Earnings call transcript Q2 2023

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Operator

Good morning. And welcome to Intra-Cellular Therapies Second Quarter Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. [Operator Instructions] As a reminder, today’s conference call is being recorded.

to conference like to now would turn over the Dr. I and Vice President, Sanchez, Investor Corporate Juan Communications Relations. ahead. go Please

Juan Sanchez

Good morning and thank you all for being here today.

the Executive Chief on Chairman and Larry Durgam, me call Financial Dr. Officer; are Joining Officer. Chief Sharon Chief and Medical Chief Officer; Officer; Commercial Neumann, Hineline, Mark Dr. Suresh today Mates,

today’s during call, making reminder, will a be forward-looking certain As we statements.

reports. cause information, involve These made Exchange Commission, forward-looking and uncertainties actual change that and including a are from in of expectations to annual those that statements periodic risks Securities are These the results might described assumptions, based materially quarterly differ forward-looking filings our subject and in the our on and and number current are risks contained with to other statements. and

undue You these disclaims to on company the cautioned forward-looking statements. obligations and not to such any place reliance update statements, are

call the Sharon. turn now will over to I

Sharon Mates

which pleased XX% continue an XXXX. Today Thanks our sequentially In the second Juan. XX% conference for by demand total today's Good QX, results, of quarter second QX call. to with increase compared to CAPLYTA. morning, CAPLYTA And prescriptions share to demonstrate to welcome high consistent increased past compared I'm everyone. quarter XXXX, to quarters

performance million, $XXX.X providers and XXXX. patients. $XXX.X the net same date well by healthcare Second CAPLYTA our extremely to received robust revenues and continued increased growth. period continues XXX% In growth quarter total of to sales to in a confidence increased CAPLYTA million, versus to in our be recognition

guidance million $XXX depth launched, a coming of product the to the with million to solid million from CAPLYTA’s raising well increasing our $XXX $XXX we've of sales XXXX prescriber CAPLYTA to previous guidance our foundation, as are our full base, range Since breadth prescribing. built growth net as We year increasing million. from $XXX of

will how will use CAPLYTA further treatment real their This is Mark in have efforts build commercial later with experiencing patients discuss this are during the and call, world reflection success. confidence we of benefits prescribers continue CAPLYTA will CAPLYTA. on of in describe to their that gained a our the and on

We rest of pipeline. continue advanced to disorders and lumateperone other develop the for our

lumateperone Let's of mood with breadth disorders. positioning start in

features has reception from We are that leaders about mixed in pleased received the Study community and excited XXX with the positive are numbers the large to potential study, patients. of psychiatry very equally help drug’s

Montgomery this study, mixed features. statistically in reminder, for or significant of XX populations endpoint MADRS Scale, bipolar of MDD Rating feature a with was bipolar population combined the primary the features As depression the and MDD individual on depression patient mg Aspirin lumateperone symptom and reduction and patient with the Depression on mixed mixed of

will The robust XXX to effect presenting sizes results September, psychiatry Study in meetings. be major X.XX X.XX. Starting range from we at from

the and important half manuscript and week regulatory refining to Last this program submit later with We in this year FDA plan Study to agency. We've been analyzing the of describing our we the a meet and strategy. the second discuss also plan year. results XXX with XXX this results commercial

we'd today for even potential like share confidence our strengthens conducted important pre mood further hoc population, we to post to CAPLYTA’s analysis patient Study a and analysis a and this analyze you continue specified data as as in with disorders. treatment other We XXX an of MDD

commonly current during and of documented of criteria. DSM-X the we a a specifier Anxious At known anxiety presenting DSM-X using is anxious patient to study, the distress the distress, the into entry episode population depression. symptoms depression, concomitant as with refers anxious presence in

effect robust X.XX versus difference with depression with features were total point, MDD less Our placebo mixed lumateperone In the robust. that anxious distress mean placebo combined significantly analysis a of and with P effects a features anxious value MADRS compared with XXX, the improved of bipolar mixed of lumateperone size shows X.XXXX. antidepressant than a in with of patients score distress population Study in and X.X

detailed treatment with and showing patient of depression. risk evidence distress important a plan The that a longer meeting It of robust bipolar distress Additionally, as these anxious lumateperone associated another of the the We each of XX% potential nonresponse, anxious data of of antidepressant duration patients estimated had MDD is distress about and population anxious year. mood is disorders. of analysis effect illness. analysis medical patients spectrum MDD mixed robust presence later suicide bipolar features this and depression This with at rate to is line experienced with present to patients estimated CAPLYTA’s across similar higher in of and results. for

patient depressant In now difficult have to MDD to populations including more any bipolar mood has MDD depression. treat, both healthcare effects And shown disorders, we mixed depression, to These different system. and anxious in be with populations, features, known with in lumateperone those costly comorbid both the in and depression. bipolar and are with patient depression, schizophrenia are bipolar distress and total,

