TVTX - NASDAQ

Good afternoon, and welcome to the Travere Therapeutics Second Quarter 2025 Financial Results Conference Call. Today's call is being recorded. At this time, I would like to turn the conference over to Nevi Nehra, Vice President, Corporate Communications and Investor Relations.

Vice President of Corporate Communications & Investor Relations Thank you, operator. Good afternoon, and welcome to Travere Therapeutics' Second Quarter 2025 Financial Results and Corporate Update Call. Thank you all for joining. Today's call will be led by Dr. Eric Dube, our President and Chief Executive Officer. Eric will be joined in the prepared remarks by Dr. Jula Inrig, our Chief Medical Officer; Peter Heerma, our Chief Commercial Officer; and Chris Cline, our Chief Financial Officer. Dr. Bill Rote, our Chief Research Officer, will join us for the Q&A. Before we begin, I'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 6, 2025, and Travere specifically disclaims any obligation to update such statements to reflect future information, events, or circumstances. With that, let me now turn the call over to Eric.

Thank you, Nivi. Good afternoon, and thank you all for joining us. The second quarter of 2025 was a standout for Travere, a reflection of strong strategic execution and continued momentum in delivering against our mission. At the heart of this progress is FILSPARI, where we are advancing our leadership in rare kidney disease by deepening our impact in IgA nephropathy and laying the foundation for potential expansion into FSGS. In IgAN, we delivered our strongest commercial quarter to date with continued demand driven by both new and repeat prescribers. As the IgAN treatment landscape evolves, physicians are increasingly adopting FILSPARI as foundational care, recognizing the meaningful and consistent outcomes it delivers and doing so earlier in the disease process. This growing confidence reflects our ongoing strategy to establish FILSPARI as the new foundational therapy for IgA nephropathy. There are several pillars to this strategy that we expect to be further solidified through year-end. First, the continued generation of robust clinical evidence to support the use of FILSPARI across a broad range of patients and in combination with other classes of medicines. Second, broad access aligned with the full approval indication statement, payer coverage, and an expected modification of the liver monitoring REMS and removal of the pregnancy testing REMS. And finally, the continued real-world clinical experience and growing recommendation by nephrologists and treatment guidelines that recognize FILSPARI's ability to reduce proteinuria and reinforce the benefits of getting patients to complete remission. I am pleased with the tremendous progress that our team has made to date, which sets us up for sustained growth in an expanding IgAN market. Our performance in Q2 reflects the strength of this positioning and the growing use of FILSPARI as a foundational nephroprotective treatment in IgAN, even as new treatments enter the market. While it's still early days in the evolving IgAN treatment landscape, FILSPARI's performance is directly aligned with the expectations that we have set over the last few years and validation of its path to foundational use. Jula and Peter will review the progress of our strategy in greater detail. We've also seen strong progress outside of the U.S. by our partners, CSL Vifor and Renalis, as they look to expand access to FILSPARI internationally. We've entered the second half of the year from a position of strength, and we're ready to build on this momentum. The sNDA review process for a potential second indication for FILSPARI in FSGS is advancing as expected. We're preparing for what could be an extraordinary milestone for Travere and the FSGS community. If approved, FILSPARI would become the first ever treatment approved for this underserved patient community, a breakthrough for patients and a near- and long-term growth opportunity for our company, given that there are no other FSGS therapies likely to be available in the near future. Beyond FILSPARI, we continue to advance our pipeline with a drive to transform paradigms in rare diseases like classical homocystinuria, and we remain on track to reinitiate enrollment in the HARMONY study for pegtibatinase next year. With a robust and growing foundation in IgAN, the potential to be the first approved medicine in FSGS, and a pipeline built for continued innovation, we remain confident in the road ahead. I will now hand the call over to Jula for an update on our clinical programs. Jula?

