KRTX - Earnings call 3 2023 | Karuna Therapeutics Inc

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Operator

Welcome to the Karuna Therapeutics Third Quarter 2023 Financial Results Conference Call. [Operator Instructions] Please note, this call is being recorded. I will now turn the call over to Alexis Smith, Head of Corporate Affairs and Investor Relations.

Alexis Smith

Good morning, everyone, and thank you for joining the third quarter 2023 Financial Results Conference Call. I'm joined today by Bill Meury, President and Chief Executive Officer; and Jason Brown, Chief Financial Officer, who will begin our call prepared remarks. Chief join and the Bill of call. and Commercial Kane, Q&A Founder our will Officer, and Miller, Operating Will Officer; Chief portion Andrew Jason for

page encourage our find release and today's visit Before investors.karunatx.com to press everyone related begin, website at I the we Investors call. of presentation our to to

SEC activities call. related may our be risk outlook from implied important to regulatory with differ forward-looking Please actual Forward-looking over could performance release financial and our to filings product statements for press it and commercialization during And factors this and development, our plans, refer today's our cause research those presented to that results statements. Bill. that, hand to in materially I'll or expressed these and

William Meury

morning, months to clinical, CMC our worked I days our and KarXT by of submission partners of everyone. preclinical, over of our external for past information. achievement thousand NDA. years begin to of hundred represents R&D team many regulatory treatment a the the and schizophrenia. the work Karuna several Good major high-quality timely thanking on want a write detailed The KarXT and on long Thanks, and NDA weekends team Alexis. for several and pages was culmination It submit across and for

of ABPM Ib milestones activities Phase ahead and month. submission first step line There important other from in this just the the course Now the process. including is several the NDA are review trial data top

XXX and inspections the month as well preparing We things. our information already FDA their this safety site hear later and expect on update to other back day filing among from we're decision for

next potential in half review about, the talked we've a the of standard and launch therefore, we approval second As and year. expect

for over of be of As XXXX-XX. that important schizophrenia served the for KarXT and product X launches I continue this the the you treatment in could their one in class believe years to would And and potential of change of patients biopharma physicians. medication has XX approval by know, been most

track. In terms of on remain the prelaunch activities, they

the and focused ago funding managed on nurse scientific and have weeks primarily over program. several MSL started and which build the several We've KarXT teams, payers, to we're out anticipation practitioners. our from very medical Interest to needed next capabilities with this optimize We the on now pre-approval care information continue requests meetings exchange high to responding psychiatrists access and and quarters. for in community right is we'll the and built

next emerging potential we from prespecified and of of and tolerability clinically achieved was reduction a the to differentiated responders, final and year this will X and week trial, data analysis Last nearly to end symptoms provide includes the in we PANSS the KarXT's program the from by on endpoint relief. trial Additionally, and XX% continue the XX% year. which presented of patients present month, highlighted meeting trial. at of that EMERGENT-X, in meaningful new symptom the The secondary receiving KarXT our European have new demonstrated data Neuropsychopharmacology College publish data profile at EMERGENT-X pain

X, disorganized placebo. On also from improvements over on statistically hostility, data to Marder shared additional PANSS the X KarXT severity were first the and X baseline with excitement time. motor primarily including occurred GI PANSS week depression to consistent demonstrated and the events EMERGENT-X nature, common we associated adverse of significant and treatment, where in and positive, events adverse thoughts, characterize We the transient compared the KarXT treatment-emergent were mild factors, most domain, data provided with weeks EMERGENT-X to in within symptom anxiety uncontrolled safety,

in in EMERGENT-X, efficacy negative and NEI month. additional CNS Colorado trials symptoms and events from analysis analysis we'll X Summit safety X the adverse ahead, on as at this Looking and as Boston Springs pooled sharing and be well

the commercial market outreach and launch preparations peer-to-peer force sales and for deployment programs. track and including On our anticipated are on research, front, sizing consumer too, the

the what team are in our KarXT as support and Phase evaluating of operational a conditions. what we of is know experience pre-commercialization have doesn't regulatory launch. Equally depth, and new the a program, people We our III the of believe and KarXT work works carefully to with product all great strategic a for continued achievements psychosis-related deal treatment and potential decisions a They for execution ongoing neuroscience. of which to and rise proposition reinforce important value launch

activation with States and For and XX United active the improvement is ongoing ARISE, site across Europe. about sites currently

sharing of we our second impact of rates the may target manage that very enrollment factors on enrollment and half in basis. monitor day-to-day As and site we top activation line XXXX, a data maintain to continue closely

added program Although prevention reinforce be remain track no the to adjunctive to standard of use. we trials relapse psychosis approved share in of the in ARISE, weakness schizophrenia, and can of treatment the and care. I'm lack our KarXT patients efficacy share ADEPT-X the support Through also of Alzheimer's evidence KarXT differentiating clear is is acute evaluating KarXT's antipsychotics ADEPT-X therapy and use despite data hope X from combination there is on on treatment the as adjunctive of in the of that clinical third the pharmacological X, clinical quarter. to top rationale of around XXXX. underway and for for and to seen safely and unique profile, XX% treatment effectively initiation fully pleased of and demonstrate We of our following ADEPT

psychosis benefit demonstrated a as As the where from of cognition. in an promising fundamental KarXT as originates therapeutic behavioral reminder, well concept xanomeline symptoms treating related and trial, Alzheimer's

