Earnings call transcript Q1 2023

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Operator

Good morning and welcome to Intra-Cellular Therapies First Quarter Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today’s conference call is being recorded.

I would now like to turn the conference over to Dr. Corporate Investor President, Vice Sanchez, Communications Relations. and Juan go ahead. Please

Juan Sanchez

thank Good being you here and today. for all morning

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

making a As be during statements. call, today’s forward-looking reminder, will we certain

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

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

will turn Sharon. I call to the now over

Sharon Mates

welcome morning Good everyone, Juan. Thanks, today’s and call. to

off Following XXXX year, great is a a performance strong to start. last

made for quarter, During our first and development the on strong team growth the front. clinical CAPLYTA important delivered progress

few depression will a this features from robust patients a positive in lumateperone disorder, we weeks features. mixed with major announced about results depressive evaluating XXX, patients bipolar in MDD, with exhibiting Study and or talk top mixed more exhibiting I line ago, in Just moment.

performance in by XXXX. sequentially compared XX% XXX% to Let’s compared Demand for of in prescriptions increased and been XXXX our CAPLYTA increased start CAPLYTA with has to QX. first with Total and prescriber strong. adoption QX XXXX QX quarter

total First million. to revenues quarter increased $XX.X

in drove versus XXX% XXXX. growth revenues a growth Our $XX.X same CAPLYTA of net strong period million, the prescription

CAPLYTA $XXX sales guidance QX in million. for between our $XXX We full are pleased with and and reiterate very our million prior net year performance

the in future continued growth CAPLYTA. We are confident of potential and

and positive profile efficacy depression very receive Physician patients CAPLYTA’s prescribers a sites from clinical patients. with for broad and bipolar of schizophrenia. feedback to both range and continue We

belief This symptoms reinforces positive often patients profile. patients. to change CAPLYTA’s effect side our highlight that feedback helping Importantly, and CAPLYTA the of favorable further improvements is lives in their

programs On the our clinical front, other pipeline we continue development to programs. our and advance CAPLYTA expand

news. at with to Let’s the disorder results of compared depressive Study six, start we features was MADRS the placebo a In the on population lumateperone lumateperone patients as drug In less patient of and mood and with The a bipolar study. for and major mixed effect for broad The clinically the with populations primary XXX. positive with individual features. score the evaluated LS milligrams total week top March, we results was to demonstrated and X.XXXX major as endpoint patient reduction well. placebo X.XX. results of strong result meaningful monotherapy in disorders. points combined our spectrum patients features features. depression treatment size mixed most announced from These potential value than strong statistically mean treat was recent with further X.X with of consistent a line depressive P validate difference were the the for robust This in Lumateperone exhibiting of depression study, exhibiting XX the bipolar in mixed MDD demonstrated episodes mixed this significant

all also Consistent prior populations or the in meaningful significant scale, and met demonstrating Impression evaluated. lumateperone well was For placebo P mixed milligrams the X.XX. clinician’s at less week reduction a six with features, features population the was X.XX X.XXXX. clinically key size MDD statistically populations depression bipolar generally the in these patient XX patient population was and with for secondary compared Global to of effect by individual than The size for the with effect was each tolerated. trials, the safe CGI, endpoints mixed value Lumateperone and

suicide Patients with severe higher and of rates, recurrence rates and illness more have comorbidities features episodes experiencing depressive suicidal with mixed ideation.

features conditions. mixed mixed profile respond results to the bipolar and data treat patient study addition, of lumateperone Study difficult build in and about of tolerability, antidepressants. features. depression poorly safety these provide with MDD of These on These we subset XXX the for patients to post-hoc analysis In important on efficacy, results with data our reported the exhibiting

We this has April Journal are just in Clinical in been pleased published to the that announce of Psychiatry. analysis

We study the for plan year determine this meet with our and next to discuss the steps FDA to later program. results the

Our neuropsychiatric major conditions, MDD. extends including across lumateperone several program