Thank you, Eric. As a nephrologist, it's incredibly rewarding to witness the continued innovation in IgA nephropathy, a disease where, not long ago, patients had very few options. We are expanding the body of evidence that supports the foundational role of FILSPARI across a broad spectrum of IgA nephropathy patients at risk of disease progression, ranging from those who are newly diagnosed to those with recurrent disease post-transplant. FILSPARI's unique ability to target 2 pathways causing kidney injury, endothelin 1 and angiotensin 2, provides patients with IgAN nephropathy a non-immunosuppressive treatment option to help preserve kidney function. We were pleased to engage with the medical and patient community at several recent congresses where we presented important new data that continue to reinforce the nephroprotective effects, strong safety profile, and emerging disease-modifying potential of FILSPARI. Select data from these congresses included in the Phase II SPARTAN trial, when used first line in treatment-naive IgAN nephropathy patients, FILSPARI-treated patients achieved an approximately 70% proteinuria reduction, with nearly 60% of the patients in the study reaching complete proteinuria remission and stable eGFR through 24 weeks. Also in the SPARTAN study, an analysis of patient samples showed that FILSPARI-treated patients with IgA nephropathy demonstrated rapid and sustained reductions in urinary B-cell activating factor or BAF, and complement factor C5b through 9, as well as reductions in pro-inflammatory and pro-fibrotic biomarkers. When taken in combination with our preclinical data showing FILSPARI protects from mesangial deposition of IgA, these data suggest a potential role of optimal dual inhibition of endothelin-1 and angiotensin 2 in modifying the underlying disease. In the Phase III PROTECT open-label extension that is ongoing, patients transitioning from maximally titrated irbesartan to FILSPARI after the double-blind period also achieved approximately 50% reductions in proteinuria and a relatively stable eGFR out to 1 year. Together with the kidney function preservation FILSPARI provides, these new data further reinforce FILSPARI's disease-modifying potential in IgA nephropathy without immunosuppression. As the IgAN treatment paradigm evolves, we expect combination therapy to become the new standard to help more patients reach complete proteinuria remission, which is recognized as a treatment goal in the draft update to the KDIGO guidelines. FILSPARI remains uniquely positioned as the only medicine to replace RAS inhibitors as a more effective foundational therapy in IgA nephropathy with a profile that is complementary to the emerging therapeutic classes. We are also approaching the August 28 PDUFA date for the removal of the embryo-fetal toxicity REMS and the potential modification of the liver monitoring REMS to quarterly. With no cases of Hy's law to date, we remain confident in the safety profile of FILSPARI to support this change. Turning to FSGS. Our sNDA seeking full approval of FILSPARI in FSGS was accepted by the FDA with a PDUFA date of January 13, 2026. As a reminder, the work by the independent PARASOL group established proteinuria as a valid surrogate endpoint for kidney failure in FSGS and helped pave the way for regulatory consideration of proteinuria reduction for full approval. The sNDA review process is advancing as expected, and we're preparing for an advisory committee to discuss FILSPARI as the first potential approved medicine for FSGS. Our team is actively preparing to present the strong data from DUPLEX and DUET in the context of the independent PARASOL findings. For example, earlier this quarter, we presented new analysis from the DUPLEX study that confirmed the PARASOL findings. In DUPLEX, significantly more FILSPARI-treated patients achieved either partial or complete remission compared to irbesartan. Importantly, those patients who achieved partial or complete proteinuria remission in the study, irrespective of treatment arm, had a 67% to 77% lower risk of kidney failure, respectively. These data represent the first trial-level evidence in support of the independent PARASOL analysis of proteinuria as a validated surrogate endpoint in FSGS. Lastly, on our HCU program, we continue to be excited about the potential of our investigational enzyme replacement therapy, pegtibatinase. We have made strong progress on our manufacturing scale-up to support our Phase III trial and a future commercial launch, and are on track towards restarting patient enrollment in the Phase III HARMONY study next year. I'll now turn the call over to Peter for a commercial update. Peter?

