion this year. If you are using a speakerphone, please make sure your mute function is turned off to allow your, Again, please press star 1 to ask a question. From TD Caltech. Tyler Van Buren, you're live.

Eric Dube: Thank you, Chris.

Eric Dube: Through the first half of 2024, we've delivered meaningful growth in Fils-Phari, continued the collaborative engagements with regulators and payers, and have made meaningful progress in bringing both Fils-Phari and PEG-dibatinase to patients.

Eric Dube: It's for this reason that I and my colleagues at Travere have executed with focus and passion this year. We are well positioned to achieve further progress in the remainder of the year, which should condition Travere for meaningful growth now and in years to come.

Eric Dube: We know that they are waiting for us. It's for this reason that I and my colleagues at Travere have executed with focus and passion this year.

Nivi Nara: We are well positioned to achieve further progress in the remainder of the year, which should position Travere for meaningful growth now and in years to come. Now let me turn the call over to Nivi for Q&A. Nivi?

Nivi Nehra: Now, let me turn the call over to Nivi for Q&A. Nivi. Thank you, Eric. We can now open up the line for Q&A. Rachel. Thank you. If you are dialed in via the telephone and would like to ask a question, please signal by pressing Star 1 on your telephone keypad. As a reminder, we ask that you limit yourself to one question. If you have another question, please rejoin the Q. If you are using a speaker phone, please make sure your mute function is turned off to allow your signal to reach our equipment. Again, please press star 1 to ask a question.

Nivi Nara: Thank you, Eric. We can now open up the line for Q&A. Rachel?

Rachel: Thank you. If you are dialed in via the telephone and would like to ask a question, please signal by pressing star 1 on your telephone keypad. As a reminder, we ask that you limit yourself to one question.

Eric Dube: If you have another question, please rejoin the queue. If you are using a speakerphone, please make sure your mute function is turned off to allow your signal to reach our equipment. Again, please press star 1 to ask a question.

Tyler Van Buren: We will take the first question from the line of Tyler Van Buren from TD Cowan.

Speaker Change: We will take the first question from the line of Tyler Van Buren from TD Cowan.

Tyler Van Buren: Tyler Van Buren, your line is now open.

Unknown Executive: Hey, guys. Thanks very much for taking a question, and congratulations on the quarter. Regarding a potential removal or modification of the REMS upon a full approval next month, can you just remind us what you guys suggested to the FDA as we think about the potential scenarios and outcomes?

Speaker Change: Tyler Van Buren, your line is now open.

Eric Dube: Hey guys, thanks very much for taking the question and congratulations on the quarter. Regarding a potential removal or modification of the REMS upon full approval next month, can you just remind us what you guys suggested to the FDA as we think about the potential scenarios and outcomes? Well, certainly, Tyler, thank you for the question. I'd say, first, let me share that we believe that this is the first natural opportunity for us to engage with the FDA on the additional data needed for full approval. And there is, as you know, no precedent for something being changed this early in approval, and the process requires us to engage with multiple divisions.

Speaker Change: Hey guys, thanks very much for taking the question and congratulations on the quarter. Regarding a potential removal or modification of the REMS upon a full approval next month, can you just remind us what you guys suggested to the FDA as we think about the potential scenarios and outcomes?

Unknown Executive: Well, certainly, Tyler. Thank you for the question. I'd say first, let me share that we believe that this is the first natural opportunity for us to engage with the FDA with the additional data for reviewing for full approval. And there is, as you know, no precedent for something being changed this early in approval, and that the process requires us engaging with multiple divisions within the agency. And I think with that said, we certainly are looking at multiple scenarios, including a modification, a potential removal; but again, both of those, there is not much precedent this early, or that there would be a continuation for liver monitoring as it stands.

Speaker Change: Well, certainly, Tyler. Thank you for the question. I'd say, first, let me share that we believe that this is the first natural opportunity for us to engage with the FDA with the additional data for reviewing for full approval.

Speaker Change: And there is, as you know, no precedent for something being changed this early in approval and that the process requires us engaging with multiple divisions.

Eric Dube: Within the agency, and I think with that said, we certainly are looking at multiple scenarios, including a modification, potential removal, but again, both of those, there is not much precedent this early, or that there would be a continuation for liver monitoring as it stands.

Unknown Executive: What we've got previously is that we're committed to putting our best foot forward during this S-N-D-A review and to provide an update at full approval.

Eric Dube: What we've got previously is that we're committed to putting our best foot forward during this S&DA review and to provide an update at full approval. And what I'd say with regard to the scenarios is we're ready for anything. You know, if we take a step back, and independent of where we are with this process,

Unknown Executive: And what I'd say with regard to the scenarios is, we're ready for anything. You know, if we take a step back and independent of where we are with this process, I'm really proud of our ability to demonstrate strong growth and performance in Silspari with the reps. So regardless of where we land with this process and the near term, we can expect significant growth moving forward given that Silspari is now becoming the foundational therapy for the treatment of IGAN. Thank you.

Speaker Change: I'm really proud of our ability to demonstrate strong growth and performance in Fils-Pari with the REMS. So regardless of where we land with this process in the near term, we can expect significant growth moving forward given that Fils-Pari is now becoming the foundational therapy for the treatment of IGAM.

Anupam Rama: We will take the next question from the line of Anupam Ramma with JP Morgan. Anupam Ramma, your line is open. Hey guys, thanks so much for taking the question. Just a quick one from me. When you think about patient start forms and what you're seeing, how much of that can you attribute to say new prescribers versus... Roses, repeaks, prescribers, and how that's kind of changed over time. Thank you so much.

Speaker Change: Thank you. We will take the next question from the line of Anupam Rama with J.P. Morgan. Anupam Rama, your line is open.

Anupam Rama: Hey guys, thanks so much for taking the question. Just a quick one from me. When you think about patient start forms and what you're seeing, how much of that can you attribute to, say, new prescribers versus? Great. Thanks, Anupam, for the question. Peter, I'll turn that one over to you. Yeah, overall, I think we see a nice continuation of growth, both from a broadening of the prescriber base as well as a deepening. I think it's exactly what you would expect.

Anupam Rama: Hey guys, thanks so much for taking the question. Just quick one from me. When you think about patient start forms and what you're seeing, how much of that can you attribute to say new prescribers versus repeat prescribers and how's that kind of changed over time? Thanks so much.

Peter Heerma: Great. Thanks, Jonathan, for the question.

