Travere Therapeutics Q2 2024 Earnings Call Transcript

Quartr
Provided by Quartr
August 1, 2024

There are 16 speakers on the call.

Operator

Good day, and welcome to the Travira 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 Narra. Please go ahead, Nivi.

Speaker 1

Thank you, Rachel. Good afternoon, and welcome to TUVIA Therapeutics' Q2 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, Doctor. Eric Dubey.

Speaker 1

Eric will be joined in the prepared remarks by Doctor. Julia Enrich, our Chief Medical Officer Peter Hiehrma, our Chief Commercial Officer and Chris Klein, our Chief Financial Officer. Doctor. Bill Roeth, Senior Vice President of Research and Development, will join us for the Q and 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.

Speaker 1

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 10 ks 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 Travir 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.

Speaker 1

Eric?

Speaker 2

Thank you, Nivi, and good afternoon, everyone. In the Q2, 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 Q2, we set new highs in demand and revenue and we are on track to outperform benchmark launches in year 2.

Speaker 2

VOSPARI is the only rare renal launch to consistently deliver quarter over quarter growth in new patient start forms through the first 6 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 2 year data from the most rigorous study conducted in IgA.

Speaker 2

We anticipate that a broader label would enable us to reach more patients. Specifically, we estimate Vilspari's addressable iGAN patient population in the future could nearly double over the time from the current level. And the 2 year data should build even more conviction in prescribing HILSPARI since it will potentially provide an opportunity for our teams to clearly highlight long term durable proteinuria reduction, long term kidney function preservation and 2 year safety data and our teams are ready. We also continue to make progress in bringing Vilspari to IgAN patients in other parts of the world. Our partner in Europe CSL V4 is preparing for the first launch of TILSPARI in that region very soon.

Speaker 2

In Japan, Rinalis recently dosed the first patient in their pivotal study, which is expected to have results in the second half of twenty twenty five 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, tegivatinase continues enrollment activity in furtherance of a planned top line readout in 2026.

Speaker 2

As we outlined at the start of the year, 2024 is a year of execution for Treveren. 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?

Speaker 3

Thank you, Eric. From a medical perspective, we continue to be focused on achieving full approval of VILSARI and providing the education and support to enable VILFARI 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. ZOSPARI is unique in being a single pill that directly blocks 2 harmful pathways, endothelin and angiotensin, which are overactivated in the kidney and lead to kidney injury and IgA nephropathy.

Speaker 3

And we believe that VILSPARI with its superior clinical profile addressing the overactivation in the kidney and providing long term nephra 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 Valsari 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 VOSPARI for patients with IgA nephropathy. We hear more nephrologists referencing VOSPARI as foundational care in their practice, including initiating treatment with VOSPARI as a first line therapy.

Speaker 3

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 VOSPARI 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 VILSPARI, patients can achieve proteinuria reductions of about 80% and stabilization of eGFR and that VILFARI 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.

Speaker 3

This is aligned with the increasing recommendations and treatment guidelines and algorithms to replace RAS inhibitor therapy with ZILSPARI 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 over activation in the kidney and the immune system. We expect ZOSPARI 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.

Speaker 3

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 FILSARI. This would be grounded in the 2 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 benefit, as well as robust safety data seen in our PROTECT study. Pending full approval, we believe these data will only further reinforce the necro protective effects of Filspari, providing further context and conviction for nephrologists to prescribe VILSPARI to more of their patients and to continue our progress towards VILSPARI achieving foundational care. Now let me briefly discuss our efforts with FSGS.

Speaker 3

As a reminder, in our Phase 3 DUPLEX trial, our Sensen 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 ml 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, then another endpoint such as proteinuria needs to be proposed and validated. With this background, NestCure, the FDA, EMA and academia created an initiative called Parasol with a 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.

Speaker 3

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 Vilspari in 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 pegtobatinase program for patients with HCU. We are excited about our potential to deliver pegtovatinase 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 pegtobatinase program.

Speaker 3

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 3 program and commercial launch. Let me now turn it over to Peter for a commercial update. Peter?

