ITCI - Earnings call transcript Q4 2019 | Intra-Cellular Therapies, Inc.

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Operator

Good morning, ladies and gentlemen, and welcome to the Intra-Cellular Therapies Fourth Quarter and Full Year Ended December 31, 2019 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 would 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

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

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

Dr. Vice Sharon Dr. Joining and Mates, President and Hineline, and today me Executive President Officer; on Mark Officer; Executive the Senior Michael Financial Chief President Commercial Vice Officer; Andrew Medical and are Satlin, Vice and President call Chief Executive Vice Executive Counsel. Officer; General Chief Halstead, Chairman Neumann, and Chief Larry

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

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

I Sharon. will call the turn now over to,

Sharon Mates

schizophrenia for year XXXX for today's morning for successful a we received FDA in December, and approval was welcome very Intra-Cellular Good everyone treatment Therapies. to adults. Juan. CAPLYTA of call. In Thanks the

are excited of the later We month. CAPLYTA about launch very this

is fully Our comprehensive plan launch our track. preparations on and are

highly and and to place, in ready execute. We competitively-sized commercial experienced they have a team are

team and representatives are all our in sales Our the we of sales of board their on final are substantially and stages leadership training.

Our on access activities product related are actively to team with Manufacturing Commercial continues Mark Chief our market and place. shortly. readiness Neumann, be in discussions launch chain will engaged expand our also Officer payers. supply in

reporting Phase our preparations, and heart In Medical X/X continue Chief to to X our from our clinical more provide addition our programs. forward in development detail advance on commercial Lumateperone bipolar trial We Satlin, midyear. Andrew to trial results we will depression failure in look pipeline. Officer, ITI-XXX our

results. review financial Following Officer, our Andy's Financial Chief Hineline, will our comments, Larry

then line will We open for Q&A. the

often the in impacting provides population, and the of treatment profile schizophrenia, United movement with in side changes to disorders. of a treatment seek as adults as discontinued result States. patients, an illness is X% their global Important such needs medical firmly mental As gain, exist, option label, the continue compelling. million physicians translating new unmet X.X and disturbances this reflected weight serious or metabolic CAPLYTA We patients for the into clinical treatment believe of approximately CAPLYTA effects, important

from that profile depressive including Last safety either other broad Schizophrenia We important depressive indication. be results Bipolar in various just believe These Bipolar is Lumateperone's bipolar this Lumateperone a are our this soon. have and broad patients to we for episode with Study depression efficacy demonstrated III from program Phase Lumateperone results patients We in has and schizophrenia, safety robust resolve associated indications, reinforced suffering potential to to very program. II XXX, clinical CAPLYTA start we therapeutic bring pleased reported robust a disorders. the will July, efficacy development that or patients translate and of I our have the trial the with available medicine disorder. to of to

ongoing Phase Phase an adjunctive anticipate on our Bipolar X track is II XXX, episodes, Lumateperone disorder. or with Study in have as evaluating global Patient study, an XXX, Study we commenced study depressive associated mid-year. results I Bipolar and treatment enrollment topline reporting either We of additional X a clinical design Further, in programs and depressive other this on XXX. pipeline and update as Shortly, year. efficacy conduct Study trial provide a initiate global to study of that plan major well. disorder proof on will mirrors an the later monotherapy We assets our these of Andy elaborate Phase X

year a $XXX the financial net of completed which million earlier offering cash investments. we $XXX and resulted ended with our million million. in in strength, proceeds $XXX year, to We public approximately this follow-on Adding

commercial We are programs. development fund our advance well continue capitalized to and to our activities to

our XXXX, In commercial capabilities. growing we in clinical infrastructure development, including made organization, in research our and to investments our appropriately strategic and support

than stronger are our accomplishments. and ever proud We very I'm of

I CAPLYTA. launch to will for team call has of Mark? busy, the very Mark turn now preparing whose the over been