MDD now to Let's our on program. lumateperone new clinical turn adjunctive

three top we as studies, XXX, of evaluating adjunctive and MDD the expected in for an Xstudy, respond of XXX, XXX as our any treatment depressants, sNDA who line guidance with to patients and Study been our filing of provide we as timing in ongoing have results the lumateperone FDA. clinical on We Phase approach has partially practice, time, program, our completion registration

first are We of MDD our at adjunctive conduct this trials. now two the point

we of second XXXX, results in in expect our StudyXXX these filing of XXXX. Subject half from and XXXX. second We the from line of the results studies, in the quarter in XXX Study the quarter anticipate first top sNDA to results

broad about are mood MDD potential excited across our As see, program disorders. we can and adjunctive you CAPLYTA’s

of including of lines based different supporting interactions serotonin the strong the antidepressant optimism and mechanism clinical of populations. Our the systems across effects on evidence is via glutamate and multiple action the CAPLYTA dopamine, patient with evidence

continue our Injectable We to formulations. study also Lumateperone Acting Long new

and these studies dose month later single effective, studies is a with continue well ascending This formulations Long Phase safe of step key to Injectable Acting treatment several year. tolerated We through next expect X new of with year, or one durations expect our in that developing longer. LAI and formulations to initiate are this

XXXX to ITI-XXXX expansion year, generalized important agitation and neuropsychiatry patients Alzheimer's pipeline, program Phase evaluating in an initiate of with Turning X our for programs Alzheimer's expect This disorder in we franchise. disease our anxiety is in with the to patients psychosis in disease.

efforts. are We ongoing franchise building our committed to through neuropsychiatric R&D

focused to introduce on this program. I'm program psychedelics. of Today, pleased development is new non-hallucinogenic novel our ITI-XXX,

interest and As hallucinogenic of reemerged potential treatment psychedelics the in disorders. you are anxiety mood aware, the of has for

liability, hallucinations due to effects have X-HTXa agonism to agonism limit cardiac disorders However, psychedelics safety these and raised may receptor related hallucinogenic use. including adverse pathology of X-HTXa broad perceptual of persistence issue, abuse that

the chemists with a cardiac allow serotonergic Compounds retain full potential hallucinogenic neuropsychiatric Our psychedelics, psychedelics new series, the have In models drug safe class. exploration call therapeutic the that animal pathologies. this valvular liabilities these novel of of X-HTXa this ITI-XXX program, interact of which in of beneficial unique in developed the compounds the potential, known of effects receptors disorders, way. including and compounds while we lacking

late lead in currently expected profile, possesses enter desirable testing and ‘XX pharmacologic in early enabling or in evaluated IND this Our this to XXXX. ITI-XXXX, studies being and human is compound program,

forward conferences, program we this to this We on and scientific upcoming present look at data sharing you. data to plan with

year. to in upcoming later hold next this program R&D We expect also which or we plan an Day, early this year discuss to

inhibitors Turning ongoing Parkinson's Lenrispodun enrollment motor with to Phase which changes and is patients our PDEX clinical evaluates X in in platform, in disease. trial our patient biomarkers cognition, in improvements of symptoms, inflammatory

of phase different our volunteers. single the immunotherapy candidate, X is cancer For in ITI-XXXX, doses our healthy evaluating ongoing, dose and study safety tolerability ascending pharmacokinetics

Lastly, and we of ongoing for also use opioid ITI-XXX, pain. studies the have of treatment disorder

we this the completed ascending study engaged And the results dose the in looking in the and have later XXXX. receptor the We forward ascending dose are in to ascending study. study multiple of We single dose the single at occupancy. dose multiple year, presently study study sharing ascending look and PET

performance quarter The strong cash which ending investments, company our second million cash, to position, and proud approximately of our patients enabled in has and We're a no $XXX development and debt. equivalents in securities serve expand with programs. very us is the financial

care our continuing forward We We to are patients look to with share you. to be delivering with transformative pleased to progress neuropsychiatric conditions.

turn now on to CAPLYTA’s over this to Mark additional Mark? call details quarter. share will performance the I

Mark Neumann

Thanks, exceptional year great an to morning, to growth CAPLYTA. It's for as everyone. both bipolar XXXX today. markets. Sharon. be successfully our be depression Good continues with commercialization penetrate we implementing the you delivering We're all robust schizophrenia and further and strategy

our quarter, XX% team growth, of total compared to second commercial increasing versus During year, and same quarter prescriptions this year. last QX strong the drove sequentially the XX%

