Travere Therapeutics Q2 2025 Earnings Report

Travere Therapeutics EPS Results

• Actual EPS: -$0.14
• Consensus EPS: -$0.28
• Beat/Miss: Beat by +$0.14
• One Year Ago EPS: -$0.65

Travere Therapeutics Revenue Results

• Actual Revenue: $94.84 million
• Expected Revenue: $100.18 million
• Beat/Miss: Missed by -$5.33 million
• YoY Revenue Growth: +111.50%

Travere Therapeutics Announcement Details

• Quarter: Q2 2025
• Date: 8/6/2025
• Time: After Market Closes
• Conference Call Date: Wednesday, August 6, 2025
• Conference Call Time: 4:30PM ET

Travere Therapeutics (NASDAQ:TVTX), a biopharmaceutical company, identifies, develops, and delivers therapies to people living with rare kidney and metabolic diseases. Its products include FILSPARI (sparsentan), a once-daily, oral medication designed to target two critical pathways in the disease progression of IgA Nephropathy (endothelin 1 and angiotensin-II); and Thiola and Thiola EC (tiopronin tablets) for the treatment of cystinuria, a rare genetic cystine transport disorder that causes high cystine levels in the urine and the formation of recurring kidney stones. The company's clinical-stage programs consist of Sparsentan, a novel investigational product candidate, which has been granted Orphan Drug Designation for the treatment of focal segmental glomerulosclerosis in the U.S. and Europe; and Pegtibatinase (TVT-058), a novel investigational human enzyme replacement candidate being evaluated for the treatment of classical homocystinuria. It has a cooperative research and development agreement with National Institutes of Health's National Center for Advancing Translational Sciences and Alagille Syndrome Alliance for the identification of potential small molecule therapeutics for Alagille syndrome. The company was formerly known as Retrophin, Inc. and changed its name to Travere Therapeutics, Inc. in November 2020. Travere Therapeutics, Inc. was incorporated in 2008 and is headquartered in San Diego, California.

Travere Therapeutics Q2 2025 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: In Q2 FILSPARI net product sales hit $71.9 million in the U.S., marking an ~82% year-over-year increase driven by a broadening prescriber base and high therapy persistence.
• Positive Sentiment: The sNDA for FSGS was accepted with a PDUFA date of January 13, 2026, potentially positioning FILSPARI as the first approved therapy for this underserved rare kidney disease.
• Positive Sentiment: FDA review is underway for REMS modifications on FILSPARI with an August 28, 2025 PDUFA date, aiming to reduce liver monitoring to quarterly and remove pregnancy testing requirements.
• Negative Sentiment: THIOLA and THIOLA EC sales of $23 million in Q2 face anticipated generic competition in the coming quarters, which may pressure future revenue.
• Neutral Sentiment: The Phase III HARMONY trial for pegvatinib in classical homocystinuria is set to resume enrollment next year after successful manufacturing scale-up.

Presentation

[Operator]

Good afternoon, and welcome to the Traveer Therapeutics Second Quarter twenty twenty five Financial Results Conference Call. Today's call is being recorded. At this time, I would like to turn the conference over to Nivi Nera, Vice President, Corporate Communications and Investor Relations. Please go ahead, Nivi.

[Nivi Nehra, VP - Corporate Communications at Travere Therapeutics]

Thank you, operator. Good afternoon, and welcome to Trivia Therapeutics' Second Quarter twenty twenty five Financial Results and Corporate Update Call. Thank you all for joining. Today's call will be led by Doctor. Eric Dube, our President and Chief Executive Officer.

[Nivi Nehra, VP - Corporate Communications at Travere Therapeutics]

Eric will be joined in the prepared remarks by Doctor. Jula Enrigg, our Chief Medical Officer Peter Hirma, our Chief Commercial Officer and Chris Klein, our Chief Financial Officer. Doctor Bill Roat, our chief research officer, join us for the q and 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.

[Nivi Nehra, VP - Corporate Communications at Travere Therapeutics]

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 ks filed with the SEC. In addition, any forward looking statements represent our views only as of the date such statements are made, 08/06/2025. Interviewer specifically disclaims any obligation to update such statements to reflect future information, events or circumstances. With that, let me now turn the call over to Eric.

[Eric Dube, President & CEO at Travere Therapeutics]

Thank you, Nivi. Good afternoon, and thank you all for joining us. The 2025 was a standout for Trevere, a reflection of strong strategic execution and continued momentum in delivering against our mission. At the heart of this progress is Filspari, where we are advancing our leadership in rare kidney disease by deepening our impact in IgA nephropathy and laying the foundation for potential expansion into FSGS. In IGAN, we delivered our strongest commercial quarter to date with continued demand driven by both new and repeat prescribers.

[Eric Dube, President & CEO at Travere Therapeutics]

As the IGAN treatment landscape evolves, physicians are increasingly adopting CILspari as foundational care, recognizing the meaningful and consistent outcomes it delivers and doing so earlier in the disease process. This growing confidence reflects our ongoing strategy to establish Vulsarpari as the new foundational therapy for IgA nephropathy. There are several pillars to this strategy that we expect to be further solidified through year end. First, the continued generation of robust clinical evidence to support the use of ZILSPARI across a broad range of patients and in combination with other classes of medicines. Second, broad access aligned with the full approval indication statement, payer coverage, and an expected modification of the liver monitoring REMS and removal of the pregnancy testing REMS.

