Neurocrine Biosciences (NBIX) 2 Nov 212021 Q3 Earnings call transcript

Company Profile

Participants

Todd Tushla	Vice President, Investor Relations
Kevin Gorman	Chief Executive Officer and Director
Matt Abernethy	Chief Financial Officer
Eric Benevich	Chief Commercial Officer
Eiry Roberts	Chief Medical Officer
Neena Garg	Citi
Paul Matteis	Stifel
Carter Gould	Barclays
Tazeen Ahmad	Bank of America
Phil Nadeau	Cowen Company
Anupam Rama	JPMorgan
Josh Schimmer	Evercore
Brian Abrahams	RBC Capital Markets
Jeff Hung	Morgan Stanley
Brian Skorney	Baird
Chris Shibutani	Goldman Sachs
Ami Fadia	Needham
David Amsellem	Piper Sandler
Kelly Shi	Jefferies
Vamil Divan	Mizuho
Myles Minter	William Blair
Charles Duncan	Cantor Fitzgerald
Eddie Hickman	Guggenheim
Laura Chico	Wedbush Securities

Call transcript

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Operator

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

Todd Tushla

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

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

Kevin Gorman

out to brief Todd. comments. am just Thanks, going afternoon. I everyone. with two Welcome, start Good

is continued have continued First, I'm growth. to anticipate going very the This see we're we row And pleased quarter INGREZZA's I this growth to growth. a where in of the year. the remainder see for second

not pre-COVID has to being interacts but us, COVID's to trajectory, but well. continued number still field yet experienced is impacts we're are and the behind not back increase. in the growth territories Now of we've adapted

will business INGREZZA. Eric healthcare again, behind we But and utilized about are are professionals. telemedicine in addition, by being well growing still In our heavily is how adapting investing talk we

clinical we goal, in robust of we going several pipelines an most the Now Phase of goal these programs. X to highlight And second, aggressive neuroscience industry. start are extremely X number with that Phase the growing of And we meet the a will and to one year started trials.

over it that, Matt. turn with I'm going to to So

Matt Abernethy

a still momentum levels, reflecting We and sales prescriptions with anticipate is QX encouraged to QX start telemedicine pre-pandemic representing Kevin. patients psychiatric by growth. team offset INGREZZA record opportunity approach Thanks and progress slightly sales portion continues just patients strong tremendous even elevated year-over-year of a QX large great were with most of business. a commercial we're more see with over representing QX off million gross XX% solid $XXX million $XXX importantly, to discounts. of execution, new to a help QX strengthening INGREZZA's The medicine, seeing driving with reflects net demand a seasonally TD. many significant

both $XXX our from being ahead Behind Looking allocation throughout growth priority, INGREZZA we Field top to Team INGREZZA, advancing and Sales million exit to we continue INGREZZA this additional pipeline; our INGREZZA to Fundamental important XX the our clinical seeing clinical to XXXX, data with we growing next the capital with are strong over expand an our two year. invest and to in expect years. invest pipeline [Indiscernible]. we programs campaign many will with DTC coming our year readouts and continue growing

the key to neuroscience Eric a attract line, be call our We to of that short for and invest to members team Bottom I in Neurocrine company. executing well growing the company. long-term in hand our people becoming growth, positioned top and With we will leading Benevich. continue talent now over are our Eric? will strategy

Eric Benevich

Matt. Thanks

Let's jump it. into right

interact sales improvements new quarter leading the high executed starts. driving see million. in to we Our time all $XXX INGREZZA of team perspective, well throughout prescriptions patient an in total to continue record From

come that were note QX, related the consistently to quarter year. a reservations certainly our levels, seasonally pandemic is to quarter remained persistence I'll said, strong to the start challenges. compliance the a medicine. quite But as QX, we QX. impact While and speaker interacts are still level that And bring beginning historically of steady throughout an regions the flow solid indicators to we've rates have nation. due levels expect seen sample slower to are such throughout off the with a as high improvement distribution; having call performance In and key not on since in sales pre-pandemic is at growth volume, patient Matt back we access historically programs customer

like team. relying psychiatrist into to about addition, gears challenge particular more on insight a our TD In in half time, diagnosis. now the a to is for expand which provide still the telemedicine bit presents sales shift I'd decision to

this learn We adapt that is that watch healthcare continue we provider patients have to and and a learning meet needs of articulated since to better customers. XXXX, the

