ITCI - Earnings call transcript Q1 2022 | Intra-Cellular Therapies, Inc.

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Operator

Good morning, ladies and gentlemen. And welcome to Intra-Cellular Therapies First Quarter Earnings Call. At this time, all participants are in a listen-only mode [Operator Instructions].

As a reminder, today’s conference call is being recorded. I’d now like to turn the conference over to Dr. Corporate Investor President, Vice Sanchez, Communications Relations. and Juan Juan?

Juan Sanchez

all us on morning, and call joining you, thank Good the for today.

quarter results Our corporate earnings is the available financial at Web press update a March first for intracellulartherapries.com. and details on XXXX. press for the release release This ended in provides site XX, our company’s

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

periodic the that reports. including may our cause with and These made statements. statements forward-looking in a product the As assumptions our based include a other the of our COVID-XX certain quarterly development, from statements to report and present possible forward-looking and call, of on candidates, cash of future and non-clinical data, risks and future change and are conduct our of pandemic development regulatory use efficacy, anticipated number differ and will contained may plans trials, forward-looking our actual annual Exchange are impact other These or among and be resources. research intended in ongoing the things, current filings business the results commercialization filings, our and existing clinical information, plans CAPLYTA, regarding reminder, subject regarding Those and potential results clinical making today’s during the investment involve of those and regarding, risks described safety and plans, statements company's statements. expectations. plans uses to materially to on Commission, are the and uncertainties additional Securities These and we of expectations

not to update to on these cautioned reliance call Sharon. now statements. place any over to I such statements, obligations and turn company the the undue disclaims You will forward-looking are

Sharon Mates

to launch our bipolar welcome our results CAPLYTA to morning, today's of present call. XXXX I'm everyone to first Thanks, strong and in quarter of overview Juan. Good and an pleased depression. provide

share late development pipeline progress in in immediately will FDA and programs. great its we're of approval CAPLYTA to year I following last our a bipolar our Additionally, and December programs depression lumateperone We other off with launched start. clinical

Consistent clinical this by we with expansion, with bipolar of depression, been In first in increased accelerated an patients. prescriptions living XX% option prescription increased by CAPLYTA quarter first is XXX% by and highly physicians prescriptions label the feedback individuals the prescriptions new XXXX as XXX%. fourth In their Following with important XXXX bipolar to compared the total quarter profile total regarding CAPLYTA's from growth receiving early CAPLYTA's of -- range increased and the patients QX has significantly. has broad treatment of new prescriptions CAPLYTA to the compared strong important increased as XX% quarter, a help demand experience with by to well are positive disorder. XXXX.

We several growth for confident are continued CAPLYTA's reasons. in

II II episodes therapy is with first clearly for which in The or adults. novel adjunctive million only I are morbidity mania one in hypomania bipolar than approved disorder There or often bipolar as treatment is only or few worse characterized and bipolar as than and profile, depression. bipolar XX I. prevalence reflected both with I depressive are CAPLYTA more approved adults, Depressive increased CAPLYTA's depression, I lower common bipolar greater the bipolar is affects are a was bipolar decreased with bipolar only episodes a US for patients CAPLYTA more of anti a broad both and significantly frequency and that II linked with approved and last drug strong in are overall longer impairment, First, approval, bipolar its for is functioning by prognosis, Bipolar similar. higher Prior and to which monotherapy higher II a to psychotic rates. quality than clinical label. of lithium depression disorder II life, treatments suicide of valproate.

