Travere Therapeutics, Inc.

Good afternoon and welcome to the Travier Therapeutics first quarter 2025 financial results conference call. Today's call is being recorded. At this time, I would like to turn the conference call over to Victoria Prescott, manager of investor relations. Please go ahead, Victoria.

Thank you, Chloe. Good afternoon and welcome to Travier Therapeutics first quarter 2025 financial results and corporate update call. Thank you all for joining. Today's call will be led by Eric Dubay, our president and chief executive officer. Eric will be joined in the prepared remarks by Dr. Jula Inrich, our chief medical officer, Peter Hirma, our chief commercial officer and Chris Klein, our chief financial officer. Dr. Bill Rowe, our chief research officer will join us for the Q&A. Before we begin, I'd like to remind everyone that statements made during this call regarding matters that are not historical facts are forward-looking statements within the safe hardware provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not guarantees of performance. They involve known and unknown risks, uncertainties and assumptions that may cause actual results, performance and achievements to differ materially from those expressed or implied by the statement. Please see the forward-looking statement disclaimer on the company's press release issued earlier today as well as risk factors section in our forms 10Q and 10K filed with the SEC. In addition, any forward-looking statements represent our views only as of the date such statements are made, May 1st, 2025. And Trevier specifically disclaims any obligation to update such statements to reflect future information, events or circumstances. With that, let me now turn the call over to Eric.

Thank you, Victoria, and good afternoon, everyone. We entered the year determined to solidify Phil Spari's foundational positioning in i-janephropathy, unlock additional growth for Phil Spari through a potential new indication in FSGS, and continue advancing toward restarting enrollment in our pivotal harmony study of peg-debatinase in HCU. And I'm pleased to report that we are making great progress with strong results in each of these three areas. Let me begin with Phil Spari in i-janephropathy. Following its full approval last fall, we saw momentum continue throughout the first quarter. Net sales at Phil Spari grew 182% year over year and 13% versus the prior quarter, which reflects continued demand and strong uptake. We also continue to see high compliance rates, a growing patient base and an expanding group of prescribing physicians, which illustrates the positive Phil Spari experience. This strengthens our confidence in the durability and long-term trajectory of growth. At a time of continued evolution in the i-jane treatment landscape, Phil Spari remains uniquely positioned as the only fully approved non-immunosuppressive kidney-targeted therapy that has shown superiority over the historical standard of care. Recent market research continues to validate this positioning as nephrologists regularly highlight Phil Spari's strong clinical data, real-world effectiveness and safety profile for chronic use, all of which underscores its role as a foundational therapy for i-janephropathy. We continue to believe that Phil Spari can become foundational care outside of the US as well. Recently, the European Commission and the MHRA in the UK converted Phil Spari's conditional approvals to full approvals for the treatment of adults with i-janephropathy, an important milestone that will enable our partner CSLV4 to expand access to patients across Europe and the UK. Our partner, Renalis, also continues to make good progress, and they remain on track to report top-line data in the second half of this year from their pivotal study in i-jane to support a regulatory submission in Japan. Turning to FSGS, we have made excellent progress towards our role of bringing Phil Spari to a community that currently has no approved medication. After aligning with the FDA on our plan to submit an S&DA for an FSGS indication, we completed our submission in March. This reflects our team's dedication to a community that has been waiting for decades. We expect to receive notification of the FDA's acceptance of this filing later this month. If we are granted priority review as expected, Phil Spari could be approved and ready to launch in FSGS as early as September. This would mark a historic milestone. Phil Spari would become the first and only approved medication indicated for patients with FSGS. We continue to believe that the opportunity in FSGS is potentially even larger than that in i-jane, given the urgent unmet need in this disease. Our team is advancing preparations to execute a successful launch so we can deliver Phil Spari to the FSGS community quickly if approved. We also remain very enthusiastic about Peg-Dibatinase, or Peg-T, our investigational therapy for classical homocystinuria, or HCU. Peg-T has the potential to be the first disease-modifying treatment for HCU, and we continue to make strong progress towards restarting patient enrollment in the Phase III Harmony Study next year. We remain committed to the HCU community and believe Peg-T has the potential to significantly improve the lives of these patients in the future. Looking ahead, we remain confident in our strategy with strong fundamentals and a clear focus on executing our key priorities. Let me now hand the call over to Jula for a clinical update. Jula?

