Neurocrine Biosciences (NBIX) 3 May 232023 Q1 Earnings call transcript

Company Profile

Participants

Todd Tushla	VP, IR
Kevin Gorman	CEO
Matt Abernethy	CFO
Eric Benevich	Chief Commercial Officer
Eiry Roberts	Chief Medical Officer
Kyle Gano	Chief Business Development & Strategy Officer
Philip Nadeau	Cowen & Company
Tazeen Ahmad	Bank of America
Paul Matteis	Stifel
Josh Schimmer	Evercore
Neena Bitritto-Garg	Citi
Chris Shibutani	Goldman Sachs
Brian Abrahams	RBC Capital Markets
Anupam Rama	JPMorgan
Carter Gould	Barclays
Myles Minter	William Blair
Marc Goodman	SVB Securities
Brian Skorney	Baird
Danielle Brill	Raymond James
Jay Olson	Oppenheimer
Laura Chico	Wedbush Securities
Sumant Kulkarni	Canaccord Genuity
David Amsellem	Piper Sandler
Akash Tewari	Jefferies
Ashwani Verma	UBS
Yatin Suneja	Guggenheim Partners
Uy Ear	Mizuho Securities
Ami Fadia	Needham

Call transcript

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Operator

Good day, everyone, and welcome to the Neurocrine Biosciences Reports First Quarter Results. At this time, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the question-and-answer session. [Operator Instructions] Please note this call may be recorded and I will be standing by should you need any assistance.

It is now my pleasure to turn the call over to Todd Tushla, Vice President of Investor Relations. ahead. go Please

Todd Tushla

Chief and Officer; quarter operator, by everyone. to Business Benevich, Strategy Abernethy, Welcome Gorman, Chief and Roberts, Thank Officer; Development Kyle Medical earnings good Gano, call. first Eric our Matt Officer; XXXX Chief Chief joined Officer; This Neurocrine's Eiry our our Commercial you, our Executive morning, Financial and morning, Officer. Kevin Chief I’m our

subject you statements. to during that call, will to These today’s filings. and statements we prepared all forward-looking actual discussed materially. are the your After risks I’ll may remind everyone best remarks, SEC address of factors will our certain be we our uncertainties, to and differ making again latest once risk questions. our our in results I review encourage do

hand I'll over to call the Kevin now, Gorman. And

Kevin Gorman

the Todd, to you, this but INGREZZA a yet occurred than another and good reauthorizations. has remarkably to quarter ever stronger say with had insurance importantly, in Well, of this good sales. perspective, more from because I very our Thank is new patients toughest And typically fundamentals dollar of and prescriptions bringing QX me, even of INGREZZA quarter morning. more

of know, two As a it we you call quarters. tale

impressive on ever. reauthorization strong that impact their QX first on remain to additionally on prescribers second a I is has The patient What adherence process singular that and dyskinesia and as diagnosis through weeks for patients their several and half recognize working find INGREZZA lives. the also focus the persistence and going back Patients and tardive the treatment.

well in momentum like with strong year. QX fundamentals entering this we're very QX, very it bodes a with for So and

strong. those that for make But some are the quite up cautionary XXXX context Matt in but to valid. QX, be setting will Now statements very is take

Neurocrine decisions. make I the am ability of in aspects is proud difficult our One most that to

our we patients changing goal, resources bring ultimate are With wisely to life to business. able to many be our fiscal deploy making to requires the medicines tough capable cash grow as as decisions to talent and our that utilize to our

end, ONGENTYS drug that no positive to we that evidenced morning is good feedback very by be rights Make of plus received the commercialization this we mistake the To this in returning the on a Unfortunately, which from we as over have therapeutic the the ONGENTYS past announced BIAL. category medicine challenges. two commercial we (X:XX) pose went years. fundamental Parkinson's the licensed through time adjunctive XXXX, launch significant to changes will

we been to efforts, best our have unable Despite those surmount challenges.

company category. experiencing in therapeutic are not challenges these the this only We

both forward, do new ONGENTYS interruption BIAL’s is focus as receiving and any transfer ensure primary Going activities. our to and not commercial patients we in existing experience

Now track discuss Phase number very on and the PDUFA finally, make a disease. of August portfolio valbenazine as readouts progress X and will clinical for to call, our X we the on chorea are Huntington's good in this on treatment this of Phase of later Eiry continue and for year

these programs level the programs As on you but while number factors impacted all have was have by of the worked our several and on in retaining of know, enrollment a teams quality. highest kept diligently macro time, budget,

that, with call will over So to Matt. turn I the

Matt Abernethy

on channel patient GM $XXX payer dynamics up small benefit was performance orders Good us seasonal interact (X:XX) driving navigating great team with customer sales QX INGREZZA timing job Thank million. excellent strong in see coming you, in driving days an morning. day Kevin. a in did record of of the did at and in new end year. a We inventory. several increase a from setting for at QX, The

quarter. during net to out this We second expect the

so existing expect in far patients but this quarterly both a underlying very demand lead in headwind orders this customer can from and to strong QX, to of lumpiness year. sales new Timing and both be appear

for we're one say INGREZZA into year. second the set are guidance we'll quarter. up after reiterating sales great only is Needless reevaluate to XXXX, Given a quarter we and

On for SG&A the expect an for maintaining R&D Voyager financials, we to to the are IPR&D the remainder year. it exception our spending years had down prior Similar increase collaboration. in with SG&A QX of the expense and guidance and step of

to With Eric. and that, I call look Eric? forward now your hand the questions over to

Eric Benevich

for another Kevin QX the Matt. us were fundamentals XXXX Thanks, was strong. good as said, quarter and

these As challenges, sales good compliance to with number the new quarter of XX% seasonal year-over-year treatment. And dynamics. managing portion usual, of a growth we a starts continued spent we record through payer strong achieved patient and despite

