Neurocrine Biosciences (NBIX) 6 Feb 252024 Q4 Earnings call transcript

Company Profile

Participants

Todd Tushla	executive
Kyle Gano	executive
Matthew Abernethy	executive
Eric Benevich	executive
Eiry Roberts	executive
Philip Nadeau	analyst
Paul Matteis	analyst
Tazeen Ahmad	analyst
Akash Tewari	analyst
Cory Kasimov	analyst
David Amsellem	analyst
Chris Shibutani	analyst
Marc Goodman	analyst
Lee Hung	analyst
Mohit Bansal	analyst
Ashwani Verma	analyst
Sumant Kulkarni	analyst
Myles Minter	analyst
Laura Chico	analyst
Ami Fadia	analyst
Uy Ear	analyst
Leonid Timashev	analyst
Malcolm Hoffman	analyst

Call transcript

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Operator

Good day, everyone, and welcome to today's Neurocrine Biosciences Reports Q4 and Fiscal Year 2024 Earnings Call. [Operator Instructions]

Please note today's call will be recorded, and I will be standing by should you need any assistance.

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

Todd Tushla

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

and Medical me Chief Eric Financial Officer; Gano, are Benevich, Roberts, Officer; Commercial Joining Kyle Chief Executive today Officer. Matt Abernethy, Chief Eiry Chief Officer;

our During actual statements risks subject These forward-looking discussed are the differ may our we materially. our and you to custom in our risk latest to at remarks will is SEC the review filings. and call, will Kyle. we uncertainties, making Q&A statements. be and go results this certain to turn I -- with encourage factors prepared after and try We'll to I'll call get help, over your as to point

Kyle Gano

Good Thanks, afternoon, everyone. Todd.

from research development last commercialization. and the years, evolved several meaningfully enterprise Over to has Neurocrine across entire our

evolution, a demonstrate are stable is biopharmaceutical items coming strong, results positive we build these we this efforts, fully and as own growing. from impacts entered successes. and upon XXXX XXXX integrated from With to excited that Our company our

are a treatment We deliver once shareholders. introducing Eight first on and after capitalize dyskinesia and tardive year-over-year continues patients for continue challenges From opportunities years industry to again perspective, set on achieved the to INGREZZA the to this standard. to and double growth for commercial prepared take year.

has sensitive such unsurpassed and with reflects and the formulation INGREZZA advantages will advantages a profile a for in swallowing focused impaired. all of enable differentiated us patients opportunities on as are on relative as While absence to TD in to highest are novel do efficacy, we the titration, picture to that. Korea certain hepatically XXXX, impact that population, and INGREZZA sprinkle a just potential big rate those guidance patient HD moderated of growth INGREZZA's patients. all-time to our difficulty complex such year, which was perspective, growth our its maximize From continue

quarter, decade. next of to many out to tardive clinically inhibitor. was dyskinesia with the patients XXX,XXX currently enhanced U.S. meet in sales organization, positioned we remain an the now This which XX% who the more our than of for When better ensures differentiated the combined approximately the ability are foundation rolled last help untreated needs with VMATX strong patients the in ever

Just of as INGREZZA transform do for in plexical will adrenal people patients, hyperplasia. anticipate same cronessity living care TD for standard congenital we the with

As medicine specifically reminder, designed developed the a option new and community first over years. in is first CH the for the and XX Genessity patient treatment

believe to not Launching a treatment be we has the but therapy. time, new groundbreaking neurocrine potential is second over Crenesity blockbuster without challenges,

cadence, launch its Looking are will Chinese Frerneste diversity at potential. best-in-class We we and for we medicine long-term in but long-term near- drive sales growth. and profile anticipate growth and to a first-in-class, initially ramp-up to growth patients, for look forward measured be leveraging as confident

Turning sustainable engine areas new In now specifically will become of to productivity research of a modality, expect and the to XXXX, what advanced biologics development. we address and we foundation internal new improved establish ultimately innovation. R&D therapeutic and

broad industry. launch commercial we to this programs enhanced deliver, clinical XX by year which at biopharma will to We the on new the X pipeline a state. every XX year-end alone, from this pipeline Starting represent will stage expect grow productivity robust our will years average, study neuroscience in most anticipate and

end with have of decade disorder which osavepator into in and and initiate a schizophrenia, at drive this the significant and will of the major transform III MDI-XXX both depressive next. programs multiple Neurocrine potential the growth further to we Importantly, Phase year this

leading way is neuroscience becoming As sustained a to well on we with strong this a enter order year in company. a and for its foundation nearline

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

Matthew Abernethy

anticipate MX muscarinic Phase year was tremendous II INGREZZA sales XXXX, positive and at and These In the mean the to the strong growth and range. future midpoint launch INGREZZA of with Thanks, programs, record Neurocrine's billion billion, growth achievements Conesity. for for success. foundation but a not both of for Neurocrine XXXX be a data AMPA sales $XXX of $X.X and $X.X approval least, reflecting the Kyle. we million last for to

While the increased a heading led good we of reflects guidance well as dollar competitive into saw growth ization course XXXX. payers over This trajectory growth, management by XXXX. range to pressure the slower

last X which half well We of address in are force currently with of efforts expansion inhibitor, as have to and year, growth, PMET will patients a expect and who were recent still this, are to including efforts further proactive for not full being beyond. future XX most steps XXXX taking treated notably develop educate we TD as in impact second the sales QX approximately the

Cronecity, although your providing guide, to want few provide do develop models not XXXX. to we an thoughts for you a Turning annual financial as

in the orders our will be pharmacy be patient medicine, novel for blockbuster classic are the December. partner recognize cronesaby. medicine million into initial experience to we as First, additional like -- product; in of factors: trialing from to Cronesity patients disease We QX flow of occur that frequency for a the to One CAH third, $X measured naturally reimbursement expect note on did delayed late due revenues primarily a a rare helping with expected offices; and many timing second, real-world early bottle clinicians new X net in prenet obtain but sales with

