BTAI - Earnings call transcript Q1 2024 | BioXcel Therapeutics, Inc.

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Operator

Good morning, and welcome to the BioXcel Therapeutics First Quarter 2024 Earnings 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 are forward-looking statements 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 ending December 31, 2024, which can be found at 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 March 31, 2024.

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

Speaking on today's call are Dr. Officer; Executive Chief Mehta, Dr. Vimal of Vince and and Officer; Development Steinhart, O'Neill, Chief Chief Richard Financial Medical Product Officer. They will session by be joined in the Q&A Dr. and Scientific Chief Chief Matt Dr. Officer; Yocca, Frank Officer; Commercial Wiley, call Neuroscience. It Rob Chief my turn Medical of over Risinger, is Dr. to Officer pleasure now to the Mehta. ahead. go Please

Vimal Mehta

has BioXcel levels. Starting Thank you, Therapeutics, the and corporate XXXX both our and important Neuroscience period for joining thank at operator. an you of with program. Good us. morning, been progress for program

expand with the setting. potential BXCLXXX agitation is into journey to portfolio underway Our our market well for the retail

option We bipolar home potentially are focused bringing on schizophrenia-related this the novel into treatment for agitation and setting.

are the unique known shareholders. FDA-approved We larger in in-care much and value a therapies and home with no represent these expanding for our dedicated are and also transformative the setting. We company into opportunities both indication, Alzheimer's-related drivers agitation believe to X

SERENITY to We TRANQUILITY late-stage are the and both pleased plans for be programs. advancing

the point a nearer XXX-microgram shortly, to discuss expansion with programs a shareholder details term these we will previously the for may label us dose. enter At-Home through our In-Care value untapped with believe we similar is TRANQUILITY that Vince design Phase this a SERENITY significant growth in is create out While provide trial, of the to potential opportunity want there The approved I TRANQUILITY to III market. this be II see to first long-term trial larger We believe a positive potential program. to upside

believe development protection key assets in us U.S. international in solid recently which for X patents In program, foundation Japan, have gives partnerships and further We our of we addition pursue we property expanded Neuroscience further progressing potential franchise. this and granted for to intellectual were to markets. a development long-term BXCLXXX our new from our provides and clinical

Our IP is substantial. portfolio

XXXX, and prosecution. in than of additional XX patents granted allowed more have or patent As April we XXX applications

Orange FDA's in Patent Trademark additional allowed approved and for one Book, patents drug, Office. recently IGALMI, listing, have eligible U.S. the also our X U.S. the patents for with We listed X by issued

Turning to commercialization traction. IGALMI

yielding and driven Our existing QX customer by revised we implemented volume results, growth primarily utilization acquisitions, permanent being contracting, XX% for recently IGALMI. revenue in as QX increased focused new customers and strategy increased XXXX over is the by is XXXX. the This net the J-Code from

are quarter with volume already seeing into first second that this We exceeding of momentum carrying this year. the forward quarter the carton

reaching for and providers, symbiotic this a We health is bipolar of market care strategic. expect greater patients are schizophrenia-related home and setting agitation and pleased institutional continue. Both to that and commercially are IGALMI number momentum and

development uptick setting. are We utilization for having excited achieving home about a and clear path IGALMI an in the

now to the corporate Turning front.

completed $XX continue important provides are clinical our strategy million runway. to We cash to and multiple This strengthening balance our pleased business the have bridge offering registered sheet our announced. focused an transaction and including partnerships recently potential extend plans. We trial financing options, remain we to further direct exploring advancing on

optimize strong. believe wrap business our We we operational fundamentals also are to continue efficiencies. To up,

and seeing property company. With with will turn I a Vince. These proposition that, are by to future We intellectual accomplishments progress driving underpinned programs, the are value it for of clinical late-stage for X growth commercialization advancing over strengthening IGALMI. compelling

