Travere Therapeutics Q1 2025 Earnings Call Transcript

Quartr
Provided by Quartr
May 1, 2025

There are 15 speakers on the call.

Operator

Good afternoon, and welcome to the Traveer Therapeutics First Quarter twenty twenty five Financial Results Conference Call. Today's call is being recorded. At this time, I would like to turn the conference call over to Victoria Prescott, Manager of Investor Relations. Please go ahead, Victoria.

Speaker 1

Thank you, Chloe. Good afternoon, and welcome to Traveo Therapeutics first quarter twenty twenty five financial results and corporate update call. Thank you all for joining. Today's call will be led by Eric Dube, our President and Chief Executive Officer. Eric will be joined in the prepared remarks by Doctor.

Speaker 1

Julia Inrich, our Chief Medical Officer Peter Hirmer, our Chief Commercial Officer and Chris Klein, our Chief Financial Officer. Doctor. Bill Rhodes, our Chief Research Officer, will 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.

Speaker 1

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 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, 05/01/2025, and Trevya 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.

Speaker 2

Thank you, Victoria, and good afternoon, everyone. We entered the year determined solidify FILSPARI's foundational positioning in IgA nephropathy, unlock additional growth for FILSPARI through a potential new indication in FSGS and continue advancing toward restarting enrollment in our pivotal HARMONY study of peggedabatinib in HCU. And I'm pleased to report that we are making great progress with strong results in each of these three areas. Let me begin with DILSPARI and IGAN. Following its full approval last fall, we saw momentum continue throughout the first quarter.

Speaker 2

Net sales at VILSPARI grew 182% year over year and 13% versus the prior quarter, which reflects continued demand and strong uptake. We also continue to see high compliance rates, a growing patient base and an expanding group of prescribing physicians, which illustrates the positive VILSPARI experience. This strengthens our confidence in the durability and long term trajectory of growth. At a time of continued evolution in the IGAN treatment landscape, VILSPARIA remains uniquely positioned as the only fully approved non immunosuppressive kidney targeted therapy that has shown superiority over the historical standard of care. Recent market research continues to validate this positioning as nephrologists regularly highlight VILSPARI's strong clinical data, real world effectiveness and safety profile for chronic use, all of which underscores its role as a foundational therapy for IGAN.

Speaker 2

We continue to believe that Tulspari can become foundational care outside of The U. S. As well. Recently, the European Commission and MHRA in The UK converted FILSPARI's conditional approvals to full approvals for the treatment of adults with IGAN, an important milestone that will enable our partner CSLV-four to expand access to patients across Europe and The UK. Our partner, Rinalis, also continues to make good progress and they remain on track to report top line data in the second half of this year from their pivotal study in IGAN to support a regulatory submission in Japan.

Speaker 2

Turning to FSGS, we have made excellent progress towards our goal of bringing VILSPARI to a community that currently has no approved medication. After aligning with the FDA on our plan to submit an sNDA for an FSGS indication, we completed our submission in March. This reflects our team's dedication to a community that has been waiting for decades. We expect to receive notification of the FDA's acceptance of this filing later this month. If we are granted priority review as expected, could be approved and ready to launch in FSGS as early as September.

Speaker 2

This would mark a historic milestone. VILSPARI would become the first and only approved medication indicated for patients with FSGS. We continue to believe that the opportunity in FSGS is potentially even larger than that in IGAN, given the urgent unmet need in this disease. Our team is advancing preparations to execute a successful launch so we can deliver VILSPARI to the FSGS community quickly if approved. We also remain very enthusiastic about pegzibatomase or PEG T, our investigational therapy for classical homocystinuria or HCU.

Speaker 2

PEG T has the potential to be the first disease modifying treatment for HCU, and we continue to make strong progress towards restarting patient enrollment in the Phase III HARMONY study next year. We remain committed to the HCU community and believe PEG T has the potential to significantly improve the lives of these patients in the future. Looking ahead, we remain confident in our strategy with strong fundamentals and a clear focus on executing our key priorities. Let me now hand the call over to Juleh for a clinical update. Juleh?

Speaker 3

Thank you, Eric. Across our programs, we continue to deliver on our mission of transforming care for people living with rare kidney and metabolic diseases. We are making strong, steady progress toward our goal of establishing VILSPARI as a foundational treatment for patients with IgA nephropathy across the full disease continuum from early diagnosis through post kidney transplant. As the only available medicine that optimally blocks two critical pathways, endothelin one and angiotensin two in a single pill, Vilspari offers unrivaled efficacy and convenience for preserving kidney function for patients with IgA nephropathy and with a safety profile comparable to irbesartan. At the National Kidney Foundation spring clinical meeting, we were pleased to receive highly encouraging feedback on the foundational role of Vilspari for treating patients with IgA nephropathy.

