Neurocrine Biosciences (NBIX) 6 Feb 232022 Q4 Earnings call transcript

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

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

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

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

prepared will of customary, as after We remarks and do best all to will we be your get questions. to is into our jumping Q&A

over I'll Kevin. that, With to things turn

Thanks, morning. Todd, and good

their bring initiatives Over TD patients the number a last relieve of launched several we to INGREZZA have suffering. to years, and

of those of INGREZZA Now growth successful morning. announced as we most XXXX the initiatives this evidenced very many by in recently have been as

to continue continued out efforts future. and the build growth in We’re going XXXX on meaningful into foreseeable to those anticipate

most and are medical are our time, their healthcare disease aimed making sure force advisers you but educating multipliers in direct-to-consumer efforts that obvious that first the advocating for TD and sufferers importantly, expansion are the are all groups of important very patients for at these treated. are initiatives the their What of and staff, appropriately is care. Now professionals, have Many the within payers teams sales company their the are our and obvious force to advertising. less the other

undiagnosed will significant medicines of of and research XXXX. in untreated. and consistent have date, to the and diversified deep and new multiple basis vast and clinic efforts invested remains portfolio Switching molecules important continue majority these ensure development TD will the to flow We've results and will we sufferers a gears, a because year momentum our that the have product that we have yielded readouts mid on this Again, enter for into meaningfully a into that such year future. late-stage each

over with And that, there. turn it stop to Matt. I'll

Good the Good month. for patients in TD With come. you, to see over a you of and of is many number excellent Thank sales million position pipeline, of growth morning. in advancing to an in Kevin. past Neurocrine over INGREZZA $XXX record helped years XXXX,

top enrollment data clinical during of line the this the half fourth us accelerated year. second side, in the to On CAH quarter, provide enabling

sheet million $X.X On front, ending retire the debt. balance while financial our the year to strengthened using cash in portion of $XXX our over convertible large in a XXXX, billion with

XXXX, $X.XX reflecting to marketing initiatives. expect underdeveloped by market we billion, year expanded supported an another for TD between $X.XX of For billion sales INGREZZA strong force with growth sales an and ongoing

questions investment do we XXX in in indication leverage points. of expect to your to expense, SG&A well For the in we to intend in SG&A around INGREZZA look including later as as just and XXXX research to XX related growth the expanded to increase expenses, in hopeful increase overall I spending, billion our our late-stage advancing primarily R&D in TD over continued muscarinic our Huntington's, XXXX, Specific SG&A to forward while an show $X.X support mid will basis efforts. programs, call. reflecting clinical R&D preclinical to franchise invest

Eric. over Now to

year-over-year XX%. in XXXX INGREZZA's Matt. growth exemplified row Thanks, performance with strong a was four exceeding by in quarters

work that into those carry of diagnosis been not of approximately U.S. Yet first-line inhibitor. executed TD affairs standard with the before, living in diagnosed. people XXXX. Our commercial the have of time, VMATX out and with teams medical much still aren't remains treatment of care ever to a more we this treated a the tardive help well dyskinesia get us. than really ahead patients receive And momentum Seven offered XXX,XXX XX and half

the significant. organic So for growth INGREZZA opportunity remains for

guidance approximately patient midpoint. The while of billion contemplates XX% $X.XX revenue in $X.XX a at the [ph] estimate billion headwinds the growth assumes Our accelerated to macro and year-over-year is conservative reflects end pre-recessionary pressure range low XXXX high the and U.S., end new less growth.

developed and anticipate in our business. the growth by business psychiatry the majority driven relatively of our which neurology You XXXX more be to segments are segments, should of

a site is of are care care just there. INGREZZA, completely getting we new and ground for Long-term the off

up that speed impacts has making complex LTC strides TD and unique operational been the great dynamics to within care. Our team on long-term how getting care and

estimate we in tangible XX% smaller an to likely LTC before a patients of impact XX% overall we the a are in size few and will it While more TD somewhere sales see environment. setting, quarters range given that complexity take relatively business of of the to higher

direct-to-consumer exceeded internal expected year's campaign On metrics. patient front, the our last activation

in that So investment XXXX. with we will continue

DTC beyond. refer as it's highlights newest The for treatment tardive prescribed well impressions, now we Our choice as poised proven INGREZZA with in digital campaign, broadcast, on via one to growth simple the air we're channels. and the which is the campaign number streaming dyskinesia. XXXX for and and All-in-all, efficacy

Eiry clinical to will Dr. With progress. now turn the Eiry? that, I to my colleague, Roberts, our call discuss over

