Neurocrine Biosciences (NBIX) 1 Aug 242024 Q2 Earnings call transcript

Good day, everyone, and welcome to today's Neurocrine Biosciences Reports Second Quarter Results. [Operator Instructions] Please note today's call will be recorded [Operator Instructions] It is now my pleasure to turn the conference over to Vice President of Investor Relations, Todd Tushla. Please go ahead.

Thank you, Chloe. Welcome to Neurocrine Biosciences Second Quarter 2024 Earnings Call. Kyle Gorman, Officer; Chief Officer; on Eiry Chief Officer; Kevin Abernethy, Officer; Eric October are Development Commercial Financial Business Neurocrine's Chief Roberts, and XX, me will our Officer, next Executive current Matt Benevich, and become With Strategy Chief CEO. who Gano, Chief Medical

share this thoughts following closing will earnings So few Kevin's yes, call, and a last be he plans to Q&A.

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

With that, Kevin. call I hand to the

Yes, Todd. I thoughts good you, have Thank closing But wish told you would have today. me everyone. I morning,

to first neither blinded over what our or is go But MX information have with out luvadaxistat Both lot like been locked. start statement share trials morning. I'd and that a we NBI-'XXX, database agonist. to is no this have We either to on a have

Now I probably me say get me I -- hearing this tired this, know you excellent been do. of has never quarter. an

our depressive We will compelling INGREZZA compounds of be II modulator for SPRINKLE, review company finally the of for than crinecerfont, year-over-year that disorder, major rid clinic. AMPA multiple for in We've new the the had are priority data in XX% have INGREZZA. of best all, better approval Phase growth product me. And

educate advertising to either been made utilizing more very we've a HCPs sales to patients now more INGREZZA propel ROI-positive. And obvious perspective, that be reach to because TD patients. treatment. from that about has a purely will a and and INGREZZA in time so It's to while Now our patients. it we're or to expanding able to financial takes Eiry investments want are and many that I'd very always level speaking share get It more each and And crinecerfont Eric investment, these force few need observations. there more detail, new direct-to-consumer like

But the investment doesn't stop there.

clinic the are dyskinesia being for and the for area schizophrenia. will be an We going as continue finally, This a Neurocrine. we on next adjunctive a generation cerebral of we very inhibitors. palsy that in be an and plan developing to INGREZZA in long time to in treatment of VMATX important is explore very And part and

to drug PDUFA Now working in and We're designation, review medicine, drug with have date crinecerfont. for the drug along the excited the the and life-changing with year orphan additionally, treatment another to designation, now change end. at And CAH we of have get priority FDA we paradigm patients. The breakthrough are we review. entire will

biologics have clinical And we world. most the our pipeline apparent this robust neuroscience next in enter more year believe the I as will in clinic. the preclinical even become Finally, and

over turn I'll shut Matt. to it and up now

to come. you, Kevin. and as depressive build, for continues data be many our tremendous crinecerfont AMPA growth. to XXXX for major neuroscience Neurocrine a a years positive in for positioning in priority Thank review to between continues disorder, leader us year potentiator Momentum INGREZZA for

compared year, range to guidance year-over-year were billion $XXX to $X.X versus XX% range this INGREZZA QX $X.X prior the of $X.X growth. sales to billion INGREZZA in net $X.XX $XXX billion. are the we to million billion million sales performance, guidance With our XXXX raising previous representing

million vacating of space associated guidance and growth non-GAAP a with the expense We are to with continued INGREZZA to $XX sales also charge updating by our $XX $XX impairment with office team our expanded support we campus. approximately migrate our as million million, GAAP new SG&A

programs R&D with revenue With pipeline allocation the this success. into advancing the launching blockbuster building INGREZZA's advancing potential Neurocrine continued to our decisions Phase continue for and accelerating Being III, company, a future. momentum, clinical growth we blocks second a capital high-growth sustain to to has make prioritize crinecerfont into and

not point for a expectations. few do to provide I consider XXXX, items highlight a for operating develop want Although financial at while guidance official expense you to your we're you to

