Travere Therapeutics, Inc. (NASDAQ:TVTX) Q1 2026 Earnings Call Transcript

Travere Therapeutics, Inc. (NASDAQ:TVTX) Q1 2026 Earnings Call Transcript May 4, 2026

Travere Therapeutics, Inc. misses on earnings expectations. Reported EPS is $-0.4 EPS, expectations were $-0.24203.

Operator: Hello, and welcome to Travere Therapeutics, Inc.’s first quarter 2026 financial results conference call. Today’s call is being recorded. At this time, I would like to turn the conference call 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, Inc.’s first quarter 2026 financial results and corporate update call. Thank you all for joining. Today’s call will be led by Eric M. Dube, our President and Chief Executive Officer. Eric will be joined in the prepared remarks by Jula Inrig, our Chief Medical Officer, Peter Heerma, our Chief Commercial Officer, and Christopher Cline, our Chief Financial Officer. William E. Rote, our Chief Research Officer, will join us for the Q&A. Before we begin, I would 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 statements. 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, May 4, 2026, and Travere Therapeutics, Inc. 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.

Eric?

Eric M. Dube: Thank you, Nivi. Good afternoon, and thank you for joining us. This has been a tremendous start to the year for Travere Therapeutics, Inc. We have made significant progress across our three strategic priorities. We achieved the first FDA approval in FSGS, we reported a new high in demand for FILSPARI in IgA nephropathy, and we dosed the first new patient in the Phase III HARMONY study of pegtibatinase following restart of enrollment. April 13 marked a pivotal point for the FSGS community and Travere Therapeutics, Inc. Achieving the first full FDA approval for FILSPARI in FSGS established it as the first and only approved medicine for this rare and devastating kidney condition. With the potential to help more than 30,000 people living with FSGS without nephrotic syndrome, this approval is a significant indication expansion for FILSPARI and meaningfully increases the opportunity ahead for us.

The first quarter also marked another period of exceptional commercial performance in IgA nephropathy. We delivered another quarter of record new patient start forms. As we look ahead, we are already building upon our experience gained from the successful launch of FILSPARI in IgA nephropathy and are executing a strong launch in FSGS. Across IgA nephropathy and FSGS, we are now estimating that more than 100,000 patients in the U.S. could be eligible for FILSPARI. Together, we believe this represents a $3 billion potential peak sales opportunity for FILSPARI, reinforcing a compelling long-term growth trajectory for the company. We are also advancing our pipeline to support further sustainable growth. We recently dosed the first new patient in our pivotal Phase III HARMONY study evaluating pegtibatinase in classical homocystinuria following the restart of enrollment.

Importantly, achieving this milestone puts us on track to deliver top-line results in 2027. Based on the data we have generated to date, we believe this program has the potential to become the first disease-modifying therapy for the HCU community. We expect there are approximately 7,000 to 10,000 people living with HCU globally who would be addressable for pegtibatinase. I am incredibly proud of our team’s accomplishments and look forward to accelerating Travere Therapeutics, Inc.’s growth as we expand our reach and serve more patients across the rare disease community. With that, I will turn it over to Jula for a medical update. Jula?

Jula Inrig: Thank you, Eric. I am very excited to have the first ever approved medicine for the FSGS community now available for patients. As a reminder, FILSPARI was approved to reduce proteinuria in adults and children eight years and older with FSGS without nephrotic syndrome. I would like to take a moment to highlight how nephrotic syndrome is defined in clinical practice and what it means in the context of which patients may be eligible for FILSPARI. Nephrotic syndrome is a clinical diagnosis and is typically defined by the presence of all three of the following criteria: high levels of proteinuria greater than 3.5 grams per day, low serum albumin levels of less than 3.0 grams per deciliter, and the presence of edema. If a patient is missing any one of these criteria, they are not considered to have active nephrotic syndrome.

This is different than nephrotic-range proteinuria, which is typically greater than 3.5 grams per day. For example, a patient with 4 grams of proteinuria and low serum albumin, but no edema, will be eligible for FILSPARI. Importantly, nephrotic syndrome is not a chronic state. If a patient with FSGS presents without nephrotic syndrome, which represents the majority of the FSGS population spanning all types of FSGS, they are immediately eligible for FILSPARI. For those who initially present with nephrotic syndrome, physicians will typically use immunosuppression induction to try to control the patient’s proteinuria and stabilize them, after which these patients may also become eligible for FILSPARI. In addition, based on the data from DUPLEX, patients treated with FILSPARI demonstrated sustained reductions in proteinuria over time, with proteinuria levels reaching approximately 1.5 grams per gram or less on average at study end.

