Neurocrine Biosciences (NBIX) 1 Aug 232023 Q2 Earnings call transcript

Company Profile

Participants

Todd Tushla	VP, IR
Kevin Gorman	CEO
Matt Abernethy	CFO
Eiry Roberts	Chief Medical Officer
Eric Benevich	Chief Commercial Officer
Kyle Gano	Chief Business Development & Strategy Officer
Paul Matteis	Stifel
Tazeen Ahmad	Bank of America
Anupam Rama	JPMorgan
Phil Nadeau	TD Cowen
Jay Olson	Oppenheimer
Leon Wang	Barclays
Marc Goodman	Leerink
Brian Abrahams	RBC Capital Markets
Brian Skorney	Baird
Jeff Hung	Morgan Stanley
Myles Minter	William Blair
Danielle Brill	Raymond James
Evan Seigerman	BMO
Laura Chico	Wedbush Securities
Sumant Kulkarni	Canaccord
David Amsellem	Piper Sandler
Ash Verma	UBS
Yatin Suneja	Guggenheim
Uy Ear	Mizuho

Call transcript

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Operator

Good day, everyone, and welcome to today's Neurocrine Biosciences Reports Second Quarter Results. [Operator Instructions] It is now my pleasure to turn today's program over to Todd Tushla, Vice President of Investor Relations.

Todd Tushla

Good morning, and welcome to Neurocrine's second quarter 2023 earnings call. Today, I'm joined by Kevin Gorman, our Chief Executive Officer; Matt Abernethy, our Chief Financial Officer; Eiry Roberts, our Chief Medical Officer; Eric Benevich, our Chief Commercial Officer; and Kyle Gano, our Chief Business Development and Strategy Officer.

During today's call, we will be making forward-looking statements. to differ and materially. subject actual and are may results statements certain uncertainties, risks our These I factors latest discussed you in encourage to our SEC review filings. the risk into After prepared will jump remarks, we Q&A.

over I'll that, Gorman. turn call With to the Kevin

Kevin Gorman

morning, Thank guidance. can pleasure be you, press see a strong from here a the of this had to first We've our Todd, half morning, we morning. year, It's our good very and are everyone. raising this as release you

of end and the is what our was high So range, INGREZZA. performance the bottom the strong commercial with the very range of there previously now of team very out proud

We're now exciting half set of really second the year. for up a

associated pipeline, by from We have date coming multiple our led readouts Huntington. with the for our Chorea PDUFA INGREZZA and

Focal adult coming the We pediatric in also coming that we'll least Onset - data but data say and to the And is population, a at questions be a Eiry all, going Seizure about little your in Anhedonia and and out. later, both taking that. to out, last have not is on lot the more and studies, have CAH a

far. bit So very thus It's on all going nice been here. quite a

going the for year. over it I'm half So now, I'm really the Matt. second to And looking of turn right to

Matt Abernethy

continues Neurocrine INGREZZA sales, pipeline. improving with morning. to Good growing advancing execute profits and an

with $XXX During growth of year-over-year the driven were XX%, record second million INGREZZA patients. quarter, by new sales

patients do treatment. affair to TD prescribers teams an medical helping developing and continue market, receive job commercial new excellent the Our and many educating

midpoint the $X.XX guidance INGREZZA $X.XX growth guidance our to the INGREZZA billion, range. from to $X.XX This year, billion billion sales solid we of of compares the billion. are sales With XX% of the reflecting at over range to XXXX first $X.XX half previous increasing

operating market $X.X of and of strong hand, will financial profit have advancing cash research in reduced These create allocating clinical execute strategy providing over term. plenty and long quarter over by the pipeline TD INGREZZA, to net our for and our the internal improved developing growth flexibility billion non-GAAP our now generated short to our cash believe $XXX expenses, and strategy flow million shareholder value of profile efforts. We during the both sales income. in With this profits capital on towards expanding

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

Eric Benevich

strong with very first Matt. Thanks, patients. and INGREZZA's sales half performance across existing new Year-over-year pleased year. the by I'm of prescription through sales grew XX%, the demand driven

anticipate be and to to As expect noted, develop care. growth in neurology psychiatry previously we gaining are driven most that as we patients good TD see to a care, business of majority segments In and by the where traction their XXXX growth we segment. long-term continue receive

now $X.XX said, year, Matt half With billion. throughout to updated we high range of of the it The driven end in of starts by to of $X.XX primarily patient the pace the is and of the second INGREZZA year. new to to $XXX million billion the range low the the guidance first as raise half billion, from up $X.XX felt prudent sales $X.XX

this options, been the disease. Huntington Outside associated of the and for of teams across of anticipated TD, Despite need launch population. medical availability approval patient Chorea with to our significant have improved subsequent commercial treat remains valbenazine and preparing treatment a unmet FDA there

a are a HD safety suffering positive patients approval forward potential in and and the to the for any Chorea can HD confident guidance, efficacy data next into with While difference look have we not we clinical we that potential we valbenazine we've generated Chorea. from in HD believe sales Chorea month. in program, our factored We in make

sixth especially impressive year on record on for like in its results of to INGREZZA. these year our are Growth we numbers market. track all, the another are in product All deliver for

know the a have for their diagnosis or movements. of However, still even not HD as soon, a We the patients TD tremendous hopefully, and someday patients TD received TD any explanation remains still fact to more well. Chorea we help patients that majority have opportunity

