ITCI - Earnings call transcript Q2 2022 | Intra-Cellular Therapies, Inc.

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Operator

Good morning, ladies and gentlemen, and welcome to the Intra-Cellular Therapies' Second Quarter Earnings Call. At this time, all participants on a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, today's conference is being recorded. I would now like to turn the conference over to Dr. Corporate Investor President, Vice Sanchez, Communications Relations. and Juan you. Thank Please go ahead.

Juan Sanchez

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

Our XXXX. at morning The and corporate intracellulartherapies.com. a release crossed company's the release available earlier details press quarter press this wire second XX, the for financial on update June ended is the of results earnings and provides our website

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

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

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

Sharon Mates

results. Juan. share I'm everyone. quarter pleased Good second our morning, to Thanks, Today, with you

the our depression, you of well in Bipolar clinical will following performance Bipolar I progress as I our the strong We development CAPLYTA as update programs. in on launch and

quarter We pleased same quarter were the a in compared million, a same XXX% the increase XXXX, details to XXXX provide for quarter XX% period representing Larry additional will remarks. performance million $XX.X revenues total million a $XX.X his our second and that XXXX on for $XX to first over the in period in of product for were net XXX% increase. are second report the increase representing over revenues XXXX XXXX. CAPLYTA the financial

continues Our extremely commercialization of CAPLYTA well. to go

the depression new In FDA's and XXXX. December respectively, late versus approval quarter, in of growth. we enthusiasm in bipolar have health our care increased reflected same and and CAPLYTA strong the seen the prescription professionals Following prescriptions total which in tremendous been has period for XXXX, CAPLYTA XXX% from second XXX%

and Second XXXX first CAPLYTA increased prescriptions versus total quarter XXXX. new XX%, XX% quarter respectively, and

of highly have on increases CAPLYTA's the profile health regarding and medication. safety clinical their feedback from practitioners continued addition the In strength CAPLYTA including having to care are efficacy we the experience received in the patients profile both prescriptions, positive positive and

approved one disorder. or adjunctive as depressive episodes proud number bipolar for with patients indicated a as was medicine and or be monotherapy of therapy managed the I or lithium as Prior bipolar with to adults, bipolar to We CAPLYTA, in only helping II and are only first treatment disorder growing their for depression monotherapy. is II there only associated valproate. CAPLYTA bipolar

have II, both bipolar size. of uptake similar such and I CAPLYTA pleased that disorders are to population to have a seen We bipolar a patient treat significant

CAPLYTA's neuropsychiatric comments. it in Mark including schizophrenia. CAPLYTA also involved systems major the increase during neurotransmitter be an CAPLYTA will to key have prescriptions for of his medicine treatment for an believed conditions, makes seen further profile disorders. with interact depressive important patients. in We elaborate

X-HTXA consistent disorders a favorable Although to dopamine the effectively characteristics uptake by offers CAPLYTA mechanism with the interactions significant serotonin the schizophrenia. in clinical these safely to treat need and inhibition relevant of action indirect system with that has a There disorders. of profile. mood for lumateperone addition antagonism tolerability and safety the glutamate is modulation medicines and studies, our is In coupled distinct supported unknown, shown system pharmacologic treating of efficacy

in In fasting pharmacologic have to all bipolar change, results to glucose, The fact, programs to were or EPS, disorder properties MDD CAPLYTA mixed beyond total and schizophrenia include akathisia, major triglycerides placebo. depression. and metrics clinical MDD us depressive in weight key our as bipolar features changes similar of and including disorder expand such and cholesterol, safety and led

are at XXX enrolling approximately are studies an XXX III as each global study. remind studies placebo-controlled XX milligrams to We MADRS The baseline is week adjunctive To currently evaluate patients lumateperone global the XXX X. changed patients our and primary you, studies Phase with in double-blind, MDD to antidepressants. e endpoint in and treatment from

is population. safety study this Additionally, open-label in rollover study patient XXX an to long-term assess

and progressing patients the planned approximately to trial new evaluating CGI-S and as XXXX. point. I'll safety drug A in exhibit with mixed study, study of discuss assessment treatment XXX, this bipolar last changes of feature dose MADRS study. features. follow-up a with X approval application is supplemental well-controlled mixed a file baseline depression the with lumateperone placebo from is of medication. who a for milligrams is enrollment an this adjunctive expect global to well antidepressants change of study primary The in end large, now MDD Patient week lumateperone the as XX secondary study therapy the weeks after patients We endpoint on FDA versus key MDD in our for in at clinical X

