Neurocrine Biosciences (NBIX) 1 Nov 222022 Q3 Earnings call transcript

Company Profile

Participants

Todd Tushla	VP of IR
Kevin Gorman	CEO
Matt Abernethy	CFO
Eric Benevich	Chief Commercial Officer
Eiry Roberts	Chief Medical Officer
Kyle Gano	Chief Business Development & Strategy Officer
Tazeen Ahmad	Bank of America
Paul Matteis	Stifel
Phil Nadeau	Cowen & Company
Neena Bitritto-Garg	Citi
Anupam Rama	JPMorgan
Brian Abrahams	RBC Capital Markets
Carter Gould	Barclays
Chris Shibutani	Goldman Sachs
Myles Minter	William Blair
Brian Skorney	Baird
Laura Chico	Wedbush
Ashish Sharma	UBS
Jeff Hung	Morgan Stanley
Jay Olson	Oppenheimer
Marc Goodman	SVB
David Amsellem	Piper Sandler
Uy Ear	Mizuho Securities
Conor MacKay	BMO Capital Markets
Yatin Suneja	Guggenheim Partners
Mohit Bansal	Wells Fargo
Sumant Kulkarni	Canaccord Genuity

Call transcript

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Operator

Good day, everyone. And welcome to today's Neurocrine Biosciences Reports Third 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 that this call may be recorded, and I will be standing by should you need any assistance. pleasure President the of my Todd over now Vice Tushla, Investor is to conference turn to It Relations. Please go ahead.

Todd Tushla

Thank and to our Officer; our our Roberts, our On afternoon, Chief Abernethy, our everyone. Commercial XXXX Officer; Medical Strategy Officer; Chief Good Business have Chief call. Eiry Financial our we today’s you, earnings Gano, call, Officer; Matt and Gorman, Executive Chief Officer. Kyle Chief third Development operator. quarter Kevin Welcome Eric Benevich,

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

get to go hand after We to everyone’s we Kevin. prepared With Q&A will that, the and I'll best call will remarks questions. to do our

Kevin Gorman

making the and continue in it we suffer QX. Todd, and sales so this expectation continued don't sets Thanks, are very year another ability morning, pleased Well, our is results last will to I'm of to they and that growth good show nice well increase INGREZZA quarter that treat starting TD and us our investments for in we up needlessly. to patients have this been to everyone. year INGREZZA see

Disease. In good sNDA the for addition, with progress. activities demonstrated we showing our are Chorea filing of the Huntington seeing valbenazine This in clearly are clinical development of by is most treatment

your progress our and on Eric clinical, build questions. but commercial We let detail to and stop move and continue more and quickly then going provide to pipeline, I'm to Eiry now and

Let's Matt. start with

Matt Abernethy

everyone. morning, Good

sales, levels in patient with for patients. of INGREZZA additions quarter coupled quarter great for million momentum high $XXX new in compliance existing with continued Another reflecting third

expect billion us With results, $X.X heading and we for billion be now $X.XXX between into up a XXXX. setting trajectory annual INGREZZA nice these to sales strong

to specific comments call to Eric, make will the handing next year. over Before I a few

January, February. in plan but our to and in guidance, call provide sales we results sales do preliminary early XXXX early provide QX sales earnings we INGREZZA, not For will our during

For the our clinical XXXX reflect including and to force year encourage given rate your expansion. ensure our program the of also (ph) muscarinic reflect I run pipeline sales you a expenses, estimates full progression

in We continue also in INGREZZA and invest TD to help our and initiatives pipeline will growth to Huntington's. both support

over Now to Eric.

Eric Benevich

strong INGREZZA growth Thanks, million year-over-year sales With was and Matt. we and XX,XXX prescriptions, QX perspective. another last of total an from QX of year. quarter $XXX performance robust over saw execution XX% versus

consistency commercial We marks dyskinesia diagnosis now this INGREZZA rates fact, for sixth the that's and approximately initiatives quarter rates of most believe prescribed effectiveness sequential preference TD news. highlights that VMATX having the inhibitor. In on are our driving well growth as diagnosis for XX% and straight great the improving as are which tardive of as treatment and

work plenty of for remains do line half still not of much uncontrolled with to remains even over the diagnosis about largely out diagnosed patients received living only the to room are movements. as seven treatment time. have their with of when there diagnosed, inhibitors, offered first ten underdeveloped VMATX patients patients treatment. standard help And However, with more This of a care market effective TD for

sales the for been has field two team Our now expanded in quarters.

care dedicated in and early structure team reminder, As a three long-term and transitioning to a neurology sales customers single to QX, from psychiatry, respectively. reorganized expanded teams our we force, distinct

and our around for pleased new over LTC. TD in past years made customer we care our segment is the INGREZZA psychiatry Over for INGREZZA us Long a the we and the focused neurology of quarters launch in five two are in on mode progress INGREZZA essentially, members midst some I'm and coming benefit team helping respective will providers. their healthcare the additional sales variance, seeing with first that and new to already TD this Activity of in term launch, our we upside education reimbursement are we've are we from prior Based promoting hit from support expanded appears and with see customers. we high quarters. to the their investment it providing the Education, levels believe appropriate force. stride on

noted, VMATX in excited the expenses chorea TD Matt the you As INGREZZA continue launch potential year about in team performance the the HD I'm the very patient opportunity in SG&A HD QX who in All-in-all, year. be call to Roberts. our over should slightly and options. both over leading in next disease. course my to of invest colleague, expect With the inhibitor the higher and I'll and Dr. particular, to bring brand this we commercial in of better we're with now expected to pleased Eiry chorea population and to deserve the more as Huntington's Valbenazine turn