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

Eiry Roberts

Eric, everyone the and you, call. Thank good to morning on

and lead clinical come. Our steady years the progress, which make of to continue programs and this to several throughout rest data will important milestones to readouts the year in

efficacy of Looking mid- this with package associated with to August date highlighted We've approval. forward be year, Eric valbenazine the FDA for programs, we soon the beginning Huntington's a in the regarding strong for the confidence approval specifically we feedback and data points the support good will had important second inflection the XX to of the the half indication disease. of PDUFA to very engagement reaching Chorea late-stage look agency's for treatment and also potential and safe an second for valbenazine. for have generated to with number

Separately, fourth report the the depressive line top year. of adults II enrollment the the studies, and treatment readout With of seizure studies onset disorder. NBI-XXX includes on of Congenital is with pediatric from respect studies for NBI-XXX registrational from to includes readouts, the now to Crinecerfont focal we anhedonia QX. in in Hyperplasia. of complete which and track treatment This Adrenal X results remain to both remain quarter adult track data treatment this major data on for of in associated both in of This X Phase for

to Turning our now portfolio. muscarinic

in for are study Phase the with enrollment of treatment We very of good schizophrenia. II making NBI-XXX the progress

explore wave just we and of expect we're assets progress year, to muscarinic molecule, the ever with continue our the I, a into very and are first this number addition, second most first In NBI-XXX, Overall, our MX clinic be I neuropsychiatric progress the MX compounds, pleased had. to into the Phase with muscarinic across dual diverse over has X a These of conditions. advancing represent Neurocrine time making pipeline agonist. teams broad

Kevin? And with back call the that, I'll hand Kevin. to

Kevin Gorman

we're take ready to And questions now. much, very Thank Eiry. you

Operator

Stifel. our Matteis [Operator from will Instructions] take And we first with Paul question

line open. Your is

Paul Matteis

taking question the so if pipeline congrats ask the you and kind mind quarter. for BD a I on of don't Hey. much Thanks Hope question.

that a your just kind crinecerfont do that, rare not budget so line. about for do endocrine, and the near scope. how as I If crinecerfont in what guess, the and that of on could could top start hoped, well of Neurocrine of foreseeable about think really the to how historically In of it assets as fit impact neuroscience lot future? direction go works much. neuroscience high-quality really context the could into to Neurocrine either you not Thanks make and you midterm of talked there's kind You've be disease to

Kevin Gorman

the add endocrine what look to say space would morning. is, can Good bit. but we Thanks Kyle a I question, do quite Paul. for in the

at him and and his As you also discussions that know he and had - several into with into conferences, your look neuropsychiatry. of neuroendocrinology, endocrine you've from neuro broad and team neuroscience Kyle speaking both deeply

an our assets not to you at that it all all Kyle, criteria. want we've really are we meet is So to that poised if we of that add area that? ignored do see go into to

Kyle Gano

Yes.

to endo add are it with historically. would done remarks, crinecerfont, to data later looking the interesting side, things with to open is on stage positive that be Just what the does commercial think we at door which Kevin's haven't I

what and look know await those crinecerfont our like, we data. opportunities we So

Operator

of our America. will take We with question Ahmad next Bank from Tazeen

is open. line Your

Tazeen Ahmad

expect giving a us Thanks focal Maybe not what or The just of you get care product your And a whether improvements sense question. currently be expect? to in that onset guys. for have to data XQ, we terms top should we taking for sense Hi, for that what expect given... what Okay. of my but of comparing in to should really seizure. of standard line could

Eiry Roberts

Tazeen, it's for Thanks Eiry that. here.

bit. we onset much looking Phase the I are the dose-finding study, data the forward think Three I you II context our a of were But predominantly so - to concept. questions reading very got this II in focal interested of study. things proof-of-concept up initial from we're a seizures. Phase in all It's proof breaking little out

tolerability population First XXX patient in of this and in of initial the all, adults. safety obviously,

position obviously us dose well exposure to pharmacokinetic we're which selection successful. us is second is the And if other future help for in the third The will understanding response trials, understand with the and profile, baseline seizure the from seizure end X-week seizure we at normalized period looking of essentially, will primary look measures point. of comparing we an And over at frequency. be frequency And the to monitoring. frequency

any the XX% And between so the compared in whether treatment patients Also, obviously, able from also placebo. at become are we'll in study to small reduction the from a be interested and And achieving the baseline change absolute of looking patients seizure-free. seizures. number

discussions. will at seeing information, strength and that that us the well then future give any that for position will us indication totality Looking obviously, we're signal the of of of that an

Tazeen Ahmad

improvement of minimum And amount is looking that no go, you're in determine rate for terms there a would kind go? that seizure of in any

Eiry Roberts

number steps. in have fair this there space. to understanding of new information a the our obviously, And the for We'll in in molecules demonstrated on efficacy of reality, own But this new that trials have we'll in in be recent interested focused be data. the that context been past area understand next

Operator

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

Your line is open.