Jula Hussain-Burkman, MD, MD Thank you, Eric. Across our programs, we continue to deliver on our mission of transforming care for people living with rare kidney and metabolic diseases. We are making strong, steady progress toward our goal of establishing Filspari as a foundational treatment for patients with IJ nephropathy across the full disease continuum, from early diagnosis through post-kidney transplant. As the only available medicine that optimally blocks two critical pathways, endothelin-1 and angiotensin-2 in a single pill, Filspari offers unrivaled efficacy and convenience for preserving kidney function for patients with IJ nephropathy and with a safety profile comparable to herbicartin. At the National Kidney Foundation Spring Clinical Meeting, we were pleased to receive highly encouraging feedback on the foundational role of Filspari for treating patients with IJ nephropathy. Physicians reported earlier diagnosis of their patients with IJ nephropathy, driven by referrals and biopsies earlier in the disease process. Importantly, more clinicians are now prescribing Filspari earlier in the disease course and treating to lower targeted proteinuria thresholds. This is based on data demonstrating that reducing proteinuria to the recommended draft KDGO treatment thresholds of less than 0.5 grams per day or ideally 0.3 grams per day, preserve kidney function and result in better kidney survival in patients with IJ nephropathy. It is important to remember that Filspari is the only non-immunosuppressive kidney targeted therapy indicated for adult patients at risk of IJ nephropathy progression, regardless of their proteinuria level. And we are increasingly hearing from nephrologists that they are observing consistently positive results across the wide range of patients with IJ nephropathy that they treat, some of which were presented in real world case series at NKS. We also presented additional data from the Spartan study, which adds further depth to Filspari's clinical story. In Spartan, Filspari is being evaluated as a first line treatment. The data reported at NKF showed that treatment with Filspari resulted in approximately 70% proteinuria reduction from baseline and stabilization of EGFR over 24 weeks. Additionally, nearly 60% of patients achieved complete proteinuria remission during the treatment period. We also presented the first evidence in humans of Filspari's anti-inflammatory effects, specifically a 50% reduction in urinary soluble CD163 over 24 weeks in newly diagnosed treatment naive patients with IGAN. This data resonated with nephrologists as Filspari not only addresses the kidney damage, but has the potential to also reduce immune system response and inflammation in the kidney that contributes to progression of IGAN and without the need for systemic immunosuppression. We expect to share additional exciting data from this ongoing study later this year. Recognizing that nephrologists are data driven, we are generating additional evidence to support the use of Filspari across the full continuum disease, including in recurrent disease after kidney transplantation. This remains an area of high unmet need and our upcoming studies present a critical opportunity to generate data that will help physicians evaluate Filspari as a potentially beneficial non-immunosuppressive treatment option. We are currently in study startup for these studies and plan to provide further updates in the future. For a safety update, we are pleased with the progress of our submitted SNDA for modification of the liver monitoring frequency, as well as removal of the embryo fetal toxicity REMs. Notably, as patient exposure to Filspari increases, we have not seen any cases of Heise's Law. And we now have enough exposure data to rule out a potential risk of drug induced liver injury of one in a thousand. We remain on track for our August 28th PDUFA date for this submission and look forward to providing further updates as they become available. Now turning to FSGS, Filspari continues to be the only potential treatment in development with data showing efficacy across patients with either biopsy proven or genetic FSGS. Importantly, the Filspari data have shown remarkable consistency in reducing proteinuria across all FSGS subtypes studied, particularly important for difficult to treat populations, including primary and genetic forms of FSGS, as well as in pediatric patients. Data supportive of this broad efficacy is even more critical in FSGS than in heterogeneity and complexity of the disease. At NKS, we presented new analyses from the FSGS duplex study, which demonstrated that patients achieved partial and complete remission of proteinuria earlier and more often with Filspari versus herbicartin. And importantly, those patients who achieved partial or complete proteinuria in the study had 67 to 77% lower risk of kidney failure, respectively. These important findings are the first randomized clinical trial analyses to validate the observational data from Parasol and further support the Parasol recommendation of proteinuria as a surrogate endpoint in FSGS. Following our SNDA submission for FSGS, our interactions with the FDA have been productive and consistent with the experience we had during the IGAN process. As Eric highlighted earlier, we anticipate notification of our acceptance of our application later this month, and if granted priority review, we expect potential approval this fall. Finally, our PEG-T program continues to make good progress. And we are on track to restart enrollment in our phase three Harmony study next year. We are also pleased to share that our phase one to compose study manuscripts has been accepted for publication in the top tier peer review journal, Genetics and Medicine. This publication will further reaffirm PEG-T's potential to become the first disease modifying therapy for the HCU community. In summary, the first quarter marked another strong period of clinical and scientific advancement. Our programs are maturing in ways that deliver not only improved clinical outcomes, but real meaningful change in how physicians approach these chronic and complex diseases. We are excited for what lies ahead and look forward to keeping you updated as we move through the rest of the year. I'll now turn the call over to Peter for a commercial update. Peter?

