Neurocrine Biosciences (NBIX) 7 Feb 242023 Q4 Earnings call transcript

Good day, and welcome to Neurocrine Biosciences Year-End and Fourth Quarter Results Call. [Operator Instructions]. Please note today's call will be recorded, and I'll be standing by if you should need any assistance.

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

good to a and you, Wednesday everyone. morning Thank Quarter Year XXXX to Neurocrine Call. Full Fourth Biosciences Welcome Earnings and

Joining us Medical Chief Chief Financial Chief today Matt Officer; Business Officer; Officer; are Commercial Officer. Eiry Kevin Development Gorman, and Roberts, Kyle Chief and Officer; Strategy Benevich, Chief Eric Gano, Executive Abernethy,

questions earnings discussed making be the we as of Q&A. longer I will our can actual will statements all bit results in differ in statements. materially. are when a cover. risk uncertainties, your subject best Today's During to the forward-looking do and duration assure our call, to lot we versus a you get our prior and that review to encourage we address do factors will be filings. calls remarks SEC These into certain risks have latest you may I we to ground of prepared

over turn So Kevin. to I'll the now call

and Todd, good everyone. you, Thank morning,

XXXX of expansion I same market, without the of business a on had years year great we years it's about INGREZZA not in we and whole, continued property indication very downs, INGREZZA like but growth INGREZZA are another said disease. the at you and of So performed intellectual was mean, to exceptionally the XXXX, then well. said looking get for incredible in few of Both years ] XXXX, approval XXXX, again, those XXXX. [ on Huntington's out Xth the great. in one ups those there and were I thing and their had I XXXX. it

that more than And our Phase beat in a that Crinecerfont experienced that clinical Neurocrine we've had the at ever even also year in high past. expectations We data X for that. grew pipeline III

And then is a a quite pipeline that bit. growing preclinical

because now, will give XXXX. take about equally going of successful a But not right XXXX we're from the colleagues details into go you the perspective an going let's from of Matt? that. expect are also to he how I'm And talk and to a my financial XXXX. that in we Now room snapshot Matt, viewing

Thanks, sales XXXX growth, and Partly few Crinecerfont for years I performance. our a pipeline to XXXX Kevin. Record R&D all our an Good incredible financial with progress year. continued results want us financial jumping to position XXXX come. an morning. INGREZZA for comments was positive into advancing associated guidance. provide

performance. sales INGREZZA's First,

billion, million During dynamics. to patients the new sales growth fourth in $XXX INGREZZA by slightly sales growth million, quarter, XXXX growth. continued driven net reflecting year-over-year $XXX were reflecting offset over near $X.XX INGREZZA sequential finished by

XXXX Next, our SG&A one for of goals financial leverage. was to demonstrate

of approximately GAAP As you points leverage XXX and can see, a we basis and non-GAAP points basis, SG&A basis delivered respectively. XXX on

progress in XXXX, I'll which continued expect discuss We shortly.

net reflecting non-GAAP income, generated in of offset over development in cash $XXX flow million we XXXX, strong million Finally, partially business by investment. $XXX

these areas Turning year INGREZZA the were with the Neurocrine to associated for shareholder with to activities will our which This XXXX. will We commercial recent growing for believe highlighted investing in Day. sales, be many Crinecerfont another in portfolio, Analyst at long-term advancing the R&D pivotal returns. drive continue preparing

in financial XXXX at gross our XX% the $X.X guidance. or reflecting sales demand and underlying billion, growth to INGREZZA net on net to an billion Now sales $X.X guidance to is strong resulting midpoint. of $XXX XXXX improving million over

expect midpoint at previous play on basis. the with and is and to the midpoint SG&A always, at INGREZZA and As to operating the in non-GAAP expense launch, we at demonstrate discuss million $XXX of for million $XX XXXX as what million Crinecerfont, of basis out Eric $XXX a to to total we've total years. seen leverage potential or $XXX revenues revenue Crinecerfont the continued million investment an Even dynamics XX% midpoint will and XX% GAAP GAAP we the SG&A expect XXX million to reflect or basis in range. incremental points in XXX costs shortly. similar $XXX non-GAAP These also investment seasonal points prepare of guidance to in the

