Q2 2025 Travere Therapeutics Inc Earnings Call
Good afternoon and welcome to the trivia Therapeutics second, quarter 2025 Financial results conference call. Today's call is being recorded at this time. I would like to turn the conference over to new vinera vice president corporate Communications and investor relations. Please go ahead. Maybe
Thank you, operator. Good afternoon and welcome to trivia therapeutic, second quarter 2025 Financial results and corporate update call. Thank you all for joining. Today's call will be, will be led by Dr. Eric Dube, our president and chief executive officer Eric will be joined in the prepared remarks by Dr. Julia enrich our chief medical officer, Peter herma our chief commercial officer, and Chris Klein. Our Chief Financial Officer Dr. Bill wrote Our 2, research officer will join us for the Q&A. Before we begin, I'd like to remind everyone that statements made during this call regarding matters that are not historical. Facts are forward-looking statements within the safe harbor. Provisions of the private Securities. Litigation Reform, Act of 1995 forward-looking statements are not guaranteed as of performance. They involve known and unknown risks, uncertainties, and assumptions that may cause actual results performance and achievements to defer material from those expressed or implied by the statement, please say the forward-looking statement disclaimer on the company's press release issued earlier today as well.
As well as the risk factor section in our forums, 10-Q and 10-K filed with SBC in addition. Any forward-looking statements represent our views only as of the dates that statements are made, August 6, 2025. In particular, we specifically disclaim any obligation to update such statements to reflect future information, events, or circumstances. With that, let me now turn the call over to Eric.
Thank you knee. Good afternoon and thank you all for joining us. The second quarter of 2025 was a standout for Trae, a reflection of strong, strategic, execution and continued momentum in delivering against our mission.
At the heart of this progress is Phil spari where we are advancing our leadership in rare kidney disease by deepening. Our impact in IGA nephropathy, and laying the foundation for potential expansion in fsgs.
And Ian, we delivered our strongest commercial quarter to date with continued demand driven by both new and repeat prescribers.
As the Ian treatment landscape evolves Physicians are increasingly adopting, Phil spari 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 Safari as the new foundational therapy for IG 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 Phil spari 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 rims and removal of the pregnancy testing ramps. And finally the continued realworld, clinical experience and growing recogn. Recogn uh recommendation by nephrologists and treatment guidelines that recognize Phil spar'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 Ian Market.
While it's still early days in the evolving, Ian treatment landscape. The sparas performance is directly aligned with the expectations that we have set over the last few years and validation of its path to foundational use. Juul and Peter will review the progress of our strategy in Greater detail.
We've also seen strong progress outside of the US by our partners cslb for and rales as they look to expand access to Phil. Spari 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 fpar and fsgs is advancing as expected.
We're preparing for what could be an extraordinary milestone for trivia? And the fsgs community, if approved, bill spari 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 therapy likely to be available in the near future.
Beyond Phil spari. We continue to advance our Pipeline with a drive to transform paradigms in rare diseases like classical home assistant urea and we remain on track to reinitiate enrollment in the harmony study for Peg to bat mates. 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 Julia for an update on our clinical programs. Jula
Thank you, Eric.
As a nephrologist, it's incredibly rewarding to witness the continued innovation in IGN 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 Phil spari across a broad spectrum of ignify patients at risk of disease progression.
ranging from those who are newly diagnosed to those, with recurrent disease post-transplant,
Bills as far as unique ability to Target 2 Pathways causing kidney injury, 1 and Angiotensin 2 provides patients with IGN nephropathy. A non-immune 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 nephro protective effects.
Strong safety profile and emerging disease, modifying potential of falari.
select data at these congresses include
In the phase 2, Spartan trial when used first line in treatment naive, IJ nephropathy, patients, Desaree treated patients, achieved an approximately 70%, proteinuria reduction.
With nearly 60% of the patients in the study reaching complete remission from proteinuria.
And stable egfr through 24 weeks.
