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

Thank you for joining the BioXcel Therapeutics Virtual Commercial Day event highlighting BXCL501 as a potential treatment for the acute treatment of agitation associated with schizophrenia and bipolar disorders. [Operator Instructions] At this time, I would like to turn the call over to Vimal Mehta, Chief Executive Officer of BioXcel Therapeutics.

Thank you, operator. Good afternoon, everyone, and thank you for joining our Commercial Day to discuss our launch strategy for BXCL501, which is currently under FDA review for the acute treatment of agitation associated with schizophrenia and bipolar disorder. As a reminder, during today's presentation, we will be making forward-looking statements regarding our commercialization plans. These statements are subject to risks and uncertainties that may cause actual results to materially differ from those forecasts. A description of these risks can be found in our most recent 10-Q on file with the SEC. Next slide, please. Joining me on today's call is Will Kane, our Chief Commercial Officer; Reina Benabou, our Chief Development Officer; and members of the commercial leadership team to discuss topics, including the commercial landscape, market access, operations and sales force build. In addition to our commercial team, we would like to welcome our distinguished guest speaker, Dr. Leslie Zun, Professor of Emergency Medicine at Rosalind Franklin University of Medicine and Sciences, Chicago Medical School, who will discuss perspective from his clinical practice. Next slide, please. I will begin today's presentation with a brief company overview of BioXcel Therapeutics. We are a clinical-stage biopharmaceutical company utilizing artificial intelligence and machine learning to identify and develop transformative medicines in neuroscience and immuno-oncology. Our 2 most advanced programs are BXCL501, an investigational proprietary orally dissolving thin film formulation of dexmedetomidine for the treatment of agitation; and BXCL701, an investigational orally administered systemic innate immunity activator in development for the treatment of aggressive forms of prostate cancer and advanced solid tumors. Today, we will be focusing on our commercial strategy for neuroscience candidate, BXCL501, if approved by the FDA. Next slide, please. In just over 2.5 years, we were able to go from conducting our first in-human trial with BXCL501 to receiving FDA acceptance of our NDA filing. In this short time frame, we also successfully performed a total of 7 clinical trials in over 800 subjects across a range of disorders, laying an extremely robust clinical foundation for this neuroscience candidate. Last month, we received FDA acceptance for the filing of our new drug application for BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders with a PDUFA action date of January 5, 2022. This acceptance marks an important milestone toward our goal of providing a new treatment option for the millions of patients struggling with agitation. This is the first major medical advancement for these 2 indications in almost a decade. While the FDA reviews our application, we are executing on our comprehensive commercial strategy to ensure we are well-positioned for potentially bringing BXCL501 to both patients and health care providers across the U.S. The build of our commercial infrastructure is designed to support the potential commercialization of BXCL501. Additionally, it will be the foundation for expanding into potential follow-on indications, including dementia across multiple treatment setting, significantly expanding the reach and impact of our products. But today, we will focus on our preparations for the first phase of our commercialization journey, for treatment of agitation associated with schizophrenia and bipolar disorders. And with that, I would like to turn the call over to our Chief Commercial Officer, Will Kane. Will?

Thank you, Vimal. Mary, if you will advance to the next slide. Thank you, Vimal, and good afternoon, everyone. Thank you for joining us today to learn more about the agitation market landscape, the opportunity for BXCL501 and our ongoing preparations for potential launch of 501 in 2022. To start, we'd like to provide perspective on agitation associated with schizophrenia and bipolar disorder and its impact. To do that, we would like you to hear directly from patients as well as Dr. Les Zun. Please play the video. [Presentation]

As the video clearly underscores, agitation is a challenging symptom for patients with schizophrenia and bipolar disorder as well as their caregivers and their clinicians. Their words convey clearly and emotionally the distress and impact that agitation causes them, which reinforces and drives our work at BioXcel to develop and commercialize the potential new treatment for agitation across neuropsychiatric diseases. Next slide. With our PDUFA date set for January 5, 2022, I can report that commercialization efforts are tracking right on plan on all fronts. We have completed a substantive amount of market research with health care providers, patients and payers that has provided valuable and actionable insights. This has informed our go-to-market strategy. Through this research, we have also heard 3 clear themes: first, the unmet need is significant; second, that the SERENITY I and II data are strong; and third, that BXCL501 offers differentiable features among currently available treatment options. Over the next 6 months, we plan to continue to deepen our understanding of market dynamics, complete our positioning and messaging work, refine our field design and execution plans as well as finalize our pricing analysis to set our gross and net pricing strategies. Next slide, please. The marketplace we intend to disrupt has seen limited innovation in decades. HALDOL, a first-generation antipsychotic approved in 1967, is still a main stage product for agitated patients despite the lack of an indication for that use. More recently launched brands such as the typical antipsychotic, ADASUVE, offer a novel inhalation formulation, but the product has not been able to differentiate itself on safety and tolerability among current treatment options. Next slide. Consequently, the current standard of care remains antipsychotics and benzodiazepines, only 4 of which have an FDA approval to treat agitation in schizophrenia and bipolar disorder. Limitations related to oversedation, black box warnings and tolerability have been noted across the market research we have conducted. We believe patients and providers deserve additional options. Next slide. Based on the insights and feedback we have gathered to date, we believe strongly that BioXcel has a solid platform for the potential commercialization of BXCL501 and for its commercial success. First, the agitation marketplace is large due to high disease prevalence, high agitation prevalence and frequent agitation episodes. The location of these episodes can span both institutional and community settings. Next slide. Recall that the prevalence of schizophrenia and bipolar disorder in the U.S. is approximately 9 million. We estimate that about 1/3 of patients experience agitation associated with their disease and their episodes can be quite frequent. Based on our market research, we estimate the frequency to be about 12 episodes per year. There are approximately 36 million agitation episodes per year in this population based on our calculations. The potential market opportunity in dementia is larger. The prevalence of dementia today is approximately 6 million in the United States. The Alzheimer's Association projects that the number will double over the next 20 years. Agitation can occur in up to 70% of patients with dementia and the frequency of episodes we estimate to be between 2 and 3 per year. So we estimate approximately 100 million episodes in this patient population today, which will increase in the future with the increasing prevalence of the disease. Can you go back a slide, please? Second, the basis for formulary access, we believe, is strong. Hospital pharmacy directors acknowledge the unmet need as well as the resource and overall cost during that treating agitated patients can have on their institutions. We expect that this recognition, combined with the output from our planned health economics' analyses will inform BXCL501 value proposition. Third, our infrastructure and organizational build is on track, and we anticipate being ready for a launch in early 2022. Our approach leverages the capabilities and strengths of a cadre of best-of-breed vendors and consultants, each contributing their expertise in support of both strategic and operational initiatives. The scalable infrastructure we are building will not only support our anticipated launch, but also support potential subsequent launches of new indications across treatment settings. The flexible model we are putting in place should allow us to pivot to any changing requirements, such as what we have experienced this past year with COVID-19. And the fourth pillar, supporting our commercialization platform, is BXCL501's pipeline and a product potential with multiple clinical development opportunities, and several neuropsychiatric diseases, including schizophrenia, bipolar disorder and dementia as well as patent protection through the next decade, our land and expand strategy could provide for sustainable growth across the spectrum of treatment settings from hospitals to outpatient treatment facilities to community care. Next slide, please. One more, thank you. BioXcel's comprehensive development plan is best represented on this slide, which depicts our ambition to evaluate 501's potential utility across the full spectrum of agitation treatment, intervention points from pre-agitation to acute and chronic intermittent treatment, to chronic use to prevent or reduce the number of episodes that a patient experiences. Our immediate priority is advancing 501's clinical development as an acute and chronic intermittent treatment option and to do so across treatment settings of care. Step 1 in this journey is the hospital. Based on the design and data generated from the SERENITY pivotal trials in schizophrenia and bipolar disorder I and II patients, and this is our focus today. Next slide. To discuss our commercial preparedness, I am joined by the BioXcel commercial leadership team: Iris Francesconi, Michelle LaBonte and Rob Scala. The company is fortunate to have such experienced and capable leaders. Allow me to introduce them to you. Iris Francesconi has 10 years of pharmaceutical industry experience, having managed multiple commercial franchises across various therapeutic areas, including a hospital-based business. Prior to her time in industry, Iris spent almost a decade as a financial equity analyst, both on the sell-side and buy-side. Michelle LaBonte brings over 20 years' experience in both large and small organizations, building strategic market access plans and teams. She has an extensive knowledge of payers, the changing market access environment and a deep understanding of various reimbursement models, having worked with both medical and pharmacy benefit designs. And Rob Scala has over 25 years of cross-functional experience within the pharmaceutical and biotech industry. He has held positions in finance, marketing, strategic planning and commercial operations. As a management consultant focusing on integrations, turnaround, sales force technology and biotech startups, Rob's work included transitioning development stage biotechs into fully integrated commercial entities, which is exactly where BioXcel is today. I am sure you will agree that the potential launch of BXCL501 is in good hands. Iris will now speak to the market landscape and 501's opportunity. Iris?

