- Earnings call transcript Q3 2022

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Operator

Good morning, and welcome to the BioXcel Therapeutics Third Quarter 2022 Financial Results Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions] After the presentation, there will be a question-and-answer session. [Operator Instructions] Just to remind everyone, certain matters discussed in today's conference call and/or answers that may be given to questions asked are forward-looking statements 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. be affect on are quarter be Form XX, XX, which may company's in ended updated that or XXXX. the XXXX report www.BioXceltherapeutics.com quarter report quarterly XX-Q can XX-Q in factors its future which on detailed results the June on quarterly Risk www.sec.gov, at Form will for found for September the ended

reminder, conference is today's a As recorded. being

Matt Officer; Frank Therapeutics. pleasure Medical are call Officer to Please Steinhart, us go Vimal Chief Scientific and Dr. of Chief my Executive call Dr. O’Neill, today's the CEO Richard Risinger, of now Officer; Joining Officer; to ahead. over Medical Chief is Financial Dr. Rob Mehta, and Dr. Wiley, turn Officer; Mehta, Vince Yocca, Commercial Officer BioXcel Oncology. of Chief on the It Founder Chief Neuroscience; Chief Dr.

Vimal Mehta

everyone Thank today Therapeutics discuss BioXcel call you, you operator. our and Welcome for joining to highlights. performance and financial thank business

of and pivotal few months, marked quarter last transitioned a to The a have launched the the organization IGALMI. commercial moment history BioXcel In we third XXXX successfully of Therapeutics. in

and We progress have facets XXXX all our and made are for excited across business very of tremendous beyond.

believe market the XX and and fully in diagnosed Alzheimer's. in for approximately schizophrenia three agitation expected seen indications, in XXX first In our the first agitation expense under bipolar treated and agitation This of US product truly to these of our the agitation disorders market will decade. emergence consists adults. broad from a that are million as options to a market XXXXs. for bipolar of depression $XX IGALMI opportunity. of of fashion Agitation underserved to market in million trials growth the us novel ongoing is agitation treatment early days label this treatment nearly We with IGALMI have We billion like readouts a the In the allow which on trails in treat similar our by regard, products of the a in of in introduction creation a for has execute a in medical IGALMI an annually, is hosted are innovation conditions approved the leading commercial schizophrenia continue performance matrices. this and the recently spectrum disorders. never X rapid multiple bipolar not and acute and believe BXCLXXX on for schizophrenia in launched and we of disorder, we neuroscience are lead been setting. program, treatment and and setting. We could that institutional an the introduction There to total following strategy institutional positive has drive is our full franchise. FDA episodes in land agitation novel agitation build the the agitation pivotal episodes outlined including capitalize short, XXXX. data We clearly novel mechanism the neuropsychiatric X to of market. action new In initial in agitation evolving momentum with launch dynamics, IGALMI market half

of is is from pharmacoeconomic there professional obvious demand Yet hospitals Our commercial health clear and for with path unprecedented a benefit arrogate. the patients. safety no care

hospitals. our and market reps expand By targeting in a drivers. market these already initially leading first to leading in and all only have PIVOTAL efficient hospitals, sales facilitate covering and four sales and and agitation favorable been approvals, of published of highly formulary validation efforts two and we extensive that industry our revenue, affairs commercial target drive key medical scientific and reviews scheduled fuel U.S. We all integrated our strategic formulary from awareness additional focus major the XXX have P&T engaging To product cover journal. total actively reps force recently We Community XX will the teams with of scripts to we to result our have in and hospitals country. We fully reach access, observed medical a growth. deploy increasing understanding the the are with conferences with addition the IGALMI, within participating markets. necessary a pleased across our demand factors, geographic X,XXX our first TRIAL will recorded our now infrastructure Based across scientific market awareness short-span. IGALMI made hundreds Medical the on and Within Xst, SERENITY teams to committee market members XX continues to to have target months believe we Medicare December with these of increase entire cover in footprint generation. will approximately decision

launch Our Chief shortly. through will performance Commercial the Officer, launch Matt walk Wiley and progress review will our basis to-date you

pipeline our our advancing clinical In is loan robust addition to progress, rapidly.