Speaker 4

Thanks, Lila, and good afternoon, everyone. In the first half of this year, we have been focused on delivering strong execution in TOSPARI launch, 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 Q2, 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.

Speaker 4

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 Q2, approximately 2,400 nephrologists were REMS certified, and we are exceeding reasons 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 society prescribers that their patients are experiencing what we saw in clinical trials. Rapid and sustained reduction in proteinuria with a well tolerated safety profile. As non nephrologists adopt Silspari, they are having these positive experience with their patients, and we are pleased that they then become advocates for using VOSPARI with their peers.

Speaker 4

Threat access and reimbursement is strong with 96% of the U. S. Lives having a pathway to Fospario reimbursement. And we are very pleased with the claims approval rates we are seeing, also reflecting the strong authorization criteria for first party 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 CILSPARRI.

Speaker 4

All of these efforts have resulted in $27,100,000 of net postparti sales in the 2nd quarter, an increase of 37% over the 1st quarter. I am really pleased with this inflection in revenue as it positions us to outperform recent revenue benchmarks in the 2nd year of loans, especially the strong catalyst ahead of us. As we look ahead, the most important catalyst is our upcoming PDUFA date next month. As Johan mentioned, we are preparing for full approval with the broadening of the Kilspari label, which, if granted, we believe will allow for an acceleration of demand based on 2 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 again patient population from approximately 30,000 to 50,000 patients to up to 70,000 patients.

Speaker 4

Alongside this, with the full approval and updated label, we would expect to finally be able to educate physicians on our exciting 2 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 interim analysis, so we expect a 2 year confirmatory data to further support foundational use of Valspari in daily practice. We are ready, prepared and fully energized to leverage this anticipated milestone to elevate TOSPARI. Preparations are underway to position our teams to engage with patients and physicians to amplify the profile of FOSPARI on full approval. Additionally, we anticipate that the new CAGIGO guidelines will become available soon.

Speaker 4

Timing, it is potentially lining up quite nicely. We anticipate that for the first time they will include Velspari 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 target. 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 FOLFIRI profile and broadening the addressable patient population in the second half of the year.

Speaker 4

We are driven by the prospects of serving even more patients moving forward by establishing Fotriospari as the foundation therapy for IgA nephrology patients. Let me now turn the call over to Chris for financial update. Chris?

Speaker 5

Thank you, Peter, and good afternoon, everyone. During the Q2, 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 Q2 of 2024 grew to $52,200,000 compared to $29,500,000 for the same period in 2023. This increase of approximately 77% is attributable to growth in net product sales from the ongoing U. S.

Speaker 5

Launch of Filspari and IgA nephropathy. During the quarter, we also recognized $1,900,000 of license and collaboration revenue, which results in $54,100,000 in total revenue reported for the period compared to $32,200,000 in the same period in 2023. Research and development expenses for the Q2 of 2024 were $54,300,000 compared to $66,500,000 for the same period in 2023. On a non GAAP adjusted basis, R and D expenses were $50,600,000 for the Q2 of 2024 compared to $59,500,000 for the same period in 2023. Selling, general and administrative expenses for the Q2 of 2024 were $64,800,000 compared to $68,200,000 for the same period in 2023.

Speaker 5

On a non GAAP adjusted basis, SG and A expenses were $48,300,000 for the Q2 of 2024 compared to $49,700,000 for the same period in 2023. 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 advanced for its completion. Total other expense net for the Q2 of 2024 was $1,900,000 compared to total other income net of $2,100,000 in the same period of 2023. The difference is largely attributable to a $3,400,000 non cash charge to other expense related to the Rinalis collaboration announced earlier this year. Net loss including from discontinued operations for the Q2 of 2024 was $70,400,000 or $0.91 per basic share compared to a net loss of $85,600,000 or $1.13 per basic share for the same period in 2023.

