BioXcel Therapeutics, Inc. ($BTAI)

Greetings, and welcome to the BioXcel Therapeutics webcast. [Operator Instructions] It is now my pleasure to introduce Vimal Mehta, Chief Executive Officer and Founder of BioXcel Therapeutics. Thank you. You may begin.

Thank you, operator. Good afternoon, everyone, and thank you for joining us today. We appreciate your time and interest as we share an update on the commercial strategy and launch plan for IGALMI, ahead of its potential approval for the treatment of acute agitation episodes associated with bipolar disorders and schizophrenia in the home setting. As you all know, these episodes represent a frequent and challenging reality for patients and caregivers. Often occurring outside of clinical settings where there are currently no FDA-approved therapies. We are entering a key period for BioXcel Therapeutics as we prepare for the upcoming November 14 PDUFA target action day for IGALMI. At this time, our focus remains on executing our launch readiness, activities to ensure we are well positioned to bring this treatment to patients and caregivers as efficiently as possible if approved. Finally, I would like to thank our Interim Chief Commercial Officer, Mark Pavao, who has been instrumental in developing the launch plan and commercial strategy for regard and our moderator, Michael King, for leading today's ever. With that, I will turn it over to Michael King.

Thanks, Vimal, and good afternoon, everybody. It's nice to join you today. I'm delighted to have been asked to moderate the Q&A session of this event, which I hope will illuminate the significant opportunity for IGALMI at home and in conjunction with that, of course, with BioXcel stock. In the interest of disclosure, before I introduce Mark Pavao, I would like to just read the following disclosures. First, BioXcel is an investment banking client of Rodman and Renshaw. Number two, we cover the stock, which is rated by and we've established a $17 price target for the shares. Then finally, neither I nor any member of my household owned shares in the company. So with that, let me introduce Mark Pavao. Mark Pavao has more than 30 years of U.S. and global commercial leadership experience across the biopharma industry, including extensive prelaunch planning and on-market commercialization in CNS and additional therapeutic areas. He has contributed to the commercialization of multiple CNS therapies, including Abilify for schizophrenia, bipolar disorder and depression, Paxcel for depression, Risperdal for schizophrenia and Nurtec ODT for migraines. And I would just add editorially that the parallels here are very strong. So without further ado, let me let Mark launch into his presentation, and we will come back at the end with a Q&A. Mark, over to you. All right. Now can you hear me? Am I coming through?

Yes, go ahead, sir.

