BioXcel Therapeutics, Inc. (BTAI) Earnings Call Transcript & Summary

Good morning, and welcome to the BioXcel Therapeutics conference call to discuss the FDA approval of IGALMI. [Operator Instructions] Just to remind everyone, certain matters discussed in today's conference call and/or answers that may be given to questions asked are forward-looking statements subject to risks and uncertainties related to future events and/or the future financial performance of the company. Actual results could differ materially from those anticipated in these forward-looking statements. Risk factors that may affect results are detailed in the company's most recent public filings with the U.S. Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2021, which can be found at www.bioxceltherapeutics.com or on www.sec.gov. As a reminder, today's conference is being recorded, and a supplemental presentation is available on the Investors section of BioXcel's website. Joining us on today's call are Dr. Vimal Mehta, Chief Executive Officer; Dr. Rob Risinger, Chief Medical Officer of Neuroscience; and Matt Wiley, Chief Commercial Officer. For the Q&A portion of the call, we will also be joined by Frank Yocca, Chief Scientific Officer; and Richard Steinhart, Chief Financial Officer. It is now my pleasure to turn the call over to Dr. Mehta, the CEO of BioXcel Therapeutics. Please go ahead.

Thank you, operator, and good morning. We are extremely excited to be here this morning to discuss the most important milestone in the history of BioXcel Therapeutics, the approval of IGALMI for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorders in adults. As many of you know, we are a biopharmaceutical company utilizing artificial intelligence approaches to identify and develop transformative medicines. With today's approval, we are one step closer to realizing our 5-year growth vision of becoming the leading AI-enabled neuroscience company. This approval represents a monumental achievement on many fronts. First and foremost, this assures in the first and only FDA approved orally dissolving sublingual film for the full spectrum of agitation associated with schizophrenia or bipolar I or II disorders. There has been no new innovation for this indication in nearly a decade. For BioXcel Therapeutics, this approval validates the strength of our AI platform and drug discovery and development capabilities. We augment human expertise with the power of AI and have gone from first-in-human trials to FDA approval in just under 3.5 years, well ahead of industry benchmarks. To our knowledge, no other AI-driven company has navigated the drug development journey as efficiently as BioXcel Therapeutics, and we view this impressive timeline as further evidence of potential of this R&D approach. Before we begin, I would like to sincerely thank the patients, their families and the investigators who participated in our clinical development program. I would also like to congratulate the entire BioXcel Therapeutics team on this incredible accomplishment. We are very pleased with the final label for IGALMI, which we believe positions our product for significant differentiation for the following reasons: it is approved for multiple indications; it will be available in both 120-microgram and 180-microgram doses; if agitation persists, up to 2 additional doses may be administered at least 2 hours apart; and it is approved for mild, moderate or severe agitation episodes. Additional label details can be viewed on Slide 4 of our supplemental slides. IGALMI can be self-administered sublingually or buccally under the supervision of a health care provider. What this means is that IGALMI can be administered in supervised treatment settings. This broad label represents significant game-changing potential for IGALMI for the schizophrenia and bipolar agitation treatment landscape. As we have stated, with our launch strategy, we have completed a number of key foundational activities to support a rapid and efficient ramp-up and we are ready to launch. Matt will provide additional details, but I want to emphasize that our launch strategy is designed to support both our near-term vision of bringing IGALMI to schizophrenia and bipolar patients and their clinicians as well as our long-term growth strategy. In summary, we are executing on our land and expand strategy as we transition into a commercial-stage company. We are successfully executing on this strategy with plans to continue expanding through additional indications, medical settings and geographies to build a leading agitation franchise. With that, I will ask Rob to provide more detail on the IGALMI clinical program and highlights from the final label. Rob?

