Neurocrine Biosciences (NBIX) 4 Aug 212021 Q2 Earnings call transcript

Company Profile

Participants

Todd Tushla	VP, IR
Kevin Gorman	CEO
Matt Abernethy	CFO
Eiry Roberts	Chief Medical Officer
Eric Benevich	Chief Commercial Officer
Kyle Gano	Chief Business Development and Strategy Officer
Tazeen Ahmad	Bank of America
Phil Nadeau	The Cowen Company
Paul Matteis	Stifel
Brian Abrahams	RBC Capital Markets
Brian Skorney	Baird
Jay Olson	Oppenheimer
Neena Bitritto-Garg	Citi
Anupam Rama	JP Morgan
David Amsellem	Piper Sandler
Chris Shibutani	Goldman Sachs
Charles Duncan	Cantor Fitzgerald
Vamil Divan	Mizuho
Josh Schimmer	Evercore
Myles Minter	William Blair
Danielle Brill	Raymond James
Laura Chico	Wedbush Securities
Eddie Hickman	Guggenheim

Call transcript

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Operator

Good day, everyone, and welcome to today’s Neurocrine Biosciences Reports Second Quarter Results. At this time, all participants are in a listen-only mode. Later, you’ll have the opportunity to ask questions during the question-and-answer session. [Operator Instructions] Please note, this call may be recorded. And I will be standing by, should you need any assistance. pleasure of the Investor my your over now President Vice Relations, is to conference turn to It Todd Tushla. ahead. go Please

Todd Tushla

and Thanks, Chief Gorman, Officer; our and Financial our Officer; you Eric thank Executive Officer; second Benevich, call. afternoon, Roberts, Business our us Gano, Strategy Chief today’s Kyle Good Chief Abernethy, On Kevin our Officer. earnings quarter Officer; our for is Chief call Eiry Development Commercial Matt on our XXXX Chloe. joining and Chief Medical

During then uncertainties, today’s you Gorman. into we in be I’ll discussed review will materially. making this one head forward-looking where subject to to hand statements. are as factors get call, we to actual our yourself differ At call These will latest to Kevin certain and limit so questions may over session, you ask risk we statements risks question, results SEC can point, encourage the many and to filings. question-and-answer I remarks, the prepared possible. our our please as we to After

Kevin Gorman

afternoon, Todd. Good everyone. you, Thank

saw very providers. new you lessening to factors: main utilizing with second our As and We with levels. prescriptions little just A educate to the attribute INGREZZA very from of back QX good bouncing strongly and teams and the quarter medical had good care tools we during this earnings work bit ago, a health two in in QX a of the pandemic marketing our engage sales, release

can well But, I psychiatric where see, than you of telemedicine. psychiatry an -- visits environment in still as adapting are to we are are greater we Now, this. think XX%

this strong for bodes QX QX. exited well we and Now,

do However, headwinds. face we

spread I’m anything worsened the know. not of aware pandemic the Delta several past you all has don’t weeks variant. you with are You in the The telling

-- growth seeing bottom the fundamental to we pockets as I versus to there’s prescriptions. the In to and opportunity Also, remains as while consistent being But, that have starting and X unchanged. this: only strong are help the patients adds new are clinics access has restrict XX that Now, QX, dyskinesia X XX QX out are guideline, years, us. are that more where prior emphasize, QX less anticipate but we are record the term, in Only with of diagnosed, we’ve line those treated growth, to environment do variant not acknowledging out country said four tardive the closing to a unpredictability are is seasonality VMATX of Delta long vaccinated, of inhibitor. is sequential want is with offices more adapted years. short APA and patients now for the term, In this showing that we the and

year, team and INGREZZA, start on beginning epilepsy precision no go over, continues region very by in clinical more resources are substantial on trials the indications our where Europe, X by the invest COVID, into and of the to initiate disorders our all be is psychiatry are rest impacted studies the to year-end. movement approach far nicely. X At pleased all continue late-stage call. medicine Crinecerfont small set in the this Switching clinical in and detail we programs greater a we this U.S. to We to progress will these I’m the our forward year, and track pipeline. of on considering out are of the CAH, mid- of and to moving with This seriously number feat, than various this

colleagues, my turn the I’ll starting So, to Matt. call over with

Matt Abernethy

demand of and sales across reflects medical affair with our million quarter of $XXX million underlying team. second commercial efforts INGREZZA’s $XXX the Kevin. you, Thank dedicated

driven March, our achieved to since last addition force TRx activity. levels, we sales In record quarterly by highest increased performance NRx

INGREZZA impact see visits into keeping pandemic, to Delta variability bumpiness, accounts in commercial near-term greater adapt in both seeing due half long-term a growth to will around seasonal of and by Regardless we close will into restricted and the eye given past we’ll access As the execution, the dynamics. still psychiatry, continue variant current year, normal the we accordingly. expect quarter head continue on growth tempered on near-term telemedicine remains, XX% of COVID recent of driven the some optimism expect our the near quarter country telemedicine We and of second of clinics we we’re Telemedicine the the sequential somewhat growth million, strong and trends for the anticipate in pockets and than third to this of the cases. environment, rise $XX in by be in society. do third

Turning to costs.

contribute make to XXXX. into our of our quarter sales progress in full reflects to we continue investments, We in fully investment more R&D, as advancing will INGREZZA and first programs the DTC, which anticipate P&L we branded

billion the cash, $X.X continue to financial over with our call to now I flexibility in over Roberts, With Eiry Medical hand Chief have strategy. our execute Eiry? the Finally, to will we that, Officer.