Day. develop at a ] tier models, midpoint As operating to at we XX% $XXX XXXX [ XX% $XXX QX. basis. range step-up milestone programs, Analyst midpoint total specifically A our our are seasonal you a payments reflect investment total ongoing include or other pipeline few to they spending to XX this the early highlighted $XXX R&D million costs financial Crinecerfont including nature stage have million metrics These non-GAAP million not Muscarinic or guidance $XXX and and the until do note. does deemed in of the on GAAP guidance clinical studies, of partnership is expense Note at probable. revenue in revenue a to programs our million any

revenue SG&A and tax be cost with be our of X% of is million $XXX expect to in around to we and in million non-GAAP XX%. We $XX compensation expect R&D $XXX million be expected sales. effective rate Stock-based to

future it billion X As next With Officer. I to a Crinecerfont, sales, With reflect Commercial that, our is the the in on an hand been about the INGREZZA Eric now advancing we Eric? over the are Benevich, journey and Chief leg call financial well growth feel of now pipeline quite with remarkable. years, our quite and trending over positioned profile, story to I we've past the above strong for $X fortunate.

to milestones the in provides year disease marked was XX included that our chorea in several for associated of The INGREZZA Matt. with and Thanks, increase continued more settlement launch. out for and XXXX. tardive addition the diagnosis year treatment the a stellar sixth market another the new since years rates for XXXX for exclusivity ANDA litigation Huntington's patients This and with for indication includes franchise. dyskinesia. XXXX important

growth sales HD nearly in year continued chorea. about of TD volumes While both is XX% need that growth the unmet full impressive, speaks and

Looking ahead, patients. opportunity we still to more have help a tremendous many

this medicines the and This XX,XXX motivate commercial continue approximately TD with care and only the for still are HD diagnose VMATX treat patients. treated medical yet XX% X/X class progress, and steady a in make health to and the U.S. as patients TD of patients severe our continue FDA-approved approximately chorea, moderate for undiagnosed being screen, XXX,XXX we will remain not to indication. with educate chorea HD providers teams to to inhibitor, of year, the and While

with continue and we'll patients addition, treatment and chorea or if our to them their to care their and, TD with recognize reach to them appropriate, health In efforts involuntary as INGREZZA. provider HD help about possibly movements diagnosis encourage talk caregivers

TD, as across of looking year cost average and we all the its of TD early and of XXXX $XX. growth the we to approval build to for billion is franchise to is degree neurology long-term pace continue phase past new exemplified I'm fact, Overall, INGREZZA of range where than get guidance remains markets. still Access remains written anticipate in towards smaller patient to solid robust by and driven launch starts to as and sales the $X.X $X.X these greater regardless opportunity the we forward less is growth strong, by made segments scripts majority out-of-pocket the years, these another to the of after ahead of INGREZZA of care. primarily X of X INGREZZA billion launch a the the last for than filled end XX% Although business great Specific have status in psychiatry, us. progress The formulary of HD, INGREZZA year. in

We Medical why launch. our things At Dr. Chief we're start? to remarks. important you prepared mix XXXX don't little to are Eiry to Eiry, efforts normal Roberts, organizations our colleague, this it versus an time, our to bit going update. going provide highlight I Officer, Crinecerfont integrated thought between My for up the a for a prepare respective anticipated cadence and

Thanks, Eric, and good morning, everyone.

by face the adrenal everyone start challenge incredible reminding me hyperplasia congenital Let today. of patients

entrenched lifelong of patients, glucocorticoids GCs their their replacing difficult cortisol with are flawed. face this these treatment taking GCs both choice androgens. paradigm, both option either excess tasked excess and only long-term thus with missing reduce and In androgens the and For Patients, to therefore, suppressing the high-dose the real as dyslipidemia, high-dose as disturbances exposure is immunosuppression adult short fertility. age, or stature, bone puberty, the complications menstruation consequences cardiovascular irregular GC osteoporosis, of minimize such with of long-term disease, they advanced androgen exposure live in face or such to precocious GC excess the or can production, try hypoglycemia, psychiatric and

living patients the CAH make day. with difficult with trade-offs are must These every

journals end, the data new and Crinecerfont efficacy the sharing combined bring Crinecerfont, medical With in to conferences. a CAH this tolerability key for year, additional from between prepare efforts we from in these to well organizations registrational efficacy impressive and markets. the and and this we in European are studies Neurocrine's provide commercial and registrational studies adult underway peer-reviewed and U.S. we the To paradigm patients. data for patients look to forward to pediatric Later potentially safety scientific hope as

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the as serious the FDA. within focus exists report of second potentially disease of and nature quarter past for last the treatment that highlights at with approved will the This I'm treatments adults year. the and years this Crinecerfont end development application the for no of Recall, XX-plus on new occur designation is CAH, patients Crinecerfont and now Crinecerfont the the in submission Our NDA treatment a for Breakthrough to of CAH. clinical agency for of in and as the key identifies unmet designation acknowledgment of life-threatening the the with need Therapy the valuable that significant with drug in an serves regulatory completion year. pediatrics granted pleased

the we the for to priority While ultimately review, FDA. Crinecerfont breakthrough are lead that decision that with designation will granting rests of hopeful

possibility So we in advisory including proactively us are an prepares moving eventualities, all way the of committee. forward that for a

within commercial now will pre-approval cover the activities Eric the organization.