Okay. So I got that. I was muted. Michael, thank you very much, and I'm excited about the opportunity to share the IGALMI at home opportunity from a commercial perspective and talk about what we've learned from our market research as well as how we're thinking about the go-to-market plans for IGALMI. Let me start off by setting the stage by reminding us where IGALMI has come from and where we're going. IGALMI was approved back in '22 for use specifically in the institutional setting with administration under health care supervision. Fast forward to last year, the SERENITY At-Home study demonstrated that IGALMI can be used successfully at home by patients administering it to themselves without medical supervision. That data has now been filed through an SNDA. S&D was accepted for review. We have a PDUFA date of November 14 and are looking forward to launching in first quarter of '27. So as you will see, as we go through the story, the market opportunity expands significantly from the institutional setting to the at-home setting. But more importantly than that, the value proposition completely changes. In the institutional setting, there are other medicines indicated for the treatment of acute agitation, in the at-home setting, nothing is indicated. Further, the goal in the institutional setting is to calm patients down who have presented to the ER. The goal in the at-home setting is to help patients deescalate, so they don't end up in the ER. So very, very different value proposition in the at-home setting. So let me -- going to walk through a couple of slides that summarize what we've learned in the market research that we've done. First, we've talked to physicians, we've talked to patients, we've talked to payers and what's come through about the condition itself, acute agitation in the at-home setting, it happens frequently. It happens often, 36% of bipolar patients who are well controlled on their underlying mood stabilizers, 50% of schizophrenia patients who are well controlled on their underlying antipsychotics experience breakthrough agitation, which can be distressing, disabling and if it escalates can lead to those hospitalizations or worse. The symptoms span a range of areas from emotional symptoms like tension and irritability, behavioral symptoms like restlessness and overactivity, cognitive symptoms like impulsivity. And despite all of this, nothing is indicated to treat acute agitation in the at-home setting. The market opportunity is very large. And the IGALMI profile is very, very strongly fit with the unmet need. So as we talk about the opportunity itself, agitation at home is under-recognized and undertreated. And I say that it's -- the analogy is the tree that falls in the woods. If you're not there, you don't hear it. So physicians know that patients get agitated. They're very aware of the patients who are agitated at home and end up in the ER. They are less aware of how frequently and how often patients are agitated on their own, but they do know that it happens. When they do treat patients at home, they're basically doubling down on typical or atypical antipsychotics, oral antipsychotics, which are slow to act or benzos which are controlled substances and have other issues. So physicians recognize that the current treatments are not optimal. And when they see the IGALMI profile for at-home use, they're very excited, and they projected IGALMI will be used in 70% of their appropriate schizophrenia bipolar patients who experience agitation in the home setting. We've talked to patients. Patients, all of whom have experienced what it's like to be in the ER, be treated in the ER and be calmed down with either injectable antipsychotic or an injectable benzo. That -- those experiences are not pleasant, and when we talk to patients and we present them with the TPP, the target product profile for IGALMI at Home, very, very high interest. And they project that they would use this in 80% of their future episodes. We also talk to payers in our market research to understand how they would think about placing IGALMI on formulary. And the consensus as we talked to 5 payers, these are payers that represented very large health plans. The consensus was that because nothing is indicated because this is an unmet need, because appropriate treatment that avoids the escalation and an ER visit or hospitalization that IGALMI will be covered on formulary with common restrictions such as prior authorization to label. So making sure that only patients who have an indication for schizophrenia bipolar get the medicine and potentially quantity limits as well since this is not a medicine indicated for chronic use, but it's a medicine indicated for episodic use. So moving along in the research, we also were able to dimensionalize the size of the opportunity. And in our research, we were able to calculate that there's 2.3 million treated bipolar schizophrenia patients who have frequent acute agitation. Frequent in the research was defined as 10 to 15 episodes per year. And of those treated patients who have episodes, when you map out the number of episodes they have, which is about 4 per month, that adds up to an addressable population of about 86 million episodes per year. When you think about this in the context of the 16 million episodes per year that are seen in the institutional setting, you understand that this represents a significant expansion of the addressable market for available to IGALMI as we move forward and secure this indication and take it to market.

Mark, can I just ask a quick question of sure about this side -- why do you think the hospital setting is so much smaller? Those numbers are significant as far as the number of episodes? Is it because patients never get to the ER, -- are they reluctant to go to the ER, they treated elsewhere? What explains that dichotomy?

Yes. I think it's a couple of things. First, we know the patients are reluctant to go to the ER. They've been there before. It's not a pleasant experience. So they will avoid it if possible. And secondly, I think patients are largely -- they're suffering in place. They're experiencing distress that's ruining their day. They're becoming uncooperative or perhaps belligerent in whatever work setting or home setting that they're in. But it doesn't get to the point to require hospitalization. In our research, both in the clinical study, but in the market research we did, we learned from both physicians and patients that the agitation episodes come in different levels of intensity. And we found that about 1/3 of the episodes are mild, 1/3 are moderate and third severe and often a sort of mild so can escalate to moderate, which can escalate to severe. So the goal here is going to be when you have a medicine that is uniquely designed and specifically indicated for this condition in the at-home setting, you help patients avoid the escalation that can lead to the hospitalization.

Okay. So that's super helpful. Yes.

