Zevra Therapeutics, Inc. Q1 FY2022 Earnings Call

Thank you for your patience, and welcome to the KemPharm First Quarter 2022 Results Conference Call. I will now pass the call to your host, Jason Rando from Tiberend Strategic Advisors. Please proceed.

Good afternoon, and thank you for joining our call today to discuss KemPharm's First Quarter 2021 Financial and Corporate Results. Before we begin, I would like to remind our listeners that remarks made during this call may contain forward-looking statements that involve risks and uncertainties and are subject to change at any time, including but not limited to, statements about KemPharm's expectations regarding future operating results. Forward-looking statements are made pursuant to the safe harbor provisions of the federal securities laws and represent management's current expectations. Actual results may differ materially. KemPharm disclaims any obligation to update or revise its forward-looking statements, except as required by law. More complete information regarding KemPharm's forward-looking statements, risks and uncertainties can be found in KemPharm's filings with the SEC, which are available on the company's website under the Investor Relations section. Speaking on today's call will be Travis Mickle, KemPharm's President and CEO; and LaDuane Clifton, CFO. Following remarks, there'll be a question-and-answer session. With that, it's my pleasure to introduce Travis.

Thanks, Jason, and thanks, everyone, for joining today. For those that aren't as familiar with KemPharm, I'll just give a brief introduction here and discuss our value proposition. KemPharm has historically been focused on the discovery and development of prodrugs. To date, we have 2 FDA-approved and partnered medications, AZSTARYS and APADAZ, and that has certainly been the history of the organization. As we announced back in January, our new focus is on rare disease and CNS drug development, looking at innovative therapies, including in this particular case, a prodrug, but we are not limited to that. The development of these novel treatments, we believe, will create the largest value for us and our shareholders in the future. Today's update will actually be relatively short. We provided an update just about 6 weeks ago as well and have been making great progress on all the items that we discussed and had planned for this quarter. There are several items that I have in the update here that we'll be looking forward to scheduling and/or updating as we move forward. So in the first quarter, we accomplished a number of different goals that we had, as well as in the early part of the second quarter here. We filed the IND for KP1077 for the treatment of idiopathic hypersomnia, as well as got underway with the planning and the trial initiation around the Phase II. That should officially initiate in the second half of this year. Once that study initiates, we will follow that shortly with the narcolepsy trial. So those two will be working almost in parallel at that point. I think most importantly, with the near-term sort of milestone that we have for KP1077 is our cardiovascular trial. This is looking at the safety of doses used, and I have a little more data here to provide, but we should actually have a data readout in that in the third quarter. This is a key differentiation for that particular product. We provided a wholesome description of how AZSTARYS is proceeding. Of course, this is our ADHD product partnered with Corium, where they expanded the launch of AZSTARYS. It would support that we still believe there is an opportunity to earn milestones and royalties in the continuing part of this year. I did mention on the last call that we are planning to have an update from Corium. We're still in the planning stages of that. Of course, it's not on the near-term horizon. We're kind of looking at what time ideally works for them as well as trying to time that when it may be most effective for them to discuss upcoming school year sales activities. I mentioned our attempt here to move forward and build the pipeline of differentiated assets in the CNS and rare disease space. We have an internal product candidate that we plan to advance into development stage, and we'll be announcing that, more than likely, this quarter. Again, it's an expansion upon some of the internal work we've done, so it’s a little bit earlier in that process. Then LaDuane will be providing us with a financial update on this call that includes our strong balance sheet to support all of our efforts and external business development, internal development, as well as advancing some of our own candidates. If we look just very quickly here in our pipeline, I've already mentioned KP1077 for the treatment of idiopathic hypersomnia, as well as our plans to develop that in narcolepsy. Both of these are rare sleep disorders, many of you may be familiar with. Again, these both have milestones with trial starts in the latter half of this year, and shortly after the idiopathic hypersomnia in the case of narcolepsy. We do have an internal candidate we hope to advance this quarter, and we could have that announcement once we have all the details around that available to us. Then as I mentioned previously and as we've discussed before, we continue our activities around business development, looking for late-stage assets that we can acquire in license that would add value to our pipeline, whether it be near-term value or a little bit later, say, Phase II. Again, looking for good value that we can potentially add with our technology as well and develop those products for potential commercialization. So let me just briefly discuss some of the product attributes and then the trial that I’ve discussed a few times now in the cardiovascular safety. So KP1077 actually consists of 100% of serdexmethylphenidate, also known as SDX. This is the prodrug that's 70% of the product in AZSTARYS. So something we understand, and it's been well studied. It's also already designated as a Schedule IV by the DEA. When we look at the product candidate, what we like about this is there are already features and benefits that distinguish it from the alternative products. This would include generics as well as modafinil and other products that could be used to treat idiopathic hypersomnia. One is, of course, the scheduling feature. Another is the fact that it doesn’t have drug-drug interaction potential with contraceptives and antidepressants, which are actually used quite heavily in that population. What we’re trying to show here is the potential additional features and benefits that could be studied. We have a hypothesis; we really believe there's great support for it. As we get greater tolerability, fewer side effects, and fewer issues with cardiovascular effects, we believe we’re going to be able to provide a higher dose. The higher dose should be more effective. We also believe we have our dosing regimen that’s actually unique here, where a dose in the evening will start to work in the morning, providing that additional lift during the waking hours. This is a major side effect symptom of idiopathic hypersomnia. As the day progresses, the morning dose will be able to provide relief from the other major symptom, which is brain fog. We all know that methylphenidate is great in helping with cognitive abilities, and just given the severe detriment of brain fog, we believe we’ll actually be able to show a bigger difference. The product itself is, of course, eligible for fast-track orphan drug and breakthrough therapy designations and has solid IP through at least 2037. Specifically looking at the cardiovascular study and why we believe this is important: as I mentioned, brain fog is one of the most debilitating symptoms of idiopathic hypersomnia. It's something that is inadequately addressed by current therapies, whether that’s off-label—well, it's actually off-label for most idiopathic hypersomnia patients. The ability to actually dose higher and provide more methylphenidate, we believe, is going to provide a greater effect and be more effective at treating brain fog. The cognitive enhancement you can receive with methylphenidate due to neurostimulation has been well documented. It has its limitations in this population as you have dose limitation, not just from a safety perspective, but from a side effect perspective, that physicians see. High blood pressure and heart rate are known to increase with stimulant treatments, and this has more to do with their immediate release or their double extended-release features. SDX comes on very slowly under a nice gradual curve that increases to about a peak about 8 hours after dosing. Then again, comes down very slowly towards the end of that day. We believe that profile will allow us to dose higher and have fewer cardiovascular issues related to its dosing. We have a study that we initiated and it's ongoing right now, in order to assess that cardiovascular safety, head-to-head with both immediate release and long-acting formulations of Ritalin. These are the only two products that are actually approved to treat narcolepsy, a related rare sleep disease. We should have top line results from that as early as Q3 this year. With that quick overview, LaDuane, I'll pass it over to you for a financial update, and then we will conclude with some upcoming milestones.