[Eric Dube, President & CEO at Travere Therapeutics]

And finally, the continued real world clinical experience and growing recommendation by nephrologists and treatment guidelines that recognize Tulspari's ability to reduce proteinuria and reinforce the benefits of getting patients to complete remission. I am pleased with the tremendous progress that our team has made to date, which sets us up for sustained growth in an expanding IGAM market. Our performance in Q2 reflects the strength of this positioning and the growing use of VILSPARI as a foundational nephroprotective treatment in IGAM even as new treatments enter the market. While it's still early days in the evolving IGAM treatment landscape, VILSPARI's performance is directly aligned with the expectations that we have set over the last few years and validation of its path to foundational use. Jill and Peter will review the progress of our strategy in greater detail.

[Eric Dube, President & CEO at Travere Therapeutics]

We've also seen strong progress outside of The U. S. By our partners, CSL Vifor and Rinalis, as they look to expand access to Filspari internationally. We've entered the second half of the year from a position of strength, and we're ready to build on this momentum. The sNDA review process for a potential second indication for Fulspari and FSGS is advancing as expected.

[Eric Dube, President & CEO at Travere Therapeutics]

We're preparing for what could be an extraordinary milestone for Trevyr and the FSGS community. If approved, VILSPARI would become the first ever treatment approved for this underserved patient community, a breakthrough for patients and a near and long term growth opportunity for our company, given that there are no other FSGS therapies likely to be available in the near future. Beyond FILSPARI, we continue to advance our pipeline with a drive to transform paradigms in rare diseases like classical homocystinuria, and we remain on track to reinitiate enrollment in the HARMONY study for pegvatinib next year. With a robust and growing foundation in IGAN, the potential to be the first approved medicine in FSGS and a pipeline built for continued innovation, we remain confident in the road ahead. I will now hand the call over to Jula for an update on our clinical programs. Jula?

[Jula Inrig, CMO at Travere Therapeutics]

Thank you, Eric. As a nephrologist, it's incredibly rewarding to witness the continued innovation in IgA nephropathy, a disease where not long ago patients had very few options. We are expanding the body of evidence that supports the foundational role of Cilsparri across a broad spectrum of IgA nephropathy patients at risk of disease progression, ranging from those who are newly diagnosed to those with recurrent disease post transplant. VILSPARI's unique ability to target two pathways causing kidney injury, endothelin one and angiotensin two, provides patients with IgA nephropathy a non immunosuppressive treatment option to help preserve kidney function. We were pleased to engage with the medical and patient community at several recent congresses where we presented important new data that continue to reinforce the nephroprotective effects, strong safety profile, and emerging disease modifying potential of Vilspari.

[Jula Inrig, CMO at Travere Therapeutics]

Select data at these congresses include in the phase two SPARTAN trial, when used first line in treatment naive IgA nephropathy patients, VILSPARI treated patients achieved an approximately seventy percent proteinuria reduction, with nearly sixty percent of the patients in the study reaching complete proteinuria remission and stable eGFR through twenty four weeks. Also in the SPARTAN study, an analysis of patient samples showed that Filspari treated patients with IgA nephropathy demonstrated rapid and sustained reductions in urinary B cell activating factor, or BAF, and complement factor C5b-nine, as well as reductions in pro inflammatory and pro fibrotic biomarkers. When taken in combination with our preclinical data showing Vilspari protects from mesangial deposition of IgA, these data suggest a potential role of optimal dual inhibition of endothelin one and angiotensin two as modifying the underlying disease. In the phase three PROTECT open label extension that is ongoing, patients transitioning from maximally titrated irbesartan to Filspari after the double blind period also achieved approximately 50% reductions in proteinuria and a relatively stable eGFR up to one year. Together with the kidney function preservation Filspari provides, these new data further reinforce VILSPARI's disease modifying potential in IgA nephropathy without immunosuppression.

[Jula Inrig, CMO at Travere Therapeutics]

As the IGAN treatment paradigm evolves, we expect combination therapy to become the new standard to help more patients reach complete proteinuria remission, which is recognized as a treatment goal in the draft update to the QDIGO guidelines. Vilspari remains uniquely positioned as the only medicine to replace RAAS inhibitors as a more effective foundational therapy in IgA nephropathy with a profile that is complementary to the emerging therapeutic classes. We are also approaching the August 28 PDUFA date for the removal of the embryo fetal toxicity REMS and the potential modification of the liver monitoring REMS to quarterly. With no cases of Hy's law to date, we remain confident in the safety profile of VILSPARI to support this change. Turning to FSGS.

[Jula Inrig, CMO at Travere Therapeutics]

Our sNDA seeking full approval of FILSPARI in FSGS was accepted by the FDA with a PDUFA date of 01/13/2026. As a reminder, the work by the independent Parasol Group established proteinuria as a valid surrogate endpoint for kidney failure in FSGS and helped pave the way for regulatory consideration of proteinuria reduction for full approval. The sNDA review process is advancing as expected, and we're preparing for an advisory committee to discuss VILSPARI as the first potential approved medicine for FSGS. Our team is actively preparing to present the strong data from DUPLEX and DUET in the context of the independent Parasol findings. For example, earlier this quarter, we presented new analysis from the DUPLEX study that confirmed the Parasol findings.

