BTAI - Earnings call transcript Q3 2021 | BioXcel Therapeutics, Inc.

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Operator

Good morning and welcome to the BioXcel Therapeutics’ Third Quarter 2021 Financial Results Conference Call. [Operator Instructions] Just to remind everyone certain matters discussed in today’s conference call and or answers that may be given to questions asked or forward looking statements are subject to risks and uncertainties related to future events and/or future financial performance of the company. Actual results could differ materially from those anticipated in these forward-looking statements. Risk factors that may affect results are detailed in the company’s most recent public filings with the U.S. Securities and Exchange Commission, including its quarterly report on Form 10-Q for the quarterly period ended September 30 2021, which can be found at www.bioxceltherapeutics.com or on www.sec.gov.

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

Officer Joining Chief to Mehta, Financial Executive today’s Clinical Therapeutics. call Development. Chief Officer; President BioXcel now the Senior Vimal turn Mehta, are Dr. go the Scientific Yocca, CEO Officer; Frank pleasure O’Neill, It Medical of us Rob of Dr. ahead. Chief Risinger, Vice on Vincent Officer; and my Richard to is Steinhart, Please Chief over call

Vimal Mehta

joining Welcome, our operator. and everyone you for today. you, call Thank thank

We quarter performance the will our business and financial update you of on highlights for third XXXX.

we Therapeutics as As a January pleased you PDUFA is we in commercial progress tremendous know, well biopharmaceutical a neuroscience to BioXcel transformative near as and our approaches neuroscience is very intelligence exciting utilizing immunooncology report to medicines are develop franchise our company, as And in and artificial time It stage and X planning for immunooncology. launch clinical company. the date.

to discuss We have today. many accomplishments

our Let’s neuroscience, most BXCLXXX. start advanced with in program

For the X. with schizophrenia treatment X associated bipolar disorders and and of acute agitation

that a candidate our are and years. NDA any AI-driven speed in X this download from FDA company is for development lead has drug filing under investigational trials not our milestone as that efficiently. remarkable as aware reminder, we is This acceptance this first-in-human of As discovery to other we achieved

activities well. than away advancing potential commercial from readiness less launch approval months now X our are are We and and

large working outpatient We on-boarding with experience deep neuroscience launches expertise, institutional in and for product and startups have VP have settings expanded They sales Director. Regional our leadership, including and Sales Sales a companies. multiple and of both

our on recruitment sales territories. across are team We focused key for also

educate XXX. evidence-based pricing similar audiences finalizing analogs. market no launch key are Through to about our continuing research for We and strategy innovative our with strategic initiatives, we products two are through access market

designed This thought is launched broadcast theater the agitation that campaign schizophrenia of bipolar a signs, around symptoms healthcare leaders. disorder. includes and fully the on by acute of with patients agitation, schizophrenia education broad campaign campaign, severity educate and our for in and the is have key and importance providers treatment The disorders. we to of prompt treatment bipolar and multi-channel First, of with non-invasive disease associated product promoting awareness level presentations full spectrum

managed agitation Second, our and and and institutional medical that bipolar level treatment on at country. are we schizophrenia engaged patient booths educational conferences participants the science conferences, providers and around liaison with a teams medical healthcare effectively actively care several informed to and assess at follow recent had how At the guidelines.

to conferences We continuously with launch, while will months neuropsychiatric the at valuable are providing building of leading actively with initiatives agitation ahead. insights continue for us participate disorders. Two awareness strategic associated commercial industry important in

option about than bringing be associated the and excited agitation are more for in therapy Equally treatment We indications to new first new a potential bipolar the possibility with schizophrenia millions potential these decade. struggling to significant, of patients has of a product the acute XXX innovative the disorder. with

rapidly. Our growing neuroscience franchise is

and a medical approval extend XXX, indications the you we geographic pending expansion treatments recall commercialization will three-pillar and our XXX beginning. that believe grow reach have expand offered. where for is BXCLXXX. we for fact, In to intend strategy the are our just We portfolio And settings

within our review progress quickly each these me of Let three pillars.

the potential. are regulatory the in We type of disease U.S. this a in related program Alzheimer’s patients indications. with in the evaluating Alzheimer’s agitation across QX disease represents is most considerations This multiple clinical, and and meetings pipeline XXX advancing and several follows plan a Phase pillar treatment year. expansion with FDA indication our of we strategic of prevalent the commercial dementia to XXX acute to X initiate a XXX within for product reflecting First,

