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

Zevra Therapeutics, Inc. (NASDAQ:ZVRA) Q1 2024 Earnings Call Transcript May 8, 2024

Zevra Therapeutics, Inc. isn’t one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).

Operator: Good morning, everyone. Thank you for joining the Zevra Therapeutics’ First Quarter 2024 Corporate Update and Financial Results Call. Today’s call is being recorded and will be made available on the company’s website following the conclusion of the call. With that, I will now turn the call over to Nicole Ochsner, Vice President of Investor Relations and Corporate Communications at Zebra Therapeutics.

Nichol Ochsner: Good morning, and thank you for joining us today to review Zevra Therapeutics’ progress in the first quarter of 2024, outlining our clinical advances, operational achievements and financial results. Before we get started, let me take a moment to provide some important information. I encourage you to access the news release which was published this morning and is available in the Investor section of Zevra’s website. As we begin our call, it’s important to highlight that today’s discussion will include forward looking statements. Forward looking statements are not promises or guarantees and are inherently subject to risks, uncertainties and other significant factors that may lead to actual results differing materially from the projections made.

Please refer to the Risk Factors section in our most recent Quarterly Report on Form 10-Q and other filings with the SEC on Annual Report on Form 10-K. I am pleased to welcome Zevra’s management team members participating in today’s call. I’m joined today by Neil McFarlane, President and Chief Executive Officer; LaDuane Clifton, our Chief Financial Officer; Joshua Schafer, our Chief Commercial Officer and Executive Vice President of Business Development; Christal Mickel, our Chief Development Officer; and Adrian Quartel, our Chief Medical Officer. Now, I’ll turn the call over to Neil.

Neil Mcfarlane: Thank you, Nicole, and thank you all for making the time to join us today. During the first quarter, we made steady progress in executing on our strategic objectives. On our last earnings call, we announced that we were focused on three key priorities. First, to successfully launch OLPRUVA and ensure access for patients. Second, to prepare for the potential launch of Arimoclomol, and third, to advance the KP1077 program in sleep disorders. I’m pleased to report that we are executing on all of these objectives, and today, we’ll share with you a summary of our key accomplishments in the first quarter and the reasons we are optimistic for 2024 and beyond. In addition to executing on our three key priorities, we refinanced our existing debt with up to $100 million in committed capital, led by premier biotech investors, including Perceptive Advisors and Healthcare Royalty Partners.

This new credit facility, which LaDuane will cover in more detail, has further strengthened our balance sheet and provides added capital flexibility to support our mission. The company continues to work through a period of significant growth and transformation with the addition of talented people and capabilities for each of the three companies that have now come together to become one Zevra. The team is making significant progress advancing our rare disease portfolio and in Q1, we initiated a long-range planning process, including a portfolio prioritization review with a focus on building a sustainable business with reliable cash flows. Achieving our strategic objectives to commercialize OLPRUVA and then upon approval, successfully launching Arimoclomol are key to reaching that seminal inflection point.

We initiated the full commercial launch of OLPRUVA at the end of January 2024. As a reminder, OLPRUVA is indicated for the treatment of certain urea cycle disorders or UCDs, which are a group of rare genetic disorders that can cause harmful levels of ammonia to build up in the blood, potentially resulting in neurocognitive impairments, brain damage and in some cases, coma or death. We estimate that there are approximately 2,000 people in the US with UCD, of which roughly half are diagnosed and treated. The UCD market in the US is estimated at approximately $350 million annually. Despite the availability of therapies, unmet needs for people living with UCD persists. We believe that OLPRUVA is well suited to address these needs as it provides personalized doses for each patient’s requirements, it is portable and easy for patients to take.

And most importantly, it is pallatable as it was formulated to overcome the challenging taste and smell associated with other formulations of sodium phenylbutyrate. Since launch, we’ve been focused on raising the awareness of OLPRUVA and demonstrating our commitment to UCD patients. In the quarter, we had four new patient enrollments, which we define as a prescription for a patient eligible for benefits investigation or our Quick Start program. We are encouraged by the progress that our rare disease specialist accomplished in the first few months of launch, meeting with more than 90% of the specialists at the 40 centers of excellence that treat people with UCD. We’ve also assembled a team of marketers, patient services, and market access professionals as well as medical science liaisons and patient advocates for engaging with key stakeholders at patient events and medical conferences.