Thank you, Jula. The first quarter marked a strong start to the year for our commercial team and Phil Sparry. We saw continued momentum following full FDA approval in IDA nephropathy, which resulted in approximately 56 million in net product sales of Phil Sparry in the first quarter. This reflects further growth driven by an increasing prescriber base and deepening penetration amongst experienced prescribers. We received 703 new patient start forms in the first quarter, a robust continuation of the heightened demand we have seen since full approval. Importantly, we saw consistent -over-month growth throughout the quarter, culminating in March being our strongest month since launch, and demand in April continued this trend. This highlights the beliefs physicians have in Phil Sparry's efficacy profile as the only kidney targeted therapy to demonstrate rapid and sustained protein reduction and benefit in kidney function preservation, with efficacy superior to that of a maximally dose active comparator and a safety profile that is comparable over two years. The expansion of Phil Sparry's label to more patients with IDA nephropathy, regardless of their proteinuria levels, has also amplified physicians' confidence in choosing Phil Sparry for the broad spectrum of their patients. In fact, what we are seeing is a meaningful shift in prescribing behavior. The median proteinuria levels at initiation continue to trend below 1.5 gram per gram, and many existing prescribers are now initiating treatment in patients with proteinuria levels below 1 gram per gram. This change reflects growing alignment with the updated draft Codigo guidelines, which recommend earlier intervention and more ambitious treatment goals to optimize long-term outcomes. From an access and fulfillment standpoint, patient experience remains strong. We have maintained broad coverage across players, with criteria easing across the board following the label expansion at full approval. Most notably, this has resulted in the removal of proteinuria thresholds in multiple payer plans. These developments are making Phil Sparry more accessible, more quickly, to the patients who need it, which pairs nicely with the efficiencies we continue to realize in our fulfillment process. Also, our patient services are highly valued as evidenced by survey responses indicating that 90% of the Phil Sparry patients are highly satisfied with the services provided through Travier Total Care. Patient compliance and persistent rates continue to be higher than benchmarks, further reflecting the convenience, durability, and efficacy of Phil Sparry, and an indicator of patients being highly satisfied with their Phil Sparry experience. Looking ahead, we are well positioned to upgrade the historical standard of care of ACE inhibitors and ARBs, which will drive continued revenue growth in 2025. As the only non-immunosuppressor therapy that is fully approved for the adult IgA nephropathy patients at risk of progression, independent of proteinuria levels, Phil Sparry continues to see broad uptake across some groups of patients. We expect Phil Sparry will remain the leading choice for upgrading foundational care, and we anticipate the largest segment of patient uptake to continue coming from those with UPTR levels below 1.5 gram per gram, which we estimate represents roughly 70% of the 70,000 addressable patients. The expected upcoming finalization and publication of the KidEgo guidelines will likely reinforce the shift to earlier and more ambitious treatments, consistent with the Phil Sparry label and prescribing trends. Our latest market research shows that approximately 75% of nephrologists are now targeting proteinuria below 0.5 gram per gram, with nearly a third targeting even more ambitious goals of 0.3 gram per gram, meaning complete remission. Our market research and feedback from nephrologists also indicates that the REMS requirements do not have a meaningful impact on the intention to prescribe. That said, potential future modifications to the REMS will further enhance the product convenience, particularly for newly diagnosed or lower risk patients. Turning to FSDS, we are preparing our commercial organization to be ready for a successful second response in anticipation of a potential new indication. With up to 30,000 addressable patients, FSDS is the most progressive and symptomatic glomerular disease. If approved, Phil Sparry could be an important new treatment option for a community with no approved medicines today, representing a significant opportunity, potentially even greater than in IGN nephropathy. We are in the early stages of expanding our commercial team, building upon our existing infrastructure. Given the significant overlap between the prescriber basis for FSDS and IGN nephropathy, we are confident that we can efficiently and effectively deliver Phil Sparry to FSDS patients from the outset, if approved. I am pleased with our progress and we will be prepared for a potential approval later this year. In summary, our performance in the first quarter clearly demonstrates the strengths and effectiveness of our commercial team. Phil Sparry is delivering on its promise and our team is building strong, sustainable momentum heading into the rest of the year. Positioning us for significant growth in IGN nephropathy and preparing the organization for a successful launch is approved for FSDS. Let me now turn the call over to Chris for the financial update. Chris?