To close profile. a investment comments few our on

capital priorities, growth; align to with our our expenses number top our revenue drive one, two, and operating are: programs. allocation continue number advance R&D X which We

the launch investment SG&A behind XXXX Cronesiti and a force. year Our operating expense sales of also expanded INGREZZA reflects the

the increased of fully we investment psychiatry now at Please guide, advancing initiation with X Osavampator our major the programs Neurocrine included reflecting aligns program. Phase into million previous III XXXX in our will $XX we funding $XX the update in achieved, programs. $XX guide of R&D, note milestones our with If Nexera development including OpEx milestones Phase appropriate. for of our for million initiation and R&D, associated future the as development Takeda million are For III other

call Commercial now our Chief to over Benevich, Eric the Eric? With that, hand Officer. I

Eric Benevich

Thanks, of Matt. and transformation important XXXX an commercial for marks our organization. year execution

to we for With the the portfolio. recent of the add launch and important raise standard opportunity community congenital second an commercial Neurocrine's of care hyperplasia the to to adrenal have driver growth CRENESSITY

Before to a sales was gross $XXX approximately further driven in increased highlight that CRENESSITY, insight provide dynamics. strong by growth take net continued I by annual to all-time moment for XXXX want increasing on and record an compliance to I improvement year INGREZZA, million, volume,

them performance, record inhibitors, from highlighted, U.S. with TD foresee VMATX as our being we with treated come. still have suffering opportunity a in ahead years of growth Even than less in substantial the franchise, we with the this XXX,XXX and people INGREZZA for tremendous Matt potential approximately to currently XX%

high in TD address in settings. and education remains unmet the the psychiatry With last care of and our teams high patients. commercial business. and to turnover continue Notably, in to care for year's provider expand growth the Therefore, direct-to-consumer motivate long-term investment diagnose medical force, our efforts, prior health education continued to XXXX provider expect we care Huntington's as psychiatry, years, need neurology, providers care care across disease health ongoing and treat state particularly Korea screen, and in health and segments sales medical long-term to

payer key range contemplates increasingly dynamics. the growth guidance dyskinesia Korea, sales environment factors the of Huntington's complex across and tardive of class $X.X into external VMATX $X.X continuing net like and and INGREZZA XXXX the billion competitive account Our to billion takes

generation differentiated XX and next while product expect to exclusivity, position and the with remaining leader continue develop the XXXX, inhibitors. of Looking beyond to market, in profile, our years talented the INGREZZA's we of we expanded team maintain and as VMATX VMATX

mid-December So the delighted and this now CRENESSITY. in on first-in-class broad disease with were approval medicine. for labeling turning to early FDA and first We the

Following provider FDA CAH than before the family approval of forms and the holidays, came right Even were to start though XX enthusiasm communities. approval, across new there level the exiting significant XXXX. X in weeks full is endocrinology less we pleased patient a patient receive in excitement before

a is plans. medicine, starting As out all a drug as nonformulary health brand-new across CRENESSITY

starting them nonreimbursed in treatment going is majority of expect Quick be launch, will secured. reimbursement on our Start of via initially while program we the Therefore, early the CRENESSITY get to phase patients the prescriptions being dispensed

patient, and to work companies Rare. we with broadly each commercial Ultimately, be product. For Rx, partner, insurance We'll Panther reimbursement to their to process pharmacy team, them together CRENESSITY our our transition expect paying secure specialty driven by reimbursed be or CRENESSITY less majority educate our reach month $XX with per medicine. of patients the breakthrough out will ability on and success with this the to community Long-term of pocket. through CAH

are from INGREZZA our know no shortcuts can some this with markets. building comes There time. it new when to effort We take that experience

receptivity won't happen couldn't have pleased to to All be the said our care in programs living and standard in appointments but about endocrinologists months CRENESSITY exciting CAH of new considerable coming with Our more teams improve all this for field opportunity. excited prospects hyperplasia. to number the of all, the blockbuster the CRENESSITY adrenal next It the of potential. from and people hallmarks community we're educate we the medicine. congenital its We've long a classic on has excited about overnight, with booked

it that, colleague, my Roberts. to with So hand I'll over Eiry now Dr.

Eiry Roberts

development there of could more treatment perhaps just CRENESSITY. good program start final program Thanks, successfully transformed approval no afternoon the the Neurocrine to of approval programs. today, team a is time, just finish. the the reached than and CRENESSITY, of members many joined have for We to process more XXXX, into emblematic over tardive regulatory thanks progress not and who clinical FDA outcome transformation extremely other X significant Eric, different ago, INGREZZA years vastly X I dyskinesia we've made. and pipeline development were for everyone. our Over of organization received has Since with and cross-functional steered to pleased be this proud through the the When from all we and labeling I

has classic to With the for from paradigm that and includes hyperplasia. tolerability adrenal opportunity label efficacy treatment and a data studies congenital CRENESSITY patients with the the pediatric impressive strong registrational adult transform

and first treatment physiologic glucocorticoid for and only and dose of that usually with to the CRENESSITY. this only reduce years floored ACTH control until to with superphysiologic the more patients the the creating available glucocorticoids, classic enables androgens, over approval, patients only lifelong XX patients their For doctors nonsteroidal to for treatment families approach their levels. with doses, CRENESSITY's CRENESSITY CAH high and for approved for to treatment is replacement opportunity was prior fundamentally option at work endocrinologists CAH independent

