Travere Therapeutics, Inc.

Good morning and welcome to Travere 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 Nehra, Vice President, Corporate Communications and Investor Relations. Please go ahead, Nivi.

Thank you, operator. Good afternoon and welcome to Travere Therapeutics' second quarter 2026 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 Peter Heerma, our Chief Commercial Officer, Dr. Jula Inrig, our Head of R&D and Chief Medical 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'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 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, August 4th, 2026. Interviewers 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, Nivi. 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. Travere 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 to Batenase in its pivotal phase three study, and the addition of Sivobrutinib 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 IgA 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 on the launch shortly, but we are encouraged by the early performance. As we build on Phil Sparey'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 sparsentin in Hygiene Apropathy. Upon issuance, the patent is expected to provide US patent coverage for those methods. We also continue to pursue additional patent coverage for sparsentin, including through a pending U.S. application directed to certain methods of using sparsentin 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. Pegdibatinase remains a very important program for Trevir and for the HCU community. It has the potential to become the first and only disease-modifying therapy for classical homocysteineuria, 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, PEG-2-Batinase 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 Siborabrutinib, 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 Siborabrutinib as a meaningful long term growth opportunity in addition to Filspari and Pegdibatinase. 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 Travier. Following our FSDS 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-fueled sparring demand with over 2,000 new patient start forms across IgA Nephropathy and FFDS 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 FSCS. Let me begin with IGA nephropathy. Demand remains strong, growing again compared to the prior quarter. Importantly, this growth was achieved despite additional treatment options entering the market, reinforcing Filspari's established and differentiated positioning. Filspari 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 platenuria target, We have observed physicians treating patients earlier and pursuing more ambitious treatment goals. PhilSparry's foundational positioning with superior efficacy demonstrated against an active, maximally dosed ARB gives physicians confidence that more patients can achieve those goals, whether PhilSparry 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 inmate need, along with the compelling proteinuria reduction PhilzPari provides, has created strong physician 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 IGA 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 lots. 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 demands during the initial launch periods. Importantly, overall demand has been broad. The vast majority of physicians who have prescribed Filspari for FHDS 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 IGA nephropathy 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 launch 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 FSDS 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 Filspari 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 loss and it is not prudent to extrapolate 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 REMS 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 Spary'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 Spary. are the only approved therapy that can replace RAS inhibitors while directly addressing key drivers of ongoing kidney injury. By reducing proteinuria, Vilspari provides a differentiated foundational non-immunosuppressive treatment that delivers long-term nephroprotection across both IgA nephropathy and FSGS. As the IgA nephropathy treatment landscape evolves, Our discussions with nephrologists reinforce Silspari'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 one mil per minute per year, remain the two key treatment goals for all patients with IgA nephropathy. This is aligned with the CADIGO guidelines and data from both our PROTECT and SPARTAN studies support that BILSPARI, 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 Phil Sparry's approval as the first medicine approved for FSGS. Phil Sparry 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 Phil Sparry into clinical practice. This includes utilization across primary, secondary, and genetic forms of FSGS and reflects confidence in Filspare'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 PEG-2-batinase, 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 reinforce the significant unmet need and excitement about PEG2Batinase's potential to meaningfully reduce total homocysteine and overcome many of the limitations of current treatment approaches. Enrollment in our phase three 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 Sivorebrutinib into our development portfolio. Sivorebrutinib 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, Sivorebrutinib represents a strategic and complementary addition to our rare disease portfolio. Vilspari provides kidney protection, and Sivorebrutinib 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, continued to invest in the programs with the greatest opportunity to create value for patients and shareholders, strategically expanded our pipeline with the addition of SIBO or Brutinib, and strengthened our balance sheet through successful convertible note transactions. Collectively, these actions have further strengthened our financial position and support our confidence in Travere'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 PhilSparry grew approximately 96% year-over-year to $141.1 million, representing a strong start to the FSGS launch and continued growth in IJ and the crop of it. As expected, growth to net discounts for PhilSparry in the second quarter were slightly lower compared to the first quarter. We expect gross 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 net discounts for Filspare to be in the mid-20% range. Diola and Diola EC also contributed $20.3 million in U.S. net product sales during the second quarter, and we recognize $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 Chugai Partnership for Sparsentin 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 expense. 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 IG and nephropathy. Royalty expense for the quarter was approximately $7.1 million. As we mentioned on our call last quarter, the Tiola Intangible Asset reached the end of its accounting useful life at the end of March. As a result, royalty expense now reflects Tiola 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 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 due 2029 and issued $525 million of half percent convertible notes due in 2032. Following the close of the Seaborg Brutinib 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 Filspare 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 Filspare NFSGS and foundational positioning in IG nephropathy, the advancement of Pax Effect Vatinase, and the development of C. borobrutinib. 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. and I'll 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 today. 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, Bill Sparey 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 Travere 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 Filspari sales and continuing to advance an exciting pipeline with multiple drivers of long-term value. With that, I'll turn it over to Nivi to begin Q&A. Nivi?

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, please rejoin the queue. We will now take the first question from the line of Vamil Devan from Guggenheim 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. Are they starting at a much higher point than we were expecting? I know you mentioned some summer seasonality, 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 also on the same page as we think about sort of the growth outlook from here, but also maybe some of the headwinds around the summer. and also, you know, competitive dynamics and IGAN too. So, just want to make sure we're all reasonably in the same spots. 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 FSJS against the backdrop of growing demand in IgA 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 IgA nephropathy. What we basically have seen since Q4 last year, basically after the modification of the RENDS program that we have seen patients' thought forms north of 900. And we are confident in our continued performance in IgA nephropathy there. while also having a very strong long for FHDS. I mentioned the approval was highly anticipated by both physicians as well as patient communities. And what we have seen is 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 had very distinct phases in the loss, moving from accelerated to full approval, for approval to the REMS modification. You won't see those same catalysts 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.

