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spk09: and welcome to the Travier Therapeutics Second Quarter 2024 Financial Results in 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 Nera. Please go ahead, Nivi.
spk10: Thank you, Rachel. Good afternoon and welcome to Travier Therapeutics Second Quarter 2024 Financial Results in Corporate Update Call. Thank you all for joining. Today's call will be led by our President and Chief Executive Officer, Dr. Eric DuVay. Eric will be joined in the prepared remarks by Dr. Jula Inrig, our Chief Medical Officer, Peter Huma, our Chief Commercial Officer, and Chris Klein, 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 statement. Please see the forward-looking statements disclaimer on the company's press release issued earlier today, as well as the risk factors section in our forms 10Q and 10K 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. Interviewers 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?
spk15: Thank you, Divi, and good afternoon, everyone. In the second quarter, we continue to make significant progress on our key priorities. At the center of our growth is PhilSparry, which is becoming a foundational therapy for iGinopropathy, 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. PhilSparry is the only rare arena launch to consistently deliver -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 S&DA review process for full approval in iGin 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 iGin. We anticipate that a broader label would enable us to reach more patients. Specifically, we estimate PhilSparry's addressable iGin 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 PhilSparry 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 PhilSparry to iGin patients in other parts of the world. Our partner in Europe, CSLV4, is preparing for the first launch of PhilSparry in that region very soon. In Japan, Rinalis 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 Paracel Group, and we remain hopeful that we will be able to identify a regulatory path to bring PhilSparry to patients diagnosed with FSGS. We plan to engage with regulators later this year and to provide an update following those discussions. And finally, Peg de Batinay 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 Travier. 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?
spk21: Thank you, Eric. From a medical perspective, we continue to be focused on achieving full approval of PhilSparry and providing the education and support to enable PhilSparry to replace RAS inhibitors as foundational care for IgA nephropathy. I am 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 over activation in both the kidney and the immune system. PhilSparry is unique in being a single pill that directly blocks two harmful pathways, endothelin and angiotensin, which are over-activated in the kidney and lead to kidney injury in IgA nephropathy. And we believe that PhilSparry, with its superior clinical profile, addressing the over activation in the kidney and providing long-term nephroprotection, 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 PhilSparry 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 PhilSparry for patients with IgA nephropathy. We hear more nephrologists referencing PhilSparry as foundational care in their practice, including initiating treatment with PhilSparry as a first line therapy. At the heart of this momentum is our data. We have incredibly strong results from the most rigorous phase three study completed in IGAN, one in which PhilSparry 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 PhilSparry, patients can achieve protein area reductions of about 80% and stabilization of EGFR and that PhilSparry 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 PhilSparry. And for those that need an additional treatment, they're combining PhilSparry with an SGLT2 inhibitor or a steroid. This is aligned with the increasing recommendations and treatment guidelines and algorithms to replace RAS inhibitor therapy with PhilSparry 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 PhilSparry 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 PhilSparry. 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 three study and an accrual of EGFR benefits, as well as robust safety data seen in our protect study. Tending full approval, we believe these data will only further reinforce the nephroprotective effects of PhilSparry, providing further context and conviction for nephrologists to prescribe PhilSparry to more of their patients and to continue our progress towards PhilSparry achieving foundational care. Now, let me briefly discuss our efforts with FSGS. As a reminder, in our phase three duplex trial, Varsentin demonstrated a statistically significant difference on the modified partial remission proteinuria endpoints and clinically meaningful improvements in kidney function and the composite kidney failure endpoints compared to herbicartens. 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 three FSGS trial, then another endpoint, such as proteinuria, needs to be proposed and validated. With this background, Nescure, 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 datasets 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 PhilSparry 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 -to-Batinase program for patients with HCU. We are excited about our potential to deliver -to-Batinase 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 -to-Batinase 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 three program and commercial launch. Let me now turn it over to Peter for a commercial update. Peter?