physicians Second, patients consistent effects profile. and looking of treatments across concern. a identify side as with side and patient are consistently patients broad a and CAPLYTA effect and favorable has for safety profiles favorable with shown effective akathisia weight tolerability efficacy great population Bipolar

similar baseline fact bipolar was to in term with in in across longer of weight schizophrenia year. clinical to patients gain had months, while lost placebo our from average six studies, patients an with trials, our Importantly, weight pounds open one gain label depression and no X

glucose fasting In were recent akathisia, rate market safety performance to also including measures. triglycerides placebo. cholesterol, on highly psychiatrists Additionally, efficacy similar total research, and and CAPLYTA’s EPS,

the dose label for CYPXAX expansion hepatic or and we Third, or populations, patients The is titration. be dose dose impairment. allows FDA an population expansion a the approval even simple It label. to is CAPLYTA that straightforward. does of starting for a day CAPLYTA. This provides without inhibitors a address To administration recommendations with recently taking moderate patients to with food. medication for label and not require strong special moderate have therapeutic dose can once and received taken This access concomitantly greater is CAPLYTA severe patient adjustments or

the of to provide additional total Larry execution in launch will in by pleased is our financial minutes. revenues Finally, our quarter-over-quarter. provide will a team, We're increase and his remarks. period the continued $XX confidence increase million XX% in fueled on few that continues market details Mark COVID our further first subside. their XXXX, launch our performance about of were report XXXX the improving commercial more as and details quarter over XXX% for representing strong a to same growth CAPLYTA's conditions

ongoing MDD studies have of which millions including disorders, as to an to features medical label of Patient treatment broad mixed or lumateperone programs addition the CAPLYTA, disorder MDD commercialization affect These and treatment In adjunctive of major ongoing range expand in patients, depression. enrollment registrational mood to unmet important bipolar our we with include of MDD to antidepressants. a our have evaluating in our is disorders, depressive needs.

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

the effects MDD, In study XXX, who in with of lumateperone or Study exhibit our ongoing. antidepressant evaluating is depression, patients addition, mixed features bipolar

second to this expect complete We year. clinical conduct study the in of of half this

injectable currently for different are sites advancing phase our formulations is treatment of which injection. addressing long additional lumateperone schizophrenia, We acting program clinical in X development, and also the of

certain XXXX, ITI-XXXX of for and to with disorders disease, related by agitation followed patients pipeline expand the with In the are robust depressive addition probable our or studies ITI-XXX. phosphodiesterase we in we advancing treatment elderly. psychosis In in to ITI-XXXX-ODT-SL, one our continue dementia PDEX lumateperone, Alzheimer's in and inhibitors

We of patient for also shortly. Parkinson's Lenrispodun, begin disease compound, the a plan in Phase enrollment II to PDEX treatment lead study clinical our of

proceeds cash multiple ascending In $XXX.X received completed dose we successfully Phase to have with of future common ascending dose we its Phase study study. plan addition, and studies, in with and selection cash, We stock. million In offering including ended $XXX.X January, neuroimaging the our equivalents public a from net support first single a for studies for ITI-XXX continue dose million securities. I investment I development quarter to in

our Across debt. same. no the efforts, remains all have our We goal

lives with to We of neuropsychiatric patients are neurologic the disorders. developing effective, innovative and treatments improve

team towards of goals. have our proud are and our the We progress made we very

provide encouraged will year to to forward increasing over by of CAPLYTA We months I'll our additional look launch. call patients Mark? and start to the are performance to who Mark, the about successful our off turn ahead. numbers bringing in the now details

Mark Neumann

to here great Thanks, everyone. with be Sharon and you morning, today. all of It's good

the of growing robust in our depression new broad is XX% in late execution. This seen well-differentiated and profile, performance CAPLYTA Sharon prescription tolerability label. approval highly driven prescriptions been safety by XX% Initial very the I and successful launch the of and has first CAPLYTA bipolar total uptake depression. and profile positive successful and for feedback a trends, quarter. Following favorable product initial access marketing expanded upward of And bipolar December, the is as and market physicians prescriptions quarter from strong CAPLYTA prior and in regarding versus strong by by marked it efficacy launch. sales both QX the full exciting mentioned, of a has inflection bipolar a II

