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TVTX Q2 2026 Earnings Call Transcript

Operator: 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.

Nivi Nehra: 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 4, 2026, and Travere 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?

Eric Dube: 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 4 key pillars: continued growth for FILSPARI in IgA nephropathy, the successful launch of FILSPARI in FSGS, the advancement of pegtibatinase in its pivotal Phase III study and the addition of civorebrutinib 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 IgA 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 FILSPARI's commercial momentum, we continue to advance our intellectual property strategy. During the quarter, the USPTO issued a Notice of Allowance for a U.S. patent application directed to certain methods of using sparsentan in IgA nephropathy. Upon issuance, the patent is expected to provide U.S. patent coverage for those methods. We also continue to pursue additional patent coverage for sparsentan, including through a pending U.S. application directed to certain methods of using sparsentan in FSGS. Beyond FILSPARI, 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. Pegtibatinase remains a very important program for Travere 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, pegtibatinase 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 civorebrutinib, 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 civorebrutinib as a meaningful long-term growth opportunity in addition to FILSPARI and pegtibatinase. 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?

Peter Heerma: 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 FILSPARI demand with over 2,000 new patient start forms across IgA nephropathy and FSGS and record U.S. revenue of more than $141 million for the quarter. Our Q2 performance reflects 2 complementary growth drivers: one, continued strength in our established IgA nephropathy business; and two, exceptionally strong first few months of launch in FSGS. 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 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 proteinuria target, we have observed physicians treating patients earlier and pursuing more ambitious treatment goals. FILSPARI's foundational positioning with superior efficacy demonstrated against an active maximally dosed ARB gives physician confidence that more patients can achieve those goals, whether FILSPARI is used as a monotherapy or in combination with other treatment modalities. Turning to FSGS. 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 unmet need, along with the compelling proteinuria reduction FILSPARI provides has created strong physician and patient enthusiasm. Furthermore, our established nephrology relationships, combined with our team's robust FSGS launch preparation have supported rapid early adoption by the FSGS community. At approval, we expected FSGS 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 have seen during the initial phase of the IgA 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 FSGS 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, enable 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 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 FSGS patient community. Looking ahead, it is still early in the launch, and it's 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 FSGS uptake curve to differ from IgA nephropathy. In IgA nephropathy, adoption evolves through several distinct phases, including the transition from accelerated to full approval and subsequent REMS simplification. In FSGS, 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 FSGS patient communities, grounded in FILSPARI'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?

Jula Inrig: Thank you, Peter. I'll start with FILSPARI, 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 nephroprotection 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 ml per minute per year remain the 2 key treatment goals for all patients with IgA nephropathy. This is aligned with the KDIGO guidelines and data from both our PROTECT and SPARTAN studies support that FILSPARI, 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 the first medicine approved for FSGS. FILSPARI is indicated to reduce proteinuria in adult and pediatric patients aged 8 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 5 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 IV 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 pegtibatinase. 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 pegtibatinase' potential to meaningfully reduce total homocysteine and overcome many of the limitations of current treatment approaches. Enrollment in our Phase III 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 civorebrutinib into our development portfolio. Civorebrutinib 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, civorebrutinib represents a strategic and complementary addition to our rare disease portfolio. FILSPARI provides kidney protection and civorebrutinib 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?

Chris Cline: Thank you, Jula. In the second quarter, we delivered exceptional commercial results, continue to invest in the programs with the greatest opportunity to create value for patients and shareholders, strategically expanded our pipeline with the addition of civorebrutinib 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 of FILSPARI grew approximately 96% year-over-year to $141.1 million, representing a strong start to the FSGS launch and continued growth in IgA nephropathy. 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. Thiola and Thiola 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 Chugai partnership for sparsentan in Japan. Total GAAP R&D and SG&A expenses for the quarter were $156.4 million, which includes approximately $22.2 million in noncash 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 pegtibatinase during the quarter. For SG&A, the year-over-year increase is primarily attributable to investments in FILSPARI'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 IgA nephropathy. Royalty expense for the quarter was approximately $7.1 million. As we mentioned on our call last quarter, the Thiola intangible asset reached the end of its accounting useful life at the end of March. As a result, royalty expense now reflects Thiola royalties 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 due 2029 and issued $525 million of 0.5% convertible notes due in 2032. Following the close of the civorebrutinib transaction in July, we paid Everest, the previously disclosed upfront amount of $112.5 million. As we look ahead, we remain confident in our outlook and continue -- 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 FILSPARI in FSGS and foundational positioning in IgA nephropathy, the advancement of pegtibatinase and the development of civorebrutinib. 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'll now turn the call over to Eric for his closing remarks. Eric?