Speaker 5

On a non adjusted basis, net loss including from discontinued operations for the Q2 of 2024 was $50,100,000 or $0.65 per basic share compared to a net loss of $60,100,000 or $0.79 per basic share for the same period of 2023. As of June 30, 2024, the company had cash, cash equivalents and marketable securities of $325,400,000 Cash used during the Q2 included approximately $71,000,000 of previously disclosed milestone payments and approximately $45,000,000 of operating cash use. Importantly, operating cash use declined by approximately $20,000,000 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 TILSPARI sales, continued contribution from Thiola and declining R and D investments for our sentiment over time as the supporting study is complete. We also anticipate multiple milestone payments from CSLV4 upon conversion of Filspari to full approval in Europe and market access achievements.

Speaker 5

With these elements, we continue to believe that our balance sheet can support current 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 comments. Eric?

Speaker 2

Thank you, Chris. Through the first half of twenty twenty four, 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 pegdebatinase to patients. We know that they are waiting for us. It's for this reason that I and my colleagues at Tredere 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 Travir for meaningful growth now and in years to come.

Speaker 2

Now let me turn the call over to Nivi for Q and A. Nivi?

Speaker 1

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

Operator

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

Speaker 6

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?

Speaker 2

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.

Speaker 2

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 FilSparri 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

Operator

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

Speaker 7

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?

Speaker 7

Thanks so much.

Speaker 2

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

Speaker 4

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 it's exactly what you would expect. It's 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 it's in line with best practices I've seen in the past for successful launches.

Operator

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

Speaker 8

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 1100 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 PSF since or as of the end of the quarter, could you talk a bit about how much success you're having converting PSF to scripts?

Speaker 8

How long does that take? And how we think about that cadence of conversions over the balance of the year?

Speaker 2

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

Speaker 4

Yes. Thanks, Joao. 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 are making in the fulfillment process. What you're speaking to is like the cumulative number of patient platforms.

Speaker 4

And as we mentioned at the earlier call, last summer, we observed a part of the 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 And I would say within that context, I'm really pleased with the progress we are making. I think we are well within the rare disease benchmarks, both in the amount patients that we are serving as well as the time to fill 2 paid shipments.

Speaker 2

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.

Speaker 8

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

Speaker 2

Julia, why don't we take that one?

Speaker 3

Thank you. So we're pleased to have the first patients 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.

Speaker 3

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.

Speaker 4

Thank you.

Operator

Thank you. As a reminder, We will take the next question from the line of Carter Gould with Barclays. Carter Gould, your line is now open.

Speaker 9

Great. Thanks for taking the question. Maybe tackle the guidelines from a little 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.

Speaker 9

Thank you.

Speaker 2

Yes. Thanks, Colin. First of all, I'll hand that one over to you.

Speaker 4

Yes. Thanks, Karl. First of all, I think you're referring to the Acadia guidelines and you are answering as you're 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 well, given our strong proteinuria efficacy data of 50% absolute reduction as well as our complete remission data.

Speaker 4

And additionally, this lower treatment target will also allow to broaden the patient population. So we are really excited about the momentum that this generates for filocellari. With regards to the second part of your question, how fast will Bayer's adopt this in that plans? Well, we are ready to go with our updated value proposition with payers on the 12 starry profile. And to start with payers are in their payer plans, I'm not only referring to the label, but also the guidelines.

Speaker 4

So I'm really excited that those are coincided quite nicely in the time. I think it provides a great opportunity for our clinical our initial account managers to have that conversation with payers and to update authorization criteria very quickly.

Speaker 5

Thank

Operator

you. Thank you. We will take the next question from the line of Jason Zimansky with Bank of America. Jason Zimansky, your line is now open.

Speaker 10

Good afternoon. This is Bhavan Patel on for Jason Zymanski. 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?

Speaker 10

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 Filspari, 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 bolus? Thank you.

Speaker 2

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

Speaker 4

Yes. Maybe to take those. And the first question is really like what HealthProtect 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 EGFR and long term kidney preservation data. So that's really you have seen in the medical science liaison that had that conversation in the field.

Speaker 4

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 2 year proteinuria reduction, then you see that about twothree of the air based arm, the active control arm, proteinuria effect was waning, while Celsari actually continued to hold quite nicely. And that gives thought and gives confidence that there will be that long term continued kicking preservation. I mean, we measure this up to 2 years. But given that you impact one of the main damaging factors, botanuria is a marker of damage, if you really are able to continuously reuse that, there is a translation to long term kidney preservation.

