BioXcel Therapeutics Inc. Q1 2023 Earnings Call
Good morning, and welcome to the bio cell Therapeutics first quarter 2023 financial results Conference call.
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Just to remind everyone certain matters discussed in today's conference call and or answers that maybe given to questions asked are forward looking statements that are subject to risks and uncertainties related to future events and or the future financial or business performance of the company.
Actual results could differ materially from those anticipated in these forward looking statements risk factors that may affect future results are detailed on the company's annual report on Form 10-K for the year ended December 31, 2022, which can be found at www dot biotech cell therapeutics dotcom or on.
<unk> Www dot FCC, docker, and which will be updated in its quarterly report on its Form 10-Q for the quarter ended March 31 2023.
As a reminder, today's conference is being worked for joining us on today's call our Doctor BMO matter, Chief Executive Officer, Richard Steinhart, Chief Financial Officer, Matt Wiley Chief Commercial officer, after Rob Risinger, Chief Medical Officer of Neuroscience, Dr. Vince O'neill, Chief R&D officer of Arcos <unk>.
Therapeutics and Dr. Frank JAKO, Chief Scientific Officer, and it's now my pleasure to turn the call over Doctor Mehta, CEO and founder of biotech cell Therapeutics. Please go ahead.
Thank you operator, welcome everyone and thank you for joining our call today to discuss buyer comes out of your Big plus Florida 2000, joining me to the financial performance and business highlights.
This is shaping up to be a momentous year, whereby it comes out of your day our success in advancing our corporate objective continues on an exciting trajectory we are maturing as a commercial organization.
Our position as a leading innovator in amazing education market and advancing our pipeline toward.
Well look at everything and business fast permitting milestones.
We believe we are on track to realizing our vision of becoming the leading yeah. Your neighbor neuroscience company.
Slowly and that would mean more excited than I am.
Today, four five acts as a promising future.
Now, let me highlight our commercial progress and upcoming clinical milestones.
On the commercial front, we continue to execute on our launch but he got on me.
Room for the acute treatment of mind moderate and severe forms of agitation.
But it gets so granular in bipolar disorder.
With our integrated commercial team now fully deployed but only one full quarter, we are already seeing encouraging mark infection.
For example, since our last earnings call, we have more than doubled our number of formulary wins there.
This is opening a significant addressable market opportunity, but he got on me.
I would like to emphasize that we are continuing to bring the new education market because it got in May we presented the first innovation for this indication in nearly a decade.
While we recently celebrated the antibody to figure we got FDA approval was in April 2020, due it is still less than one year since our trade launch last July .
I am proud of the strong performance, we have achieved today and the real world utility ergotamine demonstrating.
I will be sharing favro inspirational anecdote of this later on the call.
On the clinical front, we are very excited for the PK key.
Key data readouts across our lead neuroscience program <unk> 501.
These data readouts that on track and expected to enable significant potential market expansion.
The overall education market remains underdiagnosed and underserved.
And then Steve maybe 839 million education episodes are putting each year in the U S. Ethanol the tower three priority indications bipolar disorder schizophrenia, and Alzheimer's disease.
Miller Lite market exists for these conditions in other geography.
The U S.
Starting with bipolar disorder and schizophrenia, we are looking.
So potentially expanding into the add on Saturday.
S T. Maybe 23 million agitation episode of care in the U S every year.
We're sitting at 83 program is investigating <unk> in 501, and the same BARDA and starting through a two part study design.
We anticipate announcing top line pivotal data from part one of those started this month.
We also look forward to initiating our two of the study this quarter.
So I mean, theoretically I must've disease, a very large underserved market with no approved therapy.
Shouldn't that be so one of the primary reason for these patients to more into long term care.
After an estimated 200 million agitation episode of good annually in the U S.
Our <unk> program.
Stuart Vaughn and we are on track to report topline data in June .
In Basra, Android and mandated advancing four tranquility three here.
And we are investigating fiber one in patients with moderate to severe dementia and long term care facility.
Outside of agitation, we are making strides toward unlocking big scale 501, all therapeutic potential. It has a novel mechanism of action or potential use as an adjunctive treatment for major depressive disorder.
We look forward to sharing top line results from our phase one be multiple ascending dose trial. This month.