We across have range monotherapy of depression, is and adjunctive utilization including II bipolar a and CAPLYTA broad of both I seen patients, use. both and bipolar

are started and from Newly both diagnosed switching as antipsychotics. patients CAPLYTA being branded products. from are on as to those CAPLYTA, well generic switches These coming other

have by reflected as or following CAPLYTA's starts, patients prescriptions increased depression approval. approximately NBRX, bipolar new-to-brand New XXX%

future adoption reflect indicator this New early prescribers growth. leading a by to considered prescription metric key is brand of and prescriptions

in confidence the throughout to our We and expect of brand are the indications the continue overall trajectory prescriptions upward brand. bipolar new in phase growth of depression launch to continued

greater coverage with commercial XX% Part than for continue of in XX% over broad maintain and to including We and channel. formulary patients Medicare Medicaid CAPLYTA, the D

of Supporting as We coverage have in those the being supporting patients expect as LYTAlink channel the coming patients CAPLYTA increase effectively launch, program expect insurance. prescription this in in growth a through is gains commercial process, for to rapid the the see through the with minimizing the we of months. seen commercial channel costs of well depression pocket the year. Bipolar out remainder this our uptake, commercial additional prescribed in Since number additional rapid and

optimize plan the executing and our a market opportunity large bipolar sales and in launch to commercial Our efforts depression and schizophrenia. marketing sized is both are team comprehensive

and force. During for improving our the saw to access conditions patient relating first visits quarter, market physician we sales

direct These supported a education the by health these person “let care In combining to summary, I'm light” to media comprehensive digital also Our are as execute patients Consisting to early campaign, continues are engagements. ad, current people and reaches typically depressive the campaign, hearing particularly target growth. very new sales anti because informed proactive are our prescribers. the II to providers and our vocal We television future extensive our in in the suffering symptoms virtual of we in bipolar and I from and we to announce discussing “let force bipolar in physicians. they and a well our type We're primarily depression, their to to extend I'm and are to with side about extending of initiatives hybrid feedback model, April. efforts from the with and effects national with awareness in seamlessly other pleased excited launched medical digital light” bipolar audience. medications, physician initiatives, reach well and are trends social disorder presentations patients, supplemental their existing growth which believe about psychotic as programming concerns they with receptive out our and with proud campaign commercialization consumer this

the turn call in have to to continue commercial place strong execute Larry. will We to Larry? over a now team our results. drive plan and I'll

Larry Hineline

Mark. the the you, million quarter $XX summary compared a recorded the million now in or Thank period first the quarter compared to of the XXXX. to for our XXXX million quarter $XX.X March first of quarter I financial $XX.X in in XXXX. Total of for revenues XX, results first net summary first product XXXX. CAPLYTA same will we revenue to provide of of and million ending in $XX.X $XX.X fourth the million In grew quarter,

to The quarter gross XXXX consistent the net percentage low-XXs first guidance. prior was with in our of

increase since with Mark the dynamics, depression net payer the in gross This, in to mentioned, increase number commercial seasonal the an quarters. to patients channel together QX approval. had As the of contributed over we standard prior bipolar

of of administrative XXXX the and throughout remain to lumateperone Selling, million for due expenses is in an XXXX. the marketing increase increase percentage for prepared related public loss remarks. for $XXX.X primarily XX, compared XX, for and $X.X line of offering Research expenses XXXX X, $XX.X December and quarter of stock, of On $X.X related our net costs. approximately net due in $XX.X costs development consistently labor XXXX. concludes January a XX.XX quarter XXXX. sold in XXXX in is first to in open the compared million was XXXX. to first in we non-clinical March for $XXX.X non-lumateperone compared completed This equivalents, commercialization, $XX.X and proceeds common approximately we at trial Operator, at questions? quarter of million were please the gross billion. This Net increase Cost to This XXXX, to million securities the $XXX.X aggregate in of of higher to low-XXs proceeds $XXX the XXXX to million XXXX. the investment increase the first totaled restricted shares of project our period were common for could of first and were first the million and million same product for clinical loss Cash, gross $XX.X compared million cash and XXXX million CAPLYTA's compared of general million million period same quarter the first for expect $XX of sales $XX.X which to an stock quarter you XXXX. cash million We for net to quarter cost. a

Operator

comment [Operator from line the comes Instructions] question Jefferies. from Our Andrew first or Tsai of

