Neurocrine Biosciences (NBIX) 1 May 242024 Q1 Earnings call transcript

Company Profile

Participants

Todd Tushla	executive
Kevin Gorman	executive
Matthew Abernethy	executive
Eric Benevich	executive
Eiry Roberts	executive
Tazeen Ahmad	analyst
Philip Nadeau	analyst
Julian Pino	analyst
Jaskaran Singh	executive
Chris Shibutani	analyst
Akash Tewari	analyst
Jay Olson	analyst
Mohit Bansal	analyst
Brian Skorney	analyst
Brian Abrahams	analyst
Carter L. Gould	analyst
Anupam Rama	analyst
Marc Goodman	analyst
Myles Minter	analyst
Kyle Gano	executive
Lee Hung	analyst
Laura Chico	analyst
Danielle Brill	analyst
Delma Caiati	analyst
Sumant Kulkarni	analyst
Evan Seigerman	analyst
Leo Watson	analyst
David Hoang	analyst
Ami Fadia	analyst
David Amsellem	analyst

Call transcript

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Operator

Good day, everyone, and welcome to Neurocrine Biosciences Reports First Quarter Results. [Operator Instructions] please note this call is being recorded. [Operator Instructions] It is now my pleasure to turn the conference over to Todd Tushla, Vice President of Investor Relations. Please go ahead.

Todd Tushla

Good morning, everyone, and welcome to Neurocrine Biosciences First Quarter 2024 Earnings Call. Chief Gorman, Roberts, Officer; Benevich, Chief Officer; Kyle Kevin Financial Abernethy, Chief are Strategy and Eiry and Officer; Medical Gano, me Chief Matt Executive Chief Commercial Officer. With Development Business Officer; Eric

disorder. top We're with which Vice of also positive recently serving the read Psychiatry Neurocrine's NBI-XXX, major for II includes President program which out joined lead Dr. line Development, our Singh, adults by as today depressive results Jaz in Clinical AMPA Phase potentiator,

at where been Prior the joining XXX and Eiry things, Jaz, has have esketamine XXXX. Jaz Neurocrine at on few program. today you'll to Kyle sure the led a Neurocrine, for since but years program questions XX for Johnson he I'm only the through clinical for also Jaz among spent efforts & approval. Johnson, other not

remind differ will statements uncertainties, introductions that our may results are With filings. encourage factors latest the discussed SEC to in risk making These and certain subject you I'll risks and you to materially. forward-looking actual statements. review complete, we I our be

At this turn point, to call Kevin. over I'll the

Kevin Gorman

received We've Thank X week and giving the morning. Good of week a NDAs rest had the remarkable offering you, only for off. Wednesday on I'm morning, Todd. it's a approval thinking about everyone. We've an crinecerfont, new INGREZZA. FDA submitted of company the

it has never opportunity so Neurocrine lives to today. the had as impact has positively many

hear progress life-changing business, will bringing in from focused Eric making our in forward. you As of are detail medicines Eiry, aspect Matt, and greater every we on

treating we and TD treated today. We HD as many have as are patients never

group we and coming promise sight line number of potentially the several into a clinic research mid- We in medicines and have a good the as next never years, late-stage have with of the X our disease new them clinical of of from a modification. pipeline, into had now deep

enviable the We're able support programs of pipeline. position our based to on future Now current in prioritizing our funding the constantly and to we're data. be

-- Now a molecule, seeing recent major example increased funding of a XXX increased our depression. treatment modulating program is as a for will will be be that AMPA

The trial program. meeting is we further this FDA be define and will with efficacy registration to seen and very the tolerability in compelling,

press our in more information we in release this Now comments upcoming, and this Eiry's morning on share trial.

our intellectual will future property additional this publication we However, as file limit comments we and set protect on opportunities. data

with remarks, starting to I'd So those brief colleagues, it like Matt. over my turn to with

Matthew Abernethy

Thanks, Kevin.

results announcement XXXX. start ongoing positive Phase growth, been neuroscience With II depressive has Let never into disorder, the to a with foundation of INGREZZA us in our company last leading stronger. activities and continued Neurocrine major week's to crinecerfont build

payer and finished sales QX reevaluate million, challenges are has our INGREZZA's changes associated dynamics and through and seasonal these third quarter. guidance quarter consecutive plan year-over-year well impacting we'll sequential once sales we refill years, reaffirming second with per patient rate Consistent in managed of previous dynamics but approach XX% growth. our QX after the The again. the $XXX reflecting reauthorization over with poses always the at growth to year team

doing as year-over-year on in made As R&D to prior of leverage basis see The a review the leverage, X,XXX can remains will flow capital cash. believe year. basis IP we investments intact. when franchise. our routinely evaluate generating significant team billion over over our allocation INGREZZA strength We the financials, These shareholder drove excluding value $X.X great we with points ended of you in operating QX strategy is job SG&A results and reflecting non-GAAP significant a cash drive our what

on for crinecerfont fourth, internally third, INGREZZA our commercialization; and advancing prioritizing opportunities. First, pipeline; assessing preparing second, growth; external

million past convertible The the dilution shares. of convertible and our excess March P&L, million. of a reducing you've and record retiring and million face we XX further the $XX have as that debt In capital, from face notes recorded shareholders And this to we settle we'll $XXX settlement excess settled value few value seen opportunistically notes manage of by dilution, capital over million. of costs $XXX weeks, cash, final in to fully managing our the million a by approximately have charge $XXX years, fair remaining not cost will May the we a value. $XXX GAAP notes convertible around in representing of we fully few portion May, the an our us convertible return QX with convertible notes As accomplish to upon XXXX

will I Commercial the over Eric Eric? to that, now Chief call Officer. hand our With Benevich,