Thank you Peter and good afternoon everyone. As you heard from the rest of the team, we are pleased to report another quarter of great execution. This was driven by continued momentum in the ongoing Phil Sparry launch and leveraging our strong financial foundation to strategically invest in the key priorities that are delivering growth now and in the future. I'll start with revenue where we generated net product sales of $75.9 million in the first quarter, representing 90% growth over the same period last year as well as continued sequential growth over last quarter. Phil Sparry maintained great momentum in the first quarter generating $55.9 million in net product sales. We achieved this despite gross to net discounts being higher as a result of the typical insurance coverage changes in the beginning of the new year and the implementation of the RRD redesign. As we outlined at the beginning of the year, we continue to anticipate that we will have higher gross to net discounts for Phil Sparry in 2025. That continued momentum in demand, high compliance and persistence will drive significant growth in Phil Sparry sales throughout the year. Viola and Viola EC also contributed $20 million in net product sales for the first quarter. We continue to anticipate more generic competition for Viola and Viola EC in the coming quarters. We continue to be pleased with the performance thus far. During the quarter, we also recognized $5.9 million of license and collaboration revenue, which results in total revenue of $81.7 million reported for the first quarter of 2025. Of note, during the quarter, we sold drug product to our partner, CSLV4 as they continue their launch of Phil Sparry in Europe. This activity accounted for $3.8 million of the license and collaboration revenue and a nearly proportional increase in goods sold for the quarter. Starting to operating expenses, our research and development expenses for the first quarter of 2025 for $46.9 million compared to $49.4 million for the same period in 2024. The decrease in RRD is largely attributable to reduced costs associated with the development of Phil Sparry as our Phase III programs advance towards completion. On a non-GAAP adjusted basis, RRD expenses for $42.2 million compared to $45.8 million for the same period in 2024. Selling general and administrative expenses for the first quarter were $72.8 million compared to $64.2 million for the same period in 2024. The increase in SG&A is largely attributable to increased investment in the Phil Sparry launch following full approval, as well as increased amortization expense related to Phil Sparry royalties. On a non-GAAP adjusted basis, SG&A expenses were $53.3 million for the first quarter compared to $48.2 million for the same period in 2024. Total other income net for the first quarter of 2025 was $1.5 million compared to $3.5 million in the same period in 2024. The difference is largely attributable to lower interest income during the period. Net loss for the first quarter of 2025 was $41.2 million for 47 cents per basic share compared to $136.1 million or $1.76 per basic share for the same period in 2024. On a non-GAAP adjusted basis, net loss for the first quarter of 2025 was $16.9 million or 19 cents per basic share compared to $116.2 million or $1.51 per basic share for the same period in 2024. As of March 31, 2025, we had cash, cash equivalents, and marketable securities totaling $322.2 million. We expect to receive a $17.5 million milestone payment from CSL v4 during the second quarter as a result of the recent conversion of conditional approval of Phil Sparry to full approval in Europe. We also anticipate additional milestone payments tied to key market access achievements later this year and sales-based achievements in the future, which should further enhance our financial flexibility. As we look to the remainder of the year and beyond, we expect continued strong demand for Phil Sparry and IG and Afropacy with net product sales projected to grow meaningfully this year and maintaining a pace well above benchmark launches. We're continuing to thoughtfully invest in both near-term execution and longer-term growth drivers. This includes supporting the further success of the IG and Afropacy launch, advancing launch readiness for potential FSGS approval, and enabling the restart of enrollment in the FIBITL PEC to BATINAS program. Like many others, we are continuing to monitor legislative developments and geopolitical uncertainties. Based upon what we know today, if tariffs are extended more broadly to pharmaceutical products, we believe the impact to Phil Sparry would not be material. Importantly, with a strong balance sheet, a clear set of priorities, and continued strong execution, we're well positioned to fund our strategic initiatives and drive sustainable growth. With that, I'll turn the call over to Eric.