American patients of fact a tardive Inhibitor, however, diagnosed with VMATX third treatment the patients with with INGREZZA. our diagnosis are time Association dyskinesia, diagnosed recognition TD about of recommended be We standard care. the offered half on efforts patients estimate have Therefore, treatment educational continue the focused now of encouraging ongoing to Psychiatric first-line of the been and around only and appropriate remains even

reiterate our momentum and XXXX. guidance about good QX our growth carry performance, We QX into our for feel very

Furthermore, month. now, For the call dyskinesia May, also QX as first-week which our awareness several years is tardive designated of May week. designated mental as coincidentally is earnings occurs health awareness

decade and we back, progress and over will with to treatment so we've rates the while over proud made INGREZZA we more since strive come. improve years last of or the to Looking the do for still launch, next six are diagnosis TD

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

Eiry Roberts

everyone the throughout the Thank you, made and call. progress portfolio pleased on steady Eric, entire quarter. to that first clinical I'm good the report morning to

onset adrenal treatment as the occur proof-of-concept Phase firmly for remain results of associated for of Anhedonia top four of treatment we NBI-XXX major disorder. track line congenital report and both to depressive will focal All pediatric and QX studies, well NBI-XXX of two ahead, with Looking as epilepsy adult Crinecerfont the studies hyperplasia data in on adult the for registrational these readouts namely XXXX. II the in

with are for Huntington's chorea to patients potential forward for In disease. a looking with we associated PDUFA option August date the as addition, XX valbenazine treatment

community living with patients to in the in and HD eager We the are further chorea approval. of ready successful to service engage event with HG

with of Phase In and portfolio make of say number to pleased our disorders. of there muscarinic progress first a address study dose-finding is neurological neuropsychiatric I'm the with that under in currently broad evaluation in significant I enrollment. molecule schizophrenia potential a of to agonist progress our a speaking to range know II excellent NBI-XXX investors, interest continues in with

and other teams executing plan development to over as with MX/MX addition NBI-XXX, to clinical pleased NBI-XXX, updates agonist time. selective our followed MX/MX further agonist our performance part into forward Overall, to sharing goals portfolio differentially I with you progresses. I'm we In in year, to a dual year take this by of potentially very Phase look the the this

back this Kevin. At point, I'll to turn Kevin? things

Kevin Gorman

we you, and Thank Eiry, questions. ready your for are now

Operator

Nadeau from question go Instructions] Company. take [Operator first with ahead. Cowen We'll Please our & Phil

is line open. Your

Philip Nadeau

Good us. questions morning. on for our Congratulations and progress from Two related thanks taking commercial questions.

of And the past? the that about Thanks. inventory days estimate? does done issue, reasonable you Matt, what of down in the few $XX that saw like it our QX isn't think you quarter. quarter translates said bit problem Can (ph) more QX. terms INGREZZA number, that growth by you stocking to about million seem a into I in stocking in with increased, of your In that seasonality perhaps math Is it second, quarter-over-quarter a been ensure the on you've the talk a had

Matt Abernethy

so what I'd say inventory was. much just than around is it's million $XX less $XX million. the it's build No, or

of patients relates good patients a inventory, it and and really, really it through brand As I'd felt medicine through we sequential quarter for million new say QX the really we've seen but what touch of about benefit the to saw year quarter, numbers year to similar did, Eric with can on growth. we ensure to that reauthorization process. $XXX year-over-year the persistency talk QX QX growth ensuring and shook good QX something course, a this was QX. record of to that the last how out. very quarter of bit over a we've was year, strong we the done you a And stayed first on kept But medication patients from had

Eric Benevich

learn and number year. are of potentially really base bit that people refills. We though frankly there the success patients and could the reauthorization gets get as are say standpoint a years gone the of provide execution part what are more likely require little teamwork to our of the for to that the we even we And teams interruptions can where can this through what's year, from in field most a would our better we bigger first an that's just to assistance, patients involves how improve. I the with lot ultimately, QX. works identify Phil. launch Yeah, attempted on where every And have of INGREZZA, it last growth. we've driving treatment are that practices experience of few year What annual each the the

Philip Nadeau

Perfect. Thank you.

Operator

take We’ll from ahead. with Tazeen Ahmad next go question our Please of Bank America.

Tazeen Ahmad

around I question. was that that follow my is of a found challenge to taking height during have the highs. still the used navigate patients But that to I something case follow-up. are that. ways is that's its for status just in the know the or what a I it big person. you And pandemic virtually of come as to coming of off COVID, is has guess, Thanks seen I back Thanks. being and neurologists, a current lot guys up wanted that of on then

Eric Benevich

Hi, Tazeen.

really are of all different of estimate degree regard. specialties less that are quite psychiatry So XX% than patient pandemic, physician visits neurology it's went to But in in neurology virtual virtual. high the Obviously, care. during today, we a and patient

pre-pandemic levels. physical that to is, hear neurologists extent, you back So do we pretty on I for can't feedback rely close And it's think a exam. that the gone remotely. to great And a they

in big telemedicine psychiatry, we what So in degree of between utilization. neurology and what still see there's there's we a delta where a high see

Tazeen Ahmad

Okay.

psychs more area. would coming now what split in -- be versus right scripts I know from was So psychs, your because neurologists established

Eric Benevich

quarter-to-quarter. split obviously, Yeah. range little the of from a it it's in We changes still bit about XX-XX though, estimate

Tazeen Ahmad

Thank Okay. you.

