Earnings call transcript Q4 2022

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Operator

Thank you for standing by and welcome to the Intra-Cellular Therapies Fourth Quarter 2022 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker’s presentation, there will be a question-and-answer session. [Operator Instructions].

As a reminder, today's program is being recorded. like your would program, for I Dr. now to host introduce today’s And President, Investor Communications Sanchez, Corporate Juan Vice and Relations. Please go ahead.

Juan Sanchez

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

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

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

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

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

Sharon Mates

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

We we are that quarter I report you to we for excited CAPLYTA growth am pleased and year results with the of full and continue to strong XXXX. sales share achieved the fourth our for promising successfully depression. our advance in CAPLYTA’s exceptional of the for year XXXX we was CAPLYTA tripled as to to launched growth indication XXXX. an compared new XXXX our pipeline. bipolar prescriptions

having CAPLYTA’s very We is physicians impact and positive tolerability efficacy, on of patients. feedback ease have We patients positive CAPLYTA a received and on use. believe from

were a of for the $XX.X For CAPLYTA’s sales XXX% in quarter a CAPLYTA sales XXXX XXXX, increase. our net were $XXX.X XXXX, revenues million XXX%. $XX.X million year-over-year versus were total million. representing $XXX.X net increase million fourth representing

the growth. for near-term near-term, CAPLYTA. is focused in mind, and has growth current the been net of first confident XXXX, In potential bipolar this expect million be In on we guidance to CAPLYTA $XXX indications our invest consistently significant future sales our we in for maximizing and With are we continue team between XXXX, and provide and in continued we to revenue to pleased CAPLYTA the time. In Demand schizophrenia our strong of $XXX are million. CAPLYTA commercial for depression. for

by Our the as the of well success be CAPLYTA as driven programs. of our will future continued execution growth clinical

Let clinical me on further our elaborate programs.

respond We with excited ITI-XXXX, CAPLYTA disorders, Americans at these PDEX label depressive potential about major one major disorders program the our of disorder, injectable million effects are and respond year. and partially long to for ITI-XXX, line in major mood first lumateperone. Many XX patients about expansion Beginning acting or don't inhibitors, least who experience episode only for each which depressive depressive other of treatment.

disorder evaluating depressive antidepressants Our adjunctive global respond as pivotal lumateperone in ongoing. treatment program major patients who to is partially for

two placebo-controlled and in studies Patient week X and to assess efficacy randomized Phase XXX, XXX double-blind enrollment continues trials six global safety.

We for supplemental expect the in an to drug adjunctive treatment for to application the XXXX. as new of MDD of FDA approval antidepressants therapy file lumateperone with a the

we This way indications the XXX. strategy Phase of we is the we Additionally, we conducted development is our disorder This adjunctive shortly. is ongoing are for study to a study, approach studies initiating our programs third consistent designed Study begin pleased in MDD plan mood common patient global are today with similarly announce previous to X enrollment and to and programs.

trial patients population program. depression in features. who XX features line Study We utilization this mixed announcing and more evaluating associated anticipate global comorbidities, higher severe milligrams risk higher with is top with more results patients our than attempts patient of symptoms, to This and on move results clinical exhibit in a This suicide without quarter. features. costs. later has mixed healthcare MDD bipolar and patients lumateperone XXX mixed our now Let's

into programs Now disease, and development X conditions increase or million will patients Alzheimer's Alzheimer's and treat by Alzheimer's let's talk XX% in clinical for XXXX patients. affects and with psychosis symptoms. unmet experienced aging Americans population. with generalized is X.X urgent Alzheimer's to in XX% XX Phase an are than These advancing are disorder in including in greater about further difficult disease, needs, ITI-XXXX. the This age education Agitation highly psychosis anxiety year, prevalent over multiple to is XX% and there to medicines symptoms GAD. we treat these of of occurs disease need

severe progress ITI-XXXX of initial adults of or other updating you the effects is Our GAD not the patients look these X We approximately impairment. on experiencing therapy. of for U.S. these in in GAD. do year, Half patients studies. three quarters Phase program million to forward functional each moderate X with respond to