Speaker 3

Physicians reported earlier diagnosis of their patients with IgAN, driven by referrals and biopsies earlier in the disease process. Importantly, more clinicians are now prescribing Filspari earlier in the disease course and treating to lower targeted proteinuria thresholds. This is based on data demonstrating that reducing proteinuria to the recommended draft KDIGO treatment thresholds of less than zero point five grams per day or ideally zero point three grams per day preserves kidney function, and results in better kidney survival in patients with IgAN. It is important to remember that Filspari is the only non immunosuppressive kidney targeted therapy indicated for adult patients at risk of IgAN progression regardless of their proteinuria level. And we are increasingly hearing from nephrologists that they are observing consistently positive results across the wide range of patients with IgAN that they treat, some of which were presented in real world case series at NKF.

Speaker 3

We also presented additional data from the SPARTAN study, which adds further depth to VILSPARI's clinical story. In SPARTAN, VILSPARI is being evaluated as a first line treatment. The data reported at NKF showed that treatment with VILSPARI resulted in approximately seventy percent proteinuria reduction from baseline and stabilization of eGFR over twenty four weeks. Additionally, nearly sixty percent of patients achieved complete proteinuria remission during the treatment period. We also presented the first evidence in humans of Filsari's anti inflammatory effects, specifically a fifty percent reduction in urinary soluble CD163 over twenty four weeks in newly diagnosed treatment naive patients with IGAN.

Speaker 3

This data resonated with nephrologists as Filsparin not only addresses the kidney damage, but has the potential to also reduce immune system response and inflammation in the kidney that contributes to progression of IGAN and without the need for systemic immunosuppression. We expect to share additional exciting data from this ongoing study later this year. Recognizing that nephrologists are data driven, we are generating additional evidence to support the use of Vilspari across the full continuum of disease, including in recurrent disease after kidney transplantation. This remains an area of high unmet need, and our upcoming studies present a critical opportunity to generate data that will help physicians evaluate Vilspari as a potentially beneficial non immunosuppressive treatment option. We are currently in study start up for these studies and plan to provide further updates in the future.

Speaker 3

For a safety update, we are pleased with the progress of our submitted sNDA for modification of the liver monitoring frequency, as well as removal of the embryo fetal toxicity REMS. Notably, as patient exposure to Filsari increases, we have not seen any cases of Hy's Law, and we now have enough exposure data to rule out a potential risk of drug induced liver injury of one in one thousand. We remain on track for our August 28 PDUFA date for this submission and look forward to providing further updates as they become available. Now turning to FSGS, VILSPARI continues to be the only potential treatment in development with data showing efficacy across patients with either biopsy proven or genetic FSGS. Importantly, the ZILSPARI data have shown remarkable consistency in reducing proteinuria across all FSGS subtypes studied, particularly important for difficult to treat populations, including primary and genetic forms of FSGS, as well as in pediatric patients.

Speaker 3

Data supportive of this broad efficacy is even more critical in FSGS than in IgAN due to the heterogeneity and complexity of the disease. At NKF, we presented new analyses from the FSGS DUPLEX study, which demonstrated that patients achieved partial and complete remission of proteinuria earlier and more often with Vilspari versus irbesartan. And importantly, those patients who achieved partial or complete proteinuria remission in the study had sixty seven to seventy seven percent lower risk of kidney failure, respectively. These important findings are the first randomized clinical trial analyses to validate the observational data from Parasol and further support the Parasol recommendation of proteinuria as a surrogate endpoint in FSGS. Following our sNDA submission for FSGS, our interactions with the FDA have been productive and consistent with the experience we had during the IGAN process.

Speaker 3

As Eric highlighted earlier, we anticipate notification of our acceptance of our application later this month. And if granted priority review, we expect potential approval this fall. Finally, our PEG T program continues to make good progress, and we are on track to restart enrollment in our phase three HARMONY study next year. We are also pleased to share that our phase onetwo composed study manuscript has been accepted for publication in the top tier peer reviewed journal Genetics in Medicine. This publication will further reaffirm PEG T's potential to become the first disease modifying therapy for the HCU community.

Speaker 3

In summary, the first quarter marked another strong period of clinical and scientific advancement. Our programs are maturing in ways that deliver not only improved clinical outcomes, but real meaningful change in how physicians approach these chronic and complex diseases. We are excited for what lies ahead and look forward to keeping you updated as we move through the rest of the year. I'll now turn the call over to Peter for a commercial update. Peter?