Operator

our take question Stifel. go We'll Please from Matteis next with ahead. Paul

Paul Matteis

I a reluctant to Appreciate, endpoints know steroid around the talk sparing. Hey. you Crinecerfont studies. endpoints you. on in studies Thank open-label wanted best on secondary these and and the shot to more about taking at secondary in clinical extension, commercial corroborate broadly just to steroid the been steroid regulatory set to showing consequences what I in from both a sparing. a or I questions. so much. Thanks benefit bar ask the effects as think reimbursement question wanted the or to related What But the side do endpoint, you've trial primary so you have perspective. the

Eiry Roberts

are just and of III Phase III adult this question, studies year. remind to think important the that look in the have fourth set benefit pediatric understanding group, a read as across the and of the have studies endpoints, overall we'll out that in Crinecerfont. Crinecerfont, I we so of we in studies, of all two profile On we quarter those Phase The risk which

and good in we've of And around androgens. foremost, demonstrated control in androgen our interested Crinecerfont Phase First efficacy ability we're the already control. II to really program obviously

controlled obviously, the will that about extensive at outcomes, Crinecerfont have we're the metabolic obviously, is of third thing, very will the And for both data successful. terms open-label endpoints, interested in submission, things impactful dose is of we steroid the a if second measured measures clinical are if broad The ability and in endpoints. randomized clinical interested in way the be that outcome trial time patients for think Across that patients. in to part of we're in bone-related of endpoints the also set most you those reduce the a range and

pediatric And patients. other the for milestones developmental those setting and in growth

potential will risk the understanding terms be the that Crinecerfont. We in of looking benefit of totality data of at

I say what our time in point this And that's at so would I of looking in at terms think that.

Operator

We our Please Schimmer question with next Josh will from go ahead. Evercore. take

Josh Schimmer

very Thanks much.

the Matt, INGREZZA? ones. was quarter, majority you. saw then drawdowns, build Thank script couple think first the that I inventory of led for what a to INGREZZA Just for in of the an inventory think products biopharma What the happened number do vast quick And quarter? you

Matt Abernethy

the that timing of I our the just would the a intentional order really end at at of down leads say channel way end reminder the that was don't QX. the QX on big was stocking front, of really operate of It an the an the first a timing had in buying part Yeah. to do the question? in It on of came We the quarter. it Josh, inventory just down channel. of with quarter. orders with simply And to by a bolus

that So where now TRx TRx that, point to reached to be going on publicly we've anymore. we're scale providing not

say. our what it how third-party I’d available. directionally sales, set full INGREZZA. It’s commentary going capture net around of the is, doing around course, We’re be on we doesn’t course, data interaction, price for is what correct, commentary of data net to There see we’re But providing syndicated internally of that’s doing.

the provide TRx it’s this made distribution in at given we’ve model, time, it’s prudent So our shifts like the no longer feel the we year, beginning publicly. of to given

Operator

We Bitritto-Garg go Neena will with from take our Citi. next ahead. question Please

Neena Bitritto-Garg

Hey, guys. Thanks questions. taking my for

and So was efforts also and force where for year saw wondering the starts just in the could the just whether comment different growth and just script you if primarily could per from net that targets. for of about expand think on the per still coming point, price on the price. year. then to And INGREZZA whether strength you if comment and full anticipate you that's target sales just average on you Thanks. wondering QX where from net that coming physician in I on on last script you $X,XXX new is some

Matt Abernethy

first the second of Eric of take the that part and question, take will part then I'll the question.

our As see to revenue for it of here expect would did seasonal more of gross to to I'm what expect the as We touch net year. per in per relates the the expect per a give exact or revenue in on not to be QX, terms in for $X,XXX to TRx, talk it's script we X% around it net around about headwind, year going for full it but QX, so. script of going we average year you this net XXXX. still

So really the of net to increase for a overall, X%. around year expect price X%

Eric Benevich

Neena. Hi,

psychiatry, not the that now the sales reorganization may by super -- post record is as belief our this teams we are being coming mean evidenced a sales dedicated of part our all segments growth number paying those So answer, we're QX last seeing to dividends. expansion And growing of force And have LTC. starts is this of be the everywhere. question in we by already and what And patient is expansion. satisfying but year, I field forces from that really nicely, past by the and three neurology expansion quarter. new the was force that results especially second and And your is the of related this sales the saw driven that

Neena Bitritto-Garg

you. Thank Got it.

Operator

Please next Chris with Shibutani go with Sachs. move ahead. We'll Goldman

Chris Shibutani

much. you very Thank

ONGENTYS, there? particular also the you broader With regulatory the announcement think us I some the out as in to status obviously, you you've sort the Crinecerfont deal the of over strategic of the portfolio on XXXX. decision Remind plans, UK decade. expect balance is done that you did in of what reviews for the the in Can comment about international

the of have morning in opportunities out I in commercial been realm at we And Thanks. within across your focus, this that neurology front. but landscape, then, point view Alzheimer's point you guys? the play not another how this does all on Alzheimer's of necessarily positive that obviously, the that believe for terms has change scope, data biopharma a could

Kevin Gorman

the respect mind INGREZZA, absolutely able made have With the Crinecerfont, Thanks, there. Crinecerfont way Crinecerfont, Diurnal of into wood, us approval up of with is and that data a purchase good for Europe setting We internationalize you're morning being understand. as Chris. INGREZZA I to this you on an sorry, to with initially in right. -- the an could knock was With on entry

infrastructure begin and presence. wanted able to we there, have over the do be a lot on Europe. to trials the in clinical to begin an have We ground of So to UK

addition I the already. a there have CRAs leveraging now over the that way big the a there. folk and They have development in say, folk, they also to from we're are clinical the MSLs and that should Diurnal So in over Neurocrine standpoint,

that now. So out us well turning is right for

following Commercially, to strategy it will into now build in able be that. much easier be The be to would to our EU file. FDA

EU. Neurocrine is followed and molecules, about of cross When U.S. see the psychiatric with by good what Neurocrine the we to and whether I when a is because will doing think what have needed neuro data be an active diseases, you currently barrier. neurological the the that then to portfolio they filing really we be course, here So first an a Company, had we would broader Crinecerfont comes it have it exquisite portfolio, them, we many being talking focus small blood-brain and of have orally have been you're and

But what more is with us molecules, making that do we're going what biologics. more see is the recently, into you with we've been large

Well, in you be to diseases. reach in disease curative actual now step research, You're order therapies and within gene modifying broaden into get to antibodies. and I developing neuroendocrine neurological therapies and antibodies, tell we're not seeing seeing and in can that peptides, it, you may preclinically us our proteins, but the

I continue course, strength has, of think and forward. will that of psychiatry active with by orally molecules, going which been small a dominated ours traditional be will we that

seeing a be But the in to clinic starting the you're midst to we right XXXX and introducing transformation the Neurocrine throughout from forward and now into the drugs come. going type are years of of in moving decade

Chris Shibutani

the Thanks for perspectives. Great.