Peter Heerma: Peter, I'll turn that one over to you. The overall, I think we see a nice continuation of growth, both from, both of the bargaining of the prescriber rate as well as the deepening. I think that's exactly what you would expect. It's, I would say it's almost people on, if you look at the increase in basin stock funds, where it comes from, from new prescribers as well as existing prescribers. So I think it's very nice, trajectory, and I think very much in language; best practice I've seen in the past for successful launches.

Speaker Change: Great. Thanks, Anupam, for the question. Peter, I'll turn that one over to you.

Peter: Overall, I think we see a nice continuation of growth, both the broadening of the prescriber base as well as the deepening. I think that's exactly what you would expect.

Peter Heerma: It's I would say it's almost equal if you look at the increase in patient stock forms where it comes from from new prescribers as well as existing prescribers. I think it's a very nice trajectory and I think it's very much in line with best practices that I've seen in the past for successful ones. Joseph Schwartz, your line. Thank you.

Peter: It's I would say it's almost equal on if you look at like the increase in patient stock from where it comes from from new prescribers as well as existing prescribers.

Speaker Change: So I think a very nice trajectory and I think very much in line with best practices I've seen in the past for successful launchers.

Unknown Executive: Thank you.

Joseph Schwartz: We will take the next question from the line of Joseph Schwartz with Learning Partners. Joseph Schwartz, your line is open. Thank you. Congrats on a strong quarter. Based on the sales for the quarter and our estimate for price, it seems like there's just over 1,100 patients on therapy by the end of the quarter. I was wondering, is that estimate reasonable? And given the company has received over 2,400 P.S. absence, or as of the end of the quarter, could you talk a bit about how much success you're having. And converting P.S.F. to scripts. How long does that take?

Speaker Change: Thank you. We will take the next question from the line of Joseph Schwartz with Leering Partners. Joseph Schwartz, your line is open.

Joseph Schwartz: Congratulations on a strong quarter. Based on the sales for the quarter and our estimate for price, Joe, thanks so much for the question. And Peter, I'll turn this one, too, over.

Joseph Schwartz: Thank you. Congrats on a strong quarter. Based on the sales for the quarter and our estimate for price,

Joseph Schwartz: It seems like there's just over 1,100 patients on therapy by the end of the quarter. I was wondering, is that estimate...

Speaker Change: reasonable and given the company has received over 2,400 TSFs since

Speaker Change: As of the end of the quarter, could you talk a bit about how much success you're having converting PSF to scripts, how long does that take, and how should we think about that cadence of conversions over the balance of the year?

Peter Heerma: And how should we think about that cadence of conversions over the bounce of the year?

Peter Heerma: Joe, thanks so much for the question.

Unknown Executive: And Peter, I'll turn this one also over to you. Yeah, thanks, Joe. I think it's a good question. I was the first; I was for inflection in close in that revenue. And the second quarter is a reflection of the continuing efficiencies that we're making for the film process. And what you're seeking to is like the cumulative number of patients platforms. And as we mentioned earlier last summer, we observed a part of the patient that required additional support and education, in particular, in the ramp certification process. But the measures we made and implemented allow some better patient engagement on this ramp certification process.

Speaker Change: Joe, thanks so much for the question. And Peter, I'll turn this one also over to you.

Peter: Yeah, thanks, y'all. I think it's a good question. I would say, first, our strong inflection and growth in net revenue and, second, water is a reflection of the continuing efficiencies that we're making in the fulfillment process.

Speaker Change: What you're speaking to is the cumulative number of patient platforms, and as we mentioned in an earlier poll, last summer we observed a pocket of patients that required additional support and education, in particular in the RAM certification process.

Speaker Change: But the measures we made and implemented allow for better patient engagement on this RAMP certification process. And I would say within that context, I'm really pleased with the progress we are making.

Unknown Executive: And I would say, within that context, I'm really pleased with the progress we are making. And if you will, well, within the rail this is benchmarking both on the amount of patients that we are serving, as well as the time to fill two patients.

Peter: I think we are well within the rare disease benchmark, both in the amount of patients that we are serving, as well as the time to fill two paid shipments.

Unknown Executive: Thanks, Peter. And Joe, I'll just reiterate that I'm really pleased with how those efficiencies have been going in how Peter's team has been executing. I think the fundamentals that we're seeing in Q2 and into Q3 are exactly right. Hope to be going into full approval, where we really are seeing those operational efficiencies of pull through and conversion happening.

Peter Heerma: Thanks, Peter, and Joe. I'll just reiterate that I'm really pleased with how those efficiencies have been going and how Peter's team has been executing. I think the fundamentals that we're seeing in Q2 and into Q3 are exactly where I'd hoped to be going into full approval, where we really are seeing those operational efficiencies of pull-through and conversion. Great. And that's very helpful. Thanks.

Speaker Change: Thanks, Peter. And Joe, I'll just reiterate that I'm really pleased with how those efficiencies have been going.

Speaker Change: in how Peter's team has been executing. I think the fundamentals that we're seeing in Q2 and into Q3 are exactly where I'd hope to be going into full approval, where we really are seeing those operational efficiencies of pull-through and conversion happening.

Unknown Executive: Great. And it's very helpful. Thanks.

Unknown Attendee: And then a question on a peg board about bat names, if I could, how has site activation been going and enrollment up until this point? As we've said before, we're not going to provide specific patient numbers along the way, but our goal, and we're planning for top-line data in 2026. Thank you. Thank you. As a reminder, please limit yourself to one question, and you may rejoin the queue with additional questions. We will take the next question from the line. Maybe tackle the guidelines from a little bit of a different angle. Yeah, I'm happy to take those. And the first question is really, like, what part of the text is responding most?

Unknown Executive: And then a question I picked a bad news if I could. How has site activation been going and enrollment up until this point? Do what?

Speaker Change: Great, and that's very helpful, thanks. And then a question on PEG2BAT and then if I could, how has site activation been going and enrollment up until this point?

Unknown Executive: Why don't we take that one? Well, thank you. So we're pleased to have the first patient go earlier this year. And, as I mentioned on the call, we really have a strong interest from patients in the community. And this is both in the US and abroad. As I previously mentioned in the past, we're metering enrollment to ensure we have strong quality and can scale up for CNC for the full study and commercial launching. We said before we're not going to provide specific patient numbers along the way, but our goal and we're planning for top line data in 2026.

Jula Inrig: Jula, why don't we take that one?

Jula Inrig: Well, thank you. So we're pleased to have the first patients dosed earlier this year. And as I mentioned on the call, we really have a strong interest from patients in the community, and this is both in the U.S. and abroad.