CAPLYTA our product for the full years. continue into the second sales strong and of growth importantly, guidance positioning the to to the expect confidence in XXXX net year increase coming We performance consistent providing half

to new each for as as consistently launch add new important prescriptions prescriber. the indication, of During a of the prescribers well number it's increasing

over than quarter, prescribers pay a During expanded We new the bipolar continue we quarter the of added with their Weekly before the label Xx total they to depth again base to level new our prescribing. both number we of and the to second CAPLYTA were first since during XX,XXX. CAPLYTA start to of higher X,XXX launched depression. breadth prescribers at patients our Xx be nearly increasing into increase continue of time cumulative prescriber

to of breadth key our base. further year, the Earlier designed this prescriber depth we initiatives implemented two expand and both

to specialists team during reach enabled First, first volume more we our us and neuroscience prescribers XX more sales And highest the has our interact this with frequently new added prescribers. new quarter. to even

pleased their far the the CAPLYTA to progress in the expect very with team growth to are contribution this the of thus half made second and expand selling further year. We and productivity by of

educate advertising raising CAPLYTA. about depression, as launched well awareness prescribers requests patients a prescribers. patient campaign new of national is The for and generating Second, to awareness CAPLYTA, direct-to-consumer as benefits of significant raise to bipolar and campaign interest potential the among and brand we

throughout the pleased with the we'll are year. these is continuing that impact efforts be and the having, campaign half second of the We

three strategy efforts look and And uptake to and helping effective are coverage execute We to Prescriber optimizing broad Support Patient access payer supported [inaudible] we'll by our with objective access the CAPLYTA. also been our in all creation. continue to market of which very continue channels. patients access has These value enjoy across Program market

we benefits the a launch proud execution way, depression success provides commercial and forward see and very We year. the compelling product look for profile bipolar and salesforce in seen of and to the XXXX believe continuation exceptional a continued has of strong patients depression. marketplace. bipolar half schizophrenia heading commercial some the broader substantial that with of the team of strong our the I'm CAPLYTA and of indication, second momentum In into CAPLYTA’s has half the of first

to I'll quarter second call Larry the financial our Now performance. pass through walk Larry? over to

Larry Hineline

financial to of our for million over sequentially compared the increase results. revenues of the in Thank second of the XXXX, quarter were total CAPLYTA same to highlights $XX.X million primarily product million million in sales prescription I $XX.X a quarter-over-quarter was Total net you, strong XXXX. Mark. increase representing a quarter Net of XX% XXXX, year-over-year This driven in the quarter second XX% the in second growth $XXX.X CAPLYTA quarter XXXX. In the period were increased first of XXXX, $XXX.X of will XXX%. compared provide for period sales for same by demand.

In by strong minimal net. hand on with sales in in CAPLYTA, driven from the impact increase to current for changes the was gross quarter, and days product demand

million expenses in $XXX the of XXXX demand from period to general for raising XXXX. to guidance CAPLYTA the of and expenses were in performance to percentage $XXX same XXXX increase for the $XX.X full in the Research for remainder million to period low million net operating We XXs and guidance for $XXX quarter million $XX.X the for our of of $XXX to and Due same CAPLYTA prior sales compared range million the $XXX.X XXXX quarter compared Development expect second were gross million XXXX. year for to our administrative million, full XXXX. that second $XXX remain increasing to the to million. net Selling, to year the strong product we're and nominally year date, for

$XXX to year to $XXX we between full continued range estimate expenses and and year million XXXX, expenses $XXX million between and For range $XXX SG&A million. full million R&D to

open $XXX.X cash Our remains concludes XXXX. strong. financial questions. for June remarks. total in prepared investments XX, please at position Operator, This cash restricted Cash, securities line our million the equivalents,

Operator

[Operator Instructions]

first Andrew comes Our the Jefferies. from of question of line Tsai

Andrew Tsai

Appreciate quarter. great the on congrats and morning good updates. Hey, the all

on on the just raise. to the revenue the about it? or to benefit volume are maybe what goes end guidance. benefit talk For to for end of guidance price more assumptions the the core So drove the raise more instance, question that top guidance side? imply you Same of lower

many was also some year, in And applied think it for particular. CAPLYTA, though drugs last I to summer seasonality secondly, there neuro

is less phenomenon So, time? same QX going you. year are that seeing pronounced be you that Or this in to far? this so Thank more or

Sharon Mates

your Great. Mark, if Larry, Hi, add? then do and Maybe anything Andrew. Thanks you to start questions. for you to want have

Mark Neumann

Yes, sure. of some strength the for our trending Andrew, in the say the trends. in question. I the year, the based Yes, of first see guidance on it's of prescription our is the thanks the and those would half that we trajectory just volume, variation around range

volume days with each inventory hand and the said indicates the continued strong gains quarter as both was the range on their impact strong year, gross second remarks, from second half think end driven net. initial Sharon and of from in I minimal to the improvement of by growth definitely Larry in

each seasonality see in some quarter, then do Regarding to summer a quarter. seasonality. your and summer Yes, tend stronger see fourth year, third we we

don't I add. to had Larry, he anything if So know, else

Larry Hineline

No, hit points, you I all think the Mark. high

Operator

Our of Leerink. comes next line Goodman Marc from of question the

Marc Goodman

Good you formulation like And had you and moving seemed now talk were you gone one that on working about second, the different back LAI liked. you've a you morning. you're program it Can formulation. for a forward,

because acting big of just curious, I'm we on that? Where longer a one on time? So is moving this kind like, this the picture, been? just we've where are you're working

from work if to the that on going is the curious then do, I'm additional do work? that And do of on? down slow just parallel? Thanks. question all move just you this FDA of to a you in quick you before tox just rest they you are XXXX, have Can making studies the that