They're not all but 300 million anti depression depressant prescriptions annually.
Annually in the U S.
Currently available treatment option is I've got X terrorized by slow onset of action and completing this fall.
We believe this represents a significant market opportunity as a chronic treatment in depression and other neuro psychiatric conditions.
So I think Don what's the extent that a verdict we remain excited about our subsidiary for subsidiaries potential we continue to explore strategic options for this business and advance our immuno oncology clinical pipeline.
In the second half of this year, we expect our new shared our randomized phase II trial evaluating <unk> 701, as monotherapy and in combination with Keytruda for small cell neuroendocrine prostate cancer F E N C.
This trial could serve as a potential registration study what is CNC pending our discussions with FDA.
And that's to me they are doing an 88000, new prostate cancer patients expected in the U S. This year with approximately 11500 progressing too at CMT.
This patient population is in dire need of treatment options as there are no approved FDA therapy.
To close we.
We have had a very productive quarter.
A solid foundation for many near term exciting development.
I am confident we will continue to meet the high expectations, we have set forth for ourselves.
With that I would now like to turn the call over to Robert singer to provide some additional detail on our three upcoming data readout this quarter.
Yep.
Thank you demo. This is indeed, a very exciting time for our neuroscience clinical pipeline at bio cell therapeutics, we are expecting three near term data readouts across the Bx C. L 501 program.
These will potentially help expand this novel assets outside of the institutional setting and into additional therapeutic areas of significant unmet need.
Me briefly summarize these important milestones and their clinical relevance and significance.
We are on track to announce top line data in schizophrenia, and bipolar disorder from part one of our Serenity three study this month.
This study will report both efficacy and safety information for a 60 microgram dose.
The purpose of this study we chose a lower dose to help establish a greater safety margin for at home use while maintaining a margin of efficacy.
Dose selection was informed by our experience with the 60 microgram dose in our phase one b trial.
Our goal is to arrest agitation episodes in its earliest stages at home patient.
Patients at home are aware of becoming agitated and have not yet reached the magnitude requiring emergency treatment.
This contrasts with the magnitude of improvement impact total scores and serenity, one and two which were designed for the emergency setting where patients require rapid onset of action considering their acuity.
In part one of the Serenity three study, we have 80% power for a single 60 microgram dose to separate from placebo by one point or greater in the <unk> total score with an alpha of 0.05 or better for.
For potential home use we have powered the serenity II trial for a dose intended to maximize the margin of safety for broader community use.
Data cleaning and verification is in progress with expected readout this month.
Part two of our surrounding <unk> III study is expected to initiate this quarter and is designed to evaluate the safety of a 60 microgram dose class a second dose if required at home.
Let me turn now to tranquility too, which is evaluating 501 for the acute treatment of Alzheimer's related agitation in assisted living facilities and residential settings.
The primary endpoint is the change in baseline PEC total scores two hours after the first dose as in tranquility, one and treatment over a three month observation period.
Confirmatory measures include the clinical global impression of improvement the Pittsburgh agitation scale and agitation calmness evaluation scale and tranquility, one we observed a statistical significance for the primary endpoint as well as efficacy across these confirmatory measures for the 60 Mike.
Gram dose.
The data cleaning and verification process is underway, we expect to announce topline data from this pivotal trial in June .
Lastly, our phase <unk> multiple ascending dose trial was designed to test safety and Tolerability of daily dosing of <unk> 501 for seven days in healthy volunteers to inform proof of concept trial dose selection.
In phase two program treatment and M. D D patients will be evaluated with B C. L. 501 in combination with first initiation of selective serotonin or serotonin norepinephrine reuptake inhibitors, ssris or <unk>, respectively in order to assess axa.
Elevating the response to an anti depressant.
This study lays the foundation for combination of <unk> 501, with antidepressants for M. D D.
And for the potential chronic dosing.
A variety of other neuropsychiatric conditions.
We anticipate announcing topline results this month.
To summarize over the next several weeks, we expect to announce key data via three separate Readouts for <unk> 501 with plans intended to further unlock this assets full therapeutic potential by demonstrating its ability to treat agitation across additional indications.
An additional medical settings, and potential expansion and the illnesses, which require chronic dosing.
