ZVRA - NASDAQ
Zevra Therapeutics, Inc.
ZVRA·NASDAQ
$11.27
+3.6%HealthcareBiotechnology
Zevra Therapeutics, Inc., a rare disease company melding science, discovers and develops various proprietary prodrugs to treat serious medical conditions in the United States. The company utilizes its Ligand Activated Therapy technology to generate improved prodrug versions of FDA-approved drugs, as well as to generate prodrug versions of existing compounds that may have applications for new disease indications. Its prodrug product candidate pipeline is focused on the high need areas of attention deficit hyperactivity disorder, stimulant use disorder, and CNS rare diseases, including idiopathic hypersomnia (IH). The company's lead product candidate KP1077, which is under Phase II clinical trial for the treatment of IH and narcolepsy, is based on its prodrug of d-methylphenidate, known as serdexmethylphenidate. It is also developing KP879, a prodrug product candidate for the treatment of stimulant use disorder and is under Phase II clinical trial. In addition, the company has received FDA approval for AZSTARYS, a once-daily treatment for attention deficit hyperactivity disorder in patents age six years and older, and for APADAZ, an immediate-release combination product containing benzhydrocodone, a prodrug of hydrocodone, and acetaminophen. The company's product pipeline include, arimoclomol It has collaboration and license agreement with KVK-Tech, Inc. and Commave Therapeutics SA. The company was formerly known as KemPharm, Inc. and changed its name to Zevra Therapeutics, Inc. in February 2023. Zevra Therapeutics, Inc. was incorporated in 2006 and is headquartered in Celebration, Florida.
At a Glance
Live SnapshotMarket Cap$666.23M
EPS1.4000
P/E Ratio8.05
Earnings Date08/11/2026
Earnings Call Transcript
ZVRA • 2023 • Q1
Operator
Good afternoon, and welcome to the
Nichol Ochsner
Good afternoon. Thank you for joining us today to review updates related to
Tamara Favorito
Thank you, Nichol, and thank you all for joining us today. Before the team reviews our first quarter 2023 progress, I'd like to share a few thoughts about where we are today and where we're headed. This has been a busy and eventful period for
Christal M. Mickle
Thank you, Tamara, and good afternoon, everyone. The rebrand of our company as
R. Clifton
Thanks, Christal, and good afternoon. During Q1 2023, we saw the prescription trends for A
Christal M. Mickle
Thanks, LaDuane. I'm excited about what lies ahead as we continue to transform
Operator
[Operator Instructions] Our first question comes from Louise Chen, Cantor Fitzgerald.
Louise Chen
Congratulations on the progress this quarter. So I wanted to ask you a few things. Firstly, on the milestone potentially in 2023, can you give us a sense of the amount and timing that you might -- when you might hit these different milestones, how much they are? And then secondly, on KP1077 for narcolepsy, can you talk about what unmet need that you're addressing here in the market for narcolepsy? And then lastly, just on your data as early as third quarter '23 this year for IH, what would you consider a successful outcome in that interim readout?
R. Clifton
Thanks, Louise. I appreciate that. This is LaDuane, and I'll start with the milestone question, and then we'll go to the other two. So at this point, we have not been able to disclose publicly the milestone amounts under the license agreement for A
Christal M. Mickle
Sure. And I believe your first question was on the -- was it on the interim data or on narcolepsy?
Louise Chen
Yes. The first one was on narcolepsy, and what unmet need that you're addressing there. And then, yes, the second one was on the interim data for IH.
Christal M. Mickle
So regarding the unmet need, narcolepsy is very similar to idiopathic hypersomnia and the fact that they also have the same issues with brain fog and having that wakefulness, excessive daytime sleepiness as IH. And so we do look to -- there are products that are on the market that are helping to consolidate sleep, but they're really -- there are a few products that are on the market, but they do have some limitations based off of the doses that they can give and don't -- aren't necessarily as effective as we feel like ours could be with our unique profile. So we do feel like there is some unmet need there on narcolepsy as well.
Joshua Schafer
And this is Josh Schafer, Louise, if I can also just add. One of the basket from 1077 is the lack of potential abuse. And with its profile, we think 1077 would be a much safer alternative to some of the current stimulants at the same time as having an improved clinical efficacy as well.
Christal M. Mickle
And then going to your other question about the interim data and what we're looking for there, so really, the whole point for the -- there's a couple of things for the Phase II study is we're looking to see if we are powered enough based off of the analyses that we're looking at. And then obviously, safety is also -- that's our primary endpoint here, so continuing to look at that. As far as for the interim, those are the things that we would be looking for as well as we are looking into 2 different dosing regimens and the potential for those and what may -- which one may be more effective with the least amount of side effects as far as if there's any insomnia or things like that, that come with stimulant use. So those are the things that we would be looking for, and those would all help us to begin designing those first stages of the Phase III study as we go into the planning for that.