LAI to with our In long goal development effective, initial formulations that of continue X to program. lumateperone treatment Phase with is advance the are acting the initiate We month of completed several with we a X XXXX. tolerated well safe, of LAI formulation. plan one and program longer. in Phase formulations XXXX, injectable our and development We durations studies of The this study

and pathological PDEX to appropriately program. to regions, normal preventing this of its disease cells certain PDEX cells in microglia. an immune cancer and state environment. our respond uncontrolled, is inhibitor brain function. a and to in states, PDEX cells, restores including In Inhibition certain Moving expressed ability enzyme highly enzyme becomes macrophages highly active

strengthening Parkinson's normal neurodegenerative and function cancer, in in in PDEX inhibitors dopamine restore in also immunomodulators important pathways by pathways example, can where function are cells. affected, pathways compromised and diseases as disease, dopamine inhibitors these signaling. are For immune PDEX

for and a impairment disease. Phase Parkinson's PDEX our inhibitor in cognitive of the treatment We symptoms motor are in study X evaluating Lenrispodun

later begin neurodegenerative disease. common Parkinson's after this to second enrollment disease most is Alzheimer's expect month. the We

we IND inhibitor to now PDEX from For letter our may active and proceed FDA ITI-XXXX, this received a newest recently have compound. evaluate an you the

immunotherapy, cancer start healthy plan first novel Phase XXXX. a study in the volunteers a to of X As we in half

in at use well mood pain deaths as overdose epidemic deaths The XXXX, Opioid involved to more use treat reported in the levels. with opioid XX,XXX increase opioid up disorder number and of be has XXXX. the from as in disorders. ITI-XXX U.S. than continues Finally, to continues potential to XX,XXX disorder

Phase We have recently study. multiple X completed a started and ascending single study dose ascending a dose

an study neuroimaging have occupancy. looking ongoing receptor at also We

We they to areas programs needs. unmet our have the are about currently development for of in excited patients as from potential disorders the who serve potential suffer serious

opportunity. turn the to and and sharing to call We're over Our investment growth year our I'll with equivalents, company look across of no further Mark. Mark and is the financial forward proud we performance you. cash, company in CAPLYTA’s performance very have now in securities commercial position, ending $XXX.X the cash a strong with to continued debt. and progress our million and discuss

Mark Neumann

Thanks, Sharon and good morning, everyone.

depression Since As the exceptionally launched have depression launch, CAPLYTA was label prescriptions for an than new year times total expansion. bipolar indication. Sharon and tripled higher noted patient we successfully five are before new strong bipolar now starts levels our XXXX at as

For new is CAPLYTA’s team. marketing total commercial a driven the and compelling full product the profile, year execution by access, and prescriptions XXXX, year. market and This broad XXX% increased experienced growth our and over XXX% sales being prior respectively by strong

in with we both prescribers their the marketplace received from positive well the patients been experience and by has and regarding gratified feedback are CAPLYTA the product. overwhelmingly

base, as of consistently and adoption demand expanding new for We adding both the numbers prescriber average CAPLYTA number the prescriber. prescriptions continue increase prescribers see unique to and significant we the strong our and depth breadth per underlying of prescriber of

of same another the essentially XX% We've quarter Total outperform our XXXX delivered strength carried throughout prescriptions time. flat commercial sustained market We grew the gives CAPLYTA’s that the great for market. significantly and the versus QX, during CAPLYTA again confidence was while CAPLYTA. antipsychotic fundamentals positive that year. prescriptions achieve into metrics CAPLYTA antipsychotic growth will us this momentum sequentially overall and

steps of promotional XXXX activities and continuation a the since consumer We prescriber the have experienced in depression. for growth to bipolar robust launch taken our ensure we have of several

and market This us demand increasing increased with First, we penetration team. XX commensurate our team to and connect highly larger and allows the commercial sales of market. neuroscience continue to CAPLYTA date, our more our representatives with and to have positive to reach, share expand added our prescribers reception the recently into footprint experienced frequently strong

recently through need we broad patients the implementing to and about CAPLYTA. campaign social educate are platforms awareness media Secondly, our benefits the light direct II I and launched potential advertising and in about raise in of bipolar the unmet of iteration digital, lead to and next television, depression continue national the consumer to bipolar

All of three these efforts all coverage channels. are supported by strong across market access payer

lives D than covered. CAPLYTA Medicaid has in maintained of XX% the Medicare broad with coverage channels, Part and more

further expanded disorder. bipolar for channel, the which patients living primary is have commercial coverage payer in the with We

achieve to quarter. of expect this end by approximately of lives XX% for the coverage We commercial

of plenty launch, investing brand the are very room this a we pleased strong and belief the at grow of we there CAPLYTA behind uptake that remains While of we have to the accordingly. are with stage

market depression and large is remaining unmet has significant need. The a bipolar

both CAPLYTA patient with Our current adjunctive II address us label, as to tens treatment in large monotherapy allows bipolar of bipolar thousands I which of depression and prescribers. populations and includes the of use as

with is approved growth As with sustained breadth of This depth increases. for disorders, and branded volume generate line the years. for precedents acquire growth experience historical where building is medicine. mood positive our trajectories CAPLYTA, have and to prescribers antipsychotics for for continue dynamic utilization demand This antipsychotics long in positive

CAPLYTA. We expect for dynamic the same

successful year was we to year tremendous another summary, XXXX and In a forward XXXX. look in

as that we are will excited improving building extremely focused our executing executing to lives we in momentum. as to coming continue grow been the has confident continue on the of we plan. team possible. year and on Our commercial robustly I'm our well patients laser remain as We're many growth

over our call detail the to Larry to Larry. financial hand I'll Now, performance.

