TVTX - NASDAQ

Good day, and welcome to the Travere Therapeutics' Second Quarter 2024 Financial Results and Corporate Update Conference Call. Today's call is being recorded. At this time, I would like to turn the conference call over to the Vice President of Corporate Communications and Investor Relations, Nivi Nehra. Please go ahead, Nivi.

Thank you, Rachel. Good afternoon and welcome to Travere Therapeutics second quarter 2024 financial results and corporate update call. Thank you all for joining. 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; Peter Heerma, our Chief Commercial Officer; and Chris Cline, our Chief Financial Officer. Dr. Bill Rote, Senior Vice President of Research and Development will join us for the Q&A session. 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 statements. 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, August 1, 2024, 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, and good afternoon, everyone. In the second quarter, we continued to make significant progress on our key priorities. At the center of our growth is FILSPARI, which is becoming a foundational therapy for IgA nephropathy, giving patients hope for a better future. Our launch performance continues to strengthen. During the second quarter, we set new highs in demand and revenue, and we are on track to outperform benchmark launches in year two. FILSPARI is the only rare renal launch to consistently deliver quarter-over-quarter growth in new patient start forms through the first six quarters of launch, which speaks to high demand from physicians and patients, and our ability to achieve our goals. This strength is being driven by positive trends in all of our key growth factors, including increasing breadth and depth of prescribers, strong payer coverage, and continuing improvements in our pull-through process. From a regulatory perspective, our sNDA review process for full approval in IgAN continues as planned, and we are eagerly preparing for full potential approval next month. To date, our educational and promotional focus has been on the rapid and profound impact on proteinuria and the results from our interim readout from PROTECT. We are excited about the opportunity to build further momentum in the launch that an updated label would provide, including the ability to educate on two-year data from the most rigorous study conducted in IgAN. We anticipate that a broader label would enable us to reach more patients. Specifically, we estimate FILSPARI's addressable IgAN patient population in the future could nearly double over the time from the current level, and the two-year data should build even more conviction in prescribing FILSPARI since it will potentially provide an opportunity for our teams to clearly highlight long-term durable proteinuria reduction, long-term kidney function preservation and two-year safety data, and our teams are ready. We also continue to make progress in bringing FILSPARI to IgAN patients in other parts of the world. Our partner in Europe, CSL Vifor is preparing for the first launch of FILSPARI in that region very soon. In Japan, Renalys recently dosed the first patient in their pivotal study, which is expected to have results in the second half of 2025, and to support a submission to Japanese regulators for approval. As for the additional priorities to expand our growth, we are encouraged by the ongoing work regarding FSGS endpoints by the PARASOL Group and we remain hopeful that we will be able to identify a regulatory path to bring FILSPARI to patients diagnosed with FSGS. We plan to engage with regulators later this year and to provide an update following those discussions. And finally, pegtibatinase continues enrollment activities in furtherance of a planned top line readout in 2026. As we outlined at the start of the year, 2024 is a year of execution for Travere. As we move into the second half of the year, I am proud of our teams and how they have continued to execute exquisitely across our priorities, all while keeping the needs of patients front of mind. I'll now turn the call over to Jula for an update on our development activities. Jula?

