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

Operator: And our next question will come from Greg Harrison with Bank of America.

Greg Harrison: Are you able to give any color on the volume of patient start forms in the periods before and after the announcement of the PROTECT data, and what feedback are you hearing, from physicians on their appetite for prescribing FILSPARI in light of the data?

Dr. Eric Dube: Greg, thanks for the questions. I would say, before handing it over to Peter to provide a bit more perspective on what he is hearing including some market research that his team quickly did. It is really too early to be able to look at projections sort of for after PROTECT in terms of prescribing. What I can say qualitatively coming out of ASN where there was much greater exposure to the actual data was a real excitement, particularly for those that attended ASN much more academic. Peter’s team did some really great research quickly to understand that. So, Peter, why don’t you share a little bit more about what your team learned.

Peter Heerma: Thanks. Thank you for that question. I would say, first of all, the patients start forms of 430 in the third quarter. I think it is a really good number and that lead to, like, a thousand pages for a function only the first seven-and-a-half months. So I think we are making really good progress there. To Eric’s point, it is too early after the top-line data announcement to see any change in inflection But I think overall, what we saw in the market research and it was those market research, right, after the press release of the top-line is that, there is good confidence in the profile of your style. And having been at the ASN and having had many of the conversations with physicians, I think, there was a really good reception of the FILSPARI profile, the totality of the data, and what FILSPARI to need for those physicians patients. So I think overall good reception and more to go.

Operator: And our next question will come from Vamil Divan with Guggenheim Securities.

Vamil Divan: Hi. Great. Thanks for taking my questions. I am just curious, if you can share some more feedback on the REMS and safety side of things. I think you said you have now touched about 5,500 nephrologists, I believe, was the number you shared. Can you share anything in terms of how many nephrologists are now sort of worked their way through the REMS program are certified to prescribe it? And then again, the team has any other questions, just any feedback on the safety side of things, now that we have seen, the doctors in the poll, data both on PROTECT as well as DUPLEX?

Dr. Eric Dube: Vamil, thanks for the questions. Before I hand it over to Peter, what I will just share is that, we can provide some qualitative and directional feedback on the REMS as well as safety profile. We are not providing metrics on REMS certification, but we continue to see that grow. Peter, why don’t you talk a little bit about what the reaction and what direction you are hearing both from the physician and the patient perspective? And, certainly, Jula, if there is anything further you want to add on reactions to safety coming out of ASN by all means to add that. Peter?

Peter Heerma: Certainly, Eric, And I think you were referring to the amount of nephrologists that we have seen in face-to-face interactions that indeed I did call out 5,600 nephrologists that we have seen in face-to-face interactions with our field force is the launch. And that is — I think a very good progress because as we announced during the launch call, we are consistently want to call on about 6,000 nephrologists and discovering about 85% of the patient population. And so, I think we are making really good progress and we are nearly there from overall nephrology perspective. With regards to the safety profile, I think that was the second part of your question. Maybe Jula, that’s a more an appropriate question for you to answer.

Dr. Jula Inrig: Yes, I think that I would respond significant reassurance with regards to the safety profile around sparsentan across the program to date, both PROTECT and DUPLEX where we saw the exact same safety profile with regards to the liver elevations of 3x upper limit of normal, and really no new elevations since our interim from PROTECT. And so, where physicians rapidly move to is, can this be changed over time, which of course we will readdress this as we continue to accrue data and go back. But that’s where physicians quickly move to. So we feel reassured by the safety profile at this time.

Chris Cline: Well maybe I can just add one other insight that I think is, might be helpful. And it’s really behind some of the comments that Peter shared in his prepared comments. And that’s really the reaction of physicians versus patients to the REMS. Most physicians are familiar with how to read prescribing information, what a box warning is and what a REMS is. And in fact, many nephrologists have familiarity and are accustomed to REMS. For patients on the other hand, some of them may just be accustomed to going to their local pharmacy and picking up a prescription for an ACE or an ARM or others. So for some patients, it requires a bit more education, a bit more handholding through the process for that segment of patients that Peter talked about.

It really does require a bit more information, education and support. And so, there is a segment as we refer to where the REMS does take a little bit more time. But overall, what we’re hearing from physicians is, the REMS doesn’t take that much time. It’s very straightforward for many patients, it works incredibly well, but I think we do need to make sure that we’re providing all patients the information that they need to be able to move from patients start form to actually fulfilling their prescription. So, I think that was the key insight and the pivot that we had this quarter to make sure that we’re able to move all patients as quickly through the process as possible.

Operator: And our next question will come from Liisa Bayko with Evercore.ISI.

Liisa Bayko: Can you just give us a little detail on things like gross to net, for example, where you’re at there, and then actually how many patients did you have on therapy by the end of the quarter?