Speaker 4

So that's what I'm most excited about. And maybe Gil, I can talk about like what the MSL's experience in the field.

Speaker 3

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.

Speaker 3

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.

Speaker 4

So, next

Speaker 2

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?

Speaker 4

Yes, Perfel is going to get there. And I think the question was really like how fast uptake do you expect. Yes, I think given I mean, as we spoke about it at the launch call last week, in general, the nephrologists are 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.

Speaker 4

And we really allow for that uptake as well, the strengthening of the FOLFIRI 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 proteinuria benefit, that will have an impact. But I wouldn't say it's a long time step. I think it's a continuation of growth that we anticipate moving forward.

Speaker 5

Thank you.

Operator

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

Speaker 11

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

Speaker 2

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

Speaker 3

Thank you. So given that we've published the PROTECT data and we have approval of TILFARI both in U. S. And Europe, ZILFARI we know are included in the KDIGO guidelines. And consistent with other guidelines and recent publications, we anticipate ZILFARI 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.

Speaker 3

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, so far in the guidelines as foundation for treating the kidney injury as well as diagnose and treat the lower levels of proteinuria, we believe the KDIGO guidance can really help expand the population of patients who would be treated with filtparate as a foundational treatment.

Speaker 4

Julien, building on that, I think, to Julien's point, it's really about 2 categories, one like really the natural protective medicine that acts within the kidney and then the second category is more immune radiation. And to the point that you make, like where we see feldsparin, I think that will be reflected in the PDU guidelines as well as really replacing RAS inhibition, in particular ACE inhibitors and ARBs. And that's the case already today. And that's also how TELSTARI is being affected in payer plans. I think that was the second part of your question.

Speaker 2

Yes, that's right. I mean, I think if we take a step back and we think about how the Codigo guidelines are going to help in driving what we're already seeing within the treatment paradigm. 1, 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 Codigo draft guidelines, I think we fully expect that the underlying trend that seeing within this space is increased combination.

Speaker 2

And as we're already seeing, ZOSPARI 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 Codigo 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.

Operator

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

Speaker 8

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'd have to run a new supplemental study?

Speaker 2

All right, Mark. Thanks for the questions. Jule, why don't you take these?

Speaker 3

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.

Speaker 3

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 end point? And they are looking at measures of proteinuria and other aspects.

Speaker 3

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.

Speaker 8

Got it. Okay. Thank you.

Operator

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

Speaker 12

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 twenty twenty four, what is more impactful to FOSPARI out Would it be the potential Codigo guideline revisions? Or would it be a potentially updated FOSPARI prescribing label?

Speaker 2

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 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 Filsparia as a foundational therapy.

Speaker 2

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.

Speaker 12

Thank you.

Operator

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

Speaker 13

Hey, thanks for taking our question. I just want to follow-up again on Peristalt. I think you had mentioned in the past that there is an initial meeting, I believe in June. Can you were you in attendance, someone from Cheuvre are in attendance? And was this discussion of moving towards a proteinuria endpoint really the topic of the conversation?

Speaker 13

Any color on the meeting itself would be helpful. Thank you.

Speaker 2

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

Speaker 3

Yes. Thanks for the question. So Parasol is a partnership with academics, FDA, EMA. Industry was invited and yes, we were at 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.

Speaker 3

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 Valspari for the treatment of FSGS, not only because of our data, but also the unmet need.

Speaker 13

Great. And 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.

Speaker 3

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 predicting preservation of kidney function, which is avoiding of 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 endpoint, let's move past eGFR and look at other measurements of which proteinuria is the top of the list.

Speaker 2

Yes. I think the only thing that 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 Jule mentioned, really we've got to wait till they report out later this fall.

Speaker 13

Great. Thanks, Jill and Eric.

Operator

Thank you. We will take the next question from the line of Tim Lugo with William Blair. Tim Lugo, your line is now open.