Thanks, Will, and good afternoon. During the next few minutes, I will share with you key findings from our market research and how they have informed both the potential positioning as well as place in therapy for BXCL501. Next slide, please. Simply put, the market for the acute treatment of agitation associated with schizophrenia and bipolar is sizable and underserved with current treatment options. The target product profile for BXCL501 was perceived well and differentiated from current treatment options by future -- by potential future customers. All marketing launch preparations are hyper-focused on capturing the full potential of BXCL501, if approved. Next slide. So let's talk about how to set up a successful launch from a marketing perspective in more detail. In general, there are 3 pillars: First, a clear understanding of the marketplace, key drivers and, most importantly, the opportunity. Second, an in-depth knowledge of what motivates customers when selecting a pharmacological intervention approach. And third, a positioning of your product that captures the market opportunity, reflects customer insights and clearly differentiates from competitor products making your product the treatment of choice. So let's look at these 3 pillars in the context of acute treatment of agitation associated with schizophrenia and bipolar. Next slide. As Will just mentioned, we estimate there are about 9 million adults with schizophrenia and bipolar in the U.S. Roughly 1/3 of these patients experience agitation on a regular basis. On average, we estimate the agitation rate per year for both disease states combined is around a dozen with bipolar patients experiencing slightly greater numbers of agitation episodes compared to schizophrenia patients. Having said that, we have seen a wide range of responses to this question in market research. And the key reason behind the challenge in estimating the agitation rate, in any disease state for that matter, is the fact that agitation is a symptom, and there's no generally accepted definition. Based on these prevalence and agitation rates, we estimate the opportunity in bipolar disorder is about 5x the opportunity in schizophrenia. So when we talk about statistics around agitation rates across different disease states, we also think it's important to discuss how these agitation episodes are distributed across different treatment settings. Based on claims data analyses, where we use patient analog models to identify relevant claims, we estimate that about 2/3 of the drug-treated agitation episodes occur in the institutional setting, with the remainder occurring in the outpatient setting. It is important to differentiate the 2 settings since pricing dynamics vary substantially on stake -- based on stakeholder type, reimbursement dynamics and patient payer mix. It is this difference in pricing as well as the lack of FDA-approved self-administered oral options for the acute treatment of agitation in the community setting that the community setting is a significant commercial opportunity as well for BXCL501 in the future. Next slide. When we then look at the market opportunity from the viewpoint of the severity of the agitation experienced by patients, both published literature as well as our own market research have shown that 90% plus, so clearly, the vast majority of patients, fall into the mild to moderate agitation category. Naturally, when asking providers about agitation in the emergency department, they tend to think of that last patient, who was yelling at the ED staff and threatening to hurt themselves or others. But when probing around the percentage of patients that present with this level of agitation, providers consistently state that it's by far the minority of their patient population. What is actually much more common is the patient that is restless, fidgety, tense and somewhat incoherent in their thoughts and speech. This is exactly one reason why we decided to launch an unbranded campaign to educate providers around the benefits of early intervention when the patient is in a state of mind where they are willing to accept oral self-administered medication. Having said that, let me remind you that 20% and 25% of the patients, respectively, in Serenity I and II were scored as severely agitated based on their PEC score. So we believe there's even a small percentage of the severely agitated patient population that is willing to accept oral medications if appropriately deescalated. Now while we confirmed that the majority of patients experience mild-to-moderate agitation, we've also confirmed, based on extensive claims data analyses as well as market research, that the majority of patients receive intramuscular medications with generally greater IMUs in the ED as compared to the inpatient institutional setting. The key reason behind the use of IM medication is their rapid onset of action as compared to currently available oral options. In fact, in our market research, the #1 criteria for providers to select medications for the acute treatment of agitation is onset of action. The difference between the institutional settings is primarily attributable to patient observation and monitoring in the inpatient setting, which enables earlier intervention before the agitation reaches a level that requires rapid de-escalation. Next slide. Talking about currently used medications, the most commonly used drug classes for the treatment of agitation are antipsychotics and benzodiazepines. More specifically, antipsychotics make up 60% to 70% of the drug used for agitation, depending on the institutional setting. However, as you know, there are only 3 atypical and 1 typical antipsychotic that carry an actual indication for the acute treatment of agitation in schizophrenia and bipolar; though, none of them carry the indications for their respective oral formulations. What you may hear from some providers is that one benefit of the antipsychotics is that they treat the underlying disease. Based on our market research, we believe that in the ED, between 60% and 70% of the antipsychotics used in agitated schizophrenia and bipolar disease patients, is actually for the treatment of agitation. That percentage is somewhat lower in the inpatient setting, where a key focus is on getting patients on a regular drug regimen to control their underlying disease. Next slide. What has also become very clear from both market research as well as claims data analyses is the fact that many patients receive a cocktail of drugs, particularly for their first administration. Most commonly, haloperidol, lorazepam and the at times mixed with Benadryl, which is often referred to as B52. While these cocktails tend to have rapid onset of action, they also tend to put patients to sleep oftentimes for several hours. Not only does this make it impossible for providers to assess the patient's condition, but it also reduces that turnover in what commonly is already a capacity-constrained ED situation. And just to remind you, over 70% of schizophrenia patients in SERENITY I and over 50% of bipolar patients in SERENITY II were on antipsychotics for the treatment of their underlying disease when they entered the trial. Having said all that, an interesting finding in our market research was that many patients received multiple drug administrations during a single ED visit. There are generally 2 reasons: First, some patients truly do not achieve the desired level of calmness with their first drug administration. And what is more often the case, though, is that patients experience a recurrence in agitation, because of the lengths of time they spend in the ED, often waiting for a transfer to the inpatient setting at the same or another institution. Next slide. So let's move on and talk about what customers are telling us when we talk to them about the acute treatment of agitation in patients with schizophrenia and bipolar disorder. When we talk to providers and patients about their level of satisfaction with current treatment options, what they would desire in the new therapy is -- here's what we hear about what they would desire in a new therapy. On the provider side, there's a general desire for an oral medication with fast onset that doesn't overly sedate. This would address both the need for speed when trying to calm an agitated patient; while at the same time, maintaining a positive provider-patient relationship, which facilitates a collaborative treatment approach. Of course, providers do not want to trade onset for safety. In fact, providers are looking for a product that doesn't carry some of the safety warnings and side effects associated with currently used medications, particularly, in certain patient populations. Next slide. Patients are generally aligned with providers on the desired characteristics for an acute treatment of agitation. They are looking for a fast acting, preferably oral medication that doesn't put them to sleep and that allows them to have a clear enough mind to discuss treatment options and engage in a treatment plan. In fact, in our research, multiple patients have explicitly stated that they like to retain and regain control of their situation. In addition, both patients and caregivers have frequently expressed concerns over the coercive treatment approaches, which are fairly common in the context of managing agitated patients. So our findings from both provider and patient research clearly indicate that there is a need for a novel treatment option for the acute treatment of agitation associated with schizophrenia and bipolar disorder. Next slide. So let's talk about how BXCL501 stacks up against our market and -- marketing customer insights and how we translated our findings into its potential positioning and place in therapy. Next slide. Over several months, we conducted extensive qualitative and quantitative target product profile testing and simply put, the feedback from providers on the clinical profile of BXCL501 was very positive. The elements that stood out were the demonstrated fast onset of action, the overall safety profile, including the lack of unarousable sedation and the long duration of effect. On the negative side, providers highlighted that severely agitated patients are likely not willing to accept a self-administered drug, that the mechanism of action does not treat the underlying disease and that many providers are generally comfortable with current treatment options. Based on insights from providers and patients as well as TPP feedback, we have landed on the potential positioning of BXCL501 as a treatment that can provide rapid stabilization without unarousable sedation in a novel oral film. As such, BXCL501, if approved, could become an emergency medication of choice for any signs of acute agitation in adult schizophrenia and bipolar disease patients. This positioning allows us to capture all appropriate patients based on their level of agitation, who receive either oral or parenteral antipsychotics or benzodiazepines for the acute treatment of agitation as opposed to treating the underlying disease. In addition, for those patients that will continue to receive parenteral medications as a first-line treatment, BXCL501 could become a viable option in those cases where patients don't achieve the desired level of calmness or where there is a recurrence in agitation. Next slide. So how do we translate all this work into tactical action plan? We generally think about the launch in 3 phases: pre, at and post-launch. The goal in the prelaunch phase is to raise awareness of the unmet need, and correct current behaviors and false perceptions around treatment approaches. More specifically, this includes addressing any misperceptions with regard to efficacy and safety of currently used medications, redirecting the frequent focus on therapeutic intervention only at the state of severe agitation and educating about the benefit of early noncoercive treatment approaches. Our unbranded campaign called Boiling Point, which you can check out at www.partnersincalm.com, has already gained significant visibility with key audience even during the current soft launch phase. Providers have specifically commented on the value of some of the tools we've developed to assess patients' level of agitation and provide guidance on more collaborative treatment approaches. You can expect to see the full media launch of the campaign starting in September. We plan to feature the campaign also at our booth in various -- at various conferences, in product theaters and throughout various sponsorships at 6 key psychiatric and emergency medicine conferences in the fall. In addition, we have engaged with key professional and patient advocacy groups, including the American College of Emergency Physicians, the Emergency Nurses Association, the Depression And Bipolar Support Alliance, and The Schizophrenia and Psychosis Action Alliance. The goal of these collaborations is to build relationships with key stakeholders and provide educational support around mutually relevant topics. Next slide. At launch, the focus, of course, would shift to introducing BXCL501 and its benefits as an option for the acute treatment of agitation associated with schizophrenia and bipolar disorder. We are planning for a 360 surround sound digital campaign targeting both providers as well as patients and their caregivers. More specifically, the professional campaign is designed to hyper target the institutions and affiliated providers that we have identified and profiled to be early and rapid adopters of novel branded CNS products. This approach would complement the activities from our field force and should allow us to create significant momentum with key audiences early in the launch. In addition to these activities, we plan to introduce a series of KOL speaker programs to give providers an opportunity to discuss both the unmet need as well as BXCL501 with leaders in the field of agitation in a peer-to-peer discussion environment. Next slide. Following the initial launch phase, our focus is expected to be on maintaining the momentum and broadening the influence of our branded campaigns as well as peer-to-peer engagements to a wider audience. We will closely monitor the impact of all these activities to optimize the return on our marketing investment and if necessary, pivot to new tactics or modified channel strategy. We plan, of course, to also continue to engage with key professional and patient advocacy groups to gain support for our various initiatives. Next slide. Before I turn it over to Michelle to discuss our market access strategy, I want to leave you with again a few thoughts. The market for the acute treatment of agitation associated with schizophrenia and bipolar disorder is sizable and underserved with current treatment options. The target product profile for BXCL501 was perceived well and differentiated from current treatment options by potential future customers. And lastly, all marketing launch preparations are hyper-focused on capturing the future potential of BXCL501, if approved. With that, I will now turn it over to Michelle.