Eric Benevich

X May with commercial once dyskinesia a simple one years, or complex X-year always TD. launch VMATX Today, day INGREZZA dosing, symptoms in reduce X XXXX. of the the tardive #X since capsule the INGREZZA the marks prescribed the for titration. Matt. Thanks, to is INGREZZA anniversary treatment and inhibitor proven TD only no treatment After of is

very We're made and Huntington's coming progress INGREZZA the or chorea will be in that even excited X of these to past more with we're the years. many years, help with able TD of about thousands the proud we've over people living

Awareness X our which TD In early away Week May Awareness week X-year than Each we're mental addition from from month. May, year, Week health TD through being less as launch, to XX. of designated today's Week. occurs TD the Awareness awareness in year, This is occurs anniversary a

the organizations, reduce to Movement TD. providers join advocacy of word Disorders our across please Washington, Coalition, XX stigma policymakers care health Policy and So various metal the all the efforts in Neurocrine, and in states health spread D.C.

results. Now to on

sales of year-over-year requirements seasonal reauthorization QX the challenges million by represented caused switches. QX annual of typical robust payer sales health growth XX% and plan Our $XXX despite

of who The good from franchise all patients long-term psychiatry, undiagnosed. yet make of to continue with segments of We benefit neurology progress -- our TD and their remain across as care. their X majority could business treatment growing

awareness, on treatment driving focus to continue diagnosis INGREZZA. with we and So

X chorea is making experience months will there. patient positive, for growth HD lion's the drive we're gaining early feedback share Overall, For much Huntington's that always TD population, the The smaller launch. a very neurologists of progress indication, has chorea HD INGREZZA from chorea good in associated into with so with and INGREZZA. about disease been we're

SPRINKLE carry all, start of momentum HD good Just the FDA represents new with option INGREZZA. This XXXX, or difficulty into the QX. forward a approved patients formulation to new and in chorea TD off formulation yesterday, valuable again swallowing. treatment we that All a INGREZZA to is for

for potential are We've now experience been of sales members many excellent to with been on quickly attract endocrinology in the We've treatment Now new of staffing for our our up able franchise adrenal rare place. disease busy categories. in and or field leaders CAH. crinecerfont hyperplasia, in congenital team headquarters

hiring field year. half teams complete to We the in second expect of the of this

What CAH rare educational C@H Our pathophysiology, including in and acknowledges primary gap in of understanding rolled and treatments ], educating CAH called, end, close focus is CAH. new the [ experienced challenges managing to genetic the and research in members to which XXXX in of recently the disease-based with steroid current new on important And endocrine this on challenges out the by a aims the community condition. the initiative topics, community frustration areas CAH we understanding that

in ensure our the potential laying success We're to we're crinecerfont and year launch excited going the of this forward. about XXXX, foundation

call our Eiry the Medical that, to I'll Dr. Officer. Chief over with turn my Roberts, So colleague,

Eiry Roberts

Thank last our regulatory progress you, the made Eric. and pipeline. clinical Since teams Good morning. tremendous our call, with have earnings

adrenal crinecerfont Just yesterday, of the for hyperplasia. the for INGREZZA submitted pediatric patients to new congenital drug of FDA the application we the approval adult and received from FDA and SPRINKLE classical capsules with treatment

crinecerfont presented summaries in Given from quarter, the this. the full in available. CAH, teams the forward at interactions a FDA's working studies and soon posters priority decision on forward they're unmet merit In including ENDO well as publication as for crinecerfont, details additional and meantime, designation also will may this our Throughout peer-reviewed the hearing of the previously for a number be the medical conferences, believe granted with We in look submission on look the are prepared to in we future. of agency. data all We're and the sharing review the of journal upcoming June. publicly near this need to breakthrough registrational

Phase Phase a potential II several broad relative the in part positive major encouraging Takeda margin selective of very to maintaining safety results the collaboration. synaptic in with of to modulator is This one study designed programs was potent, pipeline. the first-in-class induce adults positive NBI-XXX as of with a of II activity. NBI-XXX AMPA ready while plasticity receptors, I'll begin depressive seizure Moving to of highly molecule licensed disorder. Recall, allosteric

is depression of plasticity. neurobiology reminder, years associated a converting in in lines impairment of there recent an have As suggesting significant advances evidence that the been depression with with synaptic in understanding

factors via Ampakines an example, factor, For brain-derived neurotrophic enhance neurotrophic synaptic BDNF. plasticity in increase

fact, the activation effect receptors of In of antidepressant for necessary AMPA is ketamine.

we reduction announced total SAVITRI Scale secondary endpoints the week, primary Montgomery reduction well, with endpoint total met at statistically Last the in met in day the key statistically score Rating The Depression score the as Åsberg significant study XX. XX. including study significant at MADRS day

In a effect size. addition, strong NBI-XXX demonstrated

mechanism severity. in events headache, events, seizures, was majority serious of were dissociative psychotomimetic adverse which There action, this The and no or of mild the most was were generally tolerated well in NBI-XXX event common Importantly, transient adverse for throughout. a no study. no

engage in failed to FDA in due tried we before path and Based near update I on sure AMPA forward as we the Neurocrine to of you encouraging clinic toxicity forward. plan issues to to therapeutic the the index. with potentiators registration. define be will Many and these companies data, progress future have to to progress

