ITCI - Earnings call transcript Q3 2018 | Intra-Cellular Therapies, Inc.

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Operator

Good morning, ladies and gentlemen and welcome to the Intra-Cellular Therapies Third Quarter 2018 Financial Results Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions] Later we will conduct a question-and-answer session and instructions will follow at that time.

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

Juan Sanchez

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

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

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

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

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

Sharon Mates

overview progress Phase Thanks, Juan. plans, patients conference you describe inhibitor our our results. results our evaluating our of programs, Today thank us X/X Good third provide and provide summarize phosphodiesterase financial future we quarter for for with Parkinson’s morning, joining presented with recently everyone and will Andy from ITI-XXX, today’s an X our call. will disease. our in

Finally, Larry the will results for our review will financial and open we line Q&A.

important lumateperone to results treatment the of this our examine in to is schizophrenia. from patients study for safety This label study antipsychotics and other the closely for clinical practice. current study year. in resembles remind this real safety from To follows outpatient you, when and the schizophrenia. XXXX of favorable and second stable designed symptoms evidence program agency with of to is the of development quarter, FDA to the lumateperone believe NDA look for continuing With our safety our we of clinical of the for provides profile living bringingth individuals filing, to the we treatment completed schizophrenia. of the acceptance the submission to schizophrenia U.S. During our of conducted setting to present Later with we over patients forward stable quarter switching of an the lumateperone with in schizophrenia. in strong Pending medicine clinical lumateperone to aim, world NDA we with individuals of plan work up XX lumateperone switched one exposed trials FDA efficacy open part is

endocrine that of lumateperone in duration which the two-week care. were of to switched who this in parameters. body a stable These care care We of significant Statistically part XXX improvements metabolic worsened medication. first of medication. back a period safety switched lumateperone favorable from observed from when standard results in and to patients standard followed antipsychotic were standard they study back switched treatment profile switched exhibited included parameters patients were with of antipsychotics six-week were care study from which a by who positive have were weight, previously again presented to other patients standard cardio In from

lumateperone or was associated antipsychotic lumateperone metabolic cardiovascular schizophrenia scale with with associated upon total motor, notable PANS switch with score. not negative the symptoms other significant not often was treatment or in positive from statistically improvement disturbances is syndrome that care, of did worsen the medications. Additionally, standard from and of to It baseline rather mean observed

has our areas Executive He Neumann of of we experience in expand that commercialization commercialization Mark and Chief and therapeutic to marketing advance extensive continue joined categories indications. match lumateperone, we has our senior lead lumateperone and As President our our leadership as prepare Vice infrastructure the build pipeline the and Officer. recently To for further team. Commercial sales

and experience On the Officer; led Development Senior our President and Regulatory have complement teams Satlin, side includes by CNS development Medical Senior Suresh with regulatory Andrew clinical recently Kim joined Vice They clinical clinical Affairs; significant a Chief antipsychotic. Dr. Senior both Dr. Dr. Durgam in President, Medical President to Late Dr. Vice oral Clinical Stage Olchaskey as Michael Vanover. joined Head Vice They as strong approved of and Affairs. respect which our including and

clinical early result a a decade development. translational the overseeing stage now of Kim and who clinical development medicine our has efforts growth for As been company, is our of leading over

agitation in disorders. advance lumateperone including our patients in we and programs Beyond depression, bipolar to dementia, continue with schizophrenia, depressive other

depression adjunctive Our and one program two study. studies bipolar monotherapy of consists

XXX in United monotherapy study expect the complete conducted second we We our our have in in enrollment XXXX. patient study, conducted patient globally study, enrollment QX in first XXX to States and completed monotherapy study

XXX these expectation in reporting Given studies potential trial unlocking, anticipate trial study conduct in well-documented the influences which in study from we clinical the to introducing depression bias avoid trials FDA aim the bipolar outcome topline reporting completion increasing ongoing Subject analyzing rates the of two patients placebo. has by study bias to positive of an report depression of for in The to of ongoing bipolar overall in second is trials challenge those half of of on XXX relative these from mitigating including outcome one we Expectation study and response. XXX placebo QX and two regulatory of for expect XXXX. a and both of results XXXX. results timing response to the submit approval concurrently this simultaneously the effect the decision the on

assumptions to the the objective with interim for to size. Alzheimer's addition analysis we continue In make effect conduct including in analysis we to and patients which trial dementia, our variability in is response of to interim Phase depression X associated disease, expect of year. lumateperone bipolar clinical with program, The an our agitation this later regarding progress evaluate

we the Following make analysis study, be to as adjusting sample could should planned that the able determinations size. interim include the continuing dropping or

our our with progress with I turn heart and comment study selective PDEX the phosphodiesterase patients X substantial in the will to We Andy? exciting or over in our to call results on inhibitor. failure. elaborate have made Parkinson's further of congestive Andy ITI-XXX on to program disease ongoing

