ITCI - Earnings call transcript Q2 2018 | Intra-Cellular Therapies, Inc.

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Operator

Good morning, ladies and gentlemen and welcome to the Intra-Cellular Therapies Second Quarter 2018 earnings conference call. [Operator Instructions]. I would now like to turn the conference over to your host Dr. Juan Sanchez, Vice President of Investor Relations and Corporate Communications.

You may begin.

Juan Sanchez

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

press corporate at quarter Our of providing available a release earnings a and ago financial XXXX the it’s for short XX, time the our update resources the June second website ended on crossed wire intracellulartherapies.com. company’s details and

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

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

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

Sharon Mates

It’s thank and our of Intra-Cellular and plans. our morning, for Good review for and an time our for quarter the busy a Juan. we future overview share our summarize financial second everyone programs our Q&A. Then will financial will today’s results XXXX, call. provide at up progress conference joining exciting open Today for we’ll us and with results you Larry Therapies. line Thanks,

treatment will submission We for the NDA our schizophrenia. of of lumateperone shortly complete

this lumateperone, later major and important ITI-XXX. we reach milestones addition, for expect programs In to ITI-XXX, year including

Our depth updates breadth today reflect and our of development the drug pipeline.

schizophrenia the label results part we later switching of plan this from safety the safety setting. to significant continue one of clinically patients part in remind the real have lumateperone FDA. with evidence world completed in also made team cardiovascular of initiated you, our XX issues profile designation potential evidence of We present associated as our Last strong to today me lumateperone expanding trials on schizophrenia. first we our well-controlled lumateperone. schizophrenia with from fast-track based for year, up for open connection that year demonstrating recently of treatment agents. to the data submission study, rolling and development prepare the X,XXX the we clinical progress to second studies address submission in follows of with of schizophrenia our and in lumateperone including we needs with let our study, many supportive people motor and study significant we for clinical treatment with with the the pleased NDA the designation favorable program of are stable schizophrenia, the antipsychotic build lumateperone which of And third exposed two available currently including efficacy we over a patients of received lumateperone we treatment parameters safety has commercialization schizophrenia our fast-track requested provides believe medical to year. the the treatment infrastructure In for the We safety unmet for we clinical several With positive metabolic, on a improvement and and of

first addition Study line In be our later Phase ‘XXX bipolar depression III to we anticipate top this will or study the lumateperone milestones that from available results year. schizophrenia

interim We our patients III also expect ongoing agitation to in with conduct analysis including Phase with trial Alzheimer’s disease. an clinical of lumateperone associated dementia

to are activity, we preclinical as on and evaluate treatment evaluate which expect rapid-acting antidepressant of and a we developing also later we and serotonergic we year. to We indications. to initiate lumateperone previously disorders for this glutamatergic clinical demonstrating Based depressive the studies plan described, several intend a trial lumateperone

other regarding more our As details and progresses depressive will year disorders. this plans in for we studies the share

Parkinson’s receptor. central as through intracellular disease In signaling nervous failure. made DX or the PDEX of addition disease well as in for occurs X disorders of and the a have of our downstream treatment inhibitor to is phosphodiesterase in other progress program. treatment the activation advancement we development dopamine system Parkinson’s needs substantial unmet In selective the of of for ITI-XXX in heart lumateperone nucleotides cyclic ITI-XXX programs,

a is As actions enhancing we cyclic the we for trial, ITI-XXX this cyclic rising oral of objective PDEX nucleotides receive In of with I/II GMP signaling pathways the dopamine patients these described and and previous signaling dose have To are test primary the double-blind, once publications effect the breakdown PDEX inhibition cyclic disease the tolerability days. brain. both in on in patients to multiple ITI-XXX. X this of prevents in thus Phase the disease of evaluate randomized Parkinson’s inhibition safety brain, thereby The in and ITI-XXX. restoring study with doses of Parkinson’s of placebo-controlled, conducting daily AMP