Our managed care team has been working with government and commercial payers to ensure broad access for patients. We have seen meaningful growth in reimbursement coverage, which was 55% at the time we acquired OLPRUVA to nearly 75% of covered lives as of May 1. Overall, I’m pleased with the progress we’ve made in the first few months of launch and look forward to reporting more details as the launch matures. Diverse commercial footprint was established to provide high strategic fit between OLPRUVA and Arimoclomol, given that the majority of prescribers for both products work within the same centers of excellence. If Arimoclomol is approved, we believe this close proximity and overlap in patient care will allow us to realize synergies and scale with our commercial infrastructure.

In fact, our team has already begun to identify and compliantly engage with key opinion leaders and prescribers who treat UCD and Niemann-Pick Disease Type C or NPC. Our market access team has initiated clinical discussions with payers regarding NPC and Arimoclomol. These and other synergies across our brands will allow us to accelerate the launch of Arimoclomol and ensure patients have access to this much-needed therapy. As a reminder, Arimoclomol is our investigational drug candidate in development for the treatment of NPC, a rare genetic progressive and potentially fatal neurologic disease. If approved, Arimoclomol would be the first drug indicated for the treatment of NPC in the US. Currently, there are approximately 900 people living with NPC, of which, roughly 300 are diagnosed.

Of those, approximately 70 are enrolled in our Expanded Access Program or EAP. During the quarter, the FDA assigned a new PDIFA date of September 21, 2024 and reaffirmed its intent to present the resubmission for discussion at an advisory committee meeting, for which we are thoroughly preparing. In National Niemann-Pick Disease Foundation, known as NNPDF, spearheaded efforts with six other advocacy and research organizations to compile a petition of nearly 1,000 signatures from NPC patients, caregivers and physicians with direct experience utilizing Arimoclomol that was submitted to the FDA in Q1. We were overwhelmed by the outpouring of support for Arimoclomol within the community. As the FDA review continues, we will maintain our EAP and continue working tirelessly to bring this potential therapy for patients living with this devastating rare disease.

We continue to work closely with key opinion leaders to educate on Arimoclomol’s disease-modifying clinical profile and raise awareness of the heterogeneous presentation of NPC. In April 2024, we presented new long-term real-world data during the Society for Inherited Metabolic Disorders. The presentation included data from EAP patients from the US centers and it demonstrated that adults treated with Arimoclomol, including those with and without the migalastat use had stable disease course, which is defined as not showing disease progression over the three years of treatment. The safety profile was consistent with that observed in the Phase 2/3 study. If approved, we intend to utilize our clinical data as well as the emerging real-world evidence from our EAP to establish Arimoclomol as foundational treatment for people living with NPC.

Now I’d like to turn your attention to KP1077, our clinical candidate being developed as a treatment for idiopathic hypersomnia or IH, a rare chronic sleep disorder. IH is just characterized by excessive daytime sleepiness or uncontrollable need to sleep and difficulty waking. There remains an unmet need and we estimate 37,000 people in the US are currently diagnosed with IH. As you may recall, KP1077, serdexmethylphenidate, or SPX, was designed to steadily release d-methylphenidate, its active ingredient. This unique pharmacokinetic profile allows for flexible dosing to overcome these primary IH symptoms. This profile ensures that patients receive the optimal drug concentration during waking and active hours. SDX is currently designated as a Schedule IV controlled substance by the US Drug Enforcement Administration.