Thank you, Iris. Good afternoon, everybody. Over the last 6 months, a lot of work has been done to gain insight and feedback to develop our evidence-based market access pricing strategy. If all goes as planned, we are about 6 months away from launch and are continuing to build and refine the plan. And advancing our thinking, we will certainly continue to get perspectives from multiple payers and institutional stakeholders. Each of the stakeholders has a different perspective depending on their role, especially important to our pharmacy directors and hospital systems. An example of an integrated delivery system would be a system of different hospitals, including academic, community and psychiatric that treat a diverse patient population across the geographic region. To ensure we are understanding their perspectives, we are actively engaging both pharmacy and medical directors across these institutions. Additionally, we will continue to engage payors to gain their perspectives on access and pricing. So let's take a look at the feedback that we received to date. Next slide, please We heard from Iris about provider and patient perspectives. In our discussions with pharmacy directors and payers, we learned that they view the unmet needs in a similar way. Our market research shows that they both recognize and understand the challenges and clinical burden of treating patients. They acknowledge the struggles of the caregivers and the care team, treat and support the patients. Both agree that despite good care, patients come back. Pharmacy directors welcome additional therapies that improve on clinical efficacy and safety. Payers acknowledge that the biggest cost drivers are medical with a high use of emergency room resources needed to treat patients and to retreat when they come back. They are not focused on drug costs as the current standard of care are all generic. Next slide, please. From our qualitative market research, pharmacy directors and payers perceive moderate to significant therapeutic value of BXCL501. They have positive perceptions of the clinical efficacy and speed of onset observed in our clinical trials. They felt BXCL501 safety results were positive and could support product differentiation versus orals. The potential for pharmacoeconomic outcomes and ability to affect quality measures resonate as important attributes. Some of the reservations they cited were a lack of familiarity with the PEC score as it's not typically used in clinical practice. Pharmacy directors and payers typically like to have studies that show head-to-head comparisons. So it was not a surprise when they commented that placebo as a comparator was not ideal. This is standard feedback that they give when clinical trials are not versus competitors. Lastly, as I noted earlier, current standard of care drugs are all generic and low cost. Next slide, please. The biggest cost driver identified was medical, with total cost of care and mainly, it was the cost of the ER resources, including length of time in ER, time to onboard, the use of benzodiazepines and the need for restraints. So for an example, when you look across the literature, there were 3 studies that we were looking at. One tracked ER resource utilization to identify areas for improvement. In the first article, Weiss et al., conducted a prospective study of 1,092 adults treated over 5 emergency departments. They found that psychiatric patients spent an average of over 11 hours in the ER seeking care. The article identified areas where efficiencies could reduce the overall length of stay, resulting in reduced ER time. The second article looked at adverse events, while patients were onboarding and identified that psychiatric patients awaiting inpatient placement remained in the emergency department 3.2x longer than nonpsychiatric patients. The last article looked at the meantime to medical clearance for discharge based on different drug protocol treatments. We are in the process of launching a retrospective study to gain insights on the current standard of care, and this will help us build our pharmacoeconomic strategy. Our medical team is engaging with KOLs to gain additional insight and feedback. And recently, we had a conversation with a KOL that provided some perspective. And talked about the patient -- talked about the patient use and what was important to the different decision-makers. The ER physicians tend to focus on quality and also time in the ER to be reduced. The psychiatric physicians tend to focus on how they can reduce readmittance of the patients. Next slide, please. So as we look at the P&T process and the process to get on formulary, the patients -- it starts with the physicians, and we need to get in advocates to support our formulary access. And the time depends on the P&T process and it varies by system and institution. Some institutions have a waiting periods similar to help payers approach their new drugs. On average, the process takes approximately 3 to 12 months once the process has been initiated by the health care provider. The psychiatric hospitals sometimes review a little bit earlier while the community hospitals review later. Once the P&T process is approved, there's also a process where they need to update their electronic health record platform. And that includes updating and supporting the protocols and the drug ordering. This process can add a few more weeks on to the overall access process as well as to the time line. And as I said previously, the whole process starts with having an advocate. And someone that will stand up and champion for our product and recommended it for formulary. But in addition to championing for formulary will actually help ensure to used within the system. Next slide, please. So as we take a look at the key focus of our strategy, it's balancing both near and longer-term opportunities for BXCL501. As I mentioned earlier, we have done work already that will continue to build and refine our evidence-based pricing, access and distribution strategy up until launch. ADASUVE is the most recently launched product in the category. They launched in 2013 with a WAC price of $150. We have stated previously, we consider that the ADASUVE price and reimbursement approach to be informative as we advance our pricing and access thinking. As typical for new product launches, we expect to announce the BXCL501 WAC price at launch as we work over the next 6 months to complete our thorough analysis. Our goal is to pursue broad formulary access to enable adoption and accelerated abuse. Next slide, please. Now let's take a look at the payer mix based on data for schizophrenia and bipolar disorder. Recall that the average age of patients in the SERENITY trials was between 45 and 50, populations most covered by Medicaid and commercial payers. Reimbursement and pricing sensitivity varies by patient type, setting and contractual agreements between the institutions and payers. Institutions with more government business, that would be Medicaid and Medicare, tend to be more price-sensitive versus academic hospitals with a larger commercial mix. All of these factors are being taken into consideration as we build our access plan. Next slide, please. So as we look at the account management, customer-facing positions and how we're going to engage in the market. We -- our current thinking regarding customers focuses around the account team, calling on national and regional accounts, creating awareness for both the company and BXCL501 as well as educating on unmet needs and gaining insights and feedback. Our key targets would be medical and pharmacy director decision-makers, which will help us identify the early adopter accounts for launch. Next slide, please. In summary, market access will continue to build on the work that has been done to finalize the strategy and pricing plan and time for potential launch. Payers and hospital pharmacy directors recognize the unmet need. They want a product that has faster onset of action, few side effects. They were also positive on the potential for improved pharmacoeconomic outcomes. To continue to engage with the key decision-makers will be important to refine the launch price and distribution strategy. As the account team begins to engage with customers, we hope to gain a greater level of insight and feedback to support our best-in-class launch plan. Next slide, please. Now I'll hand the discussion over to Rob.

