Travere Therapeutics, Inc. (TVTX) Q2 2026 Earnings Call Transcript

Good morning, and welcome to Trevier Therapeutics' second quarter 2026 financial results conference call. Today's call is being recorded. At this time, I would like to turn the conference over to Nivi Nera, Vice President, Corporate Communications and Investor Relations. Please go ahead, Nivi.

Thank you, Operator. Good afternoon, and welcome to Trevier Therapeutics' second quarter 2026 financial results and corporate update call. Thank you all for joining. Today's call will be led by Dr. Eric DeBay, our President and Chief Executive Officer. Eric will be joined in the prepared remarks by Peter Hirma, our Chief Commercial Officer, Dr. Jula Enric, our Head of R&D and Chief Medical Officer, and Chris Klein, our Chief Financial Officer. Dr. Bill Roat, our Chief Research Officer, will join us for the Q&A. Before we begin, I'd like to remind everyone that statements made during this call regarding matters that are not historical facts are forward-looking statements within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not guarantees of performance. 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 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, August 4, 2026. Interview specifically disclaims any obligations to update such statements to reflect future information, events, or circumstances. With that, let me now turn the call over to Eric. Eric?

Thank you, Nivy. Good afternoon and thank you for joining us today. The second quarter was exceptional. Our performance demonstrates the strength of the company we are building and the disciplined execution of our teams. Trevere has now entered a new chapter, one that we expect will deliver near and long-term growth driven by clear momentum across four key pillars, continued growth for Filspari in IJ nephropathy, the successful launch of Filspari in FSGS, the advancement of PEG-dobatinase in its pivotal phase three study, and the addition of Sivorbrutinib to our rare kidney disease pipeline. At the center of this strategy is Filspari, which we believe is becoming an increasingly important rare kidney disease medicine. This was the first quarter with Filspari commercially available across both IJ Nephropathy and FSGS, and we are very pleased with the performance. Our teams delivered growth in IJ Nephropathy demand compared to last quarter despite additional market entrants and achieved successful early adoption in the first months of the FSGS launch that exceeded our high expectations. Peter will provide more detail in the launch shortly, but we are encouraged by the early performance. As we build on Filspari's commercial momentum, we continue to advance our intellectual property strategy. During the quarter, the USPTO issued a notice of allowance for a US patent application directed to certain methods of using Sparsenton in iJ Nepropathy. Upon issuance, the patent is expected to provide U.S. patent coverage for those methods. We also continue to pursue additional patent coverage for Sparcentin, including through a pending U.S. application directed to certain methods of using Sparcentin in FSGS. Beyond PhilSparry, we are building a robust pipeline of potential disease-modifying, best-in-class medicines that is strategically aligned with our rare kidney disease expertise and positioned to drive long-term growth. Pegdabatinase remains a very important program for Trevere and for the HCU community. It has the potential to become the first and only disease-modifying therapy for classical homocystinuria, a rare metabolic disease affecting 7,000 to 10,000 patients and their families in the U.S. today. With pivotal data expected next year, Pegdabatinase is positioned to become the next medicine we deliver from our pipeline to address a significant unmet need within the rare disease community. We are also very pleased to recently close our exclusive licensing agreement with Everest Medicines for Ciboribrutinib, adding a differentiated upstream immune modulating approach to our rare kidney disease portfolio with potential application across multiple immune-mediated kidney diseases. While it is still early, we see ciburibrutinib as a meaningful long-term growth opportunity in addition to filspari and pegdabatinase. With continued momentum across our business, we are entering the second half of the year from a position of considerable strength. I'd now like to turn the call over to Peter for a commercial update. Peter?