Let me now turn the call over to Matt for an overview of our commercial progress.
Thank you Robin good morning, everyone before we dive into the specific commercial metrics for the quarter I want to underscore gummies positive reception.
As our commercial organization continues to build and shape the agitation treatment market.
Following the full deployment of our 70 person field Force last December and.
And building upon a strong early launch foundation, we've had a very productive first quarter and start to the second quarter across our sales market access and marketing functions.
While we're still relatively early in the hospital launch.
Particularly for the recently deployed two thirds of our field force our commercial momentum is building.
We are very enthusiastic about our progress and confident in our prospects for success.
The team is working diligently to ensure a gummy is on hospital shelves and available to patients as quickly as possible.
We have made great progress with the gourmet formulary adoption, achieving more than 130, formulary wins, which more than doubled the number of wins reported just two months ago.
Along with approvals for over 14000 target integrated delivery network or IBM beds. This equates to over $55 million of addressable market that has been unlocked to date.
Beyond these secured approvals the efforts of our combined field teams have resulted in formulary boats scheduled for approximately 600 hospital PMT committees and variety and covering another 70000 target beds. This represents 25% of our target IGN universe take.
Taken together this represents approximately an additional $255 million in market opportunity that's scheduled to vote.
Yeah.
We're pleased with our current approval rate up nearly 70% of votes.
This reinforces our confidence in our gummies perceived value to our hospital customers.
Okay.
Given the standard formulary timelines, we expect to see a meaningful uptick in votes in process later this year.
We have also observed that more than half of all ordering hospitals have reorders, which we believe demonstrates real world utility and growing health care provider interest in the value of Agal me.
To provide additional color on this we recently analyzed our top hospital accounts to benchmark adult gummy adoption.
Our target hospitals, each manage over 4000 agitation episodes per year, and we estimate that each of our early adopting institutions have treated over 160 episodes in the first six months of use.
This represents an implied market share of over 4% in that short time period we.
We have provided this uptake case study on slide 25 in our corporate presentation, which was posted this morning on our company's website.
Our broader integrated commercial team continues to increase awareness of <unk> and further amplify our message.
The sales team has reached over 75% of the 1700 targeted hospitals with focus on deepening advocacy and driving demand.
Late in the first quarter, we successfully deployed our <unk> Hospital free trial program and since then have observed nearly 700 ordering website interactions with several early orders having already shipped.
This program is designed to facilitate early experience with the gourmet and to support hospitals and health systems and value determination.
We expect this will help accelerate demand for our gourmet and de novo institutions nationwide.
Additional marketing efforts are bolstered customer engagement and include over 90 peer to peer speaker programs. So far in 2023, educating nearly 1300 health care providers.
Our comprehensive first half media Blitz has generated over 12 million impressions in the first quarter, which represents a 70% quarter over quarter increase.
We expect these enhanced sales and marketing efforts will drive a meaningful acceleration in formulary voting volume and increased pull through demand as we move throughout the year.
In summary.
All early indicators are tracking well on point to growing revenue uptick in the second half of 2023.
We are incredibly pleased with our progress to date and look forward to leveraging and building. Upon these efforts as we generate further demand and unlock additional opportunity for <unk> to reach patients in need.
I'll now turn the call over to Richard who will discuss first quarter financial results rich. Thank you Matt.
I will now review the first quarter of 2023 financial results.
Net revenue was approximately $206000 for the quarter similar to our prior quarter.
We expect to see a notable uptick in revenue in the second half of the year as we believe we will continue to accrue more formulary approvals.
Research and development expenses were $27 8 million for the first quarter of 2023 compared to $18 6 million for the same period in 2022.
The increased expenses were primarily attributable to multiple clinical trials and CMC costs are related to our upcoming three data readouts.
Sales general and administrative expenses were $23 6 million for the first quarter of 2023 as compared to $12 9 million for the same period in 2022.
The increased expenses were primarily attributable to personnel sales market access and marketing costs associated with the commercialization of <unk> in the United States.
<unk> Therapeutics had a net loss of $52 8 million for the first quarter of 2023 compared to a net loss of $31 5 million in the same period of 2022.
Cash and cash equivalents totaled $165 5 million as of March 31, 2023.
