Travere Therapeutics, Inc. (TVTX) Earnings Call Transcript & Summary

Good day, and welcome to the Travere Therapeutics Corporate Update Call. Today's call is being recorded. At this time, I'd like to turn the conference call over to the Vice President of Investor Relations, Naomi Eichenbaum. Please go ahead, Naomi.

Thank you, and thank you all for joining us today. Earlier today, we announced the accelerated approval of FILSPARI. A copy of the press release, along with the slides that we'll be referencing on today's call [indiscernible]. Today's call will be led by our Chief Executive Officer, Dr. Eric Dube. Joining Eric for the prepared remarks will be our Chief Medical Officer, Dr. Jula Inrig; our Chief Commercial Officer, Peter Heerma; Our SVP of Research and Development, Bill Rote; and our Chief Financial Officer, Chris Cline. 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 future 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 such statements. [indiscernible] forward-looking statement disclaimer in our accompanying deck as well as the Risk Factors section of the quarterly and annual reports on Form 10-Q and Form 10-K filed with the SEC. In addition, any forward-looking statements represent our views as of today, February 17, 2023, and we specifically disclaim any obligation to update such statements to reflect future information, events or circumstances. With that, it is my pleasure to turn the call over to our Chief Executive Officer, Dr. Eric Dube. Eric?

Thank you, Naomi, and thank you, everyone, for joining today's call. We are incredibly excited to announce the FDA accelerated approval of sparsentan under the brand name FILSPARI, the first and only nonimmunosuppressive therapy for the reduction of proteinuria in adults with primary IgA nephropathy, or IgAN, at risk of rapid disease progression. Today marks an incredibly important milestone for the patients living with IgAN, raise the rare kidney disease community and for Travere. First off, I would like to thank everyone who contributed to getting us here today, especially the FDA and the patients and their caregivers whose participation in our ongoing trials has led to FILSPARI's approval. I would also like to congratulate and thank our employees, all of whom have been dedicated to advancing FILSPARI to this historic milestone. Additionally, thank you to the investment community for the continued support that has enabled our development of this program to date. At Travere, we are driven by our mission to identify, develop and deliver life-changing therapies to people living with rare diseases around the world. Specifically, we focus on therapeutic areas where there are no or limited treatment options like IgAN because we know that if we are successful in pursuing our mission, we can create real hope and make a difference in patients' lives. IgAN is a rare disease that attacks the kidneys, typically manifesting in adults in their 20s and 30s. Following a sometimes long road to diagnosis and treatment, many patients still progress to kidney failure and require dialysis or a kidney transplant within the prime of their life. Current treatment options do not effectively delay time to kidney failure and even a kidney transplant may not be enough as the disease recurs in about 30% to 40% of post-transplant cases. Therefore, seemingly healthy individuals with IgAN quickly find themselves preparing for dialysis or transplant within approximately 11 years of their diagnosis. And many end up putting their personal and professional lives and futures on hold due to their rare kidney disease. The physical complications are often compounded by the overwhelming psychological and social challenges brought on by this rare kidney disease and the life-disrupting, costly and invasive medical care it can require. One such person who I met recently and comes to mind today when thinking about our mission is a young man named Chris. At only 19, he had a promising future ahead of him as the United States Merchant Marine Academy student. One morning before class, Chris experienced blood in his urine. After a month of rigorous testing and ultrasound and eventually a biopsy, Chris was diagnosed with IgAN. Left with unanswered questions about his rare disease and discharged from the Academy due to his potentially disabling prognosis, his future dimmed before his eyes. Alone in his diagnosis, he attempted radical diets that resulted in massive weight loss, confusion and severe depression. Today, Chris understands how to better manage this disease and has found joy and support in the IgAN community. However, with his permanent and progressive diagnosis, he is hopeful for a new treatment option that would allow him to control his disease and more fully embrace his life. The accelerated approval of FILSPARI holds immense promise for the IgAN community as it provides an important new therapeutic approach. Shortly, you'll hear from Jula on FILSPARI's profile and how we believe it will ultimately transform the treatment landscape for nephrologists and patients living with IgAN, and from Peter on how his team will deliver a successful launch under this accelerated approval. Ultimately, our goal is to position FILSPARI as the future foundational treatment standard for patients with IgAN and believe this accelerated approval is the first step on this journey. I could not be more confident in Travere's ability to help patients, and our hope is that this will lead patients and their caregivers to a brighter path and more hopeful future. With that, I will hand the call over to Jula, our Chief Medical Officer, to discuss the interim data from PROTECT, and the label we received under accelerated approval. Jula brings 20 years of nephrology experience and as a physician, will share deep insight on the importance of this milestone to the nephrology community. Jula?

