TVTX - NASDAQ

Good afternoon, and welcome to the Travere Therapeutics First Quarter and Full Year 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, Cloy. Good afternoon, and welcome to Travere Therapeutics First Quarter and Full Year 2025 Financial Results and Corporate Update Call. Thank you all for joining. Today's call will be led by Dr. Eric Dube, our President and Chief Executive Officer. Eric will be joined in the prepared remarks by Dr. Jula Inrig, our Chief Medical Officer; Peter Heerma, our Chief Commercial Officer, and Chris Cline, our Chief Financial Officer. Dr. Bill Rote, our Chief Research Officer will join us for the Q&A. Before we begin, I would 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. Please see the forward-looking statement disclaimer on the company's press release issued earlier today as well as the Risk Factors section in our Forms 10-Q and 10-K filed with the SEC. In addition, any forward-looking statements represent our views only as of the date such statements are made, May 01, 2025 and Travere specifically disclaims any obligation to update such statements to reflect future information, events, or circumstances. With that, let me now turn the call over to Eric.

Thank you, Victoria, and good afternoon, everyone. We entered the year determined solidify FILSPARI’s foundational positioning in IgA nephropathy, unlock additional growth for FILSPARI through a potential new indication in FSGS and continue advancing toward restarting enrollment in our pivotal HARMONY study of pegtibatinase 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 FILSPARI and IgAN. Following its full approval last fall, we saw momentum continue throughout the first quarter. Net sales at FILSPARI 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 FILSPARI experience. This strengthens our confidence in the durability and long-term trajectory of growth. At a time of continued evolution in the IgAN treatment landscape, FILSPARI 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 FILSPARI’s strong clinical data, real world effectiveness and safety profile for chronic use, all of which underscores its role as a foundational therapy for IgAN. We continue to believe that FILSPARI can become foundational care outside of the U.S. as well. Recently, the European Commission and MHRA in the U.K. converted FILSPARI’s conditional approvals to full approvals for the treatment of adults with IgAN, an important milestone that will enable our partner CSL Vifor to expand access to patients across Europe and the U.K. Our partner, Renalys, also continues to make good progress and they remain on track to report top line data in the second half of this year from their pivotal study in IgAN to support a regulatory submission in Japan. Turning to FSGS, we have made excellent progress towards our goal of bringing FILSPARI to a community that currently has no approved medication. After aligning with the FDA on our plan to submit an sNDA for an FSGS indication, we completed our submission in March. This reflects our team’s dedication to a community that has been waiting for decades. We expect to receive notification of the FDA’s acceptance of this filing later this month. If we are granted priority review as expected, FILSPARI could be approved and ready to launch in FSGS as early as September. This would mark a historic milestone. FILSPARI would become the first and only approved medication indicated for patients with FSGS. We continue to believe that the opportunity in FSGS is potentially even larger than that in IgAN, given the urgent unmet need in this disease. Our team is advancing preparations to execute a successful launch so we can deliver FILSPARI to the FSGS community quickly if approved. We also remain very enthusiastic about pegtibatinase 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?