Thank you, Michelle. Next slide, please. Everything we're putting in place today starts with our patients and customers. So I'd like to share with you how we're thinking about that customer base. The requirements of these customers will also drive our final sales force design and the commercial infrastructure that we're in the process of putting in place. So let's start with the overall hospital market. According to the AHA, there are approximately 6,000 hospital systems in the U.S. Of those 6,000-plus hospital systems, we performed the segmentation analysis to hone in on the most relevant high-value institutions to target. And with these institutions, we're primarily targeting the emergency and psychiatric departments within these hospitals. So who will our ultimate targets be at launch? Our priority accounts will be Psychiatric Centers, Academic Medical Centers and Community Hospitals. As we've previously stated, we've identified about 1,500 hospitals. These 1,500 hospitals represent 75% of the total market volume. Also important to note are the integrated delivery networks or the IDNs that Michelle mentioned. Specifically, there are 57 IDNs that control 2/3 of that hospital target market that we're going after. As you can imagine, these 57 IDNs are a key focus for us to drive with the option among their affiliated hospitals. So now let's discuss the methodology we use to segment these accounts. Next slide. To understand these accounts more in detail and to ensure we're allocating our resources appropriately, we looked at customers in a number of ways. The first was to understand the potential for each account. We looked at where patients were treated, the providers who are treating them and the analog products that they were using. We also wanted to determine the likelihood to adopt 501. We evaluated whether an account is research focused, and we looked at their historical adoption of branded products. Lastly, we identified their IDN affiliation, which, in turn, will then form our key account strategy at the IDN level. So this clear profile of each target will help us target the most relevant hospitals and IDNs as well as inform both the account level strategy and overall execution. Next slide, please. Since IDNs are so important, it's worth going into a bit more detail on them. As I mentioned, we're planning to target about 57 IDNs, and this work continues today. These IDNs are affiliated with the -- with 2/3 of our 1,500 hospital targets, and they have a similar profile. They have a very strong provider alignment. They drive clinical integration across affiliates. They have high payer negotiating power and, most importantly, they make decisions centrally and push those recommendations down to their affiliates. An example would be Banner Health. Banner Health is a typical large hospital system that operates 30 hospitals in 6 States. Their network includes 3 academic medical centers and a very strong psychiatric division. We would approach IDNs like Banner Health from both the top-down and a bottoms-up approach. Now let me share how we will reach them. We will have key account managers that will cover the United States in roughly these 3 key geographies. The camps will orchestrate overall account efforts supporting product access and pull through. They'll focus on key decision-makers at the corporate level, while the institutional specialists will focus their efforts at the local affiliate level to drive demand. Our segmentation process has allowed us to have a clear profile of these 57 IDNs and develop tailored account management strategies for each IDN. We expect to deploy these camps in the fourth quarter of this year. Now let's talk about the institutional specialists that will work at the individual hospital level. Next slide, please. As we previously stated, we're planning on a field force of about 57 institutional specialists that will call on these -- sorry, 75 institutional specialists that will call on these 1,500 hospitals. They'll be segmented into 9 regions, and we expect to hire the regional managers, the leadership team in Q3 of this year to begin district and account planning and, of course, start the recruiting process. We expect to onboard the institutional specialists in the fourth quarter of this year. From a recruiting perspective, we've developed a competitive compensation package, including equity, to ensure we attract experienced representatives with the right experience needed to call on these institutions. In terms of access, we continue to monitor the restrictions put in place due to COVID. As recently reported, in-person provider visits and details are increasing month-over-month. While no hospital-specific access information is readily available, we're doing our own benchmarking, and we gauge access today around 50% and climbing monthly. While we can't predict the access environment in Q1 of 2022, we will have the tools in place and the technologies for both in-person and virtual access to all of our targets. This will help us also reach more providers virtually across the broader geographies. In addition, we've built additional flexibility into our IT infrastructure to allow representatives to use any video conferencing applications they choose, if a provider or their institution dictates a certain platform that is required. In fact, a lot of the technology that we're putting in place is actually being used by our MSLs today. Next slide, please. This is a high-level map of the geographies we will cover. Not surprisingly, our target institutions are concentrated in major metropolitan areas. These are the typically densely populated areas and where most of our high-volume institutions are located. We used a bottom-ups approach to ensuring optimal coverage across the U.S., anchored by these high-potential hospitals. Again, our plan 75-person institutional specialist team would cover these hospitals in these geographies that represent roughly 75% of total market volume. I'd like to thank you for your time, and now I'll turn the presentation back over to Will.