and the related indication enthusiastic large We are estimated this in extremely approve represents expansion dementia. unmet received growing and agitation medical $XXX our Track the in Alzheimer's-related FDA therapy current for episode Fast with FDA therapies agitation, no U.S. annual a opportunity and need. for million patients an designation to XXX agitation breakthrough from about these

be year. trial data half forward we this XXXX. from pivotal in trial the of are TRANQUILITY the the of We by first line to TRANQUILITY X end announcing looking initiating will Also, top X pivotal

agitation from product, the these also evaluated The efficacy SERENITY top adjunctive and SERENITY a potentially data to BXCLXXX within III is episodes Depressive more expected use are SERENITY our expanding has half line SERENITY readout for bipolar pivotal We to Disorder, and an XXXX. with of use IGALMIs to first program in agitation associated III with parallels for in the or for expected XXX of the approval. At continues treatment market Major annually. MDD. II double also opportunity form be a XX There basis home conditions trials US treat and trial III the with many is III pivotal Truly, about at-home schizophrenia. disorders than the current are excited I approximately IGALMI. that pipeline as million

completed We cohorts X top half report our in results to escalation volunteers the healthy of have line expect XXXX. and Phase first in multiple in dose trial already

with fully forms activator to me owned is on focused lead Therapeutics. OnkosXcel turn program cancer for development growth aggressive indemnity of franchise. Let in our This subsidiary BXCLXXX, systemic in immuno-oncology the company's is sustained a prostate combination KEYTRUDA. of of

in pleased small mortality a about no high and is neuroendocrine are XXX Scientific Retreat. rate. for the recently Prostate Foundation SCNC treatment or Cancer there SCNC, data cell We the cancer presented Recall, at promising in FDA-approved

a the rate median evaluable first XX patients for response XX% demonstrated months responders. composite duration SCNC nine of data the five Our of in first a and

in Phase top expect II completed now line We early XXXX. in ongoing SCNC and have to trial data the present

predictive in In on patients acute including with for addition, today XXX presenting are leukemia, myeloid at potential biomarker data Sydney, we leukemia.

have on believe solid our website these biomarkers tumors. corporate for also call. We potential after will be could implications available this The poster

We our intellectual portfolio. property strengthen continue to

in allowance this quarter, we had new and offices. XXX notices two from For two foreign of patents issued, US seven patents US

be approved commonly known therapeutic in will is evaluation, patents Orange these FDA's with expect as book. products which drug We included equivalent

has a patents eight Therapeutics allowances/issuances XXX, we BioXcel quarter. for remarkable In had received foreign had Additionally, closing, offices. from

are position now the to XXXX. for to like I catalysts are progress. a well over market, growth launch positioned review developing Matt call would have leadership the multiple to turn agitation our Matt? We in in and Wiley, upcoming data

Matt Wiley

Thank morning, you, everyone. good Vimal, and

updates continuing efforts Day reported IGALMI are you performance our we with a we launch As ago, to our These in additional our launch Commercial progress on making specifically efforts. and weeks pleased off, relation metrics. are to in few I'm very some today, good share to pay

activities component critical a our Our market strategy. access are of

contracting with organization or group GPO our So efforts. I'll with start purchasing progress

mentioned communications, GPOs the to frame time in nine have we months. previous As contracting typical six averages of

We the have to and progress throughout steady access our GPO increased made quarter.

the contracted XX% with two covering nearly largest including target our the now We GPOs, in in bed the universe. of are country,

continue in and improve We our are and ongoing coming in GPOs other the the with to to expect access weeks months. negotiations leading

over reminder, a largest represent As target three beds. GPOs XX% our of the

date. to tandem, systems further utilization achievements happy of our integrated we very on to control IGALMI. with focusing exert IDNs, or drive continue So those we downstream networks, with engage to are that high delivery In

