Earnings call transcript Q4 2022

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Operator

Good morning, and welcome to the BioXcel Therapeutics Fourth Quarter and Full Year 2022 Financial Results Conference Call. At this time, all participants are in a listen-only mode. [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 will Form XX, XX, which may company's in ended be that or XXXX. for XXXX report www.BioXceltherapeutics.com the Annual quarterly XX-Q can Form updated factors in future and Report detailed results the September on its Risk www.sec.gov, at on which XX-K found for December the year-end

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

Matt Dr. are call Steinhart, us Vimal Chief Chief Executive Yocca, Dr. today's Officer. Richard O’Neill, of of Officer; Chief Chief Joining Officer; R&D Chief Financial Frank Officer Vince Mehta, Dr. Wiley, and Officer; Rob Commercial Officer on Dr. Medical Scientific Neuroscience; Chief OnkosXcel Risinger, Therapeutics;

and now go to It my Founder over turn BioXcel pleasure to Therapeutics. ahead. call Please the is the of CEO Dr. Mehta,

Vimal Mehta

company, everyone ago artificial BioXcel Thank mission using and fourth Therapeutics to immuno-oncology became a uniquely thank neuroscience business highlights. exactly you, clear with bring discuss medicines model joining a company in It financial and journey our and you quarter to today our public patients. transformative performance biopharmaceutical that and Welcome disruptive approaches was build and Therapeutics years a to intelligence to operator. call BioXcel full XXXX on embarked year for we X

We we are At are accomplished. what proud time, ahead. of what the even about same we have lies more excited

great significant new high shareholders. of enthusiasm company patients I that need areas to and share treatment unmet with in millions why potentially pride been has never the of and it I better you options deliver our is believe And positioned so with to value to bring

for for truly patients a for of which company. decade. Therapeutics for option been transition BioXcel in a bipolar the innovation as had a This transformative we approval on We our adults. market where stage mild, has our acute level brought are building period first forms strides drug, making treatment for accomplishment a severe nascent and year, IGALMI new FDA commercial schizophrenia there in to received broad of agitation and we no moderate XXXX, nearly Last great was treatment in disorder in a in

using We and than we we the drug accelerating platform that remain IND have in on years. first building AI neuropsychiatric accomplishments X in and XXXX notably, are advanced for to commercial laser-focused believe less AI condition. introduced launch acute Most our on Today, we an growth our these beyond. discovered from

reasons about many There why near-term opportunities. excited our are so we are

agitation, of sales path institutional To of with no is progress underway. ability and execution treat a rep. force field commercial impressive action IGALMI's of our XX IGALMI creates in fully commercial made we have mechanism obvious First, believe initial an date, analogue. We that our with setting

U.S. this with markets all the accelerating deployed sales Now, with in across reps look operation to major momentum. forward our XX commercial fully We

commercial progress his IGALMI are pleased about health families that especially care follow. difference launch details market the will favorable reception dynamics. IGALMI, excited positive, initial to the our with extremely and Matt more health supported of and highly from has already We been market providers. is in by about share patients, providers which about metric that response hear for rewarding are we is care making remarks

to various priority comprised estimated episodes and settings. believe turning significant program potentially the In BXCLXXX. market of our indications the lead watershed may medical It that quarter, data support company. Alzheimer's, under pivotal remains schizophrenia to and across agitation robust is million agitation opportunities underserved. per pipeline, neuropsychiatric year XXX second this an expansion our bipolar for believe three We clinical across diagnosed our disorder, we announce moment a the market Second, expect for upcoming represent clinical quarter we

second the Phase two expect XXX and in we include II SERENITY announce III TRANQUILITY data from studies Specifically trials. to pivotal quarter. X These for trial studies

to evaluate agitation Our Alzheimer's the to is acute XXX occur U.S no treatment Up FDA agitation. there related program of population this are approved designed where episodes the million currently annually are therapies. in in XXX for patient TRANQUILITY estimated to

trial is fully And II having the accelerating sample. patient cleaning nursing III and with TRANQUILITY begun. process -- data has with verification TRANQUILITY dosing severe we dementia The enrolled. largest in third a then home, are of patients enrollment In first to and moderate

with associated acutely I The and the two-part, III, in II bipolar SERENITY disorders the to agitated, or We who in support and upon in trial benefit XXX's agitation in efficacy occur for build of pivotal estimated U.S,. ETS is we episodes this demonstrated setting. disorder, Turning schizophrenia XX the a use program safety dose agitation adults. or setting. this and bipolar million schizophrenia at home XXX patients in II I microgram of evaluating XX

to part III, XX% imminent, Part With shortly. enter validation phase cleaning SERENITY data X are With of trial to the of enrolled. than the more One, quarter. Part Part begin plan second is complete enrollment SERENITY -- the two X already expected and we patients in

results Xb to onset reporting of the options action depressive In multiple quarter. U.S and are response. are There antidepressant second addition, dose and prescriptions slow incomplete trial Phase in we line from suboptimal disorders, XXX over filled top the treatment our in major ascending annually due anticipate million for

period, safety an XXX chronic For the X=day and are first antidepressant. of combination dosing a a twice-daily with dosing over evaluating its in we tolerability on volunteers, including or and in healthy basis conducting time, daily

The with or selection trial MDD to norepinephrine in expected serotonin, Serotonin those inform selective reuptake inhibitors outcome in is combination patients.