Thank you, Eric. Before discussing our commercial performance, I want to recognize the extraordinary work of our commercial organization and colleagues across Travere. Following our FSGS approval in April, our teams have executed with urgency, focus, and discipline while continuing to serve the IGA nephropathy patient community. I couldn't be more proud of what this team is accomplishing together. Their efforts resulted in record-fieldering demand with over 2,000 new patient platforms across IGA Nephropathy and FSDS, and record U.S. revenue of more than $141 million for the quarter. Our Q2 performance reflects two complementary growth drivers. One, continued strength in our established IGA Nephropathy business, and two, exceptionally strong first few months of loans in FSDS. Let me begin with IGA Nephropathy. Demand remained strong, growing again compared to the prior quarter. Importantly, this growth was achieved despite additional treatment options entering the market, reinforcing PhilSparry's established and differentiated positioning. PhilSparry remains the most widely utilized treatment option approved for IGA nephropathy, and we continue to see high levels of repeat prescriptions alongside ongoing adoption by new physicians. Since the treatment guidelines were updated last year to recommend a lower proteinuria target, we have observed physicians treating patients earlier and pursuing more ambitious treatment goals. Phil Spari's foundational positioning with superior efficacy demonstrated against an active, maximally dosed ARB gives physician confidence that more patients can achieve those goals, whether Phil Spari is used as a monotherapy or in combination with other treatment modalities. Turning to FFDS, the beginning of the launch has been strong. Prior to April, there had been no FDA-approved medicines for FSGS, one of the most progressive rare kidney diseases. This high-inmed need, along with the compelling patenuria reduction Phil Spari provides, has created strong precision and patient enthusiasm. Furthermore, our established nephrology relationships, combined with our team's robust FSDS launch preparation, have supported rapid early adoption by the FSDS community. At approval, we expected FSDS uptake would outpace that of the beginning of the IEJ Nephropathy launch, and this is what we are seeing. All fundamentals regarding demand, payer access, fulfillment, and revenue are exceeding the metrics we had seen during the initial phase of the IGI nephropathy launch. Leading into the approval, there was high awareness among physicians and patients. A small portion of our early adoption likely reflects physicians prioritizing patients they have already identified or those patients more frequently seeing their physician, resulting in a slight acceleration of demand during the initial launch period. Importantly, overall demand has been broad. The vast majority of physicians who have prescribed Filspari for FIGS have written for a single patient to date, while we also continue to see steady activation of new prescribers. This reinforces our belief that we remain in the early stages of market uptake, which supports confidence in the durability of demand. Additionally, we are encouraged by the early progress we are making with payer access. First-pass approval rates in FSGS track ahead of what was experienced at a comparable stage of the IGN property launch. And while early launch conversion always takes some time, conversion trends are progressing well. We entered the FSGS launch with existing payer relationships, an experienced patient services organization, and an established field reimbursement team. This organizational experience, together with robust, advanced preparations, enabled drug availability upon approval and shipments to begin within the first week following approval. Importantly, payers understand the rare and progressive nature of FSGS and the lack of effective and approved medicines for this condition while they continue to establish and refine their coverage policies we remain focused on educating on the clinical value of phil spari supported by health economic evidence at the same time our field reimbursement teams continue to work closely with nephrology practices to support navigating reimbursement requirements and help patients access therapy as efficiently as possible this work will continue throughout the year to further increase access to the fsds patient community looking ahead it is still early in the launch and it is not prudent to extrapolate from a thing from a single quarter that said we are encouraged by what we have seen since approval from a demand perspective we expect the FSDS uptake curve to differ from IGA nephropathy. In IGA nephropathy, adoption evolved through several distinct phases, including the transition from accelerated to full approval and subsequent ramps simplification. In FSDS, those foundational elements were already in place at launch, enabling broader adoption earlier in the launch curve. While we expect some normal quarter-to-quarter variability in patient starts, including potential seasonal impact during the summer months, we expect continued demand as we activate new prescribers and deepen prescribing within existing practices. I am incredibly proud of what our customer-facing teams are accomplishing for the IGA nephropathy and FSDS patient communities. grounded in Phil Spari's differentiated clinical profile and the growing body of evidence. On that note, I'd now like to turn the call over to Jula for the medical update. Jula?