Thanks, Eric, and good afternoon, good evening, everyone. To echo Eric's opening sentiment, I would like to extend my deepest gratitude, first and foremost, to the patients and their families as well as to the clinical investigators and their staff, patient advocacy groups and our research partners for supporting the development and now approval of FILSPARI. As a nephrologist with experience in treating IgAN patients, I witnessed firsthand the toll that this disease can take on otherwise healthy young adults. It was heartbreaking to partner with patients and their families, knowing that the treatment options were limited and that we would be watching and waiting, preparing for dialysis or the long road of kidney transplantation. Several years ago, Travere made a courageous decision to study FILSPARI and IgAN based on it's mechanism of action, effects on reducing proteinuria and overall safety profile, believing FILSPARI could potentially change the treatment paradigm for this disease. And now we're here discussing the accelerated approval of FILSPARI, a significant milestone for the IgAN community. Now on Slide 8, I will dive into the disease state of IgAN. You will see here that IgAN is driven by mesangial deposition of galactose-deficient IgA immune complexes, instigating the upregulation and release of endothelin-1, ET-1, and angiotensin II, or Ang II, which act in tandem to cause proinflammatory effects on the glomeruli, the tubular interstitium and the vasculature. The consequence of this is increased proteinuria, continuing damage to the glomerular filtration barrier, glomerulosclerosis and tubulointerstitial fibrosis with progression to kidney failure. FILSPARI is the only, single molecule, dual endothelin angiotensin receptor antagonist, also known as DEARA that targets these 2 causal pathways critical to IgAN disease progression. Moving to Slide 9. Proteinuria and estimated glomerular filtration rate, or eGFR, are 2 of the most important indicators of IgAN disease progression. While eGFR is usually monitored for changes over years, proteinuria provides a rapid and noninvasive indicator of a patient's current disease activity and the likelihood of disease progression. As you can see from the data on the left, there's a clear correlation between persistently elevated proteinuria and faster time to kidney failure. Importantly, on the right, you can see that reducing proteinuria in patients with IgAN has been shown to have a significant and sustained impact on preserving eGFR and delaying time to kidney failure. Moving to Slide 10. In order to evaluate the safety and nephroprotective potential of FILSPARI and IgAN, we initiated the PROTECT study in 2018. PROTECT is a global, multicenter, double-blind, randomized, active-controlled Phase III trial that enrolled 404 patients with IgAN, ages 18 and up. The PROTECT protocol requires that patients be on a stable dose of maximum tolerated ACE or ARB therapy, which is at least 50% max label dose for at least 12 weeks prior to screening, and have proteinuria greater than or equal to 1.0 grams per day, which is roughly equivalent to 0.7 grams per gram. Patients in PROTECT were randomized 1:1 to receive initial doses of 200 milligrams of FILSPARI or 150 milligrams of irbesartan. After 2 weeks, patients were titrated up to 400 milligrams of FILSPARI and 300 milligrams of irbesartan. PROTECT utilize the most rigorous trial design with an active control to demonstrate the benefit of FILSPARI versus fully maximized RAS inhibition. This approach eliminated the overestimation of treatment effect that can be seen in studies without an active control because we know that patients aren't always optimized on background ACE or ARB therapy. On Slide 11, you can see the PROTECT baseline characteristics, which are representative of the IgAN population. Specifically, PROTECT enrolled patients with a median age of 46 years, a greater proportion of males compared to females, baseline median UP/C of 1.2 grams per gram and an eGFR of 57 mls per minute. While not shown here, baseline characteristics were well balanced across treatment arms and will be presented at an upcoming congress. Moving to Slide 12. In August of 2021, we announced positive top line results from the prespecified interim analysis that evaluated the primary endpoint after 36 weeks of treatment in all randomized and treated patients. As a reminder, the trial remains ongoing and blinded until the last patient completes 110 weeks of the study. So we will continue to be limited in what we can share beyond the label we received today, but we look forward to reporting the full data in the fourth quarter of this year. According to the pre-specified interim analysis after 36 weeks of treatment, patients on FILSPARI achieved the primary proteinuria endpoint with a mean reduction in proteinuria from baseline of 49.8% compared to 15.1% for irbesartan-treated patients. This is a 3x greater reduction of proteinuria compared to a maximally titrated active control. Treatment with FILSPARI resulted in a rapid, superior and sustained reduction in proteinuria throughout the study period for the interim assessment in comparison to irbesartan. Importantly, within the first month, there's a significant reduction in proteinuria with FILSPARI. The treatment effect of FILSPARI on proteinuria at week 36 was consistent across subgroups, including age, sex, race and baseline eGFR and proteinuria levels, affirming our belief that the study is well designed to demonstrate a clinically meaningful benefit across the broad range of IgAN patients at risk of disease progression at the final analysis. Interim safety results indicated FILSPARI was generally well tolerated and appeared consistent with the previously observed safety profile with no new safety signals emerging. The results from PROTECT served as the basis for the accelerated approval of FILSPARI and the associated label for the period prior to traditional approval. We believe the label we received will provide nephrologists with a robust view of the differentiated clinical profile that has been established throughout development and that upon confirmatory data, the label should expand. With that, I'd like to briefly review some key aspects of the FILSPARI label on Slide 13. FILSPARI is a once-daily oral therapy indicated to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression, generally, a urine protein-to-creatinine ratio, or UPCR, greater than or equal to 1.5 grams per gram. The full U.S. prescribing information for FILSPARI can be found on our corporate website, travere.com. We believe the FDA is leveraging the accelerated approval pathway to advance innovative therapies for patients with IgAN, they are at high risk of rapid disease progression and is standardizing that in IgAN, this should be defined as generally greater than or equal to 1.5 grams per gram until traditional approval has been obtained. Moving to Slide 14. Per requesting the FDA, the efficacy data contained in the FDA-approved label is a post hoc sensitivity analysis that evaluates the first 281 randomized patients, a subset of the full trial population. The mean reduction in proteinuria from baseline in the post hoc sensitivity analysis is 45% for FILSPARI versus 15% for the active-controlled irbesartan. Most importantly, both the prespecified and post hoc sensitivity analyses have demonstrated that FILSPARI achieves a rapid and sustained reduction in proteinuria, with statistically significant and clinically meaningful improvement compared to the active comparator irbesartan. Moving to Slide 15, we turn to safety. Here are the adverse events occurring in greater than or equal to 2% of FILSPARI-treated patients in PROTECT. As you can see, the results from PROTECT showed that FILSPARI was well tolerated with a safety profile that has been consistent across clinical trials conducted to date. The main adverse events are consistent with what is expected with FILSPARI's dual mechanism of action and include peripheral edema, hypertension, dizziness and hyperkalemia. Importantly, when we look at the AE of interest of aminotransferase elevations, ALT/AST, of at least 3x the upper limit of normal, this occurred in 2.5% of FILSPARI-treated patients as compared to 2% of patients on irbesartan. Additionally, to date, there have been no reported cases of drug-induced liver injury, or DILI, or Hy's law with the sparsentan program. As expected, FILSPARI has a required risk evaluation and mitigation strategy, or REMS, for prevention of pregnancy and monitoring of potential liver abnormalities. Pregnancy monitoring, which is required of all molecules, antagonizing endothelin is in place to prevent potential embryo-fetal toxicity. This will be required on a monthly basis for all patients of childbearing potential. Because some ERAs have caused elevations of ALT or AST, hepatotoxicity, and liver failure, liver monitoring is required to identify potential liver abnormalities resulting from treatment with FILSPARI. Liver monitoring will be required on a monthly basis for the first 12 months of treatment and then every 3 months thereafter for all patients on FILSPARI. To further elucidate the REMS monitoring, the labs for liver function and pregnancy can be collected in a single sample at a physician's office or a local laboratory testing facility. Based on our research, and consistent with my prior clinical practice, patients at risk of rapid disease progression will have at least 1 visit per month to a health care provider, and, at a minimum, nephrologist visits every 2 to 3 months, which almost always include lab work, as the patient will be able to conveniently arrange lab testing during their regular course of engagements with the health care system. Overall, we believe the REMS will be effective in monitoring and seamlessly integrate into a patient's current course of care. We also recognize that nephrologists are time-constrained, and we will provide ample support to ensure the REMS process is as convenient as possible for them and their office staff, reinforcing a positive experience with FILSPARI. This approval of FILSPARI comes at an important time for nephrologists and their patients, where there is an increasing focus on finding targeted and more effective nonimmunosuppressive therapies. Importantly, FILSPARI is well positioned to become a new standard of care in IgAN. With that, I'd like to pass the call to Peter to discuss the commercial launch strategy. Peter?