insights the and on our Phase Ib while the in and is in is KarXT volunteers. healthy ADEPT to And Our that our with trial designed objective ADEPT from efficacy associated initial of based with treating safety delusions program primary hallucinations Alzheimer's. and strategy evaluate

program, acquired we disorder discovery next this year. with most may symptoms such Outside and in plan of also KarXT's reinforce as timing Alzheimer's, the evaluate agitation, inform promise refined be have with data, the anticipate ADEPT cognition. The potential but additional initiating for of to and for early KarXT. stage relevant not Alzheimer's psychosis, of the Phase be aggression and inhibitor design TRPCX/X clinical Goldfinch collecting other including that shared potential KarXT, in only of clinically additional We also year. start as we're will KAR-XXXX our help also treating from and of future at trial We providing into early treatment with headway depressive to insights and KAR-XXXX, data notably Ib making XXXX the Bio from major details treatment the trial developments in KarXT prominent a

maximize we Now transition operational year, I'll strategic value to had of X that, With fully our look Jason. from just as a we organization. XXXX, to our this that a earnings made capabilities the couple earlier of Those perspective; excellent to With forward these strong. in it highlighted commercial call set work XXXX. out on development left a X two, organizations. We've KarXT integrated priorities scale company priorities and months progress our the of R&D scale were finishing on hand reflects our over I year and in fronts, hard which to the pipeline; we expand three, of the achieve and operational

Jason Brown

stock-based increase growth for you submission driven and QX year period to was organization. III continued the in Total pleased $XXX company quarter XXXX compared to offering efforts Research ongoing proceeds equivalents approximately in XXXX, September compensation. Cash, I'm well primarily a and expenses count $XX operating for The development by head share $XX.X and as were offset million. NDA expenses increased cash year in expenses our as efforts, quarter prior million billion $X.X significant discuss administrative the of $XX.X expenses runway Bill. for cash $XX.X The quarter driven by billion our higher March to expenses results was related by the that third period. as driven compared across in resulted progress the higher million follow-on investment XXXX. Operating expenses clinical our KarXT, slightly $XXX.X and to employee the our was with of were and guidance. XX, for to today compared increase of net third financial of to net the for public RXT million and in to of of stock-based related $XX employee income, programs, million securities the XXXX, for comfortably you, prior XXXX. our to to this strong end the for another increase third totaled the our across quarter KarXT million with same to million our to at pre-commercialization be quarter the full Thank count $X.X year loss for compensation. General Phase head interest programs, by $XX were increased all a primarily $XXX a million $XXX.X was pre-commercialization $XX.X million million compared third due ongoing year million. resulting of were through us period. providing The

top G&A range the $XXX in operating $XXX relative and our with the and decrease we reiterate to full come that, is expect million, third to the anticipate and we of the the million. year, total at respectively. at be ahead fourth Of rest the XXXX, R&D of expense to of Looking to end expected in in the quarter year guidance range quarter the million towards $XXX around expenses R&D for

in over related I'll the enrollment costs the with monitoring increase Bill. ambulatory driven continued safety it being trial. associated to R&D program guidance trials and in ADEPT to back our our With by by pressure blood primarily hand activation now long-term costs

William Meury

Jason. the open Thank that, you, to With questions. we can call

Operator

is [Operator Suneja Your Yatin Guggenheim. of line the question Instructions] from first with

Yatin Suneja

progress. the all on Congrats

if Just X ones for quick may. I me,

we added tolerability you to anxiety say, pipeline depth front maybe to of responses? the you your So on behave the over, drug onset monotherapy about are then impact. And how let's study. to of you And MDD about going into the about the expect with maybe Could the rationale and you XXXX, MDD. talk first ARISE is first the should on one similarly Could other the maybe disorder. talk expectation? prioritizing in think Would regard the terms

William Meury

Thank questions. I'm Thank for Andrew. turn to you, going it both to Yatin. you over

Andrew Miller

endpoint that to across end maybe the the X in X. efficacy. A the study, primary with study total an is ARISE PANSS first, from the and point as So respect the same expectations X, speak EMERGENT to reminder primary perspective, the score ARISE to

And is think So those comparison it's difference a very focused to the we observed are you MX we would MX treated things meaningful we're care. background lower the a X-point meaningfully our do effects to we the clinically with respect the at obviously, change benefit on our program based X- what EMERGENT observed would primary given the more with KarXT ARISE the And of significantly severity on safety the That same baseline clear ARISE being adverse across the of on a dynamic one statistical expect unique tolerability being distinct and the do patients expect overall the we actively excited with standard to about the receptors. patients. what in programs. With Because in to ARISE all the conservative, symptoms PANSS antipsychotic inform XX-point and change powering when on see I EMERGENT of of look completely X and expect existing that perspective, program. It's that key expectations to comparison expectation from again, and that it's end pharmacology, less little about and safety total in most are that, in tolerability, current to medicines. range is point muscarinic it profile, in program. to still be we consider

don't for see or the and meaningful we consistent to background with So KarXT associated things instance, overlap muscarinic expect side [indiscernible]. pharmacology effects to expect worsening continue with of of

Yatin Suneja

to And then supporting want [indiscernible]? at XXXX preclinical the comment you utilization evidence on