Thank you, Jula. I'm pleased to report that our commercial team executed exceptionally well in Q2, as demonstrated by our strong performance metrics. FILSPARI net product sales reached approximately $72 million in the U.S. in the second quarter, representing significant year-over- year growth. This performance was driven by strong demand, expansion, and deepening of the prescriber base, as well as further efficiencies in our fulfillment process and solid therapy compliance and persistence. As the only fully approved non-immunosuppressive kidney-targeted therapy for IgA nephropathy, FILSPARI remains uniquely positioned to replace the historical standard of care in this evolving treatment landscape. The growing recognition of FILSPARI's nephroprotective profile, not just from returning prescribers, but also from nephrologists who are newer to the brand, resulted in 745 new patient start forms this quarter, approximately a 43% increase compared to the same period last year. At a time when new treatment options are emerging for IgA nephropathy, feedback from our field teams and recent market research emphasize physician confidence in FILSPARI's established position in clinical practice. Nephrologists regularly cite FILSPARI's consistent, rapid, and sustained proteinuria efficacy with long-term kidney preservation benefits, a safety profile that allows for chronic use, and a patient-friendly, once-daily oral administration that optimally inhibits 2 critical kidney-damaging pathways as key reasons for making FILSPARI their foundational therapeutic option. Importantly, many physicians are choosing FILSPARI earlier in the treatment journey. This reflects a growing emphasis on earlier intervention and a shift away from legacy approaches, such as the off-label use of RAS inhibitors or steroids. Based on our research, about 70% of the addressable patients with IgA nephropathy have elevated proteinuria levels but below 1.5 grams per gram. With the proteinuria threshold being removed in the FILSPARI label at full approval, FILSPARI is particularly well-positioned in this large patient segment, allowing for sustainable demand potential. As we look to the remainder of the year, as with any rare disease product, seasonality could drive some variability quarter-over- quarter, but we expect that we will continue to identify new prescribers and that the use of FILSPARI will further deepen as foundational care amongst current prescribers. We believe this will be driven by continued positive experience consistent with FILSPARI's superior clinical profile relative to the historical standard of care, and also driven by the anticipated final KDIGO guideline publication and the potential REMS modifications, which may further simplify access for patients. Turning to FSGS. If approved, FILSPARI would become the first approved therapy for FSGS, a progressive and often debilitating rare kidney disease with a significant unmet need. Given the feedback from nephrologists and the broader FSGS community, we believe FSGS could be an even bigger opportunity with a more rapid uptake versus what we have experienced with our launch in IgA nephropathy. We are actively expanding and preparing our commercial organization to be ready to serve this patient community, beginning with potential approval early next year. In summary, Q2 was another quarter of strong execution and meaningful growth for FILSPARI amidst the evolving IgA nephropathy treatment landscape. We remain confident in our strategy and are encouraged by the feedback from the medical community and the continued momentum in U.S. adoption. With a growing body of clinical and real-world evidence, expanding prescriber engagement, and the potential to serve more rare kidney disease patients through future label expansions, FILSPARI is well-positioned to continue its leadership as a foundational treatment. Let me now turn the call over to Chris for the financial update. Chris?