Thank you, Eric. From a medical perspective, we continue to be focused on achieving full approval of FILSPARI and providing the education and support to enable FILSPARI to replace RAS inhibitors as foundational care for IgA nephropathy. I'm very pleased with the progress that we have made on both of these priorities during the quarter. We have long held the belief that the future of treatment in IgA nephropathy will be combination therapy designed to address the overactivation in both the kidney and the immune system. FILSPARI is unique in being a single pill that directly blocks two harmful pathways, endothelin and angiotensin, which are overactivated in the kidney and lead to kidney injury and IgA nephropathy. And we believe that FILSPARI, with its superior clinical profile addressing the overactivation in the kidney and providing long-term nephro protection will ultimately replace the use of RAS inhibitors, which have been the standard for addressing the damage in the kidney for decades. We are seeing tangible signs of this evolution and a growing excitement within the nephrology community and among patients with IgA nephropathy. We recently attended an IgA nephropathy patient and caregiver conference and heard hope and inspiration through personal stories from patients on FILSPARI who now feel they have better control of their disease and a brighter outlook for the future. We've seen a substantial shift this year in how nephrologists are speaking about and using FILSPARI for patients with IgA nephropathy. We hear more nephrologists referencing FILSPARI as foundational care in their practice, including initiating treatment with FILSPARI as a first-line therapy. At the heart of this momentum is our data. We have incredibly strong results from the most rigorous Phase 3 study completed in IgAN, one in which FILSPARI demonstrated superior results over an active comparator arm that significantly outperformed the placebo arm in other studies. And we've continued to generate additional data showing that if treated early with FILSPARI, patients can achieve proteinuria reductions of about 80%, and stabilization of eGFR, and that FILSPARI can be used safely in combination with SGLT2 inhibitors. This is why we're seeing physicians continue to upgrade their patients from RAS inhibitors to FILSPARI. And for those that need an additional treatment, they're combining FILSPARI with an SGLT2 inhibitor or a steroid. This is aligned with the increasing recommendations in treatment guidelines and algorithms to replace RAS inhibitor therapy with FILSPARI in patients who remain at risk for progression. We believe the future for effective treatment of IgAN will call for diagnosing patients earlier and treating them with the goal of getting them into complete remission of their disease. This will require simultaneous therapy addressing both the overactivation in the kidney and the immune system. We expect FILSPARI will be part of the foundational kidney targeted therapy in that algorithm. From a regulatory perspective, the sNDA process has been collaborative and is moving according to our expectations. We are pleased with the interactions and we look forward to our PDUFA date early next month. Upon full approval, we would anticipate a broader label for FILSPARI. This would be grounded in the two-year PROTECT data that showed significant and durable reductions in proteinuria, kidney function preservation, including the slowest eGFR decline seen in a Phase 3 study and an accrual of eGFR benefits, as well as robust safety data seen in our PROTECT study. Pending full approval, we believe these data will only further reinforce the nephroprotective effects of FILSPARI, providing further context and conviction for nephrologists to prescribe FILSPARI to more of their patients and to continue our progress towards FILSPARI achieving foundational care. Now, let me briefly discuss our efforts with FSGS. As a reminder, in our Phase 3 DUPLEX trial, sparsentan demonstrated a statistically significant difference on the modified partial remission proteinuria endpoint and clinically meaningful improvements in kidney function and the composite kidney failure endpoints compared to irbesartan. And while we demonstrated a 0.9 mils per minute per year favorable treatment effect on chronic eGFR slope, there was considerable variability, so the eGFR endpoint was not achievable. These data are important because a benefit on eGFR can't be statistically shown within a reasonable timeframe and sample size in a Phase 3 FSGS trial than another endpoint such as proteinuria needs to be proposed and validated. With this background, NephCure, the FDA, EMA, and academia created an initiative called PARASOL with the goal of defining a better pathway to bring medicines to people living with FSGS. In order to accomplish this, PARASOL is compiling and analyzing data sets to define what should be the right endpoint in FSGS for regulatory approval. We are grateful for the work this group is taking on and we continue to be optimistic that we can identify a path to approval for FILSPARI and FSGS. We plan to engage with the FDA once the PARASOL results are available and expect to provide an update on our program later this year. Briefly, let me discuss our pegtibatinase program for patients with HCU. We are excited about our potential to deliver pegtabatinase as the first disease modifying therapy for classical HCU. Our team recently attended an HCU patient summit and consistently heard encouragement and hope from patients and their caregivers around the pegtibatinase program. We remain on track with our enrollment targets to enable top line data in 2026. In parallel, we continue to work on manufacturing scale-up to support the full Phase III program and commercial launch. Let me now turn it over to Peter for a commercial update. Peter?