Mark Neumann

morning and good Sharon, everyone. Thanks

team an this months to we the help opportunity update very busy, anticipate conditions, bring preparations to the to option from schizophrenia. to treatment month commercial the to have excited the has been to commercialization. our describe new provide give have and CAPLYTA important of improve I'm on Our this very access market to and are an and launch market execution we later suffering individuals lives you in of opportunity pleased early

the XX,XXX and website in the has XX% after executed and visitors million December, to impressions driven unique has date. CAPLYTA digital robust, of of campaign, Immediately over nearly which approval to late now awareness audience, approved, X delivered over our we CAPLYTA psychiatry a reached print

to will mid-March available late in our full pharmacies will CAPLYTA March. activities promotional be in launch and commence

providers the schizophrenia in national account sales the We healthcare including antipsychotic approximately a force who XX,XXX on have a XX% of plan focus the approximately which, of our specialists of marketing XXX place, prescriptions. multichannel in deployment comprehensive sales for efforts neuroscience will branded

substantially, sales on and our leadership training the sales board are final representatives of are entire their stages. activities all in team, Our and

representatives talent an pleased We have very them XX% in the biopharmaceutical than They of experience. average experience have are of we attracted. sales greater years of with caliber psychiatry have prior XX the and selling the industry almost of of

group with professionals patient activities, including account provide in early and and our access now relationships deep neuroscience on market established market been area. mental achieving fourth and medicines national me our experience, regional This update team quarter since leadership our of access the an Let competencies payers strong in health for place year, in entire executives. has access the organization of has last in the

there similarly way new predictable dynamic a antipsychotics. class market branded is the the enter previously launched and payors the we drug coverage in established well Consequently, has to are and other CAPLYTA, to assigned. been manage expect antipsychotics Antipsychotics formulary

antipsychotics As Under you D D, the Medicare days. Part rapidly Part are Medicare protected as and for payer considered know, products class, is payers, of reviewed complex landscape Medicaid. approved XX such, and within including a includes and several are coverage types newly

another on market the we timing team second determinations for role. meeting based these payers we dynamics the precedence, expect been Medicaid from Our And quarter. be determinations for has with similar CAPLYTA represent established important and in access through to coverage Commercial recent now payers would channel. expect coverage

discussions in progress this payors, over in to channel. the determinations all are time. with coverage major starting This see and in will are We uptake

to fully across XX access expected payer timelines a we nine at to within pathway market to there formal launch. their months, note expect access we formulary decisions. for other these how status managed with for reviews, payors in all will CAPLYTA established expect all review antipsychotics that channels be while be are CAPLYTA, and consistent is important accordance conducting were Overall, to with It

Additionally, a savings we are appropriate assistance. CAPLYTA, very In authorization summary, comprehensive this to patients. new support access patient and prior medicines to co-pay have support to excited designed bring including to important facilitate program we

strong team CAPLYTA providing a forward this have we we plan plan. updates launch look highly future experienced to We against and commercial execute a as and

Thank to programs. you. our over And clinical would discuss to call Andy? hand I development Andy like to now the

Andrew Satlin

everyone. Mark, and morning Thanks good

opportunity efficacy in for from clinical help excited adults, With The safety the this CAPLYTA to observed schizophrenia approval the and label illness. lifelong suffering our of patients serious of reflects studies. CAPLYTA we are about mental treatment in profile clearly the the

for CAPLYTA XX-milligrams The somnolence/sedation and most studies, placebo. weight mouth. data fasting gain, adverse dry In from triglycerides were similar baseline CAPLYTA cholesterol extrapyramidal pooled incidence X.X% the placebo-controlled glucose, trials, and reactions in short-term symptoms of total common and and demonstrated efficacy The placebo. were two X.X% in CAPLYTA mean was was for changes from between of

and active Our and participation Congress discussions the and medical very scientific with opinion leaders medical community, team pharmacy with key exchange has directors. and energized been affairs including individual medical by

presence strong the its Psychiatric profile, have CAPLYTA at year, at year, Last Meeting. this and tolerability we conferences Annual presented safety and upcoming several highlighting will a we on conferences medical American Association data including medical

of We study, pivotal in The for safety Christoph with describing Correll. JAMA our Study a publication and lumateperone one lead Psychiatry, schizophrenia, randomized titled, XXX. treatment are clinical of article efficacy pleased the of with trial author is Dr. results the of

we for and to including bipolar other the lumateperone indication, our depression major indications, schizophrenia, In disorder. of initial addition advance to continue depressive including other development disorders depressive

