ITCI - Earnings call transcript Q4 2021 | Intra-Cellular Therapies, Inc.

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Operator

Good morning, ladies and gentlemen, and welcome to Intra-Cellular Therapies Fourth Quarter and Year-End Financial Results Conference 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. Juan Sanchez, Vice President, Corporate Communications and Investor Relations. ahead. go Please

Juan Sanchez

thank and for us joining Good you today. morning all

year release Our for update and short XXXX. time provides on wire and is website. crossed press press the December release This details quarter ago results corporate a financial our earnings the XX, company’s of fourth available and ended our the

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

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

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

Sharon Mates

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

results. XXXX full commercial in bipolar excited year productive launch was by fourth for be late quarter discuss highlighted CAPLYTA an our and year today here of our to approval to company, for extremely December are We and FDA depression. the

We associated CAPLYTA treatment opportunity to are schizophrenia. first disorder and very help and is with in expansion patients for bipolar disorder monotherapy to the label addition with the depressive patients episodes bipolar bipolar only as this or We this lithium important excited adults with indicated the about establishes therapy II strong as or I with market or an in and believe in advance the differentiation bipolar limited provides Throughout achieved adjunctive CAPLYTA’s environment. indication, bipolar even prescription face a disorder. bipolar accelerated the our disorder, options This in treatment initial I label prescription for of growth until patients approved have for XXXX for and depression XXXX, of II bipolar uptake challenging now. following pandemic had growth with expansion the in has with conditions we schizophrenia with underserved robust that valproate. quarter-over-quarter consistent

a We we’ve launch prescribers highly prescriptions seen new significant early we inflection the and and been have are by positive in and patients. of the in total feedback from encouraged weeks receiving the both

is is plan, are depressive clinical options. monotherapy. bipolar believe gain, important that weight last depression disturbances and because a more symptoms with manic only reasons Bipolar and there on episodes. bipolar episodes II only to launch in The the profile of as patients are bipolar higher condition depression. tends populations comprehensive cardiometabolic are are there safety disorder. common for CAPLYTA Bipolar clinical trade-off more and for worse a II Bipolar We prognosis than Our of parameters There favorable can a favorable risk often consistently longer treatment. for CAPLYTA, demand CAPLYTA’s bipolar common size. I one for trials, patients and with is longer suicide. a hypomanic receive having have patient a to recur such commercial attention or and severe team and Side few use to extrapyramidal I last we difficult was is agents. and of most bipolar or EPS. I continued limit approved bipolar treatments approved cardiometabolic treat well only clinical safe, prior discontinue and depression and with depressive of for switch depression. effects are to well leading profile depressive complex is a and growth. a tolerated tolerability CAPLYTA depression, as patients for and medicine executing more debilitating These bipolar movement disorders A confident product become positioned is shown presentation II has to and effective, weight treatment episodes than In episodes are Safety similar more disorder

with bipolar weight, weight depression about respect Specifically, in baseline placebo with studies, year. were pounds patients at gain similar stable one our lost in registration weight EPS, including to In months, were to changes akathisia open-label long-term of and no from average at seven in six trials. schizophrenia with while patients with our

made development programs. Now turning our to other the clinical progress in we have

studies. XX controlled United major and with milligrams with Our to lumateperone therapy as include establish treatment of Bipolar and plan half adults. evaluating double-blind to treatment MDD of our depression. CAPLYTA another disorder in depressive XX XX to approval remission. approximately ongoing respond million studies or a affects are of Patient to range the adjunctive expand disorder is is approximately mood disorders, the initial as has MDD treatment in antidepressants. enrollment our Only across that is our one-third goal States six-week already patients bipolar to for achieve adults choice of broad affects only placebo which started the million MDD, registration label These our

bipolar MDD patients mixed and disorder lumateperone MDD depressive in evaluating bipolar MDD in of study monotherapy program experienced one-third have patients In who addition features. features. our or we depression, XXX, to with episodes adjunctive as with are exhibiting Roughly mixed

formulations injectable are of lumateperone. developing Additionally, we long-acting