At these proteinuria levels, patients would be expected to have a much lower risk of relapsing to nephrotic syndrome. Based on our discussions with key opinion leaders following the approval, there is wide enthusiasm for using FILSPARI across the types of FSGS, including among secondary and genetic FSGS. This is supported by our recent publication in CJASN demonstrating consistent efficacy and safety in patients with genetic FSGS, a population often considered the most difficult to treat. Physicians consistently highlight the need for effective, non-immunosuppressive options for long-term disease management. Now let me talk about IgA nephropathy. We recently published data in CJASN from the PROTECT study showing that patients with IgA nephropathy who achieved complete remission of proteinuria to less than 0.3 grams per gram experienced a rate of eGFR decline of less than 1 milliliter per minute per year, a rate which is similar to healthy aging.

The KDIGO guidelines recommend a treatment approach for IgA nephropathy that addresses both kidney injury and upstream immune drivers, and include FILSPARI as a first-line option for patients at risk of progression. The data published this month reinforced FILSPARI’s role as a foundational medicine in IgA nephropathy, demonstrating that it helps more patients reach complete remission, which is associated with improved preservation of kidney function over time. Turning briefly to our pipeline, we are pleased to have reinitiated enrollment in our Phase III HARMONY study of pegtibatinase, with the first new patient now dosed. HARMONY is a randomized, double-blind study designed to evaluate the efficacy and safety of pegtibatinase compared to placebo, with a primary endpoint focused on reduction in plasma total homocysteine, a key driver of disease in classical HCU.

The primary endpoint for HARMONY is assessed at 12 weeks, consistent with the primary endpoint timing from our Phase I/II COMPOSE study. Patients who complete the HARMONY study are eligible to enroll in the ENCOMPOSE extension study. This open-label extension will allow us to evaluate long-term outcomes, including sustained homocysteine control, as well as meaningful aspects for patients such as the potential for greater dietary flexibility and self-administration. This program is supported by data from our Phase I/II COMPOSE study, where pegtibatinase demonstrated rapid, sustained, and dose-dependent reductions in total homocysteine levels. At the 2.5 mg/kg dose twice a week, pegtibatinase delivered a 67.1% mean relative reduction in total homocysteine from baseline to 12 weeks, as well as maintenance of mean total homocysteine below the clinically meaningful threshold of 100 micromoles, and was generally well tolerated.

Pegtibatinase has the potential to become the first disease-modifying therapy for patients living with classical HCU, and as Eric mentioned earlier, we expect top-line data from the HARMONY study in 2027. Finally, we continue to generate and share new data across IgA nephropathy, FSGS, and HCU, and we look forward to upcoming medical meetings. At NKF this week and ERA next month, we will present additional analyses in both IgA nephropathy and FSGS. I will now turn it over to Peter for a commercial update. Peter?

Peter Heerma: Thank you, Jula. I am pleased to share that we started the year strongly and set new records with our FILSPARI performance. The first quarter marked the highest demand to date as we received 993 new patient start forms, reflecting continued expansion among new prescribers and deepening utilization across established accounts. Importantly, we continue to see an increasing number of practices treating multiple IgA nephropathy patients with FILSPARI, with PPU as a meaningful indicator of physicians’ confidence with the medicine’s foundational and nephroprotective positioning. As new treatment options become available for this indication, FILSPARI remains the most commonly prescribed medicine approved for IgA nephropathy in the U.S. This broad utilization supports our confidence in FILSPARI’s continued growth potential in IgA nephropathy, and we are seeing strong demand at the start of the second quarter.

For the first quarter of 2026, we reported approximately $105 million in FILSPARI sales, despite the typical beginning-of-year insurance resets and gross-to-net dynamics, as well as recognizing fewer revenue shipping weeks. The strength of our performance in IgA nephropathy and the momentum we have with FILSPARI is directly relevant as we enter the FSGS launch. There is significant overlap in the prescriber base between these two indications, and many nephrologists already have experience with FILSPARI in their IgA nephropathy patients. This will support early adoption in FSGS patients, and we anticipate a faster uptake compared to the initial IgA nephropathy launch. In fact, early feedback from the FSGS community has been overwhelmingly positive.

