TVTX

Image source: The Motley Fool. Tuesday, Aug. 4, 2026 at 4:30 p.m. ET Vice President, Corporate Communications and Investor Relations - Nivi Nehra President and Chief Executive Officer - Eric Dube Chief Commercial Officer - Peter Heerma Head of R&D and Chief Medical Officer - Jula Inrig Chief Financial Officer - Chris Cline Chief Research Officer - Bill Rote Operator: Good morning, and welcome to Travere Therapeutics Second Quarter 2026 Financial Results Conference Call. Today's call is being recorded. At this time, I would like to turn the conference over to Nivi Nehra, Vice President, Corporate Communications and Investor Relations. Please go ahead, Nivi. Nivi Nehra: Thank you, operator. Good afternoon, and welcome to Travere Therapeutics' Second Quarter 2026 Financial Results and Corporate Update Call. Thank you all for joining. Today's call will be led by Dr. Eric Dube, our President and Chief Executive Officer. Eric will be joined in the prepared remarks by Peter Heerma, our Chief Commercial Officer; Dr. Jula Inrig, our Head of R&D and Chief Medical Officer; and Chris Cline, our Chief Financial Officer. Dr. Bill Rote, our Chief Research Officer, will join us for the Q&A. Before we begin, I'd like to remind everyone that statements made during this call regarding matters that are not historical facts are forward-looking statements within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not guarantees of performance. They involve known and unknown risks, uncertainties and assumptions that may cause actual results, performance and achievements to differ materially from those expressed or implied by the statement. Please see the forward-looking statement disclaimer on the company's press release issued earlier today as well as the Risk Factors section in our Forms 10-Q and 10-K filed with the SEC. In addition, any forward-looking statements represent our views only as of the date such statements are made, August 4, 2026, and Travere specifically disclaims any obligations to update such statements to reflect future information, events or circumstances. With that, let me now turn the call over to Eric. Eric? Eric Dube: Thank you, Nivi. Good afternoon, and thank you for joining us today. The second quarter was exceptional. Our performance demonstrates the strength of the company we are building and the disciplined execution of our teams. Travere has now entered a new chapter, one that we expect will deliver near- and long-term growth driven by clear momentum across 4 key pillars: continued growth for FILSPARI in IgA nephropathy, the successful launch of FILSPARI in FSGS, the advancement of pegtibatinase in its pivotal Phase III study and the addition of civorebrutinib to our rare kidney disease pipeline. At the center of this strategy is FILSPARI, which we believe is becoming an increasingly important rare kidney disease medicine. This was the first quarter with FILSPARI commercially available across both IgA nephropathy and FSGS, and we are very pleased with the performance. Our teams delivered growth in IgA nephropathy demand compared to last quarter despite additional market entrants and achieved successful early adoption in the first months of the FSGS launch that exceeded our high expectations. Peter will provide more detail on the launch shortly, but we are encouraged by the early performance. As we build on FILSPARI's commercial momentum, we continue to advance our intellectual property strategy. During the quarter, the USPTO issued a Notice of Allowance for a U.S. patent application directed to certain methods of using sparsentan in IgA nephropathy. Upon issuance, the patent is expected to provide U.S. patent coverage for those methods. We also continue to pursue additional patent coverage for sparsentan, including through a pending U.S. application directed to certain methods of using sparsentan in FSGS. Beyond FILSPARI, we are building a robust pipeline of potential disease-modifying best-in-class medicines that is strategically aligned with our rare kidney disease expertise and positioned to drive long-term growth. Pegtibatinase remains a very important program for Travere and for the HCU community. It has the potential to become the first and only disease-modifying therapy for classical homocystinuria, a rare metabolic disease affecting 7,000 to 10,000 patients and their families in the U.S. today. With pivotal data expected next year, pegtibatinase is positioned to become the next medicine we deliver from our pipeline to address a significant unmet need within the rare disease community. We are also very pleased to recently close our exclusive licensing agreement with Everest Medicines for civorebrutinib, adding a differentiated upstream immune modulating approach to our rare kidney disease portfolio with potential application across multiple immune-mediated kidney diseases. While it is still early, we see civorebrutinib as a meaningful long-term growth opportunity in addition to FILSPARI and pegtibatinase. With continued momentum across our business, we are entering the second half of the year from a position of considerable strength. I'd now like to turn the call over to Peter for a commercial update. Peter? Peter Heerma: Thank you, Eric. Before discussing our commercial performance, I want to recognize the extraordinary work of our commercial organization and colleagues across Travere. Following our FSGS approval in April, our teams have executed with urgency, focus and discipline while continuing to serve the IgA nephropathy patient community. I couldn't be more proud of what this team is accomplishing together. Their efforts resulted in record FILSPARI demand with over 2,000 new patient start forms across IgA nephropathy and FSGS and record U.S. revenue of more than $141 million for the quarter. Our Q2 performance reflects 2 complementary growth drivers: one, continued strength in our established IgA nephropathy business; and two, exceptionally strong first few months of launch in FSGS. Let me begin with IgA nephropathy. Demand remained strong, growing again compared to the prior quarter. Importantly, this growth was achieved despite additional treatment options entering the market, reinforcing FILSPARI's established and differentiated positioning. FILSPARI remains the most widely utilized treatment option approved for IgA nephropathy, and we continue to see high levels of repeat prescriptions alongside ongoing adoption by new physicians. Since the treatment guidelines were updated last year to recommend a lower proteinuria target, we have observed physicians treating patients earlier and pursuing more ambitious treatment goals. FILSPARI's foundational positioning with superior efficacy demonstrated against an active maximally dosed ARB gives physician confidence that more patients can achieve those goals, whether FILSPARI is used as a monotherapy or in combination with other treatment modalities. Turning to FSGS. The beginning of the launch has been strong. Prior to April, there had been no FDA-approved medicines for FSGS, one of the most progressive rare kidney diseases. This high unmet need, along with the compelling proteinuria reduction FILSPARI provides has created strong physician and patient enthusiasm. Furthermore, our established nephrology relationships, combined with our team's robust FSGS launch preparation have supported rapid early adoption by the FSGS community. At approval, we expected FSGS uptake would outpace that of the beginning of the IgA nephropathy launch, and this is what we are seeing. All fundamentals regarding demand, payer access, fulfillment and revenue are exceeding the metrics we have seen during the initial phase of the IgA nephropathy launch. Leading into the approval, there was high awareness among physicians and patients. A small portion of our early adoption likely reflects physicians prioritizing patients they have already identified or those patients more frequently seeing their physician, resulting in a slight acceleration of demand during the initial launch period. Importantly, overall demand has been broad. The vast majority of physicians who have prescribed FILSPARI for FSGS have written for a single patient to date, while we also continue to see steady activation of new prescribers. This reinforces our belief that we remain in the early stages of market uptake, which supports confidence in the durability of demand. Additionally, we are encouraged by the early progress we are making with payer access. First pass approval rates in FSGS track ahead of what was experienced at a comparable stage of the IgA nephropathy launch. And while early launch conversion always takes some time, conversion trends are progressing well. We entered the FSGS launch with existing payer relationships, an experienced patient services organization and an established field reimbursement team. This organizational experience, together with robust launch preparations, enable drug availability upon approval and shipments to begin within the first week following approval. Importantly, payers understand the rare and progressive nature of FSGS and the lack of effective and approved medicines for this condition. While they continue to establish and refine their coverage policies, we remain focused on educating on the clinical value of FILSPARI supported by health economic evidence. At the same time, our field reimbursement teams continue to work closely with nephrology practices to support navigating reimbursement requirements and help patients access therapy as efficiently as possible. This work will continue throughout the year to further increase access to the FSGS patient community. Looking ahead, it is still early in the launch, and it's not prudent to extrapolate from a single quarter. That said, we are encouraged by what we have seen since approval. From a demand perspective, we expect the FSGS uptake curve to differ from IgA nephropathy. In IgA nephropathy, adoption evolves through several distinct phases, including the transition from accelerated to full approval and subsequent REMS simplification. In FSGS, those foundational elements were already in place at launch, enabling broader adoption earlier in the launch curve. While we expect some normal quarter-to-quarter variability in patient starts, including potential seasonal impact during the summer months, we expect continued demand as we activate new prescribers and deepen prescribing within existing practices. I am incredibly proud of what our customer-facing teams are accomplishing for the IgA nephropathy and FSGS patient communities, grounded in FILSPARI's differentiated clinical profile and the growing body of evidence. On that note, I'd now like to turn the call over to Jula for the medical update. Jula? Jula Inrig: Thank you, Peter. I'll start with FILSPARI, the only approved therapy that can replace RAS inhibitors while directly addressing key drivers of ongoing kidney injury. By reducing proteinuria, FILSPARI provides a differentiated foundational non-immunosuppressive treatment that delivers long-term nephroprotection across both IgA nephropathy and FSGS. As the IgA nephropathy treatment landscape evolves, our discussions with nephrologists reinforce FILSPARI's role as a foundational treatment for patients with IgA nephropathy. Nephrologists emphasize that reducing proteinuria ideally to complete remission of less than 0.3 grams per day, and slowing the rate of loss of eGFR to less than 1 ml per minute per year remain the 2 key treatment goals for all patients with IgA nephropathy. This is aligned with the KDIGO guidelines and data from both our PROTECT and SPARTAN studies support that FILSPARI, particularly if used early in the treatment paradigm, has the potential to achieve both of those treatment goals for many patients. As additional immune-mediated therapies become available, nephrologists anticipate a more individualized and layered treatment approach with kidney-directed therapies serving as the foundation and immune modulating therapies used when clinically appropriate for certain patients. Importantly, the expanding therapeutic landscape is increasing awareness of IgA nephropathy, accelerating diagnosis and encouraging earlier treatment. We believe this is an important step forward for patients because it creates more opportunities to intervene early, preserve kidney function and ultimately improve long-term outcomes. In FSGS, we continue to see tremendous enthusiasm among patients and physicians following FILSPARI's approval as the first medicine approved for FSGS. FILSPARI is indicated to reduce proteinuria in adult and pediatric patients aged 8 years and older with FSGS without nephrotic syndrome. Importantly, the conversation has shifted to how best to incorporate FILSPARI into clinical practice. This includes utilization across primary, secondary and genetic forms of FSGS and reflects confidence in FILSPARI's dual mechanism being superior to RAS inhibitors as well