pipeline. research we readouts, important Beyond are these our three development near-term advancing and data

as in We agitation related conditions. antagonist dementia with potential neuropsychiatric are of patients treatment serotonergic chronic and receptor therapy developing other for a a BXLXXX, novel

has been and to developed studies. announce initiating are prototype formulation pleased enabling that I'm IND we

pathways rare our have is advancements for neuro and unique approach Our novel disorders. new focus product This AI continued candidates of the for for in company. neuropsychiatric area to discovering diseases. And a validate

and that evaluated concepts being pipeline our are XX as XXX. we product beyond expand to more than We have look identified XXX neural

R&D in to to in near detail. day strategy the progress outline an more future and We host plan our

cancer and proposition hard and adenocarcinoma, SCMC to novel by a we with been efficacy has innate types in peer activators. date positive progress results of which Lastly, is small and It two value with a clinical cancer, most journal. are in tumors and is prostate subjects demonstrated is thrilled the and database. oral BXCLXXX. our advanced has supported neuroendocrine XXXMO CRPC clinically It immune -- XXX one cell compelling safety The has published reviewed

the BXCLXXX, the with no most promising a SEMC. at pretreated KEYTRUDA, As in GU rate This XX% in heavily presented this We and FDA moving as patients in with support in ending forward of discussions potential a KEYTRUDA study is half of for combination therapies. results with ASCO believe in BXCLXXX second in FDA year, February, response SEMC to complete approved combination in with ready pivotal a result monotherapy

tremendous and unlock are are to actively potential for excited full the of seeking we about OnkosXcel our value its shareholders. Therapeutics Finally,

We an update expect to provide on this shortly.

for of paradigm lives. that on year validates approval impact fronts. launch back, significant XXXX on can AI accomplishment and and a the was Therapeutics BioXcel I The all with our development on Looking say discovery IGALMI patients of use positive drug proudly and of

the have set demonstrated out became We driver development that company we and reduce industry change of mission R&D improve fulfill we the timelines, probability economics. a reflect years These the our company that of approach a can to are enhance truly the success, and ago. when accomplishments public based AI of X

to now to would I commercial Wiley exciting call launch the to Matt? over progress like turn Matt review and our [indiscernible].

Matt Wiley

and everyone. Vimal, good morning, you, Thank

last decade. want to activities, provide I only IGALMI. an commercial entirely in market are on agitation and on for there with year building episodes, we the necessary and new treatment area proud developments Not how a have an reinforce in been we than approval focus strong our we accomplished update launch the did new more building I what we the Before commercial organization, of an message took no Vimal's which steps of of investment a of

market later to sales important to from year. this to context move this as It's development understand acceleration launch we

the we year. the Our firing all new running commercial as is and engine cylinders into heart efficiently move of on

XXXX, at report Looking organization. for commercial can the transformational that was fourth back I quarter the

Most as with target to we one for representatives to the exposures to expanded patients, sales importantly, XX We're hard us of working IGALMI full of we last the pave objective, XXXX. to IGALMI X,XXX us. Considering we to commencing launch entered access December. to us lives positioned hospitals to matters treatment. way patient force XXX This to each allowed and meaningful deployment volume potential than from the and improved broader of this successfully change and the continue our fully reach more expand that

year our from They more did our original or extended years our team the over same product depth unique target eight has of providers. hospitals This an the already of of sales reaching sales our care necessary to launches. begun an team original experience last X,XXX team impact. momentum and expanded and have of new launch have average of more X,XXX average to date an health members than to industry team as XX The members with continue experience reach making

increase process year. Interest adoptions IGALMI And is on provide formulary some this formulary progress. reviews in and grow. expected continues share to in accelerate With updates in this and that P&T our to I'll mind, of adoption voice

of XX secured we know, total team team more to of in XX with with a formulary X X. XX representatives. last small XX and those is you accounts is Tier has year launched As than This date hospitals IGALMI access Tier

XXX that have few these also reviews approximately XXX P&T more process the or we place should have We and -- X Tier hospitals. months. than next Of over also take

within to months. review right typical that window of the X time are now We of XX

made sales XX% the original or lining with targets to in its So scheduled meetings approved vote. these either progress original significant has of up team

of matriculate in these months. coming more the P&T's We into expect to scheduled efforts votes

result and IGALMI third IGALMI. have providers. wins with Our second and This deployed their due the prior efforts. to see research representatives P&T our expect uptick XX we second should pleased to to to care Market meaningful formulary their and in wave hospitals, health that for the in patients in just to and we to date, newly process continue expect experience begun would value has a quarters launch been majority indicate be a formulary of of perceived we see and hiring efforts votes boats to

prior as to We hospitals see encouraged approval. the systems and are significant full We firsthand ordering this develop experience have win. a product several begun and already that

As IGALMI, anecdotal safety. and response, possible hospitals feedback regarding received experience staff we've -- positive throughput patient with gain

qualifying On and program this trial a specific to hospitals facilitate to own free IGALMI they can topic, determine to quarter. This provide system with experience to value. launch this and hospital early their to later metrics expect designed analyze program we is

We demand Novo Institutions nationwide. expect De of this IGALMI with program the to accelerate

Turning to market access.

with covering contracted half now have the We hospital organizations purchasing GPOs, or three beds. of targeted group

and GPOs, discussions help negotiations in reviews, with the are adoption pace specific that major contracting While focused system our IGALMI. remaining access have or provide attention IDN delivery the of we integrated on to system to two wide we will and network accelerate