Thanks, Jula, and good afternoon, everyone. In the first half of this year, we have been focused on delivering strong execution on FILSPARI launch, and I'm very proud of the progress that our teams has made across the board. We continue to see strong demand from physicians and their patients. In the second quarter, we again achieved quarter-over-quarter growth and generated 521 new patient start forms or PSFs. We have now demonstrated continued growth in new PSFs each and every quarter since the beginning of our launch and we are continuing to build momentum as we head towards our early September PDUFA date for full approval, which we believe will further accelerate FILSPARI's growth. Notably, new PSFs were generated both by a broadening of the prescriber base, as well as by further deepening of prescriptions by nephrologists. By the end of the second quarter, approximately 2,400 nephrologists were REMS certified and we are exceeding recent rare nephrology benchmarks for the number of total prescribers after 18 months. We believe one of the key drivers of this continued growth is that, we are continuing to hear from FILSPARI prescribers that their patients are experiencing what we saw in clinical trials, the rapid and sustained reduction in proteinuria with a well-tolerated safety profile. As more nephrologists adopt FILSPARI, they are having this positive experience with their patients, and we are pleased that they then become advocates for using FILSPARI with their peers. Product access and reimbursement is strong with 96% of the U.S. lives having a pathway to FILSPARI reimbursement, and we are very pleased with the claims approval rates we are seeing, also reflecting the strong authorization criteria for FILSPARI payer plans and formularies. We are also driving additional efficiencies in our pull-through process, which is supporting our increasing prescriber base and the growing number of patients initiating therapy having a positive experience with FILSPARI. All of these efforts have resulted in $27.1 million of net FILSPARI sales in the second quarter, an increase of 37% over the first quarter. I am really pleased with this inflection in revenue as it positions us to outperform recent rare nephrology revenue benchmarks in the second year of launch, especially with strong catalysts ahead of us. As we look ahead, the most important catalyst is our upcoming PDUFA date next month. As Jula mentioned, we are preparing for a full approval with a broadening of the FILSPARI label, which if granted, we believe will allow for an acceleration of demand based on two factors. We believe that a potential wider indication statement coupled with our further data initiatives and nephrologist evolution towards earlier treatment of IgAN patients will have the potential over time to increase the addressable IgAN patient population from approximately 30,000 to 50,000 patients to up to 70,000 patients. Alongside this, with a full approval and updated label, we would expect to finally be able to educate physicians on our exciting two-year data from the most rigorous pivotal trial conducted in IgA nephropathy to date. Thus far, our uptake has been largely driven by the results from the interim analysis, so we expect the two-year confirmatory data will further support foundational use of FILSPARI in daily practice. We are ready, prepared, and fully energized to leverage this anticipated milestone to elevate FILSPARI. Preparations are underway to position our teams to engage with patients and physicians to amplify the profile of FILSPARI on full approval. Additionally, we anticipate that the new KDIGO guidelines will become available soon, timing that is potentially lining up quite nicely. We anticipate that for the first time they will include FILSPARI as part of the treatment paradigm, that they will emphasize the urgency to diagnose and treat IgA nephropathy patients earlier with a more ambitious proteinuria treatment targets. This would provide an opportunity to broaden the addressable patient population. I couldn't be more proud of the progress that our talented and dedicated teams have made in the first half of this year. These accomplishments provide a solid framework to strengthening the FILSPARI profile and broadening the addressable patient population in the second half of the year. We are driven by the prospects of serving even more patients moving forward by establishing FILSPARI as the foundation therapy for IgA nephropathy patients. Let me now turn the call over to Chris for a financial update. Chris?

Thank you, Peter, and good afternoon, everyone. During the second quarter, we continue to have strong operational performance led by a significant increase in net product sales and reduced operating cash use. Net product sales for the second quarter of 2024 grew to $52.2 million compared to $29.5 million for the same period in 2023. This increase of approximately 77% is attributable to growth in net product sales from the ongoing U.S. launch of FILSPARI and IgA nephropathy. During the quarter, we also recognized $1.9 million of licensing collaboration revenue, which results in $54.1 million in total revenue reported for the period, compared to $32.2 million in the same period in 2023. Research and development expenses for the second quarter of 2024 were $54.3 million, compared to $66.5 million for the same period in 2023. On a non-GAAP adjusted basis, R&D expenses were $50.6 million for the second quarter of 2024, compared to $59.5 million for the same period in 2023. Selling, general and administrative expenses for the second quarter of 2024 were $64.8 million, compared to $68.2 million for the same period in 2023. On a non-GAAP adjusted basis, SG&A expenses were $48.3 million for the second quarter of 2024, compared to $49.7 million for the same period in 2023. The decline in year-over-year operating expenses is attributable to the restructuring enacted at the end of 2023 and reduced clinical expense as the sparsentan Phase 3 studies advance towards completion. Total other expense net for the second quarter 2024 was $1.9 million compared to total other net income -- other income net of $2.1 million in the same period of 2023. The difference is largely attributable to a $3.4 million noncash charge to other expense related to the Renalys collaboration announced earlier this year. Net loss, including from discontinued operations for the second quarter of 2024 was $70.4 million, or $0.91 per basic share, compared to a net loss of $85.6 million, or $1.13 per basic share for the same period in 2023. On a nonadjusted basis, net loss, including from discontinued operations from the second quarter 2024 was $50.1 million, or $0.65 per basic share, compared to a net loss of $60.1 million, or $0.79 per basic share for the same period 2023. As of June 30, 2024, the Company cash, cash equivalents and marketable securities of $325.4 million. Cash used during the second quarter included approximately $71 million of previously disclosed milestone payments and approximately $45 million of operating cash use. Importantly, operating cash use declined by approximately $20 million in the quarter, and further declines in the second half of the year are expected, as well as throughout 2025 and beyond. This is driven by expected growth in FILSPARI sales, continued contribution from Thiola, and declining R&D investment in sparsentan over time as the supporting studies complete. We also anticipate multiple incoming milestone payments from CSL Vifor upon conversion of FILSPARI to full approval in Europe and market access achievements. With these elements, we continue to believe that our balance sheet can support current operations into 2028. I'll add one administrative note, alongside the filing of our 10-Q today, we're also filing a new shelf registration statement with the SEC. This is a housekeeping measure as our current shelf registration statement is set to expire on September 3. With that, I'll now turn it back to Eric for his closing comments. Eric?

