ITCI - Earnings call transcript Q4 2020 | Intra-Cellular Therapies, Inc.

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Operator

Good morning, ladies and gentlemen, and welcome to the Intra-Cellular Therapies' Fourth Quarter and Year End 2020 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] As a reminder, today's conference call is being recorded. I'd now like to turn the conference over to your host Dr. Corporate Investor President, Vice Sanchez, Communications Relations. and Juan go ahead. Please

Juan Sanchez

thank Good joining you us and for for all morning call. today's conference

Our December on at a XXst, short corporate our a A press company's website the release ago the details XXXX. quarter press wire crossed fourth ended the for financial and update year intracellulartherapies.com. and time release of results earnings and provides is available

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

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

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

Sharon Mates

three our execution approved Thanks, Juan programs for call. We began FDA the COVID-XX our adults, for our just Throughout CAPLYTA successful disruptions made teams' development commercial cause Therapies today's as a major product addition and in bipolar schizophrenia to challenging given particularly progress ongoing proud the depression the in clinical objectives pandemic advances treatment program that development advanced and patient we on to we areas. CAPLYTA, care. and environment transformational XXXX welcome was in programs. commercial our launched major of we're substantial successfully everyone to also other caused. efforts has year, This first for our year in of of the Intra-Cellular I'm year, and pursuing

FDA look First, label submitted with recently half action an the to for forward second we CAPLYTA supplemental applications target our and We in anticipate drug in bipolar new date this of the year. CAPLYTA indications expanding depression.

Second, continue disorders. in Lumateperone programs we will our depressive for late development stage

Third, newly we the clinical as of ITI-XXXX, introduced inhibitors will ITI-XXX formulation our program. Injectable as well PDEX Acting Lumateperone. development of our Long continue our and advance to

treat. neuropsychiatric disorder. step help a of for benefit our patients We who to give conditions to with company's efforts, diseases potential and with context our and medicines belief back I depressive the major progress create living difficult set with to of prevalent has disorder take I provide ITCI people of bipolar are want like most an strong overview its the commercial schizophrenia, some to lumateperone in living develop highly to in out Before better our put mission.

in use. through efficacy profile which in that significant medicines schizophrenia, unmet help focus million has to tolerability about States. United first X.X schizophrenia. or demonstrated safety a needs address patients Our and the was CAPLYTA discontinuing favorable to contribute Antipsychotics effects have and affects cycling adults side

bipolar disorder most as is of Another adults is treatment patients condition to the disorder. difficult additional common by and than this is disorder. treat with in XX a and depressive these episodes exist II only for depression most one million approved affected only But and monotherapy. Bipolar Bipolar American more few therapies options approved for manifestation this need of a only

In addition, large America. depressive a this major need more for year, patients there's with adults with condition than are in disorder. XX million unmet Each affected

depression for be these are We line a first However, adequately additional few patients sum, conditions. adjunctive for need There there's important antipsychotics In treatment these over to patients. are lumateperone XX% well and respond to these options treatments for and major drugs addition approved safety patients. tolerability these treatment. and tradeoffs will require of an of believe fail safe neuropsychiatric and tolerated therapies significant for available there for with to effective,

Now third quarter. the million let grew million compared some year. $X.X you highlights me prescription $XX.X to of of quarter We're compared prescriptions product the pleased in prior Net past quarter. CAPLYTA quarter-over-quarter QX, to fourth growth. CAPLYTA for with give the were the XX% In revenues

coinciding launch national we major infrastructure COVID-XX strengthened with our the to For the will in million revenue. to by Officer CAPLYTA remarks. our performance hiring in our CAPLYTA Hineline, further first launched late our on successfully our later and Financial in generated Chief We full CAPLYTA Larry team March financial disruptions. start was our product. the commercialize began year sales XXXX details XXXX $XX.X provide year of

will and team Commercial remarks. salesforce the direct-to-consumer to of include our we details and promotion. launch In his and initiatives strong those had digital provide virtual commercialization with We quickly marketing in-person COVID-XX challenges, Mark further our commercial Our and model spite medical of accompanied CAPLYTA adapted a during Chief efforts Officer interactions education. Neumann;

