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

So I think that gives you kind of a ballpark of where we’re headed and we’ll have more once the study has started.

Operator: And our next question comes from Laura Chico with Wedbush Securities.

Laura Chico: I wanted to go back to the patient start forms for a moment for FILSPARI, and 430 over 417. I guess the question I’ve got is, have you plateaued in terms of how high you can go with patient start forms? If I look back, for example, at the first year of TARPEYO was launched, I believe they peaked out at 589 enrollments during those first four quarters. So I’m curious as to whether you think you can actually grow this much more beyond 430?

Dr. Eric Dube: So, Laura, I think the question is unequivocally yes. We have nearly a thousand patients start forms through the third quarter of this year. And as we think about the number of patients that believe are addressable that that will increase, I’ll turn it over to Peter, but I want to be able to emphasize our confidence and be able to identify those patients. But equally the enthusiasm that we hear from nephrologists, not just that anticipate prescribing, but those that have prescribed, we’re seeing repeat prescriptions and new prescribers added every month. That’s a really important lead measure for any launch. In my experience, those are critical. Those and the clinical experience, the feedback anecdotally we’re hearing, we are seeing really positive results there. So, we do expect it to grow. And Peter can talk a little bit more about what he’s seeing and where we expect to go from here.

Peter Heerma: Yes, thanks Eric and thanks Laura for that question. I think there’s really three components here that I would like to highlight. To answer your question, like how far can you go and how many patients are out there? The first one is, I would say there have been limited innovations in nephrology in the last 30 to 40 years. And that’s what you see as well with physicians. Nephrologists are relatively conservative in adaptation of new medicine, and part of that is also the education in particular in IgA nephropathy where there have been little investments in education. And I think the RaDaR publication that we discussed actually at the last earnings call and Jula can provide a little more context on that really is providing that that increased in urgency of to treat.

Because historically, a lot of the physician thought like IgA nephropathy is a relatively slow progressive disease. But what we are seeing right now based on new data and registry research is that those patients actually progress much more rapidly. So I would expect that the patient population over time will be increasing also with new guidelines in new guidance. So within that context, I would say I’m really pleased with the progress we have been making. To Eric’s point, we have now nearly a thousand patients in the first seven and a half months of FILSPARI. And I see with all the continued investments and education in community, there is that recognition that these patients should be treated more early and more urgently. So Jula, maybe we can provide a little more context on your perspective on, for example, RaDaR.

Dr. Jula Inrig: Yes. I think that as we educate the physicians and they realize that what they historically understood and were trained in their educational program 10, 20, 30 years ago, that IgAN is a benign disease and they can send them back to their primary care physician and see them every few years is not the case. And the patients even with 500 milligrams of proteinuria are at risk of progression to kidney failure within their lifetime. We had additional data presented at ASN that confirmed the RaDaR data and this is U.S. registry data that showed similar results. Patients even with lower ranges of proteinuria are at risk to progression to kidney failure. That dissemination of information needs to get out to the community physicians, who don’t always go to these kidney meetings and don’t always read the journals.

And as they see this information, that urgency to then treat their patients increases. And to Peter’s point, then that translates into the need to treat them with a foundational medication such as FILSPARI, which reduces proteinuria and preserve kidney function.

Operator: And our next question will come from Tim Lugo with William Blair.

Unidentified Analyst: Hi. This is John on for Tim. Thanks so much for squeezing us in. So with the recent irbesartan data, I was wondering if you could just give us some thoughts on that data and how you might think that might impact the regulatory landscape moving forward.

Dr. Eric Dube: I mean, we certainly expect that, there are going to be additional data, potentially new therapies that are going to be approved. I think it is hard for us to comment because there were no data disclosed. And so, I think we will have to wait to see what is presented from irbesartan for us to be able to comment. I mean, our working assumption is that it is an endothelin blockers. So it should show benefit. We certainly have demonstrated that with PROTECT with the sparsentan, and we have seen that proof-of-concept with other endothelin blockers, but we’ve got to see the data on benefit and safety before we can comment.