[Jula Inrig, CMO at Travere Therapeutics]

In DUPLEX, significantly more Vilspari treated patients achieved either partial or complete remission compared to irbesartan. Importantly, those patients who achieved partial or complete proteinuria remission in the study, irrespective of treatment arm, had a sixty seven percent to seventy seven percent lower risk of kidney failure, respectively. These data represent the first trial level evidence in support of the independent parasol analyses of proteinuria as a validated surrogate endpoint in FSGS. Lastly, on our HCU program, we continue to be excited about the potential of our investigational enzyme replacement therapy pegged to battenase. We have made strong progress on our manufacturing scale up to support our Phase III trial and a future commercial launch and are on track towards restarting patient enrollment in the Phase III HARMONY study next year.

[Jula Inrig, CMO at Travere Therapeutics]

I'll now turn the call over to Peter for a commercial update. Peter?

[Peter Heerma, CCO at Travere Therapeutics]

Thank you, Juha. I'm pleased to report that our commercial team executed exceptionally well in Q2 as demonstrated by our strong performance metrics. TULSPARI net product sales reached approximately $72,000,000 in The U. S. In the second quarter, representing significant year over year growth.

[Peter Heerma, CCO at Travere Therapeutics]

This performance was driven by strong demand, expansion and deepening of prescriber base as well as further efficiencies in our fulfillment process and solid therapy compliance and persistence. As the only fully approved non immunosuppressive kidney targeted therapy for IgA nephropathy, Filspiry remains uniquely positioned to replace the historical standard of care in this evolving treatment landscape. The growing recognition of Vilsparri's nephroprotective profile, not just from returning prescribers, but also from nephrologists who are newer to the brand resulted in seven forty five new patient start forms this quarter, approximately forty three percent increase compared to the same period last year. At the time when new treatment options are emerging for IgA nephropathy, feedback from our field teams and recent market research emphasize physician confidence in Filspiri's established position in clinical practice. Nephrologists regularly cite Filspiri's consistent, rapid and sustained proteinuria efficacy with long term kidney preservation benefits, a safety profile that allows for chronic use and a patient friendly once daily oral administration that optimally inhibits two critical kidney damaging pathways as key reasons for making FILSPARI their foundational therapeutic option.

[Peter Heerma, CCO at Travere Therapeutics]

Importantly, many physicians are choosing FILSPARI earlier in the treatment journey. This reflects a growing emphasis on earlier intervention and a shift away from legacy approaches, such as the off label use of RAS inhibitors or steroids. Based on our research, about seventy percent of the addressable patients with IgA nephropathy have elevated proteinuria levels below 1.5 gram per gram. With the proteinuria threshold being removed in the filspari label at full approval, FILSPIRI is particularly well positioned in this large patient segment, allowing for sustainable demand potential. As we look to the remainder of the year, as with any rare disease product, seasonality could drive some variability quarter over quarter, as we expect that we will continue to identify new prescribers and that the use of VILSPARI will further deepen as foundational care amongst current prescribers.

[Peter Heerma, CCO at Travere Therapeutics]

We believe this will be driven by continued positive experience consistent with Tilspari's superior clinical profile relative to historical standard of care And also driven by the anticipated final PDEO guideline publication and the potential REMS modifications, which may further simplify access for patients. Turning to FSGS, if approved, Tilspari would become the first approved therapy for FSGS, a progressive and often debilitating rare kidney disease with a significant unmet need. Given the feedback from nephrologists and the broader FSGS community, we believe FSGS could be an even bigger opportunity with a more rapid uptake versus what we have experienced with our launch in IgA nephropathy. We are actively expanding and preparing our commercial organization to be ready to serve this patient community beginning at potential approval early next year. In summary, Q2 was another quarter of strong execution and meaningful growth for Pilspari amidst the evolving IgA nephropathy treatment landscape.

[Peter Heerma, CCO at Travere Therapeutics]

We remain confident in our strategy and are encouraged by the feedback from the medical community and the continued momentum in U. S. Adoption. With a growing body of clinical and real world evidence, expanding prescriber engagement and the potential to serve more rare kidney disease patients through future label expansions, Tulspari is well positioned to continue its leadership as foundational treatment. Let me now turn the call over to Chris for the financial update. Chris?

[Chris Cline, CFO at Travere Therapeutics]

Thank you, Peter, and good afternoon all. Our financial foundation continues to strengthen. In the second quarter, net product sales grew approximately 82% over the same period last year, and we continue to make disciplined investments in areas of high growth, such as in building further momentum for Filspari and IgA nephropathy, preparing our organization for a potential launch of Filspari and FSGS, and advancing manufacturing to restart enrollment in the pivotal pectivatinib study. Beginning with revenue, in the second quarter, we generated US net product sales of $94,800,000 As Peter highlighted, FILSPARI continued to grow significantly in the second quarter, generating $71,900,000 in U. S.