Eiry Roberts

valbenazine fully of on Huntington’s program. to of especially to disease, top results a incredible posed example Phase deliver Matt, valbenazine, KINECT-HD line X that pleased I’ll Rochester, for prepared their pandemic. the the franchise and on completing keep enrollment, everyone patients afternoon and face afternoon focused Group the to and to remarks study announce the Study good challenges all at the track of today’s partners the which I’m a at enrolled, on with our now we update thanks by even pipeline in Neurocrine’s families team CTCC, serves and INGREZZA, an my staff, commitment prototypical collaboration call. the to the Huntington on in beginning KINECT-HD, is registrational this our perseverance Neurocrine, and the as Many all year-end. remain investigative Thanks, by to within our in and University

studies, remained clinicians assess and educating impact on TD the through care and on to how has patients inhibitors heavily pharmacology data we year education education. this focused In from on quarter, focus the dyskinesia second TD. of medical on telemedicine, of recognize differentiated in our effectively on INGREZZA, on and VMATX the For several further partners tardive presented

the Clinical of Journal award in Psychopharmacology pharmacoepidemiology. paper Balter the our awarded B. with RE-KINECT addition, Mitchell In

the techniques the impact importance the that document dyskinesia editors in pleased by settings. practice and real-world We’re study tardive RE-KINECT recognize of assessment outpatient presence of seeking using to innovative the in

the study pressing been in epidemiologic extensively conducted routine of the study clinical extent the largest such team of and and clinicians tardive this partners Although of study. studied dyskinesia patients experience caregivers public RE-KINECT education dyskinesia field RE-KINECT from external to this patients, Neurocrine need generation all have our Thank data TD. to in burden to trials, and the the to support inform and in program our remains by health ongoing you contributed practice. the there data has date and at with analysis who a from and continues ongoing to understand controlled tardive remains The suffering

year. today, are with for indication this investigating registrational addition, announced of the each the indications potential intent two we valbenazine new before In end we initiate studies to for

functional potential schizophrenia. experienced inadequate study The of first psychiatry Antipsychotic schizophrenia. and limitations with are will to the by the for often symptoms treatment program valbenazine alone adjunctive as individuals a therapy all medications address in

experience treat In need significant which living to creates their symptoms addition, people therapy for of debilitating about a adjunctive relapse of take in symptoms, with medications these psychotic XX% effective schizophrenia who psychosis. antipsychotic

early affecting patients X palsy those to motor multiple program to into cerebral low off about study end in no potential second presents up taking cerebral disability due cause as currently childhood, with medications rates unwanted palsy. the label Cerebral children, adulthood in and neurology will in for treatment Many and with U.S. is but approved affects approximately There valbenazine palsy in XX% a persists cerebral efficacy of and due palsy. are The side palsy. dyskinesia for common cerebral children dyskinetic effects. the treatment X,XXX most of Dyskinesia

New needed therapies population. therefore this are in significantly patient

So, now? database a in VMATX that tardive selective mechanism together why highly with action inhibitor treated with a exists profile, with valbenazine’s why the patients combination these indications provide of We unable as these The both of coupled positive regarding details, safety in have many other of questions a clinical extensive reason INGREZZA, collective generated investment pharmacological with differentiated with dyskinesia now. right indications. may and to the of address which we’re field, you in design compelling anecdotal know new and study evidence for

portfolio. progress However, portfolio. The later is clinicaltrials.gov I’m forward team’s you, information R&D to with of steady this this classical supporting proud year. are of with more our for currently and adult the steadily across trials, comment team hyperplasia. the newer and briefly I’m pleased the to we I’ll also expanding enrollment clinical portfolio approximately look the studies the sharing initiation in remainder Neurocrine work XX pediatric once our of post closing, in crinecerfont on making of studies of the ongoing including programs. adrenal congenital In treatment these a study year we

we in track initiate data back I’ll to that, over readouts the X and in mid which beyond. to remain of studies turn Importantly, course important XXXX, late-stage to With to on turn lead will things you, XXXX Kevin.

Kevin Gorman

much, Thank you and very Matt. and guys, Eiry

to prepared open our I’d operator, point, for So, like done at we’re it And remarks. up this with questions.

Operator

our of And Bank question from Please first Instructions] take go Tazeen we from ahead. [Operator will America. Ahmad

Tazeen Ahmad

of could We quarter. Thanks We knew was a for it. so much a great taking matter my it and time. Good afternoon. question, just Okay. congratulations you on knew do

relates you about would visits was pitching clarify, on back Thanks. So, changes related these in-person or been commented as draw on that, can to that just in-person? see of virtually dynamics, on versus more that your to can to XQ, the you’d more to ability you and did in great. to seeing, Delta, based you based talking clarify, it doctors results If you you what decreasing Kevin, be might impact going about more the the actually are be adopting

Kevin Gorman

appreciate I the Tazeen. Thanks, question. Yes.

of on to than to put say quickly. going I’m So, just it kind Eric, over other

case said while in-person. neurologists, different call movement -- of But, the As psychiatrists of we where it remarks, psychiatric the telemedicine, telemedicine, -- opening through still during XX% a be offices continues disorder in are XX% are more about in up they virtually They’re I practices specialists QX. their from visits the on. are the to XXX% opened

Eric, could healthcare if psychiatrist the been But, asking was was And the you answer other you’ve access opposite, what about, than on available not to color for that? more so, professionals more there. there

Eric Benevich

Hi, Yes. Tazeen.

a there. little it’s think described bit everything, what of I you

see the course practices, a people. these of access throughout their of of exiting course, up were QX, of Over the shift. a bit so in-person, opening more of our more QX patients to seeing practices we and of more did we’re that and allowing And

then, these coronavirus, starting a mentioned as with we to have imposed, including recently, more of and remarks, some into is restrictions the there some we it’s prepared of in clinics all in-person. customers wherever areas So, pockets be new things. in our some the patients combination the coming seen our surge And the in ability country, on restrictions on restrictions see to recent

this very So, are carefully. the story we’re part QX. But conditions certainly, our monitoring ground on improving performance in of in terms of the

Todd Tushla

let’s take next question. Chloe, the

Operator

Phil next and with We’ll Nadeau Cowen to move go Please The Company. ahead.