as the need for an effective kidney-targeted therapy that can serve as a foundation of care with immunosuppressive therapy added when clinically appropriate for certain patients. At ERA in June, we presented long-term DUPLEX open-label extension data, demonstrating sustained proteinuria reductions for up to 5 years with no new safety signals, further reinforcing FILSPARI's well-characterized long-term safety profile. We're also continuing to expand the evidence base for FILSPARI across a range of FSGS and IgA nephropathy patients. We recently completed enrollment in our post-transplant study evaluating recurrent FSGS and recurrent IgA nephropathy, areas of significant unmet need. We anticipate data from this study in 2027. In addition, in the second half of 2026, we plan to initiate a Phase IV open-label study to further evaluate the efficacy and safety of FILSPARI in adult and pediatric patients of African ancestry with FSGS and at high risk of disease progression. Turning to pegtibatinase. Enthusiasm among physicians, investigators and patients remains high for a potential disease-modifying therapy that addresses the underlying CBS enzyme deficiency. Recent investigator meetings and the HCU Network America Patient Conference reinforce the significant unmet need and excitement about pegtibatinase' potential to meaningfully reduce total homocysteine and overcome many of the limitations of current treatment approaches. Enrollment in our Phase III HARMONY study is continuing with site screening and enrolling patients. We continue to expect top line results from HARMONY in the second half of 2027. Finally, we are excited to officially bring civorebrutinib into our development portfolio. Civorebrutinib is an investigational oral covalent reversible BTK inhibitor that we believe has the potential to become a best-in-class therapy for multiple rare immune-mediated kidney diseases, including primary membranous nephropathy, immune-mediated FSGS and minimal change disease with the potential to expand into development for additional rare kidney diseases over time. Importantly, civorebrutinib represents a strategic and complementary addition to our rare disease portfolio. FILSPARI provides kidney protection and civorebrutinib adds a distinct immune-mediated mechanism to our portfolio. Each program reflects our long-term strategy of developing therapies that can be tailored to the biology and clinical presentation of patients living with rare kidney diseases. Following the recent closing of our agreement with Everest Medicines, our teams have been focused on advancing our development planning. Our next step is to open an IND in the U.S., and we look forward to engaging with the FDA on the global clinical development pathways to support multiple studies across these important rare kidney diseases with high unmet need. I'll now turn it over to Chris for a financial update. Chris? Chris Cline: Thank you, Jula. In the second quarter, we delivered exceptional commercial results, continue to invest in the programs with the greatest opportunity to create value for patients and shareholders, strategically expanded our pipeline with the addition of civorebrutinib and strengthened our balance sheet through successful convertible note transactions. Collectively, these actions have further strengthened our financial position and support our confidence in Travere's near- and long-term growth trajectory. In terms of commercial performance, we generated $161.4 million in total U.S. net product sales in the second quarter, reflecting strong sequential and year-over-year growth. U.S. net product sales of FILSPARI grew approximately 96% year-over-year to $141.1 million, representing a strong start to the FSGS launch and continued growth in IgA nephropathy. As expected, gross-to-net discounts for FILSPARI in the second quarter were slightly lower compared to the first quarter. We expect gross-to-net discounts to be slightly higher in the third and fourth quarters as we see more FSGS patients initiate therapy with a higher CMS utilization. But as previously guided, we continue to anticipate full year gross-to-net discounts for FILSPARI to be in the mid-20% range. Thiola and Thiola EC also contributed $20.3 million in U.S. net product sales during the second quarter, and we recognized $8.2 million in license and collaboration revenue, resulting in $169.6 million in total revenue for the second quarter. License and collaboration revenue for the second quarter included recognition of a $5 million milestone from the Chugai partnership for sparsentan in Japan. Total GAAP R&D and SG&A expenses for the quarter were $156.4 million, which includes approximately $22.2 million in noncash stock-based compensation and depreciation expense. The year-over-year increase in R&D expense is primarily driven by enrollment activities in the Phase III HARMONY study and manufacturing for pegtibatinase during the quarter. For SG&A, the year-over-year increase is primarily attributable to investments in FILSPARI's launch in FSGS, including the expanded field team and promotional efforts in the first month of launch as well as investments to continue our momentum in IgA nephropathy. Royalty expense for the quarter was approximately $7.1 million. As we mentioned on our call last quarter, the Thiola intangible asset reached the end of its accounting useful life at the end of March. As a result, royalty expense now reflects Thiola royalties expense for the quarter as well as the amortization associated with contractual milestones and royalty payments related to FILSPARI that are capitalized to intangible assets and amortized on a straight-line basis over its accounting useful life. Total other expense net for the quarter was impacted by the recognition of an inducement expense of $40 million related to the repurchases of 2029 convertible notes during the quarter. As of June 30, 2026, we had cash, cash equivalents and marketable securities of approximately $489.2 million. This includes the net proceeds of approximately $158 million from our convertible refinancing transaction where we repurchased approximately $221 million of 2.25% convertible notes due 2029 and issued $525 million of 0.5% convertible notes due in 2032. Following the close of the civorebrutinib transaction in July, we paid Everest, the previously disclosed upfront amount of $112.5 million. As we look ahead, we remain confident in our outlook and continue -- for continued near- and long-term FILSPARI revenue growth and are committed to investing prudently behind the opportunities we believe will create the greatest long-term value. These include the continued launch of FILSPARI in FSGS and foundational positioning in IgA nephropathy, the advancement of pegtibatinase and the development of civorebrutinib. Supported by a strong balance sheet, we believe we are well positioned to execute our strategy and fund our planned operations with current resources while continuing to create durable value for patients and shareholders. I'll now turn the call over to Eric for his closing remarks. Eric? Eric Dube: Thank you, Chris. We are excited about the trajectory of our business, and we are approaching this next chapter with the same discipline that has defined our execution to date. Our priorities are clear. Our infrastructure is scalable, and our focus remains on investing in programs with the greatest potential to deliver meaningful outcomes for patients and durable value for shareholders. Our commitment is reinforced by the impact we are already having on the lives of people living with FSGS. As one mother shared with us recently, FILSPARI has been so helpful. My son went on his bike for the first time this week since his diagnosis. I am giddy and grateful. With that foundation, we believe Travere is increasingly well positioned as a leading rare disease company with the opportunity to positively impact the lives of significantly more patients. The potential to achieve more than $3 billion in peak annual FILSPARI sales and continuing to advance an exciting pipeline with multiple drivers of long-term value. With that, I'll turn it over to Nivi to begin Q&A. Nivi? Nivi Nehra: Thank you, Eric. Operator, we can now open up the line for Q&A. Operator: [Operator Instructions] We will now take the first question from the line of Vamil Divan from Guggenheim Securities. Vamil Divan: Congrats on the quarter, very impressive results here. So I guess my question is on -- still on the FSGS launch and following up on some of what Peter said regarding sort of the shape of the curve from here and how we should think about it, starting at a much higher point than we were expecting. I know you mentioned some summer seasonality. But if you can just give us a little bit more guidance, and I know you're not giving formal guidance, but just some sense of how to think about the next few quarters so we're in a reasonable spot and people are on the same page as to think about sort of the growth outlook from here, but also maybe some of the headwinds around the summer and also, obviously, the competitive dynamics in IgAN, too. So I just want to make sure we're all reasonably in the same spot. Any further comments there would be very helpful. Eric Dube: Vamil, thanks so much for the question. We are very excited about the rapid uptake that we've seen thus far in FSGS against the backdrop of growing demand in IgA nephropathy. I do want to reiterate what Peter said, it's early in the launch with FSGS, and so it's difficult for us to project from here. But Peter, why don't you comment on some of the dynamics that you are seeing that really help us think about the outlook and the dynamics for growth from here on out? Peter Heerma: Certainly. I'm happy to do that. And maybe good to reiterate that we won't be breaking out performance by indication, but what we are seeing overall is continued strength in IgA nephropathy. What we basically have seen since Q4 last year, basically after the modification of the REMS program that we have seen patients start forms north of 900, and we are confident in our continued performance in IgA nephropathy there, while also having a very strong launch for FSGS. I mentioned the approval was highly anticipated by both physicians as well as patient communities. And what we have seen a small portion of patients that were identified early, those are the patients also that are often seen more frequently by their physicians. And to your point, we also mentioned that the trajectory of FSGS may be slightly different than IgA nephropathy, where you have very distinct phases in the launch, moving from accelerated to full approval and then from full approval to the REMS modification. You won't see those same catalysts in FSGS. But I think most importantly, what we are seeing is broad prescriber base for FSGS with most physicians only having 1 patient while they have multiple patients in their practices. So we're very confident with what we have seen, and we believe there will be continued demand moving forward. Operator: Our next question comes from the line of Anupam Rama from JPMorgan. Anupam Rama: Congrats on all the progress here. Just following up on Vamil's question here on FSGS. Just wondering if you could expand a little bit on what you're seeing on time lines from start form to paid script and how you expect this to evolve? Eric Dube: Thanks, Anupam. Peter, why don't you take those? Peter Heerma: Yes. Thank you for the question, Anupam, and thanks for the high five as well. Overall, what we commented and therefore, we were expecting that you would see a faster conversion from patient start forms in FSGS versus what we saw initially in IgA nephropathy. Having said that, it still takes time to educate payers and to get FILSPARI included in the formularies. So while we're ahead of IgA nephropathy, there's still work to be done. But overall, very pleased with the progress we have been making so far. And yes, we look forward to educate payers consistently to our label and our health economic evidence. Operator: Our next question comes from the line of Joe Schwartz from Leerink Partners. Joseph Schwartz: Congratulations on the great performance, Travere team. For FSGS, what did you learn in the first full quarter post approval about where demand is coming from the most in terms of prescribers and the patients they're prescribing FILSPARI to? Are any patterns notable amongst academic centers, community nephrologists, pediatric nephrologists or prior DUPLEX investigators and their FSGS patients? Eric Dube: Joe, thanks so much for the question. You're going to get 2-for-1 answer. I'm going to share with you my thoughts, and I'm going to hand it over to Peter. One of the things that's most striking to me about the uptake thus far, and I think what gives us incredible confidence in the continued demand here is just the breadth. I mean, Peter talked about the breadth of prescribing, we saw that very