spk04: Thank
spk08: you,
spk04: Zula, and good afternoon, everyone. In the first half of this year, we have been focused on delivering strong execution on .R.E. loans, and I'm very proud of the progress that our teams have 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 star forms, or PSFs. We have now demonstrated continued growth in new PSFs each and every quarter since the beginning of our loans, and we are continuing to build momentum as we have towards our early September -by-days for full approval, which we believe will further accelerate .R.E. 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 RAM-certified, and we are exceeding recent RAM nephrology benchmarks for the number of total prescribers after 18 years. We believe one of the key drivers of this continued growth is that we are continuing to hear from society prescribers that their patients are experiencing what we saw in clinical trials. The rapid and sustained reduction in proteinuria was a well-tolerated safety profile. As more nephrologists adopt .R.E., they're having this positive experience with their patients, and we are pleased that they then become advocates for using .R.E. with their peers. Product access and reimbursement is strong, with 96% of the US lives having a pathway to .R.E. reimbursement, and we are very pleased with the claims of approval rates we are seeing, also reflecting the strong authorization criteria for .R.E. in 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 .R.E. All of these efforts have resulted in $27.1 million of net .R.E. 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 revenue for all the revenue benchmarks in the second year of loans, especially with strong catalysts ahead of us. As we look ahead, the most important catalyst is our upcoming Padua date next month. As you mentioned, we are preparing for full approval with a broadening of the .R.E. label, which in gringotts, 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 the fraudous evolution towards earlier treatment of IgM patients will have the potential over time to increase the addressable IgM patient population from approximately 30 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 on the most rigorous pivotal trial conducted in IgM infraday 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 .R.E. in daily practice. We are ready, prepared, and fully energized to leverage this anticipated milestone to elevate .R.E. Preparations are underway to position our teams to engage with patients and physicians to amplify the profile of .R.E. on full approval. Additionally, we anticipate that the new Cadego guidelines will become available soon, timing that is potentially lining up quite nicely. We anticipate that for the first time, the world includes .R.E. as part of the treatment paradigm, that they will emphasize the urgency to diagnose and treat IgM infraday patients earlier with a more ambitious Pantoneuria treatment targets. This will 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 springboard to strengthening the .R.E. profile and broadening the addressable patient population in the second half of the year. We are driven by the prospect of serving even more patients moving forward by establishing .R.E. as the foundation therapy for IgM infraday patients. Let me now turn the call over to Chris for the financial update.
spk08: Chris.
spk02: Thank you, Peter, and good afternoon, everyone. During the second quarter, we continued 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 .R.E. and IgM infraday. 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, SGN 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 -over-year operating expenses is attributable to the restructuring enacted at the end of 2023 and reduced clinical expense as the first sentence phase three study is advanced towards completion. Total other expense net for the second quarter of 2024 was $1.9 million compared to total other income net of $2.1 million in the same period of 2023. The difference is largely attributable to a $3.4 million non-cash charge to other expense related to the Reynolds 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 non-GAAP adjusted basis, net loss, including from discontinued operations for the second quarter of 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 cashed cash equivalents and marketable securities of $325.4 million. Cash use 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 PhilSparry sales, continued contribution from Tiola, and declining R&D investments percent in over time as the supporting studies complete. We also anticipate multiple incoming milestone payments from CSL v4 upon conversion of PhilSparry 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 3rd. With that, I'll now turn it back to Eric for his closing comment, Eric.
spk15: Thank you, Chris. Through the first half of 2024, we've delivered meaningful growth in PhilSparry, continued the collaborative engagements with regulators and payers, and have made meaningful progress in bringing both PhilSparry and PEG-DBATNA to patients. We know that they are waiting for us. It's for this reason that I and my colleagues at Travier 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 Travier for meaningful growth now and in years to come. Now let me turn the call over to Nivy for Q&A. Nivy?
spk10: Thank you, Eric. We can now open up the line for Q&A. Rachel?
spk09: Thank you. If you are dialed in via the telephone and would like to ask a question, please signal by pressing star one on your telephone keypad. As a reminder, we ask that you limit yourself to one question. If you have another question, please rejoin the queue. If you are using a speakerphone, please make sure your mute function is turned off to allow your signal to reach our equipment. Again, please press star one to ask a question. We will take the first question from the line of Tyler Van Buren from TD Cowan. Tyler Van Buren, your line is now open.
spk16: 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?
spk15: 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 gotten 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 Philspari 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 Philspari is now becoming the foundational therapy for the
spk14: treatment of IGAN.
spk09: Thank you. We'll take the next question from the line of Anupam Rama with JP Morgan. Anupam Rama, your line is open.
spk03: Hey guys, thanks so much for taking the question. Just quick one from 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's that kind of changed over time? Thanks so much. Great, thanks Anupam for the question.
spk15: Peter, I'll turn that one over to you.
spk04: Yeah, 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 it'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, 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 practice that I've seen in the
spk08: past for successful launches.