Thank you, Jula, and once again, to all of you joining our call on this exciting day. We believe we are on the cusp of a paradigm shift in the treatment of IgAN, as for the first time, nephrologists will be able to integrally block 2 critical pathways in both -- in disease progression for IgAN, specifically endothelin and angiotensin. We, therefore, believe that with the accelerated approval, FILSPARI has the potential to become the new foundational treatment option for IgAN patients at risk of rapid progression. Our focus from day 1 will be to reach these patients. This launch has been years in the making, and our incredible team is focused, excited and ready to deliver an innovative treatment option that can help patients manage their proteinuria, the strongest prognostic driver of disease progress in IgAN. Our commercial strategy is focused on 3 areas of strengths that are noted on Slide 16. First, our deep market insights based on the high and urgent unmet need for a more efficacious treatment option for IgAN patients at risk of rapid disease progression. Second, the strong and innovative product profile, which will allow us to position FILSPARI as a new foundational treatment option for IgAN, patient at risk of rapid progressing based on its "interim efficacy data and safety." This includes rapid, sustained and superior proteinuria reduction as demonstrated versus the active comparator irbesartan in the landmark PROTECT trial. This is a safety profile consistent across clinical trials conducted today. And third, we have built upon strength. We have expanded our proven commercial infrastructure, which has delivered consistent results over the past 8 years, and established a dedicated launch team with specific expertise and experience in the rare kidney disease space. This team is ready to execute with a sense of urgency. Moving to Slide 17. Over the past 3 years, we have been preparing for this launch, and we began with understanding the marketplace with deep customer insights to appreciate the market potential. We obtained a solid understanding of the addressable patient population and immediate need of more effective treatment options. We believe that there are about 150,000 patients with diagnosed IgAN in the U.S. And based upon our multiple analyses, we estimate that approximately 30,000 to 50,000 patients are at risk of, rapid disease progression and directly addressable for FILSPARI at launch. We expect this addressable patient population may grow over time. Based on extensive market research and scientific engagements, we know that nephrologists are struggling to sufficiently treat IgAN patients at risk of rapid progression as target proteinuria levels often cannot be reached with currently available treatment options. Nephrologists have expressed the need for a product profile like FILSPARI, a targeted and efficacious nonimmunosuppressed treatment option. Market research among U.S. nephrologsits, most of our own as well as external syndicated research, have consistently indicated that FILSPARI is the most anticipated product in development for IgAN. In fact, 90% of the surveyed nephrologists indicated an intent to prescribe FILSPARI in the first year of launch with about 70% intending to prescribe within the first 6 months. These are highly supportive numbers, not often seen for a new product launch. These findings strengthen our confidence in achieving our objectives of positioning FILSPARI as the new foundational treatment for IgAN patients as rapid disease progression. Although IgAN is a rare disease, most U.S. nephrologists have at least a few rapidly progressing IgAN patients in their practice. These patients already diagnosed are under the frequent care of the nephrologists, at least quarterly, and have failed the currently available therapies. These are the patients directly addressable with FILSPARI. We believe that FILSPARI will have at least a 2-year lead time before following therapies may potentially be approved. This presents the unique opportunity to establish and strengthen our leadership position, and to realize our FILSPARI strategy to become the foundational treatment for these patients. We use the word foundational deliberately here because FILSPARI's mode of action addresses the 2 critical pathways, endothelin and angiotensin that amplify them, leading to increased proteinuria levels. New therapeutic modalities that could potentially be approved in the future may be complementary to FILSPARI's mechanism if needed. Having the experience of launching products and learning from recent product launches in the rare nephrology space, we anticipate 3 critical dynamics in the initial launch phase. One, nephrologists' adoption and new product utilization; two, the process of payer access and reimbursement; and three, ensuring the initial experience of patients and prescribers. Let me provide you some context around this, and tell you how we have been preparing for these dynamics and have built our organization around this. Moving to Slide 18. First, it is important to understand that there has been little innovation for kidney disease patients in the past 30 years, meaning nephrologists are not as accustomed to adopting new medicine at some other specialties. Additionally, nephrologists are typically data and mechanism-driven and given FILSPARI novel mode of action, we anticipate that some nephrologists will have time to review the FILSPARI data to become more comfortable with this new innovative treatment option. Also, physicians have yet to see our PROTECT data, since it was blinded due to the accelerated approval requirements and data protection associated with the ongoing nature of the trial. And nephrologists will need to get familiar with the REMS as part of the prescription process for FILSPARI. Comprehensive physician education is therefore integral to the uptake of FILSPARI. This is not new to us as we have been building upon an established and successful commercial organization that have consistently delivered results based on our ability to educate prescribers in the rare renal space, including nephrologists. Moving to Slide 19. We have expanded our commercial nephrology field team to over 80 seasoned individuals that have an average of nearly 20 years of nephrology and rare disease experience. This team has a specific expertise and established relationships with nephrologists to achieve our educational objectives. Over the past 6 months, our field team has been preparing for this day. This has allowed us a robust understanding of the metrology practices across the country, both in academia as well as community centers. Our field team is eager, trained and fully energized to educate physicians on FILSPARI. Their ultimate objective is to be consistently calling on about 6,000 nephrologists, which is estimated to cover about 85% of the addressable patient population. And I'm proud to say that our field will be actively promoting FILSPARI as of Monday. The second dynamic that I was referring to is about payer access to innovation and the process to get to covers. As is the case with all new therapeutic launches, particularly in the rare disease space, there will be the necessary process to get to formulary inclusions and it takes time to get to the pharmacy and therapeutics committee decisions. To allow for timely and high-quality interaction with payers, we have established a top-notch market access team. Our national account directors have been actively engaging with payers since last summer, and I'm happy to share that we already have pre-approval scientific presentation with payers covering more than 150 million lives. The feedback we have received so far is encouraging. Payers understand the burden of IgAN and appreciate the importance of proteinuria reduction in relation to disease progression. Our primary objective is ensuring that the addressable IgAN patients who are prescribed FILSPARI have access to this innovation. In pricing FILSPARI, we have factored in the high burden of disease, both emotionally, physically as well as economically, together with the innovative product profile of FILSPARI, and its product efficacy and tolerability data, as well as the feedback we have received from IgAN community, nephrologists and payers. Taking all of this into account, we have priced FILSPARI at the wholesale acquisition cost of $9,900 per 30-day supply. This price is reflecting the strong value that FILSPARI offers to patients and society, and is below other recently launched medicine in the rare kidney space. We believe this price supports our approach to allow for broad access and foundational use of FILSPARI for addressable IgAN patients. We anticipate having meaningful FILSPARI coverage and formulary policies in the next 6 to 9 months. Our preapproval engagement and established relationships with the payer community provides us confidence that this is an achievable target. We look forward to sharing additional details on these discussions and coverage decisions as the launch progresses. Moving to Slide 20. The first dynamic that I mentioned earlier -- the third dynamic that I mentioned earlier is ensuring an exclusive initial FILSPARI experience. We are dedicated to support patients, the prescribing nephrologists and the nephrology offices in a seamless FILSPARI prescription process. These support services provided through Travere TotalCare and our specialty pharmacies distribution channel will offer personalized education, assistance in the REMS process, supporting the reimbursement process in co-payer system to the eligible patients. Importantly, we expect commercial insured patients to have as little as $0 co-pay. To further amplify our organizational readiness, our CMC supply and distribution teams are exceptionally well prepared for launch, and we expect to distribute FILSPARI to our specialty pharmacies beginning in the week of February 27. Recognizing the dynamics of some regions, rare nephrology launches that I outlined before, we anticipate that our initial launch period will be aligned with these benchmarks over the first 6 to 9 months. Our launch plan has anticipated these dynamics, and we are prepared to work through these with a sense of urgency. Once we gain broad payer coverage, and prescribers gain their initial experience and observe the same rapid and sustained proteinuria reduction in their own patients, consistent with what was observed on the interim readout in the landmark PERFECT trial, we anticipate accelerated adoption towards the end of the year. Beyond this first year, we expect continuing robust growth into 2033, and we believe we will be well-positioned to achieve update that outperforms what we have seen with most other rare renal product launches. Over the past years, many nephrologists have expressed challenges in helping their IgAN patients at risk of rapid progression as the lack of adequate treatment options to sufficiently lower proteinuria levels. We believe that FILSPARI will fill that gap. We have built a world-class commercial organization and a strategy that is well-positioned to deliver on the promise of FILSPARI and provide these IgAN patients that have been waiting for too long with new hope.

