BTAI - Earnings call transcript Q3 2024 | BioXcel Therapeutics, Inc.

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Operator

Good morning, and welcome to the BioXcel Therapeutics Third Quarter 2024 Earnings Conference Call. [Operator Instructions] After the formal remarks, there will be a question-and-answer session. [Operator Instructions] Just to remind everyone, certain matters discussed in today's conference call and/or answers that may be given to questions asked are forward-looking statements that are subject to risks and uncertainties related to future events and/or the future financial or business performance of the company. Actual results could differ materially from those anticipated in these forward-looking statements.

Risk factors that could affect future results are detailed in the company's quarterly report on Form 10-Q for the quarterly period ended June 30, 2024, 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 year period ended September 30, 2024.

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

Vince Speaking Chief Medical of Chief Executive call Officer; are Dr. by Financial and Chief Neuroscience. Product Vimal Dr. Mehta, Dr. Rob Dr. session Officer; Q&A Officer; be Frank in on Chief Medical Officer joined of Development today's Officer, the O'Neill, Scientific and and Yocca, Richard Steinhart, Chief Risinger,

call over now to Mehta. It's turn my to the pleasure Dr.

Vimal Mehta

us. and Phase or Thank Tuesday, agitation This BXCLXXX. you, joining morning, and you with past pivotal bipolar everyone, schizophrenia announced X thank These home dementia. setting operator. III for milestones important disorder for the associated with we for associated Good agitation Alzheimer's in with trials our are trials with

be treatment these for could needed patients much of millions BXCLXXX option the conditions. do believe not FDA-approved acute who We potentially have for challenging therapy a

treatment At-Home area. we clinical placebo our evaluate growth BXCLXXX Our this BXCLXXX paradigm. with Starting a focus represents in goal with opportunity leveraging our acute study double-blinded bipolar designed experience transform conducting treatment near-term and is controlled our trial to the XX this indication of immediate SERENITY We trials. schizophrenia-related to for substantial believe agitation,

excited advance particularly in the trial marks because home it first are We to setting. evaluation this the of BXCLXXX

the duration was as late initiation Trial be patient expected is look months September enrollment. last communicated. randomized advancing to from first to forward The week, and we to we X previously XX

growth a planning for longer-term opportunity. related BXCLXXX a treatment as are larger for Alzheimer's TRANQUILITY evaluate to represents This potential also our We continuing In-Care our trial agitation. acute much

study. which the largely Phase second for pivotal condition III be TRANQUILITY III on We which our recently FDA our from received proposed will our Phase and protocol this II trial for mirrors feedback trial, the

acutization, funded academic through are conducted treatment addition with currently potential In chronic study leading research the pleased externally institutions. opportunities with we being to BXCLXXX by

This efficacy IIa discovered of a University our for marks therapeutic second AI of of using further Defense BXCLXXX, pleased and stress-related and Department at see the are BXCLXXX grant a we to its Carolina. Phase announced remind to acute of recently funded stress North everyone, BXCLXXX safety externally We the fund validation to disorder broad study platform just of trial potential.

clinical are with to product, on we focusing continuing market our IGALMI approved While resources. development, maintain the minimal in

time data strategic to We brand sheet, maintaining available to equity. balance are financing with to evaluating support are our same working trials drug patients our reaching continue committed our alternatives. this readout, making strengthen To we the goal while we the at of

we unmet protection of we TRANQUILITY In agitation. needs a in with intellectual pleased BXCLXXX. progress This to summary, are position the our the medical we address opportunities patent provides that from portfolio property believe attractive long-term reinforced market of the to substantial which potential growing for expanding and leadership program. belief aim is while a SERENITY treatment by have We build

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

Richard Steinhart

XXXX of from customers. existing for reorders Thank decrease $XXX,XXX in The to of compared for the the primarily to XXXX. was quarter Vimal. from sales the Net revenue period was third same due you, timing IGALMI $XXX,XXX in

result million $X.X in an XX% of million for IGALMI the to excess produce, related a to represents goods from revenue charges higher or XXXX, period sold important ended out it's for noncash is to inventory. obsolete net XXXX. inventory of XXXX, cost were reflects XX, X million However, XXXX, of point new or increase is same context, and activity same well $X.X for to for that months the XX, package in in period in increased increase compared related customer ended sold as September to goods The to XX, X $XXX,XXX, months and the of XXXX, X respectively. the months acquisitions September rising obsolete as and increase The for in for Cost sold of customers ended and $X sales cost excess the XXXX. deliver goods reserves utilization. Cost the costs September