Secondary non-motor be safe profile available and which completed ITI-XXX improve evaluating study X, of been start milligrams and of inform favorable first the will a and doses symptoms. contractility. action potential that for Phase AXB results distinct new to by later of blocking by dose ITI-XXX when as contractility objectives XX scheduled a receptor of demonstrate results increasing novelty Therefore, drugs increasing ITI-XXX PDEX the ITI-XXX by to ITI-XXX induced motor signaling higher X, with exerts by Based amplified novel we drugs, AXB contractions the failure novel is AMP we mechanism prevented in signaling, in and expanded and of year. will provide represent include available cyclic enhanced the clinical these with heart irregular contribution to AXB beta associated muscle muscle failure. design inhibitors action such of effects a treatment that mechanism potentially We of inhibitors, cardiac both year. to adenosine an like the showed of has beta cardioprotective. acts agonists improved study X pre-clinical levels on been signaling ongoing. a safety next has mechanism profile explore is unaltered conduct the these not. This this and combined Due alternative the elevating that failure with PDEX was II be simulation. PDEX other At ITI-XXX Furthermore, ITI-XXX tolerability beta-adrenergic well-tolerated. XX This contractility. cohorts [the] time and anticipate cardiac signaling. utility when cohort beta doses and are treatment Recently cardiac was investigators intracellular heart conduct generally dangerous that a pathways this to University a available Clinical levels for to spend inhibitors the heart the milligrams. to its adrenergic calcium its studied exciting for shown to and therapies models data strengthen of was online and adenosine the calcium to with agonists involves of actions heart output but little The indicate inhibitors to unlike that a ITI-XXX heart in adrenergic did in modulation heart, Whereas in of believe from chronic by Circulation failure. associated receptor intracellular science which I different for so that would complications use. field adenosine pharmacological both cells and on increased acute pathway mechanism effective our Hopkins findings the cardiac than adrenergic John increased Currently an without safer been journal a version of PDEX XX receptor calcium of cardiac ITI-XXX cardiac these offers heartbeats. did dobutamine and blockade cells. and to such as amrinone/inamrinone inducing These contraction but has has experimental contractility involving thus AMP the intracellular potential cyclic may augment as

failure. The effect effects We are to conducting randomized escalating to clinical evaluate of This failure. determine study of ITI-XXX patients pre-clinical the is patients. placebo and of the study to a treatment models in heart cardiac for controlled ITI-XXX single seen hemodynamic trial heart of I/II whether systolic of safety with Phase doses double-blind, in is the aim a translates

triple of progress the of to to constipation, the to as on urgent attenuates The profound new faced physical drug addiction DX antagonist continue safe, States with provide symptoms need nearly symptoms crisis opioids and and causing dosing. pain at partial reduces as Survey substance opioid dependence opioid treat make an mu at preclinical a XXXX. to novel in receptors development withdrawal is In modes including effective, it or abuse administration, a States programs Drug Triple suppression, develop X-HTXA National and of misused an key with non-addictive in is and has candidate X chronic X analgesics. We million Health, According XX agonist and action, X self receptors. drugs without ITI-XXX. after United the models our there our United preclinical acts people Use other respiratory oxycodone and withdrawal to

use plan disorders of program year. pain to ITI-XXX disorders. for and substance initiate expect other mood next X opioid to in We disorders use and the are for We substance developing and examine a triple treatment clinical

development we with who second to and review us in will Lastly, call the to a programs investments, over turn in the ended places quarter position strong our financial cash commercial which now the $XXX.X I advance Larry, activities. results will quarter. million and the for

Larry Hineline

and development increase costs reviewing were XX, for with quarter The I and XXXX ended the loss provide our for is net administrative million, increase dementia, $XX.X is Basic XXXX, net patients agitation financial was for dementia share and the were XXXX, quarter with for labor of our net results to per lumateperone-related for per other loss bipolar quarter and The in compared primarily XXXX due investments. loss $X.X cash June of second non-clinical our to increase approximately cost due quarter XXXX to quarter incurred and and comparative diluted expectations $XX.X Sharon. quarter development second loss an and a Thanks, pre-commercialization costs the $X.X for to associated the the XXXX. quarter for $XX.X of offset second bipolar and expenses General III the expense million XXXX of costs quarter the In for and use expenses period an was to patients external of of $XX.X net III second $X.XX manufacturing compared lumateperone-related of diluted of second Cash, the compared patients million by of trials. and primarily external XXXX securities will Phase million the professional overview in of depression of of second depression In quarter compared were $XX.X trials, $X.XX and for XXXX. with compared share December million the with at for totaled same lower basic compensation XXXX and be Research XXXX. million of cash the to XXXX. million program. XX, stock in other cost. second the and for the clinical of XX, for $XXX.X our at clinical primarily lumateperone in second clinical the incurred XXXX second of with of Phase The quarter for and $XXX.X trials PDE million a trials second June were of and for fees. investment XXXX. million equivalents cost lumateperone external is