Thank you, Peter, and good afternoon, all. Our financial foundation continues to strengthen. In the second quarter, net product sales grew approximately 82% over the same period last year, and we continue to make disciplined investments in areas of high growth, such as in building further momentum for FILSPARI in IgA nephropathy, preparing our organization for a potential launch of FILSPARI in FSGS and advancing manufacturing to restart enrollment in the pivotal pegtibatinase study. Beginning with revenue. In the second quarter, we generated U.S. net product sales of $94.8 million. As Peter highlighted, FILSPARI continued to grow significantly in the second quarter, generating $71.9 million in U.S. net product sales. THIOLA and THIOLA EC contributed $23 million in net product sales for the second quarter, and these medicines continue to be a meaningful option for patients living with cystinuria. But as we've highlighted previously, we anticipate more generic competition in the coming quarters. During the second quarter, we also recognized $19.6 million of license and collaboration revenue, resulting in total revenue of $114.4 million. Included in the license and collaboration revenue line this quarter is the previously announced one-time $17.5 million milestone payment from CSL Vifor, which resulted from the conversion of conditional approval of FILSPARI to full approval in Europe earlier this year. Turning to operating expenses. Our research and development expenses for the second quarter of 2025 were $49.4 million compared to $54.3 million for the same period in 2024. The decrease in R&D is largely attributable to reduced clinical activity in the Phase III HARMONY study while we optimize our manufacturing efforts. On a non-GAAP adjusted basis, R&D expenses were $45.4 million compared to $50.6 million for the same period in 2024. Selling, general, and administrative expenses for the second quarter were $76.2 million compared to $64.8 million for the same period in 2024. The increase in SG&A is largely attributable to increased amortization expense related to FILSPARI royalties, as well as increased investment to support the ongoing launch of FILSPARI in IgA nephropathy following full approval and preparing for a potential FSGS launch in January. On a non-GAAP adjusted basis, SG&A expenses were $55.5 million for the second quarter compared to $48.3 million for the same period in 2024. Total other expense net for the second quarter of 2025 was immaterial compared to the net expense of $1.9 million in the same period in 2024. Net loss for the second quarter of 2025 was $12.8 million or $0.14 per basic share compared to $70.4 million or $0.91 per basic share for the same period in 2024. On a non-GAAP adjusted basis, net income for the second quarter of 2025 was $11.9 million or $0.13 per basic share compared to a net loss of $50.1 million or $0.65 per basic share for the same period in 2024. As of June 30, 2025, we had cash, cash equivalents, and marketable securities totaling approximately $319.5 million. As I highlighted earlier, this cash balance reflects the net proceeds of the $17.5 million payment we received from CSL Vifor during the quarter, and we remain on track to potentially achieve additional milestone payments tied to key market access achievements later this year and sales-based achievements in the future, which should further enhance our financial flexibility. Looking ahead, we expect continued revenue growth driven by robust underlying demand for FILSPARI and IgA nephropathy, with a strong balance sheet and potential additional incoming milestone payments as well as a disciplined approach to investing in our key growth drivers, we are well positioned to execute on our strategy and deliver sustainable value over both the near and the long term. I'll now turn the call back over to Eric for his closing comments. Eric?

Thank you, Chris. As you've heard, our team has delivered strong performance across our priorities for the first half of 2025. We are well-positioned and eager to continue this momentum. My team and I are deeply motivated to support the rare disease communities we serve. Recently, I had the honor of attending the annual Spark Patient Meeting of the IgA Nephropathy Foundation. At the meeting, I heard many stories of resilience and of hope. This community has been advanced advocating and hoping for a future with therapies developed for them that can save off kidney failure. We are proud to be part of this journey, and we are committed to the same goal for the FSGS and HCU communities. Now let me turn the call over to Nivi for Q&A. Nivi?

Vice President of Corporate Communications & Investor Relations Thank you, Eric. Operator, we can now open up the line for Q&A.

[Operator Instructions] We will now take the first question from the line of Joseph Schwartz from Leerink Partners.

This is Will on for Joe. Congrats on the strong progress this quarter. So one for FSGS. As you prepare for the ADCOM, what do you anticipate the major topics could be? And how do you plan to respond to the FDA's inquiries here? Do you have a sense for who might be on the panel itself? And given this group of experts will likely include nephrologists and cardiologists, how do you plan to effectively message your case to these 2 different groups of physicians?

Well, thanks so much for the questions. Jula, I will turn those over to you.