Our next question comes from the line of Anupam Rama from JP Morgan. Anupam Rama, 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 page script and how you expect this to evolve. Thanks so much.

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

Yeah, thanks for the question, Anupam, and thanks for the high five as well. Overall, what we commented, and that's what we were expecting, that you would see a faster conversion from patient start forms in FSGS versus what we saw initially in IHJ nephropathy. Having said that, it still takes time to educate payers and to get Phil Spy included in the formularies. So while we're ahead of IHJ nephropathy, there's still work to be done. But overall, very pleased with the progress we have been making so far. And yeah, we look forward to educate They are consistently to our label and our health economic evidence.

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

Congratulations on the great performance, Travere 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 Filspare to. 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. And Joe, thanks for that question. 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 filspary in IgA 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 IJ nephropathy patients as well. and so like a positive experience with Phil Spary and after SGS, we would expect also then provide enthusiasm to start prescribing an IgA nephropathy. So early signals are positive there. With regards to the patient segments, as you would expect, and this 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, that gives me great confidence on continued demand moving forward. Thanks.

Our next question. Our next question comes from the line of Tyler Von Buren from TD Common. Tyler Von 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 IG nephropathy launch? and was there a steady growth in IGAN or would you say that the FSGS approval really reinvigorated IGAN PSS 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 IGN nephropathy. and we're not gonna break that out but what we would say is that we did see quarter over quarter increase in the number of PSFs with IgA nephropathy which has been our expectation and I think is incredibly encouraging given both the increased number of treatment options within the IgA space but also what we have been talking about and now we're seeing is an acceleration in the growth of the IgA nephropathy space Peter, why don't you take, you know, 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, or Phil Sparry. And to Eric's point, I mean, the love 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 Redbush. 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 our expectation in terms of guidelines and what your medical affairs team are hearing from nephrologists. Peter?

Yeah, overall, I would say that field sparring is very well established in payer plans and formularies. We price field sparring for broad access. I mean, if you consider it compared to B-cells or other therapies, that's considerably higher. So I think it is a component to take into consideration. I think also that we have the highest rigor of evidence. I mean, what players are looking for is preferably head-to-head comparison. And that's exactly what we are having with an act of control, highest dose ARB, where we showed superiority. And I think overall what we are seeing so far is that players understand The complementary role of like other modalities, like, for example, these cells that you were referring to. But so far, yeah, we are confident with the positioning of TILS-PARI and formulary so far.

And 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 KDCO guidelines. You target the kidney injury where Fosfari 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 that's what we're hearing from the field at this point.

Thanks very much. Our next question comes from the line of Precar Agarwal from Cantor Fitzgerald. and Prakhar Agrawal. Your line is open.

Hi. Thank you so much for taking my questions and congrats on the strong quarter. We have just a couple. How do you expect the persistency in SSGS 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 in 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 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 Burka, I think you had three questions in one. Eric addressed the first one with the spend of 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 spilt sparring. With regard to dosing, also here early in the launch, but overall we see basically the same uptitration behavior as that we saw in IgA nephropathy, meaning that for FSDS physicians are uptitrating from 400 to 800 milligram 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 IGAN 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 bit about the dynamics of conversion early in the launch of IGANT versus what we're seeing thus far.

Yeah, Eric and Kevin, 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 IgA nephropathy. But as you would expect, I mean, we have an established patient services team. We are experienced with the rents process. Offices 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 Sparry 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.

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 then 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 a model conversion.

Our next question comes from the line of Mohith Bensal from Wells Fargo. Mohith Bensal, your line is open.

Hi, this is Sadia Rahman on for 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 field sparring across IGAN and FSGS. You know, maybe this makes that $3 billion estimate seem conservative. And just related to that, when we think about penetration into that 30,000 patients that you framed as addressable in FSGS, just 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 are there any analogs that we should consider here? Thank you.

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 PhilSparry long-term. With regard to the penetration, we do see that we are starting off of a strong position, but we're only 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. 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 IG 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.

Okay. Our next question comes from the line of Maury Raycroft with Jefferies. Maury Raycroft, your line is open.

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

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

We haven't disclosed what patients 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 RAS inhibition to Philzpari before considering other branded modalities. Thank you.

Our next question comes from the line of Joe Pantginas from HA Winwright. Joe Pantginas, 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 is 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 have a 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 nephrology syndrome.

Great.

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

Hey, Grace. 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 based on the FSGS experience here, what could be the potential outcome in membranous nephropathy 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 clinical development strategy moving forward? Thanks.

Alex, thanks so much for the question, and particularly that it's on SIBO. 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 APOL-L1 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. 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. Our next question comes from the line of from Citi. Your line is open.

Hi, this is Carolyn on Seagull. 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 to date gives us the confidence to have top-line data in the second half of 2027, and part of that comes 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.

Got it. Thank you. Our next question comes from the line of Jason Zemanski from Bank of America. Jason Zemanski, 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 breath 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 FSGS. The majority were 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 Vamil Devan with Guggenheim Securities. Vamil Devan, your line is open.

Great. Thanks for taking the follow-up. Just a quick one from me on the IP side. Apologies if 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. Thanks.

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 concludes 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.