Eric Dube: 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, FILSPARI 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?

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

Operator: [Operator Instructions] We will now take the first question from the line of Vamil Divan from Guggenheim Securities.

Vamil Divan: Congrats on the quarter, very impressive results here. So I guess my question is on -- still 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, 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 the next few quarters so we're in a reasonable spot and people are on the same page as to think about sort of the growth outlook from here, but also maybe some of the headwinds around the summer and also, obviously, the competitive dynamics in IgAN, too. So I just want to make sure we're all reasonably in the same spot. Any further comments there would be very helpful.

Eric Dube: Vamil, 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 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?

Peter Heerma: 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 REMS program that we have seen patients start forms north of 900, and we are confident in our continued performance in IgA nephropathy there, while also having a very strong launch for FSGS. 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 launch, moving from accelerated to full approval and then from full approval to the REMS modification. You won't see those same catalysts in FSGS. But I think most importantly, what we are seeing is broad prescriber base for FSGS with most physicians only having 1 patient while they have multiple patients in their practices. So we're very confident with what we have seen, and we believe there will be continued demand moving forward.

Operator: Our next question comes from the line of Anupam Rama from JPMorgan.

Anupam Rama: Congrats on all the progress here. Just following up on Vamil's question here on FSGS. Just wondering if you could expand a little bit on what you're seeing on time lines from start form to paid script and how you expect this to evolve?

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

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

Operator: Our next question comes from the line of Joe Schwartz from Leerink Partners.

Joseph Schwartz: 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 FILSPARI to? Are any patterns notable amongst academic centers, community nephrologists, pediatric nephrologists or prior DUPLEX investigators and their FSGS patients?

Eric Dube: Joe, thanks so much for the question. You're going to get 2-for-1 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?

Peter Heerma: Yes, absolutely. And Joe, thanks for that question. Fully in the right 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 IgA nephropathy, 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 that is 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 FILSPARI and FSGS, we would expect also then provides enthusiasm to start prescribing in IgA nephropathy. So early signals are positive there. With regard to the patient segment, 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 FSGS patients, that gives me great confidence on continued demand moving forward.

Operator: Our next question comes from the line of Tyler Van Buren from TD Cowen.

Gregory Wiessner: This is Greg Torres on for Tyler. Congrats on the quarter. 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?

Eric Dube: 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 IgA 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 IgA 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?

Peter Heerma: Yes. 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, FILSPARI remains the most utilized treatment option approved for IgA nephropathy. And I think that reinforces the established and differentiated positioning of FILSPARI. And to Eric's point, the launch 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.

Operator: Our next question comes from the line of Laura Chico with Wedbush.

Laura Chico: One area of concern we've heard from physicians is being in a challenging spot. So if they get payer pushback on combining something like FILSPARI 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?

Eric Dube: 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?

Peter Heerma: Yes. Overall, I would say that FILSPARI is very well established in payer plans in formularies. We price FILSPARI 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 dosed ARB where we showed superiority. And I think overall, what we are seeing so far is that payers understand the complementary role of like other modalities like, for example, B cells that you were referring to. But so far, yes, we are confident with the positioning of FILSPARI and formulary so far.

Jula Inrig: 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's aligned with the KDIGO guidelines. You target the kidney injury, where FILSPARI 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.

Operator: Our next question comes from the line of Prakhar Agrawal from Cantor Fitzgerald.

Prakhar Agrawal: 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 in 3Q and beyond?

Eric Dube: Prakhar, 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 evidence of bolus where you would see 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?