Thank you, Vimal, and good morning to everyone on the call. Before reviewing some of the more exciting aspects of IGALMI's label, I'd like to remind everyone that agitation is a common occurrence in many neuropsychiatric disorders, yet it is a significant burden and long-standing challenge for patients, health care professionals and the entire health care system. This tremendous unmet need has driven our innovation and motivated our team each day to reach this critical milestone. The current standard of care has been antipsychotics and benzodiazepines with frequent off-label use to treat agitation. There's been little innovation in the space, evidenced by the last drug approval, an inhaled antipsychotic, nearly a decade ago. Best practice guidelines have recommended treating agitation with behavioral calming techniques, verbal de-escalation and medications that are voluntarily accepted by patients without coercion. Unfortunately, the need to get a patient's agitation under control may result in having to use physical restraints and forcibly injecting heavily sedating medications, which jeopardizes trust, hampers a positive therapeutic outcome and can create a hostile and adversarial relationship between provider and patient. Both deserve a better option. We believe IGALMI represents much-awaited innovation in the therapeutic landscape for the symptom. So how did we get here? Our SERENITY I and SERENITY II trial results served as the basis for approval and underpin IGALMI's label. These were 2 randomized, double-blind, placebo-controlled 3-arm parallel group trials across 17 U.S. sites in patients with acute symptoms of agitation. SERENITY I included 380 patients with schizophrenia, schizoaffective or schizophreniform disorder. SERENITY II included 378 patients with bipolar I or II disorder. Two doses of IGALMI were evaluated, 120-microgram and 180-microgram, both of which are included in IGALMI's label. Our data results were sound, which I will touch on in more detail shortly. The most common adverse reactions associated with IGALMI were somnolence, paresthesia, oral hypoesthesia, dizziness, dry mouth, hypotension and orthostatic hypotension. There were no serious adverse events, and all adverse drug reactions were mild to moderate in severity, indicating that IGALMI was well tolerated by patients. It was this strong body of data that gave us confidence in approval and led to our ultimate label. I'd like now to touch on a few key aspects of IGALMI's label, which we are excited to share and believe support a strong and differentiated product profile. First, IGALMI is indicated for the acute treatment of mild, moderate or severe agitation associated with schizophrenia or bipolar I or II disorder in adults. This means that IGALMI can be prescribed across the full spectrum of agitation severity, thus positioning it to be used as a potential first-line therapy. Additionally, IGALMI is indicated for administration under supervision of a health care professional with no limitation to a specific setting of care. This sets IGALMI up for potential broad use not only in the institutional setting but also in other settings such as skilled nursing facilities. Second, IGALMI is approved for self-administration under the supervision of a health care provider. We believe this could significantly improve the treatment experience for both patients and their providers and further supports preferred deescalation protocols. The current standard of care depends on approaches that can unfortunately exacerbate patients and escalate an already tense situation, such as the use of intramuscular agents or even physical restraints. Our noninvasive sublingual formulation aligns with treatment guidelines that recommend the use of oral medications after verbal de-escalation to promote early intervention of an agitation episode and to support a positive therapeutic alliance and a collaborative patient/provider relationship. Third, with regards to efficacy, and as shown on Slide 5 of our supplemental slides, both doses of IGALMI demonstrated statistically significant reductions in agitation at 2 hours following dosing, as measured by the mean change from baseline in the PANSS Excitatory Component, or PEC, score. IGALMI also demonstrated a rapid onset of action, with statistically significant separation from placebo observed at 20 minutes for both doses in SERENITY II and at 20 minutes and 30 minutes for the 180- and 120-microgram doses, respectively, in SERENITY I. Fourth, with regards to safety, excessive sedation is one of the adverse events that health care providers are most concerned about with current treatments. This is a known side effect of standard-of-care treatments that can hinder the clinician's ability to assess a patient's condition and reduce hospital bed turnover. New treatment options without over-sedating effects can empower patients to actively participate in their evaluation and recovery. It can also contribute to a collaborative patient/provider relationship. Furthermore, we are conducting additional studies to further understand the treatment landscape and characterize the clinical and potential economic benefit of IGALMI. This includes a retrospective chart review to describe current standards of care and treatment patterns and a budget impact model. This will demonstrate the economic impact of IGALMI on overall hospital systems and its opportunities. We expect IGALMI will offset the biggest total cost of care drivers, such as length of stay, triage, bed turnover rate, as well as the use of benzodiazepines and need for restraints. The output of this work will continue to enhance our health care provider engagement strategy and contribute to the already robust set of data available to our customers. Needless to say, we are excited with IGALMI's label and the value it will bring to patients in need, their caregivers and our health care system as a whole. Our planned next steps are to build on this initial label with an eye towards expanding IGALMI's use into the community setting. Now I would like to turn the call over to Matt Wiley, our Chief Commercial Officer, to provide an update on our commercial strategy and launch plans.