Operator

question will we go Markets. Brian with take And from next ahead. Abrahams RBC our Capital Please

Brian Abrahams

our regards Thanks my thanks suggested taking all the treatment a use, And to I plan how that some some Congrats but and new option, disrupt there's progress guess so are much. about may very have make Crinecerfont, patients to steroid equilibrium which this. you question. them research wondering on I'm on reticent excited With address market that to has struck may their things. so for

obviously this think of have just markets. enough? being do and expertise totality strong You it's -- a having of data you matter building a lot Is convincing of that

may just question. real thinking maybe this and potential think how that And uptake might timing or you optimal campaigns this then $XX you targeting And candidates about shipment quick shipment we should that curves for or impact impact and might populations, is you just educational be or that million about mentioned, envision. both Thanks. how cell to does a inventory be there Are who inventory might certain drug? The else? refer housekeeping timing initially, something

Eiry Roberts

in is be some kind fact, Brian, from Crinecerfont nothing over is need space. new for no think Crinecerfont. why Phase steroid and patients successful to and been years by believe with thanks. we're if switch ambivalence steroid. unmet significant II with I you our about The XX hear need, there reason can had willingness We patients there's for this these program in that have living unmet CAH met medications approved And for of but that

And to so I think care. optimal less settle have for had than people

to And support so need in by broad a in and unmet will to have allow of of need will your to to point, TD. of and and approaches I of INGREZZA with our risk supported be amount similar significant a range to fashion think ability the address benefit done what that data robust we that demonstrate a other Crinecerfont us education

Eric Benevich

that just yet. Yeah. And days I'll early add its

as the with We Crinecerfont is doing haven't can of and data expect. of and other they treatment within educate completed side and our the to Crinecerfont haven't that on [indiscernible] on value efforts what think, of launch leading what approval the then up our communities And patients, really to to we'll knock shift. to what be means partner CAH. educate I formal on and care administrational does trials. and a reach represent, various company, meaningful patient a we started paradigm And part pretty

from a You success of scratch and towards think we learnings opportunity market I the apply new in some noted CAH. in can building that in TD our we've demonstrated

Matt Abernethy

once to you a -- recognition -- Brian, shipped delivered bottles distributor. a distribution from revenue and from perspective, So the the recognize are revenue your

do shipped, at It and just say what delivered in the just cadence when timing would the yes, to of of I it a order placed was of those normally the that pharmacies would terms your than what of with bit distributor. was end had question, be quarter. distributors, held and specialty really at So it higher the out

Brian Abrahams

everyone. much, so Thanks

Operator

from our question Rama go next Please Anupam with take We'll JPMorgan. ahead.

Anupam Rama

taking for question. so Thanks the much guys. Hey,

INGREZZA trust Just as I of wanted in earlier in this specifically? in bit But on a made know some area you trends you've are maybe comments seeing care to and more an this call. facilities. little segment brief the dig long-term terms in what for growth of the

Eric Benevich

Anupam. Hi, Yeah.

on. still a decided care would to long-term the we're brand the of a very I yet. had say have we that the few that in, is So us, beginning new care that but days and quarters launch capacity at This of early looked we for that and segment didn't it's site take

so success relative off obviously, all out built that's the made and for commitment. things dedicated doing a in the to And long-term area year, it's the team care. necessary been still there ultimately, they've getting we But ground long-term and We last just bit certainly, further the psychiatry the development. we're and But get progress a that more providing are of that pleased forward little in more little neurology as down I further details with terms seeing. look road. we bit along a very market an to And

Anupam Rama

Thanks much taking question. – so my

Operator

from We Gould with our question go Please take Barclays. ahead. Carter will next

Carter Gould

thinking believe Great. you at to the I Good for looking don't Phase Maybe that? clarify AUC I on And TMS trough front? morning. about XXX. if of Any you on the sort you. more guess, disclosed that doses the that, color a be maybe study, if FOS broadly, Thank but of steady And informative Thanks you're state levels? in the data you're or target just I exposure, sort Eiry, have. a have questions. guys taking of kind may how coming

Eiry Roberts

parallel is dose dose-finding study. randomized XXX four-arm study So study, and seizure in XX-week three understanding that the reduction frequency study focused XXX seizure on a in It's is of with frequency from a for that levels endpoint patients. individual baseline a different

and all epilepsy, clinic data of animal data the know, that took define we the doses terms order Phase there, In of used the that well models into were of as in which that from chose into the reasonably the you to doses different we preclinical study. I the translate

in this signal-seeking are efficacy benefit for study and we with is of risk covering dose range a the are so XXX. terms and confident And that that target the we well-controlled that

Operator

go take our Please William from will ahead. with Blair. next we Myles question Minter And

Myles Minter

taking for questions. Thanks Hi. the

way growth INGREZZA is maybe moving you've Just Maybe that on cautioned you against on decision getting I the as career more And much through of to on it INGREZZA. the Huntington's on your for then or secondly, about in wanted that accuracy [indiscernible] you just prescription the build better forward. tardive updates track from a the that, I IMS, that Is to market? not the our comment are thoughts can to taking how just it already we Thanks. disease provide to share the can previously, dyskinesia rate is comment know need similar can you VMAT see inhibitors scripts that space? but whether

Matt Abernethy

Hi, Myles.

the directional won't historically. been it would syndicated a into affirm has is TRx, than been give XXX% the We, the performing. we're bit course, But say It's for stable in had data directionally will I'd than more accurate. say a that about how it's you past. it correct So more third-party view of what I

specific HD. second I'm with of the to going to to hand Eric, that, the So part over question

