ITCI - Earnings call 4 2023 | Intra-Cellular Therapies, Inc.

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good morning, ladies and gentlemen, and welcome to Intra-Cellular Therapies Fourth Quarter and Year-End Financial Results Conference Call. [Operator Instructions] Please note that today's conference is being recorded. I would now like to turn the conference over to Dr. Juan Sanchez, Vice President, Corporate Communications and Investor Relations. Please go ahead.

Juan Sanchez

you full joining year thank fourth on and and quarter XXXX morning, all us for our Good earnings call.

and the current Executive be from forward-looking change are uncertainties statements statements. Chief a reminder, on reports. Chairman annual to making and Larry Durgam, including a certain in me call subject today's information, number actual Financial made Dr. and are Officer; These other described based expectations. forward-looking risks involve are are Joining that filings Commission, Officer.Â As periodic Chief Sharon Chief our and Medical Chief forward-looking results with of Officer; call, and Officer; quarterly risks statements. the our Commercial and Newman, These to during assumptions, These those the and Hineline, cause in Exchange Mark on may Dr. Securities Suresh differ today materially Mates, we will contained and

the forward-looking to You're place not and Sharon? such cautioned any on undue these obligations statements. to statements, company reliance disclaims

Sharon Mates

everyone, Good call. Juan. to today's and Thanks, welcome morning,

quarter excited fourth results patient throughout by option populations and company. we and as growth to depression our major schizophrenia. full broad established past achieved the was milestones for We share key strong consistent XXXX. the as CAPLYTA defined a our are year for year We This and treatment with bipolar

to and Similarly, programs were Study XX% million XX% top-line XXXX CAPLYTA announcing compared $XXX XXXX, in revenues representing in to our CAPLYTA results XXXX. to $XXX remains for major grew forward XXXX advanced increase. million strong. scripts in Study and XXX sales studies, Demand look by XXX.Â Our depressive were XXXX compared net an million. to our also disorder pipeline full We $XXX total in year

momentum, net sales a will existing Our well-executed advancements performance to positive for in drive elaborate on demand will regarding to and in further beyond our XXXX strategically Based CAPLYTA the report commercial we range I'd expect for CAPLYTA current more new commercial year late, programs and million. CAPLYTA. mid-, continue million like several anticipate to growth We plans product XXXX. share of on and its our expanding our prescription this Mark am that early-stage to we I our pleased our full-year $XXX indications. continuing plans pipeline, of invest clinical for both anticipate specifics and additional prescribers. strong this in to from share efforts in be then financials.Â We details and moment, continue regarding in to Larry $XXX

III an Phase use top-line in for readouts lumateperone depressive upcoming X or of have as major the We disorder adjunctive MDD. treatment

study.Â The continue Our to to treatment. to the most We they fully qualified rationale believe be that has small the for double-blind targets were of enrolled our possibility participated patient the and continue in to number screening previously and phase participate reached treatment. in should the the patients determined that completed for have ethically, enrollment allowing allowed is patients these a patients is process treatment double-blind be of who enrollment, in receiving if XXX we screening the we allowed treatment when randomized of study and

those the anticipate with results, supplemental this dialing second we report new year. the XXX application remain April rather FDA continue half Study this a As from of March. this in drug to from year. late results than XXX top-line result, results expect top-line we quarter of report in We second a track the Study to year to in late of to on Subject

evidence of a starting multiple and have high serotonin, glutamate with in our shared, modulating confidence degree of mechanism simultaneously confidence, systems. support lumateperone's have MDD We of dopamine, we previously action, program.Â As this lines

depression bipolar and schizophrenia antipsychotic monotherapy both with in with bipolar significant MDD. the adjunctive Of MDD have I patients evidence MDD for is market. significant in adjunctive as II approved mixed and patients by last exhibiting The several with antipsychotics the opportunity only with patient populations, patients of uptake underscores in and we including bipolar comorbid depression, both Importantly, the helping the for note, X with clinical patients unmet as symptoms. of therapy.Â We approved depression, excited possibility millions large need treatment of remain in continued this CAPLYTA very

in Given future the date, are patient population. we profile this to safety in CAPLYTA's confident efficacy and potential

a we minutes prior that we interactions report and patient with statements of we MDD previously, with to results FDA making have regarding the any meeting, population as As constructive pleased with discuss XXX, to you I'm were FDA. expecting we know, features, Study particularly the mentioned the the to to meeting recently to had a respect for you to mixed wait our with