our in schizophrenia. clinical in single pharmacokinetics long-acting initial and completed to conduct tolerability the dose with ascending injectable our safety patients Phase of evaluate X have We study formulation

results by safety we the tolerability this date. in study to and encouraged seen are We have

injection efficacy progressing month formulation We are one other as now assist in treatment well alternate strategies that and and study. durations will our develop longer. us are for sites of The goal formulations. This formulation, is with this dosing our formulations effective, as exploring safe, with and tolerated evaluating to well of of program

continued our In studies program, doses our XXXX studies, selected we be in tested. tolerated have excellent In ascending In for multiple dose generally and shown advance addition these demonstrating other well single it allowing young at and next subject studies. completed to rapid we to be pipe ITI-XXXX-ODT-SL our absorption exposure, was and healthy, lumateperone, programs to in line. have to doses and elderly drug all safe

brain Additional effect Phase X studies studies. including planned, either and imaging are food ongoing or

disease commence our ITI-XXXX Alzheimer’s program conduct We clinical XXXX. expect in to agitation in

studies also have the in in We elderly. depressive in XXXX dementia-related additional planned psychosis certain and disorders

making our or I Additionally, PDEX inhibitor we are type program. phosphodiesterase in progress

evaluating disease. our lead PDEX compound in are for clinical We lenrispodun Parkinson’s X a Phase program

expect year. begin of this first half We in the patient to enrollment

inhibitor PDEX PDEX preclinical potential inhibitors data We explore presented checkpoint immunotherapy. inhibitors. of of the conjunction we year, with our effects antitumor when describing applications continue administered in additional Last to

presenting the excited forward year. additional other with be of immunotherapies. to preclinical inhibitors to data with by cancers continued PDEX options treatment We limited later treating by look our this prospect We combining

for XXX% required this a my our progress make forward and In program safety, we pain. continued our to pharmacokinetics Testament ITI-XXX brief Phase achieved above of ITI-XXX. summary quarter-over-quarter, resilience continue We full year ascending XXX% and with as financial his over preclinical same of million single we the representing performance. to was additional increase details XXXX safe for in and prescription in the candidate $XX.X use We XXXX were recently in a the XXXX, in agility, provide a the plasma to organization. commitment, dose on opioid I’ll end details CAPLYTA tolerated of Finally, quarter Total the of drug remarks. commercial year by well increase. deliver will fourth growth is full coronavirus study, generally still the at those growth QX This representing disorder Last financial year-over-year tolerability revenues study, a treatment of period our market on consistent models. and for for further XXXX, as efficacy this environment, or the determined completed performance and providing X remarks of evaluating pandemic. and constrained exposures look million and progresses, to $XX.X ITI-XXX our Larry year,

continued summary, million we our equivalents common investment and We’re in the In debt. I updates granularity I’m and to ended approximately cash, commercial public in ahead. we you to accomplishments, performance. commitment our who strong to on further on January, received proceeds stocks, will sharing we approximately our of position, in productivity and Mark? and and patients. cash additionally, team, XXXX, financial Mark, in of have forward bipolar no million In very net the with our our growth QX $XXX.X turn proud provide with our progress look launch call a securities. from now our offering over $XXX I’ll year XXXX

Mark Neumann

to very our highlight indication. I’m strong XXXX start good on new opportunity accomplishments update the depression launch have and pleased provide morning, bipolar an and of the our Sharon, Thanks, to commercial to everyone. the during

following trends FDA uptake our approval We the robust expansion. and for are of initial very label encouraged by prescription CAPLYTA accelerated

we the and end. channels approximately broad greater throughout antipsychotic coverage for physician from maintain by of XX% to on broad receptivity the a in covered, D EPS market patient metabolic and periods. in in coverage in More Total CAPLYTA and access increased launch in growth in outpaced bipolar fourth profile. XX% overall XXXX. quarter encouraged Part quarter-over-quarter, commercial Medicaid of We a the markets Throughout year-over-year Medicare we just with the than expanded XX% execution XXXX, quarter and its cover channel branded we are sales approximately lives CAPLYTA’s the both XXXX COVID including psychiatrists, the who versus sequentially positive year XX,XXX practitioners, to growth population XXX bipolar bipolar weight primary sales treat over favorable prescriptions of strong fourth also by approval and neuroscience and quarter moment. prescribers, an consistent drove environment. customer third expanded and CAPLYTA depression. significantly care prescription performance the for demonstrating to This increased QX, the our XX% increased the In nurse base force physicians XX% over to specialists