Speaker Change: As I've previously mentioned in the past, we're metering enrollment to ensure we have strong quality and can scale up for CMC for the full study and commercial launch. We've said before, we're not going to provide specific patient numbers along the way, but our goal and we're planning for top-line data in 2026.

Unknown Executive: Thank you.

Carter Gould: As a reminder, please limit yourself to one question, and you may rejoin the Q with additional questions. We will take the next question from the line. and Carter Gould with Backlace.

Speaker Change: Thank you.

Speaker Change: Thank you. As a reminder, please limit yourself to one question and you may rejoin the queue with additional questions. We will take the next question from the line of Carter Gould with Barclays.

Carter Gould: Carter Gould, your line is now open.

Peter Heerma: Right, thanks for taking the question. Maybe you tackle the guidelines from a little bit of a different angle. You know, upon the guidelines kind of being announced, what's your expectation that the time frame from that announcement to pay your policy and language being updated?

Speaker Change: Carter Gould, your line is now open.

Carter Gould: Great. Thanks for taking the question. Maybe tackle the guidelines from a little bit of a different angle. You know, upon the guidelines kind of being announced, what's your expectation that then, like sort of the timeframe from that announcement to payer policy and language being updated?

Peter Heerma: Thank you.

Peter Heerma: Carter, thanks for the question.

Peter Heerma: Peter, I'll hand that one over to you. Yeah, thanks. Well, first of all, I think you're referring to the idea of guidelines, and you are answering as a part of the script that we are expecting that soon. And I would say timing could be better. Lowering the part of the Muria part of the really position feels very low. Given our strong part of the Muria efficacy data, 50% absolute immersion, as well as our completed mission data. And additionally, there's a lot of treatment also allow to broaden the pay population population. So we're really excited about the momentum that this generates for a fulfilled salary.

Speaker Change: Thank you.

Speaker Change: Thanks for the question. Peter, I'll hand that one over to you.

Peter: First of all, I think you're referring to the Cadegal Guidelines, and you mentioned

Peter: as a part of the script that we're expecting that soon. And I would say timing couldn't be better. Lowering the proteinuria target, really positioned Phil Spirey well, given our strong proteinuria efficacy data, 50% absolute reduction, as well as our complete remission data.

Speaker Change: Additionally, this lower treatment target will also allow to broaden the patient population. So we are really excited about the momentum that this generates for Philospory.

Peter Heerma: With regard to the second part of your question, how fast will pay us a doctor's in that plan? So we are ready and ready to go with our updated knowledge of the proposition with payers on the first time profile. And the spot that my payers are in their payer plans, I'm not only referring to the label, but also to guidelines. So I'm really excited that those are coincided quite nicely in the time. I think it provides a great opportunity for our clinical mission or cloud managers to have that conversation with payers and to update the authorization criteria very quickly.

Speaker Change: With regard to the second part of your question, how fast will players adopt this in their plans? Well, we are ready to go with our updated value proposition with players on the Phil Starry profile.

Speaker Change: And to start with, when payers are in their payor plans, I'm not only referring to the label, but also to guidelines. So I'm really excited that those are coinciding quite nicely in the timing. I think it provides a great opportunity for our clinical.

Speaker Change: National Account Managers to have that conversation with payers and to update the authorization criteria very quickly.

Unknown Executive: Thank you.

Jason Zamansky: We will take the next question from the line of Jason Zamansky with Bank of America. Jason Zamansky, your line is now open. Good afternoon.

Speaker Change: Thank you.

Speaker Change: Thank you. We will take the next question from the line of Jason Zemansky with Bank of America. Jason Zemansky, your line is now open.

Unknown Executive: This is Bob Anpatel on for Jason Zamansky. Congrats on the quarter, and thanks so much for taking our questions. With the protect data in hand, could you please highlight the feedback that you've been getting from prescribers? What's thus far been the biggest hurdles to update in the community and academic settings? And then, as you think about the likely potential label update, what factors do you think could be the most critical or impactful in terms of driving uptake? And then in terms of the sales trajectory for Phil Sparry, do you expect patient inflection to be immediate in conjunction with the label, the broader label update, or a more gradual without seeing sort of an early ballast?

Speaker Change: Good afternoon, this is Bhavan Patel on for Jason Zemansky. Congrats on the quarter and thanks so much for taking our questions.

Bhavan Patel: With the PROTECT data in hand, could you please highlight the feedback that you've been getting from prescribers?

Speaker Change: What's thus far been the biggest hurdles to uptake in the community and academic settings? And then, as you think about the likely potential label update, what factors do you think could be the most critical or impactful in terms of driving uptake?

Speaker Change: And then, in terms of the sales trajectory for Phil Sparty, do you expect patient inflection to be immediate in conjunction with the label, the broader label update, or more gradual without seeing sort of an early bull list? Thank you.

Unknown Executive: Thank you.

Peter Heerma: All right. Thank you for those questions and Peter. Why did you take those? Yeah, I'm happy to work to take those, and the first question is really like what kind of protect is resonating most? If food is closer, like given that we don't have the full label, we are not able to talk initially about the EGF or a long term; it would be preservation data. So that's really dual seeing in the medical science. So that had the conversation in the field in personal conversation that I've had with physicians is there. They're excited about the continuation of the near reduction.

Bhavan Patel: All right, thank you for those questions. And Peter, why don't you take those?

Peter Heerma: In full disclosure, like, given that we don't have the full label, we are not able to talk commercially about the EGFR and long-term kidney preservation data. So that's really Jula's team and the medical science liaison that had that conversation in the field. In personal conversations that I've had with physicians, they say they're excited about the continuation of proteinuria reduction. And if you look at the data and you look after two years of proteinuria reduction, then you see that about two-thirds of the herbase arton, the active control arm, had the proteinuria effect waning while psilocyte actually continued to hold quite nicely.

Peter: Yeah, I'm happy to take those, and the first question is really like, what out of the text is resonating most?

Speaker Change: In full disclosure, given that we don't have the full label, we are not able to talk commercially about the EGFR and long-term kidney preservation data, so that's really Jula's team and the medical science liaisons that had that conversation in the field.

Bhavan Patel: In personal conversation that I've had with physicians is they're they're excited about the continuation

Peter Heerma: And if you saw, if you look at the data and you look after three of Potomuria production, they received that about two thirds of the airbase art on the active control on Potomuria effect was raining while Sparry actually continues to work quite nicely. And that gives far less confidence that there will be that we want to continue to keep the preservation. We mentioned a couple of years, but given that you impact one of the main damage impactors. Potomuria is a mortal of them. If you really are able to continuously reduce that there is a translation to longer getting preservation.