Eiry Roberts

Huntington's recent the to for HD year approach disorder. study XXXX. schizophrenia, with for NBI-XXX believe MX/MX while If we agonist depressive proceeding also a Phase information testing highly good depression. forward provide call. with patients to planned the pathway testing critical report oral all to move potential through for treatment as from United Phase valbenazine's on currently our we treatment major for treatment resulted and NBI-XXX their at here. I'm Center in an XXX in with Chorea which living valbenazine Thank X schizophrenia for Phase X XX a by we testing priority clinical our muscarinic studies pleased lead indications through morning a we molecules, clinical platform also successful, more marks approved supplemental as the of initiate MX everyone is to progressing of This for we treatment has program And a X and the of We've NBI-XXX X late-stage submission beyond the as the to testing. platform could Coordination will potential addition as progress as total the sharing many next continue to continued NBI-XXX, of programs recent dual portfolio in bring States. hope the selective Huntington now commenced milestone, Clinical clinical Chorea. of to associated XX molecules hard enrollment testing the NDA This this for look our the Trials development. the of also in of validated that high Phase track for initiated disease. evaluate availability shows and option on progressing forward other with in X additional We're pipeline for agonist subjects potential of a you, Group achievement pre-clinical for successful Neurocrine novel clinical Study The to our Eric, a a and the that colleagues to work NBI-XXX I'll of mid people of at begin congratulating a treatment clinical Phase

the months. to of We to clinical readouts over deliver coming XX XX a number are poised

With the sleep. readout next epilepsy with during NBI-XXX, in occurring continuous for spike-in-wave

teams our Here, I the questions call during year. both for building out addressing to us program, adult we and enrollments work. clinical next remain that, hard programs on registrational the and pleased look want I’m track to has line make in hand end. for R&D for studies progressed I With pediatric top most both to delivering for cross Q&A. line going by Overall, all And the track on I'm continue advanced your results functional back we to year keeping results top Crinecerfont, With portfolio. by their Neurocrine forward Kevin. thank the progress the to well

Kevin Gorman

you, to time. take Operator, we're Thank Eiry. ready questions this at

Operator

of America. with Bank Instructions] question come from will [Operator Our first Ahmad Tazeen you. Thank

Your is line now open.

Tazeen Ahmad

Hi, guys. to on morning Coast. Good West the early you

guide would for maybe beyond, INGREZZA. Just unmet for wanted to Where adjusted year and right the going your And post now, about get into but Thanks. full launch? you and look about of now? you current be the we market provide you kind need indication to opportunity as next not with think guidance see a do you’re Huntington's sense for should is what how the year greatest your Huntington's complementing thinking ultimately

Kevin Gorman

Speakers] [Multiple Matt,

Matt Abernethy

Hi, think Matt. in It's I And three you Tazeen. questions have there. Sure. Thanks. Yeah.

appreciate I So attempt. the

a me year guide, $XXX on really, the growth. the with full company year really you really, million when Let significant for XXXX take reflect in over

how to do year. So feel we're Huntington's? that really us with for exiting want the Eric, and about next sets good you talk how up

Eric Benevich

Good Tazeen. morning. Yeah,

excited to with we So for option valbenazine there. new to And Huntington's that a the we're Chorea. patients treatment bring meaningful opportunity certainly, about a opportunity think there's

And look some at the with about U.S. approximately Huntington's are you population, of degree XX% them with severe. Chorea actually about eligible XX,XXX actually If treated of have of inhibitors. only in the considered individuals VMATX to getting a there's of moderate XX% those would be patients Chorea. XX%

a concerns warning meaningful dosing about untreated untreated significant So reasons, whether for for of products. There's of those Chorea. for still whether there's patients, that a administration, patients various box their the it's are it's number the complex proportion

that about excited have in a certainly opportunity to of population. in the the product would TD bring the with And and have attributes and HD to carried valbenazine. some profile attractive forward we we're we the that very over so, be those labeling are TD Certainly,

option And looks TD to different today new available we're patients we our primarily audience a that these going is patients. team. audience, see bring but positioned which these disorder have I'll the and we're a what So believe is treatment well to it's to cover for to certainly that moving say that, a physician to other neurology -- -- like, thing one valbenazine labeling the through we that neurology important the indication have with

Operator

Thank you.

Stifel. Matteis come Our from Paul question with next will

Your line now is open.

Paul Matteis

congrats taking my for much so Thanks question quarter. the on and

at a psychosis, indication about productive in of If side is and mechanism. look by class (ph) or depression historically labeling you more drugs oftentimes less

point, get to advantage box versus like a you TD INGREZZA so, you FDA broadly be could a labeling So you. (ph)? Do And or if more to for include the risk? the suicidality at add nullifying black risk in and to AUSTEDO marketing of class do feel as employ to that Chorea that Huntington's have you warning label. Thank expect ready you

Eiry Roberts

the for Thanks question. Paul. Thanks,

in generated treating we're It's that FDA's the that in terms this applied at be but we've Valbenazine. valbenazine, in Huntington's this whether across around we that from And waring Let me saw black safety the what have to in tardive do HD. and tolerability in package X And of very profile that there. we were in terms the indication. INGREZZA and time AUSTEDO start course, confident would tolerability not difficult that similar and in disease for box for program with perspective in the with very data the disease deutetrabenazine that predict pleased valbenazine in to that the to the to profile exists is have box of point black safety study completed going dyskinesia. as warning we to particular, in Phase We respect we with data. very of outcome states the And the of

Kevin Gorman

And the psychiatry you Yeah. acknowledging I'll Eiry sure what about. again you're can we and about I'm thing of specific how reversible had antagonist. that the number long and bit Paul, the of echoing been quite offline, about only black said box treated add, of aware and warning been talk patients with But came That's the division. time of since quite ago history work tremendous and a VMATX a

Paul Matteis

to marketing black important How box positioning your is today? warning

Kevin Gorman

probably I INGREZZA that that. don't of -- a I mind of we not attributes Obviously, it's are think other warranted. the outweigh

that's so with strongly our therefore, why case the we're And making agency.