Speaker 4

Thank you, Juha. The first quarter marked a strong start to the year for our commercial team and FILSIARI. We saw continued momentum following full FDA approval in IgA nephropathy, which resulted in approximately CHF 56,000,000 in net product sales of VILSPARI in the first quarter. This reflects further growth driven by an increasing prescriber base and deepening penetration amongst experienced prescribers. We received seven zero three new patient start forms in the first quarter, a robust continuation of the heightened demand we have seen since full approval.

Speaker 4

Importantly, we saw consistent month over month growth throughout the quarter, culminating in March being our strongest month since launch, and demand in April continued this trend. This highlights the beliefs physicians have in Filsparis efficacy profile as the only kidney targeted therapy to demonstrate rapid and sustained proteinuria reduction and benefit in kidney function preservation with efficacy superior to that of a maximally dosed active comparator and a safety profile that is comparable over two years. The expansion of FILSPARI's label to more patients with IgA nephropathy regardless of their proteinuria levels has also amplified physicians' confidence in choosing FILSPARI for the broad spectrum of their patients. In fact, what we are seeing is a meaningful shift in prescribing behavior. The median proteinuria levels at initiation continue to trend below 1.5 gram per gram, and many existing prescribers are now initiating treatment in patients with proteinuria levels below one gram per gram.

Speaker 4

This change reflects growing alignment with the updated draft GDiGO guidelines, which recommend earlier intervention and more ambitious treatment goals to optimize long term outcomes. From an access and fulfillment standpoint, patient experience remains strong. We have maintained broad coverage across payers, with criteria easing across the board following the label expansion at full approval. Most notably, this has resulted in the removal of proteinuria thresholds in multiple payer plans. These developments are making FILSIRI more accessible, more quickly to the patients who need it, which pairs nicely with the efficiencies we continue to realize in our fulfillment process.

Speaker 4

Also, our patient services are highly valued as evidenced by survey responses indicating that ninety percent of the FOLSPARI patients are highly satisfied with the services provided through Travir Total Care. Patient compliance and persistent rates continue to be higher than benchmarks, further reflecting the convenience, tolerability and efficacy of FILSPARI and an indicator of patients being highly satisfied with their FILSPARI experience. Looking ahead, we are well positioned to upgrade the historical standard of care of ACE inhibitors and ARBs, which will drive continued revenue growth in 2025. As the only non immunosuppressive therapy that is fully approved for the adult IgA nephropathy patients at risk of progression independent of proteinuria levels, continues to see broad uptake across subgroups of patients. We expect Solstari will remain the leading choice for upgrading foundational care, and we anticipate the largest segment of patients uptake to continue coming from those with UPTR levels below one point five gram per gram, which we estimate represents roughly seventy percent of the seventy thousand addressable patients.

Speaker 4

The expected upcoming finalization and publication of the QEDIGO guidelines will likely reinforce the shift to earlier and more ambitious treatments, consistent with the Vilspari label and prescribing trends. Our latest market research shows that approximately seventy five percent of nephrologists are now targeting proteinuria below zero point five gram per gram with nearly a third targeting even more ambitious goals of 0.3 meaning complete remission. Our market research and feedback from nephrologists also indicates that the REMS requirements do not have a meaningful impact on the intention to prescribe. That said, potential future modifications to the REMS would further enhance the product convenience, particular for newly diagnosed or lower risk patients. Turning to FSGS, we are preparing our commercial organization to be ready for a successful second launch in anticipation of a potential new indication.

Speaker 4

With up to thirty thousand addressable patients, FSGS is the most progressive and symptomatic glomerular disease. If approved, VILSPARI could be an important new treatment option for a community with no approved medicines today, representing a significant opportunity, potentially even greater than in IgA nephropathy. We are in the early stages of expanding our commercial team, building upon our existing infrastructure. Given the significant overlap between the prescriber basis for FSGS and IgA nephropathy, we are confident that we can efficiently and effectively deliver FILSPARI to FSGS patients from the outset if approved. I am pleased with our progress and we will be well prepared for potential approval later this year.

Speaker 4

In summary, our performance in the first quarter clearly demonstrates the strength and effectiveness of our commercial team. VILSPARI is delivering on its promise, and our team is building strong sustainable momentum heading into the rest of the year, positioning us for significant growth in IGN and property and preparing the organization for successful loans if approved for FSGS. Let me now turn the call over to Chris for the financial update. Chris?

