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

Operator: And our next question will come from Alex Thompson with Stifel.

Alex Thompson: Great. Thanks for taking my question. I guess in the past, you have commented through with this uptick in sales in the second half of the year that you are comfortable with consensus numbers for the year, which I think on Bloomberg are in the low 30 million range at this point. I guess maybe if you could reiterate your confidence there? That would be great. And then could you also maybe comment on the impact at all of stocking in the revenue this quarter? Thanks.

Dr. Eric Dube: Thanks, Alex. I will take the first part of that question and then I will turn it over Peter to talk about the impact of stocking throughout the year. What I can say is that, I am incredibly proud of the progress that we have made on FILSPARI launch and the ability to continue to grow demand, to be able to show the early signs of that inflection that we expect. And as we have guided in the back half of this year, we will start to see revenue track more closely with that underlying demand with a number of patient start forms. I think as Peter alluded to, we still have some room to go in terms of aligning that more closely. We expect that we are going to make that progress in the fourth quarter. And in fact, when we look at other rare renal launches, we have seen that there is a meaningful proportion of their first year of sales in that fourth quarter.

We fully expect that to be the case with us as well. We have seen the inflection so far. And in terms of providing specifics on guidance, we have not provided that this year. We won’t for the rest of the year. But we are confident in the continued selection of both patient start forms and end of revenue.

Operator: And our next question will come from Allison Bratzel with Piper Sandler.

Allison Bratzel: Hi. Good afternoon guys. And thanks for the update and for taking my question. First one on the SPARTAN study, update at ASN. And this is kind of a follow-up to a prior question and prior discussion. But just based on your interactions with Nephrologists and KOLs, could you help us understand what kind of additional clinical data you think you need to generate to really catalyze or just drive widespread first line use of FILSPARI in IgAN or just earlier line used more broadly? Thanks.

Dr. Eric Dube: So, first let me take a part of that and I’ll turn it over to Jula and then to Peter. What I would say is our focus right now is within, under accelerated approval, we’ve got a focus very much on the label at hand. We would expect that with traditional approval that we would expect to see that expansion. But Jula, do you want to comment on what additional data you’re hearing from Nephrologists, and Peter then perhaps further what you’re hearing in market research?

Dr. Jula Inrig: Well, to Eric’s point, right now, we’re primarily being utilized in prevalent IgA nephropathy patients who remain at risk for progression per our label. Physicians are very excited about the sparsentan data, because we are one of the only ones that’s generating this data. Patients who are newly diagnosed, who haven’t failed RAS inhibitors yet, and the potential for sparsentan to be used as a first line treatment and the magnitude of proteinuria reduction in kidney function preservation. So I think that the sparsentan data can incrementally show that. The other important data that we’re going to have in this is some of the biomarker data, the fluid data, the bio impedance that shows the safety profile, as well as some of the novel data that’s going to come out from this study is the repeat kidney biopsies in these patients.

So incrementally, the information that’s going to come out of sparsentan will further give confidence with regards to the place of therapy that sparsentan can play in patients with IgA nephropathy.

Peter Heerma: Yes, thank you. And building on that, I would say we have very strong data now for patients that basically have failed RAS inhibition, both ACE and ARBs. And we know for market research that over half of the patients that are on ACE and ARBs are not getting to the target levels of proteinuria as a physician would like to. So, we have still a lot of patients to go in that segment. But now we also have patients’ information and very strong data in patients that are RAS naive. And then, I think the third category is really building upon the evolving treatment landscape and being prepared for combination therapies, as Jula was mentioning. And I think the combination data that we presented last week at ASM with SGLT-2 provide that additional context as well. So, I think we are building the data and the evidence across a broad patient population that could benefit from first-party treatment.

Operator: And we’ll take a question from Ed Arce with H.C. Wainwright & Company.

Ed Arce: Peter and Jula, it’s great to see you this weekend in Philadelphia. Three questions for me. First of all, in one of the sessions at the conference, I saw Eliza Thompson discuss the chronic versus total slope and basically acknowledge that there’s a hemodynamic effect there early on. And so in light of that, I’m just wondering if you could discuss your thoughts as you approach the meeting with the FDA and discuss all the other supportive data in the context of the totality of the data for full approval. And then two more just in terms of the ongoing launch of FILSPARI. Firstly, can you discuss the PFS in October, if there is any further acceleration from the third quarter? And then lastly, I’m wondering if you can discuss the conversion timeline from PFS to treatment initiation perhaps now and then also eventually steady state expectations?