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 IgA nephropathy across the full disease continuum from early diagnosis through post kidney transplant. As the only available medicine that optimally blocks two critical pathways, endothelin one and angiotensin two in a single pill, FILSPARI offers unrivaled efficacy and convenience for preserving kidney function for patients with IgA nephropathy and with a safety profile comparable to irbesartan. 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 IgA nephropathy. Physicians reported earlier diagnosis of their patients with IgAN, driven by referrals and biopsies earlier in the disease process. Importantly, more clinicians are now prescribing 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 KDIGO treatment thresholds of less than 0.5 grams per day or ideally 0.3 grams per day preserves kidney function, and results in better kidney survival in patients with IgAN. It is important to remember that FILSPARI is the only non-immunosuppressive kidney targeted therapy indicated for adult patients at risk of IgAN 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 IgAN that they treat, some of which were presented in real world case series at NKF. We also presented additional data from the SPARTAN study, which adds further depth to 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 of 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 start up 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 Hy’s [ph] Law, and we now have enough exposure data to rule out a potential risk of drug induced liver injury of one in one thousand. We remain on track for our August 28 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 IgAN due to the heterogeneity and complexity of the disease. At NKF, 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 irbesartan, and importantly, those patients who achieved partial or complete proteinuria remission 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 3 HARMONY study next year. We are also pleased to share that our Phase1/2 COMPOSE study manuscript has been accepted for publication in the top tier peer reviewed journal Genetics in 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 FILSPARI. We saw continued momentum following full FDA approval in IgA nephropathy, which resulted in approximately $56 million net product sales of FILSPARI 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 month-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 FILSPARI’s efficacy profile as the only kidney targeted therapy to demonstrate rapid and sustained proteinuria reduction and benefit in kidney function preservation with efficacy superior to that of a maximally dosed active comparator and a safety profile that is comparable over two years. The expansion of FILSPARI’s label to more patients with IgA nephropathy regardless of their proteinuria levels has also amplified physicians’ confidence in choosing FILSPARI 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 one gram per gram. This change reflects growing alignment with the updated draft KDIGO 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 payers, 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 FILSPARI 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 FILSPARI patients are highly satisfied with the services provided through Travere Total Care. Patient compliance and persistent rates continue to be higher than benchmarks, further reflecting the convenience, tolerability and efficacy of FILSPARI and an indicator of patients being highly satisfied with their FILSPARI 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 immunosuppressive therapy that is fully approved for the adult IgA nephropathy patients at risk of progression independent of proteinuria levels, FILSPARI continues to see broad uptake across subgroups of patients. We expect FILSPARI will remain the leading choice for upgrading foundational care, and we anticipate the largest segment of patients 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 KDIGO guidelines will likely reinforce the shift to earlier and more ambitious treatments, consistent with the FILSPARI 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 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 would further enhance the product convenience, particular for newly diagnosed or lower risk patients. Turning to FSGS, we are preparing our commercial organization to be ready for a successful second launch in anticipation of a potential new indication. With up to 30,000 addressable patients, FSGS is the most progressive and symptomatic glomerular disease. If approved, FILSPARI could be an important new treatment option for a community with no approved medicines today, representing a significant opportunity, potentially even greater than in IgA nephropathy. 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 FSGS and IgA nephropathy, we are confident that we can efficiently and effectively deliver FILSPARI to FSGS patients from the outset if approved. I am pleased with our progress and we will be well prepared for potential approval later this year. In summary, our performance in the first quarter clearly demonstrates the strength and effectiveness of our commercial team. FILSPARI 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 and property and preparing the organization for successful loans if approved for FSGS. 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 FILSPARI 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. FILSPARI maintained great momentum in the first quarter, generating $55.9 million in net product sales. We achieved this despite gross to net discounts being higher as a result of the typical insurance coverage changes in the beginning of the New Year and the implementation of the Part D redesign. As we outlined at the beginning of the year, we continue to anticipate that we will have higher gross to net discounts for FILSPARI in 2025, but the continued momentum in demand, high compliance and persistence will drive significant growth in FILSPARI sales throughout the year. Thiola and Thiola EC also contributed $20 million in net product sales for the first quarter. We continue to anticipate more generic competition for Thiola and Thiola EC in the coming quarters, but we continue to be pleased with the performance thus far. During the quarter, we also recognized $5.9 million of license and collaboration revenue, which results in total revenue of $81.7 million reported for the first quarter of 2025. Of note, during the quarter we sold drug product to our partner CSL Vifor as they continue their launch of FILSPARI in Europe. This activity accounted for $3.8 million of the license and collaboration revenue and a nearly proportional increase in cost of goods sold for the quarter. Turning 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 R&D is largely attributable to reduced costs associated with the development of FILSPARI as our Phase 3 programs advance towards completion. On a non-GAAP adjusted basis, R&D 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 FILSPARI launch following full approval as well as increased amortization expense related to FILSPARI royalties. On a non-GAAP adjusted basis, SG&A expenses were $53.3 million for the first quarter compared to $48.2 million from the same period in 2024. Total other income net for the first quarter of 2025 was $1.5 million compared to $3.5 million in the same period of 2024. The difference is largely attributable to lower interest income during the period. Net loss for the first quarter of 2025 was $41.2 million or $0.47 per basic share, compared to $136.1 million or $1.76 per basic share for the same period in 2024. On a non-GAAP adjusted basis, net loss for the first quarter of 2025 was $16.9 million or $0.19 per basic share, compared to $116.2 million or $1.51 per basic share for the same period in 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 Vifor during the second quarter as a result of the recent conversion of conditional approval of FILSPARI 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 FILSPARI and IgA nephropathy 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 IgA nephropathy launch, advancing launch readiness for potential FSGS approval, and enabling the restart of enrollment in the pivotal pegtibatinase 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 FILSPARI 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 for his closing comments. 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.

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

Thank you. [Operator Instructions] Our first question comes from the line of Tyler Van Buren from TD Cowen. Your line is open.

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

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

Yes, 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 FSGS sNDA, we see consistency there and our FDA interactions have been progressing as we expected. As we continue to anticipate the PDUFA date for the potential REMs toward the end of the summer and our continued review on the sNDA for FSGS, I can report that the interactions that we have are very similar to what we've experienced in the prior year with the IgAN indication at this stage in the process. 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 FSGS.

Okay, Operator, do we have any other questions?

Yes. [Operator Instructions] Our next question comes from the line of Vamil Davin of Guggenheim. Your line is open.