Our sales hybrid engagements. a supplemental in to combining primarily commercialization force person presentations continues with virtual execute model, effectively

commercial quarter, prior quarter, the weeks in grown same XX% total new following prescriptions. prescriptions me period and the launch bipolar the Comparing launch. bipolar inflection Now first and on CAPLYTA both by FDA following additional December, approval and for our We by some seven subsequently of significant the late have total to provide let prescriptions seen a has XX%. the initiated this launch new of in in CAPLYTA detail immediately depression

We profile favorable the as signaling clinical adults not patient’s EPS, need. as I and in have CAPLYTA a samples appreciate safety in has evaluate significant II, without to as and efficacy the medication. feedback taken patients tolerability And physician the captured dispense can CAPLYTA’s point in to important and weight leading indications or product all of indicator unique They highly a typically therapy Early and experience food. bipolar daily free, metabolic adjunctive It’s these new both CAPLYTA’s tolerability titration as changes, in placebo as valproate once of future proven cite with that or also the prescription bipolar be with, data bipolar to II effectiveness bipolar to to with unmet akathisia seen the approved a product and that and depression prescriptions profile Physicians and convenience the monotherapy in they I increase sample note addressing been requests, positive. to samples on both prescribe. reasons services. Physicians with in powerful initial bipolar well lithium and their as dosing and growth. similar

provide penetration proven a important safety those patients to Looking new I and expanding II for drive both or indications, major increasing bipolar an CAPLYTA’s market and a by for bipolar brand or for suboptimal, penetration efficacy and forward, treatment antipsychotic. including seeking diagnosed tolerability combined tolerability existing issues we opportunity due convenient This either market. market and or treatment CAPLYTA. CAPLYTA for the dosing see newly with option growth change will by

in we patients we of Many expect are II effective of This continue receiving resulting our In in market is patients current true Over therapies misdiagnosed with are initial drugs where trajectory. see time bipolar the depression stages CAPLYTA’s one Additionally, launch summary, delay expand. depression initially unipolar number being and a disorder CAPLYTA bipolar the approved. especially of bipolar for very properly education, we launched with encouraged to diagnosed treatment. to increasing. and in only inappropriate the is bipolar two patients with with

able help Larry. we be growth continue to privileged prescription over to with patients to are to will now that confident I’ll We accelerate. call and bipolar CAPLYTA’s depression, turn are the

Larry Hineline

of quarter XXXX QX and to million fourth Mark. financial fourth fourth for the I and year-over-year million an in we’ve quarter XXXX in $XX.X to the XXXX, quarter $XX.X increase CAPLYTA our and were expenses development revenues period for $XX.X $XX.X growth to quarter product million $XX.X million $XX.X for in ending XXX%. expenses XXXX. the same compared you, Research to of results a of in quarterly versus XXXX to compared representing will for grew the $XX.X the Thank a the in for million of XXXX. the and $XX.X administrative million same of for of $XX.X million year Selling, Total quarter revenue recorded for XXXX. fourth third quarter compared XXXX, and general fourth of of quarter million million XXXX, quarter compared of the net fourth XX% XXXX, fourth XX, of the were December now the period provide summary the in