Thank you, Chris. Through the first half of 2024, we've delivered meaningful growth in FILSPARI, continued the collaborative engagements with regulators and payers, and have made meaningful progress in bringing both FILSPARI and pegtibatinase to patients. We know that they are waiting for us. It's for this reason that I and my colleagues at Travere have executed with focus and passion this year. We are well-positioned to achieve further progress in the remainder of the year, which should position Travere for meaningful growth now and in years to come. Now, let me turn the call over to Nivi for Q&A. Nivi?

Thank you, Eric. We can now open up the line for Q&A. Rachel?

Thank you. [Operator Instructions] We will take the first question from the line of Tyler Van Buren from TD Cowen. Tyler Van Buren, your line is now open.

Hey guys. Thanks very much for taking the question and congratulations on the quarter. Regarding a potential removal or modification of the REMS upon a full approval next month, can you just remind us what you guys suggested to the FDA as we think about the potential scenarios and outcomes?

Well, certainly, Tyler, thank you for the question. I'd say, first, let me share that we believe that this is the first natural opportunity for us to engage with the FDA with the additional data for reviewing for full approval. And there is, as you know, no precedent for something being changed this early in approval, and that the process requires us engaging with multiple divisions within the agency. And I think with that said, we certainly are looking at multiple scenarios, including a modification, potential removal. But again, both of those -- there is not much precedent this early or that there would be a continuation for liver monitoring as it stands. What we've guided previously is that, we're committed to putting our best foot forward during this sNDA review and to provide an update at full approval. And what I'd say with regard to the scenarios is, we're ready for anything. If we take a step back and independent of where we are with this process, I'm really proud of our ability to demonstrate strong growth and performance in FILSPARI with the REMS. So regardless of where we land with this process in the near-term, we can expect significant growth moving forward given that FILSPARI is now becoming the foundational therapy for the treatment of IgAN.

Thank you. We'll take the next question from the line of Anupam Rama with JPMorgan. Anupam Rama, your line is open.

Hey guys, thanks so much for taking the question. Just a quick one for me. When you think about patient start forms and what you're seeing, how much of that can you attribute to, say, new prescribers versus repeat prescribers? And how has that kind of changed over time? Thanks so much.

Great. Thanks, Anupam, for the question. Peter, I'll turn that one over to you.

Yes, overall, I think we see a nice continuation of growth, both from -- both the broadening of the prescriber base, as well as the deepening. I think that's exactly what you would expect. I would say, it's almost equal on if you look at like the increase in patient start forms where it comes from new prescribers, as well as existing prescribers. So I think a very nice trajectory, and I think very much in line with the best practices I've seen in the past for successful launches.

Thank you. We will take the next question from the line of Joseph Schwartz with Leerink Partners. Joseph Schwartz, your line is open.

Thank you. Congrats on a strong quarter. Based on the sales for the quarter and our estimate for price, it seems like there's just over 1,100 patients on therapy by the end of the quarter. I was wondering, is that estimate reasonable. And given the company has received over 2,400 PSFs since -- or as of the end of the quarter, could you talk a bit about how much success you're having converting PSFs to scripts? How long does that take? And how should we think about that cadence of conversions over the balance of the year?

Joe, thanks so much for the question. And Peter, I'll turn this one also over to you.

Yes. Thank you, Joe. I think it's a good question. I would say, first, our strong inflection in growth in net revenue in the second quarter is a reflection of the continuing efficiencies that we're making in the fulfillment process. What you're speaking to is like the cumulative number of patients start forms. And as we mentioned at the earlier call, last summer we observed a pocket of patients that required additional support and education, in particular in the REMS certification process. But the measures we made and implemented allow for better patient engagement on this REMS certification process. And I would say within that context, I'm really pleased with the progress we are making. And see, we are well within the rare disease benchmarks, both on the amount of patients that we are serving, as well as the time to fill two paid shipments.

Thanks, Peter. And, Joe, I'll just reiterate that I'm really pleased with how those efficiencies have been going and how Peter's team has been executing. I think the fundamentals that we're seeing in Q2 and into Q3 are exactly where I'd hope to be going into full approval, where we really are seeing those operational efficiencies of pull through and conversion happening.