SG&A, our of previous top $XXX on past our several years, has with revenue benefits an the will delivering into growth, with focus Heading reaping generating and INGREZZA successful priorities the the investments. been our support investment increase over For of to million growth. XXXX, incremental line launch top crinecerfont

want R&D to important invest preclinical programs behind that although positive clinic. data has willingness turn to into this year, investments, for are still cards waiting heavily any emphasize accelerate data we the Regarding program to over high-value our proof-of-concept and I

sales ourselves Neurocrine. advance to the growing like unique position over through but here our clinic second the a half advancing find with exciting and decade times pipeline, this A we of program, important potential medicines, flexibility a in at of manner. in lot nondilutive ahead very work Between an financial AMPA

hand the I'll call over that, With to Eric.

performance Thanks, Huntington's momentum growth last quarter. tardive strength is prior Matt. QX through chorea. testament our across saw the QX disease versus XX% of our INGREZZA a to The the carried and we dyskinesia over of into year business certainly with underlying in

billion $X.X this At midpoint, narrowed year, the growth XX% range our first top $X.XX raised to sales year sales in at equals the we've the approaching full range and XXXX. of guidance, mentioned, as a approximately With billion half end. this billion to versus Matt of $X.X

learned INGREZZA the since It's continuously ago. benefit podium we June, in order more approach lot important critically from to of invest in help a and X of TD launch a that the As we've years our evolve therapy. sell-side can that the conference from even about INGREZZA appropriately noted market patients Kevin

the increase before, twice tried size team. sales of our We've

to by neurology existing for in time the teams creating more time the launch structure; and key second dedicated specialists long-term early by care. splitting the business and in in sales and segments one-team our now adding The first psychiatry,

a a couple deployment the Each are usually TD has INGREZZA terms HCPs people these after substantially responsive. we number The that time treatment expanded in quarters and the sales promotionally grown and treating diagnosis salespeople. new force of with the we clear saw market seen and diagnosing of the increase of of time with past, in over we TD, have in HCPs resulting

the adequacy Every reach of for. to care HCPs meet of and year, that living TD for carefully care our patients to or needs. recognize much they carefully and needs adjust HCP and we commercial footprint their to that educate customers more the and to with need resources strategically opportunity HD We there the we our our patients chorea, commercial that evaluate meet remains

as year plan new to accelerate team diagnosis of members to year. teams this the June, INGREZZA. appropriate of size increasing our With long-term treatment fourth mentioned the with have and by in We the that as backdrop, sales this help we're Kevin in care field the psychiatry quarter and

people, sales prior quarters once contributions board, tangible with from a few new on the expect we As sales to later. be force increases,

We invest INGREZZA we strong continue to in in the because have opportunity. conviction

team, pill. the offers have investing brand. swallow to an We're we administration to our to not made our that formulation the alternative With a who a are proud addition SPRINKLE benefit patients formulation. option in investing new or prefer available only have difficulty recently dysphagia, swallowing SPRINKLE launch, of INGREZZA provides INGREZZA in In this experience for

a us experience of of data HD without with new Our dysphagia of treatment for option to XX% or patients living It's provide us of pill. important want the people that potential or swallowing this the to chorea challenge who tells difficulty swallowing. upwards benefit TD

INGREZZA the as people can soft for or INGREZZA food, sprinkled capsule both inhibitor apple easy only VMATX with oral living yogurt is dose, or offering open once-a-day complex HD to The granules reach oral and titration sauce, to dosing capsules be pudding, SPRINKLE the with no SPRINKLE effective administration. the an on pill, is offer chorea. one needs meet the formulation such of to to diverse and TD

runway for that XX and out investing to markets. HD the more growth our And given the commercial remain ahead on to XXXX, the and gives in years expanding us in significant the chorea capitalize opportunities the footprint exclusivity long brand TD opportunity of

Now shifting to crinecerfont.

had over no as the XX suffering crinecerfont will same congenital to learning adrenal had TD hyperplasia, CAH Just INGREZZA, apply launch have CAH. new we've concept treatment or years. from in People options in a in with

the initiatives year-end, better and endocrinology now inform of team, is is community. a CAH focused the crinecerfont commercial on our at to Before fully hired, understand number development market approval potential rare which of

held by team in and for July meeting struck excitement a CAH kickoff franchise the and their I we was community. our helping fact, endo enthusiasm In for really

with, profile crinecerfont emerged, great on than place to endo clinical than of members unmet experience CAH the and been that on our diseases. rare more terrific attract the in XX as team of and reputation more XX of biopharma average, clear fortunate we've to need to focused years Because a our years work,

unbranded acknowledge health our educational set living care gap experienced that team managing will rare focus What and in the condition. genetic balance C@H?! on aims initiative. challenges the understanding of This of CAH to and year, close and the education to delivering frustration featuring this with the CAH endocrine providers endocrinology the For this resource disease by members community primarily

successfully With new We've committed approval. INGREZZA to again do year demonstrated ready we with we'll in crinecerfont. priority we're FDA and and be new with to review into all that bring a excited to after We're crinecerfont hand, over build launch quickly on patients that therapeutic the can category.