spk09: Thank you. We will take the next question from the line of Joseph Schwartz with Liering Partners. Joseph Schwartz, your line is open.
spk06: 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 or as of the end of the quarter, could you talk a bit about how much success you're having converting PSFs to Scripps? How long does that take? And how should we think about the cadence of conversions over the balance of the year?
spk15: Joe, thanks so much for the question. And Peter, I'll turn this one also over to you.
spk04: Yeah, thanks, Joe. I think it's a good question. I would say first, our strong infliction in growth in net revenue in the second quarter is a reflection of the continuing efficiencies that we're making in the fulfillment process. And what you're speaking to is like the cumulative number of patients platforms. And as we mentioned at an earlier poll, last summer we observed a pocket of patients that required additional support and education, in particular in the RAM certification process. But the measures we made and implemented allow for better patient engagement on this RAM certification process. And I would say within that context, I'm really pleased with the progress we are making. And I think we are well within the rare disease benchmarks both in the amount of patients that we are serving, as well as the time to fill two page shipments.
spk15: Thanks, Peter. And Joe, I'll just reiterate that I'm really pleased with how those efficiencies have been going in 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.
spk06: Great, and that's very helpful, thanks. And then a question on Peg Tabatman, how has site activation been going and enrollment up until this point? Jula, why don't we take that one?
spk21: Well, 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 US 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 gonna provide specific patient numbers along the way, but our goal and we're planning for top line data in 2026.
spk08: Thank you.
spk09: Thank you. As a reminder, please limit yourself to one question and you may rejoin the queue with additional questions. We will take the next question from the line of Carter Gould with Backlays. Carter Gould, your line is now open.
spk13: Great, thanks for taking the question. Maybe 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.
spk14: Carter, thanks for the question. Peter, I'll hand that one over to you.
spk04: Yeah, thanks, Claudia. First of all, I think you referred to the Cadeo guidelines and you mentioned as a part of the script that we're expecting that soon. And I would say timing could be better. Lowering the proteinuria target really positions first priority role, given our strong proteinuria efficacy data, 50% absolute reduction, as well as our complete remission data. And additionally, there's lower treatment target will also allow to broaden the patient population. So we're really excited about the momentum that this generates for PhilSparry. 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 on the PhilSparry profile. And PhilSparry payers are in their payer plans, I'm 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
spk08: authorization criteria very quickly.
spk09: Thank you. Thank you. We will take the next question from the line of Jason Zamanski with Bank of America. Jason Zamanski, your line is now open.
spk19: Good afternoon, this is Baben Patel on for Jason Zamanski. Congrats on the quarter and thanks so much for taking our questions. With the protect data in hand, could you please highlight the feedback that you've been getting from prescribers? What's thus far been the biggest hurdles to uptake in the community and academic settings? And then as you think about the likely potential label update, what factors do you think could be the most critical or impactful in terms of driving uptake? And then in terms of the sales trajectory for PhilSparry, do you expect patient inflection to be immediate in conjunction with the label, the broader label update, or more gradual without seeing sort of an early bull list? Thank you.
spk15: All right, thank you for
spk14: those questions. And Peter, why don't you take those?
spk04: Yeah, I'm happy to take those. And the first question is really like, what out of protect is resonating most? In full disclosure, like given that we don't have the full label, we are not able to talk commercially about the EGF or in long-term IP preservation data. So that's really due as seen in the medical science liaison 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 reduction, then you see that about two thirds of the urbexartan, the active control arm proteinuria effect was waning while PhilSparry actually continued to work quite nicely. And that gives thought, it gives confidence that there will be that long-term continued kidney preservation. We mentioned this up to three years. But given that you impact one of the main damaging factors in proteinuria is a marker of them, if you really are able to continuously reuse it, there is a translation to long-term kidney preservation. So that's what I'm most excited about. And maybe Julia can talk about like what the MSL's are experiencing in the field.
spk21: 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 gonna have an even incremental role across the spectrum being able to treat patients with IgA nephropathy.
spk15: So for
spk08: the
spk15: next part of the question. Yeah, Peter, why don't you take the next part of the question on what parts of the label do you think are gonna drive uptake?
