ITCI - Earnings call transcript Q3 2019 | Intra-Cellular Therapies, Inc.

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Operator

Good morning, ladies and gentlemen, and welcome to the Intra-Cellular Therapies Third Quarter ended September 30, 2019, Financial Results Conference Call. [Operator Instructions].

As a reminder, today's conference call is being recorded. I'd now like to turn the conference call over to your host, Dr. Juan Sanchez, Vice President, Corporate Communications and Investor Relations. sir. ahead, go Please

Juan Sanchez

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

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

Dr. Officer; Vice Joining Development Kimberly the call Vice Counsel. Chairman Financial Vice and Officer; Executive Hineline, President Chief Satlin, Vanover, me today Executive Mates, Executive on Dr. Early-Stage Officer; and Executive President Senior Vice General Chief and Senior of President Mark Chief and Officer; Clinical Commercial Halstead, Medical and Larry and Michael Chief and Translational Medicine; President are Dr. President Neumann, Vice Andrew Sharon

anticipated conduct be and the regulatory and during future forward-looking nonclinical clinical development among other and reminder, today's certain or report statements include and will safety company's plans and plans, regarding our of efficacy, additional research our plans we call, NDA intended lumateperone, the the our statements regarding resources. of lumateperone for uses ongoing making commercialization possible of of may plans existing a ongoing FDA utilization trials, process product filings, things, regarding, to These present statements. clinical our review development, As candidates, and future and investment with results the data, cash the

in contained filings to forward-looking our that and materially the information, and periodic These actual that in those number cause and change annual current These subject reports. on are other risks involve Exchange risks statements. assumptions expectations with of might forward-looking are the differ including described and quarterly uncertainties statements based our results from made Securities a Commission, and are and to

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

Sharon Mates

morning, Good everyone. Thanks, Juan.

potential These this the for treatment of a approval and date of times exciting months schizophrenia with very now action are of PDUFA year. of the are lumateperone company. XX We X within our transformative for December of

today's lumateperone commercialization. updating you the our our will on on preparations programs on company, such, progress across and particular with call, emphasis towards As made be we

Mark Officer, our our programs. Andy provide Chief will Neumann, Commercial development our activities; clinical an Chief and on Officer, of commercial elaborate Medical our Satlin, overview will

Q&A. our Officer, our review Hineline, open financial Larry will Lastly, we will for results, Chief Financial up the and line

our schizophrenia with program to and approved, with clinical of health care Our including provides drug, represent and, support evidence NDA safety if treatment providers the patients. individuals may safety of and new treatment X adequate the the and schizophrenia option is supported the long-term trials individuals important X,XXX their in an for We well-controlled efficacy and for exposure. believe by exposed database over that lumateperone

continue make We XXXX. substantial of the of to the progress quarter launch to support first lumateperone in

have market building organization, and been expanding teams. and sales, access the our We our including infrastructure marketing commercial commercial

his remarks. are commercial track during Mark In in supply manufacturing chain and are addition, on will operations to place, support supply. we elaborate and

episodes of mania more Bipolar depression, and and Bipolar than episodes. in programs, patients This Americans. depression. tend the patients to hypomanic or in serious progress bipolar is X Bipolar Bipolar have II clinical affecting characterized Bipolar continued of by We other million I longer psychiatric I make last prevalent lumateperone in highly is significant condition Both hypomania recur patients. our often adult to II a or disorder approximately manic which disease including episodes experienced

bipolar of about episodes. While bipolar for patients, Bipolar options disorder. treatment indicated there only I patients that a treatment the mania, only the of the options are depressive population drugs patient with Recently treatment represents are there depression for for several few for are approved half of of

to the We its to profile suffering advance II disorder. favorable the for are and or safety to potential Bipolar Bipolar enthusiastic treatment tolerability patients potential patients and bipolar of about due depression treat the lumateperone from with I