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

several in substantial everyone to Eric, I'm quarter, the made Thank we to good delivery clinical our of you, last call. important clinical the milestones. pipeline pleased including on that morning and share with progress

begin potentially I'll with a highly selective first-in-class positive modulator. AMPA potent, NBI-'XXX, allosteric

treatment. study in announced a inadequate Depression currently a total the XX. available achieved results the from Scale Montgomery-Asberg top day study the disorder was The reduction Rating As major with at patients in April, in SAVITRI score reminder, endpoint NBI-'XXX significant primary in response demonstrating line with statistically to depressive we with

significant MADRS secondary also the at endpoints, study a statistically The XX. key in day including met total score reduction

demonstrated NBI-'XXX generally a effect well strong was tolerated. and size Importantly,

for the next working an of II initiation support year currently this FDA are the Phase of meeting registration later studies with We towards year. NBI-'XXX study to end

adult from Medicine. Turning Journal publication June, both studies both In pediatric presented the crinecerfont. parallel of England Phase results in with the results meeting, III at the to study and ENDO CAHtalyst the we of New

NDAs the the In chronic solution crinecerfont PDUFA the significant granted of this seriousness oral further debilitating with and for disorder. for congenital high patients are need benefit for July, set The that the can provide and crinecerfont recognizing filing unmet now capsule late for and both crinecerfont dates priority thus the adrenal review, living the December. FDA hyperplasia, accepted potential

review, process the designation agency designation for granted orphan crinecerfont. will to then a enable to disease review breakthrough priority voucher a therapy pediatric In approval, rare latter the pediatric FDA and disease accelerate to designation Upon program. activate addition rare review had registrational could utilized previously be designation, which drug to future priority the Neurocrine

review FDA planning teams an the meeting, at if is with engage agency point. scheduled process, for to an not FDA outcome, outcome including support is prepared the in some our While it well are the of

This schizophrenia. expect track potential score change, quarter, total you size we Phase as data orthosteric as deliver a II selective to treatment communicate agonist remain effect call, safety and placebo-adjusted should PANSS tolerability conference measures. on plan and We results to well a press for study via NBI-'XXX, the PANSS muscarinic MX release see change, to study, where our score as from

as we luvadaxistat potential schizophrenia. for QX, on remain associated In with impairment for also treatment track cognitive deliver data to a

compounds which agonist stage now they an I programs I color a other All development. last of MX-preferring and the the for and II. clinic: totals including our Phase movement I NBI-'XXX, Phase disorders; make We'll in remainder NBI-'XXX, four Phase provide of the from muscarinic antagonist, portfolio, the quarter, continue molecules advance early portfolio. agonist treatment Phase entered MX as two programs new portfolio progress, In clinical these potential towards more muscarinic the to selective on our expanding

efforts meaningful I'm all, to of the I with living Neurocrine's of expand portfolio, in new for debilitating fields these broadest neuropsychiatry, neuroendocrinology pipeline and which the reflects forward provide continued pleased advance to patients therapies All the in neurology, with our chronic look neuroimmunology. deepest, in evolution history. diseases continuing to and

in but for Our few with great clinical outcome patients needs, options. to goal improvements deliver remains important

to one last time, for Kevin. back And you,

Eiry. Thank much, you very

it's that questions your giving last this face So ready you for time this that is she's ]. We're one imagine how can't happy morning. she [

We'll TD Cowen. our question Nadeau take from first Phil with

Kevin, congrats to you a first, tremendously career on successful at Neurocrine.

and your have bellwether built patients. countless really biotech a insights helped and efforts You've

you long, well-deserved So retirement. we healthy happy hope have a and

Phil. much, very you Thank

diligence of What's information review believe of what that There's been the to side Eiry, the been on table on data? muscarinic any released? future. from 'XXX. known data in a potency to study. has for to question that's target, from healthy I that's not published lot you. ton Sosei Phase I setting presented other announce a a because for the been or there's the volunteer you're a terms Could in effects, some effects, It's going Thanks for on us but it, compound hard you cardiovascular focus