Unidentified Analyst

Chris. Hi. Good morning, team. This question. Steven our on is taking for Thanks for

framing business. think helpful overall macroeconomic some trends been has of range see with the and historically, in in team factors your what terms your you guidance just I means

you. $X.XX billion frame billion context? was you to if I that So could wondering this $X.XX Thank in range

Kevin Gorman

by the demand $XX doing new say I be the outcomes year. patient demand. job. depending is of in the primarily sequential to I'd year. range is the what really of on to just the driven an patient the the million. say We would And going growth had half show going driver going year, of second new half nice the It's And range in to be excellent that that's first Yes, of team rest It's the strong is. the guidance a for step-up for

to confident room and we have So say of the it really and we our business from new down perspective, operating, with based market provide of upon continuance I'd the disruption. you today. always it's how a patient bit comes is macro provided get how the feel operating additions, guidance some a But for to

Unidentified Analyst

you. Awesome. Thank

Operator

Rama we next question from Anupam take JPMorgan. with And will our

Your open. line is

Anupam Rama

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

PDUFA indication? of how Huntington's INGREZZA shift INGREZZA so month, are properties in much. How the this launch about later curve do might market the the that Thanks thinking there? With you for dynamics the

Kevin Gorman

Anupam. morning, Good

the Chorea only population. about VMATX decision so FDA inhibitors, patient which unmet of estimate the only look the And We associated we're Chorea medicines, in significant opportunity are that XX approved opportunity, - up with patients XX,XXX Huntington's that way excited So it, we're out the forward disease. treated there's X obviously, The are with looking currently with around coming or tetrabenazine’s. at the to in the need U.S. we're for and August. still yes, HD

there. And so unmet opportunity there's significant still and need

certainly and and off numbers opportunity the perspective, future. would in a able labeling it's the getting patient that significant XXXX financial category, to to But and still our help we're there's being to tucked forward with year. looking be the From We're forward not in being modest. to able looking valbenazine patients ground into this not-too-distant get more guidance,

tuned. So stay

Operator

take Phil our next TD will from We question with Nadeau Cowen.

is open. line Your

Phil Nadeau

Morning. question. Thanks taking for our

to drive particular. trial likely in and get reduction we we're the consider CAH in to approval pivotal that's reducing QX, on for forward your As meaningful look you the in support clinically Thanks. adult And what protocol curious to What that thoughts trial? would is data steroids use? early a the

Eiry Roberts

important that and adult of we say that androgen will Morning, is each for protocol drug be real-world clinicians steroids setting, on that to steroid in that patient of the And protocol being that the III used the that to of guides about Phil. the in of talked actually is the face study rather the is the will than it What steroid specifics reduction trial. not once reduction need be what primary and was which individual the control is trial, because how successful have control in there degree the the endpoint approved. is reduce a though, experiencing. if of more I believe the Phase We've

problems that say Phase to III meaningful reduction our dosing said of with would this issues, stakeholders, take patients steroids clinicians physiologically these life comorbidities, in doses disorder, needed significant their the interactions With steroid program payers in we've respect - of of including results many higher growth duration of issues, start level, consistently cetera. as bone and and for in metabolic from fact than and patients, et the the that discussions the for clinically a I

any for reduction steroids so individuals. in And is meaningful

data soon to the get when is the context of read the a we crinecerfont treatment. way, to steroid clinical in very of reduction obviously trial, are out understand face In the we trying and steroids reduce opportunity in of the we what protocolized will degree the possible

Phil Nadeau

have me, you you study? of powering the Can the disclosed remind

Eiry Roberts

the within disclosed is endpoint. the that's powered study powering and the not of do to and that by conversations primary registration, that very the trial endpoint. have address that believe the with safety patients number database We trial support driven agency the against to the of in regulators that is and needed the the adequately We was predominantly

Phil Nadeau

Perfect. Thank you.

Operator

We Oppenheimer. from Olson Jay with will take our question next

is line open. Your

Jay Olson

especially on your Congrats potentially Thank And assets the Hey. pipeline crinecerfont how talk question. the scope can about you to globalize quarter. beyond taking the leverage infrastructure if for of the and your Can geographic in thanks business, you could Diurnal Neurocrine you. other crinecerfont?