Up We over Alzheimer X.X Americans XX.X over of million disease in in in XXXX experienced the orally agitation increasing agitation if with XXXX. where an patients old, available estimated mark year. U.S. years, to XX% XX believe every no in there context, therapy, approved million from first to the is would next For XXX episodes million to XXX approved, expected FDA XX double of are the currently those years therapies.

the pursue of area, other this unmet as Given to development. in subtypes part medical intend future need we in our BXCLXXX dementia

as into Americans It an on major public depressive is are currently or new XX% Phase in diagnosed with treatment. high remaining those more we major unmet million evaluating trial that XX burden dementia, after indications, need. estimated with expanding of starting including health are or disorder XXX MDD, adjunctive Beyond a a Xb/X treatment XXX ill a antidepressant,

preparing initiate submit trial is expect IND Our XXXX. half in to and to first the we clinical a an of team

Second, to the of with Medicines application a as a geographic our part European strategy, we XXXX. in expansion authorization expect marketing the first of submit half Agency

a market to similar represents sizable BXCLXXX, the For EU believe opportunity we the U.S.

move strategy setting, is grow XXX outpatient across another multiple our our part opportunity. represents settings has XXX of expansion potential market pillar to which the third The to into treatment strategy. the of as franchise land-and-expand large

development are our strategy for both We the and current indications. expansion pursuing and actively future

into we shared continues and of how BXCLXXX. to in look accelerate Our Day, platform an AI our this R&D drug innovation and platform apply we in-depth the September, at spurred and clinical our the development drive efforts. progress BXCLXXX At discovery has MDD to of discovery

a will We for pipeline. building to R&D platform leverage continue sustainable AI our

potential dementia. chronic combining maybe clinical as agitation planning of agitation begun XXX benefit We believe and a XXX have monotherapy and designed and dementia. of treatment development treatment and already the for for is XXX there a BXCLXXX of we as formulation a and

franchise, immunooncology program. BXCL great we made progressing the our also to strides Turning

activator immunity advanced forms As is an XXX solid being the developed and treatment orally systemic administered for of reminder, tumors. of a candidate aggressive prostate cancer of

with This a profile BXCLXXX adenocarcinoma. demonstrated heavily potential evidence also high further tumors with emergent novo positive patients safety results, these study de we in KEYTRUDA, with area combination of pretreated our cancer no broad cohort. efficacy CNC Xb/X in ESMO neuroendocrine we is metastatic in presented from treatment and As an of interim prostate at hard-to-treat the upon Building in Phase medical September, standard care. of XXX’s announced of at expansion our encouraging current data ongoing of castrate-resistant need small-cell unmet and favorable

additional pancreatic present from of efficacy in reported These enhance encouraging findings validate T-cells to – Phase of highlight cancer XXX Last Journal XXX’s tumor Anderson-led that efforts immunotherapy in type KEYTRUDA expect our the types of the for such tumors suggesting Immunotherapy to the solid week, MD of results We Cancer and data of may tumor cold data also trial XXXX. XXX findings open potential identify of basket first cells could efficacy in natural cancer These half continued label growth. help advanced regulating novel pancreatic importance action. as killer the importance from mechanism along cancer. other benefit with X

the progressing take We strategies. near uniquely we that we preparing Therapeutics a our of franchise advantage immunooncology franchises both time for multiple continue in market as for summarize, potential optimize commercial To are BioXcel is this to are the positioned long-term. advanced opportunities to we of launch. and believe as and rapidly clinical very exciting We

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

Richard Steinhart

in attributable costs. a part clinical offset increase XXX XXXX in results. related XXXX. These and in trial cost in were were same quarter to by review period for XXXX Thank as expenses primarily for to third financial were you, development amounts the expenses, reduction I The million in Vimal. our our compared Research decrease will an quarter million the $XX.X BXCLXXX. clinical now trial $XX.X of third to

XXXX a related our fees. the to loss to of expansion teams, commercial the to costs were period for In $X.X company of the XXXX. primarily XXXX. addition, of quarter we due BXCLXXX the compared General in in in primarily loss of $XX.X a same well experienced of The administrative to to BXCLXXX. for the reported increase and consulting preparation the professional million greater as marketing was of and as related The and development increased for third which legal insurance, quarter of the million million cost personnel fees, period due compensation third professional higher the and million net of stock-based our compared to for the launch increased U.S. net potential were XXXX expenses same $XX.X $XX.X continued and

