Neurocrine Biosciences (NBIX) 30 Oct 242024 Q3 Earnings call transcript

Company Profile

Participants

Todd Tushla	executive
Kyle Gano	executive
Matthew Abernethy	executive
Eric Benevich	executive
Eiry Roberts	executive
Chris Shibutani	analyst
Paul Matteis	analyst
David Amsellem	analyst
Tazeen Ahmad	analyst
Jay Olson	analyst
Ashwani Verma	analyst
Anupam Rama	analyst
Evan Seigerman	analyst
Cory Kasimov	analyst
Carter L. Gould	analyst
Mohit Bansal	analyst
Marc Goodman	analyst
Myles Minter	analyst
Laura Chico	analyst
Uy Ear	analyst

Call transcript

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Operator

Good day, everyone, and welcome to today's Neurocrine Biosciences reports third quarter results. [Operator Instructions] Please note that this call will be recorded, and I will be standing by should you need any assistance. It is now my pleasure to turn today's call over to Todd Tushla, Vice President of Investor Relations. Please go ahead.

Todd Tushla

Thank you, and happy Halloween Eve. Third Earnings Biosciences Neurocrine to Quarter Call. XXXX Welcome our Officer; Benevich, Matt me Medical Commercial are Chief Executive Gano, Kyle Officer. Chief Roberts, Eric With Abernethy, Chief Financial and Eiry Officer; Chief Officer; be will we today that making statements. forward-looking Note and These actual and results certain our materially. uncertainties, statements differ to are subject risks may risk to our discussed latest SEC encourage you factors I filings. review the in With call to that, Kyle. for the first time, I hand the

Kyle Gano

Todd. you, Thank

to is share dive I'd enthusiasm CEO. like my this first in, that Neurocrine earnings we future. Before I'm our acknowledge excited my for as call to

So bit my opening longer than remarks may run usual. a

Neurocrine First, Board to this Thanks I want to next my express become confidence is position on the contributions my I growth. Gorman, strong CEOs, company's Gary to deep neuroscience. of the gratitude in invaluable Kevin a leader exceptional my Kevin of to for leadership a to our chapter heartfelt extend embark guidance Directors as of thanks to success. we and both in and Lyons their in past their true our for Gary

company's most future multibillion-dollar significant on we registrational innovation Crinecerfont the creation INGREZZA, our in driven and operational as pipeline. growing neuroscience-focused at the this franchise the with core, ahead. blockbuster, by of and for be industry's -XXX a to our potential and company next believe NBI-XXX NBI is what bright are robust Neurocrine's programs Built our value Given we excellence.

growth, pipeline. strategy diversification Our regenerative by revenue and capital allocation reflects prioritizing this

expected repurchase opportunity. to early As our significant and we pipeline, our the $XXX million, for implement is believe which accelerated underlying share through Considering high-return revenue valuation, to late-stage both authorized growth announced to making discount of of enterprise transaction. trading investment a we at in plan repurchase INGREZZA breadth of Neurocrine morning's Crinecerfont repurchase a this the press a its release, share share has Board intend Directors an and

our In business. further addition, of growth in invest to we flexibility the maintain the

ensure is strategy in psychiatry, company two, for position R&D commercial capital be as NBI approach growth and a can growth. NBI-XXX, aggressively preparing as strategically rapidly shareholders excess pipeline allocation, developed that expertise to such neurology, by creation. On This a accelerating organic leading driven expand topic revenue aligned three, in for with assets portfolio our continue launch; while and our our is our expertise. ourselves to neuroscience to value that endocrinology commercial plan high-growth with is the scale by and of early-stage we pillars INGREZZA drive and as our key and four, our strategic with into highest X develop return a external pursue of are: aligned assets investing beyond value plan proof-of-concept; organization opportunities successful one, Crinecerfont and The pillars inorganic for infrastructure and programs commercial scientific both our and leveraging products, to what required capital XXX X

shareholders. guiding With and are near- value positioned substantial deliver to to these we both and patients well pillars, long-term

patients Huntington's there To symptoms, and are more year we inhibitor raising Now as is much full end, XX% guidance. a suffering receiving chorea. of continue and Disease QX reach tardive VMATX the to opportunity work more for an dyskinesia dyskinesia far again from with INGREZZA we not and as INGREZZA, the With with ahead. tardive patients yet XXX,XXX estimated this

X to track have on approved groundbreaking Regarding with to diversify excited for leg over patients and of medicine approvals revenue Neurocrine option same first-in-class will for has a a by helped a patients our blockbuster Like a of potential and be lacked Crinecerfont hallmarks INGREZZA, year-end. will deliver We're offer a XX for medicine. time. doubt, growth business the No second Crinecerfont crinecerfont, years. treatment our regulatory activities remain who new

of X On that comes in psychiatry X spent risk area, the drug pipeline assets expectations inherent novel in nearly X significantly understand development XX with biology. our proof-of-concept data exceeded success therapeutic within in of Phase Achieving and front, I have years this year, this programs. our been of -- we Having II out both remarkable. and just psychiatry. X their derisked one these internal would associated succeeding in programs obtained

As agonist after R&D key NBI-XXX, internally becomes want programs schizophrenia developed we are to up and we disorder, molecules this positioned modulator Crinecerfont. decision care involved like MBI XXXX, studies. Today's INGREZZA lined the approach. easy, for our acknowledge to studies critical. families clinical With move to for registrational into more -XXX, disciplined inform next selective allosteric and trials year, early depressive for deprioritize the value next never and positive drivers I AMPA for luvadaxistat reflects major thank Decisions well set enter health several our and investment professionals and these and III patients, even and the in Phase are prioritizing multiple muscarinic NBI-XXX,

to turn with in to and the industry it With cornerstones for I'm evaluate allocation with and organization, potential more positioned inspired capital best expressed and great ahead shareholders. collaborate the to this leading become well in and and like are offer value the have year drive earlier but we invest value exceptional work patients future other of with proud my to people than release wrap our needs, to by measurably Kevin of up clinical company. over and I'm we continue to neuroscience closing, team his confident will I'll by sharing for and are we In an our all in ensure leadership options we few our alike. programs the shareholders treatments that to remarks for Matt. suffering meaningful preclinical I team that, I'd energized retirement. thoughts a dedicated our announced when strategy, the discipline of potential Pipeline now