Thank you, Peter. FILSPARI has now received accelerated approval from the FDA for the treatment of IgAN patients at risk of rapid progression. We know that there is a significant need for an innovative and differentiated treatment like FILSPARI, the only nonimmunosuppressive medicine indicated for IgAN, and that nephrologists are excited about the FILSPARI profile. We have a highly experienced team that is ready to be in the field, calling on physicians and leading with a patient-inspired approach that we expect will drive positive uptake and increased awareness. Our strong execution, along with the focus on supporting a positive experience for nephrologists and patients should position FILSPARI as a foundational treatment in IgAN for these patients. At this exciting juncture, we're just beginning to build momentum for FILSPARI. We're also looking forward to a potential approval for IgAN in Europe in the second half of this year. Additionally, we expect the 2-year data from PROTECT in the fourth quarter of this year, which have the potential to support a submission for traditional approval next year and further support our confidence in FILSPARI becoming the future foundational treatment standard for patients with IgAN. Additionally, we remain on track for top line data from the DUPLEX study of sparsentan in FSGS in the second quarter of this year. If supportive, those data could lead to a second indication for FILSPARI in another one of the leading causes of kidney failure due to glomerular disease. At Travere, we say that we're proud to be in rare for life. This is a shared experience throughout our organization where many of our team members are rare disease patients, have rare disease in their family or are caregivers of someone living with a rare disease. This fosters a collective sense of urgency and unrivaled dedication to delivering life-changing treatment to patients. We will bring this energy to the launch of FILSPARI, and as we seek to continue the momentum with the further evolution of our company, I can't wait to see what we'll be able to accomplish for patients in the rare kidney community. Today, we are proud to begin delivering FILSPARI to patients, and I couldn't be more excited about the road ahead for Travere. With that, I'd like to turn the call back to Naomi for Q&A.

Thank you, Eric. Operator, please go ahead and open the line for Q&A.

[Operator Instructions] The first question comes from Joseph Schwartz with SVB Securities.

Congratulations on the approval. This is truly calls for applause. So my first question is how do you feel about your ability to achieve analyst revenue estimates for FILSPARI? Is there anything that analysts should be appreciating or incorporating more in our models as we estimate the revenue ramp for this year?

Joe, thank you so much, and appreciate your well wishes. You probably might hear the cheering and the applause from the offices out of my office. When we look at the consensus models, really, I think that it's just under $40 million for the first year after launch. And that's largely in line with what we've seen in the first year of sales for other recently approved rare renal medicines. Well, we're not going to be providing guidance. I think that what I would point you to is that what Peter mentioned around the dynamics that we're going to be focusing on in the first 9 months of launch, really making sure that we can have a good experience for nephrologists, that we can have strong payer access and that we're able to educate nephrologists. We believe that, that's going to be our main focus now. When we look beyond that next 9 months, we really are confident that with this label and with this profile and the team that we have in place, we're going to be able to accelerate well beyond what we've seen from other rare renal launches. I think that's certainly aligned with the market research that we've seen. Hopefully, that gives you a sense of where we are in terms of looking at, at least in the first year and then looking beyond that initial year.

Yes, that's very helpful. And then I guess, how much do you think there may be a gross to net adjustment on that WACC price that you provided?

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

Sure, happy to do that, and thanks for the question, Joe. And really what I would look to for the gross to net is that we'll -- we expect them to be variable to start as we work through the reimbursement process. But ultimately, we expect the payer mix of more than 60% commercially insured. And so, at stable state, once we get there, we would expect things to normalize around the mid- to high-teen percentage range.

And next, we'll go to Greg Harrison with Bank of America.

Congratulations on the approval. Wanted to get your sense on the potential of changing the REMS schedule down the road from monthly to quarterly off the bat or even discontinuing it eventually. What factors would be necessary for something like that to happen? And is that something that you're focused on and looking at as part of your internal projections?