Okay, great. Maybe just if I just have one question, I'll keep it on the FSGS side and just again, tied to the regulatory discussions and the label you mentioned, the data is supportive across a broad range of patients with FSGS. 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 FSGS, or do you think there might be some restrictions in how the indication is defined? Thanks.

Vamil, thanks for the question. I'll turn that one over to Bill as well.

Yes, I mean my expectation is that the indication statement would be for the treatment of FSGS in patients ages 8 and up because that matches what we studied. The inclusion criteria for the duplex study was broadcast and we also know from post study analysis we have a very good description of the patient types based on their histology and their genetic makeup for many of those patients where we can segregate their causes. And what we can conclude from that is that we recruited a population of primary FSGS, Genetic FSGS, and saw consistent effects across all of those subtypes. So I think that when we think about FSGS as a podocytopathy, the injury and the cause may come from different sources, but ultimately FSGS is a damage to the podocyte and treatment with sparsentan blocking angiotensin and endothelin, it's a common disease pathway that's beneficial independent of those the of the heterogeneity that's, part and parcel of the FSGS diagnosis.

Okay, thanks.

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

Great. Hi everyone, this is Will [ph] on for Joe, congrats on a strong quarter in progress here. So I guess one from us with the recent approval or accelerated approval of Novartis's second therapy in IgAN [ph], could you provide a bit more color on what your sales reps are seeing in the field? Is there some counter detailing that's ongoing and 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 FILSPARI combined with the eGFR data on the label might make it a preferred choice for a new patient. Is that something you're seeing in the field or is it a bit early to tell? Thank you.

Thank you, Will. Thanks so much for the questions and I will turn that over to Peter.

Yes, thanks Bill. Well, it's, it's very early. It's one month now that Sparsentan [ph] has been approved. I think first of all it's good for patients to have more medicine in the market and I think especially is has IgA Nephropathy is a marketing development that historically was seen as a relatively benign disease and now there is 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 further grow the market and in particular grow the market for Endothelin. With regards to like competition and what we have heard, it's very early, we haven't really heard so far too much in the marketplace. But what I mentioned in the call is that we have seen continued growing demand this year so far and that growth continued in the month of April, which was the first month that [Indiscernible] was in the market. And I think that speaks to the confidence that physicians have on the profile that FILSPARI. And I think Jula mentioned in her prepared remarks, data matters for nephrologists. They have seen that FILSPARI has long-term kidney preservation data and unprecedented proteinuria reduction that's sustained over long period of time, which is really the consistency of inhibiting two receptors that results in efficacy benefits as well as convenience benefit for patients. One pill, one co-pay. So I'm confident in the profile of FILSPARI and yes, 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 JPMorgan. 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 gross net comments in your opening remarks maybe helping us understand the type of impact you saw in 1Q and give us a little color here about if looking to the balance of the year, gross net is actually a tailwind with the reversal of the impact that you saw on 1Q? Thanks so much.

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

Yes, 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 gross to net really in the mid to high teens. And what we experienced there was the highest discount at the beginning of the year and then it eased through the balance of the year. This year we're guiding to gross to nets that are going to be in the low 20s. And with the changes to, just the insurance coverage as well as with Part D redesign, we did see that increase in the first quarter as we normally would expect. But we also anticipate with the Part D redesign and also, 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 gross to net be a bit stickier than it was last year. So it'll probably be a little bit more even than it was last year, but we do expect at least for the fundamental pieces of gross to net to be the highest in Q1.

Thanks so much for taking our question.

Our next question comes from the line of Laura Chico from Wedbush Securities. Your line is open.

Thank you very much. Good afternoon. One question for you on the cadence of patient start form. It was interesting to see the number tick up a little bit over the prior quarter. And Erica, 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?

Yes. 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 the growth trajectory was 703 new patient start forms in the first quarter. I think most importantly is that you have to realize that FILSPARI is a chronic treatment and we continue to see very strong compliance and persistent rates. So we build 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 -- of an upgraded therapy, essentially those patients that are on RAS inhibitors that are not at the new KDIGO 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 FILSPARI, and that really is a sustainable source of growth moving forward because there are so many patients that are not yet at that guideline of 0.5 or 0.3. 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 FILSPARI.

That's helpful. Thank you.

Our next question comes from the line of Liisa Bayko from Evercore. Your line is 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 you talked about this a little bit, but what percentage of prescriptions are you seeing that are below 1.5 grams now that you have label expansion versus above 1.5 grams? And then are you seeing any change in sort of new patient ads now that we have Irbesartan? 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, Liisa, thanks so much for the questions. And, Peter, why don't you take those?