increase million per million we to at we $XXX compared line XXXX. remarks. XX, and loss concludes XXXX. compensation was completed due public ended a December compensation XXXX compared for approximately $XXX.X in compared gross proceeds compared Cash, for is product revenues full at million securities, development loss to cash to for million aggregate XXXX. year open common the In trial expenses the XX, XXXX an $XX.X approximately to the million $X.X $XXX revenues higher Operator, $XX.X $XXX.X of of share-based Net and XXXX to $X.XX for December for were full for proceeds to and was million of XXXX. totaled were of year net for based sales million a compared million and December marketing, year share ended million compared total This in administrative year million million compared the for December increase $XX.X were $X.XX of our an our January, net product for $XX.X for million cost. labor total This XXXX, year ended is due revenues Research in and $XXX.X general investment year $X clinical XX, million the XX, million This Cost primarily XX, share in XXXX. CAPLYTA Selling, increase million and offering Net for XXXX, ended for $XXX.X December stock million shares stock equivalents For for or $XXX.X to XXXX. per or XXXX $XXX.X which million. and XXXX XXXX, the of sold $XX.X to share to were increase cost approximately the prepared lumateperone $XX.X cost. please expenses XX.XX non-clinical of XX, questions. common December XXXX.

Operator

Instructions] from comes from JPMorgan. Fye first of line [Operator Our the question Jessica

open. line Your is now

Jessica Fye

return so, to sales future commercial And infrastructure adjunctive expansion when about then that? prescribers? to is framework there. on Would this on And we require Good even How morning. you And talk kind another those taking good Can measure Couple How questions. success? Hey strategy? more sales to about MDD? your is into its CAPLYTA. target DTC measure for think of the expansion question. what force about strategy what’s how do my here? leverageable a the Thanks a use you I current your do guess, efforts? you if think

Sharon Mates

Great. Mark the questions, please. And I’ll for thanks these take questions. Good Jessica. morning, to ask

Mark Neumann

if part driving thanks, Certainly, Sure, an bipolar execute track having start reaching overall prescriptions, that. important do them, of believed with appropriate to them patient Jessica. we believe message. we Yes. our Sharon, and is levels, to physician that on starting we and expect the continuing patients, that to and potential as CAPLYTA and Yes, the we important schizophrenia, we into consumer treatment an we that from for awareness plan, track the strategy marketing on ask with for is track continue an out, we their is CAPLYTA, awareness certainly mix, of part receptivity

tell just things are those of All will us consumer successful how efforts our being.

any is stage, on sales numbers of Regarding with nurse the a primary the too it’s specific the think be overlap there with force expansion. I MDD. or early Certainly, of little practitioners sales early to probably force and I a infrastructure, any – into still a think with potential potential commenting little kind this about force psychiatry But at care. sales community, to magnitude it’s talk expansion

Jessica Fye

Okay, thank you.

Operator

Thank you.

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

open. is line Your

Brian Abrahams

Russia on time ongoing studies convert with And should mixed comment I to about then effort of how was patients sites. having feature degree Thanks. timing and Hey taking required by get guys it guess progress – a sounds I and terms for of Congrats good like launch on of morning. on evolve? differences you real and to the thanks my commercial conduct wondering scripts lot we question. impacted comparable just be and we if patient you’ve patients there? for then versus to MDD headway in that to still to on be payers. might made the – thinking gross And you’re pay public comparable to and point the a respect commercial anticipating I’m might quick, you whether where access for curious, could when which payer, can the nets any or access think Ukraine it’s public

Sharon Mates

for of with to Sharon. ask access, then repeat Larry tried talk talk payer but of were will write you about conflict for need Good some to as to impact questions. we speaking, our as start studies. them quickly on morning, clinical Mark to you then I gross Brian. thanks This to your may And our about net. And them. I’ll I is ongoing

Mark, So to would please? like start, you

Mark Neumann

And Medicare sure. schizophrenia access, important the payer have in just a in as to for Medicaid. very and on very Yes, the access questions, the we the broad only, Thanks us of the to that for was aware, take We channels and yes, XX% achieved the step in indication it patients. on back launch Brian. when access you’re launch, broad had in Part we’ve course that maintained two early over those of over D

began we the bipolar that come a for more the channel as to opportunity, is shift through prepare schizophrenia, about As would XX% be towards channel, closer to but depression mix commercial bipolar, only to public markets. recognized we XX% XX-XX in patients there commercial the commercial with patient of and with it

increased to middle about the and weeks of coverage we grow over and in do up our the that XX% continue So year, year-end, months. by coming the coming expand the in commercial and to XX% to we expect from

over So maybe I nets. can on to comment turn Larry to to gross it

Larry Hineline

And good bipolar channel commercial the would to the expect, that increasing, potential off and as have start a co-pay you our patients. a of amount with provided would launch to sure. Yes, very assistance impact on

end you, result, we look think which mid-XXs the our range that I the to to to at the higher to a net for of As gross be disclosed low-XXs. previously had is you the would