Thanks, Rob, and good morning, everyone. We've been rapidly progressing our commercial readiness efforts, and with today's approval, we are excited to begin the final stages of our launch preparations. Before discussing our commercial strategy and launch, I'd first like to review the large and underserved market for IGALMI. There are approximately 7.3 million adults diagnosed with schizophrenia or bipolar disorder in the United States each year, approximately 21% to 25% of whom experience agitation, with each patient experiencing on average between 10 to 17 episodes. This results in up to 25 million episodes annually. As Rob described, patients and health care providers are looking for an oral, noninvasive treatment that acts quickly, has not been shown to overly sedate, and is voluntarily accepted by patients. We believe that with the differentiated label and compelling clinical profile, we can position IGALMI as the emergency medication of choice for our target patient population. We will immediately begin executing our integrated commercial rollout, which includes deployment of our field sales force, strategic marketing campaigns, IGALMI trade launch and market access efforts. More details are available on Slide 7 of our supplemental slide deck. With today's approval, we will begin to onboard our sales and market access field teams and initiate training for both. This will culminate in our launch meeting in Q2, after which we will begin field execution. We continue to build on health care provider awareness through our Boiling Point on-branded campaign launched last year. This campaign has seen great success in promoting awareness around the treatment of agitation in schizophrenia and bipolar disorder and educating providers around the benefits of early intervention. We'll begin rolling out our IGALMI branded marketing campaign and media platforms to engage and educate health care providers over the course of this year. Approximately 2/3 of drug-treated agitation episodes occur in the institutional setting, and we've identified 1,700 target institutions based on agitation potential, representing about 75% of the overall volume. These include psychiatric centers, academic medical centers and community hospitals. Within these institutions, we are primarily targeting emergency and psychiatric departments. IGALMI will be available as a 120-microgram and 180-microgram orally dissolving sublingual film, packaged into heat-sealed foil pouches of 10 and 30-count films per carton. Our wholesale acquisition cost, or WAC, will be informed by strategic considerations, current and future market dynamics, and with patients in mind. On the latter point, we are finalizing research with payers on pipeline indications to allow for broad reimbursement with as few restrictions as possible over the life of the brand. Please stay tuned for additional information on the wholesale acquisition cost for IGALMI, which we plan to share in the coming weeks. We've built a highly experienced commercial field organization to navigate a market with no obvious analogs. At a national level, the accounts team will cover group purchasing organizations, or GPOs; large integrated delivery networks, or IDNs, leading efforts to support product access and pull-through. At the local level, our hospital institutional specialists and regional managers will cover target hospitals and help drive demand. Our team is very familiar with navigating the formulary process. While this varies by system and institution, it takes approximately 6 to 12 months on average once the process has been initiated and will be a key tactic in driving initial uptake with our target institutions. Over the next few months, we will focus on expanding our ongoing education efforts. This includes identifying and engaging with health care providers within our targeted institutions who are interested in submitting IGALMI to their formulary, supporting the review process and advocating product use. To support these activities, we plan to launch a series of peer influence programs to educate health care providers about IGALMI and the current unmet market needs. With our launch of IGALMI this quarter, we're confident in our commercial readiness and field mobilization efforts to help ensure that this important drug can be widely accessible to patients in need. I'll now turn it back to Vimal for a summary and closing remarks.