Also in the Spartan study an analysis of patients samples showed that Phil spari treated patients with IG nephropathy demonstrated rapid and sustained reductions in urinary B cell activating factor or bath.
And compliment Factor C5. B through 9 as well as reductions in pro-inflammatory and Prof. Firic biomarkers.
When taken in combination with our pre-clinical data, showing Phil spari protects from Los Angeles deposition of IGA.
These data suggest a potential role of optimal dual inhibition of endothelial and angiotensin II as modifying the underlying disease.
In the phase 3, protect open label extension that is ongoing patients transitioning from maximally titrated, herbick to fill spari. After the double blind period also achieved approximately 50%, reductions in proteinuria and a relatively stable egfr out to 1 year.
Together with the kidney function, preservation. Phil spari provides these new data further, reinforced the sparas disease, modifying potential in ignoring without immunosuppression.
As the Igan treatment Paradigm evolves, we expect combination therapy to become the new standard to help more patients, reach complete protein area remission which is recognized as a treatment goal in the draft update to the kdigo guidelines.
The emerging therapeutic classes.
We are also approaching the August 28th Padua dates for the removal of the embryo. Fetal toxicity rims and the potential modification of the liver. Monitoring rims to quarterly.
With no cases of high flaw to date, we remain confident in the safety profile of Phil Spar to support this change.
Turning to fsgs our snda seeking full approval of Phil spari in fsgs was accepted by the FDA with a Pua date of January 13th 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 protein area, reduction, for full approval,
The SMDA review process is advancing as expected, and we're preparing for an advisory committee to discuss BILL SPARI as the first potential approved medicine for FSGS.
Our team is actively preparing to present the strong data from duplex and Duets in the context of the independent parasol findings.
For example, earlier this quarter, we presented new analysis, from the duplex study, that confirmed the parasol findings.
In duplex significantly more falari treated patients achieved. Either partial or complete remission compared to herbick.
importantly, those patients who achieve partial or complete protein, remission in the study irrespective of treatment arms had a 67% to 77% lower risk of kidney failure, respectively,
these data represent, the first trial level evidence in support of the independent parasol 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, Peg to Baton Ace.
We have made strong progress on our manufacturing scale up to support, our phase 3 trial and a future commercial launch and are on track towards restarting. Patient, enrollment in the phase 3 Harmony study next year.
I'll now turn the call over to Peter for a commercial update. Peter.
Thank you, Joan. I'm pleased to report that our commercial team executed exceptionally well in Q2 as demonstrated by our strong performance metrics,
The sparring, net product sales reached approximately 72 million in the US. In the second quarter representing significant year-over-year growth.
This performance was driven by strong demands.
Expansion and deepening of prescriber Base as well as further efficiencies in our fulfillment process and followed therapy, compliance and persistence.
As the only fully approved non-union suppressive kidney targeted therapy for Ida, neuropathy feels very remains, uniquely positioned to replace the historical standard of care in this evolving treatment landscape.
The growing recognition of Phil's power is nephro protective profile.
Not just from returning prescribers, but also from the farthest who are new to the brand resulted in 745 new patient, star, forms this quarter.
Approximately a 43% increase compared to the same period last year.
at the time, when new treatment options are emerging for a property,
Feedback from our field. Teams and recent market, research emphasized, physician confidence in Phil's Paris established position in clinical practice.
Neurology is regularly cited as feeling Paris, consistent with rapid and sustained pro-efficacy with long-term kidney preservation benefits.
A safety profile that allows for chronic use and a patient friendly 1, daily oral Administration that optimally inhibits 2, critical kidney damaging Pathways and key reasons for making Phil's party. Their foundational treat therapeutic option.
Importantly, many Physicians are choosing first party earlier in the treatment Journey, this reflects a growing emphasis on earlier interface. Tension and is shift away from Legacy approaches such as the off label use of Ras Inhibitors or steroids.
based on our research about 70% of the addressable patients with IGN and property have elevated potential levels, but below 1.5 gram per gram,
with the proia threshold being removed in the fields by label at full approval,
2 segments, allowing for sustainable demand potential.