Thank you, Travis, and good afternoon. For Q1 of '22, we had revenue of $4 million derived primarily from consulting service fees. There were some royalties and then the success fee that we had reported from Corium related to our assistance in the approval of their product called ADLARITY. For this quarter, we had a net loss of about $1.9 million or $0.05 per basic and diluted share. As we look forward to the rest of the year, as you would expect, R&D expenses will begin to increase quarter-over-quarter as the KP1077 program continues forward. Looking at the balance sheet, we remain in a very strong position with the balance at the end of the quarter being $119.1 million. As we've noted in prior quarters, we remain confident that this extends our cash runway well beyond 2025. Therefore, we have everything we need to execute our strategic plans as well as the development programs for KP1077 that Travis has enumerated. So with that, Travis, I'll turn it back to you.

Thanks, LaDuane. So looking forward at the upcoming milestones for some of these we've already hit. Again, the Phase I trial, the IND filing that occurred this quarter, and the Type B meeting with the FDA in the first quarter. We should have, again, the data from the cardiovascular differentiation trial in the third quarter and be initiating the Phase II trial in the second half of this year. Shortly after that, we would start the process within narcolepsy; of course, we'll have the Type B meeting and the IND prior to that trial initiation. We already had, and I didn't mention here some results on KP879, and we continue to look for external funding and collaborations. That has been part of our plan for that particular candidate. Just briefly to remind everyone, we expect the last half of this year to have some additional clinical stage candidates that we bring in through our business development efforts. With that, I'd like to thank everyone for your time and see if there are any questions.

Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.