Eric Benevich

Yeah. Hi.

that XX% program that, valbenazine this experiencing need chorea. So most group to patient from approval. But that chorea excited we HD for need about unmet Only believe development the is treated with VMATX that And introducing Obviously, the patients clinical would are there's excited we regards apply disease are with here HD. about prescribed INGREZZA with that profile get we have and see the chorea our of as we're in before, are opportunity, we're the to actually that with plans only and about still significant in of we some TD we've inhibitors, indicated the which living chorea. that population. said for emerged HD actually reasons and obviously, that equally agent HD people the are chorea in agents of that Huntington's to market

that the forward to we’re to for advance to And doing you that. all need eventual expansion looking things in that label. do of the obviously, prepare We’re

Operator

We'll from Jeffrey take our Morgan ahead. next Please Hung question go Stanley. with

Unidentified Participant

questions. taking Jeff Mike Hung. for (ph) on is This our Riyadh for Thanks Hi.

We a in FOS. on also study Phase XXX had the question II

drug-drug So any be running? patients to on those ability be pharmacodynamics the XXX’s this therapy. during could required what mitigated and interactions background for does there Are are measure the limit or to you. Thank extent concerns

Eiry Roberts

in context That Mike, trial given does the so that is previously design one trial. or is of allow in population the and patient pharmacokinetics coming are up data. disposition serving have response that from we understand to Obviously, into why interested preclinical the inadequate patient XXX population to the of here we four we and medication. the the well other used the -- medications incomplete I anti-seizure Phase

as you that low data. exclusions of of that criteria the we've number clinicaltrials.gov, in inclusion/exclusion the see the in so is the And from and previous required context of reflects seen lack drug-drug interactions our

In pharmacodynamic of the effect terms medication. of the

suppression these that for controlled. seen order to I in need treatments you’ve seizure useful not there as the ability think, other epilepsy, adjunctive be additional experiencing since they benefits patients an well are in is still to demonstrate

have the medication. demonstrate around we don’t ability And is that so an concern effective to a XXX if

Unidentified Participant

Perfect. Thank you.

Operator

go Securities. We’ll Goodman with Please Marc take from our ahead. SVB next question

Marc Goodman

sense on we the of kind sense going spending Can Matt, I or guess to of And about be or next the continue I just what percent you process increase? a you're us And be of thinking it seems just go should continue up, scenes. expect to behind we over give to increase like there's us in how years. a and the give we of this should how we're company few will a the because R&D sales a managing obviously, is will could of as gain mean, R&D? that going to get I leverage? big. numbers just modeling we as lot thinking mean, R&D that

Kevin Gorman

Marc. Thanks, Yeah.

just just advantage science right in out serious from going now address the amazing that just really and changes order start neuroendocrine the diseases. to have I'm to saying So that taking high and taken place we're of real the in neurological level

think that's move in bolus couple research so early you're a of not -- heavily the progress made to invest and just in sales see, I company going seen impressed molecule -- about I to from that's the last against the you're of stack real big more and on. little biologics our years investment why the to we've or standpoint. especially seeing you've we've in here being how And that so, just a development, able very from bit us small And a think, I'm over research company think preclinical going and to can I so -- up Matt financials. talk a ourselves And

Matt Abernethy

want R&D is cause invest in sales that a think a about we somewhere would a pipeline and XX% build would we in perspective of to that that it How around us like look from where be sustaining the portfolio to feel in you that allocation us at level we'd capital to allow some clinic. be muscarinic a company. perspective FOS, from dozen we the we're now if the about trials P&L programs ongoing, a other that programs, think at CAH would When today, a have you

have lot momentum now. We of a right

And expect And available up we've table start QX. several I And second that from cards this all looking for last think the has seeing really CAH are the early efforts all in years. us really year. the the be I teed that around of data flagged turnover as to we the think of forward undertook to the half

want find but patients And value drive going capital it's a perspective, from to that and for programs. We for upon dependent not really for it's value I assume fair so, quality to the quantity. or just XX% think So creating shareholders. will allocation obviously we're

Marc Goodman

we've been there? question oral dosing you've you Thanks. the week, anhedonia you're a just quick Eiry. talk how If just work, I and about done the how on could a dosing what's that Can and work to about done, gotten mean, thinking once the support I ask

Eiry Roberts

Yeah.

our the in the and preclinical that clinical associated understanding an based schedule defined on study Phase anhedonia target. Phase for So of was we're with that using our II this I and data program, dosing biology

the to so us that esketamine is in testing some depressive medications And similar the the this schedule major we're ketamine, up a that enabled fashion there. in study. disorders. as from what come Obviously, other That's used to with perspective, proof-of-concept dosing a of such

approved this medications anhedonia, disorder able work symptom the There demonstrate Also, is of very know. And the signal look done there in as of been in anhedonia, spectrum. the understanding for treatment you study. to anhedonia this QX, in we a depressive we're is which has at difficult whether in forward really end little within no a year, that major to are historically

Marc Goodman

Thanks.

Operator

next our Please Baird. Brian ahead. Skorney with question go take We'll from

Brian Skorney

question. understand sized can of statistical Hey. And -- everyone. Thanks set is in I these my taking the clinically morning, are mean these up the be maybe to would studies hurdle? for sort kind hoping gained Good sort differences well sort just us of significant? between Eiry as of what My of study. on Crinecerfont. question fairly was I significant just

to for hit be it So of really a demand looking we significant is hitting this enough value very key But seems a the data would think commercially of that -- of and on like for you sort you'd kind can statistically. Like to wondering is I'm justifying. see totality what product?