As we look to the remainder of the year,
Add with any rare disease product, seasonality could drive some variability quarter over quarter. If we expect that we will continue to identify new prescribers and that the use of sales by Will further deepen as foundational care, amongst current prescribers
We believe this will be driven by continued positive. Experience consistent with skills, Parish Superior clinical profile relative to historical standard of care.
And also driven by the anticipated final, pedo guideline publication and the potential Rams modifications, which may further simplify access for patients
During to fsds.
If approved feels very, would become the first approved therapy for fsds a progressive and often debilitating rare kidney disease with a significant unmet needs.
Given the feedback from the nephrologist and the broader fsds Community. We Believe fsds could be an even bigger opportunity with a more rapid uptake versus what we have experienced with our launch and idea in front of you.
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 an other quarter of strong, execution, execution, and meaningful growth for pillari amidst the evolving idea in fraud State treatment landscape.
We remain confident in our strategy and are encouraged by the feedback from the medical community and the continued momentum in U.S. adoption.
With a growing body of clinical and real world evidence.
Expanding prescriber engagement and the potential to serve more kid rare kidney disease patients through future labor. Expansions feels Barry is well, positioned to continue its leadership as foundational treatments.
Let me now turn the call over to Chris for the financial update. Chris.
Thank you, Peter and good afternoon all our financial Foundation continues to strengthen in the second quarter. Net product sales, grew approximately 82% over the same period last year. And we continue to make discipline investments in areas of high growth such as in building, further momentum for so far in IG and the properties preparing our Organization for a potential launch of those sparring fsgs, advancing manufacturing to restart enrollment in the pivotal back to bad study.
Beginning with Revenue in the second quarter, we generated us, net product, sales of 94.8 million as Peter highlighted, Phil spari continue to grow significantly in the second quarter generating, 71.9 million in US, neck product sales.
Biola and Fiola EC contributed $23 million in net product sales for the second quarter. These medicines continue to be a meaningful option for patients living with serious conditions.
But as we've highlighted previously, we anticipate more, generic competition in the coming quarters.
During the second quarter, we also recognize 19.6 million of licensed and collaboration Revenue which results in total revenue of 114.4 million.
Included in the licensing, collaboration Revenue line. This quarter is the previously announced 1 time 17 and a half million dollar Milestone payment from cslv for which resulted from the conversion of conditional approval of salar to full approval in Europe, earlier this year.
During the operating expenses, our research and development expenses for the second quarter of 2025 were 49.4 million compared to 54.3% in 2024.
The decrease in R&D is largely attributable to reduce clinical activity in the phase 3 Harmony study while we optimize our manufacturing effort.
On a non-GAAP adjusted basis, R&D expenses were $45.4 million compared to $50.6 million for the same period in 2024.
Selling General and administrative expenses for the second quarter were 76.2 million compared to 64.8 million for the same period in 2024.
The increase in sgna is largely attributable to increase amortization, expense related to Phil Spar royalties, as well as increasing investment to support the ongoing launch of Spar. And I J to property following full approval and preparing for a potential fsgs launched in January.
On a non-gaap adjusted basis. Sjn sgna. Expenses were 55.5 million for the second quarter, compared to 48.3 million. For the same period in 2024.
Total other expense net for the second quarter of 2025 was immaterial compared to net expense of 1.9 million in the same period in 2024.
Sense for basic. Share, compared to 70.4% in 2024.
On non-gaap adjusted basis. Net income for the second quarter of 2025 was 11.9 million or 13 cents for basic share compared to a net loss of 50.1 million or 65 cents per basic share for the same period in 2024.
As of June 30th 2025, we had cash cash equivalents and marketable securities totaling approximately 319.5 million. As a highlighted earlier, this cash balance reflects the net proceeds of the 17 and a half million dollar 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, space achievements in the future which should further enhance our financial flexibility.
Looking ahead. We expect continued Revenue. Growth driven by robust underlying demand for Salesforce and IGN the prophecy.