Thank you, Matt. As you have heard from us today, we could not be more pleased with the approval of IGALMI. This approval is the culmination of years of hard work, offers an important new therapy for appropriate patients and neuropsychiatric health care professionals and is a monumental milestone for BioXcel Therapeutics. This is also just the beginning for this franchise, as we remain committed to our 3-pillar portfolio expansion strategy. It includes indication expansion, extending our geographical reach and growing the medical setting where IGALMI is offered. We continue to progress BXCL501 in additional indications, including 2 Phase III trials evaluating 501 for the acute treatment of agitation in patients with Alzheimer's disease. This represents significant potential future growth opportunities for our neuroscience franchise. An estimated 100 million episodes of agitation associated with Alzheimer's disease in the U.S. occur each year, with no current approved therapies to our knowledge. Additionally, the FDA recently accepted our IND for 501 to initiate a trial as a potential adjunctive treatment in major depressive disorder. MDD remains the most common type of depression in the U.S. with approximately 27 million cases a year and over 300 million antidepressant prescriptions filled annually. We look forward to advancing 501 as a potential novel treatment option for this patient population and continuing to unlock the vast potential of this program. Secondly, and regarding our geographic reach, we remain on track to submit a marketing authorization application with the European Medicines Agency in the second quarter of 2022. Europe represents a sizable market opportunity similar to the U.S., and we are working diligently to grow our footprint and reach more potential patients who could benefit from IGALMI. As part of this strategy, we continue to actively seek a commercial partner in Europe. And lastly, as you already heard Rob mention, we want IGALMI to ultimately be accessible to patients regardless of treatment setting. In closing, IGALMI represents a novel approach to treating the full spectrum of acute agitation in schizophrenia or bipolar I or II disorder in adult patients. While there are no historic commercial precedents to our knowledge, we believe we are well positioned to deliver this much-needed new treatment option based on our broad label, integrated commercial strategy and robust SCP engagement and MSL efforts. With that, I would like to open the call for questions. Operator?

[Operator Instructions] Our first question is coming from the line of Greg Harrison with Bank of America.

Congratulations on the approval. To start off, what proportion of the target institutions that you've identified do you plan to meet with prior to the launch? And how would you expect the cadence of formulary additions to unfold?

Thank you. I will pass this question to Matt.

Yes, thanks. So the effort to build out the sales team and the market access team is going to touch basically what I would call the top of the pyramid or the most important deciles of the institutions in our target list. That's how any commercial activity would begin, and so that's ultimately how we're targeting [ out dates ].

Got it. Okay. And then one more, if I can, on the safety warnings in the label. Can you just give your thoughts on those, specifically with respect to the QT prolongation? And maybe if you can talk about the impact you would expect commercially when thinking about the proportion of patients who could be at risk -- higher risk there in this indication and in future indications?

Sure. I'm happy to speak to this. The label insert includes the milliseconds of QT prolongation. It ranges up to, I believe, 8 milliseconds. We don't believe this is an impact. After all, all medications that are used for psychiatry -- or I'll say, virtually, I'm sure there are some exceptions -- all tend to prolong QT. And so it's just a given and physicians, in general, are well aware of this with any, certainly, psychotropic medication.

Our next question is coming from the line of Chris Howerton with Jefferies.

I will also offer my congratulations. This is great. So with respect to some of the questions, first, I wanted to just -- maybe if you could help define what it means specifically or what you understand it to mean in terms of the medically supervised setting. Like how broad exactly can that be? Is this as simple as a nurse observing it in somebody's home? Or I guess, what exactly does that mean as you interpret it? And then the second question that I would have is, in terms of pricing, what are some of the indications that you're considering right now with some of those pharmacy benefit managers to describe what the overall opportunity would be and, as you say, to limit some of the step edits and hurdles that might be in terms of access later down the route?