Operator
Our next question comes from Jonathan Aschoff, ROTH MKM.
Jonathan Aschoff
What kind of efficacy would you need to see with 1077 in Phase II to proceed to a pivotal trial in IH? And maybe it's the same, maybe if not, but what kind of efficacy would you have to see in Phase II to proceed in both a pivotal in IH and in narcolepsy?
Christal M. Mickle
So as far as efficacy with this, we haven't -- we are looking at products that are similar. And so while we don't have a particular point that we are looking at, a different point differential, but on the Epworth Sleepiness Scale, I believe that there is other products out there that maybe I think the differentiation was maybe a 3-point difference or something like that. But again, those are other products. We don't have a specific point that we are looking at yet. Again, that's why we are doing the Phase II trial to see -- looking at that as well.
Jonathan Aschoff
Okay. By the way, just to nitpick, what was the consulting fee? What was the revenue that wasn't A
R. Clifton
The consulting fees during Q1 were very small. It was around $25,000. So it's a very modest final payment.
Jonathan Aschoff
Okay. So how do we look at R&D, which kind of popped significantly in the first quarter? What's that going to look like this quarter, third quarter, fourth quarter?
R. Clifton
So R&D is kind of tracking up as we have the active Phase II trial in KP1077. And I think that the trend we're on here during Q1 is going to be similar as we go through the year and complete the trial, but then also then begin preparing for the Phase III going into 2024.
Jonathan Aschoff
Okay. So at the very least, slightly up from Q1. Has another -- same kind of popped in SG&A? Is that your new run rate or new low for the year?
R. Clifton
Currently, I expect that we'll be around flat in that area. But as we get into the resubmission process or once that's completed, I should say, and then we look forward into 2024, there could be some uptick in G&A as we think about beginning to prepare more deliberately for the commercial launch of arimoclomol. So we're going to be very thoughtful and stay flat. So just to repeat, the G&A is going to be in a similar place where it is right now for a few more quarters. And then we'll kind of assess how it might change after the resubmission.
Jonathan Aschoff
Okay. And one thing I kind of would like to know, if you don't mind stepping back and answering this, is typically when managements change this much, there's a change in what's going to happen and how it's going to be done. There really doesn't seem to be much in the way of any change with how you're going forward with
R. Clifton
Yes, Tamara, maybe if you're still on the call you'd like to address that?
Tamara Favorito
Yes, I'd like to take that. Thank you, Jonathan, for asking that. And as you may be aware, we just went through a contested proxy fight and 3 new Directors were elected to our Board and our CEO, Rich Pascoe, was not reelected. He was 1 of the 3 Directors that we had put up for reelection. And because he was not reelected to the Board, he chose to resign as CEO as well. And I think what you mentioned is very, very important for
Jonathan Aschoff
Lastly, on the data that Louise was referring to, the interim data, so the Phase II data coming in as early as the third quarter, that's just an interim look to see primarily how powered your trial is?
Christal M. Mickle
So yes, that's exactly right. So the interim data is just that, in the middle of the trial to see if there's any adjustments that we need to make, primarily in the powering of the study to see if we need to increase the numbers to fit the effects that -- or to be able to see the effects that are coming out of our molecule. And then -- but again, we can also look at things like the dosing regimen and other things because we do have that open titration portion of it.
Jonathan Aschoff
Okay. So what again was your intended in initial enrollment? And what could that jump to if you are -- if you see that you are underpowered?
Christal M. Mickle
Sure. So our initial enrollment, we're looking to enroll 48. And I don't remember when the exact number was. We do have a percentage above that, and I can go back and look at that. I don't remember exactly, but we do have that planned if it does need to go up.
Operator
[Operator Instructions]. This concludes the Q&A portion of today's call. I'd now like to turn the call back over to Christal Mickle for any additional or closing remarks.
Christal M. Mickle
Thank you very much. As we conclude today's call, I would like to leave you with a few additional thoughts. As one of the founders of the company, I have devoted a significant part of my career helping to build this company from scratch and to a team that has been able to take not one but multiple products from discovery through development, culminating in regulatory approval where these products are now available to patients, providing for previously unmet needs. And today, our journey continues as we move forward with more opportunities to build upon our legacy of success in drug development. The addition of commercial capabilities is a natural part of
Operator
This concludes today's
Transcript from May 15, 2023
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