The strong balance sheet and potential additional incoming Milestone payments as well as a discipline 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 there.
Thank you, Chris. As you've heard our team has delivered strong performance across our priorities for the first half of 2025.
We are well positioned and eager to continue this momentum. My team and I are deeply motivated to support the rare disease communities we serve.
recently, I had the honor of attending the annual spark patient meeting of the IG and a property Foundation at the meeting. I heard many stories of resilience and of Hope.
This community has been Advanced advocating and hoping for a future with therapies developed for them, that can save off kidney failure. We are proud to be part of this journey and we are committed to the same goal for the fsgs and hcu communities. Now, let me turn the call over to nibby for Q&A nibby.
Thank you, Eric. Operator, we can now open up the line for Q&A.
Thank you. We will now begin the question and answer session to ask the question. You may press start, then 1 on your touchdown phone, if you're using a speaker-phone, please pick up your handset before pressing the keys to withdraw your question, please press the pound key. As a reminder, we ask that you limit yourself to 1 question. And if you have another question, please, rejoin, the queue.
We will now take the first question from the line of Joseph's watch from lyric Partners. Your line is open.
Your question, and congrats on this drawing progress. This quarter.
The 1 for fsgs, as you prepare for the Adcom, what do you anticipate the major topics could be? And how do you plan to respond to the fda's inquiries here? Do you have a sense for who might be on the panel itself? And given this group of experts will likely include nephrologists and cardiologists? How do you plan to effectively message your case to these 2 different groups of Physicians? Thank you.
Well, thanks so much for the questions joola. I will turn those over to you.
Thanks for the question. So good point. Anytime a rare disease goes before an advisory committee. There's certainly an educational component that we need to do about the disease and the pathophysiology, the pathophysiology,
Importantly, there's both neurologists 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 endothelial in 1 to reduce cardiovascular and renal outcomes.
So we certainly are prepared to educate the mix of panelists. I think importantly about the biologic plausibility supporting proteinuria as a validated endpoint, why eGFR is challenging in FSGS, and then followed by the strong clinical data showing Behrendt and meaningfully and significantly reduced proteinuria compared to an active comparator.
Great, thank you so much.
Thanks Paul.
All right. Next question comes from the line of anupam Rama from JP Morgan. Your line is open.
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 RIMS update for Phil Spari, 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.
Yeah, thanks for the question on the problem. And certainly we've been monitoring, uh, the the overall landscape with regard to the FDA Bill. Why don't you comment on, uh, what we've seen with our programs?
Uh what we've seen is basically through the lens of 2 s ndas both with the uh snda for the modification of the Rams frequency and the removal of the embryo. Fetal toxicity rims as well as the fnda for fsgs. Our interactions uh have been progressing as we'd expect and those uh 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. So we certainly see on in our part a very engaged and and active uh review uh review review team.
Thanks so much for taking your question.
Thank you.
Our next question comes from the line of Florida. Chico from wedbush, your line is open.
Uh, good afternoon. Thank you very much for taking the question. Um, another regulatory question as I might be able to, um, 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, um, on a regular Cadence as would be anticipated, but we detected another possible shift in Cedar, severe head count. So, just trying to understand is there, um, any expected timeline that you would receive notice for the advisory committee meeting. Thank you.
Thanks Laura for the question Bill. Why don't you take that 1.
Certainly, we don't know at this stage what the date of the advisory committee will be, but once we do know it, we will certainly provide that update given that. We have a Padua date of January 13th, it's reasonable to anticipate that the advisory committee should be taking place, sometime in Q4,
Thanks very much.
Thank you. Next question, is from Tyler van from TD security if your line is open,
Hi. This is Francis on for Tyler. Congratulations on a really amazing quarter. So just wondering what would it take after the Rems pufa to get the Rems potentially removed entirely? And on what timeline would you expect out to be?