clinical We XXXX. complete study conduct in expect to this late in

Study QX of in XXX data represents medical of needs. area in another important to completion an are expect safety where report there lumateperone the XXXX. study results Following opportunity top analysis, to and efficacy we line

patient higher presentation. mixed exhibiting recognized of to the to rates inclusion difficult poorly suicide and and at Features DSM-X depressive patients more roughly severity greater tend or by their to patients suicidal unipolar is recurrence one is defined depressive symptoms higher and important During comorbidities. clinical third have highlight Mixed underscores episode. depression specifier ideation, These patients mixed mania disorder episodes, with a the and episodes The presentation in this clinical importance respond treat having these patients antidepressants. of hypomanic illness as features of present bipolar of are co-occurring than recently during depressive with rates sub-threshold features. of This to with classic

depression we Bipolar XX supports multiple the medical Annual the at lumateperone further lumateperone American with meetings life treatment XX switching at American we and mood the activities, time the presentations These at CAPLYTA patients pre-specified had with schizophrenia milligrams lumateperone life. s meeting measure, received severe favorable placebo At Lumateperone International by patients to criteria quality no placebo. and favorable between having In XX patients antidepressant safety International at Clinical these end who compared These broad and moderate, presented scientific presented our from ASCP, post received evidence favorable antipsychotic of daily During percentage SIRS analysis included a XXsingle highlight and presented meeting, Meeting illness. from mild of lumateperone the in with syndrome Research these marked placebo. results treatment improvements were featuring evidenced with lumateperone. the compared the of end we total were data At Data placebo from placebo-like to of lumateperone Society. enjoyment tolerability ISBD, profile in metabolic highlighting bipolar disease score Society prominent significantly Psychopharmacology several the ISBD total marked Conference life presented I'll stable life, who of hoc post at effects this from further switched syndrome of we or of versus presentations. from metabolic leisure outcome other demonstrating to another lumateperone MADRS ASCP to short improvements longer conferences. the presented and and functional items placebo. previous patients family across scale, overall the analysis patients a regardless study of schizophrenia. the in Rates items satisfaction we patients as supported disease activities, in and and similar baseline meetings analysis, improved shifting for of statistically as who improvements no ISBD, antipsychotics. quality evaluating in profile profile quarter, as well At of open-label higher of with analysis use and Association of of Schizophrenia safety the and of At questionnaire and More of ability day safety metabolic Meeting, Disorders metabolic baseline now Psychiatric highlight the at in the lumateperone scientific function representing lumateperone versus satisfaction. and baseline form additional relationships, hoc secondary disability the from households schizophrenia. or tXhere improved milligrams with

parameters lumateperone In improvements from in or concentrations. had olanzapine addition, significant and to risperidone/paliperidone cardiometabolic patients switching proactive

in have We advance also our to programs pipeline. other continued

patients to formulation working options injectable and are provide suffering tolerated that well longer last of are one and We mental and treatment to illness. safe from long-acting lumateperone for effective, develop month more

with of development LAI formulation pharmacokinetic I we long-acting and study study formulation. single the tolerability of preclinical evaluated We have conducted in lumateperone patients This Phase an dose of completed a and this with the schizophrenia. have ascending injectable symptoms stable safety

with evaluating exploring for studies. will injection efficacy now sites strategies this other our formulations and assist alternate as are We formulations. in us formulation, well with of This as dosing progressing

form program. of oral as administration. a a Next ITI-XXXX sublingual disintegrated chemical is is formulated tablet our an for entity deuterated new XXXX lumateperone,

We studies, Phase ITI-XXXX-ODT-SL are evaluating including interaction studies. presently in drug-drug I

disorders we inhibitor conduct We've I clinical bioavailability clinical XXXX. II Phase Parkinson's with the enrollment effect with lenrispodun II clinical commence in scale-up in drug-drug in for psychosis in half trials, including in of Phase to program interaction, our have commence ongoing Phase disease or dementia-related and expect and in patient from completed and probable depressive disease expect food PDEX have patients elderly batches in We in studies. In Alzheimer's agitation XXXX. programs, to certain our initiated the trials second

presented we of the an of effect AACR, inhibitors. in preclinical inhibitor breast immunotherapy model investigate effect inhibitors data PDEX to continue cancer. We At when PD-X antitumor checkpoint triple-negative conjunction animal with the administered demonstrating of in anti-cancer

can now have inhibitors PDEX the models and of cancer. colorectal, breast that glioblastoma shown inhibitors action We of checkpoint our potentiate various kidney, in