As noted approximately our account in previous team the in IDNs, calls, targeting is having States. XX XXX,XXX a beds total United of director corporate

X,XXX for beds with formulary the anticipating two or secured approval more we've just far, So next X% over XX,XXX vote over than quarters of or XX% those a or so.

further these the So yet the process with systems engage. not may entities to lots [ph] of remaining some of contracting that with have review accelerate

efforts we're teams. beginning time, significantly We're access. marketing ramping our same the field to our to support up At gain

on is a positive as campaign providers Based both patients campaign providers to our ER managing and bipolar helps position on IGALMI practice for launching and new are nurses. such We collaborative approach schizophrenia as as health advertising research care and staff us advanced this a IGALMI to and a motivating solution agitation focused targeted patients. and HCP

media, our in second institutions applications. media may media print more and on and team in digitally sales those our means hospitals the see This websites or in encircle smartphone deploying IGALMI to We're quarter. XX.X through We've deployed digital campaign effort a generate a U.S. anyone than the expect also and with impressions popular to this million computer geotargeting advertising target

attendance We've more HCPs. regional large a that with effort a than speaker In to planned further the deployed promotional six scale our message on XXX provide local exposure. national conferences amplify will at presentation conferences IGALMI to marketing comprehensive also team or targeted and this addition, year peer

tremendous organizations of commercial the bring to important patients. of proud new treatment to launch IGALMI with this option progress I'm

norms. brand field and interest and outpace the team success palpable early industry energy is to Our our continues in

and While the hospital to launches excitement this receptivity drug peerless. and grow continues market uptake, there's an expected of traction patients is to for and promise to

in are and a in We agitation. creating not our could be disrupting market And this confidence higher. brand

OnkosXcel of an turn Vince I'll call Vince? Now to overview the to recent over progress. provide

Vincent O’Neill

and Thanks, morning, good Matt, everyone.

many the reviewing Therapeutics. minutes few a our subsidiary milestones spend exciting to recently like I'd So by OnkosXcel achieved

which immune me action AI let DPPX our our immunotherapy design via platform. So lead This oral novel inhibition. turn BioXcelXXX, a investigational [indiscernible] identified our mechanism start to is of activator innate is by candidate with

expand KEYTRUDA, given by of In underserved for the focusing potentially immunotherapy XWE of recent medical need major landscape a with addresses combination patient believe populations. large, in even into This the setbacks on This immunotherapy challenge unmet XXX development relevant very immunotherapy tumors today. aggressive the cold more forms can combo in cancer. activity is prostate high

So as the very prostate aggressive results in II mentioned a data are promising for with efficacy rare combination demonstrated form in safety Phase most and cancer. XXX of KEYTRUDA

and know cell clinical continues derisked, neuroendocrine as Importantly, we small in have be pathway believe we XXXs to both clinical cancer. demonstrated adenocarcinoma POC

FDA We potential small a for XXX pursuing many, positive to half X initiate potential indication, year. In Xb registrational we and particularly Building our half and shares with cell phase data deep of in of BioXcel to it cell neuroendocrine neuroendocrine and on study commonalities cancer. Phase cancer, and trial this we of many are We're initiate small year, for knowledge new DPP to subject XXX plan a biology small indications. this the about line. the the in XXX's second lung based Xb cancer cancer clinical second this excited because cell on intend

we're addition, potential partnering academic two Cancer beyond trials. company our sponsored premier to explore In XXXs with Institute's

in Lombardi AML. and Dana-Farber Phase Phase a First a with trial Institute in pancreatic Cancer with Xb/X Georgetown in and X cancer; trial secondly, Cancer Center,

to inhibitor. overexpression DPPX DPPX We're lead as also a our and developing next are candidate biomarker generation evaluate continuing

our So we're OnkosXcel. very about progress for taken with excited future and recent XXX program together, pleased are the lead for immunotherapy the

hand to Rich. to like over CFO, now our I'd

Richard Steinhart

quarter, I review from trials revenue now nor to stocking full our resulted Net Vince. Due model the was and the for year the you, limited direct company's which and $XXX,XXX Thank for early expected wholesaler approximately full to hospitals, $XXX,XXX financial fourth quarter access. results. and XXXX reflects neither XXXX, shipping will occurred. market product was year

trial XXXX. related were $XX.X compared expenses in an XXXX R&D -- quarter increased the the period expenses to the million year fourth Research fourth $XX.X for year XXXX period attributable to the our expenses pivotal BXCLXXX the increase to development same in to million compared same and the $XX.X primarily in million and both for XXXX. expense for increased quarter full $XX.X the of were full for clinical The were programs. cost multiple clinical million

compared XXXX. the costs quarter for were the were $XX.X SG&A in $XX.X period increased related the of due to compared expenses expenses in $XX.X were year for SG&A million year the the the costs the to fourth as quarter of million million XXXX. as million and XXXX to XXXX States. same both for in primarily $XX.X IGALMI full for and United to personnel launch The full