Yes, let me. So it's two questions that you're asking. The first one is with regards to, like, what is the breakdown of different levels of protoneuria? We haven't broken it down specifically, but what we are seeing is that the median trend of protoneuria levels are going down and is now well below 1.5 gram per gram and in particular with experienced prescribers, we see that there is a meaningful amount of physicians that are now prescribing below 1 gram per gram as well. I think that is the most important takeaway and to your earlier point, that allows for a sustainable growth opportunity over time since FILSPARI is the only non immunosuppressive treatment that is fully approved without a proteinuria limitation. With regards to your second question on ATRA and what trends we are seeing? Well the trends that we are seeing is very consistent to what we have seen so far. 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 far the trends that we have seen are positive and continue on very strong growth trajectory.

Operator, can we go to the next question please?

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

Hey, good afternoon guys and thanks for taking the question. 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 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 the REMS in August, late August. And Peter, why don't you talk about your view on what that impact could have.

Yes, happy to. Eric and Greg, thanks for that question. I would say first and foremost ramps has not been an obstacle in our performance. In fact FILSPARI is being the most successful of the four most recent rare nephrology launches. All of the comparators actually did not include REMS. So with the REMS we were able to kind of like set a best-in-class benchmarks. 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 Farco. Your line is open.

Hi, this is Fadi Arman [ph] on for Mohit. Thanks for taking our question. So I have a question on FSGS on the Dimerics. Recently there was a partnership announced for us commercialization of that asset. How are you thinking about the benefit of that drug versus sparsentan, and FSGS. And do you think they could still be significantly further behind from launching in the U.S. 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.

Yes, thanks for the question. I would say the important takeaway is that we're very pleased to see the alignment with the FDA on PARASOL that proteinuria can be an endpoint for full approval at 2 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 Dimerics 200 and it's going to be many years before we see their full 2 year protein area data because as they stated, they're still enrolling. They hope to finish by the end of this year, but to be determined when they complete that enrollment. But I would also add that the MOA of DMX200 as CCR2 antagonism is certainly complementary for FILSPARI if it becomes available in the future.

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

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

All right, Maury, thanks for the questions, Peter. We'll hand that one over to you.

Yes, this split is slightly more skewing to experienced prescribers, but very 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, yes. And I mentioned that in the prepared remarks as well. If you compare the FILSPARI compliance and persistence to compare to benchmarks, chronic disease, non symptomatic disease, it's at a very high end. We haven't given color what it is exactly, but it's at a very high end what you would expect, which speaks To the confidence and the satisfaction of patients as well.

Our next question comes from the line of Prakhar Agrawal from Cantor. 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. Just wanted to get some color there. Among the fifth 15 to 30,000 addressable patients for FSGS in the U.S. how many of these are currently managed by FILSPARI prescribers and any thoughts on how you expect the launch to be when approved and if I can just follow up here on the payer discussions on FSGS pricing wondering if you got any feedback there given the possibility of double the Eigen pricing and whether that's feasible here. Thank you.

Sure. Prakhar, thanks for the question. I'll take the one on pricing and outlook 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 FILSPARI, which is really critical for us in establishing it as a foundational therapy where a broader swath of the community should have access to FILSPARI. We have mentioned that it's likely that it would be double the price for adult patients at the target dose given double the dose and we believe that given the unmet need and the more rapid progression that FSGS patients have to kidney failure, that that higher price certainly would come with high benefit for these patients. 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 IgA nephropathy. 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 to your point. And depending on the label, we see that there's up to 30,000 patients that could be addressable for FILSPARI. I think to Eric's other points, I think that there may be an even bigger opportunity in FSGS compared to IgAN nephropathy because within IgAN nephropathy, and I was alluding to that earlier, we really have to establish the urgency to treat and change treatment. 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. To your other points, we have already very strong brand awareness with basically the same prescriber base for FSGS as for IgAN nephropathy with many of the prescribers already having the experience in IGAs. I think that that allows for a much more rapid uptake in one additional aspect. Building on your pricing question, FILSPARI is already well established in payer plans and formulary. So all the the heavy lifting that you do normally in the first 12 to 18 months, we have done that already for IgAN nephropathy and this gives me confidence that we will see a rapid uptake for this patient population that has been underserved for so long and is really waiting for the first approved medicine that could be FILSPARI.

Our next question comes from the line of Jason

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 KDIGO 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.

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

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

Anything you'd like to add?

Yes, I'll echo what Peter said. It's taken data from RADAR publication as well as the KDIGO 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's an awareness that they need to bring their patients back, treat them, treat them more aggressively and to lower targets. And they're starting to further understand exactly how to do that. You upgrade the RAS with FILSPARI, you can get more patients to lower ranges of proteinuria. And that's starting to resonate. I think that to Peter's point, the publication of the KDIGO guidelines will further help cement and educate because there'll be continued education around the importance of getting patients to lower ranges. But it certainly is starting to sink in that what we've done historically isn't good enough for this patient population.

Perfect. Thanks for the color.

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

Thank you, Cloy. And thank you, everyone, for joining today's call. Have a great rest of your day.