XXXX. major an in evaluating of partially file depressive results ongoing to to adjunctive to respond antidepressants. we SNDA who have disorder We patients program as lumateperone expect an in the our for registration treatment Subject studies, ongoing

month month next We or year. develop long-acting program to completed this formulations effective, several safe and a are evaluating this of plan our treatment have evaluating completed longer. one longer. of one studies formulations, or preclinical tolerated The is well one which durations Phase formulations that study X having drugs continued on deliver we and have progressing continued invest lumateperone and these year in for can goal also with – injectable to program formulation We

phosphodiesterase lumateperone ITI-XXXX continue patient innovative inhibitors Beyond to programs, focus on programs significant pipeline X program other with areas our these lumateperone, we need. and Consistent with make ITI-XXX. therapeutic PDEX are or pipeline unmet progress including with our

with we and patients begin Alzheimer’s studies with patients ITI-XXXX clinical plan and with anxiety are form in highly disease, conditions. disorder, disease, lumateperone. Starting generalized Phase deuterated to with of agitation Alzheimer’s all and prevalent XXXX, patients psychosis In X

program proof-of-concept being in Our patients lenrispodun, has developed initiated X treatment our patient Parkinson’s motor symptoms study with of enrollment which disease. Phase PDEX inhibitor is for been the for in

of the evidence supports Changes in involvement Parkinson’s biomarkers will inflammatory cognitive measures disease. assessed. and in development of be also neuroinflammation Extensive the

signaling lenrispodun in that brain modulating microglia. pathways neuroinflammation in by the called intracellular reduce directly to acts cells shown have We

may function, A particularly solid similar certain involved macrophages controlling cell be immune non-CNS including in tissues, and pathway tumors.

well-tolerated of for the cancer safe and indications. prospect part establish to forward single as novel a exciting an is for small armamentarium is of which The begun conduct oncology in further active an We for treatment study developed normal safe and for as study. tolerable volunteers range to healthy indications being ascending have advancing has of a program. newest in look ITI-XXXX, molecule this doses IND inhibitor potential immunotherapy PDEX we Clinical a and our a dose

Finally, In our and partial and study in disorder volunteers we pharmacokinetics receptor we continue in of treatment tolerability evaluating QX, pain. and receptor X-HTXA the opioid ascending μ-opioid for use antagonist of agonist began dose to develop ITI-XXX, multiple the clinical molecule. a conduct healthy safety

ongoing. study neuroimaging is Our

Our with company is cash million equivalent financial investment in position in quarter securities. ending strong the and $XXX.X cash, a

Additionally, we debt. have no

we and remain deeply company lives that effective improve goal developing treatments of a innovative As of the to committed our patients.

to believe growth potential forwards pipeline, to and in We look have of we We forward continue continuing the to goal. this take significant CAPLYTA step rest our progress. we achieve our and

Mark discuss to CAPLYTA’s now turn performance opportunity. Mark? will over commercial the and I to further call

Mark Neumann

good and everyone. Sharon, Thanks, morning

As in quarterly XXX% CAPLYTA off antipsychotic growth total generated modestly. only grew XXXX, of a start last facing Sharon quarter noted, versus of performance same total prescriptions of is despite CAPLYTA growth headwinds XX% QX versus and typical XXXX. first Registering that the market to this great impressive prescriptions sequential in year-over-year overall and year. period an

by underlying starts bipolar prescriber being strong now were prior expansion six CAPLYTA, patient they higher depression. new our in are to demand driven weekly to of label and adoption continued five than times growth CAPLYTA. Additionally, of This times is

well and breadth As increases as we of saw of as prescribing. depth consistently prescriber both base QX the the strong our in monthly

prescriber base prescribers CAPLYTA’s the alone first more adding continue to the penetrate X,XXX prescribers, time we to X,XXX new of end XX,XXX quarter, close March the grown QX, including unique By prescriber as adoption over had to than first in in curve.

that CAPLYTA believe just We and for this fundamentals beginning strong evidence, of the room are is growth continue highly will long-term The to plenty experience healthy the of throughout with year launch beyond. this market are opportunity we this. for for several a growth. and reasons and There’s is large, believe confident CAPLYTA we

product bipolar patient depression, frequent than has affecting switching significant CAPLYTA changes, prescribers and our tolerability mood and There all highly reasons powerful a to with patient. remaining the are similar need has million a depression depression medical disorder search optimal has approved of XX in prescribe. in trials. in each class more clinical in the safety effective placebo bipolar metabolic to balance CAPLYTA favorable with a with EPS proven and and First tolerability These akathisia, schizophrenia a bipolar medication efficacy in prevalent compelling as for large is profile weight, including for Americans. unmet and populations profile

label, strong this competitive includes us and Our depression bipolar monotherapy as adjunctive depression marketplace. I which puts a II and the of in bipolar both use CAPLYTA in position in treatment bipolar as