Great. That's very helpful. Thanks. And then a question on pegtibatinase, if I could, how has site activation been going and enrollment up until this point?

Jula, why don't you take that one?

Thank you. So we're pleased to have the first patient dosed earlier this year. And as I mentioned on the call, we really have a strong interest from patients in the community, and this is both in the U.S. and abroad. As I've previously mentioned in the past, we're metering enrollment to ensure we have strong quality and can scale up for CMC for the full study and commercial launch. We've said before we're not going to provide specific patient numbers along the way, but our goal and we're planning for top line data in 2026.

Thank you.

Thank you. [Operator Instructions]. We will take the next question from the line of Carter Gould with Barclays. Carter Gould your line is now open.

Great. Thanks for taking the question. Maybe to tackle the guidelines from a little bit of a different angle. Upon the guidelines kind of being announced, what's your expectation that then like sort of the timeframe from that announcement to payer policy and language being updated? Thank you.

Carter, thanks for the question. Peter, I'll hand that one over to you.

Yes, thanks, Carter. First of all, I think you're referring to the KDIGO guidelines and [indiscernible] actually part of the script that we are expecting that soon. And I would say timing could be better. Lowering the proteinuria target really positioned FILSPARI well, given our strong proteinuria efficacy data, 50% absolute reduction, as well as our complete remission data. And additionally, this lower treatment will also allow to broaden the patient population. So we are really excited about the momentum that this generates for FILSPARI. With regards to the second part of your question, how fast will payers adopt this in their plans? Well, we are ready to go with our updated value proposition with payers from under the FILSPARI profile. And when payers are in their payer plans are not only referring to the label, but also to guidelines. So I'm really excited that those are coinciding quite nicely in the time. I think it provides a great opportunity for our clinical national account managers to have that conversation with payers and to update the authorization criteria very quickly.

Thank you.

Thank you. We will take the next question from the line of Jason

Good afternoon. This is Pavan Patel on for Jason

All right. Thank you for those questions. And Peter, why don't you take those?

Yes, I'm happy to take those. And the first question is really, like, what are PROTECT is resonating most? If full disclosure, like, given that we don't have the full label, we are not able to talk commercially about eGFR and long-term kidney preservation data. So that's really Jula seen in the medical science result that had the conversation in the field. In personal conversation that I've had with physicians is they're excited about the continuation of proteinuria reduction. And if you saw, if you look at the data and you look after two year proteinuria production, then you see that about two-thirds of the irbesartan, the active control arm, proteinuria effect was waning, while FILSPARI actually continued to hold quite nicely. And that gives thought leaders confidence that there will be that long-term continued kidney preservation. I mean, we measured this up to two years. So given that you impact one of the main damaging factors in proteinuria is a marker of damage. If you really are able to continuously reduce that, there is a translation to long-term kidney preservation. So that's why I'm most excited about. Maybe Jula can talk about [indiscernible].

Thanks, Peter. Well, our teams have been in hand with the PROTECT data and being able to engage both community and academic leaders, and they continue to hear a change in the momentum from when we first released the data and people didn't understand it. But we're doing things like journal clubs and engagement, where they really have a full understanding of the magnitude and durability of proteinuria reduction, the preservation of kidney function, which gets better year-over-year combined with long-term safety. And as I mentioned on the call, we are starting to hear back that this should be a foundational treatment for patients with IgA nephropathy. And as we have full approval, a full label, and the commercial team also able to discuss this, I believe that we're going to have an even incremental role across the spectrum, being able to treat patients with IgA nephropathy.

So, for the next part of the question. Yes, Peter, why don't you take the next part of the question on what parts of the label do you think are going to drive uptake?

Yes, I was going to get there, and I think the question was really like, how fast update do you expect? Yes, I think given -- I mean, we spoke about it at the launch call last week. In general, the nephrologists are a relatively conservative audience. I don't think things go quickly in general. But having said that, we are really excited about like the full data that we can now communicate with physicians, and we really allow for that uptake as well. The strengthening of the FILSPARI label, the strengthening of the profile, all the elements that Jula was talking about, the long-term kidney preservation and safety data, and the long-term proteinuria benefit that will have an impact. But I wouldn't say it's a onetime step. I think it's a continuation of growth that we anticipate moving forward.

Thank you.

Thank you. We will take the next question from the line of Yigal Nochomovitz with Citi. Yigal Nochomovitz your line is open.

Hi, this is Reena [ph] on for Yigal. Thanks for taking my question. Just wanted to ask, on the inclusion of the KDIGO guidelines, what are your expectations around where FILSPARI will fit? Do you see it being used as an independent frontline option only after failure or in combination? Do you have any additional detail on physician-payer perspective for this?