Phil Nadeau

for taking Thanks my Yes. question.

my productive Tazeen’s a This me a to Let kind congratulations quarter. question. actually of follow-on add on is

the of volumes for On overall psychiatrists And as you in of based reiterated, never believe, the also volumes was above the where of XXX% last reasonable XX% time around, on in quarterly in-person for math past? last And you volumes of kind too sounds once then, low. questions are in normal. XX% it from XX% visits. level And level quarter, in-person they? stand It do the total think call, normal? in those ultimately if back are to Have off, this recovered future. COVID’s you where of seems then, we’ll two will so, Where were in XX% normal. does they that, far get telemedicine It in to telemedicine I part mentioned psychiatrists? today that of the visits But, visits is, think

us? is So, where do you behind think once COVID to, could ultimately go that number

Kevin Gorman

bit of a ball question. Yes. a of Phil, the for type question, crystal thanks

reimbursement and end how of place CMS for think, takes towards calls. going the telemedicine of be the will is it tell that I with to about year a versus us in-person lot -- determined

the was point, give volume pre-pandemic. can this You’re It’s it would you never settles and XX% to what it I is -- that your are never best about and total right. going going guess out, whether between Eric, patients where go XX% range it’s it’s to be talk you. like in views? Where somewhere to back of to at

Eric Benevich

Yes.

the which the tardive volume most it was played public patients perspective it total of from to are visits which were and telemedicine the whether So, to in recognize certainly, there’s the policy used. some there in once we’ve still a through in visits past said, represent, about patients. relates very emergency on happening like are to role, of as a there Where that half important hasn’t the months and And that bounced face-to-face, reimbursement, last below is psychiatry visit. new a But, where visit have that recent pandemic, we Certainly, and some certainly, remains especially a an especially diagnosing total of in of we especially levels. that telemedicine virtual disorder are also is waivers back that we it’s should public to ultimately, ends health as over a pre-pandemic to to lifted, or pandemic seen, recognizing providers. that get year lot forward. it old, challenges And a Based response allowing the the limits be can data of be terms what pre-pandemic. telemedicine conversation dyskinesia, And has carry of up enacted still declaration it movement early reimbursed are the appears it seen. should we and still pandemic for it it recognize couple the access

not and Kevin proportion described that the Matt here to Likely, sake, no, virtual visits or to we is going I expects adapt it’s the neurology, proportion to are to the we But of environment, think a comparison’s telehealth and time. what that evolve. also that said that. in pre-pandemic. testament what decrease total going things QX don’t and to telehealth But, are in will are to think as was to that I close back it was to to, but as over But that fair has the bit continue anyone of gone go for psychiatry So, recognize close pre-pandemic. visits down continue results it we exactly, said, for

versus meaningful a telehealth there’s the expect neurology utilize has So, degree difference, telehealth think, of forward. psychiatry which going terms in I embraced continues to to to and

initiation less us is recognize be So, successful away. It for important not might but in variable going for make for and growing accurate treatment it’s TD many INGREZZA future. as recognition be with continue as franchise to this as possible, us, helping ultimately we and to our the an in and But, diagnosis patients and customers. INGREZZA we ECT need straightforward to possible our of as

Operator

And Stifel. Matteis we’ll move next to Paul with Please go ahead.

Paul Matteis

as for Great. a congrats cadence quarter big question. prior XQs, add like looks the And second this taking Thanks so the have to much where let me ask years’ I as quick year? elevated wanted about there Thanks. It net follow-up. didn’t that? well. price question this same And is one price. we XQ my have Is you one that? to of And of kind anything to Should have then, improvement whole after expect contracting the there dynamic. gross to net I remain the anything behind rest net throughout

Kevin Gorman

ahead, Go Matt.

Matt Abernethy

to Yes, from did a we years you step like you. nice from the back previous not Paul, have hear see up, in price net Hey Yes. perspective.

around of period however, some for walked something would of see up, of donut typically to What you the the similar our access the stick to $X,XXX investments in to out mix the that bit gross expect a did that likely us I’d we’ve that some to would rest for that the made we the and also said skew on price and say some through Where what the should You past Medicaid. the hole $X,XXX net you reflects year be side is is with net towards TRx. exposure per of is we elevated see heavier then in that I really step that I’ve guide QX. walk as patient time, with

Paul Matteis

is that, setbacks, then, I if quickly, of A And had need transactions on or your risk opportunity for comment forward? business neuro. to I have you’ve of of you great. which Okay, of sort you development. backfill kind some guess, on done obviously ask And best for to But wanted the see your few just norm appetite Thanks. the where what’s the pipeline? could context taking the in do going

Kevin Gorman

Kyle, ahead. go Thanks, Paul.