quickly. And so physicians are trying it, but it's going to obviously lead to further depth of prescribing, and we still have a lot of opportunity to broaden to physicians that haven't yet prescribed for FSGS. That to me is the most striking learning. Peter, why don't you talk a bit about the breadth and the types of patients that you're seeing in the early parts of the launch? Peter Heerma: Yes, absolutely. And Joe, thanks for that question. Fully in the right what Eric is saying with regards to the breadth of prescriber base. As we were expecting, a large part is coming from physicians that already had experience with FILSPARI. In IgA nephropathy, that's about 70% of the prescribers had that experience already. At the flip side, that also means that you have 30% of the prescribers that is new to the brand. And we have spoken about the halo, potential halo effect in the past. This is where we see an opportunity because these physicians often have IgA nephropathy patients as well. And so like a positive experience with FILSPARI and FSGS, we would expect also then provides enthusiasm to start prescribing in IgA nephropathy. So early signals are positive there. With regard to the patient segment, as you would expect, and this is typical in every launch, patients with relatively high proteinuria levels, those are the patients that are also seen more frequently by physicians. And that's what we saw in particular in this patient population. But overall, reinforcing what Eric said, the breadth of prescriber base, most physicians having a single patient so far while seeing more FSGS patients, that gives me great confidence on continued demand moving forward. Operator: Our next question comes from the line of Tyler Van Buren from TD Cowen. Gregory Wiessner: This is Greg Torres on for Tyler. Congrats on the quarter. So the 2012 PSF significantly exceeded investor expectations. Can you help us understand how much of the upside was driven by stronger-than-expected FSGS uptake versus continued acceleration of the IgA nephropathy launch? And was there a steady growth in IgAN? Or would you say that the FSGS approval really reinvigorated IgAN PSF as well? Eric Dube: Greg, thanks so much for the great question. What I'll say before handing it over to Peter is that, we did see growth in demand for IgA nephropathy, and we're not going to break that out. But what we would say is that, we did see quarter-over-quarter increase in the number of PSFs with IgA nephropathy, which has been our expectation and I think is incredibly encouraging given both the increased number of treatment options within the IgAN space, but also what we have been talking about and now are seeing is an acceleration in the growth of the IgA nephropathy space. Peter, why don't you take further in terms of what you've seen in terms of the growth and the FSGS uptake? Peter Heerma: Yes. I think you've covered a lot of the questions already or the element of the question. I think one thing to add is that, FILSPARI remains the most utilized treatment option approved for IgA nephropathy. And I think that reinforces the established and differentiated positioning of FILSPARI. And to Eric's point, the launch for FSGS was highly anticipated. And we knew there was a high level of excitement across physicians and patient communities, and that's exactly what we are seeing. Operator: Our next question comes from the line of Laura Chico with Wedbush. Laura Chico: One area of concern we've heard from physicians is being in a challenging spot. So if they get payer pushback on combining something like FILSPARI and an APRIL inhibitor, they might have to make a tough decision on which one to take over cost considerations. So I'm curious, a, are you actually seeing this happen at all in practice and realizing it's early days still, but b, what's your expectation for patients to be on multiple branded agents going forward? Eric Dube: Laura, thanks so much for the question. Peter, why don't you talk a bit about what we're seeing today in terms of dynamics? Jula, I'd like for you to talk about our expectation in terms of guidelines and what your medical affairs team are hearing from nephrologists. Peter? Peter Heerma: Yes. Overall, I would say that FILSPARI is very well established in payer plans in formularies. We price FILSPARI for broad access. I mean, if you consider it compared to B cells or other therapies, that's considerably higher. So I think that is a component to take into consideration. I think also that we have the highest rigor of evidence. I mean what payers are looking for is preferably head-to-head comparison. And that's exactly what we are having with an active control, highest dosed ARB where we showed superiority. And I think overall, what we are seeing so far is that payers understand the complementary role of like other modalities like, for example, B cells that you were referring to. But so far, yes, we are confident with the positioning of FILSPARI and formulary so far. Jula Inrig: I'm happy to add to that, Laura, we've heard some of that from nephrologists that they're anxious because they want to use multiple therapies in order to reach both targets of proteinuria remission and eGFR stabilization. And it's not a specialty that has had a lot of experience with multiple branded agents. So while there's angst, as Peter said, we haven't had the pushback of being able to utilize multiple therapies to achieve those targets. It's really more around uncertainty. And we continue to hear that physicians want to use multiple agents to achieve both the targets, complete remission, eGFR stabilization. And by that, it's aligned with the KDIGO guidelines. You target the kidney injury, where FILSPARI has shown the only head-to-head superiority versus the historical standard of care and then you use an immune-mediated therapy. And the combination is really what is in discussion at this point, and that's what we're hearing from the field at this point. Operator: Our next question comes from the line of Prakhar Agrawal from Cantor Fitzgerald. Prakhar Agrawal: Congrats on the strong quarter. Maybe just a couple. How do you expect the persistency in FSGS to track relative to IgAN given the dosing and patient population is slightly different? And maybe if you're able to quantify some of the bolus that was there for FSGS, especially given it matters on how we model the new patient starts in 3Q and beyond? Eric Dube: Prakhar, thanks so much for the questions. Let me take the second one first. We did not see evidence of a bolus. What we did see is a rapid uptake based on the high anticipation of this approval, both by patients and the nephrology community. So I think it's important to reiterate that we do not see evidence of bolus where you would see potential slowdown in demand. We do not expect that we expect continued demand and the opportunity certainly is there. Peter, why don't I turn it over to you to talk about the persistency across FSGS and IgAN? Peter Heerma: Thanks, Eric. And, Prakhar, I think you had 3 questions in 1. Eric addressed the first one with the pent-up demand. Let me talk about the persistency and the dosing. Persistency, I mean, it's very early in the launch, but we are not expecting that FSGS will be meaningful different versus IgA nephropathy. And what we have commented in the past is that the compliance rates of IgA nephropathy are really high with FILSPARI. With regards to dosing, also here early in the launch, but overall, we see basically the same up-titration behavior as that we saw in IgA nephropathy, meaning that for FSGS, physicians are up titrating from 400 to 800 milligram, consistent to the label. Operator: Our next question comes from the line of Gavin Clark-Gartner from Evercore. Gavin Clark-Gartner: Congrats on the initial launch thus far. I just wanted to circle back on some of the conversion metrics. So you noted that the conversion rates you're seeing are exceeding what you saw in IgAN previously. What was the rate that you saw with IgAN? And just to be clear, I'm less interested in the conversion speed and more what the rate was at any point in time. For what it's worth, I model 70% off the bat, increasing to 75% or so as access is established. It seems like access is really good. So I'm wondering if I'm too conservative there. Eric Dube: Gavin, thanks for the question. Peter, I'll turn that over to you. But just to keep in mind, we're not going to be providing specific metrics on this, but I think Peter can share a bit about the dynamics of conversion early in the launch of IgAN versus what we're seeing thus far. Peter Heerma: Yes, Eric and Gavin, certainly happy to provide some color here. And we haven't disclosed the specific on the rates of what we saw early in the conversion rate for IgA nephropathy. But as you would expect, I mean, we have an established patient services team. There is -- we are experienced with the REMS process. Offices are experienced with that as well. And so the process, as you would expect, through the Patient Services division and the distribution as well as FILSPARI often already in formularies, even though not specifically for FSGS, that, that conversion rate is higher than what we saw in IgA nephropathy, and that's exactly what is materializing in FSGS. And like I said, I'm really pleased with the progress, which is very consistent to how we had anticipated this. Eric Dube: Yes, let me just add. I think the really important aspect, Gavin, as we look forward is that, from near day 1 of launch in FSGS, we're in a much stronger position than starting out with IgA nephropathy. And it does take some time to get payer policies in place, but everything that we see thus far aligns to a very strong outlook within FSGS, if that helps you to think about and model conversion. Operator: Our next question comes from the line of Mohit Bansal from Wells Fargo. Sadia Rahman: This is Sadia Rahman on for Mohit. Congrats on the quarter. So maybe a big picture question. Just curious if the strong launch in FSGS has changed your confidence in your prior estimate of the size of the opportunity for FILSPARI across IgAN and FSGS, maybe this makes that $3 billion estimate seem conservative. And just related to that, when we think about penetration into that 30,000 patients that you framed as addressable in FSGS, just considering there are no other treatments approved in FSGS, how should we think about penetration in this market? Are there any factors that you'd highlight that could limit penetration? And are there any analogs that we should consider here? Eric Dube: Sadia, thanks so much for those questions. I'm going to take those, and then I'll ask Jula and Peter to add anything that I might have missed. First, we remain very confident in the revenue opportunity exceeding $3 billion at peak across both FSGS and IgA nephropathy. I think as we continue to learn more, and this is a single data point in a very strong uptake, we remain confident in the growth outlook for FSGS, but we've not revised anything further with regard to peak year sales. So more to come on that, but I think it reiterates the confidence and the very strong outlook that we see for FILSPARI long term. With regard to the penetration, we do see that we are starting off of a strong position, but we're only scratching the surface with regard to the patients that could benefit from FILSPARI. It remains the only approved medication in FSGS. There are no other therapies that are available. There are some that are being studied, particularly for subtypes of FSGS that are earlier in development. But at this point, we do not see in the foreseeable future treatment options, unfortunately, for this community, but we do fully expect that there will be other therapies available since we have now paved the way for others to follow. Those that are in development, we see as complementary, and we believe that for many patients, they'll benefit from combination therapy, much like we're starting to see emerge in IgA nephropathy. So all in all, we're very pleased with the early uptake. And I think as we look long term, really strong opportunity for revenue and I'd say even more importantly, the opportunity to truly make a difference in the lives of these patients as we reach more. Jula, Peter, anything that you'd want to add? Okay. Operator: Our next question comes from the line of Maury Raycroft with Jefferies. James Stamos: This is James on for Maury. Congrats on all the progress. Otsuka disclosed approximately 50% of VOYXACT's prescriptions are switches. Do you have patient level switch data quantifying outflows in 2Q? Eric Dube: James, thanks so much for the question. Peter, I'll turn that over to you. Peter Heerma: We haven't disclosed what patients comes from like new branded prescriptions versus switch, but I can tell you that most of the prescriptions of FILSPARI are new to branded therapies. And that's very consistent to our positioning. It's