Andrew Satlin

Sharon. Thanks

mild-to-moderate presented tolerability with was objective maintained Sharon results on dose to clinical disease placebo from we randomized, safety medication. evaluate As patients and recently of our The of double-blind, evaluate disease. inhibitor X/X our controlled, in trial with our Parkinson's primary ITI-XXX, stable PDEX Phase Parkinson's study in topline said, patients to the concomitant ITI-XXX multiple ascending

were range on relative reduced the X improvements these patients in after was both only Part scores ITI-XXX disease ITI-XXX in from both performance state of were improvements trial were ITI-XXX experienced placebo trial. for of motor multiple symptoms to and efficacy mg. assesses on favorable Parkinson's total and the across subscales, on Parkinson's impairment with which including X cardiovascular For observed and serious dyskinesias. The of of non-motor scales the mg ITI-XXX scale. of No generally that from motor and the a or vital of raters. XX motor disease improving which ITI-XXX motor improved disappear Several dyskinesias of of seen improvements In providing and demonstrated treat ITI-XXX Patients complications. found symptoms Parkinson's Parkinson's on signs Part disease. two favorable site safety by and or without of promoting These while both and cessation to the this scale results example severity associated results motor ITI-XXX clinician laboratory presence the motor in worsening reductions compared dopamine reported seen doses on the ratings manifestations placebo. well-tolerated ITI-XXX profile Signals in or motor parameters patients have adverse entered with symptoms replacement the significant explore demonstrated the the with by encouraged therapies Topline no dyskinesias. events safety we X potential was and this effects rating of to input to are broad to taking UPDRS context the differences disease profound in complications motor unified severity treatment. a and with clinically in in and of reflects disease

the measured without time rated Unified reduced dyskinesias increased patients In as symptoms addition, ITI-XXX on Motor the Dyskinesia Patient on Rating and Scale total by Diary. Hauser time dyskinesia and by as using

results We present study additional will of meetings. this future at

advance Phase for to translate clinical year. encouraged treatment with treatment preclinical the Parkinson's findings very X development to trial important with to the this population studies and are by ITI-XXX of results plan our the next of disease. a We information us of of ITI-XXX of from provide program a Parkinson's for which the continue trial clinical We this

As ITI-XXX failure. ongoing treatment you know, the to we of potential evaluate for of have the an program heart also

we that whether Hashimoto print an models seen in the Our determine trial note, al Journal ongoing aims the a article preclinical Of in Circulation of back clinical highlights X in call heart XXXX positive pleased now XX, October Sharon. the effects ITI-XXX models. failure approach inhibition are to with by by turn the addition preclinical translate patients. as et of to based phosphodiesterase the of on accompanying results treatment the for to an I editorial will novel cardiac

Sharon Mates

submission In we our summary, continue completed NDA Andy. to our lumateperone. make preparation Thanks in and commercializing progress for have

pipeline lumateperone depressive which and continue ITI-XXX. with bipolar includes ITI-XXX agitation programs disorders, well in as and our depression, We advance as to patients dementia, and our

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

Lawrence Hineline

to September million our $X.X lumateperone for financial $X.XX of the million XXXX $X line million due million million the XXXX. a XX, third the General with million September million $X This loss expenses remarks. $X.X of stock results lumateperone to XXXX. million clinical development XXXX. XXXX. and the projects please XX, expenses. our million cost, $XX.X and of $X.XX per for totaled compensation due XXXX approximately comparative million diluted XXXX for of $XXX.X primarily the net for diluted was I The at million for expenses. pre-commercialization for questions? for compared reviewing the XX, related stock other of The same Sharon. third quarter XXXX. the Operator, the $X will equivalents, is third prepared $X.X Research compensation, the could and and share quarter of third $X.X open and was increase cash $XX.X loss basic XXXX. manufacturing and for in December were primarily compared and expense, third of quarter for a costs net net ended share compared of expenses compared quarter labor, efforts, you net to quarter concludes investment to overhead Cash, third to of quarter be loss securities and third costs compared Thanks $XX.X per for loss of of million of of increase were quarter expense, of nonclinical increases to to XXXX administrative million This for at period is $XX.X Basic $XXX XXXX