Rob, you do want to take the question about the supervised setting?

Yes, Chris. Good morning. The "medically supervised setting" or "under the supervision of a health care provider" is pretty broad, actually. It really simply means that a physician or a provider, a nurse practitioner, et cetera, any prescriber can prescribe this, and it should be monitored at some point. But it doesn't mean that it has to be technically supervised. So it is self-administered. All of the patients take it themselves. And the setting at this point would be not just hospitals or emergency rooms for -- but could include, for example, skilled nursing facilities, rehabilitation centers. It's a broad range of physical locations where the BXCL501, or IGALMI, can actually be administered.

And Chris, regarding your question about our pricing work, we're considering our downstream work on the outpatient setting as one, and then Alzheimer's dementia is the other. So we have a good line of sight on what the payers would accept from a net-to-plan perspective. And so that work is wrapping up, and we should be able to communicate a WAC in the coming weeks.

Our next question is coming from Robyn Karnauskas with Truist Securities.

Congrats on a great label and success of getting through [ something ] with the FDA. A couple of things. So for your MAA application in the second quarter, what additional data are you requiring for that application versus the U.S.? And when would we expect a timing of a commercial partner? And a second question I have is, do we have an update on the timing of your dementia trials that are reading out? Are they still -- can you give any more color besides just being on track by the end of the year?

Good morning, Robyn. This is Vimal. Answering to your first question, for MAA, I think we were just waiting for our approval by the FDA. We have all alignment what we need to put it in the package, and we are on track to submit the MAA. We don't need any additional data. We have gone through the process with the agency, and we'll be ready to file. Coming back to your second question about the commercial partner. Now IGALMI has been approved in U.S., and now we are filing our MAA application. So this will be the time we will initiate serious discussions with the potential partners who can not only partner for schizophrenia and bipolar I or II, we want to maintain a long-term perspective of upcoming indications like our Alzheimer's indication. And regarding your question about the dementia trial, we expect TRANQUILITY II to read out first because that's how we have staggered the trial. They are in like 2 different type of facilities. One is in assisted living centers and residential setting and the TRANQUILITY III is in the nursing home. So it's about 150 patients. It's not a lot, but we wanted to make sure that any kind of COVID impact that can have impact on these facilities is not there. Now it's all behind us. We are actively opening the site and we'll start enrolling the patients. So we will be in a position to provide a very accurate guidance when that data readout is expected from the TRANQUILITY II and III. It will be staggered. These will be 2 data readouts in next like time period as we provide the guidance more accurately.

Great. And just one follow-up. So in the label, there's an outlining of options to use half dose, which I think is a little different than what you evaluated in the clinical trial. Talk to me about -- I guess, maybe it's a question for Matt, how you're thinking about what percentage of patients may need a half dose or an additional dose, which is beyond, I think, how you've modeled it before? And how do you think about this in the context of pricing, since like half the dose could be half the price of the drug?

So it's a great question. And one of the things that we observed in the clinical trials is that roughly 15% of patients got an additional dose. So that's kind of how we think about it from a modeling perspective. And Rob, anything else?

Yes. The clinical trials did allow the option for a second or even a third half dose only for patients who required it. And so exactly what Matt was saying, on average, it's around 14%, 15% who required or actually received a second or third. So that's in part why it's in the label. We believe this affords the treatment provider flexibility, in fact, to treat their agitation. It's entirely according to, for example, the required urgency or circumstances. It allows for a repeat dose after the initial response or subsequent additional doses as needed, depending on the response to the -- each individual treatment.

And Robyn, coming to your question about the pricing, we don't expect it will be any different. Currently, the way approval is that physicians can cut the film and give the half dose, and they will discard the second half dose.

Our next question is coming from the line of Sumant Kulkarni with Canaccord Genuity.