as Phase in studies proud In filings and a serve two of the to findings the demonstrated our previous from with These XX bipolar sNDA positive Study as the we depression. primary improvement in This in basis Both X follows to positive for our studies well. efficacy from our tolerability that of we're results as the milligrams our profile mood lumateperone Lumateperone therapy 'XXX as endpoint XXXX, consistent reported robust 'XXX, studies. accomplishments launching depression. results bipolar all favorable met lumateperone evaluating depression. stabilizers monotherapy. CAPLYTA, Study safety other adjunctive of in September addition In evaluated a for study an

XXXX, Looking ahead or our for first therapy label. valproate treatment in depressive II If disorder CAPLYTA the positioned as Bipolar the to and be indicated lithium we're episodes approved, the expand adults. I with of CAPLYTA would monotherapy therapy to with Bipolar or both as adjunctive associated

depressive will We this our disorders year. progress make to program continue in

large Study Our mixed or with is depressive is evaluating and of who Bipolar mixed with major antidepressant disorder. exhibit Depression effects ongoing features stage the patients lumateperone in 'XXX late features

the adjunctive began our XXXX. In of this study and later in we in MDD depressive disorder anticipate evaluating program X the patients XXXX, from results Phase second lumateperone expect year. in major an treatment two half as studies Adjunctive We enrolling

In addition, our Acting formulation we're advancing Long lumateperone. Injectable of

second in X in and is initial the Our single Phase anticipate ascending we of progress dose results half XXXX. study

elderly our use is offer we're disintegrating to as recent for populations. in deuterated the may pipeline ODT-SL continuing XXXX patients is pipeline. form ease like to of abbreviated most Finally, I'd benefits of program. with addition advance ODT-SL. ITI-XXXX a orally pharmacologic and XXXX, an as lumateperone sublingual particularly our other tablet, which to start delivered

to circulation The depressive absorbed and recently of into the treatment of high systemic dementia. initiate Our and evaluating metabolically behavioral found elderly. with psychosis in stable disturbances with was X treatment related We for completed of ITI-XXXX studies in systemic rapidly patients Phase in for the resulting plan certain ITI-XXXX program the the treatment that exposure. disorders dementia

this year. We late expect next to and initiate year these studies

is for heart program, including our failure I inhibitor I'll cell opportunities our treatments pursue other in discuss disease and/or to disease over-expressed diseases This diseases function on focused PDEX to and PDEX type enzyme Phosphodiesterase Parkinson's, the contributes innovative Next, pathology. program immune is multiple states. abnormal inhibitor provides which

reported with patients known ITI-XXX, from evaluate year. positive We Phase in later X/X already chronic with have Phase Parkinson's into failure. clinical heart lenrispodun in studies plan a Parkinson's to We systolic this lenrispodun patients disease study disease results in advance as X formerly and

pipeline We program half this Phase more the on study Day our which We ascending details year. We we ITI-XXX second R&D in initiated an ITI-XXX is healthy QX. opioid anticipate safety, our our single conducting a this compound during of for X volunteers. ITI-XXX lead the evaluating in and use platform pipeline anticipated of Another pharmacokinetics and with treatment disorder. in forward development tolerability in providing the study our to results programs these look from of dose in

to efforts. details in and and remarks. growth turn with ahead. on over to past year continued look commercial call summary, In the equivalents Finally, will his very we year additional accomplishments cash all proud Larry cash, the I'll in year the investments. provide approximately I Mark? our now $XXX Mark Neumann of for in forward details the ended I'm million in our and expansion

Mark Neumann

Thank you, morning, and good Sharon everyone.

