Travere Therapeutics, Inc. (NASDAQ:TVTX) Q2 2023 Earnings Call Transcript

Laura Chico: Hey, good afternoon. Thanks very much for taking the question. I just had two quick ones. So first Eric, just following up on your earlier comments with respect to potential label expansion. And I think this might have been asked a little bit but are you not seeing any patients kind of below that threshold of the proteinuria indicated on the label, or is there kind of some indication that they are waiting for label expansion to begin moving into that kind of patient population set? And then just real quickly, FSGS, what are the range of outcomes that we should expect from the upcoming meeting with the FDA?

Eric Dube: Great. Why don’t I take the first one and then Jula can take the FSGS question. So we are seeing some patients that are below 1.5 grams of proteinuria, because there are other factors that physicians do determine the level of risk of progression. So we are seeing that. But as you can imagine most of the patients early in launch are the most severe, that really have very few options if any in the treatment armamentarium. So, we do expect that a label expansion will help in increasing the number of patients that would be available for us to treat, but also just the level of evidence that would be within that full approval label. So as Peter mentioned, is sort of a rolling launch with additional evidence and support moving forward. So, I think we’ve been pleased with the clear understanding that physicians have about helping treat patients with those parts that are at risk. And Jula, why don’t you address the question about potential outcomes for FSGS?

Jula Inrig: Yes. So as we said on the call, we have a meeting with the FDA, that’s scheduled. And with the DUPLEX results in hand, which we have been analyzing and as I mentioned, we released the interim data which shows durable effects on proteinuria positive trends on eGFR positive trends on kidney outcomes and then a great safety profile. We’re really seeking to understanding agency’s expectations for a submission and really overall willingness to accept a submission based on the totality of data that we’ve already released and the additional data that we have analyzed. And we do expect to be in a position to provide an update to you all later in the fall.

Laura Chico: Thanks very much.

Operator: Thank you. Our next question comes from the line of Alex Thompson with Stifel. Alex Thompson, your line is now open.

Alex Thompson: Great. Thanks. Maybe for Peter, could you provide any color on patients and liver monitoring the setting in which the blood test is ongoing and patients may be getting a second course of therapy so far? And then maybe for Chris, could you talk about what assumptions are embedded in your runway guidance around past 2025? Thanks.

Eric Dube: All right. Peter, would you like to take the first one?

Peter Heerma: Yes absolutely. Alex, thanks for your question. If I understand you correctly is like what is the repeat prescription of FILSPARI with like the monitoring of liver testing. What we’re seeing so far the patients that have started FILSPARI that there is a high level of repeat prescription and compliance. So we don’t see at this point that there is any implication or complication with the monthly liver testing. It’s really on the launch, but so far on high compliance.

Eric Dube: And Chris, the runway.

Chris Cline: Yes, I’m happy to take that. Thanks Alex. So included in the cash runway guidance are a number of things. The first is of course the IgA nephropathy launch, second being investment in the pegtibatinase pivotal program and getting off the ground later this year. Also, baked into that is maintenance of disciplined spend for FSGS while we have those discussions with FDA and evaluate next steps. We also bring into that continued competitive dynamics for Thiola and potential pressure on that business. And then, any milestones that we would either receive and/or pay as a result of the various different programs that are going forward and sales trajectory. So, hopefully that gives you a good sense for all of what’s in there.