Matthew Abernethy

Thank Kyle. you,

year-over-year fully this tardive billion, Our market at INGREZZA sales, demand our investing to benefit The to strong mentioned, growth sales XX% range remains and $XXX Kyle priority delivered midpoint billion allocation psychiatry QX remains positioning very during see in the as the and reflecting complete us expansion expect care of to guidance of team increase And INGREZZA. continued capital $X.X dyskinesia year. #X patient and this reflecting million half the next our to $X.XX range. note, in is Of our first attractive. expansion force of long-term

our date Crinecerfont field Neurocrine our resources commercial continued INGREZZA invest Crinecerfont the market growing In medical in teams will over adrenal addition, to ahead late and growth congenital for [indiscernible] provide to the years in PDUFA build and December. and hyperplasia the pipeline. of awareness preparation in

side, X the teams R&D major III of programs for initiation Phase the the major On depressive in busy are and schizophrenia. preparing disorder

through range XXXX, overall an increase of percentage be dollars both for should the you working still we're next revenue process allocated -- budget revenue expect year. low R&D in Although of mid-XX% to our to in likely and to

for meeting into provide will and expectations We R&D the investment QX agency further in be during both MBI-XXX earnings over coming the we'll months with early call insight on our XXX program and XXXX the February.

progress into billion focused revenue advancing will growth believe Returning over we long-term We shareholder value. in our continued pipeline. we expanding investment be a future, in $X growing our have to year and XXXX, for significant the anticipate will which drive on to made that XXXX

approved to nor neither has achieve transaction, In we the days, As our accelerated price the levels highlighted expect we growth today into Board intend share share a the in our coming enter current our with subject $XXX million Together recent repurchase conditions. a market we release, press million $XXX plan. the future. share value of company believe reflect prospects in the Board, to repurchase to

our preserving while financial also neuroscience of leading we this capital our As will flexibility continue use a the make shareholders benefit believe to advancement result, of investments company. required the to

With launch our Officer, hand preparations. update Eric? also now Chief that, the to over CAH call an I'll to provide Eric our and INGREZZA on Commercial Benevich,

Eric Benevich

TD been a Huntington's to prevalence We U.S. sales prevalence and quarter literature now growth, a patients. now over annualizing tremendous least disease patient since we data years still even by we the ahead XXX,XXX a the our conducting us, over After XX% help tardive estimates. for billion. individuals of of across number analyzing at of more delivered more we're with thorough demand utilization, Matt. antipsychotic have dyskinesia last and again strong chorea estimating indications. INGREZZA Thanks, of And XX at with exclusivity compliance years driven opportunity are $X.X primarily It's continued INGREZZA in for year-over-year updated claims a review TD and

of blocking the our efforts treatment for increasing dopamine appropriate the continues size to health antipsychotics, candidates utilization identify the population we INGREZZA. continually and of care and providers TD to Given continue grow educate

expand developed This and last in few expand the with our X/X over psychiatry TD with that significant and opportunity. pleased expansions decision segment. manner to to a INGREZZA years increased the decision sales note, with of force. care or substantially patients now are psychiatry our On made of treaters teams number is long-term reflection diagnosed the commensurate complete. INGREZZA the currently remaining made in the especially the market X really sales we I'm only field the We consistent that TD TD market franchise things: the the in report dynamics growth a force expansion potential the of and year, less this Earlier to

field the their into team now roles. are newest members settling and Our in

call, expansion earnings treatment a see couple the based on QX take impact previous and from our quarters on diagnosis noted it of this our will As full to upon rates. experience,

endocrinology hyperplasia, endocrinology disease disease providing or Crinecerfont, adrenal education team state the and our rare health care on providers to Turning focused communities. patient remains to CAH, congenital

Crinecerfont is be year-end. contemplating eager many the the community team working Crinecerfont to with investors FDA begin the and approved I Our know CAH by should ready at are dynamics. launch immediately

reimbursement familiar formulary won't the a launched good of the launch approval, managing the coverage benefit payers the with offer the months profile interactions in year, a when estimated While INGREZZA. to first exceptions product be future when typically adjudicated period. state as insurance intend of to CEH endocrinologists enable launched. patients to have but of we'll patients blockbuster, And Crinecerfont. assuming And experience XX% while positive our will all in the first date payer have disease a are or many -- of managing X happen newly under the during up with with is reimbursement characteristics process claims XX% We seen With to this products, building adept during to to goods efforts it been educational Crinecerfont to has restrictions commercial mean period half coverage, position with our quickly. reimbursement the and policies even overnight. get an within as being program patients for the a to new-to-market delayed We're free most such situations we're block prelaunch foundation commercial at for risk

help CAH all, is who the CAH their reimbursement. endocrinology through help work while goal appropriate in new super get The option to to team the patients excited a All about treatment had we rare on population in treatment not patient is years. over opportunity have started the XX

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

Eiry Roberts

Eric, you, clinical morning, I'll begin with today's update good Crinecerfont. and everyone. Thank

We have and FDA interactions continue to the date. track and remain for on constructive XX PDUFA December XX the with

the it timing, be approval calendar year would for formulations potentially end on of to December on receive which Monday. the not a both Given falls and surprising XX,