Since patients data approval, to educational younger from highly in pediatrics, ongoing affairs than towards effort development support our old. been open-label and conducting community, our valuable generate Meanwhile, adults to years engaged generation critical field studies of clinical continues the launch. and have in endocrinology with data work medical the longer-term to extension extensive X programs teams the

of feedback proposition choice. teams health the are our as treatment on great been importing value generating will with data focused important for an groups KOLs of while I effective parallel, we disease are patients advocacy treatment characterize new reiterate needs CAH, CAH. burden outcomes CRENESSITY for from In in the bring patients looking early a option better who and this has with encouraging, to as to

year is this to studies multiple Phase for Turning set programs. our as Neurocrine's in adjunctive III with transform major we also Osavampator, disorder ampotentiato initiate late-stage depressive the treatment to pipeline starting adults. of registrational

in X the months the week, selective treatment II with the half we X studies also for initiate Phase recent the XXX results III give of orthosteric of II agonist molecule NBI to initiate Last first meeting for a registrational the MX Phase The conviction advance will The FDA. schizophrenia, as well our ahead. we successful Phase of in to study from following remaining MDD. this last rapidly the Osavampator and III initiate the of II in of study us Phase studies the year's in announced Phase positive into as end confidence program the studies initiation second mania proof-of-concept Separately, year. will this registrational bipolar of

is this masculine studies collaboration also with expand to as set progressing the dual NBI-XXX, anticipate antagonist year. early-stage for I healthy in which studies. I a Phase into this to MX/MX Xenon acute this Meanwhile, in half earlier several with pipeline our notably, through continues most II second initiated epilepsy, for And initiating NAVX.X/X.X study portfolio advance a agonists, recently we year. a Pharmaceuticals, selective potential dual Phase in The treatment of week. programs with Phase the psychosis volunteer early-stage NBI-XXX

Phase I NBI-XXX of this inhibitor and well. developed VMATX to begin We also as the quarter next-generation internally anticipate study

with progress Chief of and our Officer, Furthermore, our team tremendous peptides Jude molecules, large Onyia and and his Scientific including totes made gene internally portfolio preclinical therapies. have developed

later well neuroscience-focused to they molecules up we've year one very this this industry, we of pipelines in additional for clinic the In these coming broadest closing, built the progress As the tox be in potential first-in-man and through beginning. just believe GLP deepest and what the entries if XXXX. months, and set is us successful, into

call back Kyle. With that, the Kyle? to I'll hand

Kyle Gano

I Operator, take Eiry. questions Thanks, to think we're now. ready

Operator

take [Operator from question Phil Nadeau Instructions] And with TD we'll first our Cowen.

Philip Nadeau

good of new start half of second first on willing any very people year revenue isn't. new we this today. of what investors of start curious expect you in You've a is giving vigorous during XXXX. very did debate guided into half clear trajectory provide We've of what forms through there's year. that of the and measured what also among been was start terms you first a a for you as CRENESSITY half pace I launch should forms to the perspective forms of as to and anticipate the to Neurocrine's this new if

Eric Benevich

Eric. This Yes. Thanks, Phil. is

off, first to gave got a that -- get year last at opportunity us label the we the end late an bit pleased year it with. early And a of great just year. an little broad before and really to last So very obviously, approval work moving

so And So each JPMorgan prior we to We're represents excited good, of good dynamics of on on far, in. providing good the as the I'm with the Treatment forms we're that quarters. turn conference, specifically XX% providers. But CRENESSITY be frankly, at quarter and here. a days, updates those we working more the this the before terms constitutes not I'm And year so the . early feedback I'd year. have said than a just earlier -- from that getting launch launch had ramp. few really what pleased the say dynamics. really about in going comment would come that

Matthew Abernethy

Just over for new first a reminder, XX years. in these this patients is medicine the

Eric everybody adoption wanting far. you incredibly receptivity so think too. curve really know what in other you the look to I And that So is that the that market like. as checks thinking said, Phil, the think would has like, look been -- what it's about might investors I But sense probably strong all and

early but to a launch, going I'm May. share So, victory so and detail we'll yet, good, so far, claim and in not the more we're in

Operator

to next Stifel. Mattis move We'll with Paul

Paul Matteis

The confused is appreciate Can And I have you guys I guidance. the like at given grew upon because I looking than you historically, question. some I'm less driver feel expound guidance. sequentially. you model, XX%. conservative really our guide XX% know

a here to into done this here, of And just quarter? I'm something us end. I high during are VMAT, above great I'm wondering but You've seeing the are opens the is changing what Street of just XXXX? sort think making concerned, job is that you the send trying a if message that is Like going actually given greater you market

Eric Benevich

Yes, I'll Paul. tackle that,

that. proud billion guidance to a as years provide dynamics, And factors to all, to we're the and really of excellent that we're external recently XXXX, historically, to $X.X record payer had such launch, as VMATX prepared reiterate I sales team to XXXX complex amazing going our access steps environment forward. after expanded that want category growth of to order continue we're to taking first of in to competition, about my and terms maximize our including INGREZZA address in billion an and access growth done for reimbursement, increasingly continued So remarks, the really our and of proactive in well customers DTC, we in we've that going $X.X and and reflects mentioned INGREZZA competitive just support their to X it's here the I

and TD inhibitors XX% VMATX a being see growth to of currently exclusivity of with continued expect and beyond. and really expanded differentiated and long treated than runway product talented patients less INGREZZA's profile XXXX strong for we team, With INGREZZA