Kyle Gano

Paul. the Thanks Yes. question, for Yes.

think first too. to looking here you’ve this the the we’re I needs of so afternoon that pipeline, at So, what looking heard support and at, a in is call our new on with the both commercially from is priority, also INGREZZA, that pipeline perspective then indications developing the

end, And be at development-wise. well as haven’t deals you active looking pipeline a to it to seen building programs come Beyond up any being into recently. that’s going there, go internally-driven that to business that, as is we although from research clinic the active to continue

different us continue it’s opportunities late-stage look that looking time. neuropsychiatry and and risk neuroendocrinology. psychiatry, review neurology that assets. to term aware to to the and we’re know programs be We to with of in types an in the most like have are in see technologies that I primarily we augment of a And to and we in interest that space that may lot in to things But, might in always near companies we terms help as area over programs our fill. neurology, would of add what it’s for, play mid- looking

and are turned we where at years. the coming the as here’s to look those mature in like So, see pipeline cards look over adding these as what programs they

for we’ve epilepsy to take-home searching Xenon for at development. science look that, look that programs have we Idorsia at technologies, with the or innovative platform states for that and is this the programs us seen our multiple as franchise help again programs So, have driving disease opportunity in

Kevin Gorman

we add team so to for internal our programs, to we it obviously, only the property look and that whatever with invest strong going thing in, very intellectual be able just we’re the position, his can years. And as -- that, over in bring is Kyle I would

Operator

And go we’ll Markets. next to move ahead. Capital with RBC Brian Abrahams Please

Brian Abrahams

the indications to you’re was for about I new hear pursuing interested valbenazine.

study, So, I or there additional rationale confirm about. additional curious speak a maybe and the bit formalized your be was at those you if guided guess, Thanks. investigator may IP small decision? hear data Is any INGREZZA. of with the And protection I’d additional more studies any, collection mechanistic -- for those there in indications any those wondering could little about to I settings, that data investigator

Kevin Gorman

Eiry?

Eiry Roberts

of obviously to the Brian. of inhibition, to mechanism the Yes. safety obviously the as itself Well, in ATS movement database mechanism I of been of cerebral antidopaminergic in potentially to to therapies. and that Thanks, used by to valbenazine, as terms always the the use that, we of for the schizophrenia, palsy in extensive obviously, treatment context a that in have to interested well tardive mechanism context think tardive currently being in VMATX lends we’ve other speak that I really, in akin INBREZZA And we we’re would disorder, in that addition adjunct also say the both, encouraged And effect dyskinesia dyskinesia. movement program then, disorders. somewhat dyskinetic

directly know in Beyond the about into data talked And we actually registration-based signals or that interpret. moving to that, the that are And smaller lead is we can that to studies in that particular reason haven’t that are difficult for we studies. schizophrenia we have hand studies.

this program the point test in reason at for and time. And into hypothesis so, fully, going this want registrational that’s we this clearly to

Kevin Gorman

Orange point, And that Book patents XX listed. about we Brian, at this I have, will say

I from appropriately we’re an covered. think, intellectual property So, position,

Operator

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

Brian Skorney

anyway. guess, indications what and want want in too, of nice jump guys, disclose lot be you’re don’t would a of begin trials of just I the could -- kind of a what I the schizophrenics with. INGREZZA is on are of and of bit, an But, lot of technically you with lot so think either guess, question test therapy I patients Hey. understand Good of these just want considered kind it kind a off to a adjunctive to A here of clinical INGREZZA, with afternoon, until I Brian’s to evaluating that posted. to really commercial might commercial I experience of sort aren’t effectively quarter. have I experience think congrats little --

dyskinesia seemed I you see guess, like patients a benefit be the over that powering beyond rebound if would could drug characterize antidyskinetic what movement at terms certainly of sort of in of on I’m symptoms, commercial time and who study? getting and just hard some It a for see hearing discuss in in might any that sort of So, as benefits maybe to you’re providers that benefits of but all socialization a have just wondering from you designing positive a And additional applied patients kind the you negative you symptoms? aren’t experience, exhibiting disorders. maybe the

of how sort any on So, a schizophrenia kind to the reads commercial indication? of that comment and experience

Kevin Gorman

said that. to because Yes. or these And cut anecdotal mislead done lesson feedback, X feedback. It ambiguous in that things here We’ve sites our embarked into explore Eiry of really decision mechanistic a Phase you one these It’s as I really if anecdotal where we that single get from this. anecdotal like want clinical but been of or indications go these feedback have have aspect you. we is small study anecdotal is to more get as on just that drives on we Tourette, what you our studies information is into can both think at will, learned that answer indications. clear the

study good. two said, answer into. that mechanistic underpinnings going clinical you And is explore do the to give to go into out very these good, well you new So, thought Eiry as indications unambiguous of as

that? do to And truly any more there. us what want so, that is draws in add Eiry, you to

Eiry Roberts

studies very Kevin. Phase and schizophrenic smaller information. I in of needing I have your tolerability to it safety data for already one safety generate X reasons is that is mean, face other to point, we or said that, individuals. tolerability of only in the lot And obviously, think there Brian, a you thing is maybe add of well, the the think, I’d I So, doing

those us well-powered of into gives confidence to And well-designed, programs. being a able so, X go in Phase that level

Operator

Olson Please go next we’ll And Jay Oppenheimer. ahead. take our from question with

Jay Olson

Thanks trials, Yes. the might you And Hi. continue seeing to be those on potential comment just maybe spontaneous new on you time for about new you use questions. you submit Thank taking of that indications, registrational going to talk indications? new initiating in you. the maybe And, the line any theme maybe would regulatory non-promoted could could since are those you to the indications? for be expect potentially filings

Kevin Gorman

Yes.

half On going early that, of say be. the it’s to to Jay, too second what the are time lines

say As studies, get always, we let into us going. let’s enrollment the get

we we As uptake intelligent look like time a then give about have going for good an enrollment, to what answer these. in can exactly are you lines the

for not the any adults we stay So, any other tardive dyskinesia, in anything we anything use of INGREZZA other with tuned other when in again, in in manner dyskinesia. -- And don’t than to tardive support company, that. this promote do than

on we don’t lot would data, and So, anecdotal is anecdotal a that at all. put data whole I only again, that reiterate

likely mechanism be So, again, I just the VMATX that. involved reiterate states. Mechanistically, looks to disease these in

that’s so, to them. going why explore in And use INGREZZA of the we’re

Operator

go Neena question next with Citi. our take we’ll Please And Bitritto-Garg from ahead.