global depressed in Based on excited important efficacy and positive Lumateperone about indication the the our strong for and of for this are XXX, to all help both Study these II safety across and profile and this individual suffering in from we we bipolar July, study Phase monotherapy very disorder. possibility Lumateperone Last observed I study Bipolar our Lumateperone Bipolar favorable reported programs, the depression. in opportunity in results X

endpoint effect on mean score Lumateperone points p-value between milligrams statistically total baseline met MADRS groups, with placebo the Study for less Lumateperone difference improvement for In the XX was significant six. XX.X than primary XXX, size milligrams of points X.XXXX. at greater a two the improvement over point a of XX.X from week significant for X.XX XX statistically The a placebo X.X robust versus and

Global population ex-US bipolar, score, encouraged very of the remission both responder the illness endpoint by the for II Bipolar benefits the the both improvement of results, are and total primary placebo a significant separation and the versus severity, by subgroups, and reflected significant in seen scale I results US patients, for on statistically well internal as in secondary in on as consistency the as endpoint, statistically Bipolar key Clinical strong We the Impression analyses.

are medical received very The were positive for that or including be results this only by Meeting in condition, presented from an the pleased has be addition to can area the and Annual depression Bipolar I a reception continues patients Lumateperone need. ACNP, we treatments, one December medical from Bipolar II of this approved community. Bipolar which the for disorder. the at trial a few of with valuable believe unmet We only

Study XXX, anticipate X our Enrollment, Study study and we Building Phase adjunctive mid-year. you designs: global XXX is momentum, initiated study, study. a on on results in program ongoing the track line we through monotherapy also the take I'll top

Study in or XXX as six on for daily XX or being study is XXX Bipolar Valproate Lumateperone randomized therapy II placebo, will episodes evaluate patients Lithium XX stabilizers. approximately while milligrams for Lumateperone or and receive patients with as adjunctive This one-to-one-to-one conducted globally, include I being depressive treatment of once weeks, to the milligrams, disorder. maintained mood Bipolar

disorder. for Study patients monotherapy being in six I Lumateperone placebo with XXX and or also It is globally evaluates milligrams lumateperone conducted once as XXX XX one-to-one daily to II include approximately patients randomized receive Bipolar weeks. and will Bipolar

regarding a treatment bipolar supplemental for late submit XXX our is endpoint Study new total and regulatory to program, versus score the FDA, six expect the both placebo. interactions trials, change FDA Subject with approval bipolar application pre-specified depression XXXX, Lumateperone the MADRS for drug at of depression. primary on for in the from to our to results the for baseline week of we The

development drug anti-psychotics of efficacy disorders. profile major including Lumateperone's limited support to use across psychiatric and the trade-offs. We strongly existing and safety existing the indications in profile, safety illnesses, major The psychiatric believe bipolar due depression and tolerability mood is pharmacological other and of

in this continue our to advance a Phase study year. program We clinical depressive disorder initiating major ongoing X and anticipate

in XXXX. a plan initiate of Phase of formulation X lumateperone clinical have development long-acting preclinical study a and We completed injectable to

our We a from where replicate This ascending for completion. Phase of XX this seen is in trial cohorts, concerns failure ITI-XXX failure. the of is first anticipate advance PDEX reporting our nearing in heart Clinical third milligrams to and X/X continue Program, study the results heart aims positive clinical successful milligram final dose of model We preclinical effects inotropic conduct milligram cohort completion dose single to following were the XX ongoing, XXXX. XX of safety identified. in the half no and study ITI-XXX, topline

opioid for single to modulator healthy year. serotonin treatment program subjects in and of our initiate of substance clinical ITI-XXX, this A use mu pain is and Finally, mood our disorders, disorder. we ascending dose novel, expect and opioid oral receptors to initiate later study for the other planned

to the I will Larry, turn will now Larry? review call who over the financial results.