Thanks for the question. So good point. Anytime a rare disease goes before an advisory committee, there's certainly an educational component that we need to do about the disease and the pathophysiology. Importantly, there are both nephrologists and cardiologists part of the panel, and they all know that proteinuria is harmful, and they know the importance of blocking both the RAS system and endothelin-1 to reduce cardiovascular and renal outcomes. So, we certainly are prepared to educate the mix of panelists, I think importantly about the biologic plausibility supporting proteinuria as a validated endpoint, why eGFR is challenging in FSGS, and then followed by the strong clinical data showing sparsentan meaningfully and significantly reduced proteinuria compared to an active comparator.

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

Just wondering if you could comment a little bit on the cadence and level of engagement you've had with the agency heading into the REMS update for FILSPARI, just given the evolving landscape and what we've seen from a regulatory perspective in other cases in the sector.

Thanks for the question, Anupam. And certainly, we've been monitoring the overall landscape with regard to the FDA. Bill, why don't you comment on what we've seen with our programs?

Yes, certainly. What we've seen is basically through the lens of 2 sNDAs, both with the sNDA for the modification of the REMS frequency and the removal of the embryo-fetal toxicity REMS, as well as the sNDA for FSGS. Our interactions have been progressing as we'd expect. And the back and forth have been very similar to what we experienced just last year with the NDA for full approval in IgA nephropathy. The frequency of interaction, the types of questions, it feels just the same. So we certainly see, on our part, a very engaged and active review team.

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

Another regulatory question, if I might be able to. I'm curious at what point you would gain insight into the timing of the Advisory Committee panel meeting? It sounded from the prior comments that the interactions are occurring on a regular cadence, as would be anticipated, but we detected another possible shift in Cedarceiver headcount. So, just trying to understand, is there any expected timeline that you would receive notice for the Advisory Committee meeting?

Thanks, Laura, for the question. Bill, why don't you take that one?

Certainly. We don't know at this stage what the date of the advisory committee will be. But once we do know it, we will certainly provide that update. Given that we have a PDUFA date of January 13, it's reasonable to anticipate that the advisory committee should be taking place sometime in Q4.

Next question is from Tyler Van Buen from TD Securities.

This is Francis on for Tyler. Congratulations on a really amazing quarter. So, just wondering, what would it take after the REMS PDUFA to get the REMS potentially removed entirely? And on what timeline would you expect that to be?

Okay. Thanks, Bill, another one for you.

Sure. Well, thanks for the question. Our strategy has always been to have the ultimate removal of the REMS. And per our prior interactions with the agency, we've always approached this as a 2-step process, seeking first to lessen the testing frequency and then full removal as a second step. Historically, the FDA has been anchored on completing our PMR following 3,000 patients for 2 years. And we're going to continue the dialogue to evaluate opportunities to potentially remove the REMS ahead of that, following the PDUFA date on the 28th of this month.

Next is from Vamil Divan from Guggenheim Securities.

This is Arseniy on for Vamil. Congrats on a great quarter. You presented new data from the Spic and SPARTAN studies at recent conferences. How are these data being received by the nephrology community? And do you anticipate further real-world evidence of biomarker data to support FILSPIRI's positioning as a disease-modifying therapy?

Thanks for the questions. Jula, why don't you comment on what your team has been hearing when the data has been presented?

Yes. Been received very positively. There's a lot of excitement about the data that we're generating, both as you mentioned, in combination with SGLT2 inhibitors, that it's safe, and we have good efficacy when used in combination. And then to your point around the SPARTAN study, we've been increasingly showing data showing the effect of FILSPARI on reducing disease-modifying biomarkers such as soluble CD163, which we released last year. And then, as I mentioned on the call, additional data on reducing inflammation, B-cell activation, and complement activation. And so people are now starting to think that FILSPARI works directly within the kidney on reducing the inflammation in the kidney, and that is part of the role for why it's nephroprotective over the long term. And then your second part was additional data. We certainly want to validate this. We have a large Phase III study from which we have biomarkers that we can confirm and validate this, and we plan to present that data in future congresses.

Next question is from Maury Raya from Jefferies.