All right, Jula, why don't you take that one? And Peter, you can add anything on the payer perspective.

So, given that we've published the PROTECT data and we have approval of FILSPARI, both in U.S. and Europe, FILSPARI, we know, are included in the KDIGO guidelines. And consistent with other guidelines and recent publications, we anticipate FILSPARI will be included as part of the foundational care for treatment of kidney injury that we know occurs and leads to diagnosis of patients with IgA nephropathy. The other aspect that Peter started to discuss is, we know that there's evidence that patients remain at risk for kidney failure with even low levels of proteinuria. So we anticipate the guidelines will push for earlier diagnosis and treatment to even lower levels of proteinuria. So these two components, FILSPARI and the guidelines as foundation for treating the kidney injury, as well as diagnose and treat the lower levels of proteinuria, we believe the KDIGO guidelines can really help expand the population of patients who would be treated with FILSPARI as a foundational treatment.

Building on that, I think to Jula's point, it's really about two categories, one, like really the natural protective medicine that acts within the kidney. And then the second category is more the immune mediation. And to the point that you make, like, why we see FILSPARI, I think that will be reflected in the KDIGO guidelines as well, is really replacing large inhibition, in particular age inhibitors and AMDs. And that's the case already today. And that's also how FILSPARI is being affected in the payer plans. I think it was the second part of your question.

Yes, that's right. I mean, I think if we take a step back and we think about how the KDIGO guidelines are going to help in driving what we're already seeing within the treatment paradigm. One, we now have the opportunity to reach for complete remission, and we know that most patients on ACE or ARB and steroids don't achieve or sustain complete remission. And so, there is going to be the ability to reach that, but it's going to require for most patients, combination therapy. So while we don't yet have the KDIGO draft guidelines, I think we fully expect that the underlying trend that we're seeing within this space is increased combination. And as we're already seeing, FILSPARI is going to be a core part of that, because we have the superior profile for that action in the kidney and the proteinuria reduction. So I think fundamentally the KDIGO guidelines and whatever they shape are going to help in driving more aggressive therapy, because remission is now within reach for many of these patients.

Thank you. We will take the next question from the line of Maury Raycroft with Jefferies. Maury Raycroft your line is open.

Hi, congrats on the quarter and thanks for taking my question. I'll shift gears and ask about FSGS. For the PARASOL Group's work to establish alternative FSGS endpoints, do you have a sense of what the outcomes could entail? And can DUPLEX potentially satisfy those endpoints in post-hoc analyses or in a subgroup of FSGS patients? Or do you expect you would have to run a new supplemental study?

All right, Maury, thanks for the questions. Jula, why don't you take these?

Yes. So PARASOL is continuing their efforts, and while I can't speak for PARASOL, we do know from the DUPLEX study, as I earlier mentioned on the call, eGFR is not an appropriate endpoint for FSGS. There's too much variability. So the next reasonable endpoint to look at is proteinuria, how you measure that other different aspects. And importantly, within DUPLEX, we saw a meaningful effect that was statistically significant on the modified partial remission endpoint. Now, PARASOL was created to establish new endpoints. And what we've heard from public commentary and what they've analyzed so far is that, similar to what we saw with DUPLEX, eGFR is not suitable. So then what they're moving to next is, well, what is the right endpoint? And they are looking at measures of proteinuria and other aspects, and they're making very good progress on these alternative endpoints with a plan to read out at ASN, and they're on track for that. What that translates to us is a very exciting place to be for FSGS patients and a potential path forward for FILSPARI and FSGS, based on the work that they've done to date. More to come, and we'll give you more of an update later this year.

Got it. Okay. Thank you.

Thank you. We will take the next question from the line of Laura Chico with Wedbush Securities. Laura Chico your line is now open.

Hi, thank you very much for taking the question. This is Dylan [ph] on for Laura Chico. So when you consider the setup for the second half of 2024, what is more impactful to FILSPARI uptake? Would it be the potential KDIGO guideline revisions? Or would it be a potentially updated FILSPARI prescribing label?

Yes, Dylan, thanks for the question. I would say that we are in such a great position because the timing for us could not be better. It's really the synergy of both. To be able to have KDIGO guidelines that could potentially lower the target, to be able to reach more patients that need better therapy at a time where we're able to expand our label and reach more patients, we're really excited about both of those occurring near simultaneously to drive further uptake of FILSPARI as a foundational therapy. So, I don't know that we really parse them out as either. We're seeing that they're going to really influence each other in the treatment paradigm.