the first change that physicians make is move from generic RAS inhibition to FILSPARI before considering other branded modalities. Operator: Our next question comes from the line of Joe Pantginis from H.C. Wainwright. Joshua Korsen: This is Josh on for Joe. So last quarter, you had mentioned that the without nephrotic syndrome language would be more of an education opportunity rather than being a barrier to adoption. So I was just wondering if this has still continued to hold true? Or have you encountered any unexpected issues? Eric Dube: Josh, thanks for the question. Peter, I'll turn that one over to you. Peter Heerma: Yes. I'm happy to comment on that, Josh. I think with every launch, you want to educate physicians on what the indication is, and that was no different for this indication. I think physicians understand the indication very well because I think it's very consistent how physicians are practicing nephrology in FSGS patients, but also very consistent with the KDIGO guidelines. So while there's still education to do, physicians understand the positioning for patients that are currently not in nephrotic syndrome. Operator: Our next question comes from the line of Alex Thompson with Stifel. Alexander Thompson: Congrats on the quarter. Maybe shifting gears just civorebrutinib. The PARASOL group is now looking at membranous nephropathy and there's a workshop later in September. I guess like based on the FSGS experience here, what could be the potential outcome in membranous nephropathy with PARASOL? Is it your view that there could be a faster path to pivotal development in this space? And how might that impact your clinical development strategy moving forward? Eric Dube: Alex, thanks so much for the question and particularly that it's on civo. So, Jula, I'll turn that one over to you. Jula Inrig: Yes. We're excited by the continued efforts to define endpoints to help accelerate therapies for high unmet need, including membranous. There's also work in APOL1 and Alport with other groups. We're going to be closely following the data that comes in as well as the analysis. So it is the standard development strategy in membranous nephropathy is to look at complete remission over 2 years. That's been pretty well established. Certainly, there's many who would like to have something short of complete remission or shorter duration or biomarkers that could help accelerate development. That's going to require getting the data and analyzing it and getting alignment with the agency. But certainly, we'll follow close and have our development strategy aligned with the data that's available. Operator: Our next question comes from the line of Yigal Nochomovitz from Citi. Caroline DePaul: This is Caroline on for Yigal. Following the restart of HARMONY enrollment, what gives you confidence in maintaining the 2H '27 top line time line? And how should we think about enrollment momentum through the remainder of 2026? Eric Dube: Caroline, thanks so much for the question. Jula, I'll turn that one over to you. Jula Inrig: So we don't provide specific enrollment targets or time lines, but our progress to date gives us the confidence to have top line data in the second half of 2027. And part of that comes from the patient identification work that was done over the last couple of years as well as the continued execution of our clinical operations teams and then our engagement with the patient community and with our sites. Operator: Our next question comes from the line of Jason Zemansky from Bank of America. Jason Zemansky: Congrats on the great quarter. Peter, maybe regarding your comments over the depth of FSGS prescribers, what clinical or practical experience do you think these physicians need before prescribing FILSPARI more broadly across their eligible patients? And when should we begin to see whether the early breadth of adoption is translating into greater depth? Peter Heerma: Thanks for question, Jason. It's early in the launch. I mean that's, I think, the first thing to say. This is very consistent to earlier launches that I've been involved in. Physicians have sort of patients in mind when a new product becomes available, they prescribe to the patient -- to that particular patient. They see what the experience is and that then encourages repeat prescription as well. That's what we saw with IgA nephropathy, and we see that more rapidly now in FSGS. And so to Eric's earlier point and my earlier point as well, we see a broad prescriber base for FSGS, the majority with single patient so far. But given that we are early in the launch, I'm expecting that we will see depth of prescription moving forward quite quickly. Operator: Our next question comes from the line of Vamil Divan with Guggenheim Securities. Vamil Divan: Just a quick one for me on the IP side. Apologies if I missed -- I heard your comments on the IgAN method of use patent. I'm curious if there's any update on the FSGS side regarding method of use or any extension out of the patent protection. Eric Dube: Vamil, thanks so much for that question. We do have patent prosecution ongoing in FSGS. Nothing to report at this point, but we will provide an update at the appropriate time. Operator: Ladies and gentlemen, this concludes the question-and-answer session of today's conference call. I'll hand the call back over to Nivi. Nivi Nehra: Great. Thank you, everyone, for joining today's call. Have a great rest of your day. Operator: Thank you, everyone, and have a great day. You may disconnect the call. 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This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Travere Therapeutics (TVTX) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

Find your next quality investment with Simply Wall St's easy and powerful screener, trusted by over 7 million individual investors worldwide. Travere Therapeutics (TVTX) drew investor attention on 4 August 2026 after reporting second quarter results that combined higher revenue with a wider net loss, driven by performance of its rare kidney disease portfolio. See our latest analysis for Travere Therapeutics. At a share price of $62.45, Travere Therapeutics has a 90 day share price return of 46.6% and a 1 year total shareholder return of 269.31%. This suggests momentum has been building around recent revenue beats and interest in its rare kidney disease treatments. If Travere Therapeutics has sharpened your focus on high growth healthcare, it could be worth widening your watchlist through the 42 healthcare AI stocks Travere Therapeutics now appears to be a stronger rare kidney disease business, supported by recent revenue beats and a sharp share price move. The key question is whether that strength is already fully reflected in today’s valuation. Travere Therapeutics closed at $62.45, while the most followed narrative suggests a fair value of about $68.36. The gap reflects how analysts tie rare kidney disease momentum and future profitability to a higher long term valuation. Read the complete narrative. Want to see how this potential new indication feeds into the numbers? The narrative focuses on rapid top line growth, rising margins and a richer profit multiple. It raises the question of which specific earnings and revenue paths support that fair value. Result: Fair Value of $68.36 (UNDERVALUED) Have a read of the narrative in full and understand what's behind the forecasts. However, Travere Therapeutics still faces meaningful risks if FILSPARI underperforms against competing rare kidney treatments or if regulatory and pricing pressures erode the expected cash flow profile. Find out about the key risks to this Travere Therapeutics narrative. While the narrative and analyst targets point to Travere Therapeutics being about 8.6% below fair value, the P/S ratio tells a tighter story. TVTX trades at about 10x sales, which is higher than its own fair ratio of 8.2x, yet lower than the US Biotechs average of 11.5x. That mix hints at some valuation risk if expectations ease, but also suggests the stock is not the most stretched in its peer group. The key question is which signal you trust more when sentiment cools or new data arrives. See what the numbers say about this price — find out in our valuation breakdown. Sentiment around Travere Therapeutics is clearly mixed, and the data points pull in different directions. It makes sense to review the details yourself and decide how comfortable you are with the current setup before acting. To see what is driving optimism under the surface and to weigh it against the risks, take a closer look at the 3 key rewards. If you are serious about building a stronger portfolio, use the Simply Wall St screener to uncover fresh stock ideas that might not be on your radar yet. Target potential mispricings by reviewing companies highlighted in the 50 high quality undervalued stocks and see which ones justify a place on your watchlist. Strengthen your downside protection by filtering for resilient businesses through the 78 resilient stocks with low risk scores that may better fit your comfort with volatility. Get ahead of the crowd by scanning the screener containing 19 high quality undiscovered gems and spotting quality stocks before they attract wider attention. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include TVTX. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management attributes the exceptional quarter to the first period of dual commercial availability for FILSPARI across both IgA nephropathy (IgAN) and FSGS indications. IgAN demand grew sequentially despite new market entrants, which management believes reinforces FILSPARI's differentiated position as a foundational, non-immunosuppressive treatment. The FSGS launch exceeded internal expectations, driven by high unmet need as the first FDA-approved medicine for the condition and established nephrology relationships. Management noted that physicians are increasingly treating IgAN earlier and pursuing more ambitious proteinuria targets (less than 0.3 grams per day) following updated clinical guidelines. The company is pivoting toward a 'layered' treatment narrative, positioning FILSPARI as the kidney-directed foundation upon which immune-modulating therapies can be added. Strategic expansion of the pipeline via the civorebrutinib license adds an upstream immune-modulating approach to complement FILSPARI's downstream nephroprotection. Management maintains a peak annual sales target for FILSPARI exceeding $3 billion, supported by broad prescriber adoption and long-term nephroprotection data. The FSGS uptake curve is expected to differ from IgAN because foundational elements like REMS and full approval were already in place at the FSGS launch. Top-line results for the pivotal Phase III HARMONY study of pegtibatinase in classical homocystinuria remain on track for the second half of 2027. Guidance for full-year gross-to-net discounts remains in the mid-20% range, though Q3 and Q4 may see slight increases due to higher CMS utilization in FSGS. The company plans to initiate a Phase IV study in the second half of 2026 specifically evaluating FILSPARI in patients of African ancestry with FSGS. The company strengthened its balance sheet through a convertible refinancing transaction, resulting in $489.2 million in cash to fund operations and the $112.5 million civorebrutinib upfront payment. A $40 million inducement expense was recognized during the quarter related to the repurchase of 2029 convertible notes. R&D expenses increased year-over-year primarily due to manufacturing and enrollment activities for the pegtibatinase HARMONY study. A Notice of Allowance was issued for a U.S. patent application regarding methods of using sparsentan in IgAN, with a similar application pending for FSGS. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management stated they do not see evidence of a 'bolus' or pent-up demand that would lead to a slowdown; instead, they see rapid uptake from high anticipation. The vast majority of FSGS prescribers have only written for a single patient to date, suggesting significant remaining depth within existing practices. Conversion from patient start forms to paid scripts is tracking faster in FSGS than it did during the initial IgAN launch. Management attributed this to established payer relationships and an experienced patient services organization already in place from the IgAN business. Management noted that while there is some physician 'angst' regarding the cost of multiple branded agents, they have not seen significant payer pushback on combinations yet. They emphasized that FILSPARI is priced for broad access compared to B-cell or other high-cost immune therapies, aiding its foundational positioning. The company is monitoring the PARASOL group's efforts to define accelerated endpoints for membranous nephropathy. Management indicated they will align their global clinical development pathway with the FDA once the IND is opened in the U.S.

