Zevra Therapeutics Q1 2024 Earnings Call Transcript

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Provided by Quartr
May 8, 2024

There are 9 speakers on the call.

Operator

Good morning, everyone.

Operator

Thank you for joining the Zevra Therapeutics First Quarter 2024 Corporate Updates 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 Communications at Zebra Therapeutics.

Speaker 1

Good morning and thank you for joining us today to review Zebra Therapeutics' progress

Speaker 2

in the

Speaker 1

Q1 of 2024, outlining our clinical advances, operational achievement 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 Investors section of Zevor'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 ks.

Speaker 1

I am pleased to welcome Zebra's management team members participating in today's call. I'm joined today by Neil MacFarlane, President and Chief Executive Officer Lidwane Clifton, our Chief Financial Officer Joshua Schafer, our Chief Commercial Officer and Executive Vice President of Business Development Crystal Mickle, our Chief Development Officer and Adrian Cortell, our Chief Medical Officer. Now, I'll turn the call over to Neil.

Speaker 3

Thank you, Nicole, and thank you all for making the time to join us today. During the Q1, we made steady progress in executing on our strategic objectives. On our last earnings call, we announced that we were focused on 3 key priorities. 1st, to successfully launch ORKUVA and ensure access for patients. 2nd, to prepare for the potential launch of Aramarkol.

Speaker 3

And 3rd, to advance the KP-ten seventy seven 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 Q1 and the reasons we are optimistic for 2024 and beyond. In addition to executing on our 3 key priorities, we refinanced our existing debt with up to $100,000,000 in committed capital, led by premier biotech investors, including Perceptive Advisors and Healthcare Royalty Partners. This new credit

Speaker 4

mission.

Speaker 3

The company continues to work through a period of significant growth and transformation with the addition of talented people and capabilities from each of the 3 companies that have now come together to become 1 Zebra. 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 sustainable business with reliable cash flows. Achieving our strategic objectives to commercialize Opuva and then upon approval successfully launching Aramothamol are key to reaching that seminal inflection point. We initiated the full commercial launch of OPRAV at the end of January 2024.

Speaker 3

As a reminder, Opryvat 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 U. S. With UCD, of which roughly half are diagnosed and treated. The UCD market in the U.

Speaker 3

S. Is estimated at approximately $350,000,000 annually. Despite the availability of therapies, unmet needs for people living with UCE persists. We believe that Alprove is well suited to address these needs as it provides personalized dosage for each patient's requirements. It is portable and easy for patients to take.

Speaker 3

And most importantly it is palatable 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 Opruva and demonstrating our commitment to UCD patients. In the quarter, we had 4 new patient enrollments, which we define as a prescription for a patient eligible for benefits investigation or a Quick Start program. We are encouraged by the progress that our rare disease specialists accomplished in the 1st 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 who are engaging with key stakeholders at patient events and medical conferences.

Speaker 3

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 Opruva to nearly 75% of covered lives as of May 1. Overall, I'm pleased with the products we've made in the 1st few months of launch and look forward to reporting more details as the launch matures. Deborah's commercial footprint was established to provide a high strategic fit between Olpruva and aramothamol given that the majority of prescribers for both products work within the same centers of excellence. If aramothamol is approved, we believe this close proximity and overlap in patient care will allow us to realize synergies and scale with our commercial infrastructure.

Speaker 3

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 requiring NPC and aramathimol. These and other synergies across our brands will allow us to accelerate the launch of aramothamol and ensure patients have access to this much needed therapy. As a reminder, aramofol is our investigational drug candidate in development for the treatment of NPC, a rare genetic progressive and potentially fatal neurologic disease. If approved, aramoximol would be the first drug indicated for the treatment of NPC in the U.

Speaker 3

S. 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 PDUFA 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. The National Neiman PCC Disease Foundation known as NNPDF spearheaded efforts with 6 other advocacy and research organizations to compile a experience utilizing our Ramothimol that was submitted to the FDA in Q1.

Speaker 3

We were overwhelmed by the outpouring of support for our multiple within the community. As the FDA review continues, we will maintain our EAP and continue working tirelessly to bring this potential therapy to patients living with this devastating rare disease. We continue to work closely with key opinion leaders to educate on Aramach LaMol's disease modifying clinical profile and raise awareness of the heterogeneous presentation of MPC. 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 U.

Speaker 3

S. Centers and it demonstrated that adults treated with aramothimol, including those with and without amygdalastatin use had stable disease course, which is defined as not showing disease progression over the 2 years of treatment. The safety profile was consistent with that observed in the Phase twothree study. If approved, we intend to utilize our clinical data as well as emerging real world evidence from our EAP to establish our omofemol as foundational treatment for people living with MPC. Now I'd like to turn your attention to KP-ten seventy seven, our clinical candidate being developed as a treatment for idiopathic hypersomnia or IH, a rare chronic sleep disorder.