XXXX loss period compared of $XX.X -- million of quarter XXXX. for for had same million fourth had of a in a a to the $XX.X a million Therapeutics -- $XX.X BioXcel net the loss loss net

year, in loss $XXX.X reported to for includes a of For compared net of The company year loss the the million the XXXX. for in same noncash compensation. $XXX.X million approximately a loss $XX.X stock-based million, net period the full

believes Total totaled cash XXXX, at December $XXX.X XXXX. that Qatar tree into cash Investment XXXX approximately oak million of XXXX. would our The in to expenditures company with XX, cash the execution compared a equivalents December runway XX, million. at financing for Cash Authority $XXX.X strategic million result $XXX totaled and and full

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

Vimal Mehta

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

Operator

proceed of with first Please question. UBS. Our your from the comes Bristow [Operator with line Colin Instructions] question

Colin Bristow

the continued progress. Hey, and morning congrats all good on

and ongoing hospital. you use IGALMI wins. the hand formulary the the XX Could walk one you available just the us you of first here denominator being then help drug launch voted? in terms have us the And from timeline on a actually typical for is have formerly win how in through what formularies maybe The many to

know Secondly, some guidance give pushing lot. how you keep a progress TRANQUILITY on further progressing? is enrollment on I the update making, XXXX. revenue given an And Could the then potential the III. you just sort provide just this. you Thanks lastly, looking just what's are future, on just of a in I guys bit to into us

Matt Wiley

morning. your Colin. good Matt. question first about is This Well, denominator. On the

our said the of we're one in the we're a two. prepared things about And I winning wins. formularies So process. our that's of is of remarks round two-thirds sorry, winning that majority in I'm

XX would we to we out saw XXX, means market that and is, what and that research, that's roughly so that continue. have expect what of expected. we in And We

what right more we're In cases, mean now that exclusion cost. Colin, they doesn't is no for many driver finding, experience. necessarily want And no. primary just The is

So in their own in value. hospital their they want in to a to trial system site the or or a assess drug two

no year, -- a So little hospital of the how come the not getting cost we're offset back bit the system. to a in impacts our hard we're getting more we understand information want

that's and timeline I a you would of Day So I to. Commercial that the question. second deck formulary the There's couple between the win in think point a uptake? actually slides

formulary process market care about year. then providers anticipated to the in that X the months. to would of X And first roughly months XX% on between And a XX% a research, So trial thereafter, takes average. X to health in goes drug months the up we that third XX between somewhere and

P&T when to that's approval, demand there a through. really as we between begin sales we So generate when a to organization. and freedom And have is that's lag operate it pull

for these in I -- X said, peak somewhere types a protraction the is there's of hospital to products. years why That's there to the ramp process. So a is between XX as

Colin Bristow

take morning. Colin, third let Good question. So me, the

as wanted our and enrollment II II. can with been TRANQUILITY was we learn as that primary focus to TRANQUILITY much has we Now completed,

ALF is trial in that know, residential you setting and As now.

for setting. nursing moving are We the home

So but conducted the resources have the III. trial all trial collecting II, been will not expect data to is data we TRANQUILITY than enrollment have provide are when we be the directly any once have all different don't we we the to expected. guidance data We TRANQUILITY a any and readout

Colin Bristow

Great. And on the guidance in 'XX?

Vimal Mehta

a is think have under confidence been have we start And know, asking confidence where we question. will is the quarters metrics in we fair demand, of the belt then he Once a in launch that And once launch matrix have I I the providing. our we in we keep multiple our projecting robust. has resulting high-level Matt, matrix launch revenues. that's demand.

XXXX, we that guidance goes, like So we provide how What will you add XXXX to provide. can Matt, anything?

Richard Steinhart

just revenue a is that Yes, lagging indicator.

steady a So how of add now it that decent most idea, the providing a but should should provide the as to you revenue that lot be we're things give idea get and of of able up a progressing. metrics some behind comes ramp more we right as up. get The we're you will those

Colin Bristow

lot, a Thanks guys.

Vimal Mehta

Thanks, Colin.

Operator

question Please Our comes line next with from your Securities. with Karnauskas of Truist Robyn proceed the question.

Robyn Karnauskas

for you thank my question. guys, taking Hey,

So minutiae date here to in, not questions of so But it implies launch. that orders coming guess, the several deeper your you some into looks scripts X,XXX used. said this like And sales to over I drill down are there first.

is stalking you available. formulary, XXXX beds a we stalking? or hospital once number, Like you have the of if how get are at is it Because much how now look that So drug? you said they on hospital

you about access? a market number. sort Have for had It total the can cost purchases? amount. just the us situations. of to you how thought certain wins improve of many have And gives adjusting we the cost? actually Are you that Thanks. good And cost formulary factor then amount a of understand I'm apply date adjusting lastly, that mentioned to So, was XX how X,XXX then color, trying to

Vimal Mehta

All unpack right, a there's to bit there. quite

take it. me let a So shot at

exposures that that draw wouldn't think those at those went those look we would that fair disclosing We So in of that shipped we're we could might QX. how metrics. patients? But a assessment many I reordering the that it's indicate yet. into patient have. units Typically, number you necessarily of not in total patterns and many How know just hospitals films

drugs. development units, their some where could a to be and how one could may guide each there it So of works in be shot, it units, be it waiting could in patients, be type they for several help that hospitals in order bring them of it protocol to just and to give strength see utilize

yet, So reorder necessarily that's been every a we're the early still carton process. ordered, triggered has in not but