Speaker Change: of Potomiria Reduction, and if you saw, if you look at the data, and you look after 2 years of Potomiria Reduction, then you see that about two-thirds of the Earth-based arton, the active control arm, Potomiria effect was waning, while Psilocari actually continued to float quite nicely.

Peter Heerma: And that gives thought leaders confidence that there will be that long-term continued kidney preservation. I mean, we mentioned this up to two years ago, but given that you impact one of the main damaging factors, proteinuria is a marker of them.

Speaker Change: And that gives thought leaders confidence that there will be that long-term continued kidney preservation. I mean, we measure this up to two years, but given that you impact one of the main damaging factors.

Jula Inrig: Dr. Muria is a model of them. If you really are able to continuously reuse that, that is a translation to long-term kidney preservation. So that's what I'm most excited about. Maybe Jula can talk about Dr. M. Zell's experience in the field.

Jula Inrig: If you really are able to continuously reduce that, that is a translation to long-term kidney preservation. So that's what I'm most excited about. And maybe Jula can talk about what the MSLs are experiencing in the field. So I think that. Ligal Nochomovitz, your line is open.

Peter Heerma: So that's why I'm most excited about it. And maybe you can talk about like Potom cells, quite a serious need of fuel.

Unknown Executive: Thanks, Peter. Well, our teams have been in hand with the protect data and being able to engage both community and academic leaders, and they continue to hear exchange in the momentum from when we first release the data and people didn't understand it, but we're doing things like journal clubs and engagement where they really have a full understanding of the magnitude and durability of protonary reduction, the preservation of kidney function, which gets better year-over-year combined with long-term safety. And as I mentioned on the call, we're starting to hear back that this should be a foundational treatment for patients with hygiene and apropathy, and as we have full approval, a full label, and the commercial team also able to discuss this, I believe that we're going to have an even incremental role across the spectrum, being able to treat patients with hygiene and apropathy.

Jula Inrig: Thanks, Peter. Well, our teams have been in hand with the PROTECT data and being able to engage both community and academic leaders, and they continue to hear a change in the momentum from when we first released the data, and people didn't understand it, but we're doing things like journal clubs and engagement where they really have a full understanding of the magnitude and durability of protein-array reduction, the preservation of kidney function, and how much it gets better.

Speaker Change: And as I mentioned on the call, we are starting to hear back that this should be a foundational treatment for patients with IgA nephropathy. And as we have

Speaker Change: Full approval, a full label, and a commercial team also able to discuss this, I believe that we're going to have an even incremental role across the spectrum being able to treat patients with IJ nephropathy.

Unknown Executive: So, I think the next part of the question, Peter, why don't you take the next part of the question on what parts of the label do you think are going to drive off-take? Yeah, after I was going to get there, I think the question was really like, how fast do you expect? Yeah, I think, I mean, we spoke about it at the long-term last week. In general, the morphologist is a relatively conservative audience. I don't think it's so completely in general, but having said that, we are really excited about the full data that we can now communicate with physicians, and we're ready to really allow for the top data, you know, the strengthening of the first battery label, the strengthening of the profile, all the elements that you know are talking about, the length of kidney preservation, the safety data, and the rest of the virus benefit.

Speaker Change: So, the next part of it.

Speaker Change: Yeah, I think he...

Speaker Change: I mean, we spoke about it at the launch call last week. In general, the morphologists are a relatively conservative audience. I don't think things go completely in general, but having said that...

Speaker Change: We are really excited about like the full data that we can now communicate with physicians and we're ready to really allow for that uptake as well, the strengthening of the phosphoryl label.

Unknown Executive: Then we'll have an impact, but I wouldn't say it's a long-term step. I think it's a continuation of those that we anticipate before us.

Unknown Executive: Thank you.

Yigal Nochomovitz: We'll take the next question from the line of, you galvanicomovits with city. You galvanicomovits, your line is open.

Speaker Change: Thank you.

Speaker Change: We will take the next question from the line of Yigal Nochomovitz with Citi. Yigal Nochomovitz, your line is open.

Unknown Executive: Hi, this is Renault for you, gal. Thanks for taking my question. Just wanted to ask, on the inclusion of the Cthegal Guideline, what are your expectations around where, if it's so sorry, we'll fit you, be it being used as an independent frontline option, only after a failure, or in combination. Do you have any additional detail on physician, payer perspective for this?

Yigal Nikomovits: via being used as an independent frontline option only after a failure or in combination. Do you have any additional detail on physician pair perspective for this?

Unknown Executive: All right, Julie, why don't you take that one? Peter, you can add anything on the payer perspective. Thank you. So given that we've published the protect data and we have approval of Hilfbari both in US and Europe, Hilfbari we know are included in the Cthegal Guidelines. And consistent with other guidelines and recent publications, we anticipate Hilfbari will be included as part of the foundational care for treatment of kidney injury that we know occurs and leads to diagnosis of patients with IJ and Acropolis. The other aspect that Peter started to discuss is we know that there's evidence that patients remain at risk for kidney failure with even low levels of protonuria.

Jula Inrig: All right, Jula, why don't you take that one, and Peter, you can add anything to it. That's right. I mean, I think if we take a step back and we think about how the CADICO guidelines are going to help in driving what we're already seeing within the treatment paradigm, one, we now have the opportunity to reach for complete remission, and we know that most patients on ACE or ARB and steroids don't achieve or sustain complete remission.

Speaker Change: All right, Jula, why don't you take that one? And Peter, you can add anything on the payer perspective.

Jula Inrig: So we anticipate the guidelines will push for earlier diagnosis and treatment to even lower levels of protonuria. So these two components, Hilfbari and the guidelines as foundation for treating the kidney injury as well as diagnose and treat lower levels of protonuria. We believe that Cthegal guidelines can really help expand the population of patients who would be treated with Hilfbari as a foundational treatment. Stretman.

Speaker Change: I'm building on that. I think to Jula's point, it's really about two categories. One, like really the natural protectors.

Peter: Medicine that acts within the kidney and then the second category is more the immune mediation.

Peter Heerma: The case is already today, and that's also how the site is being affected in Bay and Plains. I think there was this particular part of your question. Yeah, that's right.

Peter Heerma: I mean, I think if we take a step back and we think about how the Kedigo guidelines are going to help in driving what we're already seeing within the treatment paradigm. One, we now have the opportunity to reach for complete remission, and we know that most patients on ACE or ARB and steroids don't achieve or sustain complete remission. And so there is going to be the ability to reach that, but it's going to require for most patients' combination therapy. So, you know, while we don't yet have the Kedigo draft guidelines, I think we fully expect that the underlying trend that we're seeing within the space is increased combination.