IDNs on currently targeted with of formulary beds. are high-value voting the scheduled XX for XX% We concentrating

we've and driving As team a our team our the contracting corporate deployed part of ramp-up efforts, account sales formulary activity. coordinating with of and to directors dedicated

chose learned XX XXX lot first high-volume have resoundingly We process we covering months the our In positive field. last four a about in the territories the and being deployment, traction. sales wave received accounts target of deployment the in

been the to July. agendas. since full our IGALMI force, to this significant We will over deploy X,XXX have continue P&T These strong target committees interest initial momentum to in as give made add pull-through we of and approximately seen future XX% us us to universe results great able upon positive This reach to have in equip have launch confidence sales targeting XX-person hospitals. build trade now

schizophrenia to of we the patients and out force, XX hierarchy field taken December than the this We target location to we have optimization unique able this have of deploy expect States. lake, agitation agitation refine records site team XX% the our United a informed strategy building of targeting our billion by data more X. sales frequency and five years. and takes informed To building examine spanning in represents model into of bipolar nearly ensure of and methodology With field the the by The episodes our in deployment hospitals base to ongoing are a by majority total in by of a in episodes. we approach database account today

Turning now to marketing.

have website. significant peer-to-peer of efforts and to with continue engaged our date, programs build the will conventions. We And IGALMI the peer-to-peer amplify for engagement marketing visits our over balance To over XXX,XXX speaker and now and to venues XXXX. programs in X,XXX year these efforts campaign yielded has on HCP digital at digital available the HCPs our

strengthen. IGALMI’s Our this market and proposition value continues understanding in to evolve of

the was that Just much been or Bipolar American Physicians and ago, previously sustaining paradigm a dynamic conditions room of injury. success for receptivity tailwind going in summary, more with showing for emergency from the to released, have exacerbating this and of nice IGALMI market assaults and are value of emergency month physicians the and in patients may College provides an proposition. are department additional The likely half treatment one-third an assaulted, XXXX issue. to more agitated than setting enter a Emergency highlighting and new market, schizophrenia so come current physically In data up us beyond. the for patients underappreciated be

contract have our GPOs XX% others We process. beds targeted with nearly with under of in

XX% progress. X in XX,XXX beds and additional an vote beds We the to Tier of beds scheduled Target with target nearly IDN have XX,XXX

process. the in climb. out XXX XXX in hospitals over is nearly expect improved XXX target Keep territory our votes scheduled mind will and votes and hospitals have XX this vote, last in of Tier scheduled on we figures deployment. these for initial P&T Additionally, of reflective IDN for P&T reported and process Both continue Commercial to votes P&T these have we since Day, we X

specific formulary more last future metric Additionally, we readout, and since details positive provide have on we'll this added our wins calls. in

turn will a Now, call I'll to Richard, who update. give over the financial Richard?

Richard Steinhart

for with review hospitals, to primarily development model was The third at-home XXXX in third increase expanded I for no for BXCLXXX XXXX. you, $XX.X the of million trial Thank agitation of company expected. as quarter attributable compared same million will were schizophrenia of million period to MDD. personnel loss expenses quarter stocking market States. million quarter compared Alzheimer's Cash the two primarily to driven were net for quarter access. $XX.X United XXXX. Therapeutics quarter and for for IGALMI third administrative the period the by in to and to Research an quarters in approximately burn our expenses general for the net $XXX,XXX, shipping of first third was in in XXXX. increase costs which million, clinical reported million in expenses launch quarter XXXX the trial direct with a Selling financial related the a consistent compared $XX.X of and Due and same for Matt. the its limited $XX.X XXXX was of million IGALMI expenses and was -- The loss to XXXX costs due increase agitation, revenue now use quarter program bipolar-related of same primarily XXXX. early and results. of the for $XX.X BioXcel wholesaler was clinical $XX.X the the to is in company's for R&D the to the SG&A $XX.X Net the related period

approximately totaled $XXX.X and As XXXX, September cash million. of cash XX, equivalents

I'd Now, to to like turn the Vimal. back call

Vimal Mehta

would the Thank for you, like Operator? open questions. now Richard. We to call

Operator

you. Thank

[Operator question-and-answer is be now first Greg Instructions] Our from coming Harrison will of conducting from question America. Bank our today session. We

Your line live. is now

Greg Harrison

for guys. Hey, see our Glad taking morning, good progress. Thanks questions. to the

the to convert should you P&T cited So on timing XXX and decisions you which how we be rate expect thinking those the here at about into from could wins? formulary the

Vimal Mehta

you Thank Greg. will question. to it Matt. morning, for Good on I pass your

Matt Wiley

Yes.