variability important of disorder estimates activities approved a their bipolar common which X studies X.X% depression, regarding of treatment disorder, spectrum placebo-controlled expect XX% for their program, have in concern system for and approved, in in we disorder. We these populations. this program. prevalence patient our depression in steps and of of Otis antipsychotics in believe lumateperone have children its and R&D especially an outcome the pediatric next study autism minutes you approved lumateperone invest continue in the are later meeting time.Â Beyond is and the treatment address heightened families, double-blind and this placebo-controlled metabolic to patients Accordingly, safety antipsychotics receive spectrum with the with to and bipolar MDD pediatric initiated efficacy open-label associated Irritability XX% if and ranging the schizophrenia given irritability population.Â We needs that our plan lumateperone includes bipolar younger to we program, patients. study from these the and favorable Approximately spectrum the regarding There about to quarter associated update motor our X that issues those with double-blind disorder. and United from at safety X for daily medical autism States profile, pairs a can only with

continued of launch are and injectable continue our summary, will the confident advance long-acting formulations.Â In in we to in the program CAPLYTA robust treatment about first disorder nearly the XXXX, lumateperone each for important X growth with of and scripts of for account antipsychotic studying option Additionally, XXXX. XX schizophrenia. CAPLYTA million bipolar the patients very market, different year. is continue XX% we These half U.S. an conditions successful throughout

to potential of addressable prescriptions. MDD, addition the With market's our expand market would total of nearly the XX% cover

work soon. others expected our complete disease expect ITI-XXXX programs in is anxiety forward product in healthy to the begin oncology trials to clinical first clinical the evaluate to Starting to late half enrollment will study in in program, with enrollment lumateperone program, important with X our disease.Â In first younger results and we neuropsychiatry study to SSRIs of portfolio. and portfolio.Â Outside Also adjunctive II In move to maximize our today Phase Parkinson's top-line our development ITI-XXXX II generalized Phase patient injectables in respect with to plan XXXX, pipeline Alzheimer's treatment psychosis Phase and In single XXXX, volunteers XXXX of program, of and for SNRIs. disease With expect is addition, agitation in the of ITI-XXXX clinical ascending value as our the long-acting with patient of continues we endless the our disorder progressing. our I trials. several an potent populations further to XXXX. in clinical of phosphodiester we trial lumateperone, our is among commencing underway ongoing, initiate and our our in will our conduct Alzheimer's first first half inhibitor dose evaluate half XXXX we in treatment

our for ITI nonbusinogenic at ascending use psychedelic tomography is development emission preclinical Also stage program. disorder past dose and compound, lead a ITI-XXXX. data American earlier include for in programs study in which This a our pain opioid ongoing. the presented both Our Neuropsychopharmacology, College are we development of December the study positron multiple from

encouraged reception in medical the our XXXX, by presentation our newÂ CAPLYTAÂ data and XXXX human early to positive for development late testing presented We scientific forward programs and look are very ITI-XXXX and received regarding medical the several we at community, into we meetings. advancing XXXX.Â In from scientific

We results demonstrating course progress various year. the our medical also in the of published journals throughout

we are ahead starting operationally off financially XXXX, strong. Looking to and

had securities, I'm and phase next incredibly December and of plans of have now debt. over our accomplishments, and XX, XXXX. our approximately we further investment call embark the discussÂ CAPLYTA'sÂ performance Mark cash, and no million growth proud our will in As we equivalents, XXXX. I to cash Mark? our team I'm on $XXX to to for and XXXX, in of excited turn

Mark Neumann

robust you It's depression as with everyone. morning, stage option for be a year and and Good Sharon. to growth leading today. establishing CAPLYTA XXXX tremendous progress XXXX bipolar the for beyond. patients continued in treatment with of in great setting a schizophrenia, Thanks, was

physician base to launch and adding up of XX,XXX during year first-time the growing of prescribers to We end than since our over way continue the work CAPLYTA cumulative our curve, more year. breadth prescriber of by the physician XX,XXX adoption the to new

saw QX potential with in to also strong advertising. XX was consistent and as appropriate enhance capital of activities, versus sequentially prescriptions the who including promotional in benefits professional expansion advertising adults growth it and in significant caplited force peer-to-peer campaign featuring for treatment.Â This year in to of by these versus executed finishing our and robust the identified the national the the Complementing by sales our prescribers the social medical existing broad and was with of bipolar patients.Â For increases of depth growth, XXXX our prescriptions QX media increasing programming through a progress consumer are year,Â CAPLYTAÂ posted promotion television digital communicate disorder QX. awareness quarter-over-quarter We comprehensive and to comprehensive education total patient prescribing among in total accelerating and XXXX more for XXXX, patients more million driven XX% XX% momentum, extensive