X the a study. presented X II robust studies: In this depressive demonstrates our as monotherapy of Scale, monotherapy patients and primary consists bipolar quarter, study Our the of and or Study remission in line new in important treatment from or we disorder. II suffering adjunctive depressive treatment patients Bipolar rate Impression total global trial such improvements supported third X and Bipolar are from evaluating Depression studies measurements over endpoint measured treatment and disorder. the program by positive Results the Clinical lumateperone from in the Bipolar results with clinical episodes for potential episodes lumateperone in MADRS, robust depression Rating or response observed, I as as option CGI. for as of of I the by 'XXX, Montgomery-Åsberg Scale, top The placebo the results score, major Global results

profile accompanied safety are lumateperone studies. results of previous the confirmation of in the by These seen

will Study global in announce late mid of our be pleased bipolar next results both I is Bipolar adjunctive on and at progressing conference reporting anticipate top line that 'XXX, I'm to data for we We study, this program also depression year. well, year. and presenting II scientific treatment patients this the

places a investment in our activities program programs. of and to the ITI-XXX our development the fund continue our development the details advance treatment schizophrenia, and PDEX to lumateperone, to us made and commercial advance securities, cash, Andy programs. schizophrenia with in depression position programs. quarter ended programs, program including provide our and indications, progress continue in and of will We the equivalents our for our $XXX.X we million depressive lumateperone strong pipeline, our other platform on long-acting preclinical Beyond disorders including in injectable bipolar our which these cash and

Mark. I'll now turn to the over call

Mark Neumann

good and everyone. Sharon, morning, Thanks,

As Sharon months of potential are we X within mentioned, the approval lumateperone. of now

PDUFA commercial on making this track areas XX, December execution planning Pending of we pleased we this an our of update the to commercial launch, remain our date launch in FDA So we've preparations. for in substantial of on in have are all to time quarter first progress approval XXXX, I'm opportunity you line. a meet give lumateperone to by and the been

an me out the our customer-facing with progress access on market the Let teams. field-based in force including sales teams, begin update building and

to sized highly prescribers the We XX,XXX who of we top XX,XXX treat force effort. antipsychotics, are the sales market have competitive and high the we've potential, identified schizophrenia, have of to confident representing that majority promotional a the

previous the advanced, all sales of board, well Our that we hiring Of psychiatry QX are area for in on sales team both have directors ongoing this is This the level for far, with XX% our time we as onboard have hired are approval and of the our recruiting we hiring plan regional of point, the is the actively business joining recruiting process to of the is and talent well than and At pleased been leadership quality we the in sales attracting. launch, as lumateperone. company greater experience. leaders pending sales in interviewing who managers. interest thus and representatives, have

of And addition nearly in to operational sales support our activities, complete. infrastructure the our is force hiring in

have organization national and the market now the team our account access including also regional executives. in and place, We entire leadership

strong payer all team, experience, in patient of our sales appropriate specific competencies biopharmaceutical and with neuroscience relationships with leadership these access ensuring join existing As medicine. deep us individuals to

FDA claims who in antipsychotic volume communications. regarding with the processing for of payers, vast top-tier the prioritized represent engagement initial accordance have and preapproval guidance We majority

quarter. executives continue account and Therapies Our directors as throughout activities engaging discussions. Intra-Cellular fourth and schizophrenia are well in planning medical to the business-to-business will as pharmacy awareness introducing important disease These

excellent highlight strong in American of our a make had disease launch product in supply to of meeting to And in in all and finally, an manufacturing and remain campaign medical remains the our may tracking digital continue conjunction This Association We that that above treatment the needs the where progress metrics with in launched are chain, in area launch at community the significant the timeframe. you and to campaign the is the recall for unmet and expectations. or first ensure quarter May position schizophrenia. supply print ongoing, support we available Psychiatric to we successfully awareness are of to QX that medical

of points, Our touch by audience. has received been medical szjourney.com, over also has delivered print well and has the XX% digital community. website, the reached our XXX,XXX psychiatry print and effort Combined

unbranded focus on updates. up to plan then to continue to lumateperone. branded time hand to campaign Andy? our the this development We of we program you. promotion clinical begin will to And the over of Andy Thank now potential discuss when like approval, to call would I