Charges for million expenses for and or were XXXX, excess reserves the to million for XXXX obsolete and the $X.X $XX.X $X.X X compared and respectively. of September XX, Research million quarter inventory months ended for third for development $XXX,XXX XXXX, decreased reprioritization expenses and and decreased in were personnel trial XXXX well the in from reduction fees in the same costs of period in to force XXXX. May August company's professional expenses, clinical primarily XXXX. as The due related as were resulting

as expenses administrative and commercial to expenses company's expenses. and decreased same decreased and third lower $X.X the for $XX.X The period costs million and of were general million compared XXXX further resulting for to XXXX. personnel fees due as the in primarily XXXX August well reprioritization quarter the in in professional related Selling, May from force in were XXXX reduction

period had Therapeutics XX, compared million totaled net the for loss a million company net XXXX. third of cash quarter of operating XXXX the $XX.X the Cash third The a XXXX. $XX.X during $XX.X million cash used and BioXcel $XX.X XXXX. in same as of in for quarter equivalents September to of loss of million

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

Vimal Mehta

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

Operator

Alec from America. first coming Bank is Instructions] Our question Stranahan of today from [Operator

Alec Stranahan

And follow-up. study rate so the could enrollment for the walk us. got accelerate whether SERENITY guess or study. XXX ones the similar on process the the a or X of getting gone patient first, the first Maybe on far? I expect of other study I've Just how maybe and the has be from then us of through you so quick patients launch the

Vincent O'Neill

this Vince here. Alec, morning, Good is Sure.

hand detail I'll start feels over then to bit and I'll to I'm give that, So more he Rob missing anything. a if

I know, this. will you like will in coming essentially, randomized mention right be ramp-up for patient we're a the the We're off, study So season. phase relatively now. recently. has typical kicked into first the as study It totally holiday

at little then slowdown would a a the see but we would January bit the rebound frame. of typically a time typically sites, in So that involve

seen far is study so absolutely this So what approach and our standard. is to we've the

have we lastly, a mention just number of large sites. I'll

and patients, XXX number the I XX final So site. is active think

a that's the of number enrollment. number So sites target large or patients for of

So state X, I'll line, it again, we're comfortable to and time very months. just to anticipated Rob. with Anything XX the add that,

Robert Risinger

we're ramp-up track, moment. occurring is No, on and right the at the

So these out coordinating we're and this of and rolling multiple all tracking across activities. sites

across integrated truly sites. it's So

Alec Stranahan

actually makes the study just XX-week That Okay. point medications us the measuring are on especially if the that arm might And you a you helpful placebo over thinking randomization, then could data this period. allowed, be remind and be may whether rescue about sense.

Robert Risinger

XXX medications may you be necessary. a literally in said, Patients trial. Yes. patients, allowed rescue are the the -- Rescue if placebo. XXX versus half receive of receiving And will X/X as

for a an we'll And yes, inefficacy sort indicator safety of tracking call it's surrogate patients of we on that in are efficacy, sort placebo. it, So as measure. a of, those of

Operator

question next Instructions] Our is Graig [Operator Suvannavejh from coming from Securities. Mizuho

Graig Suvannavejh

got X. I've

the just you to provide missed First, cash on And just, was got I runway what options that this have protocol, where you was the are are hoping TRANQUILITY optionality that could the that? on you funding any I and you or company. an then feedback earlier, trial with update but with color secondly, from specific if considering the could if on might you regards provide FDA,

Vincent O'Neill

Vince. this take of that the question. first part I'll is Sure,

typically What don't can this. feedback FDA we very mean, I comfortable in though, say, concise. I was actionable blow-by-blow very The give details and comments. of direct saying really So

So second to want we're part Rich? with the handle received. feedback very we actually happy Did you

Vimal Mehta

that Is can any good. else you embellish feedback did will is the more trial. of you? because handle Or that design the what feedback elements anything and FDA the have are for already it. outlined Graig, we have what the I key needed design on there that's . trial you of we

Graig Suvannavejh

thank very very That's No, good. you much.