when our If the we antagonist, of first-ever CAH With approved for be X Crinecerfont, in TD. ago treatment as we the for specifically launch build first Crinecerfont approved, a with for would a set an launch out we prepare the Thanks, the exciting time CAH. the we're just INGREZZA medication for of privilege. Eiry. market. approved This opportunity CRF Crinecerfont. the like had the be to medication for years market is also is first presented to Building team just not as commercial Crinecerfont a opportunity new but

remains work much ahead of However, us.

for stakeholders better CAH state disease on need and community. treatment awareness, One focus challenges will all of in of currently our be will strategies treatment This in XXXX focus recognition education with effort areas available primary the options. of of the educational the

we're members managing directed up Given commercial to bring Crinecerfont of the high-dose change ramping GC CAH control or from the better understand complications generated suffering the educational treatment to glucocorticoids. endocrinologists the challenges Eiry potential the dramatically quo. the status organization, to trade-offs efficacy III androgen We the with androgens chronic our excess In extremely the the reducing dose efforts CAH we're forward treatment of help and of parents, excited and production patients, tolerability nature fully data levels. for studies, current understand unsatisfactory between more impressive family towards from under simultaneously disease while and of more community highlighted that bringing replacement of Phase possibility the the to

have and the set that the the simpler reach In process. good time patient community, doesn't a but to trade-offs. compliant take CAH plan the table approach news It some new will to already challenging that is for require and treating broadly to way, educate current a started we CAH that we

who As build new we in our CAH U.S. excited expected better their prepare to another for sorely disease. market a bring an to are medicine a manage option patients in need to XXXX, and the launch teams potential

I'll Now Eiry. to it back hand

Thank you, Eric.

pipeline As we in as begin it year, XX-year broad diversified the as has is our history. Neurocrine's been and ever

Catalyst-rich marks year. a XXXX Importantly,

in for depressive Inhibitor, AMPA first DAAO the reading the readouts psychosis this impairment second of This in the schizophrenia also associated year, MX of half, on the pipeline half schizophrenia, for for delivery. data track with major and NBI-XXX remain half. Phase for in data Luvadaxistat, disorder an in the includes several NBI-XXX Our the which cognitive Potentiator with II and out orthosteric all second agonist treatment features

NMDA data NRXB these to a for modulator addition In as for currently major oral NBI-XXX, study initiating we depressive efficacy II allosteric disorder. are treatment potential the Phase readouts negative a

in and of early-stage these the Phase the believe together progress have In muscarinic with remarkable X provide excluding I this MX months we industry. value new potential recent These over programs pipeline, muscarinic opportunity Phase company differentiated with and molecules the made at NBI-XXX, the system of MX explore represents development. and target programs MX. I agonism X our the agonism broadest entering we MX the selective to receptors at always any deepest pipeline while of and

have molecules and neurological We clinical development selectivity. in from this differentiate best disorders benefit psychiatric early the might and tools determine these which to thus differentiated

includes In innovative final of the development of end NBI-XXX proud and new team continuing small neurological a with treatment hand addition, to large discovered about our today's it inhibitor, the bring enthusiastic an our partner and disorders. to and and internally Kevin. targeted potential of the next-generation I'm back the Phase broad muscarinic prospects I for molecules clinic range diseases. outstanding The VMATX closely portfolio MX is next entry research Phase I preclinical extremely portfolio research from and neuropsychiatric the his NBI-XXX, antagonist, years. movement of targeting over clinical a here in forward generation coming I'll and to into Kevin? and Jude look pipeline selective to

you, Thank Eiry.

So remarks, due opening that our mainly year. a and gone a last ended lot here year morning on this there is that we on longer fact a the was there going with lot we've this little to

of do the to as your to through many the going as we're before our possible So top get best of hour. questions

we first for open could question. operator, up So it the

Instructions]. [Operator

will with Matteis Our first come question Paul Stifel. from

includes year. of the readout dose a different study I coming in this arms. ask of wanted number about half design to The the muscarinic up second

I PAMS ] we with dose that has of just could arms study that a you this dose are a success dose expand or arms acceptable selected are that if big, isn't and [ looking right you safety. emraclidi and Or at those how a the So to curious you how at And p range? in with look was hitting confident readout are you number all because upon you're the KarXT changes similar as value? in looking more X and then

question. for the Thanks

a study, dose explores alluded adoptive is it that levels. an to as is several So dose-finding NBI-XXX, different you this and for designed

the looking is have potentially we that year. and for large in is not It's what different dose it tolerability And that second more a individual the powering effect for -- with so in terms seen profile. of and of powered to we of a ultimately, XXX also are patients for an trial reading has But forward is p-values study, over arms similar there. finding differentiated the study before sizing a reasonable been and size will this to it sized look out that somewhat half