NBI-XXX years the profile in enormous this and favorable at partners seen led credit deserve design of activity with Takeda we've molecule their this to research field, date. which of the that for to Our

study give addition, SAVITRI I their the outcome. to thanks working diligence the delivering In high-quality want for this on sincere team to in

U.K.-based Efmody, also addition for both Phase X adrenal of with positive in our our and studies Efmody results Phase CAH, ]. The top II XXX, of II delivered diurnal study Efmody II results. In Phase of the the positive acquisition we to in study glucocorticoid the long-acting classic and of adults obtained adolescents through insufficiency with [ line adults separate reported

consistent respective data. study, tolerated each secondary was both primary with published studies met Efmody endpoints. In and key their profile Efmody Additionally, a clinical safety with well

together total initiation the which study of Phase a X initiation -- depressive NRXB a of negative initiated and NBI-’XXX, of NBI-'XXX, for new a clinical submission data inhibitor; of for development with I targeted Phase NDA the our crinecerfont's positive number of a to I Phase modulator over clinic. disorder; I study as disorders. Phase initiation II also programs providing of NMDA coming not major III II Phase VMATX readout, through of programs last look progress oral information top we've include On next-generation studies, least, an allosteric study the they antagonist Phase in and of MX agonist forward other NBI-’XXX, a on our movement months muscarinic but more of these We each

Looking agonist with selective schizophrenia. muscarinic and ahead that XXXX. say to upcoming now We II to for anticipate readout, our QX top deliver in potential our a line both schizophrenia NBI-'XXX, data orthosteric potential as data from I'm data currently treatment studies from treatment track as on pleased for for Phase cognitive to we're associated MX these a luvadaxistat study impairment

back make In Neurocrine With summary, we to of that, behalf order things I'm in with Kevin? of to I'll hand on continue the we that at deliver portfolio Kevin. serve. the proud patients clinical the to very progress

Kevin Gorman

Nicky, And Eiry. much, for now. very you ready we're questions Thank

Operator

America. our [Operator take Instructions] Bank from of Tazeen We'll question Ahmad with first

Tazeen Ahmad

the and for dosing forward in The about dose seeing that did XXX. reason one you you the response and Phase dose is We that on mechanistically Congrats can not data we're there questions to III? a talk results me encourages ultimately positive extent released. on response. a about get response, dose first still And is few press any moving

then us have do formulation sales to have on the on this Can question just have of swallowing impact that formulation? you second patients you INGREZZA. what what that new now And kind expect trouble of remind percent for SPRINKLE you and

Eiry Roberts

first Tazeen. the Thanks take me let for Yes, that. one,

about doses. the reached the saw than in doses anything both said significance. improvement what we And in statistical of there actually was you haven't the from released, doses We one other as [indiscernible]

we anything And say to terms here other really in we in so we can on the is position before and well. that that through tolerability encouraged we're of Kevin of both talking end say key and by points, overall, robustness I about very secondary What property are and data, a as at intellectual the impact the issues further. said, want work we're the the primary as

serious no event with majority of events. common mild obviously, and class were adverse headache, like their There given really the transient with psychotomimetic both which history of in profile. adverse As the and safety said, events throughout no were important, looking this associated were of the we there placebo terms no most seizures, of doses -- that's medications. And in severity,

Eric Benevich

tackle Tazeen. I'll the question, second Yes,

formulation, people of SPRINKLE or swallowing. we the living estimate So X% with Huntington's chorea difficulty dyskinesia XX% tardive that to experience

nice So INGREZZA. get to them alternative this think, treated for represents, able with we a to be

terms the in of on guidance. it's into And already forecast, impact the our integrated

billion So we and earnings $X.X in the billion. last expected guidance of our get to to issued $X.X we approval at call range

baked So already in. it's

Operator

next with Nadeau comes question Our TD Philip from Cowen.

Philip Nadeau

Congrats progress. on the

give particularly efficacy the you you And some tolerability to to next what data quarter, what data data see give you'd you curious XXX need to compete? us program thoughts additional given most that development, we're safety expected like the now would results advance landscape? of your competitive that on With get and Can confidence XXX to what idea updated could into see?

Eiry Roberts

Yes, progress we've that to with happy be with We're in share happy Phil. made forward data. the be really third XXX we'll coming to quarter, the with able and

you, XXX remind to in study to an in the finding here. study, it's and this a dose patients. dose of full It's us done around response fashion enable Just explore is adaptive about to order a

outcome, relative in what study the pretty think other class, we'd And terms this and drugs terms obviously, PANSS of precedent impact a In clear the the reduction the of seen on of area of that something for primary in I be. in from We've is expectations primary in in be of looking effect the the size terms it's there our good endpoint. the impact kind placebo. score would

However, here. it's you important diseases schizophrenia, really for that's I will the that say think therapeutic if index like about medication

safety tolerability think of And and so we'll totality data, here. looking the which profile, the the critical at be I is including

and the steroid data. Our rather has agonist differentiate, direct approach about the a all of our to choosing a potentially to selective going opportunity believe, MX we than it's agonist but be modulator,

to And see profile, the the at PANSS improvement, so terms as taking both make that into decision we'll move be we benefit looking we tolerability of forward. consideration that the in the

Matthew Abernethy

One last comment.

expect muscarinic timing Just a quarters. forward an big top team. We're data, of when a it's shout the at by This a line important is very out to to I program. the example push able Neurocrine, of really we'd think, couple

So team in Samir ] muscarinic and including by as effort whole excellent in [ job Jaz the the well.