Kyle Gano

our the dose help XXXX potential, the have year to over on certainly into in starting space, our add in to competitor force more product always about steam differentiation we're QX that But some starting present formulation first believe to being the swallowing growth and with ever in to profile we ability this with growth I new and force the up the just INGREZZA, remains reasons of the in years. VMATX a Maybe longer them us get is hepatic here. think opportunity patient particular, the that we we subsequent over ever with we're for majority and disruption, the this into other the efficacious causes treated but did have, into some having the We more Kyle. we all dose, the those the have time opportunity on expansion pick patients headwinds that sales of tetrabenazine for the certain the difficulty as vast bullish aren't which the that efficacy sales and advantages patients to appreciate in us excited continued still some there being the are inhibitor. to do that populations, and And expansion, moving year, in with with pyramid, expect

Operator

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

Tazeen Ahmad

Mine year? comparing talk about revenue a more I'm XQ for given you per that that prior to could 'XX seasonality. was just should is on also about it Can for year, you to expectations thinking year quarter-on-quarter general we guess this XQ, part decline curious of maybe script I have be the relative on which XXXX, this revenue potentially this expectations INGREZZA. lowered

Eric Benevich

Yes. Thanks, Tazeen.

treatment the dispensing are customers timely plans their course, pharmacies retain a their busy this continuing manner. can't to need ECP our due on challenging year, refills our the and of inter-quarter reauthorize specifics of with And working and the really any I minimize to many patients a executing gaps to patients. the the comment in our is and of But typically, teams So performance. time get to with

earnings payer-related to performance something when of year able quarter these bit each biggest the to co-pay working But contribution it's a on commercial we launch. QX the all that rebate little to call. the for color sets this in. provide over know, kicking QX the we've better be and net more to impact us through each is with course incremental you be And gross agreements of get is As due issues. to at the I'll year typical got QX and

Matthew Abernethy

revenue an year-over-year. what guidance sequentially, moving to similar saw to is net revenue per is embedded script in is So year. around very that to assumption clear, net we which be you going just is QX, XXXX. headwind say into script would Tazeen, be it, that in in this mentioned I our that XXXX there per from call QX X%, But

influence is The on I be The sets eye way at that little don't the how hard for flag itself the other predict but the order, quarter, case to the obviously out itself the just and it calendar noise item causes that net ordering year. end there may so will am a just but we through the in of rest keeping that, of very up largely bit flag I quarter, an patterns. folks that the at obviously, noise, it we of of you would end

be And Neurocrine. wouldn't unique to

So here. moving a of parts lot

and to focus very just for help regard. that our force is get get able patients being generated more remains diagnosis, to our think I new be to hungry in is sales TD

Operator

move to Tewari Akash Jefferies. We'll next with

Akash Tewari

your we implies before team's evolving the guide. that a dynamic need INGREZZA will A person guide split expect X% in Teva's your loss and X% to about then currently CRENESSITY. likely up then INGREZZA on share holding prescribing CRENESSITY. share and to Should And market talked market patients see versus physicians payer quick XX-XX given one OITO, on them between

And new KOL otherwise, has you that actually your done starts see with our dynamic time? do Some how telehealth? how many of are over patient evolving suggested work of

Kyle Gano

I'll over great the doing is INGREZZA brands here. question. couple category. in Maybe overall well What with both growth the seen quite the appears we've past that start years of It are

CRENESSITY that on to forward that market differentiating. profile leader that we quite the think On and piece, with will one. be we have we continue is moving Eric which and on that let what think I we I'll INGREZZA, lead see in the chime is expect

Eric Benevich

indicates think prescribe comfortable work all endocrinologists virtually Yes. are some Certainly, the to up that that treatment there them to are with first or endocrinologists done before or the their going have want we've with majority CRENESSITY. prepared I of are leading to patient accompanying do visit. patient that the CRENESSITY recommend person in that But they remotely launch and an without to see conversation necessarily

with the of a And initiate and more And get more get fact mechanism over comfortable I corresponding. start doctors without think action. totally It's patient experience, given that potentially they it's a then new understandable. time, medication treatment new as to a visit

Operator

next to Evercore. Cory We'll Kasimov move with

Cory Kasimov

free program kind provide can additional traction long you of drug far? CRENESSITY last? if detail payer expect with And thus on Wonder might how feedback you the

Eric Benevich

Yes.

Coming in we get to sure the gate they So formularies get when medicine. It's treatment not launch, put that on a system CRENESSITY of this brand-new yet. prescribed patients on a that can out quickly. is place with make CRENESSITY pretty here any

for each process if is a yet, product get exceptions being people process is to have the ship fast been patient. start plan but them them a prescription In about approved free to order through a we week, get will while to which hasn't secured, reimbursement health So after claim do program, to the every formulary and started go started.

in or X transition And to of months able a is over most free they're early will to the launch, the expectation require before month patients product. possibly goods that reimbursed

able start What the as plans, In product to we're yet. of are it's terms had the that from these is to commercial seeing But free of have on pretty some from get-go. program initially. we feedback on patients goods many early going have had days quickly, prescription right and they've patients expected, the reimbursed claims their been health that,

so estimate I that reimbursed patients confident of from with $XX the that get accessible the to community, majority the we're and will we're pay endocrinologists before, and that less hearing feedback CRENESSITY affordable, it's month. So than pleased we said feedback per make so And our sure and to good. far, CAH really and in from as ability we're

Matthew Abernethy

a win had just an we Corey, example, And even yesterday. great

policy very I One friendly of plans of of require X, with confirmed coverage was being guess, age would the over between being with what CAH. out it a major terms came diagnosed that the in

a plans disease, team is And so the the those really understand job I good the do educating think plans. doing

say But are things X weeks into positive. launch. And we're that only I'd so far,

So a go, to lot still signs very early but positive. are

Operator

will We Piper Amsellem Sandler. move next David to with

David Amsellem

utilization So management to Can what your elaborate in that's you INGREZZA. like? competitors' terms you payers. to does of more And cited that plans? your in behavior related vis-a-vis on payers tie is competitor with how looking positioning getting In on aggressive other words,

Eric Benevich

Yes.