You bet. So moving on to the next slide. Here, we'll begin to talk about how we're thinking about bringing IGALMI to market and the impact that we're trying, that we think we can make on the market. And basically, we have an opportunity to redefine the standard of care. Now that we have a medicine that is specifically studied for specifically indicated to treat patients in the outpatient app home setting for the first time because nothing is indicated today, we have an opportunity to help patients treat themselves. And this was very, very motivating to patients. What do we need to do to make this happen? One is to elevate the recognition of agitation in the at-home setting as being a real condition that happens frequently and can be treated with IGALMI. As we do that, we'll want to -- we'll then look to establish that the right way to treat is as early as possible. So as symptoms are coming on, have IGALMI on hand, treat it, don't let the episode escalate, which may lead to hospitalization or worse. And as we're successful in establishing the practice of medicine in the pattern of care IGALMI as a new standard, we can then work with the guidelines agencies, the path lines agencies to hard code a galley into the pathways into the guideline. So at a 30,000-foot view, this is the opportunity we have. And I'll say that for people with agitation who experiences at home, schizophrenia and bipolar patients experiences at home, this is kind of like having the EpiPen. That's -- it's a great analogy. So patients who are at risk for allergy, severe allergy, they have an EpiPen on hand. And that's what IGALMI is going to present to our patients. Moving forward, as we think through the different audiences, the kind of work that we'll be looking to do in the period leading up to launch, it's all scientific communication. We've got great data. So we want to get that data out. We want to be presenting the data and elevating awareness about the unmet need that exists in helping patients with schizophrenia bipolar who experience agitation at home. So it's elevating the awareness of the unmet need and making sure that physicians are -- have been exposed to the SERENITY At-Home data. So there are many scientific congresses that we can get to present the data. We'll be engaging with physicians and some physicians in the context of advisory boards to get their advice on how we can best bring the message to the market and then obviously, leverage those insights in the finalization of our go-to-market plan.

Mark, I just wanted to jump in real quick. If you just spend back 1 slide, if you don't mind, I don't want to get too granular with this question. But as far as these congresses are concerned, can you talk about what you're permitted to -- you as a company are permitted to do and say at these conferences under the regs. And from -- who from the company is allowed to participate in these congresses. Are they medical affairs people, what can you say about these.

Yes, absolutely. So all of this is done under scientific exchange. We have great data. The data gets written up in the context of abstracts and posters and publications and we have obviously medical people within the company, and we'll be adding to our medical affairs leader who's within the company at this point, eventually a team of MSLs. So all this will be done in the context of scientific disclosure. So moving on to an important part of the building blocks for the launch plan and getting ready for launch is preparing the value proposition, the data that goes into building out the economic justification to the payers to make sure that IGALMI is broadly available as quickly as possible. This is not flipping the light switch exercise. It will involve significant conversation with payers over time, understanding their needs, understanding their level of awareness of the situation and then probably, in many cases, I expect we're going to have to do some education here. Because when you enter a situation where nothing is specifically indicated, there's going to be the need to educate payers on why a fast-acting sublingual pill or sublingual film that is calming without being sedating that the patient can administer on their own at home is better than an oral atypical, which is being used now in the case of the home setting, which does not work fast and exposes the patient to a typical side effects or benzo which is a controlled substance and exposes the patients to other side effects. So there will be the need to educate. But the point here is that with the payers there's a value proposition to be built. There are pricing and contracting strategies to be developed, with the goal being that we get to launch and through the launch year, with the opportunity to establish formulary presence with as little friction to patients as possible. Moving on to the prescribers, mission critical for the launch of IGALMI, home setting is going to be educating prescribers. The prescribers in this particular case are basically doctors that treat schizophrenia bipolar. This is a market that I know well. We've talked to these doctors over many years. It's a very concentrated group of physicians. So approximately 65% of the opportunity in schizophrenia and bipolar is covered by less than 10,000 doctors. So it doesn't take a very large sales force. If you figure -- I think on the order of magnitude, we're talking somewhere in the 80 rep range to cover this kind of opportunity. So with a relatively small sales force, we're able to cover 65% of the opportunity from an education perspective. And then over time, obviously, we can expand as we gain traction or as we move further and have additional indications for IGALMI.

Mark, you anticipated my question about the size of the sales force, so I'll leave that alone. But in terms of the physicians, is this an 80-20 type of situation? Or where 80% of the scripts are written by 20% of the docs? Or is it more evenly distributed?