X,XXX numbers, launch actually, the organization. both care So through of the saw expanded to sales and providers actually that year date, we our original health number -- unique to

the actually within universe number represents as non seen hospitals. be in continue there of well, So just team our see the and reach, that we where of hear We back we in that that our good institutions that on hospitals when we seen, But really which contacts target X,XXX in necessary, XX% so hospitals physicians over to Again, seen. hospitals considering inflection want number an are were target downstream and we've us. we're at see we might systems about X,XXX expanded making from total we've December. around we've those that to is

So number from. that's X,XXX the where comes

of almost it either means Right targeted half either we look so, those in within that P&T at original reviews are of the -- process. now which formulary there XX, original for original over or of XXX they access, institutions team sales the the process, implies have vote. those half XXX to in that process are they have are have our Roughly they hospitals or their those, for targets in when

So how on of have purchased? guidance given of those the haven't historically. formulary wins, any many We that,

order. little those to have a ordering kind those have that of the had approved bifurcate or too early the now non-formulary drug order, that we've we've it's access patterns had think I

the to product it that is that formulary, What these them not they're it is reorder, easier tell you product more hospitals of trialing can we on expect the bring would because time. I online. just we pattern continue for at so as makes And the to once

anticipate the at all. adjusting cost, drugs. doing Adjusting considering We that wouldn't the whack the we're price of not

with contracting may the with GPOs We selective and place the have IDNs. in do will we contracts

quite And small. of is net that implication so the gross

that However, it's that especially something may those broader our universe. are hospitals, to within of swath to do get we target access a not

always has plan. approvals of of been throughout And accelerate the help system expect part year. that those that of we the So that'll course the pace wide the

Robyn Karnauskas

Great. really helpful. just XXX. That's on And one

be the Would high, Given even your sort KEYTRUDA tumors cost. How to doing combine inhibitor? going inhibitor. going know these to with have in are to the you you expensive. to you're that academic you about checkpoint in a checkpoint reduce to thinking of if is -- forward, a turn cold you partnership consider of I you're studies expand obviously or help with in-licensing supply lot own

Vincent O’Neill

Yes. Hi, this is Robin, Vince.

So to discussing need us would certainly know given we that agreement as purchased KEYTRUDA of has open on partnership. most some or flexibility, we to a since definitely But the you have supply market, negotiate partner. then to with or be kind wouldn't deal date open and with

So is we're to the short certainly that answer. open

Robyn Karnauskas

Okay.

Vimal Mehta

Thank you, Robin.

Operator

America. with question. with comes Harrison question your proceed Please Greg of Bank next Our from

Greg Harrison

Thanks guys. questions. taking the morning, good Hey, for

Just two from me.

setting? providers First, you have And expectations what who TRANQUILITY in the expressed that have data, then and what they SERENITY used have how IGALMI what home there? are heard III II from in far? responses the so will disclose interest your And and you clinic

Vimal Mehta

So Greg, first handle one Rob. the I'll with

potentially they exactly be, they would staff avoid of of expect it is seeing consider the hearing they're IGALMI onset it everything the has injuries, from that that landing been field what thought to, So would way promise it it we'd to want we're rapid. everything better action we throughput. They're the using is

cooperative And them we care does so that it want to fulfill experience have.

it great gotten for we've so to specific And from the field. rob I'll a feedback turn example.

Rob Risinger

Sure.

course, So and worst of the worst. the this trying are And I on get messages. text email contacts, seemingly frequent providers of

they in you the to give provide I'll So both within to improving, film. were let shackled patient in XX such the And and discharged us ankles out and And wrists, restraints, released X know. to result. they were hospital. wanted patient point are they both out of saw This reached the minutes, arm from one fact, point X an Physician some restraints, and they was the later to hours clearly anecdote. the us impressive was gurney,

physicians And standards clinical care, new I So treat to sort this certainly fits this of people. more at having practice very positive of hope effect and reception that the nicely an in a the point. think clearly of is it's humane with way we

Vimal Mehta

it in patients I And that, to And like you mild, real if moderate label, of that are top says are of life severe we severe. treated. just our being and think seeing add on

So is market mild will severe. that have market not excluded, we to from

your Greg, how -- second Regarding question, is Vimal. this

we your in done question we plan Regarding process company follow the to disclose the which have the will we second past. data, how

a of two have in are the weeks. followed a will street. we happening several pattern that That’s really It's release We for plan up line follow have those press top the data, have datasets call and we the with and gearing to next we it. all for

Greg Harrison

guys. Thanks That's Great. helpful. again,

Vimal Mehta

Greg. you, Thank

Operator

of from with Suvannavejh your with comes Securities. the question. Mizuho Please line question Graig next Our proceed

Graig Suvannavejh

going. morning. you've reported think One, sales much second line that I Hey, to and you of number pretty how first good just sense is how questions. the in were wanted a the get two, quarter just taking quarter better whether And you my for particular. had with Thanks is in thinking. uptake

good resetting expectations hospital It still you job into than expected. think uptake and I process gradual, formularies. done us slow have that I given the of would think many is a on be lower the getting

just around that. So comments

just about then to awareness kind efforts of maybe of your to the product. wanted And secondly, also raise the ask

that But with drug are we know selling previously, these we're whole think And I is itself. or wants response planning basically what the campaigns. this made an Thanks. just the newer clinician product these to the had is on [indiscernible] to uptake initiatives hearing if a yet perhaps think are you've that that there's impression free program, how targeting been in time? call in line I there's now