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

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

Vimal Mehta

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

Operator

Thank Bank with you. coming Instructions] Our [Operator of America. from your question. Harrison is with question of first the Greg proceed Please line

Greg Harrison

Hey, taking our good Thanks morning, guys. for question.

or discussions labeling there what review, and expectations how your and for commercial are different drug? XXX options do have the the goals expectations for the impact label you your the On started

Vimal Mehta

labeling the start to We discussions expect soon.

go shortly. expected is are we that requests There have medical supervision from scenarios. We outpatient into or two be and a are window the labeling can setting requirement then be launch setting. addressing setting supervision under medical will the we the the we discussions no institutional are and been information And and institutional then can is or have the in One FDA. it there in

out commercial are that case setting, the we are we and the be case for looking that of we turns base So, kind in a presented if at our base to day that are launch our product ready institutional for label. to

Greg Harrison

Thank Great. you.

Operator

you. Thank

Truist. coming Our with your of the question. with next from line proceed is Karnauskas question Robyn Pleased

Robyn Karnauskas

combination taking strategy on I the question. the guess I had Alright. Thanks just for a question XXX/XXX.

are you just about talk Phase challenging. little You strategy thinking I about for for X are you development know can a depression, Can a starting that? how trial. very be it bit

of about if are you forward? could really you sense good X when you a that whether Thanks. X, get see And signal we think will a or not so you how Phase Phase designing go

Vimal Mehta

you, asking question. So Robyn, thank for the

the plan do to for XXX first is Our formulation.

as extra monotherapy. But that be going We the provide work with XXX benefit that working for don’t to chronic provide early well been benefit, start a if, are formulation disease. candidate, as like The therapies provide that you pursue combination drug They benefit of the we one don’t purpose almost weeks. that maintain six identified can have know can as can it chronic of onsite any the aspect that completed has lot a can benefit. a recently of any for as combination

thought that’s monotherapy. there. But to initially, So, start the as a going are process we

Robyn Karnauskas

the And dose Thanks. will we then update also just the same for data? and XX XX depression get milligrams milligrams when

Vimal Mehta

features. all X on blinded microgram safety And we other two our data to completing we and selecting have doses trial will some that Phase in we dementia, be report XX for and our and that will So, that. utilizing related been program data doing analysis for

Robyn Karnauskas

Okay. Thanks.

Operator

Thank you.

coming Canaccord. with question with from line next Kulkarni is of your Our question. Sumant the Please proceed

Sumant Kulkarni

have morning. what announced are you Good couple, at you taking had that in date. my have are secondly, so closer feel on had you you variables questions. Are the data more you give that versus changes commercial to or there the now for focus could your action that are a you starting the any I of need Thanks you Commercial at top? Thanks. some might X on some Day the a dementia exactly on of specifics light us aligned dementia, FDA there? potential on Phase And what on far what with

Vimal Mehta

in sales Sales, regional commercial, sales we leadership have our been hired for hire organization team to specific continue have regions, of the strong For that with building and the those sales we and have directors. a our we as commercial directors territories preparations. reported focus team – as I to VP our regional sales And sales continuing has have we hired launch

part piece related is that is second And that process of strategy. our progressing finalizing the to well. pricing So,

the to quantitative qualitative, what will whack allow come up of discounting – price. That will be that lot a research, the medical evidence of the that a strategy done up And settings, maximum BXCLXXX. research potential with whack capture strategy once based will with a coming encompass have the to we strategy price, have be. pricing on depending we So, what

So, all it’s near going work on, been has of and completion. that

lay sNDA the about which we the have with by Phase by data once that the that out will resulted ready to high of aligned keep that a get the of for the have to year we FDA. us the pure trial end have we specifics, And those strategic population and approval you can get the for your pieces, I FDA. focus therapy program disease the is we our the going our Alzheimer’s components So, of have to initially to second chosen dementia X have go a because breakthrough are that we important two initiated will designation. reasons a say upon together the Alzheimer’s. with of question full One At noticed drug level, in in provide launch it’s lot regarding TRANQUILITY, come to thing in

provide few we feature to continue outline what as So, key elements our weeks. program, in we the design will Phase X are of

Sumant Kulkarni

Thanks. helpful. Very

Operator

Thank you.