Speaker 3

IH is 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 U. S. Are currently diagnosed with IH. As you may recall, KP-ten seventy seven, Sirdex methylphenidate or SDX was designed to steadily release overcome these primary IH symptoms.

Speaker 3

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 U. S. Drug Enforcement Administration. During the quarter, we reported top line data from our Phase 2 study of KP1077 in patients with IH.

Speaker 3

We are encouraged by the results, which show 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 an end of Phase 2 meeting with the FDA in Q3. Since completing the trial and reporting top line results in March, we've 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.

Speaker 5

As part

Speaker 3

of the strategic planning initiative kicked off in January, we completed our preliminary evaluation of the salivol program for the treatment of vascular Ehlers Danlos syndrome or VENZ, which impairs call 3A1 connective tissue and leads to vascular and hollow organ ruptures. Solipol'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. Solipol received orphan drug and breakthrough therapy designations from the FDA. The Phase 2 protocol is being conducted under a special protocol assessment or SPA agreement with the FDA. We recently restarted recruitment of the Phase 2 trial also known as the DISCOVER trial to support patients currently enrolled and to preserve the value of the program while we complete our portfolio review.

Speaker 3

This is a decentralized event trial designed of saliparol on beds related event reduction. Saliparol is a primary treatment option in various European countries and we believe that it could address the significant unmet need in the U. S. As there are no approved treatments for the 7,500 diagnosed patients with beds. Looking ahead, we have 3 areas of focus.

Speaker 3

1st, continue to drive the launch of ARPUVA. 2nd, to prepare for a potential adcom and launch of Arimacamol. And 3rd, to advance KP-ten seventy seven. Now I'll hand the call over to LeDuane, who'll provide an update on our financial results.

Speaker 6

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, Q1 was a time of solid execution as we drive the business towards the accomplishment of our strategic objectives. Our financial results for the Q1 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 $3,400,000 which includes $2,200,000 in net reimbursements from the French EAP for Eremarkable and $1,200,000 of royalties and other reimbursements under the Astarus license.

Speaker 6

Currently, we recognize commercial product revenue when shipments are received by our specialty pharmacy. Based on the early stage of launch and inventory in the channel, OPREUVA sales were de minimis during the quarter. R and D expenses for the first quarter increased to $12,300,000 which was primarily driven by the KB1077 Phase 2 trial in IH that has since been completed, as

Speaker 3

well as our work

Speaker 6

to support the Eramachma 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 $9,900,000 and reflect an increase in personnel costs and professional fees associated with our commercial infrastructure. Net loss for Q1, 2024 was $16,600,000 or $0.40 per basic and diluted share. As of March 31, 2024, total cash, cash equivalents and securities were $52,700,000 which was a decrease of $15,000,000 compared to December 31, 2023. Total shares of common stock outstanding were 41,800,000 and fully diluted shares outstanding decreased by 1,400,000 to $56,800,000 which includes approximately 5,600,000 shares issuable upon exercise of warrants.

Speaker 6

As Neil mentioned, on April 10, we announced the refinancing of our existing debt with a new credit facility, which provides up to $100,000,000 in committed capital. With the initial draw of $60,000,000 we have refinanced our existing debt of approximately $43,000,000 and added an incremental $14,000,000 in net cash proceeds to the balance sheet after fees and discounts. A second tranche of up to $20,000,000 is available until October 5, 2025 and a third tranche of up to $20,000,000 will become available upon approval of Aramakimel in each case subject to certain terms and conditions. By restructuring the amounts previously outstanding on 2 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 continuing compliance with our debt covenants.

Speaker 6

Our forecast includes commercial revenue from sales of Opruva, reimbursements from the French EAP for Aramacamole and ongoing royalties under the Astartes license agreement. It does not include commercial revenue from the sales of Aramocaml 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.

Speaker 6

We will now turn the call over to the operator for questions.

Operator

Thank you. We'll take our first question from Tim Lugo with William Blair. Please go ahead.

Speaker 7

Thank you for taking my question. Of niklostat. Can you just clarify how you expect the product to eventually be used by patients in 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?

Speaker 4

Tim, thanks for that question. So in clinical trial that was before, we indeed had patients that were both amiglostat and not amiglostat. And what we found is that patients, whether they were on migrastat or not on migrastat, improved whilst we be on aramoxolone. What we saw overall is that there was not a big difference between the improvement in patients with MACRUSTET or without MACRUSTET. So we believe that once we go to market, that aramucinib will be the foundational therapy.