Lawrence J. Hineline

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

guidance. gross Our on remained remained in consistent with the XXs measured level trade the CAPLYTA net levels days in to consistent quarter, by the the our Inventory quarter. of wholesale at the percentage low throughout fourth hand in

quarter of XXX%. full XXXX. year $XX.X in for an CAPLYTA XXXX, XXXX, $XX.X $XX.X compared were million representing million Net SG&A product to for for XXXX. the were compared the full XXXX period to the to total the For Selling, million expenses for of in XXXX fourth year same million revenues general, $XXX.X $XX.X increase $XXX.X million and were million of administrative, compared sales

to quarter of $XXX.X fourth XXXX. year million XXXX million the were compared for fourth for cash the compared $XXX.X totaled December For in full XXXX in million investment million $XXX.X expenses $XX.X full $XXX.X compared to expenses development, the at XX, at Cash, R&D $XX.X R&D million of were million securities were XXXX. compared $XXX.X quarter XXXX. to and SG&A and the for December XXXX. expenses to million year million, XXXX $XX.X equivalents, Research XX,

sales we to CAPLYTA’s takes XXXX. Turning percentage expectation mid-XXs outlook as Sharon This $XXX will net million gross to $XXX sales account increase our that and mentioned, expect net for between million be to reflecting guidance continued XXXX, strong growth. our to CAPLYTA in into the

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

we XXXX, share million approximately and million $XX R&D between $XXX range $XXX includes estimate expense. compensation based which to million, For non-cash of expenses

developmental the programs prepared investments that including and questions. R&D to Our will clinical our substantial line our robust total of In R&D to programs. XXXX, our platforms. multiple support This guidance we other anticipate portion a lumateperone lumateperone our Operator, expenditures development remarks. pipeline, for open related concludes in be studies our please three reflects our

Operator

our comes Instructions]. Tsai [Operator of And first line Jefferies. the Andrew from question from

question please. Your

Andrew Tsai

uh Thanks. Good a and guidance. the on quarter great big morning great and congratulations

you. that we conservative, aggressive gauge or guidance guidance what kick in can guidance more overall a secondly on expect ask of drove your more so guide provided you're more potentially to Team, beaten whether to accurate is here? giving I'll things year, off decision So the way a just type your trying revenue raises such throughout about revenue? Thank the XXXX. And and for

Sharon Mates

thanks strong guidance and words. then I'll This for turn and with our for confident we're because and Andrew I'll Thanks, giving the is we're we've Sharon in seen it very kind our over and to launch CAPLYTA. now start Obviously, what trajectory Mark.

I'll rather stealing So then add. I to anything why that's then And to than don't maybe further overall the Mark if Mark’s there's ask statement. comment back thunder, else and come

Mark Neumann

of the we're really as you've prescribers we're it consistently up year, we've so seen reasons a grow Yeah. breadth for depth been of increasing that Sure, been question, And of are Andrew. increasing depth little Sharon. for that there off, and to is believe the about while trajectory month populations. to we pleased throughout unique of to prescriber. of room and is this CAPLYTA left large what and And strongly of been adding prescribing first to also average time prescribers thanks your supports seeing around the CAPLYTA Yeah, the still to update the patient the And course of that, XX,XXX with date prescriptions number well, their where XXXX the the remarks. expanding month. we date pick in and both our we've Sharon that per prepared These over plenty with lot talked there's prescribing over context new provide over we're CAPLYTA month a addition that have in every

with of a and a large remaining unmet base thousands prescribers of significant have need. prescriber We tens

XXXX so this remarks And that experience in a this year. degree a invest fuel brand growth I'd detailed to steps we'll prepared say confidence this -- of I continue the to And just behind we've to some belief high growth and in we that the that have strong really we taken robust further.

Operator

from Thank comes RBC. from line our Brian Abrahams And question the of next you.

Your question, please.