spk04: Yeah, I was going to get that. I think the question was really like how fast do you expect? Yeah, I think, I mean, we spoke about it at the long scroll last week. In general, the nephrologists are a relatively conservative audience. I don't think things go completely 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 first priority label, the strengthening of the profile, all the elements that Juno was talking about, the long-term kidney preservation, the safety data and the long-term progeny benefit, then we'll have an impact, but I wouldn't say it's a long time step. I think it's a continuation of
spk08: growth that we anticipate going forward. Thank
spk09: you. Thank you. We will take the next question from the line of Yigal Nekomovic with CIDI. Yigal Nekomovic, your line is open.
spk20: Hi, this is Rena Onfregal. Thanks for taking my question. Just wanted to ask, on the inclusion of the CIDIGO guidelines, what are your expectations around where the cell spariate will fit? Do you see it being used as an independent front-line option only after a heart failure or in combination? Do you have any additional detail on physician pair perspective for this?
spk15: All right, Jula, why don't you take that one? And Peter, you can add anything on the pair perspective.
spk21: Thank you. Given that we've published the PRoTEC data and we have approval of cell spariate both in US and Europe, cell spariate we know are included in the CIDIGO guidelines. And consistent with other guidelines and recent publications, we anticipate cell spariate 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, cell spariate and the guidelines as foundation for treating the kidney injury as well as diagnose and treat the lower levels of proteinuria, we believe the CIDIGO guidelines can really help expand the population of patients who would be treated with cell spariate as a foundational treatment.
spk04: Jula, building on that, I think to Jula's point, it's really about two categories. One, like really the method protective medicine that acts within the kidney. And then the second category is more the new mediation. And to the point that you make, like what we see cell sparing, I think that will be reflected in the CIDIGO guidelines as well, is really replacing large inhibitions, in particular, A's inhibitors and ARBs. And that's the case already today. And that's also how cell sparing is being reflected in the payout plans. I think that was the second part of your question.
spk15: Yeah, that's right. I mean, I think if we take a step back and we think about how the CIDIGO 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, you know, while we don't yet have the CIDIGO 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, cell sparing 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 CIDIGO guidelines and whatever they shape are going to help in driving, you know, more aggressive therapy because remission is now within reach
spk14: for many of these patients.
spk09: Thank you. We will take the next question from the line of Morrie Raycroft with Jeffries. Morrie Raycroft, your line is open.
spk12: 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?
spk15: All right, Morrie. Thanks for the question. Jula, why don't you take these?
spk21: Yeah. 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 Phil Spari 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.
spk07: Got it. Okay. Thank you. Thank
spk09: you. We will take the next question from the line of Laura Chico with Wedbush Securities. Laura Chico, your line is now open.
spk17: Hi. Thank you very much for taking the question. This is Dylan on for Laura Chico. So when you consider the setup for the second half of 2024, what is more impactful to a FSGS uptake? Would it be the potential Codigo guideline revisions or would it be a potentially updated Phil Spari prescribing label?
spk15: Yeah, 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 Codigo 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 Phil Spari as a foundational therapy. So I don't know that we really parsed them out as either. We're seeing that they're going to really influence each other in the treatment paradigm.
spk07: Thank you.
spk09: Thank you. We will take the next question from the line of Alex Thompson with Stiefel. Alex Thompson, your line is now open.
spk22: Hey, thanks for taking our question. I just want to follow up again on Perisot. I think you had mentioned in the past that there was an initial meeting, I believe in June. Were you in attendance, someone from Chair Vera in attendance, and was this discussion of moving towards a proteinuria end point really the topic of the conversation? Any color on the meeting itself would be helpful. Thank you. All right, Julia, why don't you take that one?
spk21: Yes, thanks for the question. So Perisot 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 end point. 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 end points to analyze. And importantly, as I said earlier, we feel solid about the duplex data and about a path forward for Fils-Safari for the treatment of FSGS, not only because of our data, but also the unmet need.
spk22: Great. Just to clarify, I guess your focus today talking about proteinuria, is that based on the discussion explicitly or just your view of duplex? Thanks.
spk21: 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 end point, either based on kidney function, GFR, and predicting preservation of kidney function, which is avoiding dialysis long term. So we increasingly feel encouraged based on the fact and analysis that they've done around EGFR, saying this is a difficult end point. Let's move past EGFR and look at other measurements, of which proteinuria is the top of the list.
spk15: Yeah, I think the only thing that I would add, 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 end point like the FSGS partial remission end point, as well as subsequent analyses from our Phase II 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 Julio mentioned, really we've got to wait until they report out later this fall.
spk14: Great. Thanks, Julio and Eric.