Nice to see a new treatment option for patients and all the work the company has done to make this a reality. I have a couple of questions. Just as a follow-up on what supervision actually means, how long is the optimal duration for supervision? Could that be done remotely? And how would that work for repeat doses? That's my first question, and then I have a second.

Very interesting question. I'm not sure how to answer. Certainly, a health care provider, since COVID has become common, that remote monitoring is almost standard-of-care at this point through Zoom or whatever teleconference, there is no requirement in the label for a particular kind of monitoring or by whom, but it must be administered under the supervision -- I'm sorry, under a health care provider. So how that supervision is done, I believe, should be free to the provider and not for us per se to dictate.

Got it. So we also noticed the label has a fairly generous starting dose for geriatric patients. Clearly, SERENITY was not a geriatric-focused program. But what might this label language mean for your TRANQUILITY program? Is it fair to assume that safety has been derisked unless something new comes up in older patients and all you need to do is show efficacy of the chosen doses in the TRANQUILITY program?

I believe that's a fair assessment.

Our next question is coming from the line of Colin Bristow with UBS.

Congratulations. This is Elliott Bosco on behalf of Colin Bristow, UBS. I just wanted to ask, is there anything you could say about sales guidance and what the reasonable timelines might be for establishing reimbursement?

This is Vimal. On this call, we are not providing any sales guidance, as we begin our launch process and as we start putting the launch metrics, which Matt, our Chief Commercial Officer, will be sharing in due course, and we'll be providing how to measure the launch of this drug. What I can say is there's no analog, and there's no commercial precedent. But our label, as you heard, is really broad. And our team we have hired is highly experienced. So we are super excited to bring this drug to the patients. So stay tuned for more guidance.

And I'll follow up on the question on reimbursement timing. And so as I said in those prepared remarks, on average it takes 6 to 12 months to secure formulary access, and that's inclusive of the GPO contracting apparatus that needs to take place and also working directly with the IDNs to contract with them. So it's a 6-, 12-month process. Some can be sooner, some take a little bit longer, but we're guiding to that timeframe.

Our next question is coming from the line of Yatin Suneja with Guggenheim.

Let me add my congratulations as well. A couple of questions from me. In terms of the price, can you just talk about, are there any relevant comp in the space? What about ADASUVE as an example, could that -- is that a relative comp? And then -- so there are 2 dynamics. So one is that the drug needs to be given under supervision. But how will the reimbursement work? Is this going to be an inpatient reimbursement dynamic where you have to negotiate with the hospital, or an outpatient setting where the reimbursement dynamic is a little bit different? Can you just help us understand these dynamics and how they will play out?

Sure. So on the first question about benchmarks, there aren't rate surrogates. ADASUVE was launched about 8 years ago at a price point of $145 WAC single-use. So there weren't incremental doses. It did have a REMS program. So it's hard to benchmark necessarily against that particular product. So we're doing a lot of market research work, both for the institutions -- and most of that has been completed at this point -- but also for the outpatient setting and downstream indications to strike the right balance. What is the net-to-hospital expectation? What is the net-to-plan expectation for the payers? That will guide the WAC price for us. Regarding reimbursement in the institutions, these drugs are typically rolled into the APC or DRG codes. So it's not carved out specifically, and there is no specific code for drugs like this.

Okay. Got it. And just one more thing. Can you just tell us the size of the sales force and by when do you -- like how many of them have been already hired currently?

Yes. So as we've said in previous calls, we have designed 70 territories in total. And just so everybody is aware that the sales team that we're bringing on board, that those offers were contingent on FDA approval. So those technically are live today.

Our next question comes from Corinne Jenkins with Goldman Sachs.

Congratulations on the approval. I guess a couple of questions from me. First, should we think about there being any sort of differential pricing at the different doses, 120, 180 micrograms, or should we expect it to be the same price regardless of dose?

Yes. So you can anticipate flat pricing.