Speaker 5

Thank you, Peter, and good afternoon, everyone. As you heard from the rest of the team, we are pleased to report another quarter of great execution. This was driven by continued momentum in the ongoing Filspari launch and leveraging our strong financial foundation to strategically invest in the key priorities that are delivering growth now and in the future. I'll start with revenue, where we generated net product sales of $75,900,000 in the first quarter, representing 90% growth over the same period last year as well as continued sequential growth over last quarter. Valspari maintained great momentum in the first quarter, generating $55,900,000 in net product sales.

Speaker 5

We achieved this despite gross to net discounts being higher as a result of the typical insurance coverage changes in the beginning of the New Year and the implementation of the Part D redesign. As we outlined at the beginning of the year, we continue to anticipate that we will have higher gross to net discounts for VLSIRI in 2025, but the continued momentum in demand, high compliance and persistence will drive significant growth in VLSIRI sales throughout the year. Thiola and Thiola EC also contributed $20,000,000 in net product sales for the first quarter. We continue to anticipate more generic competition for Thiola and Thiola EC in the coming quarters, but we continue to be pleased with the performance thus far. During the quarter, we also recognized $5,900,000 of license and collaboration revenue, which results in total revenue of $81,700,000 reported for the first quarter of twenty twenty five.

Speaker 5

Of note, first Our research and development expenses for the first quarter of twenty twenty five were $46,900,000 compared to $49,400,000 for the same period in 2024. The decrease in R and D is largely attributable to reduced costs associated with the development of VILSPARI as our Phase III programs advance towards completion.

Speaker 5

On a non GAAP adjusted basis, R and D expenses were $42,200,000 compared to $45,800,000 for the same period in 2024. Selling, general and administrative expenses for the first quarter were $72,800,000 compared to $64,200,000 for the same period in 2024. The increase in SG and A is largely attributable to increased investment in the FILSPARI launch following full approval as well as increased amortization expense related to VILSPARI royalties. On a non GAAP adjusted basis, SG and A expenses were $53,300,000 for the first quarter compared to $48,200,000 for the same period in 2024. Total other income net for the first quarter of twenty twenty five was $1,500,000 compared to $3,500,000 in the same period in 2024.

Speaker 5

The difference is largely attributable to lower interest income during the period. Net loss for the first quarter of twenty twenty five was $41,200,000 or $0.47 per basic share compared to $136,100,000 or $1.76 per basic share for the same period in 2024. On a non GAAP adjusted basis, net loss for the February was $16,900,000 or 19¢ per basic share compared to $116,200,000 or $1.51 per basic share for the same period in 02/2024. As of 03/31/2025, we had cash, cash equivalents and marketable securities totaling $322,200,000 We expect to receive a $17,500,000 milestone payment from CSL V4 during the second quarter as a result of the recent conversion of conditional approval of VILSPARI to full approval in Europe. We also anticipate 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.

Speaker 5

As we look to the remainder of the year and beyond, we expect continued strong demand for FILSPARI and IgA nephropathy, with net product sales projected to grow meaningfully this year and maintaining a pace well above benchmark launches. We're continuing to thoughtfully invest in both near term execution and longer term growth drivers. This includes supporting the further success of the IgA nephropathy launch, advancing launch readiness for potential FSGS approval, enabling the restart of enrollment in the pivotal pectobatinase program. Like many others, we are continuing to monitor legislative developments and geopolitical uncertainties. Based upon what we know today, if tariffs are extended more broadly to pharmaceutical products, we believe the impact to Tulspari would not be material.

Speaker 5

Importantly, with a strong balance sheet, a clear set of priorities, and continued strong execution, we're well positioned to fund our strategic initiatives and drive sustainable growth. With that, I'll turn the call over to Eric for his closing comments. Eric?

Speaker 2

Thank you, Chris. In closing, I'm proud of our strong start to 2025. Our teams continue to demonstrate solid execution, and we are confident in our ability to maintain this momentum throughout the year. We look forward to keeping you updated as we achieve key milestones in the quarters ahead. Now let me turn the call over to Victoria for Q and A.

Speaker 2

Victoria?

Speaker 1

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

Operator

Our first question comes from the line of Tyler Van Buren from TD Cowen. Your line is open.

Speaker 5

Hey, guys. Thanks very much,

Speaker 2

and congratulations on the progress. Can you just elaborate on any interactions with the agency you've had since you filed the sNDA for FSGS and how those have gone? And is the FDA feedback that's been publicized by competitor, Dimerix, consistent with your experience with the agency? Tyler, thanks for the question. I'll turn turn that one over to Bill.