Sharon Mates

a to we’re low-XXs. gross Well, of so at the range higher in looking net the now

Okay.

the on our questions, I’ll your then ongoing clinical of an impact conflict the I studies. take think is and think, of I last that

conflict. have the again, just that let’s and may in look particular, from those program, and step our take So ongoing again, clinical back another exposure at

with Study mixed start XXX. our features Let’s or

global this the includes know, in enrolling study Russia. a that and Ukraine is and you been sites As have

to complete to response implemented that year. strategies, have these we conduct in given continue we And expect will We clinical this recent events. later mitigation strategies

have top-line reporting clinical As said previously, late year completed, data, we on year. the either conduct this early when is next depending we anticipate or

look with has numerous been as countries sites program the and in let’s Now U.S. MDD a program, which at designed also our in Europe. global

international As regulatory longer you than the sites at in take know, U.S. approvals

in Russia. received in to Ukraine, European begin and we and approval the countries clinical expect also have shortly in recently We approvals several conduct

however, have, as have Russia. well. implemented or not Ukraine in And enrollment the we commenced We these studies, patient mitigation strategies also in

by additional number And their remain of response some filing approval, FDA so some clinical to we with timelines to make sites. and comment in sometimes like thinking patients Each divide Clinical and That – patients. of of of filings from continue the intact enrolling people to have some of those one X does our the an about not to a studies and you’re isn’t and about would we’re and XXXX. questions for comments enroll them okay, up country. I clinical tended to analysts saying, in and getting particular just expect these and it’s number our number clinical made site by be same therefore, number this. patients your sites of the way should take the

put wouldn’t I each on equal So weight site.

to that well, you mind as So in I’d ask keep okay?

Brian Abrahams

expectation? That’s was really low-XXs year helpful, first net, Sharon. Maybe for full to quickly just Thanks clarify gross or XXXX so to mid-XXs the quarter that to this much. for

Larry Hineline

No, we Sharon XXXX. headed – is be low-XXs said where the propose that we that in and we’ll

Brian Abrahams

really That’s Thanks again. helpful.

Operator

Thank you.

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

Your now open. line is

Andrew Tsai

Thanks. everyone. Okay. morning Good

first to half? as talk prescriber It well there you’re And secondly feel then in that So for more going QX they paying you into seems XXXX. indicators as sampling, if dynamic your attention can kind include QX, And very you’re as to leading are you PCP. we’re like wrapping And me. are second base other to about addition maybe is is outlook how acceleration? pointing to of – continued the about up target to interesting question a indeed and increasing

or antipsychotics think you promoted do drugs setting wonder setting. much how also in the can I And that other that if growth being once-branded are for drive So branded CAPLYTA?

curious the be big PCP Thank just opportunity you. marketplace uptake. CAPLYTA’s yes, a could whether So for

Sharon Mates

that? take you mute. Mark, are to want you on do Mark,

Mark Neumann.

that I do once was at going knew, to least today. I

looking acquisition. about me we look of strong believe and that. leading a the of we look CAPLYTA. is the your new new-to-brand indicator let addition thanks at indicators there’s When significant levels those to and of we we’re the accelerating in things Certainly, at growth Andrew, we a about launch, inflection one seven that with CAPLYTA of – in that at signals for the what prescriptions continued or the So is back in new question sampling go prescriptions, and also at to total part signal first prescriptions, levels weeks when they now which the were before And depression. very been approval at that look those first are bipolar patient eight triple NBRx in true right

So very acquisition that’s we’re new continued a signal a that to signal for strong us growth. gaining patient future and that’s

In awareness like to awareness going addition, all growth at to signaling is to that things indicators performance of the of those we look general it is continue the us levels, accelerate. indication, going and and are key

and the expanded our Regarding addition believe that to to physicians we of prescriber added we CAPLYTA psychiatrists our yes, do prescribers And the a force we base, in bipolar sales and and will who antipsychotics we of over PCPs, for growth when and of this treat course nurse contribute practitioners, high expanded depression. primary are ongoing target growth the in group XXXX. care branded acceleration

that’s hope I So helpful.