Andrew Miller

TRPCX/X for I as and psychiatric illness illness. mental target mean think with and I general, in therapeutic XXXX a

there lot interesting possibilities. are think I a of

broadly I think there's that's is to antilytic the properties. both question, your really support and of that basis evidence antidepressant

TRPCX/X but more broadly, Specifically, XXXX a as target. a molecule,

could for to that that disorders. information ability to would and of evaluating interested being with different is in safety say forward on XXXX our but meaningful Particularly, certainly confidence therapeutic insight initially specifically that focus next details a number preclinical that doing into here representative or think more remain something some our the generalizing the study data, potential of in study towards as to I MDD our that a plans provide speak program. a of disorder quite anxiety also will of anxiety we're we year longer-range Phase interested execute well think this Phase study our in as Ib as able well look both of early in represents a Ib patients provide benefits. We I context, scientific

William Meury

And MDD would is is noradrenergic. today that everything and effectively add available the other serotonergic I only thing in

do MDD efficacy And so be essentially 'XX, to we, to is would work we'll is to the a of course, which produce be the completely atypical human what but because the KarXT of know novel market, early the and could attractive XXXX. end respects, schizophrenia have depression to some this at approach, data. in pharmacological more But market, many

Operator

question next the Laura Your Securities. Wedbush is of from with line Chico

Unknown Analyst

with This now a expectations space. of represents in cycling around even on completely base discontinuing would little if for for KarXT had trials? real-world Wonder hallmark longer-term is you've you Ingrid experience expectations treatment How and therapies talk Laura of describe duration you case Chico. that your schizophrenia bit the among your about a clinical KarXT could therapies

William Meury

few Ingrid year rates probably now at turn Officer. can are range tell study second-generation and comments real-world then with the depending real-world at. I between number that Kane, XXX over experience our of I'll look that XXX Commercial will when adherence about therapy days on make you right each XX%, it first, is look observational Chief and the Will you XX% of which What the to only missed of a you to is atypicals, and in

And increased noncompliance relapse, have efficacy real the safety so that that results a of hospitalizations problem course, visits results ER and then, given costs. experience in and patients and healthcare some is in

to be little we adherence bit. KarXT that with would have therapy don't of could and be setting real-world lower. just of to expect But it turn course, could in Will persistency the experience missed add yet. I'll longer real-world And days higher, a We, over

William Kane

also just Thanks, is value talk is the adherence when comments, I'll and the they see marketplace potential to KarXT. increased to in echo a clinicians the payers Bill. some we Bill add of for for made, real which

incremental and interest and As strong in Bill the typical seen realize mechanism in long-term from we've KarXT. profile far mentioned, emergent atypical, the full of increase to there's the the there was clinical the seeing the given so to data potential program,

either be discontinue adherence. And don't And really could data the typically will a about talked signaling have by nonadherence. of and may first intolerability that so indicating opportunity there when them real-world an the really and M&A X/X adequate and Patients increased there's the driven here we've a or high is of have about we efficacy XX address as opportunity of occasions, data, on for XX% to market. the KarXT months, or in that's those lack of both in needs rate

Operator

question is William Blair. with the next line Myles from Minter of Your

Myles Minter

the quarter. on Congrats

in acceptance to that First would one Are pressure And you as X second dropout the you a in the just use naive is if that to an have how experienced. also us ambulatory on you update that the going clarifying. KarXT to us the an NDA forum fully been rate second is setting. And to that since filing compares and that? treatment a then get announce ongoing give outpatient quarter. you give just has at EMERGENT-X patients data EMERGENT-X that do that's monitoring That's enrolled the been patients blood are Can time.

William Meury

question. Myles. take turn answer I'll over question and second first Great, of the part to it to the Andrew your then

couple of at the we As month. in results, a away. it announced announce have we quarter, is to it to will Andrew? as the ABPM weeks relates that fourth the which the we then end the of middle expected relates those the to of acceptance, And only expect

Andrew Miller

mentioned, any studies from as conclusions with respect too be those and those you to to continue of on comment EMERGENT-X, sort it's EMERGENT-X specifically studies. premature ongoing, to Yes, Myles, obviously

study where X an do in the see to predominantly with and generally profile effect, of a as And data GI releasing to by and earlier, long-term profile we've short-term effect both side course, to think quite with from we'll overall consistent by mild-to-moderate receptors. those see characterized the look for MX looks pharmacology that and able is characterized the the here for all great spoke we studies. EMERGENT-X, the at something those being look X, demonstrate to studies, XXXX in I we complete. as KarXT data safety a what But of the right profile the effects. We'll, being been our a consistent opportunity us KarXT. a studies again, are of potentially release is unique of forward tolerability time expectation further broad robust transient MX those efficacy and differentiated we at

Operator

Your of next Stifel. Paul Matteis from question is with the line

Paul Matteis

was serve curious, that, amendment. the just the now not more of FDA can that data, of with Ahead Any a right what's data confidence your major you level color I ABPM as will or about TRPCX/X like of analogs? launch? deal are how broadly, And business doing the next thinking development so any in provide the year then you possibility more or the another and just before

William Meury

then let the I'll for tackle Paul, for questions. first Thanks, the I answer the question Andrew you. second can question,