Neena Bitritto-Garg

my Hey, guys. on the Thanks taking Congrats earnings. for question.

are following of around lot on patients who given of I guess, schizophrenia, the question around kind dyskinesia a schizophrenia. commercial to help tardive an kind therapy through in questioning just of indication? this indications, Brian’s the versus Thanks. already INGREZZA kind us current line today walk again schizophrenia potential kind on of about the may just of of So, earlier new just kind have that of think differentiated you adjunctive should how as Can us we

Kevin Gorman

now into embarking adjunctive study treatment differentiation, as a a again, ahead about getting talking we’re Well, of as We far the are bit schizophrenia. on of just ourselves.

well-known through a cycle and of known is it schizophrenic -- patients So, patients number antipsychotics. different that

And signaling. order all you in in know, inhibit in of that postsynaptically the decrease to clear that’s choice, dopamine different is available amount work mechanisms. more as more And order need so, INGREZZA the synapse. it’s need working you dopamine to you presynaptically Antipsychotics

here. going we that’s And for so, are what

would a and completely translate would Eric product, that and to how anything if I As more. order differentiated far for the one. Eiry as know different into to need how INGREZZA between add profiles you There’s safety say that be in will tolerability antipsychotics exactly data to want don’t able differentiate.

Eiry Roberts

Well, of I make comments, couple a Kevin. just would

the obviously first thing is currently schizophrenia. approved treatment there I no that for think, is adjunctive

from not the response unmet point, of significant. their suffering do of available schizophrenia terms to and get your living symptoms is there need with treatments. so, And psychosis a schizophrenia full significant in very to a proportion patients Also, currently

And that’s so, in we and to keen and rationale in the articulated, think described this to registrational to that test mechanistic able given were be mind going I with a why very study. hypothesis that Kevin

Operator

And we’ll take our JP ahead. Morgan. Please with go next question from Anupam Rama

Anupam Rama

a gave here Delta seasonality were range where here of and inflecting you where Thanks to us were the scripts with of the by and a guidance lot some directional of a guys. kind land bit comfortable. moving was going question, there XQ have taking you for with variant. Matt, a INGREZZA and And thought -- of Hey, moving we the call, you and little on congrats on of a -- offset XQ then parts some lot again, XQ lot and quarter. on the parts, call, there were

Thanks more might comfortable any keep any So, to be little on XQ that? and with you us so giving anything like wild directional you’re thinking numbers possibility going a just much. bit or how about guidance

Matt Abernethy

momentum Yes. QX. we to did shed nice of some remarks that’s pretty to today in would specific tried July, expect. We see actually be exiting and thus as what No, continued And we to happy most far. color. our through prepared And

access up variant the So, we’re very around and encouraged limit has the by stepped the what we’ve starting that’s acknowledge to over seen last we certain thus regions several far, also Delta but country. weeks, in

look is around where look how sequentially, is a based XXXX INGREZZA numbers, our QX. sequential there at and $XX in then that Q we XXXX, we’re back us history, So, when increase what over have puts upon around million in performed has we somewhere for what anticipating

coming the quite chosen in more why step-up in just quarter, to that’s a so, regarding give with But personally, did QX, bit for you the me, growth to said, moving I parts, specific in QX was QX. to in and QX. Anupam, And see the regarding we’ve QX we like all like guide encouraged

our the out, going the confirm there’s I opportunity significant a more the sales helps and patients. us ahead engaging that side, on market NRx TD paint of and and really many responsiveness for developing of helping Just it promotional picture force seeing think with the the customers response

Operator

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

David Amsellem

Thanks. Hey.

your to INGREZZA. thoughts wanted switch about on exclusivity for and ask gears just I So, the runway

against, get four litigation New Jersey, it’s there? your case into filers, and in wanted thought in anything You in ANDA process and also if there’s recently litigation Delaware on believe, read one I to initiating can then, initiated aware of runway? or general, And pike? down just extensions any about talk And be secondly, that that’s Thank how exclusivity you you’re coming in overall the about term thinking should we restoration you. to patent

Kevin Gorman

that. for Thanks Yes.

generic strong also a our normal confident position. a those We a These ANDA of file very business. defending feel have then We very and is course having business in course manufacturers patent just days, of it. is normal

patents a Book. said bit in Orange the we XX I little earlier, As have

confident exclusivity And so, we in have a that very long runway with we’re INGREZZA. of

can even patents future. And extend well the into of these that some runway,

of it to comment because business is but going pharmaceuticals these detail, We are litigation, more is course in normal it just not the ongoing in days. any

Operator

Chris next move ahead. go to We’ll Goldman Sachs. Please Shibutani with

Chris Shibutani

Great. you for the questions. Thank

as to about XXXX? we of arc that of at what invest you your that’s campaigns. think DTC were think your the are what metrics plans we if effectiveness quarter, you’re going about the direct-to-consumer, kind level And we having? for how your talk in how to of it, During announced of to sustain investment, last about particularly determining kind should look Can you long

Kevin Gorman

Eric, that? you don’t why take

Eric Benevich

Yes, for question. happy And thanks, the to. Chris,

brand we call may which launched early it’s days, what So, DTC through with we’re -- that campaign, effectively Spotlight, recall the terms the was far, very yet mid-May, did the you pleased we’re thus indicators. in Spotlight of leading about And in seeing TD so quarter. halfway

website, views, spending like after at information visitors example, or has better traffic this things expected. receive based the downloading look all to way And what the that cases, for tested. look content, of perhaps ad certainly, in campaign, amount are we those immediately page on. the line high so it registering that the are for at have So, indicators than We especially And of the in with time we on to number some run. we we and at the expectations of on look website,