Andrew Tsai

guys. Yes, very helpful. Thank you

Operator

you. Thank

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

now line open. Your is

Mike DiFiore

Umer. is and This DiFiore taking in much Thank the congrats guys. so on for Mike quarter. my for Hey questions

on any as the basis? that to guys quarterly you application guys you will expectations depression are is, there’s second my for question one you Street into That to subsiding, Just we a year I process. potential and about if think updates the two key remains whether question or beat years additional continue patents were half updated guidance time I the spoke, said, seeking? And last for on for giving bipolar With to sales Omicron thoughts either this this any CAPLYTA guess me. year.

So you. I front. to on any updates see Thank that want if there’s

Sharon Mates

Hi, thanks Mike.

that the I can update Book to think I said that reverse the Is questions. patents you this you I bipolar maybe to When both extensions, right? – remember think as listed we’ll Orange in meant to well patents, the as take so correct? order updates

Mike DiFiore

yes. That’s correct,

Sharon Mates

right. All Okay.

any when typically, about and But extensions, so on you’ll the will So because a to do we’re haven’t yet. three-year we – we list answer updates that know getting process, it’s obviously the we’re sure And on had is, be simple there. that. we

So about like little now? then next a we’re guidance saying – talk Then about quick and year. very maybe, then providing simply to you’ve bit so talk is the not I seeing with a and Omicron would you guidance seen one. Mark, one And what this that’s what can you’re

don’t Mark, ahead? why So you go

Mark Neumann.

Yes, sure. that I things seeing in improvements I would out normal. guess return we and begins say environment just the begin Omicron to back subside simply as to continued there to are

for representatives means that what our us, is For greater sales access physicians. to

for the lifting think indication I doors sales honestly, lot declining representatives cases, and, the is perhaps our the new the the about quite a excitement more depression opening of than restrictions bipolar in in past.

we go we certainly progress this as year. And throughout will so we sign, the hope see that encouraging continue and that as an

Mike DiFiore

you. Thank Great.

Operator

Thank you.

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

Your line is open. now

Charles Duncan

then about morning, but I’m provided launch. I he color, expand prescribers team, the for what pushes mostly to Sharon that efficacy you that II? on as giving it and launch year, if about on questions. Good question to taking had the well patient the Is experience. the are year, it congrats might wouldn’t feedback and Yes. to the initial Thanks is but back some CAPLYTA and and as regard the the or initial this that? pipeline it across you BPD on And is statement imagine that tolerability both your pulls could he’s you mentioned board next giving approval guidance, And Mark with progress. in relative good on be feedback? about wondering recent I hearing from a

Sharon Mates

up with and last part start, I’ll come on then you the Mark, ask guidance. I’ll rear the on

Mark Neumann

Yes.

short all areas. hearing we’re the is, I’d all say – feedback three the Charles, answer positive of on very So

where that convenience food. You without tolerability, dose with without XX-milligram the the CAPLYTA’s at taken medicine can patient I the effective mentioned of the can physician also efficacy the and start and add to or would single titrate be dose to having

particular they only when bipolar other good in and underserved physicians a we where in are that big lot see II. of efficacy to area, see a And there’s I the area one condition, and both recognize it’s is So, really deal bipolar an clinical get and they product that educated they on that’s feedback our this on in bipolar profile and II, from them. proven an clinical do in the that indicated trials, learn

efficacy an they addresses when product unique bipolar for certainly this II, So in unmet and bipolar that something I they is the need proven the see they see both as and have.