So, the of of the into year. currently end Greg, or between are QX now those next and scheduled year

they'll in on things of the formulary, the IGALMI them would should one once I expectation Day expect So go to the to we go we typically, put time, to then can on decision Commercial is And which vote. provided made had uptake. is the happen of the expect that actually these time, to agendas get that but majority vote things those of on would pushed,

emergency over try the that IGALMI the would formulary expect of psyches, physicians post majority of so, department both first within year, access. and And to the them year course

Greg Harrison

helpful. then for differences what Got your between on KEYTRUDA the OnkosXcel the the it. arm are That's side, combo. and XXX And monotherapy expectations the

think through the what to response for be trying XXX expectation mechanistically alone? could Just

Vimal Mehta

that undertake you question? do Vince,

Vincent O’Neill

do that. Hi, Happy to Sure. Greg.

Vimal Mehta

the know we of So, from and by preclinical a between generated as behave how We was checkpoint We tumor, seems line we've do a a really [ph] that some will don't Point XXX preclinical normal and XXX bottom that that's that. quite a monotherapy and cold time and to a But the in extensive the be ago. synergy work I now think, activity in hot has we presented is, data Therapeutics it single-agent XXX. know know lot work done, the tumor.

but primarily fundamentally, think is So answer know, that's can we probably I drugs. the And two don't best it that synergy between give. the we the

Greg Harrison

for thanks questions on Well, taking progress, congrats and again. it. Got the

Vimal Mehta

Greg. you, Thank

Operator

Thank you.

Bristow Colin from UBS. coming is question Next from

Your live. line now is

Colin Bristow

and morning congrats and continued questions the for on thanks Hey, good taking my progress.

more details on broad in a you're OnkosXcel, First your sort is I a update important a provide And think path I when B, one, XXX, substantive you topic, conceptual on A, sort from sales of it's sort structure report that and and expect when number and of one curious just standpoint. of, what but Thank provide of guidance? the there? to, to know guess second the forward best a just you'll a this of then of sort position an on is one an ongoing one guess, be debated I about sales enthused much investor you. more

Vimal Mehta

Thanks, Colin, for your questions.

said because IGALMI So in area, institutional launched regarding never we the in that unprecedented sales been are currently guidance, like an product with as mechanism has a novel I a action setting. -- of

the we you robust launch are providing confidence And we our those see, what in will start building doing, based build matrices. is So as once on that, we guidance. matrices, can

So it with more pass Matt to provide that, I can to on details.

Matt Wiley

Yeah.

X up XX So to takes typically for think process this. access I that frame way it would mean, Colin, I the the we said formulary I is months.

of to with in about change. just XX We have ongoing the field. activity reps That's a lot

the demand. And very Certainly, we're formularies true formularies when truly that on is encouraging. would progress rapidly to pull these able expect early demand up very so we that these driving through hospitals to our open in are making can adopted that be getting going is we team activities. as And

trial early shortly the formulary and that this market formularies hospital Now expectations enthusiasm the expectations mentioned do of approved uptake good are get hospitals the earlier, we gives there know, when do demand I follow. research. that and But in will us some the early that on based confidence from

is department. point, launched drug in unprecedented. that. And feel dovetail has neurocyte No emergency about on we So the Vamil's this been just really good

new response getting. but breaking we're about here, we're the we really so good feel And ground

Colin Bristow

OnkosXcel update Great. sort And path-forward on the structure? of

Vimal Mehta

that Colin, can you please repeat question?