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

Thank you, Eric. Operator, we can now

open the line up for the Q&A. Thank you. At this time, if you would like to ask a question, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, please press the pound key. Thank you. Our first question comes from the line of Tyler Van Brin from PDCOW. When your line is open.

Hey, guys. Thanks very much, and congratulations on the progress. Can you just elaborate on any interactions with the agency you've had since you filed the SMDA for FFGS and how those have gone? And is the FDA feedback that's been publicized by competitor Dimerics consistent with your experience with the agency?

Tyler, thanks for the question. I'll turn that one over to Bill.

Yeah, thanks, Tyler. Well, we're seeing the same headlines that everyone else is, and it's clearly a dynamic situation. With that said, as we look at the reviewers for our FFGS SNDA, we see consistency there, and our FDA interactions have been progressing as we expected. As we continue to anticipate the PDUFA date for the potential REMS toward the end of the summer, and our continued review on the SNDA for FFGS, I can report that the interactions that we have are very similar to what we've experienced in the prior year with the IGAN indication at this stage in the process. So, you know, the experience that we're seeing on the other side of the table matches what we would expect and what we've been used to in the past. With respect to your other comment, it was pleasing to see the confirmation from the FDA with a different product that there was consistent feedback supporting the use of proteinuria as an approval-based endpoint for FFGS.

Okay, Operator, do we have any other questions?

Yes, as a reminder, we ask that you limit yourself to one question. If you have another question, please rejoin the queue. Our next question comes from the line of Amir Dabin from Kogan. Hi, your line is open.

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

Thanks. Well, thanks for the question.

I'll turn back to Amir. My expectation is that the indication statement would be for the treatment of FFGS in patients ages eight and up because that matches what we studied. The inclusion criteria for the duplex study was broad and we also know from post-study analysis, we have a very good description the patient types based on their histology and their genetic makeup for many of those patients where we can segregate their causes. What we can conclude from that is that we recruited a population of primary FFGS, genetic FFGS, and saw consistent effects across all of those subtypes. I think that when we think about FFGS as a podocytopathy, the injury and the cause may come from different sources, but ultimately FFGS is a damage to the podocyte and treatment with sparsentin blocking angiotensin and endothelium hits a common disease pathway that's beneficial independent of the heterogeneity that's part and parcel of the FFGS diagnosis.

Okay, thank you.

All right, next question comes from the line of Joseph Schwartz from Urine Care. Line is open.

Great. Hi, everyone. This is Will Anford-Joe. Congrats on a strong quarter in progress here. So I guess one from us with the recent approval or accelerated approval of Novartis' second therapy in high GANS. Can you provide a bit more color on what your sales reps are seeing in the field? Is there some counter detailing that's ongoing and what are the main types of questions your reps are getting? And then maybe piggybacking off of this, it seems like the nephrologist's more extensive experience with Sils-Sparry and buying with the EDFR data on the label might make it a preferred choice for a new patient. Is that something you're seeing in the field or is it a bit early to tell? Thank you.

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

Yeah, thanks, Will. Well, it's very early. It's one month now that Atos and Ton has been approved. I think first of all, it's good for patients to have more medicine in the market and I think especially as IGA and property is a marketing development that historically was seen as a benign disease and now there's much more recognition that those patients should be treated earlier and more aggressively and I think more companies raising that importance I think is good for the market. To have an endothelin inhibitor in the market will also further amplify the importance of inhibiting endothelin as part of foundational care. So I think in that respect it will help us to competition and what we have heard. It's very early. We haven't really heard so far too much in the marketplace but what I mentioned in the call is that we have seen continued growing demand this year so far and that growth continued in the month of April with what the first month that Atos and Ton was in the market and I think that speaks to the confidence that physicians have on the profile that Phil-Sparry has and I think you mentioned in her prepared remarks, data matters for nephrologists. They have seen that Phil-Sparry has long-term kidney preservation data and unprecedented proteinuria reduction that's sustained over a long period of time with this weird consistency of inhibiting two receptors that results in a efficacy benefit as well as convenience benefit for patients. One pill, one co-pay. So I'm confident in the profile of Phil-Sparry and yeah I welcome other modalities coming to the market because I think that further reinforces the importance for patients to be treated earlier and more aggressively.