Interested in Travere Therapeutics, Inc.? Here are five stocks we like better. Record FILSPARI performance: Travere reported $169.6 million in total second-quarter revenue, including $141.1 million in U.S. FILSPARI sales—up approximately 96% year over year. FSGS launch exceeded expectations: Early adoption, payer access, fulfillment and prescription conversion are tracking ahead of the initial IgA nephropathy launch, with more than 2,000 new patient start forms across both indications. Pipeline and finances: Travere expects pivotal HARMONY trial results for pegtibatinase in the second half of 2027, while holding $489.2 million in cash and investments at quarter-end before paying a $112.5 million civorebrutinib licensing fee. 3 Under-the-Radar Healthcare Companies Travere Therapeutics (NASDAQ:TVTX) reported second-quarter results marked by record FILSPARI demand and revenue, driven by continued growth in IgA nephropathy and an early launch in focal segmental glomerulosclerosis, or FSGS. The company generated $161.4 million in U.S. net product sales during the quarter and $169.6 million in total revenue, including licensing and collaboration revenue. FILSPARI accounted for $141.1 million of U.S. net product sales, up approximately 96% from a year earlier, while Thiola EC contributed $20.3 million. → SpaceX’s First Earnings Report Could Decide Whether Shorts or Bulls Have Control Travere Therapeutics Still On The Rise After Encouraging Data Chief Commercial Officer Peter Heerma said FILSPARI demand reached a record level, with more than 2,000 new patient start forms across IgA nephropathy and FSGS. He said the quarter represented the first full period in which FILSPARI was commercially available for both indications following the April approval for FSGS. Travere said the FSGS launch has exceeded its expectations, with early adoption, payer access, fulfillment and revenue metrics tracking ahead of what the company experienced during the initial IgA nephropathy launch. → Why Rare Earth Processing Could Be the Real 2027 Opportunity Heerma said FSGS uptake was supported by the lack of previously approved medicines for the progressive kidney disease, along with established nephrology relationships and launch preparation. Shipments began within the first week after approval, according to the company. Management emphasized that prescribing activity has been broad rather than concentrated among a limited group of physicians. Most FSGS prescribers have written FILSPARI for one patient so far, despite having additional FSGS patients in their practices, which the company said supports its view that the market remains at an early stage of adoption. → TSMC Insiders Are Buying the Pullback—But Is the Signal as Bullish as It Looks? “We did not see evidence of a bolus,” Chief Executive Officer Eric Dube said in response to an analyst question about whether early demand reflected a one-time wave of previously identified patients. He said the company instead saw rapid uptake based on high anticipation among patients and nephrologists and expects continued demand. Travere said first-pass approval rates in FSGS are ahead of those seen at a comparable point in the IgA nephropathy launch. Heerma added that conversion from patient start forms to paid prescriptions has been faster than it was initially in IgA nephropathy, though he did not disclose specific conversion metrics. The company expects some quarter-to-quarter variability in patient starts, including potential summer seasonality, but said the FSGS launch has foundational elements already in place that were not available during the earlier IgA nephropathy rollout. In IgA nephropathy, Travere said demand increased sequentially despite the arrival of additional treatment options. Heerma said FILSPARI remains the most widely utilized approved treatment option in the indication, supported by repeat prescriptions and adoption by new physicians. Chief Medical Officer Jula Inrig said discussions with nephrologists continue to support FILSPARI’s role as a foundational kidney-directed therapy. She said physicians are increasingly focused on reducing proteinuria to less than 0.3 grams per day and slowing eGFR decline, while using immune-modulating therapies for patients when clinically appropriate. Management said it has not seen payer pushback that prevents the use of FILSPARI alongside other branded therapies. Inrig said physicians have expressed uncertainty because nephrology has had less experience using multiple branded agents, but the company continues to hear that clinicians want to combine therapies when needed to pursue proteinuria remission and eGFR stabilization. Travere also said most FILSPARI prescriptions are new to branded therapies rather than switches from other branded products. Heerma described the typical treatment transition as a move from generic RAS inhibition to FILSPARI before physicians consider other branded modalities. The company said enrollment is continuing in the pivotal Phase III HARMONY study of pegtibatinase for classical homocystinuria, or HCU. Travere continues to expect top-line HARMONY results in the second half of 2027. The company described pegtibatinase as a potential disease-modifying therapy designed to address the underlying CBS enzyme deficiency in HCU. Travere also completed enrollment in a post-transplant study evaluating FILSPARI in recurrent FSGS and recurrent IgA nephropathy, with data anticipated in 2027. In the second half of 2026, the company plans to initiate a Phase IV open-label study of FILSPARI in adult and pediatric FSGS patients of African ancestry who are at high risk of disease progression. In July, Travere closed an exclusive licensing agreement with Everest Medicines for civorebrutinib, an investigational oral covalent reversible BTK inhibitor. The company plans to open an investigational new drug application in the U.S. and engage with the Food and Drug Administration on development pathways across rare immune-mediated kidney diseases, including primary membranous nephropathy, immune-mediated FSGS and minimal change disease. Total GAAP research and development and selling, general and administrative expenses were $156.4 million in the quarter, including about $22.2 million in non-cash stock-based compensation and depreciation expense. R&D spending increased primarily due to HARMONY enrollment activities and pegtibatinase manufacturing, while SG&A rose with the FSGS launch and continued IgA nephropathy investments. As of June 30, Travere held approximately $489.2 million in cash, cash equivalents and marketable securities. The balance included approximately $158 million of net proceeds from a convertible refinancing transaction. After the quarter ended, the company paid Everest Medicines a previously disclosed $112.5 million upfront payment related to the civorebrutinib agreement. Dube said Travere continues to see the potential for more than $3 billion in peak annual FILSPARI sales across IgA nephropathy and FSGS, though the company did not revise that estimate following the early FSGS launch performance. Travere Therapeutics, Inc (NASDAQ: TVTX) is a biopharmaceutical company headquartered in San Diego, California, dedicated to the development and commercialization of therapies for rare kidney and genetic disorders. The company's mission is to address unmet needs in conditions with limited treatment options by focusing on diseases that affect small patient populations. Travere combines research, development and commercial capabilities to bring innovative medicines to market. The company's lead product is sparsentan, a dual endothelin angiotensin receptor antagonist that has received accelerated approval from the U.S. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Travere Therapeutics Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

This article first appeared on GuruFocus. Total US Net Product Sales: $161.4 million in Q2 2026, reflecting strong sequential and year-over-year growth. FILSPARI US Net Product Sales: $141.1 million, up approximately 96% year over year, driven by the FSGS launch and continued IgA nephropathy growth. Thiola and Thiola EC US Net Product Sales: $20.3 million in Q2 2026. License and Collaboration Revenue: $8.2 million, including a $5 million milestone from the Chugai partnership for sparsentan in Japan. Total Revenue: $169.6 million for Q2 2026. GAAP R&D and SG&A Expenses: $156.4 million, including approximately $22.2 million in noncash stock-based compensation and depreciation. Royalty Expense: Approximately $7.1 million for the quarter. Other Expense: Impacted by a $40 million inducement expense related to repurchases of 2029 convertible notes. Cash Position: Cash, cash equivalents, and marketable securities of approximately $489.2 million as of June 30, 2026. FILSPARI Demand: Record demand with over 2,000 new patient start forms across IgA nephropathy and FSGS. Gross-to-Net Discounts: Slightly lower in Q2 versus Q1; full-year guidance remains in the mid-20% range. Warning! GuruFocus has detected 8 Warning Signs with PCRX. Is TVTX fairly valued? Test your thesis with our free DCF calculator. Release Date: August 04, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Record FILSPARI demand with over 2,000 new patient start forms across IgA nephropathy and FSGS, and record US revenue of more than $141 million for the quarter. Successful early adoption of FILSPARI in FSGS exceeded high expectations, with all fundamentals regarding demand, payer access, fulfillment, and revenue exceeding metrics seen during the initial phase of the IgA nephropathy launch. Continued growth in IgA nephropathy demand despite additional market entrants, reinforcing FILSPARI's established and differentiated positioning as the most widely utilized treatment option approved for the condition. The USPTO issued a Notice of Allowance for a US patent application directed to certain methods of using sparsentan in IgA nephropathy, providing additional US patent coverage upon issuance. Closed an exclusive licensing agreement with Everest Medicines for civorebrutinib, adding a differentiated upstream immune modulating approach to the rare kidney disease portfolio with potential application across multiple immune-mediated kidney diseases. Strengthened the balance sheet through successful convertible note transactions, ending the quarter with approximately $489.2 million in cash, cash equivalents, and marketable securities. Pegtibatinase Phase III HARMONY study enrollment is continuing, with top line results expected in the second half of 2027, positioning it as a potential first and only disease-modifying therapy for classical homocystinuria. Gross-to-net discounts for FILSPARI are expected to be slightly higher in the third and fourth quarters due to more FSGS patients initiating therapy with higher CMS utilization. The company recognized a $40 million inducement expense related to the repurchases of 2029 convertible notes during the quarter, impacting total other expense net. It is still early in the FSGS launch, and the company cautions against extrapolating from a single quarter, with potential seasonal impact during the summer months expected to cause some quarter-to-quarter variability in patient starts. The company paid a $112.5 million upfront amount to Everest Medicines following the close of the civorebrutinib transaction, which is a significant cash outflow. There is ongoing uncertainty regarding payer pushback on combining FILSPARI with other branded agents like APRIL inhibitors, as physicians express angst about using multiple therapies to achieve treatment targets. The company has not yet provided an update on the FSGS method of use patent, with patent prosecution still ongoing and no specific timeline for resolution. Q: Can you help us understand how much of the upside in the record 2,000+ patient start forms (PSFs) was driven by stronger-than-expected FSGS uptake versus continued acceleration of the IgA nephropathy launch?A: Eric Dube (CEO) confirmed that demand for IgA nephropathy grew quarter-over-quarter despite new market entrants, reinforcing FILSPARI's established positioning. Peter Heerma (CCO) added that FILSPARI remains the most utilized treatment option approved for IgA nephropathy, and the FSGS launch was highly anticipated, with strong physician and patient enthusiasm driving rapid early adoption. Q: Regarding the FSGS launch, what are you seeing on timelines from start form to paid script, and how do you expect this to evolve?A: Peter Heerma (CCO) stated that conversion from patient start forms to paid prescriptions is faster in FSGS than it was initially in IgA nephropathy, as expected. However, it still takes time to educate payers and get FILSPARI included in formularies. While ahead of the IgA nephropathy launch pace, there is still work to be done, but the team is pleased with the progress and continues to educate payers on the label and health economic evidence. Q: For FSGS, where is the demand coming from in terms of prescribers and patients? Are there notable patterns among academic centers, community nephrologists, or prior DUPLEX investigators?A: Eric Dube (CEO) highlighted the breadth of prescribing as the most striking learning, with physicians trying the drug but still having room to deepen prescribing. Peter Heerma (CCO) added that about 70% of FSGS prescribers had prior experience with FILSPARI in IgA nephropathy, while 30% are new to the brand, creating a potential halo effect. Early patients tend to have high proteinuria levels, but the broad prescriber base with most physicians having only a single patient supports confidence in continued demand. Q: How do you expect persistency in FSGS to track relative to IgAN, and can you quantify any bolus or pent-up demand seen in the early launch?A: Eric Dube (CEO) clarified that the company did not see evidence of a bolus, but rather rapid uptake based on high anticipation of the approval. Peter Heerma (CCO) noted it is too early to assess persistency differences, but compliance rates in IgA nephropathy are high, and early FSGS data shows similar up-titration behavior from 400mg to 