Andrew Miller

an late extension topic Phase prior with that's not study day We our to I safety specifically review submitted specifically, study, idea the XXX. a result again safety at earlier date. study, to Phase that prior think of but pre-NDA based the agency the not certainly highly on a with And is expect NDA in which major sort submission that to we're PDUFA quarter again, amendment result that September day year. the precedent a general the because NDA of I Ib discussion process. Again, would And this at second and to that happen in I January our time respect the specifically And obviously, late XXX to of a meeting, ABPM the the Ib a frame. in were study, midpoint the pre-NDA in submitted be will will with which at confident think update, think FDA was that would review to meeting study, conversation safety also

William Meury

as development, relates pipeline. only and business it's second priority is say would it's launch a very good question. most for I to approval us important our a And Andrew. Great. KarXT, the important Thanks, the to build priority. to then it Paul, which obviously It's of

that TRPCX/X financially. And neuroscience new inhibitor think Goldfinch a them boxes. look depression, about like, given the monthly our Look, opportunities and make fits number pipeline lifeblood. TRPCX/X several capabilities those company, sheet, on broadly we flows our the Alzheimer's, other scientifically, We about something focus focus, #X any with we of product building think You new and right strategically, that see is schizophrenia, neuroscience we on the If all do basis. we priority at balance anxiety, our transaction, mentioned something. Obviously, KarXT, conditions. #X but now I checked is fairly think the weekly, sense our We inhibitor. the a would for yes,

that And things. we'll if of at like, continue we it. look so something we we'll, we'll to see course, And do

Operator

Your Ash next the UBS. of Verma is line from question with

Unknown Analyst

wanted any in ABPM. the So patients' pretty effect I the blood and agonism the ask, clean of impressive way haven't to just on KarXT ABPM know was or MX any previous additional molecule But for on seen study, could on I impact KarXT, in so for theoretically MX pressure? study study like we mechanistically

William Meury

Andrew. it the question. for Thanks to I'll over turn

Andrew Miller

Yes. Thanks, Ash.

is to separate So often pharmacology specifically from contributions. the individual a challenging perspective,

to the programs, modulator some We think effect the cetera, the look exists you molecule being of pressure think tied data That when any multiple see potential that have hitting at receptor. for et said, targets. you a I tend MX to allosteric being I

of I seem with don't not pressure increase the certainly MX chronic you see the will pharmacology. And on we effect sustained an as emergent and basis already. a MX to across is program the any RXT expectation think we our see meaningful So that referenced,

systolic offers of further will we data sort able remain hypothesis ABPM of that. the study here final to And with soon, statistical the the think I ability reject blood quite coming pressure. confirm certainly X-millimeter sustained confident we to us increase that be in that any

Operator

of from line is Bansal next Fargo. Mohit Your with the question Wells

Mohit Bansal

on all Congrats progress. the

Again, your data regarding in increase to was there are ask increase was competitor's wanted TRPCX/X suicidal small small. on the ideation. -- numbers this Just and

the just with high So just why wanted will small Or numbers? you this there is theoretical any understand, law to of is it ideation mechanism. reason suicidal see

William Meury

Mohit, repeating said. Would we what mind just question? had the trouble you you hearing

Mohit Bansal

Sure.

early and this regarding TRPCX/X Boehringer So the we the is saw from data Ingelheim. October in

in I'm the are was trial terminated rate it you. due small slow Thank really is So this trying was anything in Or arm has with suicidal it a mechanism? the to placebo. treatment versus the -- understand, this but law numbers to there these just to numbers, recruitment, small of here. X% of anything is just is a ideation XX% do

William Meury

Go ahead. Andrew.

Andrew Miller

Thanks. Yes.

of where So remote you're a referring were terminated recently was [indiscernible] result mobile-based That on study actually, that results was the that to by done a clinicaltrials.gov early. study posted study pandemic. was the

was single-digit like low of I think the final number subjects. enrollment

It's to often some program ideation, until you specific rating rare. I I well. the like challenging ideation, the that around much to into that like details to implement things or numbers. There's tend think make emergent conclusions also, or generally, more and as you speak it's to those given MDD larger that. adverse suicidal Particularly across that with think, get in like We which scales suicidal to too respect -- when any about things studies more schizophrenia, are for there to in be depression things more read premature results. of study considerations study really that effects

XXXX in be why obviously that effect diligent [indiscernible] We'll anyone certainly expression see TAEs being I and would or program. studies preclinical at push don't in further looking adverse And that our would simply the scientific when be perspective, I of with evidence from TRPCX/X. say, potential as any not, assessing thorough would forward the a for we we certainly a with effects. carefully specific conducting So assessment rationale an into could that associated is say

Operator

Piper line Amsellem David Sandler. question Next is of from with the

David Amsellem

specifically, agitation. on vis-a-vis thinking to you can ARISE, sites? of and Just then enrollment? that where to you it on flavor a ADEPT psychosis pace things about how more are are onboarding AD you are wanted secondly, on trial? So And talk AD still get for And

Do think wanted without that companies psychosis. I a agitation, of are much And to at you of that. on psychosis and at is your looking you looking just pick distinction agitation are that sort guys difference? brain Some a

William Meury

Thanks questions. ahead go David, for the Andrew.

Andrew Miller

Yes.