We believe that full execution of our strategic financing with Oaktree and Qatar investment authority and they'll gummy revenues will result in a cash runway into 2025.
Thank you and now I'd like to turn the call back to demo.
Thank you Richard.
Before turning to Q&A I would like to briefly highlight a few of the many of you soon.
On solid same day.
And one example that relate to me by avid.
I'd say its organization.
These two anecdotes demonstrate the profound benefit economies, having ah patients and caregivers.
And FCB customer last week described a highly educated uncontrollable patients who are jumping on the bed, taking their clothes off and yellow.
The patients appear to be a dangerous to themselves and to help with those.
The patient was all part of the economy.
And in under 30 minutes in back on buyback for Libre has had much more cooperative.
Thus I can't tell you. This feedback was that regarding me walk fabulously participation.
Another hospital informed us that they have multiple patients coming in and requesting economy by its name.
One of these patients after taking economy, while the described by <unk>.
Yeah.
Being able to hold conversations and that she desperately wanted people get me to use at home.
As you heard Amir <unk>.
Well one is currently under investigation for at home use.
We are constantly receiving such anecdotal feedback.
Part of that assures us that not only is it gotten me providing real world utility for those in need in the institutional setting, but it also supports our expansion strategy.
Getting firsthand accounts of these positive changes we added creating also continues to be both.
Buying and motivating.
As you know we are beginning to make an important societal change.
We will now like to open the call for questions.
Later.
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One moment, please while we poll for your questions.
Our first questions come from the line of Robyn Karnofsky with through Securities. Please proceed with your questions.
Alright, great. Thank you guys. So I have one main wide and then you follow it so with regard to sort of the three thank you for giving the powering but what can we expect for the bar to be considered keeps Dr. Paul in terms of the pet score change in regulatory approval.
So I appreciate that there is confusion over the magnitude of change in <unk> total score, which could be considered approval by regulatory authorities. So I'll be clear the magnitude does not have to be large as always for regulators. It's the safety that allows approve.
We've all hopefully for at home use safety as.
The critical bar for FDA to approve any drug for at home use. So for example look at Flonase or claritin are older treatments, even like tylenol not only were lower doses approved but the increased margin of safety was really enabling for these drugs to move all the way to non <unk>.
Scripture over the counter use.
So to back it up for a moment our overall regulatory strategy has been built upon moving a drug routinely used in the ICU setting and gaining our initial approval demonstrating discrete low exposure to treat agitation in an emergency room at 120 180 microgram doses.
This trial surrender E. Three is next designed in order to potentially expand upon this safety to potentially enable approval for at home use.
Although low doses of drugs has been approved with marginal statistical significance achieving significance versus placebo is of course, the regulatory bar.
So to answer your question. This study is engineered to achieve this.
Prior to initiating our pivotal serenity, one and two trials, we tested the 60 microgram dose and a dose ranging trial in schizophrenia, we observed a group mean difference versus placebo of one point or greater across multiple time points through two hours. This dataset was the basis for our initial.
Powering assumptions were in <unk> of 200 provides 80% power to detect a statistical separation from placebo with an alpha of 0.05 on the change from baseline impact total score so to confirm that estimate after 40% of subjects were enrolled in <unk> III.
We conducted a blinded interim sample size re estimate.
Which concluded a sample size increase was not necessary. Therefore with 200 total patients randomized one to one ratio.
Meaning 100 assigned a drug 100 assigned to placebo this provide 80% power to detect a significant difference versus placebo.
So there's a lot of color you actually answered a bunch of my follow ups. So thank you very much I appreciate it.
Thanks Ravi.
Thank you. Our next question comes from the line of Greg Harrison with Bank of America. Please proceed with your questions.
Good morning. This is Mary on for Greg. Thanks for taking our question maybe also looking at the at home setting here I guess, how are you looking at the potential commercialization strategy for this getting it approved compared Q the ongoing institutional.
Yes, so it's a great question, we're going to provide more color on at least a 30000 foot view of the market market reaction and a potential deployment scenarios as we read that data out so stay tuned on that.
I used to say that we're building.
Momentum now in a very nice bridge to get to the community I think as <unk> mentioned, we had a case of and we've had several instances across the country, where patients who have already received gaumy have asked if they could have this therapy at home. So we believe that that bridge will be very strong and we will accelerate our up.