Speaker 6

Yeah. Thanks thanks, Tyler. Well, we're we're seeing the same headlines that that everyone else is, and and it's clearly a dynamic situation. With that said, as we look at the reviewers for our FSGS, sNDA, we see consistency there, and our f d FDA interactions have been progressing as we expected, as we continue to anticipate the PDUFA date for the potential REMS toward the end of the summer and our continued review on, on the sNDA for FSGS. I can report that the interactions that we have are very similar to what we've experienced in the prior year with the IGAN indication at this stage in the process.

Speaker 6

So, you know, the the experience that we're seeing on the other side of the table matches what we would expect and what we've been used to in the past. With respect to your other comment, it was pleasing to see the confirmation from the FDA with a with a different product that there was consistent feedback, supporting the use of proteinuria as a an approval based endpoint for FSGS.

Speaker 2

Okay. Operator, do we have any other questions? No.

Operator

Our next question comes from the line of Vamil Daban from Guggenheim. Your line is open.

Speaker 7

Okay, great. Maybe just if I just have one question, I'll keep it on the FSGS side. And just, again, tied to the regulatory discussions and the label, you mentioned the data is supportive across a broad range of patients with FSGS. Be a little bit early for you to comment on this. I'm just trying to get a sense of what you think the label would look like.

Speaker 7

Do think it would just be literally for all patients with FSGS? Or do you think there might be some restrictions in how the, sort of indication is is defined? Thanks.

Speaker 2

Hummel, thanks for the question. I'll turn that one over to Bill as well.

Speaker 6

Yeah. I mean, my my expectation is that the the indication statement and it would be for the treatment of FSGS in patients ages eight and up because that matches what we studied. The the inclusion criteria for the duplex study was broad. And we also know from post study analysis, we have a very good description of the patient types based on their histology, and their genetic makeup for many of those patients where we can segregate their causes. And what we can conclude from that is that we recruited a population of primary FSGS, genetic FSGS, and saw consistent effects across all of those subtypes.

Speaker 6

So I think that, you know, when we think about FSGS as a podocytopathy, the an injury and the cause may come from different sources, but, ultimately, FSGS is is a damage to the podocyte. And treatment with sparsentan, blocking angiotensin and endothelin, hits a common disease pathway that's beneficial independent of those the of the heterogeneity that's part and parcel of the FSGS diagnosis.

Speaker 7

Okay. Thanks. Mhmm.

Operator

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

Speaker 8

Great. Hi, everyone. This is Will on for Joe. Congrats on the strong quarter and progress here. So I guess one from us.

Speaker 8

With the recent approval or accelerated approval of Novartis' second therapy in iDN, can you provide a bit more color on what your sales reps are seeing in the field? Is there some counter detailing that's ongoing? And what are the main types of questions your reps are getting? And then maybe piggybacking off of this, it seems like the nephrologist's more extensive experience with Vilspari combined with the EGFR data on the label, might make it a preferred choice for a new patient. Is that something you're seeing in the field, or is it a bit early to tell?

Speaker 8

Thank you.

Speaker 2

Will, thanks so much for the questions, and I will turn that over to Peter.

Speaker 4

Yes. Thanks, Will. Well, it's very early. It's one month now that atarsentan has been approved. I think, first of all, it's good for patients to have more medicine in the market.

Speaker 4

And I think especially as IgA nephropathy is a market in development that historically was seen as a relatively benign disease, and now there is much more recognition that those patients should be treated earlier and more aggressively. And I think more companies raising that importance, I think, good for the market. To have an endothelin inhibitor in the market will also further amplify the importance of inhibiting endothelin as part of foundational care. So I think in that respect, it will help us to further grow the market and in particular grow the market for endothelin. With regards to like competition and what we have heard, it's very early.

Speaker 4

We haven't really heard so far too much in the marketplace. What I mentioned in the call is that we have seen continued growing demand this year so far, and that growth continued in the month of April, which was the first month that Alto Sao Paulo was in the market. And I think that speaks to the confidence that physicians have on the profile that FILSPARI has. And I think Juha mentioned in her prepared remarks, data matters for nephrologists. They have seen that FILSPARI has long term kidney preservation data and unprecedented proteinuria reduction that sustained over a longer period of time, which is really the consistency of inhibiting two receptors that result in efficacy benefits as well as convenience benefits for patients, one pill, one co pay.

Speaker 4

So I'm confident in the profile of Filspari. And, yes, I welcome all the modalities coming to the market because I think that further reinforces the importance for patients to be treated earlier and more aggressively.

Speaker 8

Great. Thank you so much.

Operator

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

Speaker 7

Hey, guys. Thanks so much for taking the question.