Yes, Greg, thank you for the question. And I'll turn that over to Jula. What I can first say is that with the REMS that we have in place, we don't see that this is a barrier to our uptake to begin with. So I think it's really important that while it's in place, and we'll make sure that physicians are educated, we absolutely have heard consistently from both nephrologists and IgAN patients that this is not an issue for them. That said, we are absolutely going to be focusing on continuing to grow our database and going back to FDA for updating that. Jula, do you want to give your thoughts on that plan?

Yes. I think that, Eric, you made a really good point around that. But additionally, to your question, we're going to have additional data this year. Realize, we're going to have the DUPLEX data readout, and we'll have that full data and sNDA submission by the end of the year. We have the PROTECT full data package, which we'll be submitting. And then we're going to have patients on commercial therapy and data through the REMS. We'll be collecting if we have any adverse event to be able to fully characterize and have continued engagement with the FDA to potentially modify or potentially remove the liver monitoring portion of the REMS over time.

And our next question will come from Carter Gould with Barclays.

Guys, you've got Edwin Delfin on the line for Carter. Congrats on the accelerated approval. We just wanted to ask why the label reflects, I guess, treatment in the greater than or equal to 1.5 gram per gram considering you studied a population above 1 gram per gram. And can you walk us through how FDA came to that decision and separately how that changes your pitch to doctors? And then we have a follow-up after that.

Adam, thanks so much for the questions. I think first and foremost, it doesn't change our approach to the launch or how we discuss with doctors. I think we certainly have known that nephrologists are going to be most eager to begin with in reaching those patients for whom they're progressing most quickly, so the patients with highest unmet need. That's always been our plan. So this very much is aligned with that. I'll have Jula talk a bit about some of the feedback and insights that we've gathered from FDA on why we have this label under accelerated approval.

Yes. Thanks, Carter, for the question. I think it's really important that we demonstrate we have a consistent treatment effect across the patient population that we studied. So I do want to reiterate that. But accelerated approval is reserved for drugs intended to treat serious condition. And remember, under accelerated approval, you haven't fully elucidated your risk/benefit until full approval. And so when we've engaged with the division, they recognize that high proteinuria put patients at high lifetime risk for progression to kidney failure. But for the purposes of accelerated approval that their current practice is to limit the indication to patients that are particularly high risk for rapid disease progression over a relatively short period of time between when you get accelerated approval and full approval. And that they generally want to define this as having a UPCR greater than or equal to 1.5 gram per gram. Now realize this is just one example of disease risk of progression and that there may be other factors that clinicians can use to determine a patient at high risk. And the last thing I'll point out is that the division also noted that once the full benefit has been verified, it's possible to broaden the indication to the full patient population, which we've studied.

Great. That's helpful. And then our follow-up question is on the economics to Ligand. So far, it seems like we're seeing royalties of 15% to 17%. And total milestones left at, call it, $120 million. If you can talk about how the royalties are tiered, and what the milestone tranches are, i.e., approval you're getting invoiced for now? Any details there would be helpful.

Sure, Adam. I'll have Chris take that question.

Sure. Thanks, Eric. So we will be, as part of the approval today, paying a $23 million milestone. And as you mentioned, we do have the blended royalty of 15% to 17%. We haven't disclosed at this point the specifics of that in terms of when they kick in, but it is a blended royalty as we go up in revenues on global net sales. And in terms of milestones, what you can expect or what is left, you referenced the overall amount of $114.1 million. We've already paid some milestones along the way, and so after today's approval, we would anticipate having about $72.7 million or $73 million left in milestones and those are going to be based on other regulatory -- special regulatory approvals and sales-based milestones.

And we'll take a question from Maury Raycroft with Jefferies.

Much congrats on the approval today. For the 30,000 to 50,000 addressable patients out of the gate, do you have an estimate on what proportion are greater than 1.5 gram per gram? And can you talk about your strategy to get to earlier patients with lower levels of unmet need and also in getting to become a frontline treatment?

Yes, Maury, thank you for the questions. Certainly, we believe that this label is fully aligned with our estimates of 30,000 to 50,000 patients. So no change in our outlook there. I'll have Peter talk a little bit about the work that was done to do that estimation and to achieve that range and how we believe this is consistent based on now the label we have. Peter?

Yes. Thanks, Eric, and thanks, Maury, for the question. I think it goes back to what Jula mentioned earlier, right? I mean the label reads like general -- like rapidly progressing patients generally with a proteinuria level higher than 1.5. So it's not excluding the patient population. So having the label in hand right now, I think it is well in the range that we have, which is approximately 30,000 to 50,000. And I think over time, the patient population will be growing because I'm expecting there's new therapies coming to market, you will start to see like earlier confirmation in the biopsy as well, right? Now there's not really incentive to do a biopsy, and with more biopsies, I'm expecting that, that addressable patient population will be growing over time. But most importantly, we don't think that there is a restriction in the patient population based on the label today.

And maybe to follow up more on your question about how we might be able to reach patients that are perhaps earlier in their treatment paradigm. Bill, maybe you can share some thoughts on what that strategy is from a regulatory perspective.

Certainly, Eric. The label right now, it gives us a range of patients that are at risk for rapid progression. But as one of the callers noted, generally, you look at drug approvals granting, you get what you study as the paradigm for regulatory approval. And I think the agency is going to be much more in line with that when we're at full approval. So we'll have the confirmatory data at the end of this year -- fourth quarter of this year for the PROTECT study, and we'll be filing quickly for that. So that gives you a reasonable time line for where we'll be able to go back and seek a broader label because then, at that point, we'll have the full benefit/risk profile for sparsentan. We'll have the impact on EGFR, the longer-term safety data and the longer-term proteinuria reduction. So with that total package, we'll be in a different paradigm, and that's probably the opportunity for IgAN patients to hand that broader label.

Thanks, Bill. Yes. I mean I think, Maury, what's -- the 2 important things that I'll comment on is, first is, we have a plan with the data and what we've studied. And in the label, and as Jula mentioned, we've noted that there is a consistent benefit across patient types and baseline characteristics. That's really important that this label and this indication is not based on the data or the clinical profile of FILSPARI, but rather in how FDA is thinking about subpart H within this space. The second thing that I'll mention is really, as I think about the launch outlook, we're going to be very much focused on these patients that are high risk, or at risk of rapid progression. There are many patients that we believe will benefit from FILSPARI. This opportunity for us to have additional data and then potentially an expanded label with traditional approval allows us to continue to grow this portfolio, this brand over time. So I think it's important to not think of this as a limitation, but a continued launch upon launch that we have with FILSPARI, with a really important and meaningful profile starting today.