So their paying over high priorities with terms example, of really prescription starting affordability course what really in obviously, time. Neurocrine. up out the . the something high and And management of especially the $XX in were year, utilization month. for evolves than periodically. And And we dispense second access and tighten patients really the for utilization are management, that what to of rates per of done and saw, historically, us like, is that's last pocket might that at half some we've plans less criteria changing of most look that was well PA

and basis. ultimately, so to plans plan-by-plan how that of top need on payer on INGREZZA managing are And stay we a environment

patients. to access a pretty that really have We for maximizing we're make our sophisticated infrastructure sure

a have field have that we should really in sure. good to specialists data We the pharmacy we network say make we all place. have also And utilize reimbursement that I

continue prepared evolve a I drugs. forward, in Payers we terms as of environment. a managing guidance. see specialty it's factor that's to how said that's complex our payer my and in And So going remarks, something to that they're expect in

Operator

Rama We'll Anupam with to JPMorgan. move next

Unknown Analyst

for actually Kono Anupam. is Malcolm This

a of growth from amongst outsized to the levers little of segments? regard segments? you the about INGREZZA X So guidance, X expecting talk with the growth can you Are bit any the

Kyle Gano

generally this still Malcolm, We start continue the from come the Yes, growth I'll is Kyle. to psychiatry segment. see as maybe question.

a portion the we investment years investment see good that and larger in well. of expansion also over couple see or of space. think our the efforts the return business work in being in combination LTC past I with from on and neurology as

But growth think I psychiatry. still opportunity remains the in largely

still best and that of using those of is to frequency different interaction, in the for sales those aspects top different that's TD keeping way the way to where some in involve are headwinds turnover PPs know us. You in of tackle offices telemedicine the well. and Telemedicine through there groups those greater is the mind to breaking force look that at the comes and as having the And through of through

of the So looking in LTC psychiatry, board will overall but in we're the in it neurology. psychiatry, at and terms that growth segments in come across

Operator

Sachs. Chris next to We'll Shibutani move with Goldman

Chris Shibutani

I you. could the operating Thank with Maybe if move side to guidance. expense the equation, particularly of the

of then how several reassessed, over INGREZZA, about the upon you some market thinking about launch? to thinking you about some in the differences, obviously should other INGREZZA Now a think have with be in we a where did confidence of in your the either and more how or that potential down adjust way reinvested up or CRENESSITY's need terms will periods How at what and the current reflecting course has years, with . extensive potential levels. confident are you

Matthew Abernethy

Yes.

it very our that's within and periodic #X of exactly that is sales we've that and think expansion. last clear whether force another where advertising you the of driver was this in to, force money recently, I it's revenue space X those expansion then direct-to-consumer shareholder years referred reassessments growth, sales over more or been INGREZZA value putting the

tremendous the XX%. mid-XX% the in going leverage, SG&A, us last you've show years, the way seen just So from over perspective, the all from an X revenue of low SG&A investment down to

coming little both and see a year It's you this expanded investment bit going to in be sales CRENESSITY the of the So out that that. less force. leverage

is support both in today going change itself brands. look or need we expectation of population. and the when the sitting CRENESSITY we here infrastructure aren't and increase patient a thinking to we're the that of 'XX that beyond, required at and in significant a to But disease nature being rare

as perspective will that's think We quickly. quite extremely you profitable, from expect up be something this But leverage that P&L show XXXX. to about a

Operator

next move Goodman with Partners. to Leerink Marc We'll

Marc Goodman

comments one your for pushing is then the just ordering first helped forward. on to that suggesting inventories describe of that been to you reverse? differentiated guess with from you you're molecule to product have I my change for Can MX/MX, Matt, may Eiry be and it that today. that characteristics talk inventory? the quarter quarter the And patterns, XXX by are the Yes. how market the you about expect you're expecting maybe Did fourth on question really and that's

Matthew Abernethy

and QX Yes, our I'll largely of Tuesday, so And XX pattern phenomenon. on first that have when and a business, September. on that's then for you pop order when setup cover of only look the just nature the Tuesdays The typically, recognized ordering have products our at revenue you quarter, is Tuesdays. a question. up you more in the wholesalers Monday is Really calendar delivered XX

this calendar So in it how of year. I there issue, nets timing the flagged do case nature anything timing the itself We course the falls. just of become of orders that is of the to something out just not it's because noise orders. don't may dictate of around throughout the I an just know but

mention, would So nothing that associated I QX Mark. with

Eiry Roberts

to Mark, that. for question. answer Yes. thanks the Happy

confident with that we completing to that were prerecorded still actually Phase the evaluation to the agonist. profile study pleased schizophrenia that XXXX subjects, and evaluation pharmacology in an As associated pharmacology we can and I in we II Phase I very both in the we we in in said the opportunity molecule our whilst the of with XXX MX for remarks, selective And MX/MX Phase the saw MX. I healthy both MX results are have say

as the to MX such potential cognition through benefit potential in obviously There's add agonist a areas for additional effect. dual

so forward test to the year schizophrenia as And that reason, very half II in in second to take Phase this we're of that keen for molecule study it a well. of

Marc Goodman

there . Are Corona's versus obvious differences drug?