ITI our for opioid program continues X to advance. use Finally, disorder

this cash market who no growth bipolar equivalents of we will accomplishments. are cash, now advancements play have and that strong our a Mark? occupancy receptors results will investment the cash, million our we neuroimaging second In financial and have CAPLYTA's launch. the role study to for We for debt. studies. ascending a provide completion substance pipeline. pain. to ended look The position continued turn details summary, for securities, applicability Following pleased have results disorder future the call brain in commenced and forward with We a over I and our study, the with in in and second proud our schizophrenia our study to will recent $XXX.X Mark, and in of dose about single of use quarter successful additional support in selection depression dose investigate we quarter to

Mark Neumann

our expansion. the first the the new times that sustained label as our first growth new-to-brand following continued robust just prescriptions, in In to I continue launch total in they throughout significant patient were and in launch, Significant X by that to level CAPLYTA CAPLYTA's approximately saw starts depression. bipolar pleased both prescriptions, we bipolar new reflecting doubled inflection have new report Sharon. and am to the Thanks, of and approval we second quarter total quarter reflected five progress. months prescriptions are and make prior

An both CAPLYTA, well on as initiating Prescribers CAPLYTA, increased newly patient other both quarter increasing are and including adjunctive and diagnosed CAPLYTA CAPLYTA monotherapy new branded the and I using including first broad therapy patients diagnosed with is population prescriptions both antipsychotics, Second A and those using bipolar XX% switching and versus are number by medications. bipolar therapy. patients of generic from as total quarter. II. as XX%, respectively,

the extra II, low CAPLYTA of including akathisia CAPLYTA dysfunction, majority a this as both professionals, required. symptoms risk bipolar profile. indication a performance future. titration prescriptions strong the from schizophrenia. safety clinical the broad recently significant coverage of in to pleased the of to channels has with weight low increasingly of risk of rated commercial that In larger prescribe a dosing of of treatment are In CAPLYTA bipolar maintained XXX robust we with broad Medicaid research portion well access successful of are Medicare expanded in I efficacy, gain, coverage fielded with covered. execution, the low ease and pyramidal on and CAPLYTA risk metabolic greater of XX% bipolar depression, market attributes driven during includes and we HCPs coming channel the by market While intend continued differentiated in of health commercial growth further of these dosing no covered quarter, and lives for Part broad with also D bipolar and than been the approximately physicians research, and lives CAPLYTA's XX% an care second depression

to continue coming increase the coverage We to expect in months. this

launching the in now dosage bipolar revenue option We throughout were the the later Larry? or confident Larry. month. during with schizophrenia strengths FDA robust continued moderate strengths inhibitors half forward of patients our are hepatic be to severe pharmacies this new anticipate prescribers to patients XX second of will and quarter XX.X for access will in is new moderate in milligrams, appealing very looking are drive I prescription to the these and which and has CAPLYTA approved who XXXX. with over we CAPLYTA expand We strong and closing, the CYPXAX In available CAPLYTA, to impairment. to ability depression year. or patient dosage and population two for turn a patients taking call growth also for specifically This second milligrams

Larry Hineline

the and of to the of increase same increase XXXX. year-over-year the in in quarter quarter, period recorded $XX.X of compared quarter in June XX, million second Thank first $XX the we a net product Total quarter provide $XX.X for revenue XX% XXXX. you, and second Mark. CAPLYTA million million a second compared summary a of first grew I $XX.X will XXX% quarter million XXXX. our quarter the represents results XXXX now XXXX. in of for ending to $XX the of revenues million of financial the to This In second over

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

million XXXX. net In the million million to June The of The of the of XXXX. second the net $XX.X XXXX low cash XXXX, quarter Operator, the second same non-lumateperone you. $XXX.X $XXX.X XXXX. increase the CAPLYTA's XXXX. first concludes expenses for expect in and in million to net expenses the lumateperone to and XXXX. and an for investment coming were for the development $XX.X throughout question We XX, to deducting at product ahead. second for million completed totaled and This line higher quarter of compared January $XXX of consistently Cash, million related to Research loss XXXX you project sales for please $XX.X prepared million approximately compared labor-related million due is $XX.X questions. the for Thank loss million the non-clinical quarter in public December gross increase offering equivalents, XXXX. XXs compared of primarily the percentage we $XX.X to increase resulting increase period clinical net quarter at the Jefferies. company. compared an $X advertising XX,XXX,XXX Please million to same common $X.X XXXX costs. period restricted was remain to securities costs. and from a paid second XXXX, $XXX.X cash to of in for and in million and by is XX, costs the Selling, million of Cost in for of due second Andrew administrative of trial marketing second This compared a is shares company This our [Operator in could open Tsai of XXXX go were $XXX.X our quarter quarter stock remarks. proceeds to Instructions] general expenses of were from sale after offering the expenses

Andrew Tsai

of sales far, Thanks, and whether physicians. good you Or [Technical the and your touch on outlook the ask trends. prescription reps targeted innings. the your the the so you Difficulty] surface have you've think exhausted that do To Maybe barely morning. all points still in remain scratched early

curious could just Thanks. if expect to inflect So we trajectory time? the can even further Or over maintain? scripts

Larry Hineline

and ahead Go take that.