800mg consistent with the label. Q: You noted conversion rates are exceeding what you saw in IgAN previously. What was the rate with IgAN, and are you being too conservative in modeling 70% conversion?A: Peter Heerma (CCO) did not disclose specific rates but explained that the established patient services team, experience with the REMS process, and FILSPARI's existing formulary presence have resulted in higher conversion rates in FSGS than early IgA nephropathy. Eric Dube (CEO) added that from near day one of the FSGS launch, the company is in a much stronger position than when starting with IgA nephropathy, aligning to a very strong outlook. Q: Has the strong FSGS launch changed your confidence in the prior estimate of the $3 billion peak sales opportunity for FILSPARI across IgAN and FSGS?A: Eric Dube (CEO) reaffirmed confidence in the revenue opportunity exceeding $3 billion at peak across both indications. He noted the company is only scratching the surface of the addressable FSGS patient population, and while other therapies are in development, they are seen as complementary rather than competitive, with combination therapy likely to emerge as a standard approach. Q: Otsuka disclosed that approximately 50% of VOYXACT's prescriptions are switches. Do you have patient-level switch data quantifying outflows in 2Q?A: Peter Heerma (CCO) stated that the company has not disclosed whether prescriptions are new or switches, but most FILSPARI prescriptions are new to branded therapies. This is consistent with the positioning of FILSPARI as the first change physicians make, moving from generic RAS inhibition to FILSPARI before considering other branded modalities. Q: Last quarter, you mentioned the "without nephrotic syndrome" language would be an education opportunity rather than a barrier. Has this held true?A: Peter Heerma (CCO) confirmed that physicians understand the indication well, as it is consistent with how they practice nephrology in FSGS and aligns with KDIGO guidelines. While there is still education to be done, physicians understand the positioning for patients not currently in nephrotic syndrome, and no unexpected issues have been encountered. Q: Regarding civorebrutinib, what could be the potential outcome in membranous nephropathy with the PARASOL group, and could there be a faster path to pivotal development?A: Jula Inrig (CMO) stated the company is excited by efforts to define endpoints to accelerate therapies for high unmet need. The standard development strategy in membranous nephropathy is looking at complete remission over 2 years, but there is interest in shorter durations or biomarkers. Any acceleration will require data analysis and alignment with regulatory agencies, and the company will align its development strategy with available data. Q: Following the restart of HARMONY enrollment, what gives you confidence in maintaining the 2H '27 top line timeline, and how should we think about enrollment momentum?A: Jula Inrig (CMO) did not provide specific enrollment targets but cited progress to date, patient identification work over the last couple of years, continued execution of clinical operations teams, and engagement with the patient community and sites as reasons for confidence in the second half of 2027 top line data timeline. Q: What clinical or practical experience do physicians need before prescribing FILSPARI more broadly across their eligible FSGS patients, and when should we see breadth translate into depth?A: Peter Heerma (CCO) explained that it is early in the launch, and consistent with previous launches, physicians initially prescribe to specific patients they have in mind. After seeing positive experiences, they are encouraged to prescribe more. The company expects depth of prescription to increase quickly, given the broad prescriber base and the majority of physicians having only a single patient so far. Q: Is there any update on the FSGS method of use patent or extension of For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Strong FSGS launch and continued IgAN growth drive robust FILSPARI demand; 2,012 new PSFs received during the second quarter U.S. net product sales of FILSPARI grew 96% year-over-year to $141 million Enrollment of pegtibatinase Phase 3 HARMONY Study in HCU continues; Topline data expected in 2H 2027 In-licensing of civorebrutinib expands long-term growth opportunities in multiple immune-mediated rare kidney diseases SAN DIEGO, August 04, 2026--(BUSINESS WIRE)--Travere Therapeutics, Inc. (Nasdaq: TVTX) today reported its second quarter 2026 financial results and provided a corporate update. "With an exceptional second quarter, Travere has entered a new chapter of near- and long-term growth," said Eric Dube, Ph.D., president and chief executive officer of Travere Therapeutics. "Our performance reflects the strength of the company we are building and the disciplined execution of our teams as we continue to deliver on our strategy. During the quarter, we made meaningful progress across each of our strategic growth pillars, driving continued commercial momentum for FILSPARI, including a promising early launch in FSGS and continued strength in IgA nephropathy, as well as advancing our pegtibatinase program toward its pivotal Phase 3 readout and expanding our rare kidney disease pipeline through the addition of civorebrutinib. Together, these strengthen the durability of our growth profile, diversify our pipeline and reinforce our commitment to delivering meaningful new therapies for people living with rare diseases." Financial Results for the Quarter Ended June 30, 2026 U.S. net product sales for the second quarter of 2026 were $161.4 million, compared to $94.8 million for the same period in 2025. U.S. net product sales for the six months ended June 30, 2026, were $285.8 million, compared to $170.7 million for the same period in 2025. U.S. net product sales of FILSPARI totaled $141.1 million in the second quarter of 2026, representing 96% growth year-over-year. U.S. net product sales of FILSPARI for the six months ended June 30, 2026, were $246.2 million, representing 93% growth year-over-year. The first months of the FSGS launch and continued growth in IgAN resulted in 2,012 new patient start forms (PSFs) received during the second quarter of 2026. Research and development (R&D) expenses for the second quarter of 2026 were $60.3 million, compared to $49.4 million for the same period in 2025. For the six months ended June 30, 2026, R&D expenses were $117.4 million, compared to $96.3 million for the same period in 2025. The increase is primarily attributable to advancement of the Phase 3 HARMONY Study and manufacturing of pegtibatinase for classical HCU. On a non-GAAP adjusted basis, R&D expenses were $53.4 million for the second quarter of 2026 and $105.0 million for the six months ended June 30, 2026, compared to $45.4 million and $87.5 for the same periods in 2025, respectively. Selling, general, and administrative (SG&A) expenses for the second quarter of 2026 were $96.1 million, compared to $62.6 million for the same period in 2025. For the six months ended June 30, 2026, SG&A expenses were $176.4 million, compared to $123.0 million for the same period in 2025. The difference is largely attributable to commercial investments supporting the recent launch of FILSPARI in FSGS, as well as ongoing commercialization efforts in IgAN. On a non-GAAP adjusted basis, SG&A expenses were $80.8 million for the second quarter of 2026 and $150.1 million for the six months ended June 30, 2026, compared to $55.5 million and $108.8 for the same periods in 2025, respectively. Total other expense, net for the second quarter of 2026 was $39.0 million, compared to $0.1 million for the same period in 2025. Total other expense, net for the six months ended June 30, 2026, was $38.8 million, compared to total other income, net of $1.4 million for the same period in 2025. The difference is largely attributable to a recognized inducement expense of $40.0 million related to 2029 convertible note repurchases completed in the second quarter of 2026. Net loss for the second quarter of 2026 was $34.8 million, or $0.37 per basic share, compared to $12.8 million, or $0.14 per basic share for the same period in 2025. For the six months ended June 30, 2026, net loss was $71.9 million, compared to $54.0 million for the same period in 2025. On a non-GAAP adjusted basis, net loss for the second quarter of 2026 was $9.0 million, or $0.10 per basic share, compared to a net income of $11.9 million, or $0.13 per basic share for the same period in 2025. For the six months ended June 30, 2026, non-GAAP net loss was $4.8 million, compared to $5.0 million for the same period in 2025. As of June 30, 2026, the Company had cash, cash equivalents, and marketable securities of $489.2 million. This includes net cash proceeds of approximately $158 million from the Company’s convertible note transactions in May 2026, in which $525 million of 0.5% convertible notes due 2032 were issued and approximately $221 million of the Company’s $316 million 2.25% convertible notes due 2029 were repurchased. In July 2026, the Company made a $112.5 million upfront cash payment to Everest Medicines following the closing of the civorebrutinib in-licensing transaction. Program Updates FILSPARI® (sparsentan) – IgA Nephropathy (IgAN) The SPARX Study evaluating FILSPARI in post-transplant patients with recurrent IgAN or FSGS has completed enrollment, with data presentations anticipated in 2027. In May 2026, the United States Patent and Trademark Office (USPTO) issued a Notice of Allowance for U.S. Patent Application No. 19/253,088, titled "Biphenyl Sulfonamide Compounds for the Treatment of Kidney Diseases or Disorders," directed to certain methods of using FILSPARI in IgA nephropathy. Upon issuance, the patent is expected to provide U.S. patent coverage for certain methods of using sparsentan in IgA nephropathy into October 2037. In June 2026, the Company’s partner, Chugai Pharmaceutical, submitted a New Drug Application for sparsentan in Japan. Travere remains eligible to receive milestone payments related to the sparsentan regulatory process and net sales achievements in licensed territories, as well as tiered royalties. FILSPARI® (sparsentan) – Focal Segmental Glomerulosclerosis (FSGS) In April 2026, the U.S. Food and Drug Administration (FDA) approved FILSPARI to reduce proteinuria in adult and pediatric patients aged 8 years and older with FSGS without nephrotic syndrome. FILSPARI is the first and only FDA-approved medicine for FSGS, with an estimated addressable population in the U.S. of more than 30,000 patients without nephrotic syndrome. At the 63rd European Renal Association (ERA) 2026 Congress, Travere presented long-term results from the ongoing Phase 3 DUPLEX Study open-label extension (OLE). Patients who initiated FILSPARI in the double-blind period and remained on therapy in the OLE maintained durable reductions in proteinuria, resulting in further achievement of clinically meaningful low proteinuria thresholds over time. Patients who transitioned from active control maximum labeled dose irbesartan to FILSPARI at the start of the OLE experienced rapid and sustained reductions in proteinuria similar to those who initiated FILSPARI at the beginning of the double-blind period. In 2H 2026, the Company plans to initiate a Phase 4, open-label, single-arm, multi-center 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 (SPARLIGHT). Pegtibatinase (TVT-058) – Classical Homocystinuria (HCU) The Company is continuing to enroll new patients in the pivotal Phase 3 HARMONY Study, with topline data anticipated in 2H 2027. The HARMONY Study is expected to enroll approximately 70 patients aged 12 to 65 with plasma total homocysteine (tHcy) levels ≥50 µM. The primary endpoint is change from baseline in plasma tHcy levels, averaged across weeks 6 through 12, in patients receiving pegtibatinase compared with those receiving placebo, with durability of response through Week 24 as a key secondary endpoint. Pegtibatinase has the potential to become the first and only disease-modifying therapy for people living with HCU. Civorebrutinib (EVER001) – Primary Membranous Nephropathy (pMN) and Other Renal Indications In July 2026, the Company closed an exclusive licensing and collaboration agreement with Everest Medicines for civorebrutinib (also known as EVER001), an investigational, potential best-in-class oral, covalent reversible Bruton’s tyrosine kinase (BTK) inhibitor, obtaining rights in the U.S. and global markets excluding Greater China and certain countries in East and Southeast Asia. Civorebrutinib has the potential to serve as a pipeline-in-a-product across multiple immune-mediated kidney diseases. Travere plans to investigate civorebrutinib in pMN, immune-mediated FSGS and minimal change disease (MCD), with the potential for additional indications. These diseases share immune-mediated mechanisms that can lead to glomerular damage, resulting in proteinuria and impaired kidney function that may ultimately require dialysis or transplant. Civorebrutinib may also broaden future treatment approaches in FSGS, where both nephroprotective and targeted immune control approaches may play important roles. Civorebrutinib represents a strategic and complementary addition to Travere’s rare kidney disease portfolio. Conference Call Information Travere Therapeutics will host a conference call and webcast today, August 4, 2026, at 4:30 p.m. ET to discuss company updates and second quarter 2026 financial results. To participate in the conference call, dial +1 (800) 715-9871 (U.S.) or +1 (646) 307-1963 (International), conference ID 7357374 shortly before 4:30 p.m. ET. The webcast can be accessed on the Investor page of Travere’s website at ir.travere.com/events-and-presentations. Following the live webcast, an archived version of the call will be available for 30 days on the Company’s website. Use of Non-GAAP Financial Measures To supplement Travere’s financial results and guidance presented in accordance with U.S. generally accepted accounting principles (GAAP), the Company uses certain