other While the prevalence This opportunity is bipolar only II bipolar important bipolar bipolar patient population drug similar, an population are for the II represents there for one I as underdiagnosed. depression. and approved II remains CAPLYTA patient disorders of

we bipolar are efforts, disorder. of marketing II the As awareness part our importance of increasing treating and

with base prescribers. prescriber Secondly, of thousands the large is of tens for antipsychotics

frequently increase expand As our penetration. in volume prescribers, we’ve increasing and to been connect and our our numbers our of organization average depth prescriber. of number I more as expanding unique us recent of thereby mentioned the with and before, the allows base, well the breadths increasing per the prescriptions consistently to of continuing this The highest adding both prescribers, size significant market as sales reach, share

prescribers amongst I promotion, patients Light optimize are sales about to growth Together, physicians these peer-to-peer the direct-to-consumer and in Let plan potential medical and and efforts bipolar in patients behind bipolar of new unmet complimenting campaign. benefits raising commercial and about depression awareness a have with comprehensive the our of CAPLYTA. digital We and are brand program, the advertising the need II and educating investing national efforts CAPLYTA education are the

now Medicare extensive compliment efforts. channels LytaLink D our our cover to support market QX, strengthened have continued maintain position to Finally, we Part In channels. and and access three all insured Medicaid approximately and greater market lives offerings comprehensive promotional XX% patient our coverage across the in access coverage commercially XX% than our of payer

throughout to revenue team of Our of on and delivering needs proud experience sustained and is our focused our remain we progress and the prescription date, year. the and patients growth physicians supporting commercial

call to our Larry detail Now, performance. to over I’ll financial hand the Larry?

Larry Hineline

XXXX, were will period period representing the the quarter Net in our quarter $XX.X XXXX CAPLYTA you, in sales Total Thank I the XXXX to of same year-over-year million of results. revenues of for a to compared first million of provide for were increase XXX%. million of Mark. same compared for product million first $XX.X highlights XXXX. $XX.X the $XX financial in

In total grew over of XX% the sales quarter X% increased the fourth sequentially. XXXX, quarter first CAPLYTA net prescriptions and

payer gross-to-net and co-pay Our favorable reflecting the dynamics, to due more placement was anticipated than anticipated managed formulary favorable lower low-XXs lower rebates. care more including in cost than percentage assistance

our of towards for We percentage mid-XXs gross-to-net year. the to the the remainder increase expect

CAPLYTA there of on the quarter, was wholesale hand a at level. the During in modest days decrease

net sales underlying to are As of reiterating demand we prior expect $XXX year remain CAPLYTA million guidance to we strong, for XXXX million. our full $XXX CAPLYTA

Selling, advertising to This XXXX for in administrative, expenses million general in the $XX.X SG&A quarter increases first for the increases costs. $XX.X marketing same due and were million and to XXXX. of compared period

Research the the XXXX primarily is and development, R&D costs, expenses XXXX. due in to first compared cost. higher project were $XX lesser to increase of million extent same a $XX project to lumateperone period million and This for for non-lumateperone quarter

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

between XXXX, million. continue to million and R&D range SG&A $XXX expenses $XXX estimate For million full we and $XXX $XXX full range and to year year between to expenses million

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

Operator

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

Vardhman Chhajed

our Jessica. for question. morning. good on Hi, Vardhman Thank taking you is for This

MDD, would readouts? provide You trial the improve how do given to Is range. GTNs able third you. you timelines how in you into talk talked about the you in Can any think be it And that on XQ? us XX% the now, the XQ the it data to going see Study to is underway sequentially? secondly adjunctive about about with in being likely Thank XXX low

Sharon Mates

Thanks questions. for your

got think them. I both of I

that I net. first – your that on on might to was on starting repeat ask let’s to beginning, but net, Larry have the right, is to I I’ll think second gross one. the gross I XXX. you Study and do the first question one, take it question And ask to if then

to do net gross want So you Larry, take question, please? the

Larry Hineline

Yes, I do.

as think – that. the I I is decrease didn’t quite net go hear percentage we or you forward? why gross the to going asked increase to