Operator

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

is line now open. Your

Jessica Fye

acceptance Great, thanks you for me, of did review? taking you lumateperone from priority couple my the and A will questions. request announce filing

Sharon Mates

NDA our did the we hope for announce question. able yes, thanks This ask And be of to Sharon. the acceptance filing Jessica, the and to review. of we priority for is Hi

we that to and know designation you fast-track us had for priority As ask review. allowed

Jessica Fye

expecting about then the a disorders data, still for can to late-stage you And about it you on clinical more help bipolar depressive us should in great. with on Okay, couple year-end? extension think also studies? begin XXXX And as the just timing the coming by think a label adjunct we opportunities, monotherapy are

Sharon Mates

wants if, think he first specific studies, answer to and I'll were pretty said we I'll anything can. add about what if mention the Andy part of and I then the we that then again but bipolar

it, got Oh again. question label first the the expansion me tell Just on depressive.

well. disorders telling of second So we depression, program our year. on the more the year year you… program in those as before we that yes that into announcing we've then be be about started and next in and next think I Andy, the end we said depressive bipolar quarter will of you results do the And will

Jessica Fye

was I one? think, study that was when think Just to about a there should bipolar clarify third adjunctive we that and depression

Sharon Mates

Oh, that right, one. I'll Andy answer ask to

Andrew Satlin

do have in bipolar with on depression we study in ongoing. who is study patients therapy so Yes, lumateperone [indiscernible]. an adjunctive stabilizers ongoing with That are

As the the you about now know pace future. recruitment study a that and the and in we've have the assessing we'll global further expanded be to of we're study information

Jessica Fye

questions. for thanks Great, taking my

Operator

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

open. is now line Your

Unidentified Analyst

is Hey taking Brain. Owen for question. guys, on for this Thanks the

the XQ now, again the ones aspects data two analyses specific follow between up, intact? it on may that the just for just is quick the all of the maybe in have I'm present that bipolar data of at changed timelines you anything the for looks XXXX terms expectation Thanks. affecting change was given there And studies real release that like a are the your how Just you, going enrollment pooling bias to view few if wondering to studies? that on

Andrew Satlin

thanks good so Yes, question.

right trials sense even that clearer as in to two as this the are minimize is to Sharon and bias. that of order mentioned intact became recently the made to expectation consider it to the us approach You timing

expectation two the that this to makes in it that not not it's between sense expectation, approach fact that the close far, reduce take too the of and given is the it's relative completion trials bias. order a proximity So in too to there reduce to

is on there. might analyze be So indicated what the is, already we're clinical reporting This and completing once trials second the the we only of be doesn't the we'll doing two as more data to say complete. trial portion study about we've the going anything monotherapy how

Unidentified Analyst

Okay great, thank you.

Operator

Duncan Our next Charles from question Cantor Fitzgerald. with comes

now line Your is open.

Charles Duncan

congrats Sharon, guys, my Hey questions. on progress, taking for thanks the

but and going cycle days First recently first meeting I'm wondering answer, is and two guess it you we to that are of different I'm day question may than be ask the to hard if was from the the that day I and ADCOM anyway witnessed second lumateperone cite two first the expecting and that as at from preparing out elements besides day and you clinical one program ADCOM from if you the least very an the experience profile the for being or could different point would the drug? of in schizophrenia of

Sharon Mates

Andy Charles. Thanks or and if then I'll for the start anything. question I'll ask to add wants Kim

to downs start, So have it novel mechanisms medicines lose CNS cetera, with not that exciting ups treatment first medication to is patients. can of and while goal new medicines of better the in be think and populations think of there let's sight It the medicines to disorders need here. and addressing these develop to for bring is it's very et no I I that we

that that. are novel they applaud of think these we seeing forward coming and mechanisms both we So committees advisory

really specifically, us it's whether committee to has or FDA think you as to meeting. advisory up I an As one the not know

committee will So an we you we'll progress. for you'll as And know. prepare we tell when meeting we we'll and you know that advisory update

So you that, Kim add want anything? to if Andy, to or

Kimberly Vanover

Sure, Charles. hi

I new speak it's at our favorable our here. always any will safety benefit for, schizophrenia with to received among drug FDA profile So profile the really that I highly at I that's and will track that and looking think the loudly lumateperone whole it's fast remind when the look and the data risk treatments profile package safety differentiated we what just here think and everyone for with think that's designation really