No, it's definitely 80-20. It's probably even more concentrated than that. I mean we're covering 65 with less than 10,000 doctors. And it doesn't take that many more doctors to get to 80%, very concentrated footprint. So thanks for that, Michael. So moving on to the to the patients once we have physicians educated and we've got really good access through the payers, and importantly, the payers we're talking not only Medicaid and Medicare, which is important for schizophrenia, but the commercial payers are going to be important for us. So once we have really good access across the payers, messaging the patient is going to be important. So this is not something we'll do at the beginning. But I think in the fullness of time, there's an opportunity to help patients recognize that there is a new medicine that can help them manage their agitation on their own at home, help them understand how easy it is to use, given the confidence to know when and how to treat themselves. And in some cases, help educate the caregivers to support their family member with schizophrenia bipolar to treat appropriately when they feel the agitation coming on. So in the fullness of time, there's definitely an opportunity for consumer messaging, not I'm not talking big DTC from day 1. I'm not even talking big DTC in the second year, a very, very targeted messaging opportunity. At launch that what will be important for patients is making samples available to patients through doctors' offices and in those samples having patients starter kits that make it very clear what this medicine is and how to use it, how to administer the dose to yourself. And of course, we'll have those dosing instructions available online as well. So wrapping up, and then, Michael, we can get to whatever questions you and others have. IGALMI, it's a great story. The clinical data that was completed in last September came through very, very nicely, studied 250 patients. Those 250 patients had over 2,500 episodes of agitation that were successfully treated. And largely what that study showed is that patients can dose themselves successfully at home wiigalmi. That data has been packaged. It's been submitted to the FDA. We've got a PDUFA date of November 14. We have a really good work plan for the next 9 months to get us ready to launch with assuming success. On November 14, we'll be ready to launch in the first quarter of '27. So I'll wrap up there and happy to take any questions.

Thanks, on. That was brilliant. Yes, and I have to commend the company for having done an extremely thorough job of not only conducted trial, but some of these -- the comparator trial for sort of basically operating the patient's ability to treat themselves is outstanding. So I think that in my opinion, reduces regulatory risk pretty significantly. Mark, let's start off with kind of the patient vignette. What is it -- what does it look like to live with bipolar or schizophrenia and being someone who gets these fairly frequent bouts of agitation. Walk us through what that experience may look like, what happens or what is the patient's options -- when there's no options available and it escalates into a crisis. So maybe you can talk a little bit about that.

Sure. I'll take that one. Thank you, Michael. So look, schizophrenia, bipolar, these are serious mental allies. These are distressing, debilitating very serious medical conditions. They are controlled with strong medicine, typical and antiplapsychotics. There they're great medicines, they help patients significantly, but they have a lot of side effect burden. So -- and bipolar, the mood stabilizer is the same. So -- so first, you have to think about this in the context of the underlying medical situation that these people are already working through. And then on top of that, a patient who is diligent with their medicines, they're well controlled. They're living the at-home setting. They then have -- and we know from the research, many of them will have breakthrough symptoms of agitation. And these are just stressing symptoms. As I said earlier, it's -- the symptoms exist. You've got emotional symptoms, where there's -- it's -- they get anxious. There -- they feel kind of uncomfortable. It can escalate to behavioral where they get -- there's ferocity in escalating situations, progression -- we've had -- we've heard from patients who experienced this at work where they basically become not only dysfunctional at work, but they potentially are exposed to losing their job. So it's a very distressing situation for patients. And up until now, without anything specifically studied for an indicated they're left to use off-label medicines. Right now, the off -- what is used are the atypicals, which I said earlier, expose this to even more side effect burden or the benzos, which have different side effect issues and also are controlled or in the case of escalation, they end up back in the -- if they're lucky to end up back in the ER. If they are so out of -- so agitated a lot of control, so belligerent -- it's not -- some patients end up in handcuffs. So it's just a terrible case from a patient perspective. So the ability -- and I'm going to go back to the EpiPen analogy because I love the idea that for the first time, these patients are going to have something that they can carry with them whether they're at home, whether they're out in the park, whether they are at their job and if they feel this coming on, they can control themselves. They can dose themselves and as I said earlier, the nice thing about IGALMI, the profile at the highest level, it calms the patient without knocking them out. And that's what's very attractive here.

In the -- in your comment about the fee comment. So there is a prodromal effect in many cases.

Yes. I wouldn't describe it as prodromal -- it's not like a migraine prodrome, but they do before someone is moderately or severely agitated, they're mildly agitated. So they do feel kind of an internal disquite and internal anxiety that if not addressed, and people had different coping mechanisms, but if not addressed, it can't escalate and that's what we're trying to get to.

Got it. Got it. Okay. I think you also answered 1 of the questions that was in the question queue about the benefits or downsides of benzos and the other agents that are used off the table. Also, just with regard to what now is sort of bridges into what changes now that there is an option where the where something could be used or substance could be used, earlier in the home instead of waiting and calling either 911 or the ambulance comes. What is it about the mechanism and formulation of IGALMI, the speed of onset, tolerability. All the -- as you mentioned in your formal comes that makes it well suited to that moment in a way that the existing off-label options do not.