Sharon Mates

And a thanks study correct. this, a that. start Sharon. absolutely be it do formulation we mean, can you we which tweak one LAI, believe start we with me did believe that's month contender. your we with others. other LAI. to And is -- than that And tweak questions, with let are me Marc, we even believe an And Because Okay, do longer formulation all other in I in the would formulations for formulations a that fact, still that developed. we've the And we've is been we're a well. why than developed what formulation that have formulation, of do we month. that a this got We testing. have we have that maybe these could that's one better development. formulation been first let that But as want those that we And also

have the to meantime. other tox I ongoing. doing other is is what say in guess As we're would the XXXX, studies been what studies I

that we're new with not us deemed done down. excited further So required be has the And program total, that pretty tox actually different slowed just coming studies doing entity, package. would in which being I mean, It's a be the it first. to is molecular

Operator

Capital Markets. Abrahams the comes RBC of next Brian Our from of question line

Unidentified Analyst

is taking success the I for potential anxious of an subgroup the question work CAPLYTA about? question. talk also study in implications from you than Thanks. contemplating Hi. guess, explored paths, guess increased work. guess opportunity be depression talked done. that an for anxiety the or any I in endodontic for that a Allen CAPLYTA you've this could Can work from future general focusing talk rather as potential you you on about is an development of anxiety, commercial indication? others a being This confidence the anxiety I And thanks rationale from on the the are depression such you depressed And our of the instance. on I had group about for patients Can Brian, XXXX

Sharon Mates

like Great, everybody if at. that? it's maybe, take would look first, And maybe, so you why Hi, I anxious and to you would, think maybe Suresh, is remind Allen, what to distress important

Suresh Durgam

Yes.

So feeling symptoms. concentration anxiety One following having at is least five anxious least some of is feeling by distressed restless, difficulty is a because worry, at definition of unusually DSM-X symptoms or of having presence at fear depressive specifier. symptoms in these two two tense, or depressive presence happen, they of is feeling meeting episode considered might patients least have of symptoms an the that individual control if something with may anxious episode, that awful lose that a basically

why this and depressive have some disorder patients So symptoms have is important reason major of anxiety. the clinically is who

they we step less patients, these is Here likely to shown time anxious takes that's treated. based are longer respond And especially study. And clinically calling why is specifier these to are important. also distress it antidepressant. be the been remission also has patients, poorly on the the medications, in these patients the for in this And

Study Coming XXX. study, to our

this disorder depression who with prospectively, have And looked distress. bipolar we major both looked And added both anxious have have and both where we you studied for analysis overall also metformin. are also that in also we at patients combined is depressive criteria looking in at have sub and population at shown that We then strong today met the efficacy populations. individual discussing of population populations

Sharon Mates

it's did with do highly amongst major you, have episodes. because distress anxious depressive regards who is prevalent answer to why patients this, To we so all

thought we at this look important very population. it patient So to

Suresh Durgam

I thing that that I And lumateperone add a would space. of mood wide has also range disorders there question your it one confidence, does demonstrated say more increase shows a would in efficacy about, this that was

So adds this that. also to

Operator

Duncan next question comes of Cantor Our from Fitzgerald. Charles line the of

Charles Duncan

patient new adds that prescription be And to guess seems more over but to function being volatility can we seeing. speak Okay, in yes, team, thanks as I I'm so or questions, commercial. I'll lessening really and you limit really just if taking know nice updates quarter. that Sharon, wondering consistent congratulations you're time. trends the a prescription One is well, question. to lots of of mine, And the a for on many persistence

the so me coming, is that impactful, can you the versus from impact importance, when of it And focus mania to part not is, feedback relative time. on mechanisms that follow you prescribers new you about guess Maybe terms to or and getting of refills on more those bipolar, what more that seem think a over depression be kind that of question therefore mania in questions? speak So I could would more are depression the important, to in two psychosis?