Kevin Gorman

Neurocrine. Thanks, Jay. could crinecerfont Yes, globalize,

worldwide mainly as this the a ran study States, based in we United So Europe.

is And excellence that basically United which here. States, It's Neurocrine of part centers so obviously with we of one the this throughout also by by throughout Diurnal And excellence indication Europe. being would of commercialize driven driven as centers with now.

see as Europe. our So operations a entree good we commercial would to this in

we'll look So we worldwide - to on be in this U.S. Europe. commercialize and and filing both a do

Jay Olson

Thank much. you Great. very

Operator

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

open. is line Your

Leon Wang

Hi. on BD. on Leon is question Congrats for A on Carter. quarter. This Wang the

on So hasn't of position Thanks. given that Robert color that the in going additional any is that XXXX have retire fill successor And line, you kind or on additional process? given to can doing BD? better look are time announced extended you any you in would give yet, Dr. before the and position to where details been

Kevin Gorman

had Neurocrine. What to like Thanks, at an them III forward are approximately here, programs, scale that move excellent Neurocrine. has Phase Several built say clinical are ago, is allows for an as organization time. going rejoined at on programs when on programs and of mid-stage a dozen and she's over have built we that Neurocrine going a X Eiry I years organization late-stage now X added nearly I'd over these programs Leon. We well or others dozen programs.

of You which years rarely has Eiry given notice us, get here. full what X is

order as highly So a time if she be and look thing good as involved we'll of exists, replacement possible. in is to here period really for in a efforts make our transition to efficient her for such the

the Eiry, again, for that. So organization. entire Thanks,

Operator

from We take Goodman question next will our Marc with Leerink.

Your line open. is

Marc Goodman

X that got you've MX, you're of the past, in the an got talked be press about morning. all MX was Good just kind about X. got there, to of Yes. Phase initiating you've I MX how and in Eiry, and you've going I them the for MX, release you've obviously, curious talks forward. MX moving the strategy the the

curious blood yet? that if of I pressure going or looking And with you the kind whole have of one these study franchise the a was you're package at. about But each Thank you're you. to run and

Eiry Roberts

Marc, There's thanks. questions lot there. a in of

the was of from to Sosei the fact importance portfolio clinic. Heptares think going to the have just could had selective that I pharmacology of And very important, these it we the for that start to really with think muscarinic one explore pharmacology to different across differential molecules. really set attracted us is I me opportunity the Let this into the the candidates at I to the of bringing us is consider be opportunity think given they I different selective a things very partner mean, top. that that

data to obviously, that of treatment really make well for enrollment all we that good we our acute now really opportunity say in I'm MX focus With in in States because delivery that to XXX, agonist is the have and schizophrenia primary our trial in the is that going said, psychosis is of selective is right continue United progress. pleased on our is trial currently of the first very hand. that which

us have that earlier, different little opportunity molecule I is progressing. a to indications. of across for MX/MX the we agonist. The in XXX And I the second are is up that hand referred that look think the to an opens candidates more and that broadly dual And

we'll about will to Phase have able in We selection molecules obviously as be But understand that then there. profile that, we the we we more finalized course. our indication preclinical intend clinic the to bring other say do that move in of I molecule, haven't setting, due into the yet And that. and into behind

to profile think of to for in need the With respect cardiovascular we each see I clinic these, first.

look we've I So pressure comment make to pressure really we required get blood monitoring the at will or a can't in about required or what whether until will clinic. not be be blood studies seen

Marc Goodman

Okay.

Operator

We will RBC question Markets. take our Abrahams from with next Capital Brian

is line Your open.

Brian Abrahams

taking Thanks guys. my question. for morning. Hey, Good

to INGREZZA. quarter what you that? the see into Can and And then to good identify about you good embedded of versus regards where the with also, market I and dynamics for the share - that market on Thanks. your And year in So you're rest another with guess, growth in growth another next? reported growth diagnose others' TD I efforts ground guess, patients? talk this overall inventory of you seeing do going

Kevin Gorman

bleed market. the driven that So And I'd as quarter. it's they're reflective with the additions both in second strong by the the of say medical we but team, did market saw occur were customers patient the first anticipated, have and that commercial then also a results our the to quarter testament team largely how new engaging we and and the with our real developing both TD and here

comments. going hand provide to I'm it to to Eric few more So a

Eric Benevich

the in first raised our Yes. for year. the happy of the reflects half the growth really optimism we've our with that guidance seen half. We're second obviously, And

nicely. that say INGREZZA Our growing firing now is but the right growing and all on team cylinders is more even I'd nicely, commercial is market

be TD majority patients growth. remain We've And on focused very the and those undiagnosed we bringing optimistic very untreated. And medicine The few as actually of about share quarters. to important with patients. past yet continued to over this continue gained we're vast

Brian Abrahams

Thanks so and congrats much quarter. on the

Operator

with next We question will Skorney Brian our take Baird. from

is line open. Your

Brian Skorney

Thanks a my morning, big in XQ want bigger quarter sequential to growth jump ask guys. going sequential I about sort in historically any to for taking just is then know into be XQ. little then to Good and XQ. for really less consider of INGREZZA tends a Hey. seasonality question. I and there XQ a

the sort any So how any the et guidance think historical we for changes, of there remainder consider to model of just out kind dynamics year the we quarters? with context few about price looking Are cetera? that channel of and as next

Matt Abernethy

questions try Yes, Brian, I'll to address the here.