Well, you -- I think you just said it yourself, -- it's fast acting, right? So onset of action as quickly as 20 minutes. That is really, really important. In the ER setting, -- the -- what is used, what is indicated and used are often the IM. So the injectable atypical antipsychotics or IM or IV benzo. And the reason that they're administered intramuscularly or intravenously is for speed of onset. So now you have an opportunity to get speed of onset in the at-home setting with a medicine that patients can administer themselves. So when I -- as I think about a IGALMI, if there's one attribute that is highest on the priority list of attributes, it's absolutely that. It's -- patients can administer themselves and speed of onset. But beyond that, next -- it's -- this is not an antipsychotic. This is not a benzo. This is a novel mechanism that calms the patient without sedating them. And we saw this in the clinical studies that the patients were -- as part of the clinical work, they had to respond to questions every 10 minutes. And there was no patient that couldn't respond to questions. And that's very valuable because in the ER setting, often patients are knocked out. In fact, when I was -- I'm going back many years when we were developing aripiprazole, Abilify, for IM injection. One of the issues was and what we thought Abilify would hopefully overcome was patients that get an Zyprexa, they're knocked out. And when the patient is not down, they're taking up space in the ER, the doctor can't intervene until the patient is aroused. That's not the case with the IGALMI.

Yes. And then they can't go back to work if they work at x -- that's exactly right. There is productivity -- all right. I'm going to ask a couple more questions. We're getting a bunch of questions in the queue, which is nice. I'm going to -- the ones that have been addressed, I will not -- I will not bring up but the ones that have not, I'll hope to get to. Just a couple more questions, Mark, before we get to the online questions. And again, the size of the opportunity, how does that I kind of asked this before when we talked about the 86 versus the 16, but in sort of again the real-world setting, how does that funnel down? Are there patients that are not so severe that they just sort of ride it out? Or are there others that Medicaid with other things, alcohol or a bit of substances substantive abuse or whatever. But how does that funnel down?

Yes, that's a great question, Michael. So the funnel -- I'll just talk through the funnel first, and then I'll talk about what we heard from physicians and patients around how patients within the funnel would be treated. So at the top of the fall, you have about 8 million people with -- diagnosed people with schizophrenia bipolar. Of those, about 6.5 million are treated. Of those, we then took cuts based on are they living at home because our population of those living at home. And what share of those patients have frequent agitation. And we've got this by asking doctors, okay, think of your population, what percent of your schizophrenia bipolar patients experience frequent agitation defined as 10 to 15 episodes per year? So that got us from the $6.5 million, $2.3 million. We then took on more haircut which was based on of these 2.3 million, let's make sure that we are screening out patients that did not fit the serenity at-home entry criteria. So for example, if a patient was abusing illicit drugs in the last 6 months, they were excluded. So we excluded about 20% of the patients. So that got us to about 1.8 million addressable patients -- and in the study, we saw that on average 4 pesos per month, that's 48 per year, 48 x $1.8 million gives you the 86 million episodes per year. In our research, and very consistently whether we talk to patients, whether we talk to doctors, those episodes appear to be a third mild, 1/3 moderate and 1/3 severe. First, I'll say that in the clinical study in the SERENITY At-Home study, the product works regardless of the level of severity. So we saw reduction in agitation whether the patients were mild in severity, moderate in severity or severe in severity. So from a clinical perspective, we know that it works across the spectrum and then we ask physicians, and we ask patients, well, would you reserve this just for severe cases? Or would you want to use it in mild cases to prevent the escalation? And the general consensus was -- you know what, we're going to use it across the board because if you're mild and moderate, you obviously want to avoid escalation to severe. And if you're severe, you want to manage that. So I think that broadly, there's going to be broad interest in this. And now once we get out in the real world and patients have experience with it, I suspect that patients -- doctors and patients will develop their own strategy around when is my agitation, the kind of agitation that I'm going to jump on, I'm going to take IGALMI for it. But right now, based on what we know today, it works well across all 3 disease spectrums and there's no reason to think that it wouldn't be used in all 3.