Lawrence Hineline

$XX.X Andy. XXXX were our the for XXXX. ending I $XXX.X is Thanks, Lumateperone is be ended a XXXX. the primarily reviewing compared for results Research by ITI-XXX year extent, due trial CAPLYTA, year costs. labor and million The to clinical financial expenses million and development lesser non decrease costs lower and December for projects $XX.X will offset related XX, cost to and higher to for manufacturing million partially

and and XX, to resulting company at completed million follow-on from $XXX.X December related million expenses $XXX equivalents securities, of of increases million year million $XXX $XX.X common January ended shares facilities pre-commercialization of XX, approximately and XX labor the General million XX, compared the investment expense, net Cash, primarily we XXXX. proceeds for sale our million public $XXX stock. to in compared The offering stock of due increase were December totaled cash administrative million for cost. $XX.X XXXX costs, at XXXX, million compensation On to a cost, $XX.X XXXX, to is XXXX. in the

This for prepared the remarks. concludes please line could Operator, you our open questions?

Operator

Thank you. with Charles Fitzgerald. Cantor first question comes [Operator Our from Instructions] Duncan

line is open. Your now

Charles Duncan

taking the and in congratulations questions then our Thanks had morning, for of last great question for Good year. regarding on follow-up team. commercialization Quick a Sharon I year, terms CAPLYTA, pipeline. one and

profile you about kind gotten feedback and terms on access need thinking prescribers value, outreach from from schizophrenia, what and of as and differentiated pharmacoeconomic especially given -- of have the clinical unmet CAPLYTA market of of in payers and the value terms In proposition CAPLYTA? in pricing the

Sharon Mates

question. the for it? Thanks would take you Charles. like Hi, Mark, to

Mark Neumann

Yes, sure. Good morning Charles.

there described out research the we've had So, prior directors been quite of meeting by, couple the a we've as with our payers: conducted that medical are and well to with payers, that account the bit as pharmacy across have heard directors across we've encouraged with we very of and a themes channels payers, different now different that as before, been executives approval market both

value the -- is be tolerability is a they those in Number antipsychotic are they unmet importantly, with medical antipsychotic overview that they and very is provided very a we're pharmacy need continues and an that's all a and and treatment recognize significant a profile effective when and we and marketplace of that seeing a a have the the a safety medical schizophrenia effective as favorable begin that safety profile. needed exactly with and one there with of discussions that the clinical to profile, profile has an profile directors. tolerability favorable see secondly, of differentiated that you what proposition having by has product of know, for And pharmacoeconomics the when what the is CAPLYTA, with

Charles Duncan

That's if helpful. on And one just could one. that more I add

but first need CAPLYTA to. does today's these chain, in terms supply supply? years for couple [indiscernible] never world, of your questions guess or supply in chain, How I the generally, look of asked terms In of we've we

Sharon Mates

add I'll he Mark ask start and wants I'll then if anything. to

rolling is are and in chain roll out I don't and we very on States that chain out forward, supply and the any robust, can CAPLYTA. think keep we supply we Our have ready supply that issues have going our robust a to United very for

Mark Neumann

term, mid launch late would ready related all the go activities late March And of In -- on and retailers our et cetera just to Yes. much add in track very in to timeframe. wholesalers, the with chain I the Charles. are and the near supply we're

Charles Duncan

bipolar there, out finally on this design quick Study is number you XXX relative anything then, depression. that terms XXX in new more placebo could then question do to for with clinical you guess, new, limit implementing XXX anticipate you that drove relative of if be to and One study? sites overlap And study to I significant XXX of than the additional the wondering design really the study? kind And good. for that initiate very some of provide in to the I'm insights Andy, XXX Okay, you'll effects. features

Andrew Satlin

Yes. Thanks, Charles.

of Study in a So, design in study, the -- the globally, is Study single-dose successful is placebo, versus XXX, trial to XXX, Lumateperone similar new which monotherapy same was with which done indication. monotherapy our very

placebo sites, criteria response. We study, very for those actively replicated. we're globally using XXX, are this using XXX, are and data some in we're we're those countries, in this be of hopeful the done doing line some we're training who've investigators the other that the same past the we're we've in about been the the with the so will of all same what doing the states, same preparation for where generally and successful for Again, that as in is

completion. the new it's we'll the we're do of nearing that said. regard have by XXX, expect think on year, that and results I report anything for With We to we've results trial. to let's proceeding wait very well, to the say of have that, don't We middle as

Charles Duncan

info. Okay, very the good. Thanks for added

Operator

Thank you.

question comes Leerink. next with Goodman Our SVB from Marc

is line now Your open.