Eiry Roberts

Coruna's Well, a agonist. drug pan is muscarinic

peripheral MX And the the from potential the to only the effects MX added has molecule and hits not in MX. and subtype MX why be MX with side muscarinic And associated MX, reason off-target order also trospium MX, the and so manage that's the to MX Coben but it to effect. other

MX MX would or differences there a hit MX. so MX, MX not do So anticipate and will we be selective for we

into the year, be complete to as see. I talk anticipating about hoping we II study more we're what our when and And able and this later Phase Phase I said, to go we'll

Operator

Morgan Jeff We'll to move Stanley. with next Hung

Lee Hung

from feedback the II dose talk of or you concern meetings . heard Phase response XX-milligram any seen on And you with FCC, the for Can dose? there of benefit mainly was and with the lack ozavamtor for that XXX? end the agency about the by was

Kyle Gano

want you that to do Eiry, take one?

Eiry Roberts

it XXX. were we think And asked of with it, meeting was as both the both Phase registration selection from agency support you defined as of the around for interactions Yes. We support particularly happy got and designed end I those the the program and and for Osavampator we very alignment dose XXX. guidance II of that for of

there forward was Now complete support program. with dose moving the III the XX-milligram for into Phase

alignment endpoints using on we nature and that also registration got the were whole We the plan. the of

we future programs, moving first is are near on III to as the already initiated in very initiating XXX towards we Phase study now our study. well. those acute focus And moving the implement the So right Osavampator

Operator

Brian to Skorney next with Baird. Move We'll

Unknown Analyst

This is on Charlie Moore for Brian.

dual targeting track that's if as from trials it gene we And the cardiac in think were would looking it collaboration well with just therapy gene initiate X ataxia this to stage tissue current just you color human could wondering, So to and how differentiate in great get on still as clinical some first Voyager. Friedreich's therapies, on X about year. be your earlier pipeline

Kyle Gano

that into have question, We've I'll capsids we've that us through Voyager. into this. CNS. to in have have deliver as approach targeted And free gone have We're with that tax free tax our the been tissues. to a IV-administered second-generation patients Eiry opportunity allow collaboration. I'll gene delivers of FA that Maybe here this have fill the and what we cardiovascular excited something part that's so for an gaps as that is working on exciting first program on really the as take several It's system well years therapy the the and we about any

the movement component of disease, a stand-alone cornerstone or treatment. disease, outcomes gene addressed the would either therapy So heart our by symptoms in the be cardiovascular

that. about excited very So

to development We this later program this track are from graduating on year. clinical for preclinical

Operator

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

Mohit Bansal

your quarter if assumes -- the Sorry staying number, straight end here. the If just looks at like of using flat INGREZZA line I guidance for keeping look low fourth fourth I on just line it quarter. it,

in something is dynamic? like seem It does pricing comments. your your changing there massively the or So contracting that from

So help understand us can you that?

part And but seem expansion doesn't here. to force bump, would that second quarter be of half then Because also, the of that second are you guidance mean expecting or sales modeling any -- benefit here?

Matthew Abernethy

Yes.

much the some have contracting clear, but enter On into did the to just that incremental increase. some rebates, pretty it offsets price front, annual we be contracts

little So year-over-year on a price, to flattish, as earlier. pretty from a I mentioned maybe QX, down QX perspective sequential

new including straight-line additions the of a variables to for play lot that understand of discontinuations, math, I much a patient bigger So pace on patient example, there's base. relative at

expect the those nice time force them the sales to we up so bit we to it's speed. mentioned, momentum normal year, for going half but are dynamics. And of to growing with a in And as expansion, take launch of little full have the do to get second

Operator

to next move Verma We'll UBS. with Ash

Ashwani Verma

more just on one So INGREZZA.

do of burden they drugs to more plans? plans in expect the We've D on moving up, see the to And heard because management dollars headwind need lower are Medicare So D Part that make with catastrophic branded going utilization up they XXXX elsewhere. the coverage. have the part you

on If be great. that, that can would you comment

Eric Benevich

Yes.

But are that impact changes potentially thing not we're contribution negotiated of in and certainly, any happening in is out the the the small major don't that XXXX we're a so on terms get with we point and XXXX. phase. just versus manufacturer, to catastrophic phase-in And other medicines what's closely And expect because the in the So any other have significant benefit looking seeing We comment. coverage classes. see been wave those designated a first our we drugs far, I'd shifts. of quick the monitoring of to

as does So our -- competitors.

class. So that VMATX regard that's within advantaged there's . the in one no

Operator

with Sumant Canaccord. next Kulkarni to move We

Sumant Kulkarni

The on another product some INGREZZA. It's one for time has been on now. market the

debate there's But intensify. initial around in trajectory you kind some seem few to that go then around to at to the Your the grow on dyskinesia point comments the growth out And a suggest of still of seems INGREZZA your when we penetration tardive numbers. be quarters by every market. beating way

somewhat, or detail for INGREZZA your might So to in on on any uncertainty offering be help what this you latest sales what's debate U.S.? settle philosophy think peak the potential eventual

Matthew Abernethy

are having models funny. about and XXXX, $XXX year-over-year $XXX close almost of it here original the INGREZZA million billion. now grown market and Yes, $X week in being was sales million were were I this this Kyle earlier peak for we with to talking

with dyskinesia as So as to do give see, out VMATX we're of not with alluded still X what the that's going we of not treated a potential. patients currently being to, Eric we -- has inhibitor. But part peak are XX

significant flows dyskinesia. you've So as for we do process out anticipate market up card and And demand ebbs there. said, there there's in the are development

Some are others like feel clear. But ahead. trajectory growth pretty a to less clear lot do understand of we there's

Kyle Gano

the exceeds unique prevalence that that the of to really at aspects we had we Maybe dyskinesia that, population. rate to continues of part the add growth just grow rate the is one underlying our that discussion the tardive of general is to believe a of