Speaker 14

Hi, team. This is John on for Tim. Thanks so much for taking our question. So I was wondering if you could give us an idea of, say, if the requirements for the current COSPARIA 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?

Speaker 2

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 Vilspari 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.

Speaker 2

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.

Speaker 14

Thanks.

Operator

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

Speaker 1

Hi, this is Sadi on for Mohit. Thanks for taking our questions. So with a complement inhibitor expected to be approved soon, wanted to get your view on how, ZILFARI 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?

Speaker 1

And do you think costs of these drugs would be a limitation as far as combination use? Thanks.

Speaker 2

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

Speaker 3

Thanks. So I want to highlight the treatment algorithm has really always been 2 pronged. You target the kidney injury with RAS inhibitors and maybe SGLTQs. And then you may also add immunosuppressants to block the immune system activation. So this 2 pronged approach, target the kidney, target the immune system.

Speaker 3

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 ZOSPARI 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 over activation, we're excited that there's going to be a replacement for steroids on the horizon, whether it's going to be C cell back, 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.

Speaker 3

And Eric mentioned this, but we have very strong data around complete remission. A third of patients in PROTECT got there, 2 thirds of patients when they were started earlier gotten to 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 or likely going to be using therapies early on after diagnosis and in combination really to optimize long term outcomes for patients with IgA nephropathy?

Speaker 5

Peter, anything more?

Speaker 4

Yes. From a pricing perspective, first of all, let me reiterate that you said, I mean, complement stays in a different category than Valsari. From this, Valsari is really the nasal protective within the kidney, replacing large inhibition. And take in mind, all new modalities are always being studied on top of large inhibition. With regard from a payer perspective and how they think about innovative combination therapies, You have to take into consideration a full style is priced for broad use and broad utilization, really allowing to position it as a foundational care.

Speaker 4

It's priced at a very different level than the complement inhibitor that you were referring to that already has an indication in PMH. Additionally, I also want to say like we had a very strong uptake at the payer side, and we are now already included in over 12.50 formularies across the nation. So a very strong positioning in formularies for TILESPARI. So I feel quite good about it. But again, it's based in a different category and Telsari is priced at broad utilization.

Operator

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

Speaker 14

Great. Thanks for taking my questions.

Speaker 15

So just one going back

Speaker 14

to the patient start forms

Speaker 15

for FOSPARI. So it looks like you've had sort of steady increases in the number of patients 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 PSF getting started on therapy? Is it maybe something more on the sort of net pricing side that is 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 build.

Speaker 15

So maybe just a little bit more visibility there would be helpful to kind of get

Speaker 4

a sense of what to expect going forward?

Speaker 2

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

Speaker 4

Yes. First of all, I mean, it was the continuation of growth in both sectors, both facing 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 is like why 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 like the pocket of patients that we saw last year that are part of the cumulative amount of patient storms.

Speaker 4

That forced a little slower uptake in the transition to paid shipments. But we have made our modifications there, and we've seen now much faster ramp certifications early on, and that allows them to pull patients through and get them to pay shipments early on. And I think that is really the reflection, the efficiencies in the post fall, that's the reflection that you see in net revenue growth.

Speaker 2

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.

Speaker 2

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.

Speaker 14

Okay. Thank you.

Operator

Thank you. Thank you. We will take the next question from the line of Ed Arce with H. C. Wainwright.

Operator

Ed Arce, your line is now open.

Speaker 8

Hi, good afternoon, everyone. This is Thomas Yip asking a couple of questions. Thank you so much for taking my question. So one from us, can you discuss the average consistent rates of patients on RUXARI? And what is the average time to convert PSF to drug fulfillment for ROSARI?

Speaker 8

Thank you so much.

Speaker 2

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

Speaker 4

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 Vospar, 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 60 days. I think we are well within the benchmark.

Speaker 4

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.

Operator

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.

Speaker 1

Great. Thank you, everyone, for joining us for our Q2 2024 financial results call. We look forward to providing additional updates on our progress. Have a great rest of your day.

Operator

This does conclude today's call. Thank you for your participation. You may now disconnect.

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Earnings Conference Call
Travere Therapeutics Q2 2024
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