Thanks, Yes. Phil.

be mentioned comments, see I schizophrenia. can data on to hope to Phase in we And will, as you of plan the delivering proof-of-concept our So study see Kevin that. result articulated II this the from in quarter, a as what and

muscarinic-related is can doses range we both as terms and clinic. that information In of of into tolerability that broad pharmacology. take and of for study, the that range I terms timing to say a had were choosing preclinical confident in very we of the of what And us the saw, Phase made expected, that I we data safety the the

II Phase that in some more selective really think also in anticipate -- forward study about seeing the hints moving we and the doses of for us agonist. This give which little pharmacology and the remind is schizophrenia and took it's learn terms in tolerability to reflects dose-finding of I of study this differentiation MX the efficacy interest. the the range study around because this of I'll going potential you molecule a we're study, that The this from bit our of into confidence we the the a purpose

And independent of adaptive in fashion chosen cohort. Each the to it's cohort essentially up X-cohort is this on study. basis the in the seen tolerability previous so potentially

be I in will it be the And maximally class. you potential to that within will range informative the from And at opportunity study. the minimally dose allows hopefully drugs broad effective as differentiation for what think most you to so this us other from look tolerated demonstrate this

shuffled the And adaptive patients have By between you rules? disclosed rules the the arms? what are

What and for in guides cohort. of go that's that. or study disclosed not an cohort supposed we the the it's as recommendation and data. what the each terms actually makes get We but next dose not the total do dose can data is is long very doses for say in obviously, reviews this have be that is to not independent know -- We tolerability those I to study going there cohort through those to for the the DMC

call around when a our spend we're And this have that quarter we to design the sure there's during lot review going will of make this we going time through data, clarity that. study here to

congrats again. Kevin,

for I that made that other you going And I probably lot, I the pair of Phil. was together, observation I'll can it grew I a up Thanks Phil. worked analyst and -- seems, and that term, as prepared have remember. We're through getting today, I both any together, use longer CEO than

did. We we did,

I it's couple a been decades. think of

with to next move Paul We'll Matteis Stifel.

you always with echo lot Kevin, a It's been I'll and Phil's fun to talking And congratulations. working of you.

There's hurdle, for target you as relates with of been to How of about attributes And the molecule? is another conversation have to interesting the effect are I profile the advancing it product what on question important to muscarinic. you else size a thinking PANSS the would Eiry be efficacy? here? lot other related what

it, that's QD Eiry, what expectation and GI or versus something if what you more comment And is, of whether you? emraclidine-like that's expecting KarXT-like? important your BID, about kind Specifically, side you're you just to love also on I'd whether effects could think

mean, the I all to go first here. I back Yes. mechanism think, I'll of

MX is this an agonist. selective So

able the from the of profile a a terms be relative also, profile, will for that muscarinic PAM our soon we certainly tolerability agonist obviously, understand in PAM see expect data will And so of to to And think I can be we particularly. different MX. to both

say or problematic that any preclinical I our to issues that GI from data of the I have from and not we Phase sort. of tox In anything seen evidence our data. can date,

of profile, the bit within the of to In a to benchmark I able here good pretty class. been a terms in is things compare think overall we've consistent saying this of have one we be

score placebo-adjusted in change signaled And we've thereabouts something more. at looking for endpoint like or primary that a of the X PANSS so we'd or be

have that of you lot we'll look also due full of totality a the it's at profile. able the in the the endpoints important really study be other a into course, obviously, to mentioned, within And data, integrate we But of that, tolerability looking at picture we're benefit/risk. including to as

dosing? anything Eiry, on

sorry, On the BID. QD versus -- the

will, we'll depends efficacy program, at We at in day, our the regimen of regimen. molecule. the this tested have, for QD but dosing We in II now, actually right BID think And I Phase know looked it very know both that the Phase soon. of I the the dosing tolerability that were and study and don't finally in on obviously what's terms best end

to next move Tazeen Ahmad America. of We'll Bank with

congrats, Another be do to building missed. and a company. It's hard you're to Kevin, going great on

do wanted is quarter, I just for INGREZZA a practically several a it's have beaten that to you Trends size justifies minute. to sales it to size every force? you already. go with doing Eric. clearly, need that your think expectations seems, question increasing and well it have Maybe to you the back been still the be you seem for What quarters. that Because of