So the the half had of growth. first tremendous year

of half second The the we similar growth. year, expect

if the patients. think at $XXX the look you in INGREZZA half type it's driven million by of growth, year, do here expect new the range, I performance and we $XXX largely sequential to continued million second

- is QX seasonality difficult to of a in always past, has the but it's touch predict. had

nothing perspective, we we're And to So specifically going this net then I've that you also if percent anticipate price revenue script per $X,XXX, from as to XXXX. out call. increase which of compare our couple on said a be to is a call here it previously, do around

all perspective. price net So a stable feels from

comes new second good myself, forward really evolving, you to And the patients. hear of market driving executing half and with down we is the it very feel team year. So look from I the performing to how how and our can think Kevin, is Eric, what

Brian Skorney

Okay. Matt. Thanks,

Operator

We with take Jefferies. our next Akash question will from Tewari

Your line open. is

Unidentified Analyst

for on This morning. Akash. Avi is Good

over next the beyond enough the comment historically end years, cash high So more you've $X flow billion. that few point. than But you think range the free INGREZZA go I will think that I was considered to M&A, of around generate on

the pursue $X beyond factor landmark? would another company? on [ph] appetite stage our any CES - what's a merger that I in gating gating teams like of to for And Thank be So M&A commercial billion you. doing there guess, the

Kevin Gorman

of is what have we're going rest going pipeline, to that growing the a outstanding adding franchise multiple into to would another So right I at say the this INGREZZA we readouts going time, we next indication which very it. in good on within have early have And year now we're year. same an and be and to

we No, but that's growth Neurocrine have doing So organic large at time. pretty at a opportunity is and we to substantial Neurocrine everything in focus a great for acquisition? look frequently. our at here driven this But point

Operator

Jeff take will with our Stanley. Hung Morgan next from We question

open. line Your is

Jeff Hung

taking Thanks treatment my for about Thanks. INGREZZA advantages of others adjunctive potential in for the you question. schizophrenia approved the Can as talk over indication?

Eiry Roberts

Thanks, Jeff.

think, don't I there First adjunctive believe approved treatments in actually space the of of currently all, are any I schizophrenia.

about that schizophrenia this we adequate with studies Phase who would the available be so a have first fail adjunct medication. response a are And approved ongoing to get an obviously, pivotal excited in And potential to to opportunity as have valbenazine patients evaluate treatments. we currently X very from III

And need then patients they efficacy important very to that on relapse from psychotic majority if response of get The episodes patients from the emphasize it's do later exists available unmet full and initially, think those of not there. I effectiveness disease. many suffer do currently get an treatments. acute the in

background. to valbenazine us into different of and in with So of encouraged is respect what a pieces combination interested this about going valbenazine, program three made

confident was and of together, huge first INGREZZA information for very use in we're tolerability INGREZZA in And and the the in antipsychotics have dyskinesia, program. in treatment The now marketplace and dyskinesia have valbenazine treatment our safety the we the patients received a tardive of obviously of tardive of who database of context with that.

for data data the have readouts, And of combination valbenazine antipsychotic synergistic In because psychiatry end studies We from the at to in of fully year. treatment in in next go trials we those a background as addition reading currently inappropriate the look the we effect. first in that's But forward what we're trials. generated result, results to preclinical shows elected the with failed a we pivotal trials implementing, Phase was that addition, powered directly the out and II models into of and that challenges data do clinic. to animal have not of obviously

Jeff Hung

you. Thank

Operator

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

open. line Your is

Myles Minter

Hi.

with anticholinergic been sort vomiting [ph] Phase mechanism, components nausea Xanomeline XXX the and I just to agonist Are MX/MX you for any on running Lilly. that to referring of seen experience to Eli CTA that's Just with that at dual obviously the mask, here.

whether So that CTA? just compound in there's as additive an curious to Thanks.

Eiry Roberts

Yes. as don't for specifics on by Xanomeline the background, want I of the design to of at much additional side which the thought profile mean requirement anticholinergics, out be and I program, peripheral but effect least MX, understand normally, too peripheral the effect. the seemless it, is I comment reasoning I due to Phase the of is of knock predominantly the just that then because to MX anticholinergic

centrally have such, We selective are penetrant And we agonists. as highly developing them fashion. in that

I'll at think leave probably I So just it that.

Operator

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

is line Your open.