[Chris Cline, CFO at Travere Therapeutics]

Net product sales. THIOLA and THIOLA EC contributed $23,000,000 in net product sales for the second quarter, and these medicines continue to be a meaningful option for patients living with cystinuria. But as we've highlighted previously, we anticipate more generic competition in the coming quarters. During the second quarter, we also recognized $19,600,000 of licensing collaboration revenue, which results in total revenue of $114,400,000 Included in the licensing collaboration revenue line this quarter is the previously announced onetime $17,500,000 milestone payment from CSLB4, which resulted from the conversion of conditional approval of Vosparri to full approval in Europe earlier this year. Turning to operating expenses.

[Chris Cline, CFO at Travere Therapeutics]

Our research and development expenses for the 2025 were $49,400,000 compared to $54,300,000 for the same period in 2024. The decrease in R and D is largely attributable to reduced clinical activity in the Phase III HARMONY study while we optimize our manufacturing efforts. On a non GAAP adjusted basis, R and D expenses were $45,400,000 compared to $50,600,000 for the same period in 2024. Selling, general and administrative expenses for the second quarter were $76,200,000 compared to $64,800,000 for the same period in 2024. The increase in SG and A is largely attributable to increased amortization expense related to Filsparia royalties as well as increased investment to support the ongoing launch of FILSPARIA NIGEAN to property following full approval and preparing for a potential FSGS launch in January.

[Chris Cline, CFO at Travere Therapeutics]

On a non GAAP adjusted basis, SG and A expenses were $55,500,000 for the second quarter compared to $48,300,000 for the same period in 2024. Total other expense net for the 2025 was immaterial compared to net expense of $1,900,000 in the same period in 2024. Net loss for the 2025 was $12,800,000 or $0.14 per basic share compared to $70,400,000 or $0.91 per basic share for the same period in 2024. On non GAAP adjusted basis, net income for the 2025 was $11,900,000 or $0.13 per basic share compared to a net loss of $50,100,000 or $0.65 per basic share for the same period in 2024. As of 06/30/2025, we had cash, cash equivalents, and marketable securities totaling approximately $319,500,000.

[Chris Cline, CFO at Travere Therapeutics]

As I highlighted earlier, this cash balance reflects the net proceeds of the $17,500,000 payment we received from CSLV for during the quarter, and we remain on track to potentially achieve additional milestone payments tied to key market access achievements later this year and sales based achievements in the future, which should further enhance our financial flexibility. Looking ahead, we expect continued revenue growth driven by robust underlying demand for TYLSPARIA and IgA nephropathy. With a strong balance sheet and potential additional incoming milestone payments as well as a disciplined approach to our investing in our key growth drivers, we are well positioned to execute on our strategy and deliver sustainable value over both the near and the long term. I'll now turn the call back over to Eric for his closing comments. Eric?

[Eric Dube, President & CEO at Travere Therapeutics]

Thank you, Chris. As you've heard, our team has delivered strong performance across our priorities for the 2025. We are well positioned and eager to continue this momentum. My team and I are deeply motivated to support the rare disease communities we serve. Recently, I had the honor of attending the Annual Spark Patient Meeting of the IgA Nephropathy Foundation.

[Eric Dube, President & CEO at Travere Therapeutics]

At the meeting, I heard many stories of resilience and of hope. This community has been advanced, advocating and hoping for a future with therapies developed for them that can stave off kidney failure. We are proud to be part of this journey, and we are committed to the same goal for the FSGS and HCU communities. Now let me turn the call over to Nivi for Q and A. Nivi?

[Nivi Nehra, VP - Corporate Communications at Travere Therapeutics]

Thank you, Eric. Operator, we can now open up the line for Q and A.

[Operator]

Thank you. We will now begin the question and answer session. You. We will now take the first question from the line of Joseph Schwartz from Leerink Partners. Your line is open.

[Will Soghikian, Equity Analyst at Leerink Partners]

This is Will on for Joe. Thanks for taking our question and congrats on the strong progress this quarter. So one for FSGS. As you prepare for the AdCom, what do you anticipate the major topics could be, and how do you plan to respond to the FDA's inquiries here? Do have a sense for who might be on the panel itself?

[Will Soghikian, Equity Analyst at Leerink Partners]

And given this group of experts will likely include nephrologists and cardiologists, how do you plan to effectively message your case to these two different groups of physicians? Thank you.

[Eric Dube, President & CEO at Travere Therapeutics]

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

[Jula Inrig, CMO at Travere Therapeutics]

Thanks for the question. So good point. Anytime a rare disease goes before an advisory committee, there's certainly an educational component that we need to do about the disease and the pathophysiologist pathophysiology. Importantly, there's both nephrologists and cardiologists part of the panel, and they all know that proteinuria is harmful. And they know the importance of blocking both the RAS system and endothelin one to reduce cardiovascular and renal outcomes.

[Jula Inrig, CMO at Travere Therapeutics]

So we certainly are prepared to educate the mix of panelists, I think importantly, about the biologic plausibility supporting proteinuria as a validated endpoint, why eGFR is challenging in FSGS, and then followed by the strong clinical data showing sparsentan meaningfully and significantly reduced proteinuria compared to an active comparator.