Brian Abrahams

to end bit mentioned for to taking and the you Hey, morning. ranges, the more guidance you progress. of with Maybe Thanks of the the some ends question within congrats good well your about as expectations, all Thanks. but talk would you my versus and range? contemplates overall that puts regards takes question. that growth, with -- my gross I net additional little towards another different a Can any scenarios guidance. the maybe CAPLYTA And on also end the changes I with to would demand in just I entrants, generic dynamics what guess, high guidance curious the the regards low the steer guess, the the wondering, additional and steer of guess,

Sharon Mates

Mark, do you want to take that?

Mark Neumann

to looking had said with expectation before We've it's I an simply at we the launch, we've significant significantly on believe remaining have the products Yeah, a the go trends continue will that that products and CAPLYTA. category, Latuda trends XXXX. Historically, in from those of when Brian, not think bipolar entries lurasidone to impact not this generic and date generic, impacted. the should that continue branded throughout are

their and Latuda went not they So generic, the of growth Abilify growth for impacted, when SEROquel example, and and was VRAYLAR continued trajectory.

with lurasidone we generic. and continued of belief So the we build with throughout I across our our just anticipate and the the And that a continue the then similar that in mix, latter dynamic force, towards investment going increased the trend think sales especially the should feel DTC investment part year. marketing XXXX in

Brian Abrahams

just the And it. of in variance? Got terms

Mark Neumann

just as we're literally are think, to field a it's the force added expect so expect think I we month. they out sales I variance, we investments those and Yeah, great deal don't them, trend the just of recently in we continue. And this specifically -- with just in that the the incremental making

will territories, the in growth. get and they their comfortable As accelerate that more more

should Our the to continue patients, DTC CAPLYTA, educate benefits on among raise that year throughout awareness we'll to and go. the continue of see them

increased well that had of implemented the by as in and which particularly more to access broad now always to been we've balance As had in of commercial, the good we end and month. through market recently we With Medicaid last at expect space, with have the XX%, over be Medicare year, XX%. XX%, the access,

those robust So think throughout year. growth I should drive of all things the real

Sharon Mates

momentum of with the revenue, you a variance, year the as you, remind And we build like course just to expect I telling that we this it's the would over growing to just isn't some then and in, first first has the further and quarter quarter. Obviously and less built second in go dynamics quarter so seasonal quarter the then from fourth building quarter quarter-to-quarter. into third

Operator

for moment question next Fye J.P. our Chase. the you. of And One question. line Jessica comes our Thank from next Morgan from

question Your please.

Unidentified Analyst

give a guide. Congratulations from you on the the latest on top line Could we the trials Hey on hear for Thank for trial guys, Jessica. color on can about adjunctive little this year? starting Masan another can this fantastic the provide -- your MDD adjunctive us you [ph] reasonings talk when bit and is results you. expectations

Sharon Mates

This Sharon and our for We guided adjunctive to you add. and XXX is and XXXX he ask in based and XXX filing start a then wants Suresh I'll Yeah, I'll SNDA sure. of that's if MDD and to studies on an XXX.

there. your We other question anybody I have that, said repeat please. me just other Operator, your was question, for think

Operator

proceed. may You

Mark Neumann

She may have Sharon. disconnected

Sharon Mates

got she Oh, disconnected.

Well, Okay. her and come Hopefully does was, the back just question, re-engages. on to it. then think paraphrase to it or I she just want why anybody to next we are question should go -- we'll we

Operator

one question. moment for Certainly our next

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

question, Your please.

Michael DiFiore

is this Mike guys, on questions our in Hi, the congrats quarter much and Umer. and Thanks for taking so progress. DiFiore for

for that The your me; features at we've seen mixed commercial. group from trial, I may top depression line the quarter. patients. broker placebo mentioned clinical you But two recent Just a conference, sometime different due know, one patients this index are in clinical what very results one one be regarding

added question seems the that high is on how how that, since a conservative. regarding of So pretty partial every we new point, patients do on week doable. patients, response in greater response which already to placebo these frame our -- XX as being pretty think adjunct were could that? roughly patients, about treated thoughts around And adds experiencing a depressed just it expect guidance we your your seems assumes average, the commercial any guidance, patients they're is depressed At prescriptions

lines? weekly, added just I average the any XXX been year, thoughts of the beginning there's an prescriptions those along think Thanks. of since around

Sharon Mates

And I'll want Suresh go take will question. take clinical the and of one to you start us commercial do question. the to with Mark, I'll or let's -- that the then So we'll take ask

Mark Neumann

don't degree the have Mike, confidence that much growth we other we high that appropriate in add we've what seeing. was CAPLYTA have we than Yeah, range, and growth of we've set I continued range what know that to the at thought I the the more a given said of been

So degree overall, just got range, have would high we've I we that the -- say of right. confidence a we're