lumateperone existing of XX, And activities will of depression, patients June cash lumateperone clinical if the $XXX.X investment development pre-commercial for cash, with disease. treatment continuation used clinical dementia, and and approval, conjunction schizophrenia fund development lumateperone with in as patients To including and including; of other be to development of prepared of trials and We of of questions. injectable agitation concludes disorders; fund the advance pre-commercial non-clinical Operator, heart treatment the in program, program, programs million pre-clinical Alzheimer’s disease, fund lumateperone ITI-XXX disorders. for for regulatory disorder. development expect bipolar equivalents the clinical to PDE Parkinson’s activities, open clinical to agitation to including and with that in for of our of manufacturing securities and primarily our associated XXXX This and dementia, trials please fund could fund lumateperone the the for you including with our activities other non-clinical remarks. depressive other the efforts activities, commercialization lumateperone our treatment failure receives related initial for with pre-clinical activities associated and activities and lumateperone clinical long-acting line to bipolar

Operator

from the with of RBC line [Operator Abrahams Instructions] Our Capital question Brian first comes Markets.

is line open. Your

Brian Abrahams

all very for on Thanks much congratulations the and progress. questions taking my

to of tox terms or us needs of it forths FDA previously I on or a submission additional been discussion part – with review was all toxic Have is the filing, done color me up. any go progress follow that the observed. – whether on what you sort and/or of from other question First like And had whether back NDA priority then I – through of signal could the process? the you as still pre-clinical be if potential in give the there, and the sort guess wondering and

Sharon Mates

Hi to question. for I’m the Brian, Sharon going the This question. is to CMO Andy our Satlin, thanks and answer ask

might was But, it so chime or parts, I in at point. think one I Andy? X X in

Andrew Satlin

Okay questions. so Brian maybe – for the thanks

question address me Let last the first.

had as begun designation issue which rolling longer submission. by submission NDA. So know to we fully us the resolved and submissions. itself, a has submission and issue regard NDA no tox already process for the And to fast-track you allowed getting do this that’s the an the have we as With submitting been that –

regard FDA submission expect strong We going and a complete track with the package we’re you update forward on and get. had do discussions type We’ve shortly will we that the of to with to believe this have that. to review We will

first for a standard review. or in a standard getting preparations on approval, it’s cycle And case. a whether it’s commercial track focused our a review, We’re whether on or priority priority launch are either

good So we’re the progress confident NDA we’re of making shortly. and submitting

Brian Abrahams

key that Alzheimer’s bit then scenarios you a more little there or potential on are study – or the efficacy scenarios guide key could Is follow analysis. the, to are give being different that stop outcomes early on just us parameters looked What Can more it hop guess, up are I that this some there? And for potential queue. a resizing there? maybe interim the clarity of at of either a the futility. the I will and the And in possible back is

Andrew Satlin

Sure. Yes.

thanks again. So

As regarding and interim evaluate analysis, effect is size this which the in trial. to know pre-specified variability we’ve an the assumptions you

can as be So sample as the to after the we either interim able you analysis continue study, will suggest stop planned, or adjust we the size.

futility and later or the sample the proceeding a and/or this of look results success including will stopping doing any adjusting to for We options size. be interim this year. those are possible, forward a We or

Operator

Morgan. with question from next JP Fye Our Jessica is

open. Your line is

Unidentified Analyst

an Yugo learn Jessica you the our for stage question. set on taking for thank the [ph] second results Oli what stage is from of we the study of call you switching for Would are could the This year? ADCOM? will expected filings? the with what acceptance later submission, initiation the And there And of for in the be rolling which expectations the whether current this announced you your of addition NDA

Andrew Satlin

is regard trial. to to on follow so, collect safety demonstrated the excellent long-term safety profile to Yes already the in we’ve the study, up data with long-term that this safety short-term

results be later to long-term to trial the the of of able – year. this the We trial expect safety report

regard just question me for remind asked, last you’d the for your we We NDA to for what what And need are track what submission. safety with was. everything on

Sharon Mates

can I yes. answer,

acceptance NDA We about just long-term of filing. like will Andy just add announce I an study. the also to said what to safety

[Technical don’t if we’ve request action. Part nothing safety a did safety new see if of see the trend what we ADCOM, to believe we looking to continues know, maintained switching you you purview. we’re And excellent So, otherwise. we if We is to it. I profile. study suggest request we’ve and – As I able more to as maintain think A and is that the molecular been ADCOM, agency’s does that seen we’ve get welcome a would an in first not know Difficulty] you a this in an remember in sponsor class. to are X or there, not had but solely A and

it’s and So, it. could to we to forward under would us. But terms, have up those an again, ADCOM we not look

Operator

question next the Canaccord. Our from Sumant with is line Kulkarni

Your line is open.