Andrew Satlin

Mark. Thanks,

clinical pipeline. We programs in drugs advance other our our continue for new investigational and to lumateperone

Congress, in stakeholders by we and received lumateperone very data presented has psychiatry. conferences, XXnd the have profile results, during Psych program. positive been team Neuropsychopharmacology we've Our the Recently, meetings at on the programs meeting established and and we tolerability interactions at made the schizophrenia pleased presentations College with reception and highlighting lumateperone's had of lumateperone European important its including at has medical the in clinical these annual our favorable safety Annual

global in X. for statistically each placebo of a MADRS We lumateperone on versus X.XX primary with significant points are points X.X-point lumateperone X.XXXX. at study week less in groups, for the analyses score. p-value the improvements study, placebo XX 'XXX, statistically a on The was significant the diagnosis, over X statistically total XX three seen baseline improvement XX.X the improvement patients subgroup results effect than of greater our In in met II both Bipolar from demonstrating Phase very Bipolar difference observed depression. Study and about I patients, size placebo for this Benefit MADRS monotherapy XX.X mean between for excited a robust endpoint, and significant with versus bipolar milligrams robust milligrams with

placebo Clinical countries, Impression Bipolar Lumateperone Scale effect Global the U.S. was that This both significant significant Score a Total the of the met including improvement subgroup, ex-U.S. specifically for statistically Scale of Clinical an subgroup. There and an trial population of was X.XX representing and on endpoint Illness population conducted approximately in for statistically Europe. size assesses States of the key X the of effect on XX% with United X.X. primary on enrolled Impression the depression separation component the and patients, versus in in size also Severity Global secondary with endpoint

In uniquely not very A in a conducted response in We effects Bipolar Large clinical Study patients psychiatric in success II are disorders, the in potential treatment U.S., trials positions lumateperone these more the was separate and entirely observed our as by placebo. and other depression in I placebo common from disorder. Bipolar trials increasingly 'XXX advance robust which, opinion, in United suffering study, both high placebo in trial. separate making from in a challenging. lumateperone States, encouraged are did especially the these of the results,

of rates lumateperone and seen The as than symptoms safety a trials, less akathisia, both in similar and tolerated, in demonstrated extrapyramidal favorable restlessness previous were and well studies. profile X% In to in studies combined placebo generally both was schizophrenia.

anticipate Study patients program bipolar therapy Study and from results line of continues in for study to weeks. our This conducted approximately as Bipolar is or Our depression is episodes XXX 'XXX randomized study X disorder. will mentioned, advance, or with X:X:X evaluating and reporting once adjunctive depressive to milligrams, II treatment Sharon include milligrams we lumateperone Bipolar being lumateperone XX patients, the for 'XXX top mid-XXXX. in as XX I placebo globally daily receive

is bipolar X depression placebo. other versus the changed on primary prespecified trial score endpoint the our in week total from at studies, baseline MADRS for As the

rapid and on lumateperone for from In strengthen, improvements potential Our of with schizophrenia depressive depression development rationale different depressive program the results to of and patients seen has unique and includes for as drug potent the an our pharmacology assessment program rapid-onset activity, of depressive Lumateperone's administration treatment to formulations potential the continues of and have order including ongoing lumateperone to the believe major on modes effect symptoms in to and novel as antidepressant program in We 'XXX disorder. comorbid well antidepressant Study explore exhibit of disorders, bipolar our positive we depression. the effects, in in the lumateperone. of the based in MDD, is pursue

formulations these XXXX. X anticipate in We disorder are in initiating clinical a of Phase major depressive and to explore continuing the pharmacokinetics study

contributor in the with pleased and also action made pursue intend of program PDEX excessive CNS cardiovascular indications is the in of We where inhibitors been demonstrated continue CNS, and of pathogenesis. a novel to development important on explore and to treatment to We're with several the for has conditions. increased diseases as PDEX progress being our other of our potential we this focus non-CNS PDEX disease activity inflammation mechanism an the

proof of We was have clinical modulate mechanism of year. functional brain The of translational ITI-XXX This data to central the the of volunteers system indirectly dopaminergic in in will study We from variety neuroimaging. designed line completed disorders. provide this inform development top a in study systems supporting MRI nervous results behavioral anticipate a study this results to inhibition for tasks. using ITI-XXX complex later healthy PDEX during