Okay. Thanks Bill. Another 1 for you,
Sure, well, uh, thanks for the question. Our strategy has always been to pursue the ultimate removal of the REs, 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 to achieve the full removal in the second step. Historically, the FDA has been anchored on completing our PMR, following 3,000 patients for two years, and we're going to continue the dialogue to evaluate opportunities to potentially remove the REs ahead of that, following the Paducah date.
The 28th of this month.
Thank you breakfast. Next question.
Next is from from your Divine from Goen him. Security line is so
Hi. This is uh, thank you for taking our question and congrats on a great quarter. Uh you presented new data from this particles and Spartan studies at recent conferences. Uh how are these data being received by theology community? And do you anticipate further real world evidence of biomarker data to support as far as positioning as a disease modifying therapy?
Great, thanks for the questions. Joola why don't you comment on what your team has been hearing? When they uh data have been presented?
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 it's safe. And we have um, good efficacy when using combination and then to your point around the Spartan study we've been increasingly showing data showing the effect of silari 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. And so people are now starting to think that Phil spari works.
Directly within the kidney, on reducing the inflammation in the kidney, and that is part of the role for why it's Nefra, protective over the long term, and then your second part was additional data, we certainly want to validate this. We have large a large phase 3 study from which we have biomarkers that we can uh confirm and validate this and we plan to present that data in future congresses.
Thank you. Next question. Is from Marie. Wake up from Jeffrey. Saint is open.
Hi. This is Farina from my Congress on the study 2q number. Is there more prospective that you can provide on the Dynamics and breakdown of the growth contributions from stocking new patients and persistent traits and how could this look for the rest of the year?
All right, F, and thanks for the question. Peter, I'll turn that on to you.
Yeah, I think the question indeed, very strong performance both in 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, uh, Revenue growth
and then on the persistence rate and the new patients versus the carryover patients, from the last quarters,
Uh, yeah, so the persistence rate continues to be very high. There's been no change in in what we've seen and, uh, I think it's 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 remains very strong. So, um, it really is the underlying performance. And as you would imagine over time much of the uh, volume becomes continuing patients. Uh you know, and growth from, you know, adding new patients, that's precisely the dynamic that we're seeing. And we expect that
That to be sustainable for the foreseeable future.
Next is from your movies from City Group, your line is open.
Yeah. Hi, thank you. Um, I had a question on fsgs as you may know, there was a paper published in uh October 2024 was called prinary as an endpoint clinical trials for fsgs and they make a very specific point in their with respect to the reference to a quote sustained Crescent. And I'm just wondering if you could comment as to your understanding of what that means. Um, and whether it's associated, with any particular time point or not, uh, I know that in the study you you obviously had a 2.5 times better CR response rate uh, versus Iber Sarten in the double blind period. And I'm just wondering if that is consistent with the definition of sustained, Crescent, or sustained Crescent refers to a, a specific point in time as opposed to over the entire course of the trial. Thanks
Thanks for the question. Julia. I'll turn that 1 to you.
Yeah, thanks for the question. I was part of that manuscript, so happy to answer it. Um, so complete remission can occur at 1 point in time or it can be durable. And when there's not a, we didn't Define exactly what that meant. But I can tell you when we look at the duplex data and you mentioned the 2 and a half times greater rate of complete remission. What we commented at least within the duplex manuscript than the New England Journal. Is that 85% of those
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, uh, 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 and any questions that they have around additional ways in which we can analyze the data, we certainly can respond to them around that.
Yeah, maybe just some additional things that I'll add you go. Sorry. Uh, sorry your call, uh, anything you wanted to clarify before I add something else. No, I was just saying that was super, super helpful answer. Thanks. Yeah, 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 uh, FP, which was the pre-specified endpoint within our trial. Uh, that is sustained. Whether you look at it, 9 months, or 2 years. And, and the treatment effect, uh, continues to be consistent and significant. So, I think, you know, in the ways that we've looked at as Julie jalouse 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
Recognize that the analyses and conclusions from parasol are the largest, they reflect the largest analysis of, uh, registry data from from, uh, within fsgs. 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 parasol represent a very robust data set.