Colin Bristow

Just in details plans the terms around of just path-forward your for and more OnkosXcel, there? structure

Vimal Mehta

there a presented we first our encouraging XX% the responses response in Sure. therapy. that's durable rate update tumor OnkosXcel data SCNC in very XX and where for approved as with initial no composite is patients

the will getting we as the is hand, analyzed will XX now this next including patients, We investments. of all With be in explore and well year. have completed strategic that options, third-party presented as cohort possible data now partnering data OnkosXcel. full early and

excited in very seen we what with have are SCNC. We XXX, for the progress

Colin Bristow

Okay. you. Great. Thank

Vimal Mehta

Thanks, Colin.

Operator

Thank you.

is question Next from from Truist. Karnauskas Robyn coming

now line Your live. is

Unidentified Analyst

Thank much discussions have that my on hearing I the Hi. if you Robyn. for from that you This your question. and peers one is pushbacks so Hey. and IGALMI. the taking -- [ph] for any, are What highlights positive or with are observed, Anvesh on and position? main also you

Vimal Mehta

the I on Well, the first of for itself. really pushback all, I negative haven't mean thanks Robyn. product -- any heard question, so

nature, are the of proposition that that a former negative. directors of question that about we're we reduction do profile hearing to but action our things The either favorable. truly is or the hearing onset what of the always truly IGALMI reading product expectation think administrators very understand and and course, throughput value. and potential story, And hospital the proposition. are of Of understand IGALMI through in is injuries pharmacists the and do staff isn't just actually, for of going value when the A lot price, the they value

where XX%, that we we're that getting field in Keep great And use we're market the we product provided after intent product prior now profile, research just mind that based we that to the a just doubled. the the profile. on launch, response. told using drug So was complete in to conducted story

research, the out pretty five field. our this from compelling patients a reps. to hearing expect of the they drug. set get We're So market thing playing and of same in two out That's every that's

Unidentified Analyst

one Okay. dementia market. And more on Great.

nursing in you and anticipate dementia than homes or how So and bipolar schizophrenia market? dementia schizophrenia the in facilities looking different bipolar long-term faster being adoption would be market? slower ahead and do market from launch the care And a to market,

Matt Wiley

So now a the Robyn create [ph], market doing entry we're to strategy. work

have market seeing And that definitely say, we'll early time is we're over when an in Suffice on so very this communicate research that clarity and market. that to better there's we the unmet it. need compelling

So into to really expect market. good have it penetration we that

Vimal Mehta

dynamics, And been not different institutional it's it's because market a in an setting.

a Matt data to lay as we it readout. close So developing out said, our strategy entry market we are more and

Unidentified Analyst

Thanks it. Okay. Got questions. my for taking

Vimal Mehta

Thank your for question. you

Operator

you. Thank

Chris Next question is of coming Jefferies. Howerton from

now is line Your line.

Unidentified Analyst

This questions Two me. for about first is My for A.J. launch. [ph] one is the Chris.

concentration of geographic trends you is still you seeing use too early? yet, in kind And do are it So otherwise? any or have or early reorders

Richard Steinhart

first. I formulary the our your early I'll first case. pretty where there's interest There's is orders part any much the reorders. question, there's Yes, we've access. second Where seeing geographically. we're So geographical early answer seen part concentrations adoption seeing -- been of or the That's not yes, are or think we where

And anywhere have territories the we that within so currently deployed. XX that's

Unidentified Analyst

you. Got okay. And

second MDD. So is question my about

the So use in is Phase intention similarly bipolar study, of goals the idea for safety at profile? space episodic or we the schizophrenia are already have a as XXX X what given good that home of

Rob Risinger

This disorder Rob will dosing daily regimen. regimen. a depressive Yes. an major It's be not as-needed is The Risinger.

with So conjunction SS items in And the inhibitor. SNRIs, we Rating least the BXCLXXX XX seven it Depression of reuptake serotonin-norepinephrine their affects taken of or Hamilton will be Scale. at that know

three sleep it improve items know, and for we insomnia. or So the example, on scale. will augment That's treat

of that's that example, the anxiety. studied, a we they in regardless reported we've an of patients know compression. component We improvement know For major illness reported

And study. dosing be get twice-daily what is is a regimen. tolerability that day on will dosing? can that that is or What daily regimen readout again, a from the help it people the the a So the even given, daily we'll

Vimal Mehta

our again, is, will move our home this to III program. setting at SERENITY the be setting, strategy like and medical this So

Unidentified Analyst

you. Thank Okay.