This is Farzin on for Maury. Congrats on the solid 2Q numbers. Is there more perspective that you can provide on the dynamics and breakdown of the growth contributions from stocking, new patients, and persistence rates? And how could this look for the rest of the year?

All right. Farzan, thanks for the question. Peter, I'll turn that over to you.

Yes. Thanks for that question. Indeed, very strong performance, both on the demand side as well as the revenue side. I think your question is mainly referring to the revenue side. We didn't see stockings. It was really like performance-driven revenue growth.

And then on the persistence rate and the new patients versus the carryover patients from the last quarter?

Yes. So, the persistence rate continues to be very high. There's been no change in what we've seen. And I think, as Peter mentioned in his prepared comments, really all of the fundamentals that we look at, particularly as lead indicators of performance moving forward for the rest of the year, all remain very strong. So, it really is the underlying performance. And as you would imagine, over time, much of the volume becomes continuing patients and growth from adding new patients. That's precisely the dynamic that we're seeing, and we expect that to be sustainable for the foreseeable future.

Next is from Yigal Metchomovitz from Citigroup.

I had a question on FSGS. As you may know, there was a paper published in October 2024, was called proteinuria as an endpoint in clinical trials for FSGS. And they make a very specific point in there with respect to the reference to a "sustained CR". And I'm just wondering if you could comment as to your understanding of what that means and whether it's associated with any particular time point or not. I know that in the study, you obviously had a 2.5x better CR response rate versus ibesartan in the double- blind period. And I'm just wondering if that is consistent with the definition of sustained CR, or sustained CR refers to a specific point in time as opposed to over the entire course of the trial.

Thanks for the question. Jula, I'll turn it over to you.

Yes. Thanks for the question. I was part of that manuscript. So happy to answer it. So, complete remission can occur at one point in time, or it can be durable. And we didn't define exactly what that meant. But I can tell you, when we look at the DUPLEX data, and you mentioned the 2.5x greater rate of complete remission, what we commented at least within the DUPLEX manuscript in the New England Journal is that 85% of those patients stayed below their baseline rates of proteinuria, so had some level of durability of complete remission response. We did look at it at any point in time during our DUPLEX trial data. We haven't specifically elucidated others other than what we have published to date. If there are additional questions around durability, there are lots of ways in which you can define that. Our focus is on what the FDA wants. And so that's what we've given to them, and any questions that they have around additional ways in which we can analyze the data, we certainly can respond to them around that.

Yes. Maybe just 2 additional things that I'll add, sorry, Yigal. Anything you wanted to clarify before I add something?

No, I was just saying that was a super helpful answer.

That's great. And while this isn't specific to complete remission, if you look at our corporate deck, Slide 31, you'll see that the patients that were able to get to FPRE, which was the prespecified endpoint within our trial, that is sustained, whether you look at it 9 months or 2 years and the treatment effect continues to be consistent and significant. So, I think in the ways that we've looked at it, as Jula's talked about it, you have a reduction in proteinuria that is rapid, that is sustained, and that is consistent. The other thing that I'll point out about that publication, which was really informative, occurred before PARASOL. And what's important is to make sure that we recognize that the analyses and conclusions from PARASOL reflect the largest analysis of registry data from within FSGS. So, it's certainly consistent and informative, but it's really important to keep in mind that the thresholds that were put forth in PARASOL represent a very robust data set.

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

Congrats on all the progress. I would like to understand, I mean, you have a good cadence of patient start forms here. Can you comment on what is the conversion rate of those forms to the number of patients that are on the drug? And how would you characterize where are you in terms of the penetration in this market? And how do you see it evolving now with more competition, but at the same time, more awareness of that competition?

Okay. Great. So thanks, Mohit. I think we've got 3 questions. So Peter, why don't you take all of those conversion rates, penetration rates, and then how do you think that will evolve with the market? I think we got them.