KINECT-HD accepted on everyone important results six-month the including date readouts, formed to PDUFA Thank the an from for as up, the which of Huntington's to by Drug the Application safety August XXXX subsequent the patients that with be for option with efficacy from a very supplemental basis data and morning with New Eric, of year our and pleased associated the promises was in follow FDA data for valbenazine of disease. We number with December with XX the study a and the treatment good chorea were Neurocrine XXXX. potential milestones call. you, and pipeline

congratulate These and agencies were in and pediatric like both with designed patients, in studies this registrational all are crinecerfont and congenital treatment all forward from of set in the we including work involved adult the both This regulatory data generated sharing from where input their clinical pleased second experts clinical as patients is the getting with to will key adrenal hard the largest for On front, complete today. to trial I'm in the us everyone U.S. the field, And top look announce ever provide the enrollment advocacy the that program to program crinecerfont studies of I'd stakeholders, trials Europe. hyperplasia. year. groups in results to in of line we half CAH. in

studies, seizure in adults reporting are two of second NBI-XXX treatment in onset major NBI-XXX anhedonia crinecerfont, to addition from line as Both studies sets expected with focal of the half we disorder. In anticipate these for data treatment and depressive top the XXXX. for X a Phase proof-of-concept associated

a enrollment to progress X NBI-XXX, our muscarinic the continues for the of study MX Turning growing the portfolio, of with in very schizophrenia. treatment make Phase agonist team good selective to

We current additional this also robustness remain year. of in year. to Onyia. X, this new early-stage agonist Officer, Jude on X our Phase pipeline chemical the very Phase partnership into the with further forward pleased track continue To I'm later of and our dual this pipeline look pipeline growth Phase X entities Chief in strengthening and study to with of by our clinical a complement NBI-XXX, Scientific to platform, we this X a from this plan initiate MX/MX robust pipeline advancing

for of treatments in preclinical modifying of peptides, disease leadership and small Jude's deliver the serious patients range in symptomatic gene the a development, modalities, of providing Under and molecules, neuroscience. curative and to with diseases research we're of on proteins field including therapy investing goal living

we where been the pipeline as on reflect are the opportunity R&D organization, for stronger. foundation and I As has an our never

Kevin? turn I'll that, back to With the call Kevin.

for will with you, it open that, Thank questions. Eiry. up And I

take question go from Stifel. with our We'll Instructions]. first [Operator Matteis Paul ahead. Please

your comment does about with Hi. Thanks just it adds assume quick embedded expectations and met your you Is that? high be INGREZZA so of seasonality XXXX. XQ much. much By guidance Thanks guidance end your And guidance wanted years? net And then like assumptions back for math, ask that our in to quarter. to on maybe the accurate? the a prior fewer what this aside, relative of patient envelope just can congrats for on year. I seems the could the so in on

Yes.

the reauthorization On it top delay patients. overall however, a you end the fill the net. of expect bit a have over adds growth But great and guidance XXXX, in say to are. growth. have a do And the we little higher typically what year with here we first XXXX. in new QX we is of gross year rate, I'd similar expect does relates very go $XXX do front, new new million of bigger always patient reflect very pressure as patients, base they at attrition to Keeping And patient through QX, in range of their year-over-year a acceleration Patients net here the strong as have QX. process, on to a

main we've Our sure lead five QX, little going year the a that's And years. I QX, patients in you at stay very see on to here that and bit a to is think past been medicine, a is and great to make mission that in over successful slower nice XXXX. what recovery

Thanks, Matt.

Neena We Please with will next Bitritto-Garg Citi. ahead. to go go

for taking Thanks guys. questions. Hi, my

So on just question INGREZZA. another

net for you metrics backing based For net growth to the what think the gross on like had provided into to. was I the the think it bit little per guided price script a higher volume discount XQ, seems quarter, of I off you that than

per just about if that's a somewhere think then still the expect in X,XXX Thanks. I'm So about should getting script? mid And net you price correct? Can verify we range. in if also XXXX, should how we the script X,XXX

to was of revenue QX. sequentially should net per That price X% be should per consistent revenue X%. to place net year-over-year, script a about script. puts QX as But expect you expect it Net that range, a in of increase think and relates X,XXX the you fairly at in XXXX, $X,XXX you when to you between Yes.

So that's correct, Neena.

you. Got helpful. Thank it. That's

Bank Tazeen we'll question of And with Please ahead. our from America. go take next Ahmad

my Good guys. for morning. Thanks taking Hi, questions.