During the quarter, we reported top line data from our Phase 2 study of KP1077 in patients with IH. We are encouraged by the results which shows that KP1077 is well tolerated and demonstrates early signs of differentiated and clinically meaningful benefits. The study successfully fulfilled the objectives of informing the design of a pivotal efficacy trial, and we are planning for end of Phase 2 meeting with the FDA in Q3. Since completing the trial and reporting top line results in March, we have been working closely with the sleep community to interpret these results. With only one approved treatment, there remains a large unmet need for therapies with different mechanisms of action to address the symptoms of IH. We look forward to presenting the full data package from our completed study at the upcoming SLEEP 2024 Conference in early June.

As part of the strategic planning initiative kicked off in January, we completed our preliminary evaluation of the Celiprolol program for the treatment of Vascular Ehlers-Danlos Syndrome, or vEDS, which impairs COL3A1 connective tissue and leads to vascular and hollow organ ruptures. Celiprolol’s mechanism of action is designed to reduce the mechanical stress on collagen fibers within the arterial wall through vascular dilation and smooth muscle relaxation. Celiprolol received Orphan Drug and Breakthrough Therapy Designations from the FDA. The Phase 3 protocol is being conducted under a special protocol assessment or SPA agreement with the FDA. We recently restarted recruitment of the Phase 3 trial, also known as DISCOVER trial, to support patients currently enrolled and to preserve the value of the program while we complete our portfolio review.

This is a decentralized event trial design of Celiprolol on vEDS related event reduction. Celiprolol is a primary treatment option in various European countries and we believe that it could address the significant unmet need in the US as there are no approved treatments for the 7,500 diagnosed patients with vEDS. Looking ahead, we have three areas of focus: first, continuing to drive the launch of OLPRUVA; second, to prepare for potential adcom and launch of Arimoclomol; and third, to advance KP1077. Now, I will hand the call over to LaDuane, who’ll to provide an update on our financial results.

LaDuane Clifton: Thank you and good morning. Before I begin, I would encourage you to refer to our Quarterly Report on Form 10-Q, which we intend to file Thursday post market for more detailed information. As Neil has already outlined, first quarter was a time of solid execution as we drive the business towards the accomplishment of our strategic objectives. Our financial results for the first quarter reflect our foundation of financial strength as we continued our investments in building out our commercial capabilities and in the advancement of our development programs. Net revenue for the quarter was $3.4 million, which includes $2.2 million of net reimbursements from the French EAP for Arimoclomol and $1.2 million of royalties and other reimbursements under the AZSTARYS license.

Accordingly, we recognized commercial product revenue and shipments are received by our specialty pharmacy. Based on the early stage of launch and inventories in the channel, OLPRUVA sales were de minimus during the quarter. R&D expenses for the first quarter increased to $12.3 million, which was primarily driven by the KV1077 Phase 2 trial in IH that has since been completed as well as our work to support the Arimoclomol NDA during the ongoing review cycle and to prepare for a potential adcom sometime prior to the upcoming PDUFA date. Selling, general and administrative expenses were $9.9 million and reflect an increase in personnel costs and professional fees associated with our commercial infrastructure. Net loss for Q1 2024 was $16.6 million or $0.40 per basic and diluted share.

As of March 31, 2024, total cash, cash equivalents and securities were $52.7 million, which was a decrease of $15 million, compared to December 31, 2023. Total shares of common stock outstanding were $41.8 million and fully diluted shares outstanding decreased by $1.4 million to $56.8 million, which includes approximately $5.6 million shares issuable upon exercise of warrants. As Neil mentioned, on April 10, we announced the refinancing of our existing debt with a new credit facility, which provides up to $100 million of committed capital. With the initial draw of $60 million, we have refinanced our existing debt of approximately $43 million and added an incremental $14 million in net cash proceeds to the balance sheet after fees and discounts.

A second tranche of up to $20 million is available until October 5, 2025, and a third tranche of up to $20 million will become available upon approval of Arimoclomol in each case, subject to certain terms and conditions. By restructuring the amounts previously outstanding on two different facilities, we have simplified and extended the maturity while also providing additional non-dilutive capital to support our mission. As a result of this transaction and based on our current operating plan, available cash, cash equivalents and investments are expected to extend our cash runway further into 2026, subject to continued compliance with our debt covenants. Our forecast includes commercial revenue from sales of OLPRUVA, reimbursements from the French EAP for Arimoclomol and ongoing royalties under the historic license agreement.