Danielle Brill

good curious believe question. curious, competitor indication of Thanks CRFX Hi, I'm for for also or much. Thanks this strategic is morning. and an Is for not? so interest the I their your why PCOS. why antagonist you developing

Kevin Gorman

at point, their Actually, an indication PCOS that that's this not But We're is data. we're this at time. following upon. following - not

Operator

take will question from our with next We Evan BMO. Seigerman

Your line is open.

Evan Seigerman

hear more Hi, into about INGREZZA it. for about care long-term guys. And to setting. hear know a love so We of taking a that's didn't expansion little unique my the Thank much the I'd question. much market. you I

that So some that Thank maybe could this help or year how growth more you. next just year? support and on

Kevin Gorman

and So in have on, but long-term that we segment mental top care. psychiatry, outpatient help This opportunity neurology. to excited XXXX, to at patients time INGREZZA health outpatient didn't the we with of in the back community on we're attracted that is a take the more capacity to were about launch of

a a is We team. with various total good our residential year, population of facilities. so resides that launched care What so dedicated long-term of the progress really TD we just And efforts year into ago, little strong about far a XX% actually, we've lot over care XX% estimate to in a growth. and last seen

terms business segment. that it's in so And days early of yet

neurology signs our going segments optimistic forward. LTC. very psychiatry about Our and more be But all to there the established we opportunity than and are positive, are continue

Operator

take question with next Laura Chico from Wedbush will We our Securities.

is Your line open.

Laura Chico

treatment? one. that are increase for impacting, in any been much the any you the pick taking patients of very the people is you long I'm INGREZZA, wondering question. And of Has offer have duration that number question. the experiencing here? on duration comments quantified a you. with just Thanks just Thank treatment board. INGREZZA, curious can morning. there on staying been improvements has that Back in Good to how on commercial for if example, And were or I'll increases guidance of therapy? And actually how

Kevin Gorman

haven't I came every last the on continues lockdown in though disclosed say of grow patient therapy, that will since number of environment. terms I'll patients quarter. of take we new even we've your to we And seen No, COVID question it out starts, adds first. strong ever

persistency of early we on patients expected that and what underlying certainly the is launch, with we've And meds. with seeing terms seen at than the ever longer since psychiatric prior XXXX, treatment longer are staying days had been the our to strong that's persistency, XXXX launch and and than we're what really and In serially we've XXXX, of someone. looked to back this going what

of patients compares very of antidepressants are seeing those that persistency meds - The haven't duration we're I for to the a patient. antipsychotics, though duration majority these we - psychiatric out given on a And What numbers or is specific treatment for are patients either we both. of that these favorably think taking. average

Laura Chico

much. very Thanks

Operator

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

Your line is open.

Sumant Kulkarni

morning. Thanks and with you patients? in your serum Good discussions endpoint its pediatric reduction taking pediatric mean And week as Could week in AX being that could XX drive what at primary remind successful regulated for while the with glucocorticoid XX. our adult terms of question. drives ability patients, the adult for us to at endpoint nuance glucocorticoid to patients being secondary this difference a

Kevin Gorman

that? So Sumant, mind you you in Do came mouthful. repeating pretty

Sumant Kulkarni

is I better. that. hope this about Sorry

glucocarticoid for with primary mean reduction serum this you being ability difference the what week the remind pediatric could successful us terms secondary as in endpoint of And pediatric your regulated adult that AX XX? So at it's being patients? gleucocarticoide drive week patients, could a in to adult drives while to nuance endpoint XX at in patients and discussions

Eiry Roberts

Thank you, Sumant.

secondary end clinical management the adult are demonstrate in both kind The point to the measures important a function choice versus really adrenal in population of population. the heterogeneity pediatric the ability of ability terms hyperplasia congenital setting and in outcome. reflects of of in of trial primary So that the and the of

me And a bit little more. that on expand let

from that dosing. background reduce act of first obviously, is such, perspective, primary crinecerfont look androgen androgen androgen of at extremely the trial mechanism and actually an So action on axis on adult the HPA crinecerfont a do steroid that and X treatment stable of control weeks levels. levels And important, is as with to of the adult is

at happening In as in that development reduction a is and look endpoint. understanding there adults, possible however, the important the to things the to of And pediatric was protocolize and because extent you the of same endpoint. information the patients. management these don't we much impact look sort. on in seeing population steroid forward have crinecerfont are of physiologic and the growth, steroid that changes to dose that very And that primary It

pediatric the developing androgen changing obviously, over important endpoint growing, In since setting, control, X-week and extremely a they and in is that the patients time. primary rapidly these the obviously, measure is as are

weeks. of however, real-world reduction, measured XX which is do In a more - a steroid assessment addition, have we out real-world to assessment of

used patients I across of how the the look initially, consistency And the in the in able this endpoints important could we as conversation we be information have. as data, at so to both in mentioned out medicine around field. we'll populations And be I look at the think become the

Operator

Mohit with Bansal our Wells Fargo. will question next from We take

is is your line line Your Mohit, open. open.