Tazeen. Yes,

in INGREZZA, terms and mentioned So the in putting on that TD market, we've And INGREZZA evolved the as remarks, but investing X HCP resources continuously the years prepared of I to approach to also of over my market the forward. has take educating developing growth. we that that the the we're in course about we're customers been

was part of meet so And years to And extent, of that needs few it to evolving is a we're a certain just evolution. this the like ago, just customers. our

has increase of in treaters TD And at majority FTEs sales segment XXXX. to that the in segment. actually size potential seen and continued business back number TD over time. the That's of psychiatry grow treaters the in in that terms didn't we've expansion, looking so force particular of is our And a we this

prudent it's tremendous additional is psychiatry segment. And ago. our was the add feel that potential LTC That's may smallest moved recall a a that of into couple you FTEs sales in been we've what to LTC seen we've we in there's so years the support years and few segment that that in And And for we LTC. team.

so makes us. lot to for And support a of customers adding additional the LTC sense

we're what But time seen quarters, it's monitor past, in couple this an said, in see of done within we're with we've like this, extension of as how continue off paid ROI Matt and terms going doing. to expansion. that's every the to So a to positive we expect we've

just reflects that's VMATX conviction of market the being inhibitor The ahead the add of only it firmly treated the today. that is, with We really I'd X X patients around us. out are thing XX not have TD opportunity still or believe

when help to market patients. many lot and left So at the look still overall a grow you opportunity, room of more

move Rama to Anupam JPMorgan. We'll with next

Kevin, best going epic Wishing I'm going definitely you. all miss you the run, forward. man. to

getaway. I longer to no it. that Dang I'm take Beach the it means Pebble invited

invite that. No, you about the like man. have every professor worry emeritus Don't year,

the dinner come as You night can to Sunday on well conference. on

what the outsized of segment, guidance Is So range? key there INGREZZA care? for the the that sort terms in growth physician seeing rate growth levers any neurology, long-term guidance psychiatry, driving there that's driving of are the for you're

as what is a of seeing INGREZZA is our are Anupam, nicely. really And sensitive business segments ultimately, promotionally all I product. very we're growing so three mentioned, that

efforts. that's see through continue to TD, through and we teams field positive our as and as we've so educate our differentiate well continued drive to awareness, both And INGREZZA, recognition raise And results. DTC around diagnosis as

comfortable And guidance. the we guidance the through raising our sales. felt billion And in also $X.X year. narrowed We're very over we halfway so

second treatment, that #X and allow to grow what's VMATX the recognition with So year really of diagnosis as driving to INGREZZA the and is to going in continued most half prescribed inhibitor. continue the us and

Akash Jefferies. next with Tewari move to We'll

team built. pleasure And with the truly to you've Kevin, work been you it's a and

been 'XXX, There's Does both given did biomarker, measure MX MX that concern? such For versus share similarity. your that some of selective Nxera questions receptor any how for target can be team engagement? you targets

exposures? from do patients if be for Or will a tolerability? measuring determine your perspective? cohort up also safety readout, upcoming how you blood it to additionally, another can And you Is dose

Akash. Thanks,

your Let first. question me take second

titrate from about this This when just cohort clarify But Let the me But the we'll study not study. to dose an the for adaptation share chosen and a clarify, more trial. the that we just could within range adaptive give it's means be design. -- and data. that all within different next is individual so the information that patients

And by then dose It time. we to has then brand review that patients that have that independent is decision tolerability. dose new next move of by group to the study of a of a a based on group is of that a cohort at point enter been patients number. the series in the level into given an made to And the given

believe, we patients to So should we we the take it be be will reasonable dose a as in further the be benefit we it clear, profile. don't have see what tolerability study -- event positive choose And that to won't into and that titrate. that to

On question. the first

and highly done are think both a in vitro significant about selectivity whole of work has profiling confident And our molecules. Nxera in of of I vivo, We a range amount molecule. the preclinically, very

So from And MX as such is as a other selective agonist. and our molecules confident in 'XXX. more activity, exploring that this perspective, are MX you portfolio, have balanced MX we as we're well see that

in clinical that. we'll as data, think more move confirm our and forward share the that about be I we of so context And to able

