Travere Therapeutics, Inc. ($TVTX)

Good afternoon, and welcome to the Travere Therapeutics Business Update Conference Call. Today's call is being recorded. At this time, I would like to turn the conference call over to Nivi Nehra, Vice President, Corporate Communications and Investor Relations. Please go ahead, Nivi.

Thank you, operator. Good evening, and thank you all for joining us today on such short notice. Earlier today, we announced the FDA has approved FILSPARI in FSGS. A copy of the press release, along with the slides that we'll be referencing on today's call, can be found on our corporate website. Today's call will be led by our President and Chief Executive Officer, Dr. Eric Dube. Eric will be joined in the prepared remarks by Dr. Jula Inrig, our Chief Medical Officer; and Peter Heerma, our Chief Commercial Officer. Dr. Bill Rote, our Chief Research Officer; and Chris Cline, our Chief Financial Officer, will join us for the Q&A. Before we begin, I'd like to remind everyone that statements made during this call regarding matters that are not historical facts are forward-looking statements within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not guarantees of performance, they involve known and unknown risks, uncertainties and assumptions that may cause actual results, performance and achievements to differ materially from those expressed or implied by the statement. Please see the forward-looking statement disclaimer on the company's press release issued earlier today as well as the Risk Factors section in our Forms 10-Q and 10-K filed with the SEC. In addition, any forward-looking statements represent our views only as of the date such statements are made, April 13, 2026, and Travere 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?

Thank you, Nivi. Good evening, and thank you all for joining us. Earlier today, we announced that the FDA has approved FILSPARI to reduce proteinuria in adults and pediatric patients aged 8 years and older with focal segmental glomerulosclerosis or FSGS, without nephrotic syndrome. With this approval, FILSPARI becomes the first and only FDA-approved medicine for FSGS, a milestone that fundamentally changes what it means to be diagnosed with this condition. For patients and families, this is more than a regulatory event. It is the beginning of a new path forward, where for the first time, there is a medicine specifically approved to reduce their proteinuria, which is central to slowing disease progression. We now have the ability to redefine the treatment landscape. Importantly, the approved population spans across types of FSGS and aligns closely with how the condition is managed in clinical practice, where patients are routinely assessed and treated based on whether they have current nephrotic syndrome. This approval is based on data from our Phase III DUPLEX study and reflects alignment with the FDA on a well-defined population where the evidence demonstrates meaningful clinical benefit, including proteinuria, eGFR and kidney outcomes. From a commercial perspective, FSGS marks an additional indication for FILSPARI, and we are ready to launch. Together with IgA nephropathy, we believe the addressable patient population for FILSPARI now exceeds 100,000 patients in the U.S. We will be leveraging our experienced rare nephrology teams, established physician relationships and proven success in launching FILSPARI as a foundational care in IgA nephropathy to drive a successful launch in FSGS. This is an extraordinary day for the FSGS community and a defining moment for Travere. It represents both the culmination of years of perseverance and the beginning of a new chapter. Today's approval further strengthens our strategy to accelerate growth in our leadership position in rare kidney disease. Before I turn the call over to Jula, I want to extend my sincere gratitude to the patients and caregivers who participated in our studies, shared their stories and advocated for new treatment options, the physicians and advocates who've worked alongside us for many years and who, along with regulators, were instrumental in changing the way FSGS is studied today. I would also like to thank the entire Travere team whose dedication and perseverance over the last 10-plus years made today possible. With that, I'll turn it over to Jula to walk through the approved indication in more detail. Jula?