We received our first patient start forms on the first day following approval. We are encouraged by the enthusiasm and engagement we are experiencing. Having spent time in the field over the past two weeks, I have seen that enthusiasm firsthand in discussions with nephrologists in their offices. It reinforces our belief that the FSGS opportunity is expected to be even bigger than IgA nephropathy. Established payer access in IgA nephropathy is helping to position FILSPARI for a supportive access environment in FSGS. In fact, we saw our first FSGS reimbursement approvals in the first week. Payers often manage access at the product and indication level, and our team is focused on expanding payer plans and formularies to include FILSPARI for FSGS.

While education on the FSGS indication will be important, we are starting from a position of strength with an experienced commercial team and established infrastructure. We believe there are more than 30,000 patients in the U.S. with FSGS who are currently eligible for FILSPARI, and we expect that number to grow. In summary, the start of 2026 reflects exceptional commercial execution with record demand and revenue growth. With our continuing performance in IgA nephropathy and FILSPARI’s recent FSGS approval, I am confident in our ability to continue delivering strong, sustained growth and long-term leadership across these rare kidney disease indications. I am incredibly proud of our team and the impact they continue to have on patients and physicians.

I am excited for what lies ahead for us in 2026. I will now turn the call over to Chris for the financial update. Chris?

Christopher Cline: Thank you, Peter. As you have heard from the team, we delivered another strong quarter of execution across the business, and recently we achieved an important milestone with FILSPARI’s approval in FSGS that further strengthens our outlook for continued growth. In the first quarter, we generated $124.5 million in total U.S. net product sales, reflecting strong year-over-year growth. Importantly, U.S. net product sales of FILSPARI grew approximately 88% year over year to $105.2 million, despite typical beginning-of-year gross-to-net impact and fewer revenue recognition days. As Peter noted, for FILSPARI, we recognize revenue when product is delivered to our specialty pharmacies, which typically occurs a couple of days after shipment from our logistics partner.

Due to the quarter-end timing and typical early-week ordering patterns, the first quarter had one fewer shipping week than usual. As a result, some FILSPARI shipments made in the first quarter will be recognized in the second quarter. Adjusting for this dynamic, and supported by record demand during the first quarter, we believe FILSPARI is on a strong trajectory in IgA nephropathy for the balance of the year. Elsewhere, Thiola and Thiola EC contributed $19.3 million in U.S. net product sales during the first quarter, and we recognized $2.7 million in licensing and collaboration revenue, resulting in $127.2 million in total revenue for the first quarter. Moving to operating expenses, our research and development expenses for the first quarter of 2026 were $57.1 million, compared to $46.9 million for the same period in 2025.

On a non-GAAP adjusted basis, R&D expenses were $51.5 million compared to $42.2 million for the same period in 2025. The increase is primarily driven by the restart of enrollment in the Phase III HARMONY study of pegtibatinase during the quarter. Selling, general, and administrative expenses for the first quarter of 2026 were $80.3 million, compared to $60.4 million for the same period in 2025. On a non-GAAP adjusted basis, SG&A expenses were $69.3 million compared to $53.3 million for the same period in 2025. The increase is primarily attributable to investments in preparation for FILSPARI’s launch in FSGS, including an expanded field team, as well as investments in IgA nephropathy. Beginning in the first quarter, we revised the presentation of our amortization expense associated with royalty and milestone payments to a separate royalty expense line item in order to provide greater transparency to underlying operating expenses.

In the quarter, we recognized $24.8 million in royalty expense compared to $12.4 million for the same period in 2025. The increase is primarily a result of the Thiola intangible asset reaching the end of its accounting useful life, resulting in amortization of the full amount of the royalty payments accrued this quarter, as well as an increase in capitalized FILSPARI royalties. Under accounting policy, Thiola royalties will now be expensed to royalty expense in the same quarter as the corresponding net sales. Contractual milestones and royalty payments related to FILSPARI will continue to be capitalized to intangible assets and amortized on a straight-line basis over its useful life, with only amortized expense recognized within royalty expense.

Total other income, net, for the first quarter of 2026 was less than $1 million, compared to $1.5 million for the same period in 2025. Net loss for the first quarter of 2026 was $37.1 million, or $0.40 per basic share, compared to a net loss of $41.2 million, or $0.47 per basic share, for the same period in 2025. On a non-GAAP adjusted basis, net income for the first quarter was $4.1 million, or $0.05 per basic share, compared to a net loss of $16.9 million, or $0.19 per basic share, for the same period of 2025. As of March 31, 2026, we had cash, cash equivalents, marketable securities, and receivables of approximately $352 million. Receivables include the $25 million sales-based milestone payment from Mirum Pharmaceuticals, which was recognized in 2025 and received in April.