Specifically continued X sites course and this second around have programmable first we really at of we area, over year, quarter, are sites ARISE point time. to to countries third in cross the question initiated new as for There's part the we the of program, activate this about this. the have in that active XX that so

aren't psychosis as agitation-related more indication much distinction program our forward think out going psychosis. years, studies, updates basis. for site already. And the X maybe think extent additional studies years, lack I a on with you're of part do mentioned anything across respect the ARISE that always program. with the you XX among the Bill will last think over of for psychosis, look typical a and to approval day-to-day any really to given, sites if there over perhaps week-to-week of are they rewind clock that's wasn't at ADEPT to XX agitation. program. broadly some then provide we'll the focus also frankly, it's the continue as to the little see drop earlier, to an I think likely good and obviously, separating But We XX about as managing pretty as I we actively we off program, see enrolling. see a activations obviously, who are you like that feel that to time whenever where we're and I additional But momentum Again, ARISE this,

data, have sort at that's that part published, original of of at of look you agitation and I KarXT. Bill delusions was hallucinations, are delusions, advantage non-antipsychotic psychosis, sedative where more, the really taking Whereas I when patients you effects all we of the and the somnolence is And first is that effect aggression, at where effects, drugs that antipsychotic that when you of agitation by the look a core Specifically to the aggression hetroparadigm. on see referred and or xanomeline or potentially and hallucinations that's xanomeline benefits call, think, population, Alzheimer's based this across that sort in look discovered. in which as specifically program. of think, opening of affected fundamentally, the

really capture ADEPT hallucinations But we KarXT at the delusions effect. primary specifically and program. the to broad starting look with for the that with basis So the as something endpoints opportunity as in

William Meury

I'd know that which that David, very And the a trial observed in was effect, has product Andrew other the procognitive about. we talked only same just thing add the to,

And so other aspects both when we of a on I would cognition, into Thanks area. that this compelling step Alzheimer's official for we go data in there's think the Alzheimer's approved about an as first opportunity aggression but be FDA population, think psychosis, or for creates the course, for indication indication know that disease, agitation, of and we us which question.

Operator

Your the next question Oppenheimer. with is from line of Jay Olson

Jay Olson

concerned for that by narrative ultimately, running blood false a competitors? just the signals remind have the pressure in progress. about? that KarXT blood can rationale be be lot investors interest just us And a ABPM pressure this study, seen study? the contrived in is a behind past? legitimate concern there the to is you you of Or all on seems Since Congrats there What's should what

Operator

Go question, for Thanks the Jay. ahead, Andrew.

Andrew Miller

Obviously, study point the of even and X it's blood drug even in of at could we've data about seen, But to would don't when the scenario. a internally. have pressure to running what lot fundamentally KarXT definitive any also in what that to of projects more which Yes, sure. the ABPM effect kind we're has where be. vital not paradigm of concern about signs describe Cmax just look which respect worst-case at we dosing a start more study, dose. We something a see how a provide the that increase that a hours as I I Happy setting of set, EMERGENT the to X-millimeter with speak that of and we as you in think sort the with, think schizophrenia first program, same I'll ABPM measuring maybe we're patients living [indiscernible] with ABPM,

That's something with the with having have you've some paradigm. clinical this selective any why was of into of we not we really across high generally seen effect So that last observed successful meaningful we the pressure couple a until development mechanism translate that the of historical have data compounds early-stage and from outcome over in that KarXT, study. Consistently, ABPM level consideration come program MX into years. a confidence the such not or

I pressure our obviously to the think final public from that point data But consistent potential around in see most to into to which clinical provide be we've get looking in our forward expect greatly any be So emergent data already perspective, domain, with and ABPM minds, we able we're program. that effects. out assessment our the in definitive the will the seen what

Operator

question Hung Stanley. Morgan Your line from Jeff is next of with the

Lee Hung

What latest feedback and And clinicians. you're KarXT? the on with resonating is payers benefit is from the on cognition how hearing payers

William Meury

started question, and comments, Medicaid Yes. Great turn it Kane. and just then meetings States. couple of I'll over United make the exchange already scientific I'll to We've a Will all with across programs

first groundwork of formulary year We're to have on months more now level we to that plenty away coverage during achieve launch. high sort of the we're lay than so opportunity market. proper going of So from XX the the relatively

us the XX over on is for more the X past about KarXT And class out pharmacological decades. had I here for already programs, Medicaid a haven't months. to think think we've position significant. carve opportunity They I the several pretty novel formularies in been maybe to a

that. were different, to getting we may With introduce payers bit little but if DX think it ready over isn't to antagonist, conversations that, I'll turn -- with was I if a Will. be another think I I this

William Kane

Sure. Thanks, Bill.

with X a had interactions commercial. Medicare So dozen and we've the have initiated payer to exchange also And in that we've Medicaid, just September, Since I'm particularly more the year, between go we on meeting over and with pleased channels, continues date and interactions D scheduled the we up. end across Part the scientific to had community. dozen number than of now

a I've new in almost if opportunity and the case, learn, this data -- into with couple there real I cetera. heard the -- is information will, et think this the patients of schizophrenia. There One is meetings, it serious particularly is of as one time presented in things. reflects medical illness in allows mental options things exchange treatment we preapproval interest, to directly us is you for

look is over can XX next something received. is on months. The interaction, capitalize which they forward so well we And to the that really data

the the into unique KarXT tolerability they're to the but PANSS, appreciate and offering which be subscales, of data I and their your encouraging question, They in for products about total currently to where but relative X mechanism they the relatively are knows on date. They formularies. symptoms, think reflected positive the negative a really have questions dive real the to to the fundamentally the and particularly the and we negative the good of the present, they of course, the on domains find have that different deficits safety anticognitive community clinical do, are they that's just appreciation needs schizophrenia, symptom the we positive, of the data profile where as know, certainly cognitive. drugs some

program clinical be more able to about offer actually learn where to potential drug and interested may evolving there. So the KarXT's benefits they're very