Paul Matteis

very Thanks much. Okay.

Operator

you. Thank

with Our from Nadeau next question Cowen. will Phil come

line open. Your is now

Phil Nadeau

We on good quarter. want morning. about Congrats another to ask crinecerfont. Good

February suggesting, to like XXXX. in clinicaltrials.gov Phase looks it is to adult the forward X complete enrollment trial, is going Looking

the talk in So a dose Thanks. biomarkers should can steroid in what the protocol year? the that saw of second tapering in steroids Phase that you data the reduce gives will then for in And confidence is about the you results half changes we adults? that bit you trial? itself, what X the And for expect on the next

Eiry Roberts

Thanks, those questions. Happy Phil. answer to

reporting. we've enrollment studies for keeps the the months and next track study both to of year. data of very in the much as terms said, the from on is the that the think six And us Our endpoint that releasing you for know, as the each on regard, adult in out -- study think I total pediatric And data is from track. I

and that And to so endpoints consistent are the we the data with the X with how study enrollment. Phase X. With respect would translate right Phase be where to now adult and

saw of we the the decrease And effect to saw just on in I in think levels endpoint that the androgen the patients in dosing. more that that all a levels. the with several individuals. most of androgens the just a pleased in in important we majority extremely context stable saw of achieving patients for dose and you, We XX% study proof-of-concept management remind reduction X were steroid of we for normal study than XX range decrease hormone achieving substantial Phase in And CAH, probably including a the treated days backbend related importantly biomarker are the with

number And in taper able so us term androgen great of levels And we're regain in down normalize I the treatment in reasonable confidence continued context of least those think to even to a of we access HPA phase steroids. control that data hopefully, the the that with in if gives to of can at physiologic mind, range then the longer of of reduction treatment. patients those steroids actually that

of hopefully say information study. end that primary good actually is obviously of though we've it day terms study, tapering the that and adult us which at that. controlled for protocol readout We'll any released the not the the well endpoints, In around within is the the on for the a in detail positions

Phil Nadeau

That's very Thank you. helpful.

Operator

Thank you.

will question next Citi. from with come Bitritto-Garg Our Neena

is Your now line open.

Neena Bitritto-Garg

Hey, to performance the taking just about quarter. guys. for my Thanks question. ask I for want INGREZZA

think If the increase just you impact could how on then give us numbers? was in recently to XQ gross also about price And in taken? inventory any or that to the whether the there net not given Thanks. an was update

Kevin Gorman

the for question. Yeah. Thanks

what from On build somewhere you per perspective, the look fourth inventory out And range, reflecting be in then at that call time. the to or slightly took. be going increase the we front, that is revenue into a And decrease what expect will a would is below to in then no price as $X,XXX should frame $X,XXX net the channel quarter. XXXX, I'd script net this inventory recent gross we you

So hopefully that provides some clarity.

did slightly a effective we For increase on we gross those gross revenue I a November net guide net you alluding were in front, charge net I taking that's Neena, script Thanks. per be to or typically below that's And the will but channel reflected X. we close, price essentially for to on who as to the -- take and think, purposes, X% inventory discount our accounting provided. just aren't as on $X,XXX

Neena Bitritto-Garg

Perfect. Thank you.

Operator

Thank you.

question with come next JPMorgan. Rama Anupam from will Our

is line Your open. now

Anupam Rama

so Thanks on MDD, taking there were mainly little. a side, pushed question. the a think Any time There adjustments pipeline couple lines Thanks out so schizophrenia for NBI-XXX guys. those and I much color timeline valbenazine on the Hey, been and the and on have adjustments? much.

Eiry Roberts

what the Eiry earlier here. that. with us. the you consistent Yes. background Yes, have fairly impacted other we on three things Thanks, to there's main timeline that have for as may of I Anupam. move startup [Technical trials. reasoning I companies Difficulty] the It’s some from these I in there answer of phase did think Happy And probably well. mean, a year three there's of trials the hearing been think couple

is Russia. was even first Ukraine The of that trials in obviously and potentially those each enrolling in

the elsewhere we a And them (ph) through that the so still have onboarding in we're trials. ensuring those to world the so with have Ukraine, in as identify we're had and working sites conflict in we site and

that many a of has this led trials particularly come in The second on is adjunctive some COVID an psychiatry, patients' fact of turnover since COVID slower actually enrollment, back particularly of with in off the environment, that actually and coupled treatment the start space patients have process. part sites depression, up that prescribing and our actually trial had treatment and third to the fallen our in startup result right period. seen world, but the one post-COVID is we some point psychiatry the that's into of And that the quite to during themselves of I as even heard impacts sites, we've but thing in the during in a U.S., and sites in recovering the now. the environment think the lot immediate staff in experienced also elsewhere Many reluctance

seeing that a did of trials. that so now. And those timing. trial We're startup ahead some of out we're delay Again, pickup in our

And right accelerate working to but can take hard to now. delay we so those have timelines, as we're obviously some as

Anupam Rama

Thanks taking question. for our so much

Operator

Thank you.

Markets. with Abrahams Capital come Our will Brian next question RBC from

now line Your open. is

Brian Abrahams

Congrats quarter good Hey, guys. my for morning, and taking question. thanks another strong

about with what I'm and what and this CAH, bigger then operating And capabilities and to the to strategic acquisition. relationships? trial site about margins overall the to internationalization ask regards means back conduct for Going picture, learn curious company? brings commercial to Diurnal KOL Thanks. maybe wanted footprint, for term long more expenses, the vision

Eiry Roberts

very Thanks much.