Thank you, Peter. I'll start with Phil Spari, the only approved therapy that can replace RAS inhibitors while directly addressing key drivers of ongoing kidney injury. By reducing proteinuria, Filspari provides a differentiated foundational non-immunosuppressive treatment that delivers long-term nephra protection across both IgA nephropathy and FSGS. As the IgA nephropathy treatment landscape evolves, our discussions with nephrologists reinforce Filspari's role as a foundational treatment for patients with IgA nephropathy. Nephrologists emphasize that reducing proteinuria, ideally to complete remission of less than 0.3 grams per day, and slowing the rate of loss of EGFR to less than 1 mil per minute per year, remain the two key treatment goals for all patients with IgA nephropathy. This is aligned with the KDGO guidelines, and data from both our PROTECT and SPARTAN studies support that phil spari particularly if used early in the treatment paradigm has the potential to achieve both of those treatment goals for many patients as additional immune mediated therapies become available nephrologists anticipate a more individualized and layered treatment approach with kidney directed therapies serving as the foundation and immune modulating therapies used when clinically appropriate for certain patients Importantly, the expanding therapeutic landscape is increasing awareness of IgA nephropathy, accelerating diagnosis, and encouraging earlier treatment. We believe this is an important step forward for patients because it creates more opportunities to intervene early, preserve kidney function, and ultimately improve long-term outcomes. In FSGS, we continue to see tremendous enthusiasm among patients and physicians following Filspari's approval as dispersed medicine approved for FSGS. Filspari is indicated to reduce proteinuria in adult and pediatric patients aged eight years and older with FSGS without nephrotic syndrome. Importantly, the conversation has shifted to how best to incorporate Filspari into clinical practice. This includes utilization across primary, secondary, and genetic forms of FSGS and reflects confidence in Filspari's dual mechanism being superior to RAS inhibitors as well as the need for an effective kidney-targeted therapy that can serve as a foundation of care with immunosuppressive therapy added when clinically appropriate for certain patients. At ERA in June, we presented long-term duplex open-label extension data demonstrating sustained proteinuria reductions for up to five years with no new safety signals, further reinforcing Filspari's well-characterized long-term safety profile. We're also continuing to expand the evidence base for Filspari across a range of FSGS and IgA nephropathy patients, we recently completed enrollment in our post-transplant study evaluating recurrent fsgs and recurrent iga nephropathy areas of significant unmet need we anticipate data from this study in 2027. in addition in the second half of 2026 we plan to initiate a phase four open label study to further evaluate the efficacy and safety of Filspari in adult and pediatric patients of African ancestry with FSGS and at high risk of disease progression. Turning to pegtabatnase, enthusiasm among physicians, investigators, and patients remains high for a potential disease-modifying therapy that addresses the underlying CBS enzyme deficiency. Recent investigator meetings and the HCU Network America Patient Conference reinforced a significant unmet need and excitement about Peg-to-Bat Mesa's potential to meaningfully reduce total homocysteine and overcome many of the limitations of current treatment approaches. Enrollment in our Phase 3 Harmony study is continuing with site screening and enrolling patients. We continue to expect top-line results from Harmony in the second half of 2027. Finally, we are excited to officially bring sevorabrutinib into our development portfolio. Sevorabrutinib is an investigational oral covalent reversible BTK inhibitor that we believe has the potential to become a best-in-class therapy for multiple rare immune-mediated kidney diseases, including primary membranous nephropathy, immune-mediated FSGS, and minimal change disease, with the potential to expand into development for additional rare kidney diseases over time. Importantly, seborrebrutinib represents a strategic and complementary addition to our rare disease portfolio. Filspari provides kidney protection, and seborrebrutinib adds a distinct immune-mediated mechanism to our portfolio. Each program reflects our long-term strategy of developing therapies that can be tailored to the biology and clinical presentation of patients living with rare kidney diseases. Following the recent closing of our agreement with Everest Medicines, our teams have been focused on advancing our development planning. Our next step is to open an IND in the U.S., and we look forward to engaging with the FDA on the global clinical development pathways to support multiple studies across these important rare kidney diseases with high unmet need. I'll now turn it over to Chris for a financial update. Chris?