Mark Neumann

Yeah.

I growth for is and confident for remain And long-term potential continued yeah, question. we're drive bullish very would your what in say XXXX CAPLYTA. robust ability on thanks our throughout Andrew, to the So

with effort sales the educating and profile but and programs strides prescriber continue very in reach, target is with on virtual further the target execute our in that target physicians to of reach reached continue with our the in progress digital been that a in would sales our levels CAPLYTA the differentiated the activities. And to to recently I'd making and that continue with our and our What clinical target say CAPLYTA supplementing promotional we fielded representatives both in-person as The say way we have. awareness bipolar. and audience we promotional to capability have in make the significant I in with the continue rise Our profile that force, them we strong that audience. a our furthering market audience additional then have the majority audience, with we we pleased research that reaching personal of penetrate on about activities, comprehensive we're also the to we've benefits recognize we've our

additional so for stage pleased room at Still with additional this progress the but that. with launch far. progress good room very reach, for been the of making we've we're frequency, So still

Andrew Tsai

all for Thanks the color. Okay.

Operator

Fye from question Please go JPMorgan. is next Jessica of coming The you. ahead. Thank

Larry Hineline

Hey, Jess. Good morning.

Jessica Fye

me? hear you Can

Sharon Mates

Before Mark that. couldn't Jessica what a that trajectory, short everything okay, Mark before. I hear adding good Andrew, into what wanted we you answer just still that are can to said. you into Yes, add something, added add me on you the give think we and to then to

Operator

please Jessica, you, go ahead. Thank

Jessica Fye

being Great. by or launch Maybe robust kind Sharon we about to X new I don't to period of quarter, following it's on month talked of if last characterized for phase most Mark. the But up the that. XX know growth. brand sort

depression the or than months to X that think launch, we're bipolar XX you to phase Now months little the closer to into be going here talked before? X that closer that do more a months the about is you launch

Mark Neumann

Yeah.

have But said, impact a CAPLYTA. you in of sort you et vacations some Jessica, we've cetera. So And in the of trends physicians, I we've July, for Day And interrupt we that is Memorial week-to-week as think we which think very just recent rise continue second of you very market. gone week, the when seen with - period Sharon the weekend, that launch, into take holidays always on believe where of trajectory you impacted tend half. kind to Juneteenth. be And that through, there's Xth seen we're the to us some the has summer cases, seasonality going remain longer-term have some with that good that healthy a overall will patients, we Summertime prescription COVID to have have you have have the in variability. the of

Jessica Fye

the at in XQ? channel a Got any end for there it. end amount on Larry. hand follow-up. the of in ask XQ the Were Mark relative of to just could inventory of If changes days the I

Mark Neumann

Yeah, Larry, you…

Larry Hineline

they're sales have relatively rising on have much been stable But hand when and pretty Things rise. stable. been

Jessica Fye

you. Thank

Operator

Raffat from Thank Evercore. question coming Please is you. next ahead. The Umer go of

Mike DiFiore

question. in Umer. for a my DiFiore Mike is lot Thanks This for taking

First on Mixed Features the trial.

[indiscernible] halfway seen bipolar saw trial solid for was continue Phase about the MADRS and You a trial. into on X-week the of to improve end the III, the in the

criteria of score these inclusion least MADRS of score the XX specified XX. whereas was the around However, patients features, mixed a at trials,

inventory, behave any of can may fall this whether And the Fixed ex-U.S. is there you results. why reason the the quick that baseline many MAGRS trial So in really the there and us bipolar you group may where Thank and weeks how keep population a give could differently the versus do sense with where – separately, also, is, placebo any the depression the U.S. you. relative on patient scores may affect dynamics channel? where I'm And in be in going typically just this to Mixed trial.