Okay. Great. I just wanted to ask 1 more question on reimbursement, and then I'll take the questions that came in online and there's time left, I can come back. But as far as the payers are concerned. A couple of questions on that. Have you -- has BioXcel undertaken any kind of pharmacoeconomic study to demonstrate to the payers avoided costs of hospitalization, loss productivity, risk to ER, personnel, et cetera. Have you done any studies like that. And then in the case of Medicare, Medicaid dual eligibles, how does that situation look? Because I know there's a fair number of -- a fair proportion of patients with schizophrenia that are unfortunately indigent. How do they get covered? And do you have to go sort of state by state with that population to get your approvals?

Yes. Yes. Both good questions. On the economic models, we work yet. That's in the plans. And -- but I mean let me just point out an obvious point of practicality. Before the drug is on the market and has broad use, the models will be building will be hypothetical theoretical models, right? Post approval, once we actually have use we can then reinforce those models with real-world data and bring really robust economic justification models to payers. So in the launch period, we'll have a nice model that will project the opportunity to offset costs of an ER visit or hospitalization based on using IGALMI. Although I'll tell you, and that's going to be important for the payers. At the same time, we're not going to shy away from painting the picture of patients today that are in distress because the drug that are available to treat acute agitation at home are not great. And this is a new paradigm and having the freedom to carry medicine around that can help abort a case of agitation quickly, whether the patient is at home, in the park at work is very valuable. So that's the case from the health economic perspective. To the Medicaid, yes, Medicaid and dual eligibles, Medicaid is a state-by-state thing. So we will have to go state by state and do what's necessary to get this on the state Medicaid formularies. And is it -- I mean, how difficult or straightforward is it to access those patients with kind of challenge in -- we're talking patients with severe mental ones, there are protections in place for this category of patient, this category these medicines. So nothing is ever easy, but there will be willingness to hear the story. I'm fully sure of that.

Okay. Wonderful. All right. Let me take these questions in order of the -- of which they came in because I think that's the only fair way to do it. So the question is, how do you think about preventing overdosing in the real-world setting?

Yes. Nice question. The -- we knew from the payers that they will -- this is a medicine that will be used episodically, not chronically. And one of the criteria from the payers will be quantity limits. So first, patients will not have a large number of film strips on hand. And it's too soon to say what the limit will be. But if you extrapolate from the fact that on average, we see 4 episodes per month per patient. You need to think about more than 4 per month because you don't just do for the average patient. You need to make sure you're covering most of your patients under your quantity limit. Plus the medicine is designed to be redosed within 12 hours, so 1 episode could get 2 doses. So I would expect maybe patients have 10 on hand at any given time. But the second thing to realize is that the underlying medicine, dexmedetomidine, is used in the ICU setting as a sedative anesthetic. So this is not the kind of medicine that's going to get overdosed from a, hey, I like this medicine, I want to take more of it -- and if someone does take 2 or 3, the primary thing that will happen is they'll get tired. So we've had -- I know the company has had those discussions with the FDA. That was an important part of doing the at-home study and demonstrating that it could be safely administered by patients in the at-home setting, and the clinical data stands for itself, 250 patients over 3 months. We're able to identify when to treat themselves and how to treat themselves and to treat themselves on their own without medical supervision.

And I would add to your comment, Mark, about the opioid withdrawal studies used doses of 240 micrograms. So we know that if you get approval for the high dose at 180, you have clinical experience was a dose that's at 240. So that's 1 -- if the question is concerned about safety. The other point I would make from your -- the question about sort of the maximum amount of drugs someone could have. If you look at lofexidine, which is marketed under Lucemra, that is typically given 3 tablets 4 times a day. maximum of 16 a day and up to a maximum of 14 days. So there may be some constraints put on IGALMI at home as well. Would you -- is that fair to say?

Yes. I think the -- yes. I think the primary constraints will come from, look, this is a medicine that's designed to be used episodically. So let's estimate how many episodes should we reasonably expect to treat over the course of a month and make a prescription based on that?

Perfect. I think this is a bit -- this is a question that's related to that, which is based on the payer feedback. What do you think the pack size will be? Sorry, pack size will be that they will accept per prescription. And I think we've talked about that. I don't know if you want to do anything to add there?

Yes. Not really. I mean right now, it's packaged in units of 10s and 30s. I think the 10 pack sets up nicely for a monthly prescription. But what's interesting about IGALMI, the film strip itself is actually individually packaged in a sealed package that has its own NDC code. So whether we put 5 films in the box or 15 films in a box, those changes can be made pretty quickly. But right now, we've got a 10 pack, and that feels like a good number.