COVID And me any over from a like to has way up affect May maybe if psychiatrist the then Biden getting that. one telemedicine? paid that in quick after just How declaring guess I XX. President Just guess on that way officially I follow Thanks. does with that is regards been

that the is do the going are in health order May. to already I from with think for expire the Hi, expiration. we the morning. health years telemedicine is emergency the to And what Tazeen. -- order two health in emergency are Actually, last orders emergency that mandates know post Good supposed

bet about And two it's that years been the kicked May. post you down can road so for

And certainly So know hopefully, 'XX. into any go we'll don't we changes we in as see 'XX. more

to have if in-office, more doctors with office? back does that, go Without certainty into you it the go back on provide to Okay. upside the that would if

Our order the the upside telemedicine. back account number did of do or the in emergency changes take any physicians in into have health changes into that any with not office to

Okay. Thanks, Kevin.

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

Day morning, assumptions around my muted internal taking investor you year. Commercial neuro half Good this question. iteration compared data expectations through programs. here this a commercial some Thank know X the the does of seem market number an out I of are CAH, earlier had could when hoping of program. a somewhat your walk Hi. like It given your the market Phase you maybe years you everyone. in reading I you latter did to ago, of discussing around for was opportunity

how get of look you commercial kind a light to hoping currently of think here? the can about out just like what So

morning. Good

we're this So in of the we the approved opportunity about course, for let excited by crinecerfont not CAH. medicine the saying that, investigational yet still clinic. treatment have preface that certainly, of an it It's presents. But me

to U.S. care step of taking well. that Just living between these XX,XXX dose today improvement essentially trial the to as their similar there the What back, and control of potentially lives. patients. hyperplasia, in a congenital the cortisol in but with number they're glucocorticoids is crinecerfont opportunity reduce not is that also adrenal androgens steroids of only missing of for somewhere XX,XXX intended clinical to are taking a see in required Europe to we the people the for is replace is do patient's day-to-day hope essentially and entire Standard what the the

And this so of CAH game decades. the for certainly of new care. we for no significant And are see standard a terms in treatments changer there as

treatment about potential with So reduce the to is steroids. the and the look to able from there's issues down a in see improve terms have these excited like. disease what let's anything really to of you for long-term bodes and what being help unmet overall need their We're it Eiry, add? data day-to-day opportunity, patients, management significant do

opportunity add the non-steroidal that think ever obviously, in patients if I a the reading that given need pediatric you I'd through as patient about and look disease through no this about there's think CAH, area. gives new this we're us -- study think years to in mentioned, this is, both year. for in And includes been to of unmet it and really from Eric forward serve understand an in treatments adulthood. nature were I data our And adult study, opportunity early No, program childhood to thing that population how only excited really out later the actually right

Great. Thank you.

Phil & next from Cowen Nadeau with Please And our we'll take question ahead. Company. go

in remind you two powering be two studies? adult you dose the endpoint question. you. would also to pediatrics and in our endpoints Good what trials. different are meaningful endpoints? It's different morning a change for the thanks us glucocorticoid in about two Brian's is CAH Thank change the primary primary is of And chose in the the why serum trial in what then while changes for follow-on The considered trials Can and those the clinically AX. taking the

Yes. Thanks Eiry It's very here. much.

that endpoints patients steroid androgen alluded to those both the of are important the reduction very CAH. and both to, you So with itself dose,

we trials. both both of important and read sets be as adult the the from so information And the will data out pediatric

terms things. into pediatric happening embedded physiologic anyway as with predominantly looking are clinical trials. managed really the population also of we important all the are The endpoints patient such secondaries study data in development care difference is in information. are having in and so the and choosing that for across be growth associated we'll the and And of reason level the pediatric holistically And the in the their for be patients is primary see as how based patients that the in the will the important androgen on at variability that outcomes of significant pediatric as changes interested some that you well other being

trial and -- so for days crinecerfont. the just steroid of And powering we and second your if proof-of-concept a each treatment in take of reduction significant the levels study, pediatric part first, to you in also terms of saw reduction question with XX from trials, adolescent the adult around then androgen getting after our

a we're the And primary have so a trial overpowered that androgen change levels we significantly the XX-patient in given study. for as that pediatrics, in to see

physiologic into our We the treatment, also is secondary. change to patients. levels, powered so endpoint. reduction XXX is in believe of patients highly if the reduction steroid adult study. super And lot from the key actually GC discussions dose with patients baseline in the for in at is number you long-term And for us the a adult to remember, comparing treated of placebo. trial is the steroid the better The steroid give particularly is that to from more endpoint stakeholders a address know steroid reduction safety, study detrimental insight the address we and same a to the true tolerability

reduction will And patients steroids important see during so in long the program be run. believe that for we in the any we

That’s you. very Thank helpful.