Thank you, Eric. As a nephrologist who treated patients with FSGS for decades, today's approval represents an incredible advancement for the field and most importantly, for patients who until today had no approved medicine. FSGS is a rare progressive condition that frequently leads to kidney failure. For many patients, the journey begins with abnormal lab findings, mainly elevated protein in the urine called proteinuria or nonspecific symptoms such as fatigue and in some cases, swelling, eventually leading to a kidney biopsy confirming FSGS. From there, treatment can be complex and iterative with physicians trying different off-label therapies over time, typically starting with steroids and then moving to other immunosuppressive therapies. In the absence of a clearly effective medicine, this often becomes a process of trial and adjustment rather than a defined treatment path. Proteinuria is a hallmark of podocyte injury, is a key driver of disease progression and is strongly associated with long-term kidney outcomes, making it a critical treatment target. Persistent proteinuria leads to irreversible kidney damage, which over time requires treatment with dialysis or kidney transplant. And even after transplantation, FSGS recurrence remains a real and frightening possibility for many patients and their families with up to 55% recurrence rates post transplant. And in some cases, the disease returns almost immediately. As Eric highlighted, FILSPARI is now the first medicine ever approved for FSGS and is indicated to reduce proteinuria in adults and pediatric patients 8 years and older without nephrotic syndrome. Importantly, the approved indication for FILSPARI reflects a patient population defined by clinical characteristics. Now many of you will recall that the approval we were originally seeking did not draw this distinction with nephrotic syndrome. Early last month, we met with the FDA to discuss the ongoing review and for the first time, they highlighted this path for patients without nephrotic syndrome based on the strength of the data on proteinuria, eGFR and kidney failure in this patient population. Nephrotic syndrome is a clinical diagnosis, which commonly refers to meeting all 3 of the following criteria: high levels of proteinuria greater than 3.5 grams per day, low serum albumin of less than 3 grams per deciliter and the presence of edema. Notably, this is distinct from nephrotic range proteinuria on its own. For example, a patient with 4 grams of proteinuria, but without low serum albumin would be eligible for FILSPARI. Also, a patient who has 4 grams of proteinuria, edema and low serum albumin could become eligible after they experience a change in any one of these criteria after treatment with alternative approaches. In clinical practice, when a patient presents with active nephrotic syndrome, they're typically evaluated promptly, including with a kidney biopsy and started on immunosuppressive therapy such as steroids. This approach is based on the KDIGO clinical practice guidelines, which recommend assessing patients based on nephrotic syndrome status and using immunosuppression for those with nephrotic syndrome versus optimizing foundational care among those without nephrotic syndrome. Importantly, FSGS is a relapsing and remitting condition. And once a patient with nephrotic syndrome has been stabilized with steroids or other immunosuppression, they may become eligible for long-term treatment with FILSPARI. Patients without nephrotic syndrome represent a population whose disease progression is initiated by podocyte injury and also driven by maladaptive glomerular hemodynamics and pro-inflammatory and profibrotic pathways. All of these mechanisms are directly targeted by FILSPARI's dual endothelin and angiotensin receptor blockade. This is supported by the DUPLEX study, which enrolled a broad population of patients where those without nephrotic syndrome demonstrated even more pronounced treatment effects compared to irbesartan across proteinuria, kidney function and kidney outcomes. The data in patients without nephrotic syndrome included robust, durable and nominally statistically significant reductions in proteinuria with a 48% reduction for FILSPARI-treated patients compared to 27% with irbesartan at week 108. This subgroup also had a favorable treatment difference of 1.1 mL per minute in mean eGFR from baseline to week 108 compared to maximum dose irbesartan. As noted in our corporate deck, treatment effects on eGFR total and chronic slope both also meaningfully favored FILSPARI over irbesartan and each were nominally statistically significant. And progression to kidney failure over the 2-year measurement period occurred in less than 2% of patients without nephrotic syndrome treated with FILSPARI compared to 8% with irbesartan, which was also nominally significant. FILSPARI was generally well tolerated with a safety profile comparable to irbesartan and consistent across clinical programs as well as across clinical subgroups as noted in our label. FILSPARI will be available through the same REMS program that physicians are familiar with for IgA nephropathy. From a medical affairs perspective, we look forward to continuing to educate and engage with the nephrology community through peer-to-peer forums and field medical education or engagement to support informed clinical decision-making as physicians integrate FILSPARI into their FSGS treatment plans. This approval represents an incredible advancement for the FSGS community who have waited far too long and we are profoundly grateful to them, their families and the many physicians whose dedication and perseverance made this moment possible. This approval exemplifies a clear commitment to do better for people living with rare disease such as FSGS. I also want to thank our internal teams at Travere, who have worked tirelessly and with urgency to accomplish this outcome for the FSGS community. I'd now like to pass the baton over to Peter for a commercial update. Peter?