Sharon Mates

into I'll our that a address questions, and Suresh break of ask let's Mixed So to Features. couple

Suresh Durgam

Yeah. Mixed Features right now. study. It ongoing is

enrollment are track We on by year. for the end of

same the usually XX, - in will be it of question adjunctive have what the for seen, are will be in XX, trials But of what our terms range the seen in this what baselines you be monotherapy have I range is where this terms XX around in expect we that trial. to have in the baseline, correct for would it and mix, we so trial In that about too. the we is

is about general, response. with - In it bit rate had terms XX,XXX in - to placebo We higher. even of and have know, that question little successful depression trials, your you again, bipolar, trials have a these as that, a

shown in in in to saw this monotherapy demonstrate trial. our depression, we use seen have that post-hoc with the analysis therapy. as XXX we Mixed that have analysis, efficacy we Mixed study adjunctive were the Features – both proxy population mixed the Also features, patients a where in a we for there analysis and able we in However, Feature which of separation post-hoc in YMRS where clear bipolar

for And results. wait the see so we'll and

Sharon Mates

studies. you at, can a - Suresh for of MADRS as that points mentioned, come MADRS would range again, cutoff have both as these that, in patients just just in add the scores. I to monotherapy our is and adjunctive for like bipolar, But these scores therapy there

Mike DiFiore

real How weeks also do question. in the the keep And inventory you channel? helpful. many just quick typically Very on Great.

Sharon Mates

Yes.

chime start, wants Larry and in. if I'll So ask then to I'll

the efficient of is this distributors you are very keep country move category not order. able being where product stocks The around amazingly short remember, on So large a inventory. at to very,

least in know, add don't our category, to large that. to if inventory are you So Larry, hands. stocks at for anything this wanted I there

Larry Hineline

days stable more Yeah. low. of and relatively on about asked a sort we're is hand - earlier just-in-time is question There seeing. on been a hand that days of and has effect was And it's

So a inventory of lot in channel. there's not the

a have stop said. the but inventory sheet, channel. efficient, lot very out it our balance We in Sharon of doesn't It's on as

Mike DiFiore

very Thanks it. much. Got

Operator

next Brian question Abrahams coming you. RBC is ahead. from Markets. The of Capital go Thank Please

Brian Abrahams

Hi, the may Thanks it curious is seeing. long-term taking growth having you much launch. my good on about continued have morning. potential Do also long the DTC strong relative a that expect Maybe curious how sense for for the impact you're on I'm I launch be? campaign as congrats run campaign and then I'm the and alone? we're from expansion question Mark. that contributing the the to to you and DTC impact how a would how and Thanks. also expect guess be the question for thinking on SG&A the you to bipolar inflection might what margins the And label

Mark Neumann

the question. Thanks Sure, for Yeah. Brian.

all metrics say is point. what successfully is with reaching running we And So quarter audience. and media as I are in have the depression and interim cetera. our bipolar you metrics pleased TV at how cable, we streaming have targeting et know, second broadcast, syndicated, early think with I and the some media began would But TV, we do our bipolar ad this don't of of mix a

CAPLYTA. to would continues about has we an for patient And ads our TV expect requests of to reporting seeking website, to as substantially increase increasing ad they're And driven are to CAPLYTA. seeing more we Our see physicians visitors number this information our air. continue where

very DTC expectation XXXX. run would So we to overall, say of been pleased the with is the that I'd and throughout we've our continue impact DTC

Brian Abrahams

Thanks.

Operator

Charles The ahead. go next from Duncan you. is Fitzgerald. Thank question Cantor Please of coming

Charles Duncan

on hi. qualitative our a Good what the is is some forms, wondering see morning. further or halo prepared And relative if provide to experiencing. Thanks Mark if that that that Sharon, not dosage uptick patients you, information guess congratulations wondering a I of a additional remarks I'm are adoption? you result for provide any could positive CAPLYTA to to for on in And uptick, are an - persistence. relative drive taking on question and that providing experience Sharon. then of patients how effect you good being multipart in And prescribing? schizophrenic quarter. information qualitative could the to Yeah, new the on could even if I'm It's Thanks. questions. being prescribed single percentage

Sharon Mates

Yeah.

for And to So I'll our continued them. thank But on, ask launch. you, yes, yes, Charles, on first comment Mark comment the questions. take to your just strong

the We will to I are that, here. very with these launch now ask comment strong launch and lower and also we'll further doses, pleased Mark into from continued

Mark Neumann

Yeah. Sure. me And Charles, let start there.

with moderate or We to antipsychotics. to are the launching but you and are population these strong severe strengths offer populations, to CAPLYTA And difficult CYPXAX the an have moderate for And patient either are to now of inhibitors. about we obtain precise taking hepatic be taking we X% appropriate be who be population it impairment to for taking that are to for who to shortly. numbers dose specifically, this will now patients able will patient moderate access pleased expanded as saw in press release, estimate

these available to doses next expect be in and We new strengths week. pharmacies by

been to the who to with and we've track the launch patients a on persistence question, So that continue we're that the we first that's since that have additional have that before. that continue our profile given On would making seen looking same that available and see safety time launch. CAPLYTA perspective, CAPLYTA see all of quite schizophrenia recent the suggests we this talk beginning we've and a of compliance the see a may in the and hypothesis good each data that persistence we access to improved tolerability We yeah, bit and we particularly profile we did data forward about get and from the through to your together, translate CAPLYTA, - most patients monitoring kind persistency case. had it not to of into

there what with pleased we're seeing as So well. we're

Charles Duncan

for the Great. added Thanks color.