Sharon Mates

ask on wants effects. he on be also have or not think really further. clinical certain would there I'm Suresh, study. the But any other more studies question all than And placebo any here I'll any if less Okay. I to comment placebo,

Suresh Durgam

These the Also monotherapy there mixed has is play adjunctive good they individual the are two And is different is populations. concomitant of coming reads on. already study. in the treatment antidepressants. kind the different and that to future populations Yes, patients, other with are who study within set out. they All populations. study is are responded been the study how to own are comes These patients a of One have each is partially differences -- are what morning. the antidepressant. adjunctive that these several determining its deviated study patients from, role the its medications issues what That

cannot especially another individual reason you study at look different when similar designs had those why sets to when two they two are in not And So make different populations. you the between one comparisons are of that’s there to studies.

Michael DiFiore

you. thank it, Got

Operator

next for our Thank of to question. you. And comes moment Marc Goodman from question SVB line One Leerink. next the our

Your question please.

Marc Goodman

what XXXX looking just of psychosis, AD added quickly, programs anxiety here at are patients color reps, endpoints just are quarter? the one? they a in Can that were different Thanks. be you're added on give XX for in to in or X more sales these morning. added AD reps fourth will any XXXX were them that Phase getting different very And the us how you the then good agitation, little and Yes, these

Sharon Mates

psychosis? definition to Suresh, take [Multiple versus versus do you want Speakers] the

Suresh Durgam

Yes.

other for studies It's first OTD behavioral there patients the have and [ph] looking But agitation. we different Alzheimer's indications agitation and to So one different are have different are XXXX endpoints. purely symptoms, is in with they MS who in patients This progressing common three psychosis. is the both agitation One, indications. for have disease. at

regarding be and study at the of the come would So agitation looking study know. the part the we closer endpoints we the details you study. let the And we of starting will as designs, first to the trial,

basically be lot is to help an within once And Alzheimer's the and population. of psychosis the also in that are next this the treating from study failures unmet In there of disease, And details patients to And indication unmet we talking is still of also is Alzheimer's year. in And generalized And of a about communicated endpoints this with terms drugs. symptoms partially there of treatment call, at is at the need have looking disorder, will been anxiety disease. different that study the has patients psychotic going those is Alzheimer's who and adding have the as respond our a there that some only drug this in start and to the that there big indicated studies GAD, start. need. individual populations all symptoms, closed anxiety the designs of these will this is

Operator

one. you Thank

Marc Goodman

for question a is there Sharon, Mark.

Mark Neumann

Mark, the can question. Yeah, timing sales I representative answer

representatives brought in All of XXXX. were the on

So in a the the only two they of last in in been recently up. of latter February trained much start they on the month or had for out the week and And in dates, January getting ways boarded been selling. of have part field couple pretty and had

the that's timing. So

Operator

One moment our you. question. for Thank next

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

Your question, please.

Ami Fadia

move ahead the sort need in to soon, read to us why Hi, registration, sharp demonstrate, approval third indication. ongoing? that share and are ones of prior seek then help feature going the out question. you good and initiating of MDD taking that us Thanks morning. sort seek study stay with of be regards adjunctive with the that just readout to to think understand that mixed what study Can for to a able rationale the you to for And you the we're

study, -- further you at indicated discussions they in in You but the patient then a to past approval, the think an up bar end seek that appeared to will that we'll understand, be run that have drive your not I'm pleased FDA. data in Thanks. trying did least they the it on had with maybe that? high probably that so was thoughts get approval to subset, us to getting What

Sharon Mates

I know you start do then I Suresh, in. chime don't and Okay. can to want

Suresh Durgam

this first when at about the third time believe asked to good study. the And major landscape, other depressive to start the It's disorder a of depression great our is strategies look additional we how expanding Yes, in kind study and decision deciding disorders Similar for studies been commitment integration. to now highlights this in program, you starting adjunctive running you are regarding near-term what and treatment the what followed mood to it applied being question is right the add and opportunity. program, development study. the trials. to bipolar appropriate third is clinical including a they why In many our example, countries are have our conducted, when run prudent it initiate

depend how of of terms we're the indicated, readout quarter, we the the readout question as on this in the and the about study second expecting strong will have features, are. mixed In the results

indicated path we based we not there the next discuss it As in what to in presentable to also will times, go have and I FDA that's to the go and has depends that mixed what for indicated results on we a been path. the know Once approval want features. we results, FDA. to the the established previous remind we and have will show data, on have discuss the

one path with depression especially is bipolar or While established that with features the for treatment the for adjunctive no approval, indication, there MDD with there features. mixed is mixed mixed features

for there Now, an yet. that not is indication

the disorder. So mood spectrum, we both to the would across is discuss that and our FDA. in disorder And mainly unipolar with like to bipolar strategy expand

some I study speak I this made had other and because -- but what know were you question company think don't not a that, relations having approval, other cannot internally. doing an some about to I

Ami Fadia

much. so you thank Understood,

Operator

Thank line question. Charles And from from comes our our question of next Duncan moment Cantor. you. for One next the

Your question, please.