So, disease very are that in to we good majority have of said the feel improved intend haven’t DTC. received both an TD out an X is to for fact diagnosed. patients a XX certainly, be this haven’t option to we treatment that invest direction suffer diagnosis, about vast area We with TD the abnormal this movements. where that that the from the in feel explanation we’re with educate past Certainly, TD heading. yet there’s like people the received And INGREZZA. their about we and of ad people continue campaign,

see ad to XXXX, towards we’ll that next So, end and we as year ‘XX, expect get that in in would progress and importantly, we start more ask specifically year, pronounced through terms of a number tangible benefit the the and more more the about times, to provider, of motivated patients having in and campaign for talk seen and from the to their ad TD INGREZZA. been activated of a

So, to patients -- we’ll benefit continue going our in to DTC, it’s franchise. because benefit think that INGREZZA and we to going it’s invest

Matt Abernethy

question into And of to, on this not to the we XXXX, is just Matt. Eric I’ll as out of as the development where given diagnosed chime is that XX X look at point. being alluded market the in the as this investment

half see continuing up if you more our results seeing in showing be we’ll the we the later success that But, to it something looking future. next performance through would first keep year be XXXX. foreseeable of for fully ultimate sales expect likely would this apprised. and we’re And the You would forward we year, into

Operator

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

Charles Duncan

chorea. you how part Hi. Huntington back luvadaxistat enable I question, you you a year. Okay. on second win X Kevin study I is of on you. do more that the And especially has to team, year, guess, Thank parts. Huntington, good wanted had CIAS And to quarter. but candidate the if is positive half rationale, wondering, that’s are challenges a this X. in in at wondering filing given color it heterogeneity? the looking in an starting about part two -- allosteric about little I study one’s I’m actually relative sNDA to, first relative a a congrats for And mechanistic pipeline feel a to modulation? could year? part asked No And and the I’m And Thanks. MX that going patient valbenazine. could the start say, provide next

Kevin Gorman

then let any I’ll Eiry, you if on by questions further So, Charles. the have comments Kyle, and

Eiry Roberts

absolutely. Yes,

for thanks that. So,

rationale data, are Firstly, luvadaxistat as the on the biological the back It question. in pretty mean, both, goes the behavioral inhibitor, also of preclinical to DAAO the cognitive neuro associated to actually schizophrenia. the associated developmental mechanism with strong. itself, for potential treating actually the schizophrenia a schizophrenia is think, that I with impairment luvadaxistat supporting issues mechanistic I

endpoint mean, our study, And to a schizophrenia. we the INTERACT saw of the of although we in saw X not signal pretty the Phase addition for so, both, against it I assessment impact in in assessment primary was cognitive functional that, cognition and impressive the the study,

that so, X of in and fully the being well-powered study by X that, we Phase year. Phase hypothesis study. test this And keen of And very we’re stages of in with prepped that and rationale to track designed, the and well-designed that to is a all actually end on hand, currently final study in were start

that’s in of quite in mechanisms supports in our just share are With be the you associated in several in think are to schizophrenia. of that I changes believe the HD, But the the a about with luvadaxistat that may accommodate rationale we potential respect regard, muscarinic potential treating COVID we part the with there to mechanisms what think challenges actually, wanted the symptoms. I made actually course those so, role I’d pandemic. -- I valuable strongly factors we to symptoms that including luvadaxistat. that say Obviously, cognitive other or And treating negative trial,

I of actually more in those of assessments a that is very in were we telemedicine a support that in confident actually type generated environment so, And set extensive program. anything changes have HD the the have don’t of on to obviously, very to track that and, study And completement Kyle, were of enrollment with deliver data pleased that there? end context very program. data add we the know were We for made to you KINECT if by the of year.

Kyle Gano

I occupancy. the compound majority luvadaxistat. their engagement pathway NDA that compound here to add and symptoms. potentiate relevance think, I on behaved some that interesting now the ours we you like is and there covered target it’s things have nice would field going And and on an like on work negative well and molecules in the just that a understand that’s

that we’re Phase So, next mechanism trial into a drilling really of the state step envisioning. the as the X disease for just we’re

Operator

And with Mizuho. Please next go ahead. we’ll to Vamil Divan move

Vamil Divan

So, maybe new on the development. indications questions just for and valbenazine business question following earlier up the the on also some of on

as it of in product that line be may number a beyond and a did more maybe now So, two, or investing you extensions, external and past there valbenazine the a a feels in just little highlighting HD. year little like deals bit shift, the of TD a pipeline in

opposed it does of future, attractive in BD later so, why now if is if what that signal maybe less indications on from way to in wondering based maybe a I’m a been perspective. opportunities or two And these the as at shift. you’ve sort natural or previously So, external any intentional looking

Thanks. insight would further there any helpful. So, be

Kevin Gorman

no, that is and be Vamil, mechanism. appreciate all. The on it spent could at not said best I very any same next remains quite some and time our I the been has of there No, INGREZZA for say shift the Yes. always use question. capital the would But we -- dollar now. VMATX

here. us you what see doing that’s So,

we world-class I is some add in want research, using here, invest you We externally. believe and pipeline. here internal exactly invest also in The to a more what build looking do internal we’re resources. And our also and external doing goal that’s then, internal to Kyle, resources, to that?