Thank you, Jula. In the second quarter, we delivered exceptional commercial results, continuing to invest in the programs with the greatest opportunity to create value for patients and shareholders, strategically expanded our pipeline with the addition of ciboribrutinib and strengthened our balance sheet through successful convertible note transactions. Collectively, these actions have further strengthened our financial position and support our confidence in Travear's near- and long-term growth trajectory. In terms of commercial performance, we generated $161.4 million in total U.S. net product sales in the second quarter, reflecting strong sequential and year-over-year growth. U.S. net product sales at Filspari grew approximately 96% year-over-year to $141.1 million, dollars, representing a strong start to the FSGS launch and continued growth in IJ Nefroptovit. As expected, gross-to-net discounts for Filspari in the second quarter were slightly lower compared to the first quarter. We expect gross-to-net discounts to be slightly higher in the third and fourth quarters as we see more FSGS patients initiate therapy with a higher CMS utilization. But as previously guided, we continue to anticipate full-year gross-to-net discounts for Filspari to be in the mid-20% range. Biola and Biola EC also contributed $20.3 million in U.S. net product sales during the second quarter, and we recognized $8.2 million in license and collaboration revenue, resulting in $169.6 million in total revenue for the second quarter. License and collaboration revenue for the second quarter included recognition of a $5 million milestone from the True Guide Partnership for Sparsenton in Japan. Total GAAP R&D and SG&A expenses for the quarter were $156.4 million, which includes approximately $22.2 million in non-cash stock-based compensation and depreciation expenses. The year-over-year increase in R&D expense is primarily driven by enrollment activities in the Phase III Harmony Study and manufacturing for pectobatinase during the quarter. For SG&A, the year-over-year increase is primarily attributable to investments until SPARE's launch in FSGS, including the expanded field team and promotional efforts in the first month of launch, as well as investments to continue our momentum in IGN and Prophecy. Royalty expense for the quarter was approximately $7.1 million. As we mentioned on our call last quarter, the Biola intangible asset reached the end of its accounting useful life at the end of March. As a result, royalty expense now reflects Biola royalty's expense for the quarter, as well as the amortization associated with contractual milestones and royalty payments related to Filspari that are capitalized to intangible assets and amortized on a straight line basis over its accounting useful life. Total other expense net for the quarter was impacted by the recognition of an inducement expense of $40 million related to the repurchases of 2029 convertible notes during the quarter. As of June 30, 2026, we had cash, cash equivalents, and marketable securities of approximately $489.2 million. This includes the net proceeds of approximately $158 million from our convertible refinancing transaction, where we repurchased approximately $221 million of 2.25% convertible notes through 2029 and issued $525 million of half a percent convertible notes due in 2032. Following the close of the CIVOR-Brutniv transaction in July, we paid Evers the previously disclosed upfront amount of $112.5 million. As we look ahead, we remain confident in our outlook for continued near and long-term Filspari revenue growth and are committed to investing prudently behind the opportunities we believe will create the greatest long-term value. These include the continued launch of Filspar NFSGS and foundational positioning in IgE and nephropathy, the advancement of effective adenates, and the development of C-bore brudeness. Supported by a strong balance sheet, we believe we are well positioned to execute our strategy and fund our planned operations with current resources while continuing to create durable value for patients and shareholders. I now turn the call over to Eric for his closing remarks. Eric?

Thank you, Chris. We are excited about the trajectory of our business, and we are approaching this next chapter with the same discipline that has defined our execution to date. Our priorities are clear, our infrastructure is scalable, and our focus remains on investing in programs with the greatest potential to deliver meaningful outcomes for patients and durable value for shareholders. Our commitment is reinforced by the impact we are already having on the lives of people living with FSGS. As one mother shared with us recently, Phil Spari has been so helpful. My son went on his bike for the first time this week since his diagnosis. I am giddy and grateful. With that foundation, we believe Trevere is increasingly well positioned as a leading rare disease company with the opportunity to positively impact the lives of significantly more patients, the potential to achieve more than $3 billion in peak annual will fill SPARI sales, and continuing to advance an exciting pipeline with multiple drivers of long-term value. With that, I'll turn it over to Nivy to begin Q&A. Nivy?

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

Thank you. I would like to remind everyone, in order to ask a question, press star then the number one on your telephone keypad. As a reminder, we ask that you limit yourself to one question. If you have another question, rejoin the queue. We will now take the first question from the line of Vamil Devan from Gogenheim Securities. Vamil Devan, your line is open.

Great. Thanks so much for taking my question. Congrats on the quarter of the very impressive results here. So, I guess my question is on the FSGS launch and following up on some of what Peter said regarding sort of the shape of the curve from here and how we should think about it obviously starting at a much higher point than we were expecting i know you mentioned some summer seasonality um but if you can just give us a little bit more guidance and i know you're not giving formal guidance but just some sense of how to think about these next few quarters so we're in a reasonable spot and people are on the same page just to think about sort of the growth outlook from here uh but also maybe someone had went through on the summer and also, you know, some of the competitive dynamics in IGAN, too. So just want to make sure we're all reasonably in the same spot. Any further comments there would be very helpful.

Well, thanks so much for the question. We are very excited about the rapid uptake that we've seen thus far in FSGS against the backdrop of growing demand in IG nephropathy. I do want to reiterate what Peter said. It's early in the launch with FSGS, and so it's difficult for us to project from here. But Peter, why don't you comment on some of the dynamics that you are seeing that really help us think about the outlook and the dynamics for growth from here on out?