Sharon Mates

patients question episode, that's with this. to Suresh Suresh, a we'll Maybe And into think know you further a the upon Because take so in most But most spend I point. don't maybe first. psychiatrist? to bipolar their a a of depressed important I disorder yes, little do time very would want go that second expound as want

Suresh Durgam

again, XX% Yes, to fold you have, of phase. that are episodes disorder, bipolar And have of you predict fold depressive depressed, of the manic depressed folds, span But l. both and spread during the time, manic time course, time period. the most being close is into about in you the they

at So medications space. in that's becomes more patients help why and look to it that important

Sharon Mates

And the another but depressive And not effect most the that's of have should say, been shown reason why phase. have help of it's treating anti-psychotics the not I it's drugs the important in to in have anti-psychotic they are them the do any or depressive to many phase, do that manic many so phase.

hope the to remember first which art, back commercial? your question the Mar, Now on you I

Mark Neumann

terms on XX,XXX the the add Charles. now. that both been to question, launched And ever I indication. pleased the seeing growth interesting trajectory that it's well we're has prescribers been it's I to with over as I strength start, as yes, those good that each see. that do. And are that prescribers we how new the an due continue And patients have prescribing quarter-over-quarter. of since I persistency And impressive each good bipolar think depression we to we the and fact it's very our the there, consistent volume observation. And of and CAPLYTA now, of volatility, trajectory average, I new of are contributing know more we're prescribers, up the in think, a we And probably think

see that I well. tends new for continue in that that you in take new So on should earlier the And think to as a of we launch the indication. of some a volatility the future see to away product

Operator

comes of of of next from Our question Gerberry Jason the line Bank America.

Jason Gerberry

guys. you thank Hey, morning. And taking Good for questions. my

was strip which unmet you what psychedelic long me like sharing, seems approach. question that hallucinogenic the a can to the guys do standing non-hallucinogenic For if some out I kind interesting, with expand a you program, need curious of of properties upon molecule, maybe that just of

Sharon Mates

Suresh, receptor And Thanks, Jason. anything. with a to who just and the and to deep overview. I'm actually we've wants the X-HTXa space. knowledge scientists R&D series develop have of Day, And molecules, developing that these started give like and a you global if on been our going ask start our he then I'll we'll Then it molecule of contribute and

X-HTXa I no and we, X-HTXa So of took be who other when are the to biologists around for wanted took to it's we they they deserve have chemists, wanted and and in I [inaudible], then took course, a a they make core, are this, build they, we of it's core, because sure credit didn't that. terrific say we modified the really to and agonism. properties, and And they

profile, a are of rat. modifying for the drugs, adverse they several for years looking proxy continuously because on and important animal series very hallucinations in so this models, of into things spent have going So, event

to in see hallucination. models, So it's difficult preclinical

proxies, have you proxy. common and head the So twitch is most

battery a molecules side through profile. desirable any bring and in effect properties of the have and you now would exclude a and tests, that all molecules, molecules that through profile a head go way gamut you have side modified So then series where and up from with of they've this molecule take how them with that's they behavioral come back of do not twitch effect the anywhere other these can the put come can

they're lead the the of it XXXX five looking about about into chemistry. preclinical chemistry, a we'll studies, when -- sort we of a will couple at, further And is And molecule. years’ have worth is of you So tell I that's other, actually been years’ some several as of of lot that including but or they molecules go a that's worth XXXX. more said, about

Operator

next Morgan from Our of Jeff line comes Hung question the Stanley. of

Michael Riad

Jeff Michael for you a with congrats Riad on depressive quarter. this how major a follow for just often anxious to comment And and I'm how distress? therapy more eligible also anxious distress? would is so on guess distress? features shows Hung. I the questions Thanks the patients develop want wondering what depression I many to Hi, percent between previous the Thank episode and up benefits bipolar mixed on that from is overlap patients on do on anxious be benefit taking our much.

Sharon Mates

Sures, take do that? you to want

Suresh Durgam

Yes.

distress, anxious And looked overlapping. So depressive talking just of higher is also but if anxious patients that we understood approximately to of distress, much mixed there's distress, this of in it number this. have terms have patient there or are is, a depression can these and two And anxious of people, bipolar to have And about And course, overlap and anxious numbers, who again, there XX%. major have distress of why is the then varies significant also approximately responding patients portion percentage patients patients importance have between are disorder XX% patients these an who even features other. these between the of poorly that's you're one overlap some about two, antidepressants. at populations. the And

Sharon Mates

used that of But of XX% a large with haven't studies. numbers. the to and many mix the patients good Yes, has anxious so over very number up a bipolar we've overlap, that different MDD been the and with do most patients, percentage difficult depression all there have come know couple distress. And of literature we conservative of numbers because a it's just

and answer yes. So that's I mixed is distress? that your features there anxious question. is, question have And that your the are have patients think MDD, outside more to within

patients are are obviously mixed anxious And features there distress. also there have have anxious lot features who with of patients who distress. Additionally, mixed don't with a

as have next diagram. exactly it. overlap out Venn see our And map we'll for we call, maybe So we'll the a

Again, clear have We working working well to get hard been you numbers. studies succeeded. distress an been we not hard field been very a question, by should to have not has it's very And I get. have studied. that very mean, this done great that is been enlarge, that I have the anxious very tell

So patients even tell given do again, data, have with depression we numbers. of makes it in numbers the fact, numbers MDD we've you distress. and it you published data, again, from, the anxious really published out even. the bipolar higher that know tease difficult And But about which and are the more in conservative exact XX% other to much

Operator

comes Our line of the Sumant next Kulkarni of question from Canaccord Genuity.