ERUDITE mid-stage end to Turning thus subjects. month, not meet impairment baseline from potential treatment with on primary cognition to across in previously point. that luvadaxistat confounded its study and studied of by the as associated characteristics replicate the in study. The Last for cognitive population for schizophrenia, results the INTERACT findings pipeline. measures potential failed in were a the and we did variability cognition enrolled positive imbalance the the Erudite disclosed reported

and of we're to focusing therefore into enable treatment studies towards these channel occur registrational the with the Phase [indiscernible]-positive XXX CSWS XXXX. each together NBI XXX, continue make modulator the of good for the III in with progress first NBI over resources for the agonist Both of our of on the end which calcium T-type major in mentioned, anticipate few and interactions orthosteric program, Kyle depressive MX XXX, and we NBI the NBI months advancing discontinuing antagonist treatment program start Phase selective of schizophrenia programs XXX NBI half II this disorder, the our to allosteric As studies. will for FDA next XXX of

together X are programs is NAM the part disorder, the major With months, the II of including pipeline provide Phase running. muscarinic molecule Shifting treatment will to to in depressive Phase programs coming NBI publish studies key well, call also XXXX I Kyle? these from program modulator our Phase our line more NRXB enroll study the Kyle. remainder of of I'll II of plans once the and back We allosteric NMDA insight data into latter top over for XXXX. continues currently The these registration the XXX, development. well in to this progressing up the to anticipated specifics information each negative with that, hand with for in

Kyle Gano

take Thanks Eiry, ready questions. to

Operator

[Operator Instructions]

We'll take Shibutani from first with Goldman question our Sachs. Chris

Chris Shibutani

clearly a wanted as people to about really pipeline, quarter the on strategy Congratulations strong I I about ask appreciate your going comments. commercially. well thinking forward, as

have the step who of you think on that a business thought be previous noticed I Eiry you involved I will that people you're given running role, previously to since announced point away. leadership there was which the have development Kyle, as the with as capital bit well focus looking really managing your to has been role allocation. quite

at start visibility when I an next-gen more great? us And we update secondly, on year, just you some but inhibitor. VMATX would know be I we Phase this could learn of into the started can the give

Kyle Gano

is are that here which base we potent patients. to INGREZZA compound. but and Thanks, team for anything to Eiry here same all missed opportunity is important Chris. as for then prescriber we be injectable, also follow-on develop see looking have and add advantages long-acting This we're to -- what to amenable know start compound a to I to our offer indications This EMA is Kyle. would the a do that more the is the as well that I'll the

Phase year, program review on data. We'll ongoing in move the staying I. patients into that look Phase is to So I the that, currently the of next pending

Operator

with to next Paul Matteis Stifel. go will You

Paul Matteis

on to and the you CEOC. BD just congrats I to want about philosophically where a ask you Kyle, moving stand. question

and which you now? prioritizing your How is capacity spread the Neurocrine later-stage smaller talked something and over larger do have that's in guys, versus strategy do a to And about do of you like and you've far? commentary billion right asset? range. this flowed Or deals billion the more do $X public kind you've of time bolder You $X feel this the BD years to the the next ebbed employed kind something about that year, for think to strategically, meaningful degree you to years smaller over X.X like still best so for that

Kyle Gano

Paul. Thanks, Appreciate the question.

BD our work here of activities, that team to In we terms of the urgency. degree a with have high continues

And got late talked investments either with NBI-XXX, a have in we've stage NBI developing. pipeline early of Fortunately, we don't those feel about and small. deep or like a mid-stage are in that's diversified some something that within very rich now, already with a we large have programming our next XXX major making and to that, do we depressive schizophrenia. in we're very portfolio We've developed behind year, of to that right disorder number

making focused are possible enviable pipeline in program, utilize that that that what whatever comes a sure we we my situation something take the mind there look that we road, infrastructure. in expertise a feel the and But advantage could really we're in the landscape now, and can right technology is for but success. areas what now, very And to on like invest executing that our put best want a doing now figuring is those position. of out and if in We'll about something is programs out which learning in forward, assets at So the down we seriously. the right that right to have those and we areas, in we're

Matthew Abernethy

Yes.

our sheet aware. lot cash earlier this Fortunately, cash, balance at year, generation, to moment. very and flow debt very you're our continued the financial is flexibility strong a A convertible retire clean of

the as said, we Kyle in. enviable be could very us for to So financial to was into position have and that if decide a do something we future do flexibility

Operator

next Amsellem Sandler. We'll take Piper our David from with question

David Amsellem

on how some on beyond, about -- on the So in you your thought other negotiations. is looking any INGREZZA thinking beyond understand indications In into schizophrenia, And looking you say, and at spillover secondly, remind you about instance. us just you IRA you -- to 'XX potential negotiations? OSTETO? the psychosis, IRA OSTETO anticipate as just once might how there. words, help that more then included Do need are thinking you're about hold pricing for share us compete for schizophrenia, impact beyond to versus INGREZZA think or XXX, of indications and if other just are process will, sort effect, And you muscarinic then of, price

Matthew Abernethy

respect we expect muscarinic as we'll David, only to seen as QX, on So price. do handle leave to the The to for to give XXXX or of in we're others script going specific do just what to revenue out be going But it you relates per questions. of the today, to real can sitting Eric And chunk question similar price on XXXX. others. net in -- first your here very our we're we've comment

that this here. So change at time no significant we can see for 'XX.But

Eric Benevich

Yes.

is assess think contracted I'll say in In we that And have -- continue favorable. what we invest we some it make other So sense. where cases, access look our And cases, strategies. think to makes contracts every we in the contracting pull decisions that we at to year, it's back. and contract where we