Certainly. I'm happy to do that. And maybe good to reiterate that we won't be breaking out performance by indication. But what we are seeing overall is continued strength in IJ nephropathy. What we basically have seen since Q4 last year, basically after the modification of the RENDS program, that we have seen patient platforms north of 900. And we are confident in our continued performance in IGA nephropathy there, while also having a very strong one for FFDS. I mentioned the approval was highly anticipated by both physicians as well as patient communities and what we have seen a small portion of patients that were identified early those are the patients also that are often seen more frequently by their physicians and to your point we also mentioned that the trajectory of FSGS may be slightly different than IGA nephropathy where you have very distinct phases in the lungs moving from accelerated to full approval and then from full approval to the REMS modification you won't see those same catalyst in FSDS. But I think most importantly, what we are seeing is broad prescriber base for FSDS, with most physicians only having one patient while they have multiple patients in their practices. So, we are very confident with what we have seen, and we believe there will be continued demand moving forward.

Okay. Thanks. I'll get back in the queue. Thank you.

Thank you. Our next question comes from the line of Anupam Marama from J.P. Morgan. Anupam Marama, your line is open.

Hey, guys. Thanks so much for taking the question, and congrats on all the progress here. Just following up on Vamo's question here on FSGS, just wondering if you could expand a little bit on what you're seeing on timelines from start form to paid script and how you expect this to evolve. Thanks so much.

Thanks, Anupam. Peter, why don't you take those?

Yeah, thank you for the question, Anupam. and thanks for the for the high five as well overall what we commented and therefore we were expecting that you would see a faster uh conversion from patient start forms uh in fsgs versus what we saw initially in hygiene property having said that it still takes time to educate uh payers and to get phil spy included in the formularies so while we're ahead of iga nephropathy there's still work to be done uh but overall very pleased with the progress we have been making so far and And, yeah, we look forward to educate payers consistently to our label and our health economic evidence.

Our next question comes from the line of Joe Schwartz from Leering Partners. Joe Schwartz, your line is open.

Congratulations on the great performance, Trevere team. For FSGS, what did you learn in the first full quarter post-approval about where demand is coming from the most in terms of prescribers and the patients they're prescribing, Phil Spari, too? Are any patterns notable amongst academic centers, community nephrologists, pediatric nephrologists, or prior duplex investigators and their FSGS patients?

Joe, thanks so much for the question. You're going to get a two-for-one answer. I'm going to share with you my thoughts, and I'm going to hand it over to Peter. One of the things that's most striking to me about the uptake thus far, and I think what gives us incredible confidence in the continued demand here, is just the breadth. I mean, Peter talked about the breadth of prescribing. We saw that very quickly, and so physicians are trying it, but it's going to obviously lead to further depth of prescribing, and we still have a lot of opportunity to broaden to physicians that haven't yet prescribed for FSGS. That, to me, is the most striking learning. Peter, why don't you talk a bit about the breadth and the types of patients that you're seeing in the early parts of the launch?

Yeah, absolutely. Absolutely. And Joe, thanks for that question. I fully underwrite what Eric is saying with regards to the breadth of prescriber base. As we were expecting, a large part is coming from physicians that already had experience with Filspari. In IAGI nephropsy, that's about 70% of the prescribers had that experience already. At the flip side, that also means that you have 30% of the prescribers new to the brand. And we have spoken about the halo, potential halo effect in the past. This is where we see an opportunity because these physicians often have IGA nephropathy patients as well. And so, like a positive experience with Phil Spari and anti-SGS, we would expect also then provides enthusiasm to start prescribing an IGA nephropathy. So, early signals are positive there. With regards to the patient segment, as you would expect, and it is typical in every launch, patients with relatively high proteinuria levels, those are the patients that are also seen more frequently by physicians, and that's what we saw in particular in this patient population. But overall, reinforcing what Eric said, the breadth of prescriber base, most physicians having a single patient so far while seeing more FSDS patients, they just need that great confidence on continued demand moving forward.

Our next question comes from the line of Tyler Van Buren from TD Common. Tyler Van Buren, your line is open.

Hi, this is Greg Torres on for Tyler. Congrats on the quarter and thanks for taking our question. So the 2012 PSF significantly exceeded investor expectations. Can you help us understand how much of the upside was driven by stronger than expected FSGS uptake versus continued acceleration of the IGA nephropathy launch? And was there a steady growth in IGAN, or would you say that the FSGS approval really reinvigorated IGAN PSF as well? Thank you.