Eiry Roberts

Having way benefit the the as that the we've risk week of the levels and to Brian, are in important study the endpoints at obviously, steroid parameters context Crinecerfont. is adult designed similar. lot programs, of study beyond studies Those significance themselves. in androgen a and looks step the the namely we've four chosen, that. very obviously, parameters that, Well, very the two the in the of in pediatric that the hitting primary for across patients believe of are understanding And at reduce statistical ability dose first different endpoints said the study. we important And

important totality will the support in short-term will the Crinecerfont well. of And of data, label that as in the data the for correct that with be CAH. in generate patients study to in open you're potentially of interested we're value overall understanding addition the so longer-term data of Crinecerfont And terms

on in that is not really And these would so the and from it's everything able to I to fourth emerge we think we the of data that being now, year. set be what possible think I that trials, these relevant data that overall quarter are turn measuring encouraging, this the and say right cards for forward to but patients of most might context over pattern look

Brian Skorney

Great. Thank you.

Operator

next We'll James. from ahead. take Please go Brill question our Danielle Raymond with

Danielle Brill

the Teva's you offset disruption as I’m to and unwinding from INGREZZA, Hi, any you've you. headwinds Thank encountered guys. question for about quickly much. then, have expect functional risk. I on once measures mitigate it a curious on I'm so new potential well. or Good curious Thanks that daily taken morning. (ph)? if And CAH any

Eiry Roberts

place I subjects central that, think to as is in of central data of clinical data quality to the throughout And trial subjects trial. actual in many us Kevin including measures our in the safety of itself. terms of discussion alluded we to our overview and of ability discussion the address the order of endpoint, earlier, paramount blinding design and obviously, to have the the trial and protect of integrity

and I of at worried time. And these issue things throughout think in the that, of functional the their in they hormone terms we the so for context about patients other experienced and variability not that levels lives, are course of I the unblinding think this of the of

Eric Benevich

and out hasn't Yeah. profile With the But to treatment Most weeks. yet. at question been is remains perspective. about regimens requires strengths different your the will for to administrative take of from had mandatory of look to that up seven XR, still require and regards say chance maintenance and pills data complicated the a product deutetrabenazine rolled I we've a it two a that titration what an

we've So this. prepared for

a pill trained. remain only prescribed once have been And the mandatory one titration. dosing teams no and treatment. Our confident TD INGREZZA very that with one will We're preferred, most most the it's day

market the going about and leader. to we’re good our the to So market we’ve to doing feel in [Technical continue Difficulty] do momentum the we be the to things or develop market been that

Danielle Brill

you. Thank

Operator

question next Jay Please take go We'll ahead. with our from Olson Oppenheimer.

Jay Olson

update thanks recognizing on books a Well, year. hey. for Congrats this that large the you've already on deal got and the quarter

your Just for allocation thoughts remainder Thank your priorities additional year? the the development, appetite areas what capital curious for interest of you. and business of about are potential for on

Kyle Gano

question. part the side do we of This of Thanks, quite that's remain the at BD active I what Kyle. Jay. Obviously, here on is we things appreciate Neurocrine.

to I think at like that anything technology, type of do we we looking work with a the to spirit seeing program of urgency, the without right program it's but our feel if in company. the bring we and to need don't

psychiatry, interest in immunology we've things at those with neurology, across previously, endocrinology categories. our and neurology looking a lens outlined we're that As on currently broad

business INGREZZA course, pipeline of development. Our priorities and are of and in valbenazine pillars, the

medicine a science, could technology interest you theme potentially programs talked of areas the standard innovative changes is us lot We've in also well. look comes see terms at strong to We've that But technologies about are of differentiating bring and a you IP the can those stage here ourselves of platform time, in we've bring in on done over overarching And opportunities, opportunities. that that diversity the we're modalities. and migrating deals of as that But types it the in to care. when as where towards meetings we also later along well. that agnostic mentioned we a commercial with given find deal that previous structure. in And of open that we're

over more remain So on that in news to programs at active. the we to look having time. new bringing We'll and company continue

there. I'll So stop maybe

Jay Olson

Kyle. you, Thank Great.

Operator

Please The go ahead. from with next question Wedbush Laura Chico Securities.

Laura Chico

if the question. Good wondering remind for strategy us you morning. to could muscarinic with Thank to you the respect very pivot back agents. taking towards I schizophrenia. And on wanted the much

year. how picture the commentary there advancing multiple you're advancing you maybe and MX/MX. agents this guess MX on you. bigger MX/MX I mentioned ultimately You evolution an see later would selective consider an Thank guess any dual proceeding. as you such though, I

Eiry Roberts

of starting, set Sosei There's space, of one access with was a with muscarinic neuropsychiatric just That with the we extremely were to neurological to of one not mentioned huge II Matt patients in doing agonist and to that We're psychosis. range disorders deal a we earlier able the to enrollment molecule again, of ability believe was and to MX of there. opportunity, differential serve that reading And in with broadly in disorders. Heptares the data the selective do study, attractions the with molecules portfolio the we're to the Thanks. acute I but this obviously, as the a we well, agonist selectivity. look for as Phase of targets treatment think both well out

molecules will to we about gain range which a year additional are that the they different this then also disorders have within actives both that We similar neurological clinic MX/MX MX potentially portfolio agonist neuropsychiatric into the disorders. from And and considering progressing of disorders be an are of obviously we we of other opportunities we ranging cognition think neuropsychiatric dual or broad access too, also selective when molecule. but there

for believe portfolio set a we patients indications. about that of of and be very broad potentially mechanisms beneficial excited can very that we’re across So this range

Operator

next question Canaccord. Please our take Kulkarni We'll Sumant with from go ahead.

Sumant Kulkarni

Good question. morning. for taking Thanks

could Crinecerfont, to us approved, very and your on potential give very latest frame would you helpful. dyskinesia is annual Crinecerfont give reference of be different Assuming us pricing? a INGREZZA tardive if disease that could Clearly, relative states. for CAH are at thoughts least But you pricing,

INGREZZA if at at launch time. the this exceeded remember far is Another I investor asking reason price because expectations right, I'm

Kevin Gorman

discussions for patient III very come on already But in. of to prices. that the point any Lot to Sumant, at but this the bring work beneficial to of a hinges think through pricing settle one of has highly the the Phase data this premature ultimately data actually develop have the of it's be set, the goes go we that with needs go of which do we a is We see in we ultimate FDA, the on data with out is the beginning Pricing of this about entire on to is range much can I very have wealth that before started, population. population. developing do Crinecerfont of not and label. least you patient one benefit talk very number not reasons, that what

question, thank So the premature. but too you for

Sumant Kulkarni

it. Got Thanks.