So to future think, continue back of more opportunity has XX I really data come clinical the engaging XX months. we them to the as next welcomed and in and positive over the to learn present every one to far, more

William Meury

of sort governments utilization fewer to prior and payers the control policies would And direction. are just prescribing the use moving every system of states in is healthcare just of is would fewer now words, see right as right about to we mental add authorizations. formularies health certain of thing using and the it in the management general, and other state even talked in relates only area we reducing say the rethinking drug I and In I techniques corner

XX I states, PA in there's no fact, think allowed. In

step the You in are these the reduction very edits, use or the and of elimination also see good I trends. think very,

If momentum up the you communities isolation. there headwinds they years. trends dynamic the you for think take areas a therapeutic and more all are that in being frankly, are across across I to different doing in coverage to more than than mental patient compound compared there's then other look very think health serious it's other at there if groups advocacy are set more mental the reduce these States. And of and stigma introduced community And and ever been work illness? all than more the before health providers, are United a I in centers tailwinds at to will United market, that's has in enable aspects and And the those access in mental and KarXT as States new of look

year. And introduce for when position KarXT in so States Thanks start that to puts very us good the the question. in a next we United

Operator

Salveen of Richter is Next from Goldman the with question Sachs. line

Unknown Analyst

Salveen. Anamed This on is for

like? there there color population would the Just provide launch on MDD asset? is on you some next an the year. what suitable for days early guess, in? with interested geographies that you're be And or certain a of look could this KAR-XXXX, launch physicians most Are most specific KarXT Could that then I on

William Meury

you is going in a the the great about practitioner Will. the for going we question. many is as of health States. KarXT. for it as broad-based to can This covered. as program. mental practitioners as anticipation centers to over be physicians community say, Thank There turn nurse United in to Yes. And as would the we're I'll psychiatric cover be just community introduction KarXT community, many I in many nurse the think as

data we from nurse we that that's lot be managed a And a well-funded It and program, very a the completely approach. novel United least EMERGENT but practitioner very, sales there's not access will where KarXT. The but compelling. and I our instruct DX complementary there'll in a still X antagonist. it's that the care have or course, under the deploy full course, FDA, don't X, of think a psychiatrist review our It's may of of And data to evaluating at here. be States organization, interested comprehensive at program teams, the X exactly

would is make new they switched accurate complete, consistent that patients or wouldn't perhaps presentation with indication to they it that we our then all launch. balance that job patients so either those are we a And have patients data information although add in the of that be on label, they'll patients, sure at aware have, is and everyone get try our that which see a and of utility

no of that launch. for market aspect out and this we it there'll And leave be preparing so

William Kane

we don't as add would where earlier since just Thanks, about this to to that, what states on priority to are that of to those the important we And be Bill. mental KarXT, high see see we the health states comments they that mix. [indiscernible] but that large in so be some build moment out I a X tend particularly mix, gate, particularly would Medicaid opportunity, refer require to on authorizations states in states. step. Those prior population is where

opportunity. So on we'll be fully prepared to capitalize that

loaded. robust fully have We is force nearly sales sampling complete. our be very and will a analysis structure program, We'll

them. launch market, and support that that practitioners, and So point, community, it's have we our engagement KarXT or again, potential there level to be will cetera. clinicians something Bill was to high see be available looking drug go the they're potentially said, psychiatry whether will to to and and of et across we a the will will when KarXT excitement psychiatrist any progress this that that There's a nurse of interest with about payers. And and

William Meury

second take Great. Andrew, question? want the to do you

Andrew Miller

patients. depressive to we or TRPCX/X a MDD respect specifically applicable being subset with of we're major focus this disorder. population, speak focused think point, patient broadly at on at particular that that to We our broadly or point the not in program, XXXX, to MDD Yes, about this

from MDD believe between but I think a potential anxiety substantial we also anxiety depression that benefit and perspective. There's comorbidity a from disorders. an perspective there's

for will potential role our a antidepressant for to benefits on applicable and remains be for But I look place given the right a effects. MDD. antilytic rationale scientific think preclinical treatment at this at time natural of the us for that So specific and focus point, sort

Operator

the Your America. from from is of Bank Gerberry question next Jason

Unknown Analyst

Jason. This the Congrats Diana for this progress on quarter. with the submission Ann NDA is

a molecule Just target you're confidence just I'm this this profile it the has other trial? and molecule with that quick the what to FSGS how curious of leveraging KAR-XXXX. for as the the all CNS referring prior failure your on it sort right specifically MDD disorders. was underpins data because Was the X wrong in and and

Andrew Miller

specifically are preclinical the antilytic replicated to the you're that biological not molecules as preclinical relying which Sure. XXXX, but Obviously, unrelated program depression that to running on other compounds Happy tool data, to medications that effects. rationale looking We've respect suggests target are data XXXX to speak well as or anxiety, referring with development And at but antidepressant specifically target models. to the following, we've both given been renal and compounds, previous with being a XXXX, in that. was TRPCX/X or those disease. with

with the really respect confidence to our that's molecule. So of this basis

experience it the leverage I with us does offer think human opportunity to previous a great XXXX.