Brian. that, with start me Let

the and Diurnal to strategy of Diurnal for we pretty me really respect to I clinically course couple disorders. as -- which our a that the integrate metaphase think let CAH space will disease to able we and and So endocrinological Neurocrine. well for Kyle space, to parts and seek expertise, colleagues in other clinical I'll helpful us believe address actually we answer remainder. will subsequently be and are pleased endocrine both in expertise the then very into rare have With known address. deep due be newer in

helpful that for us. was perspective, from So really it

In had being plan addition, a them the outside the UK, for obviously, while we're with United doing. to we the trials global position that how many some about thinking in placed to States been support

forward Kyle? think that I well. And we'll then so moving And see as

Kyle Gano

Yeah.

Just front, that two little are in bit have at number looking on commercializing a a they of products commercial countries. the

formulation a insufficiency. adrenal product is called for First patients if formulation tablet you a sprinkled [indiscernible]. It's mini pediatric for will

time of the as release and addition to release adrenal hydrocortisone that, in here as In CAH well insufficiency development in both in Europe that's have profile they for U.S.

So total those U. conjunction products to market. and we'll for the be in with and forward moving S. [indiscernible] optimize those at in looking European

that crinecerfont Eiry. thanks, Kyle the development. moves through more nascent as have about commercial time clinical Thanks, leverage and hope opportunity So and as moves excited – in we organization Europe learn and along exciting to us, we for here

Operator

Thank you.

question next come Gould Our with Carter will from Barclays.

is line open. now Your

Carter Gould

Right. morning. Thanks Good the taking for question.

year just For are Eiry, week enrollment early was things around the bit efforts and you. the, to focusing that of guess, there, the planned believe know complete of next the XXX sort given anti-seizure talk it's background an a of a on I end sort I just And data like mitigate Can you I of schedule medications? on of XX data heterogeneity next little Thank maybe, the originally for the year. study. to by ahead population the some only year. the and challenges and

Eiry Roberts

I'm and epilepsy focal just clarifying our talking study. Carter, XXX about

Carter Gould

Correct.

Eiry Roberts

Okay. Thank you.

Okay.

get questions just to timing first. me the let So

signaled will to and with focal we available that. study and that addresses the that seizures onset currently with it -- program a available have I during that respond in patients This year XXX think data sales have we've is remain next from that signal on fully treatments. track seeking for a X on population we Phase really

these background anywhere the for patients so And agent. one from therapy other four antiepileptic ranges to

seizure have study. seizure at for seizures threshold to the that to with us when variability so that for take which reach measure that be way look does the have population a week eligible frequency allows of in the population seizures the because And efficacy we some before well, compare individuals run-in in a And certain study population. for to de the primary the terms relatively to variability of reduction the an said end look that Having address in is long starting trial. you And novo that in to out eight in as treatment is individuals. of is other within point it the period we a period the a

track And next in So I variability we as of study. are enroll looked to the continue year. well in those on have at we a data are We're managing said, for readout there. that some which ways of

Operator

you. Thank

Sachs. from Our next Goldman with Shibutani Chris come question will

now Your open. line is

Chris Shibutani

Thank much. you very

this looking at of space expect program the given anticipate It be kind meaningful we And the with in might front, On the for agonist could excitement week you progress point for of clinicaltrials.gov any prior Thank overall? what to XXXX. December timeline pan interim Sosei. (ph) of appears the the you data dosing clinically readout all MX completion? with measuring us give is for primary a you're at, that this six sense you. what if the efficacy and kind in that score on to Might

Eiry Roberts

the for question, Chris. Thanks

the just study We So we're just it. initiated actually. starting

data terms with in of so And the respect guidance availability. to

X we our study. I of think now, actually go to Phase terms adaptive study guidance this safety, study. in the will probably referring study, And more change over of somewhat in of time of as able terms because we in to nature and within is a in be is That's completion doses dosing. the findings I dose best finding say response into the provide may the other you're it's and clinicaltrials.gov. design kind to that estimate the of right the tolerability study, reason number the but and

the be will company basis, we seeing the because in though, understanding in We the fashion trial. are data of not the are interested on blinded ongoing obviously end a the an by efficacy

the terms And I of essentially so previously would (ph) then fashion Phase is in pan interim results a the terms powered in effect score, there's make the there. And the planned to that on studies in no of the of we've interim similar of see therefore performed in magnitude mean, interim seen we terms X CAR-XT study that the analysis and in formal public. of analysis, the

the would very are signal people well be effect. magnitude an efficacy we that similar that to if see And that. of to address that, by think I encouraged designed to are study

Chris Shibutani

Thank you.

Operator

you. Thank

will Minter question come with Myles next from Our Blair. William

Your line open. is now

Myles Minter

questions the quarter. taking on the and for congrats Thanks

just the TD care proportion what points actually facilities is you [indiscernible] on. on long question term that My INGREZZA. neuro accounts have on back in are touch Just to patients the already of relative

targeted to looking that Thanks. as specifically force? INGREZZA Just with you're within penetrate market the sales

Kevin Gorman

Myles. the Yeah. for Good morning, Thanks question.

percentage. small a it's treatment, on patients current of terms in So

we're That space. launch in long my term this deployed up that scaling in team prepared in essentially, we're mode care. earlier got just As and in I still mentioned remarks, year

hadn't patient However, focused we that that potential launch. segment meaningful that we there's on previously and the think in

TD opportunity with term INGREZZA. obviously the on to we're driving recognizing so treatment care providers excited educate long and about diagnosis And in

I help the like to segments, neurology quarters say of be But very more and underdeveloped. segment that excited long term to about a we yet. lot the going would it's even we're able that it's days years. I we're and think relatively in and psychiatry coming the patients opportunity in So care compared said, to early

Operator

you. Thank

from next Baird. Our question Brian come Skorney will with

Your line now is open.