We'll with to Oppenheimer. move Olson next Jay

the all put for done team on Kevin that the you've to patients you in in need to Congrats place amazing progress. and work continue

to ask if long-term you Kyle, this maybe Neurocrine share time please step that, the an for role. appropriate you would leadership could as with your be into And vision

work with Kevin's question Great, opportunity morning. answer been the almost honored left that learnings a past in that's this along Kevin's exactly rare and done. made been here of at a you him it lot can Neurocrine the toughest really company give industry reinvent XX legacy this quite a have It's Jay, the see me have there's way. And in what and the here to you and that years. to succeed,

strategic years the we'll a company later that role put that think and right the the and place fall. one today I as in this it's So continue plan on ago, step few one the I executing thinking about into the we in

level, developed I future about medicines. a that delivered that there's that lot of and time of it's in we thinking we've they those past ahead on about some Huntington's we're realizing class. disease. a approved a today. We opportunities Neurocrine, At pull starting first one at INGREZZA, awaits three growing think high us talk If It's that's fully blockbuster, exciting that gotten and the questions out, the have a and promising things FDA-approved their here we've and we each were at of company discovered approval, of in integrated the we on first-in-class. dyskinesia There's tardive medicine INGREZZA for our today. with

It's a not has that TD. even a still today X/X getting patients of diagnosis of medicine

still for amount and us. but of work a ahead, very opportunity, exciting So also tremendous that's

tremendous heard Still all great of announced initiatives dollar ahead another and lies for patients the crinecerfont spent approved. for seeing we the treat There's still that we when here many data about You've that us. In some is us opportunity the to INGREZZA on the for of have opportunity here CAH. thousands CAH at XXXX, Neurocrine. best with in

another a for as this CRFX like is at crinecerfont hallmarks and at believe, we it us a Neurocrine, sets just early started an dates up of blockbuster. medicine If PDUFA year, this approved. first-in-class when the antagonist launch is you XXXX year, another later look our And nicely reminder, I has,

so to in we that our pipeline 'XXX, cognitive clinical Neurocrine. muscarinic take Eiry NBI-'XXX, either we at QX with 'XXX for year. And our that forward, that hear I'm the everyone in very program new And about are the that we data from something excitement here sees next in future for think touched products. that's talking that's the see an very cards year commercial at much theme entire things more and that III modification impairment something here luvadaxistat underfoot, both on and pipeline a decide of agonist; discovered shortly: entering one programs is vision internally and symptomatic transformation Phase that here are they'll programs hoping very next moving opportunity have. and organic then curative of two moving have at about me to thinking us. we you'll the Neurocrine here externally R&D programs, a late-stage schizophrenia. or those Neurocrine targets. validated growth produced And in MX and therapies. to about sourced from These robust to registration invest that disease our join that's So therapy positive, the next have great you'll a the more year unvalidated QX as in If moving provide data here gene and you clinic, about robust away on That's in just associated we from deal all away

on organic looking are It's going to So really based underfoot lot growth, forward future. looking that things disease at bright to a We a be talked about the some of here. psychiatry, strategy. right with the to winning and using the a spans that, we at think, neurology, looking right endocrinology, modality be that states match and choosing is target neuroimmunology going to

strongest R&D along the at that's patients financial There's this my medicines to here a position a been bring of time. way. to in we Neurocrine, we've $X.X new the to And wrapped we shareholder all bring innovation with differentiated to in lot company and value in add patients increase billion that and things is that cash. certainly can hope that do

for of year I'm remainder little hope So of Neurocrine terms in forward of the that vision I can the why excited we that gives thinking the feel for of to some about you XXXX. things and look the in a

move And to we'll next Chris Shibutani Sachs. with Goldman

on is for Chris. This Strang Kevin trying

Kevin the and on congratulations add for my the just quarter Let me to team.

net gross to dynamics questions going release. of And net, you something the half press think should we for the of to gross the mentioned then second expect? Any Just was quick for a in had should that? couple quarter, there? specifics about this what we year, How into that