Sumant Kulkarni

progress very what depression is do traction? in expect to X you to adjunctive morning, I or and on with potential timeline you in all specifically And during your if features depression discuss results program and do good you I'm but the given of you hand, this, wait prefer have Good Nice one well? anxious thanks mixed to until Phase questions. taking as have for the our FDA terms sorry the missed latest trial results see your the on interactions

Sharon Mates

data and to study, report so going the in the did we the later other for other feature with simple the we FDA all say prepared answer than for of anything our not the is you for waiting and that's no, discussing with mixed study the the on will in clinical the we them. still CSR remarks And on case. waiting report, be Yes, words, we're our this that year, been program have

Sumant Kulkarni

to it. anxious discuss And as do that you well? depression as Got of part expect

Sharon Mates

on you we, we really very, a comment discussions to that about the be meeting, whole think it's meeting complex discussing, in Yes, study, as going see, to have prior can program. a don't particulars that the I it's we'll discussing we'll the but well, a And program. again, we'll be

Operator

the of Sachs. Our Goldman next line of question Corinne comes from Jenkins

Corinne Jenkins

had of that the a of maybe be follow kind helpful characteristics. have trial it the a depression, I on in patients up was have then these follow quick would patients questions. and a have couple that understand to portion of enrolled, patient Yes, what anxious of up portion baseline And

Sharon Mates

Suresh?

Suresh Durgam

distress. anxious XX% study, in with patients the close had to whole about who we For had of the patients

Corinne Jenkins

Okay, that's helpful.

Sharon Mates

very over up that matches bipolar told we've XX% and anywhere XX% number. given They anxious again, with this of you from And MDD literature. about range the or XX% to you I distress. conservative in patients

Corinne Jenkins

that And great. cadence these ramp think revenue see studies? should then about separately, consider sufficiently of pursue those next year, funded the through the we maybe, to on you hand? And as expansion particularly at do Okay, yourself you CAPLYTA how opportunities spend of some into R&D you

Sharon Mates

been And we next do call. consider add want I mentioning take yes, you And I'll part. given that? anything to into that sufficiently Larry, that you you today's haven't guidance think progress did every year. I'll second to to So program the is ourselves we've we funded But ask to on

Larry Hineline

that No, I And to going guidance results year. you stay of see, first can for pace think, we're within a to, in within the but you the by XXXX numbers, on that half, be the were again, that to the this position we're R&D. those not to giving gave guidance as we we point guidance Sharon at we're be like for this going said,

Operator

comes Ash UBS. of from Verma next Our line question of the

Ash Verma

my for the question. on congrats And progress. Thanks taking Hi.

be like past And So for MDD the for other when into onset you it of the the translate MDD watching just just that suppliers things. on the action, setting. study combine , in you any will antidepressants, DDI can with similar out benefits

Sharon Mates

I'll over have and of all may I that. -- see. on repeat expect -- start you any drug issues hear first the to to ask question. didn't it I'll not first to to question. any then in that the your I to with we But date done, about might we studies we've Suresh had turn And part heard we need DDI. So I the part your CAPLYTA, asking hear you're interactions would couldn't of we

said, really were I could I you as So asking. what understand not

and -- take to Suresh do Would the question I'll please. can't repeat ask You maybe whole then you it,

Ash Verma

Sure.

So yes, suppliers what can onset benefit translate when I was of action, a the fast setting. in asking MDD into similar

Sharon Mates

I'll don't I'll I You're at In onset an want there further Right. the know, that week, don't or? start what you was a in action, one we asking is either And, Suresh, to the points, by studies, to and first of saw two bipolar our weekend at fast if between it second in or action? week, weeks. -- time do and the turn onset Suresh. of any certainly just our or over go into we again, measure

Suresh Durgam

two I efficacy obvious early to one MDD week, program, week, have we some we And at seen least as are no, the ongoing. is drug in of we even one or within the studies the weeks, weeks, measure interactions, Yes, as terms two have and far. seen one studies again, think in so

studies have we now issues new say DDI. not right exactly issues with in safety any So ongoing no seen

Operator

Sandler. of question Our comes which of Piper the next Amsellem from line David

David Amsellem

thanks. Hey,

back and coming My that development LAI used just mania. I'm in the program. are schizophrenia LAI mainly is to understanding So

So wondering used I'm just a you about LAI primarily depressives? of are in context an in lumateperone How how it's where commercially you drug like that? see the thinking

you. loud, with lumateperone. beyond I'm how secondly, any And pipeline. talk on then just And Thank words, outlines potential or just lots are and going allocating are the resources? about wondering And exploring prioritization In you out you just partnerships? things other