Brian Skorney

hoping the Hey. on taking some coming more I pulling pace new looks over insight get prescriptions was on questions. on growth Good like morning, on the the annual somewhere everyone. in year of average to north an Thanks for it of XX,XXX patients you're last INGREZZA, basis.

this one and Given when sales the of accelerate? the thoughts a terms the that about size make of negotiation? in that's to by preliminary the or there potential how should we ways keep slowing market will, in impacted the that that percentage And you we a you Medicare INGREZZA explicitly think of to can be list potentially see might think both IRA impact durably do you could iceberg, on Are pace even would drugs that quick considerations terms if negotiated up? on think in of there down you are about a of

Kevin Gorman

Yeah. Hi, Brian.

to are is XX% TD they time of diagnosed think overall of with market. terms sort a the about have back growth in about their So underdeveloped the go remarks of when dynamics the VMATX in offered and here, or prepared diagnosed, are with so now that treatment TD. inhibitor. patients of we Only I'll been they We half thinking said the our relatively still market. the This

recognition a we're now really with about to it's segments recently So tremendous and across terms here amount outpatient talking we're upside And INGREZZA. of drive of treatment there's neurology in that LTC. diagnosis continuing whether all still most in, and psychiatry, in the

XX% this year to we've robustly a over guidance ago. twice, And now quarter the versus in So we've same our grow continued with seen that QX we've growth raised essentially. year

So care very where a growth we in place this franchise have good a with we're of continuing we presence. the segments across feel to all like organically in drive terms

Eric Benevich

Brian. Hey,

that bio or have the is the lot to of we were -- On estimate XXXX. of HHS, biotech small legislative as perspective, a around price news IRA part the going that we relates eligible we our we're decade from still with should And to right a the the is be good for exemption. so work it best not be there direct later this likely now through front, but part to negotiation until

lot does the and a right years. look to now when few gets like biotech in we're small still exemption. it phase the rebate, between perspective through of And from this there's on a So part work in now, a implemented

do we this kicks we'll what is before have clarity ultimately in So time over time. have potential more and around impact

Brian Skorney

guys. Thanks,

Operator

Thank question you. next Our Chico Wedbush Laura with [Operator Instructions] Securities. come from will

line now Your is open.

Laura Chico

for on for Thanks INGREZZA I'm over wondering And Thank sales you few to see made related today further I I of do on ago. where payer you a changed one investments morning. of have guess increase. the diagnosis kind taking rates you INGREZZA the wondering payer There's growth. Good time? question. lot how a has that been also you. I'm INGREZZA and mix front and the mix expanding elaborate evolving if prescriber base and as the you're could years a little seeing versus

Eric Benevich

Hi, Laura.

that payer of given markets launch. it's neurology outpatient we stable we're a And now prescriptions the in psychiatry XX And of continue. been pay. and since continuing the from the government to out coverage to shared mix that So filled. I would LTC, expect been say being eight the approximately place in We've the written that perspective, very early reimbursement develop majority good days existing of been fact with we've dynamic terms has remarkably

And payer across as alluded good expect with to, formulary the segments. year. Matt net next discussion, very all We the have gross that we to coverage to into continue

Laura Chico

Thanks.

Operator

you. Thank

UBS. Ash from question next with Sharma Our come will

now is line open. Your

Ashish Sharma

for Thanks taking my on I INGREZZA. Hi. question. two have

just it's scheme from what could that to working that for has competitive rate comment significant the the just there for simplify quarter-over-quarter the you think impact refill standpoint, then on reached indicating steady third a potential you initial a titration a state availability, been the aside can INGREZZA? And second, rates do here? on or create And September is AUSTEDO, First, quarter? kind have refill of improvement keeping

Kevin Gorman

years shared five the We the it's we that the high the that on present been So enjoyed the continues throughout at a very we've market. it with this about other that medication to course medicines over regards day. with to the of relative psychiatric get steady and to benefited good we've looked And been your very compliance launch. take. compliance, patients And that and from question these

the growth one that's we've that including fact, robust In year, QX. reasons such of in had this

don't new because pleased here with increasing see So which for a getting already patient well certainly quite ton headroom it's high. that high compliance. of having it's And combination starts, as I we're as a of

Operator

you. Thank

Our come Stanley. Jeff from next will with Morgan question Hung

Your line is open. now

Jeff Hung

Thanks my for question. taking

what CSWS, XXX the top results? success? of show the do Thanks. in to And what you you line study to see consider in expect to just For we should need remind can us

Eiry Roberts

Thanks Jeff. very much,

higher time. that epileptiform are patient. the at reported is the first number as signals a of sleep the So the index study between first track the the year this we during and patient of and is And And sleep completion study XXX the spike-in-waves on course is this Phase sleep. seen And non-REM for The XXX. hour EEG percentage, on in by during signal of measured and remain X in as seeking the of the that during XX percentage the by spike-in-wave the this readout end data we end of abnormal that looks of year. in EEG that primary the individual will zero all, and discharge CSWS, it's worse the the of used measure measures

studied very of little of of this change what type study. be clinically medications in looking In have in there's of field that would known about active we terms type magnitude been this for,

XX% And about have patients. that is for to is seem from that clinically so be real in very We're treatment. relevant reduction spike-in-wave these a index comparison steroid the only we

looking in to obviously In addition at spike-in-wave more though, study themselves seizures index, reduction and we're that of life the measuring measures. the other quality in

and we'll at actually study. given that's totality of primary be data is we're looking for. a looking the terms it so But in in measured And how seeking signal endpoint, what the that it's