to to very and which favorable we days titrate effective compliance from profile our at we efficacy to safety instead CAPLYTA strong In well-positioned important XXXX, appreciate enhancements changes poor several lead placebo.Â CAPLYTA'sÂ favorable growth and as optimizing physicians clinical these to of to all parameters, to In cholesterol, Equally are dose the similar robust once-daily tolerability hear having weight, comprehensive will studies,Â CAPLYTA'sÂ metabolic a also has to profile waiting convenience growth patient continued they caplets CAPLYTA their often benefit are patients important, very plan. We that discontinuation.Â Another side continue a Physicians throughout similar is EPS also without process. compelling movement that and profile. dosing. with include effects promotional the weeks in real of XXXX. drug features and like or in and placebo. drive that can start complete our invest to are disorders acathesia of glucose can is the product

our growth.Â We've of additional we XX we introduced representatives platform, will are contributing in I efforts with with access late position our lives and enjoy representatives had approximately these and sales and XXXX to a Medicare being favorable continue covered lives. Medicaid also commercial to of As covered now those previously, added in QX.Â Finally, throughout market established direct-to-consumer mentioned and QX comprehensive about over consistently XX% significantly firmly from results and continue campaign new creative XX% a strong we XXXX,

the largest the authorization some with mentioned turn the and full with changes CAPLYTA CAPLYTA's XXXX, utilization criteria from steps of robust quarter, made fourth payers. benefits already Larry to status call fourth ofÂ CAPLYTAÂ growth are XXXX prior We've of discuss generic progress and a in that withÂ CAPLYTAÂ in expect in to the and tremendous from the we end Larry? investment the We were the favorable and the incremental I the XXXX. an will D behind Part year.Â In quarter, brand seen call, see we we this move confident for now of profile CAPLYTA these QX of to to our in As in I'll in our impact to Medicare plans. from beginning a initial summary, X we negotiated performance. financial year unrestricted last result promotional and our able this these improvement X product

Lawrence Hineline

product were XX, and fourth the for Thank our $XXX.X sales year-over-year period the $XX.X you, net of ending Mark. to in fourth increase In compared XXXX, December outlook for I quarter will a million for the results our CAPLYTA year provide XXXX. and XXXX, financial of XX.X%. representing highlights same of million quarter,

increase hand increase the fourth the by still of consistent driven versus days prior percentage caplet our low Our growth, trade, offset was high by QX primarily percentage line and the XX% with in in quarter. higher end XX% by level on quarter mid-XXs a measured we sequential throughout XXXX that to levels wholesale XXs, in same over in the a of guidance.Â For to underlying prior inventory This quarter remained increase at XXXX. partially the of increase expectÂ CAPLYTA'sÂ gross-to-net in third at the was be year. the prescription net gross-to-net the in relative a was product sales XXXX, the strong the quarter

$XXX.X year revenues of full the with XXXX. XXXX, guidance. our increase sales million were full $XXX.X the line XXXX.Â SG&A XXXX, an were ended the total compared expenses for million million year our $XXX.X product XX, For XXXX. $XXX.X ended to for million $XXX.X This year expenses year to December to XXXX, ofÂ CAPLYTAÂ were compared in million Net for XXXX, to for December XX, compared XX.X% million December outlook XXXX. XX, $XXX.X December to in XX, the for year XXXX.Â Turning were for ended million $XXX.X the ended compared the year R&D represents

million, continued $XXX mentioned, CAPLYTA between As sales we and million be expect product net demand. strong Sharon to reflecting $XXX

investments our approximately R&D to activities.Â For CAPLYTA we range million range which sales and expenses continue approximately compensation commitment of which $XX.X expenses million efficiently share-based $XX.X and between million, of non-cash reflects XXXX, organization commercialization noncash and $XXX and includes expenses. XXXX, our through estimate marketing includes $XXX $XXX For in to This to million expenses. support million to share-based million, estimate SG&A $XXX effectively between we compensation

R&D anticipate lumateperone will use expenditures reflects our broad to to continue our development support related pipeline. R&D we the populations. of be lumateperone XXXX, investments we explore to our patient a additional of guidance portion large Our as in In programs total that

our totaled prepared and remains open December $XXX.X Operator, equivalents, questions. Our XXXX. remarks. line concludes the strong. restricted cash for XX, please position This investment financial at million Cash, cash securities,

Operator

the you. from [Operator of Andrew line Thank Jefferies. And it Tsai comes Instructions] with

Lin Tsai

execution Congrats and strong the progress. on the continued

anything thinking in a on then we is what think aboutÂ CAPLYTA'sÂ potential response Street understanding efficacy expect So as today. rates, terms else a MD I placebo-adjusted latest safety And encourage wanted differentiation remission rates, for else? be would look in But me, adjunctive to release MDD should you good there April? result. see top-line guys' also of ask in can is change in What is to to your the as we for anything profile, X-point our the such