Speaker 5

I was wondering if you could expand a little

Speaker 7

bit on your gross to net comments in your opening remarks, maybe helping us understand the type of impact you saw in 1Q and give us a little color here about if looking to the balance of the year, gross to net is actually a tailwind with the reversal of the impact that you saw in 1Q? Thanks so much.

Speaker 2

Thanks, Anupam. Chris, why don't you take that question?

Speaker 5

Yeah. Thanks for the question, Anupam. And and, I think it's probably easiest to compare it back to what we saw last year versus this year, where last year, we had gross to net really in the mid to to high teens. And what we experienced there was the highest discount at the beginning of the year, and then it eased through the balance of the year. This year, we're guiding to gross to nets that are gonna be in the low twenties.

Speaker 5

And with the changes to, you know, just the insurance coverage as well as with Part d redesign, we did see that increase in the first quarter as we normally would expect. But we also anticipate with the part d redesign and also, you know, the the coverage that comes along with that or exposure to the catastrophic coverage going forward, we're gonna see at least that portion of our gross to net fee a bit stickier than it was last year. So it'll probably be a little bit more even than it was last year, but we we do expect, least for the fundamental pieces of gross to net, to be the highest in q one.

Speaker 7

Thanks so much for taking our question.

Operator

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

Speaker 9

question for you on the cadence of patient start form. It was interesting to see the number, tick up a little bit over the prior quarter. And, Eric, I think you had made some comments prior to this about expectations around maybe the the rate of growth here. So just wondering if you can have any comments or thoughts on the sustainability of this kind of metric and where this might go over the course of 2025. Thank you.

Speaker 2

Sure. Laura, thanks for the question. And Peter, why don't you take this one?

Speaker 4

Yes. Thanks, Derek, and thanks, Laura, for that question. What I would say is that we have seen significant acceleration of growth with the broader label after full approval, and we continue that the growth trajectory with seven zero three new patient start forms in the first quarter. I think most importantly is that you have to realize that FILSPARI is a chronic treatment, and we continue to see very strong compliance and persistence rates. So we build upon a very robust and healthy revenue base.

Speaker 4

And it gives me confidence that we will see a continuation of meaningful revenue growth moving forward.

Speaker 2

Thank you, Peter. Laura, the other thing that I would add is as we look at the the patients that we believe are in need of of an upgraded therapy, essentially, those patients that are on RAF inhibitors that are not at the new QADIGO guidelines, Peter alluded to this in his prepared comments that this is where we're seeing the majority of the new growth coming from. Physicians are looking earlier for patients to be upgraded from the RAS inhibitor to FILSPARI. And that really is a sustainable source of growth moving forward because there are so many patients that are not yet at that guideline of 0.5 or 0.3. And so we expect that, that is going to continue to be a major driver of our PSF growth moving forward.

Speaker 2

And as Peter also mentioned, you know, not many of the other therapies have that broader indication or the support of the guidelines to be able to to reach those patients. So I think that's one of the key drivers as we think about the sustainable, you know, addition of new patients to FILSPARI.

Speaker 9

That's helpful. Thank you.

Operator

Our next question comes from the line of Lisa Baco from Evercore. Your line is open.

Speaker 1

Hi, there. Thanks for taking

Speaker 10

the question. Just a couple for me. I was wondering if you could just break out. I know you talked about this a little bit, but what percentage of prescriptions are you seeing that are below one point five grams now that you have label expansion versus above one point five gram? And then are you seeing any change in sort of new patient adds now that we have atrasantan?

Speaker 10

I mean, in some ways, having another player there can grow the market and grow awareness. In some cases, you see kind of new patient adds sort of stabilize or even drop off a little bit. I'm just wondering what kind of early trends you're seeing there. And I think that's it for for me. Thanks.

Speaker 2

Alright. Lisa, thanks so much for the questions. And, Peter, why don't you take those?

Speaker 4

Yes. Let me so it's two questions that you're asking. The first one is with regards to like what is the breakdown of different levels of proteinuria. We haven't broken it down specifically, but what we are seeing is that the median trend of proteinuria levels are going down and is now well below 1.5 gram per gram. And in particular with experienced prescribers, we see that there is a meaningful amount of physicians that are now prescribing below one gram per gram as well.

Speaker 4

I think that is the most important takeaway and to your earlier point that allows for a sustainable growth opportunity over time since Tilspara is the only non immunosuppressive treatment that is fully approved without proteinuria limitation. With regards to your second question on ATRA and what trends we are seeing, well, the trends that we are seeing is very consistent to what we have seen so far. That's a continued demand growth that continued in April as well. So we haven't seen any impact. And to your point, I mean, mentioned that earlier, there is a market improvement with more companies talking about like the urgency to treat.