Vimal Mehta

Thank you, AJ.

Operator

you. Thank

Suneja Yatin question next from Partners. Your with Guggenheim is coming

live. line now Your is

Yatin Suneja

you. for Thank as well. me Two

on Could you episodic, us do what the learning maybe expect It is a have the if Thanks. articulate just on further are a have dosing you expectations that is TRANQUILLITY. to learned in side. you us to safety more for be of then learning's down that just healthy than one First frame show? the half completed studies? schedules. first the MAD from voluntary the study from a elaborate dosing going like daily that for is it given you dosing far, you seems for few so or little XXXX, perspective, you bit And can What the of

Rob Risinger

Sure.

not fact first. cohorts you an So been whereby I'll stopping MAD reverse in and run your to dosing study doses. study not study means it well the has testing that greater dose study continue ascending and ongoing, enroll volunteers, or It's those question it's that a is We've greater the we last multiple handle cohort. daily dose The scheduled in healthy next would the into ongoing, tolerated. criteria,

thing. in what we – when we'll So depression. finally then dose. in reach a doses read study, I as of we of be have We've a that The out we maximum view maximum When will called tested then a of dose. major tolerated SNRI. an commonly or trial have when escalate. to trial a a is point, with reached conjunction is not it very proof enable continue tolerated the range and And testing it And that will in that cause positive

now is study TRANQUILITY, to at first and primary be change efficacy after Excited the similar question X. readouts two to TRANQUILITY TRANQUILITY PANSS measure we baseline very the Component the from will dose. X first turning what reported your the for the So for about The hours

We have repeated doses.

and over report whenever receive first both about the safety of dose period. may an of and that dose they they every three-month So have that agitation we'll tolerability episode

of clinical be that example, some Agitation reporting global exploratory efficacy the also We Pittsburgh improvement. or secondary the measures are and will for Scale

those so in we of able XXXX. should be report half And first the to will be what

Vimal Mehta

have in therapy X, breakthrough we forms it much FDA. So for similar which the study, Rob seen TRANQUILITY just basis with designation Yatin, pretty add to the to what said, a is what

up patient. we for So here, pretty first much dosing three are after each everything months is more same except following

Yatin Suneja

Got it. Thank you.

Operator

Mizuho coming Suvannavejh from Securities. is Graig question Next from

Your line is live. now

Graig Suvannavejh

telegraphing have a And Thank you you. on that and for some gradual. would Good it morning slow question for reported you just and been I have congratulations progress. be certainly, sales. time, on what did the

were I this anticipating. we slower have been than a might bit perhaps think

the we and into will that So as it quarter similar after this be there's inflection of be fourth of a should about maybe and think year the XXXX, X. then to perhaps expectation kind kind

color any And have the we about a on Thanks. then uptake be thinking Just I how curve? follow-up. should

Matt Wiley

Yes.

Graig, it's So Matt. one. that handle I'll

and morning, mentioned over again we a we this Day Commercial have dozen as wins. at reiterated formulary So

And But of post so XX-or-so IGALMI after percent of know, the the what research six expectation the physicians in it's uptake we like. you or can you expect to formulary and so look roughly back that site try kind formulary win, first looks did months market see in approval. emergency department to

falling things think on I So are metrics. based in line those

We very the approvals expect in formulary nice there couple will quarters. be over acceleration of next a

metrics improving see we'll time. mind, we don't Keep demand true so over stock in wholesalers. the that And in

a model hospitals. are directly to ship drop So the we doing

concerned no of to expanding with. the in midst that. first field. the we of And there's So stocking XX We're recorded be reps inventory quarter this revenue with in

on of and X, December to think that by metrics. a meaningful and all deployed going that's acceleration have XX have these we improvement will We