Vincent O'Neill

opportunity programs for the Vimal. you, made development Thank with XXX. we've appreciate the our clinical I late-stage to review progress

the designs for both announced we on plans have that the the received the speaking FDA meetings development the trials. from programs. since and So with March, with feedback, developed TRANQUILITY of Based and SERENITY regarding Phase minutes III pivotal we our you in

bipolar for and potential development Alzheimer's-related sNDA and We submissions, are may pleased lead on agitation X to have which agitation. paths, schizophrenia-related both clarity to

reminder, an treatment with acute in as for Alzheimer's TRANQUILITY agitation XXX associated evaluating a the dementia. As we're program,

that and placebo-controlled XX-microgram X hours safety double-blind, a a at change as designed dose score note XXX is XX-week PEC trials that use FDA the this studies important period. post-first the of TRANQUILITY the the program, XXX trial It's is disorders of primary approval efficacy In-Care of of or with is in the The study a IGALMI. In evaluating SERENITY same agitation end supported endpoint in evaluate we're dose. previous point TRANQUILITY in bipolar associated Our potential used to multicenter and at-home for schizophrenia. positive over to

tolerance, address episodes following treatment. in current around tachyphylaxis schizophrenia days selection. In of of designs, designed disorders of withdrawal evaluate look the trial forward use with site study efficacy whether deliberate bipolar approach the patients SERENITY and agitation the efficacy double-blind, clinical for is Our mind, be our enrollment with of been our in limitations multicenter designed finalized These the recently dose our a FDA the the protocols or to of period. after repeated being shared is to and occur language and PMR or a X study. safety, that It's The label. is IGALMI XX-week results now have to our accessing measures safety of exploratory evaluate end retail of XX and primary for XXX a CRO At-Home precautions dosing points. Again, trial goal and warnings dose study, placebo-controlled frequent to over to objective setting trial with of XXX-microgram in XXX-microgram and plans. advancing the thoughtful completed with a ultimate IGALMI's of repeat open-label taken can we are help trial we we've and The as

of by patient in our The asset, with combination adenocarcinoma. forward comments XXX are year, of we this look in this lead pancreatic Phase metastatic led We announced a to portion Cancer currently my ductal like Lombardi Earlier enrollment from II in KEYTRUDA and study data announcing the results PMR is the safety trial shortly. I'd performing trial being XXX. completion Comprehensive few end the to immuno-oncology Center. with cleaning about remarks of Georgetown

look forward Annual to We and abstract selected sharing was Meeting the are X June pleased that on a at XXXX the presentation data late-breaking with you. for ASCO

of asset. I process the this turn of first for 'XX. Richard? the will formally would monetization review for results to like financial over now have quarter our call Rich, who to the We initiated

Richard Steinhart

net attributable IGALMI fourth for volume-based million down the of TRANQUILITY period of million loss used was $XX.X Vince. This of the in The were personnel period development Net fees XXX% and a of XXXX. and for of professional million the during a first to offset the to $XXX,XXX quarter a in previous to first equivalents million the SERENITY company same same were $XX.X costs XXXX. to offering guidance of direct for XXXX XX, $XXX,XXX periods the XXXX. for the contracting. Research million the a increase. with the on for increased with XXXX, first the same from revenue were our XXXX. quarter the XXXX our orders customer you, compared revenue the operating had attributable for registered XXXX XXXX. and Thank to announced The the quarter in of March for wind first increased the compared million first XXXX. Cash as XXXX. in demand quarter totaled in includes This the and and the first $XX.X from XXXX. BioXcel million same Sequential cash the $XX.X XXXX. IGALMI trials, the The half the costs. Selling, decreased $XX.X mid-XXXX administrative increasing XX% XXXX net were to $XX base, of decreased $XX.X of quarter new XXXX were period year-over-year $XX.X quarterly II expenses general reduced as of period primarily partially approximately of primarily compared expenses of of million into extends III expenses investment for of commercialization during for associated cash in III first in XX, decrease beyond existing to XXXX. by from quarter runway both compared quarter expenses well the second customer compared loss our first The was $XX.X primarily and quarter addition as personnel of of and million reduced professional March expenses related quarter Therapeutics the of cash increased fees, The and revenue attributable to

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

Vimal Mehta

to forward the call open coming to care investor we I'd health and Operator? weeks, attend upcoming like plan you, questions. to add the continuing look our like to that now in Thank for discussions. conferences several Rich. would We

Operator

[Operator from Instructions] is Colin Our first question Bristow UBS. with

Colin Bristow

what of the the has kind With So a for Alzheimer's on to can specifically for wrestling to time I are as you path with expect follow-up this in approval regarding agitation? think you agitation, major just data? approval this the in XX-month do safety to investors regards are need that. say the cost FDA what Alzheimer's the question And And the be? is program what data line of said then

Operator

Instructions] [Operator

Vincent O'Neill

now? us hear you Can

Operator

Yes, we can.