Speaker 4

And now in particular with more companies talking about the importance of endothelin. So, so far the trends that we have seen are positive and we continue on very strong growth trajectory.

Speaker 5

Operator? Operator, can we go to the next question, please?

Operator

Yes. Our next question comes from the line of Greg Harrison from Scotiabank. Your line is open.

Speaker 5

Hey. Good afternoon, guys, and thanks for taking the question. Wondering about your assessment of the impact that the removal of the REMS program could have on the trajectory of new patient starts in IGAN. Is it maybe on the level of of the inflection you saw since you were granted full approval compared to the period before that? Or, just trying to get a sense of, you know, the the additional, patient, flow that you you may see, if if that's granted.

Speaker 2

Greg, thanks for the question. And, for context, we are on track with the PDUFA date to modify the the REMS in August late August. And, Peter, why don't you talk about your your view on, what that impact could have?

Speaker 4

Yeah. Happy to it, Eric, and, Greg, thanks for that question. I would say first and foremost, REMS has not been an obstacle in our performance. In fact, Vulsari is being the most successful of the four most recent REMS nephrology launches. All of the comparators actually did not include REMS.

Speaker 4

So with REMS, we were able to kind of like set a best in class benchmarks. Having said that, and to Eric's earlier points, we want to provide the best in class treatment option, and we want to do that in the most convenient way for patients and physicians. And we are therefore looking forward to the modification we anticipate in late, late August.

Operator

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

Speaker 11

Hi. This is Fadia Rahman on for Mohit. Thanks for taking our question. So I have a question on FSGS on the dimerics. Recently, there was a partnership announced for U.

Speaker 11

S. Commercialization of that asset. How are you thinking about the benefit of that drug versus farsentan and FSGS? And, do you do you think they could still be significantly further behind from launching in The US based on, their enrollment status and how long it took, for DUPLEX to enroll? Thanks.

Speaker 2

Alright. Thank you for the questions. Jula, I'll, pass those to you.

Speaker 3

Yeah. Thanks for the question. I would say the important takeaway is that we're very pleased to see the alignment with the FDA on Parasol, that proteinuria can be an endpoint for full approval at two years in FSGS. When you look at their data, we really don't have a lot of data. We have some phase two data from Dimerix two hundred, and it's gonna be many years before we see their full two year proteinuria data because, as they've stated, they're still enrolling.

Speaker 3

They hope to finish by the end of this year, but to be determined when they complete that enrollment. But I would also add that the MOA of DMX 200 as CCR two antagonism is certainly complementary for filspari if it becomes available in the future.

Operator

Our next question comes from the line of Maury Raycroft from Jefferies. Your line is open.

Speaker 12

Hi. Thanks for taking my question. I'm wondering just for Filspire and IGAN, what the split is between new versus repeat prescribers? Can you provide more granularity on what you're seeing on compliance and persistence rates? I guess, what's the average amount of time that patients are staying on treatment?

Speaker 2

Alright, Maury. Thanks for the questions. Peter, we'll hand that one over to you.

Speaker 4

Yeah. The split is slightly more skewing to experienced prescribers with very with a very healthy continuation of new prescribers as well. So that was the first part of your question. The second part of your question?

Speaker 2

Compliance.

Speaker 4

Compliance. Yeah. I would and I mentioned that in the prepared remarks as well. If you compare the FILSARI compliance and persistence to com compared to benchmark chronic disease, non symptomatic disease at a very high end. We haven't given call what this exactly, but it's at a very high end what you would expect.

Speaker 2

Got it.

Speaker 4

Which speaks to the confidence and the satisfaction of patients patients as well.

Operator

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

Speaker 13

Hi, thank you for taking my questions and congrats on the quarter. So on the FSGS and expectations for the launch, just wanted to get some color there. Among the 15,000 to 30,000 addressable patients for FSGS in The U. S, How many of these are currently managed by Filspiry top prescribers? And any thoughts on how you expect the launch to be when approved?

Speaker 13

And if I can just follow-up here on the payer discussions on FSGS pricing, wondering if you got any feedback there given the possibility of double the eigenpricing and whether that's feasible here? Thank you.

Speaker 2

Sure. Prakhar, thanks for the question. I'll take the one on pricing and outlook, and Peter can talk about the overlap and where these patients are being treated. So our overall pricing strategy for FSGS is very similar to IGAN in that we want to make sure that there is broad access to Fulsari, which is really critical for us in establishing it as a foundational therapy where, you know, a broad swath of community should have access to to Fulsari. We have mentioned that it's likely there would be double the price for adult patients at the target dose given double the the dose.