Greg, thanks so much for the great question. What I'll say before handing it over to Peter is that we did see growth in demand for IJ nephropathy, and we're not going to break that out, but what we would say is that we did see quarter-over-quarter increase in the number of PSFs with IJ nephropathy, which has been our expectation and I think is incredibly encouraging given both the increased number of treatment options within the IGAN space, but also what we have been talking about and now are seeing, is an acceleration in the growth of the IgA nephropathy space. Peter, why don't you take further in terms of what you've seen in terms of the growth and the FSGS uptake?

Yeah, I think you've covered a lot of the questions already, or the element of the question. I think one thing to add is that Phil Spirey remains the most utilized treatment option approved for IgA nephropathy, and I think that reinforces the established and differentiated positioning of Phil Spari and Eric's point. I mean, the law for FSGS was highly anticipated, and we knew there was a high level of excitement across physicians and patient communities, and that's exactly what we are seeing.

Our next question comes from the line of Laura Chico with Red Bush. Laura Chico, your line is open.

Thanks very much for taking the question. One area of concern we've heard from physicians is being in a challenging spot. So, if they get peer pushback on combining something like Silspari and an April inhibitor, they might have to make a tough decision on which one to take over cost considerations. So, I'm curious, A, are you actually seeing this happen at all in practice and realizing it's early days still? But B, what's your expectation for patients to be on multiple branded agents going forward? Thanks very much.

Laura, thanks so much for the question.

Peter, why don't you talk a bit about what we're seeing today in terms of dynamics jula i'd like for you to talk about your expectation in terms of guidelines and and what your medical affairs team are hearing from uh nephrologists peter yeah overall i would say that phil spari is well very well established in payer plans um in in formularies um we price your spari for broad access i mean if you consider it compared to B-cells or other therapies, that's considerably higher. So I think that is a component to take into consideration. I think also that we have the highest rigor of evidence. I mean, what payers are looking for is preferably head-to-head comparison. And that's exactly what we are having with an active control, highest dose ARB, where we showed superiority. And overall, what we are seeing so far is that payers understand the complementary role of other modalities, like, for example, B-cells that you were referring to. But so far, yeah, we are confident with the positioning of Tilspari and formulary so far.

I'm happy to add to that, Laura. We've heard some of that from nephrologists, that they're anxious because they want to use multiple therapies in order to reach both targets of proteinuria remission and EGFR stabilization. And it's not a specialty that has had a lot of experience with multiple branded agents. So while there's angst, as Peter said, we haven't had the pushback of being able to utilize multiple therapies to achieve those targets. it's really more around uncertainty. And we continue to hear that physicians want to use multiple agents to achieve both the targets, complete remission, EGFR stabilization. And by that, it aligns with the KDICO guidelines. You target the kidney injury where FOSPARI has shown the only head-to-head superiority versus the historical standard of care. And then you use an immune-mediated therapy. And the combination is really what is in discussion at this point. And And that's what we're hearing from the field at this point.

Thanks very much. Our next question comes from the line of Rekar Agruel from Cancer Fitzgerald. Rekar Agruel, your line is open.

Thank you so much for taking my questions, and congrats on the strong quarter. Maybe just a couple. How do you expect the persistency in FSGS to track relative to IGAN, given the dosing and patient population is slightly different? And maybe if you're able to quantify some of the bolus that was there for FSGS, especially given it matters on how we model the new patient starts and 3Q and beyond. Thank you so much.

Thanks so much for the questions. Let me take the second one first. We did not see evidence of a bolus. What we did see is a rapid uptake based on the high anticipation of this approval, both by patients and the nephrology community. So, I think it's important to reiterate that, you know, we do not see the evidence of bolus where you would see a potential slowdown in demand. We do not expect that. We expect continued demand, and the opportunity certainly is there. Peter, why don't I turn it over to you to talk about the persistency across FSGS and IGAN?

Thanks, Eric. And, Rika, I think you had three questions in one. Eric addressed the first one with the stand-up demand. Let me talk about the persistency and the dosing. Persistency, I mean, it's very early in the launch, but we are not expecting that FSGS will be meaningfully different versus IGA nephropathy. And what we have commented in the past is that the compliance rates of IGA nephropathy are really high with skills firing. With regard to dosing, also here early in the launch, but overall, we see basically the same up titration behavior as that we saw in IGA nephropathy, meaning that for FSGS, physicians are opt-out rating from 400 to 800 mg consistent to the label. Thank you so much.