Vincent O'Neill

Okay.

sorry, glitch have site. on technical the we So a

So Colin, thanks for the question.

and can't of TRANQUILITY the design. similar dates today, can in for to trials see this In-Care what terms Just I But delay. look they're answer that, in very try study, sorry TRANQUILITY the We give and II, to morning. specific

a very similar to So we would cost TRANQUILITY study. II time a anticipate line and the

Colin Bristow

And Okay. FDA on the safety? requirement XX-month for

Vincent O'Neill

Yes.

of TRANQUILITY to the sNDA. think be for the not and we details In-Care in is So that for part to long-term reapproach the we've FDA specifically doubt. will form the done, that trial. discuss trial need That around I as package the has safety said, clearly But would the

Operator

H.C. Wainright. Our next Ram question with is Selvaraju from

Raghuram Selvaraju

to contracting to there the months, when respect regarding anticipate quarters? offer expected in the contracting you GPO of Are you status decisions to and IGALMI. in color net us manifest impact purchasing itself Can the group additional With coming coming the some please? important discussions any the revenue

Matthew Wiley

This is Matt.

had the So matriculate the to contracts We continue we in is to QX. multiple yes, question answer contracts.

increase QX, We volume. and plan, execute in continue the seen we've an over unit to

Vimal prepared than remarks, QX. we've we in volume as more what in fact, QX already so seen In unit increase in far said posted the

new strategy We strategy, contracting customers contracting is the and also accounts, the really order, important we see continued throughout see the is continue of existing I the volume that for year. to So think acquisition growth which working.

Raghuram Selvaraju

respect develop is these? the Neuroscience in-house? them are earlier then continue options And to aim with strategic stage the exploring assets, to secondly, effectively for to you Or

Vimal Mehta

Ram, this is Vimal.

as primarily X clinical on program, late-stage focus, and Our mentioned, I the is At-Home TRANQUILITY In-Care. SERENITY

programs. explored if certainly to for explore. our are is But We plan resources will we dedicating that, be those programs And potential partnership. early there to interest all

Operator

Alec Bank Stranahan from with question Our of is America. next

Alec Stranahan

treat both expect expecting this X patients? treatment from then the I these is typically in should PDAC to how of with us what be data we high designed in monotherapy would as through at KEYTRUDA XXX level, metastatic And on walk follow-up, guess maybe ASCO. just Maybe line patients. us. a these we Just

Vincent O'Neill

this Alec, Vince. is

is part monotherapy. a your second as active the take I'll So of not first. question KEYTRUDA

exception only would generally the that's MSI-high label KEYTRUDA definition a think separate Pancreatic a is tissue-agnostic pancreatic tumor. accepted. cancer. I be really a cover cancer tumor, to cold MSI-high of The has patients. very cold very,

that's So X% approximately, pancreas. of

So not active there. KEYTRUDA is

second-line in to approach with patients XXX of It's approximately plus in KEYTRUDA, Our patients XX is a KEYTRUDA refractory XX total, Simon XX another cancer, X-stage, pancreatic stage combine about by so patients. followed X combination.

at we're have is that point that presented. And pancreas it's that published essentially the reason show we've general just know, We've surrounded, data a very The makes difficult data of tumor. makes lastly, all and doing also by cold a strong combination, again, disappear. preclinical the approach. which, gist the that's XXX to encouraging So the which fibrous because as And treat. very it that layer, collagen you now is the we study for all on

you'll multiple ASCO. reasons there's those at to results results, and So encouraging in anticipate see June

Operator

Our Avantika from next Securities. with question Mizuho Joshi is

Avantika Joshi

me? hear you Can

Operator

Yes.