Peter: Yeah, that's right. I mean, I think if we take a step back...

Speaker Change: We now have the opportunity to reach for complete remission, and we know that most patients on ACE or ARB and steroids don't achieve or sustain complete remission.

Jula Inrig: And so there is going to be the ability to reach that, but it's going to require combination therapy for most patients. So while we don't yet have the CADICO draft guidelines, I think we fully expect that the underlying trend that we're seeing within this space is increased combination therapy. And as we're already seeing, psilocybin is going to be a core part of that because we have the superior profile for that action in the kidney and the proteinuria reduction. So I think fundamentally, the CADICO guidelines and whatever they shape are going to help in driving more aggressive therapy because remission is now within reach. Thank you. We will take the next question. Hi,

Speaker Change: So we, you know, while we don't yet have the CADEGO draft guidelines, I think we fully expect that the underlying trend that we're seeing within this space is increased combination. And as we're already seeing, phosphoryl is going to be a core part of that because we have the superior profile for that action in the kidney and the proteinuria.

Peter Heerma: And as we're already seeing, as far as going to be a core part of that, because we have the superior profile for that action in the kidney and the prognaria reduction. So, I think fundamentally, the Kedigo guidelines, in whatever shape, are going to help in driving, you know, more aggressive therapy because remission is now within reach for many of these patients. Thank you.

Speaker Change: So, I think fundamentally, the Cadego guidelines, in whatever they shape, are going to help in driving, you know, more aggressive therapy because remission is now within reach for many of these patients.

Mori Raycroft: Will people take the next question? From the line of Mori Raycroft with Jeffries. Mori Raycroft, your line is open.

Speaker Change: From the line of Maurice Raycroft with Jeffreys. Maurice Raycroft, your line is open.

Jula Inrig: Hi, congrats on the quarter, and thanks for taking my question. I'll shift gears and ask about FSGS for the Parasol groups work to establish alternative FSGS endpoints. Do you have a sense of what the outcomes could entail, and can duplex potentially satisfy those endpoints in post hoc analyses or in a subgroup of FSGS patients, or do you expect you would have to run a new supplemental study? All right, Mori. Thanks for the question.

Unknown Attendee: Congratulations on the quarter and thanks for taking my question. I'll shift gears and ask about FSGS. For the parasol group's work to establish alternative FSGS endpoints, do you have a sense of what the outcomes could entail and whether duplex could potentially satisfy those endpoints in post-hoc analyses or in a subgroup of FSGS patients, or do you expect you would have to run a new supplemental study? All right, Maury, thanks for the questions. Jula, wanna... Yeah, Dylan, thanks for the question.

Morrie Raycroft: Hi, congrats on the quarter and thanks for taking my question. I'll shift gears and ask about FSGS.

Jula Inrig: Jula, why don't you take these? Yeah. So, Parasol is continuing their efforts. And while I can't speak for Parasol, we do know from the duplex that he, as I earlier mentioned on the call, EGFR is not an appropriate endpoint for FSGS. There's too much variability. So, the next reasonable endpoint to look at is Prognaria, how you measure that other different aspects. And importantly, within duplex, we saw a meaningful effect that was statistically significant on the modified partial remission endpoint. Now, Parasol was created to establish new endpoints. And what we've heard from public commentary and what they've analyzed so far is that, similar to what we saw with duplex, EGFR is not suitable.

Speaker Change: All right, Maury, thanks for the questions. Jula, why don't you take these?

Jula Inrig: Yes, so Parasol is continuing their efforts, and while I can't speak for Parasol, we do know from the duplex study, as I earlier mentioned on the call, eGFR is not an appropriate endpoint for FSGF.

Speaker Change: So the next reasonable endpoint to look at is proteinuria, how you measure that, other different aspects. And importantly, within duplex, we saw a meaningful effect that was statistically significant on the modified partial remission endpoint.

Speaker Change: Now Parasol was created to establish new points and what we've heard from public commentary and what they've analyzed so far

Jula Inrig: So, then what they're moving to next is, well, what is the right endpoint? And they are looking at measures of prognaria and other aspects. And they're making very good progress on these alternative endpoints with a plan to read out a DSN, and they're on track for that. So, what that translates to us is a very exciting place to be for FSGS. Patients in a potential path forward for Phil Spari and FSGS based on the work that they've done to date.

Speaker Change: is that similar to what we saw with duplex, EGFR is not suitable. So then what they're moving to next is, well, what is the right endpoint? And they are looking at measures of proteinuria and other aspects and...

Speaker Change: They're making very good progress on these alternative endpoints with a plan to read out at ASN and they're on track for that.

Speaker Change: What that translates to us is a very exciting place to be for FSGS patients and a potential path forward for Philspari and FSGS based on the work that they've done to date. More to come and we'll give you more of an update later this year.

Jula Inrig: More to come; we'll give you more of an update later this year.

Laura Chico: Thank you. We will take the next question from the line of Laura Chico with Wedgish Securities. Laura Chico, your line is now open.

Morrie Raycroft: Thank you. We will take the next question from the line of Laura Chico with Wedbush Securities. Laura Chico, your line is now open.

Unknown Executive: Hi, thank you very much for taking the question. This is Dylan on for Laura Chico. So when you consider the set up for the second half of 2024, what is more impactful to a phosphoryaptic? Would it be the potential Kedigo guideline revisions, or would it be a potentially updated phosphorypistcribing label?

Morrie Raycroft: Hi, thank you very much for taking the question. This is Dylan on for Laura Chico.

Dylan: So, when you consider the setup for the second half of 2024, what is more impactful to a Fils-Phari uptake? Would it be the potential Codigo guideline revisions, or would it be a potentially updated Fils-Phari prescribing label?

Unknown Executive: Yeah, Dylan, thanks for the question. I would say that we are in such a great position because the timing for us could not be better. It's really the synergy of both. To be able to have Kedigo guidelines that could potentially lower the target, to be able to reach more patients that need better therapy, at a time where we're able to expand our label and reach more patients, we're really excited about both of those occurring near simultaneously to drive further uptake of Phil Sparry as a foundational therapy. So I don't know that we really parse them out as either.

Jula Inrig: I would say that we are in such a great position because the timing for us could not be better. It's really the synergy of both. To be able to have Cadego guidelines that could potentially lower the target, to reach more patients that need better therapy. At a time when we're able to expand our label and reach more patients, we're really excited about both of those occurring near-simultaneously to drive further uptake of Philspori as a foundational therapy. So I don't know that we really parse them out as either.