Take into that market.
Great. Thanks, and just one more if I could Dan will discuss with the anecdotal feedback maybe just looking at another steady as you enroll patients for the tranquility trial could you comment on the interest you are receiving from physicians and caregivers for fall about wanting Alzheimer's.
Uh huh.
I can say there is interest.
At this point were not approved for use for example in a nursing home setting and we're also not approved for use in Alzheimers. However, we are studying this so I encourage family members and patients to stay tuned.
We are going to present this data to the FDA.
Posthaste extremely fast.
And as you know we have breakthrough designation for the development and fast track. So we hope to meet with the FDA probably shortly after.
We describe the topline results to investors.
Thank you.
Thank you our next questions come from the line of Colin Bristow with UBS. Please proceed with your questions.
Hey, good morning, and thanks for taking the questions.
I guess the main one that we've been getting from investors is just.
What is the disconnect between these improving metrics youre getting in terms of forming wins and institutional outreach.
Sure.
Thus as the sort of essentially a flat sales performance in and when do we start to see the correlation between these metrics and the sales performance.
And then just as a follow up to this can you give any metrics in terms of repeat orders.
And then I have a follow on after that thanks.
Sure So I'll address the quest.
Question about revenue versus the day metrics I mean, the metrics that we focus on is.
Obtaining formulary wins, because that is a leading indicator of revenue as a lagging indicator.
Revenue can be the gating of that revenue can be disjointed, especially early in launch and so I think that you are seeing the phenomenon of that now as hospitals are ordering units. They may be worked through that inventory before reorder we cannot.
Predict those ordering patterns it should smooth out over time, and we expect it to.
As I said before we expect to see a significant inflection in the revenue later this year.
And then on the repeat orders can you give any color there.
Yes, so I would point you to that slide 25, and the corporate deck that we that we posted this morning that will give you a really good indication.
Yeah.
The ramp that we're seeing in <unk>.
In hospitals that have begun already now.
We had to perform that analysis as they had to have ordered at least for six months and had to have.
Some experience with the drug.
But what youre seeing there is a pretty nice inflection.
In fact, we get to I think four 3% on average.
The impact of our penetration into that annual agitation market. So I think that's a fairly useful way of maybe predicting the ramp we've had we've observed over half of our ordering hospitals of reorder.
And thats to be expected early in launch I mean, remember as we pull new hospitals online and they placed their first order.
The if we're including those in the calculation as we do.
They will have ordered one time and so we expect them to have repeat orders in fact, we've seen that as hospitals at trial. This in patients in a hospital, they're pretty impressed with its performance.
Okay, Great and then just as we look forward to the outside mirror launch, which I think is the focus of everyone.
Should we expect a similar lag between these metrics and the sales performance.
Because there'll be some established at that point.
Tests are much.
How much greater correlation.
Rapid uptake.
So that's a great question, Colin and no we wouldn't expect that I mean, this is a traditional rx therapies. So.
We would expect to see the same type of ramps that you see in traditional retail markets and in fact being able to build that bridge from the hospital experience to the community even in Alzheimer's dementia can be very important remember, 20% of those 100 million episodes in Alzheimer's dementia.
Wind up in the emergency Department, where we're going to have a lot of experience with the gourmet and bipolar and schizophrenia patients. So we expect to leverage that and build a similar request for those patients who've been treated with Gaumy go back out in the community and requests are from their physicians.
Okay. That's really helpful. Thanks, a lot guys.
Thank you. Our next question comes from the line of Corinne Jenkins with Goldman Sachs. Please proceed with your question.
Hi, This is Tyler on for Christian and I have a couple of questions.
So Danny Betsy how would you expect doctors do determine the doors in the emergency room, setting and then should they choose to use the newer doors are there any implications to revenue we should be thinking about.
So the approved and labeled doses or 120, and 180 microgram, which may be given again half doses two hours. After the first dose in the emergency room or hospital setting.
60, microgram dose is being tested for at home use.
And.
This is the model I can add that currently there is no differential based on their doors, whether it's <unk> our WAC pricing.
And my other question was could you contextualize. This is co funded in the chunk will it be study and what do you view as a tornado bill Gite within this population.