Kyle Gano

to a just Kevin on some mentioned. interest about There was clarify the of previously. points good touch our that And wanted BD Yes. and question

led functioning relates we’ve It more our in had and augment get of That’s there was a as in medicine. INGREZZA. our is of where program I or some in the couple and we in what longer a across epilepsy could disorders to and to our disease states, building and complements programs interest our what to our time. there, of less always it to neurology valbenazine things go over ATS terms Firstly, of see interest if areas could sequencing the how to initially vision psychiatry, with may support business states efforts collaboration And do out, you endocrinology. there of these at you movement years And the roll that interest that’s everything work, and portfolio out see then past our disease into require data then, neurology, with the look to us of programs. to in Takeda And of us pivoting states precision the be led trying able psychiatry and had think first the to in exactly terms and what’s move support interest to we’re there. disease DCP additional those development that of good and

that see here companies of team with think you’ll forward, done other and in been capabilities our looking bring much and we moving work and that innovative the I science, leverage technology, that’s same programs So, by at resources. our can

Operator

Please And we’ll move Evercore. ahead. to next Josh Schimmer go with

Josh Schimmer

moving to treatment about be formulation? brand about separate into of How thinking point an think for schizophrenia you tardive are adjunct kind under the Would approach you you the for Thank current price application how reconciling compared thinking the managing about are As separate a dyskinesia? you. antipsychotic for that? of a likely or INGREZZA, that

Kevin Gorman

indications just exploring would I are that new valbenazine. what we again, is say these Josh, for Yes. two

would And there, going and be like so, be too look clinical talk to pricing to benefit of is differentiation, it’s premature any these it’s to in about and such too what things early able what ultimate therefore, as indications.

So, that question. I -- let’s would hold

very indications by led further of unmet there, also large exploration We is need. science we by diverse in neuropsychiatry. something much that covers the and the led keep we’re until have these. actually neuroscience, It that and Let’s medical neuroendocrinology that along pipeline and here go a into

we multiple that taking the underserved shots completely schizophrenia in are in us population they see you so, And there. feel because

will and other that. make -- of based bringing are So, try the patients. And we decisions to to the the it as value our is intent we on medicine, we’ll to see patients, serve what we then,

Operator

And Myles William Please ahead. go take we’ll Minter our question Blair. next from with

Myles Minter

don’t the about think Congrats quarter. so, ONGENTYS I guys. maybe anyone I will. has yet, Hey, on asked

there investing the granular more was more in color with that mentioned whole on there INGREZZA can you interest if that more expertise telemedicine, what specific in there? commercial in is bolster that. little aspects Wondering here? You during also, the quarter. are Any whole be great. metrics would Thanks. you is sort the And you specific, that a or that a bit of get think to make bringing the looking pickup And

Kevin Gorman

Eric, why handle don’t you this?

Eric Benevich

many inhibitor inhibition. of I Yes, COMT U.S. happy customers, process. neurology still to the very ONGENTYS, And to that first medicine reintroducing once-a-day And COMT them introducing This O C to. in this the is or it’s essentially there of reaching versus them HCP T With that idea to to M we and we’re the our heartened new see regards QX improvement have QX. were launch certainly, reinforce still was in early to the in

the in neurology getting have has been positive started the in providers so, that And from to this very that their utilize first feedback we’re patients.

many which what In providers treatment the maybe it said potent their surprising in thing patients, a of fact, have me how strong seeing that exceeded hear. effect in they’re expectations these great it is is terms one for of that elements is, a to

to agonist, are or of when alternative for providers levodopa. potentially execute disorder disease launch, option consider dose to a into in these early of going we’re especially we’re encouraging dopamine adjunctive Right provider on were the that should and using their well patients the movement inhibitors ONGENTYS say, And third using continuing about to certainly a introducing increasing our COMT as many continuing think as this and plan, an a line treatments. I it the So, providers or essentially having treatment paradigm. neurologists to as -- a general about patient provider now, ONGENTYS to to encourage against treat neurologists conversation Parkinson’s earlier,

are investments we’re and progress in good feel for regards making. with yes, we’re opportunity then, the to good seeing we’re related there progress certainly, And INGREZZA. the primarily that TD making that the to So, about the telehealth telehealth,

that part, less do the And to use of we’re they need tell make diagnosis exam a telehealth neurology. would to you seeing neurologists For of physical Parkinson’s. much most in a

most psychiatrists the providers of dyskinesia with advanced of under practice example, tardive or For patients psychiatry. are in the care

as to And to going so, a at exam. easier the the diagnostic we’re to attributed whether customers process, conditions adapting, that encourage is related well better can or also how advance they’re doing telehealth for the virtually pandemic, to follow-up to as in can in physical TD helping treat in for everything better our growth really. in TD recognize really of that getting But, they do the little diagnose, but that come related recognize, a whether a to make return I they and to in Kevin diagnose be to entire QX, helping trying and can to as remotely think providers understand patients terms the ground on said, to both progress seeing diagnosis we’re

Operator

Please go Raymond with James. ahead. move Brill We’ll to Danielle next

Danielle Brill

growth quick basis? from Just XQ, an me. guidance In one sequential your the on million, $XX inventory adjusted for a Thanks. that of is

Kevin Gorman

Matt?

Matt Abernethy

adjusted basis basis. inventory Yes. That’s an on underlying on an

going that’s a commented we you range. XXXish variant. eye Delta associated seen what QX then think, that with some drawn the as are of also and would I we’ve close I and other And we on QX where put keeping is in from upon history based to variables think that somewhere the earlier, on

Operator

to with go Chico Wedbush move Please Laura Securities. ahead. We’ll next

Laura Chico

providing on like little of about good longer-term guess, more outlook earlier, card, a a but basis. a some thinking guidance. on you’re of certainly quarterly you if you Obviously, certainly just seems great are I a the providing a are on It how -- fix wild considerations? seems this for again, I like I pandemic wanted to ask bit things. guess, One And the missed framework apologies I have guidance? but what And

we how Thanks. wondering term guidance just So, emerge? to longer for should think about potential

Kevin Gorman

Yes.