Matt Wiley

say [indiscernible]. no a lot and it's that sells it. put a drug Greg commercial to the I'll So first We sales itself. behind effort be of marketing

me Let first the about uptake. talk

place. the think X, would formulary it as about really for takes, process take again, months I this way So the curve, XX to uptake

our XX July reps, first for of that was last So in year. re-launch recall

right we're XX-month X to for that representatives. the XX original So window in

curve formulary of once just shared earlier. Thereafter, that's day uptake have when P&T some approval, commercial you data I from those your begins and

will another X take to place so that And over XX months.

so timeline And we that's the expect. should that

in in started XX this next cycle, our keep mind beginning Now that December. representatives

X formulary P&T going June the going approval for that's review May, their XX-month to in So timeframe, window it's start. and be to to when is

of that's to I there's hospital. think uptake simply a So that. They curve. of the a a and through to first about months their launch the go process do of have really Theoretically, see would you lot X for revenue lot how the shouldn't mechanics drug in

free about the question that I effort we're one try [indiscernible] and said of and physicians themselves, so about. your things that before see have is exactly talking Regarding patients trial they the they program, it, what marketing experience and when

launch, drug is certainly So when a drug hat, we're big no making not it a huge as it's impact cattle, And tried. this delivers promised.

where own little why so bit some And had pushback hospital. doing quicker. their on that trial to a exactly program, see some chasm value doing That's there's or to We that cross free to them it. cost we're needs be evaluation want a in

decision P&Ts to formulary want a awareness pressure on it the and efforts, hospital. raise we these makers relates to the in As to additional put marketing on

States, and just [indiscernible] but process of have the geo-fenced every on lot. the to in part pressure target And United going the to see a awareness, we all So demand. not hospital process drive, P&T that's IGALMI they're

Vimal Mehta

Greg XX because deployed. member add, marketing why team will seeing effort, I what is have you're we more And

-- rep our a like we and lot for we XX did with designing So team strategy first XXXX. the was learned then

integrated underway I would infrastructure. the a in are say commercial full with So commercial efforts XXXX

Operator

your from proceed And Sumant Kulkarni of our the Please Canaccord. question. with question with next line comes

Sumant Kulkarni

morning. Good ones. questions. taking for have I quick Thanks three my

The focused. sales investors very behalf and of might first on be is that specific, very

way Given what the now first quarter, two-thirds hospitals say film of specifically the sales can performance? the into you actual to the into XQ relative about

Richard Steinhart

Yes, we're not.

not to that's on this quarter Sumant, question. this great But it's guidance So, -- provide a we're on call. going

Sumant Kulkarni

cleaning question data XXXX in quarters timeline relatively Are the Got it. on for P&T meetings? a my of in What might like this? heavy typical and for last that committee any pending is trial there a quick terms XXX And is TRANQUILITY II. verification especially be

Matt Wiley

over XXX expect depends schedule. committees the the out agenda, answer that saw to we this in It through commercial may cancel they I meetings, decisions process, meetings question don't quorum. may would not P&T I their in full several that they P&T their think have months. to So hospital may get about push Certainly, next on day if the happen

those up we're meetings to able good operationally done. and on put more a been themselves far. come and the quarters. online at just the see we've lot see of P&T to the the But votes So about we we next pretty really books And to those expect the feel matriculate, so what take whims couple not getting over

Vimal Mehta

you imagine, next can your and provide have in as we normally have lot than data And question three cleanup standard So all trial. going more verification, for trial data you parallel. pivotal a what when Rob can Phase the higher a you're X they're readouts. because about takes running you

Rob. So,

Rob Risinger

a it's patient. it's although a particular -- months for X is any trial, this duration quick realize So

have there's dosing patients, a data so only and source doses a other had many, to called verification. for we And of patients some had or some of have doses, couple do have what's may range

So the what's our numbers in entered against a That's the database of are that actually in clinical work. lot we literally records. medical check

anywhere sure and literally it's X to accurate, weeks our So by XX data correct is people work make precise. from of daily to many

Sumant Kulkarni

you. That's been helpful. Thank

Operator

Our with your next from of Yatin question Suneja with the comes Guggenheim. Please line question. proceed

Eddie Hickman

is for good on morning. Yatin. Hi, This Eddie

side. disease the agitation a Alzheimer's Just few us from on

showed there for are are on little prescribing And that formularies? filing about? the just able expansion, in other details Given work re-dosing you've monitoring, you Thanks. the give older spoken safety go if more would of the patient that required and label reimbursement to an get already a for us that population approval you've how can versus then and what ADA, or with beyond and been bit showing hospital setting you outpatient data what

Rob Risinger

beyond address requirements what's demonstrate So fact, above the and to straightforward, we're there's a doing, safety. I'll just additional very necessary no going safety in

of lower And outpatient know so in the adverse the And that fact, dose current in lower we're setting. will be terms expect taking greater similar requirements. why labeling a We safety safety and is, very events and to we that doses label margin. the have

I'll one setting within the to is because safety we the of as the the demonstrate home or that at be very within So expect trials. reimbursement an different a label in it the will And leave outpatient fully outpatient setting. hospital these of in setting. expansions or clinic result than a