Thank you, Jula. We are incredibly excited about today's approval and the opportunity it creates to bring FILSPARI to the FSGS community. From a commercial perspective, this is a highly actionable opportunity grounded in a patient population that is both clearly defined and actively managed in clinical practice. Nephrologists understand the grave prognosis for most patients with FSGS and are actively seeking to reduce proteinuria in an effort to slow disease progression and preserve kidney function. Our market research reinforces both the urgency and the opportunity. More than half of the nephrologists believe their patients with FSGS will progress to kidney failure within the next 10 years, underscoring the severity of this disease and the need for earlier intervention. Additionally, more than 80% of the nephrologists view FSGS as an exceptionally high unmet need and one of the most challenging diseases to manage with less than 10% of patients today considered optimally managed. There is a clear need for an effective non-immunosuppressive medicine that can provide long-term proteinuria reduction. The vast majority of surveyed nephrologists indicate that novel non-immunosuppressive therapies are highly desirable in FSGS and recent market research has further shown FILSPARI to be the most familiar and desired product candidate amongst physicians who treat this rare disease. Based on our current estimates of the -- for the approved indication, we believe there are currently more than 30,000 biopsy and genetically confirmed patients with FSGS, who do not have nephrotic syndrome under the regular care of a nephrologist in the U.S. We expect this number of addressable patients for FILSPARI to grow over time as diagnosis continues to improve and awareness increases. And we are building upon the strength with FSGS as FILSPARI is currently the #1 most prescribed medicine approved for IgA nephropathy in the U.S. And there is a large overlap in the prescriber base for IgA nephropathy and FSGS. So most of the nephrologists are already familiar with FILSPARI and many already have experience in their IgA nephropathy patients. We also see a meaningful opportunity to expand our prescriber base, including pediatric nephrologists as we extend our reach across the FSGS treatment landscape. Regarding access, also here, we have established a robust foundation. FILSPARI is already included in many formularies and payer plans for IgA nephropathy, and we have been educating payers on the high unmet need of FSGS and the lack of approved medicine. We will now educate payers on the value story of FILSPARI for patients with FSGS without nephrotic syndrome. In the coming months, we expect a supportive access environment to build. As with any new indication, we recognize that a level of education will be required to support broad adoption. In the early stages of the launch, our commercial and medical teams will be focused on educating physicians, payers and patients on the approved population, the clinical data and how FILSPARI fits into the treatment decision-making process. While education will be necessary to build momentum, we are not starting from scratch. We have already established a commercial team of over 100 field professionals who spent years building relationships in the nephrology community. That team has delivered real results. They have helped drive FILSPARI to become the most commonly prescribed therapy that is approved in IgA nephropathy to date. And now we are able to take that same experience, relationships and executional strength in applying it towards a successful launch in FSGS. With Travere Total Care, we also have an established patient services model in place for FILSPARI that can be directly applied and customized to FSGS patients, positioning us to immediately execute effectively and support education on this new indication. Just as they do now in IgA nephropathy, eligible patients with FSGS and their caregivers will receive personalized support, including REMS coordination, reimbursement assistance and co-pay support through Travere Total Care. Overall, we see a clear and meaningful opportunity to drive adoption within the approved population as we work to build momentum through continued education. In addition, we expect there will be cross-indication synergies with IgA nephropathy as physicians gain experience with FILSPARI in FSGS, which we believe will support adoption across both indications. In closing, we are incredibly excited and ready to launch FILSPARI as the first and only approved medicine for FSGS, and our team is well prepared and ready to serve this patient community. Launching in FSGS, together with our continuing IgAN performance will position us for meaningful and durable FILSPARI growth. I'll now turn the call back over to Eric for his closing comments. Eric?

