BTAI - Earnings call transcript Q2 2024 | BioXcel Therapeutics, Inc.

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Operator

Good morning, and welcome to the BioXcel Therapeutics Second Quarter 2024 Earnings Conference Call. [Operator Instructions] After the formal remarks, there will be a question-and-answer session.

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.

Risk factors that may affect future results are detailed in the company's annual report on Form 10-K for the year ended December 31, 2023, which can be found at www.bioxceltherapeutics.com or on www.sec.gov and which will be updated in its quarterly report on Form 10-Q for the quarterly period ended June 30, 2024.

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

Officer. Speaking Executive of Officer; call are Chief Product Mehta, Chief Dr. Vimal Financial Steinhart, Dr. Richard and Officer; on Medical today's Development and Vince O'Neill, Chief

Frank They will be Risinger, Officer; Scientific in the Chief Commercial Medical Matt Chief Dr. Neuroscience. Yocca, by Wiley, question-and-answer Officer; and Chief session joined Dr. Rob Officer of

Please to It the call Mehta. my Dr. pleasure turn go now is to ahead. over

Vimal Mehta

At you Thank into we BioXcel for you, bipolar today. Good and joining operator. indication our the BXCLXXX, a agitation. agitation, into for Therapeutics, thank focused asset, for expanding and setting on and are schizophrenia-related Alzheimer's-related new us morning, lead home

who We and look of much to episodes of therapeutic offers are agitation. are We this clinical believe patients advancing compelling to bring our we struggling motivated and passionate X value proposition, programs. BXCLXXX with option extremely development needed the a forward of to millions

with an time, we BXCLXXX at-home this At majority development setting, plans occur. where are of in juncture are program for the the to reach as we episodes finalizing agitation important the delighted SERENITY

marketed. beyond We providers institutional therapies believe trial there health for and patients, no that the IGALMI care a near-term The represent currently treatment could to a the this expand caregivers setting needed opportunity truly much FDA-approved home in potentially for option At-Home agitation are setting. as is SERENITY is creation value where

designation BXCLXXX FDA for to and address this pleased plans from associated we with could need, therapy a progressing. for received TRANQUILITY Our medical program breakthrough the have indication. are unmet program Alzheimer's agitation also significant This are

agitation. opportunity Alzheimer's represent address a believe million estimated potentially We to associated annual an episodes program larger longer-term XXX could growth of this

and Vince will share on TRANQUILITY SERENITY programs the shortly. updates

Turning to IGALMI.

behavioral have barriers. by growing care and adjacent a represents among product community seen and strong facilities. administrative opportunity clinics characterized adoption market health This fit segment psychiatric We lower

continued for positions the setting, This also targeting at-home we to growth sell this if could market bridge Given as to IGALMI field believe footprint, commercial setting, small a and approved. our sector scalability. home the

approach, We extends IGALMI. realize coupled that protection the XXXX, believe enable patent to this could with fully potential of us substantial to

Finally, with we reaching of late-stage goal readouts. our our to balance sheet strengthening support trials the remain clinical focused data on

financing are monetization, as also as We evaluating well such monetization partnerships. as royalty strategic alternatives OnkosXcel strategic

for In clinical summary, advancing. plans our are core programs

is Our progressing, pleased strategy and growing are IGALMI with market with patent we access portfolio.

I will the call Vince. that, With over turn to

Vincent O'Neill

Thank you, Vimal.

placebo-controlled we're safety of dose to announced, of So a Vimal pleased designed At-Home for as over SERENITY trial, be as a preparing multicenter our double-blind, which is to XXX be a study XX-week evaluate period. initiation a of reminder, XXX-microgram the efficacy to and

the We the objective primary in us support of childproof trial efficacy The site the work is completed received setting be pouches clinical preparing trial feedback defined sufficient use all to selection end the the final statement CMC exploratory the FDA. work our of CRO, recently from We've home with with finally measures and believe initiation. have as we will safety for points. protocol on and

trial also The substantially are program II. on with trial. a TRANQUILITY our advancing for focus design TRANQUILITY Plans proposed In-Care to TRANQUILITY our similar is

a XXX the of As efficacy dose and evaluate multicenter XX-microgram a to reminder, placebo-controlled In-Care double-blind, TRANQUILITY period. of a a study is safety XX-week over

dose. in the final to it primary planning to be form, X The in PEC In-Care we're score the change and The is is expected endpoint post-first protocol at TRANQUILITY to agency. hours submit

tachyphylaxis XXX-microgram no approved results positive with our top or pleased to study or dose. objective highest line have tolerance treatment dose, with The IGALMI. We withdrawal achieved reported evidence Turning to IGALMI. its of the as demonstrated PRN evaluating needed were study of PMR the and

episode each reduction following a powered was were no not observed study X-day events occurring treatment. period, during study to in reported the evaluate repeat efficacy, the dose agitation statistically serious for Although and was adverse

will Rich, financial would results call to the for review our over the turn like now to I who second quarter.

