Travere Therapeutics Inc Q4 2024 Earnings Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Malcolm Kuno - JPMorgan - Analyst : This is Malcolm Kuno on for Anupam Rama. With the expanded FILSPARI label, what are you seeing in terms of patient uptake?

Question: Vamil Divan - Guggenheim Securities LLC - Analyst : Congrats on the progress. So just one, and you touched on this a little bit in the prepared remarks, but just obviously, you might get a new competitor entering the IgAN space from Novartis. I'm just curious maybe you can provide a little more just thoughts on how that might impact FILSPARI's uptake, how you sort of see the competitive dynamics evolving here over the next several quarters, especially if the liver safety monitoring, if there's a difference between that label and your label. Thank you.

Question: Joseph Schwartz - Leerink Partners - Analyst : Based on reported sales and the current price, it looks like there might be around 2,000 patients on FILSPARI at the end of the year. And I think the company has received over 3,600 PSFs since the beginning of the launch. So I was wondering if you can provide us with any additional context on the conversion of PSFs to patients on therapy as well as the discontinuation rate. Can you help us envision what the difference between these figures is accounted by?

Question: Liisa Bayko - EVERCORE ISI - Analyst : Congratulations on all the progress. I have a couple of questions actually. First of all, can you just give us a sense of gross to net and how you're thinking about it for this year?

Question: Liisa Bayko - EVERCORE ISI - Analyst : And how is it going in the beginning of the year with kind of having -- do you have to -- are the patients required to renew any prior authorizations or anything like that? Should we expect any bumpiness in the first quarter for that reason?

Question: Liisa Bayko - EVERCORE ISI - Analyst : And then finally, I wanted to ask about sort of more about the future, and we can even go beyond the initial rollout of some of the new forthcoming APRIL and APRIL BAFF compounds. But when they do get a full label and we're kind of in that era, how are you thinking about the potential use of two branded medicines? Is that something that you think is going to be widely accepted because ideally, you'd want to be on combination of FILSPARI or some of these newer mechanisms? Or do you think you'll have to step through one to the other? Or will there be some other criteria? Will you have to pick and choose between these? I'm just curious how you're thinking about it and if you've gotten any feedback on that point from payers specifically. I know physicians want to use all the best drugs. So that's less of a concern and kind of really focused more on the payers.

Question: Yigal Nochomovitz - Citi - Analyst : Just a couple of things. So on the REMS, if you do get the shift to the quarterly, is it the expectation that that would flow to the label on FSGS or that's a different conversation? If you could answer that, please.

Question: Yigal Nochomovitz - Citi - Analyst : And then assuming it does go to quarterly, at that point, the next step on the pathway would be to nothing? Or could it be like annually? How do you foresee that thinking going forward?

Question: Yigal Nochomovitz - Citi - Analyst : And then you may have answered this one in the past, but on pricing, given the dosing increase with FSGS, is it fair to assume it's simply going to flow to be twice the price? Or is there going to be some economies of scale there that are incorporated in the pricing discussion on FSGS? Thanks.

Question: Prakhar Agrawal - Cantor - Analyst : So there are a lot of competitive readouts in the IgAN space coming over the next one to two years. Can you give your perspective on how long will the accelerated approval path in IgAN will remain open since two drugs have full approval now? And what will the competitors need to show to get accelerated approval? Thank you.

Question: Greg Harrison - Scotiabank - Analyst : Could you speak to the potential impact commercially from a REMS modification as far as any patients who maybe can't comply with the liver monitoring currently and thus aren't receiving FILSPARI, and may initiate treatment after the REMS potentially becomes less onerous?

Question: Jason Zemansky - BofA Global Research - Analyst : Congrats on the progress. I was hoping you could provide some additional color regarding your prelaunch activities in FSGS. I know, Jula, you mentioned expanding awareness of proteinuria as a biomarker. But based on PSL, there seem to be pretty broad support, at least maybe from the academic providers. Curious if you see this as a bottleneck in the more broader community. And I don't know, any other potential headwinds or, I guess, opportunities to maybe smooth adoption out?

Question: Alexander Thompson - Stifel Europe - Analyst : Congrats on the update. I guess on shifting gears to pegtibatinase. Could you talk a little bit more on sort of the progress that you've made on restarting the Phase 3 and when we might learn more about the timelines there? Thanks.

Question: Ed Arce - H.C. Wainwright & Co., LLC - Analyst : Congrats on another strong quarter of progress here. So try to get three in here quickly. First, with regard to FSGS, obviously, this pathway now has rather quickly presented itself based on the findings from PARASOL. And so the first question is, if it comes to pass that there is an ADCOM, what kind of specific questions would you expect the panel to sort of challenge the findings from PARASOL on given that that's the basis? And then secondly, I know we've talked about this a little bit on the call, but I'm just wondering regarding pre-commercial activities for FSGS. Obviously, this would be the first approved drug, and you've talked about the 80% overlap in patients. So some strong structural components to the launch itself. But just wondering what specific activities would you be focused on to really ensure rapid uptake right from the start. And then lastly, given that overlap between the two indications, wondering how much additional SG&A investment you would be considering around the end of the year, if that's when the launch happens? Thanks so much.