Unidentified Analyst

for is our taking Serena This question. Thanks Mohit. for on Sorry.

waiting an for And versus duration the you. to autistic ask patients the bolus expected expect So and or if in or you from compliance [indiscernible]? tardive about more differences patients to Thank you I launch new switched wanted can be that Chorea. Huntington's [ph] dyskinesia for alternative expectations to if any talk rates about

Kevin Gorman

the Yes, let forward. question me kind your of and of start with part last work

excited labeling FDA eagerly And with with we're potentially favorable date a think obviously, the have and So about and the opportunity. the like. we product. differentiated we've a that those anticipating PDUFA look generated, we the data outcome that We're what

HD in But - valbenazine or in we been out talking TD community. it's haven't that about HD with important excuse to note the me, there

introducing to HD these families option well. treatment majority valbenazine as introducing be patients then the community valbenazine new of that the neurologists treat to movement really the obviously and we'll and general disorder and patient So as a the neurologists

and So options. seen I or to had in patients this Chorea the either either. that are with with TD expect some newly in time, Chorea we uptake a haven't in lot that be will switching those for been market think certainly, And they've treated occur of that they've there'll be existing that don't treatment reluctant their market. initially, diagnosed We

complicated available one and INGREZZA These in efficacy, option treatment opportunity, the TD, simplicity side HD titration, the But new that side ultimately, well look are we the of over certainly, forward translate the dosing true attractive we of because things Chorea a once-daily the rate of attributes so effects. to low think without to product make making needed. the that would is

Operator

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

is open. line Your

David Amsellem

Thanks.

going ultimately, pediatric a this to as of high right to that the it is of a commercial that the about do drug? well? think think a regarding in sort market this of pitfalls opportunity setting, driven be do to Thank you. new are crinecerfont, product adults the burden way the question starts the works, in Or So growth. that obvious given more you in as and real uptake extent peds Is see to relates of you steroid the

Kevin Gorman

significant patient by of been treatment. by GC the that, and I need with glucocorticoids. high-dose opportunity need standard across for we And issues all first, significant advances opportunity just has the comments segments. caveating And data. and see CAH Literally, been was for with start by are off medical a I'll FDA. saying, to my the we as associated to get Eiry care obviously, secondly, But really see Yes. remains the discussing, there There's no decades. is significant approved

steroid in so new younger burden the about growth But adults would excess able benefit various we've will patients. who patients. might from benefit great look if treating improve the their these lives going the also seen these day-to-day being at as treatment stages ability treatment control younger a Certainly, patients that the approach. the they're And through over And both there's think as years. different to of androgens you patient benefit their from interest well to with lower segments cronesterfont, at and androgens, as for

forward significant to being that opportunity approach data different patient And population, be generating so those able of there's to looking deserves the a to to across think of CAH and going that to We're we just new all one. bring segments. totally treatment which definitely

Operator

will our take We Verma next question from UBS. Ash with

is open. line Your

Ash Verma

my IRA taking implementation. to wanted for ask Thanks Hi. about question. I

price channel how are have is down? commercial a insulated your do what Medicare post-IRA negotiating you Thanks. in And to conviction pricing the commercial So environment? respond may assuming implementation with that to you respect

Kevin Gorman

listed of for say the IRA protected Neurocrine, moving target, of be the small to while to biotech group all the said first impacts to for going here quite going companies. going we're what happening, monitor provisions especially along that carefully as it starts I'd for entire a negotiation. but while that this companies both I've we industry, of get for with are is because September is be So a

That's real we Medicare phase-in that's a as for Part we program, lower phased over first be nice us - going having payments Part The in the to one, manufacturer of be the the shoulder a to discount written, in what we're period starting specified be than because if for that new for time X-year current in small D advantage actually XXXX. to going D. should currently a us is

over the of delays to We phased negotiation the or small it's potential XXXX biotech XXXX. for exemption, qualify impact for also to that into expect in the and XXXX negotiation and

it be as be take business changes, can't will just to the this closely, will certain we're predict what into exactly We there going quite monitor changes - as So don't I've forward. be before, consideration it, our move with we following and while and said we IRA. I'm

Operator

question And we Guggenheim. Yatin from our take with Suneja will next

open. is line Your

Yatin Suneja

Thank you.

quick guidance? a what guidance, the and QX? the Chorea about start in that incorporating should you the to of And just time QX how per terms Just QX, from is question think How where comment end? maybe it trended QX on the Thanks. point expect Could revenue you then we you at in to maybe script. might on not included

Matt Abernethy

Yes.