Vimal Mehta

Sure, sure.

outlined, sheet. remarks, options and working to balance our as the Regarding in get work the that have with so key that readout to prepared partner we strategic are the strengthen all we readout also my focus and data the to strengthening previously data we sheet company's get can our we balance the that and how on

Graig Suvannavejh

follow-up is my the trial Maybe have missed if it apologies may to Again, just color Can here whether provide financing the the current sorts. trial of sufficient as to before. to completion. I or take have you with a underway you cash

Vimal Mehta

any to the we guidance We X get guidance, want initiated we get September work data we provided to which Greg, and XX are, trial far in but trial from have is not that our where all readout off to we the stakeholders the readout, months. initiated and is with we with that view to and can a not this data that so

Operator

Sumant Kulkarni from Canaccord today is from question Next coming Genuity.

Sumant Kulkarni

successful investors large covenants is, characterize with one on have trial keep I to potentially in to your completion you the larger how ability latest of the ability At-Home unlock one opportunities for how would at terms related. one second, negotiations the your two, and agitation And market. financial partnership to your bay? SERENITY financial important financial trial's The of at-home is that company

Vimal Mehta

morning, is Good This Sumant. Vimal.

as and continuing very including with collaborative, stakeholders, pleased they've all know, that speaking mentioned I partners. we strategic that. our are you As our very And with we been are

where where which to In-Care, are can year. focus that coming efficacy III think strengthen ready question At-Home and SERENITY the our the we the data trial, now we expecting had The SERENITY were out last TRANQUILITY on way get data already than back is we second like have positive we're we sheet. can for your if the the read At-Home be same trial II, continues which time, the that to we is safety, data advanced continuing next SERENITY, we company, and in that the progress, we are year, We start. the readout. And balance to and in path so about mirrors Phase to TRANQUILITY regarding At partnership,

all our value trial like patients, So other we for path are these every be be continues perspective drivers providers moving pursuing that shareholders, all forward, value can company and company. us health care stakeholders, to our a stakeholders, huge caregivers, from clinical which the of the will to allow our for that and trials maximize and focus particularly

Operator

from Our next question Samir Securities. Rx from Devani today is coming

Samir Devani

in I -- I the one first mentioned time XX that you setting. trial patients the In-Care think we TRANQUILITY just at-home the last have is cohort guess would of a spoke,

confirm, just guess that to FDA one. feedback, still question was I wanted case. the the I So that's whether following

Vincent O'Neill

here. this Vince Yes, is

day, that end took internally, the out of we the at So pilot protocol. after of yes, the discussion

that's part. currently, not So

Samir Devani

really where you've Okay. product. progress in that second question then and the options progressing for I of BXCLXXX any terms made is And guess just had on

Vincent O'Neill

Sure.

I So can following give update. the

we're in still the So process.

the at who diligence expertise has I mentioned in that least probably quarterly, I as longer process, partners, potential still maybe had our area it's on this anticipated, personally a firm activities, last within I but process with think, than et working room cetera. with

process. ongoing an still it's So

Samir Devani

if in. just more maybe can And sneak I Great. one

In terms be going you of what forward? holding still the what risk us at stock inventory you're or confirm indication just give that of could an may of write-down, sort and at

Richard Steinhart

Sure.

this is Rich. Thanks. So

good now we us We is of are I And enough noncash a think with projecting inventory shape remember, for of this. we're with plenty out. today And that pretty sustain up, sales in couple It's the charge. we'll this sell next to just should have looking product years. where write-down. have pick and to if at

So good inventory. shape I in we're think pretty with

Operator

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

Vimal Mehta

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

Operator

today's webcast. and conclude does teleconference That

participation We your lines your may at thank have You wonderful day. time, you for disconnect and a today. this

BioXcel Therapeutics (BTAI) 14 Nov 242024 Q3 Earnings call transcript