Zevra Therapeutics, Inc. (NASDAQ:ZVRA) Q1 2024 Earnings Call Transcript

Louise Chen: So I wanted to ask you on peak sales for OLPRUVA. How do you think about that and how long do you think it’ll take you to get there. And then another question we get a lot is just on KP1077, comparing it and contrasting it to other products in the market and where your competitive advantage is? And then lastly, just on your new opportunities here, the Celiprolol products, what is the market opportunity and how do you think about it? And what makes you excited about this opportunity? Thanks.

Josh Schafer: Sure. This is Josh, and I’ll address the Celiprolol question. So as we noted, the first quarter was really focused on building awareness of the drug. We have been really pleased with the performance of the team. I’d like to remind you that in the first quarter, we built an entire commercial organization of really talented, experienced rare disease experts who have been out talking with the specialists, they’ve been able to engage with about 90% of prescribers. Also, importantly, we’ve been engaged with the patient advocacy groups and the payer community, and we now have 75% of covered lives. So all of that really bodes well for what we think will be some momentum as we build into the launch. It’s also important to note that these patients like many rare disease patients really only go to see their physicians every six to nine months.

So we’re pleased with the progress that we’re seeing now, but we’ve got more to do and — clearly not — yeah, leave it at that.

Neil Mcfarlane: I’ll ask Adrian to see if he can talk a little bit about the KP1077 differentiation.

Adrian Quartel: Yeah, thanks for the question. So obviously, you’ve got so many — and it’s actually a fairly large patient populations that constitutes. We’re talking about 37,000 patients. There’s still a significant unmet medical need in that large population. We believe that KP1077 provides a unique mode of action investment specific symptoms offer to better capture them. So we believe we have a differentiated product. Specifically, clinicals has TK profiles, [indiscernible] infections, scheduled for a drug that has two in context of safety. So we believe that it lands in space with the competitors have some population.

Neil Mcfarlane: I think you also asked a little bit about the Celiprolol market opportunity, if I understood it as well.

Josh Schafer: Yeah, Celiprolol is used for the treatment of vEDS, of which there are about 7,500 patients in the US. In some European countries, it is currently being used as a standard of care for those patients. But other than that, there really is no treatment option for these patients other than surgery. So we think that if approved, Celiprolol would really offer some benefit for these patients who have no other available therapies.

Operator: [Operator Instructions]. We will take our next question from Oren Livnat with H.C. Wainwright.

Oren Livnat: Thanks for taking the question. I just want to follow-up on OLPRUVA. So I know it’s a very early and you’ve only had four patients enrolled that you’ve called out here. But can you talk about where those patients come from? Are those de novo patients or switchers from less palatable product? And what experience are you having very early on here with trying to adjudicate — to reimburse therapy with these initial patients? Are you getting any pushback regarding February end pricing, relative pricing, and how fast do you think you can convert these and then hopefully, in future enroll patients to paid therapy?

Josh Schafer: First off, it’s important to note that the four patients that we reported were just those new enrollments for the quarter. There are more than that currently on OLPRUVA who have been prescribed OLPRUVA. And these patients are coming from a variety of different places, either switches from current therapy. We also do have some patients who are new to therapy and not — have not received any treatment. Like all rare disease products, there are step throughs and step edits that take place in order for patients to receive treatments for rare diseases. But we’ve been really pleased with the progress that we’re getting from our reimbursement and covered lives to get 75% covered lives. And again, reflecting back when we closed the transaction, it was at 55%. So we think great progress there. So I think we’re — we feel like we’re in a good place right now and on par to be able to compete with severing annual [indiscernible].

Oren Livnat: If I could just follow up on — you said there, can you help us understand, I guess, how many patients were already on therapy? Was that under the prior AZSTARYS launch? And are those paid subjects? Are they getting free drug now and you’re hoping to convert them to therapy? Or is the reason that revenues de minimus is just that they are paid therapy patients now, but they’re just already from before your time, so to speak, there is already enough supply in the channels that you didn’t need to shift?

Josh Schafer: Yeah. So it’s a little. It’s kind of a combination of all the things that you just offered there. There were a handful of patients who had received OLPRUVA and were enrolled prior to the close of the transaction. However, most of them came late in 2023 into the first quarter and now into the second quarter. And again, they’re coming from a variety of different sources, whether those are switches or naive. And those — and sorry, I was just thinking about the rest of your question there. And those are a combination of both paid patients as well as those who have gone onto our Quick Start program, which allows us to pick patients onto therapy while we’re investigating the benefits and attempting to convert them to paid patients as well.

Oren Livnat: I’ll follow up with you guys afterwards. Josh, go ahead.

Josh Schafer: Well, I think there was a third part to your question which was really around the de minimus revenue. And it’s important to note that there is a disconnect, as Duane mentioned, between the revenue recognition and the enrollments due to the way that we sell OLPRUVA into our specialty pharmacy so that it’s kind of a inflection of — just that dynamic.

Oren Livnat: And are you hearing anything regarding relative pricing of these drugs or are they all expensive enough and presumably some unmet need with these patients, if they’re even considering their products that it’s not an issue, the potentially slightly cheaper nature of [Technical Difficulty]?

Josh Schafer: Yeah. So as you probably know, we’ve seen a lot of payers begin to put RAVICTI on its exclusion list as a result of RAVICTI’s high price. We are benefiting from that, given that we have a significantly less — a lower cost and more importantly, that we are able to compete on the clinical benefit OLPRUVA. And so that dynamic is certainly helping us.

Operator: We will take our next question from Sumant Kulkarni with Canaccord Genuity.