Speaker 4

It is a disease modifying treatment. And whether physicians and patients want to add on Megalstat to that foundational therapy is really up to them. I think it needs to be noted that Miglustat is not approved for treatment of neumabx C and our multiple most likely the only approved foundational therapy for patients with anumetix C.

Speaker 7

Okay. Thank you. And can you discuss it sounds like the patient advocacy groups are, I guess, kind of rallying around the filing a bit. Can you maybe summarize your interactions with those groups or some of the patient advocacy you've heard in the past quarter? It seems like it's really ramping into the I guess after the submission.

Speaker 6

Yes. Hi, Tim. This is Josh Schickert. And we have been very engaged with the patient advocacy community for several years now. And they are they have demonstrated their support of their Malcolm Mall, most recently signing a petition with 1,000 signatures of patients, caregivers and physicians who were in support of aramakamal's submission and eventual and

Speaker 4

hopeful approval.

Speaker 6

So that certainly demonstrates their support for Aramacomole and for Zebra. 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 Aramakkamal 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 U.

Speaker 6

S. That are actively being treated and we hope to be able to make Armoqamal available for all of those patients.

Speaker 7

All right. Thank you. And I guess one last question. I believe you mentioned 300 MPC patients were diagnosed, but there's an expectation of 900 here in the U. S.

Speaker 7

Can you just talk about that difference in the differential between diagnosed and expectation?

Speaker 6

Sure. 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 Miglostat today or treatment for symptomatic disease.

Speaker 7

All right. Thank you.

Operator

Thank you. We will take our next question from Jonathan Aschoff with ROTH MCAN. Please go ahead.

Speaker 7

Thank you. Good morning.

Speaker 5

I was curious if you might be able to help us out a little with de minimis, ALPUVA revenues. Any help there or you just wish to keep that quiet for now?

Speaker 6

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 the 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 pools into the pharmacy and therefore revenue will go up, but de minimis is de minimis.

Speaker 5

Okay. How about time to saliprole data, if you can venture to guess there at all or maybe help us out with the enrollment percentage at present, something that will give us a sense of at least when the data will come? I know it's several years.

Speaker 4

Jonathan, thank you for that question. So we started recruitment to support patients that are currently enrolled. We are looking at SINATOL as part of our whole portfolio. It's part of a preliminary portfolio review. We understand the value in the programs and we restarted this program.

Speaker 4

As said, this is running a spa agreement with the FDA, and we're looking at 48 events. We currently have 17 patients enrolled, and we continue to enroll throughout the rest of the year.

Speaker 5

Okay. And also, have you noticed anything on the part of Amgen regarding

Speaker 6

So 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 hyper or monogenic events. And that's probably due to poor compliance as a result of patients not being able to tolerate current therapies. We believe that Altru is going to help 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 tolerability that we think will lead to better outcomes for these patients.

Speaker 5

Okay. Thanks. And lastly, just a weird little detail. On your 10 ks, it says on threethirty, you had 43,400,000 shares. Then a day later, in this press release here today, it says you have $41,800,000 So did you buy back $1,600,000 or what happened?

Speaker 6

There was no repurchases during Q1. And so shares outstanding as of end of the year was at 41.5 and shares outstanding as of threethirty 1 is 41.8. So are you referring to the fully diluted share count, Jonathan?

Speaker 5

It's just whatever is on Page 1 in the 10 ks, I think it's never the fully diluted number. Okay. 43.4. Yes. It's a weird little detail.

Speaker 6

Yes, I'm not sure. But shares outstanding when you see the 10 Q tomorrow will be 41.8.

Speaker 5

Okay. Thank you very much.

Operator

Thank you. We'll go next to Louise Chen with Cantor. Please go ahead.

Speaker 8

Hi. Thanks for taking my question and congrats on all the progress this quarter. So I wanted to ask you on peak sales for Ultruva, how do you think about that and how long do you think it will take you to get there? And then another question we get a lot is just on KP-ten seventy seven 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 solipolol product, What is the market opportunity and how do you think about it?

Speaker 8

And like what makes you excited about this opportunity? Thank you.

Speaker 6

Sure. This is Josh and I'll address

Speaker 3

the I'll prove it

Speaker 6

question. So as we noted, the Q1 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 Q1 we built an entire commercial organization of really talented and experienced rare disease experts who've been out talking with the specialists. They've been able to engage with about 90% of us are prescribers.

Speaker 6

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 goes 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 in to see their physicians every 6 to 9 months. So, we're pleased with the progress that we're seeing now, but we've got more to do. And really not, yes, leave it at that.