In launch the very of order. execution, Looking commercial delivered from March, the of one strong ITCI COVID-XX an virtual all commercial successful CAPLYTA in in-person to even year, an pandemic. in we late short midst pivoted launch back on enabling the

COVID-XX team agility, new to Our that adapt creativity created. demonstrated environment to and commercial the ingenuity

hybrid sales interactions education. mentioned, and for a Sharon and deployed As programs we in-person of model medical virtual

to channels than the in the XX% D our major digital Medicaid. approximately of all also covered in representing These with be to market. These promotion. Part CAPLYTA efforts for more CAPLYTA's are access schizophrenia. in lives were We at successful based and clearly strong market increased continues state initiatives position payer coverage standing both performance on marketing Medicare XX% and XX% prescriptions the of of schizophrenia direct-to-consumer

in support Our end this seen through to competitive performance gain and be eligible CAPLYTA. launch prescription continues access effective program since assisting and highly to growth to and We've patients physicians of consistent XXXX. robust LytaLink patient prescribing extended the

highly increased that have time. report metabolic, antipsychotic rated patients a the surveys, essentially encouraged market QX. reaching ease prescription They much mind; grow. other need the to constraints. with compared and very was with prescriptions for to weight In and research to therapeutic favorable of for and both highlight the see drug efficacy this when We're total been also in the for fourth on confident CAPLYTA's that dose prescribers time and branded numbers COVID of experiences period quarter will because the And during to was while during performance continues continue COVID to continue to disorder overall CAPLYTA's impact care, market relative we're the overall doctors positive Specifically, a no CAPLYTA patient flat that Keep market titration. profile XX% of longer higher CAPLYTA. movement antipsychotics'

is which received have their rate they're launch. We're refilling on prescriptions. is at patients CAPLYTA who the than that by that refill CAPLYTA for products patients stay at CAPLYTA the the started their showing tend to in pleased with indicator time we see longer many other rate well Another being same for

efforts commercial to extremely and pleased fluid CAPLYTA in we performing are bring see continue product more COVID adapt schizophrenia. to environment We the marketplace to even our the to in adults will our XXXX with well to so

As bipolar patient you looking label exciting well we're are potential to for are in earlier, approved opportunity. year for this great heard underserved forward few later this depression options from with and also this there only our Sharon into planning Today, commercial anticipation treatment our expansion population.

to action safety strong has this and tolerability salesforce the to of this in prepared the advance CAPLYTA. introduction launch expect addition in our proud appropriate to the successful of We depression be plan bipolar broadest of the robust and seize demonstrated commercial be because and of and PDUFA to We has improvement lumateperone make profile be we market patients. our opportunity. of and one to potential team will a favorable target We're to depressive it the day symptoms the execution the approved on additions date welcome for range of a

our to and to with depression team be our expand and to going ready Officer, I to Financial our very now Chief Larry will the more call CAPLYTA the patients will by pleased bipolar help We with growth schizophrenia even over commercial turn continue efforts forward. Hineline. adults be trajectory

Larry Hineline

period the third in for we revenue Mark. in million quarter I the quarter for will administrative decrease expenses the a decrease of in expenses. $XX.X in the million decrease CAPLYTA same $XX.X product loss a in related development in a same sales for compared for $XX.X period This of and net primarily you, of XXXX. due million quarter and kormaed expense revenues were period reported is commercialization recorded the and expenses. XXXX. Selling, increase expenses million non-clinical in of fourth million XXXX. quarter year. Research to product This same quarter. No to and compared loss million In and clinical ending to increase XXXX fourth is $XX.X the the were to is fourth period $XX.X Thank to our primarily for quarter. $X.X of to financial compared for fourth labor in general XX, an year the This results lumateperone due the manufacturing totaled Net prior in XXXX. net review same million the the expenses $XX.X fourth of and net was $XX.X the million December

For to or year product year million and were $X.XX total the share XXXX compared million revenues compared revenues XXXX. loss net or share expenses the per pre-commercialization were a million CAPLYTA ended million prepared were development for was net were million were could cash $XXX.X expenses and XXXX million open General administrative $XXX.X the questions? Selling remarks. million Selling, $XXX.X please for $XXX for XXXX. administrative for ended restricted December concludes line year XXXX for XXXX. $XX.X million compared as $XX.X XXXX. No for of revenues for $X.XX totaled loss loss $XX.X general cash $XXX.X at XXXX in for This and $XX.X investment million year in Operator, million to compared to Net and XXXX. year million expenses Research to of and XXXX. our equivalents million. of as expenses the XX, ended expenses compared Securities for $XX.X to Cash, were you the for $XX.X million the XXXX. were reported $XX.X a $XX.X per net