Operator

SVB. Please of question go next Marc The Goodman you. is ahead. Thank coming from

Marc Goodman

Yes, good morning.

that think quarters. related low that to I to guidance inventory XX both the took guess which and you just assume to all are weeks. we in nets, without keeps fact listen from sales that then quarter gross questions channel channel, for prescriptions I you about to which and little about simplistically the inventory struggle the are second IQVIA your XX from to quarter, a the the X the get X bit moving XX change first if some to you to

from the was so think you the low or the picking is not to questioning and And I move can sometimes up maybe end where end, all IQVIA high scripts. the

can us a flavor maybe can versus had you in us question, quarter. for potential other help that then new you how net Mark, So know, is will give Thanks. can Anything first you helpful. as you market think on just you gross And that as lower second if of patients, new be many quarter us one do that a Features, with sense Mixed the you which you? a get that I range give indication, to for

Larry Hineline

You I'll would to start. - is This like Larry…

Sharon Mates

Yes.

many And Larry So the take then first on I'll to part how of Features take let part the patients Mixed ask would new bring. me the second question.

Larry Hineline

Yeah.

days the elsewhere earlier, said stable I been Okay. has at and distributors on like So hand

that. - there's not increase big been in that So a

you're revenue. hard It's with to mathematics match you're gross but when take it's launch net it, involved. the just and try do think - to I to mode off going and in rising, you IQVIA data – the to and the our be can match do a are to by then sales to

as inventory So do I know there it's far we on if about sales hard don't to can channel. the more when hand would I to because I but days add worry any see the that, math. the the is rising, nothing are color data and that in say as to

Marc Goodman

And gross the second in lower the than quarter first quarter?

Larry Hineline

gross didn't consistent quarter. the No, this in in change net our and And it's net The was to of will range. that be see to large gross rest a in fairly consistent. we

Marc Goodman

the net the just of Which every relative because so is interesting first to it product gross high the to or rest usually out there. in year quarter for

Larry Hineline

increasing, have is as higher you channel gross and our on you'll first higher end the of have still will the the range the commercial at And even see - increase range. And keep the you last the channel gross we net that to call. seasonality in impact talked about to of quarter, though an commercial usage, a net to that

So us. behind is I mechanics clear we're and pretty think that, to pretty with comfortable the

So maybe a straightforward. when give we the talk one-on-one, you but more I pretty of mechanics can it, insight little on

Operator

Sachs. Thank coming you. Jenkins ahead. The Karin question next from of Please Goldman is go

Karin Jenkins

morning. good Hi,

channel, now reaching as expect of at the the I to policies lives much XX%, under coverage? commercial should any commercial to to authorization gains on that I'm provide [ph] curious you you're then think see? omni So payer coverage past, in detail infrastructure guided what incremental we can that how additional covered XX% XX% you And you expand

Sharon Mates

to that… want do So Mark, you take

Mark Neumann

Yes, sure.

of [Technical last where in So communicated Difficulty] in Karin, and we - we've channel, was part from coverage of commercial approximately we've actually previously that we've XX% been, year. $XX had the is about what over up that

quarter, launch, to what approval were as as to that over pleased the that up and coming the get consistent. approach So they’ve the criteria, bipolar far during And we we're coverage covered we're on in and we XX% to expect to as utilization And depression began this we from mid-XXs we approximately number the been coverage, XX%. that do now quarter commercial continue is climb in that communicating further be able very second improved months. And we channel. even as the

there's no e-patient talked no means bipolar not authorizations. happens schizophrenia there's make for other sort at qualify issue. which in a step basically, tolerability channels typically that prior a through certain or accessing other But wants just use both dissatisfied authorization. X where antipsychotics to significant for which a do step that first require prior the step about criteria plans medication a And authorization physician of patient not edits, is so then You process. and typically, through bipolar program barrier they the or due category having our generic have frequently generics. this meaning navigate electronic have to to that that when They've the generics is a And all. onerous, very To generic and There's is plans payer that we've appropriate, sometimes churning helps offices that, patient we in already, already available or even unrestricted, they're depression. plans X, ensure past the prior CAPLYTA with to use that And meeting the that. schizophrenia approves CAPLYTA they through in payer LytaLink gone it's X with either X, edits

we would to we increases are strong further continued say in with happy I access we the We're channel. overall, So market very enjoy expect and see where to position. a even commercial continue