Sumant Kulkarni

Could have the have injectable on long-acting upfront. on questions. disturbance the both you And you your program for is on any ask sleep neuropsychiatric lumateperone? updates taking the Thanks specific next you disorders what us second, give I’ll program? on step that

Sharon Mates

Okay.

So, I’ll turn to start over now it Andy afterwards. and

several – We we years study and decrease were ago, maintain in did, sleep during maintenance or and II sleep we a time night improve we are Phase that wakefulness patients and insomnia architecture. improve the sleep able to showed

at rather pursuing, neuropsychiatric an disturbances the maintenance but these look insomnia within sleep diseases. moment, not sleep are indication, We as at we

add we that a long-acting might we then and anything? the that think possibly be LAI the pre-clinical long-acting safety Do clinical ask we if like long-acting on have on stay could injectable a LAI On a proceeding has well LAI, would and has market patients Andy have to to and minute. translate don’t overtake so But anything that – such to in drugs profile injectable trial the in what fill in we’ll profile the into I’ll else – oral orals, we with a you is this the a as to development the through are since safety going great think in, the it but want our favorable the injectable.

Andrew Satlin

is benefit going see primary indication in I not – to be but variety expected the sleep look right, does including add insomnia potential a dementia in that are as so program. looking we just a we pursuing to is think sleep each we additional insomnia of of affective including indication general that at as itself not at those – other that on disorders where we in but given of what do Sharon in and are Yes, benefits an

Operator

the with Our next Hazlett question of is Robert line BTIG. from

Your line is open.

Robert Hazlett

mentioned intriguing as regard Yes, Sharon. with it’s just of data the XXX. to Really you in just biology, terms released

to intriguing potential indication Just strategically, maybe cardiovascular different and infrastructure failure Parkinson’s the biology seemed required. very of for indications the the a heart disease organization, with commercially fit well type commercial

indications think you different comment future could thinking asset you’re just about investment and in strategically? then about the As about for this strategically XXX, the you the how development

Sharon Mates

I’ll if Kim I’ll and start Andy add. again anything to or then ask have

I think our science taken we’ve inhibitors. where the has the gone PDEX – first us with

to I we’re is we see first will, translational study, by to pre-clinical of think, neuropsychiatric the elderly cardiovascular elderly seen and need doing disorders. pre-clinical We of results as I encouraged that very many we’ve well the see translate to diseases humans. tend we’re you what models into do looking right in to and now have the science this we’re if the the data would at remind thing like

other with And in the these at be see so we else and diseases. cardiovascular go as we’ll and we could heart progress where looking failure we elderly

Robert Hazlett

helpful? again, incremental just year. number give of how activity given back could Could just this would more the a Any later directions? might seems the briefly, like comprehensive in of terms come us depressive disorders molecule you indication, just the a of to that to be I lumateperone, sense program sense be different know go you guess I there’s go

Sharon Mates

give Andy detail start as with of to that, put together, going the please I’ll an you give every first overview. single – would the that we we that. ask not we’re until But I’ll you understand ask to Andy study. program answer to But all, we

Andrew Satlin

a No, opportunities a for are I this disorders. you’re of absolutely of think in depressive variety of right lot use action the because that there of of mechanism drug

acting that glutamatergic are drugs that with the pharmacology of effects respects ketamine, antidepressant have about involves could the drug excited rapid a in with seen the particularly to what effect. downstream that suggesting some effects the through activation similar is DX We’re

to illnesses. So look that us part, that we’re we study determine, where with that’s things going year. But what the of open in affective in in disorders in first to And bipolar bipolar one that be the yes disorder, look that for this general, then we’re indications depression, depressive later starting a takes we’re we’re study pursue. start at with if of going at and plan to the to will already depressive a variety the to you fact potential area, studying fact other

Operator

question with is Ladenburg Matt Kaplan Our Thalmann. from next

open. is Your

Matt Kaplan

additional And I forward? dose timing in expected then detail results And X what then the can some your very going that is Parkinson’s us Phase lumateperone A give clinically with on on for X of secondly, comment will a first the study, you’re the, to seeing commercialization depression Can therapeutic we’re preparation I/II that details couple what in cohorts? how your of mono disease, or progressing of Phase dose be of program therapy and any the on bipolar you on filing? III, you you us added second XXX your PDE term for with And program? can completing I guess, XXX. given questions thoughts in and near terms the half give relevant first on your now the then and guess, with XXXX, these NDA any

Sharon Mates

of a writing I of That’s them lot hope – anybody down? been all have questions.