Our in of existing treatment cardiac resistance. vascular contractility to the that alternative to of heart for involving beta-adrenergic signaling, failure the and progress. therapies. not mechanism ITI-XXX increases does inhibition. agonism the and therefore, Unlike continues and ITI-XXX a inflow failure heart from ITI-XXX beta-adrenergic provides for receptor program cardiomyocytes, action increase different introducing PDEX without heart a potential in ITI-XXX contractility through of and the increasing AXB new agonists has adenosine to a output is calcium PDEX increase potential inhibitors, safer pathway

and in replicate conduct third were of cohort, and where safety XX XX-milligram following positive animals. seen cohorts, to dose aims study milligrams, effects dose ITI-XXX is successful ascending completion single X/X XX-milligram Phase the concerns of identified. the the Clinical inotropic final for ongoing ongoing, no Our

We this from in line first the top of anticipate reporting study results XXXX. half

oral Finally, of expect the of the in opioid use serotonin, half opioid mu program dopamine other our our ITI-XXX and pain receptors novel to modulator disorders. substance treatment we and initiate mood of for first disorders, for ITI-XXX XXXX. is and clinical

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

Lawrence Hineline

and of share I for for development of an compared the costs. of The primarily million costs the ended be a with the quarter decrease to $X.X associated for period XXXX expectations was of expenses due million and of for and nonclinical will and for a XXXX. decrease This per third Thank of diluted third is costs in per XXXX, of clinical efforts the the our net net net XXXX. you, use loss was third completion same a the with to trials, $XX.X $X.XX XX, a share approximately XXXX. quarter September Research for million Andy. and million $XX.X were XXXX, million $X.XX million September decrease financial to $XX.X basic decrease investments. loss approximately XX, $XX.X $X.X of the of our $XX.X for quarter of quarter XXXX and of certain third loss Basic million reviewing the manufacturing lumateperone a cash approximately quarter million lumateperone of of the of diluted results for our net of third of compared ending loss overview $XX.X for quarter compared provide

General the $XX million increase million increase and third compared approximately the labor compensation expense. approximately stock million cost increase an $X.X million, of administrative $X.X and XXXX. and expenses an The $X precommercialization of for primarily rent costs were result third million to in of of quarter quarter in higher the of XXXX for of $X is

cash XX, totaled Cash, XXXX, securities December at million XX, equivalents investment at and million September to XXXX. $XXX.X $XXX.X compared

the national of infrastructure including expansion in sales initial We with a developing commercialization continuation lumateperone our will the programs; candidates, expect for the our schizophrenia; clinical lumateperone, of and in activities, manufacturing precommercialization of operations. activities force treatment if including the used product these for of and ITI-XXX; connection other activities; development existing of late-stage primarily funds be development the commercialization general approved; related

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

Operator

Instructions]. [Operator

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

Charles Duncan

you've the program to observations going sure I'm be the in progress here us you've and able agency, challenges if discussions that the the hopefully, granularity not an labeling? I'm wondering with FDA venturing shared importantly, information, Sharon in coming discussed with the of give recent discussed the into but team, data perhaps be a bipolar but here on to and soon. states, up had or lot actual the or I'm and time, in Congrats patients even U.S. won't quarter. exciting wondering with for if of more kind schizophrenia? only bipolar, Or you

Sharon Mates

our hope do try your team the a Andy to so B on which you we that question that's there you part of Charles. very others question exciting dealt Wow, a Thank I for well, interactions, for think we'll and was -- to And and questions, ask the it's on them. answer comments, down, address our maybe with not writing a which FDA I remember? lot Thank you. will I of all us. time were, and was first as

Andrew Satlin

Yes.