Thank you very much. So thank you to Rob, Michelle and Iris for providing these insights that we have gathered to date and for sharing our current thinking on our go-to-market approaches. To sum up, there are 4 key takeaways from today's discussion: one, there is a significant unmet need in treating patients with schizophrenia and bipolar disorder and the agitation that affects them. And this unmet need was consistently communicated to us across the spectrum of stakeholders with whom we spoke. Two, we believe that if approved, BXCL501 could enable a fundamental and positive shift in the treatment paradigm for patients and their health care providers. Three, our preparation work for a potential commercialization of BXCL501 in early 2022 is right on track, and we continue to make steady progress to build a BioXcel infrastructure to support the first launch of what we hope will be many. And four, at launch, a launch in the hospital setting would be the first step in our land and expand strategy. Of course, the label we receive will inform the locations in which 501 can be used initially. We consider hospitals as the foundation, given the design and conduct of the pivotal trials. If potential use in other health care treatment facilities such as community mental health centers or outpatient psychiatric emergency treatment facilities, is enabled by the label, we will certainly adjust and expand our capacity accordingly to seize that opportunity. At this point, we'd like to shift the focus to gaining clinical perspectives regarding the treatment of schizophrenia and bipolar disorder patients, who experience agitation as a part of their disease. I am pleased to welcome Dr. Les Zun, Professor at the Chicago Medical School; and Dr. Reina Benabou, our Chief Development Officer, to have this discussion. Reina?

Thank you, Will, and thank you for joining us Dr. Zun. Tell us a little bit about yourself and your background?

Well, thank you so much for having me join the group today. So I'm an emergency physician. And for many, many years, I've been interested in behavioral emergencies, because there's such an unmet need for the focus on those patients. And so for the past, I don't know, 30 years or longer, I've been an advocate for their care, have a conference every year, just focused on behavioral emergencies. Wrote two textbooks on behavioral emergencies, was past President of the American Association for Emergency Psychiatry and Chair of the Coalition for Psychiatric Emergency. So this has really been my area of interest and focus.

So when you talk about unmet medical need, so how would you describe the unmet medical need when treating agitation associated with the schizophrenia and bipolar disorder in the emergency department?

Well, so there's a couple of issues. So one is training, education and experience for the staff to better understand how to deal with these patients. And we'll talk more about that. And second is, we really need better medications to treat the agitation. There are some things that are currently used, but they have their limitations in my clinical experience.

Yes. So in terms of training stuff, which kind of health care professionals are involved in all this treatment paradigm in the emergency room?

Well, for the most part and then most emergency departments in the United States, what you usually have is a triage nurse that will triage them, get vitals and the complaints and some of their medical issues and problems. Then they're usually seen by an emergency primary nurse, could be the treating nurse. Thereafter, they are evaluated by an emergency physician. It may also involve a physician assistant or a nurse practitioner, depending on each individual situation. It's a little different than psychiatric emergency department. So I'm really talking from my perspective in what some call medical emergency departments. And there's about 4,500 in the country versus maybe 150, although we don't have great numbers about psychiatric emergency services or psychiatric EDs.

That's very clear. And we heard a lot through the presentation about the time, the time of the overall patient throughput in the emergency department. Tell us a little bit about your experience, the time to evaluate, the time to make the diagnosis, to discharge, tell us a little bit about it?

Yes. Well, in my experience, it's usually the evaluation and treatment in the emergency department doesn't take a long time. And I think we averaged about -- in our ED, about 1.5 hours, but thereafter, for numerous reasons, the patients may stay hours to days for those that need to be admitted to an inpatient psychiatric facility. And the hours and days really depend on whether the patient's over-sedated or not, whether they have other issues that need to be addressed and what the availability is for inpatient beds, if that's what they need.

So do you have, do you follow a specific protocol when treating agitation associated with schizophrenia and bipolar?

Well, yes, we do follow a protocol at the hospital that I worked for many years. Now the protocol is very unique. I don't think many other emergency departments in the country use it, but our protocol was the patient was evaluated and those that came in with agitation were assessed using an agitation scale. And based on that agitation scale, we would either give them something orally, something IM. Some of those may have been restrained as well. We probably would start out with some verbal de-escalation. And if that didn't work, then we would advance. So we had a protocol that would walk through all those steps.

Yes. And how -- in your experience, how do agitated schizophrenia and bipolar patients usually present in the emergency room?

Well, in my experience, those patients can present with many different presentations, but many of them will come in agitated. They may have stopped taking their medicine. Their family may bring them in, paramedics, police, others as well. And we have to not only address their medical problem and their psychiatric problem, but their agitation issue that really interferes with our ability to properly assess and determine what meds they need, what's the appropriate disposition. So that's what I usually see in many of -- and they're brought in because they are agitated. Because if they weren't agitated, sometimes they can just call their treating physician or psychiatrist. But for the most part, these folks come in agitated.

Yes. So again, in your experience, which are the degrees of agitation that they may present, like from mild fidgety to more severe? What's your experience about it?

Well, my experience is a little different than the slides, but it's just what I see. And I'm kind of 1/3, 1/3, 1/3 person. So about 1/3 are mild, about 1/3 are moderate and 1/3 are severe.

Very clear. So let's talk a little bit about the role of the verbal de-escalation techniques that are mentioned widely in published literatures, such as the BETA guidelines. So how frequency do you think those are used and how effective are they?

Well, so the BETA guidelines, which talk about verbal de-escalation are really what I think are very kind of straightforward common sense kind of recommendations. Respecting the patient, giving them space, not being confrontational. And it's really being promoted, but I'm not sure it's being used in all the emergency departments. I think that, again, this goes back to my concern about education, training, understanding the patients better. I think this is really a good first step. Now -- and I want to be clear about who we would use this on as a first step. So in my experience, what we do is the mild and moderate categories. It would be effective, it would be a first try. But those severe patients that -- now remember, severity also has some ingredients to it. But the patient that comes in kicking and screaming with 5 police bringing them in, maybe a difficult one to have them focus enough to try verbal de-escalation.

So the first set of patients that you mentioned, they are the ones that are collaborative and can participate on the treatment?

Oh, yes. And many times, I ask them, how can I help you calm down? What's worked for you in the past? Is there a particular medicine that would be helpful for you? So absolutely. I think that, that's really a critical step in kind of this building rapport, building trust with the patient is to start with what -- how can I help you? What can we do to make you feel more comfortable and what medication would help you?

Yes. Got it. That's interesting. So with that, do you believe there is an opportunity to change the emergency department healthcare professional habits to a different approach when treating agitation associated with schizophrenia and bipolar?

Well, I'm an optimist. So I would say, yes. I think not only can they change their -- how they approach the agitated patient or the bipolar, schizophrenic patients, but I think they can. But what we need is we need education. We need to make them or get them to understand what's going on with those patients. And so part of this is the conference that we have, the textbooks that we have. But I have to say, for some, it's an uphill battle because they're so used to the way they've done it. So we do need to approach all of them and get them to understand. It's not just the physicians, it's not just the physician extenders, but the nurses as well have said that they want more education, experience and training in this.