[Will Soghikian, Equity Analyst at Leerink Partners]

Thank you so much.

[Eric Dube, President & CEO at Travere Therapeutics]

Thanks, Paul.

[Operator]

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

[Anupam Rama, Executive Director - Biotechnology Equity Research at JP Morgan]

Hey, guys. Thanks for taking the question. Just wondering if you could comment a little bit on sort of the cadence and level of engagement you've had with the agency heading into the REMS update for Filspari, just kind of given the evolving landscape and what we've seen from a regulatory perspective in other cases in the sector? Thanks so much.

[Eric Dube, President & CEO at Travere Therapeutics]

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

[William Rote, Chief Research Officer at Travere Therapeutics]

Yeah. Certainly. You know, the what we've seen is basically through the lens of two sNDAs, both with the sNDA for the modification of the REMS frequency and the removal of the embryo fetal toxicity REMs as well as the sNDA for FSGS, our interactions, have been progressing as we'd expect. And those, the back and forth has been very similar to what we experienced just last year with the NDA for full approval in IgA nephropathy. The frequency of interaction, the types of questions, it it feels just the same.

[William Rote, Chief Research Officer at Travere Therapeutics]

So we certainly see on in our part, a very engaged and and active review review team.

[Anupam Rama, Executive Director - Biotechnology Equity Research at JP Morgan]

Thanks so much for taking the question.

[Eric Dube, President & CEO at Travere Therapeutics]

Thank you.

[Operator]

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

[Laura Chico, MD - Equity Research at Wedbush Securities]

Good afternoon. Thank you very much for taking the question. Another regulatory question, if I might be able to. I'm kind of curious, at what point would you gain insight into the timing of the advisory committee panel meeting? It sounded from the prior comments that the interactions are occurring on a regular cadence as would be anticipated, but we detected another possible shift in seed receiver headcount.

[Laura Chico, MD - Equity Research at Wedbush Securities]

So just trying to understand, is there any expected timeline that you would receive notice for the advisory committee meeting? Thank you.

[Eric Dube, President & CEO at Travere Therapeutics]

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

[William Rote, Chief Research Officer at Travere Therapeutics]

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

[Laura Chico, MD - Equity Research at Wedbush Securities]

Thanks very much.

[Eric Dube, President & CEO at Travere Therapeutics]

Thank you.

[Operator]

Next question is from Tyler Van Buren from TD Securities. Your line is open.

[Frances Dovell, Biotech Equity Research Associate at TD Cowen]

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

[Eric Dube, President & CEO at Travere Therapeutics]

Okay. Thanks, Bill. Another one for you.

[William Rote, Chief Research Officer at Travere Therapeutics]

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

[Eric Dube, President & CEO at Travere Therapeutics]

Thank you, Francis. Next question?

[Operator]

Next is from Vamil Divan from Guggenheim Securities. Your line is open.

[Arseniy Shabashvili, Vice President at Guggenheim Partners]

Hi. This is Arseny on for Vamil. Thank you for taking our question and congrats on a great quarter. You presented new data from the Spartacus and Spartan studies at recent conferences. How are these data being received by the college community, and do you anticipate further real world evidence of biomarker data to support ZILSPIRE's positioning as a disease modifying therapy?

[Eric Dube, President & CEO at Travere Therapeutics]

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

[Jula Inrig, CMO at Travere Therapeutics]

Yeah. It's been received very positively. There's a lot of excitement about the data that we're generating, both, as you mentioned, in combination with SGLT2 inhibitors, that it's safe and we have good efficacy when used in combination. And then to your point around the SPARTAN study, we've been increasingly showing data showing the effect of Filspari on reducing disease modifying biomarkers such as soluble CD163, which we released last year. And then, as I mentioned on the call, additional data of reducing inflammation, B cell activation, and complement activation.

[Jula Inrig, CMO at Travere Therapeutics]

And so people are now starting to think that VILSPARI works directly within the kidney on reducing the inflammation in the kidney, and that is part of the role for why it's nephroprotective over the long term. And then your second part was additional data. We certainly want to validate this. We have a large Phase III study from which we have biomarkers that we can confirm and validate this, and we plan to present that data in future congresses.

[Arseniy Shabashvili, Vice President at Guggenheim Partners]

Thank you.

[Eric Dube, President & CEO at Travere Therapeutics]

Thank you.

[Operator]

Next question is from Maury Raycroft from Jefferies. Your line is open.

[Farzin Haque, SVP & Biotechnology Equity Research Analyst at Jefferies Financial Group]

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

[Eric Dube, President & CEO at Travere Therapeutics]

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

[Peter Heerma, CCO at Travere Therapeutics]

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

[Farzin Haque, SVP & Biotechnology Equity Research Analyst at Jefferies Financial Group]

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

[Eric Dube, President & CEO at Travere Therapeutics]

Yes. So the persistence rate continues to be very high. There's been no change in what we've seen. And I think Peter mentioned in his prepared comments, really, all of the fundamentals that we look at, particularly as lead indicators of performance moving forward for the rest of the year, all remain very strong. So it really is the underlying performance.