Our from next of question with Ahmad come America. Bank Tazeen will

that XX% prepared chorea year, in from I wanted any the market this color INGREZZA Mine several up follow bigger And been to today. directionally? think just Eric that receive for expecting is some type what made for you're a as the said I But contribution to remarks market. least has more of get I able on years in to year you of also on on they've launch you sales get think been to haven't launch the what that been the curious in therapy share at was chorea I this of see years. they don't comment the then why wanted patients

Yes.

cases, And not us, us in the a a they seen Only movements either and market to treated concerns tetrabenazine majority patients is of we've and to have or all inhibitor. market, some with effects complicated partial get what antipsychotic, patients VMATX patients deficiencies what tell now some uncontrolled prior about question because perceptions treated, we're of that tell prescribers our get with then treated either in may XX% fairly or rate research high of with chorea HD that chorea side the What is with So take an get at titration, benefit. the for the Huntington's cost. the second don't the I'll treated get products getting of first. the their about dosing led out-of-pocket with of and launch that

a VMATX INGREZZA and profile in profile so same as is Huntington's TD chorea it's of #X that most of inhibitor. And the the the the in prescribed attributes reason has the lot

In $XX remarks, I And in prepared dosing, tolerated. well less of titration, as for mentioned most terms simple than out-of-pocket is complex my no cost patients.

and that, ]. so And not providers only VMATX that patients [ category to we encourage of within more we intend HCC the treated class by grow to And be by to class, do altogether treated but growing the time. to over more expanding need within

reason is contribution, about we're your in data small. ground. just of launch around the a still that We're part One, getting to first the question it's into our was we're that really I now, treating introducing the relative Huntington's the quarter twofold. And community the and say off that The only neurology.

reason thankfully a It's second patient the is But rare disease. in dyskinesia. that it's tardive much a smaller population,

And for TD with patients to our And the ultimately, franchise. for will is out chorea, with driver there. be every there's so and growth XX TD about Huntington's patient INGREZZA continue main

Skorney will question Baird. next come Our with Brian from

happening. more basis Matt, and hoping would market for seeing the about build-out SG&A and this point a us of maybe infrastructure yearly discussion new sort a maybe loaded. Or what's launch And this of a can guidance therapy awareness of sort of thoughts a patients of building then like. demand? fully to on of some us on of endocrinologists levels look a with initial that's of cadence a see Do give for and high think you CAA I as cadence is patient for sort of was help you just of versus you year the this can launch how about think high-level kind what

Yes.

year for XXXX. $XX prepare to to going we So launch from this are a that million financial just around invest perspective, in

So nice if SG&A investment. from it at you very for an including even $XX that company, leverage showing this holistically look million perspective, and year the

get educational of Eric initiatives, you want do the and cadence expect do of to the by Eric, of have sales launch? start the for then details but to comment this the a middle in set in into to can we XXXX. place force that up launch So generally the build will us year on

Yes.

for XXXX launch, the Crinecerfont. CAH of As start I all and educating end, remarks, in that for the prepared year to process my market preparing in preparing the key the year also stakeholders And of reaching the of mentioned going we're but it's to community. is the the

family of part high-dose endocrinologists. patients, nature So the living with of members remarks that And and the current with disease. her limitations The on day-to-day basis. highlighted Eiry prepared is CAH on a it them of the treatment of And in educating challenges glucocorticoids.

of As sales be the for they'll hiring They'll expect anticipated launch XXXX. disease force, very cetera, there, we customers, scaling strong the to process deploy and a that in going getting we state up of be and profiling date. out are doing mentioned, And few a we're in PDUFA team up a in to be advance quarters that education. set et really they'll us meeting Matt customers

Phil next question will come Our Cowen. with TD from Nadeau

couple from Congratulations A on XXXX us for INGREZZA. based of on Matt year. successful guidance a for questions

only give some of improve the that second, idea the for in net Matt, about INGREZZA growth of the the QX versus guide XXXX run gross And is. bottom implies on First, revenue end you're then mentioned would guidance, for the net X% INGREZZA. expecting you price us Can what the rate revenue XXXX. to you

growth the could to dynamics that's to the relatively more at the that versus end? XX% modest assumed know the lead we're high bit curious about patient So a