Marc Goodman

Yes.

if the fourth spending all, guidance year expect, should So, of we no you us what of already, second about, supply all and of progresses the that of were talking can there right? give States the chain product what give that's you on confirm Thanks. reflected sense issues in And Just maybe saying type that you kind spending? us for for a just the the United that. then were quarter you confirm year, to this as to could why were all and is what

Sharon Mates

part to the and the chain I'll then the So, I'll take supply on guidance. address first Larry ask

right. heard you yes, So

the in here United supply robust very very, States. a have We

anything foreseeable Larry, So, coming to future. in you do want on then? the we requiring are ex-US, not dependent

Lawrence Hineline

first place throughout modestly staff quarter XXXX, commercial will million we you $XX and expenses our will stabilize research about $XX.X research we forward the expenses increase fourth and the had and in if million, put first results administrative development the of rather, quarter of in going there in that look stabilize the and forward at Marc, as expenses general in of expect the they'll the then and the expenses quarter SG&A increase and and our we rest development Yes. then quarters.

Marc Goodman

were mean the quarter, SG&A up, reps in I step fourth right. sales the the So, obviously, not

that have we regular and spending? step So, up for just a then

Lawrence Hineline

markedly increasing quarter, line. Yes, have and in SG&A the the first expenses in we'll

Marc Goodman

Right.

And so, are in and range, in first line third saying, you're SG&A first quarter the is in big second, the fourth and then quarter?

Lawrence Hineline

Yes.

Marc Goodman

it. Okay, got Thank you.

Operator

Thank you.

comes Raffat Evercore. next question Our with from Umer

now is line Your open.

Umer Raffat

Hi, thanks Sharon, so later saw release exchange you've bipolar. through press you mentioned, in you My will already, us their results? possibly much to what with for I hand on FDA question. in before you feedback my the taking the file, to year can existing want you had question is, the what walk Do Just what in the FDA shared have they file? with readout you has adjunct feedback wanted understand was? guys bipolar

Sharon Mates

Umer. thanks, and Hi Right.

told So, we be on we meeting not and goal that with FDA with have met we shots will three we here. you have yet, have them that the

successful the study. We very XXX have

We have the ongoing commenced we recently XXX XXX study, the and have study.

if would with So, different XXX we scenario is the we've FDA anticipate filing if of all we the then, of study scenario XXX be a here for by the what that's filing. plus of study, our be year-end. successful or will that A study, successful, required What B will discussing the permutations said

So...

Umer Raffat

Got it.

Sharon Mates

that's So, have we right now. the it as data

Umer Raffat

you. Thank

Operator

you. Thank

with from comes Morgan. Jessica question JP Fye next Our

Your line open. now is

Jessica Fye

the XXX results trial morning. for to next Thanks the start for hoping, the readout? the decision about was question. could taking Good -- genesis talk I my before you

Sharon Mates

start to have I'll Jessica. if ask Thanks, that and hi, Andy, I'll and you anything So, add.

more wanted shots we XXX, goal. to on simply it's start have So, to

unusual and will and this think ongoing as XXX, disorders We have have study, depressive it's the not adjunctive to studies depressive on to an positive, a you, We study, on depressive to mid-year. information very the any be think or that about -- read robust shots molecule in from all Andy in that out prudent that we the benefit -- to to with many it's disorders, no unusual we prudent mentioned as is that also have not patients do not are several in bipolar in that disorder it based have thought XXX going data psychiatric disorders the hence, we disease. that will goal, studies

many we shots it So, as can. prudent on to goal we thought have as

want any? you to did Andy, add

Andrew Satlin

you the Yes, based the the believe, made no, that in mean, lumateperone depression. we XXX important is not really. which that point, results I I of on bipolar does think work

to opportunity forward So, we're well. drug quick that this indication to with to as order moving get need have the approved everything do submit in we FDA we think to and as data in

indication. So, we I just and that part a companies in this think prudent is many is said, think as follow this would strategy Sharon of -- that is