Thank you.

Thank you. We will take the next question from the line of Alex Thompson with Stifel. Alex Thompson your line is now open.

Hey, thanks for taking our question. I just want to follow-up again on PARASOL. I think you had mentioned in the past that there was an initial meeting, I believe in June. Can you -- were you in attendance? Someone from Travere in attendance. And was this discussion of moving towards a proteinuria endpoint really the topic of the conversation? Any color on the meeting itself would be helpful. Thank you.

All right. Jula, why don't you take that one?

Yes, thanks for the question. So, PARASOL is a partnership with academics, FDA, EMA, industry was invited, and yes, we were in attendance. And there is discussion, as I mentioned, around what is the appropriate endpoint. But that work remains ongoing with a plan to publicize that work later. I would say that we're very encouraged by the analyses and the data that has been put forward, which gives us increased confidence around a potential path forward. But we need to wait for the full readout, the full alignment across the different organizations and groups to say, yes, these are the appropriate endpoints to analyze. And importantly, as I said earlier, we feel solid about the DUPLEX data and about a path forward for FILSPARI for the treatment of FSGS, not only because of our data, but also the unmet need.

Great. Just to clarify, I guess, your focus today talking about proteinuria, is that based on the discussion explicitly? Or is just your view of DUPLEX? Thanks.

So that is based on the discussion that the work has been going on, and this is public. If you look, the PARASOL says defining a new endpoint, either based on kidney function, GFR, and 22222predicting preservation of kidney function, which is avoiding of dialysis long-term. So we increasingly feel encouraged, based on the fact and the analysis that they've done around eGFR, saying, this is a difficult endpoint, let's move past eGFR and look at other measurements, of which proteinuria is the top of the list.

Great. Thank you.

Yes, I think the only thing we had, Alex, is our perspective is also informed by the work that we've done over the number of years, both in looking at identifying an endpoint like the FSGS partial remission endpoint, as well as subsequent analyses from our Phase 2 DUET study, where patients were followed for many years, showing that those patients that were able to achieve complete remission really had a better trajectory for their disease. So I think it's informed by the gestalt of all of the data that we've been doing and also what we're hearing from PARASOL at this point. But as Jula mentioned, really, we've got to wait till they report out later this fall.

Great. Thanks Jula and Eric.

Thank you. [Operator Instructions] We will take the next question from the line of Tim Lugo with William Blair. Tim Lugo your line is open.

This is John on for Tim. So I was wondering if you could give us an idea of, say, if the REMS requirements for the current FILSPARI label were not adjusted with the upcoming PDUFA, what are some of the timelines or data updates we could be looking to -- for when you'll be looking to reengage with the FDA to discuss amending the REMS again?

Sure. Well, I think what we can say is consistent with how we've shared our perspective on REMS update and providing FDA with additional safety along the way, both from the completion of our trials such as DUPLEX, as well as the post-marketing exposure that we've had now that FILSPARI is used commercially. Of course, all of that will be shared with FDA. The first opportunity that we saw to engage the FDA on a potential modification of the REMS was in the sNDA process, and obviously, we're in the midst of that. And we have a practice of not discussing updates along the way in that process, which is why we feel that the first opportunity is at full approval to share that. But we also believe that there are multiple opportunities along the way after approval to continue to bolster the safety package and continued review of the label with FDA along the way. So more to come very soon.

Thank you.

We will take the next question from the line of Mohit Bansal with Wells Fargo. Mohit Bansal, your line is open.

This is Fadi [ph] on for Mohit. Thanks for taking our questions. So, with a complement inhibitor expected to be approved soon, I wanted to get your view on how FILSPARI and the ERA class would fit into a future treatment paradigm in IgAN with complement inhibitors and also the new B cell agents coming to market? Do you think there will be a lot of combination use? And do you think doctors right now understand the potential for combination use with these various agents? And do you think costs of these drugs would be a limitation as far as combination use? Thanks.

Okay, great. Jula, why don't you start and Peter, certainly add anything further from your perspective.