Andrew Tsai

So as well quarter, set mentioned that favorable, last this as you are leading which confidence. there helped looking indicators your quarter, were drive of

accelerate or that still So can So XXXX? of leading us accelerating? indicators down direction any one trying even indeed throughout them If just continue your should you gauge to confidence them this remind these in or all of slowed to kind momentum more what of are? quarter right have time the trending

Sharon Mates

I'll ask that, Mark please. to address

Mark Neumann

indicators leading look we really at. There's three that

our of represent the and that which brand in medicine be prescriptions we've bipolar a prescription And First of considered new is increase brand indication we really a very or metric. and look foremost, in we a key indicator new that new really at leading depression, about prescriptions, to by XXX% to growth. to launched positive continues adoption since medicine to new seen for direction. prescribers, future trend with And that the the

seeing pleased So what with in we're prescriptions. new to very brand we're the

that on very And of we is Another as the identifying for looking thing seeing demand put at start we of to sample look the physicians and high patients to the indication, level samples been continuing demand, CAPLYTA new and launch demand future is finally, just a getting physicians And current is to their -- continuing feedback samples the of are on product. a look are them expected effectiveness as have bipolar and those well. use sample tolerability, positive continuing. safety and and to CAPLYTA demand we and that of get assess the their the then sample that very about and use trends from since

So to growth especially continued bipolar suggesting the the and in indicators, we your indication. when board point, leading the the at Andrew, direction in brand, pointing look they're all across the right new future of

Andrew Tsai

to QX a through indeed even that in of organically it mouth? reps is, there no and did quick warehousing was marketing is And one word sales very assume sales or effect fair grow

Mark Neumann

clinical just the getting a this their bolus anti psychotic. lot new assessment about our are our positive. interest very that's also their for indication deal out be patients the That's has profile, waiting There's on wasn't growth. been to great we significant with and of CAPLYTA. belief There's of early of and organic put there that a that physicians of true another there and excitement support from experience of believe the is a patients feedback We

all continuing. So very are strong pointing that signs launch to and a

Operator

the Our next from from line comes question Fye of comment Morgan. to JP Jessica

Jessica Fye

think now. to I get would is a we and gross payer it Where you shift lastly, for in mentioned continue throughout long of widen launch Just rest the mind? just has net net phase your looking think expect your some when Mark, curious new net little out a you And price bipolar year XQ from maybe to gross the you in grows? a to by being I'm as question, grow or depression. see depression over bipolar when the continue how driven you the companies scripts mentioned highest discounts color launch leveling to net it other around is grow over could brand should mix to XX% improving? to there. phase because the Is often coverage for to year? Could there? to you gross we use of commercial discounts, expect Second do

Mark Neumann

take part question price and to then make part the net the perhaps of some I'll to question, the Larry and the first I'll it of to and last turn net. over gross on comments

that can first So of it generally, given But happening. seen to new on, the brand and during et category, launch we we in depending are the Jessica, product new six that new at pointing to to to months launch And cetera. varies a the in that the expect see the strength as phase. launch, have you indication, XX continue indication phase, prescriptions, all would product, the the that the look signs timeframe,

broad and yes, to from the before, weeks the and climb the And coming And three have that LYTAlink would the terms we coverage, so channel very that time for XX%, have higher. of In for patients or the move about all really to channels. to XX% uptake XX% months expect across access to XX% in us even coverage perhaps gives commercial said with program do as year, taken the marketplace up of of the the And think coverage the a that towards our strong we continue commercial barrier over up launch. that the we provides in see we of range, the that's combined not product last the expect in we at product.

you maybe, to gross price comment I'll that to with So nets. ask on net Larry, and

Larry Hineline

the dynamics, negatively. to see due the know, you the gross channel uptake also But to copay greater you had in is secondly, copay first the impacts impact dynamics. programs with payer is As of the we uptake our a seasonal net of And higher seasonal year utilization the channel QX. commercial of a which And CAPLYTA of in as did other as rapid launch. program, in assistance assistance these quarter result you in know, this in drugs, essential payer have successful many for this

low is mix seasonality thirties there of channel the one the And that see also as staying we the the the rest in in for impact see less quarter, XXs Medicaid reasons of and the of first the low impact is of of the we the the what decreases. year. of are for rest the Now in year, it we

the there of minuses So to pluses low stay XXs that XXXX. in are and for expect range we but remainder