And that's an unmet medical need in itself, the change in the treatment paradigms and the education?

Absolutely. And that's what being President of that organization and Chair of the other organization, that was one of our goals. And it's going to take time. It's going to take effort and appropriate resources to get them to that point in time where we are dealing with the patient in a better fashion than some of us do today.

Thank you very much, Dr. Zun, for your valuable perspective on all those items. And with that, I would like to turn it back to Will Kane.

Thank you, Reina, and thank you, Dr. Zun. We very much appreciate your perspectives and insights. So thank you for your time, and Dr. Zun will be remaining with us on the balance of the call. So at this time, that concludes what we have prepared to share for you formally, but we'd like to open the call now for your Q&A. And so operator, if you will get the queue ready, we will start taking questions.

[Operator Instructions] Our first question comes from Geoff Meacham with Bank of America.

Great sessions this afternoon. The question is from a pharmacoeconomic perspective, is it possible that you would need additional data to help with the payer environment or to help maybe further skew the price kind of benefit or cost-benefit equation in your favor? Or do you think that there is enough data as of now to help support that?

So Geoff, thanks for the question. This is Will. So I'd start by saying that, as we indicated in our conversations to date, the payers and the pharmacy directors have really underscored the unmet need and the potential value of additional treatment options. And so that's foundational for us. Two, for the initial launch, the balance or the bias tends to shift more towards pharmacy directors and hospitals and hospital systems. The payers will defer to them based on their formulary adoption decisions, et cetera, based on the relationships they currently have in terms of contractual reimbursement. Having said that, we have a fair starting point with the literature, which Michelle went over briefly. But there is a starting point there that looks at the potential cost impacts, particularly in the emergency department, when patients are restrained or when they're boarded as Dr. Zun mentioned, potentially for hours or days sometimes. And so when we did the market research, we did hear, like if there was a way that 501 potentially could help reduce the time in the ER, that would have economic implications for them. Because if they could turn over that bed more quickly, that would be a bed they could use for the next patient that walks in through the ER door. So that's a good starting point. As Michelle also mentioned, we have started our retrospective chart pull in order to collect the necessary data to hit -- to establish the baselines for our own perspective work, which is what we intend to be starting later this year when we get the outlook of that effort. So I think the clinical data from SERENITY I and SERENITY II are strong. I think they make a good case on key areas, particularly the onset of action and duration, which will, obviously, I think, allow us to build that cadre of local advocates and champions, who request that 501 be considered for formulary and then advocated for its addition. And then hopefully, by then, we'll have a little bit more data from our initial work to help inform those conversations and evolve the value proposition.

And Will, just a follow-up to that. Is there data to support a difference between, say, a mild or moderate to severe patient or among the different patient types with respect to agitation?

That data, I don't believe exists, Geoff, from the literature, as Michelle mentioned. There is a study that looked at the use of restraints and how that can add more than 4 hours to the time in the ER, but that's the extent of it at the moment. I think kind of key takeaway is that we're going to be building the pharmacoeconomic basis here. This is a relatively quiet market today. And so we will be infusing into it some of those elements to give us the opportunity to really trump it and defend both the clinical and the economic value of 501.

Our next question comes from Graig Suvannavejh with Goldman Sachs.

Thanks for the presentation. I just had 2 relatively short questions. One, just on the product profile for 501, and how you expect it to be used in the real world, do you have a sense of what percent of use is going to be from patients, who are able to self-administer versus those where someone else will have to administer? I don't know if the assumption is all the patients will self administer. And then secondly, just looking ahead to the launch, do you have an idea of what metrics or what key metrics you might be providing us to get a sense of what initial success with the launch curve looks like and kind of gauging your own, I guess, if you're on track or not?

Sure. Thanks, Graig, for the question. So on the first point, I don't know of specific data in the marketplace on the percent of patients that could self administer. Remember today, there's a reliance on the intramuscular injections as the default. But from our SERENITY I and II trials, obviously, 100% of patients did administer 501 and the range of PEC scores at baseline went from 14 up to almost to 29. So they covered a broad range of symptomatology from mild to moderate -- from moderate to severe. So I think that's a good indicator that patients as part of the verbal de-escalation process in the majority of cases could be candidates for a self-administered product. I think the data that Iris showed relative to the distribution by symptom severity and also Dr. Zun's comments, about 1/3, 1/3, 1/3 would obviously indicate that approximately 2/3 could potentially participate with the self-administered medication. On your second point, as I've said on previous calls, our key goal is formulary adoption, so we will be tracking that. And we will also engage some of those local advocates to request stocking in the hospitals, et cetera, so they get some initial trial and usage, why the P&T process is going. So those are 2 metrics that we will -- we'll explore more as we plan for the measurement of progress post-launch.

And maybe if I could ask just a quick follow-up on the launch. As the unique product presentation in terms of orally delivered thin film, orally dissolving thin film, and so as I look at how -- or as we think about what the slope trajectory looks like, is it fair just for conservatism to assume that this will be a relatively gradual launch curve? Or is there anything that you suggest or that you have come across your market research that suggests that given that this is perhaps an innovative product that this could be something other than a gradual launch?

So I would say, I think, gradual is a good characterization, but there are a couple of reasons for that: one, as we've outlined, hospitals have their own processes and time lines in order to review and adopt new products. We believe we're in a very good position with the profile in order to make a strong case for that. And once that happens and, obviously, as we pointed out, we're really changing a treatment paradigm. Because it's not just a new product introduction in a similar formulation, but a novel formulation. One that we think will be well received not only by the clinicians, but by the patients themselves. But that will be the work of the sales force in order to really get out there and build the demand for trial and usage and then accelerated adoption. But now I would presume a gradual launch as we work through the processes in those institutions to get consideration adoption and then the beginnings of prescribing.

Our next question comes from Chris Howerton with Jefferies.

I think it's one question. So for the -- I think it's for Dr. Zun. You were describing the idea that your protocol for evaluating these agitated patients was different than what might be more kind of widely accepted and that part of your protocol was to assess based upon an agitation scale. So that's like maybe just an observation based upon what you've said. So the question is, what type of education or what modifications to protocols may become necessary to not only improve patient care within this emergency setting, but obviously, within the context of this call, what would be important to change practices to get wider spread adoption of 501?

Dr. Zun, would you like to comment?

Sure. And I need to qualify my comments. I'm not going to make any comments about the compound, but I'm happy to talk about my experience and what's needed. So there's a couple of things when we talk about protocols in treating psychiatric patients, who come into emergency departments. So what we tend to do is treat everyone the same way. So rather than trying to determine their level of agitation or what the underlying etiology is or trying verbal de-escalation, what I see in the emergency medicine community is they usually just do the same protocol that they've been doing for years. And I think there was some prior discussion on what is commonly done. And what I'm trying to say is, there's a better way. We shouldn't be treating everyone the same way. We should be individualizing based on an agitation scale. So some patients can get oral meds, some need IM meds. Some patients may need to be restrained until they get their control back. Some patients we can work together with. So the approach that I have isn't universally accepted. But things like the BETA guidelines promote that kind of working with the patient and treating them individually and using agitation scales.

Okay. Okay. That's very clear. And I don't know if I can sneak another one in, but the other kind of thing I was curious about was this idea that psychiatric patients might be boarded in the emergency department for some period of time before they're transferred to another institution or admitted into the hospital. Is that some piece of date that you would expect 501 to impact? I guess I'll give it to you, Will, to quarterback as you see fit.

