Travere Therapeutics Inc at Citi Global Healthcare Conference Transcript

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

Question: Yigal Nochomovitz - Citi - Analyst : Okay. So let's start with the full approval for FILSPARI. Just remind everybody what was required to get that approval and how you believe that's going to inflect the launch in [IgAN]? And are you seeing evidence of that inflection to the extent you can come, and obviously you can't talk about 4Q, but if you want to talk about 3Q a little bit.

Question: Yigal Nochomovitz - Citi - Analyst : Okay. Got you. So a couple interesting follow ups there. So number one people may be wondering, was it just happenstance that the KDIGO guidelines happened to coincide essentially with the full approval or was that some grand plan? Does that tell us.

Question: Yigal Nochomovitz - Citi - Analyst : That was just on a separate clock.

Question: Yigal Nochomovitz - Citi - Analyst : And then the second part of that relatedly is, you're dropping the threshold from the 1.5 to the point. So which do you think is driving more of the uptake now, the two-year data or the drop in the new year cutoff or is it the synergy of both those data points?

Question: Yigal Nochomovitz - Citi - Analyst : So for the two year data, I mean, obviously it was only formally in the label on September 5. But I mean, it was out there before, so what was stopping a physician from absorbing that information that your salespeople couldn't say it, but they could read the internet and see it. So didn't, I'm just asking, couldn't that have shown some sort of an uptick before the official change or that just didn't work that way.

Question: Yigal Nochomovitz - Citi - Analyst : So in the US, I forgot how many nephrologists there are. But what's your hit rate as far as, how many you've got a sales rep in the door to see? Sure.

Question: Yigal Nochomovitz - Citi - Analyst : Okay, let's talk a little bit about combinability of FILSPARI with other mechanisms. What work have you done there? For example, with say the SGLT2?

Question: Yigal Nochomovitz - Citi - Analyst : Okay. Now you're a fixed combination, correct? Right. So, one of the pieces of feedback I've heard from some physicians is that has its advantages, but it may also have drawbacks in terms of combinability. How do you see things?

Question: Yigal Nochomovitz - Citi - Analyst : I don't know how much of this you've disclosed. So you can, speak in Vegas terms, I guess. But, so I'm just curious what percent of your treated population are new to therapy at all? Like you mentioned, you have a study, what percent are coming on to FILSPARI from a period of steroids. What percent are switchers from say [Therapeu], can you give some color on that?

Question: Yigal Nochomovitz - Citi - Analyst : To start.

Question: Yigal Nochomovitz - Citi - Analyst : Do you also capture, you capture starting eGFR? I assume too.

Question: Yigal Nochomovitz - Citi - Analyst : That's maybe a little more complicated to plot that out.

Question: Yigal Nochomovitz - Citi - Analyst : Okay. Now, as far as just the basics on commercial, you gave some guidance yet or no, you have not. No, is that in the cards for 2025 or you still want to test the waters a little more?

Question: Yigal Nochomovitz - Citi - Analyst : Okay. And then just one more on FILSPARI and then we'll go to the other topics. I've been asking all the companies this, given change in the administration potential for this protectionist, increased protectionist policy in terms of the tariffs. What's your level of exposure to that risk? Meaning we're demanufacture the drug and the API that will finish so on.

Question: Yigal Nochomovitz - Citi - Analyst : Okay? And anything you want to throw in terms of the potential changes in the leadership of some of the important divisions of government HHS, CMS, FDA or you want to leave that one alone. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. DECEMBER 04, 2024 / 7:30PM, TVTX.OQ - Travere Therapeutics Inc at Citi Global Healthcare Conference

Question: Yigal Nochomovitz - Citi - Analyst : Okay. All right. So the next one, FSGS so that was kind of, on the back burner. And then you had PARASOL, which is this a group academic working group in Sweden or where they're --

Question: Yigal Nochomovitz - Citi - Analyst : They're global, but they had meetings in Scandinavia, right?

Question: Yigal Nochomovitz - Citi - Analyst : Okay, I was close. Anyway, so that was a fruitful initial summit that they did in, I think June meeting, right? And then there was another one on October 7 to 8 and I think Eliza Thompson was showed up for both. So, and then they presented some of that ASN, so tell us what all this means for you.

Question: Yigal Nochomovitz - Citi - Analyst : It's difficult because of the prevalence, is would be too high a bar to enroll quickly. It just be not a feasible situation.

Question: Yigal Nochomovitz - Citi - Analyst : So that's a huge chunk of --

Question: Yigal Nochomovitz - Citi - Analyst : Do you mean below 0.7 on an absolute basis or dropping on average of 0.7?

Question: Yigal Nochomovitz - Citi - Analyst : So, but you're still going to talk to the FDA or that.

Question: Yigal Nochomovitz - Citi - Analyst : But what you just said was the conclusions from PARASOL, right? But as I mentioned earlier, there were representatives of the FDA in that voicing that opinion.

Question: Yigal Nochomovitz - Citi - Analyst : So the base case is you shouldn't need to have to run another study because you have the relevant data. If with the conclusions of PARASOL are accepted by the FDA, then everybody's in alignment.

Question: Yigal Nochomovitz - Citi - Analyst : Now, by the way, when they did their, was it a meta? I don't know whether it's called a meta-analysis or what did it actually, did they put the duplex data in there or that was jacked out?

Question: Yigal Nochomovitz - Citi - Analyst : Now, by the way, the other thing which is kind of interesting is, I mean, you proved that or they proved, or they concluded that eGFR was, it was a no go too variable. But and then, so then they turned to proteinuria but I mean, honestly that's the only other, isn't that the only other option? I mean, it wasn't like there was a whole array of possibilities, it was, yes.

Question: Yigal Nochomovitz - Citi - Analyst : What the cut off.

Question: Yigal Nochomovitz - Citi - Analyst : So was it done, was it sort of qualitative or were they, did they run models and sort of use, some predictive algorithm to determine that 0.7 was the best discriminate between a bullets of patients with abnormally high risk versus in a good zone.

Question: Yigal Nochomovitz - Citi - Analyst : By the way, speaking of variability and I know we're running out of time, but eGFR can move around a lot. With proteinuria is it tend to, if we measured my proteinuria say now and then in 24 hours, what's the variability? Is it tight? I mean, just in terms of, because if you're close to the 0.7 you know, you're either in or out.

Question: Yigal Nochomovitz - Citi - Analyst : (multiple speakers) REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. DECEMBER 04, 2024 / 7:30PM, TVTX.OQ - Travere Therapeutics Inc at Citi Global Healthcare Conference

Question: Yigal Nochomovitz - Citi - Analyst : And then I left this. So HCU quickly, it's a bit further out. But you had, there was some news recently where you had to reset expectations on time lines. So just can you just run through that super-fast?

Question: Yigal Nochomovitz - Citi - Analyst : And we've done a lot of clinical discussion, but since you are the CFO, there is a piece of is it a convert that's due in 2029?

Question: Yigal Nochomovitz - Citi - Analyst : Right? So what's the thinking around, how to manage that? Are you just going to, let the debt holders, played out and you're going to pay it up and pay it off early or what can you say there?

Question: Yigal Nochomovitz - Citi - Analyst : All right. Well, thank you so much, Chris.

Question: Yigal Nochomovitz - Citi - Analyst : Good luck with the FDA [meeting].