Operator

of go Thank Please Subanavia from you. is Mizuho. [ph] coming question The ahead. next Greg

Unidentified Analyst

you of wondering for Good of additional that's the you a quarter. penetration be? schizophrenia prescribing And that? at or qualifying was quantify of Congrats questions. what of if if kind of education asking both color I I'm can have depression with bipolar terms in market the wondering provide who that my second, current if magnitude to the this it current physicians yet you and And the awareness in morning. level have resistant around brand right use if data, are do do? like you some could you can you Thanks. characterize as CAPLYTA within or the maybe it. pushback market what using CAPLYTA to the of - then comments community, taking least Thanks on would kind there potential might of to how need now? are And to

Mark Neumann

say the would launch. audience where of Yes, the among would are about right Greg. without bipolar depression numbers, second providing our awareness be expect Thanks what at At quantification for your for stage, these in I prescriber we this real them of stage levels is question this question. to the

even that we're compared the I good the indicated of more metabolic physicians profile on and is very that attributes safety so areas the dysfunction, and how physicians differentiation. at sp product and and measures, the pleased it recognize especially of CAPLYTA low of have the our with had antipsychotics. given depression. both look the and bipolar rate encouraging of bipolar levels unaided. understanding risk is market understanding XX II all they they in bring of products both a other CAPLYTA much tolerability of risk They even us we of a of their to with and for research for low low that over and own CAPLYTA And both clinical what's gain, and in Perhaps of awareness take dosing risk to list recent ease to up belief And with weight approved higher various a the can versus when being then bipolar the extra no… pyramidal symptoms also the the

Unidentified Analyst

penetrating are you kind feel schizophrenia share that? depression or in you color anything Any on terms of of bipolar of in terms like market and where

Mark Neumann

several And a you where many on [ph] years. market well. that over is a been have the This around XX ALR products years, have for been have over category branded as generics for the for years, time big for certainly, X long LATUDA

as look patients But as increasingly encouragingly, of placed sign of profile. for other in the of of areas. We steps are clinical usage. patients, allow CAPLYTA are So increasingly, we switches to those those to the for see very antipsychotics, products from we and to also at a more they're including continue being we more my whose as we source our prepared we wide as make taking They CAPLYTA. clinical both look branded well. and generic the switch understand very that when that switches patients the dynamics first-line profile, being progress of physicians patients healthy value a seeing CAPLYTA, mentioned the And month products think from for insurance variety coming on newly there's good each plenty carefully room seeing and penetration make and diagnosed penetrating in those new I remarks, upward

Unidentified Analyst

you. Thank

Operator

Bank coming go Thank Jason ahead. question from Please America. is Gerberry of of you. The next

Jason Gerberry

Hey, guys. my Thanks for questions. taking

better script we numbers, Just condition. BPD BPD big data under for the patients the heard. to numbers patient XX these [indiscernible] X massive wanted drugs of are try patient to But like an you've sort to These the million diagnosed is to connect million right? know

many diagnosed do of based Do and I you on the how average suggest [ph] Veloscripts number? have you would a sort these therapy, realistic duration are some assume how BPD much it do data I Because patient what patients might TAM be to maybe sort XXX,XXX treated because category So getting a patients market at is maybe have don't Thanks. branded reasonable right? the for look number be. the Latuda just and you sense you of to the getting like point important, I of like when think this more diagnosed. of guess, brands, how an the kind know generic trying can for like would just get? somewhere XXX,XXX what understand - to BPD bigger the with is But of

Mark Neumann

the category a Yes, is massive Jason, category.

are estimates serious times XX significant upwards disorder, patients million schizophrenia. disorder that Our suffer suggests bipolar symptomatology. are bipolar the to illness of the epidemiology mental schizophrenia with there of and of X Both X which of is from who size

their treatment But psychiatrist of on say determine from would journey exactly other to I treatment they want would their a perspective. comment diagnosed, to diagnosed, patients go this So condition of is. majority or treating a are where on they in perhaps once on is sort their go Suresh of what trying journey physician then the really and zeroing psychiatry

get patient One of go well typically is antidepressant years might might they in bipolar a the physician for and may distinguishing that II that is with maybe who antidepressants patient But depressive try II particularly because work and depression. who might major dynamics with sub-threshold and bipolar an not unnoticed in not disorder in treating between diagnosed several do them bipolar are bipolar as these symptoms, disorder. present a mania depressed, with patient

help accurate to color there. for to any time diagnosis with an address like question So I and Jason's might you'd them it know or an appropriately whether to add CAPLYTA. treated little like don't that Sharon, them get a takes get that Suresh antipsychotic,

Sharon Mates

So can me? hear you

Mark Neumann

Yeah.