program administered was duration a XXX XXX to of patients humans, the up XX Specifically, to over and weeks.

amount and with substantial tolerability XXXX. provides that informative to of that respect So quite believe safety us data and think a of we we positive is profile the

confidence those potential preclinical the in benefits. treating well highlight the So anxiety going clinical designing given potential as previous our about basis think right MDD efficacy we the given molecule of trial disorders, that as human of experience, kind a to rationale biological that's forward substantial for how and

William Meury

the for question. Thanks

Unknown Analyst

Just one quick follow-up, sorry.

able prior to be you go still anticipate do being III you trials Or given it have all data? safety to Phase Ib So straight then Phase is into this determined? would from

Andrew Miller

EMERGENT-X want what speculate I Xb Yes. future think I we III, X But far say EMERGENT-X you're our major us disorder. study, in don't in patients are I we're Phase the too a hearing mean, go the would Phase think III in Phase to we've is say to do think between if identical into a studies with from about being I you in KarXT the protocol substantial study and Phase ready look II development program with that XXXX. stress our Phase we our distinction run and perspective. II not a in there's at schizophrenia,

Ib think, that that So you XXXX. Phase run to going there. from and exists, commenting again, tolerability study results program wait us I prior forward an think our the we'll to for from given plans the data do substantial accelerated we development future But offer opportunity to safety already it does in specifically

Operator

[indiscernible] line question JPMorgan. from of with Your next is the

Unknown Analyst

Nick for Jeff. This is on

and and kind your on first initial countries you which U.S. the can in preparedness But your of ramp commercial commercial outside the logical your about thoughts strategy choice? recap an there. also be talked could previously U.S. You

William Meury

the a hope in with come. partner Japan. a regulatory in then outside important focus as would period, will before, come strategy and a the the with partnership that, States, United that mid-'XX, Nick. capabilities. we'll in and value States development the Zai. we X China both EU of It's KarXT United has of And and be XXXX have is clearly XXXX the a to geographies. course, need into those Thanks. commercial Yes. And that good more Outside said late question, we And we, other geographies

Operator

with Your from of Goldman the is question Marc Leerink line Partners. next

Unknown Analyst

Marc. is Rudy line on for This the

cognitive talk more separate moving So pursue How spending a your into as can can you pre-commercialization you also in your about about pivotal current strategy impairment trials provide you And indication. for color this Are to work? should XXXX? schizophrenia? on starting we secondly, think

William Meury

second the take will Great. part, first the part. Thanks question. we'll and Andrew for the then take

Andrew Miller

Yes.

program. schizophrenia. the included program collect future benefit original emergent as associated data with as in we X as with and patients to as about well as Specifically with cognitive ARISE to EMERGENT-X data collection will data we are [indiscernible] as with all well of with respect just cognitive impairment cognitive to also be able think further were part patients opportunities respect Alzheimer's data in there, performance endpoint the Obviously, That with demonstrated of an the course, schizophrenia. exploratory and collect cognitive studies and to

do we're are than other rather and contemplating is specifically really primary cognition dedicated specifically designed, towards And what recruited that you Going schizophrenia. means forward, reflects work that think additional symptoms of have studies endpoint cognition? that

us in indications. development about And of consideration is benefit a number we in dedicated applicable KarXT specifically cognition expect there of towards XXXX, broadly you'll of more for a us, I that's across that's potential under cognition potential from to So something believe different and psychosis schizophrenia. certainly hear think

William Meury

Thanks, take question? Andrew. want the second you Will, to

William Kane

Sure. Then indicated, is really leadership word, perspective on go-to-market and the developing we've commercial as our from in right a the strategies. place precommercialization on team is so the first, focused

new of campaign loaded opportunity we before, in mentioned be KarXT fully treatment a see eagerly we options. expect a As great to for that the out is marketplace this awaiting gate. We

Our I has mentioned, scientific the think team gone our and science our collaboration we've And account in director exchange, between we've great team. form that begun. [indiscernible] as medical

the practitioners offices in adequate payers ensure our through dialogue that to design both processes or with that also we that opportunity care they're psychiatry we clinicians reimbursement have step provide psychiatry a us healthcare the that if continue and clinicians in really [indiscernible] can primary said, allow as and in able you on physicians and area. But and sales extent it is questions completion, to landscape, nurse this particularly any cover play. provide will, to the is the broader will active information very community prior us they centers react be planning to help with give to force that need I prescribers, that the authorization we and go to address to important are health a to and get obviously cover behavior certified So to work to nearing market

program designed We have full roll. sampling that's and ready to all

shape. we're to do. from think to and want a we'll approval I'm potential work So We good human messaging, I position. this point, pleased, to et have Obviously, find But away form a in very ways our we're we're and more good still obviously a cetera. labeling very in

William Meury

second just would I Yes, what said. Will

psychiatric say And the would deal I of beauty is getting we're KarXT. as it the interest track. relates There's ahead on is here. to of that community anticipating ready. are here We a great schedule

it systems the question. promote all Thanks gone. approval, we but course, get for until can't we Of

Operator

line Jason next Securities. Butler question from the JMP Your is with of

Jason Butler

on progress. have congrats my I'll And the

and Just the to another And tolerability. to specifically, what push slower the optimize physicians to in efficacy you're they the willing maybe how experience thinking from they're versus dose you with regards experience about follow-up on their early speak hearing early be in drug taking commercial launch? prep. dose will about Can using a flexibility, gaming how with to