Operator

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

Charles Duncan

this kind Mark provide of What terms say provide did or versus a on the and BPD, you can or a I really it side population? color for efficacy feedback, color the question adoption prescribers. particular for regarding persistency is just the expectations kind he profile of he's it then follow-up of about is from safety? And if of us its really to regarding market patient in have in feedback getting on kind on population any earlier CAPLYTA us an could the some schizophrenic driving

Mark Neumann

the To the of the really all first part answer you question, things it is mentioned.

what hearing in of by foremost from and both back the the bipolar proven that very we're those So both physicians and efficacy, approved and they is indication I bipolar disorders. first in are impressed II, FDA

it the And the that had profile effects also using. anti and our they population. and But the akathisia had and weight clinical schizophrenia psychotics gain placebo to they physicians also bipolar patient all starts existing they her the of starts for of based experiencing were all in as akathisia disorder the efficacy. were with really safety, changes similar measures been in depression with EPS with And tolerability trial placebo. Sharon safety and CAPLYTA as saw bipolar mentioned safety program, similar highlight in the are So is population other two same weight in with to are patients of on to what both comments concern that some initial great tolerability limitations differentiation profile. in and CAPLYTA it side

and then prescribe sure So they without very on the to and the is start as same once weeks that viewed a effective dosing dose a point patient get food, can dose see to dose. good on to being they're that regard physician they'll a addition patient gives of milligram deal titrate and to can the And XX there efficacy, single multiple over maintain a to the as benefit that then and without day having well. the the And confidence favorable that's in much tolerability. them that safety great that that CAPLYTA,

with get bipolar us anti The a disorder coming with historically second psychotic for patients that with believe What we months, we'll we And that will early as with regarding a have that bipolar schizophrenia. bit dynamic see persistency. still to patients similar their it's gauge that you. than too tend part we patients do to we And with versus of those do. medication, share data persist longer schizophrenia the their with question while is in your with in CAPLYTA, that seen

Operator

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

Brian Abrahams

I’m you we start just little expand And could poultry that April average if time more when now I’m regards to with channels. could you’ve also curious commercial any for bit get the then from see potential what's about you And what barriers CAPLYTA, and expanded sort on CAPLYTA, into access type to if speak of to might to just started the curious a might on expect manifest? DTC CAPLYTA? you campaign that of

Mark Neumann

step very the utilization pleased different started very unrestricted, through majority first channels, anti are in want if have can means Depending generic one, the and employ different similar with which has vast available Part regardless for they CAPLYTA the prescription physician There's D patient feel plans they that that patients that the The a two, of to we cycled have And office to patients indication, either barrier the payer And behind prior staff is it schizophrenia is the And a so to depression. place. So are Certain the something in three right the being the access Medicare to the psychotics, that physician see to the three write means program to a that all authorization broad is make across payer, is there physicians label that CAPLYTA have edit, for have or on process products. sure patient. the that navigate is for again, that on which the at CAPLYTA wants of a CAPLYTA we the office for their one being happens medicine to then we that needs CAPLYTA. each or for prescribing access and schizophrenia are that to at barrier make not bipolar indication patient their an sometimes just on it. criteria. and not pharmacy, scenes and that prescribed an And this some patient it's two is do. the that not authorization others staff commercial physicians significant help that bipolar already LYTAlink Medicaid, the the all typically, or channel. electronic dynamic one, prescribed prior to

impact in we're time we of the airing you period it the begin four DTC, typically, early about month a April. started In at airing see increase with after to that to early terms very we're we're is into Web site. seeing TV in that your terms by of you generated eight pleased in a interest increased to the of in metrics CAPLYTA, see we in it And the would and on that of expect commercial -- being traffic looking our week searches as