with Colin question. is next UBS. Bristow with coming from your question Please Our proceed

Colin Bristow

taking Good thanks the and for morning questions.

how on out. as Thanks. provide Kane? have are hired your post approval? to in then hire? you build to ultimately replacing you we of many to comments you expecting guidance the are Will And build sales about the quantify Just Could launch how many just you think expect the of And on you versus then XXX, just process where revenue

Vimal Mehta

for that the Answering Thank it team. setting, be you, member number question Colin, the question. we sales it about have institutional your if that is XX guided total days, will

strategies to the So want in and recruit managers sales have team management hired and the on for we and currently, indicated, continue focus on their that The – bringing I of sales are timing and continued teams are regional sales to sales terms they as to territories the are it. that board defining we they the team. board

our know are you There the market. is market. are and IDN – XX key overall two-thirds the are As there of our IDNs they

we coverage strategy to and allow So, how team. will are maximum the up sales building us the ramp to a get what

a bringing on Chief we our we and maintain good and as we will on our current Commercial focused on what to want make as evaluating on Officer currently In the sure that and on team Officer, Chief launch that. can with the options, bring terms Commercial approval are we well momentum is timing report to board we are the of

Colin Bristow

potential the on guidance, approval? And post sales

Vimal Mehta

provide we we and have approval we have be we will what this time. are up, all the working and we what to provide are that all and we strategy we pricing of At period position can the So, the metrics. launch guide through once launch over what guidance and key all fund our to will a a like for will able use in metric that when be a will point, the we of

Colin Bristow

much. very you Thank great. That’s

Operator

Thank you.

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

Ram Selvaraju

Thanks much my very for taking questions.

initial provide in granularity was on payers to please? provide the expect XXX could the the you commentary what of us gross the attitudes XXX. with perspective of you access of various regarding any I that discounting market with to place rebating particular, over side, And commercial course could of driving nets, secondly, the you of in you if Firstly, wondering if the factors from us to anticipate and the regarding months be launch, coverage some and

Vimal Mehta

morning Thank you Good Ram. for question. the

the has proposition question research, upon discounting discounting, till is in what medical Up strategy and that started with settings. is we and approval. that need your down we a sit that now, based that and evidence happen what approval up the different we what have whack market price research, first pricing Regarding the value then the product, is the payers and up been come with what optimal will conducted about strategy, pricing, for be – only once have with come across those to one discussions can to the a

meets about research is that And what the product profile that has as and you of high rates, meets therapy. very it – guidelines, its because as know, it response has treatment responses, well is conducted. being product have encouraging payers, done well HCPs by the we with rapid groundwork or it as received very all is oral is onset XXX potential any durable a So, action,

the is are that very we marketplace proposition encouraged for value XXX in strong. So, very

the will asked. we some granularity Now, questions we drug. on the you once of to these will have initiate And be provide able we have the approval conversations more of

Ram Selvaraju

Okay. helpful. That’s Thank you.

order And in-licensing value down markets? road in expectations to timing what outside recent particularly announcement of markets strategies as is think there regarding the the could to that States. comment Secondly, in United drug any ultimately Nortech. that of of read kind ex-U.S. some you around certain development And Pfizer’s with that the you if implications business the pertains I to to ex-U.S. of you for XXX optimize might was rights this the pertaining through the and have positive if intend you XXX, on wondering think if of do from

Vimal Mehta

Ram. question, Great

Europe, in XXXX. our So, focusing half because are to the first where we initially of we are file application MA that’s planning on

the get answering then the our is partner for MA for good the So, potential the timing a will then XXXX your be have BD ready file based XXXX. on partner because question, and what in to strategy can launch, approval

first to we options. geographies, evaluate And continue getting we the But focused find receive have launch We Japan, for consider second, Europe interested Phase territories, And and we dementia. the is ready to and territories. that those other our initiating continue China we and territory, partner on in we currently, business requests are other prioritized development for well. we evaluate who global our from other including or in program as as X if all a perspective, will

Ram Selvaraju

last see And separate a not? timing entity is, Thank still out what are you it And occur? driving might we the spin are this? of into when factors question listed a you. potentially And the contemplating or of XXX