Operator

comes question next Matteis Paul Our from with Stifel.

Julian Pino

This is Julian on for Paul.

any know I but III, thinking not that potentially the you that into disclosing just saw, XXX, on you're moving what Just look anything on you could color what on for response about additional provide Phase can placebo doses, like? the

that. an there's And no historically saw reported, for the seizures then on carry but does I modality additional risk safety,

So the what do you and seizure potential profile? think broadly moving about risk forward safety overall

are the on quick arms in do the that occupancy the then the expected for at muscarinic. power have one dose How to individual lastly, receptor expect range? or active you one And much higher

Matthew Abernethy

We're one to going housekeeping we questions question can so item. to one this per all analyst at stick really answering the through time. analyst Sorry, get quick

you the if Eiry, AMPA program? comment to want on So

Eiry Roberts

Yes, and the I'll time more than the quickly, one answer we that's muscarinic very last one. do

is dose us and This it power It's the in response. trial. has understand adaptive such, an as enable to Phase to II sufficient powered

that. So we're in confident

problem and to a has start I if tolerability Takeda encouraged say. I think just in will Jaz On tolerability, therapeutic doses work both lot the as the And I'll tolerability things issue very profile. that I for in the did my by he look additional comments, profile. placebo of the the in been And wants [indiscernible] of terms overall past. for AMPA, prepared see deserves AMPA of they the mentioned in like were then credit We a years index that's navigating

think I in So we'll more perspective, the And from we profile. overall that need data as progress, Phase safety obviously more learn we about III.

further? want you say to don't know if I anything Jaz,

Jaskaran Singh

there risk seizure. think I was We clear a No, adjudicating on of event of the and very it every dosages. committee really had were no

Operator

Difficulty] the technical experiencing Please And difficulties. [Technical we line. on remain are

Okay.

speakers back conference. our in We have

Shibutani next our take question from will Goldman Sachs. We Chris with

Chris Shibutani

Thank priority likelihood much. for the of On release, you has speak that morning. you filed. NDA launch? a approval review any and and been very crinecerfont, the saw timelines potential press Can Good to

Eiry Roberts

to can that. Yes, I speak

And that in think the obviously will actually hope that a consider of so fact I pediatrics there's the decision, robustness we would adults this that mentioned, we light and yesterday. the Phase as unmet breakthrough I would designation We packaging, priority the their communicate... need both III here, significant data and Obviously, is a the [indiscernible] and of submitted review. that's FDA final just

Operator

[Technical Please line. the on Difficulty] remain We're experiencing technical difficulties.

speakers our have in conference. We

Matthew Abernethy

that Hey, you everybody. the having recently. technical visited our difficulties Apologize I room here of campus moved to we're the and many in know for here. new We've

do So apologize next for that. time. better We'll

jump likelihood back around of let's So to Chris' question priority review.

Eiry Roberts

heard sure you not of I'm if response, Yes. the any Chris.

review will breakthrough decision. communicate the sure for pediatric agency's yesterday, with were place as our be forward designation soon as We be data we'll that's and of anything to know the FDA, the further robustness that. with a able we interactions and obviously, both we adults. So by the but that to it's them, submit grounded ultimately, And the in priority look in

Operator

question Akash next Tewari. from comes your And

Akash Tewari

about that. Sorry

having your from an or -- think Phase you designing XXX adaptive What and about talk are getting study about when benefits III? II Phase sorry, for So can trial XXX, the your information of you they design? potentially

comes comes team then ] titration [ to and minimizing does Cerevel stand right? is Do think them. you to And with maximizing doesn't it it for where does. protocol a Coruna your XXX when [indiscernible] have generally efficacy? protocols, speaking, when ideal safety titration

Eiry Roberts

-- first. on first part part mean second on I the Yes. the

dosing days. will until broader explore often means don't to the the question a possible X, optimal as patients. know data, in done number range are what links Phase most actually, very the II a And limited for to Adaptive we be see X the doses little bit think second the of first. trials we I as in of

It times and doses will the that very in and that of design, we're many to studied risk so understand, II. most take the perspective, to at before. will confident we're within have successful been study to a benefit And the the a from is range broad used us it's us a into optimal Phase of end forward allow which Phase III if allow regimen

Operator

Our with next question Oppenheimer. from comes Olson Jay

Jay Olson

company program announced the Prevail's Gaucher's all to decision in that therapy a Yesterday, their X. GBAX on Type Congrats progress. gene disease acquired the discontinue study

Could you injection? gene comment a partnered the to in . therapy novel single ], systemic address requires which a on program, GBAX peripheral Voyager manifestations transcranial the advantages injection of both neurological and your Prevail's which enables versus [ program capsid

Eiry Roberts

we Yes. That's X into I [ over right. year of therapies Voyager. the take to the preclinical as work I the progress And we're ] all new mentioned so. next from new we've or think successfully think with pleased of our you're really with -- collaboration earlier, the -- yes, we made the with that with of preclinically [indiscernible] intend the next these capsids sort clinic Voyager year, And