Sharon Mates

you David. think I need, there, may have I in a few Okay, questions

I may with effective you repeat also schizophrenia, catchment, first just a used population schizophrenia believe population depressives, I patient as broad et robust a with disorders, be up we've disorders. it large lumateperone statement, much is efficacy. of need patient is where showed your hung population cetera. said, based. very mood is is I a in lumateperone patient well. mainly But have Mood to to where sales within do a bipolar where the So schizophrenia patient several ask don't than population let patient very correct We patient we But the smaller got yes, them. that's And some in because you that's point, been when start the showing me to populations

manic. in nor done for trials, everybody and patients do lumateperone studies have They the clinical treatment term clinical on haven't term we've long measured are depression. short bipolar in who they we but they and the into our are the mania, nor neither in our haven't become We of slipped for haven't YMRS. And trials,

have don't they So mania.

anti-psychotics you, that in these as I've they the the episodes tell episodes. depressive of work is that in our disorders drugs for where said don't manic would I that in of earlier many many work remarks, the So

to clarify So wanted that. I just

is continue these the think didn't program, with different they take don't the of do reason now of lumateperone one drug. safety in lumateperone, for for have the won't populations we schizophrenia. oral really actually will started oral want When that we may indication so As developing -- an for within we that We another for the an injectable who, patient a of now first But broaden the for treatment or schizophrenia. right LAI, database schizophrenia. lumateperone, in the the its our think the that drug, future. have treatment We or oral lumateperone the Either oral to trajectory. of are there is couple comply are we on LAI, we

is how an going take it's we approach have. think We need so an that the And progressing. And think it is option be do they it's injectable. We to reasonable approach. for program really And important half on over a market. an we that But think that's patients for think it's that don't to patients. to important

on I your think licensing? questions, were licensing that that other On out Is correct? and BD. Then Is right? in

David Amsellem

how Yes, programs? earlier and prioritizing stage you're your

Sharon Mates

think described you. the I Well, to we've programs

the So excited we're frankly, told we data been think because the the describe psychedelics, there. very they've we the well, getting have to once you past, about programs they other we've as been you. in they, clinic, I into Typically, we're clinic, non-hallucinogenic about that programs now in have moving the internal and

moving I And keep child our that to are like of have described for forward. program every And well It's you, like, We which when sufficient programs you to funds capitalized. who like got kind we've it's think, this all think think we do for we best? these have question. those I children, that I children. I

the moving think is forward each answer I of give one would these I is you programs own So that trajectory. that its on

moving will you get, summarize either stage And data Now, some be the forward. more you of as depending make those get Right of that now, one decisions, upon development. be, you and of and others forward, expensive. we're point, as them maybe not. move will or at clinical of prioritized these they And at one decides some you, become should the some partnering I some course, over all their later they into course, for be that they will point, more

Operator

Raffat question Evercore. of next Our from comes of the Umer line

Umer Raffat

Hi, some next to There's for guys, construction taking thanks my my question. cube.

apologies may FDA salsa any Two and/ point really distress. questions Is music. to for or you think So speak at that noise some data? label of quick anxious on that Do the any attacks, Liebowitz any And anxious the That et was there were anxiety expectation? you. scale case base or that for cetera. specific, more your that were for example, Thank depressive endpoints subgroup? also, evaluated

Sharon Mates

of Suresh am Umar. Thanks distress for the hi, anxious was the got however, questions. speak questions, sure I your stuck I music, kind Okay, salsa other I'll let the and questions. on not maybe the to all I

Suresh Durgam

this we are this in particular study, where looked study. depressive looking we we at in anxiety what and studied at looking who the terms have for looked particular was of in this there distress Yes, predefined we of scales specific patient And not prospective symptoms population in for have at the from terms anxious a population. have met criteria have patients patient DSM-X

Sharon Mates

result depression diagnosis patients as having label, remember And those was whose improved of in measuring what in we're terms this anxious their a distress. of study scale of FDA is

within a MADRS depression be doing but their we yes, improving want this population anxiety those So a is there improve the are and so scores. patient their improved scores -- and it's you to MADRS were the, questions on what

more were they in in again, studies patient And in about answer that population, we say looking the forward. yes. than go beginning? they the is are So end that clearly as were off and where the have that's at better And these we'll what to at and we

Operator

& the Needham Ami Company. Our next question Fadia comes from of line of

Ami Fadia

up distress. population? maybe on the Hi. current anxious any of Can treat for these Good patients physician distress? from differently morning, patients about talk thanks you. sort if patient around for broader you And the taking diagnosing my anxious practices question. Maybe a follow they Thank

Sharon Mates

you want to take that? do Suresh,

Suresh Durgam

Yes.