Avantika Joshi

Avantika is Graig. for on This

would between you Our more would And would make sense trial which In-Care after to it run than priority these is you question At-Home, you for TRANQUILITY one studies SERENITY the or and concurrently, guys? another? is run say

Vimal Mehta

trials Strategically, Avantika. Thanks, run both prefer we in to would parallel.

opportunity and both larger transformative big for label the There much indicated, first are drivers. one hand, on TRANQUILITY expansion value to and a XXX-microgram approved for therapies approved they FDA is a a with SERENITY, upside longer-term significant being near-term the drivers I the value As company. market. while through is no opportunity represent and are dose,

run to over one other prioritizing to, prefer will decision we If of then we question, have take the your stepwise approach. both. answer to So we or the

Operator

[Operator is question Instructions] from Genuity. Canaccord Our Kulkarni Sumant with next

Sumant Kulkarni

I have X.

and to the needs capital SERENITY on for November to the financing to additional current to TRANQUILITY million running cash relative they the now That's your you need stand and you'll in that So -- $XX you -- how your agreement? conform raise would frame as that first.

Vimal Mehta

this Vimal. Sumant, is

indicated, similar TRANQUILITY trial data. the the Vince to In-Care trial, TRANQUILITY II As we is positive where very had

of safety. are We trial another well Phase and trying have controlled III for to confirmation efficacy

cost be trial the to the similar expect we So very to TRANQUILITY.

the much what about time idea lines, like -- pretty in terms patient good per similar. very cost have we So will And of it is. be

At-Home, almost it's the we XXX think patients, smaller number of of when patients. a much While SERENITY

is recruitment cost previous X would lower, we what -- XX% is a I, and our it II in III. And what that trials, So have faster, much observed of TRANQUILITY. be much in SERENITY almost is

you we potentially, sNDA So trying And opportunity. both SERENITY, trial, complete if file we know, are can be, to with in XXXX. as we look the can the at

already because have synergistic a product. we very it's So commercial

say So a cost the cash, and previously handle. good have the we I at capital answered, and finance we how current which what And laying and is we stepwise on approach. is that then was requirement what are we the very prioritize million, would to reported out based use trials, $XX trial or our

Sumant Kulkarni

shot one it. here. then and ask second in question I'll Got And the third

on you expect enroll as chronic Alzheimer's. as a And stands that is base company be cost, things you In-Care, treatment that on? patients optimized operating for do expense TRANQUILITY already general at going to to to So think the the need relative the you in might agitation it target back to in percentage execute the Rexulti of what's currently

Vincent O'Neill

think colleague, my I ask Risinger come here. or... don't I'll to exclude Dr. we Rexulti, on So in

Robert Risinger

patients point concomitant about data, not XX% any are II exclude demonstrated patients on or antipsychotics. Rexulti to TRANQUILITY are other I'll And the We on who do of antipsychotic. which back

Vimal Mehta

last your it? question, can I'm I sorry, you to And repeat Sumant, ask

Sumant Kulkarni

the to to think things to sure. on company need midterm in the stands the base Yes, optimized is currently, as here? expense Do it near you execute you the at operating that relative all

Richard Steinhart

Yes. Thanks, continue at and to Richard. operating we Sumant. continue to the overhead, to and optimize more it ways answer The we is evaluate look It's make efficient it.

So that's here. an ongoing process

Operator

from with is Samir question Securities. Devani next Rx Our

Samir Devani

I wanted to before the required back initiate essentially trigger that, the required be to you've the study. for the confirm to that completed just also, discussions these be just TRANQUILITY I In-Care you trial? to the the XX-month FDA, what's want that comment about that would sNDA? study And now would with come that now make left safety

Vincent O'Neill

Vince. is This Sure.

we will data That's that and for the of fundamentally in think and the we need, study. So the long-term as collect FDA I will clear. we've said, the be -- the course, But to go details, not that discuss the safety. around

it's FDA. and So protocol be discuss why which, course, we go discussion, to things with of the going a is typically

I around In question guidelines. think -- ICH I numbers obviously mean, set terms the are of those your by the maybe was and requirements.

an So safety the XXX X months submission. at at XXX X We year. and would need long-term data sNDA to support

Vimal Mehta

expect Samir, when And we initiate this question, to answer study. do your to

we and readout, and place have for we financing the up with the mentioned, Vince selection. As site the initiate sharing the once data now protocol CROs in are the we it given to study. the And will FDA to

technical the readiness. We are getting

Operator

back question-and-answer We have to our closing session. of for reached management like I end remarks. the the call turn would to over

Vimal Mehta

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

Operator

conference. conclude will This today's you. Thank

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

BioXcel Therapeutics (BTAI) 9 May 242024 Q1 Earnings call transcript