well. as So we that look forward to

Operator

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

Mike DiFiore

in mix Study The well Mike the the as in study, I enrolled. at have similar is XX, Umer. to terms is MDD the for of DiFiore feature I on you if patients adjunctive primary This a the number that as of parter of two endpoint, trials may. have XXX very design in day MADRS of

lumateperone to harder of my this of in So assumptions and we these you population have can, that be what more -- state? the in are harder study? is patients since is something would treat, the there that pairing mixed what mania XXX with to that are treat, trials? is the disease I historically powering And is and be confidence is should aspects gives handling question about if of Secondly, worried you severity this greater adequate any since again, guess mania features symptom

Sharon Mates

first well mania, then certainly Suresh I Suresh, and to a and about talk we monitor call want as talk was to then But mania going the have and understands maybe talk and about so that I add you for how comments. study that and as our features do what on mixed start start depression about little then is design. everyone just bit think

Suresh Durgam

major mixed features, of disorder both of terms symptoms is that exhibits depressive episode. manic and In symptoms below during that clinical that the hypermanic threshold the depression depressive the patients bipolar these or unipolar disorder are with symptoms

Mixed mini-polar this And So applies population studying. the the that specifier depression is within that or DSM-X patient in mania hypomania is both to they clinical and depression. of in have symptoms also below to a features and need whether we the patients bipolar are the some is They threshold. because difficult these severity greater they rates, antidepressants. be difficult symptoms have These treated the And high high and of the patients antidepressants. this have comorbidities importance diagnose. illness, rates have to is also recurrence are suicidal are with respond of they fully high to to and

and are right year. bipolar completing we mixed the looked studies we mixed MADRS with study who have patients, us II patients bipolar XXX diagnostically features. The patients current meet current at features six primary mixed design in And for and the our severity secondary. based or now powered programs CGI these the this week as from of is coming for will this at as and enrollment by that ongoing patients endpoint led are mixed have major on study. of second include and study the the to patients I end what as and depressive where depression, for that's target in criteria well effect our adequately And the in an disorder, features we completed, seen both who for subset our in were our studies from on these So in features

Sharon Mates

And then address question, to your Mike.

for bipolar that of bipolar overall monitor -- scale all we the the in of is of to see patients our there YMRS any subsets into have don't not mania. about the and at powering the and So question obviously, your talked mania do first appropriately. we To powered look flipping not of And able efficacy to we don't either. studies seen to in the we we all, it have used have mania and be about study but we

in So we very patients shifting we knowing not good mania. think are that into I are

Operator

from question the SVB or from comes Marc Our line Goodman next of comment Securities.

Marc Goodman

Mark, usage that enrollment give much-off when I on at if new guess these indication see are mixed is psychotics I'm is, how using anti of depression an you anyway? what can getting label hopefully do? is already inflection then they're indication? us you how I update Just when And points much there the going. understand we just these secondly, patients, the studies, How it patients, anyway, mean, you to trying how get should is important there. using

have Some it's had also of just some trouble enrollment. Ukraine it's COVID, Obviously, companies engagement. with Russia the because not

can you enrollment going? talk how little about bit that So is and a the

Sharon Mates

you then Mark, do and comment part want of question, So first on the the I'll clinical the trials? to take

Mark Neumann

Maybe to may talking the question, that you're about patient that. on bipolar asking hung is that question mixed when a to you have follow indication? the Mark, clarify, Mark I features we on think population, are -- just or up

features, So you the could Sharon, focus of mixed speak of bipolar and speak that's question. Suresh maybe then that to the if maybe I can portion or Mark's to

a indication. this, indication rigor the being for to a an depression they II, an me, of a patient front degree product I gives really the them of bipolar on both like there's bipolar see being and of And use. label, CAPLYTA CAPLYTA of person, and specific that confidence they for that in commercial on have a confidence tolerability particular as they depression, physician For passed or safety to a great two label bipolar excellent and a them lot II bipolar a I when and gives them. when advantages sees efficacy choice can a One, whether that product is bipolar for them, big this disorder for it has

do allows on for what companies this around do. thing second labeled cannot commercial us is other The in that to aren't for organization promotional engage products that that promotion, to is activities which with label

having big on as bipolar there's So those bipolar something for and I II we me, with do label advantages two of depression.