Vimal Mehta

XXX are will from that the will some some and the ASCO to all at So, the we you data could advanced including be Board, trial. involve we the tumor be We have coming outlined. with options presented of with licensing, data our the is XXX, shareholders. our what two for is the co-commercialization, we strategic the coinciding to we of at continue work partnering, trial, in value will option our our prostate getting And which maximize keep cancer for we optimal time, out same that data trials, for option that that keep open and

in what direction So, our building data and then will are having clear plans we option, XXX for provide the XXXX. strategic a

Ram Selvaraju

you. Thank

Operator

Thank you.

line Securities. proceed your Please Guggenheim is from with a question Suneja of next with coming question. Our Yatin

Eddie Hickman

for on is taking Thanks Yes. Yatin. question. for Hi the guys. This Eddie

about in additional get Phase and side, the a additional And you more between that health which think What what you label I differs get to study, care, are don’t in the for on that the Like case. that need two how just regions? your if sNDA. current mental do file is for the talk X market? outpatient On label an big the market show little is Thanks. current you dementia you base for to standard the bit then NDA, when European change can how of the challenges especially this

Vimal Mehta

TRANQUILITY ALF, our setting. reiterate, to in is close like as just which the I dementia, trial living community to conducted was facility, Look assisted

not medical bipolar comment NDA made our schizophrenia will I I compare that So, about the setting.

we will And accounted that. Phase trial. the in dementia, see will So, that medical taken setting into for we have be conducting the already program, the that X you once account see we you have

don’t is be program. and there challenging, But we these and of in dementia. resulting with completing for market. robust allow optimal we so we So, back very see from focused that’s particularly treatment for will believe that our up Phase a There on Coming interacting a focus to disorders. to It’s of need agitation, no U.S., our needs the like That took with that program. specific XXX why diseases. neuropsychiatric dementia X sNDA some more Europe, that’s Europe us guidelines. any time for the will of that different But a standard like come the with are FDA area care I are

unmet need. So, a there is medical huge

MA. it’s use EMA can to FDA from filing agency, file that the the we advice scientific encouraging the we the MA, and So, with are package

with partner, we But there obvious countries obvious very The focused conversations we product Those in are with. And while optimal in that partners, are the are, agitation. the taking product. multiple be And challenges of the to all selecting see huge pricing. are Europe. partner a the that be successfully into are are the challenges will for are treatment all are any of our we the able work that. having this have who aware account, they to addition, to In challenges for indications we you potential launch

Eddie Hickman

question, been have point? manufacturing one quick just FDA to sites you the by final all up can And the confirm you. Thank inspected that XXX this

Vimal Mehta

in any more the confirm What don’t where process. the we inspections is FDA can expect from we I are

Eddie Hickman

Thank you.

Operator

you. Thank

a Dushyanth proceed with Our next of Anita question. coming line Berenberg. question Please your is from with

Anita Dushyanth

taking Hi, good for my morning. Thanks questions.

Firstly, on PDUFA FDA I had a the date. quick one

coming sort if early applications, a likely there by the are of possibility a all the sort to extend how they With that of earlier, currently of January receiving how you with we backlog addressing or decision is timeline? Xth, of of decision know were agency are the to or confident them

Vimal Mehta

would love Christmas Thank Anita. you a gift. to morning, We Good for the have question.

when we at multiple can process can’t feel experiences what has our that the of happen. well. where confident And a that progressing we NDA we in will process. So, team getting approval. our we spot is the we tell predict good approval is But are And review very are

Anita Dushyanth

had question a study? Okay, quick that’s then expect MD data helpful. with sort see And the on What do additional that efficacy Anderson. I basket just to of trial you from

Vimal Mehta

me to that let Vincent… pass So,

Vincent O’Neill

Sure. Good morning Anita.

So, arm that both enrollment. announce efficacy each did study proceed full or is continuing several to arms to enroll. that now ago bar passed months to We the

– without a large to that to any to year. conference And particular forum, for next oncology readout general scientific look so look committing

Anita Dushyanth

Okay. Thank you.

Operator

you. Thank

We questions at time. have no this additional

closing So, I management like back the floor to any for remarks. pass would to

Vimal Mehta

updating progress. in you, Have you a for Thank to look coming continued connecting on and of you I many joining weeks great our today. forward the with everyone, us day.

Operator

conclude your And gentlemen, may this you you and disconnect Once at does we time. teleconference. today’s Ladies thank lines for again, participation. your this

BioXcel Therapeutics (BTAI) 10 Nov 212021 Q3 Earnings call transcript