non-GAAP adjusted financial measures in this press release and the accompanying tables. The Company believes that these non-GAAP financial measures are helpful in understanding its past financial performance and potential future results. They are not meant to be considered in isolation or as a substitute for comparable GAAP measures and should be read in conjunction with the consolidated financial statements prepared in accordance with GAAP. Travere’s management regularly uses these supplemental non-GAAP financial measures internally to understand, manage and evaluate its business and make operating decisions. In addition, Travere believes that the use of these non-GAAP measures enhances the ability of investors to compare its results from period to period and allows for greater transparency with respect to key financial metrics the Company uses in making operating decisions. Investors should note that these non-GAAP financial measures are not prepared under any comprehensive set of accounting rules or principles and do not reflect all of the amounts associated with the Company’s results of operations as determined in accordance with GAAP. Investors should also note that these non-GAAP financial measures have no standardized meaning prescribed by GAAP and, therefore, have limits in their usefulness to investors. In addition, from time to time in the future the Company may exclude other items, or cease to exclude items that it has historically excluded, for purposes of its non-GAAP financial measures; because of the non-standardized definitions, the non-GAAP financial measures as used by the Company in this press release and the accompanying tables may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by the Company’s competitors and other companies. As used in this press release, (i) the historical non-GAAP net income (loss) measures exclude from GAAP net income (loss), as applicable, stock-based compensation expense, amortization and depreciation expense, and income tax; (ii) the historical non-GAAP SG&A expense measures exclude from GAAP SG&A expenses, as applicable, stock-based compensation expense, and amortization and depreciation expense; (iii) the historical non-GAAP R&D expense measures exclude from GAAP R&D expenses, as applicable, stock-based compensation expense, and amortization and depreciation expense; (iv) royalty expense excludes amortization of capitalized royalties and milestone payments associated with intangible assets accounted for under the cost accumulation model. Under the cost accumulation model, the Company records royalties based on the net sales for the period and milestones when earned from licensing agreements as an increase in the cost basis of the intangible asset. These capitalized amounts are subsequently amortized over the remaining useful life of the intangible asset. About Travere Therapeutics At Travere Therapeutics, we are in rare for life. We are a biopharmaceutical company that comes together every day to help patients, families and caregivers of all backgrounds as they navigate life with a rare disease. On this path, we know the need for treatment options is urgent – that is why our global team works with the rare disease community to identify, develop and deliver life-changing therapies. In pursuit of this mission, we continuously seek to understand the diverse perspectives of rare patients and to courageously forge new paths to make a difference in their lives and provide hope – today and tomorrow. For more information, visit travere.com. FILSPARI® (sparsentan) U.S. Indication FILSPARI® (sparsentan) is indicated: To slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression. To reduce proteinuria in adult and pediatric patients aged 8 years and older with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome. IMPORTANT SAFETY INFORMATION BOXED WARNING: HEPATOTOXICITY AND EMBRYO-FETAL TOXICITY Because of the risk of hepatotoxicity, FILSPARI is available only through a restricted program called the FILSPARI REMS. Under the FILSPARI REMS, prescribers, patients and pharmacies must enroll in the program. Hepatotoxicity Some Endothelin Receptor Antagonists (ERAs) have caused elevations of aminotransferases, hepatotoxicity, and liver failure. In clinical studies, elevations in aminotransferases (ALT or AST) of at least 3-times the Upper Limit of Normal (ULN) have been observed in up to 3.5% of FILSPARI-treated patients, including cases confirmed with rechallenge. Measure transaminases and bilirubin before initiating treatment and then every 3 months during treatment. Interrupt treatment and closely monitor patients who develop aminotransferase elevations more than 3x ULN. FILSPARI should generally be avoided in patients with elevated aminotransferases (>3x ULN) at baseline because monitoring for hepatotoxicity may be more difficult and these patients may be at increased risk for serious hepatotoxicity. Embryo-Fetal Toxicity FILSPARI is contraindicated for use during pregnancy because it may cause fetal harm if used by pregnant patients. Therefore, in patients who can become pregnant, exclude pregnancy prior to initiation of FILSPARI. Advise use of effective contraception before the initiation of treatment, during treatment, and for two weeks after discontinuation of treatment with FILSPARI. When pregnancy is detected, discontinue FILSPARI as soon as possible. Contraindications FILSPARI is contraindicated in patients who are pregnant. Do not coadminister FILSPARI with angiotensin receptor blockers (ARBs), ERAs, or aliskiren. Warnings and Precautions Hepatotoxicity: Elevations in ALT or AST of at least 3-fold ULN have been observed in up to 3.5% of FILSPARI-treated patients, including cases confirmed with rechallenge. While no concurrent elevations in bilirubin >2-times ULN or cases of liver failure were observed in FILSPARI-treated patients in clinical trials, some ERAs have caused elevations of aminotransferases, hepatotoxicity, and liver failure. To reduce the risk of potential serious hepatotoxicity, measure serum aminotransferase levels and total bilirubin prior to initiation of treatment and then every 3 months during treatment.Advise patients with symptoms suggesting hepatotoxicity (nausea, vomiting, right upper quadrant pain, fatigue, anorexia, jaundice, dark urine, fever, or itching) to immediately stop treatment with FILSPARI and seek medical attention. If aminotransferase levels are abnormal at any time during treatment, interrupt FILSPARI and monitor as recommended.Consider re-initiation of FILSPARI only when hepatic enzyme levels and bilirubin return to pretreatment values and only in patients who have not experienced clinical symptoms of hepatotoxicity. Avoid initiation of FILSPARI in patients with elevated aminotransferases (>3x ULN) because monitoring hepatotoxicity in these patients may be more difficult and these patients may be at increased risk for serious hepatotoxicity. FILSPARI REMS: Due to the risk of hepatotoxicity, FILSPARI is available only through a restricted program called the FILSPARI REMS. Prescribers, patients, and pharmacies must be enrolled in the REMS program and comply with all requirements (www.filsparirems.com). Embryo-Fetal Toxicity: Based on data from animal reproduction studies, FILSPARI may cause fetal harm when administered to a pregnant patient and is contraindicated during pregnancy. The available human data for ERAs do not establish the presence or absence of fetal harm related to the use of FILSPARI. Counsel patients who can become pregnant of the potential risk to a fetus. Exclude pregnancy before initiating treatment with FILSPARI. Advise patients who can become pregnant to use effective contraception prior to initiation of treatment, during treatment, and for two weeks after discontinuation of treatment with FILSPARI. Advise pre-pubertal females and/or their guardian(s) of the fetal risk and the need to use effective contraception once they reach reproductive potential. When pregnancy is detected, discontinue FILSPARI as soon as possible. Hypotension: Hypotension has been observed in patients treated with ARBs and ERAs and was observed in FILSPARI clinical studies. There was a greater incidence of hypotension-associated adverse events, some serious, including dizziness, in patients treated with FILSPARI compared to irbesartan. In patients at risk for hypotension, consider eliminating or adjusting other antihypertensive medications and maintaining appropriate volume status. If hypotension develops, despite elimination or reduction of other antihypertensive medications, consider a dose reduction or dose interruption of FILSPARI. A transient hypotensive response is not a contraindication to further dosing of FILSPARI, which can be given once blood pressure has stabilized. Acute Kidney Injury: Monitor kidney function periodically. Drugs that inhibit the renin-angiotensin system (RAS) can cause kidney injury. Patients whose kidney function may depend in part on the activity of the RAS (e.g., patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at particular risk of developing acute kidney injury on FILSPARI. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in kidney function while on FILSPARI. Hyperkalemia: Monitor serum potassium periodically and treat appropriately. Patients with advanced kidney disease, taking concomitant potassium-increasing drugs (e.g., potassium supplements, potassium-sparing diuretics), or using potassium-containing salt substitutes are at increased risk for developing hyperkalemia. Dosage reduction or discontinuation of FILSPARI may be required. Fluid Retention: Fluid retention may occur with ERAs and has been observed in clinical studies with FILSPARI. FILSPARI has not been evaluated in patients with heart failure. If clinically significant fluid retention develops, evaluate the patient to determine the cause and the potential need to initiate or modify the dose of diuretic treatment then consider modifying the dose of FILSPARI. Adverse Reactions IgAN patients receiving FILSPARI: The most common adverse reactions (≥5%) are hyperkalemia, hypotension (including orthostatic hypotension), peripheral edema, dizziness, anemia, and acute kidney injury. FSGS patients receiving FILSPARI: The most common adverse reactions (≥5%) are peripheral edema, hypotension (including orthostatic hypotension), hyperkalemia, dizziness, and anemia. Drug Interactions Renin-Angiotensin System (RAS) Inhibitors and ERAs: Do not coadminister FILSPARI with ARBs, ERAs, or aliskiren due to increased risks of hypotension, syncope, hyperkalemia, and changes in renal function (including acute renal failure). Strong and Moderate CYP3A Inhibitors: Avoid concomitant use of FILSPARI with strong CYP3A inhibitors. If a strong CYP3A inhibitor cannot be avoided, interrupt FILSPARI treatment. When resuming treatment with FILSPARI, consider dose titration. Monitor blood pressure, serum potassium, edema, and kidney function regularly when used concomitantly with moderate CYP3A inhibitors. Concomitant use with a strong CYP3A inhibitor increases sparsentan exposure which may increase the risk of FILSPARI adverse reactions. Strong CYP3A Inducers: Avoid concomitant use with a strong CYP3A inducer. Concomitant use with a strong CYP3A inducer decreases sparsentan exposure which may reduce FILSPARI efficacy. Non-Steroidal Anti-Inflammatory Agents (NSAIDs), Including Selective Cyclooxygenase-2 (COX-2) Inhibitors: Monitor for signs of worsening renal function with concomitant use with NSAIDs (including selective COX-2 inhibitors). In patients with volume depletion (including those on diuretic therapy) or with impaired kidney function, concomitant use of NSAIDs (including selective COX-2 inhibitors) with drugs that antagonize the angiotensin II receptor may result in deterioration of kidney function, including possible kidney failure. These effects are usually reversible. CYP2B6, 2C9, and 2C19 Substrates: Monitor for efficacy of concurrently administered CYP2B6, 2C9, and 2C19 substrates and consider dosage adjustment in accordance with the Prescribing Information. Sparsentan is a weak inducer of CYP2B6 and 2C9, and a moderate inducer of 2C19. Sparsentan decreases exposure of these substrates, which may reduce efficacy related to these substrates. P-gp Substrates: Monitor for adverse reactions and consider dose reduction of P-gp substrates with narrow therapeutic indices when co-administered with FILSPARI. FILSPARI is a weak P-gp inhibitor and may increase plasma concentrations of P-gp substrate drugs. Agents Increasing Serum Potassium: Monitor serum potassium frequently in patients treated with FILSPARI and other agents that increase serum potassium. Concomitant use of FILSPARI with potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, or other drugs that raise serum potassium levels may result in hyperkalemia. Please see the full Prescribing Information, including BOXED WARNING, for additional Important Safety Information. Forward-Looking Statements This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, these statements are often identified by the words "on-track," "positioned," "look forward to," "will," "would," "may," "might," "believes," "anticipates," "plans," "expects," "intends," "potential," or similar expressions. In addition, expressions of strategies, intentions or plans are also forward-looking statements. Such forward-looking statements include, but are not limited to, references to: continued progress with FILSPARI in IgAN and in the commercial launch of FILSPARI in FSGS; statements and expectations regarding near- and long-term growth potential and the commercial opportunity for the Company’s products and products in development; statements and expectations regarding civorebrutinib as a potential best-in-class, pipeline-in-a-product for multiple rare kidney diseases; statements and expectations regarding the Company’s pivotal Phase 3 HARMONY Study, including expectations regarding enrollment and data, and the timing and outcome thereof; statements regarding the potential for pegtibatinase to become the first and only disease-modifying therapy for people living with HCU; statements and expectations regarding the other clinical studies and data described herein; statements and expectations regarding patent issuance and coverage; statements and expectations regarding potential milestone and royalty payments and the potential achievement and timing thereof; statements and expectations regarding the activities of the Company’s partners and collaborators; statements related to the estimated sizes of patient populations; and statements regarding financial metrics and expectations related thereto. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are risks and uncertainties related to the Company’s business and finances in general, the success of its commercial products, risks and uncertainties associated with its preclinical and clinical stage pipeline, risks and uncertainties associated with the regulatory review and approval process, risks and uncertainties associated with enrollment of clinical trials for rare diseases, and risks that ongoing or planned clinical trials may not succeed or may be delayed for safety, regulatory or other reasons. Specifically, the Company faces risks associated with the commercial launch of FILSPARI in FSGS and the ongoing commercialization in IgAN, the timing and potential outcome of its and its partners’ clinical studies, market acceptance of its commercial products including efficacy, safety, price, reimbursement, and benefit over competing therapies, risks related to the challenges of manufacturing scale-up, risks associated with the successful development and execution of commercial strategies for such products, including FILSPARI, and risks and uncertainties related to the current administration, including but not limited to risks and uncertainties related to tariffs and the funding, staffing and prioritization of resources at government agencies including the FDA. The Company also faces the risk that it will be unable to raise additional funding that may be required to complete development of any or all of its product candidates, including as a result of macroeconomic conditions; risks relating to the Company’s dependence on contractors for clinical drug supply and commercial manufacturing; uncertainties relating to patent protection and exclusivity periods and intellectual property rights of third parties; risks associated with regulatory interactions; and risks and uncertainties relating to competitive products, including current and potential future generic competition with certain of the Company’s products, including potential ANDA filings or patent challenges, and technological changes that may limit demand for the Company’s products. The Company also faces additional risks associated with global and macroeconomic conditions, including health epidemics and pandemics, including risks related to potential disruptions to clinical trials, commercialization activity, supply chain, and manufacturing operations. You are cautioned not to place undue reliance on these forward-looking statements as there are important factors that could cause actual results to differ materially from those in forward-looking statements, many of which are beyond our control. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Investors are referred to the full discussion of risks and uncertainties, including under the heading "Risk Factors", as included in the Company’s most recent Form 10-K, Form 10-Q and other filings with the Securities and Exchange Commission. View source version on businesswire.com: https://www.businesswire.com/news/home/20260804067885/en/ Contacts Investors:[email protected] Media:[email protected]

FDA approval: The FDA granted full approval for FILSPARI in focal segmental glomerulosclerosis (FSGS) — described as the first and only approved medicine for the condition — with a label for reducing proteinuria in patients eight years and older “without active nephrotic syndrome,” prompting strong KOL interest across FSGS subtypes. Commercial momentum: FILSPARI demand reached a record in Q1 with 993 new patient start forms (pre‑FSGS approval) and U.S. net sales of $105.2 million (up ~88% YoY), while management reports >97% payer access and expects faster uptake in FSGS versus the earlier IgA nephropathy launch. Pipeline and finances: Travere restarted enrollment in the phase III HARMONY study of pegtibatinase for classical homocystinuria and targets top-line results in 2H 2027, and the company ended Q1 with about $352 million in cash, marketable securities, and receivables despite a GAAP net loss of $37.1 million (non‑GAAP net income $4.1 million). Interested in Travere Therapeutics, Inc.? Here are five stocks we like better. 3 Under-the-Radar Healthcare Companies Travere Therapeutics (NASDAQ:TVTX) executives highlighted a first-quarter marked by an FDA approval, record demand for FILSPARI in IgA nephropathy, and renewed progress in the company’s late-stage pipeline, according to remarks on the company’s first quarter 2026 financial results call. President and CEO Eric Dube said April 13 “marked a pivotal point” for patients with focal segmental glomerulosclerosis (FSGS) after the FDA granted a full approval for FILSPARI. Dube called it “the first and only approved medicine” for the condition and said the label expansion “meaningfully increases the opportunity ahead” for the company. → Roblox Stock Slides to New Low as Safety Changes Weigh on Outlook Travere Therapeutics Still On The Rise After Encouraging Data Chief Medical Officer Dr. Jula Inrig said FILSPARI was approved “to reduce proteinuria in adults and children eight years and older with FSGS without nephrotic syndrome.” She also spent time clarifying how nephrotic syndrome is assessed in practice and how that relates to eligibility, emphasizing that nephrotic syndrome is “typically defined” by three criteria—proteinuria above 3.5 g/day, low serum albumin, and edema—and that if a patient is missing any one, “they are not considered to have active nephrotic syndrome.” Inrig added that this differs from “nephrotic range proteinuria,” noting that some patients with high proteinuria could still be eligible if other criteria are not present. She also said nephrotic syndrome “is not a chronic state,” and described how patients who initially present with nephrotic syndrome may become eligible after induction therapy. → The Real SpaceX Play: 5 Chip Stocks Powering the IPO Before It Launches Following the FDA action, Inrig said discussions with key opinion leaders reflected “wide enthusiasm” for using FILSPARI “across the types of FSGS, including among secondary and genetic FSGS,” citing a recent CJASN publication that she said demonstrated consistent efficacy and safety in genetic FSGS. Travere reported another record quarter of demand for FILSPARI in IgA nephropathy, with Chief Commercial Officer Peter Heerma reporting 993 new patient start forms (PSFs) in the first quarter. Heerma attributed the performance to continued expansion among new prescribers and increased use within existing accounts, adding that the company is seeing “an increasing number of practices treating multiple IgA nephropathy patients with FILSPARI.” → 3 Emerging Markets ETFs to Maximize Exposure to High-Potential Countries Heerma also said that, as more options become available in IgA nephropathy, FILSPARI “remains the most commonly prescribed medicine approved for IgA nephropathy in the U.S.” He described demand early in the second quarter as strong. In Q&A, the company said it would not provide guidance on the FSGS launch pace or break out PSFs by indication going forward. Dube clarified that the 993 PSFs reported for the first quarter were generated prior to the FSGS approval and therefore reflected IgA nephropathy performance. Asked about patient persistence in IgA nephropathy, Heerma said compliance and persistence have been “very high,” without providing specific rates. Inrig said persistence appears consistent with what was observed in the two-year double-blind PROTECT trial and attributed durability to patients seeing proteinuria improvements and a side effect profile she described as consistent with irbesartan. Inrig added that patients understand FILSPARI should be “truly” long-term therapy “as long as they keep their kidneys.” Heerma said the company expects a faster uptake in FSGS than in IgA nephropathy, citing high unmet need, physician familiarity with FILSPARI from IgA nephropathy, and payer positioning. He said Travere has “over 97% access” and described early feedback from the community as “overwhelmingly positive,” including receiving patient start forms the day after approval and seeing reimbursement approvals within the first week. While the company declined to quantify early FSGS PSFs during the call, Heerma said early experience has “confirm[ed]” expectations of faster uptake and “a higher first pass approval at the payer level than what we saw initially for IgA.” Executives also emphasized physician education, particularly around the label’s “without nephrotic syndrome” language. Heerma said some community nephrologists “may not know yet that FILSPARI was approved,” and that education is needed to explain nephrotic syndrome concepts. Inrig added that the community has been waiting “a long time” for a non-immunosuppressive option and reiterated that “active nephrotic syndrome is not the same as nephrotic range proteinuria.” On questions about whether a history of nephrotic syndrome could limit use, Inrig said the company does not believe it should, emphasizing the label is for patients “without active nephrotic syndrome.” Heerma said payers understand nephrotic syndrome is “a dynamic state” and said the topic has not been a major issue in discussions to date. When asked about treatment sequencing in FSGS, Inrig said most patients are already on an ACE inhibitor or ARB by the time they see a nephrologist—“more than 70%, at least 80%”—and that physicians may also use SGLT2 inhibitors, though she characterized usage as less prevalent due to less robust data in FSGS. She added that, given FILSPARI’s head-to-head positioning versus RAS inhibition, physicians are expected to take patients off a RAS inhibitor and initiate FILSPARI. Travere also highlighted progress in its pipeline with pegtibatinase in classical homocystinuria (HCU). Dube said the company dosed the first new patient in the phase III HARMONY study following a restart of enrollment, and he said the company remains on track to report top-line results in the second half of 2027. Inrig said HARMONY is a randomized, double-blind study comparing pegtibatinase to placebo with a primary endpoint focused on reduction in plasma total homocysteine assessed at 12 weeks, consistent with the timing used in the phase I/II COMPOSE study. She said COMPOSE demonstrated “rapid, sustained, and dose-dependent reductions” in total homocysteine and cited a 67.1% mean relative reduction at 12 weeks at a 2.5 mg/kg twice-weekly dose, along with maintenance below 100 micromoles and generally good tolerability. Chief Research Officer Dr. Bill Rote said pegtibatinase has breakthrough therapy designation, enabling frequent FDA interaction, and that Travere aligned with the agency on the HARMONY endpoint through a “collaborative discussion.” He added there has been no need to revisit endpoints since alignment was reached. Chief Financial Officer Chris Cline reported $124.5 million in total U.S. net product sales for the first quarter, with FILSPARI U.S. net product sales of $105.2 million, up about 88% year-over-year. Cline said results were achieved despite typical beginning-of-year gross-to-net dynamics and “one fewer shipping week than usual,” which he said would shift some revenue recognition into the second quarter. THIOLA and THIOLA EC contributed $19.3 million in U.S. net product sales, and Travere recognized $2.7 million in license and collaboration revenue, bringing total revenue to $127.2 million. Operating expenses increased year-over-year, with R&D expense of $57.1 million (non-GAAP adjusted $51.5 million), which Cline said was driven primarily by the restart of enrollment in HARMONY. SG&A expense rose to $80.3 million (non-GAAP adjusted $69.3 million), which he attributed primarily to investments ahead of the FILSPARI launch in FSGS and continued investments in IgA nephropathy. Travere also revised its presentation of amortization associated with royalty and milestone payments into a separate royalty expense line item. Royalty expense was $24.8 million, up from $12.4 million in the year-ago quarter, which Cline said was mainly due to the THIOLA intangible asset reaching the end of its accounting useful life and increased capitalized FILSPARI royalties. The company posted a GAAP net loss of $37.1 million, or $0.40 per basic share, compared with a net loss of $41.2 million, or $0.47 per basic share, in the first quarter of 2025. On a non-GAAP adjusted basis, Travere reported net income of $4.1 million, or $0.05 per basic share, versus a non-GAAP adjusted net loss of $16.9 million, or $0.19 per basic share, a year earlier. As of March 31, 2026, Travere had approximately $352 million in cash equivalents, marketable securities, and receivables. Cline noted receivables included a $25 million sales-based milestone payment from Mirum Pharmaceuticals that was recognized in the fourth quarter of 2025 and received in April. He said the company is “well-positioned to fund” operations with existing resources. Travere Therapeutics, Inc (NASDAQ: TVTX) is a biopharmaceutical company headquartered in San Diego, California, dedicated to the development and commercialization of therapies for rare kidney and genetic disorders. The company's mission is to address unmet needs in conditions with limited treatment options by focusing on diseases that affect small patient populations. Travere combines research, development and commercial capabilities to bring innovative medicines to market. The company's lead product is sparsentan, a dual endothelin angiotensin receptor antagonist that has received accelerated approval from the U.S. The article "Travere Therapeutics Q1 Earnings Call Highlights" was originally published by MarketBeat.