William Meury

I've are follow-up XX my X most and years. principle go at probably Will. experience, it for launches I'll start an or Thanks low psychiatrists of course question. to turn make depth and slow. over the X in opening comment Great. then of the neuropsychiatry over and just been with And generally the dosing involved

sort I to think KarXT like for over novel him the guidance expect atypicals. Will that's using true compound antidepressants of comments. schizophrenia with whether with they do would practice they'll I'll or follow schizophrenia. And label, you're a turn that as I let same add his with KarXT or dealing of it as for the other atypical course,

William Kane

enable will the they I'll that tailor experience that, per of to the Sure, label, the patient for clinical product the go for drug we maximize gate. also to their on flexibility right use market to that just the prescribing the community experience to so of with but can out the add that

of one, the are patient new a patients et options. broad-based right? approach cetera, There treatment terms In with for schizophrenia, it's the many segments, looking of

of whether patient they or physicians not if opportunity on the patient We've addressed of rate a and any even an the add who, are though start, on are promote be in that could to XDXs, tolerability market who be a reiterated some or indication this you that terms to for KarXT not will, that non-adherence see experiencing will from switch polypharmacy effects an many be potentially increased adequately those and times use have looking until will there efficacy in perspective. adequate it's that we on case the of of help not discontinuation, lapsed for with will high KarXT or therapy of efficacy the for we which that new patients therefore, in have are

little a a area, is for diagnostically broad-based Again, there's it population. in decades. for this so novelty And very time been long

it already about from the they're of benefit And interest know thinking captured I their really that so think, KarXT. and you the may breadth patients that has,

William Meury

Will think I right. is

DX that another about more the of of think or far market continuum be have narrowly, should talking psychosis, we've line not second be we're antagonist, left program. about the in for had with not type what given Thanks third go that here. thinking you treatment, KarXT seen that's on opportunity think you emerging I for but a the the are I broad what patients you who is If question. broad it all on might a relapsed, episode who first the and therapy to the And the way and

Operator

Your next line Cantor the question with Fitzgerald. of from Duncan is Charles

Unknown Analyst

Cantor. XQ, the in Alzheimer's. the limiting Can of for And question if psychosis are, patient factors are hear schizophrenia. in for What your an from that [indiscernible] ADCOM? study talk and are X you progress Great progress us. to what enrollment? for any, key questions is the made for the about what And for all This KarXT for KarXT second expectations rate is topics discussion? And possible

William Meury

you. Thank Andrew. questions, Good Great.

Andrew Miller

respect study ongoing program, here has second started ADEPT-X ADEPT-X since just With the ADEPT of the XXXX. recently the third the obviously, been half in more to quarter.

also add ADEPT-X in different So slightly points on but patients the ADEPT perspective, operational from studies an into in recruiting right certainly X, study. focus those finding that

studies. severity general assumptions as well diagnosis and our tend who the limiting number key to time sites as those a psychiatry, for really I all think with finding factors. inclusion in needed and any fit to of of study sort built criteria That's successfully of patients in health into around of be respect to sort duration the

to sort nothing for of you begun ADEPT that more our preparation have would specifically program already outside considerations. With to So we the for ADCOM, I a point of respect general an process potential ADCOM. certainly

than a endpoint methodology likely XX% from that's clinical basis ADCOM. That's adults schizophrenia program really to trial well an design an views treatment and precedented on less a indication general of the our think receive I and of clinical were having for perspective.

several that the something whether topic ready what like it's But course, for decades. But Our we'll that over development that's discretion certainly certainly and does to if getting ADCOM an they'd ready of program add up ADCOM for FDA the and already the follows be we're happen. last those would of presidents be. an to

Operator

Mizuho. question Graig final comes Our line from of with the Suvannavejh

Unknown Analyst

Graig [indiscernible] Suvannavejh. is This

X So us. just from questions

KarXT the are launch of update, potential part In how elaborate additionally, who year, the can going. ABPM update data. FDA the manufacturing you with for specifically will preparations bit next terms Day the besides And inspections more a XXX regarding be little of

Andrew Miller

Yes.

of all patients to simply day XXX program. update, with XXX-day the that ongoing bulk the immersion that safety forward a the respect So are roll is in in information really, currently the

in is a the collected calendar for the safety day on which date data that's submission. XXX NDA typically, prior all So been simply included update, to date there's the by and that

but program. general a X-month forward less roll database. as data, of specific roll we'll part of completing a is of or set the safety This about have data that So that forward more studies

think for respect submission I think, sale, are sale already readiness, approval. We that we inspection and manufacturing, have quite manufacturing of to of in we've et have We expected period a sites well CMC assuming feel, from that inspection place perspective, KarXT we a currently known I general, kilogram commercial as been cetera, use a scale capsules to by as ready dispositioned supporting the agency. some are previously at agency time. for launch, been very a With a multi-hundred good potential millions that the potential in the from manufacturing perspective, from get

potential manufacturing the quite that going we And we support well the forward a confident to as have CMC felt launch. approval so strategy as

William Meury

question. you Thank the Thanks, Andrew. for

Operator

today's Thank you. Thank call. you joining. does This conclude for

disconnect now may your You lines.

Karuna Therapeutics (KRTX) 2 Nov 232023 Q3 Earnings call transcript