This is not yet reflected in our cash balance of approximately $264.7 million as of March 31. Looking ahead, we are well positioned to fund our operations with existing resources, investing with discipline across our key priorities, including the commercialization of FILSPARI in IgA nephropathy and FSGS, ongoing evidence generation, advancement of the pivotal HARMONY study of pegtibatinase in HCU, alongside building further pegtibatinase supply. We expect continued strong demand in IgA nephropathy to drive sustained revenue growth, with FSGS further contributing to our top-line trajectory. Overall, we believe our balance sheet, expected top-line expansion, and disciplined approach to investing in our priorities position us to execute with confidence and deliver durable long-term growth.

I will now turn the call over to Eric for his closing remarks. Eric?

Eric M. Dube: Thank you, Chris. As we look ahead, our priorities are clear: continue to drive growth by reaching more patients with IgA nephropathy, execute a strong launch in FSGS, and enroll our HARMONY study of pegtibatinase. With FILSPARI now approved in IgA nephropathy and FSGS, and a pipeline progressing into late-stage development, we believe we are well positioned to deliver meaningful value for patients and shareholders over the near and long term. With that, I will turn the call back over to Nivi for Q&A. Nivi?

Nivi Nehra: Thank you, Eric. We will now open the call for questions. Operator?

Q&A Session

Operator: Thank you. We will now begin the question and answer session. If you would like to ask a question, please press 1 on your keypad to raise your hand. To withdraw your question, please press 1 again. We ask that you pick up your handset when asking a question to allow for optimum sound quality. If you are muted locally, please remember to unmute your device. As a reminder, we ask that you limit yourself to one question. If you have another question, please rejoin the queue. Please stand by while we compile the Q&A roster. Your first question comes from the line of Joseph Schwartz with Leerink Partners. Joseph, your line is open. Please go ahead.

Joseph Schwartz: Hey, guys.

Will Soghikian: This is Will Soghikian on for Joe. Thanks for taking our question, and congrats on all the progress this quarter. One for us on FSGS. You have messaged several times that the launch is expected to progress at a faster rate than IgA nephropathy. Could you please characterize what you are seeing at this early stage and how it compares to the original IgA nephropathy rollout a few years ago? It seems like the full approval here could also make a difference, especially since we know nephrologists are sometimes slower to adopt innovative medicines. Is what you are seeing in these early days supportive of a more rapid FSGS launch? Thanks so much.

Eric M. Dube: Will, thank you so much for the question, and I am very pleased with the early performance and particularly the execution from our field teams. Peter, why do you not give some color to what you are seeing in the early part of the launch?

Peter Heerma: Absolutely, Eric, and Will, thank you for that question. Indeed, we are confident in a faster uptake in FSGS relative to the IgA nephropathy launch for multiple reasons. First, this is a very high unmet need and this is the fastest progressive glomerular disease as well, where for IgA nephropathy we really had to establish the urgency to intervene earlier. In addition to that, we built upon very strong brand awareness and many of the physicians already have experience with FILSPARI, given this is basically the same core point for IgA nephropathy. From a payer perspective, we already are in most of the formularies and payer plans. We currently have over 97% pathway to access for patients. We built upon a very strong foundation, and that gives me confidence that we will have a more rapid uptake in FSGS relative to our initial IgA nephropathy launch, and we believe it is an even bigger opportunity with FSGS than IgA nephropathy. Thank you so much.

Operator: Next question comes from the line of Tyler Van Buren with TD Cowen. Tyler, your line is open. Please go ahead.

Gregory Allen Harrison: Hi. This is Greg on for Tyler. Thanks for taking my question. You noted that the first FSGS PSF arrived the day after approval, and reimbursed treatment started within one week. How many FSGS PSFs have you recorded thus far in the launch, and what proportion of early starts are coming through payer authorizations versus exceptions or appeals? What are you seeing on initial behavior in general? Thanks.

Eric M. Dube: Greg, thanks so much for the question. While it is too early for us to be able to quantify some of that, Peter certainly can provide some qualitative and directional views on the demand and the payer dynamics. Peter?

