Travere Therapeutics, Inc. (NASDAQ:TVTX) Q3 2023 Earnings Call Transcript

Dr. Eric Dube: Chris, why don’t we have you go through gross to net, and Liisa, I’ll say that, we are not yet in a position to be able to comment on number patients on therapy or other types of KPIs that you might be looking for because as you can imagine, the first year of launch it is quite variable. You’ve got patients that are on free drug, as well as just working their way through the reimbursement process. So, we’re not in a position to be able to come in at this point. What I can say is that we continue to see very strong demand and we continue to see that inflection in revenue that we expect to continue and become more closely aligned with the underlying demand of patient start forms. Chris, do you want to comment on gross to net?

Chris Cline: Sure. So Lisa, consistent with our prior guidance, we expect that stable state sparsentan or FILSPARI gross to net to be mid to high teens, and that’s consistent with what we see today. There’s going to be some variability quarter to quarter as we’re getting all the processes and as Eric highlighted, the different elements of reimbursement, et cetera, in place. But overall, we feel very confident that we’re going to end up in that mid to high teen range and that’s consistent with how we’re operating now.

Liisa Bayko: And how many patients did you have on at the end of the quarter roughly?

Dr. Eric Dube: We did not report on numbers of patients on therapy because again during the first parts of launch, it is variable. And so, getting to a study state would allow us to be able to report on a consistent basis to be able to project forward. So at this point, we’re going to continue to report on those three metrics since that we shared and guided to on in February of patient start forms payer coverage and revenue. And I think as you see from the revenue inflection that we had from Q3 to Q4 that we have many more patients that are on reimbursed medicine. And we would expect that only to continue through the fourth quarter and beyond.

Liisa Bayko: And then can any commentary on or update on the new guidelines coming out the KDIGO guidelines?

Dr. Eric Dube: Jula, do you want to take the latest on the guidelines?

Dr. Jula Inrig: Yes, we’re very pleased that we were able to get our PROTECT results published and in peer reviewed. We knew that our interim data was going to be included in the KDIGO guidelines and now that we have the complete data. They will also be able to be reviewed and included in the guidelines. Those will be available for publish or public commentary in the very first quarter of 2024.

Liisa Bayko: And then just final question for me, kind of as we see the landscape evolving, I was really kind of struck by the eGFR results that [indiscernible] presented for sibeprenlimab, which is one of the B cell modulators targeting April. I guess in the context of having that kind of effect on eGFR, like how do you see kind of the need for other mechanisms on top of that, if you’re able to keep eGFR relatively flatter? Is there still like you can do better and what about proteinuria and all those other things? So just curious how you were thinking about kind of sparsentan in the context of kind of that kind of a remarkable change in eGFR?

Dr. Eric Dube: Yes, I’ll have Jula talk about the view of maybe hers or of nephrologists in kind of the evolving treatment landscape. What I’ll share is that the thing that really excites us about the profile of FILSPARI is the ability to combine with all of these new classes of therapies that are being developed. And each of them are being studied on top of RAS inhibition that occurs of to address the over activation in the kidney. I think now what we’ve seen with our two year data is the superiority of FILSPARI versus RAS inhibition alone. So, it really is the question of how and when and in what patients do you combine is really the way that we think about it in the positioning and that’s what we mean by that foundational therapy. I know that a lot of this data’s early, but Jula, do you want to comment on how you view as a nephrologist and what you’re hearing from your peers in this emerging treatment landscape?

Dr. Jula Inrig: Yes, I think it’s important, as Eric said, you need a foundational treatment. When you get diagnosed with IgA nephropathy, you have already damage that’s ongoing, and you need to reduce the proteinuria to preserve kidney function. And what we have demonstrated with PROTECT is that you replace your RAS inhibitor with sparsentan, you can get incrementally closer to a normal function in the tubes. If you want to then add additional treatment on subsequently, if that patient either doesn’t get into complete remission or continues to progress, certainly, that’s an alternative treatment option to add on, with regards to the sibeprenlimab data, that’s one year data. We showed similar 36 week data. If you start treatment very early, the SPARTAN trial data, 80% reduction in proteinuria two-thirds of patients getting into complete remission and no change in eGFR early data.

So again, we do need to follow the data that we are seeing from these Phase 2s to further out. But I do believe that sparsentan as foundational treatment with the increment of other therapies we want to preserve kidney function as much as we can, and combination therapy is absolutely the future of treatment for patients with IgA nephropathy.

Operator: [Operator Instructions] And our next question will come from Mohit Bansal with Wells Fargo.

Unidentified Analyst: This is Adam on for Mohit. Thanks for taking our question. Would you briefly touch upon the early persistent data you have for patients on FILSPARI? And how you think REMS contributes to this? And then separately, we would appreciate an update on what you are seeing in terms of step edits and prior ops that let you have more formularies covering FILSPARI?