Operator

ahead. Raffat Instructions] question with go Please comes [Operator from Umer our Evercore. first

Bo Chen

for Bo Thanks questions. for taking is Umer. may. Two, I our if This

is and First study maybe UGT question package inhibitor we're give interaction depression co-administered And us And data the the follow-up as you whether on with is, of a for know such particularly, Mark color sNDA? there is could to these some lumateperone. some updated prescription bipolar antipsychotics? treatment thoughts [indiscernible] for curious also the is drug any for on is the we mentioned comparable on you commercial. treatment your us and of duration Could give updated the in Latuda duration to you which of Should the then about think remarks Thanks. rate continued prepared similar Vraylar.

Sharon Mates

Suresh, start, Bo, is I'll anything. Thanks, question. and for I'll then he'd to add Sharon if like this the ask

for color asked our some So us you've on data package.

studies, interaction news. great submitted have this yes, bipolar have we the our in we the not for think and So treatment yes, we sNDAs UGT on updated there's seen of information depression and interaction and is our

discussions. of So that? we have to submitted part be would add course anything all of our Suresh, this you like will data label of and on

Suresh Durgam

to No, nothing further add.

In fact, that we did submit the information to the FDA.

Sharon Mates

the I and then answers part, hope part second the the question towards Yes, and second think so directed I is you the Mark. your that of question, then of first part

you So like that Mark, take please? to would

Mark Neumann

the able of is, very to do do of morning, be to far And classical duration what for sort of months Bo. We'll it Thanks has need your sure. good to CAPLYTA. several Sharon encouraging too I and say part therapy. would early compliance persistency Thanks curves. question still more is that. yes, And Yes, and about been a your launch this thus with

encouraging and the therapy. ratio on CAPLYTA in by profile terms consistent tracking compare well metric the very we as that and NRx them for antipsychotics ratio. we hypothesis had However, to find that interim is terms to closely antipsychotics' CAPLYTA oral actually rate safety other and what CAPLYTA that those the very would of of that recently allow time stay and NRx tolerability in outpacing launch. do same TRx at an that and in patients be when the we their to is refill TRx their that find And We to we launched received for with we're and

as more information share and persistency We'll something get we and that you it's to around compliance curves. we'll information So well. with as continue watch

Bo Chen

Thank you very much.

Operator

Thank you.

come will question next Duncan Your Please from Fitzgerald. ahead. go Charles with Cantor

Charles Duncan

come getting looks pipeline and congrats a on question if CAPLYTA space prescribers on prescription the ask then traction expansion. for had team prescriber and the on Sharon the the focus on a of back with this pipeline. and one you're new within great or and commercial to then goal prescribers on I or deepening But use I'll commercial pipeline regarding I'm the your a and good. is quarter wondering, Quickly, lumateperone question. year

Sharon Mates

want take to that? do Mark, you

Mark Neumann

Charles depth and when pleased we and have prescribing look overall is, that the seen support. continue Thanks on The at breadth have already what launch. would who those have breath sure. been that But of both question the also CAPLYTA is, thus Yes, in to far both I say to trajectory growth prescribers. we the The answer extend your will look tried to CAPLYTA. we of we've

one depth is is, been prescribing early as CAPLYTA the on a that build seeking depth be in and XXXX and know experience have we us really we and will the the prescribing in and well. that to go they the on do, their increase that's likely as early patients as their the medicine both them with that increase upon we the throughout to of experience of something want will physicians that having launch, favorable get We to feedback they're very things launch you have more encouraging in as positive of very on success XXXX then when to with had well. you that that

Charles Duncan

added sense. Mark. the Thanks makes color, for That

bipolar. it's acceptance I'm very was press of I seems two-part the trying just like out the the for and One apologize filing. a quickly release driven On recent pipeline to question. that. likely is, a it timing by work