Peter Heerma: Yes. Great. I would love to answer that question with specifics, but this is a Q1 call, so I am looking forward to sharing more with you in the second quarter call. Following my answer to your earlier question on the faster uptake than IgA nephropathy, I would say everything we are seeing so far is confirming what I have said, with regard to a faster uptake than our initial IgA nephropathy launch. That counts both for demand as well as for the early approval rates that we are seeing with payers. We are seeing actually a higher first-pass approval at the payer level than what we saw initially for IgA nephropathy.

Operator: Your next question comes from the line of Anupam Rama with JPMorgan. Anupam, your line is open. Please go ahead.

Anupam Rama: Hey, guys. Thanks so much for taking the question. On the FSGS launch, if you could build upon some of your prior comments, I know you mentioned that there is a need to further educate physicians. I know that it is only three weeks post approval, but I was wondering if you could speak to what is resonating with physicians in terms of the product label and the product profile. And within that, where do you think the education is required? Thanks so much.

Eric M. Dube: Anupam, thanks so much for the questions. Peter, why do you not take that? And, Jula, I know your team has extensive engagements with thought leaders, you can add anything that you might want to. Peter?

Peter Heerma: Happy to take that question, Anupam. Overwhelmingly positive responses from physicians, but you still have to educate them. I was in the field a few days, and many of the community nephrologists in particular may not know yet that FILSPARI was approved. That awareness you have to build. You have to educate physicians also on the label, in particular on patients not being in active nephrotic syndrome. That requires some education. Once you explain that, it resonates with physicians because it is very similar to how patients are being treated today. It is very consistent with the guidelines. Jula, maybe you can provide some context on that.

Jula Inrig: Yes, thanks. Our team, as Eric mentioned, has been out at conferences, advisory boards, and seminars. The approval is getting resoundingly positive feedback from physicians. This patient community has been waiting a long time, and they are excited to have a non-immunosuppressive treatment option to control these patients and get their proteinuria down. You asked about education. Part of it is a reminder that active nephrotic syndrome is not the same as nephrotic-range proteinuria, so we are educating around that. But as Peter mentioned, very positive and excitement to have this option to treat their patients.

Anupam Rama: Thanks so much for taking my question.

Eric M. Dube: Thanks, Anupam.

Operator: Your next question comes from the line of Prakhar Agrawal with Cantor Fitzgerald. Prakhar, your line is open. Please go ahead.

Prakhar Agrawal: Hi. Thank you for taking my questions, and congrats on the quarter. Going back to your comments on faster uptake than IgA nephropathy, when I go back to the IgA nephropathy launch in the first few full quarters, you had 400 to 450 patient start forms. Is that how we should think about the uptake for FSGS as well? And secondly, on access, do you expect payers to cover the secondary FSGS patients broadly as well despite the segment not being tested in Phase III? Are you hearing any pushbacks from the payers? Thank you so much.

Eric M. Dube: Prakhar, thanks for the questions. With regard to the uptake, we are not going to be providing guidance, and we will not be breaking out the PSFs by indication as we move forward. I will reinforce what Peter shared, that everything we are seeing so far in the first three weeks of launch has confirmed what we have been saying around a faster uptake, an eagerness to prescribe, and payer dynamics helping to get patients from PSF onto therapy. Peter, why do you not take the question around payer access and the different types of FSGS, secondary, etc., and any pushback.

Peter Heerma: Absolutely. I am most encouraged by the early approval rates that we are seeing for FSGS, which are higher than what we saw initially for IgA nephropathy. For context, payers understand that FSGS is a rarer disease compared to IgA nephropathy with a more progressive nature. This is what we have been educating payers on over the last six to seven months. In that context, payers are not focused on types or subtypes of FSGS. They understand the common injury pathway and how FILSPARI is the first approved medicine for this patient population that is rapidly progressing. That is what we are hearing and seeing so far in the context of the conversations we have had with payers over the last six to seven months.

Prakhar Agrawal: Thank you.

Eric M. Dube: Thank you.

Operator: Your next question comes from the line of Vamil Divan with Guggenheim Securities. Vamil, your line is open. Please go ahead.

Vamil Divan: Great, thanks for taking my questions. I wanted to get back to the topic around the history and nephrotic syndrome. We have spoken to some physicians since the approval, and there seems to be some confusion about this and whether they can prescribe FILSPARI in these patients or not. Could you elaborate in terms of whether physicians should focus on a history of nephrotic syndrome? It sounds like maybe you mentioned that some education is still needed on that topic. Can you elaborate on what you are doing to make sure it is clear, because it certainly sounds like your perspective is that this should not be a limiting factor?