Thank you, Peter. Recently, the team at Travere and I had the opportunity to meet Madi. She was diagnosed with FSGS at just 4 years old and spent much of her childhood in and out of hospitals, often unable to participate in everyday childhood moments because of her FSGS. She shared with us and I quote, "I often missed birthday parties, school and recess when I was forced to sit on the bench alone because I couldn't keep up with the other kids. I remember being embarrassed at my kindergarten graduation when my legs gave out on me because I've been standing too long." What stood out to me was not only her resilience, but the role that she and her family played in advocating for progress in this field. Because of that effort, Madi was able to participate in DUPLEX at the age of 9 years old and ultimately experienced meaningful improvements that allowed her to regain her energy and begin living a more normal active childhood. In her words, "I was finally able to live my life and be free from feeling sick all the time." She's now 15 years old and still thriving. Stories like Madi's are why we are here today. This approval underscores our commitment to transforming care for patients with rare kidney diseases and importantly, to improving what patients and families can expect after diagnosis. Today marks a defining moment as we now turn our attention to ensuring patients can access FILSPARI as early as possible because we know that time matters in FSGS. It also begins the next chapter of significant growth for our company. And finally, to the FSGS community, thank you for never giving up hope and for inspiring us throughout this journey. We would not be here today without you. Your courage in participating in our studies, your voices and advocacy and your unwavering belief in progress. You are the reason we do this work. I'll now turn the call over to Nivi for Q&A. Nivi?

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

[Operator Instructions] We will now take the first question from the line of Joe Schwartz from Leerink Partners.

Congratulations to the whole Travere team on this great win. I guess I'll ask if you guys have a sense of the percentage of patients who initially present with nephrotic syndrome who might ultimately receive a confirmed FSGS diagnosis and might ultimately be label eligible?

Joe, thanks so much for the question. Jula, I will turn that one over to you.

So when a patient presents with nephrotic syndrome, they typically get a biopsy very quickly. And for nephrotic syndrome, you want to find out if they have FSGS, but there are other causes other than FSGS. So it's harder for me to give you an overall prevalence based on nephrotic syndrome or not. But I can tell you, once they get a -- if they've got a diagnosis of FSGS, how many patients might have nephrotic syndrome at a single point in time. And that data comes from the DUPLEX trial. So in our study, patients who at the time of enrollment who had known FSGS, less than 20% of them had active nephrotic syndrome. And recall, these patients are going to be treated. So they might go in and out of nephrotic syndrome over time. It's not a static condition because this is a relapsing and remitting condition.

Our next question is from Anupam Rama from JPMorgan.

This is Priyanka on for Anupam. Congratulations on the full approval. Just a question on the sales team that's in place. I understand that there will be a proportion that will need to focus on pediatric nephrologists. I was just curious how much larger would you consider growing the broader sales team to help cover that physician population?

Priyanka, thanks for the question. Peter, I'll turn that one over to you.

Absolutely, Priyanka. Great question. And our sales team has already been expanded. We did that at the end of last year. So they're in place. Historically, we have spoken about we have focused on 6,000 nephrologists that cover about 90% of the IgA nephropathy patient population. We're expanding that now also for pediatric nephrologists. So we are now focused on about 7,000 nephrologists in the U.S., and that includes pediatric nephrologists. And maybe also important to note, and I've spoken about this in the past, there's a high overlap between those physicians that treat IgA nephropathy and FSGS. So we build upon a base that is already familiar with FILSPARI.

Our next question is from Vamil Divan from Guggenheim Partners.

Let me add my congrats also. I know it's been a long process to get to hear. So I guess my question is really around sort of the patient population here because you -- before today, you were already saying 30,000 patients that could be candidates for FILSPARI, but I thought that was more based on primary and genetic FSGS. Now this seems to be a broader approval for secondary, but then you have the exclusion of patients with nephrotic syndrome. But your number is still just saying over 30,000. So I would think the population is maybe much larger than 30,000 now. But does that sort of wash out the sort of broader indication with then removing nephrotic syndrome? So if you could just sort of walk us through the numbers there a little bit on what the secondary population means or maybe you don't think it would get much uptick there if there's other options or -- and anything around how this broader indication could impact, how you think about it commercially would just be very helpful.