The see -- [sickle opportunity to the injection allows disease penetrant that think effects such Gaucher's might not ] you intravenous the that disease, such Gaucher's. blood-brain -- the or an with but capsid a also of Voyager Parkinson's with as gives the diseases only the treat technology CNS to, effects you fact as have alluded employed us opportunity us a by to I the as barrier

of of other The that in allowing while transcription with targeting toxicity disease. copies are areas ] potentially approaches associated for are on in in the past and that [ Voyager technology has DRGs the the focused important these areas

well decision. totally Gaucher's, So effect. has too, yesterday's not central [indiscernible] as we're surprised as by

ICM administration that what that's not the us single intravenous that blood-brain be fact the of It's confidence addressed gene us. single therapy. may the So not with to surprising to a penetrant barrier administration with allow administration capsid. And gives our with

clinical months. and coming more data understand our the preclinical and Obviously, that to that over we're going basis we'll need generating be to

Operator

Your next Wells Bansal comes question Fargo. with from Mohit

Mohit Bansal

key -- you you you on the think wanted about have depression just mechanisms? I XXX. previous that any market? is approaches we do And little NMDA difference would do this in do be think bit in? on you a Where about thought a when should versus it I there How how mean AMPA potentiation think the to probe aware positioning targeting about you there of antagonist? fits

Eiry Roberts

[indiscernible] the you I the and just question? part were other fits there asking approaches? about to where I to repeat last think relative you approach the Could ask this breakdown of NMDA are -- to

Mohit Bansal

from mean I that terms mechanistically, how potentiation differentiate Yes. AMPA of out to are impact NMDA is there? in expected

Eiry Roberts

ask you Do want to going Jaz. there? commentary to I'm give So some

Jaskaran Singh

Sure.

the So are have then effect, so the is going you NMDA [indiscernible] and to [indiscernible]. mechanism bypassing AMPA. acting, you before the AMPA mechanism have down molecules to central The to go NMDA straight acts downstream, AMPA

one of that benefit that Your of any are the adverse having is the events NMDA. key not -- associated you're potential with

seen, you've to that's is which events of and addressing NMBA those really what approved the as antagonist to efficacy of consequential without the eliminating potential address [indiscernible] to the adverse similar have that you're So directly AMPA, the getting of it. But [indiscernible] adverse any and brands events those going adverse most for. events then significant with program with associated is

Operator

Brian next with your Skorney from And comes Baird. question

Brian Skorney

XXX, from also [indiscernible]. to a more response bit little obviously on maybe ask placebo-adjusted guess the I

reduction hoping was X relative placebo I baseline? to of Phase the to at I looking how you might studies, month. could think expect speak like But at about performance a the at think MDD XX-point II least other one cohort to

substantially that about anything is saw? placebo performance what from the design from studies? there Or you other wondering, Just trial would think different for that ballpark is in guys to mean

Eiry Roberts

study. And about I comment Yes. Jaz we placebo, this. very to was a may adjusted would I just that want importance the mean, say and the of shared comment, well-conducted a it. this

all us think And past psychiatry appropriate we that's and in meaningful. focused A Neurocrine lot to engage of with on the to psychs psychs. run that the have our allows how to way efforts of understanding here at level in the how studies the recent a

of will data numbers, comment the going say I'm so by specific the of terms quality not has the on were how it highly I And the we of in robustness study and but encouraged performed. to

Jaskaran Singh

really in in got and validated the a make we able future. highest that actually that to robust, of to put it's lot efforts sure internally that is the data be could quality We've it we've of externally, the replicate data

data. very So we confident with feel

Operator

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

Brian Abrahams

Congrats developmental on the commercial and progress.

go-forward question on maybe you Is plan in finite and too the Another it's based to terms move XXX. think studies? can't you suited for I details How chronic goal drug? Do of you're thinking the say best bigger but or treatment? realize into the might on seeing. for monotherapy profile pivotal treatment are explore you on data, the this directly adjunctive just much or picture . about a you

Eiry Roberts

of were I honest. the very need U.S. of to I we of actually the the engage be mean data. by And all that, think, obviously, regulators to we both encouraged robustness Kind in with

And the in get registrational efficient this program large way comment presentation our one and intent to maintained possible. to would and an just That's I where in effect early. XX. it's But a early the ketamine. in continue antidepressant, XX. relative be not was Jaz like size, within as that day day we ask antidepressant It's would day as but terms -- improve a very first. make effect to mean and to comment still Our into most actually saw you today, at think I'll a I on saw fit, to goal to of

the profile the So preclinical this readily. to date, data a chronic if both allows perspective that data our us actually And you our tolerability therapy. consider from of study, to data, that's very from Phase I the include and encouraging

would add Jaz, to may anything want you there? --

Jaskaran Singh

agree I said. Eiry. much, with everything so Thanks you

question color to we ] still of see only question go surplus to that have out. you that really I think were to them a add can't indications [ the how different but asking, play through those and lot is will had we I the

come So the future. not to it that We're ready today. will talk really about in near

Eiry Roberts

did on in monotherapy have monotherapy We means that, So patients the to clarify question. that study. some the

So something as that be we go will we'll forward. consider

Operator

next from Carter Barclays. Our question Gould comes with

Carter L. Gould

potentially of III of with to wanted moving of the the a the little to mean of able studies sort already the a run sort just got optionality potentially Phase Phase around around portfolio III. Phase you neuropsych. just Certainly I company's number Maybe be and it going about here. think change I when down around valbenazine, of up bit. to sort ask III into capacity staring muscarinic of you've the [indiscernible] on AMPA sort then maturation large

company run the half to consensus of in helpful. that doesn't plus seem have Certainly, Does sort would color there potentially Any dozen to and today. invest? be capacity willingness the contemplated IIIs that Phase

Kevin Gorman

thanks it's one. for Yes, Carter, the And question. a good

As I said and are our in we my opening doing close programs our prioritizing constantly is on spend. a eye remarks, what keeping then

that say thing financial to have do one we It's we to the which resources it all, do.