Eric M. Dube: Thank you, Vamil, for the question. We firmly believe this is not going to be a challenge. It is certainly an opportunity to educate. Jula, why do you not talk about the efforts that you are doing and the reaction from nephrologists? Peter, you can talk about how payers may be thinking about this topic.

Jula Inrig: This has not been an area of focus from physicians, and we have had a fair bit of engagement, as has Peter’s team. We do not believe that a history of nephrotic syndrome should preclude a physician from prescribing FILSPARI. The reason for that is our labeled indication: it is for patients without active nephrotic syndrome. This is very much aligned with KDIGO, which recommends patients with active nephrotic syndrome be treated with immunosuppression, while those without it receive optimized supportive foundational care, and that is where FILSPARI provides the best treatment option for these patients.

Peter Heerma: To build upon that from a payer perspective, the most important point is to educate payers that nephrotic syndrome is a dynamic state, not a chronic state, and payers understand that. These conversations have not really come up as issues, given this is a rapidly progressing disease and payers understand that as well.

Vamil Divan: Okay. Thank you.

Eric M. Dube: Thanks, Vamil.

Operator: Your next question comes from the line of Gavin Clark-Gartner with Evercore. Gavin, your line is open. Please go ahead.

Gavin Clark-Gartner: Hey, guys. Thanks for taking the question. I wanted to pivot over to IgA nephropathy quickly. What are you seeing as discontinuation rates over time here, maybe at the one-year mark and the two-year mark since patients start therapy? How does that compare to what you saw in the IgA nephropathy Phase III?

Eric M. Dube: Peter, why do you not take that question?

Peter Heerma: The compliance and persistence rates for FILSPARI in IgA nephropathy have been very high. We have not given specifics on the numbers, but we have not seen any change or disruption in those rates. We have high confidence both from patients, who are being helped, and from physicians, who are seeing that this product works for a patient population that historically did not have a treatment option. Jula, maybe you can provide context on what we are seeing versus what we saw in the PROTECT trial.

Jula Inrig: I would say consistent. We saw high persistence of patients staying on treatment during the two-year double-blind trial, and I think it is very aligned with what we are seeing commercially. Part of the reason for that is patients have that positive reinforcement: their proteinuria goes down; they see it; and they feel like they are getting better. With a side effect profile very consistent with irbesartan, patients tend to stay on therapy, and they understand this should be truly lifelong—as long as they keep their kidneys, they should stay on FILSPARI.

Gavin Clark-Gartner: Great. Thanks.

Operator: Your next question comes from the line of Mohit Bansal with Wells Fargo. Mohit, your line is open. Go ahead.

Sadia Rahman: This is Sadia Rahman on for Mohit. Thanks for taking our question. The patient start form number this quarter again looks very impressive. Can you provide some color on the conversion rate for these forms to patients ultimately starting treatment, and any reasons for any drop-off along the way? Thank you.

Eric M. Dube: Thanks, Sadia. Peter, why do you not take that?

Peter Heerma: I am glad you reflect on the 993 patient start forms as impressive because I am really impressed with my team that is continuing to show growth in IgA nephropathy in a rapidly changing environment. With regards to conversion, we continue to convert those patients quite rapidly over time. We continue to make improvements, though where we are right now is not as dramatic as what you saw in the beginning. We do not see any drop-offs or changes. With regards to translation of patient start forms into revenue, that may be part of your question. I think Chris provided some context on fewer ordering and shipment weeks in Q1 relative to the typical gross-to-net dynamics you usually see in Q1. I hope that answered your question.

Sadia Rahman: Yes. Thank you.

Eric M. Dube: Thank you.

Operator: Your next question comes from the line of Laura Chico with Wedbush Securities. Laura, your line is open. Please go ahead.

Laura Kathryn Chico: Thank you very much for taking the questions. I apologize if this has been asked already, but one question I had was on IgA nephropathy dynamics for FILSPARI. It is great to see the PSF number considering the increase, and I am presuming that is predominantly from IgA nephropathy patients. But we also had a competitive update: Novartis indicated the ALIGN confirmatory study for atrasentan did not reach its statistical significance, and while they will pursue an FDA full approval, I am wondering how that changes your views on the competitive landscape dynamics for IgA nephropathy with FILSPARI. How are you thinking about pushes and pulls on demand drivers in 2026? And then I have a quick follow-up, if that is okay.