Okay. Perfect. This has to do with Tranquility. I think I'm going to skip over that and come back to it. Let me just say I want to stick with some of the -- yes, let me ask this -- I know I'm going out of order now, but there's a question about, again, a clinical presentation of agitation. It says how long does an agitation episode typically last if untreated and will IGALMI simply shut it down? How long does it last?

Yes. How long does it last? Because it varies, but Yes, it varies. It varies. And what we know from the experience is that IGALMI works quickly, as quickly as 20 minutes.

Right. Okay. Here's another question in here about the number of units in a pack. So I think I can skip that -- let's see. These others have to do with strategic questions. So maybe, Vimal, I can get you involved here. There's a couple of questions. company in talks with any major pharmaceutical company, potentially partner assistant and marketing. Are you looking at partnerships to help with the launch? Yes. Those are the 2 questions that are related.

Those are very relevant and good questions. We are exploring all opportunities. And part of the exercise Mark is working on, we are evaluating what is required to launch this product, and he -- some of the work has been done and some of the work is in progress. And we are looking at all options to make sure we can bring this medicine to as many patients and KL givers we can, which could involve an established footprint with a partner to cut commercialization to other opportunities. So we are quite open and we are working on it, and we want to get to that by the time we get to the PDUFA date.

Terrific. I know what the answer to this question is, but I think you should at least address it VImal, which is 80 reps, what you're estimating your cost of launch in '27?

I think that work Mark and team are doing what the total cost will be. It's just not the rep cost. It's additional things that you require to launch the product. and having a strategy -- what strategy we are adopting in terms of what we discussed previously, what options we're going to use, then we will be able to provide more guidance what the cost will be for the launch of 2027.

I like that answer. Also, do you think the product is appropriately priced at $105 per film given the value it brings to the table, especially at the in-home setting, how much you think a patient co-pay would be for that? I think it's kind of tough to say. But I'll ask it anyway. And how many films do you think would be in an average initial Rx and we already talked about that. So maybe the first 2 questions of $105 per unit. And then I don't know if you can speculate on the co-pay, I don't know how you would do that, but go ahead.

Sure. So when we did the research with the payers and again, this was I would say, preliminary research to get a sense or how they would think about covering this on formulary, and we got positive feedback there. We were transparent that right now, the price -- the products available is priced per $105 per film and really had no pushback there. I think where their headwind was, okay, -- in the neuropsych market, a new branded drug is typically priced $1,500 to $2,000 per month. And here, we have a medicine that is -- works in the same space but it's about $100 a dose and how many doses per month. Well, it's not going to be 15 or 20 doses per month. So I think they felt, okay, this seems reasonable. As far as co-pays go, once we get to Medicaid, the Medicaid co-pays are low. So it's just a matter of getting on the Medicaid formularies. The commercial co-pays will vary and obviously, our strategy will be to work with the payers to very clearly elucidate the value proposition to the payers, to physicians and importantly, to the patients. So they don't put extreme hurdles in place for these, patients are suffering enough. Let's let them get access to important medicines at a reasonable out of pocket. But quite frankly, with the commercial patients, if we find that the that the out-of-pockets are too high.

There are things we can do to help lower those in the commercial world and recovery assistance. That's right. you basis, you're going to do couponing, you can do sampling. I mean, there's a lot of strategies you can at -- that's exactly it. I think it is a bit redundant, but just in order to make sure everyone is happy on the asking questions online, do you currently feel like you have the -- I think the better way to ask it is, do you feel like your sales and infrastructure and capabilities can support a full U.S. launch? Or would that require additional partnerships, and I'll let you address that as you see it.

Yes. So I'll take a stab and Vimal, you might want to jump in. At this point, we have a great launch plan. So the work that we will do between now and launch -- and we have a very, very -- we have an emerging finely tuned view of what a successful launch infrastructure needs to look like. All that is to be built over time. As Vimal alluded to, he's talking to a lot of folks. And what exactly the launch, the go-to-market infrastructure looks like will really depend on that. Vimal, anything you want to add there?

I think that's pretty much. Currently, we have some advantage because we did do the launch in the institutional setting, if they are helpful. But for home setting, we will have to build the infrastructure that Mark mentioned.

Okay. Terrific. Let's talk about -- I'm going to come back with some questions of my own in the closing minutes, but let me just put up 2 more, which is what are the came milestones investors should watch between now and the PDUFA date that could meaningfully change your trajectory?