Sure. Vamil, thanks so much for the question. Yes, we do see that today, there are over 30,000 patients that are diagnosed and under the care of a nephrologist that would be eligible based on this approval. What we do -- what we have done is we've added those patients that we believe currently have secondary FSGS and removed the proportion that we believe overall would have current nephrotic syndrome. Now over time, we do believe that with growing awareness, with the availability of an approved medication that patients may be diagnosed and biopsied earlier, which would allow for that addressable population to grow over time. So we do see this as a very meaningful opportunity. And as we've seen in other rare diseases, we do expect the addressable population to grow.

Your next question is from Laura Chico from Wedbush Securities.

Congratulations. Jula, you mentioned that the nephrotic syndrome discussion with FDA was somewhat new. And I'm wondering if you could expand on that a little bit around the labeling discussions with nephrotic syndrome. What would be necessary to demonstrate, I guess, in a clinical trial setting to expand FILSPARI's label to encompass that? And is that something that you would pursue?

Thanks, Laura. Jula?

Yes. As I mentioned in my prepared remarks, this occurred very recently. In our meeting with the FDA last month, and there were a couple of reasons why they honed in on this patient population. First, the magnitude of the treatment effect against an active comparator on proteinuria was greater in this population versus the overall population and versus those who have active nephrotic syndrome. The additional aspect is that there was also meaningful and statistically significant effects on eGFR as well as on kidney failure endpoints. And I do want to highlight that even though we don't have as great of treatment effect on proteinuria in the patients with active nephrotic syndrome, it's not that the therapy doesn't work. It's that in this patient population, the treatment effect against an active comparator wasn't as great, and it's a noisier patient population. So the signal to noise, it's messy in this patient population. And then you additionally asked about what it would take. We do believe that the vast majority of patients with FSGS, whether they're eligible today or will be eligible in the future, can potentially benefit from FILSPARI. And as I mentioned earlier, less than 20% of patients with FSGS have nephrotic syndrome at a single point in time. And it's important to consider that if a patient has 4 or 5 grams of proteinuria and low albumin and edema, if you treat them and change one of those characteristics, and remember, these are sick patients, so you're trying to stabilize them. They can get FILSPARI in the future once they get stabilized. So we are very pleased and believe that this is a broad approval for patients over time.

And next question is from Tyler Van Buren from TD Cowen.

Congratulations on the approval, a tremendous outcome for Travere and for patients. Just wanted to -- obviously, the addressable population for IgAN is significantly larger than FSGS. But I want to get your latest thoughts on what you believe the ultimate penetration of FILSPARI will be in FSGS compared to IgAN over the long term?

Peter, would you like to take that?

Yes, happy to take that question, Tyler. And you're right. I mean we expect that we will see a more rapid uptake in FSGS relative to what we saw in IgA nephropathy for several reasons. One is we don't have to establish the unmet need like every nephrologist you speak with. They are very well convinced that those patients need treatment urgently and that new treatments will be -- are necessary. And as I mentioned earlier, this is largely the same call point as that we have with already experience in a large amount of physicians and FILSPARI is already established well. Having said that, we also need to educate the stakeholders, both the nephrologists, the patients and the payers, and that may take time. But overall, we see a more rapid uptake in this patient population relative to IgA nephropathy.

Yes. Thanks, Peter. And Tyler, let me add that we see both IgA nephropathy and FSGS as very meaningful opportunities for future growth. And a patient with IgA nephropathy and FSGS deserve equally FILSPARI. As we look out, we see the potential for peak year sales over $3 billion when we look at the combination of these 2 indications. And our job right now, as Peter mentioned, is to make sure that we're out there very quickly because patients deserve it and to be able to educate physicians on this label and the opportunity to do better in FSGS.

The next question is from Prakhar Agrawal from Cantor Fitzgerald.

Congratulations on the approval. Maybe just firstly, you mentioned less than 20% have active nephrotic syndrome. Could you clarify if that's relevant for secondary FSGS as well? And what could be the uptake be in primary versus secondary FSGS given secondary population was not included in DUPLEX, but a much larger segment overall? And maybe just a quick follow-up, if you could confirm the pricing here for the 800-milligram dose. Is it double the price of IgAN? Congrats again.