I I So we're the don't seeing. how signs think And we know feel early in your in But models. framing that's helpful examine we really how certainly, think you that's bullish about about your that it. uptake if

Graig Suvannavejh

trying math, Matt. do by record has XXX, question strips. guess I in the X,XXX about Thanks, bought actual did, my question you Thanks. is just purchased or understand with WAC were used? contracting, I'm sales their to the using by they were that films other XXX,XXX the basically the the thought that dynamics Maybe divide fact, just you used that were to price? through it's that of if hospitals or the in strips those were And

Matt Wiley

Yes.

online the the came of later third quarter. contracts one in GPO So

by contract. those units that been a So would not of of impacted lot sort have

be GTN shouldn't little of But really impact much be in There thinking So a more those contracts to QX. a would way too place about some. bit really is in a net deduction. fulsome that to in wouldn't the you expect gross you lot

Graig Suvannavejh

Thanks, again. Okay.

Matt Wiley

Thanks, Graig.

Operator

question from you. coming from Selvaraju H.C. Thank Ram Wainwright. The next is

live. is line Your

Ram Selvaraju

you Can hear Thank you. me?

Matt Wiley

you. hear we Yes, can

Ram Selvaraju

ones. quick just two So

extension only approved Firstly, feature the wondering inventory question trials And other be not to in future? specific initial expect is in In second inventory XXX. you is I absence to IGALMI you the with of on that stocking be channels respect then comment forward? of clinical necessarily enrollment future and was indications of the a completion of the could if the is words, going indication the of a whether any label applicable would feature cadence for ongoing stocking to

could reach If us clinical with a topline programs data. timeline us of announcement if for those when just give just enrollment, of know give sense you sense I a expect you us you. that? could of that be Thank the you full provided you've But to would helpful.

Matt Wiley

hey it's So, Ram, Matt.

communicate it cross to hybrid out market entry we stocking or you full go wholesaler there'd the we which intend question that going more in good wholesaler is operating is stocking setting, retail, in Right if complete specialty and I some in get or you form, going So, later see be we same can to a Is have traditional is it model. bridge. retail some to full That the to date. we there. dementia, would inventory be in go future distribution think the dependent you for in that each? be of indications, on we there'll So, wholly go wholesale typically, then secondarily And strategies be our for we distribution assumption. a would expect would that wholesalers when you whether line a into centers. the channel, that use now, on to at as means stock that that a would to But some Alzheimer's stock

Vimal Mehta

morning Good Ram.

clinical TRANQUILITY trials. the about is question progressing track. other II your Regarding on

and that already your you have advanced see, in DSM meeting a had As when we trial. you well can happens normally clinical like

So, well. enrollment is progressing

after I dosing, are indicated, there first followed three are two months. As patients components, for

and of well. process we And the as So, have that once guidance point. provide well will we patients period as the we a three-month lots into have are that enrollment completed reach we full

for wanted the Rob, side? And something add was on In for to the TRANQUILITY SERENITY that II. you -- addition, III

Rob Risinger

initiating of but enrolled trials, the III be year. because is SERENITY pivotal and patients and we'll bipolar schizophrenia. have of in to during SERENITY end with designed we now III, similarly a peak perhaps II, III Yes. to matter before even isolation, our I COVID, of SERENITY both of which patients SERENITY the in the enrollment this recall opened months,

not using this same So, believe trials pivotal will we same if than we're design, the enrolling be We were. our site, raters. same believe equally, faster

fully SERENITY in half reporting are first anticipate for topline the we in so XXXX. And and of confident III

Ram Selvaraju

you. Thank

Vimal Mehta

Ram. Thank you,

Operator

you. Thank

is question coming Kulkarni next Our from Sumant Canaccord from Genuity.

now is line live. Your

Unidentified Analyst

for your is A move IGALMI This launch refused question, questions from where us. have obstacles that IGALMI timing Any on stage? can as and Hey to patients self-administration potential few any last any delay instances of to maybe enrolling Sumant. one on and potential decisions? IDN Kyle another question. hospitals guys. And notes And speaking well that? feedback experience currently as difficulties Since on giver from care any family any the then scheduled