Richard Steinhart

you, increase. the This of quarter IGALMI for Vince. period compared represented to same in $XXX,XXX Net XXXX. $X.X was second a the XXXX Thank million revenue for from XXX%

Sequential XX% and for care with in from periods increase health quarter the driven quarterly behavioral revenue primarily was increased growth of The in in QX contracting XXXX. first an revenue XXXX facilities. psychiatric both by clinics

the and related same second decreased and TRANQUILITY were well to trials costs. expenses as wind professional III quarter the XXXX. compared The II $XX million development the $X million of for expenses fees, primarily period SERENITY of were and Research attributable XXXX to as decreased III in down and the for personnel

by general $XX.X of million $X.X costs our to to primarily of expense in quarter period administrative compared decrease were reduction for expenses million for in commercialization IGALMI second was XXXX attributable and XXXX, The and the of Selling, driven associated same a second to reprioritization. XXXX. quarter personnel with the the the compared

for the operations net million second compared of by offset an was XXXX, BioXcel million to related million $X.X of of quarter net period same $XX.X second loss the derivative XXXX XXXX. liabilities. a had in of the of In Therapeutics the a loss unrealized $XX.X loss gains to quarter for from

million second $XX.X XXXX. equivalents XXXX. used cash quarter of company $XX.X in totaled XX, cash The Cash million of operating as June the during and

priorities we that enable earlier, us described clinical strategic to Vince continuing Vimal efficiencies our are have and to business. deliver our across Finally, optimize to on operational

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

Vimal Mehta

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

Operator

you. Thank

be now moment, please, Instructions] conducting question-and-answer One [Operator while session. questions. for will We poll we a

Your first question comes with Genuity. from Sumant Kulkarni Canaccord

Sumant Kulkarni

trial, that expensive might In-Care, TRANQUILITY or And quick to do that cost on might any there to us new able data fairly X you are you've be have point characterized previously? I variables know trial how the let On available? relative expect more be when the to at make what ones. less

Vincent O'Neill

or see cost, In-Care. previously to we typically have not of study the view in planned. is of cost we terms don't timing. thought this give for no essentially on second a TRANQUILITY so reason question provide -- position our specific we're changed cost obviously specific Sumant, It's in Vince the Today, guidance, but recently. your To to as

Sumant Kulkarni

is then on Got you childproof of to SERENITY are on And with trial key one you the my How aligned enabling packaging FDA the that is say the proceed? it. And would part that trial? At-Home. third

Vincent O'Neill

So I aligned are very we would say with FDA. the

As the I FDA been receive mentioned into the in remarks, we feedback did incorporated from prepared that has protocol.

the work as Also statement And work with is defined. mentioned, has been CMC also the complete. of CRO

make-ready work that the complete. is study essentially, So for

Sumant Kulkarni

Can potential areas TRANQUILITY specific FDA one any I'll in, one might on with protocol? squeeze have the talk last the you sorry. you discussion that about of In-Care

Vincent O'Neill

point versus primary efficacy endpoint more little actually obviously It's TRANQUILITY is little SERENITY one I'll I complicated, obviously, a in is, an bit longer study. think expensive. and make more a duration a little

interested that is FDA think would protocol. in And be repeat dose the right that that going efficacy. one point the forward get I to know We want with that very we

Operator

of Stranahan Next Alec Bank with question, America.

