管理層發言
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 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?
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 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 U.S. Patent and Trademark Office 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?
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 two 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, 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 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?
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 two 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 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 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's 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 topline 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?
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 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 to plan 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?
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?
Thank you, Eric. Operator, we can now open up the line for Q&A.
分析師問答
We will now take the first question from the line of Vamil Divan from Guggenheim Securities.
Congrats on the quarter, very impressive results here. My question is still on the FSGS launch and following up on some of what Peter said regarding 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 IgA nephropathy, too. I just want to make sure we're all reasonably in the same spot. Any further comments there would be very helpful.
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. 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 have seen since Q4 last year, after the modification of the REMS program, is patient 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. We have seen a small portion of patients that were identified early; those are patients who are often seen more frequently by their physicians. The trajectory of FSGS may be slightly different than IgA nephropathy, where you have distinct phases in the launch, moving from accelerated to full approval and then REMS modification. You won't see those same catalysts in FSGS. But most importantly, we are seeing a broad prescriber base for FSGS with most physicians only having one patient so far 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.
Our next question comes from the line of Anupam Rama from JPMorgan.
Congrats on all the progress here. Just following up on Vamil's question on FSGS. Could you expand a little bit on what you're seeing on timelines from start form to paid prescription and how you expect this to evolve?
Thanks, Anupam. Peter, why don't you take those?
Thank you for the question, Anupam. Overall, 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 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. We look forward to educating payers consistently on our label and our health economic evidence.
Our next question comes from the line of Joe Schwartz from Leerink Partners.
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?
Joe, thanks so much for the question. You're going to get a two-for-one answer. I'm going to share my thoughts, and then I'll 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. Peter talked about the breadth of prescribing; we saw that very quickly. Physicians are trying it, which will 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?
Joe, thanks for that question. A large part of early use is coming from physicians that already had experience with FILSPARI; in IgA nephropathy about 70% of prescribers had that experience already. At the same time, 30% of prescribers are new to the brand. We see a halo effect: physicians who start prescribing for FSGS often have IgA nephropathy patients as well. A positive experience with FILSPARI in FSGS could encourage them to prescribe in IgA nephropathy. Regarding patient segments, as expected in most launches, patients with relatively high proteinuria levels—those seen more frequently by physicians—are more represented early. But overall, reinforcing what Eric said, the breadth of prescriber base—with most physicians having a single patient so far while seeing more FSGS patients—gives me great confidence in continued demand moving forward.
Our next question comes from the line of Tyler Van Buren from TD Cowen.
This is Greg Torres on for Tyler. Congrats on the quarter. The patient start forms 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? Was there steady growth in IgA nephropathy, or did the FSGS approval reinvigorate IgA nephropathy patient start forms as well?
Greg, thanks for the great question. We did see growth in demand for IgA nephropathy, and we're not going to break that out by indication. We did see quarter-over-quarter increase in the number of patient start forms with IgA nephropathy, which has been our expectation and is encouraging given both the increased number of treatment options within the IgAN space and the acceleration in growth of the IgA nephropathy space following broader awareness. Peter, any additional color on growth and the FSGS uptake?
I would add that FILSPARI remains the most utilized treatment option approved for IgA nephropathy, which reinforces its established and differentiated positioning. The FSGS launch was highly anticipated, and we knew there was a high level of excitement across physicians and patient communities—exactly what we are seeing.
Our next question comes from the line of Laura Chico with Wedbush.
One area of concern we've heard from physicians is being in a challenging spot: 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. Are you actually seeing this happen in practice? And what's your expectation for patients to be on multiple branded agents going forward?
Laura, thanks for the question. Peter, why don't you talk a bit about what we're seeing today in terms of dynamics, and Jula, I'd like you to address expectations in guidelines and what medical affairs are hearing from nephrologists.