Okay.
Yes.
So we know that agitation itself is a risk factor for falls, obviously, the population is at risk elderly.
Elderly, especially patients with multiple comorbidities.
<unk> pension and on anti hypertensive. These are all reasons why patients fall and so I don't know that there are single fall is not a good thing it never is.
Falls with consequence, or worse consequence, like broken hips and arms and bones.
And so we'll be monitoring this in fact, we are monitoring this and we will be presenting data on this as part of our regulatory package and you will see this as part of our safety data and the top line results.
That's helpful. Thank you.
Thank you. Our next question comes from the line of guidance in Asia with Guggenheim Partners. Please proceed with your questions.
Hey, guys. Thank you.
A question on the tranquility to so I think the primary endpoint is that you know day, one but the study is three months could you maybe articulate for US how did you come up with the three months.
<unk> at least in the open label, what sort of regulatory discussions are and then in terms of funding requirement.
Help us understand what would be needed would be need to be.
Or tranquility trial to readout or two now just curious you know how did you come up with the.
The negotiation or back and forth with the FDA. When you are designing the two Wednesday towards these statistics.
Sure. So we designed these studies in consultation with the FDA.
And one of their questions was.
Okay, if you're able to demonstrate single dose efficacy and that's how we got breakthrough youll.
You will need to demonstrate that again and not only for one episode, but continued efficacy over a period whenever it may be used that's why it is in fact double blind. It is double blind placebo controlled for a period of three months. So that three months period is not.
Open label.
The FDA puts a lot of weight in double blind placebo controlled data.
Thus, we were able to describe the efficacy not just for the first dose although that is primary but we're able to describe the efficacy and safety whenever it's used as an agitation episode arises so that is.
Been agreed with FDA, we've agreed on the analysis plan and that is the data that we'll be presenting to them.
Got it one more question I have a decision regarding the agility that study to the phase one is actually in healthy volunteer or just curious.
Got it.
Would you like to.
I see that leasing how the volume to go that could inform proof of concept.
Yes.
This MTT readout. Thank you.
Yeah. So it's true the studies in healthy volunteers and it is principally designed to explore safety and tolerability of doses taken on a daily or twice daily basis, So starting with a low dose it escalates to greater doses and frequency up to twice a day.
The highest dose regimen considered acceptably tolerated is tested then in combination with a standard of care serotonin and norepinephrine re uptake inhibitor or SNRI. So will describe the development plans in terms of depression. After we have that data in hand, we do have advice.
<unk>, who will review that data and our various options for developing in depression. So at this time, we're considering.
Development is an accelerant to the anti depressant response of standard of care SaaS and SNRI.
We may choose to test 500 one's capacity to more rapidly accelerate those patients into response and remission, especially in the first month or so of treatment.
These plans will be detailed after we have the data and we've reviewed this with advisors and literally codified our strategy.
Okay.
Thank you. Our next question comes from the line of Craig synonymous with Mizuho. Please proceed with your questions.
Hi, Good morning, this is Richard on for Greg.
And so two questions from me is that.
And so rather than to me since Youre looking for the same efficacy as you have.
So far in the at home setting what is the FDA looking for specifically what are they worried about.
Yeah.
I don't know that the FDA is worried about anything.
We believe we have.
Adequate data and so we're literally taking that data to the FDA.
Okay.
So just to add to that Richard as Rob mentioned that Barbados entity is that it can be used broadly for the patients at home.
Our goal was to test.
Efficacious dose, while maintaining the same margin as well as maintaining the safety margins was 60 magazine doors was very bad.
Selected as Rob said in junior debt trial and agreed with the FDA.
This is our doors, we wanted to test in a couple of weeks, we will have the data readout. So we will do and we are getting getting up to start the two of those sturdy with <unk> magazine.
Those can be given and also a second dose patient can take it at home, which is the safety part of that.
As Tony said, it very well and gene yet, it's very thought out if they agreed with the FDA and we are excited about upcoming data readouts.
Okay. Thank you.
No.
One on Comm Marshall.
The U S.
I think questions have been asked about what you think about the uptake.
Uptake now and so I think you mentioned a matchmaker.
Your sales force penetrating 10, 5%.