spk09: Thank you. Once again, please limit yourself to one question, and you may rejoin the queue with additional questions. We will take the next question from the line of Tim Lugo with William Blair. Tim Lugo, your line is now open.
spk01: Hi, Tim. This is John on for Tim. Thanks so much for taking our questions. So I was wondering if you could give us an idea of, say, if the REMS requirements for the current post-bari label were not adjusted with the upcoming FDUFA, 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?
spk15: 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 Phil Spari is used commercially. Of course, all of that will be shared with FDA. The first opportunity that we sought 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
spk14: very soon.
spk09: Thanks. Thank you. We will take the next question from the line of Mohit Bansal with Wells Fargo. Mohit Bansal, your line is open.
spk11: Hi. This is Sadian 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 Phil Spari 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.
spk15: Okay. Great. So, Jula, why don't you start and Peter, certainly add anything further from your perspective.
spk21: Thanks. So I want to highlight the treatment algorithm has really always been two pronged. You target the kidney injury with brass inhibitors and maybe STLTQs. 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 or 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, Delspari is the only medicine approved or in development that has shown superiority to be able to replace the standard of care role of brass inhibitors on that side of targeting kidney injury. Now, when you target immune system over activation, we're excited that there's going to be a replacement for steroids on the horizon, whether it's going to be B-cell, BAS, 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. A third of patients in Protect got there. Two thirds of patients when they were started earlier got into complete remission in Spartan. 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 IGN agropathy. Yeah, I agree
spk04: with you on that. From a pricing perspective, first of all, let me reiterate what you said. I mean, complement pays in a different category than Delspari. Delspari is really the method of protecting the kidney, replacing RAS inhibition. And take in mind, all new modalities are always being studied on top of RAS inhibition. With regard from a payer perspective and how they will think about innovative combination therapies, you have to take into consideration Delspari 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 template inhibitor that you were referring to that already has an indication of BMAs. Additionally, I also want to say 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 very strong positioning in formularies for Delspari. So I feel quite good about it. But again, it pays in a different category and Delspari
spk08: is priced for broad utilization.
spk09: Thank you. We will take the next question from the line of Zanil Devan with Guggenheim Securities. Zanil Devan, your line is now open.
spk18: Great. Thanks for taking my questions. There's one going back to the patient star forms for Delspari. So it looks like you've had sort of steady increases in the number of patient star forms. So 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 a better conversion of people getting PSFs, getting started on therapy? Is it maybe something more on the net pricing side that's driving that where you're getting more net sales per script? Or maybe it's just the timing thing where there were PSFs written earlier that just took some time to get filled. So maybe just a little bit more visibility there would be helpful to kind of get a sense of what to expect going forward.
spk14: All right. Peter, why don't you take that
spk08: one? Yeah, first of all,
spk04: I mean, it was the continuation of growth in both sectors. Most patients star 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 is 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 the efficiency we have in our social 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 patients storms that forced a little slower uptake in the transition to pay chippance. We have made our modifications there and we see now much faster ram certifications early on that allows them to pull patients through and get them to pay chippance early on. I think that's really the reflection, the efficiencies in the post through that's the reflection that you see in that revenue growth.
spk15: Yeah, I think Peter, thanks. The only thing that I would add, Bommel, 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 PhilSparry. 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 PhilSparry feel like they're winning and that their protein area is under control. That drives so much of the high compliance rate that we see and that's one of the things that gets me really excited about the long-term outlook
spk14: for PhilSparry. Okay,
spk07: thank you.
spk09: Thank you. We will take the next question from the line of Ed Arcee with HCWayne Wright. Ed Arcee, your line is now open.
spk05: Hi, good afternoon everyone. This is Thomas Yip asking a couple of questions. Thank you so much for picking up the question. So one from us, can you discuss the average assistant rates of patients on PhilSparry and what is the average time to convert PSF to drug fulfillment for PhilSparry? Thank you so much.
spk15: All right, thanks Thomas. So Peter, why don't you take those questions?
spk04: Yeah, here it was referring to the high persistency and compliance rates which are at the high end, which you would expect for chronic therapy. Like PhilSparry, 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
spk08: in the revenue growth disorder.
spk09: 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 Nive.
spk10: Great. Thank you everyone for joining us for our second quarter of 2024 financial results call. We look forward to providing additional updates on our progress. Have a great rest of your day.
spk09: This does conclude today's call. Thank you for your participation. You may now disconnect.
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