Sure. So obviously, as we've seen in the literature and as we've learned from our ongoing conversations, time in the ER is a primary variable that hospitals are looking to manage. And so when we show the profile of 501, the onset is certainly key because that is the most important attribute. But the duration of effect also is noted. We've shown out to eight hours. So based on what we've learned to date, that could be very helpful to hospitals, right? Because as we've said in previous conversations, the profile of 501 from a tolerability perspective could be very conducive to actually more efficiently triaging and potentially treating once the underlying issue is missed doses, et cetera, of antipsychotics, which could move things along more quickly. There are also quality metrics that hospitals are work to meet. And one of them is on efficiency in the emergency department in terms of caring for patients. So that's clearly a priority for us to pursue that as a key pharmacoeconomic component of our strategy. And then I just want to back up 1 second to the question you asked Dr. Zun about treatment guidelines, protocols, et cetera. I just want to underscore that, we clearly have heard, not only in our conversations with experts like Dr. Zun, but in the market research, that there's a need here, which is what drove our efforts to develop the Partners In Calm campaign, right, which we launched at the beginning of May. That's our first step. But we've been pleased with visits to the site, the viewing of the actual educational videos that are on the site. And then there are some tools there that they can download, and we've heard very positive commentary about that. So there's a hunger out there. I think it's just been quiet for such a long time in this area that there's an opportunity for us to bring more effort and more resources to them that I think will be embraced and well received.

Okay. So maybe just as a -- just to clarify the point. So for the duration of effect of 501, in terms of the tail end, you think would help the ability to just move the overall kind of care process together, and that is kind of the knock-on effect for admission or transfer to another facility? Is that fair, Will?

Yes. I guess what -- maybe what I didn't make crystal clear is the tolerability profile isn't representative. We don't see unarousable sedation, right? One out of 5 patients in the clinical trials reported some somnolence with [indiscernible] et cetera. So the fact that they're not over-sedated, they're not asleep for hours on end means that someone could intervene and begin to understand what's happening and then get to a treatment plan. The way we see it -- Dr. Zun can add his comments, but there are 3 goals here: one is triage to determine what the next step is. It might be admission to the same hospital or transfer to another hospital or discharge, right? And I think hospitals are looking to be more efficient in how they get to that point where they can make those decisions. And if they need to transfer, they can't transfer a sedated patient or an agitated patient. So this could also help as well.

I'm happy to comment if that would help.

Dr. Zun, would you like to just...

Well, from my perspective, when a patient gets medicated and gets over sedated, the psychiatric service or mental health worker will say to me, call me back when the patient's awake enough to talk to me. So -- and so that's one part of it. And then trying to -- so that's one potential delay that keeps the patient there and the other is the availability of inpatient beds. But that's something that the ED folks can't do a lot to control. But the sooner we get the patient evaluate both the ED physician as well as the psychiatrist or mental health worker or crisis worker or whatever you call them, the sooner we can make a disposition decision.

Our next question comes from Robyn Karnauskas with Truist.

So I just was trying to triangulate a couple of the data points you provided, so as analysts, we can sort of monitor your progress over time. So I think, you said, it takes about 3 to 12 months for -- to put that P&T in the conduct of getting an IDN on board. Can you help me understand of the 15% of hospitals, remind me again, what percentage IDNs cover? Can you help me understand, you said, that there was a low-hanging fruit of hospitals sort of would have a willingness to adopt new CNS therapies in the ER. How much of those are at these IDNs? And then the last question is sort of to put into context the time line for getting on the formulary in the hospital with getting the IDN onboard. So like, are the IDNs going to take longer because you have to deal with them first and then you go to the hospital, and then there's another 3 to 12 months. I'm just trying to figure out like where this low-hanging fruit population really is and really help us be able to monitor that as we are monitoring the launch.

Sure. Thanks, Robyn. Those are great questions. So we're working to answer those questions ourselves, right? So we have a baseline understanding in terms of the potential value of these hospitals and their affiliations to the IDNs. We know, as Rob said, that there are 57 that we think are particularly important for us. The next step in our work is to do the segmentation work that you're alluding to, which is which ones do move more quickly than others to review and consider new products for formulary addition. And more -- and importantly, which ones can facilitate adoption throughout the system, right? So many times, the P&T is done centrally at an IDN, and then the decision is pushed down to the affiliates throughout the system. And so that is clearly what we'll be working on in the second half of the year is further refining our understanding of these target institutions, particularly, the IDNs and their integrated affiliates in order to understand how to prioritize the sales force and the account management team initially against interacting with them to kind of prime the pump, if you will, right? So that's work to be done.

And quickly, how do you get -- how do you overcome the lack of understanding on a PEC score? Does it matter? And how do you overcome the perception that the drug doesn't really treat the underlying course of the disease? I was sort of surprised by that comment a little bit given how intramuscular injections can put you out. So just how are you addressing that when you're interacting with your hospital representatives?

Sure. So what I would say is the SERENITY program primary endpoint was the PEC score. So that's what we show in our market research because that is the reflection of the clinical data. And we hear the comment that clinicians just aren't familiar with the PEC score. I don't know that that's overly important at the end of the day. What they do focus on is the 90% response rate that we saw and the curves, right, that hopefully, we will have in our product label, right, that we can show to clinicians. And so that's ultimately what's more motivating for them. As Dr.Zun pointed out, know there's high variability across hospitals, as to whether or not they use scales or not. But they're faced with an agitated patient. They're trying to understand well, which product choice would enable me to most rapidly address the situation, calm the patient, so I can then work with the patient. So I wouldn't consider lack of familiar with the PEC score to be a hurdle. Our representatives would educate them on that anyway and understand and explain to them the components of it, et cetera. So that's not a major hurdle. On the disease front, we obviously know the mechanism of 501. Based on the data we have, doesn't treat the underlying schizophrenia, bipolar disorder. We don't think that is a limitation, because our thinking is that you want to quickly treat and calm the patient and then figure out what the treatment course would be. So 501 could be very helpful in that regard, right, because it can come quickly and then you can have a conversation with patients and understand. Okay, you missed your doses, let's get you back on your antipsychotic. As Iris pointed out, many of the patients in the trials, I don't remember the exact percentages were -- they were clearly on antipsychotics already, right? So it's not that you couldn't use them together. It's just they sometimes think, well, if I'm going to treat a schizophrenic, then maybe I should use an antipsychotic. So we'll work on that, but there's no reason why they couldn't be used together. They were in the clinical trial. And as we know from the Precedex label, there's no known PK drug interactions.

Our next question comes from Yatin Suneja with Guggenheim Securities.

This is Eddie on for Yatin. For Michelle, can you just help us clarify a little bit more about who's actually paying for the drug in these hospitals? Is it coming from existing DRG? Or is there a separate reimbursement? And then how does this work for like the Medicaid and the Medicare D patients that these hospitals have to wait for state or local decisions to be made before adding it on to their formulary?

Eddie, this is Will. I'll just handle that in the interest of time. So currently, as Michelle indicated that in many instances, hospitals already have contractual relationships with insurers, that can be commercial insurers, obviously, through the Medicare or the Medicaid programs. And so we don't have to create that for them. That already exists. So then it comes back to -- the hospital needs to make a decision on whether or not to put 501 in its formulary and enable use, and they will do that in the context of the clinical data and then the cost data when we ultimately get there. But once they put it on, then it's available and usable. And in many instances, when a product goes on a hospital formulary, it tends to stay on. It's not something that gets pulled off. So we're going to continue to understand more in more detail about that over the next 6 months as well, but that is the way it works. From a payor perspective, again, the States already have contracts with hospitals as do commercial insurers. And so it's more about a patient mix, like what the hospital's patient mix looks like in terms of the approach to how they might get what we would call incremental reimbursement, right? So we mentioned -- I mentioned in the past that we will pursue a C code through the Medicare program. C-code is a code that allows for incremental payment ASP plus 6 outside of the contract, if you will. It was intended to motivate hospitals to consider new innovative products where the arrangements they already have financially may not be as much of an incentive. So we'll pursue that, and we're looking at other options as well in terms of the pricing sensitivities by hospital and how we can address them. While importantly, making sure we achieve the level of formulary access we want without compromising the value of the product.