And moving on to Tim Lugo with William Blair.

Congratulations. It's a great day for patients and a great day for the team. You mentioned you already had extensive discussions with payers with the clinical data. What you hear from them about the category in general? There is obviously immunomodulator already in the market before today. And can you remind us some of the pharmacoeconomic data you have, which supports the announced price tag? And then maybe one last part C to my one question. So we -- as we model out the opportunities, do we expect that price to fluctuate at all, maybe as the market expands or whether a full approval comes, that would be helpful.

Okay. Thanks, Tim, for your questions. Maybe I'll start with the last question, which is how the price might vary over time. I would say that this is the price that we have at launch. We have been very thoughtful about the longer-term pricing, particularly through different indications to come. But I'd say, at this point, this is the price that we'll be focusing on in IgAN. And I will turn it over to Peter to provide some of the feedback from payers and also the very strong evidence package that we have to demonstrate the value and also the burden of illness. Peter?

Excellent. And thanks, Tim, for the question. Yes, as I mentioned in the script, we are very pleased with the feedback from the payers because they understand IgAN, but also appreciate the value of proteinuria in context of disease progression. Now let me take a step back here, when I think about like the burden of disease. We know that there is a profound impact on patients that -- with kidney failure, both emotionally, physically and economically. And also kidney failure is a significant cost to society. So think about it. Many of these patients are young adults been diagnosed with IgAN and many of those rapidly progress, sometimes within 11 years as Jula pointed out in her prepared remarks. When you realize that proteinuria is the strongest prognostic factor in disease progression and that reducing proteinuria levels have been shown to have a consistent and sustained effect in preserving kidney function and delaying disease progression, we believe was the robust proteinuria level and effect of FILSPARI represents a strong value proposition and our health economic modeling indicates that FILSPARI is associated with cost savings to the U.S. health care system. I hope that gives you a little bit context how we have been thinking about our price and also how we think about the value it represent to patients, physicians, payers and the broader society.

And our next question will come from Do Kim with Piper Sandler.

My congratulations also on the approval. My first question around the label that defined rapid progression as UPCR greater than equal to 1.5 gram per gram. Do you have a sense from the FDA what the language would change to, to get a broader indication? Would they just remove that measure of UPCR?

Do, thank you very much for the question. I think two things that I'll mention is, one is we certainly are going to be focusing now on reaching those patients that are at risk of rapid progression. And while the UP/C cutoff is one component, as Jula mentioned, I think, in her clinical experience, there are many aspects that may, in a nephrologist's mind, deem a patient to be at risk of rapid progression. And I think that's going to be something that we continue to understand and share. I think with regard to how the indication statement may change, I think it's premature for us to be able to share what that might be at this point. I would just reference back to what Bill mentioned is, we studied a broader population in PROTECT. Those patients that are around 0.7 gram per gram and above, that certainly will be part of the evidence package that we go back to FDA once we have those data later this year and submit for full approval.

And on the clinical efficacy data that the FDA chose to put in the label, could you tell us why they went with the post hoc sensitivity analysis rather than the more robust data set of your prespecified analysis?

Yes. Bill, would you like to take that?

Sure. With any review of a drug application, the agency will request routinely a series of different analyses, and our review was no different. This -- the IAS that's represented in the label was one of those analyses and it's a sensitivity analysis looking at proteinuria and different ways to evaluate that. And they chose to utilize that in the label. I think what's really important to note is that it doesn't matter whether you're looking at the IAS in the label or the PAS that we've presented prior with the full data set. It shows you the same story. There's a very rapid and profound reduction in proteinuria that occurs quickly, and it's sustained and it continues to progress throughout the 36-week period, independent of which analysis that you have. So I think that's the important take-home message.

Yes. Thank you for that, Bill. I think the thing that I would add, Do, is when we think about what might be the implications or meaning of these, I think while numerically, they're different, it doesn't change in any way our confidence in how the trial was designed and powered to show a significant treatment benefit at 2 years on EGFR. And in the near term, it doesn't change, in any way, the excitement that the nephrology community has for the profile clinically of FILSPARI. So we're absolutely confident in being able to launch strongly and have a very strong data package coming later this year. And again, as Bill mentioned, this is really a sensitivity analysis on that interim data assessment.

Okay. Got it. And one last question. About how long would it take to get the REMS printed up and sent to all the physicians and nephrologists that your sales force covers and have the doc sign up for the REMS? Is that -- could that be completed within the 1-week time frame before you start launching the drug?

Great question, Do. Peter, do you want to take that?

Yes, certainly, Do. Yes, I think the REMS process, the certification process won't take that long by itself. As Eric mentioned, we want to make sure that we take the time to really educate the nephrologists about the whole prescription process, including the REMS. The REMS certification and signing up is not that difficult. It's a matter of fact, like 5 to 10 minutes signing of the appropriate form. So that shouldn't be an obstacle for prescription.

And maybe to further answer your question about the REMS forms, those will be ready when we go to detailing next week. [indiscernible] team is ready to execute, I think, would be an understatement.

And moving on to Liisa Bayko with Evercore.

Congratulations. Really great news. I wanted to ask about sort of the level of awareness and anticipation amongst nephrologists and also patients. And then have you detected any sort of -- I don't know if you call it warehousing, but kind of like clusters of patients that are waiting and will sort of initiate therapy quite immediately? And maybe can you describe any of those items?

Yes. So I would say that the level of awareness is high. And certainly, we expect it to increase as we have our sales team out starting on Monday. Peter can certainly speak in more detail, but every market research piece that we've done, or has been syndicated in the last year, has consistently shown that sparsentan is the most eagerly awaited and highest level of awareness within this space. So I think we're building off of a strong base. We've not communicated to patients, but we will be able to reach out now that we will have approval to be able to raise that. And maybe, Peter, you can speak in a little bit more detail about your views of awareness, and then I'll answer about the warehousing of patients. Peter?