Operator

you. Thank

next question Oppenheimer. from Jay with come Olson will Our

open. now is line Your

Jay Olson

do your global do would look footprint, your first you it as Thank quarter on exists congrats crinecerfont for look plans expand pipeline be and will be driven fair to question. for your you. regards or regulatory opportunities to your be say ex-U.S. likely for think expanding to more that as your submission? taking ex-U.S. Hey, that is the global to And your business With portfolio, you broaden now to thank footprint? development it you you by the

Kevin Gorman

Thanks, Jay. Yes.

and I Diurnal can think business say would of the crinecerfont absolutely be submission that we acquisition multinational side that the firm I EMA. you're Neurocrine's of are our now to with from the first that because correct

that help other said earlier do of looking Diurnal forward was -- So be that. and we're that globally. call, if drugs a the they was in because of and acquisition developing the pipeline as think will in number of And other the are that test made we there well the developing be to footprint. that out will We

So we Europe future. in would see more the going into

moves Kyle will as forward forward both surprised his for quite team addition, and not opportunities and commercialized in be the extensively over Europe. be [indiscernible] I move There In throughout as And we pre-commercialization drugs other look and years. Europe. would

Jay Olson

Thank Great. you.

Operator

you. Thank

with Securities. next Marc Goodman come Our from SVB will question

open. Your now line is

Marc Goodman

morning, Eiry. Yes. Good

projects You MX, planning goal your programs? as doing these line? the on just data both Are one. way strategy to take first an the the you're Are about thinking development just You it? Phase about far at was both curious I'm best have one, you all an I for -- and thinking you Thanks. have how X for MX/MX. look of these curious as

Eiry Roberts

us of really things beyond MX data schizophrenia the clearly, MX one the muscarinic for the companies. in agonist keen mean, Sosei see lead that explore I the agonists selective started agonist attracted just -- improvement agonism to from validation and MX to the have an mean, very Marc. to through I seen other program. was And Heptares acute produce in as Phase appears study. X target MX we've with to just obviously, from patients be sufficient Thanks, to we're the alone that schizophrenia collaboration ability Yeah. the of

I there's is and disease and schizophrenia in the Beyond that negative though, terms itself cognitive of both unmet where of mean, into areas some predominantly other need impacted. significant symptomatology within cognition

pursue And cognition alone, then in that to beyond. becomes the so MX both to opportunities interesting MX, again, And in MX I I space very a regard, ability us. and think that think, agonism agonist and provides achieve

make we being patients. exploring much that very want I disease best so opportunities that to ensure early as And space taking think very you the it areas and apt across we're molecules Phase best the in for then described the sure is central forward we're the in way possible the as studies. X And

Eric Benevich

driven reprioritize other of would by that have. from not is flows guidance. add have platform all date funds, that the we'll only prioritize Neurocrine of muscarinic We data by efforts. and but don't I be programs that clinical we thing the our data also Therefore, pipeline, to only the we The have endless so be it we the as will our out, at to

Marc Goodman

Thanks. Okay.

Operator

you. Thank

Our Amsellem next Piper with from question come David will Sander.

Your now line is open.

David Amsellem

Thanks. Hi.

you nearer asset of it's market if of can which much know will developments something obviously, line that wanted a or in or in thinking a a commercial lot build, into ready the ask pipeline. business organization I where could a you your talked the size. the is that there's have infrastructure different that I either you've an commercialization ask you and stage more But regarding So neuropsychiatry question deal that lot you of term, neurology this large question line regarding psychiatry? way, commercial real what's addition or leverage about whether to and a of sight sight, a you commercial is has Thanks.

Kyle Gano

mind, comes we a I Neurocrine. the for This with individuals lot question yourself in Thanks a is one top discuss Hi. of question. it is think for us It Kyle. like that that is because

science. development. things We with along intellectual late early to across our range care at really look strategy from and strong innovative it's With that you agnostic to that at the a things at look it first of come look stage property. bring looking do we're that, programs of standard stage. We have to foremost, with at development If the opportunity that stage change

probably will There's is a scarcity done ourselves been yourself look assets of restrict that concept. stage we strategy late you've we've later of stage has licensing there's your say that a from are and that, surprising not all work pre-proof to. at That's to that and things just had area earlier not an So a to stage. certainly We handful while successful those. to commercial. of bring that I in programs

So it doesn't take long in here have for to a we at use see what types organization of make Neurocrine. programs or products might commercial like sense

other turn talk about also to I I'll worth bit thoughts allocation, to Matt mentioning of little of it's then some capital and we're deal maybe to a our it think around here the agnostic piece over that but structure.

cost developing in We've seen us to attractive look at used you've it is deals that It we've function our also but a a profit licensing both that share. the had So portfolio. into parties, not only is for traditional we've and of brought structure diversify really company. risk

most programs think we we and endocrinology, tried areas Phase for buy about in share then share with risky our that during when neurology, by that X. have stages structure. example, the of So case and we've therapeutic risk Takeda, collaboration is working balance by In to we those we psychiatry deal development the

things that is are that as in the assess pipeline scarcity diverse at there. allows that and that are can that we is early that there's depending it I appreciates us also late So look on our assets it assets a such out to to are time think strategy available. one we are that build And our that totality, over

there side the did want Matt, allocation you add ask of me things? capital Let anything on to

Matt Abernethy

spot No, great we're profitable. flexibility have. I the think financial a in that feel like we we We're with all

$X have product growing INGREZZA. in cash have and We over in billion we a

to INGREZZA across going behind pipeline. we as possible we're do build And as that as as said, the gamut HD to able look company. help So to sense with continue at to as to grow for our us make ultimately invest leading might TD and patients continue behind invest to quickly a Kyle neuroscience what many possible. We'll

with financial that we like we're So Thanks. flexibility feel in moment. the have the a fortunate at

David Amsellem

you. Thank

Operator

Thank you.