Speaker 3

I'll ask Adrian to see

Speaker 4

if he can talk

Speaker 3

a little bit about the KP1077 differentiation. Yes. Thanks for

Speaker 4

that question. So obviously, if you have any kind of insomnia, that is actually a fairly large patient population that constitutes that. So we're talking about 37,000 patients. There's still a significant unmet medical need in that large population. We believe that KP-ten seventy seven provides the unique mode of action addressing the specific symptoms of hepatic sarcoma.

Speaker 4

So we believe

Speaker 3

we have a differentiated product specifically

Speaker 4

when it comes to its PK profile, its bone infection, which is scheduled for a drug that has proven cardiovascular safety. So we believe that lands only in the space within the hepatic heart failure population.

Speaker 3

I think you also asked a little bit about the soliprool market opportunity if I understood it as well.

Speaker 6

Yes. And soliprilol is used for the treatment of beds of which there are about 7,500 patients in the U. S. 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.

Speaker 6

So we think that if approved, soliparol would really offer some benefit for these patients who have no other available therapies.

Speaker 1

Thank you.

Operator

Thank We'll go next to Orin Livnat with H. C. Wainwright. Please go ahead.

Speaker 2

Thanks for taking the question. I just want to follow-up on Ultruva. So I know it's very early and you've only had 4 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 a less palatable product?

Speaker 2

And what experience are you having very early on here with trying to adjudicate on to reimburse therapy with these initial patients? Are you any pushback regarding Februin pricing, relative pricing? And how fast do you think you can convert these and then hopefully future enrolled patients to paid therapy? Thanks.

Speaker 6

Thanks for the question, Art.

Speaker 3

Arndt. First of all, it's important to note that

Speaker 6

the 4 patients that we reported were just those new enrollments for the quarter. There are more than that currently on Ultralpa or who have been prescribed Ultralpa. 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 and 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 their rare diseases.

Speaker 6

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've made great progress there. So I think we feel like we're in a good place right now and on par to be able to compete with Severin and RAVICTI.

Speaker 2

If I could just follow-up on what you said there. Can you help us understand, I guess, how many patients were already on therapy? Was that under the prior Acer launch? And are those paid subjects or are they getting free drug now and you're hoping to convert them to therapy? Or is the reason that revenue is de minimis just that they are paid therapy patients now, but they're just already from before your time, so to speak, there was already enough supply in the channel such that you didn't need to ship?

Speaker 4

Yes. So it's a little it's

Speaker 6

kind of a combination of all the things that you just offered there. There were a handful of patients who had received Ultruva and were enrolled prior to the close of the transaction. However, most of them came late in 2023 into the Q1 and now into the Q2. 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

Speaker 4

your question here. And those are

Speaker 6

a combination of both paid patients as well as those who have gone on to our Quick Start program, which allows us to get patients on to therapy while we're investigating their benefits and attempting to convert them to paid patients as well.

Speaker 2

I think I'll follow-up with you guys afterwards. Yes. Go ahead.

Speaker 6

I think there was a third part to your question which was really around the de minimis revenue. And that it's important to note that there is a disconnect as Wayne mentioned between the revenue recognition and the enrollments due to the way that we sell, Alprove it into our specialty pharmacy. So that is kind of a reflection of just that dynamic.

Speaker 2

All right. And are you hearing anything relative pricing of these drugs? Or are they all expensive enough and presumably some unmet need with these patients if they're even considering your product that it's not an issue potentially slightly cheaper nature of a competing

Speaker 6

product? Yes. 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 in a way significantly less lower cost, but more importantly that we are able to compete on the clinical benefits of Opruva. And so that dynamic is certainly helping us.

Speaker 2

Thank you.

Operator

Thank you. We will take our next question from Sumant Kulkarni with Canaccord Genuity. Please go ahead.

Speaker 5

Hello. This is Kyle Chan speaking with Samad. So two questions. On Aramarkamo, can you compare and contrast your approach with IntraBio and the potential for you to have an add on that is back to class with that product given the opportunity of the 2 action dates? And the second question is, have you had mock adcoms already on ParaMachival and what are potential findings and those that might have considered you guys have considered surprising or counterintuitive?

Speaker 3

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

Speaker 4

In regards to there being a 2 part being assessed for neemodexy, it's great for patients. I think let's start with that. I think it's important to understand that eramoximol with its unique mode of action is really disease modifying disease where the entire product is more symptomatic treatment addressing more symptoms of the disease. The differentiated modification and the specific clinical profile of our Amokimol, we believe will lead to be the foundational treatment for patients with hemolyticic and that's kind of where we look

Speaker 2

forward to.

Speaker 3

Thank you, Kyle.

Operator

All right. And this concludes the Q and 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.

Speaker 3

Thank you, Ashley. We continue to make solid advances towards achieving our mission of building a leading patient focused rare disease therapeutic company. As we look to our catalyst in the second half of twenty twenty four, 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.

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