Vardhman Chhajed

Likely…

Sharon Mates

Yes, he yes, right. about increasing, I said think the

Larry Hineline

was in remarks, – first Well, quarter. I to as there’s our have Yes, net – the prepared gross sure. mentioned our lower in we

as towards is – we the to expect However, increased gross experienced the the the the net well do to in to volume coverage. low in channel that was commercial increased from primarily quarter. through due commercial mid-XXs as increase going And first the XXs this

Sharon Mates

the repeat you could second part please? And of Okay. XXX, on the question

Vardhman Chhajed

sure. Yes,

for the Just adjunctive timelines thinking trials. from MDD about the data readout three

Sharon Mates

Okay.

be that first successful, we’ve XXXX. two we trials, be MDD should that in they said the would for we expect So filing

obviously So earlier readout that. than is

time, we’ve For probably conduct XXX, that would another clinical would started, that It it take more longer. has year. said would and take take obviously

So do our be ready that we filing concluding would we that would to XXXX. be expect and study in

Vardhman Chhajed

Thanks.

Sharon Mates

Next question, please. operator,

Operator

our And Markets. question line from with Brian RBC next you. Thank Abrahams the Capital of comes

Leonid Timashev

Hi. taking mixed to I the features wanted our Thanks Yes, for on it’s strong on Brian. Congratulations quarter. the Leonid for indication. on ask question.

Just how some first there to features mixed I much of or across with what’s familiarity needs education across to Thanks. the these the that guess, to done best best of be to in are needs differences any lines do think speed you how features CAPLYTA centers? finding there treatment more therapy switch? or on patients? the And – way position mixed get population in up treat the Are you KOLs to geographies

Sharon Mates

Yes, thanks, I’ll These ask if great questions wants and are anything. I’ll and add to start Leonid. Suresh

mean, DSM able I the And treat of in wasn’t now the than features to and increased specifier that’s was DSM X, increasing included think depression but in DSM I features in mixed definition Bipolar DSM awareness X, a the that the be patients. a it desire X these the X. a but a to MDD. an publication term, there was definition. which clear is technical looser looser in definition for or not an any some mixed with there’s ago, think with I been years –

have the been populations a I – X, has about These So mixed be that and and think awareness able treat patient small each again They about average suicide of these suicidal and features. higher that treat of these patients. wishes to not rates have the definitions that an third difficult ideation. on clearer increase They’re allowed patient has of in there physician patient are populations DSM to populations. with to

patient whether of I important that, aware add populations regions. of these maybe there So ask if not as differences are are wants he Suresh to he anything or not to geographical that. has to to – in but treat am I’ll

Suresh Durgam

bit – depression side In patient to is the officially of differences. the used bit side seen lower I distribution, geographical is population, specified this a for I – higher the no, any MDD, but think is, we it’s prescribers since terms a don’t And XXXX, It the more of little been – there DSM been you within don’t said, the about since as X, to bipolar is this on third there the it’s the little on prescribers. continue getting educate space. have more and and a

Sharon Mates

of And as healthcare note measures working and data end, described So other that the it’s in important think, also, that to to providers our extremely very are that as you. to I all robust these results. was publication a we’ve course, interested on we’re well

Leonid Timashev

so it. Got much. Thanks

Operator

Andrew with of from line our the Jefferies. Tsai And comes question you. Thank next

Andrew Tsai

on Hi, Thanks taking quarter. for good great morning, another our and question. congrats

to MDD today. ask I on So wanted

them – would you. line time? lining would of to you both what CAPLYTA more to CAPLYTA of data minimum both piecemeal placebo one expecting power – for first completed? versus be until two it thinking for should if then just to features for you curious MDD, differently clinically for And the Or the – consider the is, fashion on a the top open I’m indication. you MADRS? what waiting meaningful? is Or the secondly a data to one have we to are also show Thank delta be First mixed at any from in top of be be

Sharon Mates

to Suresh will in. fill I I’ll start So and ask

what primary the being are They’re on four look the And monotherapy makes these on disorders, first, adjunctive think all and measure for for helped about that, MADRS to two know, And sense a using an studies you as on we range towards you mid look being you or within as these baseline the that’s are we’re typically when just for treatment, to you lower of optimally. mood MADRS range already So, on higher helped. because our point the patients from And expecting study. not our endpoint, change adjunctive the score. it an range.