With thanks, So with Charles. regard to the discussions FDA.

is this So an active review.

We and continue forth we've regarding to provided. some back with FDA have the information that

We questions We that we within We've that the in substantiates and fashion have a have information the FDA ongoing responded all had we to to to deadline. the provided continue data previously. questions. provide believe them timely

direction we're to time with that have yet something no, That's moving With not the confident had the of for during busy to FDA. regard with in review not that with all discuss bipolar, schizophrenia, chance right FDA happened data we So the a that's But we're that. planned. those has yet.

Charles Duncan

lines really the effect sense. really, to shown makes as with placebo question regard you've That it that the But in agency sense it going bipolar? along Okay. challenges is of, schizophrenia gets you think is my your -- in do the well up of

Andrew Satlin

Yes.

think well this a actually of this in they're they've and area. published of aware I in indications variety

yes, particularly response So of the placebo across discussions and States whether are any things you aware there of well. depression, as around that particularly And these United discussions indications, as we labeling? Yes. issue in are, they're with issues in also well about labeling perhaps, been think, I the psychiatric had that well. concern rates have asked And

Charles Duncan

think reimbursement feedback that lumateperone that us queue, in patient's you the in see to do I question Mark, understand that and to that but and over wondering meant how do is, see efficacy? guess, veiled well, or about What the I'm potential value value? the you a to do authorities. and, the and pricing, time it -- you've is therefore, One really lumateperone quick then question then with ability it's discussions Okay. take pharmacoeconomic its in ability it feel differentiation you regarding gotten on of think a back authorities for what is help early about -- and pharmacoeconomic hop -- you I'll the reimbursement

Mark Neumann

of those the And and we've pharmacy X Charles, so, discussions that extensive I there would question. in with one, recognition both to market, being research there's past very have cycling the for couple research say, unmet to market both tolerability through an directors be actually several significant discussions medical Thanks, the And market from dynamic or to boards, are are a the that encouraging with particular setting Number and a And emerged with come very in over effective year continues that the of to marketplace that in have antipsychotic favorable us. for patients we've antipsychotics in physicians how of in there antipsychotics, spite themes branded, on generic in directors and recognition advisory of spoken safety need because that from payers. a the themes us. a and a Yes. the had, profile. multiple consistent

by payers so in well to that's the addition And recognized the physicians.

do And safety see a addition and that Andy same pharmacy tolerability has unique we of and profile differentiation from one in and talked that clinical physicians directors, effective that then an and program a mechanism lumateperone favorable the they that action. about the with when antipsychotic is do, has psychiatrists share the data would to the and of our medical

some make that due help adherence to profile bring they very right the will it directors with benefits our there be forward is payers, a safety and medical sure to favorable that that will able discussions if job see. recognize theoretical strong data approved, the And lumateperone, marketplace, proposition will and tolerability pharmacoeconomic to so bring pharmacy into we a that to to value be tangible in of the turn benefits and of our

approved, that's to helping real-world doing approval, once a as team will of And well. lumateperone critical then what big certainly, with also get is So speak. in medical data benefits part we role our play establish a we if affairs those as

least at we've the been So of kind question, wanted I of little in to provide that physicians. the answer about addition I payers hope more that feedback getting answered a full but to your an from

Operator

question Our JPMorgan. from of comes next Fye the with line Jessica

Jessica Fye

on indicated guess, we Should edits I question for first, payer have that Latuda, feedback. physicians that the they face on just up Great. step typical with some example? following expect

Mark Neumann

again. that to It's Yes. category access been Thanks, antipsychotic Jessica, This that payers for want a appropriate familiar category the several they ensure I is diseases, to Mark, medications to schizophrenia. like What say years. serious would around treat the It's with. question. for has the are category is that a