But what do you expect.
How does that also correlate to uptake from now on when can we see that.
Uptick.
Yes, so it's so Richard Great question, and that's why we provided the metrics. We did this morning, we dollarized whats already been voted upon as well is dollarized the market potential that we can penetrate into with what's scheduled.
Already this year, we expect that most of those votes will happen in Q2 and Q3 that our schedule. Then we will pick up additional boats in process over the back half of the year due the impact of the additional 44 reps in the field.
So I would I would take that $310 million all in.
That we have either on locker about Tom lock and.
I would use that uptake curve that's on slide 25, as a good surrogate as to how that happens once we knock down the the positive votes.
And they have the drug in their requisite systems et cetera, we expect to see similar uptake curves.
Okay.
And Richard I would like to add.
Matt said this is a memo that our current approval rate is 70% plus formulary wins, which is really very exciting. So so we are very excited that we will have lot more formulary wins in next quarter and in second half.
Great. Thank you.
Thank you our next questions come from the line of Cmos call Kearney with Canaccord Genuity. Please proceed with your questions.
Good morning, Thanks for taking my question.
Actually all of them said anything for the first one in the alcohol use context, how can be tuned into the company to embark on that in 2015 <unk>.
Next minute Robyn.
Total mucosa, Jennifer <unk> for $90 million and its related products like the neo lincolncenter might be might prevent them and do you expect an advisory committee meeting for <unk> use it again.
Well I'll point out that it is in fact that same gel was approved for horses.
Dogs and cats.
And we now have a sublingual film approved for humans with schizophrenia, and bipolar who are agitated so.
We have great confidence in our development program.
Got it and then.
How would you approach a scenario, where the 60 microgram does not have a statistically significant efficacy because otherwise.
I'm asking because these <unk> study did not get significant 30, 60 microgram dose vignettes that is that in July 2019.
So at the end of the day, the regulatory submission will entail both part one for a single dose and part two where we allow that second dose.
And I'll just say, although we remain blinded we have been closely monitoring the overall safety and part one from the single dose and we are initiating part two of the study.
I'll Skip a commercial question and a quick one what.
The bulk of the IEM whats happen.
Okay.
That depends I mean, the devoting schedule is going to be dependent on our engagement when they put it on their schedule, but we're seeing them happen now in fact, we just add a well known system relatively small system, but a well known system.
And approve us on Friday, and so that was.
That was a nice add and we see this happening every week and so.
The cadence of those should continue to improve we've been engaging with the idms.
Ratably since we've launched and we expect to see more and more of those always take place remember we have 70000 boes for 25% of the targeted IBM beds that are scheduled to vote already.
And so we should we should see even more of those come online as we move throughout the year.
Got it thanks.
Thank you our next questions come from the line of Brown <unk> with H C. Wainwright. Please proceed with your questions.
Thanks, very much for taking my questions first of all just wanted to ask if you expect to maintain reporting of the same commercial metrics going forward or if we should expect the specific changes and if so what those changes might be just what types of numbers do you expect to report going forward and the second question is.
In respect to <unk> cel.
Just give us your updated thoughts regarding the strategy, there and potential timing.
Possible spin out or other equivalent type of transaction. Thank you.
So we do expect to report out the same metrics, we've been consistent since commercial day of last year and reporting on hospitals.
Formulary process formulary boats, one and IBM beds.
In process and IBM beds, one the only difference between those metrics that we reported over the last.
Two three quarters now.
And today is that we've dollarized that opportunity. So you can actually see what market, we can impact today.
What.
Dollar value, we should be able to impact.
Assuming positive.
Positive approvals of those in process.
That's the only change everything else will stay consistent.
Good morning. This is Vermont regarding <unk>, we continue to explore our strategic options.
That includes potential financing as well as partnering.
Active process and.
We are looking forward to providing an update once we have a.
Confirmed.
Position on which direction like and are we going to do.
Thank you there are no further questions at this time I would now like to hand, the call back over to Dr. <unk> for any closing remarks.
Thank you everyone for joining us.
And if you have any question please feel free to reach out to us and.
Have a great day.
Thank you. This does conclude today's conference you may disconnect. Your lines at this time. Thank you for your participation and have a great day.