So I think approval is a major catalyst right now. We are in the review process for our sNDA and preparing for a launch, which is the commercialization activities ongoing with Mark coming on board. In addition, we have already have alignment with the FDA to initiate second confirmatory Phase III trial for our Alzheimer's agitation program. So initiation of that program would be a key to expand market from schizophrenia and bipolar related agitation to another indication in that sim. I think those are the key value drivers for 501 pro .

Okay. Great. And then I'm going to piggyback on this question, which is the -- well, this question is asking about tranquility. We know you got Breakthrough Therapy designation for Alzheimer's agitation, but studies are currently paused. So Vimal, you just mentioned Tranquility, I guess what are the obstacles to getting those started? And would you -- the question is would you convert TRANQUILITY trials to at-home trials?

So TRANQUILITY plan will be that we have done 1 Phase II trial in ALF assisted living facility, and we have demonstrated 60-microgram dose as like a positive, both from efficacy and safety perspective. Now we need to do a second confirmatory trial, just covering broader population, ALF memory care as well as nursing home. So we are covering full spectrum of Alzheimer's the patient will get maybe mild more severe agitation, mild moderate and severe. That's the second conformity study that is required to expand into the Alzheimer's agitation. And in that, as I mentioned, we have alignment with the FDA on the protocol as well as we have selected a CRO, and we are geared to initiate the trial, and we will announce when we initiate that trial.

Okay. Maybe talk a bit about -- because I think the exciting part of the story from my perspective as an analyst who tries as hard as you can to make money for its clients. Just how large the opportunity is, Alzheimer's agitation, opioid withdrawal, how do these add the layers of addressable patient populations?

So good news is that 501 as a like potential pipeline in a product potential, conceding its very unique mechanism and it can apply to various conditions, which you measure. Currently, company has focused on schizophrenia agitation and now institutional and home setting with the potential approval with this S&D. And Alzheimer's agitation expand into that tooth of them are extremely large opportunity from a company perspective. But potential is more, as you have seen, we are conducting investigator initiated trials, and this is clinical and scientific community who gets funded from the outside, and they are running these trials in opioid withdrawal as well as recently, we announced that acute stress reactions or acute stress syndrome that happens prior to the PTSD. We -- there is a trial that is being done funded by DoD by University of North Carolina and opioid withdrawal by Columbia University. So we continue to supply the drug to continue to get clinical signal that can expand. But company is currently focused on those 3 indications, schizophrenia, bipolar and Alzheimer's because these are really large opportunities and 501 can have a attention once we succeed in these 3 indications.

Great. All right. There's 1 more question in the queue. I might ask it a little differently, but the question is about now that you've got a PDUFA date, has the have the discussions with potential strategic partners changed at all? Has that moved the needle, I guess, I would say, in terms of the partnership interest?

What we observe that as you do the derisking of the opportunity, which was first Phase III data that came in last fall than it was submission of the sNDA and now acceptance of the sNDA.. All these things result in increasing the interest. That's what I would say.

Yes. Yes. I'm sure it's a cumulative effect. Okay. Well, look, we're just about at the top of the hour. I just wanted to close out or at least then we'll have your closing comments, I'll make some brief remarks, and then we'll wrap things up. So anything you want to say in closing before we go?

No, I think this is great that we were able to hold this session, and I would like to thank you, Mark. And thank you, Michael. As we have highlighted, we believe IGALMI represents a significant opportunity to have a real impact on the lives of patients and caregivers managing acute agitation in home setting. In the next several months, we will continue to advance our commercial launch preparation, and we will get the potential approval announcement. We appreciate everyone joining us today and your continued interest in our progress. We look forward to keeping you updated as we move ahead.

Great. Thank you, Vimal, and thanks, everybody, for joining us here today. Again, it's been my pleasure to moderate this event when we first heard about the BioXcel story. We got very excited about it and I'm old enough to remember a company called Avenir many years ago that had a drug that there were a lot of skeptics about, turned out to be a terrific drug, a terrific launch and a wonderful exit for the company about 10, 12 years ago. I would -- I see lots of parallels between the BioXcel story and Avenir from my past as an analyst. And again, we appreciate the company management team taking the time to do this for everybody, and we wish you an enjoyable rest of your day. So thanks, everyone.