And Chris our go Shibutani Sachs. Goldman next we'll take from ahead. question with Please

Thank you. morning. Good

you if have And about about the schizophrenia that positioning some disease, or feeling your can assets? be where you of the portfolio? with you different might share of you're could Eiry, For indications talk there complicated how pipeline probability think mechanisms you success targeted edge of perhaps

to happy do that, Chris. Yes,

focus schizophrenia disorder. aspects schizophrenia, now for a as clinical in So several main of treatment assets all we of and they development the actually have different on three right

obviously, therapies an for on schizophrenia we What interested studies not disorder the valbenazine we is and as two neuropsychiatric the And along, If valbenazine life confident do disorders antipsychotics. furthest of at schizophrenia, that patients antipsychotics going anecdotal combination registration from a patients starts very the seen of you know into people benefit in such the what further this disabling and right our of and potentially in treatment receive negative that for have us neurodevelopmental as patients that field Phase very valbenazine of X that could least that who take full both about would schizophrenia, early disorder space benefit now. current addressing one coupling also currently treatment happens positive the well as with majority area synergy in from data world in showed that the program studies symptoms is adjunctive X.X the in schizophrenia. go safe understand of the with we've failing the We're are impacted. around of the to dyskinesia major available U.S. and is from and because it's a get to that from program is with addition patient made actually their allow tardive in response that to maximum tolerated their and population and valbenazine. schizophrenia in And information by terms us preclinical some whether effect million

schizophrenia, have that in comes developmental Phase a that disorder. X therapy DAAO Takeda from our we cognitive development. seen is that given is which deficit is second a the seeks is address important That younger to with The this in particularly collaboration, patients, patients inhibitor, and is luvadaxistat, that

that impact on perspective, And luvadaxistat, measures. signal scores of [ph] that we a so to Braxton terms study from was us in in the had Phase our intriguing X the

we to further Phase that opportunity and there there so want in X. believe explore we is progress And further that

And opportunity to know, is the mechanism out And this and for the through and X. a validated agonist as study well. to psychosis. in last is started about very treat so and have acute addition this mechanism selective the X patients MX you most read year, and have treatment with is a now. a Phase And replicate going psychosis our XXX, recent pipeline we that trials And we late on third X really enrolling excited right of then acute now with very recent that this study Phase Phase we're

clinical a since that given disorder age each think for a they for life, things board, of these address we're So successful lifelong believe their the we of trials. young approaches if across all this the individuals through for from a different do space opportunity we And these different is that coexist there's in there's right a aspect to schizophrenia.

Thank you.

question from go our we'll Barclays. next And Gould take Carter ahead. Please with

and Good And Maybe all the follow care color the to in kind long-term of little Thank centers couple questions. I can on detail you there, taking efforts the give what you. quarters morning. maybe surmountable hurdles more the you the alluded of up appreciate to? of a you bit of just on for Thank these help confidence Neurocrine's And on to some segment. as front? that's sort that of just kind operational just gives next you

Yes.

on I LTC As for mentioned segment commentary, my a initial INGREZZA. is new

we opportunity it's in really that been at XXXX. back we've looking However, an since launched before

So the a of to consultant XX% practitioner, We function I LTC. to the a mean complex they day-to-day more psychiatrists put and or by many an a nursing the And basis on position through. a centers to being estimate prescribers, in commentary medical that explore by of what that environment. actually we're is where place whether team XX% my in is it's mentioned rotate directors, opportunity nurse are And LTC in run I these we've care it that that staff really setting. be that TD excited in in patients all

week. there not every a other coming they're XX/X through every week or maybe third So They're basis. on

them importantly, abnormal distinguish with drug-induced work really folks MD staff facilities dyskinesia, them for that residents to and recognize from to that the them educate further the in practitioner. movement from to potentially so and tardive on movements, other disorders flag our what identify requires need from these or evaluation And nurse help is closely the the

and so understand LTC team terms care, the you of role that to not are, facility in environment in approach prescribers who only a really also And ultimately, pharmacy. within it and of long-term the takes the the their dynamics need

the understanding to building been opportunity our need I focus we've the time. terms been seeing And And so we think is. where of narrowing good where in of our we're initial We've spend results.

we're and TD progress and But psychiatry making and the care. that I excited for of space what as about awareness so continue we're do still long-term not to seeing in But with terms is we're opportunity, the new that of we're us in very going in in it's make education progress level pleased a of neurology. the and far to end, And think XXXX. we're in along

to Minter William Please ahead. And Blair. go with we next will Myles go

Hi.

on put catalyst their curious that additional whether of that on wondering adult controlled how glucocorticoid given see back specifically, already just are AX patients controlled, we And if patients you current would trial, expectations AX on secondary the much the those these Just dose, Thanks. terms their are just levels well reductions emphasis your there. one in that should about endpoint?