Great, thank you so much.

Our next question comes from the line of Anupam Rama from JP Morgan. Your line is open.

Hey guys, thanks so much for taking the question. I was wondering if you could expand a little bit on your -to-Nes comments in your opening remarks, you know, maybe helping us understand the type of impact you saw in one queue and give us a little color here about if looking to the balance of the year -to-Nes actually tail in with the reversal of the impact that you saw in one queue. Thanks so much.

Thanks Anupam. Chris, why don't you take that question?

Yeah, thanks for the question Anupam and I think it's probably easiest to compare it back to what we saw last year versus this year where last year we had -to-Nes really in the mid to high teens and what we experienced there was the highest discount at the beginning of the year and then it eased through the balance of the year.

This

year we're guiding to -to-Nes that are going to be in the low 20s and with the changes to, you know, just the entrance coverage as well as with Part D redesign we did see that increase in the first quarter as we normally would expect but we also anticipate with the Part D redesign and also, you know, the coverage that comes along with that or exposure to the catastrophic coverage going forward we're going to see at least that portion of our -to-Nes be a bit stickier than it was last year so it'll probably be a little bit more even than it was last year but we do expect at least for the fundamental pieces of -to-Nes to be the highest in queue one.

Thanks so much for taking the question.

Our next question comes from the line of Lora Chico from Wet Bush Securities. Your line is open.

Thank you very much. Good afternoon. One question for you on the cadence of patient star form. It was interesting to see the number tick up a little bit over the prior quarter and Eric, I think you had made some comments prior to this about expectations around maybe the rate of growth here. So just wondering if you can have any comments or thoughts on the sustainability of this kind of metric and where this might go over the course of 2025. Thank you.

Sure. Laura, thanks for the question and Peter, why don't you take this one.

Yeah, thanks Eric and thanks Laura for that question. What I would say is that we have seen significant acceleration of growth with the broader label after full approval and we continue that growth trajectory with 703 new patients start forms in the first quarter. I think most importantly is that you have to realize that Phil Spire is a chronic treatment and we continue to see very strong compliance and persistent rates. So we built upon a very robust and healthy revenue base and it gives me confidence that we will see a continuation of meaningful revenue growth moving forward.

Thank you, Peter. Laura, the other thing that I would add is as we look at the patients that we believe are in need of an upgraded therapy, essentially those patients that are on RAS inhibitors that are not at the new CADEGO guidelines, Peter alluded to this in his prepared comments that this is where we're seeing the majority of the new growth coming from. Physicians are looking earlier for patients to be upgraded from the RAS inhibitor to Phil Spire and that really is a sustainable source of growth moving forward because there are so many patients that are not yet at that guideline of 0.5 or 0.3 and so we expect that that is going to continue to be a major driver of our PSF growth moving forward and as Peter also mentioned, not many of the other therapies have that broader indication or the support of the guidelines to be able to reach those patients. So I think that's one of the key drivers as we think about the sustainable addition of new patients to Phil Spire.

That's helpful. Thank you.

Our next question comes from the line up. Lisa Baker from Coriolanus

open. Hi there, thanks for taking the question. There's a couple for me. I was wondering if you could just break out, I know we talked about this a little bit, but what percentage of prescriptions are you seeing that are below 1.5 grams now that you have label expansion versus above 1.5 grams and then are you seeing any change in sort of new patient ads now that we after SanTan? I mean in some ways having another player there can grow the market and grow awareness. In some cases you see kind of new patient ads sort of stabilize or even drop off a little bit. I'm just wondering what kind of early trends you're seeing there and I think that's it for me. Thanks.

All right, Lisa, thanks so much for the questions and Peter, why don't you take those?