Yes. Let me start, thanks, Mohit, for that question. Let me start with the last part, on like the evolution of the market and how we see that. I think the market and we have spoken about it in the past, especially after our full approval, we anticipate that the market potential is about 70,000 addressable patients for FILSPARI in the U.S. And about 70% of those patients have elevated proteinuria levels, but below 1.5 grams per gram. So if you talk about penetration, it really depends on like what segment are you talking about? Are you talking about the segment 1.5 or greater? Or are you talking about the full market potential? And after our full approval and no longer a proteinuria threshold in our label, we now have access to the broader market. And I think that's really where the opportunity resides and will continue to reside as well. And in that context, I'm really happy with the progress that we are making, that we are seeing also, and I mentioned that in the last earnings call as well, the median proteinuria level by patient start form is moving to the left. And what I mean by that it's now below 1.5, and it continues to trend in that same direction. So I think we are entering a market segment where most of the potential is, and that allows for sustainable growth as well. So that's how we see the market evolving, as well as the penetration component. With regards to conversion, I think based on my experience in rare disease as well as what I've seen from rare disease benchmarks, I would say that we are at the top end of best practice on conversion, what you would expect in rare disease.

Thanks, Peter. And Mohit, one thing that I'll add, just if you look at the cumulative PSS from initial approval, we still have less than 10% of the overall addressable population. Now we've had a very strong performance, and this is one of the strongest rare kidney disease launch uptakes over the last 5 years, but that penetration rate reflects that we have significant room to grow. And this is where we talk about the sustainable growth that we expect, it's because we've been successful, and it represents a relatively small penetration rate to date.

And then, if I could ask a follow-up. I mean, from the patient start from point of view, given that there is another player on the market, how should we think about the patient's start from cadence going forward? Given that you have a competition here. So that's the part I would love to understand and level set expectations there.

Yes. Well, we've not provided guidance. So I want to be cautious of not doing that. But I will reflect on what Peter has talked about in the last 2 quarters, which is that the new baseline for new patient start forms is around 700. We clearly achieved, exceeded that in this first quarter of having a direct competitor and growing treatment options within this space. We expect this opportunity to continue. And Peter can certainly talk more about the dynamics that we expect with a new treatment option within the endothelin class. Peter?

Yes. Thanks, Eric, again. To put an explanation point on some of the points that you made. I think, Mohit, within the evolving treatment paradigm, we delivered our strongest quarter to date. Both from a demand perspective as well as from a revenue perspective. And even though it's early days since we saw some of those new entrants coming to the market, everything we have seen so far is consistent with our expectations. And new classes, new therapies coming to the market, one, further reinforces the urgency to treat those patients earlier and more aggressively; and two, it also grows the endothelin market. But I think the market is big enough to Eric's earlier point, other products will be used. But given the strong profile of FILSPARI and the recognized profile and the long-term data that we have, I'm confident that we will remain the market leader.

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

Congrats on the quarter. So another on FSGS. In Phase III, I know you have disclosed eGFR at the end of the trial, but we have not seen the eGFR curves in FSGS. So maybe even qualitatively, could you comment on what to expect when the curves will be presented during the or could be presented during the AdCom, and the latest thinking on what the FDA would like to see on eGFR here? And secondly, on IgAN, if you could comment on the gross-to-net trends you saw in 2Q and expectations for the rest of the year?

Okay. Jula, why don't you take the 2 questions on eGFR? And Chris, you can take the gross-to-net question.

Yes, certainly. With the PARASOL analysis and recommendation and the move to focus on proteinuria as a surrogate endpoint for full approval in FSGS, we haven't spent much time publishing our eGFR data, and I don't anticipate that to be a large focus of our advisory committee. Of course, we certainly can show the curves. It's consistent with what you would anticipate. We had a washout of RAS inhibitors for 2 weeks, and then we initiated the 2 therapies, sparsentan and irbesartan. We had an acute decline in eGFR, and then it was relatively stable thereafter. You have some decline, as you can see by the absolute change over time, but nothing surprising if we show our eGFR curves. It just hasn't been our focus because we're moving to proteinuria, which is a better surrogate with less variability for predicting avoidance of kidney failure. So that's been our focus.