Always to thanks you. for And Yes. good hear from question, Phil. the

it quarter then guidance, to about it what think year comes in really first generation. new and overall retention we down patient every as with also As the patient XXXX does happens and

land nuts past net years. year, contracting a into So we and price new perspective, we try be of just a throughout reassess to expect possible per consistent trade-offs, takes the per per price always And over of script. to course, the we the remind and much net will that we'll revenue net bolts the with factoring growth reference today. we our of you, guide script to From revenue $X,XXX point as that patient to around $X,XXX get are provided increases account work when course, But script guidance we as to the see did middle of as today really revenue year, and what in net would drive all we, somewhere XXXX. going

Capital Our Markets. next question comes from Brian Abrahams RBC with

the mentioned discussed You topics maybe Crinecerfont. an for if to may AdCom AdCom that might this was well what you I could tie there? as prepare payers And as efforts and to a you wondering having I be expect discussions into laying could the potential educational the speak how you the market? be going for initiating guess groundwork to furthering be year about for any you're around potential

Okay.

that's who of are paradigm educating efforts, me and potential population. let think to think, I clinicians, first educational of we group will XX patient obviously everyone last given So available first. patients. I familiar that years into one The a the mean with space the around sort Crinecerfont for engage I those incredibly heavily treating helping going us part fundamentally options the the they and the change to to that second be in population this else XX, terms have disease, the medication families the take patient to current this in require this of whilst forward that educating is experts opportunity fact in come really important of have the it's

the program. obviously, -- around will already we be side, With in side that way commercial the question a our compliance so the and those an reason ahead believe and on FDA AdCom respect any heavily the the from medical particular will to on hopeful to based of III would that investing experts both in on that articulate And that approval. with the believe that don't impressed incredibly We're the we the of of benefit and so in field have Phase engage data. And data the an clear and We be I may addition outside to just we were really, because what and is able for for to AdCom Crinecerfont. about talk space of it necessary obviously, tolerability been that, a be with years. to this said have earlier, very we many the reason an opportunity in medication hasn't AdCom, worked I mean our program there be our generate both our in are NDA

particular prepared, the the to order And so just don't we're go about. be down that we have that thinking we're to making that topics sure obviously decides It's in in that's in event route. place FDA

Our Sachs. with Chris next question Shibutani comes from Goldman

This is Chris. Stephen for on

growth Eric in year. think organization of that mentioned I remarks X expect channels your regards the all the from commercial prepared with to you growth this

So from I'm channel progress can that should and curious we channel XXXX. long-term if care meaningful made and to you be speak how points development the in in revenues expect about just

Yes.

So point, because each for where all continues cared also the of growing Psych the X Neurology in to segments of TD. of overall well. being opportunity majority the patients our nicely, contribution that's this business. drive and quite terms of And doing our from business with pretty the the I are at is are majority mentioned. similar are LTC as

So the is segment. LTC newest

and driving, it's the really be before, as segment been mentioned and educating stakeholders, it really probably treatment continues I've haven't to nicely. growing the because in developed screening, diagnosis least As there we long,

happy that quite contributing made, we're the to it's that to we with a investment and be results. so of And for short to I in think level, a the it such testament period time

Cantor. question next Josh Our with from comes Schimmer

Just quick a couple ones. of

pipeline. in that once-per-day you empathy any are share noticed [ launch? you've added market First, the as I'm seeing [ correct of ] a And stable if the result shifts then pronouncing ] to I

that a sales revenue? product Or be I design to you establishing indicated shift are building starting for more to think a at in and opposed market the that meaningful generating past, as all? perspective might you've force

your question. I'll Yes. take first

So the answer is no.

in any of XR appears market seen business. share. do cannibalizing haven't terms It overall their deutetrabenazine to in change is tetrabenazine that us We

than that deutetrabenazine gain. of franchise more share of a within So any it's shift kind

in at we The of other see share, kind don't negative market kind to any we thing in a change any of in in say is I'll XXXX. share market change and change see that that of expect didn't XXXX, market share least

thing been rich. Yes. and great is The tardive only so has with the patients There's their add, itself that need incredibly unmet help need. market I'd that Eric, that just many dyskinesia

able we who look to this achieve $XXX their opportunity dyskinesia. from And you the perspective, say continues you looking when record over do would help tardive growth million. Modi comment a want forward be to So I and year-over-year year, at Eiry, patients a were more with just what need class great this ]? [ helping on to to

Yes, certainly.

it So Fmodi [ currently. And in FModi think approval not potentially such, that Europe an has treatment ] we as for ] complementarity is is [ CAH do Crinecerfont. treatment is the currently in U.S., I approved for a steroid some of have adults. to In the

next trials reading of to in on the update this half those we'll as plans X X from the based you Phase of year. Fmodi first out trials, II are And obviously, [ our are. ] We data what

comes with Our next Anupam JPMorgan. from question Rama

quick Just pipeline maybe a question.