Jessica Fye

potential Okay, of or great. about as bipolar I few II, And there reasons just what thus for why of been the far? are you've following up think factors point to some have that, approvals differentiation, talked a two Bipolar

Andrew Satlin

think I within do our a the that study safe which we such it's population we a make made spectrum the indication. to a So, as patients available to and depression II, choice going to drug, decision Bipolar whether cover is full drug to of broad Bipolar as to possible with wanted bipolar that you're I because

approved Bipolar our not an other II in Seroquel out for drug point, which As profile there medical for, drug and because, up Bipolar only say it's is and any greater matches with you there it's think well one we I a need very approved safety as added is other there.

may made other comment We So other reasons I this it's on as who to to really with broad companies could possible. important of have patients the -- available benefit range think but drug disorders, make other why as choices. can't

Jessica Fye

help think a just and for should a path formulation Okay, that great. Lumateperone, about we could think talked us at one, maybe that level, development how injectable And high product? a just last you for about long-acting timelines you

Andrew Satlin

in assess initial in and the followed standard with how in efficacy starting fairly the establishing, and that to schizophrenia terms and metabolized it's our population. we're of studies shortly, a its study body, So, with the up drug safety development distributed is

the not forward. will move anything that unusual way this in we're anticipating So,

Sharon Mates

this study we can And, idea, on better that do once you that. study, we PK further with a so we'll give the progress we guidance that can have with first how quickly

Jessica Fye

Thank you. it. Got

Operator

Thank you.

Our comes RBC Abrahams from next question Brian Markets. Capital with

line now open. is Your

Unidentified Analyst

this question. disease some from on effect my Hi, the Brian. for importance KOLs such current on the anecdotal socialization. and aspects beginning We've other are is to [ph] taking the that not fully to Thanks potential of reports captured Leo heard a about return for as of by job improved dataset,

about could any outcomes So, expansion payers? what these or value are of to uptake, that the to plans some influence that proposition for CAPLYTA you're label longer-term formally thinking for and have potential do you these for enhance evaluate

Sharon Mates

that's do. Yes, very you elaborate Andy, we to And sound but just I'll have further, Brian, little ask I funny. exactly to like say, a really

so, to? want didn't to you off Andy, mean here. I us get track And If

Andrew Satlin

actually, we this find of Thanks most for asking Yes. one areas this that drug. because exciting is No. with the

a negative about in things including as depression or of are you results are studies term area. in and within we Lumateperone we've definitely the thinking in the those indications know, longer of As and we've benefit including symptoms schizophrenia, for studies other said, schizophrenia study, more require for additional there our pursuing while and additional signals reported one quite with now and those areas, are that as do

of with we associated symptoms, symptoms drug this have schizophrenia do other think help schizophrenia patients we to within who as yes, activity negative with broad to And that symptoms, a additional possibly clinicians data So schizophrenia of best to syndrome. use the want well. depressive them either provide to make has the spectrum

provide So, later. about additional be we to will that able information

Unidentified Analyst

Thank you.

Operator

Thank you.

from question next Kulkarni Sumant with Our Canaccord. comes

Your line open. is now

Sumant Kulkarni

for taking my Good morning. questions. Thanks

recognize pull-through CAPLYTA? First, happy do I'm recognition be asking you this to or in on to for expect question, ship revenue

Lawrence Hineline

and Yes, through. to shipment with going revenue were we're recognize adjustments pull estimated on

Sumant Kulkarni

couple a on then, of the And questions pipeline.

on preclinical completed long-acting So, development. formulation, you've the

there of assume the to led Given that CAPLYTA, was is pre-clinical prior fair approval formulation that on it oral to some responses? differences data, preclinical focus to

Sharon Mates

Can I'm try that the not sure again? question. you I -- it say understand

Sumant Kulkarni

sure. Yes,

intense So the oral before generated there. example datasets when was preclinical the approval the CAPLYTA predictable some been, in of in setting, a terms formulation the assume, that data were CAPLYTA, oral I for there the by there species the responses long-acting I on the to was translates that of preclinical meant, however question. That in focus --

Sharon Mates

predictable correct. haven't of The these that any and that seen, metabolites responses we is

for them don't and We have looked we them. see

Sumant Kulkarni

Got it. And then...