Myles. Thanks,

trial I degree in they wanted real to our control. patients CAH world are what some the general, controlled. not have was certainly, Intermittently, reflect think of situation. But well with we androgen

a in only but have trial And so androgen. of lack that requirement excess a patients dosing of control also not steroid it's the

an view, reduce direct there's which the action in of demonstrate steroid So I to of trials, point the a is then for to dosing. both patients from from benefit a of the control ability crinecerfont the context opportunity androgen think for us these and real

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

have morning. balance on a I on growth question Thanks question congrats versus nice Good Hi. another for quarter. sales taking investment. my of and the

in year-over-year roughly INGREZZA guiding in less you half guys or year-over-year. that in investment SG&A but So of at for only midpoint, the growth additional are XXX million

commercial forward going operating the direct-to-consumer time? to push you INGREZZA could is on Thanks. So be about facilities, greater care over that even or campaign successful guess there I consider perhaps continue factors long-term into are way and wondering, right other the enable thinking to going as leverage leverage I'm franchise this forward

Yes.

have out diagnosed, future. not INGREZZA dyskinesia. of still here have expect amount and growth first foremost, the in of tardive Seven XX two we been say into I'd tremendous So patients a

course, you a product of drive growing SG&A to have So to, have leverage.

second launch. also of The investment piece Huntington's the year this disease for preparing is

in do associated to is in. kick particular investment have growth more will XXXX you about leveraged going as think we So be when with the That that. holistically

of but this up our you algorithm points you is in So XXX and I expect into set exact about how continue an you don't leverage year expectation do for to even think year. of look basis leverage, want we SG&A would to as terms next leverage

really It's you. helpful. Thank

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

update congrats we role Thank on provision talk implications INGREZZA about as the and biotech you for leadership Thank the and think into all cycle small long-term negotiations the the progress. about the played that price management? a you. Can built for Neurocrine exception in was the IRA for you life that Medicare

Jay, thank you. Yes,

think bio of work organizations. and number including really I partners, with Neurocrine a effectively other

in is lot Neurocrine, And there in with companies continue to going there's extremely biotech more with fact small and are and with over to exemptions be that along manufacturer out. that legislatures years small work while to so CMS helpful we that others the work this needs a like passes, as think done work to the work to order legislation with we're rolled our the and the

you. Thank

will Duncan with Charles Please we Cantor next our from Fitzgerald. take go And question ahead.

that And And a it, Austedo. remind two wondering in as us second pricing our in for question I monotherapy. target I profile call not is, see my adjunctive team, XXX, chorea. versus Kevin depression that questions. you really morning. product the to Good That congrats One thanks had differentiates perhaps pharmacoeconomic is great it, Huntington's valbenazine or an on even schizophrenia? if as and quarter you in ones. could regarding taking development. treatment Yes. value I'm is what is guess valbenazine but a of relative wondering I'm brief if and

study. the Charles. your prop excited at about part value Huntington's Good the morning, With It's not HD the review regards obviously the FDA, the approved of valbenazine for maybe under opportunity so there the in to question. chorea, were about Erik. that we're we're that generated in take and data just I'll it's use. We're for first excited

And that opportunity HD are specialists. preparing once already for footprint fact given population. the the have in this we chorea we disorder As neurology, movement positioned especially earlier, the into mentioned the promote get to we for well approval we extensive with we're that

VMATX you movements off treated the about Obviously, are if so inhibitor. XX% And this. HD tolerability some concerned population, think are And getting of with reasons or patients formed living titration turned complicated to the for willing folks about chorea regimens about not or currently there are only chorea with issues. accept

And got do green we and excited FDA. we think bringing to we've get from so a differentiated valbenazine once forward looking light forward profile. the that the We're Eiry?

Eric. Thanks, Yes.

also ability capsules So the the in only characteristics differentiating dyskinesia true thing to in that complex splitting titration, for food is of deutetrabenazine the same that some of more disease hold challenges some for maybe not said versus of I'd [ph] add effect importance tardive with dysphagia. to there lack what see patients Huntington's have the in terms simple Eric and we of lack of the valbenazine of and even

have of will importance symptom which to now, patients study antidepressant a So depression year. by addressed point and at right we With on Phase a we're I this going anticipate in the really think available read that Anhedonia is of there's therapies. several out differentiators important there we is depressed end anhedonia currently an XXX, proof-of-concept very respect in patients not encouraged X by. view from for

treatment could whether be this at in patients have there so the will on anhedonia a monotherapy. whether adjunctive tell a addition, we patients an on for be current MADRS the the looking well. used are we In antidepressant scales there's anhedonia But scales, effect X or study, possibility early a their huge antidepressant direct be element. in depression It's to any the there's normal looking treatment as Phase as treatment. bit to get And to for would as treatment opportunity a as to