schizophrenia CAPLYTA when profile are the similar and a when as and data placebo, with of around they most, saw bipolar is those concern weight particularly experience For that what replicated our in reason patients tolerability, that physicians issues clinical see in to with which that gives their safety see and familiar the they great they well were and tolerability in them indication, that that essentially the two another akathisia, through schizophrenia, our we recognize the with to confidence that’s CAPLYTA. prescribe those that, deal each and of

together, these of positive So, their stories successes of that and all they having. patient terrific also I feedback physician we’re very relay hearing lot of patients are things a us think to

encouraging. highly that of all find we So,

the So for turn Sharon, it I’ll of the to you rest question. back

Sharon Mates

providing taking one taking one year future, Great, we for guidance. we’re think time. it point the thanks. now, it a Charles, said a at not we’re at I right year some But this We year, I At time. we’re think will. in

Charles Duncan

consistent know schizophrenia expected one just are with I Mark, in persistence Thanks. that sense. to to tolerability you question, would’ve is but improved ask the or beyond what to tolerability, in – Makes I seeing given you wanted Back relative Okay. profile? the perhaps

Mark Neumann

Charles. Thanks, Yes.

also safety little a profile to other you to from do that to those other And and curves, branded a bit the longer outpacing to we surprise that, We been and tolerability at do trials CAPLYTA us, is in their that more are still are. disorder, antipsychotics, strong CAPLYTA, the looking a data But in at clinical we branded the the it’s proxies compare not prior when have is to that you even which do that since antipsychotics bipolar historically And and launch signal back a obviously, too you when in find products mostly rates the had refill And to longer schizophrenia. on saw classical in We early for when to NRx we at need a schizophrenia. it launch, early but time tracking for with back, while hypothesis it’s you you our be tends ratio. at CAPLYTA. the look ever to persistency we TRx patients and same that persistency persisting in when it’s than look bipolar very look us. launch, CAPLYTA depression, other

would the we CAPLYTA to So, see with well. as same expect

Operator

question you. [Operator Thank next from comes Leerink. the Marc on Our Instructions] line of Goodman SVB

Your open. now line is

Rudy Li

This Marc. is the for line Rudy on

expansion Thanks. more first the force in of potential your of was completed the with you quarter, antipsychotic how And trajectory Latuda provide label another can Regarding [indiscernible] that expansion entry sales growth accelerated in MDD? think CAPLYTA’s about XQ? especially dynamics, the in upcoming color and have question, of impact generic on market should I the we

Sharon Mates

questions, thanks Rudy. So

I difficult you think understand saying. little were it bit a to was what

You little the to were but a were you questions? get muffle, coming bit able Mark, through

Mark Neumann

approval part productivity if Yes, the sales follow-up in don’t with Rudy, hit on from XXX of what We higher of approximately before due of of as I we significantly of also, level are But I about. to depression a representatives representatives. it a level something seeing before, sales sales is structure. in But out bipolar in just bipolar to in and force so. mentioned launch the excitement representatives interested up overall part detailing marketplace, in of we’re as very sales I bipolar And the you’re detailing terms additional XXX And, our our the think the is force follow-up addition, that expanded improvements environment force the our physicians in weeks exactly, new a a are seeing question. last in right. just perspective. the early of year COVID hearing indication from in And having

share detailing of of and is leading things marketplace CAPLYTA very to level a level a believe high the – in message. communicate the we at of gives that all a us those So voice strong are to

the when of certainly, a is on products the terms patent Typically, branded or don’t that, in a of category, marketplace. look in historically CAPLYTA generic will expiry, the we brand by you In impact significant entry. have that other – potential this back Latuda a impact that believe impacted

these that. be there’s been it quite by impacted already switching that’s by be And awful medicines. because category very and on the there’s will And that this brands of Latuda to Latuda goes not an obviously But an generic. have other discontinuation the a tend impacted. patients churn, honestly, is of time So of lot lot many awful of

significant CAPLYTA event So, that marketplace. on a don’t we in impact foresee the of

Operator

Thank you.