Sharon Mates

So, that...

Sumant Kulkarni

does. Yes, to when we X MDD, Thanks. Phase should On data? it the expect see

Sharon Mates

this are year. X data, Phase studies the we anticipating starting

Sumant Kulkarni

Thank you. it. Got

Operator

you. Thank

Our Bert with next BTIG. comes question Hazlett from

open. now is line Your

Bert Hazlett

Thanks. Yes.

ones two one. broader Just and then maybe a quick picture

the maybe terms said the XXX? the ones, quick of it, In you readout but timing of of

Sharon Mates

Hi, Bert.

So, that next to be finished study mid we expect year.

Bert Hazlett

chain Okay, secondly, thank back you. the to second. for that a Then supply

said incremental coming US have States, or United in the clearly if you so this internationally, supply a lot where of from You that domiciled the production and it is it domicile, point, is from? is

Sharon Mates

secondary comes -- and we've if have tertiary supplier, We have of from we necessary. our do this said, our API API talking one is a we as we're a So, all disclosed and about, that Switzerland. have disclosed

several ongoing and spot, chain in a I -- been good are years, think So as has goes. this far we for our as so supply really

Bert Hazlett

further regard event And profile to the to you. with the it then, to bit thank of Terrific, adverse differentiated brings table. CAPLYTA, clearly it's out little looking terms with regard in that a

can bit little landscape As view, competitive your evolving could give Thanks. others, receptor muscarinic competitive share schizophrenia, think, about the schizophrenia? in and some Mark think about or you just in And the regard you longer-term a how landscape see novel us you there as to unfolding mechanisms you are system. with the

Sharon Mates

in. start ask chime So, to Mark I'll I'll and

a really you huge need of for schizophrenia in all, and is unmet there is first know, I there think I several room think as players.

are of I anything that or and patients. think again brings that some of options more in for we the are early favor better moving along, programs options

either don't are themselves drugs this older as hopefully you effective, we which I of can an have that add side drugs landscape but to better think we've some think that or, replace with want seen, as that to I effects see Do So, anything? see the coming anything do evolving we market associated and an them.

Mark Neumann

has very emphasize the help confident come that out clinical of that schizophrenia. needs CAPLYTA development said is I just in would program address some we the that, that needed about, type reiterate just unmet of feel that with the profile spoke what before, profile to consistent I the Sharon and significant of of

very feel we the good well. profile the of So, forward about future CAPLYTA as going into

Bert Hazlett

Thanks. launch. the Look forward to

Sharon Mates

you. Thank

Operator

you. Thank

Our with Jason Butler next Securities. question comes JMP from

line open. now Your is

Jason Butler

Hi, question. thanks the for taking

on that a action. increase guess, focus you you're rapid bipolar in MDD, looking rapid pulling or week formulations you at there. depression, within potentially experience commented on to onset saw just of one -- from the new onset Just I

preclinical you that and focus just can data the new is on about have So, you that maybe Thanks. driving talk any goals the your formulations? here

Sharon Mates

Sure. Hi, Jason. data about Do to our want talk preclinical and... you

Andrew Satlin

preclinical Yes, really respects data similar system, was with that on basis of has ketamine to the effect that terms on I for the very this the initial is pharmacology rapid-acting again suggesting its in symptoms. drug in some moving of have in a direction, might that, effect that in seen downstream lumateperone proteins interesting the mTOR phosphorylation think in depressive

opportunity. So, trial in with the will take be be that clinical that we we're proof things advantage one this in at we'll it looking XX might the to of that see mind, that of that we've formulations And, whether year. different to been start able of at looking

Sharon Mates

we were depression, bipolar we tested. effective one in that right, you're week see was that we time which the And first at did

Jason Butler

Okay, great. question. Thanks taking the for

Operator

Thank you.

with Our Tsai next Jefferies. question comes Andrew from

Your line is now open.