Got it. Thank you.
Thank you.
Our next question comes from the line of Mohit panel from Wells, Fargo. Your line is open.
Okay, thank you very much for taking my question and, and congrats on all the progress. Uh,
I would like to understand. I mean, you have a good Cadence of patient, start forms here. Uh, 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? Uh, 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.
Okay great. So thanks MIT. I think we got 3 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.
Yeah, let me talk to. Thank you, both for that question. Let me start with the last part on my the evolution of the market and how we see that.
Um I think the the marketing we have spoken about in the past especially after our full approval, we anticipate that the market potential is about 70,000 addressable patients for Phil's party in the US.
In about 70% of those patients are have elevated through the Neo levels, but below 1.5 Grand per gram. So, if you talk about penetration, it really depends on. Like, what segments are you talking about? Are you talking about the segments, 1.5, or greater? Or are you talking about the full Market potential? And after our full approval and no longer the proia threshold,
In our label, we have no access to the browser, uh, marketing. I think that's really where the opportunity, uh, 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, uh, early score as well. The median proton, urea level by, uh, 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 uh, and that allows for sustainable growth as well.
So that's how we see the market evolving, as well as the penetration component with regard to conversion. I think, based on my experience in rare disease, as well as what I've seen from rare.
Uh disease benchmarks. I would say that we are at the at the top end. Uh best practice on conversion, what you would expect in in rare disease.
Peter. And, but 1 thing that I'll add just if you look at the cumulative psf from from uh, 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 1 of the strongest rare kidney disease, launch uptakes over the last 5 years. But that penetration rate, reflects that we have significant room to grow. And this is 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.
Got it. And then if I asked, could I ask a follow-up. I mean, from the patient start from point of view, given that uh there is another player on the market. How should we think about the the the patient starts from? Uh Cadence going forward. Given that you have a competition here. So that's the part. We love to understand and levels and expectations here. Thank you.
Yeah, what we've not provided guidance. So I just want to be, I want to be cautious of of, of not doing that, but I will reflect on what Peter has talked about in the last 2, uh, quarters. Which is that the new Baseline for new patient? Uh, star forms is is around 700, we clearly, you know, achieved exceeded that in this first quarter of having a a direct uh competitor. Uh, you know, and growing treatment options within this space. Um, we expect that this opportunity to continue and Peter can certainly talk more about the Dynamics that we expect with a with a new treatment option within the end of the day in class Peter.
yeah, I think just to put an explanation point on some of the points that you made, I think,
A mo we think involving treatment Paradigm. We delivered our strongest water 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 entrance coming to the market, everything we have seen so far is consistent to our expectations.
Um and new classes, new therapies coming to the market 1. Further reinforces the, urgency to treat those patients earlier and more aggressively and 2. It also grows the endothelial in Market
Um, but I think the market is big enough to, big enough to earlier point.
Strong profile of your Spar in the recognized profile in the long-term data that we have. I'm confident that we will remain the market leader.
Got it. Helpful and congrats again. Thank you.
Thank you.
Our next question comes from the line of the heart, a grow from cancer. Your line is open.
All right. Thank you for taking my questions and congrats on the quarter. Um, so another 1 FSS, um, in the phase 3, I know you have disclosed egfr at the end of the trial, but we are not seeing the AFR Curves in fsgs. So maybe even qualitatively could you comment on what to expect when the girls will be presented during the, or could be presented during the Adcom and the latest thinking on what the FDA would like to see on egfr here and secondly, um, on Ian, if you could comment on the gross to net Trends, you saw in 2 Cube and expectations for rest of the year. Thank you.
Okay. Uh, Julie. Why don't you take the 2 questions on egfr and Chris? You can take the course to that question.