And then III just your Phase assets. II development and given pipeline, a appetite quick there, internal Phase growing one including on and business potentially current

on we're BD the Yes, focused very front on now, developing pipeline. right the

that we a of cards have things will our and volume. flexibility, how of growth a that But great data dynamic the for on. We capital largely this lot driven read gross-to-net internally. From this have quarter out the really we was by a but into will financial future. moment, lot allocate quarter, We do have perspective, inform important some here going focus

of a QX improvement You from range. to of a more single-digit bit gross-to-net always low QX sequentially type from from perspective have in the

very what we gross-to-nets line so in much anticipated. coming And are in had with

half the So nothing of year. to second flag for the

with Baird. move to We'll Skorney Brian next

also, time And It's too. a decade, the run. been Phil, long It's let more Maybe but I've as an a at certainly story, offer on a job. me I think, incredible as my than been accolades, point. been great following this not Kevin, long

shoes in I the told still Tim's But when Matt Kevin came if here. to to to come. anything he retirement, Tim it's some great like had transition's Kyle things Kyle big the also following transition, for he same to fill Matt

Sorry, I in my just eye here. have something

right a as that the Or we that's sort on indication think you're in meaningful clinically score, And to benefits really INTERACT really a a less the it's patients? on How I that should saw statistically the study. know threshold little a cognitive PAM's sort replicate here? the marketable is for but significant absence But about of effects what able discussed of that of readout. all driver matters is BACS luvadaxistat, -- you composite if in in now?

over I highly we mean, unmet patients I of useful it and more and know more with the all treating yet suffering the area. that help suffer majority time, symptoms think, mean, obtain patients of an positive with issue, with I disease at do schizophrenia the area -- vast approved as really there's need. an impairment cognitive from treatments this significant think are I this more to is Yes. the nothing in as becomes of for that we a

first And positive that's, a why which study. were so hit able having by the give the weren't Obviously, that BACS the data that scores replicate we time II on the signal. and of And the been -- study, the signal at that strength will II that has Phase of the signal symptom both of though Phase and negative study, we saw change robust a was have magnitude primary was that of to on seen from XXX-patient indication we terms that of nature again, we that in the INTERACT Even an the us scores clinical think, we saw the the improvement, I BACS, encouraged the finding. to looking the of in so on trial.

with we of for replicate the think for I schizophrenia. area obviously with like. then a study, path INTERACT agency that's us important in step look patients seen to we've to meaningful the understand managing would The in step If forward terms this will registration what engage be next a what

to it's opportunity. next unmet agency the a we're really this this if we to But exciting It's be study, in And will be with engaging successful in huge think in certainly bring need. patients to understand able to how area. very a I interested benefit

We'll move Wells next Bansal Fargo. to with Mohit

side now from the well, for congrats, my on. best an for all retirement From amazing very And healthy Kevin, as career. the

Thank you.

mostly safety? overall adaptive efficacy well? the we you understand talk it the to the trying dose? the little should Could should as -- to a is focus for focus when say out? bit for want adaptive, And data when drug for on And of I MX. profile question data, then when that? study design the Or on we come you like it is Or at highest about the we maybe So look

point to And been this jumping regarding is on get we're the said, 'XXX. on I trial. questions we'll the those Matt what when details Eiry. know of this And like And Kevin design call. limited of into mentioned there's the for pretty about outside the So a be we at we call. We're few this in going share

levels cohort of guess, you about you all next it increase leave had Eiry the the want escalation dosing the side. we'll or of dosing. turn over as the mentioned, at so cards, at to be the looking of is I we'll do part on safety, course, course dose, see that's we'll what data And to The that. When -- all of

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next with Goodman move We'll Marc to Leerink.

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crinecerfont along And with very course, far our of are we program.

adults Kyle out year both strong very and in last read As pediatrics. we mentioned, data

pediatric I the think in unmet need exists that's given significant the population. that important

from very XX% look patients Phase And And and that staying from extension, it's each the vast you majority the into open-label is with studies the if well at of rate benefit are gaining very doing than the of that. III medicine greater rollover long-term crinecerfont clear, tolerated.

from CRFX think that we I think It's going levels. the a downstream approach antagonism Crinetics an from data approach scale sample, data. approach that see believed encouraging be we it's of anti-ACTH to with ideal some hormone we the be patient endpoints later the different of with to into The important I small And because biological that to it as how CAH. Obviously, trials an approach so translates larger we the now approach have the from treatment And sense anti-ACTH perspective way would chose have. well. makes

bring be as can. a life. this and on focused And their navigating very the hope significant We're year make process we're as think we able I to bringing and forward crinecerfont to patients next difference just in FDA really to we rapidly well

on quick 'XXX? to care that has X-point on that of of here messaging And of If no question in, relative KarXT just comes the a PANSS. there's program? like I but is kind kind what mean, set, the can this that mean the does I to delta ask safety advantage standard