XXXX provide XX sNDA could as of the terms ODT or lumateperone and do, achieve product program to interesting like looks if in for takes that patient could pipeline follow-up is target for on that, wondering you the you you. color could quarter. to and an months, just So more only to the a the elderly to the timelines form a of particular in then I'm population? and DRP six roughly what profile third I me if Thank a that date assume [ph], expansion very and PDUFA deuterated really little

Sharon Mates

Okay, onto I'll can timing sure, the XXXX on the the so our question. announced a start questions. I submitted not recently. entire the question maybe with bipolar I'll we that timing. wrote on what down I I'm we both you of go bunch then But one. take bipolar release that, either and press or asked was Suresh

review you standard guided and So have which a expect I think that review. XX-month is we a to

you that see the can where takes out work numbers you. and So

Charles Duncan

helpful. Yes. That's

Sharon Mates

either stable the systemic timing. high It metabolically molecular and entity based is our Phase bipolar X know with to well circulation to find on we at as the the elderly group that's mouth. the ODT. these adverse were So it And XXXX studies, a that did our recently cohort report Suresh, completed On adverse rapidly in dry we there events characteristics. events were in its most In XXXX into on study new add all was is XXXX? resulted no program didn't is in believe common you systemic suited transient that you about and in pharmacologic in absorbed exposure. being and population event - with adverse frequent that reported want elderly to serious we the did

Suresh Durgam

population. in in orally elderly depressive elderly and profile was patient - And we're looking dementia. adverse no and mainly we're related at well the allows you're disorders mainly Yes, terms differences Treatment common events. dry correct. events treatment adverse the transient the There the population. mouth in dementia psychosis for population what of pursuing in indication elderly. behavioral and infrequent the had disintegrating it They're safe tolerated. elderly was certain also with serious of fact, in And use of safety in There

Charles Duncan

of taking Look under studies. terms helpful. forward get questions. that seeing Thanks that's clinical for my in way to Okay,

Operator

Thank you.

Brian with Our RBC go next ahead. Markets. come from question Please will Abrahams Capital

Leo Timashev

to And commercial your This to reopening a in question. shift about How as then is to XXXX. greater as What's hybrid interest Leo, drive for such as my might I launch and for on care same CAPLYTA? sort try or the these Brian. to taking sort you bipolar aspects thinking I you've are potential Thanks. curious launch? a in on ease ahead factors the adjusting prescribers. strategy greater pandemic guess of Thanks was Do look follow-up efficacy? other of interacting to physicians bipolar schizophrenia thinking or sales you inflection the with as for of or that, equally physician in lower e a for to like ahead the the the been doing towards be profile interested in the ground the about in performance

Sharon Mates

questions. like them Great would Leo. address I'll Hi, please? to ask you Mark,

Mark Neumann

What do is, and what that in model with representatives our can't your that equipped done Yes, would about if I because at or virtual means traditionally who in in the promotional in-person sales an about about stage feel CAPLYTA Leo. to our questions. in-person to speakers they both for always what's our COVID our access the as we they've do physicians model environment have hybrid to place is say hybrid sure are very Thanks of we environment good pivot well manner. commercialization as this talks years either model an that which the happened over a again

their become through that. to Now our interaction be and virtual environment always like But speakers that. have a we for presentations adept prefer other at mechanisms Zoom, delivering would in in-person. There's very substitute no representatives the telephone

actually say And optimized we're is, for the I I we're so transpires environments COVID. say with of that what would regardless would

and and well to will commercialization through in-person engagements. will But with digital initiative. our be there that our we continues believe representatives COVID pivot other as and our operating we are where for both So COVID engagements marketing continues very change the back optimism impact beginning digital effectively. in begin model active come patient up, clinics those do, market will care as and us. becoming they supplement to we'll are open in-person down to back reasons permanent representatives engagements It cases our see the physician more the that more accessible become with There's accessible, do to offices representatives etc. to be when speakers a by