So in in the for end you look studies. change MADRS the towards lower adjunctive

first asked. So question that’s the you

these we when The they second separately? will one see read together think is we of on readout, them will or out timing them studies in when both out the will And I finish. read we

started did started bit together. they start a little sequentially, not They before one other know, the you one. As

out any they a out between them conclude? them we’ll we’ll if report there’s or two. I close – if they’re they they’re then think of the So When long report separately separately, together, see. time if conclude And we’ll If together. period then time

that I think And I not missed it give it’s to I think granularity miss anything? – on that did I covers prepared any further we’re that yet. Suresh, unless something.

Suresh Durgam

you cover. think I did No, you –

Andrew Tsai

Yes. makes Thank perfect you guys, sense.

Operator

you. from line Cantor of Charles our Thank the Fitzgerald. next with Duncan question And comes

Charles Duncan

if and nice Sharon One on a Yes. on the add observations really BPD to any is question. And he speak this I change my seeing is multi-part me part let if Good persistence year. the any pricing commercial. that on assumed population, in I’m versus, guidance wondering on have team, a later say, the schizophrenia morning Mark includes and congratulations could did quarter. in

Sharon Mates

Mark?

Mark Neumann

and a began on We the and sure. with Charles. compliance sure. Yes, persistency patient and which favorable in profile depression. continue being bipolar and with strong think through that schizophrenia to – with have has Yes, profile experience. see real continued in trials Hi, we Yes, very CAPLYTA physician is so what that’s down to, among and we other replicated very things, our tolerability clinical the world safety the

have well. assumptions built we’ve of to we’ve as of remainder we continues second your year. reiterated our both question, provided guidance the addressed, guidance for for into the all And go and of the in And this year. that that yes, Larry Sharon part So the that

Charles Duncan

thanks Okay,

Sharon Mates

Operator, question. our next

Operator

Thank of And the Jeff you. comes our from Stanley. line next Hung with question Morgan

Jeff Hung

Thanks question. for my taking

between For for about differences how your those the candidates can differences talk inhibitor you be indications? XXXX lend and and suited portfolio, different Thanks. PD-X XXX to the better

Sharon Mates

Okay.

ITI-XXX entities. molecules new each different entities, ITI-XXXX They’re they from are differ So, other. both two but molecular we’re the testing molecular and

to different scaffolds other have I we’ve affects have ability some potency and barrier to this well. and have the molecules. and potencies penetrate that the purposely several PDEX to aspects We they date. inhibitors, what to as different blood-brain these the of And in and designed their is within think been said publicly But

we’re more So, talking forward, – these about think both very excited And go and them. these I of as more about molecules. be we’ll we

Jeff Hung

Okay. you. Thank

Operator

Thank you.

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

Sumant Kulkarni

Thanks big all for Good see to and company. progress morning. the nice the at my question

mixed be dataset hand And already? any doctors is features, how – on and the way to you might physicians high perceiving that on –and on So have there gauge proactively patients how the quality that I note, request quality high to back do when for you but of SNDA proactively expect meet to feedback, in the the a on data? you very you’re know going seek submission an potential FDA,

Sharon Mates

Yes, want quite to. start? address I’m do you to not to who that sure Suresh,

Suresh Durgam

MDD individual combined as The an with with Yes. the features, population of mixed XXX bipolar depression patient features, we also population is and well both bipolar in the with feature data study our populations depression features. Yes. mixed with strong, as mixed individual with mixed the features mixed MDD have of seen

as right package you in, putting to planning on publication working we we a be also are steps we earlier, published this great the are we to And go steps data update together to to FDA. the we would As as soon are now the will publish our to and next possible. pretty and what and a on from indicated discuss, be on FDA a have

Sharon Mates

we’ll later year. going next to a as And medical be this both meeting year also as well

get I educating the with as to community – physician So, well. think we’re reception and we’ll great the data it a

Sumant Kulkarni

Thanks.

Operator

with from Leerink. Thank of the SVB Marc line Goodman next comes you. And our question

Marc Goodman

to might right higher? you thinking you’ve feel other CAPLYTA potential need can the Thanks. talk relative on if your Maybe there’s Mark, curious Vraylar? that’s it you’re and Morning. competitor making it out terms, how and share relative things whether percentage to major noise got voice of Or like about a about take you that to for just you probably there?

