Travere Therapeutics, Inc. Common Stock Canaccord Genuity's 46th Annual Growth Conference
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Hi, good afternoon, everyone. My name is Edward Nash, Senior Biotech Analyst at Canaccord Genuity on the equity research team. It is my pleasure to have with us Travere Therapeutics. From Travere, joining us, we have Chris Cline, who is the company's Chief Financial Officer. Thanks very much for joining us today.
Thank you very much for having us.
Travere. So maybe to kick off the conversation, if you could just give us a 10,000-foot view on Travere, and mainly focus on the company's clinical focus, and then we will dive into the individual programs as we go forward.
Sure, happy to do that. Before I jump in, we will be making forward-looking statements, so please review our disclosures on our forms 10-K and 10-Q filed with the SEC. At Travere, we are exclusively focused on rare disease, and we are a commercial-stage biotech with really a key focus on four main pillars. The first two pillars are focused on FILSPARI, which is the only approved dual endothelin and angiotensin receptor antagonist. There, it is really focused on driving both our near and long-term growth. The first of those two pillars is continuing the momentum that we have built over time with IgA nephropathy. For those of you that are familiar with the IgA nephropathy market, we have really seen a great evolution of more and more treatments becoming available for patients. FILSPARI has been able to develop and maintain a foundational positioning there.
Our goal here is really to continue that positioning and maintain our growth as we go forward here and as you see more entrants coming into the market. The second pillar tied to FILSPARI is going to be the continued strong uptake in FSGS. We just got approval for our second indication for FILSPARI in FSGS in April. What we've seen so far in the launch has been a very strong start and very encouraging trends from a demand perspective, and our focus really is to make sure we can keep that going. Those two together will really be big drivers for FILSPARI's growth in the near and long term. The other two pillars are tied to our pipeline. As you mentioned, the clinical activity, and there we've got the potential for two best-in-class medicines. The first is pegtibatinase. That's going to be our third pillar, where we're really focused on advancing our phase III HARMONY study.
This is a pivotal study of pegtibatinase, the first and potentially only disease-modifying therapy for something called classical homocystinuria. That's a rare disease that typically has very limited treatment options and affects roughly 7,000 to 10,000 patients in the U.S. and abroad. So a great opportunity there with data coming up in the near term. Then the fourth pillar, and really focused on driving that long-term growth both alongside and beyond FILSPARI, is the newly in-licensed civorebrutinib. This is a next-generation BTK inhibitor that we recently brought into the pipeline. There we see a really great strategic fit to not only add to our pipeline, but also to extend, again, the growth potential both alongside FILSPARI and pegtibatinase through multiple rare kidney indications.
A lot going on in the company. We've made great progress and excited to jump into some of that.
I'm always happy when the companies beat our number and consensus, and you guys did a great job with that this quarter, being the first really full quarter, I guess, with FSGS on board. You already talked about the strong growth there, but did it internally seem to beat your expectations as far as its performance?
Well, we had high expectations going into the launch. I think that there is a very clear need for the first medicine approved in FSGS, and our commercial and field teams were ready. Not only had we been preparing for quite some time, but also we were able to leverage our learnings from being in the field with IgA nephropathy, and there's significant overlap there. We had expected to have very high demand and to hit the ground running from an execution standpoint. What we saw did exceed our expectations. I think the most notable aspect of that is the breadth of demand that we've seen. We've been very pleased to see that you have a very wide prescribing group of physicians early on here, and we expect that to be able to continue.
I assume PARASOL was a real big help for that, I guess, with physicians and really realizing that proteinuria really is what you should be focused on with the treatment of FSGS.
Yeah. I think PARASOL certainly played a role in helping everybody in the nephrology community understand the importance of proteinuria in FSGS. It gave something for people to talk about over time when we were working through the process with FDA and how that regulatory decision was unfolding. That definitely heightened the awareness of FSGS and potentially FILSPARI coming to market.
From the second quarter results, or from internally, have you seen any evidence there's any warehousing of the drug at all, or is what's going out is going directly to patients?
No evidence that we believe of a warehousing effect or a bolus. Some people use that term. Really, we look at those as acute increases in demand or acute starts in demand that then decline significantly thereafter. We are not seeing any evidence of demand trends that would support that. Really what we look at is, taking a step back at the market as a whole, more than 30,000 patients out there that would be qualified candidates for FILSPARI. So you are talking about a meaningful population to start. We expect that to also grow over time as those patients that are in a current nephrotic state come out of that. But I think that the most important telling piece of what we have seen so far in launch is, again, going back to that breadth of prescribers.
We have seen a very wide range of physicians writing, and the vast majority of those have only written one script thus far in launch. So when you think about on average for the nephrologist community, you have got a handful or more FSGS patients. They are just in the early stages of writing to their patients, and so we expect to see continued demand as we go forward.
Do you guys internally have any thoughts on what you think your ultimate ability to address the whole market will be? What percentage of that market? You are the only drug out there, right? Not really sure what would be holding physicians back. We do not have safety issues with the drug. And clearly, like you mentioned, this is the first drug approved, so you would expect you would see an even greater conversion rate as you move forward now that the longer the drug has been on the market.
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