the over I'll on Sharon turn to So Suresh with maybe that, of second the comment part to it question. and

Sharon Mates

of question about our what's and but MDD I think is if I I as was happening enrollment. studies. what it of the and Russia we put global whereby strategies, the done start and Russia I'll to the in in mitigation or we've in before, place know and the studies, don't Mark our we rejoin is to and important been mitigate not, able you enrollment an all studies And have told know Ukraine, Ukraine for effects have our able

we for Ukraine XXXX And done MDD, so we treatment are in is And on are can still Russia the studies tell have and in what that you in and again, our our track we mitigate depression. as adjunctive for filing ongoing.

Operator

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

Sumant Kulkarni

a ones. have of I quick couple

later? selection First, for on XXXX, and how MDD strength already of currently mg target is second to mg have is it and those indications studies out start later approved ability XX approval led clinical that the attending the fair And this to in of that the the recent assume set optimized the elderly your you're potentially important doses XX.X year? and round studies are to

Sharon Mates

missed I question, you that. Can tell please? have you repeat I to the

Sumant Kulkarni

recent later one have optimized do doses was of first set is this mg to how mg the the second for year? start on XX you the in And that XXXX, clinical the already selected XX.X the and So is, studies are strengths? elderly important the approval

Sharon Mates

So I'll any to or Suresh, ask add. Mark start, if they have and comments I'll

those XX.X inhibition. CYPXAX recent and milligrams So special are impairment and the those the with population, XX hepatic approvals of for

they're drugs So that that other inhibit CYPXAX. means taking

we obviously, schizophrenia, larger So get impacts in overall, smaller number the for be while it's -- your these population are patients impacted. a especially of The indication, because can smaller a it more people.

for it people adjustments. XXXX who brain Suresh, certain are still we That's things different we looking like look for to functions option of So know occupancy at ensure don't XX.X want of XXXX, of doses the And to need importance we I on think that selected important and the you have to add receptor anything next want studies. answer. our dose first did that appropriate milligrams? small we percentage XX the at an for is for that

Suresh Durgam

I of severe it CYPXAX will small special that the will hepatic is these for patients a provide would doses say for especially population. And those, or those there percentage be inhibitor populations. for on important, impairments, or coverage is who for any

they're doses thing is, not to titration. sense, these populations, that So are doses One I important. for is the it remind just want special for any in

Operator

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

Jason Gerberry

any just fierce the looks gross guys XX% to the at business? of competitive sort Lybalvi guess question dynamic, I like from to -- sales second launch my versus if around seen to net you it curious gross schizophrenia net. [raylar] first one, is So have Alkermes' all gross of net XX% looking impact And then sales at just

given indicator, mix? sales CAPLYTA probably street term So is good how on their of directionally, guidance? curious, kind both just for sales a similar that medium looking like the that forecasts directional not to basis, Is the again, mix

Sharon Mates

that? Mark, to take you want

Mark Neumann

and Larry on on to Maybe take have part net. comment I can first then gross the I'll the the

in I overtime we're and have in would that schizophrenia also. seen Jason, focused seen very CAPLYTA We're and continue very, as our is say CAPLYTA addition on physicians CAPLYTA. and bipolar of expectation to patients depression, about driving and more our depression, indications other their to What we be schizophrenia in in increase more to positive prescribing more focused in strong continue on I is those there serving grow. and a bipolar growth halo experience think are well, schizophrenia So also business we like and as on And CAPLYTA business. awareness we schizophrenia business have more get increases with seeing will our

you question So could nets, the the comment to perhaps second Larry, on part of gross the with that.