Mark Neumann

access elements clinical have situation. think of profile, with out profile Yes, a mix. the that can like feel then of from maintained of CAPLYTA, thanks, the comparable the the quality we of win since that promotional we voice that comparable we we the voice much Marc. And we We pretty situation we a the maintain a perspective payer there because of share can beginning, across comparable lot if think a in that’s share and a have different

investing I as So, remarks growth I behind to are mentioned in prepared CAPLYTA. we optimize brand my think, the the of

the seeing of very and the DTC nice progress there. that build revised the beginning more impact of we highest us As our prescribers, Light force representatives you’re that. course But and we volume has we’re reach sales frequently we’re over allowed days additional aware, Marc, that been airing with but in campaign our an representatives by following interact year, the We’ve campaign, Let expanded we’re at the to our early new that with increase metrics the XX our still year. liking those with to also the expect and

feel So, the others category. I ability and to we compete in level the the about with good our think board, across of branded the promotion

Marc Goodman

Thanks.

Operator

Michael Thank One Gerberry. with our of you. of comes line the the next Evercore moment ISI. comes from DiFiore And next please. line And question from Jason question our

Umer Raffat

Hi I for have guys, two if Mike. Umer this working there is I may.

the then market about even monotherapy as consider there off-label commercial also right be much. on added used the in expansion is stuff exploring versus getting the you First, for Can of and mixed to we at like would a like what layout monotherapy separately, mixed into point sort And as your could more but very even features if speak think key well? are MDD you shares? features bigger use. trial as us your picture, MDD, that, us importantly may well as diligence Thank Because out about give can you the possibly what players, think of you side? now. MDD as any layer you perhaps adjunct on an we And

Sharon Mates

Okay.

I me I it to. let think two than who out more see can see, you had But there, go parcel even if and Umer. they

want do know, me start don’t to you or you do want start? I Mark, to So

Mark Neumann

I mean, I of then address that share can the market that, and it has turn to portion Umer the over you. question

thing I information feature I MDD What a think previously. handful you share market you’re get a Rexulti difficult approved think of mixed for is to aware, on I at Vraylar Umer, only look the at. overall is would there’s as say is, when market more Abilify products MDD recently including

can mixed but that shares products, get market more those so And is a difficult with get little those to features at. you the

me over you then. that to So Sharon, back turn let

Sharon Mates

Well, you you then these to to about I’ll bit say approved it little that, think either first is with said And to are bipolar markets comments. as this come first population. a mixed why there mixed nothing over in explain back why large features and more need that patient the turn few say depression Suresh and will to is there a for tell we I’ll in know, a I more unmet about Having features. MDD or

So Suresh?

Suresh Durgam

Yes.

symptoms depressive don’t that threshold who is a patients the of MDD have clinical mixed what full-blown meet features, in we major mania. the In in terms studying either patients the or bipolar manic disorder is who for are have some episode of this

comorbidities, of these mixed So have need rates patients in have and difficult They they who these have high higher and unmet makes have features high particular to also this they severity suicidal often and these treat And rates don’t illness, antidepressants. greater patient are patients the populations to are all they patients and higher these also recurrence of population. respond suicide. have hence rates also specific patients more

this. that’s So studied we why

a go to have mood data patients implications has lumateperone with And we to spectrum. disorder mixed with have of moving features, the the MDD FDA both discuss that range bipolar forward. in for disorders in And mixed data features our are mood the across and we we this have the robust individual demonstrated going depression we broad which plans whole – the

Sharon Mates

that they MDD, So your we treated that to know it in or question, go that know optimally the certainly not are that into at least answer is remission. patients such half we

So, very that treatment about MDD bipolar broad of for patient in population both mixed patient a the there’s a the Furthermore, we patient treatments need know population that that third we know features. population. and new have newer –

So, we know address as patient that that CAPLYTA can populations. there product the for are feature robust a such markets mixed

asked we in adjunctive you now that And the right then are I treatment studies about monotherapy question treatment. and Oh, our think place think and a that’s be. right to

Operator

Thank America. you. Gerberry Jason our line comes of from next the of And question with Bank

Jason Gerberry

Hey my questions. guys, thanks for taking

just given a technically these features, morbidity guess, as just to efficacy. effects trial bipolar. CAPLYTA Sorry a contribution approved knock with you’ve the to go just that, there. follow strong diagnose here. be and case you as patients On about seems to to is these have like couldn’t while physicians up revenue mixed laid a no out issue wouldn’t mixed site off-label, I mixed feature you And drug, I don’t elevated it single struggle patients FDA, see features these on there why about

be So, what are they to counter-arguments the single the to why able get study? shouldn’t with approved

Sharon Mates

we our a say putting never policy the Yes, together. we opine to are it that I package to think FDA for are, is

that very depression going have to I we in label are that depression the bipolar about We’re in we right we broad label now now. have them. you speak do and tell a right bipolar excited would to

more including And our we think the tuned, stay so to – I on clinical studies. programs data a that that there’s come, are lot a more lot in

as you back information. soon So, get more to we we’ll as have

Jason Gerberry

it. Got

Okay.