Vimal Mehta

Right regarding we So have about on first IDNs. our your now, of IDN question in XX,XXX votes process. targeted

have question. have votes. any your To date, are scheduled those did not, not second IDN we we yet. but negative votes response I vote, had get to had So not for Kyle,

that only then pharmacists and the some you But patients, IGALMI. I'll So velocity spoken real of maybe quick hospital have the can we've observed to move it. with repeat third to

that cetera, working and and time, we've present. discharge we feedback is the are some that the them to to profile able so seen expected drug improvements that And it's patients from that that take is well-tolerated et it, we're getting in the that the as

administration of or any anything haven't So or from patient I like difficulty perspective. heard that

was Kyle? second what So your question,

Unidentified Analyst

decisions? Second could the question formulary any delay potential that of timing is obstacles the

Vimal Mehta

P&T the things. Well, a the our of things a I expressed drug of committees beyond formulary one the handle Commercial for at of Day inclusion, mean, things lot lot evaluation that that just speaker I guest think

ourselves the would can because so a review. And schedule those risks good they and to approval. seen agendas formulary are positive a a to meeting. we believe quorum, and And expect change, getting we've of that for formulary reviewed, we we P&T a pretty be that put in committees cadence position assuming have But

Unidentified Analyst

me. from That’s it

Operator

Thank you.

is Goldman Your from next Jenkins coming question Corinne Sachs. from

Your line now live. is

Corinne Jenkins

some us you the on just of assumptions dose-dependent the response could pretty powering Yeah. just SERENITY with given Good III, with there, morning, everyone. particularly IGALMI? well share know we Maybe

Vimal Mehta

we a Serenity their response. response saw II disorder very bipolar difference precious in patients with compare, Sure. patients with consistent SERENITY and for very little with in I there's example, schizophrenia dose-dependent in We and little,

the it's or So can response, in enroll patients very with disorder both consistent a agreed we bipolar schizophrenia FDA that knowing has with trial. that the patients

size, We clinic that X number trials very Again, have the very the three. got the know smaller of much needed we shortly. end trials. will or is to than it's high be SERENITY treat or two on I N, But a total not range effect in it's a X believe, it

our around patients gives total to end in power schizophrenia So is XXX. disorder. with greater or difference from placebo that XX% bipolar us detect a And than

Corinne Jenkins

factors Okay. And between that are the initiating in curious, just study, gating are what then, still on that trial standing the TRANQUILITY X now and December?

Vimal Mehta

size and we similar CRO sure a TRANQUILITY same does X experience like pretty think pretty TRANQUILITY from been be to gaining TRANQUILITY can that learning I make X has completely same the TRANQUILITY X completed also tailing when make deploy begin X these can time. size, it And off. as is and experience much on gating focus of all sure factor on And much. are that the

there So no otherwise, factor. was -- gating was other there

Corinne Jenkins

to kind there to just any of Okay. with readouts? or a XXXX is would or earlier reason think idea, what initiation, December a does Understood. it that? And Is imply be beyond then, respect potential that

Vimal Mehta

full the you we readout, then patient enrollment TRANQUILITY be have able our dose will TRANQUILITY expected. to and the handle have X I is guidance think data once we good when readout on provide data as we first somewhere and TRANQUILITY on from -- which size much it patient X to first starting dose similar X see, us dose, take complete pretty the TRANQUILITY to did was around is how can timeframe. long But May

Corinne Jenkins

Yeah. Make sense. you. Thank

Operator

Thank turn I'd over floor question-and-answer to back session. or you. end further our We for comments. closing reach the the of like any

Vimal Mehta

for a Thank your joining great and you, for in day. everyone, us interest today Therapeutics. BioXcel Have

Operator

That Webcast. today's does conclude and teleconference

at time. have a your day. this line today. your And wonderful You participation for you We may disconnect thank

BioXcel Therapeutics (BTAI) 10 Nov 222022 Q3 Earnings call transcript