On too the material not year. yes, it's be don't incorporated, we for guidance it front, to this HD expect but

From improvement see expect about revenue to as you've fairly from think we QX. per be XXXX. typical, would it a a net is I it perspective, script QX historically, we percentage And as So few as you incorporated to seen had here. consistent from

we very nothing that net that So remain to be to than other script per flag do access $X,XXX this I'd around good. year, and expect revenue

is charge profile is not we've very asked always our perspective, that profit that want during comment compensation think had non-GAAP But there. a the did earnings. do a We One had to strong about been other I impacted we that but quarter. consistent profit. have noncash our profit, So from stock-based strong I GAAP nonrecurring, comment we

I that in expenses. We And our you expenses, figured can into the stock-based didn't did GAAP actually increase but look showing continue compensation. you financials, to operating the when operating see non-GAAP up reduce is we

So profit remains operating nice strong, and profile in the very for our seeing company business. we're leverage

and I a there left feeling bit question was to not been I've in chime since wanted out. financial So the asked

you. So thank

Operator

next our question Fadia from take will with We Ami Needham.

open. is line Your

Unidentified Analyst

you delta the This a Eason quarter, morning. thanks kind is utilization of telemedicine big quarter utilization between next the good this neurology over Thank on impact of and for evolving growth taking Ami. you for How kind you. trend? could our the psychiatry. in Hi, Last question. or and on and think INGREZZA the this mentioned about on have Congrats two do year

Kevin Gorman

were I a been is stable between dynamics jump think, and to two, all The into neurology patients as significant psychiatry levels of psychiatry being on. this saw and so use Yes. We over year the went regards visit. and saw But the less with we relatively pandemic, Early towards back pretty of started care specialties or and in both across telemedicine there restrictions have system. other come within XX% than the its the really our clinics segments. significant more difference the billed health neurology past the telemedicine the that historical back in environment lessened, visits of to improved telemedicine, and as

visits In in of that's psychiatry, It's still telemedicine hovering as higher. around billed behavioral significantly or however, being health, all half visits.

though power COVID think we is so that even diminished to some quite in psychiatry, that staying a has stay, And bit. it here has

psychiatry the And of to providers use is really think, - segment. practice dynamic, other in that I the expanded note that's important in advanced

TD little that I what's And though, two I general in nicely in creates business, work nurse helping to think so coming patient psychiatry a screen particular, in think, some psychiatry, macro psychiatry providers in those to understand for and of our of challenge diagnosing to into then a that important we've important happening are for it to And bit practitioners, providers factors, which they're understand how telemedicine, to providers adapted how associates physician educate doing telemedicine. remotely diagnose when in TD the evaluating so on. via we're terms new with

and invest market And driving so the evolves, diagnosis that the we continue continuing the is undiagnosed, majority are and to treatment. important still to thing evolve but in we're as patients of

element The of mentioned just I'll Matt another factor. throw there, the in in other that like bringing importance

DTC symptoms their diagnosis. directly partners them bring care and to is TD one invest to in DTC continue to up and mechanism motivate to We that and drive patients we reach have to

strong and raised see are our think these high all And to But growth that. that the I as ceilings growth, future of guidance about for think, important we're I the so franchise. continuing think things, you reflects and

Operator

take will question We Ear our from next Uy Mizuho. with

open. is Your line

Uy Ear

my sales have Thanks. Hi, for guys. neuros, the rates? of the also growth and long-term rate could more for what speak taking could I care psychiatry the And INGREZZA the in might tell growth volume this and question. - it, quarter? us the terms in contributions missed color to the neurology, on quarter's but to provide is Thanks you the some you

Matt Abernethy

And growth, of we've So bleed you that's a that perspective, you was XX% earlier, reflected it - nice. number as from inventory did in had about said I a dollar reported. about growth, volume when quite also incredibly the was XX% have think strong which the year-over-year we

but haven't exact strong percentage, quarter. during provided growth we So volume quite it the the was

Operator

in the have would any remarks. the all queue. addressed turn questions I or like back for We Kevin to the closing program now over to additional

Kevin Gorman

in quarter. that you fact with morning. - for too the and bit thank take team, just teams continuing, is and just some the are And become never Thank other your this of from going amount I'm much, our this growing granted. that hard quarter questions the marketing we in close out used team entire a support a that the growth for it sales, work we've while we may you INGREZZA, to tremendous to there very field. all see goes after you of This all medical

medicine like yet more a and this of a this. suffering just company very able incredible. not because efforts. along are And often. fortunate come to see those to we And continue this. We're to more do no They product have with is to hard we bring in TD patients very slowdown That

doubles. sure But of do this see there's there's other there year, pipeline. that has what medicines extremely of rest for I'm the half II potential the company Phase X not you a that you and it number any in important our Phase in out next the extend as into months year, next first of it of if number readouts coming nearly And trial we the III out do.

happy cylinders right be the with at a to much This tremendous is these. more there's way on point. improve We're hitting always company for very but about for and all that next continue way all improve, So and forward a company the business, months, to we we amount look be you of looking running this going is actually to generating in just talking couldn't to ways now. to look our few the information to we're I

in So with sign to that, near I'll off future. of talking look forward you all and the to

Operator

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

at have and time, a You may wonderful disconnect any day.

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