However, you can't do everything.

there. like if of investigation on then a, we going have with what such, well, we year, And program. muscarinics that thoughts putting and to that reading be have the positive, there's for this So currently up, Phase the the down looks that is go-forward this midst IIs the clinical in we other our are are coming out which

going spend our things a continue looks make keep we going and dig on like this what into that prioritize sure eye to we're down forward. So to good

Matthew Abernethy

the to quarter. here where to it muscarinic I with going But the quality Phase it's But We're future continuing going going as come to to like were is CIS process data great the very going in we the not be XXX% fortunate we Jaz third clear, program a that mean, a and to require the how study incremental. this is XXX, saw good to be on it in more then in through investment. and of that of said, But II, step-up on invest. we'll be Eiry the prioritize Kevin speaking hopefully data trial see and data readout to in that

Operator

Our with next question Rama JPMorgan. comes from Anupam

Anupam Rama

OpEx Maybe the guidance. R&D spend? in of color just decrease on bit on the question what's SG&A a Quick little the and driving uptick

Matthew Abernethy

Yes.

have the positive made a have milestone a like progress the aspect. thresholds. collaboration, partner we because that the we we've our it's With all certain did we On programs, make front, to that with muscarinic team R&D

in So I quarter, a here for $X quarter. I with payments that's guess we second in milestones. milestone have And the first of had in Voyager million that we example, line that's expense R&D more associated those forgot, some triggered then the well. And we also the as

or accounting achieved. that also perspective include are those in and a guidance P&L from guidance So our our don't actually until from we perspective, an R&D in

the looks that's review which just we spending prioritize So I'm a to increase SG&A seen -- investments. put our our on for and that is reason OpEx also basically you've the continuing R&D. cost of in And where reduction quarter, down we sit for the our base sure also

So the those had -- somebody, payments XXXX. program, guidance to intact a But more XXXX, expense likely increase think question the I from will our to speaking, for translate isn't generally partners. directly in AMPA related increases operating isn't outside directly the milestone remains I of

Operator

your from next Goodman question And comes Leerink. with Marc

Marc Goodman

plans up? additional are just Eiry, crinecerfont what's to plans we're for And in what going can we Europe, about crinecerfont maybe at and the we then you the to the data going when for could and staffing June? are about for Europe talk see talk for ENDO file

Eiry Roberts

Yes.

Let take the me part. second

to working authorization we're We now working application will lots of -- moving Europe. on for -- and the

general, think And communicate we'll we going the having want working the information future. information baseline the we timing, secondary in that more the in pediatric so demographic think And that characteristics, kind a information in terms that mean, publication of data our able around adult the of to when be be diligently our I and endpoints, will data through the see primary to in available and in. I already. the that. of the both will the tolerability. team we'll we will once know full and and amount -- we the of share for study largest But full separately top study publication anticipate become context I mean line be near

Kevin Gorman

in of the NDAs to is in regions this company would top United NDA. to growth something bottom world about the in the Marc, express this enough and with Obviously, normally the of X the I'd it program gratitude take filing asking like for file from that X that you're can't the CAH time on is thanks most us important just here, add States. I different to opportunity to to team here. filing region take

That a in changes the over members this at team then team the for typified to while that better by that. lot made the immediately INGREZZA now. they for that That that getting preparations here immediately brought think team -- here we've advisory SPRINKLE. of going very excellence did are assume into doing negotiations, for we Neurocrine morning early but that we're continue switched ] we I whether [ labor has to an committee, those don't will that know switched have same order for have to getting And CAH. the in over this that. We to to ready doing

extremely us lot So understand lives. have we a talented an that and crinecerfont well, of highly bring is change valuable here. We CAH asset an amazing employees to will patients to

everything at focused we And on right that. we're throwing U.S. we're market. So can now the

Operator

William question Blair. comes Our Minter with from Myles next

Myles Minter

of the put any for that got tested hold board on of on molecules seeing rabbits signal? question tox [ peer your your given just in for if you've cholinergic across ] quick studies, assets one a preclinical Just

Eiry Roberts

agonist And No, and enable think each that I not clinical those been Yes. I start, all [indiscernible] preclinical regulators testing of we have that are obviously, there the is scrutinized the we say into the the taken in issue. clinic. packages to for can by experienced that confident we've have to highly

Kyle Gano

this Myles, X, that. is just We've all X. maybe. long-term X, to completed to Yes tox Kyle, add X,

we excited forward. good, going pretty so were molecule the So are and

Myles Minter

To be use clear, did rabbits? you

Eiry Roberts

] in broad toxicity. mean rabbits, the our usually setting they the understanding, not in reprotox and [ in I use

our what for generally in Kyle And enabling as the X So talks. and toxicity preclinical the themselves have we have longer-term testing. of is the the for packages, tox to, basis gone used on molecules selection first-in-human that And into all the alluded molecules are includes chosen clinic. chronic the program species of that

have to that the clinic. the not done to unnecessary beyond We is program profile necessary and determine what safety