[Eric Dube, President & CEO at Travere Therapeutics]

And as you would imagine, over time, much of the volume becomes continuing patients and growth from adding new patients. That's precisely the dynamic that we're seeing, and we expect that to be sustainable for the foreseeable future.

[Operator]

Next is from Yigal Nochomovitz from Citigroup. Your line is open.

[Yigal Nochomovitz, Director at Citigroup]

Yes. Hi. Thank you. I had a question on FSGS. As you may know, there was a paper published in, October 2024.

[Yigal Nochomovitz, Director at Citigroup]

It was called Proteinuria as an Endpoint in Clinical Trials for FSGS. And they make a very specific point in there, with respect to the reference to a sustained CR. And I'm just wondering if you could comment as to your understanding of what that means and whether it's associated with any particular time point or not. I know that in the study you obviously had a 2.5 times better CR response rate versus iversartan in the double blind period. I'm just wondering if that is consistent with the definition of sustained CR or sustained CR refers to a specific point in time as opposed to over the entire course of the trial. Thanks.

[Eric Dube, President & CEO at Travere Therapeutics]

Thanks for the question. Juha, I'll turn that over to you.

[Jula Inrig, CMO at Travere Therapeutics]

Yeah. Thanks for the question. I was part of that manuscript, so happy to answer it. So complete remission can occur at one point in time, or it can be durable. And when there's not a we didn't define exactly what that meant.

[Jula Inrig, CMO at Travere Therapeutics]

But I can tell you when we look at the Duplex data, and you you mentioned the two and a half times greater rate of complete remission, what we commented, at least within the Duplex manuscript in the New England Journal, is that eighty five percent of those patients stayed below their baseline rates of proteinuria, so had some level of durability of complete remission response. We did look at it at any point in time during our DUPLEX trial data. We haven't specifically elucidated others other than what we have published to date. If there's additional questions around durability, there's lots of ways in which you can define that. Our focus is on what the FDA wants, and so that's what we've given to them.

[Jula Inrig, CMO at Travere Therapeutics]

And any questions that they have around additional ways in which we can analyze the data, we certainly can respond to them around that.

[Eric Dube, President & CEO at Travere Therapeutics]

Yeah. Maybe just two additional things that I'll add. Yigal. Sorry. Sorry, Yigal.

[Eric Dube, President & CEO at Travere Therapeutics]

Anything you wanted to clarify before I add something else?

[Yigal Nochomovitz, Director at Citigroup]

No.

[Yigal Nochomovitz, Director at Citigroup]

I was just saying that was super super helpful answer. Thanks. Yeah.

[Eric Dube, President & CEO at Travere Therapeutics]

That's great. And while this isn't specific to to complete remission, if you look at our corporate deck, slide 31, you'll see that the patients that were able to get to FPRE, which was the prespecified endpoint within our trial, that is sustained whether you look at it nine months or two years, and and the treatment effect continues to be consistent and significant. So I think, you know, in the ways that we've looked at, as Julie Julie has talked about it, you have a reduction in proteinuria that is rapid, that is sustained, and that is consistent. The other thing that I'll point out about that publication, which was really informative, it occurred before Parasol. And what's important is to make sure that we recognize that the analyses and conclusions from Parasol are the largest they reflect the largest analysis of registry data from from within FSGS.

[Eric Dube, President & CEO at Travere Therapeutics]

So it's certainly consistent and informative, but it's really important to keep in mind that, you know, the thresholds that were put forth in PARISOL represent a very robust dataset.

[Yigal Nochomovitz, Director at Citigroup]

Got it. Thank you.

[Eric Dube, President & CEO at Travere Therapeutics]

Thank you.

[Operator]

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

[Mohit Bansal, Managing Director at Wells Fargo Securities]

Great. Thank you very much for taking my question and congrats on all the progress. I would like to understand, I mean, you have a good cadence of patient start forms here. Can you comment on what is the conversion rate of those forms to number of patients that are on the drug? And how would you characterize where where are you in terms of the penetration in this market?

[Mohit Bansal, Managing Director at Wells Fargo Securities]

And how do you see it evolving now with the more more competition, but at the same time more awareness with that competition? Thank you.

[Eric Dube, President & CEO at Travere Therapeutics]

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

[Peter Heerma, CCO at Travere Therapeutics]

Yeah. Let me start thanks, Mohit, for that question. Let me start with the last part on like the evolution of the market and how we see that. I think the market that we have spoken about in the past, especially after our full approval, we anticipate that the market potential is about seventy thousand addressable patients for filspari in The U. S.

[Peter Heerma, CCO at Travere Therapeutics]

And about seventy percent of those patients are have elevated proteinuria levels, but below 1.5 gram per gram. So if you talk about penetration, it really depends on like what segment are you talking about. Are you talking about the segment 1.5 or greater? Or are you talking about the full market potential? And after our full approval and no longer proteinuria threshold in our label, we have no access to the broader market.