Speaker 2

And we believe that given the unmet need and the more rapid progression that FSGS patients have to kidney failure, that that higher price certainly would would come with a high benefit for for these patients. With regard to the the outlook for the launch, we certainly expect that that update could be quite rapid and certainly more, rapid than what we've seen in FSGS because of the, high unmet need, but also because of the high awareness and experience, the success that Peter's team has had in IgA nephropathy. And with that, I'll have Peter talk about what that, overlap is in prescribers and where these, 30,000 patients are.

Speaker 4

Excellent. Well, thanks, Erik. And I think you covered quite a lot of the question already. To your point and depending on the label, we see that there's, up to 30,000 patients that could be addressable for filspari. I think to Erik's other point, I think there may be an even bigger opportunity in FSGS compared to IgA nephropathy because within IgA nephropathy, and I was alluding to that earlier, we really have to establish the urgency to treat and change treatments.

Speaker 4

With FSGS, every nephrologist is convinced about the high progressive rate of those patients and also the symptomatic nature of the disease. So we don't have to establish the urgency to treat. Physicians are really well aware of that. To your other point, we have already very strong brand awareness with basically the same prescriber base for FSGS as for IgA nephropathy, with many of the prescribers already having the experience in IgA. So I think that allows for a much more rapid uptake.

Speaker 4

And one additional aspect, building on your pricing question, TULSPARI is already well established in payer plans and formulary. So all the heavy lifting that you do normally in the first twelve to eighteen months, we have done that already for IgA nephropathy. And this gives me confidence that we will see a rapid uptake for this patient population that has been underserved for so long and is really waiting for the first approved medicine that could be so faring.

Operator

Our next question comes from the line of Jason Zemanski from Bank of America. Your line is open.

Speaker 14

Good afternoon. Congratulations on the progress and really appreciate you taking our question. I wanted to ask a follow-up regarding some of your earlier comments regarding Dynamics as far as the updated QADIGO guidelines go. But do you have a sense of of what overall fraction of the community has started to embrace, treating more aggressively? You know, is it overall meaningful?

Speaker 14

Should we expect a significant inflection when these are finalized? Or or, you know, is it going to be something more, like a trickle effect thereafter? Just trying to get a gauge of of near term, impact of the different growth levers.

Speaker 2

Yeah. Peter, do you do you wanna take that? And then, Jhula, you know, you've you've engaged quite a bit with, the the nephrology experts. Maybe you can share what you're hearing as well.

Speaker 4

Yeah. Jason, I'm happy to take that question. First of all, I think there is quite an impact already. And, ASN was only six weeks after the draft KEDIGO guideline was published. And I heard from multiple, in particular academic physicians already about like how they are being more aggressive in particular by doing earlier biopsies in a patient population that I wouldn't have done that in the past.

Speaker 4

And I spoke with a few physicians, for example, that actually started doing biopsies in proteinuria levels of like 0.3, zero point four and actually found clear osis and thought that patient would be a candidate for filspiri. I think with the full publication, you have more of a trickling down effect. With the publication, it's in the broader domain as well. So I think you will have a continuation of adaptation there. And as I mentioned in my prepared remarks, seventy five percent of the nephrology community is now targeting zero point five percent as the new treatment target.

Speaker 4

I think there is a meaningful impact, but I think with the full publication you will see a continuation and tripling down.

Speaker 5

Julia, anything you'd

Speaker 3

I'll echo what Peter said. It's taken data from the RADAR publication as well as the KDIVO guidelines for physicians really to change their mindset. They thought, again, it was a benign disease, and we could let them smolder along with higher ranges of proteinuria. As they get exposure to that data and the guidelines, there's an awareness that they need to bring their patients back, treat them treat them more aggressively, and to lower targets. And they're starting to to further understand exactly how to do that.

Speaker 3

You upgrade their RAS with DELSPARI. You can get more patients to lower ranges of proteinuria, and that's starting to resonate. I think that, to Peter's point, the publication of the KDIGO guidelines will further help cement and educate because there'll be continued education around the importance of getting patients to lower ranges. But it it certainly is starting to to sink in that what we've done historically isn't good enough for this patient population.

Speaker 2

Perfect. Thanks for the color.

Operator

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

Speaker 1

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

Operator

This concludes today's conference call. You may now disconnect.

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Earnings Conference Call
Travere Therapeutics Q1 2025
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