It does not include commercial revenue from the sales of Arimoclomol nor the sale of the priority review voucher which would follow an FDA approval. Disciplined utilization of resources will continue to be our guiding principle as we make prudent investments in our commercial and development operations while matching those investments to our operating requirements. We are optimistic about the opportunities we have in store during 2024. Our focus is on creating long-term value for shareholders by executing against our plan in support of our mission to become a leading rare disease company. We will now turn the call over to the operator for questions.

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Q&A Session

Operator: [Operator Instructions]. We will take our first question from Tim Lugo with William Blair.

Tim Lugo: Thank you for taking a question. For Arimoclomol, I know the data submitted to the agency included use of Arimoclomol alone and in combination of migalastat. Can you just clarify how you expect the product to eventually be used by patients and is combination going to be more — used more? Is it going to be used alone more? Just what do you view the strength of data for both of those approaches?

Neil Mcfarlane: Thanks for that question. So in clinical trials that was for patients that were both on migalastat and not on migalastat, and what we found is that patients whether they were on migalastat or not on migalastat improved whilst — be it on Arimoclomol. What we saw overall is that there was not a big difference between the improvement in patients with Arimoclomol or without Arimoclomol. So we believe that once we go to market that Arimoclomol will be the foundational therapy. So it is a disease modifying treatment. And a lot of physicians and patients want to add on migalastat to their foundational therapy is really up to them. I think it needs to be noted that a migalastat is not approved for treatment of Niemann-Pick C and Arimoclomol will — was approved foundational therapy for patients with narcolepsy.

Tim Lugo: Okay, thank you. And can you discuss, it sounds like the patient advocacy groups are, I guess, kind of rallying around the filing that you may be summarized your interactions with those groups or some of the patient advocacy we’ve heard in the past quarter? It seems like it’s really ramping into the — I guess, after the submission?

Josh Schafer: Hi, Tim. This is Josh Schafer. And we have been very engaged with the patient advocacy community for several years now and their — they’ve demonstrated their support of Arimoclomol, most recently signing a petition with 1,000 signatures of patients, caregivers and physicians who are in support of Arimoclomol’s submission and eventual and hopeful approval. So that certainly demonstrates their support for Arimoclomol and for Zevra. And we remain very committed to that patient community. It’s a very well organized community. They have helped to build a lot of the awareness for Arimoclomol that we hope will help with the launch at approval. And as you know, there are about 70 patients in our expanded access program in the United States, plus another approximately 300 patients in the US that are actively being treated, and we hope to be able to make Arimoclomol available for all of those patients.

Tim Lugo: And I guess one last question. I believe you mentioned 300 NPC patients were diagnosed, there’s an expectation of 900 here in the US. Can you just talk about that difference in a differential between diagnosed and expectation?

Josh Schafer: Sure. This 900 is the estimated prevalence of the disease. Not all of those patients are confirmed diagnosis, that is based on some claims data that was published in 2021, I believe. And of those 900, there are about 350 who have been diagnosed and are receiving some form of treatment, whether that’s miglustat today or treatment for symptomatic disease.

Operator: We will take our next question from Jonathan Aschoff with ROTH MKM.

Jonathan Aschoff: I was curious if you might be able to help us out a little with a de minimus OLPRUVA revenues. Any help there or you just wish to keep that quiet for now?

LaDuane Clifton: Good morning, Jonathan. It’s really a function of sort of the product that’s already at the specialty pharmacies and therefore, we had modest shipments during Q1. So our main focus during Q1 has been to build awareness to get out and make contact with the key opinion leaders and prescribing physicians. And we’ve touched actually over 90% of those folks at this point. So in future quarters, as enrollments continue to build, we’ll see more pulls into the pharmacy and therefore, revenue will go up, but de minimis is de minimis.