of next catalysts the in potentiator the to next study expected one that's could you describe for and key end first the points Maybe half you the move of what you're program in looking the phase. to confidence So 'XX. MDD, here to to give in AMPA this

Anupam. Thanks,

downstream this read is is X placebo dose as treatment levels major which half treatments. disorder. This ketamine-like data of the you're a we here rapid antidepressant In that for at NBI-XXX, study of standard potentially using is X usually of different onset primary action, potentiator NMDA AMPA is score SSRIs dose-finding with actually week this the yet than seen out more AMPA compares will obviously, since and it's other mechanism goal potential with year, depressive the see a a associated potentiator of first endpoint our activity would to mechanism MADRS with the and through yes, right. we of from pretty a the So a

study, quality finding psychiatric multiple but allows we as look primary at the MADRS and which as endpoints function So secondary the at well we looking endpoint, life as dose endpoints. have this other of other other to are us within

looking a out in as finding so information at to study be decision the we'll coming And essence, make to of totality this proceed. of to dose the whether

Our next Gould with Barclays. Carter question comes from

for of one It frankly, at the got bit Day, up another a but brought Eiry. kind Maybe overshadowed by it. was little Analyst

that of the VMATX bit out of you little So your you that updates, had the of of a that. lay of you the expect kind of on ongoing. -- will next you months? and how just over next-generation And Can of is you've and expectations about ATS the this talk to sort effort, other X follow-ons the study and impact just maybe progress obviously, Can about is course many sort XX -- the inhibitors. talked the broader on sort XX the

Yes.

we is an just given entering depth terms the And which that with mechanism in a we VMATX is mechanism. And us. VMATX This of the medication to have So platform valbenazine profile are the really earlier. Eric its for of NBI-XXX, clinic that of knowledge is follow-on. this amazing important obviously, alluded and

next-generation of high And had keep the have so in with we the differentiate the really coming into ability clinic. molecules terms to bar

of generate itself seek this this too of profile characteristics the are Phase VMATX neuropsychiatric we approaches might talked molecule, would data in but long-acting differentiate other And that that into arena. of terms go about so Yet, haven't obviously we some we as other or molecule potential will of both areas intramuscular with as injection in will important do much that inhibitor. lend we that I the we also itself the such to but indications in for the

Akash our Jefferies. question Take from next with Tewari

[indiscernible] On for Akash. is This

] clinical Phase into Phase reading sounds II your forward in maybe this that XXX, MX year. efficacy. comparison It efficacy like trial are prioritizing in KarXT [ you move here on I over guess for competitors agonist [ order will out to up our ] be How III So to other you are like much give to willing studies? safety

Thank you.

] improvement and between in of in implicated blocking terms that they highly benefit [ way can a of differentiation mechanism MX agonizing of I in there both from in MX psychosis Clearly, symptoms. is of molecule psychosis agonist. ] Cerevel molecules NBI-XXX is which the the [ PAN as the we the ] a agonize and such, selective now and the KarXT molecule schizophrenia think So MX MX. terms and is the result the scores know And the [ in

And may of also so play tolerability. it terms play differentiated out terms out but in in that differentiated of efficacy, may

I terms terms that at able the will so study. both. look This we in interested of tolerability dose-finding the say of part on scores to we interested as to We're wouldn't overall is a efficacy this and of be in in tolerability. impact psychosis are only the that, in And And molecule. tolerability

path those from in our So important important determining be both Phase forward. of the are be II I and integration an it data that will think readout will

Olson Our with next question comes from Jay Oppenheimer.

Congrats on all the progress.

that of to then some separately, CAH of have with you'll you Just And can think you do besides Crinecerfont about other have you how do diseases treated to start they And file? the like be the density. to on some plans complications data patients when bone talk going back in to study Crinecerfont, before Crinecerfont benefits you CAH? of any experience long need or cardiovascular

lot of a Taking them one That's time. at a questions there.

benefit and the terms its the control. direct In of effectiveness androgen of of Crinecerfont terms in

there, to we a on Just that and that shown make see X very comment rapidly, we've occasions.