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to next move with Carter Barclays. We'll Gould

endeavors. Let and me well, Kevin of in offer future to my as congrats best luck

I to out NDD? a willingness presentation year-end? of And to as contemplate and 'XXX. beyond expect maybe contemplate of guess, meeting does invest, I full that bit SAVITRI up 'XXX that that go that to potentially shift data wanted does -- a broadening just Should things we at scientific before you the

part I'll first. second the answer

and are the encouraged major on Very data focused depressive the tolerability information the coupled there, terms We favorable the of indication signal highly in disorder in our effect profile. that right with the now. strength of by consistency saw we size,

with study the year. program II And in to so next of the starting engage our an meeting Phase next with support hopefully is end of step FDA to registration

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But question can for first repeat your Sorry. you me?

Data. About data. the

get for we shared important that program, we're sites. with we've is as and going running clear Phase share up to now. the III what mean, that been it's really we've these think, go I Actually, into what we I

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nausea impact and molecules you we've the see a against signal actually indications? seen going the potential 'XXX position clean 'XXX I that When vomiting for data 'XXX. and we guess one And with does how Just Phase that? those look does actually alone, the in that to additional are if xanomeline on I on that quick that way

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to Abrams Markets. move with We'll next RBC Brian Capital

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to wanted to MX. I So go back

expand Sosei seeing expand older bipolar? to study recommendation. like date you're about you younger So see potential indications based think do in the as well? what hope Or would into you indication the on When the schizophrenia, beyond populations to and the safety per population to to DSMB opportunities you profile from the opportunities

be that's on consider nature date, right there read data we we lot opportunities point So the time. Phase of into get at able and a all really I mean, that and now, And from into can the think study. we're focused we quarter data the based are of of II the will I say here, this on out fully. all in And we'll the this I as to really them more. say

to with next Evercore Kasimov We'll move Cory ISI.

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on next There's before. unmet is question innovation the no crinecerfont. in as with to my space a to Eiry decades, need So big in obviously alluded

can could how that with the the centers backdrop, be may you here? to speak market to whether education a not driving gating And excellence be launch? factor So of CAH force or a

of though. Yes, we are be I'll to the second the There question important. centers of many that not think going them, take do are first. Certainly, that excellence

families are and have we to treated launched living ago, we fortunately center on to excellence. in that the for There's population you of endocrinologists. And patients a not initiative so content reaching called as that, our and those may CAH being access with and that, of we're that them, have content a months directed endocrinology make towards And a accessing educational that's the related HCPs has community well CAH just sure and by actually focused few endocrinologists as “What have seen patients families. which majority C@H?!,”

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working validate customers, We're are. involved where to future also these in patients profiling

to ultimately, the launch of a to have set make in crinecerfont approval be when strong end the that a position up good hope do receive, at for And sure we really want to and so year. we're receive, to

next Wedbush. move Laura We'll Chico with to

Much Kevin. congratulations to

wanted definitely to needs I It focus guess market. happen force sales command to I the but guidance in INGREZZA one an a INGREZZA? in seems order investment of the have peak there's for to full here, here. what Obviously, revenue coming provide increasing you on like

that. understand unknowns trying kind of would limiting Just remaining kind of what are that the to be

Laura, expectations for the someday. expectations. provided is peak our with that going medicine a we've I to tremendous perspective, as as, never This will number a question. company patients, be Wall and INGREZZA also think, come market Street's from peak to continues thanks exceed And for But expectations. well large a

the And continued just a XX% foundation, X/X add future. Maybe range, reminder, that, VMATX just getting patients still with of So aren't diagnosed but we it's we here. foundation in of do providing a inhibitor. the aren't potential, practice to we crinecerfont we have into gives trough strong it with peak to to TD. believe, not tardive something really look in medicine have patients the dyskinesia, as of really a that INGREZZA couple conviction us we're long-term behind and a strong a investment the

think that dyskinesia room the here So tardive we have a for bit that there quite opportunity we is alone. in still of

to And this does would conclude for our any like it question-and-answer remarks. I closing back turn session. Kevin to

very like my in should you Thank chair right feel now. Yes. be much. I I rocking

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phase help of best we patients to Neurocrine front the strive The you. and are Thank us. in of

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

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