Unknown Attendee

is here the morning. of for on color Alec as here? the the execution Mary specifically Phase This III your trials for Kate And for Maybe additional market And on for initiation? just well? the upon were we you pace population could this potential are wondering, at-home add opportunity trial expectations what maybe SERENITY

Vincent O'Neill

Thanks. And is Vince. -- this just

correct? asking you're Essentially, study, question. about At-Home the the first your paraphrase to timing SERENITY of Just

Unknown Attendee

of could potentially guys long Yes. you Yes. once terms take trial. how initiate in And it enrollment the

Vincent O'Neill

Sure.

and just to a study, but less is study. I'll study SERENITY -- is ago, X precise complex the repeat what studies, SERENITY and less today, a time position So again, give the the expensive said faster I moment in actually that that of not therefore, the lines

Matthew Wiley

bit about a this little Kate, talk Matt. the I'll is Mary Yes, opportunities. market

So there at-home XX market. the are episodes million in

who experience or episodes schizophrenia What in or we found indicated started. patients before those their agitation that oftentimes in beginning with very is episodes, the use they XX% at even would market that research of bipolar BXCLXXX

the in the of prodromal phase So episode.

motivated to some the So million are -- the clearly, the we taking those could hospital. of draw out some patients emergency that imagine department episodes adding the as XX episodes of in and of we

Operator

Next with is Graig question Suvannavejh Mizuho.

Unknown Attendee

questions. is Avanthika a for of Graig. had I This on couple just

what both to The yourself? you thinking finance is cash SERENITY the trials actually factors protocol with the current partnering the the you you've and it is for the TRANQUILITY Are runway? is company's to first second the And you are -- actually what have And planning specifically the gating still discussed last someone with -- the that FDA for the run now was, SERENITY. is, trials? initiating studies, now, for of what the are

Richard Steinhart

is Rich. This

the haven't On really all. changed runway runway, cash we our on at guidance cash

remains similar in what it the about talked So to past. we had

Vimal Mehta

Avanthika, Vimal. this morning, Good -- is

the your question Regarding financing. on

on both as based alternatives, through funding trials Our strategy various is I fundraising mentioned.

we in opportunities exploring are parallel. all So those

begin TRANQUILITY our Vince are we At-Home As point a plans which you and SERENITY feedback said, at the the shortly, already and already mentioned. have trials In-Care, can are finalizing we both for where

are this we at along. and well I we looking in partnerships strategic prepared my are So as exercise. strategic priorities, both the remarks, a as them And as of part moving are mentioned

Operator

Selvaraju Rag with question Next Wainwright. HC

Raghuram Selvaraju

here. ones quick Three

Firstly, uptake commercial of at on just have the a what the on cadence you favorable product side. juncture? question on Can that revenue over you XXXX? experiencing of and the tailwinds this impact the that might the see any of And growth comment prescription second course half

out update Secondly, to monetize OnkosXcel, potential BXCLXXX? could which in you entity with or provide with respect of any you can ways spin other respect to conceivably that

funding? provide to And might you your BXCLXXX what additional could pipeline plans and of if on non-dilutive lastly, you the that neurology comment for perhaps then beyond sources with potentially extent

Matthew Wiley

Rag.

Matt of in centers. X over So your last behavioral this in from mean, that To about of health the one these is observed again. the answer an I the quarters XX,XXX interest is United things tailwinds, about States. community these question are we've There the increase

product the a that previous from highest use all constituents intent know to We setting. the have hospital in psychiatrists market research the of

health nicely to setting. clinic community think So this that that, we mental type translates

based we see not know typically that the a you acquiring -- does require hospital of also administrative the hurdles process We for IGALMI IDN our in setting. that on type experience,

as is next So on is an will into the progress this like year low-hanging feel opportunity we that and fruit, that the well. and near-term to of balance year over continue we

Vincent O'Neill

Morning, This is Rag. Vince.

what committed monetizing we're So just you've to obviously said, to rephrase XXX.

routine in of commercial firm that area. to addition in assessing partner specializes So this outreach through assessing And we have value that's the -- a initiated indications. a formally firm, our

with course. update you and due pleased in so we're So progress far, we'll

Vimal Mehta

is Vimal. This

pivotal forward. to question trial, in the late-stage any a very Regarding the either partnership are pipeline. like moving as programs to what -- our best to on mechanism planned it, for will neuroscience is I options which those we mentioned, look to but pipeline, your XXX, are continue ways or XXX, Currently, at move we focused through our progress third other

Operator

to Mehta for would floor the like turn to remarks. closing I over Dr.

Vimal Mehta

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

Operator

teleconference. today's concludes This

your thank time, at disconnect may participation. lines this your and You for you

BioXcel Therapeutics (BTAI) 6 Aug 242024 Q2 Earnings call transcript