Peter Heerma: Thanks, Eric. And, Prakhar, I think you had 3 questions in 1. Eric addressed the first one with the pent-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 meaningful different versus IgA nephropathy. And what we have commented in the past is that the compliance rates of IgA nephropathy are really high with FILSPARI. With regards 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 up titrating from 400 to 800 milligram, consistent to the label.

Operator: Our next question comes from the line of Gavin Clark-Gartner from Evercore.

Gavin Clark-Gartner: 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 to 75% or so as access is established. It seems like access is really good. So I'm wondering if I'm too conservative there.

Eric Dube: Gavin, thanks for the question. Peter, I'll turn that over to you. But just to 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 IgAN versus what we're seeing thus far.

Peter Heerma: Yes, Eric and Gavin, certainly happy to provide some color 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. There is -- we are experienced with the REMS 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 FILSPARI often already in formularies, even though not specifically for FSGS, that, that conversion rate is higher than what we saw in IgA nephropathy, and that's exactly what is materializing in FSGS. And like I said, I'm really pleased with the progress, which is very consistent to how we had anticipated this.

Eric Dube: Yes, let me just add. I think the really important aspect, Gavin, as we look forward is that, from near day 1 of launch in FSGS, we're in a much stronger position than starting out with IgA 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.

Operator: Our next question comes from the line of Mohit Bansal from Wells Fargo.

Sadia Rahman: This is Sadia Rahman on for Mohit. Congrats on the quarter. So maybe a big picture question. Just curious if the strong launch in FSGS has changed your confidence in your prior estimate of the size of the opportunity for FILSPARI across IgAN and FSGS, 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?

Eric Dube: 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 IgA 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 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 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 IgA 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.

Operator: Our next question comes from the line of Maury Raycroft with Jefferies.

James Stamos: This is James on for Maury. Congrats on all the progress. Otsuka disclosed approximately 50% of VOYXACT's prescriptions are switches. Do you have patient level switch data quantifying outflows in 2Q?

Eric Dube: James, thanks so much for the question. Peter, I'll turn that over to you.

Peter Heerma: We haven't disclosed what patients comes from like new branded prescriptions versus switch, but I can tell you that most of the prescriptions of FILSPARI 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 FILSPARI before considering other branded modalities.

Operator: Our next question comes from the line of Joe Pantginis from H.C. Wainwright.

Joshua Korsen: This is Josh on for Joe. 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?

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

Peter Heerma: Yes. I'm happy 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 FSGS patients, but also very consistent with the KDIGO guidelines. So while there's still education to do, physicians understand the positioning for patients that are currently not in nephrotic syndrome.

Operator: Our next question comes from the line of Alex Thompson with Stifel.

Alexander Thompson: Congrats on the quarter. Maybe shifting gears just civorebrutinib. 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, what could be the potential outcome in membranous nephropathy with PARASOL? Is it your view that there could be a faster path to pivotal development in this space? And how might that impact your clinical development strategy moving forward?

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

Jula Inrig: Yes. We're excited by the continued efforts to define endpoints to help accelerate therapies for high unmet 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 2 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.

Operator: Our next question comes from the line of Yigal Nochomovitz from Citi.

Caroline DePaul: This is Caroline on for Yigal. Following the restart of HARMONY enrollment, what gives you confidence in maintaining the 2H '27 top line time line? And how should we think about enrollment momentum through the remainder of 2026?

Eric Dube: Caroline, thanks so much for the question. Jula, I'll turn that one over to you.

Jula Inrig: So we don't provide specific enrollment targets or time lines, 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 from the patient identification work that was done over the last couple of years as well as the continued execution of our clinical operations teams and then our engagement with the patient community and with our sites.

Operator: Our next question comes from the line of Jason Zemansky from Bank of America.

Jason Zemansky: Congrats on the great quarter. 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?

Peter Heerma: Thanks for 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 FSGS. And so to Eric's earlier point and my earlier point as well, we see a broad prescriber base for FSGS, the majority with single patient so far. But given that we are early in the launch, I'm expecting that we will see depth of prescription moving forward quite quickly.

Operator: Our next question comes from the line of Vamil Divan with Guggenheim Securities.

Vamil Divan: Just a quick one for me on the IP side. Apologies if I missed -- I heard your comments on 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.

Eric Dube: Vamil, 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.

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

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

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