we're to effective world, and placed would and we think poised post-COVID we're So that. you to make that transition doing a if in well back be very

second part on engage as question your bipolar approval an etc to our label. of from bipolar The commercial at would depression be speakers do perspective salesforce not a it all around prior off

believe feedback as in can't and for well also seen our very clinical depression on schizophrenia we're depression on expect bipolar bipolar physicians schizophrenia would the patients the the that bipolar getting and any exist in marketplace received bipolar do by in what and much profile side of comment profile and the for field of depression. marketplace saw cycling replicates, through we dynamics in limitations really can of effects So the trials those that was because I been we you tolerability that we where and research other indication of well. that that exists safety say antipsychotics I safety have pretty recognize that has in some physicians market favorable in the tolerability get current antipsychotics schizophrenia the we continue to we that the once in that and

I questions. your answers let there's anything that hope I that So know. me clarify just If two can

Operator

Thank you.

will of Please America. Ashwani go Our from Bank with next Verma question come ahead.

Ashwani Verma

two. had I So

are opioids which dosing, is similar That's molecule profile the month it pursuing to profile Is is the ITI-XXX aiming competitive using which for a factors approach? in use as difficult you slightly disorder. to different one LAI, as far And in one. so formulation? to landscape? for you're the also or target opioid that that dependence You're of or driven attributes kind specific the the For for product easier, are that by this make Luma's there any of formulate

Sharon Mates

Great.

very ITI-XXX molecule take So from different that. a [indiscernible] I'll trial. is

new with associated XHTXA a antagonist. agonist intrinsic It low substance is have does it It very use partial any all, all. not also is activity. at of First opioid within

it is comparison [indiscernible] mechanism there. of action so from trial, totally different So no

for we In LAI, to yes have because molecule several characteristics development. we formulations. But and several terms an of easy the not an wasn't there we as - it we formulations this I took believe of of LAI, do have it a that's some our said that formulate was LAI lot have are

we're that it we formulation formulation administered testing that optimal is However think subcutaneously. an the and do is

think over we a subcutaneous for an So injection. IM expressed Patients an that is a have choice advantage.

formulation another can't asked month your part go I that and remember we other answer we're is Maybe does formulation question, as you it. from The question? the to testing there that If of durations. will first is, - one

Ashwani Verma

Got it.

you. Thank Okay.

Operator

you. Thank

Our next Fye JP go Jessica ahead. with Morgan. question comes from Please

Daniel Roy

This is with consensus regarding for question. Roy you from How questions Daniel while XXXX are comfortable for taking And you Thanks one Jessica for me, that that XXXX, Fye. how does others that profile indications it guidance there understand Two provided we you'll treat are to haven't be currently you're revenue. makes of our properties the two, PK other compare that interested with in any lumateperone. developing, the amenable Besides that dementia and numbers? [ph]?

Sharon Mates

we with we are that comfortable year, $XXX we consensus this numbers numbers. Daniel. say comfortable remain which with and thank So, about were did you. million Earlier those

disruptions that's we Mark second the first and be question. year course improving of over half a anticipate We the strong to COVID year remarkably. as anticipate your of the the when So stated build in particularly

So comfortable numbers. we're comfortable with and we're our

into I the that very molecule it in both in It's exposure. do the XXXX, said patients and Moving absorbed XXXX systemic because results it for we the believe and in high rapidly to we that think has stable especially circulation. formulation particularly it's use systemic that in to elderly some of advantages metabolically

Daniel Roy

Thank you.

Operator

you. Thank

go Canaccord. question next with from Kulkarni Please Sumant will come Our ahead.

Sumant Kulkarni

And so on prior the this is dose pathway used very in regular most how was second you've assume specific fair like of relative the older may molecular that for is entity? be then you was is, specifically one it frame that XXXX, data that And could far? going actually the low a to you'll trial lumateperone looked in XXXbX using that patients. have to dosing one first X it new My forward generated in Phase part

Sharon Mates

a That's Sumant. Hi, lot of questions.