Sharon Mates

I'll he is for the words. and question, much kind to for and Andrew, add. then ask start and off, anything Suresh the I'll Sharon, Thanks wants if This has

at So all what in we we do point. typically the put top-line is that that our out have of data, information

studies large you do. know, As we are these that

at top-line in are, out know all get moment we And anxious time. when we data, and And the all we so don't we it. of how since we the data both of the one data Street put get the

the we'll typically expect we from any at other monotherapy So adjunctive X- that to data you expect be certainly a lower MADRS. see we point. at to on to And study, end. be the at higher these you to on And X-point on an whereas change the end, in expect which right the you But endpoint, expect is in that MADRS. studies, baseline out have that you're put change primary also studies,

So to XX%. studies that's what we're expecting. approximately We power our

have so in on prepared as these both in we obviously, I these lumateperone's program in remarks, confidence, studies and performance we studies. in our And our said

to that, you don't have with So know, you I anything add? do Suresh, want

Operator

moment comes with One our next the Brian for from of Capital Markets. RBC question, line Abrahams please,

Brian Abrahams

in the the space? the might these Congrats as you're end all potential atypicals bit more relative it well the a degree quarter, And could how some in come us about of other that talk in most be give results have progress. guess, to differentiation then over sense -- adjunctive a of second of of I may from study, positioning impact I on this powering? continued MDD. how of my Can you thinking here terms out continuing Maybe maybe enrollment little you guess, during the the on where as of,

Sharon Mates

Okay.

Typically, process XXX a said, So this approximately to the had screen start screening `patients you and allowed had should And you patients screening you patients place, approximately will and through are the whenever that screening, to We say number we've we we patients. is into I'll -- protocol believe successfully patients put regards least did Sharon have passed be with who for plan again. that, through. of come so appropriately that studies through come enter. in yes, as we like at who in you your

patients. go typically what in. a they small we is that in it's and X% overenroll you So that and fits you number bill It's under over-screen of you to here that to allow come pass that if the allowed

do need wait But So of for have. complete. to you that course, is we to them what

coming So why April in study, read March. the it's in will rather study that up a just that's finishing weeks later out couple and are they the of than through,

So I to want don't to I Suresh, did you add know, that? -- think anything

Suresh Durgam

Yes.

think to so small. the were There's this. for asking be number going any they I about not because powering implications is powering the

would expect I So implications. any not powering

Sharon Mates

on differentiation, asked and in can favorable tolerability T efficacy CAPLYTA this you that. marketplace And in agents CAPLYTA for about real is need that think think And its Right. safety the we a also that I well profile. And there that, marketplace. additional with and has perform and demonstrated

Operator

Jessica from the with of comes Fye It JPMorgan. line

Unknown Analyst

gross the is how walk patient terms Nathan penetration? And some of it that for XXXX. to This in of you think XXXX? guidance? strong in forÂ CAPLYTAÂ in underlying us do Congratulations the assumptions then are Can mean we on Jeff. net What guidance the on does dynamics about through the

Sharon Mates

part. the want Larry, So gross then, maybe talk I'll you to ask net. to to And if to want Mark the to if first talk you

Mark Neumann

Yes, sure, Sharon.

that that continued strong we CAPLYTA. we the the the for in trend put driver underlying out, main guidance business see the demand and guidance that of demand So is the

the in range you really guidance. around any variation the So that is trend where get

as both market, breadth XX,XXX we year, remarks.Â Last we prescribers prescribing, and to increasing where bipolar of base, prepared of both over continue mentioned focus on new first-time in added expect the depression our We my prescriber schizophrenia CAPLYTA. I the the to penetrate

well base more now prescribers to find existing what to the for expect prescriber in over is more continue more XXXX appropriate see of time CAPLYTA. the We XX,XXX, writing they see of get these to at expect as are that across as continue as patients and entire increased same experience depth we and that

So to that for guidance And question main think factors we net to how also a go had the on gross provided. into you range that the think XXXX. about those I are

So I'll Larry. to turn for that, over it

Lawrence Hineline

in and XXXX gross in low be in the Thanks, we net the project compared to that's Yes. Mark. mid-XXs, XXs be to that the Yes, is going -- in to to XXXX. we saw

are increase, this drivers there going Now volume bipolar coverage. through several in a for primary the Part program. commercial strong in channel in also been of result uptake we Plus, there have where increases Medicare improvements D the recent the have as

are the the X those from increase for mid-XXs. XXs So low the the to main drivers

Operator

question Hung from is next with Morgan Our Jeff Stanley.

Michael Riad

This Riad on Hung. is Michael Jeff for

placebo to be And For extent are X adjunctive ADT effect? thinking the of terms XXX the should what MDD, response in background about influenced variability the between regimen? Study these balanced how background placebo does XXX, XXX, we studies and

Sharon Mates

speak Suresh, would to you like that?

Suresh Durgam

Yes.