There access. payers and unrestricted require a think so do payers lumateperone like the to be for they'll who prior they used would mix. to generic I products edits, are where will will X We branded agents, will employ other And other have expect you'll there to or product. provide X as be techniques step who

on in of what particular, the would But of step have so of majority I majority from met of be the payers the been if you in that they've look is suffering say are out schizophrenia, edits already that, the many about will requirements already putting who patients antipsychotics, today them, place. there the at the multiple them, vast

a typically, X the that get other prescription already physician like on or goes filled. X can approved antipsychotics, when and demonstrate and so that been then would patient write a lumateperone has to product get And

we aware something dynamic. something it's the piece So and manageable think is we're of a of that payer that

Jessica Fye

it. Got

Makes Okay. sense.

size tell also will mentioned be? sized you Can that You force. projected what you us the that sales

Mark Neumann

sales highly know very on of in this of audience majority the lumateperone with patients. little the and keep schizophrenic Jessica. high physicians sales of the competitive call, offices write continuing sized the we of to what our antipsychotic physicians I have the to size that understanding have be which we competitive the Yes. us would promotion. who for a prescribers, the those are force Thanks, good We exact to Up force or prescriptions we've enable a for not close I the And the reasons. communicated said is -- vest. until to point, What number say, of we're

going So XX,XXX you at our the where a majority of to that's force. effort I'm in at the antipsychotics, highly the for competitive for physician But sales gives on all those offices think we'll write we'll be sense I that. schizophrenia in concentrating say who those of this and if prescriptions least physicians a point, have of that offices, XX,XXX are to

Operator

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

Andrew Tsai

apologies calls, So tend in asked by timeline the canceled weeks prior preliminary before if believe this to your and company least been understanding and receive actual as conference about week has but date, confirmed the two it's I my before ADCOM prior FDA X this was maybe themselves docs, to that briefing morning. at another companies

wondering entail? if they if topics draft? just so, what have received a did So And you

Sharon Mates

Yes. actually Sharon. we we're FDA the to there, cancel was approval. say forward. because really, We, and we're we right, kind sure right. don't to has really, looking another in Thanks. not on, many do scheduled, to have quite other today. you're had This times it of missed not moving ADCOM, so timeline doesn't our and but moving I'm have This decided here I are before. your some is much date, it more been of addressed ADCOM matter towards And that our And and about than this

Andrew Tsai

PDUFA internally and extensions an there evidence you perhaps outcomes also, approval, that as since there your early support been found And good. an Sounds anecdotal would out history of the of notion has looking example. any at the that recent September,

Sharon Mates

sure I question. it? understand sorry, I'm Do the you understand I'm not

Andrew Satlin

and and progressing would our that I own we think request we're that that's except at a sure, our FDA on this satisfactory NDA, for say to not -- and wanting that's point, manner. our I'm in -- around submission focused our concern

Andrew Tsai

you my bipolar sounds a like And establish is to question to the path that still it need talk the last Okay. for just FDA program, to forward.

in could a expect out when final should scenario we base X case investors expect after be filing the mid-XXXX? to Phase a study the So And meeting? reads

Andrew Satlin

it something are So line types questions it, time yet in is do would with we yes, a for we that addressing don't we those but future. intend FDA, the be have and near the of to

Operator

Leerink. Our Goodman next question the comes Marc of SVB from line with

Marc Goodman

this has on right study, us question to can do enrollment where just spending. a you of adjunctive give with And sense is First, bipolar second depression now?

for year, disclose And Just the was I of seems this spend. And sense changes how going us that some much year? then how total spending type the incremental coming will X the to incremental kick and incremental give you're give what going of ago. now but that's just thinking smaller to guess, a R&D? the the about number, this quarter, spending and going to are than be in be sense you be, Can number, year? What than next you're going that's just thought of you're number thinking it understand going Can year, be spending into you less think year, as next that in, bigger and not us year months there's about obviously, of about promotion. to to for we of next rest reps you advertising I obviously in first then supporting so around a

Sharon Mates

Sure.

then will take I'll again the and Andy I that's So lot bipolar a the answer financial. to and ask Larry of questions.