Our next question comes from Sumant Kulkarni with Canaccord.

Can you hear me now? Sorry about that.

Yes, Sumant, we can hear you.

You had a very balanced take on some of your slides. So in that context, on slide 28, you had some key objections to adoption that were listed. Could you share any quantitative metrics, perhaps average percentages of responders that expressed objections to adoption versus the metrics for key drivers of adoption? And Will, are you -- could you care to comment on what potential peak sales might be for the product?

So I will decline on the second question, as we are continuing to build the long-range models based on the emerging data we're seeing. And obviously, we get pricing and the label to that. So -- but thanks for the question, Sumant. I appreciate that. On the actual slides you're referencing, that came from the qualitative phase of our research. We have conversations with clinicians to really kind of get a gauge on if there are any showstoppers, if you will. And the point of that side was to really inform you that there are always going to be things that the clinicians really like and some things that they hesitate about, but they're not showstoppers. And it's important at this stage to understand those, so that as we build our communications plans, et cetera, that we know where objections might be. I mean that is a standard operating procedure for a sales force, right? It's objection handling when they're interfacing with a clinician, who may ask, first and foremost, how much is it going to cost the patient? Or is it on formulary? Things of that nature. So we just need to understand that in order to plan ahead.

Our next question comes from Ram Selvaraju with H.C. Wainwright.

So first of all, I was wondering if you could comment on the CMS code procedures that would be applicable in the case of BXCL501? And how you expect that to have an impact on the launch trajectory as well as the nature of the COVID-19 pandemic situation as you envisage it to be around the time of launch? And what restrictions do you expect there to be, if any, on things like face-to-face promotional activities and interactions with key prescribers?

Thanks, Ram, for the question. So on the first question about CMS code procedure. So as I mentioned before, based on our work to date, we certainly intend to pursue a C-code for reimbursement through the hospital outpatient department, in this case, the ED would qualify for that. CMS will review those applications on a quarterly basis. We first need to have an approval though, in order to submit that application. So we'll be ready to do that once we get the approval, and we can complete and submit the application, and then it will be reviewed quarterly. Pursuit of say, a J code, on the inpatient side, will depend on the language on the label, so that we understand that we would qualify for that since 501 is a self-administered product. But we have that in the plan, if you will, so that we can do the diligence on it and make sure that if we have that opportunity, we will definitely proceed and pursue it. On the COVID-19 front, we keep monitoring that. To your question, things are changing. We don't have any hard data, but just talking to folks I know who work in the hospitals, their access is certainly improving. And as Rob mentioned, anecdotally, during COVID, it was like maybe 10%, now, it's up to 50%. As long as we continue to see improvements in COVID rates, et cetera, we expect that we'll have access to the majority of hospitals, but we'll track that. But we're also planning other tools that would allow us to have remote interaction with them. Our MSLs are using those tools right now, so that they can't get into some of those institutions, but they're still reaching out and building the interface with them.

Our next question comes from Samir Devani with Rx Securities.

I just really wanted one clarification on the slide that you put up showing the commercial opportunity in bipolar was, I think, you've said 5x what it was in schizophrenia. Can you just recap sort of how you got to that? Because my understanding was there's more agitation cases in schizophrenia, so if you could just recap that for me, that would be great.

Sure. That's pretty simple. So the prevalence of bipolar disease is 5x the rate -- approximately 5x the rate of schizophrenia. And in our research, bipolar patients actually have more agitation episodes over the course of the year. They're close, but bipolar patients tend to have more. And so therefore, that's -- when we think about the longer-term possibility and the opportunity for drug treatment, the bipolar patient population tends to emerge as a more valuable commercial opportunity. That's not specific for 501. That was true from my prior life in products I had there where the bipolar market is just so much bigger that, that is the one you certainly want to prioritize among the 2 without neglecting either one.

Just to clarify, see, the assumption is that the agitation rate in both indications is around the same.

That's our -- the rate is the same. The number of episodes tend to be higher in bipolar disorder. Folks who are in the manic phase, it's -- I can't -- and shouldn't characterize it clinically, because I'm not a clinician, but there's a heightened level of activity when you're manic. The schizophrenics tend to be more static in their behaviors, but manic patients can be much more animated and agitated.

Our next question comes from Anita Dushyanth with Berenberg Capital Markets.

Great presentation. Just one for me. Remember, you mentioned earlier that as patients came in for treatment, there was a sort of cocktail of drugs being given. Now with 501, how is that likely to change the protocol? And then what sort of language would be in the label to highlight the differentiating aspect of 501?

Sure, Anita. Thanks for the question. So on the first point, so Iris referenced the B52, which is a combination of HALDOL, lorazepam and Benadryl. And just think about that combination, and that's going to knock the patient out for a long time. And we expect that to the extent that there are those patients, who are severely agitated, as we mentioned before, that still may need to be the approach for those patients. But we would offer that as we continue to work with the FDA, and we ultimately get a label, that label, hopefully will allow us to position 501 as a first-line treatment option for patients with mild and moderate agitation symptoms. So there wouldn't be a need to go to the B52, certainly for those patients or for the use of HALDOL and lorazepam, without the Benadryl, right? So that will be our goal is to see how we can position 501 in that particular way. On the flip side, those patients that may get injected, when they do awaken, et cetera, there still may be some agitation there. We've heard in some conversations that 501 could potentially be used then, right? They're not as agitated, they don't want to heavily sedate them again. So we think there are a couple of opportunities here for that. And can you repeat your second question again? Sorry.

Yes. So I was asking like how is the language in the label sort of would be presented to reflect the differentiating aspect of 501?

Right. So obviously, that's to come over the course of the next 6 months before, obviously, the PDUFA date. The labeling negotiations usually happen towards the end of the review. So we'll see how the FDA's review of the data and the language that they're considering and willing to accept. And then that will then form our differentiation and positioning.

Our next question comes from Sumant Kulkarni with Canaccord.

Thanks for the follow-up. For Dr. Zun specifically, if BXCL501 is approved, do you think this type of product real application lies in institutional administration or at home use even before the patient comes in or is brought to the hospital?

Yes. So I'll just interject, Sumant. We greatly appreciate Dr. Zun's participation today -- participation and providing his clinical perspectives, but he obviously won't be talking about potential use of 501. But we take your question. I certainly appreciate your long-range thinking about how we can maximize the value of the product. As we stated, we do see application in multiple treatment settings, the hospital being the first part step, but should the label allow community mental health centers, maybe emergency psychiatric treatment centers that are freestanding and eventually the community. So that when you think of the profile, the delivery mechanism, et cetera, that certainly would be supportable. So operator, last question, please, if there are any more in the queue.

There are no further questions at this time. I'd like to turn the floor over to Will Kane for closing remarks.

Sure. So thank you very much, operator, and thank you, everyone, for taking time out of your day to attend the presentation. We had a great time pulling it together because we're so excited and motivated about the work we're doing. And we're in a good place, 6 months to go before our potential PDUFA. So we'll continue to work diligently and prepare as best we can to maximize the value of 501. So have a great day and a great weekend.