Our next question comes from the line of Gavin Clark-Gartner from Evercore. Gavin Clark-Gartner, your line is open.

Hey, guys. Congrats on the initial launch thus far. I just wanted to circle back on some of the conversion metrics. So you noted that the conversion rates you're seeing are exceeding what you saw in iGAM previously. what was the rate that you saw with IGAN? And just to be clear, I'm less interested in the conversion speed and more what the rate was at any point in time. For what it's worth, I model 70% off the bat, increasing the 75% or so as access is established. Seems like access is really good. So I'm wondering if I'm too conservative there. Thanks.

Kevin, thanks for the question. Peter, I'll turn that over to you. But just keep in mind, we're not going to be providing specific metrics on this. But I think Peter can share a little bit about the dynamics of conversion early in the launch of iGant versus what we're seeing thus far.

Yeah, Eric and Gavin are certainly happy to provide some call here. And we haven't disclosed the specific on the rates of what we saw early in the conversion rate for IGI nephropathy. But as you would expect, I mean, we have an established patient services team. We are experienced with the RANs process. Officers are experienced with that as well. And so, the process, as you would expect, through the patient services division and the distribution, as well as Phil Spari, often already in formularies, even though not specifically for FSDS, that that conversion rate is higher than what we saw in IGA nephropathy. And that's exactly what is materializing in FSDS. And like I said, I'm really pleased with the progress, which is very consistent to how we had anticipated this.

Thanks a lot, Peter. Please go ahead. Let me just add, I think the really important aspect, Gavin, as we look forward is that from near day one of launch in FSGS, we're in a much stronger position than starting out with IG Nephropathy. And it does take some time to get payer policies in place, but everything that we see thus far aligns to a very strong outlook within FSGS, if that helps you to think about and model conversion.

Our next question comes from the line of Mohit Densal from Wells Fargo. Mohit Densal, your line is open.

Hi, this is Sadia Rahman on from Mohit. Thanks for taking my question, and congrats on the quarter. So maybe a big-picture question. just curious if this strong launch in FSGS has changed your confidence in your prior estimate of the size of the opportunity for Filsfari across IGAN and FSGS. You know, maybe this makes that 3 billion estimate seem conservative. And just related to that, you know, when we think about penetration into that 30,000 patients that you framed as addressable in FSGS, just, Just, you know, considering there are no other treatments approved in FSGS, how should we think about penetration in this market? Are there any factors that you'd highlight that could limit penetration, and, you know, are there any analogs that we should consider here? Thank you.

Sadia, thanks so much for those questions. I'm going to take those, and then I'll ask Jula and Peter to add anything that I might have missed. First, we remain very confident in the revenue opportunity exceeding $3 billion at peak across both FSGS and IG nephropathy. I think as we continue to learn more, and this is a single data point in a very strong uptake, we remain confident in the growth outlook for FSGS. But we've not revised anything further with regard to peak year sales. So more to come on that, but I think it reiterates the confidence and the very strong outlook that we see for Filspari long term. With regard to the penetration, we do see, you know, that we are starting, you know, off of a strong position, but we're only, you know, scratching the surface with regard to the patients that could benefit from Filspari. It remains the only approved medication in FSGS. There are no other therapies that are available. There are some that are being studied, particularly for subtypes of FSGS that are earlier in development, but at this point, we do not see in the foreseeable future treatment options, unfortunately, for this community, but we do fully expect that there will be other therapies available since we have now paved the way for others to follow. Those that are in development, we see as complementary, and we believe that for many patients, they'll benefit from combination therapy, much like we're starting to see emerge in IJ nephropathy. So all in all, we're very pleased with the early uptake, and I think as we look long term, really strong opportunity for revenue, and I'd say even more importantly, the opportunity to truly make a difference in the lives of these patients as we reach more. Jula, Peter, anything that you'd want to add? Okay.

Our next question comes from the line of Mario Raycroft with Jeffries. Mario Raycroft, your line is open.

Hi, this is James Alpermore. Congrats on all the progress and thanks for taking our question. Atsuka disclosed approximately 50% of Voixak's prescriptions or switches. Do you have patient-level switch data quantifying outlaws in 2Q?

Thanks so much for the question. Peter, I'll turn that over to you.

We haven't disclosed what patient comes from, like new branded prescription versus switch, but I can tell you that most of the prescriptions of Philzpari are new to branded therapies, and that's very consistent to our positioning. It's the first change that physicians make is move from generic Raj in addition to Philzpari before considering other branded modalities.