So yes.

you're in the background end talking terms measures. of latebresponse, trials all mitigate and we program we this in approved several allowed MDD, AGC have other response. into try and in are allowed placebo trials taking so antigens the to for SNRIs SSRIs, all treatment for the And background. particular, by with are in CNS Again, So it MDD be -- that about this, to

adjudication this also making measures, severity no study is sure are that are have this So coming of proper we they allowing the for patients, right that in that in. different taking

of token individual we will So terms SSRI placebo be or of have into just in a wine. from the SNRI, taken on medications, group with class taken based those response.Â In them measures account a medications not terms individual we

Sharon Mates

program the has And done been way. the all same whole of

our in So in of each depression. studies

Suresh Durgam

all been addition, that also have And drugs are in the same done approved the also way.

Operator

of the ItÂ is line with Umer Evercore. from Raffat

Michael DiFiore

compared to progress trials regional have XXX. my is, question XXX differences more countries is the practice that for seems DiFiore more Study is of And just in it the the diverse given or local This participating in there that Study adjuvant on the set question less the have of me. for for same? makes designed be that XXX, Two And successful, the asked. could or follow-up. bit study Mike Umer. exactly all a I MDD ex-U.S. Congrats both a in One medicines variation of way to are trial confident any would you little XXXX. be

Sharon Mates

Yes.

So the are our that I'll for and and this different Mike, to the global question, the around is the start Sharon. way this of and he proportion patients ex-U.S. of you studies. same patients. look plan ask to wants Thanks is We U.S. is have in. a that Suresh, typically And ex proportion at fill all late-stage we I'll and different. fills if plan have proportion that for in. And is countries, U.S. U.S. for patients and of to of And no a XX% studies then

XXX any quite XXX So to seem isn't difference are and the didn't of a part get there's because you there the think where I difference. same. the question

what Some is with patient FDA, as of are discussions per ex-U.S. the populations but and -- what to they what like countries the in see. and practice it's common different, U.S.

Suresh Durgam

again, terms of In that's true. --

countries, have We And U.S. from the these standard XX% question different and but guidelines. practice about about all are ex-U.S. coming

throughout world. that's observed the So pretty much

practice, and select of we the practice guidance how that on as similar we the patterns. countries So practice into in look terms have that

Sharon Mates

we what on around make hear like Suresh give XX%, a aim clear, we're said, side. couldn't either I for or take percent to just

Michael DiFiore

missed is, this. it. I you Have to Got mix That's met And would discuss forgive in with adjunctive context me you commentary if if the follow-up or MDD broader data so, of helpful. FDA question features indication? be offer the color there? to my the any the able and And

Sharon Mates

did remarks, as prepared meeting wait the our we with before did minutes was that say we Yes. recently always I say for our meeting, a is and it FDA and practice, Thanks, we FDA Mike. the that, constructive have that Yes, anything. in a

meeting. will minutes on further program and update we so on have And our the you once the

Operator

Partners. Goodman from Leerink with comes of the It line Marc

Unknown Analyst

online Congrats for Mark. [indiscernible] quarter. the is on This

versus color the moving maybe should growth quarter 'XX? How campaign the DTC can first in additional the aboutÂ CAPLYTA's maybe into quarter about we think given sequential growthÂ trajectory talk plan seasonality? So XXXX. on And fourth you you

Sharon Mates

want to take Mark, that, please? do you

Mark Neumann

Yes, sure. question. the Thanks for

So we to a accelerating total prescription strong had XX%. quarter, our very fourth growth

product regard. first some we quarter, into with with see in XXXX headwinds market So patients' increasing like have the some of year co-pay business commercial also that through to Typically, When have year. momentum you deductibles in a over typical ours as channel, for you as come the assistance the an significant alluded patients associated the coming the the reset required with decreases of access portion increased in the you year. plans. you And that then switching typically, course

the their the in in So the to and quarter, experience you growth. see feel the reacceleration reception experience. underlying headwinds. But a the do have, had typically, first quarter, product, see some us in the to in business, patient's about on you the we yes, And the provide they momentum very then that second the the demand and that good we have feedback physicians business,

the think quarters. I So that's, how in general, is about upcoming

Operator

next comes Cowen. question for TD Our from Joseph Thome

Joseph Thome

setting. the would force primary the allowed care onto size the in some the on in if MDD the necessary move on just label? quarter. expected you bit heard of to know Congrats talk I indication the little is a you've forward sales could be if expansion Maybe MDD success that

MDD? for move? look more you expand for Or more a your would any little bit XXXX a there? that And be XXXX of for would of is expansion expense So to earmarked guidance