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

Your open. now is line

Jason Gerberry

guys. my Hey questions. for Thanks taking

the up last just following on to Just I question, confirm. wanted

generic my a antipsychotic BPD, one rule, is in edit the but only So more generic markets, there’s some typically edit. two understanding step there’s step in of

So for line And a edit is it that have then therapy, launch, you shift a what assumption a patient BPD too of two on of Thanks. the getting say? generic generic typical not do to would step balance just is your but curious, kind profile to going early CAPLYTA is early type it dynamic? of Latuda the days, treatments sense BPD? what just Or of prior the

Sharon Mates

Mark?

Mark Neumann

Yes, for it at across look Yes, utilization various the the you antipsychotics, the on thanks, varies across exists that various depending channels payers, really payer. when criteria Jason.

a that. through payers, those either you more available payers prior with not who a edit Typically, – you steps, employ edits. access unrestricted through associated and that possibly have have two You step or step those generic to certain than the And category authorization then usually it’s have manage that. one

a physician write a in not status marketplace. as is we the best all has scenes the that Whether do would it’s the is the it physician behind to something across unrestricted anything say, step steps, the board. step This They this electronic at or certainly, staff done for. electronically. don’t patient is two the What edit. barrier and pharmacy, So up shows significant or the prescription, the really see single I the varies

to in the isn’t usage it marketplace. barrier a really So

again, of the lines this what therapy. all early in what In terms schizophrenia, are of is second we therapy, question, still you but on in the we similar across utilization said, regard lines saw launch, to seeing, in of

products, switched patients newly we being the third line, – line, from, We’re well cetera. second as switched as the variety et when placed seeing also wide being being on a as they’re CAPLYTA from And they’re antipsychotics diagnosed that look we’re at well. antipsychotics of

are one us, like board, products really physicians again, not is or which, two from very sign. just coming encouraging is it’s to to a the specific there’s CAPLYTA it switch looking to across So that

Operator

you. Thank

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

is line Your now open.

Ami Fadia

Thanks. one I Good have and follow-up. morning. one question

Just prior on Could question might achieve comment give the us with consensus you a us year. Thank distributed regards given us to samples level secondly, with stands color regards you how that volume you million your for seeing some may to around give if able can can us I’m in give $XXX so with of you that? with at And comfort to the to with a consensus have prescriptions? a to past, are for that far? regards And new the some roughly then guidance, the you’ve you. numbers leading being comfortable for year. indicator you color prescriptions the sense some of how sampling, with regards be just regard or to total

Sharon Mates

Okay. them, to come defining parameters as on ask Mark, you I’ll see then consensus. start the you I’ll and the back sampling with

Mark Neumann

Yes, sure.

the physicians I to new order think in try medicine as a most of patients. for you are utilize samples aware,

week in issues. typically, So a samples early And give on to any if tolerability goes that then well, followed they are test there’s if to prescription. two typically a then effectiveness all samples will patient or of by see the them those

they done. samples will give and the physician the same at samples take They they’re then fill and the prescription Sometimes the a them time. it when

back write indicator of it’s it will to a believe commitment ultimately a prescription, patient, we but a medicine the which because a results patient hear want and a prescription. willingness and from future growth to in Sometimes new the the in try physician prescription then signals a

sampling magnitude, sales calls. significant to samples, for increase, as terms both have say samples would that sales in as physician make they physicians the requests our In unsolicited we requests what for force the well is, provides of I their as a seen

second back to it I’ll the turn you for part the Sharon, So question. of

Sharon Mates

Yes.

this So, no, not we you not year, guidance year. said cetera, you any numbers, so et for we’re this on we’re consensus, guidance giving giving

Sharon Mates

is that question, asked. if think not I this if more there we there one Operator, have we one can question, is up wrap or another can

Operator

over closing this to would showing Mates time, no turn further for Dr. to I At Sharon questions, like back call remarks. the

Sharon Mates

for morning. you thank everyone Thank this participating We Great. so much.

about our very, about patients. and the of launch helping excited the continuing probability very CAPLYTA. excited And very We’re and possibility expansion we’re of

you can operator, that, with So disconnect.

Operator

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

You may now disconnect.

Intra-Cellular Therapies (ITCI) 1 Mar 222021 Q4 Earnings call transcript