Operator

move Please We'll Amsellem ahead. go with next with Piper David Sandler.

David Amsellem

Hey, thanks.

pipeline. psychiatry the on just So

of terms is in psychiatry general. about but that how molecule one. Over safety second whether it's foot your I the I schizophrenia misinterpret in Thank didn't on small about development that's it sure take to wanted in differentiation, and say time, KarXT late ask thoughts stage just gas it's off versus in how you the to you On your you I product Kevin. philosophically, make efficacy, I any would that? And early, know may fair to remarks, psychiatry pipeline a do in think you. But number That's just question think development. MX/MX, want on the

Kevin Gorman

the I quickly. do saying first taking dedicated What for part to there psychiatry. we was role biologics in is future, No, not is the take psychiatry. for off no the very foot gas. I'll foreseeable We're a that see So the

robust neuroendocrine stay as So efforts actually, our therefore, targets molecule will against psychiatry targets and will as in molecule stay the ever. small neurological efforts small And robust.

in What then some exciting that neurological to of the or real neuroendocrine over years do we're it apply diseases. XX has of the XX that allows modality. Neurocrine diseases, us to do able let's with able to right the now been right science What will target biologics, choose is to it developed do, taking disease advantage what is right therapeutic hit and allow right be now to for the the it

any We just are longer small by not constrained molecules.

fingertips. our We Eiry? have therapeutic at of all the modalities

Eiry Roberts

Yeah.

about to be of talk On question differentiation, that. is early the to it really too able

will in and allow power single conduct schizophrenia differentiation. understand and differentiated experiments us that clinical preclinical indication we I to that that setting the as that value the of the ability as MX/MX think either. for And mentioned, a this to believe that we dual don't highly the I constrained is with are a muscarinic agonist I have portfolio that to

in And do portfolio. space a the neurological believe and lot I this of both for psychiatry opportunity there's so

Kyle Gano

Kyle. and This close is that. I'll add on just Yeah.

aware of my where back that there's the of require other I some -- that on of that point, to agonist muscarinic that sort there is think the activity. some doesn't effects of, is MX/MX development company off-target out starting add a point our in no we're an starting mitigate peripheral this, has that is dual

the have starting we have in right Eiry mentioned, I think and now but we we that very that don’t a data taking to one we're that forward, certainly as So being position the clinical is have with position. excited differentiate,

We around across and have have. of that we this program lot dual a molecules the excitement other

Operator

We’ll Akash Please Jefferies. ahead. go take with from our Tewari next question

Akash Tewari

much. so Thanks Hey.

in greater has the been in shown highest to other than were XX.X% dose due X% And we've it's neutropenia. indications. So discontinuations studied when that seen CNS neutropenia Crinecerfont then group, mainly

of So you in, neutropenia have Thank what dropouts powering And trial? your for you. the what your going expectations into data? your baked level are for in CH

Eiry Roberts

for that. Thanks

rightly major seen which Crinecerfont in was (ph) study sporadic disorder. were us studied depressive arm, laboratory was depressive no you of measures was white seen In of neutropenia setting, And count in to control study major a prior having II as associated citalopram a in actually which laboratory said, there disorder also the our hands in molecule. with So low the the Phase that events study. adverse the on and in measures was was that

work in We the seen or the We neutropenia of Crinecerfont. is have X,XXX context the in preclinical there that evidence no nor done of a CAH low we've signal treated white in with patients over counts now setting. have

neutropenia safety can And about worry program the is us and molecule. obviously, as context in of don't you of the we patient so this context paramount this in for imagine,

Akash Tewari

really That’s you. Thank helpful.

Operator

next Capital. Please ahead, our with Seigerman. will Evan BMO from We go question take

Unidentified Participant

like you this guys. could to to line scale mental level. look a This specifically, ways clinic what you Like, translate the Evan. in what broader on from or illness. we're could I would And Thanks. symptom. sense as think cross do then maybe on anhedonia functional DAR questions. could Keith set draw know of of (ph) But the a the taking more out. how a improvements distinct Hey, Thanks anhedonia on data a our us for of a negative on for readout, is could you guess give I symptomology

Eiry Roberts

of As trials there fact, been is And proof-of-concept disease. the a This approved depressive no are clinical treatment few in have and major done. anhedonia Phase there for very know, you II study. drugs

measures study anhedonia scales looking at the scales within major the We depressive also have both (ph) the and themselves. embedded

lines that we the the and trial for patients to well. progressing that mechanism to of data other obviously, impossible kind of at We're point unmet of interest There's prior need forward excited And look a about time this huge symptoms. is data is the with this of conclusions and depressive extremely so end disorder year. it's any very lot major a in the able at any And the readout or draw to here. be to to seeing

Operator

Please Our comes with Bansal ahead. Wells question go Fargo. next from Mohit

Unidentified Participant

so Serena Hi. This Bansal. Mohit on Thanks much taking for for is our question.

to I So questions. want ask two

First, SG&A cadence the on spend. of

they QX, wanted if the have And elsewhere? be of excellence endocrinologists on or market proportion significant that see or versus treated And Thank given only poor in comes like, any are little year? drug needing I this two, of CAH what growth be then do of general what info a the in also the during control? patients chronically of treated understand to in rest centers to patients And off found you. Just you times better. you by line,

Matt Abernethy

those of both answer I'll Hi. questions.

the QX. a spending there spending, in SG&A of bolus was On

I look expect should hit is in expense range. at step expect guidance You the QX. it that to we to down that way our And

And divide QX so spending the I consistent, pretty it by the and I take three. SG&A It's through remainder be to believe, of going QX.