Charles Duncan

Thanks, Yeah, And last on from Cantor. our year taking a year. team for congratulations transformative and question. Sharon

readout two of -- We question would that is One date call a by think related suggested prepare this prescribers, mix muscarinic it that you last the or mixed conducted publication for KOL terms do even actually a off therapy with label. schizophrenia parts. in recently or are these know label up the you think the is your is encompass strategy. and coming of modulators, a suggested you mono I to KOL the what are would feature and part that question a commercial the to in picked be franchise? of that's features patients? that I you But is, prescribing the think commercial non-event wave for mark second doing do And could that and

Sharon Mates

want Mark, to? you to do you do start or want me

Mark Neumann

Why don't you add go I'll ahead and color Sharon. necessary, some if start and

Sharon Mates

you're that with Okay, we start need the and do, right, we think promote label. I'll do label and what I really to not anything off

to and the the might us So good, are going hopeful course of we go it's the guide data what assuming towards FDA which for we would particular see data. path. do we're with to is we're going to to going wait that and very And that a we're

is and these on again, I on the think results, physicians on we're based publish and to a results premature data will we don't guess know We -- papers. little the talk expansion comment about can the read very the hopeful I good. results. And And it's because label that

On the [indiscernible], I think don't again.

our impact So we we indications much do but all. so think for are schizophrenia any be thing. of good forward. the drugs on are patients is important, specifically think Remember next for and negative populations mood expansion. that look with approved our these in can approval schizophrenia of disorders to -- look first company is We We would help larger direction that's anything and our we don't a do anything patients. wasn't patients expect that that We moving approval that cycle and with all is the us there at through the

future. we look the to forward do we First all to treat to that? more they're having of -- is to can add options say But still Mark, all, in want I anything patients. you

Mark Neumann

think No, great. that's I

Charles Duncan

for the Sharon, Thanks, color.

Operator

of Bank comes our moment question. One next America. of you. our line for next And question from Gerberry from Thank Jason

please. question, Your

Jason Gerberry

Hey, my good morning, Thanks guys. question. being for

little contingent like wanted to level in we selling in marketing and practitioners, came investment up of we've half level marketing on the possibility is then bit there really growth selling that a look I off of leverage from nurse investment big get you up, of really kind sales a step just sort is the as as more investments step And script So, and that this seen of roughly. growth investment or last sustained drill two and the into at years? and in XXXX, can this XXXX, on

broader mood a trend disorder general. see drugs we it's in so And in

So connection and in sort just up of the and all, a this wondering if marketing there's to at selling investment? step dynamic

Mark Neumann

Yeah, to Yeah, take was fuel sales incremental we when analyze our growth we're that been opportunities that stewards for very there pleased we decision CAPLYTA, dollars data, Sharon. positive seeing the what in us. that incremental we to very for have. continue an marketplace. good strong we've yield investments, all the of with the the growth force, we I that were And might investment we with been the as growth. of always We've as demand but do is And always made reception even look the for to we opportunity seeing we so can expand saw

and to them part have allow us PAs also audience And mentioned XX They like our on in couple to benefits out a will to schizophrenia target last audience. additional with we target and NPs of and expand the would adding it are continue over you, of and reach bipolar depression, and what deeper disease them high into you specialists, very reach agree do years and the is so connect PAs, our more with for states, NPs prescribers in And important neuroscience CAPLYTA. these certainly volume much become frequently audience the very educate disease a of will and us. our to especially

hope So your that question, answers Jason.