Vimal Mehta

Eddie, is Vimal. this And,

me Let said. add to a little bit Rob more what

safety, monitoring. of doing are the X-month terms In follow-up obviously, we

drug outlined to will need endpoint efficacy the is that's for initiating have also we And dementia be study they efficacy the endpoint of our show if safety in we is the primary open-label the to more show. XX-month and already are and [indiscernible] what of have So a what after primary terms to patient. we the trying safety that we the episodes,

of terms -- safety drug is understanding, Did of what the our today of primary what endpoint efficacy open-label your our of we a XX-month works as follow-up in study. of over And a in show efficacy, it question? know period there then when endpoint, answer X-month terms that current or to terms in time, So both safety. is to and

Eddie Hickman

helpful. second And to to those it if if like, sort work the you for that's decide patient reimbursement how be then on the of re-dosed, part on the be get label the did who in they needs would just monitored? that about need would setting? Yes, if work How would

Rob Risinger

in cases. for very worst what so hospital they're is of feels Yes, to a well state. it. the at them This home fact a in treatment go aware when agitation, to aversive patient brings the It's

take no to be dose. improvement, the able may if of patient time, and a the take may So they of second there's a medication after course, period

practitioner, be this would them. health of be would this, nurse outpatient typically terms who for prescribing might or prescribing And done. a mental cetera provider, et their psychiatrist be reimbursement In

Matt Wiley

mean, take entry market for I Yes, we're strategy the so, that I on that. this. done we've can Eddie, one of working things

either or the dementia for half of patients, we're When those breaking at market. Alzheimer's are prescribers who look neurologists. down therapy are initiating therapy switching roughly prescribers we the So

then and some psych as care are they I boarded, memory know Some could they're are double primary they bucket, centers what if the don't are, well. I be although put what in in

It bucket. [indiscernible] in retail through that being they're that reimbursement PBM if benefit, be traditional or reimbursement. could So is said Medicaid

of the reimbursement traditional model than hospital. a more it in it's So is

Eddie Hickman

much. so you Thank Great.

Operator

Jenkins Our your Goldman with next question Please proceed question. comes with from of Sachs. the Corinne line

Corinne Jenkins

period? program, interested over program Maybe terms too that good on physician in providing -- morning. you drug Yes, the not drug do how just but long sampling of in of designing optimize overdoing and drug, maybe to the free free think constraining product about a like getting

Vimal Mehta

long So for acting kind way of it's The hospitals question. in a injectables the great paved this. the

So there on is it. guidance OIG

We have what very order some than able more a a call specific the belts not quantity, is very and program. hospital limited trial very be suspenders to serve on to I'll

now per that months. two the right cartons So limits X are

in we our We with want want and but get And that to with so experience that's the they experienced these get hospitals the flood to right business want sure don't we to goods. rules. market patients, certainly free make

Corinne Jenkins

that could study? observation you case Okay, that program, and maybe what's kind investigators of best endpoint. and then period? happen the of the helpful. evidence How watching think to both primary on study about what regulators need And just on are scenarios the TRANQUILITY we [indiscernible] important the assuming for portion most statistical should And X-month over

Vimal Mehta

primarily getting if a period, trying have episodes, follow-up. to So the a can month, another have This Rob? what in that the we so hi, Corinne. demonstrate we that the primarily more, show they X-month -- is another is drug they or start which episodic they X-month The dose, three Vimal. get if is -- it's into week, and episodes in are agitation, effective, three episodes that's they that

Rob Risinger

FDA to in a that with agreement. efficacy, up this just safety statistical design both do. This trial what met not the also safety study We extensively is to pivotal of and designed efficacy. come Of trial course, but and is power and is for interested the is with them

Corinne Jenkins

you. Thank

Operator

proceed Our next question. from Please Wainwright. the of comes question Ram H.C. Selvaraju line with your with

Ram Selvaraju

much. Thanks so

Just a ones. quick few

but was to no, are I said before kinds if they their the formularies that what looking respect on in to which demand, Firstly, wondering they see are decision and of comment no, trends you IGALMI. have with degree for hard, to looking trends could not reconsider

focusing little and bit simply the is you comment wondering could you the OnkosXcel Thank a prioritization for longer neuroscience if XXX. juncture, was about on considered being spin lastly, opportunities of timing just potential the the pipeline of this could rest whether partnering clarify I no you're if of And out at development the Secondly, of XXX. beyond you. and

Matt Wiley

Rob. All right. Thanks,

given have the in value. their for now. evidence, what call I'll specifically they're to that more evaluate institution formularies the, the soft the institutions Certainly or looking own on So

of sorts want them be that to to their throughput, stakeholders they that's the drug, Those that response value reduction the just of patient whether the from looking hospital the time. improved going injuries, So might see certainly to noise more help. they is the things response are for, want in staff or this

really those And maybe into that and everything do soft are time. intended to turn so doing we're the all decisions that is efforts over forward a no marketing push yes the to

like hand their raise the my IDNs, the institution. say, in I we about looking and then And systems this of larger as think to they're hospitals for want their more

working decision, decision. concern noise solve sure the to value to we're where that certainly to for we're anywhere groundswell create or that able there's we them. And and those about make positive fronts a on want them to all mark the So of IGALMI to question push the a it