On some the many nice, centers CAH that is front, it's yeah, patients there help is of -- CAH. treat with there excellence

support this patients. we’ll their develop thought will And to we’ll I reduce adjunctive inform benefit and we would to take patients would think what therapy for to to the chronic their do that the exposure them local those they for lifetime like, But do the allow to be this that that looks pay level help data something CAH. leaders life, be of over see the believe steroid entire what could continue a KOLs help in – significant with potentially help And therapy CAH. there endocrinologists

Operator

take We'll ahead. Verma with from next Please our UBS. question Ash go

Ashwani Verma

for question. Thanks taking Hi. my

primary study, reduction four-week Crinecerfont for have in-house already. on data the you So endpoint info do pediatric baseline

on Thanks. And can on you that, data comment If this? the for top please? line secondaries to waiting are XX-week you the

Eiry Roberts

four-week endpoint XX-week is treatment. primary the blinded that of is the steroid the the part Although study maintenance reduction out to data,

And year. will QX of so in-house this [Multiple be in the as data signaled, we Speakers]

Todd Tushla

Nikki, we'll question. next take the

Operator

comes Partners. next Yatin ahead. Suneja Please go Guggenheim with Our from question

Yatin Suneja

Hey, you in. Thank squeezing me for guys.

delay you're just studies, FOS? Thanks. in is you study, XQ of this Just the a study. guidance? see question how a just on? update at and focused maybe And a on Can seeing give question confidence U.S. quick little an bit U.S. side, FOS where so other I focused outside have enrollment on then XXX, just looking we from bit in a especially other curious is the study little mean I is is, the enrollment don't competing the what

Eiry Roberts

is The and this that this for to enrollment on data believe deal At being great the QX has time, study performed enrollment point we us a year. have with track United States. is in helped of outside in

Todd Tushla

Thank next the you. take we'll question please. Nikki,

Operator

The next question comes Please Mizuho. from Uy with Ear go ahead.

Uy Ear

for Thanks guys. in. me Hey, squeezing

Just a question. quick

from I think you guys mentioned growth was INGREZZA everywhere. for coming

seeing you of Just or Thanks. force. are wondering physicians depth sales to more patients? breadth largely with growth terms more prescribing also drugs in added you the the from seeing Are

Eric Benevich

on care. reach we earlier we're nice To all the growth ACPs. which previously. Yeah. that long-term across able newest team, our with Obviously, and the reach segments, my psychiatry, we hadn't segment, neurology able ACPs three build sales the seeing of comments, is to been more of expansion to were

what's driving as part also of prescribers we're new patient prescriber in existing base. of the addition And the seeing are seeing we growth. increase So volume an from

business. we're again back how to very growth These ultimately, across of developed coming we're of results everywhere. with pleased our seeing the But that are theme So in going segments terms once the segments are. they of from all different

Uy Ear

If I can, can a I squeeze Crinecerfont. in on question

Todd Tushla

Uy. Hey,

We Thanks. question will to got one in. We've you. get with more follow-up

Uy Ear

Thanks.

Operator

Needham. with from And Fadia ahead. go question we Ami will Please take our last

Ami Fadia

regards what baked TD of awareness And think you level Can And for you comment that's Huntington's growth given your guidance. amongst regards on that leads pretty at do progressing? and in. of you do to sort in Thanks -- you the in me the With there? quarters guidance your secondly, how reevaluating strong squeezing INGREZZA and point you the to quickly would see physicians Thank the chorea, disease was growth about upcoming how me treat patients? quarter Great. with then that see consider into performance the the to you.

Matt Abernethy

Yeah.

middle about new we'll But I Eric have underlying expectation the QX, But as think year, specifically as our mentioned, look we And from of as an we INGREZZA a moving inventory. do think with Kevin I've in looks saw reevaluate around in good encouraged here few we'll patients, numbers demand mentioned, today, what we're guidance as things in you we see like. quarter. really parts underlying for mentioned, as sit here mentioned, the we is and perspective. what demand this as record

time On to HD, expect I it to to be of I that example, educate. going think for sales, QX, time take ramp will in a going to wouldn't bleed in massive is post-approval, bit in. something take a it's

provide and So I we get that's to post-approval our XXXX, and be towards evolving. we more into strategy think then as Thank that we'll exact how insight you. able get

Kevin Gorman

So thank I to want -- today. everyone to everyone thank want I

closing really Just broken sound performance I couple probably I today to INGREZZA's supports this. our you comments. of a know record, think performance to date a like but

undeveloped times, still We of never developing Eric market. this at he's it. an has beginnings at seen are said We the hard work very many such market.

in year really a And still it should this how undiagnosed going vast continue untreated. in in growth we to forward coming left to drug have I There's as majority we are and to of runway see done order with and the is the look huge the in the invest drug say, of future. changing patients just this we continue to that then to years, have

I look as year, to. year Yeah. is we've There's I said, just a good some like year that forward this it, we it traditionally started to really a as start started, lumpiness. Specific you

used And the quarter-to-quarter on judge growth way think performance to at to again. word is going reiterate, been it's year outstanding. not be its that's that why best full we're I to as I always why quarter-to-quarter, I giving that said probably also Matt in and And think going always outstanding I to things. INGREZZA look that the has experience

commitments to going to thing second to ourselves, this to we're are those data other focused is in on, you, we've The to going readouts. of several we patients, half made our readouts that that and perform on year that the we're have data as really

year of all And the with have are forward those in will this very PDUFA we Huntington's. of to in. We August looking date much

There So again, once get I'd have help going us this couldn't not the you're to for everyone. please, to in I'm you multiple morning questions. were like your future. times questions, sorry we all thank to to with having that absolutely

to we keep our We So give chance. try shorter. short our and remarks can closing remarks that everyone opening a

to So a in soon look you with meetings wonderful throughout the forward and the that, day, talking I’ll say have to year.

Operator

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

may at You any time. disconnect

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