Operator

Amsellem the you. our question of comes next for David Sandler. our question. Thank One Piper next moment from And line from

please. question, Your

David Amsellem

Hey, thanks.

in up behind you So there. limits around I schizophrenia the is are rationale ask more and thoughts primarily LAI that wanted understanding to mania the population. about LAIs My the bipolar, and your get

then of and about of how is how you significance the lumateperone MDD, depression Thank and more LAI in into leaning you. think scheme in and you're So, more it? I pipeline, the do as depression, form grand guess, your things of important an bipolar and

Sharon Mates

question. I'll that. Sure. the Thanks for take

that now the that does tolerability good. I all has we to we and we very and profile at which as LAI, didn't have an have know, why started to out be So think safety data turned you when looking as

are LAI, and efficacy a we fact the safety population we of it drug the an oral and such XX% our over developing because of profile. great to take don't expect tolerability has that So

it's patients can drugs for are compliant that option either for or some think option day. simply take day important However, to we patients who want an not and once just do don't every be an dosing who a to

we going our that nice So that, think think again, oral it's to that it's don't have, take we over to franchise.

in but We development we are delivery, longer a two one-month period delivery. time, not though are also a our seeking we're months profile, a of seeking only

can that are one -- we two developing in be useful and delivering hence, deliveries. product months we a So are both

David Amsellem

you it's So a say intramuscular, you've know that? I SUBQ Sharon, ever don't or if mentioned an can if

Sharon Mates

Phase X SUBQ. of that a was at did study administering ways it. mentioned The we other have been drugs. We've the I looking

are SUBQ looking we and IM. at So both

seem from patients injection. perspective, so formulation, don't a they over IM really it isn't is are patient turns like mind an depending -- the to it out other, your upon sometimes one it And but

both IM. looking we're So and at SUBQ

David Amsellem

you. Thank

Operator

Thank next Graig you. our question. from And One our line moment for question comes Mizuho. next Suvannavejh from

question Your please.

Graig Suvannavejh

got progress. on [ph] MDD it's get to is the just or Madris morning. congrats with my endpoint likely questions. taking MDD in given Thanks data study. has features be design, for. about and My you that an do we're patients Good that pipeline trial And study for to mixed as where there mainly many do question patients to that Thanks. have just questions a two the and the first given possibility you I the is the in I've also result or Thanks. I'm just could be announced. curious the consider XXX? counted against in any XXX perhaps around the you've way thoughts secondly, or wanted did you negative then of to trial, an And part new want to more add so that in that desire get study that's a to revisit XXX could to if your a perhaps FDA the study hedging MDD propose perhaps And if the this as thinking? Is should

Sharon Mates

turn Suresh. part, over it to second then the I'll and with start I'll

new our indication. It every we've an see trial It's CNS conduct way So conducted this schizophrenia, the trials of simply start the a several the is prudent. sponsor run. in within We in it did is study way the are other programs. we you bipolar, did

special here. don't magic there's here, any I anything, think anything So

I you to it's think -- think several goal. shots always prudent on have we

you do we many started time it around And look timing ongoing. to thought the part how you start countries of prudent the the the the look into hence thought you the of And that study study, of studies so to different did have we And at study. the -- want question? the of other this take right Suresh, this, at to the is and are other

Suresh Durgam

Question. can used next was Yeah, as be features first the then the -- question I the think study. about mixed MDD a

designed So the is bipolar we study have populations, depression unipolar that we population population the feature depression. two major the have a to is depressive mixed also especially and

we have age enriched So for groups. population has feature. patients similar been approximately, this also mixed And patient between

who meet criteria So indoor DSM of patients the the features mixed we for specifically features. X diagnostic for use only

I use agreeable be it So be that will study. don't to not, difficult think a would FDA the as MDD and by if it that

Sharon Mates

mixed are features, Nor be… to would These need to. want that with we patients

Suresh Durgam

yes. population, In the

Sharon Mates

was yet, were tell study you, results of just designed, patients to we any and obviously don’t have the way mean Right, but I the the stratified.

MDD should we and patient have populations. population bipolar the So roughly patient in the equal

Operator

from line for our Verma UBS. next our question moment and next comes of from question, you. the Thank One Ash

please. Your question

Ash Verma

quarter. on I some elaborate the buzz just Hey, [ph] on thanks like you making the for that DTC seems had can launched, my decent two, new taking downstream is campaign the this you we in first Congrats a that on question. for it can That's is first and much anything in DTC of you your the baked then year? SG&A for how that share track, spend the on metrics guidance the of second one. based

would undertreated patients a So Want like at differently of you was example that heard a think not to where similar can the features, you require establishment. mixed psychiatry feedback became and some are for from provide any mixed treated an understand path to this sort indication bigger indicates we've when like indication of all an and And not physicians specifically kind it if extensively. least with features market begin went through of eventually? that Thanks.