Jonathan Aschoff: Okay. And how about time to Celiprolol data, if you can venture a guess there at all and maybe help us out with the enrollment percentage at the present? Something that will give us a sense of at least when the data will come? I know it’s several years.

Neil Mcfarlane: Yes, Jonathan, thank you for that question. So we started recruitment to support patients that are currently enrolled. We are looking at Celiprolol as part of our whole portfolio as this is a part of preliminary report. [Technical Difficulty] we understand the value in the programs and we started this program. As said, this is [indiscernible] SPA agreement with the FDA, and we’re looking at 48. We currently have 17 patients enrolled and we continue to enroll throughout the rest of the year.

Jonathan Aschoff: Okay. And also, have you noticed anything on the part of Amgen regarding marketing strategy with RAVICTI or is it just absolutely not a needle mover for them?

Josh Schafer: So we can’t really comment on what Amgen is doing, but we know that there are roughly 800 patients today that are receiving some therapy for UCD and about 25% of those patients still have some hyperammonemic events and that’s probably due to poor compliance as a result of patients not being able to tolerate current therapies. And we believe that OLPRUVA is going to help to solve that problem with its ability to be personalized in its dose, to be portable, and it’s — in the way that it’s delivered. And most importantly, the palatability that we think will lead to better outcomes for these patients.

Jonathan Aschoff: Okay, thanks. And lastly, just a weird little detail. On your 10-K, it says on , you’re at 43.4 million shares. Then, a day later in this press release here today it says that you have 41.8, so did you buy back 1.6 million or what happened?

LaDuane Clifton: There was no repurchases during Q1. And so shares outstanding as of end of the year was at 41.5 million and shares outstanding as of 331 is 41.8 million. So are you referring to the fully diluted share count, Jonathan?

Jonathan Aschoff: Jonathan, it’s just whatever is on Page 1 in the 10-K. [indiscernible] wholly diluted number.

LaDuane Clifton: Okay.

Jonathan Aschoff: 43 point —

LaDuane Clifton: Yeah.

Jonathan Aschoff: It’s a weird little detail.

LaDuane Clifton: Yes, I’m not sure. The shares outstanding, when you see the 10-Q tomorrow, it will be 41.8 million.

Operator: [Operator Instructions]. We will take our next question from Louise Chen with Cantor.

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.

Kyle Qian: Hello. This is Kyle Qian leading for Sumant. So two questions. On Arimoclomol, can you compare and contrast your approach with and the potential for you to have an ADCOM that is specified with that product, given the proximity of the two estimates? And the second question is, have you had mock adcoms early on Arimoclomol and what are potential findings, and those that might have considered — you guys have considered surprising or counterintuitive?

Neil Mcfarlane: Thanks, Kyle. I’ll take the last question and I’ll hand off the question to Adrian around differentiation. To answer your question, yeah, we are thoroughly preparing for a potential advisory committee. We’ve had a number of red team, blue team exercises, preparing briefing books, multiple mock adcoms coming that we’re learning from and perfecting our craft as we move forward. So I feel like we are certainly preparing for that at this point.

Adrian Quartel: In regards to their being two targeting tests for Niemann-Pick C is great for patients. I think let’s start with that. I think it’s important to understand that Arimoclomol with its unique mode of action is really a disease modifying piece where the entire product is more symptomatic treatment, especially on this [indiscernible] disease. The differentiated mode of action and the specific clinical profile of Arimoclomol, we believe, will lead to be the foundational treatment for patients with narcolepsy. And that’s kind of where we’re looking forward to.

Operator: And this concludes the Q&A portion of today’s call. I would now like to turn the call back over to Neil McFarlane for any additional and closing remarks.

Neil Mcfarlane: Thank you, Ashley. We continue to make solid advances towards achieving our mission of building a leading patient-focused rare disease therapeutics company. As we look to our catalysts in the second half of 2024, our strategic priorities are clear, and we look forward to updating you in the future. Thanks for joining us today. Have a wonderful day.

Operator: Thank you. This does conclude today’s program. You may disconnect at any time and have a wonderful day.