In go into least this terms like DSM-X. even the this of anxious question, was to to distress, is -- why before why the was this put important. And in we the at go reason introduced I would explain

depression, with was at they looked Before found symptoms, antidepressants, your patients the that this the also not distress symptoms, who anxious trial, SSRIs anxious coming anxiety this when were from SNRIs. and responding to recognition they where of MDD, mainly patients STAR*D had

the population. them populations. important who and respond then because So that patients including maybe And to pay SNRIs. will you caution why in that discomfited are because to this treatment don't It's no signal for physicians or Right that that in this this need And prescribing particular give is attention approved have that value give can to to that case. any prescribers there for SSRIs this to these make decisions, for else comes in important? a these or Hence, done population. patient is specifically you look something patient welcome. what that's population with And patient medication treatment, now, is we new demonstrate

Sharon Mates

these And as burden the non-responders more a traditional to patients receive high well response with addition, and they healthcare be In it. therapies. on very are system, to poor polypharmacy oftentimes as

identify that our into that to a study. they by do just in able That be aim population population of help that to what population, can important the patient putting description adding And how that them. is of and it patient importance was study. So was patient was what and see a the drugs the measuring

Operator

Our of Mizuho the comes next Securities. Graig line Suvannavejh from question of

Graig Suvannavejh

guidance XXX, same for question has that design sample thanks is question. almost just the for a Hey, I trials.gov study the the size do taking timing on and clinical XXX. thanks the Congrats Study the study Study design, around the Study on my XXX. it on of as exactly and the Also, to progress. XXX seem does XXX and which with had

does from terms difference is going XXX. be a end, a to take wanted And of that just to look it to long and start might there just also, confirm that. XXX like timing study So slight how to I in from relative perspective,

XXX and XX as listed to end. think were about XXX, I months from start

start is months from end. think to XX XXX I

we so a And are get other I'm of sense due some just kind to that much. trying of and to MDD is or enroll so whether to if studies today where there's nuance. trying Thanks

Sharon Mates

you I'll add I'll just -- say if explain could Suresh, XXX. maybe Study So just maybe

may not know Study is. they phone the even on people some what XXX for think I

you XXX and is, could take from it what Study So identify there. if then

Suresh Durgam

ongoing. depressive a Yes, to And then disorder at so adjunctive XXX partially XXX program major it up and XXX blind antidepressants, study, treatment on endpoint starting is XXX, this we are primary to very and is is respond this patients have controlled program who studies have looking both added secondary in our design year. XXX this is of week, CGI. the score, of placebo similar endpoint double six sort And is Modra,

that it sense, in difference. similar. is No very So

going it's it be, takes? long And started. was other question think to I study this so how And the one was,

Sharon Mates

I that know. don't I think

mean said I it's just cut Sorry, Suffice is ongoing. to study this off. don't you

that XXX CNS, backup knows and will read trials.gov. on it don't XXX. like It's this responses are there it think everyone we a XXX. term, placebo ongoing, studies, as, started I know, we don't for as will in I But frankly, important out. says progressing. clinical it later many and I it is large and is part in XXX read and study But months ongoing XXX how it that is but than remember the out

Graig Suvannavejh

responses? on are terms I seen that a placebo lot you if typically in placebo before, of type I'm responses risk Sharon, and question but mitigation Can this sure high kind potential we've just studies. remind to what Intra-Cellular could in of us just doing asked strategies is psychiatry of of follow minimize ask up, to

Sharon Mates

Sure, start ask I'll to anything. if he wants add I'll and Suresh,

studies successful. all their they're hope certainly are. have usually And that own And most we and, mitigation. all we I they So think risk

patients blindsided something What response. do get in to main ensure a your of you Sometimes and you're study. into that you getting try is, to giving the else is appropriate we happens, high course, placebo thing

the have throughout they to study. the Also, of large a enrollment when have a a screening patients, very in course, for these in, program monitoring testing you we prior rigorous study. So rigorous and come

patients sure into you the you think that have just also don't appropriate adjudicate study. decision. are so coming make Patients have one adjudicated that I making we to patients, person

if few want I think covers anything you do. to about you things or I those don't know add. if are that the Suresh, have we that it,

Suresh Durgam

validity again, do between do part of covers different what taking process. Rig scales what and adjudication is no, internal saying the that sure the broadly make all the we use is there But there think we that's account. I to investigator what is that into patient is

Sharon Mates

a it's how placebo bane great existence, Is control you all right? of It's response, And right. our do question. of the

could Okay, to wrap want for I on here. so of joining today I if and I thank call. think up Operator, we're out the time everybody us

it forward call. on think and next as I our updating go we great our look look forward. a you was discussion to great some questions. to progress we We forward And

Thank everyone. you, great. Okay, Bye-bye.

Operator

for you concludes call. This participating. Thank today's conference

You may now disconnect.

Intra-Cellular Therapies (ITCI) 3 Aug 232023 Q2 Earnings call transcript