Speaker Change: Yeah, Dylan, thanks for the question. I would say that we are in such a great position because the timing for us could not be better. It's really the synergy of both. To be able to have Cadego guidelines that could potentially lower the target,

Morrie Raycroft: to be able to reach more patients that need better therapy.

Jula Inrig: We're seeing that they're going to really influence each other in the treatment paradigm. Thank you. Alex Thompson, your line is now.

Unknown Executive: We're seeing that they're going to really influence each other in the treatment paradigm.

Unknown Executive: Thank you.

Unknown Executive: We will take the next question from the line of Alex Thompson with Steeple. Alex Thompson, your line is now open. Hey, thanks for taking our question. I just want to follow up again on parasol. I think you had mentioned in the past that there was an initial meeting, I believe, in June. Can you, were you in attendance? Someone from cheerleader and attendance?

Morrie Raycroft: Thank you.

Speaker Change: Thank you. We will take the next question from the line of Alex Thompson with Stiefel. Alex Thompson, your line is now open.

Jula Inrig: And what is this discussion of moving towards a prognaria endpoint? Really, the topic of the conversation? Any color on the meeting itself would be helpful. Thank you.

Jula Inrig: All right, Julie. One of you takes that one. Yes, thanks for the question. So Parasol is a partnership with academics, FDA, EMA, industry was invited, and yes, we were at attendance. And there is discussion, as I mentioned, around what is the appropriate end point, but that work remains ongoing, with a plan to publicize that work later. I would say that we're very encouraged by the analyses and the data that has been put forward, which gives us increased confidence around a potential password, but we need to wait for the full readout, the full alignment across the different organizations and groups to say, yes, these would be appropriate endpoints to analyze.

Unknown Attendee: Yes, thanks for the question. So Parasol is a partnership with academics, FDA, EMA, and industry was invited. And yes, we were in attendance.

Speaker Change: All right, Jula, why don't you take that one?

Jula Inrig: Yes, thanks for the question. So, Parasol is a partnership with academics, FDA, EMA. Industry was invited, and yes, we were at attendance, and there is discussion, as I mentioned, around what is the appropriate endpoint, but that work remains ongoing with a plan to publicize that work later. I would say that we're very encouraged by the analyses and the data that has been put forward, which gives us increased confidence.

Unknown Executive: And there is discussion, as I mentioned, around what is the appropriate endpoint. But that work remains ongoing with a plan to publicize that work later. I would say that we're very encouraged by the analyses and the data that have been put forward, which gives us increased confidence around a potential path forward. But we need to wait for the full readout, the full alignment across the different organizations and groups to say, "Yes, these are the appropriate endpoints to analyze."

Jula Inrig: And importantly, as I said earlier, we feel solid about the duplex data and about a password for feels sorry for the treatment of FSGF, not only because of our data, but also the unmet need. Great.

Jula Inrig: And importantly, as I said earlier, we feel solid about the duplex data and about a path forward for Fils-Fari for the treatment of FSGS, not only because of our data, but also the unmet need.

Jula Inrig: I just to clarify, I guess you're focused today talking about Prognaria. Is that based on the discussion explicitly, or just your view of duplex? Thanks. So that is based on the discussion that the work has been going on. And this is public. If you look, the parasol says defining a new end point, either based on kidney function, GFR, and predicting preservation of kidney function, which is avoiding dialysis long term. So we increasingly feel encouraged based on the fact and analysis that they've done around EGFR, saying this is a difficult end point. Let's move past EGFR and look at other measurements, of which prognaria is the top of the list.

Speaker Change: Just to clarify, I guess your focus today talking about proteinuria, is that based on the discussion explicitly or it's just your view of duplex? Thanks.

Speaker Change: So that is based on the discussion that the work has been going on, and this is public. If you look, the parasol says defining a new endpoint, either based on kidney function, GFR, and predicting preservation of kidney function, which is avoiding of dialysis long term. So we increasingly feel encouraged, based on the fact and the analysis that they've done around eGFR, saying this is a difficult endpoint, let's move past eGFR and look at other measurements, of which proteinuria is the top of the list.

Unknown Executive: Yeah, I think the only thing that we've had, Alex, is, you know, our perspective is also informed by the work that we've done over the number of years, both in looking at identifying an endpoint like the FSGS partial remission endpoint, as well as subsequent analyses from our Phase 2 duet study where patients were followed for many years, showing that those patients that were able to achieve complete remission really had a better trajectory for their disease. So, I think it's informed by the just stalled of all of the data that we've been doing, and also what we're hearing from, you know, parasol at this point. But, as Jula mentioned, really we've got a way till they report out later this fall.

Jula Inrig: Yeah, I think the only thing I would add, Alex, is.

Speaker Change: You know, our perspective is also informed by the work that we've done over the number of years, both in looking at, identifying...

Alex Thompson: an endpoint like the FSGS partial remission endpoint as well as subsequent analyses from our phase 2 duet study where patients were followed for many years.

Speaker Change: Showing that those patients that were able to achieve complete remission.

Unknown Executive: Great, thanks, Jula Inrig.

Unknown Executive: Thank you.

Speaker Change: Great. Thanks, Jula and Eric.

Tim Lugo: Once again, please limit yourself to one question, and you may rejoin the queue with additional questions. We will take the next question from the line of Tim Lugo with William Blair. Tim Lugo, your line is now open. Hi, Tim. This is John on for Tim. Thanks so much for taking our question.

Speaker Change: Thank you. Once again, please limit yourself to one question and you may rejoin the queue with additional questions. We will take the next question from the line of Tim Lugo with William Blair. Tim Lugo, your line is now open.

Unknown Executive: So I was wondering if you could give us an idea of, say, if the rent requirements for the current FSGS are labeled, we're not adjusted with the upcoming FSGS. What are some of the timelines or data updates we could be looking to for when you'll be looking to reengage with the FDA to discuss amending the rents again? Sure. Well, I think what we can say is consistent with how we've shared our perspective on rents update and providing FDA with additional safety along the way, both from the completion of our trials, such as Duplex, as well as the postmarketing exposure that we've had now that Phil Spari has used commercially.

John: Hi team, this is John on for Tim. Thanks so much for taking our question. So I was wondering if you could give us an idea of, say, if the REMS requirements for the current postpartum label were not adjusted with the upcoming FDUFA, what are some of the timelines or data updates we could be looking to for when you'll be looking to re-engage with the FDA to discuss amending the REMS again?