Overall, FILSPARI is very well established in payer plans and formularies. We have priced FILSPARI for broad access. Compared to some other therapies, pricing considerations differ, and payers look for rigorous evidence—preferably head-to-head comparisons. We have that with an active control, maximally dosed ARB, where we showed superiority. So far, payers understand the complementary role of other modalities like B-cell therapies you referenced. We are confident in FILSPARI's positioning and formulary status to date.
I'm happy to add to that, Laura. We've heard some anxiety from nephrologists who want to use multiple therapies to reach both targets—proteinuria remission and eGFR stabilization. It's not a specialty that has had a lot of experience with multiple branded agents, so there's uncertainty. But we haven't seen systemic pushback preventing the use of multiple therapies to achieve those targets. Physicians want to use multiple agents to achieve complete remission and eGFR stabilization, aligned with KDIGO guidelines: target kidney injury with FILSPARI, which showed head-to-head superiority versus historical standard of care, and then add immune-mediated therapy when clinically appropriate. Combination therapy is what is being discussed in the field right now.
Our next question comes from the line of Prakhar Agrawal from Cantor Fitzgerald.
Congrats on the strong quarter. How do you expect persistency in FSGS to track relative to IgAN given the dosing and patient population differences? And can you quantify any bolus that was present for FSGS, since that affects how we model new patient starts in Q3 and beyond?
Prakhar, thanks for the questions. Let me take the second one first. We did not see evidence of a bolus. What we did see is rapid uptake based on the high anticipation of this approval, both by patients and the nephrology community. We do not see evidence of a bolus that would suggest a slowdown in demand. We expect continued demand and the opportunity is substantial. Peter, on persistency across FSGS and IgAN?
Thanks, Eric. Prakhar, it's very early in the launch, but we are not expecting persistency in FSGS to be meaningfully different versus IgA nephropathy. Historically, compliance rates with FILSPARI in IgA nephropathy have been high. Regarding dosing, early in the launch we are seeing the same up-titration behavior as in IgA nephropathy, with physicians up-titrating from 400 to 800 milligrams consistent with the label.
Our next question comes from the line of Gavin Clark-Gartner from Evercore.
Congrats on the initial launch thus far. On conversion metrics, you noted conversion rates in FSGS are exceeding what you saw in IgA nephropathy previously. What was the rate you saw with IgA nephropathy? I'm less interested in speed and more in the rate at any point in time. I model 70% off the bat, increasing to 75% as access is established. Is that too conservative?
Gavin, thanks for the question. Peter, I'll turn that to you. We won't provide specific metrics, but Peter can share color on dynamics of conversion early in the IgA nephropathy launch versus now.
Happy to provide color. We haven't disclosed specific conversion rates for IgA nephropathy. We have an established patient services team and REMS experience, and the process through patient services and distribution is well established. FILSPARI being often already in formularies, even if not specifically for FSGS, contributes to a higher conversion rate than we saw with IgA nephropathy early on. That higher conversion rate is materializing in FSGS, and we are pleased with the progress, which is consistent with our expectations.
Let me add that from near day one of the FSGS launch, we were in a much stronger position than at the start of the IgA nephropathy launch. It takes time to get payer policies in place, but everything we see aligns to a very strong outlook within FSGS.
Our next question comes from the line of Mohit Bansal from Wells Fargo.
This is Sadia Rahman on for Mohit. Congrats on the quarter. Has the strong launch in FSGS changed your confidence in your prior estimate of the size of the opportunity for FILSPARI across IgAN and FSGS? Does this make the $3 billion peak estimate seem conservative? And regarding penetration into the roughly 30,000 addressable FSGS patients, how should we think about penetration given there are no other approved treatments? Any factors that could limit penetration or analogs to consider?