Yes. I think our product awareness is certainly in line with the other successful launches. And to Eric's point, I think, most importantly, this is the most anticipated IgAN approval in nephrology. So we are excited. And I think now, as of Monday, as I mentioned, our field force will be in the field ready to execute. They can really have the conversation about FILSPARI. They have been active in the field for the past 6 months, but that was for profiling purposes so they couldn't speak about the products. But now that we have the 80-plus commercial field team in the field as of Monday, that awareness will grow very rapidly. And yes, I'm fully confident that we will be getting a good feedback from nephrologists and getting their first experience.

Thanks, Peter. And with regard to patients, I think there certainly is a tight community here, and we would expect that as more and more education awareness grows, that there's going to be even further engagement. So I think, Liisa, certainly appreciate your question because it's a very important part of a successful launch. Now with regard to your question on warehousing, there are -- certainly, we expect there to be patients that are waiting for this treatment option who may have tried others and are still progressing. There aren't, I would say, kind of a warehouse or bolus of patients that may have come off of clinical trial. And I'll have Jula talk a little bit about why we wouldn't expect that based on our trial design. Jula, do you want to share a little bit more?

Yes. Importantly, for our PROTECT study, we believe it's important for patients to continue on into open label. And as we've discussed before on some of our previous calls, patients are going to be offered to have the addition of SGLT2 inhibitors after they roll over. And so we think it's important for patients to continue on our open label so we can continue to gain more information through there. So we don't anticipate them rolling over to commercial therapy in the near future.

That said, I think it's important to note that there is an expected high demand. One of the things that we typically look at in preparation for a launch is the intent to prescribe. And we know that nephrologists are very eager to prescribe FILSPARI. So our goal now, with Peter's team out in the field on Monday, is to quickly reach those physicians that have expressed interest or that we do anticipate have these patients and are ready to prescribe.

Okay. Great. And are you going to have any kind of like free drug coverage or program for patients who either don't have coverage or kind of are awaiting reimbursement decisions or anything like that, that we should be considering?

Well, as a leader within the rare disease space, it's really important that we think about access, both broad access and also rapid access. If we think about kind of the intent of accelerated approval, it's reaching those patients because time really matters. And so we've been very thoughtful, particularly in working with the rare disease community, on what matters most to them. And I'll have Peter talk a little bit in more detail in the programs and services that his team has been preparing for.

Yes, Liisa. Thanks for the question. I would say we will be offering the support where appropriate for eligible patients to make FILSPARI sustainable as quickly as possible, and I would leave it there.

Okay. And then just last question for me. Are you at all following when could new KDIGO guidelines may come out? Like what's your sense on timing, and what are you doing to advocate for sparsentan being included in there? And could you get it included before full approval? Maybe you can just comment on that.

Yes. Great question. Jula, would you like to take that?

Yes. We work and engage with the folks who are working on updating those guidelines. The plan originally was for the IgA nephropathy guidelines to be updated early this year. That is not likely going to happen. It's probably going to be later this year, as they're just now getting started work on that. We are engaging to help to ensure that we can potentially be included in those, which means getting our data published and out there. So yes, that is part of our thought process because, of course, we want to have information out there and available and then be part of the guidelines over time. So that's part of our ongoing efforts.

Great. That would be fantastic. And one last question if I can sneak one in? Do you expect any changes once you get a full approval? I mean would having eGFR data be more compelling to physicians? Or are they comfortable enough just with proteinuria? Like does that help you in any way? Or is there anything else with the label or payers, like what -- any advantage you get from having more data and a full approval?

Yes. Liisa, I'll maybe start, and then I'll have Jula talk about what -- how the nephrology community may think about this. I think, certainly, we believe that we have a compelling set of data in the label to be able to meet the needs of nephrologists. They've been so eager for something that is more effective than ACEs and ARBs, we have that. And also is not immunosuppressive, we have that. I think these patients are waiting. So I think they're going to -- we're going to see a nice demand now that we are approved. Certainly, additional data and the long-term data will be helpful both in characterizing the efficacy and the safety. But Jula, do you want to give a little bit more thought there?

Yes. As you heard me talk about it a little bit earlier, we understand nephrologists, the link between reducing proteinuria, preserving eGFR and avoiding time to kidney failure. And the vast majority of nephrologists understand that, and that's how we're monitoring. If you're looking at eGFR, you're looking at changes in eGFR over many years for these patients. And so how are we intervening? Reducing proteinuria, and that's what FILSPARI offers for physicians and for their patients. Does additional data help? Yes, of course. Will that help broaden the utilization? Yes, for those of you who might say, I want us to have more data. But we understand, reducing proteinuria benefits patients. So the uptake is going to be there.

And we will take a question from Mohit Bansal with Wells Fargo.

Congrats from my side as well. My first question is related to -- so you mentioned that the accelerated approval mechanism may have played a role in terms of the FDA looking at 1.5 and above UPCR. Do you think that same logic could probably apply for the ramps as well as the black box warning they have given? Because it doesn't seem like a lot of -- a lot of those warnings are related to sparsentan in particular. They appear to be related to the class and it may cause this. So the language is a little bit more anticipatory rather than definitive there. So do you think that has played a role here? And do you think, with the full approval and more data generation, there is a path to remedy that eventually?

Mohit, thank you very much for the question. Bill, would you like to take that?

Certainly. And I think your assessment is correct. The agency is looking at the endothelin receptor antagonist class as a group of molecules, some of which have had issues with liver toxicity. And there were two factors that they described to us. One is under accelerated approval, you only have a partial view of the ultimate benefit/risk data set that you'll have at full approval and when we have the 2-year data. Additionally, endothelia antagonists, while they've been prescribed for years by cardiologists to treat pulmonary arterial hypertension, they haven't been used much in the nephrology community. And the purpose of a REMS is to educate and to ensure that we are educating the physicians as well as the patients that this class carries with it a potential risk. So we always knew that, with this class, we'd have a REMS around embryo-fetal toxicity to ensure checking for pregnancy. This adds that additional step. The question you asked about, is full approval and opportunity to remove that? Yes, I think it's one of multiple opportunities that we have to revisit this question. And when the agency first raised this subject with us, it was under the guise of potential class risk endothelin antagonist, and they followed it in the next sentence that, with an expanding data set, they would be open to discussion about modification of the REMS. So I think that they are thinking about it in this way, and we'll be developing that data set from the clinical trial experience as well as from real-world data that we'll be collecting from the commercial experience.

Bill, the only other thing -- sorry, go ahead, Mohit.

Go ahead. No, I was asking a different question, but go ahead -- sorry, just go ahead and finish.