Eric M. Dube: Thanks, Laura. Peter, why do you not take that, and Jula can add any further perspective on the evolution or consistency of the treatment landscape.

Peter Heerma: Happy to answer that question. Most important, this is a market in development. Most growth in this marketplace is not coming from competitive share, but mainly from continuing to grow the market, and that is exactly what we see and anticipated. I think FILSPARI is very well positioned to grow in this marketplace because it is really replacing RAS inhibition. There is no other product that has that ability. Most competition is in the other sector—more immunosuppressive agents—where B cells are now playing together with complement inhibitors and histories of steroids. Physicians understand the positioning of FILSPARI very well as the foundational nephroprotective treatment option, and understand FILSPARI’s positioning relative to atrasentan and others.

Eric M. Dube: And just one thing, Laura, before your next question. You asked about the PSF increase. That is all based in Q1, so that would be IgA nephropathy before the approval of FSGS. We do expect to see an acceleration of demand over time as we look at both indications, but that very solid number of 993 patient start forms in Q1 reflects our performance in an increasingly competitive landscape of multiple treatment options. I think it is a really impressive number that Peter’s team has been able to deliver.

Laura Kathryn Chico: Just real quick, we have got a few weeks in April since the FSGS approval. It does seem like a couple PSFs are coming through here. Just out of curiosity, are these originating from existing FILSPARI IgA nephropathy prescribers versus newly activated FSGS prescribers? Should we presume these are already established prescribers in these early days and quarters of launch? Thanks very much.

Eric M. Dube: Laura, thanks so much for the question. It is early. Peter, why do you not comment on what you are seeing thus far?

Peter Heerma: It is indeed early. We see both, to be honest, and more color will come in the Q2 call. In this context, it is good to talk about the halo effect. I have spoken about the halo effect in the past: experienced prescribers for IgA nephropathy who now also adopt FILSPARI for FSGS. Vice versa, we are starting to hear anecdotes as well from physicians that have been on the fence who are excited about starting in FSGS, and based on that, are now also excited to start prescribing in IgA nephropathy. I think a halo effect will benefit both indications.

Operator: Your next question comes from the line of Maury Raycroft with Jefferies. Maury, your line is open. Please go ahead.

Maury Raycroft: Hi. Thanks for taking my question, and congrats on the quarter. Maybe following up on Laura’s question, focusing on PSFs, I am trying to think about how to estimate that going forward for IgA nephropathy. You talked about atrasentan as a competitor, but Otsuka also had a good quarter for PSF growth in IgA nephropathy. Do you have any perspective on how Otsuka is launching their drug and how you are factoring that into your estimates, and any more perspective you can offer on switching to biologics and how you are thinking about that in your total estimate for $3 billion in peak sales?

Eric M. Dube: Let me take a couple of those, and Peter can comment on what he is seeing from a competitive standpoint and switching. First, PSFs moving forward will be provided in aggregate, so I recognize you are likely trying to figure out IgA nephropathy alone. There is no reason to believe we cannot continue this level of performance because of the number of patients and the very unique positioning that non-immunosuppressive kidney-targeted therapies have, which Peter can speak to. With regard to the $3 billion peak sales, that really is based on continued growth in both indications, and we have talked about FSGS being a larger opportunity than IgA nephropathy. We fully expect growth in both, but a much faster uptake in FSGS is going to allow us to reach more patients over time and contribute more meaningfully to peak growth.

We really do not see market dynamics taking away from our opportunity or performance. Peter, why do you not talk about that in the context of new patients as well as switches.

Peter Heerma: The most important point is that we do not see B-cell therapies as direct competitors for FILSPARI. Conceptually, the way patients are being treated for IgA nephropathy is similar to the past with RAS inhibition, and on top of that you use steroids when needed. That concept is not changing, while for RAS inhibition, you now have FILSPARI as a superior option for those patients. For patients needing additional treatments, you have B-cell therapies potentially replacing steroids. The growth in this market is not so much competitive growth; it is developing the market. This is a highly underdeveloped market historically. There are still many patients treated with generic RAS inhibitors and generic steroids. You have better options available now.