Thanks, Prakhar. I'll take the last part first on pricing. So the -- yes, the per patient, the dosing is higher for adult patients with FSGS. The per pill is the same. So a patient with FSGS would have a higher cost to payers. And our goal overall is to make sure that every single patient has access to FILSPARI that is eligible. Jula, I'll turn that first part of the question to you around active nephrotic syndrome and primary versus secondary.

Certainly. So the rationale for having patients with active nephrotic syndrome having a different treatment algorithm, and this is in the Kidney Disease Improving Global Outcomes Guideline is because you're trying to identify patients with clinical characteristics with laboratory findings who are more likely to have primary FSGS and treat -- be needed to be treated with an immunosuppressive therapy. So that's why that characteristic and classification is even there because patients who do not have primary FSGS typically don't have nephrotic syndrome. So your question was at the heart of it, how many patients with secondary FSGS or even undetermined cause or genetic have active nephrotic syndrome, it's a low proportion. When we took an all-comers population, primary genetic, we did try to rule out secondary, but we've got patients with undetermined cause. We do see that at that single point in time when patients got into DUPLEX, as I mentioned earlier, less than 20% had nephrotic syndrome. But it's not a typical presentation for patients with secondary FSGS.

And with regard to uptake, I think it's too early for us to comment on that. I think we see that there is a high unmet need and an urgency to really intervene with better therapies like FILSPARI. So our goal is to make sure that we're reaching all of these patients. And I'm not sure that we've heard much in terms of physicians saying that they're not excited across the board. We really are going to be trying to reach every one of these patients.

Our next question is from Mohit Bansal from Wells Fargo.

This is Sadia on for Mohit. Congrats on the approval. I'm just wondering on the question of nephrotic syndrome. In clinical practice, when doctors think about nephrotic syndrome, is the focus on that proteinuria level that patients have? Or are they also focused on edema and the albumin criteria that you outlined?

Thanks, Sadia. Jula, I'll turn that one over to you.

They're focused on all of them. So in order for a patient to have a definition -- a clinical definition of nephrotic syndrome, they need really elevated proteinuria, low serum albumin. So that's also part of it and edema. So it really is the triage of all 3 of those in order for someone to have active nephrotic syndrome. And as I said earlier, the reason you want to classify someone according to that clinical criteria is because you treat them differently. You're going to give steroids to a patient who has active nephrotic syndrome or other immunosuppression, and you're going to support them with supportive therapies if they don't have that clinical presentation. So it is an important characteristic, something that we look for to try and figure out how we should appropriately treat that patient initially.

The next question is from Gavin Clark-Gartner from Evercore.

You have [ Ivy ] on for Gavin. Congratulations on the approval. Could you provide some color on if you'll be providing FSGS-specific PSFs moving forward? Or any metrics to break out FSGS versus IgAN contribution and whether your gross to net will now change as you launch FSGS2? And the second part of my question is if you could comment on the current discontinuation rates seen in IgAN and how FSGS could compare to that?

Okay. Chris, I'll turn the first part over to you. And Peter, you can talk about discontinuation rates.

Perfect. Thanks for the question, [ Ivy ]. First on the PSFs and the planned reporting for metrics, no change at this point. We'll, of course, continue to evaluate as we move forward. But the plan for now is to provide aggregate PSFs and revenue. And then on the gross to net front, no change there. The expectation remains the same for this year. We're anticipating gross to net in the mid-20s for the full year. So Peter, I'll turn the one over to you.

Yes. With regards to the discontinuation, what we have seen is very high compliance and persistence for FILSPARI in IgA nephropathy, and I'm expecting similar rates for FSGS because this is an even more -- even higher motivated patient population that has been waiting for the approval of FILSPARI. So I'm expecting a high compliance and persistence rate there.

Yes. And Peter, if I can, I'm just going to complement your team with Travere Total Care. They do an outstanding job of supporting these patients throughout their journey. I think that, that is something that we will continue, as Peter mentioned, for the FSGS patients as well.

Next question is from Maury Raycroft from Jefferies.

I'll add my congrats on the approval. As it relates to PSF, do you have perspective into numbers of eligible patients waiting for therapy at launch? And could there be a bolus effect? And I also wanted to check on whether there are any new post-marketing requirements from FDA?