$XX overall, excellent majority XX% landscape a with the covered. as of and And we year-to-year. into lives changes expect the that to future. remain has continue over so And from or But our coverage to continues less. of access patients result, And paying the

through their drugs. first that few like The other the ways negotiation to nonnegotiated terms looks I'll go drugs in is of vis-a-vis say the process what that we're access going thing that learn from of

in access. We're perspective. So continue a goal patients that is a from trying responsible But to to sure to INGREZZA stay manner that have is need that financial ultimately, that do make a from our to tuned. access

Operator

with Tewari from We'll take Akash our next ahead. Jefferies question

Unknown Analyst

MX your for to human you the then you to expect [indiscernible] talk can Akash. with on and should MX asset, I muscarinic. data like from feel On you [indiscernible] we is don't have learn does confident additionally, what that KarXT Phase about -- for why initial next year dose This

Kyle Gano

sense it's potency that range across the and very MX On XXX, XXX one of MX. for molecule equal and is that selectivity the it's that NBI have MX from muscarinic to a development question. an in MXX molecules a Thanks in we on interesting the of basket small

explicit about we've the that the they're molecule. through our CNS the more then things in for when the so, molecule out of desire. they are of the subsequent the as molecule dial on the doing the MX and that's and we're molecules MX about [indiscernible], in think has to know muscarinic, we which make back MX and One gets without selectivity other periphery when add is the -- across MX so the piece They XXX, that of the penetrant you the interested something going they on this partner in subtypes and peripheral able MX that into versus of got to preferentially do that's discovery of need MX is XXX well of exciting as because effects the relies how just in the agonist many it stages to CNS. speed early that, blocks be forward that But us actually gate. what our And companies the to done, selectivity move

pharmacology determine of what from and now. will coming the out different from reading I the the MX be during course lot muscarnic, and what XXX the able of patient look that and they're steps that program a in right Phase the the be all learn the of totality of They'll to to will data in next at with data ongoing terms be able of molecules population. and MX XXXX In terms the across the

Operator

Bank question take We'll Tazeen of America. with next your mad from

Tazeen Ahmad

flattish. On XQ to flow a the had like quarter. really be does should tends Because know on thinking in be we could INGREZZA, it How XQ? be it I based your traditionally, you little another guidance, strong stronger about sequentially quarter. bit your a seem

little us give bit color a So of that? can on you

Matthew Abernethy

Yes.

million that into when and we somewhere historical look at a fall million right in think growth range [indiscernible], historical sequentially. I of you $XX between sequential $XX

had do comments handoff a start actively place the guidance take with last do then fourth been consideration piece our kicking a something historically that and So calling quarter. takes to just as customers to We think what some of in And on But is going net in dynamics, that -- in historical in. a we've higher little channel in team sequential increase I sales process that's that that nonetheless, because years, higher it's to into in for in does be of Eric than is has QX. but few the new a have gross bit associated occurring. the less prepared the said quarters few months, our a discount that's it gross-to-net discount

Operator

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

Jay Olson

on area difficult Congrats of about unmet proven also high in the since epilepsy progress. We're clinical your super be area of level to an curious to it's conduct all it's interest still and a need, trials.

to replace just we're you And committed plan So do to is with another molecule asset? Neurocrine [indiscernible] how the epilepsy. curious

Kyle Gano

this Kyle. very the still We take Jay, a epilepsy. your of is question commitment here. strong Thanks, have area to I'll

we of the forward calcium do NAVX.X, that We to blocker, stages number T-type next us of have development. I channel to X.X various have are with forward we're bring year. looking mixed inhibitors preclinical into a up expect don't a another while moving clinic And moving programs that

be to on player other committed That still along unmet advancing the here. them and stay we on significant GLP we around to a asset. a Obviously, those of that the to through so that lot of required of space in still move There's studies tox that epilepsy. molecules we then XX relay to a for side So need body tuned will a high data degree have are enabling as particular that. get and for forward need hope move

Operator

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

Ashwani Verma

the now had to digest some on just XXX, So time Phase in that you've results II.

about we this you've think the pipeline on the myskinetic -- in Just orthostatic learned? based Do you was what should And learning? what think rest issue agonism how this you case? are of the

Eiry Roberts

I it thinking exciting I how with your data, I but properly, question pipeline. agonism the the next now the that I we orthostatic II hope think step -- the in context that broader Ash, to was Phase about have understood respect think are of muscarinic we

address to just that. So

thank -- you. So

address encouraging data are half back of moving the So III that II and the next in saw to with to XXX program Phase just the we in we forward year, for our registration on treatment Phase schizophrenia. of of the that, rapidly so we're planning enter first molecule a schizophrenia

that will the The be of Phase that the first step with on journey our in interaction at II preparing couple the months. we're next for of end and

regard, this were significant so to mechanism they've been there this is add see a muscarinic And add for to in approved space in and pleased in more with We profile in that a we We associated agent. think and quarter. [indiscernible] activity for potential think with the room to benefit earlier I the lot the medication the improvement this in success current that there's But risk first opportunity the very area. on to of terms value believe selective the that patients. in

III And excited with so planning in Phase regard. and we're that our encouraged

in improvement psychosis, muscarinic and indications. of disorder areas we exploring beyond currently the cognition the do year, Kyle other are in I for through is XXX, and have MX could potential behind either agonist have, the to understand generate Phase important and bipolar we MX to all which orthosteric As way how data disorders or again, as way I suite activity we're where next range high as investigation from which mentioned, a all cell of agonists development, Phase those

Operator

with We'll take from our next Phil PD Cowen. Nadeau question

Unknown Analyst

of in also, data could your form This Alex And on is -- for Phil. XXX, conversations pivotal Congrats including curious emracladine trial trial XXX way? design? a Pivotal, plans through maybe us and you walk for upcoming the on will regulatory strategy just on the just any quarter broader

Eiry Roberts

Yes.