Operator

from you. our of line Verma with the Thank And question comes UBS. next Ash

Ash Verma

good Thanks morning. my question. for taking Hi,

seems MDD trials based for haven’t the sites a on for share year, enrolling that sites you the still for been you have few open XXX the anything XXX have XXX, all CT.gov, I So enrollment. last since XXX like can and for enrollment one think on but

Sharon Mates

enrollment your direction, discuss can then for your has we for well Ash. and than practice the and And cannot think, Thanks it that or reason a It to well go other go because other going not anybody. well. there’s go Yes. mislead question, enrollment our to that can want and I it’s been it don’t

tell we is we’re that seeing ongoing. surprises. fact We it the So, any do not that leave you enrollment

I with you go we’ll the think more forward that And program. we so as know let

Ash Verma

Great. Thank you.

Operator

And please. Company. question of line Thank comes the Fadia from with you. Ami One Needham moment, our next &

Unidentified Analyst

growth of do Congrats previous question, for [ph] morning. drive year? This Good you. are, the curious data label. year you guidance? Thank and CAPLYTA taking anticipate this Thanks. a is thanks sales on features contemplated if Isa And if Hi. quarter this mixed in Leon your our a even And the piggybacking this features Ami. just there tailwinds help Maybe without mixed off specific for potential to in question. BPD

Sharon Mates

that of it is the And drive and It I you present to good good us to is CAPLYTA. to your news, data meetings continue allows community. Yes. news. can awareness products tell good the important awareness of continue for with always medical at to data drive always your physician to

So that. we’re doing

anything do position indications for think guidance you is and sales our its that? our want I right add and to based CAPLYTA the marketplace we to now. in Mark, approved end on

Mark Neumann

No, it, Sharon. that I think covers

Sharon Mates

Great. the Thanks question. for

Operator

Thank you. moment please. One

from comes question David next Sandler. with Our of Amsellem the line Piper

David Amsellem

Thanks.

about wanted a you’re infrastructure that longer how you But cover? commercialization had expansion in are the they we you’re guess give How your sales what general sizing give know sales I of current Marc. to headcount thinking kind term. the a up the I you to MDD. terms for it would you have force biggest maybe think ask I have thinking need support of to sense I competitor audience of resources organization going to just about your about expansion. So, to product, with the term, us practitioner question Thank And what that us a commercial you. wave of AbbVie from of be here, [indiscernible], should how longer

Mark Neumann

give background. let Good me Yes, questions. thanks of a you David. And bit little

care as has well. also sales that of about So of made segment and up currently XX,XXX those psychiatrists, practitioners but mostly our of force primary size target a psychiatrists audience support physicians nurse a

bipolar care out that primary depression. treating treating XX% branded are and mean prescriptions schizophrenia That physicians of included depression Now, is of depression, written care care that for comfortable for those those And high aren’t, account volume there of patients. those are and antipsychotic physicians for physician part and who comfortable those primary target list. current prescribers the doesn’t XX,XXX bipolar bipolar currently for every that’s to our XX% all about the not are segment antipsychotics branded primary they’re

XX,XXX force. have feel that size we sales of the our So we with

XX,XXX. very have of We coverage good those

we think as the forward news treating MDD. treat to Now those who the opportunity and physicians depression, we good virtually lot that about of are also they MDD and there, all is XX,XXX play a bipolar schizophrenia

awareness and those able CAPLYTA And assuming built leverage up MDD to MDD built the be to have physicians. XX,XXX with be will approval messaging we about and well. So that then able about up we’ve as transition would to

but either they or Now, would schizophrenia expand branded order segment of as not look optimize they in MDD that bipolar another it comfortable a believe our of sales get do to of disorder, that treating that to lot there to is or do and we well. on antipsychotics, for treat physicians force in of amount care we write indication are segment our primary and physicians growth would the coverage that be appropriate them

ways a guys opportunity. as you and we’re for we’ll bit update little get away continue So that, still we to that to a closer little

David Amsellem

Great. Thank you.