within control data. our in also played reduction study maximal of degree II out proof-of-concept XX study antigens X-week of androgen the Phase of our days in because that dosing, it Phase in much III in pretty is how was First, the

in allows reduce the the get both how outcomes. androgens associated we does Obviously, very clinical with dosing, steroid to and terms clinicians dosing androgens, then by being benefit longer-term So reduce of Crinecerfont that's with and the controlling rapidly. able to that Crinecerfont controlling steroid that

essentially of We impressive Obviously, in bone-related clinical greater And do year, measures, the for measures XX% within into the both out data important has thing trials. the than rate pediatric elements to other program have outcome submission. growth beyond the open on and which terms metabolic date is that, essentially. NDA the rollover to other adult about X are of and label been based those our measures,

context called in we in that of general data reach a effort longer-term seen on on have market. basis, we'll the us of so put population going which registry allow the what to an Also, ongoing outcome terms catalog And are until is do continue we our collecting to CAH. will data open-label we clinical and in

for diseases. plans any And Great. other

Actually, an I that on about thinking think, obviously, we're basis. ongoing

our that alluded I Day to effort space in also whole Jude R&D around next-generation at think indications other well. we have as a CAH molecules in and that

in we'll due be so about course. And certainly that more talking

Goodman from question Leerink. next with Our comes Marc

line the This Mark. for is on Rudy

IP talk the of current your litigation you pricing on end can of decade. recent about the the towards are just what settlement? curious your this on sales following IRA patent And So your impact

with very the the we're pleased ended So that way up. litigation

this have point that XXXX We at in out protection time. goes into

patent IRA, that put to the So spoke now. know, September to first really year, molecules our first XX I we what impressive here the Neurocrine. of yielded. are it as negotiation When the comes this at the of we're drugs right all that see going those negotiations In under to behind efforts think you time

that we all we the be. to impacts seeing to look what forward think can think any I IRA going before So we on further are comment

Our with next Blair. Myles question from Minter comes William

Congrats on [indiscernible].

a Just I the volunteers. agonist trial, XXX MX JULMX one in Phase on healthy [ the ] quick

trial September. that in initiated think I

program. in is think dosing going for against XXX and that secondly, we'll would for [ Just or ever when ] CNS about you head-to-head that running wondering hear about safety studies And indication. how XXX

Myles. Thanks,

very progressing that's XXX, the well. On

lot That's more II. some program. the forward And talk usually to at put into directly whether space, And we always of in order try expected. than as them enter and another. as that are through we'll about Phase more that what trial one I to obviously, to to with profile about We tend do progressing one a going but are we a investigational discussion point, come product in things clinical there's Phase

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from Patrito-Gark Our question comes with Deutsche Bank. next Nina

I for question anything can testing there circle that Paul's activity may MX we've you the on levels maybe dosing. an CARXT Is emoracidin readout just how seen ] that of [ the year kind doses dose this you're frequency and from dosing else share originally wanted the later back and they to to about to that and compare perspective?

that our obviously, how of also testing tolerability I dose the II. doses to our integration long this we'll to Phase the say haven't it's point. pick shared efficacy the and a can from right understand data, on we're Phase preclinical and we for Phase later program where that both I get range a we're from different We an Obviously, not What based we II our lot this studies toxicology see from study that so that data, pharmacology year. on to confident to planning doses is of get explored before dose the

question next Our Jeffrey comes Stanley. Morgan with from Hung

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about ] here strategy, really the talked FModi much the We particularly Yes. haven't in [ U.S.

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next comes James. with Our Raymond from question Danielle Brill

the powder policy and expect and schizophrenia I'd the to from it's then might like I valbenazine. Should of data expect sales this sprinkle dyskinesia studies once of guess approved? formulation an ] involve we studies impact cerebral sort update from those we what the on year INGREZZA [

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better a for be may this alternative them. So

product And so we're introducing to forward looking that upon approval.

Chico Wedbush Laura Securities. from Our next question with comes

now And the if lot wondering appetite of discuss potential terms what external your sheet activities. can does today BD this But for a obviously, provide discussion So of you pipeline point? flexibility on size? in at balance internal deal your

Thanks question. Kyle. for is This the

the year. seen on from you've year what the think past X progress here over clinic. in programs our was We I put efforts internal good Neurocrine bringing last drug programs from discovery into

their help Day of efforts that discussing some accelerate us to bring R&D working that Our we team at team, would don't to to business time, particular but been currently have over research the we've our pipeline in think, year. we do something term, with the I to here expect on our the is development, here this midterm help in urgency continue this large to pipeline and transform in that their we near assets work great at we feel they're next need like

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to about Crinecerfont. in is growth drive INGREZZA, When how to you you to going can launch value, continue money drive think to ready where shareholder expect we see getting our

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question next with Genuity. Our Canaccord Kulkarni from comes Sumant

in more you do depressive or major On expect episodic an dosing. your efforts with treatment? an indication you disorder, medicine the component either durable XXX that to to any episodic or venture chronic think And there's have versus XXX approaching aspect do efficacy

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is dosing a episodic there. consideration part so the And of

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from Seigerman BMO with question Evan Our next Capital comes Markets.