Larry Hineline

should down, still forward XXXX color by to that that. comment low first the impacted quarter can't I that we don't you another with gross. I adjustments in to I the low if see and know XXs net more payer net our really company's in dynamics. some going was XXs. in did I gross was and any mentioned in the our up And a can on give mean, I that than seasonal gross

Operator

Karin or Sachs. line question comes of from the Goldman Jenkins next Our comment from

Karin Jenkins

this on competitive bipolar limited patients that or options indication? in to any how I you you the in more If might on are coming II, if II in have curious, visibility are I'm and the what bipolar it bipolar primarily drug compares particular? the bipolar expect those the in

Sharon Mates

with it candidates there either II Mark. to over about the overall patients turn CAPLYTA who is out or a statement start of think number bipolar bipolar and me an are II. or We're we very candidates for Let misdiagnosed maybe indication, are large there for excited and under-diagnosed, who

II market over give so turn to with to bipolar With think And the Mark comments going that, further that. it we to on grow we see continuing the I'm indication. to

Mark Neumann

use broad And sort source I bipolar in we can products seeing on patients of comment of the with characterizing statement range I of overarching And of labeling. the that consistent guess are CAPLYTA across a the business depression. is

depression. bipolar I as So use bipolar we're monotherapy We're II seeing as adjunctive and use both use. and both in seeing

branded as psychotics. psychotics. a In into terms as from the increase on as other newly from seeing we of diagnosed being patients well to dig switches CAPLYTA coming continued anti those are find switching well CAPLYTA, the And an in deeper psychotics, strength anti types the other are when anti both little we in bit of put patients, switching, that generic we as

range bipolar the launch a view as of across of healthy depression. And from we suffering sign utilization and broad so a patients this very

Operator

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

David Amsellem

the year impact That's for number So least any longer-term. just there's that sort a on so. the decade think trend I atypicals of in CAPLYTA to thinking happen to free towards recent overall one. you tighter then a just of of two, the questions or next of here? continuing years payer control last Do landscape, just the you the category? in of and having hassle utilization several access on, terms And number envision ton But do could sheer volumes haven't should of have exclusivity given seen loss say? be just with Do in of overtime you growing think access, considerably a is grow. going couple at the years We or Latuda over it next

Sharon Mates

the with because, will and strategies forward. Latuda CAPLYTA, then utilization effect Latuda will big the ask big going cycled very and on all, patients Mark a us, that we I been loss that long the start have time, don't exclusivity of of already and have on loss of on Latuda many to for first believe will impact Latuda. around a of has comment exclusivity And of through have a

of the step a imagine for burden for So us, through, a to already stepped Latuda -- one a they have that as have they patients, we generic. through don't be will who if as

directly add do to we're second I to that. Mark, So want you think that question? anything that to you or want about go do the to not concerned

Mark Neumann

that in other the was specific but generic, that the went were particular in years, anti over impacted The brand exclusivity, is impacted. category the only thing I add -- would this psychotics loss not and certainly by brands various as other branded of seeing the significantly anti

for how like the the managing And a they shift have. that So don't of go for recognize historical need of management payers to precedent they psychotics, recognize amount of anti we of well. these is their be then next a and moving whereby this it a for safe and forward there's psychotics They way trends category, significant conditions. in therapy. existing comfortable patients discontinue other a I think very the need, to to access They there's payer to manage of expect anti in anti psychotics ensure unmet for category, they significant also category, range that with there there their line broad terms as they're an that tolerable this effective, to churn

And category. in shift expect so be we a manage this to there payers don't significant how

Operator

this for showing remarks. to at in like to you. time. any Thank I'd closing queue over conference management questions turn the the additional no back I'm

Sharon Mates

Great.

progress progress progress go So this very on the we for bipolar can we treatment With forward pipeline, that of continued as and on and updating as -- about look we our you launch forward. for We operator, the we're to our have on that, forward bipolar you excited made look disconnect. well depression. to

Operator

the gentlemen, and today's conference. in thank concludes you Ladies program. participating for This

You Everyone, disconnect. may day. now a have wonderful

Intra-Cellular Therapies (ITCI) 10 May 222022 Q1 Earnings call transcript