Yeah, let me, so it's two questions that you're asking. The first one is with regards to like the breakdown of different levels of proteinuria. We haven't broken it down specifically, but what we are seeing is that the median trend of proteinuria levels are going down and is now well below 1.5 grams per gram and in particular with experienced prescribers we see that there is a meaningful amount of physicians that are now prescribing below one gram per gram as well. I think that is the most important takeaway and to Erika's earlier point that allows for a sustainable growth opportunity over time since Phil's Power is the only non-immunosuppressive treatment that is fully approved without a proteinuria limitation. We forgot to your second question on Atra and what trends we are seeing. Well, the trends that we are seeing is very consistent to what we have seen so far. That's a continued demand growth that continued in April as well. So we haven't seen any impact and to your point, I mean I mentioned that earlier there is a market improvement with more companies talking about like the urgency to treat and now in particular with more companies talking about the importance of endothelium. So, so far the trends that we have seen are positive and we continue on very strong growth trajectory.

Operator? Operator, can we go to the next question please?

Yes, our next question comes from the line of Greg Harrison from Scotia Bank. Your line is open.

Hey, good afternoon guys and thanks for taking the question. Wondering about your assessment of the impact that the removal of the REMS program could have on the trajectory of new patient starts in IGAN. Is it maybe on the level of the inflection you saw since you were granted full approval compared to the period before that or just trying to get a sense of you know the additional patient flow that you may see if that's granted?

Greg, thanks for the question and for context we are on track with the PDUFA date to modify that the REMS in August, late August and Peter why don't you talk about your view on what that impact could have?

Yeah, happy to Eric and Greg thanks for that question. I would say first and foremost REMS has not been an obstacle in our performance. In fact, Phil Sparry is being the most successful of the four most recent RAN nephrology launches. All of the comparators actually did not include REMS. So with the REMS we were able to kind of like set a -in-class benchmark. Having said that and to Eric's earlier points we want to provide the best in class treatment option and we want to do that in the most convenient way for patients and physicians and we are therefore looking forward to the modification we anticipate in late August.

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

Hi this is Fadi Erhan on for Mohit. Thanks for taking our question. So I have a question on FSGS on the Dimeric. Recently there was a partnership announced for US commercialization of that asset. How are you thinking about the benefit of that drug versus Farsun-10 and FSGS? And do you think they could still be significantly further behind from launching in the US based on their enrollment status and how long it took for Duplex to enroll? Thanks.

All right thank you for the questions. Jula I'll pass those to you.

Yeah thanks for the question. I would say the important takeaway is that we're very pleased to see the alignment with the FDA on Paracel. That protein area can be an endpoint for full approval at two years in FSGS. When you look at their data we really don't have a lot of data. We have some phase two data from Dimeric 200 and it's going to be many years before we see their full two-year protein area data because as they've stated they're still enrolling. They hope to finish the end of this year but to be determined when they complete that enrollment. But I would also add that the MOA of DMX 200 of CCR2 antagonism is certainly complementary for PhilSparry if it becomes available in the future.

All right next question comes from the line of Mari Raycroft from Jeff and Lisa.

Hi thanks for taking my question. I'm wondering just for PhilSparry and IGAN what the split is between new versus repeat prescribers and can you provide more granularity on what you're seeing on compliance and persistence rates? I guess what's the average amount of time that patients are staying on treatment?

All right Mari thanks for the questions. Peter we'll hand that one over to you.

Yeah this split is slightly more skewing to experienced prescribers with a very healthy continuation of new prescribers as well. So that was the first part of your question. The second part of your question. Compliance. Compliance yeah and I mentioned that in the prepared remarks as well. If you compare the PhilSparry compliance and persistence to compare to Ben's morgues, chronic disease, non-symptomatic disease at a very high end. We haven't given call what this exactly but it's at a very high end which you would expect. Got it. We speak to the confidence and the satisfaction of patients as well.

Our next question comes from the line of Prahar Agrawal from Kantor. Your line is open.

Hi thank you for taking my questions and congrats on the quarter. So on the FSGS and expectations for the launch. I just wanted to get some color there. Among the 15 to 30,000 addressable patients for FSGS in the US, how many of these are currently managed by PhilSparry top prescribers and any thoughts on how you expect the launch to be when approved? And if I can just follow up here on the pair discussions on FSGS pricing. Wondering if you got any feedback there given the possibility of double the pricing and whether that's feasible here. Thank you.