Operator

Sachs. our Goldman of the Thank you. comes One And Corinne next moment line with question please. from Jenkins

Corinne Jenkins

follow-up bit everyone. a Maybe that question. of morning good to Hey, a last

Could there a adopters? then said the you’re population like mentioned seeing of kind early related And on come basis, something new you physicians X,XXX in You any you in versus as XX,XXX saw there color that momentum quarter. where think who about just provide on you the XX,XXX. I physicians was versus prescribing target was

is or step prescriptions from recent seeing a your currently with previously? You’re sales force was that the target up XX,XXX expansion, that

Mark Neumann

Yes, good question Corinne.

adopt as new the of just market. to medicines they come in answer both I think found general different to physicians in questions those how is

a minority You ones have comes the new a it when on of certain that want market. adoption characteristics adopt of That’s first physicians. They’re the physicians the the quickly. to physicians. it by medicine very There range who to whole prescribe are be

any in end timeframes spectrum, curve to the the physicians and want medicine, at comfortable who of longer have new the the to take experience get see much it. different prescribing minority what prescribe is when to well That’s The also You they other middle they’re before of physicians. are for the also medication. have of they the majority a that comfortable wait adopting

medicine. a us the new kind see adoption is what of for we So of typical

first that, same increasing and pace we’re launch there’s slowdown our to the that or quarters think the the slowdown And the we’re probably at rate are time into encouraging And that see the no us just that adding been been six the to prescribing product. you depth we prescribers quarter-over-quarter, and in I in very numbers of now either. referenced, bipolar what’s of new time, also no

are growth there for metrics see two CAPLYTA, for lot we’ll future remainder to is room through very of robust the those of to So and into and positive well. as continue a growth year us prescription awful that signs this the very

Corinne Jenkins

Thanks.

Operator

And question from please. Graig moment of Securities. One line Suvannavejh you. our Thank Mizuho with next comes the

Graig Suvannavejh

quantitatively don’t morning. X TPP for Rexulti perhaps Thanks And population see this taking see of I’ve just lumateperone performance in on few either about market opportunity across for your to a you a much Phase good another ITI-XXXX. strong the wondering actually opportunity. Congrats I ago. a that my We patient questions. this was patient in just a CAPLYTA. the have question of qualitatively the asked going number Thanks. see and before wondering and agitation quarterly But think, disease I Hey, the in for for indications. to Alzheimer’s a how the positive Sharon, around team question particular, I saw I’m for see you you’re so maybe pipeline thoughts on program this I AdCom opportunity. product. and how you weeks just initiate

Sharon Mates

would you start? don’t for know, me Thanks question. to Suresh, I like start do you for the or want to Graig,

Suresh Durgam

starting the being let trying and as will we regarding closer study you the designs the which And start. on can once I to in come are details studies we agitation know study, this we we come to Yes, the we closer planning the disease do Alzheimer’s Yes, the itself several one studies study. starting with the and that patients. ITI-XXXX are year, of to first

Sharon Mates

that. to the And you commented we [indiscernible] very add and can were I AdCom, panel. the the endorsement on So pleased by to see

do with of use this the patients patient we product benefit for profile antipsychotics First would think our population agitation. for ITI-XXXX that in

tweaking the currently are protocols. We

And think agency, maximizing tries present committee we currently we those that both think a and tweaking from learn as reflect patients. well be what by by making the to as think AdCom on based what our I sure we’re to always to what that we one at can are benefit data. we heard that we that protocol the heard

you So update soon possible. as we’ll as

Graig Suvannavejh

Thanks Okay. Sharon.

Operator

hand CEO, remarks. Thank you. over any the I back would to not like call Mates Sharon to closing for

Sharon Mates

Thank you, today. Operator. for you And us thank joining everybody

our I think QX. pleased performance in we’re strong very saw that we with

our look As Mark moving forward of of mentioned the to CAPLYTA prescribing as of breadth programs. the the to the you, pipeline depth well forward we increasing and as

that speaking to forward disconnect. with look we And you that, with operator, quarter. can So with next you

Operator

now you gentlemen, Thank you and may this call. conference Thank concludes today’s for you. and disconnect. Ladies participating

Intra-Cellular Therapies (ITCI) 4 May 232023 Q1 Earnings call transcript