Okay. And then with respect to the hepatic impairment and the suggestions around dosing, I'm curious: one, how was that identified during clinical study of these patients; and then two, how do you expect that to translate into the real-world setting? Is it something that's relatively easy to monitor before, giving patients the dose? Or how should we expect that to translate?

We do have plans to demonstrate outpatient use of IGALMI. We plan to discuss with the FDA. And once we have those plans, we would like to expand the label in order for it to be used commonly in the outpatient setting. After all, when agitation comes to be a focus of treatment, these patients present themselves. They literally come from home. They come from the community. They come from an outpatient status. So our plans are...

Yes. I asked about hepatic impairment, not outpatient. I don't know if that came through. How do you identify the hepatic impairment of patients before you determine the...

I'm sorry I didn't hear the hepatic part. Yes, hepatic impairment, we have data on hepatic impairment that is covered in the label. There is slightly lower dosing recommended for those with hepatic impairment.

Okay. And then how would you -- like when these patients come in, is that something that's relatively easy to identify, inpatients who are coming into an emergency department? Or is that something that requires additional testing? I'm just curious how that works functionally in real world.

In the real-world, patients with hepatic impairment have a multitude of physical symptoms and manifestations. It's not that difficult to identify the patient even without, for example, laboratory work. And so I don't believe, in my practice, that this has been an issue. Certainly, patients with severe hepatic impairment are -- it's fairly obvious.

Our next question is coming from the line of Anita Dushyanth with Berenberg.

Congrats on the news from me, too. Just I have one question here regarding the metrics. Would you be in a position to share some of the metrics that you will be tracking to see performance of IGALMI at launch?

No, as we get out in the market, we will share the metrics that we'll communicate on a regular basis. But we're not in a position to share those today.

Our next question comes from the line of Samir Devani with Rx Securities.

Let me add my congrats. Great milestone for the company. I've got a couple of questions. Just on the need for medical supervision, was that -- is that a function of concerns over the falls and the syncope in the label? And if it is, how do you design a trial to avoid those 2 aspects? And then just on the second question, just on your comment about flat pricing. Are you concerned that the institutions will just cut up the 180 strip?

So let me answer your first part of the question. There were no falls. There was no syncope. There was no loss of consciousness in the trials. And so, on the other hand, it is known that if someone has robust orthostatic hypotension, there is a risk of both syncope or a fall. And so we worked with the FDA to provide proper labeling for that and warnings and precautions. But there were no fall, syncope in the clinical trials.

Yes. And then regarding the flat pricing question, there would really be no advantage to cut up the 180-microgram strip, because they would have to discard the other half. So I believe that institutions will buy the strength, the dosage strength that they see the highest velocity with, and they'll stock both, but obviously they're going to stock what is moving through the institution.

Sorry, can I just ask a follow-up on the supervision? So if it's not to do with the falls and the syncope, what are they actually supervising other than administration? And what are they looking out for?

They're simply making sure that their vital signs are within the normal range. And for the most part, patients tolerated this very well. There were some cases of, for example, hypotension or orthostatic hypotension, he is resolved. And so that's why it should be supervised.

Our next question is coming from Sumant Kulkarni with Canaccord.

Other than ex U.S. partnering, one of your options on nondilutive financing could be a royalty option. You have approval now. So is this something that's on the table right now? Or would that logistically be simpler to process after you potentially add the agitation in Alzheimer's dementia indication?

Sumant, great questions. All these options are on the table, partnering in Europe, partnering Japan and potential royalty. So we will explore what will make best sense for the company to continue to execute on its long-range plans.

It appears we have no additional questions at this time. So I'll pass the floor back over to Dr. Mehta for any additional closing remarks.

Thank you all, again, for joining us on this monumental day. This marks a truly exciting chapter for BioXcel, and we could not be more excited to make IGALMI available to patients and providers. We believe this drug will have a profound societal impact. Have a great day.

Ladies and gentlemen, this does conclude today's teleconference. Once again, we thank you for your participation, and you may disconnect your lines at this time.