[Peter Heerma, CCO at Travere Therapeutics]

And I think that's really where the opportunity reside and will continue to reside as well. And in that context, I'm really happy with the progress that we are making that we are seeing also. And I mentioned that in the last early store as well, the median proteinuria level by patient start form is moving to the left. And what I mean was that it's now below 1.5, and it continues to trend in that same direction. So I think we are entering a market segment where most of the potential is, and that allows for sustainable growth as well.

[Peter Heerma, CCO at Travere Therapeutics]

So that's how we see the market evolving as well as the penetration component. With regards to conversion, I think, based on my experience in rare disease as well as what I've seen from rare disease benchmarks, I would say that we are at the top end best practice on conversion what you would expect in rare disease.

[Eric Dube, President & CEO at Travere Therapeutics]

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

[Mohit Bansal, Managing Director at Wells Fargo Securities]

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

[Eric Dube, President & CEO at Travere Therapeutics]

Yeah. Well, we've not provided guidance. So I just wanna be I wanna be cautious of of of not doing that. But I will reflect on what Peter has talked about in the last two, quarters, which is that the new baseline for new patient, start forms is is around 700. We clearly, you know, achieved, exceeded that in this first quarter of having a direct competitor, you know, and growing treatment options within this space.

[Eric Dube, President & CEO at Travere Therapeutics]

We expect this opportunity to continue, and Peter can certainly talk more about the dynamics that we expect with a new treatment option within the endothelin class. Peter?

[Peter Heerma, CCO at Travere Therapeutics]

Yeah. I think, Derek, just to put an explanation point on some of the points that you made. I think, Mohit, within the evolving treatment paradigm, we delivered our strongest quarter to date, both from a demand perspective as well as from a revenue perspective. And even though it's early days since we saw some of those new entrants coming to the market, everything we have seen so far is consistent to our expectations. And new classes, new therapies coming to the market, one, further reinforces urgency to treat those patients earlier and more aggressively and two, it also grows the endothelin market.

[Peter Heerma, CCO at Travere Therapeutics]

But I think the market is big enough to Eric's earlier point. Other products will be used. But given the strong profile of TULSPARI and the recognized profile in the long term data that we have, I'm confident that we will remain the market leader.

[Mohit Bansal, Managing Director at Wells Fargo Securities]

Got it. Helpful and congrats again. Thank you.

[Eric Dube, President & CEO at Travere Therapeutics]

Thank you.

[Operator]

Our next question comes from the line of Prahar Agrawal from Cantor. Your line is open.

[Prakhar Agrawal, Managing Director at Cantor Fitzgerald]

Hi. Thank you for taking my questions and congrats on the quarter. So another on FSGS. In the Phase III, I know you have disclosed eGFR at the end of the trial, but we have not seen the eGFR curves in FSGS. So maybe even qualitatively, could you comment on what to expect when the curves will be presented during the or could be presented during the AdCom?

[Prakhar Agrawal, Managing Director at Cantor Fitzgerald]

And the latest thinking on what the FDA would like to see on EGFR here? And secondly, on IGAN, if you could comment on the gross to net trends you saw in 2Q and expectations for rest of the year? Thank you.

[Eric Dube, President & CEO at Travere Therapeutics]

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

[Jula Inrig, CMO at Travere Therapeutics]

Yeah. Certainly. With the parasol analysis and recommendation and the move to focus on proteinuria as a surrogate endpoint for full approval in FSGS, we haven't spent much time publish publishing our eGFR data, and I don't anticipate that to be a large focus of our advisory committee. Of course, we certainly can show the curve. It's consistent with what you would anticipate.

[Jula Inrig, CMO at Travere Therapeutics]

We had a washout of, RAF inhibitors for two weeks, and then we initiated the two two therapies, sparsentan and irbesartan. We had an acute decline in eGFR, and then, it's relatively stable thereafter. You have some decline, as you can see, by absolute change over time, but nothing surprising if we show our eGFR curves. It just hasn't been our focus because we're moving to proteinuria, which is a better surrogate with less variability for predicting avoidance of kidney failure. So that's been our focus.

[Chris Cline, CFO at Travere Therapeutics]

In regards to the question mention

[Eric Dube, President & CEO at Travere Therapeutics]

f FDA has not, requested eGFR as part of our type c meeting. So, again, I think, you know, it's not just reflective of what we've interpreted from Parasol, but, specifically, you know, the area of focus from our type c meeting that we've discussed previously. Sorry, Chris. Go ahead.

[Chris Cline, CFO at Travere Therapeutics]

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

[Prakhar Agrawal, Managing Director at Cantor Fitzgerald]

Thank you.

[Eric Dube, President & CEO at Travere Therapeutics]

Thank you.

[Operator]

Next is Jason Zamansky from Bank of America. Your line is open.

[Jason Zemansky, VP - Equity Research, Biotechnology & Pharmaceuticals at Bank of America Merrill Lynch]

Good afternoon. Thanks for taking our question, and and congrats on the progress. Maybe at this point in the launch, do you have a greater sense of where the headwinds or bottlenecks are in terms of uptakes, whether it's on the prescriber side or patient payer logistical or administrative? Just trying to get a sense of what some of the potential near term levers are. And then maybe just as a quick follow-up to one of your earlier comments regarding these new segments of the market.