So in X. a study. ascending Phase We dosing single to dose relative did

Where days. well. in study So ascending a in single day a seven ascending doses as for test multiple did it and we was dose a study dosed once then two dose

entity. I think regulatory molecular is far new a as This as pathway. the

regulatory know. the we'll We move forward. as will regulatory we soon that have authorities with And appropriate as discussions you we know let on pathway as

Sumant Kulkarni

it patients that on of Got trial dose the in to a X relative X just then the the was and in or early dosing the prior Phase in trials? lumateperone low used Phase

Sharon Mates

what till strategy it. uncomfortable until always wait on put you I'm we do what I do we're to it saying dosing would going clinicialtrials.gov? rather think that I Please we our soon do be? we'll of and Can going is - to

from and know you these different The into on know. studies Phase forward we it in the let the clinicaltrials.gov very differ be the may on will We're differ or same indication as X indications and indication. may which that depending we'll publish may dose you us. go So conservative we on

Sumant Kulkarni

Will Got it. day. check Thanks. every

Operator

you. Thank

Our next go BTIG. come will Hazlett with from question Please Bert ahead.

Bert Hazlett

I actually. two XXXX, just have another question on

persistence you you the about lumateperone? you that the all, How the us of IP exclusivity? alter expect of expect behavior talked for remind stabilizing does could lumateperone, it secondly, of lumateperone. formulation then long Thanks. it you or First of do the And specifically any metabolized

Sharon Mates

I of Can question missed your you state the again? it? first part

Bert Hazlett

any alters you're then well or you're lumateperone? of Thanks. behavior, Lumateperone And deuterated the long for Luma. IP, has metabolites metabolites the just any I'm a of persistence as the version the wondering of whether of aware. exclusivity number how again, expecting formulation

Sharon Mates

you For for XXXX, lumateperone tell I both. or can

and as all go we and profile no we forward. do We for We patent the XXXX. are metabolite for robust have can and you. describe again XXXX lumateperone both profile metabolites new there metabolites in So qualify

XXXXs. solid think asking if I XXXXs into So is the and very XXXX, mid-to-late into lumateperone is that the you're

Bert Hazlett

the you. Okay, thank that. metabolites. to forward of the for Thank you Look characterization

Operator

you. Thank

[indiscernible] with Goldman from come ahead. Sachs. will Please question next Greg go Our

Unidentified Participant

will I've and I of days look help I'm to about studies to trying know clinical your is curious two I in Study you 'XXX perhaps at you're and XXXX. SG&A. but just then what Phase if us that timeline going of the just if a about R&D we more with terms program fit like my revenue program view quarterly 'XXX. at second respect here to program. thinking start the X 'XXX you think timelines. all please, its initiate MDD financials overall about thanks. a one. how or provide looked wondering was if what the maybe expected and the that sense trial like question and got in spend could get looking early could what were progression know supporting like expected is, on Was And OpEx look to does wondering If adding I [ph] to registrational of on

Sharon Mates

they kinds studies think depressive studies, adjunctive to and are as will clinical adjunctive standard and and at you year we enrollment And said 'XXX two two studies. our should as of this Study So care. what clinicaltrials.gov readout 'XXX for begin as I conducted post years are conduct disorder these They're each looking asked major before expect financials. including US for of globally these the typical we will you That these I studies. we them Then start on of is get studies. and the think is of you

we're projections as financials and one add if easy anything giving that. not to he add, maybe, Larry of the quarterly our guidance the to on can think has I

Larry Hineline

from But see I over that expenses, it's in increasing quarterly them safe I say perspective quarter-to-quarter. see expenses we year's to can't expenses we think R&D XXXX the Yes, and will increase will give guidance. last

no but as go certainly an we see incline guidance So through particular XXXX.