Operator

Stanley. Morgan Our question with next Jeff from comes Hung

Lee Hung

cognitive ] upcoming meaningful? need into kind clinically do improvement what impact data, And would III? to be the Phase of to advance you For [luvadaxistat see and what

Eiry Roberts

you beginning if I could didn't the of the question. wonder that. I catch repeat very

Lee Hung

Yes, sure.

and see would in improvement for you kind So III What this of meaningful? cognitive luvadaxistat be do need the for what [ Phase is clinically impairment ]. to

Eiry Roberts

can and because we of study. Okay. bit that that about he [indiscernible] I did, II thinking how the may we Jaz Phase one to study give answer obviously, first in that get little a about context

Jaskaran Singh

Sure.

replicate with the in information meaningful also really importantly, function. the advance one was that So If that a was, there. course, But that in of we more saw And -- X.X secondary there's over cognition in mind of seen a data improved the effect study, would ongoing to before. done was been can address nothing keep done in initial was we primarily doses the that luvadaxistat, be saw study of in the there. study in unit. We hadn't that over absolutely the that [indiscernible] improvement negative size schizophrenia, substantial

to that a I So and benefit even think patients. is advancement substantial

Operator

question with comes Chico next Laura Our Securities. Wedbush from

Laura Chico

quick one Just follow-up.

to out you XXX sufficiently understand, you've before the anticipate program? you what's additional a coming advance program, studies said, ranging that adequately to entering your I'm these confidence respect trying the registrational So do needing of with explored as guess to discussions, dose-ranging FDA X program? dose regulatory I

Eiry Roberts

I'll transcranial that look setting. preclinical as I stimulation measures and that I look range a I broad to comment effects using at doses of ] I Jaz data, one think of data ask comments pharmacodynamic of and And the mean you was Yes, is Phase in [ and tested. other in medicine also the the a this magnetic at testing extremely then Takeda well there if cognitive translational and Phase make pharmacodynamic couple were was did well. space

really in pharmacodynamically that small doses had II. evaluation. confident the good study I on think we into And effective highly Phase were completed a first so safety going Phase just And we read study selected the out. handle And we initial the II in Phase then we for a dose II

than also, and in doses just were some is study which setting. Phase X II -- rather this one, in We common there

agency, might with our we lot -- how doses a this think I so move we the in the point selective there's forward. discussions to And of and support information to

if you don't I to Jaz, want add? know

Jaskaran Singh

I don't add. to have anything

Eiry Roberts

Okay.

Operator

question with next from Raymond Brill Danielle comes James. Bongero Our

Danielle Brill

wondering was share in Just XQ? I revenue one per if the a could patient you average INGREZZA. quick

Matthew Abernethy

reauthorization. if per most Yes. patient, quarter I QX right. where heard you is the patients revenue challenging The average go through always

as rate patient so typically refill of result per And that, a goes the down.

so this sequential from that think talked that's And historically, on about we've we've the I something sequential growth And is to had that, third where QX straight which growth. pressure has year our caused QX.

to gap did on [indiscernible] and a patient that for that team great the rate. for job those try medicine ensuring the that -- really close for So -- refill

net over that per revenue on we on to and expect the do for our script Now dollar revenue be I asking as net to XXXX. script, XXXX front, somewhere year $X,XXX in for the by $X,XXX you're call, the if said compares per

last the And then [indiscernible] we net on have is in reset. pressure of gross to the co-pay result piece typically QX as commercial seasonal ] Medicare and [ part a

And so do higher recovers you have QX points in and a -- a beyond. of then you that couple QX would a of bit discount, in

components your gives to that question. the answer hopefully, you So

Operator

Yatin from question with Our comes Suneja next Guggenheim.

Delma Caiati

is for Delma This Yatin.

initiated of you inhibitor. I the to agent what are versus what properties recently Phase I'm the the And I? with differentiating just key this curious, see a So from you INGREZZA? Phase do want VMATX next-generation study

Eiry Roberts

Yes.

about not quite [indiscernible]. I module this I was VMATX to think heard sure next-generation fully question. about breaking inhibitor. We're up. be But So our it I'm was It getting the pretty excited

is valbenazine incredibly you As performing INGREZZA an can module. imagine, well

of terms high. generation that is in really, even be about can next a really finding potentially So better

we're but that how dyskinesia neuropsychiatric but obviously, differentiation, tardive we some hand happy I. differentiate invested might now. of into we get in the as would areas -- that, We're that that more so beyond the In we have include with molecule be we'll Phase tolerability, information, right that profile and we'll PK valbenazine very just other the the setting, And in starting be I about from obviously And disorders. Phase to that specific potential potential for indication, of understand that. using and

Operator

Kulkarni with question comes next from Your Sumant Canaccord.

Sumant Kulkarni

XXX, On agonists, of those specifically for studies in older in XX enrollment being are your there I XX are criteria Phase any differences any age? by muscarinic adults? And and run

Eiry Roberts

just Yes. in -- range, that I those starting including of healthy not studies we're mean each subjects of subjects. are for the normal up age so the of initial elderly kind

of in those address molecules. each those relating specific questions to However, is to plans order designed

that of so potential and with we impact forward. understand indication molecules can MX, an those the do part cognition particularly, be that both space And MX that, important moving

path exploring us to older plan be for molecules at done And so similarly to to ready what in enable be was II we during the for chosen some subjects the Phase those will XXX, forward. point

Operator

Seigerman Next from comes Evan question BMO. with

Evan Seigerman

at recently big your cause in INGREZZA doing highlight what long-term INGREZZA on see this were where heard for this a we of the or in I haven't you're growth? part the Maybe much to pretty really space narrative used market. be push going least care to