Certainly what the parasol analysis and recommendation in the move to focus on proteinuria at the surrogate endpoint for full approval on fsgs, we haven't spent much time published publishing our egfr data and I don't anticipate that to be a large focus of our advisory committee. Of course, we certainly can show the curves. It's consistent with, what you would anticipate. We had a wash out of uh, Ras inhibitors for 2 weeks and then
And we initiated the 2 2 therapies per cent in and herbick certain, we had an acute decline in egfr, and then, uh, it's relatively stable thereafter, or you have some decline as you can see by the absolute change over time, but nothing surprising. If we show our egfr curve, 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.
We mentioned FDA is not uh, 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.
Thanks for the question on on growth in 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 and and 324 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.
Thank you.
Thank you.
Next is Tyson zamansky from Bank of America. Your line is open.
Good afternoon. Thanks for taking our question and congrats on the progress.
Um, maybe at this point in the launch, do you have uh, uh greater sense of where the the headwinds are bottlenecks are in terms of uptakes, whether it's on the prescriber side or patient payer logistical or, or administrative, um, 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 1 of your earlier, comments regarding these new segments of the market. 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 or, you know, not as advanced thanks.
Jason, thanks for the questions. Peter, why don't you take both of those?
Yeah, I think the Asian for uh, for that question.
With regards to your first.
Question on potential bottlenecks.
I think I most of all I'm really pleased with the products that we are making but if I have to think about when I think about like our launch in the last 2 and a half years, I think the name.
uh,
Issue we had to overcome was the urgency to treat.
And change treatment for those patients.
And what really will help is more more treatment options coming to the market together with the Kido guideline to reinforce that same methods that patients should be recognized.
Uh and treated more aggressively early on. I think it's it's it's it's going to help to further develop this market. So I think this is really a marketing development.
on your second question, with regards to like the new painting segments, like the the lower f****** area still elevated Pro levels, but lower than 1.5
The higher potential level patients, like 1.5 or greater. It is not in common that they actually do monthly lab testing. But when you talk about patients at the lower part of the neural levels, it's more common that they are seeing every 3 months by the neurologist. And as part of the routine, monitoring they do the measurements. So, I think our ramps modification is right on time where we are in the loan, so that's why I see the opportunity moving forward.
Got it. Thanks for the caller.
Thank you.
Next is from Greg Harrison from Scotia Bank. Your line is open.
Hey everybody. Thank you for taking our question and congratulations on the quarter. This is Joe Thomas on for Greg. Um just thinking on the patients, start forms in the quarter. I wonder if you might be able to comment on the distribution as the quarter went along. Did you see any lumpiness or any acceleration as the quarter was going and how should we think about that going forward? Thank you.
Go. Thanks for the question. Peter. Why don't you take that 1?
Thank you for that question. As I mentioned earlier, you're really pleased with the the strong performance. This, this quarter.
um, as in
As a typical in rare disease, there is often variability month over month. But overall we have seen is consistent in during the quarter and that continues in July as well.
Great helpful. Thank you.
Thank you.
Next is Alex Thomson from Steve. Your line is open.
Hey, great. Uh, thanks for taking our question. Uh, maybe shifting over to Europe, you know, to the extent to which you have visibility on CSL.
Launch, you know, when should we expect to kind of see meaningful royalty revenue? Thanks.
Yeah, so thanks so much. Alex for the the question we do want to defer to uh cslv for to comment on their performance. Um Chris I'll let you uh discuss a bit more on uh expectations for royalties.
Yeah, happy to do that. Thanks Alex. Um, you know, I think as Eric mentioned, we'll we'll just defer to CSL V4 on any kind of guidance. But as you would imagine, they're now um, you know, through the early stages of going through the country by country process and as that happens and they gain reimbursement, we would expect Revenue to begin picking up overseas and in return, royalties coming through to us. So, uh, more to come as cslv for continues to navigate that and report and as soon as we have more that we can share, we'll be happy to do so.
Great. Thank you.
Thank you.
Thank you. Thank you. And gentlemen, this concludes the question and answer session of today's conference call. I'll hand the call back to Navy.
Thank you everyone for joining today's call. Have a great rest of your day.
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