Our with from next Uy will Ear Mizuho. come question

now is Your line open.

Uy Ear

Hi, guys. congrats and question Thanks my on for the taking quarter.

a Just on crinecerfont. have question

would order data sort how of much reduction what type you in wondering what in reduction and help be see Thanks. meaningful? of And for to you of be magnitude it the patients kind could help Just for it of terms guess, the it would it males us held looking you're readout, on what reduction to need I help, or understand means, more of whether this female? clinically would whether

Eiry Roberts

Uy. Thanks,

elements programs of of design the both the you, adult remind controlling the to pediatric CAH. the Just and crinecerfont two important looks

then important the control by of identified of the exogenous patients hormone the the ability is to particularly is And that of in axis androgen that is levels, only the that currently to take the the that's androgen. the The first HPA measurement and are control control reduce the second way levels have because disease. amount itself to they glucocorticoids critical

therefore exogenous take. control able androgen goal that levels, of HPA And of being amount patients so to is and our reduce steroid with gain control axis crinecerfont to the also the while

are in all the in that other this is any experts, clear steroids is external to of it others reduction are of and for period where patients we've CAH like rising a exogenous a from because time from. metabolic of there beneficial bone currently, and high had that long that ones dose the also -- used groups are that areas discussions payers, Now with disease issues steroids run other lot long for are analogy issues suffer the

designed suffering the So trial of be to is level steroid to at look reduction control And in CAH. could also androgens. patients with the the our any beneficial that and

pediatric individuals. patients their -- disease during CAH And our control is as we to possible adult importantly, able programs so lifelong for that the can having have such potentially phase as be most and better intervene for disease parallel of be in and think goal with that early and the in get pediatric to of I because the that running

Operator

Thank you.

Seigerman from Evan will come question next Our BMO. with

Your line is open. now

Conor MacKay

be a as for taking MacKay for Conor on that sales comments IRA? also I the Thank to building us versus regarding we get step Hi How just D, better to in potential our will more next year. I SG&A? to for you also second up in the there. expensive much the on and get question. And R&D some Should touch commercial Evan. of Part want Thanks you. significant first? of is want can the the is remind made And between for a can paid expenses of much sense how investment. we Matt balance INGREZZA This the expect a just so impact sense then by investment

Matt Abernethy

Conor you, for the questions. Thank

or of have sales the And D Med disclosed a We've that. we've the On on that do publicly that. side Part we've there, mix. much course, higher commented not specifically exposure than question, commercial government but said of our the they only mix not have D we

to continue will We grow INGREZZA. make within SG&A investments to

see SG&A some of the step up dollars, that you is have that in percentage leverage in previously expectation SG&A I've we said will in a spending but a should revenue XXXX. So from

leverage The So an perspective will SG&A. leverage true we from increase investment in in I is opposite show a in but R&D. guess

as to earlier fund see increasing the percentage our revenues some of next R&D capital R&D to have higher allocation muscarinic going as our You'll year, primarily and research well programs. us of we will a into program

So we're the the to and by continue beyond muscarinics. we're pipeline enthused our progression going to invest is that making

Operator

you. Thank

come Yatin Suneja with will question next Our from Guggenheim.

open. now Your line is

Yatin Suneja

quick for me. Two guys. questions Hey,

any with price comment us can the are doing capture? much increase, the marketing one were, of side? And you're what is, can sales there First regard how the you terms able to opicapone, what on second is, in just us to you Thanks. you one remind tell the

Matt Abernethy

Yes.

the how the flows -- bit X%, essentially clearly, increase ultimately less revenue does to flow bottom, per than ultimately through price our net it to do of all much we On and half not through that script. a

be as saw couple in X,XXXs that compared range, XXXX. as a provided expect I should the per you in of revenue to script guidance I that as which XXXX, in does increase big what for reflect earlier So net the dollar Q&As, you will said our hundred the

Kevin Gorman

certainly, team. progress that out from rolling had in your that off -- this expanded Yeah. to earlier dedicated organization that we And continue picking sales earlier up we've mentioned year, the out folks our Parkinson's second to suffering neurology I part field we ONGENTYS, excessive make And to with are on including the of a regards time. rolled question population,

to would able to that's get within neurology. specialists. an having And I disorder so effort two promotional products neurologists, important be certainly part of benefit those highlight movement to the especially the of And access the

it's strategy part of So in part leverage and And big a ONGENTYS to our it's of neurology. space. certainly, that both a together commitment to our INGREZZA

Operator

you. Thank

Our next with Bansal question will from Wells Fargo. Mohit come

now open. is line Your

Mohit Bansal

well. Great. Thanks for from side and my my congrats question taking as quarter on the

another question maybe on growth. So INGREZZA

us XX% you the treated how earlier why not with that understand about today help get So this mentioned they do of INGREZZA. at get patients do not bit diagnosis Could of you a time better, to little expansion? get Thank will have or conversion far forward, treated along do those you the you. that patients going you think the come from growth and on drug? come though market the And

Kevin Gorman

that first. is is that At treatment, board. this TD penetration patient needlessly. the Now both. our let’s for and sure with approved that launch And part the time to – we I’ll were question rate answer of was TD was across low goal market suffers low treatments answer your no The make with a XXXX, there INGREZZA the last in diagnosis no