Eric Benevich

Yes. on seeing growth good INGREZZA that progress coming that the growth in and of neurology X It's seeing We've X segment progress business now long-term the an segments the and our care. the across part of with still we're psychiatry, we're care years. is up the in really making. team for been important long-term all story. pleased Frankly, I'm

contributing equal care is terms of approximately in business. to long-term neurology overall Today, our

segment. going to so continue And develop to we're that

basis, add phase, long-term I for relative thing the on would And years overall earlier it's neurology psychiatry that years now that with commercially the in less X is other is only development in a X and we've speaking, and INGREZZA the in sense care. in than that been that

there's that most about movement inhibitor. more with dyskinesia preferred So drug-induced VMATX lot familiar and still prescribed, HCPs the INGREZZA disorders are in as of tardive a becoming learning most

of to out continue going forward. long-term good care coming we'll growth see So

Operator

Ear Our next from question comes Mizuho. Uy with

Leo Watson

Uy. for on Leo is This

still of . differentiate okay? expect do impression How believe on were XXX this on it that to could you we differentiate case? action, the under is differentiate? onset the cognition. XXX else So also you Do Could

Eiry Roberts

trial. going just We're information the the Yes. from through all

we options top best we'll line be the be possibly that and will patients around data I can we I mean, here think more do think the today. the ensure Well, to Phase where to comment totality we'll that will sets designing data, to trial this we the truly differentiate can. shared can so bring that we and III be understand be the also we able of We -- that like always Jaz designed. we appropriately once

Operator

question next Citigroup. with comes David Hoang from Our

David Hoang

allosteric NMDA that expectations from had I is, modulator. the there how profile What This differentiate what I a your would the mechanism XXX seeing drug could and So with just be that question molecule. XXX? on NRXB you're think, around and

Eiry Roberts

on do that? want comment to Jaz, you

Jaskaran Singh

Sure.

NRXB So efficacy NAM for mechanism of potential mechanism in treatment a or depression depression. is treatment system of validated

from how to some at we're be will can profile looks able is II rare data looking understanding study to and to be we [indiscernible] safety efficacy have for Phase studies, to Once whether the best better further a determine like in position growth. and the profile much able efficacy. Phase the So dose we initial we I,

Operator

Ami We'll then move on with the next Fadia with Needham.

Ami Fadia

or would I have to already had question SSRI either design had just other a treatment? have Was quick patients background were The that or that failed failed on were prior there have on at? SNRI? Or modalities XXX. mentions therapy trial that a the patients

Jaskaran Singh

had least ones. which didn't have antidepressant. restrictions could nonresponse [indiscernible] So be that any have require the And on one who they've study in specific at patients taken. any We that to

adjunctive a SSRIs, use mix a looks of with of of the standard care combination what of So It's [indiscernible]. SNRIs, in antipsychotics the seen was like. what was study

Operator

comes question next Amsellem with from Piper Our David Sandler.

David Amsellem

up With for a have I antagonist. orally crinetics CAH its its coming data [ focused having question. CTH ]

CAH that to get coexistence agents multiple the on agent broader in and novel the of your more how wanted for you're about potential broadly, thinking space? thoughts Just .

Eiry Roberts

Well, of things. I mean, a couple

great thing, so data. It's time the XX mean, congenital really patients to getting focus to First the coming, in on bring making and I years crinecerfont living adults. see with before to I a pediatric think hyperplasia, adrenal both long medicines been much trying it's new

that's in crinecerfont think So flow I have great. And of well. playing space a that kind we as

crinecerfont The We second very on obviously ahead. right we're thing now. is, focused are

we patients. NDA our submitted as very data both And heard, robust have III just you We Phase and adult yesterday. pediatric in

patient And see our near always a additional And this so hopefully that options so thing. serve forward this on research And think is that good we're area with the looking to we're [indiscernible] to agonist. very opportunity future. in have waiting to population crinetics the CAH few information the I patients in

Operator

remarks. now turn I over to will the Gorman for And Kevin call closing

Kevin Gorman

much. very you Thank

by I'm all morning here know perception You we're experiencing all we of this that and it what the struck each have what the questions from reaffirms day. is

a company, every I I've the Phase our research the the has of clearly seen learn clinical of never years our position over itself the are to and with all late-stage talking h*** about way in than say the we you trials commercial XXX from will We're into company. then what aspect a XX us then next way program. into better over into today back submissions. pipeline of proven I would which into from in that's NDA questions we're even robust making mid-stage, now and And XX the several months reaching clinic. is one its And

mechanisms. And in very these to multiple can are is mechanisms do we we're multiple have that front about tackling day, we that we remind Neurocrine for one the of disease I of I of diseases, is outlined want to about R&D in length that. what you, that talked ways in And difficult. applications. this us. days best we doubt that we in and and psychiatric The far. our with out tackling what them attack choose working have we are that -- understand that addition, proofing diseases we're far, us is that by Thus at difficult are no great

Absolutely. Is guarantee XXX% success? No. But it will going ensure it to success?

projects the this And going you ourselves. about SPRINKLE INGREZZA all morning. thank our and forward. really that's you much. all pipeline to how questions conducting INGREZZA appreciate and so look very And We I And talking of forward we're to

Operator

does you participation. Thank conclude today's for this your program. And

at disconnect time. may any You Goodbye.

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