Sharon Mates

Great.

- want everybody. Sorry, everything that issues with did are is said, it Yeah, market still this I'm I has he Mark said having to he an I patient potential. Suresh, agree said the is do and it good? with population Jason, Or and untapped large that you add market II a point. at technical anything? its also you, not reached is here. that, bipolar a – think some certainly Mark

Suresh Durgam

It's Yes, market. true. an add. nothing still That is untapped to

Sharon Mates

Great. Thank you.

Operator

Thank Verma next Ash from UBS. go question ahead. Please you. coming The is of

Ash Verma

taking I for my have two. Thanks morning. good question. Hi,

that finished That's million? $XX CAPLYTA it So XQ. for strong secondly, one. number which And around beyond How first million, half in $XXX about then do OpEx. on we year you just second a half, with the on are mark is quarter up now consensus the the around expectation half of the feel

and we like that the continue seems mentioned DTC going the saw you second in program to is year. R&D, it SG&A So throughout a jump quarter,

the like of this run assume year? to remainder is Thanks. rate a for So the good

Sharon Mates

you do that? take want Larry, to

Larry Hineline

of we include also million $XXX in the for noncash for spent second year. like and R&D earlier second part. million half. expenses be guidance spend to SG&A quarter is remind year. you as Yes. had the and the in the that were of run are rate good given it we rest And it And a XXX for higher guiding Yes, - would I'll expenses expected. second the doesn't first cash which in indicates we for take that the $XXX the I'd to the I think the were what half,

you So questions that the tells for second have expenses say the the the that? - any as remain for further of Do of we to I year, the within story. you that should and think guidance related quarter, see And context would the well as first intact. what that I project rest

Ash Verma

on sales? just And [indiscernible]

Sharon Mates

Yes.

But So with we want anything trajectory don't don't give that, to guidance launch our to date our we're give you continued as and pleased add and did we very continued know. progress as you Mark, - with to guidance, that? our

Mark Neumann

No, I agree you. with completely

Operator

go from time The coming last more will Sumant Please today. question for ahead. one Thank Kulkarni have you. be Unfortunately, only question Canaccord. of we

Sumant Kulkarni

answer for Apologies first. my but noise because asked already, this any been not Morning. has and questions two mainly you background may ask I'll

us have U.S., the along bipolar nicely you for thoughts taking what sales between second, latest ex-U.S.? lumateperone any give on split your question growth? that is, a could that is internally now product you are and humming in first schizophrenia of the And current or depression that The components

Sharon Mates

part, the take to want part. you second first do and Mark, I'll take the

Mark Neumann

bipolar our with increasingly sourced the is seen business that of explosive Sumant, we've sure. in first growth the depression the over being Yes, year, from schizophrenia. half

bipolar similar we like said, and a of seen indication to is RLAR second that that that schizophrenia question business. coming I Latuda patients the And that profile the new like and those look and have disorder kick products all more as are if Sharon, I once mature mix seen from the depression. to with they to are growth the schizophrenia, we've And new the significantly more towards continued might the explosive business along with and more of stage do two in we their it consistent at Now bipolar have track growth you we to expect And the from and the you the would the coming being business you in back we in [ph] pleased that with is tracking think get part more depression. mix same bipolar branded than of of a bipolar weighing more at depression, increasingly existing look addition

Sharon Mates

Yes. Thank you.

will you that as we And and before, continue to know said let progresses. opportunities we as ex-U.S. so you've evaluate

don't we we as any information. and now, have you further have we you update for So soon right updates will as

Sumant Kulkarni

Thank you.

Operator

over to this turn to back Mates At for like floor Dr. the time, I'd closing comments.

Sharon Mates

on made again. you and very to MDD forward progress speaking look as disconnect our look for the of much, time, and our We're Mixed at everyone, to you, programs into you, as thank with thank and very And and into Features. programs Thank and operator, lumateperone move you can everyone. updating you. We I pleased development today, joining, launch, with extension thank you our as forward well those we this forward. Operator, you both on

Operator

event. today's for participation. gentlemen, you and your Ladies thank This concludes

of may disconnect webcast at day. log this You enjoy your rest time, off and the the lines your and

Intra-Cellular Therapies (ITCI) 9 Aug 222022 Q2 Earnings call transcript