And this I once the out study, forward. potential the from think a we data so have read we'll understanding path of better

you. Thank

question go Please We'll take Wedbush Securities. from Laura Chico our ahead. with next

for Thanks question. taking morning. Good the

remaining estimating. Approximately you're to are once out XX% curiosity, one duration just they how you. coming now of seeing I'm treatment to a treatment? you patients how And patients, quick of typical might are the long diagnosed. diagnosed wondering diagnosed that be just a with wondering speak of start? the could contributing drivers population Thank VMATX back Just TD And what TD patients that on inhibitor to respect the are you're there? if TD among frequently patients

underlying into with launch, actually you we subsequent compliance what we've for psychiatric Going that see, with pleased are other launch to the been We've or the taking expected their with consistent what antidepressants antipsychotics. than persistency that example, similar INGREZZA to expected. certainly, seen would medicines we for patients these very better this that be with illnesses, with

So early has been the of way certainly, of driver the through of XXXX. since and an the continued all launch important QX days and that's has really growth

are would It's And see to And are what don't that population, larger. in it any so estimates the given but see overall reason the actual what U.S. There we that meds, the and out terms with psychiatric we there XXX,XXX patient expected INGREZZA. to with certainly that to regards be the numbers is with better than other we in persistency estimate we of than then why we see around are change. better haven't what specific

over However, actually low been TD digit with record. extremely medical the the under-diagnosed, look the their of launch, given made in that patient we've an percent if we diagnosis at five people plus years the single that with progress had only you under-coded population, living was started since last

around XX%. estimate Now we that's

about So progress feel good the we've we made. that

And half patients is work to diagnosis of VMATX diagnosed, the their abnormal do. treatment inhibitor, with explanation lot or the yet a offered are any seven TD be movements. not for care. still out to XX of patients they're new living there's Still a time with when about given really standard of the However, roughly have which

So patient we see opportunity with about good frankly, of work that we a the growth recognize of lot we've lot Thanks. lot improvement a organic made, of us. for the progress in INGREZZA ahead opportunity population. but for feel and We of there's a TD

Thank you.

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

on Hi. for Thanks is for question. [indiscernible] the Anupam. This actually

What XQ. tracking seeing Thank best around sales mentioned previously or you metrics expected had to are You understand you. force that? pull-through

in look both neuroscience, psychiatry leading we And and we lagging experienced salespeople both of What XXXX, is in and in neurology. expansion hired in indicators. at our Hi.

with experience the direct a And come relationships. TD in don't and of is so market. have they lot experience they in a What

a takes that example, learn. to the than bit sales options reimbursement preferred why also lot back is there's really treatment. maybe in TD, and videos terms since kind lot is the of on occurs of our bit a an most time an antidepressant INGREZZA the think fair on of Ultimately, And customers care of in that job across treatment for have product. help that of criteria, disease support to specialty a the them This of help these antipsychotic, we the differences between so customers appreciate to not our or have a they them recognize do to educate diagnostic of help a we I And And settings. lift little only this different we across with TD end diagnostic is types. but the patient all use presentations sense different selling different we education process recognize certainly

Certainly, XXXX. and contributed our the the that as And so the past we expansion that up what we've that as level when for same few to get we to salespeople proficiency seen the believe quarters saw to the of this is a we've that legacy of in the around it team, growth took team our field well. saw new expanded strong we organization time in

believe do that forward. going we that there's However, see that we're upside going expansion from to still

you. Thank

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

help half as Thanks. thinking and us Eiry, us Good just unusual at anything how of the year how then, data spread expenses, you a year this tax potential look in little epilepsy you're that rate the Matt, the maybe just the years? you coming they'll the about of and can second market? product just and talk differentiator in on throughout can be and year the next epilepsy you that's about this a update couple with how maybe morning. And

Okay. Thanks, Marc.

and the patients the shows have seizures month's that it's of still different baseline types ongoing from but and between control onset are up agents, the The an are adjunctive X that last This for is frequency onset from period of NavX.X channel in weeks. kind to of The treatment of the in treatment. seizure lack the antagonist, being a Focal that now trial then endpoint for antiepileptic across compared treatment epilepsy. So is we four treated of seizure seizures XXX, XXX epilepsy change patients. a study XX month a kind one baseline their seen a right the is common which most to a is current is in our already period the baseline study frequency with study. somewhere a have the measured selective focal overall endpoint Phase and molecule seizure over

of with terms have think currently about somewhat unfavorable the XXX pharmacology NavX.X majority antagonist, antiepileptic a selective therapies profile. if available the benefit In differentiation, of risk broad as associated the we

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Thanks.