the that. So the that we about we'll to we think before in meeting much our trial much the trials way II around able we as of respect into talked Phase the more to program end Phase certainly, that III do will improved thinking. first the to start and design actually registration in [indiscernible] to want planning haven't on of year, be through information post I we With very detail clear of But our next half be that. get impact and yet,

by produce I our year. from dyskinesia. fact that's data fact this to I we the that approach view, chosen are appears that psychotic the back approach confident point think agonist, in think that we're very generated of on our we NXX that earlier to Phase the II of encouraged and set the [indiscernible] be we've sufficient that And that's the

we'll focused interaction. through that so own terms Phase benefit in talk we're And and II II our risk about Phase we from be And more more loading our we're very about all data III to much on trial go in understanding program as program. of into happy our Phase the the that our emerging ensuring designs incorporating into Phase III

Kyle Gano

directly or that, sort of approach of from day, are of of some end to the that own that confident far aspect be the for any safety, our be to think seen about just able tolerability. the add-back more a excitement from on be or an endogenous approach population other And the we've wider ligand thus used only and patients. lot either feeling to program we're a and to maybe physicians can the therapy at without on in efficacy stems fact for going the we have the to deliver that add promise that them activate rely And the our we need to muscarinic around any selectively

Operator

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

Anupam Rama

for years on third last quarter second the I've Going XX question to earnings. ask asked the

care health at So quarter small any guidance chance this report of is preannounced a Or fourth and a of February? in an scenario INGREZZA in conference January? earnings more

Matthew Abernethy

I even pick about Anupam, trend acknowledging a Yes. -- you're up it. can you

year and We're we looking has be your years this Kyle as this year earnings But the an will both conference I to XXXX believe with to XXXX save year. ambitious JPMorgan QX hear the always So forward do results with not glad X always we'll question. you the sales commentary until for good off guidance preannounce obviously third year at kick February -- JPMorgan our new then I'm and full in to January But for call. plan where the for both consistent revenue to last, detail. it's see

Operator

to with next Seigerman move We'll Markets. BMO Capital Evan

Evan Seigerman

we sales years? where of how treatment we Korea there. next I force with [indiscernible] know think expansion compare with TD how frame of do opportunities about and see, been investment, in does couple the I your the associated the for this you I But really disease, as the that opportunity? the with really going Huntington's market. So guess, mean should INGREZZA

secondarily, epidemiology think there's TD more not I'm why of to for that room just with that understanding to on no going you're looks where still trying a is trying that satisfied TD get emphasize that to does imply better grow. you're commercial I like? now, what focus story

Eric Benevich

And first of second take me of looked number prevalence your let Yes, reassessment our terms in haven't something for TD. that a that's of of years. question the we at

$XXX,XXX. in TD. prevalence estimate least to of time grow, an it. TD updating what that A done at the a antipsychotics, estimates where of X been updated I last launched had we that's XXX,XXX methodology of of at use since time at we with we expanded forward, so our numbers it's that in with in couple was X conditions. fast later, especially more people I XXXX, And think, would years the estimate I similarly using And to looked our And continues with commensurate nonpsychotic just people as the least U.S. consistent we at our The then living the years look think previously. or

people remarks, out least And other in And similar think the I number update number so and that, we estimates of TD that that end little at maybe frankly, on to is with the to XX,XXX U.S. a our low range. now the the in did prepared there are bit

the prevalent story. that's So

the to of sales force the was of terms certainly line we felt sales the our market.. In the expand team, growth like in with decision

opportunity expand or the change the of commercial remarks, terms in Okay. of And we was TD, that of prescriber in certainly, there's in still the part excuse the force. Huntington's in unmet opportunity is And is yet is relative lot team. of through our And consistent smaller, and as need Huntington's much dyskinesia. than a smaller neurology the I growth really chorea. that neurology it sales didn't Huntington's the is On the in strategy a team the primarily opportunity Huntington's, significant mentioned tardive base basis, neurology prepared only penetrating with our me,

recently You because that are are to is antipsychotics. some are presented of also that data showing with some chorea chorea out Huntington's use segment data think VMATX there we've INGREZZA in with on And that's that typically may that seen inhibitors. have get of that a patients Huntington's I treated that patients with important the not

on safety, wanted would so impact they but show Creaform can they we have movements. no And relative improve to that still their

primarily within future in continue is us, growth overall, will of a especially an the framework team. still opportunity so And important the TD, to driver the Huntington be but neurology for strategic

Kyle Gano

XXX,XXX patients, around TD chorea. patients summer about the a XX,XXX currently point that's HD on Maybe put that. on XX,XXX a just inhibitor. prevalence patients X,XXX We being VMATX about have U.S. to moderate chorea in for about There's about the talked finer

So patients you XX:X with that at serve look TD. ratio XX,XXX versus INGREZZA we about that patients that's the the when opportunity looking address, can we're to a of

that we more greater dysphagia space, with do population. in dyskinesia, into moving difficulty tends swallowing forward sprinkle HD the more we chorea patients be of HD Ingrezza particular, the the will in that opportunity to feel penetrate launch help but prevalent access the be our have to with in to might tardive So that look

Operator

from Evercore. We'll take our Kasimov with next Cory question

Cory Kasimov

I patient And they [indiscernible]. prescribers of the excellence many about population are talk there at are most segments approval? they of CAA treat CAH of can and the overall eager centers ask how wanted portion the upon to if certain located serve? And to the you population about are

Eric Benevich

Yes.