Sharon Mates

like to that? Mark, take you would

Mark Neumann

Yes. Joseph, question. for sure. the Thanks, Yes,

part the answer the first. second to of question So

bit evaluate expansion, any sizing, the for contemplate do any opportunities increase our in Our the any not additional don't of expect take fuel XXXX to support for and growth for and and growth. prescribers practitioners marketing them in we physicians we we're SG&A CAPLYTA continually and of in filing included advantage market.Â To year that care guidance approval, XX,XXX a lot have that primary data to is and the our opportunity contemplate our to that and ensure XX,XXX force in physicians we of antipsychotics. a material that primarily list. bipolar treat the XXXX. that depression sales of the our a see do we target we we're But a see nurse our about that of we currently the who we and would We terms background and sales in depression track give little very which optimizing current are for schizophrenia, force. target you psychiatrists segment Once high-volume and bipolar size smaller MDD, are significant major understand physician we They does expansion sales are force of activities of on

And expand increase depression X certainly primary that of it for physicians an list in MDD, not for care it contemplate be of look are MDD, very group have for because we are prescribers mostly would bipolar target approval primary with with on, MDD As treating them and there the that comfortable brand. for who schizophrenia. bipolar all that be area we will more adjunctivana they'll virtually for force.Â Now physicians of psychotics X would significantly, depression call and physicians increase will in are the our about many will who care the aren't who years prescribers of will we because high-volume that be XX,XXX to to or able sales also XX,XXX the leverage high-volume and prescribers experience currently high-volume

good we go that specifics our and to things as our will plans, determined quickly to extent talking want a with force you to And care. far about the how launch we'll physicians. are that able really we'll And sales the be about point the we expand been closer primary group come with more jumping-off by -- So bit have we how we which those we working have think to into on. And of that. back to little get a be

for background that helpful So and now. that you, is at leave it hopefully, for I'll

Operator

theÂ line with from of comes Piper It David Sandler. Amsellem

David Amsellem

about that's One talk duterated with thoughts proposition commercial in wanted over ones. one. get number form the of value the access the your ostensibly rebating think pretty safe to on legacy is, the seen plans well regarding with differentiation category. thinking I particularly So can should to the and within tolerated and in the pretty is with early you and safety, quick here gross seeing X we MDD given how lumateperone, MDD you're about just tolerability two, how current of mix? widely and terms label number as on that then expansion, to product, the net So from time lumateperone And payer particularly

So thoughts your on that. wanted just get to

Sharon Mates

out I'll it they and I you you question. with maybe to it let's thank can't David, then. ask to need And Great. Mark start XXXX to and if I'll the ask for start But remember the then Mark. by take repeat

Mark Neumann

coverage the existing for have to MDD we for depression the bipolar at That's pretty comes when to the antipsychotic that into the new expect And to with the label experienced whatever similar that we bipolar the question, the level, access. expansion a not for Yes, these MDD, to Thanks meaning the brand general, sure. at payer of the In indication addition level, from would coverage the indication process when David. it with schizophrenia potential MDD payers we to Yes, moved the is as label products category, seamless dynamics added depression. for label your well. seen to schizophrenia who indication, and an competitive already products label. carried expansion existing gets what over we've manage

quick why approval off So a similar fairly start and able we another that a to it's expect to to be to with we expect in process, reason be would MDD. get it potential

XXXX. I'll the So to over that you with turn Sharon question second it back for maybe had around that,

Sharon Mates

Great.

deuterated that just may let of the replaced listening those with carbon-hydrogen XXXX where a form bonds. familiar be with strategically So bonds deuterium for XXXX, remind lumateperone, carbon are me not everyone just who is

the have it ODTSL tolerability we into And and and be and sublingually. resulted may think in right in found PK other some of that be So based seen and the systemic you a new advantageous, lumateperone even PK the that with more was entity very studies. that's out once why I in to with XXXX think elderly the What safety populations the done was delivered it's is formulated on general to -- profile rapidly doing Phase we things day has that we And molecular a is small high the we characteristics in circulation, population as good in and profile. population metabolically very especially is point an a make program have that that we we are we're with as a that seen think studied XXXX-ODTSL a disease amenable. have absorbed it population elderly that it these we Alzheimer's and systemic exposure, so stable GAD.Â So

doing of believe that. confirm studies do you some there of advantages XXXX the are lumateperone, over that And are we results we apprised to studies we and these and move keep to we'll So as forward.

thanks question. lot the for So a

Operator

of It America. Gerberry comes line Jason with of Bank from the

Jason Gerberry

I to Sharon, clarify. First, just just wanted

adjunctive is atypical Or is the there landscape kind Mark, your the in a that thinking the so involved launch with is the switch what's efficacy trials, on wanted mix just with MDD lifting your positive confidence for the that. get feature MDD market of here for agents. to for of requirement current dynamic trial speak, And coupled Is need sense So you different to just antipsychotics. much with I game? your just share-grab then of some atypicals? to X only of a of kind boats, the these understanding all VRAYLAR I'm of X the how MDD satisfy with around these wondering filing? going of