Matt Kaplan

go over can I them again.

Sharon Mates

would in sales And continue to X our our managed Okay, so I the about implementing about and an and and them And strategies, well. we access progress as you a board, hear will we activity upon in a was are through that. and they plans are will force hiring even readiness you trigger hear as And and we as more we together, this. of as you’ll – people coming of commercialization as a so our so time, lot team first that and more on we very acceptance making our hear care are we well. lot We’ve much more, are in address can NDA we the all infrastructure mode. more, are progress certainly through advances filing, in progressed coming are year, build the

So the to want to want Parkinson’s, that? asked the and you Then, about answer that’s commercialization. I/II Andy, Phase you

Andrew Satlin

fill about I in or think the the question bipolar there. program you can was depression disorder I so

Phase we’ve they As ongoing, you going trials got are all III X know, well.

first a we based by trial, plan The to which report is U.S. we results end the this have and to you. mono-therapy of year, will study, those

other we We two are with file with we progressing well have, trials and trials. the this for when positive would be able indication to two

is have no would seen fifth focused we’ve precluded – preclude That our very that study We proceeding. a of out would trial safety we’ve signals to X we’re second Disease, going to expect and is primarily Phase done. report trial, next well. the on fifth It’s going year. Parkinson’s now with ascending cohorts regard in into our The and XXX the midst our has I/II that cohort. progressing which dose the and Then cohort, completed now

with a cohorts first next the but steps further will then done We the that that, have on about this There be meaning, for of the by will the have later this X additional results year, nevertheless. based is end currently data – year. program. the study, X will cohorts – on we are And possibility by we decisions that cohorts making

Sharon Mates

So here, six on on just patients blinded. drugs, each, are placebo the eight it’s interject to cohorts and two

anything cohort. is the know what you until signals we tell for it’s can’t in about who Because un-blinded. don’t So efficacy we

Andrew Satlin

for to be is study to Yes mentioned we do for but before. the effect, able effect, That’s sleep both And only look designed we as later. motor effect signals, that signals, for look right. will non-motor

on report as well. will we So, that

Matt Kaplan

us Any in greater we half first results and when the to of bipolar you back should terms ‘XX, the Phase III second detail from study? XXX we’re of in going can Just now give depression. the expect

Andrew Satlin

would later as No, year. be this it said we

Operator

question And with next Butler Jason JMP is our from Securities.

is Your line open.

Jason Butler

here, you up follow confident guys the other on will And not quick call enrollment needed? can case. the confidence I seeing is the mean agitation. might highly that your in interim just anything trial or the on are expectations Phase be reaffirm a happen or that sound see increases and it wanted there analysis I for III the to is you that according way you one might resizing the your that’s you that

Sharon Mates

was very we hear difficult I’ll sure start, it to heard. so not you, I’m

on analysis. and I that’s it questions interim gist think And the if know of agitation do why the study. the anything is you some we

there study approved either you resize no have for us – to and see drugs purpose As to allowing us correct are that’s make assumptions no help indication, of interim the our approved sorry, been analysis, indications know, so and other in along study. this the or lines, if the the adjustments the

think what you Andy that’s don’t want know, you asking. I I were to…

Andrew Satlin

so with will We the interim conducted confident sufficient of are are on analysis to be track for that. to we information we be able get out something

Jason Butler

enrollments… so Okay

Andrew Satlin

up hear you. can’t broke there you really Yes, we

Sharon Mates

hear you. can’t We

Jason Butler

that. All sorry about right

Sharon Mates

you. thank that, heard We

Operator

not questions. to Dr. now for remarks. I’ll call closing any Mates the back turn showing further I’m over

Sharon Mates

now everyone And participating call. progress you the updating to year. Thank can later Operator, you this in for Great. further disconnect forward as call. we look the make We you

Operator

this conclude Ladies and the gentlemen, program. does

disconnect. great now have may a day. You Everyone

Intra-Cellular Therapies (ITCI) 4 Aug 182018 Q2 Earnings call transcript