take the to we've So say a excited me year. end difference the back let the we're with about in really make of here been the for a preparing launch up with date community XXXX. coming at that and a CAH opportunity early the step PDUFA

that's practices. state customers, right They're learning about doing out disease their sales As their meeting there. have education with profiling a know, you we force now. They're and future

strong get wood to important we year. And that this on off will this -- knock start us help so later approval. a once all get work is

about still in we're patients those patient through being to or of population the those managed XX% a would patient learning that's dozen of I the there. of are And Centers there's proportion population total. the Excellence, XX% within of only care say it's terms of of about excellence In what so of range the centers proportion the centers. But in the Foundation out of of Cares

with also cared practices majority community within and still the so pediatric being endocrinology of And CAH are for endocrinology practices. within patients

we're make that lot in are obviously, we a have to you going reaching pediatric else early make population, focus X add, really are putting that we going sure Do are on well the out as care those be So and segments. also those patients practices. have for for centers. But difference to The to community this to anything on, cared us Eiry? to ultimately, as endocrinologists a of patient endocrinology to

Eiry Roberts

No.

pediatric well, a that I is in we and the there who And of the but think critical terms excitement clinicians that levels faces help that focus, been androgen medication a very growth given interest in in patient setting, know normal level lot of I I years. could patients significant there's so think reduction these mean last of are nothing obviously, you we're with we is development. management tight become for androgen with potential hearing very where said population in it do working population Eric. talking that there this in and with XX patient new as of

towards congenital a continue end else. pediatric very significant progress Eric, lot with you living hopefully a seeing approval the something year. to patients this we and by of are for interest -- we so answer as both adult an of And

Eric Benevich

Yes.

say really one has thing out is our that summer gone the to this the strong. want last I -- team since into field seen Just that we've has our receptivity been team since

community. in the need to it's there's unmet think the a testament think great endocrinology certainly, in I And I So really interest CAH.

Operator

We'll move next to Brian [indiscernible].

Unknown Analyst

This is [indiscernible] on for Brian.

trials With accelerate to you in one or the and the expect Or other? in looking the over of following XXX end progress we program psychiatry, will II pivotal emphasize to largely be upcoming Phase meeting? XXX should parallel

Kyle Gano

I appreciate the question.

for end have It's XXX. way trials any particular on for III when when going II line stand would trials look data the at reason. top be both and our any I of stagger XXXX. needs discussions would and any Phase Phase reported anticipate to don't can of think we proximity we with them commensurate be we the more starting in how We typical to given XXX up we the based

I frame, So nearly have to at time not these both of be them for expect started studies. the similar a but sign exact

Eiry Roberts

operational these The from major an only as disorder the thing psychiatry XXX X are within space. in indications XXX different perspective I'd that well, focused depressive add there, and in schizophrenia. But is on obviously, [indiscernible],

I between programs The don't is both really we extremely for anticipate competition areas about So these to in of value important. patients with moving X opportunity bring potentially think our the internal excited team programs, which is forward. these

Operator

move next Gould Barclays. will We with Carter to

Carter L. Gould

of on sit, pipeline I over about of where how talk make at portfolio, And a sort we sort Neurocrine I up in-licensing ago diversity of, of bit heavy 'XX? clearly assets? you've guess, And of mid-stage can you or that early-stage Maybe your in evolved. you're long seems the follow now kind clearly the the a and and earlier barbell up from pipeline, investments focused one where of course bubble are VMAT muscarinic, those we looked sort Phase queue, the of to time, III of homegrown more now guess, so on the least looking a that's for Phase maybe to should III guys time through expect another to those questions. -- were made those guess, at some little replenishment stage approach we in I very at had breadth you either about earlier it's investments assets

Kyle Gano

Thanks the Yes. question. for

I the out in you the spans later-stage assets that think also, agonist to VMATX. and and mentioned that we'd muscarinic earlier the that like point addition to portfolio

NRXB the we're movement We that antagonist major we also for of NAM we're variety disorders. an II, that depressive then have And in moving disorder. Phase muscarinic moving have a a for forward

to early terms And the portfolio about So in portfolio. of have in across organization what's clinical emerging there's going of earlier-stage late-stage a the terms early programs XXXX. to in lot the add to more on we'll and our say

start our time There's now So that's labs, tuned it stay that. in move that in clinic, lot bit ongoing in a just forward and that to right the seeing XXXX. we'll of a productivity of and on takes

Operator

Markets. I'll Brian take a question RBC from Capital with Abrahams

Unknown Analyst

market? versus are Brian. you us-- you degree how on competitive -- growth and terms gross on any Joe net drivers you're on for landscape you versus seeing elaborate the of the is about thinking in could contributions demand Can This more the ground INGREZZA, on to for what are the of seeing other in the you TD know

Eric Benevich

Yes.

my remarks, In terms for demand. as it's for -- primarily compliance in the driven growth strong of driven by continued I the mentioned dynamics QX, prepared INGREZZA. is primarily And

X the of obviously, we since strong years growth growing a seen is dynamics, terms market. competitive launched In this And ago we've in counting.

inhibitor, of As in the recommended treatment the XX% treatment treated in VMATX Kyle are the mentioned are patients being remarks, which currently than less prepared his with guidelines. first-line

long in XX years invest a opportunity with of we that exclusivity. continue And ahead growth. still more there's to So us of

expansion our the recent indicated of in field investment and continued sales I by think as team DTC. our

future. growth is and primarily organic for continue to So will be foreseeable the

Operator

next take question Fargo. you. Thank Wells Bansal We'll from Mohit our with

Mohit Bansal

congrats is about you are cart how a out there in think we I see direct of as where do competitor something second first Crinecerfont? could that? on see we antagonist as love a to versus I should here, the before like Kyle, this Do you therapy Maybe horse CEO. an but to mean, you you line, kind or of probably more well. competition ACTH understand line competitor line call as that your How first be about as in about the upcoming putting there would how internally are CH thinking -- thinking space?