FDA has not requested eGFR as part of our Type C meeting. So again, I think it's not just reflective of what we've interpreted from PARASOL, but specifically the area of focus from our Type C meeting that we've discussed previously. Sorry, Chris, go ahead.

Prakhar, thanks for the question on gross to net. And as you would expect, we did see some relief this quarter relative to last quarter once we got through the typical beginning of the year dynamics. And as we look ahead, we may see some incremental increases in discounts in 3Q, 4Q, but we're squarely in line with where we've guided for the year, and being in the low 20%. So everything is shaping up as expected.

Next is Jason

Congrats on the progress. Maybe at this point in the launch, do you have a greater sense of where the headwinds or bottlenecks are in terms of uptakes, whether it's on the prescriber side or patient, payer, logistical, or administrative? Just trying to get a sense of what some of the potential near-term levers are. And then maybe just as a quick follow-up to one of your earlier comments regarding these new segments of the market. But is there a meaningful or measurable difference in the use of the drug between these new patients who may be a little bit healthier or not as advanced?

Jason, thanks for the questions. Peter, why don't you take both of those?

Yes. Thanks, Jason, for that question. With regards to your first question on potential bottlenecks, I think most of all, I'm really pleased with the progress that we are making. But when I think about our launch in the last 2.5 years, I think the main issue we had to overcome was the urgency to treat and change treatment for those patients. And what really will help is more treatment options coming to the market, together with the KDIGO guideline to reinforce that same message that patients should be recognized and treated more aggressively early on. I think it's going to help to further develop this market. So I think this is really a marketing development. On your second question, with regards to the new patient segment, like the lower proteinuria, still elevated proteinuria levels, but lower than 1.5. I think this is a segment where I really see an opportunity for us with the REMS modification, as that is more in line with the clinical practice of 3 monthly monitoring of lab values, like the higher proteinuria level patients, like 1.5 or greater, it is not uncommon that they actually do monthly lab testing. But when you talk about patients at the lower proteinuria levels, it's more common that they are seen every 3 months by the nephrologist. And as part of the routine monitoring, they do the measurement. So I think our REMS modification is right on time, where we are in the launch. So that's why I see the opportunity moving forward.

Next is from Greg Harrison from Scotiabank.

Congratulations on the quarter. This is Joe Thomas on for Greg. Just thinking about the patient start forms in the quarter, I wonder if you might be able to comment on the distribution as the quarter went along. Did you see any lumpiness or any acceleration as the quarter was going? And how should we think about that going forward? Thanks for the question.

Peter, why don't you take that one?

Thanks, Joe, for that question. As I mentioned earlier, we're really pleased with the strong performance this quarter. As is typical in rare disease, there's often variability month-over-month. But overall, what we have seen is consistent demand during the quarter, and that continued in July as well.

Next is Alex Thompson from Stifel.

Maybe shifting over to Europe. To the extent to which you have visibility on the CSL launch, when should we expect to see meaningful royalty revenue ex U.S.?

Yes. So thanks so much, Alex, for the question. We do want to defer to CSL Vifor to comment on their performance. Chris, I'll let you discuss a bit more on expectations for royalties.

Yes, happy to do that. Thanks, Alex. I think, as Eric mentioned, we'll defer to CSL Vifor on any kind of guidance. But as you would imagine, they're now through the early stages of going through the country-by-country process. And as that happens and they gain reimbursement, we would expect revenues to begin picking up overseas and, in return, royalties coming through to us. So, more to come as CSL Vifor continues to navigate that and report. And as soon as we have more that we can share, we'll be happy to do so.

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

Vice President of Corporate Communications & Investor Relations Thank you, everyone, for joining today's call. Have a great rest of your day.