Sharon Mates

Maybe come I'll Mark and then Great. I'll to ask in. start,

Mark Neumann

to as we're in encouraging VRAYLAR us unmet growing successful that a a believe mean, is adjunctive a the a to space Yes, future. sure. has medical what very need be of MDD launch adjunctive I but that, the good Jason, from forÂ CAPLYTAÂ in of significantly by very to which the confirmation MDD that had And rather antipsychotic antipsychotics seeing significant market, in us, the potential for efficacy very terms we in dynamics MDD not profile. is and surprise opportunity safety in with

VRAYLAR. don't have believe Rexulti's been So share grab we launch by in impacted does it's the business a seem not significantly to

get seeing a think see that growth studies very and we of when lot to a successful very, as the a with market, we and opportunity approval, there. robust successful market forÂ CAPLYTA. So we're And we filing

Sharon Mates

studies positive. platform readouts treatment -- missed evidence. the MDD on part and your misses, adjunctive it the depends that's at not it is of features. the to one it the studies, where missed they're and And why one question, and And the X we'll to that, your If treatment looks positive Having mixed answer the see for in of first on our FDA is composed and for and how is both program. on of that MDD. about of adjunctive continue these said MDD hopefully, totality you mix asked The features

where and had of opine. And is the that does the evidence account totality However, what take happens evidence. example your FDA X the hit, miss, looks then an they of Reculty, is totality they studies, but FDA X the into X at of your

any in all so data, be data And that -- will have of at our we in our in MDD you have where that's I looked think submission.

that. very had studies I'll help we can think our strong I positive it future the data only And So very, in us. at that mixed leave

Operator

of AshwaniÂ VermaÂ with UBS. It comes line from the

Ashwani Verma

pipeline. maybe So just the a couple on

the So for SAD had I was that data there that some LAI, mentioned release think the generated. press you

trying Just what And it formulations position after segmentation? these as going that study can forÂ lenrispodun, then disease? the Are big or this stage with you that going the And show? adjunctive early be in market Parkinson different that what monotherapy this to so after new are starting? you're a is different X late -- you're or a did or

Sharon Mates

for start I to start with I LAI can to guys, Suresh, Okay. the the losing want I'm then Maybe do you over appear it lenrispodun. or voice. sorry, to actually, turn and -- be my you

month in X is what is what and So study did looking the a longer for we're -- I good what was, a fact, showed Phase we duration. and for formulation we that both study

all, not administer first a be X we The formulation, than first showed, subcu This with but study would greater forward of month. formulation it it. was for certainly go to can ideal an

about formulation of based injection. formulations types am also like we drawing on went based the of the on we and site back subcu heard a other versus I what board to So

And so the the X to over longer duration. looking and site formulations that ability we have prepared the look at the at and a both and molecule subcu both X-month versus administration of deliver IM

Suresh, the you and do answer maybe, our population-- question. to Parkinson's talk the first to So study that's about want And your

Suresh Durgam

Yes.

-- lenrispodun. Parkinson's the Parkinson's, in that intersport study is in the disease. a So study

is to as look early levodopa looking at are once existing efficacy adjunctive to of administered We therapy. lenrispodun treatment where populations at primary the objective

primary So And the is patients must be levodopa dyskinesias. house the on our stable troublesome existing of on endpoint diary time at that looking without there is increasing of therapy. doses

living. measurements, is study, at of part of looking as that We're measurements we MDS-UPDRS looking on This are important motor will are Partisans looking at at movement outside several for look CNS. also measuring forward aspects at other in daily and the the activities once both published. of based look also also what One, also studies the will and next inflammation, at our the of In be of we things. the And path data We inflammation. multiple looking programs into cognition, biomarkers cognition. defining

Operator

Kulkarni ItÂ is from the Canaccord line of with Sumant Genuity.

Sumant Kulkarni

behind lot you're see Great it. putting a a clearly I'm picture to all On to resources one. going program, of bigger ask the MDD your progress

a from and more market of needs? a be for So have MDD on whether indication accurate company? addition the unmet given the nice the is the company within you for size the the what imperative most view of to the latest alimetaparon investors, of it characterization the of as would strategic benefit Or and

Sharon Mates

then to commercial That's would can perspective, interesting Maybe we question. an start Mark, from a like I you and chime in? don't know,

Mark Neumann

continue growth, is believe and That depression bipolar for in we a growth significant business of bipolar see MDD patients and with phrased question, add we opportunity schizophremia the to innings equally to to would for I the the sure. that opportunity say penetrate early depression, in our opportunities guess mentioned opportunity I would Sumant. interestingly with our the and questions, very well. is tremendous market. bring area Certainly, a And one is in we as excited for physicians and certainly into MDD be current are still as Yes, I in previous just tapping CAPLYTA, label opportunities of what continued have answering as in we to CAPLYTA that large the to we and of