Unknown Executive: And importantly, as I said earlier, we feel solid about the duplex data and about a path forward for Phil Sparry for the treatment of FSGS, not only because of our data but also the unmet, Great, just to clarify, I guess your focus today talking about proteinuria is that based on the discussion explicitly or just your view of duplex? Once again, please limit yourself. Sure, well, I think what we can say is consistent with how we've shared our perspective on the REMS update and provided FDA with additional safety along the way, both from the completion of our trials, such as duplex, as well as the post-marketing exposure that we've had now that Philspari is used commercially.

Speaker Change: Sure. Well, I think what we can say is consistent with how we've shared our perspective on REMS update and providing FDA with additional safety along the way, both from the completion of our trials, such as duplex.

Speaker Change: as well as the post-marketing exposure that we've had now that Phil Sparry is used commercially. Of course, all of that will be shared with FDA. The first opportunity that we saw to engage the FDA on a potential modification of the REMS

Unknown Executive: Of course, all of that will be shared with the FDA. The first opportunity that we sought to engage the FDA on a potential modification of the rents was in the S and D.A. process, and obviously we're in the midst of that. And we have a practice of not discussing updates along the way in that process, which is why we feel that the first opportunity is at full approval to share that. But we also believe that there are multiple opportunities along the way after approval to continue to bolster the safety package and continued review of the label with FDA along the way.

Unknown Executive: Of course, all of that will be shared with FDA. The first opportunity that we saw to engage the FDA on a potential modification of the REMS was in the SMDA process, and obviously, we're in the midst of that, and we have a practice of not discussing updates along the way in that process, which is why we feel that the first opportunity is at full approval to share that. But we also believe that there are multiple opportunities along the way after approval to continue to bolster the safety package and continued review of the label with FDA along the way. So, more to come very soon.

Speaker Change: was in the S&DA process, and obviously we're in the midst of that, and we have a practice of not discussing updates along the way in that process, which is why we feel that the first opportunity is at full approval to share that.

Speaker Change: But we also believe that there are multiple opportunities along the way after approval to continue to bolster the safety package and continued review of the label with FDA along the way. So more to come very soon.

Unknown Executive: So more to come very soon.

Mohit Bansal: Thanks. Thank you. We will take the next question from the line of Mohit Boncell with Wells Fargo. Mohit Boncell, your line is open.

Mohit Bansal: Thank you. We will take the next question from Mohit Bansal with Welsh. I'm building upon that from a pricing perspective. First of all, let me reiterate what Jula said. I mean, complement pays in a different category than philosophy. From this, philosophy is really the method protected within the kidney, replacing Raj and Vichy. And keep in mind, all new modalities are always being studied on top of Raj and Vichy.

Speaker Change: Thanks.

Speaker Change: Thank you. We will take the next question from the line of Mohit Bansal with Wells Fargo. Mohit Bansal, your line is open.

Mohit Bansal: Hi, this is Saadi Yon from Mohit. Thanks for taking our questions.

Mohit Bansal: And so with a complement inhibitor expected to be approved soon, want to get your view on how Phil Spari and the ERA class would fit into a future treatment paradigm and I again with complement inhibitors and also the new B cell agents coming to market. And yet, do you think there will be a lot of combination use, and do you think doctors right now understand the potential for combination use with these various agents? And do you think costs of these drugs would be a limitation as far as combination use. Okay, great.

Speaker Change: Hi, this is Fadyan from OHIT. Thanks for taking our questions. So with a complement inhibitor expected to be approved soon, I wanted to get your view on how Sulfafari and the ERA class would fit into a future treatment paradigm in IgAN.

Speaker Change: And do you think costs of these drugs would be a limitation as far as combination use? Thanks.

Jula Inrig: Jula, why don't you start, and Peter certainly add anything further from your... Perspective. Thanks. So I want to highlight the treatment algorithm has really always been two prongs. You target the kidney, injury with rattan headers and maybe SLT cues. And then you may also add immunosuppressants to block the immune system activation. So this two-pronged approach target the kidney target the immune system. But increasingly now and over time we're going to have superior, safer medicines for each of those buckets. And you're right; likely combination therapy is going to be needed in the future. But I want to highlight just how far is the only medicine approved or in development that is shown to purity to be able to replace the standard of care role of rattan headers on that side of targeting kidney injury.

Speaker Change: Thanks. So I want to highlight the treatment algorithm has really always been two-pronged. You target the kidney injury with Rasenheider's and maybe SGLT2s.

Speaker Change: And then you may also add immunosuppressants to block the immune system activation. So this two-pronged approach, target the kidney, target the immune system.

Speaker Change: But increasingly, now and over time, we're going to have superior or safer medicines for each of those buckets. And you're right, likely combination therapy is going to be needed in the future.

Speaker Change: But I want to highlight, Fils-Phari is the only medicine approved or in development that has shown superiority to be able to replace the standard of care role of RAS inhibitors on that side of targeting kidney injury.

Jula Inrig: Now when you target immune system over activation, works cited that there's going to be a replacement for steroids on the horizon, whether it's going to be B cell bath, complement inhibitors. And it's clearly going to be that we're going to need multiple medications. Because no one drug now or in development can get all patients into complete remission, which is ultimately the goal. And Eric mentioned this, but we have very strong data around complete remission; a third of patients and protect off there. Two thirds of patients, when they were started earlier, gotten to complete remission and Spartan, but you're still going to need combination, and increasingly we're hearing that we're not going to wait over time.

Speaker Change: Now, when you target immune system over activation, we're excited that there's going to be a replacement for steroids on the horizon, whether it's going to be C-cell, BAF.

Speaker Change: and it's clearly going to be that we're going to need multiple medications.

Speaker Change: because no one drug, now or in development, can get all patients into complete remission.

Jula Inrig: We're likely going to be using therapy early on after diagnosis and in combination really to optimize long-term outcomes for patients of hygiene and property.

Peter Heerma: Yeah, they're going to come up from some uprising, respect the principle that we reiterate the zero set, I mean, complement phase in a different category than feel sorry from this. So, it's really the method protected with indicate me replacing a large vision and determines all new abilities are always being studied on top of the rising vision. We've got from their perspective and how they think about innovative culmination purpose. You have to take it to consideration. It's a serious ice for broad use and broad utilization. We're really allowing to position it as a foundation of care.

Speaker Change: I'm really pulling from a pricing perspective. First of all, let me reiterate what Jula said.

Mohit Bansal: Complement plays in a different category than psilocybin. From this, psilocybin is really the methyl protective group in the kidney replacing Rajan Bichin. And take in mind, all new modalities are always being studied on top of Rajan Bichin.