Lawrence Hineline

Sure.

Andrew Satlin

Yes.

going are enlarged to we've state we're and -- to as the of we've with well that 'XXX, that of trial. study, middle said from able results bipolar number anticipate up as very XXXX. we the is involved a we Study regard picked adjunctive trial And result, been having the today, enrollment by as So in countries has that this

that. think I with along it's nicely very So going

Lawrence Hineline

Larry. is this Marc,

forward, And guided estimating go the incremental you $XX right, high that quarterly We've the based as an Our spend that. quarter, it are be we're on you see can that could we'll things as you fourth spend for first under been million. as for And the do we going X had quarters. mentioned.

Sharon Mates

QX any you through in XXXX Yes. given the other We'll we've to -- we spend haven't yet gone at give guidance than you moment.

Lawrence Hineline

up it And be incrementally... going will Right.

Sharon Mates

and absolutely each tighten of look projected, really certainly able And back We've things spent Yes. less purposely. ours. up, and to right that go than done area have been we was you're and we at originally this

prudent on very our cash And think we've been so we spend.

Operator

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

Owen Drinkwater

is on for This Brian. Owen

of quick couple a from ones me. Just

side, could sales more a built give chain still front on end any noted that supply you business talk on into you're still regional that you little manufacturing you And already one, have and the us of this the be what some and managers some ongoing? noticed And First on or factors you are bit done there? gating hiring now, of sort what first to can this you and up in quarter? needs about the color year then activities, is supply at stage commercial --

Mark Neumann

Sure. Thanks. we I about Yes, remarks provide from to commercial good chain feel we confident our and we Yes. QX very my in is said commercial launch. did supply prepared to This supply and planned supply with have well, ability go. are. the manufacturing Sharon in feel ready in And a as Mark. do as where We line very perspective,

feel we all good negotiations supply So very coming are together of wholesalers, cetera. chain in pieces The there. et terms with

the we'll go we So into to we get we get out be once marketplace. approved and feel ready

supply that's and So manufacturing chain.

sales a a force more bit little perspective, From just background guess, yes, I that. on

since onboard the I've past, the Sales -- very the in Head said year. I've had of As my beginning of we

representatives. the managers and and on regional was directors sales the they've board. all business business recruiting busy sales which doing of The are the first are be of and stage, order will first-line managers, who the this hired onboard getting at They managing been the area hiring

mentioned, ongoing. I managers of hiring is regional our as the business So

fourth begun and time, that representatives We board, into with effort throughout year. continues. of at those And parallel, that interviewing in quarter on well has that same the the onboard are continue already and next already and the the recruiting, sales the as quarter first identification and will the the have many

in sales We've we but won't in said onboard plan them the the in before approval until after quarter, representatives is to first the that time our have for launch. quarter first place

So little there. terms in provides more you a were what that detail hopefully, for looking bit of

Operator

Genuity. Our of question the comes from with Sumant next Kulkarni line Canaccord

Sumant Kulkarni

few a I here. have

clinical emphasis those had has data the the characterize entirely So of NDA, the pending first, on FDA you've more else on been whether discussions something lumateperone you could the or help recent or the like agency's with in on context labeling? preclinical relative

Andrew Satlin

Yes.

discussions to So the regard areas, questions. had your areas. thanks, throughout those they discussions covered all Sumant, those I with think of different and have we've The -- to -- process continue for

with while bit There's that, But new a the well. had discussion think been as really, to of -- some talks, I we a as as around follow-up. submitted data some we back. discussions regard mentioned, labeling

So we're moving way we've a I expected. along, think, in that

Sumant Kulkarni

on depression a bipolar the data, follow-up is one to, I follow-up. to second it's a guess, My

require be to by FDA X successful global is change, trial? all, adjunctive Specifically, may the have at the would at for single results would if And point discuss answer how Phase that And meeting you you which because availability data will sNDA, that meet from of that do what expect a far? the so gated a the approved potential to schizophrenia if mean lumateperone trial? with