Kyle Gano

I'll that here. there's missing. team start in question, chime I'm I'll anything Maybe ask if to my

hypothalamus is pituitary struggled I mean, CAH, all And access. a when we So heart very access. that adrenal think HPA of about can I we by body HPA, disease. the serious think the to its this capture the is At agree matter

disease or of on mutations of it's terms dysfunction cortisol, the the synthesis results is and In the of AX which key by asking initiated, the gene, caused XX access. the that how SIP is HPA regulator in

to antigens. them to control of years, the HP that physicians of -- reduce very regulator to XX So recapture therefore, or is patient the capture or control access, control access. Crinecerfont had ability act doses for patients, their we as glucocorticoids allows get super to reducing use, physiological with the past HPA the What ACT, ACTH, for high GCs,

of a endogens, use And same the control at time, of III requirement number remove And GC able trials the their to glucocorticoids. physiological that about it of into from we you're ACHH Phase using seen that we've of excessive excessive dose. when our that, puts think your control for you patients a range

well, able at think when So and reduce HD the of then upstream with. then to coach to the we're working and at everything of competition, top control regulation the our below control the as that, the angle about Access the you uses HPA starting

right this now company And small of early Kinaxis clinical stage subjects. with an Diego [indiscernible]. number in Our San antagonist it's developing called know in here a a competitor space, we well. quite ACTH the that development

I think how approach downstream see realistic because to of work on time they ours their actually approach. work tell our will will

but our position. So they right have both and adults. match across the safety to excellent other got and needs ultimately, only adults. efficacy very very children the at the excited of cascade, and ACTH which children look about piece we we're formulations We've now, got androgens, tolerability, not are strong the We've where both and of we

we is look feel going change standard ACTH. like hopefully and in for year of the to care in important fortunate patients, to position here, launching in approval we later this medicine very So getting which we're a forward this

Operator

Partners. with We'll our Leerink Mark take question Good next from

Marc Goodman

of about been just of of noise going quarter. share agita They're into and Do just more on us feel on respect A the the out making you to us give to to to with what's I media. there. question out going INGREZZA lot come like lot a of really gun sense competition and want that one investors you're the could back There environment. the seems sense be that noise. give has the there? felt a faster. of Teva Can competitive voice a you kind growing you Maybe the

really prescription think people. the trends I confused have

So could think to help this? just do you anything about us

Eric Benevich

tetrabenazine, as the -- a we And undiagnosed it's XR obviously, just quarter market. competitor. about and their felt our rollout mentioned growing. VMATX untreated both mean, And the helped TD of before, expected, good The formulation deuterated we is remain are majority growing of vast brands the of reported. the I market I Yes. patients as growth with of

testament However, exclusivity to in VMATX prepared X I INGREZZA is of completed in written and remains invest just specifically XX remarks, continue expansion we prescribed years the of million recent prescriptions strongly force and we ahead, inhibitor in over LTC. And the with growth our it potential sales opportunity. most the my since franchise, of commenced the with is in believe that that INGREZZA think the more psychiatry mentioned as launch. I to And and with in the

didn't LTC is segment. growth been felt that Psychiatry the fast support a we and certainly, to newer there relatively And was we touch the overdue investment XXXX. were back for us. it's prescriber terms in the of the that team that we base, expanded continue to FTEs that segment more And we is growing, adding think appropriate. area our when of we in

and team conviction with of our in a investment of this the So INGREZZA. current continued in long-term DTC overall, have is other think and with the we that the we areas promotion, sign and in opportunity

Operator

Minter with William from We will Myles Blair. question next take our

Myles Minter

ago, in stocks the were about some threshold New definition Spanish couple in glucocorticoid the from used question I the of week would Journal normal Crinecerfont call daily and of you kind for correspondence a dosing. over of a there just England think that

you in like and total if confirmatory conversations, mass your to response metrics in percent that early efficacy payers as of of curious is this -- population. resistance endpoints your Just and to getting for sort they're that asking particular fat insulin are surrogate in

Eiry Roberts

Yes. Thanks, Mark.

of data And in are we vast Crinecerfont that's to the of perspective all, in effect the of case that So happy ability in reduction the I and an androgen majority III pediatric population steroids really efficacy terms first the the Phase think the we reduce population. both from with the of treated. have the both adult and

in store criteria important I to ever has a that of clinical Journal, first England Now I is been in remind et a there's what around a the terms done. discussion the you, trial, trial discussion in New used time the of we But it's think and want cetera. this this

the constitutes we highly we including to was come And that population. important because negotiated what physiologic set that to is to of with levels definitions use, very heterogeneous so of definition the the agency of a this closely

with approved. data line or we believe And is they so be patients gain of majority we CAH, connected from can really if from that that that I is think our the pediatric bonds treatment cronestipan bottom benefit the living whether of vast well generated patients result they set can

to from And from experience so real-world it's to this chronic we start start get out view, on. of very important like we we condition the point can that patients highly -- treatment to result a into long-term be that benefits of and to think the encouraged once see understand I and going once

Operator

next our Morgan take from We'll Hung question Stanley. Jeffrey

Unknown Analyst

so, to see to congrats if Hung. gauge that Kyle, like top how Privado. is adjunct on is are the it is being start. Jeff want safe the evaluating an potential about assume Michael antidepressants? to as NRXB on And developed [indiscernible] thinking you What for would the maybe -- versus XXX the strong This NMDA to background for competitive line? you program,

Eiry Roberts

in the So or inadequate course, those be that's now adjusted could, performed the to an antidepressants. response currently II, Phase both is as trial a being peaking stand-alone actually due in treatment that -- have monotherapy. that in right yes, population as potentially available

a there Once the being this things into a treatments that risk the this mechanism favorable the an some fashion space. now. oral in right we the benefit other in compared profile relative key terms translate is other differentiate from to this out could are to obviously, differentiators of of mechanism more we Ketamine of hope similar that but to action, of mechanism obviously in One acts selective

Operator

our question next with from Chico take Winu We'll Laura Securities.