Early that in been a given was remarks the that great the we people have a progress estimate TD made prepared the well. in we've And are offered so VMATX improving diagnosis. of represents living number -- half treatment in of now with as Believe diagnosis, about mentioned inhibitor. about I about And rate XX% the only actually progress but terms launch, time with or and zero. not, as it the

And try to really the that regimen historic antipsychotic abnormal might antipsychotic it TD hopes bad. unless got you instances about standard either It And some think ignore or remove was the the with tinker to in in and so to the in TD. that movements. reduce of if the reduce, replace care

when as which a they evidence In make we've guidelines diagnosis APA so offer treatment the been that inhibitors providers leveraging TD do INGREZZA. to And line with updated recommend inhibitor, encourage VMATX that to treatment. specifically VMATX first based

still diagnosis, also think sure Despite we're people in go. and progress that about are we treatments there's we've made making the those a to but offered just making that driving progress, not that And effective way domains. so fact it's both long of

of seven for their gotten planation is today with I living any movements. XX people As abnormal out TD mentioned, haven't still

and forward so that diagnosis, we higher press I effective we with consider we'll as continue treatment great sure treatments and And access make be move to going what for still continue a to have maintain to launch, offering to forward.

Mohit Bansal

Super hassle. Thanks.

Operator

you. Thank

Kulkarni will Our Canaccord. next with come question from Sumant

Your line open. is now

Sumant Kulkarni

end to morning. squeezed I'll Good here. Thanks in my there be taking have because you for questions. the

be several and price valbenazine of for differentiator key your schizophrenia, it. also generics the INGREZZA an for adjunctive because because the as I’m in market has current what's So schizophrenia asking treatment us point acquisition? Kyle, And cash numerical capacity what balance, parameters Neurocrine's an on could financial you limit any your healthy for Matt might and for upper give an given for absolute

Eiry Roberts

Sumant. Thanks,

were there who reasons current Valbenazine their in adjunctive treatment. On ATS for with schizophrenia as were treatment to for why main the question failed interested an we I three patients adequately to think Valbenazine, pursuing respond

that act The in which postsynaptically. currently increased of first patients was that with have known by addressed pre-synaptic antipsychotics, dopamine that not is schizophrenia, and proportion it's a synthesis available patients

presynaptic VMATX Valbenazine dopamine INGREZZA, decrease acting has synthesis patients. levels, on presynaptically presynaptically Now for that the inhibitor potential to the

hypothesis a to could to helpful as it And that that addition DX be setting good gives antagonism. in so and scientific why in rationale

had not animal in gave tolerability had schizophrenia program. we a to and treatment safety adjunctive from both extensive to patients an the that that with in clinic. translatable of dyskinesia synergy our at schizophrenia their tardive the into showed albeit are with X have and dyskinesia. database seen good symptoms looking treated data some to support then we obviously, addition anecdotal for easily finally, Secondly, we had go preclinical for some Valbenazine field that models, with also patients that evidence evidence But in us tardive And Phase improvement own those the the

comfortable hand, X And elements moving us all those of with that's program. a with what Phase into in so made

We have the that we X aim start second year. the now study program next first ongoing of within studies to and right the Phase doing

Kyle Gano

in comment talking indicated today is one to differentiation, what are when add adjunctive as I'll approved you're Eiry treatments just brief treatments said, which there schizophrenia. about no

serially monotherapy. on a proportion small antipsychotic The treated in at of care, than more the there with are We're patients antipsychotic patients of If are TD time, most one are schizophrenia. but currently about no adjunctive you trials. think approved standard treatments

of with a would we're shift. be itself able if for get in a Valbenazine paradigm it indication and And differentiator. Matt? to that So that is success,

Matt Abernethy

financial that much of you a about debt as cash, what per you then capacity what could to put how equity on limit, buckets convertible debt your for From your kind clearly always what Yes. use. perspective, or look and upper three sheet you balance your would

So a $X those a said billion flexibility you type levers billion could have a $X publicly transaction. potentially lot of deal. so within three and We've do to we

be also our team. would synergy It to make that asset to Of leverage our could, have clearly not large of investment. had to to and going go fit our aspect of lot an your of The whole you sales a would spend be. always pipeline then or Neurocrine course, straightforward if you in strategic commercial capacity important potentially able what's the what higher for course, overall is most you're can right

So financial flexibility said acquisition of the the the of level take question company. I a right that be earlier, of I next of make us for a kind could as And be think key course very have what is, those to as but do, nice us kinds level investments, to we prudent. we'll would

Sumant Kulkarni

you. Thank

Kevin Gorman

just sorry, throw that of at right top I'll I'm at the So hour. here from is right it the the we're of the top operator. hour,

be be I a the very focused efforts our needlessly. our to in medical as sure Obviously make is approval look brief. very We productive The commercial what Huntington's affairs no to next us. year We're think our and bringing finish an -- will hopefully to closing to exciting continue which is remarks in think on looking ahead continuing that patients going this in the team population order XXXX. for INGREZZA from into through suffer with very now all of to and all year forward goal Neurocrine TD everyone's My possible we to got questions. right year, strong is I as business.

more two to important XXXX in of readout readouts, in just making with onset on And possible seizures. be We're important them going right the best We're doing that of year. adults Neurocrine. and going be have all both an job focal now. then doubling phase, are and a line to work trials, in going then the really don't the sure down that's operationally be CAH that pediatric have all We the X progressing three Phase there's we to pipeline this to in on the at you going sight of

for think I us. many opportunities there's that exciting

we look with year. later talking forward that, and I your thank you all the to also XX this next to you So beginning in for year care. -- of questions later today in Take at and

Operator

Thank gentlemen. This you, ladies event. and today's concludes

You may Goodbye. disconnect. now

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