add the right see and talk at more some is that are trying why guidance. much of now, what without very specifics, can we’re here, point things information number, us are is recently The with of the take openings to we’re comfortable to that the very unprecedented well. give several when things to it So, the confidence that forthcoming you as can you. our these even feel our What and just degree good you to more that that now would trying nail large you because and real is dealing detailed And as and and we’ve and to with try trying in that we’re the to reason to use we’re to with difficult, facing. this and we about first, able something to getting universe is not turn, challenging And that I’ll that unprecedented facing I we’re I’ll But, these for try that always use future, jump perhaps trying and to times, do here, Matt, do go it’s particularly in the times these, in we constantly we quarters it as do see, getting closings give number. really annual pretty feel Matt we specific what not is in good right, guidance like more to to of trying we’re to of be about. more have. psychiatry, you with giving about is real give that would is that? we work is we’re we’re be In here, clinics it a challenges been telemedicine

Matt Abernethy

that talk covered you continue It’s Kevin. we something to it, No, about.

should that guide, radar continue from our something that now is we some providing detail to we’re point it an You the through. at these unprecedented would and move will would expect annual on away be But, during providing and we quarterly times. think

Kevin Gorman

that dyskinesia, I none medication of and is, much tardive in is was market dyskinesia never And tardive been there’s diagnosed would about the say extremely in never the we a virtually, were thing unusual And being programs. patients it. for the taught coronavirus, that or into last with recall, is a residency even medical without launched the fact even schools that

proud beginning, able from rate. to our get with a commercial a the diagnosis of about challenging into. to what is XX% to that I’m and That’s right very so got medical area teams we recall, do they’ve been why now So, it up

Todd Tushla

Let’s take question. last one

Operator

last go Absolutely. Yatin question from Suneja We’ll take Guggenheim. with Please our ahead.

Eddie Hickman

Yes. Hey, here Yatin. the Thanks in for squeezing quarter. me on for is guys. This and Eddie congrats on

Just and launch. But, of what opportunity it in would and it peak to there? the eventually what causing a ONGENTYS that up one what sense for do sort quick follow-up pick have the get of slow take on the could sort be be long color when that projections program and thanks Thanks. the start will the be of you could will market to -- for on how

Kevin Gorman

Eric?

Eric Benevich

Yes.

to guidance with ONGENTYS. haven’t potential what given is We for peak any specific the regards

disease, the with Parkinson’s U.S. in million two-thirds about However, and them, on of I patients there that will about say adjunctive X treatment. are levodopa is

things adjunctive treatments. market So, that’s less going the out ONGENTYS, addressable we class of was on COMT to few those that XX% constitutes the patient pointed Launching there challenges. share One than a was pool. near-term were that create that

And QX of outside that Parkinson’s fact disorder to in ability Second year, experience then, for of new of pandemic, ONGENTYS QX issue was developed frankly, get beginning were very the -- no at amongst there was and thought was in end neurologists really this fact the disease. movement that us, introduce which of biggest so was peak our U.S., we launched the last the leaders no in issue the very ONGENTYS entirely the clinical medicine. hampered front the of there

the certainly, has have And we’ve are really recognize to challenges strong medicine we select profile I try So, mentioned experience when their we really before, with overcome. But embraced, those the that and great It’s providers as that feel been positive. a it good about feedback, start in patients, all to label. clinical we ONGENTYS. a of

important this forward So, to medicine. to we’re going press with continue

disorder additional the medicines thing about practice, INGREZZA have that that frankly, movement to mention when commitment benefit And other should attention we disorders. in gives we tardive time movement we can to the to And is ONGENTYS now in certainly ONGENTYS those have movement indication. specialists movement opportunity to our INGREZZA that community to for and I two neurologists, disorder ONGENTYS in us with continuing come their represents Parkinson’s TD talk dyskinesia. disease, to The

for continue, So, our against this see of believe, we’ll positive terms plan. continue to in starts patient We’ll growth brand. and to execute momentum new I

So, what look looks forward what to next progress those on call. like the that -- sharing

Operator

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

Kevin Gorman

you. we a to I that I is from appreciate like been got most probably Neurocrine for environment in that proud thing of, all is continue the really of here the call in today. that would away we you and here. to Thank will questions we’ve that do and years take this number The be to I’m adapting that is,

soon ever. where usual back anytime to maybe We’re go or to going not was as business

do telemedicine fine. we care. that into that. for patients, in-person stay done good And health XX% telemedicine so, think certainly quite very the there is replacement providers continue future. invest care we face-to-face to And a for Psychiatry and believe no we’ve in If may for that’s that I And going but just is well. at tool

but it And care, to so, as back we and to in-person before. fine. more going that see never do more the But, that’s was level that

a that medical the treated. it to We and more by and being more community disorder recognized are TD and -- patients going be that is their has is by to caregivers

potentially and beginnings And disorders. going have growth continue good tardive to invest, see other treating continue of to to to of extremely sufferers are you’re going very and bringing the to we TD us dyskinesia at INGREZZA and these are patients, so, in we

are also each We’re passing of pipeline sticking year. is our neuroscience advancing that growing mission as a be And the see, you premier to and Company, what -- has exactly and company. with our to been we

to future, means some And us. neuroendocrinology; and neurology; at it neuroimmunology neuroscience means the so, in means point it neuropsychiatry;

going And from see so, compounds into clinic, with from to the partnering you’re research us both bringing internal new excellent continuously collaborators. and

you this we’ll meet out, personally. that I close. of able going a to to to this confident with is that, year still point bring many am we’re at with So before some be call

to in back to And to will that stay long so, I’m one all able all we visiting as hopeful be safe, that we as get get continue vaccinated another person.

So, with your Take end attention. that, you thank And I will call. for this care.

Operator

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

Goodbye. any at disconnect may You time.

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