Mohit Bansal: With regard to payers and how they will think about innovative combination therapies, you have to take into consideration that Philospile is priced for broad use and broad utilization, really allowing it to position it as foundational care. It's priced at a very different level than the complement inhibitor that you were referring to that already has an indication of PMA, or even or a lot. So maybe just a little bit.

Speaker Change: With regards from a payer perspective and how they will think about innovative combination therapies.

Speaker Change: You have to take into consideration that Philospire is priced for broad use and broad utilization, really allowing to position it as a foundational care. It's priced at a very different level than the complement inhibitor that you were referring to that already has an indication of PNH.

Peter Heerma: It's priced at a very different level than the continuing inhibitor that you were referring to that already has an indication DNA.

Peter Heerma: Additionally, I also want to say like we have a very strong update at the fair side, and we are now already included in over 1250 formulas across the nation. So, very strong positioning in foreign base of close battery. So, I feel quite good about that, but again, it's based in a different category and close battery is priced at broad utilization.

Mohit Bansal: Additionally, I also want to say, like, we had a very strong uptake at the payer side and we are now already included in over 1,250 formularies across the nation, so a very strong positioning in formularies for Pillsbury. So I feel quite good about it, but again, it's placed in a different category and Pillsbury is prized for broad utilization.

Peter Heerma: Thank you. We will take the next question from the line of the no divan with Guggenheim Securities. The no divan your lines now open. Great, thanks for taking my question. So, this is one going back to the patient's star forms for close battery. So, it looks like you've had sort of steady increases in the number of patient star forms; that the increase in actual sales is much more significant. Or even over the last few quarters relative to the percentage increase on the PSF side. So, just curious what's driving that is a sort of better conversion of people getting PSF's getting started on therapy.

Speaker Change: Thank you. We will take the next question from the line of Vanil Devan with Guggenheim Securities. Vanil Devan, your line is now open.

Speaker Change: Great, thanks for taking my questions. This is one going back to the patient start forms.

Speaker Change: Increase in actual sales is much more significant this quarter or even over the last few quarters.

Speaker Change: Relative to the percentage increase on the PSF side. So just curious what's driving that, is that it's just sort of better.

Peter Heerma: Is it maybe something more on the net pricing side? Is it driving that we're getting more net sales per script? Or maybe it's just a timing thing where there were PSF's written earlier that just took some time to get pills. So, maybe just a little bit.

Peter Heerma: More visibility; there would be hopefully going to get a sense of what's expected going forward.

Peter Heerma: All right, Peter, why don't you take up? Yeah, first of all, I mean, there's a continuation of growth in both sectors, both space and stock farms, that speaks to continued demands, but in particular also on the progress that we have made on revenue. And I think the revenue growth, where you're going, is like, why do you see a much stronger growth percentage on revenue relative to demand? I think it's really like a reflection of the continuation of efficiency; we have a more social process. And I think the only question today was about the pocket of space that we saw last year, that are part of the cumulative amount of space in storms, that, of course, a little slower uptake in the transition to pay chickens, that we have made our modifications there.

Speaker Change: on revenue relative to demand. I think it's really like a reflection of the continuation of efficiencies we have in our fulfillment process. And I think an earlier question today was about like the pocket of spaces that we saw last year that are part of the cumulative amount of patient storms.

Speaker Change: Thank you.

Peter Heerma: And we've seen our mitzvastar ram certifications early on that allows them to pay four patients for and get them to pay chickens for the organ. I think that is really the reflection of the efficiency; that's the impression that you see in that revenue growth.

Eric Dube: Yeah, I think Peter. Thanks. The only thing that I would add, Bumble, is that we have a very high rate of compliance and persistence with this medication. These patients get good support for the chronic use of Phil Spari. But I think the one thing that's impressed me so much with this launch are the personal stories that we hear on a weekly basis about patients that finally, for the first time since their diagnosis, oftentimes for decades, they finally on Phil Spari feel like they're winning and that their potent area is under control. That drives so much of the high compliance rate that we see, and that's what one of the things that gets me really excited about the long term outlook for Phil Spari.

Peter Heerma: Yeah, I think, Peter, thanks. The only thing that I would add, Vamil, is that we have a very high rate of compliance and persistence with this medication. These patients get good support for the chronic use of filspari, but I think the one thing that's impressed me so much with this launch are the personal stories that we hear on a weekly basis about patients that finally, for the first time since their diagnosis, oftentimes for decades, call? I'll hand the call back. Great. Thank you everyone for joining us for our second quarter 2024 financial results call. We look forward to providing additional updates on our progress. Have a great rest of your day.

Peter Heerma: They finally, on Philspari, feel like they're winning and that their protein area is under control. That drives so much of the high compliance rate that we see, and that's one of the things that gets me really excited about the long-term outlook for Philspari.

Eric Dube: Okay, thank you.

Unknown Executive: Thank you. We will take the next question from the line of at RC with HC Lane, right? At RC, your line is now open.

Speaker Change: Okay. Thank you. Thank you.

Unknown Executive: Hi, good afternoon, everyone. This is Thomas. You've been asking a couple of questions for that. Thank you so much for picking up questions.

Unknown Executive: So one from us, can you discuss the average assistant rates of patients on Phil Spari and what is the average time to convert PSF to drug fulfillment for Phil Spari? Thank you so much.

Peter Heerma: All right, thanks, Thomas.

Peter Heerma: So, Peter, why don't you take those questions? Yeah, it was referring to the high persistency and compliance rates with the high and what you would expect for chronic therapy. Like Phil Spari, we haven't disclosed the specific numbers with regards to the time to get to page shipments. I think at the long call last year, I mentioned that in my experience, in average, you see in rare disease fulfillment time between 20 and 60 days. I think we are always in the best part of the world, initially at a higher end, and now we are at the more efficient part of the Phil film.

Speaker Change: With regards to the time to get to paid shipments, I think at the launch call last year, I mentioned that in my experience, in average, you see in rare disease,

Peter Heerma: fulfilled in time between 20 and 60 days.

Peter Heerma: So I think we are making really good progress in the time to feel to my earlier answer. I think that's also reflected in the revenue goes this long.

Unknown Executive: Thank you.

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

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

Nivi Nehra: Thank you, everyone, for joining us for our second quarter of 2024 financial results call. We look forward to providing additional updates on our program.

Peter Heerma: Great, thank you everyone for joining us for our second quarter 2024 financial results call. We look forward to providing additional updates on our progress. Have a great rest of your day.

Nivi Nehra: Have a great rest of your day.

Unknown Executive: This does conclude today's presentation. Thank you for your participation.

Unknown Executive: You may now disconnect. Thank you.