Operator

with It Fadia comes Company. from Needham & the of line Ami

Ami Fadia

a And MDD question the are studies thinking Would about to you more data the is study to question third a the that use back label some you My read progress. the on say submission in comments misses, thinking all without going features, could of clarification on mixtures? one a other going on specific out? still of and that And what's latest mixed you waiting reading MDD then one would your also just regulatory to forward? be for about path your regulatory regulatory and pursue the in go if Congrats for from plan. hits out the the

Sharon Mates

thanks question. Ami, the for

our data really Again, depends you all to study. whether on really, will X until I always early of and It missed, what know and think to or it's can. not studies, to too a planned, as positive submit comment why tell how obviously, what data the the you really little as X on that, negative we as depends. proceed study we going we're one proceed happened, positive -- I soon it is, FDA we okay? we

can to have we little may that. it's So too And think there because says. was There your happens bit good? what leave a Or the we been what it soon answer depends at question in on data I are on think I questions another -- there? it

Ami Fadia

also and My regarding your features question thinking what is. there was mixed latest

Sharon Mates

a FDA. said you. have we'll we meeting we that prepared we always, As for remarks our have once minutes, did our to our the wait And we constructive back as minutes. with in come very And

Operator

with Fitzgerald. It Charles Duncan is from Cantor

Charles Duncan

wondered color your already terms the could good between I being prescriber guess on I'm provide those differentiation on relative later were hopping at possibility you agonist this preparation team, has with calls, of approved so Sharon schizophrenia of in muscarinic to and regard base little addressed. perspectives how if of us a candidates I'm for sorry the But And year, been and in what this congrats wondering addressing monotherapy if year. your of you're point. to I on bit a CAPLYTA this

Sharon Mates

do Mark, you to want take that?

Mark Neumann

Charles. Yes. Sure,

potential bipolar a depression, schizophrenia safety have and of and confidence the We we we have deal efficacy, a profile, feel very inÂ CAPLYTA. very we see product both strong favorable So across tolerability that in and And our great of benefits of dosing to patients CAPLYTA, and educating patients. patients physicians the and they're CAPLYTA the focus aware physicians that that for is make understand like. regimen they their really on sure

that's our where so And energy. we put

always the physicians potentially patients. to products good thing a for is mix being added for New

the As there's side experience you of tremendous either side. prior on often churn, category, amount metabolic therapy side they the effects, X in movement or would disorder a meaning on know, try we CAPLYTA, call this to patients churn, what

so they And cycle products. through different multiple

say So the the bipolar more for and our always just area of for more as from is as in choose from well. coming study, we good would a I and MDD them is to thing depression, we've talked future past, that as would about from business, talked a us, to option coming patients. about, for another be have in with successful

So see market. a we of on impact significant into the new don't coming theÂ CAPLYTAÂ business any entrants

hope I So Charles. question, that your addresses

Charles Duncan

Yes.

Sharon Mates

through think part schizophrenia, we, products. the is in state. of new and these just to can company, that It I patients for that, especially add patients. we to product And as patients these I a great said, disease that like agree Mark would And -- is any as help cycle

think and that's it benefit be terrific. patients, a can to we So

and is that there growing said having and depression, there are to million with we to with expect There schizophrenia. patients continue. that Now is patients bipolar patient And even our X.X bipolar in are the that, space, business X MDD. in more Xx size

as statement, really impact business not said, expect all. a So do as at Mark summary we our really this to

Charles Duncan

That makes impact that depression sense, it appear agents Mark, and at all. and those Sharon doesn't

their paid to on that pay royalty a given but this input with part, the that One point, any is without role So to right? in point just check. that acquisitions. to They you question, them you no know on clear Bristol-Myers think the send what's clarification, Could -- have company marketingÂ CAPLYTAÂ at small though, this -- regard I to quick of going answer differentiation. in I

Sharon Mates

have They in no role marketingÂ CAPLYTA.

Operator

And you. for Q&A final turn Sharon will comments. we ladies Mates Thank to gentlemen, and that, Dr. the conclude I with period. answer

Sharon Mates

it we're the in that so joining I'll bit for everyone, you, a time, know make .I over Thank very call little brief.

performance to our XXXX and we very of and forward to we're as proud XXXX, are think we forward everybody updating during I go look forward. really looking

call. the that, you joining for And with can again thanks operator, disconnect. So

Operator

our joining for call everybody, you, today. Thank

now may You disconnect.

Intra-Cellular Therapies (ITCI) 22 Feb 242023 Q4 Earnings call transcript