Sharon Mates

me you times. couldn't all. hear saying. I don't if could what of know We on out you were I else at I couple -- to may anybody need for a you blanked hear

Mark Neumann

I question, heard DTC. I the of if part could there, first the like. Sharon start on you'd

Sharon Mates

sure. Okay,

Mark Neumann

seeing it. and of need, seeing, that broad metrics seeking both launch patients And what in We and the of the you're all of and recently our depression it, behind CAPLYTA. the benefits light awareness potential of we agree a yeah, evolving the same iteration reasoning campaign. did lead very and we're unmet media positive So campaign II DTC implementing. bipolar social ads, I which the yes, through television We're significant it platforms, in implementing the This is upon particular educate building raise campaign that bipolar on in continuing the we'd next hi to call national continue Ash. the is digital with to intention we're platforms,

when reporting our also for are on drive website, information successfully bipolar increase visitors from to we the And looking looking Our increasing CAPLYTA about We audience. of would and as patient When media is targeting physicians, air. survey to number back that expect metrics requests and the of on increasing more bipolar this for an to know we're physicians the we're at. depression end our we continues depression. substantially reaching ad and CAPLYTA air, number we an

has spend. positive know, and turn continue about don't to that We're on specifically if know you and spend. So a selling administrative to it components seeing comments I talk to Larry you'd to we've yes, the that. been the it. don't that comment Larry. add I led campaign. know don't We any I to I can have if pleased our like the metrics But don't decision typically, of over Larry, the with the

Lawrence J. Hineline

No, that. I have nothing to to add

Sharon Mates

had repeat, a then And to to understand you none of again so going Okay. what sorry. it I'm I questions guess I know please? us we're asked, being couldn't, ask to if you of in bunch Ash, ask could could was there. have you We

Ash Verma

yeah. Sure,

disagree undertreated So a indication other on any market? that went treated becoming this to from specifically you physicians is just and give on patients at feedback that least extensively. or psychiatry you we being for features, this not have a indication, example Do through heard that can that bigger of path mixed are to now that agree

Sharon Mates

Sure.

But agree might bipolar with do looser see features think and treat it. understand for even depression do features is MDDD would specified. right, I mixed -- there beneficial that's available. a wasn't think with those So Until be and that much And patients X, the I whatever DSM psychiatrists definition. currently was you that mixed many patients no you're they label with

with you when know X bipolar DSM patients, definition that a patients be II. bipolar treat more it see to Physicians and see nothing II So We physicians they to it's to there's education just allowed agree educated. more like it with, has tighter is process an difficult.

would label for forward So we indication educating bipolar And is as on this look physicians. II to the go very we forward. having helpful to

there's of education we to a and awareness opportunity lot here So of disease. the think for expand the

example is Suresh II with if where have head. know, I only bipolar a top any examples defined quite think, few I it's off your treatments. other the now great you of well a don't

Suresh Durgam

approved. done once that examples, or they extensively Eurokind a it's closer psychosis in educational be, disease, exactly not Other highlight at if you that campaign was nothing that Similarly, the Parkinson's same, to But there, off. market the took about has there [ph] is have something least would think that, of well that importance Again, dyskinesia, lot done a of with. cardio that. to

Sharon Mates

are points Thank you. Those great Suresh.

us one for time to it's more that think up, question. I operator, wrap Okay,

Operator

then. final today comes question One for final Certainly from Corinne moment the Goldman And question. Sachs. line our Jenkins for from our

Your question please.

Unidentified Analyst

Sadaf this on for [ph] is Corinne. Hi,

course believe I us. GAD in over you [ph] for anticipate what the mid-XXs of but from couple guided range a to cadence XXXX, the you Just of year? the terms

Mark Neumann

gross the the to cadence said? were heard asking in was and you it hopefully that hi, the what for -- net a is you guidance year you, that, I Yeah, for

Unidentified Analyst

Yeah.

Mark Neumann

Yeah.

mid-XXs will as we're guidance here, -- as think, can net any our the think it fluctuate more I our But year. to to I can't I does guidance, in throughout gross granularity give you comfortable be that.

Unidentified Analyst

it. Got

for second thanks. as could end, should we just was or it as early that on data, question, MDD XXXX? Okay, the your that in And come expect

Sharon Mates

that's So, we've we giving. that on the is XXXX. in I file what think expect that And the MDD guidance said to we're

Unidentified Analyst

it. Got

Thank Okay. you.

Sharon Mates

for us wrap the in operator forward think it’s We depression. today. basis. XXXX, We and was launch forward think that us and bipolar quarterly look this in terrific to to of us up a for Okay, look progress year a for with year update time more everybody CAPLYTA I XXXX on we for thank to you we joining and

for So you participating thanks and everybody disconnect. operator, now can

Operator

your Thank gentlemen program. participation for conclude does today's This you, ladies the Certainly. in conference. and

may You disconnect. now Good day.

Intra-Cellular Therapies (ITCI) 1 Mar 232022 Q4 Earnings call transcript