Andrew Satlin

Yes.

that data other be as comments And on but that. definite So well. good -- discussed. as I a meeting our will point, all it that have moving with we're areas at toward before, in you're No, going outcomes all good don't have and for timeline although right will questions. forward we depend this FDA mentioned And available we

Operator

Our next with comes question the from Bert Hazlett BTIG. of line

Robert Hazlett

two. I have

second Just on AE side, CNS of you've the just is you lack non-CNS relative and the positive both pivoting market with successful regard back there, consider weight that to the physicians, internally? its indications and as light you done a efficacy the disorder? And or if lumateperone. with shed research, any resonate XXX, to your you attention your market profile that aspects, materially either routes with it on movement could are be or gain to you as side And particularly Are there research the for on on be one see what of might would a signals XXX, pursue breadth the great? resonating, then assuming the

Mark Neumann

Yes.

lumateperone the the that as on it where in and the come that side that dyskinesias, an I'll some is have have extensive that each And safety of or disorder or Bert, of liabilities said increase market tolerability on weight a each So amount multiple schizophrenia, of profile movement is safety dynamics and the major first profile. research that over abnormalities, and have existing tolerability. lumateperone antipsychotics to that the research supports been right. other an akathisia, them things marketplace data also I the of I the prolactin of or to the X in when through part. for X represents done you're then it as glucose, are effective think cetera. you're aware, cetera, take Sharon but be et in before, approved gain, turn lipids, clinical of has certainly, for second comes effective areas, liability and the favorable -- either in you and the yes, Andy we've has and of and And themes profile, to from et this part them metabolic Mark. or tends it And increase We antipsychotic that

cycling And antipsychotics are patients. dynamic this you patients, the many these why truly effects that's through of and side schizophrenia intolerable of multiple for to frequent get

research, data see see Now they when supporting weight profile clinical are results be find antipsychotics. they these existing the see favorable from that to of disorders, the and they lack -- very when metabolic market physicians the they in aspects the other lumateperone of and differentiating and movement

part that's think Andy for turn to it I'll about over I the the say what of I'll second and question. that, So

Andrew Satlin

Bert. Yes. Sure,

know and So area, both thanks excited which in right -- about build of and for you the could PDEX as indications CNS non-CNS a as correct. very that what compound pharmacology different asking we you're we're also And inhibition, number indications, the about on in other of about. general. absolutely ITI-XXX, considering at looking you're say, and We're this we're

or portfolio indications, of pursue data to to forward in and we'll help of to whether which with those. those to of discussions moving of is at with the is to look how overall exactly of as obviously, what is the doing the we're in, suggest, do different and to proof at need come stage that mechanism, principle, everything proof you now, concept, indications Right proof in also have potentially about think others strategic to outside some make and us companies decisions,

preliminary So very getting to looking it's we can at explore chance are fully much but this do. this little to a what compound forward stage, a

Operator

Thalmann. comes Ladenburg line question of next with the Matt Kaplan Our from

Unidentified Analyst

where [ph] formulations analysts you question, one on have the Most but for you question just Matt. I'll have indication on Raymond give my the completing is pipeline. are MDD the the of perhaps? in perhaps in This for Can some asked color

Andrew Satlin

Yes. Work as ongoing of there, PK we is mentioned, with a studies. variety

we're ongoing that's pursuing. that so work And

Operator

concludes the This I'd question-and-answer to Mates session. call back over to today's remarks. Sharon closing turn for like

Sharon Mates

were and you those who thank useful questions, Thank our in-depth operator, very and and for joining questions. to they asked thank everyone, call, you, very you,

appreciate we forward thanks, that. And soon. Thank updating we So you everybody, look and to you.

Operator

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

You may disconnect. now

Intra-Cellular Therapies (ITCI) 5 Nov 192019 Q3 Earnings call transcript