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

taking my on for the Thanks question. Hi. quarter. Congrats

XXX molecule? if Can matter or dose it's muscarinic from you perspective, a would for your a trial it's you that Phase So study. much frequency that differentiation? twice-daily competitive you previously the finding how And share for once-daily have, said X dosing

Yes, I question, think -- the thanks Ash. for

haven't information program. We in our very shared much detail about

program acute we're in study study. end and a much You're forward correct. of to agonist of to of is going year dose this towards both finding the on It selective psychosis XXX of patients with an -- that enrollment this in acute seeing The psychosis. and looking the symptoms tolerability the importantly extremely obviously also adaptive It's well is very right impact and started now, which MX profile. safety patients up last schizophrenia

Thanks.

ahead. David question Amsellem with take Please our we'll from And next Sandler. Piper go

Thanks.

XXX the profile. portfolio, muscarinic the is on MX. the for potential So an building improved safety offering you're selective

what for how from I'm mind, you're think portfolio there? in thinking on disorders, beyond dual could and if view as and muscarinic the say, and schizophrenia, proposition the you thinking a And you. mania the about kind how the potential you role are your development articulate perspective? better as competitive about would here, Thank that what's you you with of secondly, play then think guess MX/MX of and value of pipeline bipolar particularly wondering mood I of So that the

in questions There's a Thank lot you. of there.

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to early make in of really the able statement so And safety. around to be the selective differentiation a context agonist, around MX it's

trial initial Phase the an tolerability. and of Our in and estimate designed us X risk to is give benefit safety

with activity believe And safety we the agonist, study, MX/MX of we of have around for And think Alzheimer's degree commentary diseases might with sense able I better in your think that view. how from that significant deficits from be impacted opportunity dual a mechanism I a from bipolar disorders way of broader point data and in when this understanding is makes also in cognition. neuropsychiatric of impacting all the of we'll to action differentiate there we cognition are beyond the through And in a much terms to the in read so then terms tolerability schizophrenia, here. platform of addition, the

a man an world collaboration an MX muscarinic MX. specific of hypothesis compounds, that, thing with had of program coupled the MX/MX the years. deep in Sosei an And so test only in that in uniquely research in that them been the add can I muscarinics a several Heptares, we And -- with in with have positions out very all last we there number the us would agonist, the is with specific for our and

out we'll that for so pathways to And here be exactly right compound, right mechanism disease. involved and right able elucidate the and the tease able the be to are the choose

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

probably question. for the driver patients, dynamics. of the one, for you. could care you not know Thank I given some here takes guys. Hi, taking what puts the the Thank This tardive significant would population setting. that plan to -- dyskinesia DTC long-term these of assuming a just and here? out or love reaching question providers question of in my of, is is or patients kind be the in to guess I

this for agree years. to opportunity really exciting forward us Thanks that is for certainly, And an that been looking I your question. for we've

team LTC run in consultant pharmacists. LTC? So locally are the by of providers to consultant has terms these within medical do practitioner, residents, care to that I so providers As entire the dynamics the And facilities diagnosis. are would the you really in what call work pharmacies? number rotating really worked what a of the a flag of bring the do that recognize a can building Obviously, differential relationship with facilities, for really providers, are kind those number with before, through, team the much and what's that the this of nurse and an psychiatrists, full our go those and for create to you a attention outside-in movements, are account management staff them do with we in-service understand who the affect facilities do they And that are I education. staff We facilities the facilities. them but approach these in TD through, providers so how the mentioned leverage whether rotate nursing programs the essentially nursing of it's help to directors, can XX/X the of larger lot

for more hospital similar to And a to clinics. a It's example, complicated so manage And environment some those team approach. than of of most what a might outpatient more in accounts. it's ways, terms environment see, sort in it's how in you what see in need you you

the So we're opportunity. about excited

developed, as is psychiatry and mentioned I as And INGREZZA. getting that's because just this for good seeing with the not neurology It's there. are off essentially, the us earlier, progress We ground segments. business as nearly

what for And psychiatry XXXX our to XXXX neurology. in so akin in some in was and ways, like LTC launch is

feel year. as and through we making, we move you'll about the that good more the we're progress So about hear

Thanks. Great.