Sadia, thanks for those questions. We remain very confident in the revenue opportunity exceeding $3 billion at peak across both FSGS and IgA nephropathy. While this strong early uptake is encouraging, it's a single data point and we have not revised our peak sales estimate at this time. The early launch reiterates our confidence in FSGS's growth outlook long term. Regarding penetration, we are starting from a strong position but are only scratching the surface of patients who could benefit from FILSPARI. FILSPARI is the only approved medication in FSGS currently. There are therapies in development for subtypes of FSGS, but those are earlier stage. We view future therapies as largely complementary; many patients could benefit from combination approaches, much like is emerging in IgA nephropathy. Overall, we are very pleased with early uptake and the long-term revenue opportunity, but our focus remains on reaching more patients and improving outcomes.
Our next question comes from the line of Maury Raycroft with Jefferies.
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?
James, thanks for the question. Peter, I'll turn that over to you.
We haven't disclosed the breakdown between new branded prescriptions versus switches. I can tell you most prescriptions of FILSPARI are new to branded therapies, which is consistent with our positioning. The first change physicians commonly make is moving from generic RAS inhibition to FILSPARI before considering other branded modalities.
Our next question comes from the line of Joe Pantginis from H.C. Wainwright.
This is Josh on for Joe. Last quarter you mentioned that the 'without nephrotic syndrome' language would be more of an education opportunity rather than a barrier to adoption. Is that still holding true, or have you encountered any unexpected issues?
Josh, thanks for the question. Peter, go ahead.
With every launch you need to educate physicians on the indication, and this was no different. Physicians understand the indication well, and it's consistent with how nephrology is practiced in FSGS patients and aligned with KDIGO guidelines. While there is still education to do, physicians understand the positioning for patients who are currently not in nephrotic syndrome.
Our next question comes from the line of Alex Thompson with Stifel.
Congrats on the quarter. Regarding civorebrutinib, the PARASOL group is looking at membranous nephropathy and there's a workshop later in September. Based on the FSGS experience, what could be the potential outcome in membranous nephropathy with PARASOL? Could there be a faster path to pivotal development in this space? How might that impact your clinical development strategy moving forward?
Alex, thanks for the question on civorebrutinib. Jula, I'll turn that over to you.
We're excited by the continued efforts to define endpoints that could help accelerate therapies for high unmet need, including membranous nephropathy. There's also work in APOL1 and Alport with other groups. We'll closely follow the data and analyses. The standard development strategy in membranous nephropathy looks at complete remission over two years, which has been well established. Some would like endpoints shorter than complete remission or biomarkers that could accelerate development; that will require generating data, analysis and alignment with regulatory agencies. We'll follow the data closely and align our development strategy accordingly.
Our next question comes from the line of Yigal Nochomovitz from Citi.
This is Caroline on for Yigal. Following the restart of HARMONY enrollment, what gives you confidence in maintaining the second half of 2027 topline timeline? How should we think about enrollment momentum through the remainder of 2026?
Caroline, thanks for the question. Jula, please provide color.
We don't provide specific enrollment targets or timelines, but our progress to date gives us confidence in delivering topline data in the second half of 2027. That confidence comes from patient identification work done over the last couple of years, continued execution by our clinical operations teams, and strong engagement with the patient community and our sites.
Our next question comes from the line of Jason Zemansky from Bank of America.
Congrats on the great quarter. Peter, regarding 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? When should we begin to see whether the early breadth of adoption is translating into greater depth?
Thanks, Jason. It's early in the launch. Physicians typically have patients in mind when a new product becomes available and prescribe it for that patient, then observe the experience, which encourages repeat prescriptions. That's what we saw with IgA nephropathy and we are seeing it more rapidly in FSGS. We see a broad prescriber base for FSGS, the majority with a single patient so far, but given this is early, I expect to see depth of prescription increase moving forward quite quickly.
Our next question comes from the line of Vamil Divan with Guggenheim Securities.
Just a quick one on the IP side. I heard your comments on the IgAN method-of-use patent. Any update on the FSGS side regarding method-of-use or any extension of patent protection?
Vamil, thanks 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.
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.