The the is year, rate was above it prescription and general around So antipsychotic market and dynamic. that's the of continues in value $XX growth grow last low population. size the volume getting your number hands to digit million multiples something about that's

number is revisit surprised you us something learn as that last large about we'll in how more of where a ever and But more we market more into situation for on market XX the be have help years why build easily saw And quite we're we and with much annual year, to the late to that we're get be that's us that's our opportunity. how can the So basis. a increase still there ahead it work, continue work prevalence is more it lot and market. thankful to

Operator

next William Blair. Minter We'll with to Myles move

Myles Minter

Maybe one on for XXX. Eiry just back

but adults contemplating for tolerability first You not psychosis. psychosis on indication? the haven't in decision side it adults, the Does Phase that the you're experiencing I still population. as to into your just Alzheimer's Or that maybe mean molecule move prior yet, disease that curious and elderly something to that you're go you completed want seeing that schizophrenia, to to acute is

Eiry Roberts

Yes, happy that. to take

as we that. patient different I setting a into study. have a beyond you the to us obviously, going the which to choice XXX for in as think see MX well. to in well makes continue other psychosis we selective it experience straightforward And generate population respect to acute With we potential indications, very remain open XXX that pretty in adults, with obviously, evaluate initial data, that may indications

Kyle Gano

Miles, pharmacology fortunately, agonist about thing the and and and a outcomes we population that is that look type do to from there's that that think, a us dual see contrast pharmacologies class. the what the interesting still learn have. same as at a The to get to we patient direct you selective I in Mucinex of allow way in can One XXX. this that is Kyle. have too, number have a this lot about discussed compare is a be of we And to molecules target

different everything approach a that here the knowing there's and lot that have mania time. opportunities bipolar like do a the same XXX value, into of . going across molecules So we lot have the dual can't with We schizophrenia. here the of we we and into going that

Operator

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

Laura Chico

I'm trying Any new likely be guess to to sorry, the field to where guidance just I driving respect With force adherence. trying most see or patient back expansion field the biggest commentary wondering there? channel understand expansion, me. one clarification just for increasing to I whether this from XX% the here, guess the and impact relate to felt. you're the to I'm I'm force benefit starts? Is is going

Eric Benevich

expansion Yes. sales our experience A of with to point and the force out couple regards things prior expansions. from I'd

alluded up team and It to your essentially existing their them think When you team expand takes to or earlier. to we them. it some I speed to deploy of speak. First you time hire all, come stride, a for and get so to new

the from majority second we we impact of do of the so expanded year. into go see half the And expect team to the as the

driving our were with primarily team recognition presence and, care. course, the starts. what's of our expanded also They of into increase two able the initiation practices, education. and INGREZZA. terms long-term benefit and diagnosis and of team, in reach our is thing increase patient new lot Second psychiatry The in that driving of They're it's a do in existing areas to we

think And continues increased really as segment be footprint was we in And patient earlier, XXXX. the it fast-growing. back we psychiatry our still Kyle since to, hadn't going to potential I psychiatry is the that largest mentioned recognize and that has

we the So to psychiatry and ultimately, and both we see in do year. our benefit in the expand see the the relatively that expanded teams LTC those especially having half of expect new, are presence, second of to do opportunity brand footprint

Operator

Needham. We move next to Ami Fadia with

Ami Fadia

quick have very I two questions.

missing it Firstly, quite just certainly the like But given follow-up view, all the the conservatism on if all conservative keeping questions you're around prior there? It that's of or other driving in trends. mind a conservative sounds auth guidance. kind increased you seems with regards kind to you're of taking the hurdles this comment if can INGREZZA the something comments if what's around

us forms controlled on trigger prescribing well these to their corticosteroids XX patients? was they some can being color something color of sort Were about were of the where just around very Any not to they be patients current helpful. CRENESSITY, these patient for drug are high And would the with of treatments? or the what kind regards for and give then treated you sort

Kyle Gano

Yes.

the piece, commented we've INGREZZA On previously.

with titration are of once-a-day that also end of we regimen. out type course second front. getting over me. that that out payer complex on there -- something pressures these this our or about here seen on the a after are discount own I expansion Competitive things in the disruption XR saw year medicine our there think of play play excuse of But formulation, also of of their competitive that to year, on talked want in reads we the next force with I sales a thoughts half the there don't the number variables QX competitor XXXX space to that last a We've towards our pressures the XXXX.

that for we a here be factor for able that formulations product that with as on we the play all want think -- we the I disruption out will into don't here But things to differentiated subsequent force headwinds I've on that still and also touched patients have force we efficacy, I already, across XXXX to want to in are and allow out benefit upside sales expansion dividends years. us regimen, will other XXXX. quite do And that caused us lean dosing this that sales in much our And QX, heavily things difficulties. things us that will really, then think as to here this dwell in These but like all start nicely And call on too start will certainly we with that year playing subsequent over these years time. well.

both balance guidance. our of these things terms in we of So

it It's the which year. and this significant growth the in well. still not here growth going see but to ever. seeing years be year suggests, are XXXX, largest was certainly in our was this following we We as large as year as in growth guidance future as

Eric Benevich

Yes.

the terms coming in diversity quickly the sort and seeing just sort the of what of patients. forms in me comment treatment Let of we're on of the

So obviously, we've done work leading up to launch. the

is segment. expectation the Our in adoption earlier probably that or pediatric be will faster

more the see also adoption rapid we'll that expect We excellence. in centers of

TG seeing speak, patients. getting from patients, that forms getting part is what to are on adult small are started clinics. a coming from are treatment of so However, We're community seeing or relatively with size, started. hospitals endocrinologists, pediatric CH early We're sample we in seeing endocrinologists that patients are

board. it's we of really, It's we and before, on we're excited And Matt a lot and the said trajectory reach as to and said, a need about that that early really need yet, that the there's do. the just here. of diverse I very lot So still across as and days to work momentum people

beyond the early really an the with success up second in I had prepared were last that in this that for But in and we invested half teams us for and of fact set year we we well had field year, that education the CSat think approval has CRENESSITY.