Fadia And Needham. our from next ahead. Ami we'll take question with Please go

Thank are patients are patients morning. a And awareness talk do the about then, the the physicians disease separately, for Thanks you. of launch you are there as Good question. you ramp how kind Europe With the in differences CAH, Can TD, the Hi. treated if treated? you how and about bit where U.S.? opposed that Huntington's of talk think in the that? indication, have that can with taking INGREZZA where about we little talk my if about And in could chorea? to in

I'll take that. the second for one first, Thank you Ami.

issue experience diagnosis it's how We run these know usually in patients are have an CAH similarity It's of clinicians well. treated. a global certainly These of we've in think trials. we with expert think seen clinics. here. I in as our I don't have patients lot their consistent endocrinology pretty And

generated first Yes. we've off part dynamics this With I'll FDA forward saying certainly we're that the about that the question within the Huntington's regards look your by and the the start labeling data about to community, later from year. to the of getting excited

Huntington's our sales We neurologists data patients. or obviously, coverage commercial those existing that of community movement have And with change kind complete to require the need are we these label force. lift to significant But treating disorder the neurology our any neurology to introduce this footprint. the and of doesn't

we're to So a to our a need. be bring this is really and we population will infrastructure, another leverage opportunity existing what excited with think to differentiated product create in

go And we'll take with our Suneja Please next question Partners. Guggenheim ahead. from Yatin

question. question, you taking for a Hi, guys. two-part my Thank

year. is, you this catalysts major have First three

looking agonist anticipate be you. in Phase sensitive more And should And the patients? that we you why the can might talk [indiscernible] endpoint think more of are you these you Can if mechanistic you there at maybe three that in Thank data You focal and you have CAH the anhedonia you these catalysts? thinking onset MDD have of success, evaluating about what data. where and is Is for then where us on especially one there CAH the probability higher the articulate distinct how and sort anhedonia, about rationale? focal also are then on do are you onset, endpoint X?

as goes hour to Yatin, I'm as is, the speaking about we're the could through to greater going you there. dozen to about looking in of each probably obviously, call going asked to part We few better talk programs year this in them. of be forward of spend these that. get in the we questions a And data, able closer depth. to be on, What

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

one. in my expense an Good for Thanks management taking question, which morning. is effect

term thinking longer moves of -- therapy midterm, Novartis allow stake collaboration expense does collaboration Given GBAX-associated especially related the near could defray the recent timing with the a program if new are R&D of transaction tactical Voyager that related expense to your its quarter? the timing opts your in allow some into the Voyager, Voyager with to gene you as about some SG&A for your you current to in to Or strategic one? in

Yes.

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of to outside allows so as to it larger us even continue you. And strategically or gene make Thank different we investments therapy look forward.

Thanks.

with question Fargo. We'll take ahead. our final Please from Wells Bansal Mohit go

I Great. for Thank another me question squeezing in. you have crinecerfont. on

a can is bar of a bit you. clinical we potential do that all said the they that payers to are they are everything. efficacy you cheap, given that what about excited how the move the payers in and basically understand profile help to So a of to Thank glucocorticosteroids you challenges do doctors, foresee are little would there the over? talk of challenge. To And profile terms going end, there them when be of But drug? drug

Yes.

time, in most that where payer that a at we we the steroids. story emphasizing undertreated their improve an educate point any them patients the to the steroids area for And This what to what controlled. either value But steroid is given really either going and with that's on to front. And over well we'll are crinecerfont reduce poorly therefore, not to with their or demonstrate these treated The in is payers, managed. alive. disease we're with tardive burden. disease comes often control to hope quickly treatment comment is to disease where are are dyskinesia. very that did have payers be similar patients important The keep just I'll So thing that is

understand got value communities also we of So But the work the but see opportunity. the we're plan plan, carefully educate treatment the fits with a so excited in terms where it crinecerfont data. landscape. need and we've is in, patient not about they that payers and of proposition only to provider to and Obviously, the the to the overall

Super helpful. Thanks.

all a I final your I remarks of you couple have want for to just here. thank questions.

is to adding our the we're looking XXXX, foremost, and which to that PDUFA guidance First a to gave strong by our you the looking Huntington's HD, is very INGREZZA which date. in evidenced label forward disease, August, forward potential the we for and of

neuroscience. is you talked years. company And we've The of neurology areas It's data world. neuroendocrinology, cover three we is as interesting become as neuroscience being over and company year, FOS three those readouts of that, And CAH, this they look the about and know, anhedonia, of at the neuroscience we thing you the neuropsychiatry. if a talk the broadly goal lot in that to the have the other leading all

like the with And had with care. in forward you again, that, for Take thank you to you the to look together all questions I'd months. and coming getting

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

at You disconnect any may time.