Andrew Tsai

and morning. Thanks, good

is of And, few the there kind QX expect QX [ph] in think some there weeks of bolas launch upcoming the sense also, about we launch, and first in kind I a build some follow-up. should could -- have a inventory As or launch. be investors of that

Sharon Mates

take you Mark, to that? want

Mark Neumann

Yes. Andrew, it's Hi Mark.

commencing will month. will my by this the promotional and late in deployment our available as including sales month, be full product pharmacies the So, we force, mentioned activities prepared in of I the to the had be mid remarks,

you with there think I over So, that be inventory really and taken antipsychotics month and can the some then build in marketplace. in time expect the how will in March begin the been consistent up to prescriptions have quarter flow will second build of

Andrew Tsai

follow-up. a Great. And then, as

a sales So, rep doctor prescribing or sales curious, XX,XXX those with CAPLYTA? you of need do prescriber your just reps how before a many I'm interactions all reps, can your Thanks. would think make quickly curious, to starts calls high how just touch docs? XXX

Mark Neumann

is and practices. question sure, Andrew. good physician has different, a Yes, each adoption different I each think It's physician

the generate a providers that, We in have on XX,XXX kind we branded force for schizophrenia. prescriptions of the approximately getting right and that way XX% the sized as ensure we're of the anti-psychotic reach mentioned frequency healthcare to sales

they with the CAPLYTA per day. sort are will doing they to of calls background been the of on remarks, mentioned launch So, and will couple We've, excited in my I call fully month, they're will weeks, all very of these to been would be out over the those be meet ready there it with guess and many able standard providers. -- their by about opportunity -- I call industry of be representatives, they've to XX,XXX trained as past and training of they prepared the end healthcare you

Andrew Tsai

Thank you.

Operator

Thank you.

Our next with Thalmann. Kaplan question comes Ladenburg from Matt

now is line Your open.

Unidentified Analyst

is Raymond Matt. taking for this my thanks questions. [ph] in Hi, the and on for Congrats progress

Maybe... pipeline. the on quickly regarding Just

Sharon Mates

speak maybe you can't hear little a you. Can louder? we sorry, I'm

Unidentified Analyst

Oh, sorry. now? me Can hear you

Sharon Mates

Yes.

Unidentified Analyst

in the for Raymond is This congrats Matt. Thanks, progress. on Yes.

Just perhaps? monotherapy I focusing a or novel MDD ahead see was instead maybe Lumateperone or as a monotherapy, on regarding potentially with a or do the as indication, formulation, you moving of the combination the wondering on pipeline, therapy

Sharon Mates

we'll in cetera. formulations to think update our the and I Yes, of the studies future, design as near you et the

but term want Andy, that. do So, I near to add we'll to little be a it's hopefully did think able anything? bit you premature,

Andrew Satlin

we're Okay. that Yes. No, a just number considering options. of

Sharon Mates

Right.

Unidentified Analyst

MDD maybe thinking perhaps currently bipolar guess, also Lumateperone, do beyond any consider I Yes, Okay. or? other you for indication

Sharon Mates

right, heard If hear very to Yes. you it's I you. hard

you're And we are yes, is several looking think Lumateperone? at we indications are of disorders. asking, the depressive other the at I for looking answer

Unidentified Analyst

as ITI-XXX, Okay, the to asset for partner clarification. in the or And non-CNS you Just, final intend CNS the the question in one just indications do cool, thanks. indications well? then for

Sharon Mates

So, not pursuing our doing present class is, all we on be indications, we of a do to do of look own. phosphodiesterase the inhibitor, thinking of would we number those phase are on one we and of anticipate indications that certain partner that indications those would our we because for have

Unidentified Analyst

now. Okay, Thanks. all have cool, I color. thanks the for for That's

Sorry about that.

Sharon Mates

Okay. Operator?

Operator

for any now I like remarks. Dr. Sharon I'm time, Mates over call questions this not at further to back the any showing to further would turn

Sharon Mates

patients, today's work for all at all excited who bringing in everyone the CAPLYTA clinical participation of we're a our on the and very for want I and Just, call, have for new like about and thank to option patients we've to market date. done, providing whole all to Intra-Cellular our participated to team for and the I'd thank studies

with operator, you that And can disconnect call. the Thanks.

Operator

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

disconnect. now may You

Intra-Cellular Therapies (ITCI) 2 Mar 202019 Q4 Earnings call transcript