All right. Peter, why don't you take the question on eligible patients, and Bill will give you your first question on post-marketing.

Excellent. Well, Maury, thanks for that question. Your question was about warehousing. We do not expect a significant bolus of patients as FSGS patients are seen on a regular base by their nephrologists. Typically, they see the nephrologists every 3 months. And so I would think that is a natural cadence for future uptake, especially if you realize how busy, especially community nephrologists are. So not a significant bolus, but a steady uptake I'm anticipating.

And with respect to post-marketing requirements, we had no new requirements added with the approval of FILSPARI for FSGS.

The next question is from Yigal Nochomovitz from Citigroup.

Yes, congratulations as well on the approval. I was just curious, given that you mentioned that this topic of nephrotic versus non-nephrotic syndrome came up very recently last month. I'm curious if you could elaborate now on what was asked at the end of December in 2025 when you got those late data requests from the FDA. Were there clues there that they were looking down this path regarding nephrotic or non-nephrotic? Or was that something entirely different?

Bill, I'll hand that over to you.

Yes. No, it's a good question. This was a recent development. As you've heard on the call, we learned about the agency's preference for this subgroup early in March. As we stated before, the IRs that we received right at the holidays, those were related to the overall clinical meaningfulness of FILSPARI. And there, they were looking at the overall population in DUPLEX, and it wasn't split based on any subgroups at that point.

Okay. And then if I could just follow up, the definition of the nephrotic syndrome, is that a single point in time? Or does it have to be measured at multiple points to qualify?

Jula?

It's one single point in time is typically how you use it to define a patient who does or does not have active nephrotic syndrome. And again, this is a relapsing and remitting condition. So a patient can get treated with an immunosuppressant therapy today as well as other supportive care if they've got active nephrotic syndrome with the goal of changing their condition. So it certainly can change over time. So a patient who may not qualify at one point in time could qualify if there's a change to any one of those parameters. Maybe their proteinuria goes down or their albumin goes up in their blood or their edema goes away, treat them with the diuretic and the edema goes away, they would no longer be considered to have active nephrotic syndrome.

Our next question is from Jason Zemansky from Bank of America.

Congrats on the approval. Peter, maybe to connect the dots on some of your comments regarding commercial dynamics, but what are the key levers you're focused on in terms of driving adoption here? I mean I know you've mentioned education and having the large bolus of patients. But what are the, I guess, primary hurdles in getting a patient on treatment?

Yes. I don't think I set a large bolus of patients. Just to clarify on that one. I think for FSGS, I mean, this is highly anticipated. And as I mentioned before, we do anticipate a faster uptake relative to our IgA nephropathy launch because like FILSPARI is a known entity for many of these nephrologists with an overlap of over 80%. But still, you need to educate them. I mean they need to be educated that FILSPARI is now approved, what the patient population is. The same you do that to nephrologists as well as the payers and the patients. So this is the regular uptake, educating the prescriber base, the patients and the payers. But we're building on strength. I mean that's what I mentioned earlier. FILSPARI is already included in many of the formularies, the payer plans. So we build upon that access approval as well. So I think we're in a very strong position but we still need to educate the individuals, and that's our core focus in the next few months.

Our next question is from Alex Thompson from Stifel.

Congrats on the approval. Maybe one on IP. You've talked about in the past like working on expanding IP for FILSPARI and potentially extending exclusivity beyond 2033. Could you talk a little bit about the progress there and if we should expect any developments in the near future?

Alex, thanks for the question. So our current planning assumption, as you state, is 2033, and we do have several applications, some of them ongoing review. And there's no specific updates at this time, but I can say that they are actively being reviewed and we're actively working on them. And certainly, having today's approval, we believe, gives us continued support of the LOE, including our expected orphan drug exclusivity.

Ladies and gentlemen, this concludes the question-and-answer session. I'll hand the call back over to Nivi.

Great. Thank you, everyone, for joining us this evening. We're very excited about our path forward, and we'll continue to share more updates along the way. Have a great rest of your evening.

Ladies and gentlemen, this concludes the conference call. Thank you for your participation, and have a nice day.