Sharon Mates

add want you you or okay? anything are do to Andy,

Andrew Satlin

that’s think Thanks. fine. I No,

Sharon Mates

great. Okay,

Charles Duncan

you're you done helpful them for something otherwise I agree with patients for doesn't to that clearly that's and Okay, with that appear doing be lumateperone.

sure you're color this launch? bit and schizophrenia little not And prepared initial so could us point which length of be approved if that At only I'm share contemplating fast and on question. assume you I'm plans to forward to your approval should go-to-market that, button acceptance be is filing you to would second but press a lumateperone my with the going just but for strategy

Sharon Mates

record it's so successfully ago and on weeks that areas commercial years businesses product performing therapeutic you XX Mark areas couple and executive Officer know between teams a Bristol Again, good and of experience and a of building and industry joined in the has includes he Chief a over Charles. strong call question across he's of and track Commercial and as has in disease. morning which cardiovascular range a I mentioned and Thanks has announced as Squibb this executing launches the high Myers, we neurosciences Neumann Amgen of a biopharmaceutical proven our and

just few ago. he So weeks a joined

we We up have markets Development a she and think a little which the ago on groundwork a that now, I has Head Commercial been laying of hired picked as over year now about be and we groundwork I go for will you been the laying now of specific more think all to launch. forward, doing doing we've successful a need plans. that hear But

Charles Duncan

for Thanks between my taking calls. questions Excellent. hopping

Operator

with comes Our Partners. question from next Leerink Sullivan John

Your now open. line is

John Sullivan

you absence of of Thanks for speak that upon more can abatement and and shift about candidate you some so symptoms much questions. dyskinesia the administration little symptoms saw I and a ITI-XXX thanks moment, of resumption to anecdotal upon the - the cases of just saw of Can that for bit in drug? those abatement the you of signs gears a the taking

Andrew Satlin

Yes, thanks.

investigators dramatic of more condition. discontinued, perhaps So the back that decreases had that as really when the I very in cases went even detail in their some patients patients is that saw was at saw report patients to previous report in telling who a about closely that they drug the can't they they what dyskinesia who anecdotally lot but that, did provide these really baseline monitor and

So strong going we signals of are lot us think and the forward. that gives fairly confidence a

John Sullivan

Thanks you created on repeat question, in Mates your the you by at runway very just much. comment the just the the cut out financial could view? And a then on I A you - hand question if think can end, cash please? Sharon

John Sullivan

It runway just company's view time on was the hand, the a your cash runway? by about that's created of question

Lawrence Hineline

is Larry Yes, hi this Hineline.

We our our to be guidance so XXXX, our available that that with continue are into changed. cash hasn't progress and through will continuing

John Sullivan

to as If you. answer just Thank back my Satlin Andrew go just I clarify A - could well.

while So did and This about patients in by see placebo in we was it baseline. the so in had rating investigators remarks the there. that measured overall dyskinesia were there patients reductions signals at we dyskinesia controlled, dyskinesia see - the us specifically, told certain those was who we unified earlier, scale I as so mentioned as did

John Sullivan

Thank you.

Andrew Satlin

Sure.

Operator

comes from Bert Hazlett question last our And BTIG. line with of

is line now Your open.

Robert Hazlett

the for is is again the thanks schizophrenia gating looking regard what that with that launch you one My you're potential you've comment manufacturing Thanks. question. if made - your be plans could would of of is, Sharon in of manufacturing colleagues my lumateperone of question launch Yes, or forward potential a there, terrific? there for on item and and status question a taking that, lumateperone to

Sharon Mates

for thanks Bert, a not Hi gating is item. manufacturing question. No, the

in We have all. be smoothly manufacturing to with gating our clinical item a CMC at the gone you we don't submitted anticipate portion way NDA pre-NDA - as before the meeting portion, and quite and know manufacturing has we so we had fact the

Robert Hazlett

the Okay, thank you question. taking for

Operator

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

Sharon Mates

you And that Thanks joining participating Intra-Cellular you and operator all forward you Therapies'. further look for for call. from progress today's updates to in the for and thank and thank call further with then again everyone we

can disconnect. You now

Operator

a great have gentlemen, day. and Ladies

Intra-Cellular Therapies (ITCI) 7 Nov 182018 Q3 Earnings call transcript