Sure. Thanks for the question. I'll take the one on pricing and Peter can talk about the overlap and where these patients are being treated. So our overall pricing strategy for FSGS is very similar to IGAN in that we want to make sure that there is broad access to PhilSparry which is really critical for us in establishing it as a foundational therapy where a broad swath of the community should have access to PhilSparry. We have mentioned that it's likely there would be double the price for adult patients at the target dose given double the dose. And we believe that given the unmet need and the more rapid progression that FSGS patients have to kidney failure that that higher price certainly would come with high benefit for these patients. With regard to the outlook for the launch, we certainly expect that that uptake could be quite rapid and certainly more rapid than what we've seen in FSGS because of the high unmet need but also because of the high awareness and experience, the success that Peter's team has had in IGFROPCY. And with that I'll have Peter talk about what that overlap is in prescribers and where these 30,000 patients are.

Excellent. Well thanks Eric and I think you covered quite a lot of the question already. Through your point and depending on the label we see that there's up to 30,000 patients that could be addressable for PhilSparry. I think to Eric's other point, I think that there may be an even bigger opportunity in FSGS compared to IGFROPCY because within IGFROPCY and I was eluding to that earlier, we really have to establish the urgency to treat and change treatments. With FSGS every nephrologist is convinced about the high progressive rate of those patients and also the symptomatic nature of the disease. So we don't have to establish the urgency to treat. Physicians are really well aware of that. Through your other points we have already very strong brand awareness with basically the same prescriber base for FSGS as for IGFROPCY with many of the prescribers already having the experience in IGA. I think that allows for a much more rapid uptake. In one additional aspect building on your pricing question, PhilSparry is already well established in payer plans and formularies. So all the heavy lifting that you do normally in the first 12 to 18 months, we have done that already for IGA and FROPCY and this gives me confidence that we will see a rapid uptake for this patient population that has been underserved for so long and is really waiting for the first approved medicine that could be PhilSparry.

Our next question comes from the line of Jason Zemanski from Bank of America. Your line is open.

Good afternoon. Congratulations on the progress and really appreciate you taking our question. I wanted to ask a follow-up regarding some of your earlier comments regarding dynamics as far as the updated CADEGO guidelines go. But do you have a sense of what overall fraction of the community has started to embrace treating more aggressively? Is it overall meaningful? Should we expect a significant inflection when these are finalized or is it going to be something more like a trickle effect thereafter? Just trying to get a gauge of near-term impact of the different growth levers.

Yeah, Peter, do you want to take that? And then, Jula, you've engaged quite a bit with the nephrology experts. Maybe you can share what you're hearing as well.

Yeah, Jason, I'm happy to take that question. First of all, I think there is quite an impact already. And ASN was only six weeks after the draft CADEGO guideline was published. And I heard from multiple, in particular, academic physicians already about how they are being more aggressive, in particular, by doing earlier biopsies in the patient population that I wouldn't have done it in the past. And I spoke with a few physicians, for example, that actually started doing biopsies in the neolabels of like 0.3, 0.4, and actually found clear roses and thought the patient would be a candidate for Phil's fiery. I think with the full publication, you have more of a trickling down effect. With the publication, it's in the broader domain as well. So I think you will have continuation of adaptation there. And as I mentioned in my prepared remarks, 75% of the nephrology community is now targeting 0.5 as the new treatment targets. I think there is a meaningful impact. But I think with the full publication, you will see a continuation and trickling down.

Jula, anything to add?

Yeah, I'll echo what Peter said. It's taken data from radar publication as well as the KDGO guidelines for physicians really to change their mindset. They thought, again, was a benign disease and we could let them smolder along with higher ranges of proteinuria. As they get exposure to that data and the guidelines, there is an awareness that they need to bring their patients back, treat them, treat them more aggressively and to lower targets. And they are starting to further understand exactly how to do that. You upgrade the RAS with Phil's fiery, you start to see the importance of getting patients to lower ranges. It's starting to sink in that what we have done historically isn't good enough for this patient population.

Perfect. Thanks for the color.

Thank you,

Chloe.

And thank you everyone for

joining today's call. Have a great rest of your day.