can Evan. expectations And Come what I II those to you're in back be movement can disorders. antagonism schizophrenia, indications agonism the and an confidence movement the action how the gives Maybe MX you for for muscarinic, you through differences? for Phase for walk of using the in but antagonism, for mechanism for disorders? us Malcolm Phase differentiated treatment

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targeting actually we're antagonist, MX movement disorders. the For

that Parkinson's disrupted those And to and that as systems value able we are the has associated terms dystonia, this be the antagonizing so MX a is to potential such in movement disorders. add within to believe, diseases brain the tremor, treat normal system, of and in with

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We'll Hoang Citi David take from question with Group. next our

factors little talk reaching you of circle to range on to a guidance Could that in X/X accessing terms of barriers higher that any be the you that Maybe of undiagnosed would and perceive just do moment. group? along back into end for the What TD maybe bit in a would remaining lines, those XXXX? INGREZZA patients, play the about the

Yes.

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make big patients' in there's lot a terms a organic to opportunity difference So in lives. of room still growth and a of of lot

their doing. leverage those from reach things invest the PD in and we're as so are within me, of psychiatry, are of very TD on conversation care the that our Matt as terms in suffering We're continuing that long to in fundamentals and care focused long-term and HD that term neurology and excuse to have do we're existing to encouraging health them we And as said, franchises. drive across both well or what These continuing educating education, doctor. with providers to DTC -- and educate

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

maybe one side. on So expense question the

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Yes.

when you SG&A were leverage, XX%. about think I we and in where think XXXX, back at the take a we're step

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Our Ear with question Uy from comes next Mizuho.

to INGREZZA was help said to net as growth you dynamics Matt, if factors gross wondering the in to I was the gross in us will well of sort I as the think quarter net improve you number, that XQ the of offset gross and net understand XXXX. can the by

our quite of Yes. in timing of orders, timing quarter it's gyrations of saw. we When $XXX what you always et quarterly first think patients, about it's by cetera. of our QX results, terms and ever sales, million getting There's in whether we're encouraged refills,

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question Sandler. with comes next Piper Our Amsellem from David

on Skyler for is X This David.

of on targeting you the the provide payers? [ pricing and reimbursement the do updates MX agonist any And then been landscape with And second, MX. development pediatrics? potential you've any value the adults mechanistically the of discussions will expect First, having different proposition Crinecerfont be could you just MX the to thoughts versus proffering for and ] between plan and just on talk

Yes.

to we're very expect on obviously, pricing, we say rare be this pleasantly disease that acutely than chronic a to treatment. with are premature that pricing. So bit had issues with to disease of maybe have it's With emerged been about comment little aware profile pleased regards We've that little payers. would associated steroid it is the to that initial high-dose bit to with Crinecerfont. conversations And clinical I've quite they other enthusiastic and a and a the surprised seem rare

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question, final Let's please. take X

please line is with go open, your Ami Needham. question. with Fadia Ami from your ahead comes question last Our

Sounds Kevin? I'll like later. follow Ami with

Thank here. do our enthusiasm hope all here. upcoming Number morning sales our I with expansions we'll come force have point questions. only with comments years talking I The probably closing year. investment you appreciate that this I more through we interact Really -- is time X INGREZZA, the at one a you really want efforts. the ago, that to be that The DTC expect you to this starting close ramp-up and things another start for is have it's your most out XXXX lot as in to We both as I X and saw great meetings.

in years, the X seen difference the now make. have that You last can what

a here. have dollar on our hands product We multibillion

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that building into Our it's it very said This on be tip of the so X patient. more very It's this focus need investments those With I for years, able drug way. the much order going There out many is the a to still in with say year. for fulfilling is early iceberg marketplace this to lives. same the Crinecerfont, I'm seventh it is just on I know live patients are this. to that

patients that to Neurocrine of said, investments you much and the the marketplace the a smaller we that investment making leg significant lives will because what of smaller. need nevertheless, Matt going for going those But year, amount is is be very As as growth year next this I'm is confident also population incredible that that patient we're are the within forward. for of see much

see. pay lot years, And then definitely can point. But you're more, large in those the see strong clinic. get start But in whether finally, therapies. has the are into efforts you're that than tell when about Those all get to peptides, see investments internal in making that efforts going proteins, small in unfortunately, our a the coming been always off the antibodies will gene to to to molecules, you which we're I going and our we you R&D of molecules, rolling talking

talking lot you have in we here, very future. excited to So Thank more and work ahead to much. of forward very look we're the us. a We of you

Results the Quarter and conclude Call. Neurocrine This Fourth does Year-End Biosciences

may You and day. time, disconnect line wonderful your a at this have