Vimal Mehta

to they hospital way Ram, people I I've staff add beyond. for pay will so one question. cost just injury depends It to. you're IGALMI sales heard to from can will if the avoid talking many who a things that member,

case value driver. launch as presented reordering bringing, and even the are came being it's know -- and So always to is drug Now market that we it study you. that And minutes. said, of used like, out are pattern changed before seeing like to the we favorable who the gets that's IGALMI a severely Rob big used, obviously, completely what People once that we seeing XX people used ever get drug within them will the be situation agitated patient in patient? very then in allowed

our in reception That's investment So we I I'm provider. continue great them market better any point have at commercial the I is part think at very have make feedback reason pleased think the to place. commercial that And make the decided care we And health where infrastructure. are what a apparatus we in IGALMI full been have not from to of could we observed.

through working the we hospital Now system.

your that XX get can with million and already and million been setting market. home additional two place sNDAs covered to with million IGALMI, episodes, XXX we investments for Alzheimer's Alzheimer's at timing neuro agitation, will at put home in XXX, and setting back pipeline, so and million Coming plans and prioritization our that have on XX XXX all expand

billion leadership this All space. opportunity a $XX addressable target in and it's of you we know a position huge have it's market, a

continuing are generating productive already announced that, been is has it we XXX. very and more but assets and platform are we AI our So

So, we are pursuing XXX.

a We new have formulation. created

the clinic initiating to are first and can half study, We IND in believe go XXXX. enabling the we of it

So that are XXX. we kind timeline targeting for of

II, part TRANQUILITY no the III, four was on I, whether regulatory pivotal Partly, like bandwidth when there SERENITY execute in SERENITY more conducting to or the TRANQUILITY are clinical you company, things trials, II. part

to in good for is execute So clinic. timing the really XXX

are process, our In that privatization happened that R&D normally one select through before will dozen addition, a stage we have concert we and sustainable about we going will pipeline a outside concepts. and XXX. almost has XXX XX have they generate product next And now product

well So for that's X as the game to neuropsychiatric as symptoms plan years, neuro-rare. next X in the focus

Now both of on focusing we them. are

In timing is now. the OnkosXcel, couldn't better, I time the any this is terms think of be

[indiscernible] the very GU. seeking independent there. the started as as have We a and actively and presented and potential X outside pancreatic just Phase execute has CLC XXX already data ASCO that pursuing And a investment partnering AML. have at posted had both human is at outlined, the can prostate options, plan exploring cancer We potential well their in all business that so information plan trial OnkosXcel on proof-of-concept upcoming pivotal we Vince

Ram Selvaraju

Thank you very much.

Vimal Mehta

Thanks, Ram.

Operator

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

Samir Devani

a my of Thanks terms taking in operating Really, this Hi, questions. interested just I for more bit for guys. year. the guess, little costs

now Rob, a on spend. And sales incremental marketing reps and XX we've think, million got full about obviously I XX board. talk the you

marketing we should costs we year. this the just incremental And ramp and pivotal I'm wondering obviously, be about saw R&D, the sales So how ongoing reflecting on studies. thinking also

it how last QX basis, be maybe QX in away about sort quarterly Thanks a we should that? then QX. QX on QX, much. and similar so wondering and year, QX and to thinking levels dropping Is of Just

Matt Wiley

Samir. Thanks,

if you in bit conducting Our still are I some I of somewhere the a the it we look million extraordinary in quarterly XXXX to or at -- costs, was it three continuing. $XX now and quarters of programs in not because previous have them outlier, little in our so that because QX QX around you should you're thinking was pivotal be would XXXX and multiple some what say. want and completed should between Richard, would if say you it thinking cause be was …? in do were

Richard Steinhart

with that, agree completely I Samir. Yes,

trials several to the that’s should suggest through pivotal go off of deployed. fully as you not of in money drop we and be year, we as start sales So and terms force these significant burning this have much

will we money throughout year. spend the so And

Samir Devani

incremental I in fully deployed the Thanks. QX, some still is follow-up. or [Technical be just Can there force sales to that? in going QX -- for difficulty]

Vimal Mehta

full No, place, in sales have commercial we team. operators XX

have we have marketing, we team, CAT commercial have operations. We

MSL full team. have We

execution now. I it's think time

Samir Devani

Okay. Thanks very much.

Vimal Mehta

Samir. you, Thank

Operator

the And Please Graig question. from line Suvannavejh your proceed with Securities. next comes question our of with Mizuho

Graig Suvannavejh

this Yes, before. I ask forgot thanks for follow-up. my to taking

process is the as curious about other two sort price yet separate been more pushback, discussions with was perspective. any related on comments fact you it's timeline was which timelines Thanks. to you a whether Just are secured GPOs. wondering haven't could major the are the made some your with from other related they those or that run providing of their to that whether they they give I discussions or if the whether to color,

Matt Wiley

Yes, thanks Greg.

the And we're finish is that report them I nicely. And progressing so quite one to of can close line.

is raise their And They when hand. that see a notoriously do. so host we then downstream hospitals another there's we'll wait slow. to whole of their out on that And report one

engage to build to hospitals those through them working we're some momentum further. for So

side. be their [ph] discussions have expect them, We on protracted we process with them to had a but

So, other will we along. come feel good about one out of one the two and the

Graig Suvannavejh

much. Okay. very you Thank

Matt Wiley

Yes.

Operator

CEO call for session. Vimal closing I'll And the And the we reached Mehta of back over to question-and-answer have turn end the Dr. now remarks.

Vimal Mehta

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

Operator

today's conference, participation. your for concludes disconnect your at time. This Thank this you and you may lines

BioXcel Therapeutics (BTAI) 9 Mar 232022 Q4 Earnings call transcript