Unidentified Participant

fits to trying of lumateperone? you to 'XXX what context just in Sharon the Study for you're if comment And on to opportunity the could the expand do ask how

Sharon Mates

Right.

lumateperone. looking of not 'XXX came disorder it mixed So for an It of the an MDD. depressive with patients and that. expansion is is is part The I'm features. major in bipolar studies expansion. at back you It opportunity is both in Study to the adjunctive glad

depressive define mixed that please what in I'll and opportunity both are So the audience features again, and think, come I'll talk ask maybe into Suresh, disorder further for you is what go major can about before disorder and the then back we we okay? bipolar

Suresh Durgam

you. thank Yes,

suicide, not features mixed high have have to have Patients diagnosed and higher these be treated, these of patients also patients of are MDD episodes. And with patients. rates a to there's bipolar And of also later potential severity bipolar suicide the of illness. major features rates disorder. rate specified increased is high high disorder within a They for with have depressive mixed condition treat both are with followed We with also and DSM-X MDD ideation, recurrence if and disorder co-morbidities on. also difficult

was in features or having mixed patients They have also [technical mania are of the fully in to having the and This to and both there's both bipolar features. these and is patient coming difficult the the medication features specific episodes difficulty] have and this to And is conditions. in patients study following - done. are studies are populations, conducted patients depression. mixed depression hypomania a time treat mainly to in being this the a depression. Since same some these third and bipolar the right Now which registration of of now study 'XXX with amended as symptoms symptoms as no a once of full include this MDD about we're study is powered to

the on FDA steps We will next speak the regarding this. to

Sharon Mates

unmet is to of need third just on ideation. suicide have and increased and as medical features. about difficult are and said these of co-morbidities patients a patients have rates Suresh more these exhibit patients suicidal a follow-up in So to third in We this of that. large And a more think bipolar MDD treat, about disorder

important these approved patient that So patients. there population to of and within we are domains these think no drugs these are treat each

the is of So until they helping alternatives stumble all until that on are label that keep you cycling and something through off course it's available - hopefully all patient.

this that discuss the results third and we'll is FDA these with we each a and with populations, Study go medical for the will need the 'XXX results we look So of huge that at to and indication. that path patient of think a the forward unmet

this as to lumateperone. So adding we're excited our label very for that about

might I question. there's have time last one a for question. operator, more think If we

Operator

follow-up from question Yes, have a go we do ahead. Evercore. Umer with Raffat Please

Umer Raffat

if a that expect in the non-human secondly, given sort the theoretically indications the everything you're promoting CAPLYTA. about Thank any change metabolites about expansions. just we Is not consideration the humans. those than going did I've more and of MDD for couple, it know everything there how from very then will itself and know a be aniline possibly much. it we and Sharon. in formation models I to formation forward past? [ph] to you for XXXX there thinking deuteration as that studies Would may, blended One, indication mechanistic reason given And

Sharon Mates

all, So can't first of you improve on nothing.

anilines lack So as seeing in something. not you a are those you humans improve beings can't said know, you human as on species that of are and seen so in

aniline humans. lumateperone So did neither formation, have XXXX in does not

a we've other question are with very you present studying. the very we that for we're question. comfortable XXXX. about indications So that not the that to is mentioned We're And XXXX, studies lumateperone in and pleased about with indications excited

decide path with we right forward, go keep of you, But we're down for other pathway we're into stated and XXXX. about we to is indications apprised what moment, we any the the go and told now told launching stated we As you lumateperone going we'll that the for XXXX. that with the pathway you the that

tuned. stay So

Umer Raffat

Thank you.

Sharon Mates

Yes, submitted all in about the UGT's. to we're answered both of And We'd Evercore FDA. [indiscernible] all very still the way, by information studies. question beginning We've I I hope. comfortable. conducted the our the on,

with dovetails questions. of your kind that's So

Sharon Mates

Okay, then.

apprised. It's a to very time. you as just look of you you and your much forward disconnect. we're over operator, your updating the forward questions. can want They Thank very were now we forward Intra-Cellular our go for of all to year on very, look you questions think for everybody busy programs. all and call. and participating thank Thanks with keeping to we we for very I good I

Operator

participation. Ladies concludes you Thank for and conference gentlemen, your this today's call.

You may now disconnect.

Intra-Cellular Therapies (ITCI) 25 Feb 212020 Q4 Earnings call transcript