The KDIGO guideline is reinforcing that. You have more ambitious treatment targets nowadays, which will often mean more combination therapy as well. There is space for multiple products to grow, and FILSPARI is very well positioned in that nephroprotective foundational treatment category.

Eric M. Dube: Thank you, Peter. Maury, if we just take a step back, we have talked over the last couple of years about new entrants helping to accelerate growth within the IgA nephropathy market. That is not going to take away from our performance and outlook—that is exactly what we are seeing with the entrants that have come to the IgA nephropathy foundation. The performance we posted this quarter really reflects the opportunity we have, but perhaps more importantly, the opportunity for patients who have been undertreated with off-label therapies to really have innovation moving forward, both with FILSPARI as well as other therapies. That is going to be the foundation for continued performance of FILSPARI.

Maury Raycroft: Got it. That is really helpful. Thank you very much.

Eric M. Dube: Thanks, Maury.

Operator: Your next question comes from the line of Jason Zemansky with Bank of America. Jason, your line is open. Please go ahead.

Jason Eron Zemansky: Good afternoon. Congrats on the progress, and thanks so much for taking our question. Maybe, Jula, one for you. Where are you seeing FILSPARI used or sequenced in FSGS? Is it in lieu of ACE/ARBs? Are these patients usually already on SGLT2s? We have gotten some mixed feedback regarding whether this drug is going to be used first line or in those uncontrolled while already on an ARB or an ACE and an SGLT2.

Jula Inrig: Thanks for the question. Just like IgA nephropathy, the vast majority of patients are already on some form of a RAS inhibitor, an ACE or an ARB, even by the time they get sent to the nephrologist, so predating their diagnosis. It is slightly lower than IgA nephropathy because kids may or may not always be on an ACE inhibitor, but you are still talking at least 70% to 80% of patients on some form of foundational treatment. As far as SGLT2 inhibitors, I would say they are used, but potentially not quite as prevalent because we do not have as great data around SGLT2s. But as Peter has mentioned multiple times, these patients are at very high risk for rapid progression to kidney failure, so physicians will be pulling at as many things as they can in their tool belt to try and stabilize these patients.

Now they have FILSPARI, which is better in a head-to-head versus a RAS inhibitor, so they are going to take patients off their RAS inhibitor and initiate FILSPARI, ideally at their next clinic visit when they see these patients.

Eric M. Dube: And, Jula, maybe I can add something else for Jason’s question. Particularly for those patients with primary FSGS and particularly those with active nephrotic syndrome, they are, based on the guidelines, going to be treated with an immunosuppressant. Once they are not in active nephrotic syndrome, they would be eligible and likely placed on FILSPARI. In terms of not being first-line use, it is a slight nuance, but that is also an opportunity moving forward.

Jula Inrig: No, that is accurate.

Eric M. Dube: Thanks, Jason.

Jason Eron Zemansky: Thanks.

Operator: Your next question comes from the line of Alex Thompson with Stifel. Alex, your line is open. Please go ahead.

Alexander Thompson: Thanks so much. Just a quick follow-up question on IgA nephropathy, and then I would like to ask about pegtibatinase as well. Maybe, Chris, are you able to quantify the shipping week impact at all? That would be helpful for the quarter. And then for pegtibatinase, the Phase III—congrats on restarting that—have you met with the FDA review division recently, and how confident are you that total homocysteine is still going to be an approvable endpoint here? Thank you.

Eric M. Dube: Alright, Chris, and then we can turn that over to Bill for the pegtibatinase question.

Christopher Cline: Thanks for the question, Alex. We do not typically break down individual weeks of revenue. The best proxy is to take the average for the quarter. We had about 12 weeks of revenue recognition within the quarter, and that will get you to the best proxy there.

William E. Rote: I will take the pegtibatinase question. We have breakthrough therapy designation for pegtibatinase, so that allows us to have a lot of interaction with the FDA. Through that process, we reached alignment on the endpoint for the HARMONY study, and it mirrors the timing of what we saw in the COMPOSE study. It was in collaborative discussion with the agency where we settled on that 12-week endpoint.

Alexander Thompson: Has that happened since the original alignment this year or since you redosed, or was that the original alignment?

William E. Rote: That was the original discussion. We have not had reason to discuss the endpoints of the trial once it was agreed and aligned upon.

Alexander Thompson: Okay. Thank you.

Operator: Ladies and gentlemen, this concludes the question and answer session of today’s conference call. I will 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 for attending. You may now disconnect.