Yes. I think the only other thing that I would share is just in our interactions with FDA, they did share that the view -- and we certainly don't want to speak for them, but we'll share our engagement is that in the review of accelerated approval in their eyes, the evidence package, both from an efficacy and a safety database is evolving. And so you would imagine that both for an assessment of safety like liver monitoring as well as the indication statement will evolve with the data set that we have coming later this year.

Got it. Very helpful. One quick question on guidelines. How important are guidelines for these nephrologists? And do you think guidelines could adopt a more broader patient population with one or more higher UPCR, they may not -- may or may not follow FDA label? Is that the possibility there?

Jula, would you like to take that?

Well, the challenge with guidelines is often once they get out, they are already outdated. So it depends on which nephrologists you talk to, who will follow them. So I think that's why there's been such impetus for them to be updated more frequently and even also to potentially have an app that can be updated. To your point of which patients, I mean if you look at the guidelines now, who we want to treat and intervene on is a lower range of proteinuria because any protein in the urine is harmful at all thresholds. So most of us believe the lower the better. What they're going to likely do for new therapies that come in the pipeline, us included and what range will be suggested, I can't speak to that. So that would be too speculative for me to say.

And our next question comes from Laura Chico with Wedbush Securities.

I just have two quick ones. So first, the 30,000 to 50,000 addressable patients at start, I apologize I think I missed this. Where do you see that current population in terms of SGLT2 utilization? And then my second question is on the pricing. You mentioned, Peter, that was $9,900 on a 30-day WACC basis. Wondering if you could clarify how does that change for FSGS or at different dosing?

All right. Thank you, Laura. So Peter, why don't you take those questions with regard to, first, the 30,000 to 50,000, and how these patients might currently be treated?

Yes. Great questions, Laura. Thanks for those questions. So what we know from our research is that the SGLT2 utilization is about 20% to 25%, and that applies to that 30,000 to 50,000 patients as well. So we didn't specify that to a certain patient group, but I would assume that in those patients, you will see the same penetration as in the broader patient population. With regards to pricing for FSGS, well, not to make too much focus on FSGS today, but the pricing will be in line with the dosing. And as you know, for FSGS, the dosing schedule is titrating for 400 to 800 milligram, while for IgAN, it's 200 to 400 milligrams. So we will be in line with that.

Congratulations.

Thank you, Laura.

And we have a question from Alex Thomson with Stifel.

Maybe firstly, can you talk a little bit about what kind of launch metrics you expect to share during the first year, maybe physicians and patients enrolled in REMS, patient ads, et cetera? And then maybe to follow up on Laura's question, with titration, et cetera, and sort of first year dynamics, how should we think about sort of net price per patient in this first year of launch?

All right. Alex, thank you very much for the questions. Peter, would you like to take the launch metrics?

Yes, certainly. So as the launch is progressing, what we intend to share is on a quarterly basis, the net revenue for FILSPARI as well as new patient platforms. And then I think an important metric, as I mentioned in the pre remarks is what's the coverage level at payer. So we will, at a quarterly basis, also give an appreciation where we are with spare coverage. So I think those are the 3 critical metrics that I would call out that you can expect at a quarterly basis. And then your second question was...

Net pricing based on dose titration of 200 to 400.

Yes. So I think coming back to what Chris mentioned earlier, as the launch progresses, we expect like the mid- to high-teens gross to net. So I think that's the calculation you can make.

Yes. I think the only thing I would add, Alex, is that we will have dose forms of 200 and 400 milligrams. It's flat pricing. The same price for a 30-day supply. So you should not have to do any kind of advanced calculations to understand on a net patient pricing.

And we'll take a question from Ed Arce with H.C. Wainwright & Co.

Let me add my congratulations. I know there's a lot of thoughtful preparation and effort to get to this day. Just one for me. A lot of my questions have already been asked, but I just wanted to ask you if you could discuss the dynamic as you have described before, a large proportion of dispersed community physicians, and what that means on the early uptake and throughout the launch.

Yes. Ed, thank you very much for that question. Peter, would you like to take that?

Yes. Thanks, Ed. If I understand you correct -- your question correctly, it's like the first dynamic that I was talking about education of nephrologists and you are asking about like what the roles of community relative to academic nephrologists?

Yes, specifically with the community physicians, in particular, since they're much more spread out.

That's exactly right. Well, I did call out in the earlier remarks that we anticipate to consistently be calling about 6,000 nephrologists, and the majority of those physicians are actually in the community. So the community of nephrologists is actually a really important goal point. I think relatively, in the beginning, we will have a strong goal point on academicians as well. But I think the majority of the spreads we anticipate will be coming from community nephrologists. And that's why we have a field team of over 80 individuals to really call on that broad -- large group on nephrologists.

Yes. I think that's absolutely right. Peter's team has done a great job at really looking at the segmentation, particularly within the community nephrologists. And when we expanded the field-based team, there was a focus on hiring professionals that have the expertise, but also with those relationships, which I think is critically important because we know access, not just payer access, but access into the offices are critical. So I am very confident having launched many medicines that I think we've got the right team and the right plan to be able to reach those community-based and the academic-based customers.

Great. And maybe just one quick follow-up, actually, since you have characterized the sort of expectations for some degree of acceleration later this year and the early launch. I'm wondering if you could talk about -- given that, as you mentioned, nephrologists are data and mechanism-driven in adopting and trialing new drugs, talk about how you view the importance of these KDIGO guidelines that you hope will include sparsentan later this year?

Okay. Jula, would you like to take that?

Well, certainly, I think as Peter elucidated, I think as we haven't shared a whole lot of our data, I think the first step is actually more getting the information out around sparsentan and the meaningful reduction that we see in proteinuria and the early and rapid sustained reduction in proteinuria that we see. I think with regards to the KDIGO guidelines, those are more about giving general guidance around managing patients and less about the specific data that we're going to be able to educate Peter's team and the medical affairs team is going to be using over the next 6 to 9 months to really educate nephrologists about the mechanism and our data. Does that help answer your question?

Yes. Yes, that's helpful.

And that does conclude the question-and-answer session. I'll now hand the conference back over to you.

Thank you, everyone, for joining us this afternoon for our FDA accelerated approval of FILSPARI call. We're extremely excited about the year ahead and look forward to sharing more updates along the way. Have a great weekend, and thank you.

Thank you. That does conclude today's conference. We do thank you for your participation. Have an excellent day.