Laura Chico

on in peak to I'm provide to respect how revision trying color TD additional breakdown with or does this the estimates severity change you dyskinesia? in there. target kind XXX,XXX the guess Could views your or I opportunity INGREZZA the terms of understand there? Just impact of of within

Eric Benevich

We you patients X/X about Yes. -- at in terms balance and X/X estimate in literature, of to severe moderate milder Overall, any look color category. be that the when being to severity. don't that would the is of have TD. the

in medical of So the constitutes standard no severe TD. literature, there's definition moderate really or what mild,

HCP quality the milder and the what And patient that life give at impact did have the disorders, from the to understand we TD their for with drug but the movement their that only community even does and these abnormal to that movements patient that look of significantly and negatively and a impact extent functionality can patients. conversation they so movements differentiate to is other abnormal ultimately, need need really in guidance not look to

terms severe in more negatively less being with but what significantly of movements are see you severe that today people so is a lives. people and with And treated their abnormal certainly mixture INGREZZA impacting of

very there. the But XX% remains unchanged out lot and the is, on of less population, frankly, got range inhibitors, VMATX people So that overall our the in conservative of number being the XXX,XXX like estimates opportunity and we terms with the ahead. probably I supportable feel ultimately, a we've of end of that growth are more than currently treated of mission said, are

Operator

Suneja We'll Guggenheim. take from our question next with Yatin

Unknown Analyst

can day [indiscernible] And upcoming you many program? planning to run? are pivotal guide we How through your so on see expect conference? the MGT, XXX us you can in strategy studies II in for Phase the to

Eiry Roberts

that. for Thanks

comments, we terms trials antidepressants our trials year. following information other the that's lobviously, release we registrational a the those are the in next in and with talked And by latter II after development. of to of to early alluded interaction number actual in I Phase in So we engaged planning and FDA the been followed that design program the we'll the be that or we think path II year. our But will design yes, in do the part the we have Phase of next about haven't from in program trials, specifically start

Operator

our Mizuho. question Ear take Uy with We'll next from

Uy Ear

before how bit studies? whatnot that the going maybe drugs everyone do launch the on? you excitement just uptake. just us a that of moment better indicated you with on, out -- want in sort extension you'll yes, giving bit, extension of be about you drug? the demand to giving free guys currently Or focus drugs to Like you at free back Crinecerfont Would just be Just help lot to the the comes insurance safety a the this give the are sense I a comes are understand terms that your demand And number essentially a pre outset? on maybe of with maybe to on patients at of respect seeing of drugs

Eiry Roberts

in basis. comments have long-term adult We about -- answer globally now X and right extension programs both on that. long-term around the I'll extension patients the do going piece pediatric

remains indicative some number to important. very with in respect program the I think, collect I this secondly, us which patients all, which safety and longer-term real-world very, is -- of the that's about update think First dropouts, these with incredibly tolerability, patients And in program. ongoing to of the high, remaining again, Crinecerfont of enabling excellent it's and information few

Eric Benevich

and/or are in these dynamics, reimbursement reimbursement I new place. drugs. or majority the to regards insurance policies prepared community have Yes. as restrict new-to-market mentioned blocks And many through remarks, insured -- have that in patients of with for commercial in place And commercially Medicaid. in CAH either the plans my the

get even take as is therapy, it's to through that started expectation to -- time we going the the on so some work reimbursement. And patients the

to dynamics diversify us we So revenue. significant for indicated by the our in INGREZZA, early is offers and get think a we get the and both lot creates here But ultimately, with we launch. patients Crinecerfont in started that of that confident our that program for ultimately, to really and us saw commercial ultimately to opportunity to a -- going ability our that are INGREZZA community. CAH similar we're place think a started value And success patients we across Medicaid. as in have allows

launch So in we'll terms we when talk have more with lot our strategy. access a closer about the of to get

Operator

will from And our we question Company. with Ami Needham take & final Fadia

Unknown Analyst

[indiscernible]. is This

And how into So the fitting current on XXX, expectations upcoming treatment do it NBI see FDA you from meeting? are paradigm? what your the

Eiry Roberts

that Phase our of start our Phase in next enable terms in clarity will FDA will be III strategy, meeting, year. getting first and we on of the program us III So to the half

available forward. in Phase adjunctive In monotherapy generated stand-alone to terms or major as or currently context the this field of of was an the in response of indication the that a we'll treatments. either then we both disorder, antidepressants the And area data II setting, that that be depressive focus inadequate treatment and could exploring in we we anticipate to currently be move the other in as

Operator

call back are no closing And there further questions to Kyle time. remarks. the at this turn for I'll

Kyle Gano

Ashley. Thanks,

exceptional ground. our inspired and We to Today, ahead more about positioning confident great our certainly by pharmacy opening lot energized potential. our I'm leadership Neurocrine and are all close of a like this by moving message, lead morning, our commercial talked things. reinforcing team we my a deal bit covered forward. I'd our on of and a ever opportunities. in neuroscience really different we the touched that's our work So to on in pipeline strategy, organization

committed earnings I this And commitment and requires I'm our organization our committed that things from innovative thing with my our near we're see But you and developing take and risks X to shareholders. our think time Q&A. long-term equally call, you've to that that I medicines. for also from hope away delivering and our think and One opening about remarks comes first and discovery, value this our you If you commercializing being it seen hoping discussions is investment.

of So be with in year-end couple close of conferences busy for that, you us for in we're remain I some virtually here to attending with will of connecting health here looking that of the the ahead months. think many by person, that that that next saying and those we'll and care forward today all, many you

next you again for look call with forward soon. speaking the that, with So and to

Operator

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

at You time. disconnect any may

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