Our next question comes from the line of Joe Paganes from HA Winwright. Joe Paganes, your line is open.

Hi, this is Josh on for Joe. Thanks for taking our question. So last quarter, you had mentioned that the without nephrotic syndrome language would be more of an education opportunity rather than being a barrier to adoption. So I was just wondering if this has still continued to hold true, or have you encountered any unexpected issues?

Josh, thanks for the question. Peter, I'll turn that one over to you.

Yeah, I'd like to comment on that, Josh. I think with every launch, you want to educate physicians on what the indication is, and that was no different for this indication. I think physicians understand the indication very well, because I think it's very consistent how physicians are practicing nephrology in FSDS patients. but also very consistent to the Cadego guidelines. So while there's still education to do, physicians understand the positioning for patients that are currently not in nephoric syndrome.

Okay, great.

Our next question comes from the line of Alex Thompson with Steve Hill. Alex Thompson, your line is open.

Hey, great. Thanks for taking our question, and congrats on the quarter. Maybe shifting gears just before Brutinib, the parasol group is now looking at membranous nephropathy, and there's a workshop later in September. I guess, like, based on the FSGS experience here, you know, what could be the potential outcome in membranous dipropathy with parasol? Is it your view that there could be a faster path to a pivotal development in this space, and how might that impact your, you know, clinical development strategy moving forward?

Alex, thanks so much for the question, and particularly that it's on CIVO. So, Jula, I'll turn that one over to you.

Yeah, we're excited by the continued efforts to define endpoints to help accelerate therapies for high-end met need, including membranous. There's also work in APOL1 and Alport with other groups. We're going to be closely following the data that comes in as well as the analysis. So it is the standard development strategy in membranous nephropathy is to look at complete remission over two years. That's been pretty well established. Certainly, there's many who would like to have something short of complete remission or shorter duration or biomarkers that could help accelerate development. But that's going to require getting the data and analyzing it and getting alignment with the agency. But certainly, we'll follow close and have our development strategy aligned with the data that's available.

Thank you.

Thank you. Our next question comes from the line of Diego Luchemovitz from Citi. Diego Luchemovitz, your line is open.

Hi, this is Caroline. Thanks for taking our question. Following the restart of Harmony enrollment, what gives you confidence in maintaining the 2H27 top-line timeline, and how should we think about enrollment momentum through the remainder of 2026? Thanks.

Caroline, thanks so much for the question. Jewel, I'll turn that one over to you.

Thanks. So we don't provide specific enrollment targets or timelines, but our progress today gives us the confidence to have top line data in the second half of 2027 and part of that comes from the patient identification work that was done over the last couple of years as well as the continued execution of our clinical operation teams and then our engagement with the patient community and with our sites all right thank you our next question comes from the line of jason Zimansky from Bank of America.

Jason Zimansky, your line is open.

Good afternoon. Congrats on the great quarter, and thanks for taking our question. Peter, maybe regarding your comments over the depth of FSGS prescribers, what clinical or practical experience do you think these physicians need before prescribing filspari more broadly across their eligible patients? And when should we begin to see whether the early breadth of adoption is translating into greater depth. Thanks.

Go ahead, Peter.

Thanks for that question, Jason. It's early in the launch. I mean, that's, I think, the first thing to say. This is very consistent to earlier launches that I've been involved in. Physicians have sort of patients in mind when a new product becomes available, they prescribe to the patient, to that particular patient. They see what the experience is, and that then encourages repeat prescription as well. That's what we saw with IGA nephropathy, and we see that more rapidly now in FSDS. And so to Eric's earlier point and my earlier point as well, we see a broad prescriber base for FSDS. The majority with single patients so far, but given that we are early in the launch, I'm expecting that we will see depths of prescription moving forward quite quickly.

Our next question comes from the line of Vemil Devan with Guggenheim Securities. Vemil Devan, your line is open.

Thanks for taking the follow-up. Just a quick one from me on the IP side. Apology that I missed it. I heard your comments from the IGAN method of use patent. I'm curious if there's any update on the FSGS side regarding method of use or any extension out of the patent protection.

Well, thanks so much for that question. We do have patent prosecution ongoing in FSGS, nothing to report at this point, but we will provide an update at the appropriate time.

Okay, thanks. Thank you.

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

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

Thank you everyone and have a great day. You may disconnect the call.