Operator

Ear to with Mizuho. move We'll next Uy

Uy Ear

quick on Was quarter sales from guidance guidance growth Does the or the significant QX? one And expansion. from XQ. the questions in to on INGREZZA, on benefits QX the on there assume quickly force So well. volume any as

we're make that. sure Just wanted clear on to

maybe how And think I I price could about after state. just if for thirdly, after -- help us the can, perhaps to post negotiation sales XXXX think you INGREZZA the guess,

Matthew Abernethy

are answer to yes. the think I Yes, questions your

at the the sales included expansion end our Obviously, a pace. contributing it's at guidance quicker high in have of range. force the We range,

the answer And are yes. X so to just that first I your questions would say

as of other what is eyes we're day, focus In post the XXXX, situated our now space keeping in the similarly categories. right us, growing what main Eric what happens to our But regards mentioned, I'm something, with get is out end to that's for INGREZZA. happening looking the TD and at the patients see product opportunity uncertainty, to presence that going take predict, the growing be of of the is ensuring hard There's INGREZZA. TD market, diagnosed a sure we to implementation, whole with whole can lot through to control get IRA but

Operator

We'll Abrams from take Capital our Markets. next RBC with Brian question

Leonid Timashev

Brian. on Joe is This for

beyond dynamics about complexity how that more and over competitive TD to the even the dynamics changes there's XXXX? believe time are dynamics in pretty split, year share will will believe X on and stable anything payer Do related been earlier drive the thinking the has if just I market share the this you changes was So the the launch. competitor market to you after persist? I question wondering

Eric Benevich

Yes.

INGREZZA, XXXX gained said in their growth earlier, the leader yet modified have the out So to share untreated lot is the they But competitor. as And there VMATX headroom currently TD INGREZZA of deter we've with of mentioned formulation of with few VMATX class. as category, and points And rollout XX one might to continue a for a of appear formidable release the undiagnosed inhibitors. is, project I as a we we patients and expect. due for to have always that X with tetrabenazine, in extended

continue to potential terms and growth. in the So we certainly driving near-term INGREZZA long-term bullish that of are of

have and our to it. beyond mentioned a have glad Thinking to to do exclusivity and But patients complex that do environment. Act more payer we're what I'm in I this continue to going it we that and to And XXXX, sure makes do that Inflation to XXXX even year INGREZZA more access with complex. years. coming we that need it's the make Reduction time

Kyle Gano

to been to do as in everyone, we these just have specified have we add think remarks, but maybe I a to small given as that as biotech a exemption it And reminder exemption. our manufacturer small well

in be expect So event price that's our XXXX. And confirmed. observation we negotiation would to

similar So point, to the are years and be how next opportunity seeing other couple Eric's that in products of over learn, products potential as we'll to world prepare all affects at the that categories. CMS in have new adjust negotiated to the and we

Operator

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

Malcolm Hoffman

. ex rights about Seigerman with Takeda commercial beyond wanted Japan the more just to to Hoffman in on decision ask get could worldwide by the forOsavampator and . this decision was MDD decision Or in Malcolm profile alone? agreement Adam for development indications MDD? pursuing you I confidence amend increased this based additional if Is the talk driven in

Kyle Gano

start. Kyle. is I'll This

frankly, of that we're that very excited came about Phase have so the we that II the I and out think Takeda. is data program quite

away As from really a collaboration our squarely we've number several of P&L and expense years, in been classical in kind profile disease of the affected seen Osavampator making of strategic their MDD over move from they psychiatric past there. decisions terms of that them on And a nature the fits Decade their year-to-year basis.

that continue this. territory, still able they both in asset data work like which appreciated have and their where they arrangement an we to involved that be knowing are Japan. in the is towards So developing we this to

a country, efforts came work to continue facility. their take their to the we'll develop Osavampator list compound this of Japan, Japanese there's And forward and of to from together both outside quite able tepotinhare of This R&D out economics. of of bit particular pride there in and

and can. smaller companies. And this as it's us that, allow have think ultimately forward opportunity a as possibly bring We're to a win-win will the move for that quickly we to best more to being able to patients nimble we medicine both company. quickly So

excited. we're So

continue with into We work there, to to team we'll III this and put this our year. Phase look

Operator

any Kyle questions additional that to I there are And like appear time. no this remarks. turn closing it does would for or it further to at now back

Kyle Gano

afternoon. Thank thanks, for everyone, this call you, and the joining

is, going a you see And the of through on on lot remarks year commercial a As we've and growth being and year can here got products, is of does start opening time. throughout here the with company. CRENESSITY it really and our different our And about and to goal our INGREZZA hit XXXX conversation execution number points a a on drive at we've evolution. it diversification our of efforts revenue over

make So we patients it's important on commercial to possible. are as continue and quickly broadly medicines they as to very that sure brought execute and our

supporting involves assets, that's Phase the our successful of process iceberg. that III other schizophrenia, of the and tip MDD just The pipeline. talked respectively. in pieces the are in programs our And We've Osavampator those of in execution NBI-XXX about in those

well of the then quarter. half antibodies and that muscarinic all and and policy gene of portfolio in as we I coming therapy. Phase begins II in span portfolio, the dyskinesia bringing transformation Phase of of III from serial this associated are become in Those schizophrenia And R&D II sustainable of readouts our and in are new this programs the couple Phase real with as things products a adjunctive second the that that peptides, MDD diversified the treatment space with the reality have year. our fun concept starts have We onboard Phase data a

XXXX and the health excited forward into extremely we year. all news move sharing we're course conferences the as So the care about and this meeting throughout of you with at you

Operator

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

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

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