Thanks. So I want to highlight the treatment algorithm has really always been two-pronged. You target the kidney injury with RAS inhibitors and maybe SGLT2s, and then you may also add immunosuppressants to block the immune system activation. So this two-pronged approach, target the kidney, target the immune system. But increasingly now and over time, we're going to have superior safer medicines for each of those buckets. And you're right, likely combination therapy is going to be needed in the future. But I want to highlight, FILSPARI is the only medicine approved or in development that has shown superiority to be able to replace the standard of care role of RAS inhibitors on that side of targeting kidney injury. Now, when you target immune system overactivation, we're excited that there's going to be a replacement for steroids on the horizon, whether it's going to be B cell BAFF complement inhibitors, and it's clearly going to be that we're going to need multiple medications because no one drug now or in development can get all patients into complete remission, which is ultimately the goal. And Eric mentioned this, but we have very strong data around complete remission. One-third of patients in PROTECT got there. Two-thirds of patients when they were started earlier gotten to complete remission in sparsentan. But you're still going to need combination. And increasingly we're hearing that we're not going to wait over time. We're likely going to be using therapies early on after diagnosis and in combination really to optimize long-term outcomes for patients with IgA nephropathy.

Peter, anything you want to add?

Yes. From a pricing perspective, first of all, let me reiterate that Jula said, I mean, complement space in a different category than FILSPARI from this. FILSPARI is really nephroprotective within the kidney, replacing large inhibition and taking mind. All new modalities are always being studied on top of RAS inhibition. With regards from a payer perspective and how they will think about innovative combination therapies? You have to take into consideration that FILSPARI is priced for broad use and broad utilization, really allowing to position it as a foundational care. It's priced at a very different level than the complement inhibitor that you were referring to that already has an indication in BMS. Additionally, I also want to say like we have a very strong update at the payer side and we are now already included in over 1,250 formularies across the nation. So a very strong positioning in formula for FILSPARI. So I feel quite good about it. But again, it's based in a different category and FILSPARI strives for broad utilization.

Thank you. We will take the next question from the line of Vamil Divan with Guggenheim Securities. Vamil Divan your line is now open.

Great. Thanks for taking my question. So just one going back to the patient start forms for FILSPARI. So it looks like you've had sort of steady increases in the number of patient start forms, but the increase in actual sales is much more significant this quarter or even over the last few quarters relative to the percentage increase on the PSF side. So, just curious, what's driving that. Is that sort of better conversion of people getting PSFs getting started on therapy? Is it maybe something more on the sort of net pricing side that's driving that, where you're getting more net sales per script? Or maybe it's just a timing thing where there were PSFs written earlier that just took some time to get bills? So maybe just a little bit of more visibility there would be helpful to kind of get a sense of what to expect going forward.

All right. Peter, why don't you take that one?

Yes. First of all, I mean, it was a continuation of growth in both sectors, both patients start forms that speaks to continued demand, but in particular also on the progress that we have made on revenue. And I think the revenue growth, where you're going at, like, why do you see a much stronger growth percentage on revenue relative to demand? I think it's really like a reflection of the continuation of efficiencies we have in our fulfillment process. And I think an earlier question today was about the pocket of patients that we saw last year that are part of the cumulative amount of patient starts that caused a little slower uptake in the transition to paid shipments. We have made our modifications there, and we see now much faster REMS certifications early on that allows them to pull patients through and get them to paid shipments early on. And I think that's really the reflection, the efficiencies in the portfolio, that's the reflection that you see in that revenue growth.

Yes, I think -- Peter, thanks. The only thing that I would add, Vamil, is that, we have a very high rate of compliance and persistence with this medication. These patients get good support for the chronic use of FILSPARI. But I think the one thing that's impressed me so much with this launch are the personal stories that we hear on a weekly basis about patients that finally, for the first time since their diagnosis, oftentimes for decades, they finally, on FILSPARI feel like they're winning and that their proteinuria is under control. That drives so much of the high compliance rate that we see. And that's what one of the things that gets me really excited about the long term outlook for FILSPARI.

Okay. Thank you.

Thank you. We will take the next question from the line of Ed Arce with H.C. Wainwright. ED Arce your line is now open.

This is Thomas Yip asking a couple of questions for Ed. Thank you so much for taking our question. So one from us. Can you discuss the average persistent rates of patients on FILSPARI? And what is the average time to convert PSFs to drug fulfillment for FILSPARI? Thank you so much.

All right. Thanks, Thomas. So, Peter, why don't you take those questions?

Yes, I was referring to the high persistency and compliance rates, which are at the high end, what you would expect for chronic therapy like FILSPARI, we haven't disclosed the specific numbers. With regards to the time to get to paid shipments, I think at the launch call last year I mentioned that in my experience, in average, you see in rare disease fulfillment time between 20 and 60 days. I think we are well within the benchmark. We were initially at the higher end, and now we are at the more efficient part of the fulfillment. So I think we are making really good progress in the time to fill. And to my earlier answer, I think that's also reflected in the revenue growth this quarter.

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

Great. Thank you, everyone, for joining us for our second quarter 2024 financial results call. We look forward to providing additional updates on our progress. Have a great rest of your day.