[Jason Zemansky, VP - Equity Research, Biotechnology & Pharmaceuticals at Bank of America Merrill Lynch]

But is there a meaningful or measurable difference in the use of drug between these new patients who may be a little bit healthier or not as advanced? Thanks.

[Eric Dube, President & CEO at Travere Therapeutics]

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

[Peter Heerma, CCO at Travere Therapeutics]

Yeah. Thanks, Jason, for, for that question. With regards to your first question on potential bottlenecks, I think most of all, I'm really pleased with the progress that we are making. But if I have to think of when I think about, like, our launch in the last two and a half years, I think the main, issue we had to overcome was the urgency to treat and change treatment for those patients. And what really will help is more treatment options coming to the market together with the GDUFA guideline to reinforce that same message that patients should be recognized and treated more aggressively early on, I think it's it's it's gonna help to further develop this market.

[Peter Heerma, CCO at Travere Therapeutics]

I think this is really a marketing development. On your second question with regards to, like, the new pacing segment like the lower proteinuria, still elevated proteinuria levels, but lower than 1.5. I think this is a segment where I really see an opportunity for us with the REMS modification as that is more in line with the clinical practice of three monthly monitoring of lab values, like the higher proteinuria level patients like 1.5 or greater. It is not uncommon that they actually do monthly lab testing. But when you talk about patients at the lower proteinuria levels, it's more common that they are seen every three months by the nephrologist.

[Peter Heerma, CCO at Travere Therapeutics]

And as part of the routine, monitoring, they do the measurements. So I think our REMS modification is right on time where we are in the loan. So that's where I see the opportunity moving forward.

[Jason Zemansky, VP - Equity Research, Biotechnology & Pharmaceuticals at Bank of America Merrill Lynch]

Got it. Thanks for the color.

[Eric Dube, President & CEO at Travere Therapeutics]

Thank you.

[Operator]

Next is from Greg Harrison from Scotiabank. Your line is open.

[Joe Thomas, Equity Research Associate at Scotiobank]

Hi, everybody. Thank you for taking our question and congratulations on the quarter. This is Joe Thomas on for Greg. Just thinking on the patient start forms in the quarter, I wonder if you might be able to comment on the distribution as the quarter went along. Did you see any lumpiness or any acceleration as the quarter was going?

[Joe Thomas, Equity Research Associate at Scotiobank]

And how should we think about that going forward? Thank you.

[Eric Dube, President & CEO at Travere Therapeutics]

Sure. Thanks for the question. Peter, why don't you take that one?

[Peter Heerma, CCO at Travere Therapeutics]

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

[Joe Thomas, Equity Research Associate at Scotiobank]

Great. It's helpful. Thank you.

[Eric Dube, President & CEO at Travere Therapeutics]

Thank you.

[Operator]

Next is Alex Thompson from Stifel. Your line is open.

[Alex Thompson, Managing Director at Stifel Institutional]

Hey. Great. Thanks for taking our question. Maybe shifting over to Europe. You know, to the extent to which you have visibility on on CSL launch, you know, when should we expect to kinda see meaningful royalty revenue ex US? Thanks.

[Eric Dube, President & CEO at Travere Therapeutics]

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

[Chris Cline, CFO at Travere Therapeutics]

Yeah. Happy to do that. Thanks, Alex. You know, think, as Eric mentioned, we'll we'll defer to CSLB for on any kind of guidance. But as you would imagine, they're now, you know, through the early stages of going through the country by country process.

[Chris Cline, CFO at Travere Therapeutics]

And as that happens and they gain reimbursement, we would expect revenues to begin picking up overseas and in return royalties coming through to us. So, more to come as CSLB four continues to navigate that and report. And, as soon as we have more that we can share, we'll be happy to do so.

[Alex Thompson, Managing Director at Stifel Institutional]

Great. Thank you.

[Eric Dube, President & CEO at Travere Therapeutics]

Thank you.

[Operator]

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

[Nivi Nehra, VP - Corporate Communications at Travere Therapeutics]

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

[Operator]

This concludes today's conference call. Thank you for participating. You may now disconnect.

Participants

Executives

• Nivi Nehra, VP - Corporate Communications
• Eric Dube, President & CEO
• Jula Inrig, CMO
• Peter Heerma, CCO
• Chris Cline, CFO
• William Rote, Chief Research Officer

Analysts

• Will Soghikian, Equity Analyst at Leerink Partners
• Anupam Rama, Executive Director - Biotechnology Equity Research at JP Morgan
• Laura Chico, MD - Equity Research at Wedbush Securities
• Frances Dovell, Biotech Equity Research Associate at TD Cowen
• Arseniy Shabashvili, Vice President at Guggenheim Partners
• Farzin Haque, SVP & Biotechnology Equity Research Analyst at Jefferies Financial Group
• Yigal Nochomovitz, Director at Citigroup
• Mohit Bansal, Managing Director at Wells Fargo Securities
• Prakhar Agrawal, Managing Director at Cantor Fitzgerald
• Jason Zemansky, VP - Equity Research, Biotechnology & Pharmaceuticals at Bank of America Merrill Lynch
• Joe Thomas, Equity Research Associate at Scotiobank
• Alex Thompson, Managing Director at Stifel Institutional