and and XXXX in for accelerate recall time, more that decision pandemic help field of INGREZZA treatment the to the TD patients diagnosis course made that strong we uptake you especially our us to trends the lessons including to example, meet For market year, INGREZZA. with on who rely we heavily Last better saw at our upsize taught many provider how healthcare with those and telemedicine. needs customers,

have we in that established year, base to The The in set takeaway reach total, third dedicated commercial dedicated expanding market us distribution teams. has neurologists respectively. Along the time the potential field new And this we've you disorder prescribers data. three QX long-term teams our is to direct-to-consumer which getting syndicated was up been steps taking of on opportunity. educate salespeople we a branded we teams believe the clear our reliance effective campaign it have reflect movement to across key conviction by more care, needed our neurology focused will across of the over along for continued with and providers these market. care it easier that continue prescribers sales TD that make we complete with constitute and In focused footprint we've XXX diverse and by ever more and to high customers. larger QX revved on of growing and around be develop three Importantly, will specialty and a caution of to TD our to expansion to was approximately next grown will long-term network. as two and with our change, next on evolve psychiatry, salesforce To end, expansion, party year, salesforce sales we expansions distribution ongoing patients there When force. will

effort to fact the tremendously While diagnosis around there get of I'm is the is rates that TD collective today, ahead. remains taken proud up much to work XX%

in need help. belief into initiatives and strong a translated long-term of and have to people are INGREZZA still patients marketing meet our you the that the We our in investments opportunity for the the making who we needs see many

the published XXXX date, been daily to initial be of the next designs status, access access similar to Launch XX% expect to in know thus on are important be access, market to Access comp US. regards in and XXXX. continues formulary fulfilled to forward revenue this ONGENTYS, greater feedback expecting prescribers and to we've only carry planned prescription patients year With ones we and INGREZZA expect XXXX we marketplace had priority. to based we Turning with to on INGREZZA far, for more of remains the critically per And similar today, net inhibitor be rates. gaining based reimbursement have year. a INGREZZA from with regardless that experience been what the more have we than and approved into formulary the patients positive as success to

to neurology with INGREZZA and In very I'm team's terms the sales. continue leverage In together all-time net our in ONGENTYS impact I'm access to challenging main to even patients. fact we customers. about QX high total continuing performance prescriptions of for closing, circumstances our optimistic that we're addition, our in under making and was and here can grow levels represented a in strong franchise. highs growth where to we quarter from and more go pleased

hand out to Medical our Roberts. So with Eiry? Officer, Dr. Chief Eiry that, call I'll the

Eiry Roberts

good medical focus Eric's Thank regarding And afternoon generation everyone you, on today. education the Tardive living data to key Building Eric. in affairs with call support and our patients organization comments INGREZZA, on of to Dyskinesia. on continues

fact, portion practitioners as practice on the advanced and providers, of assistants. focused In field recently we team support of education such our physician's and nurse expanded

data Scale social, an analyses improvement Congress in patients, patients diagnosis functionally be more with Psych TDIS, And reported using work and continue Impact generated impact Neurocrine to Dyskinesia TD socially, patient treatment developed of Connect movements to this TD, or the study critical symptoms, treated the understand recent TDIS has the the know living important of these patient reported play registrational both X Tardive can impact studies, often from themselves. we through role we in of in our lives with INGREZZA. impact even and phase a providers functional we demonstrating both that from the TD analysis than on the the presented At the Given that and in the of subjects outcome. October,

TDIS questions assessment that show additional potential tool, now [Indiscernible] as shows ongoing. is analysis of validation this Additionally, TDIS a as the promise clinical within

change initiating I'm have thinking study response be approximately Key outcome enroll social registrational for We XX. an study baseline the with study remainder to the Valbenazine, blind about total Global CGIS, week pan patients late there controlled Phase Impression and XX. of secondary performance pleased in will open year, that to this milestones randomized, measure week placebo Clinical Turning schizophrenia, had activities expected in XXXX. to the from personal key to Valbenazine score, we're the schizophrenia in baseline enrollment scales complete highlight. and primary number from this This the in month. to of adjunctive is are And XXX Severity to and X treatment currently double announce include the of with score who of change will antipsychotics. inadequate or measures the to change a estimate The

HD on from December. Firstly, top study results Connect in disease line in to share track registrational we Huntington's remain the

our late to the stage cerebral for about due associated of mid which In initiate disorder, for partners families total, hard for as of data Dyskinesia Luvadaxistat to stage seizure delivering organization I XXX, readouts to in work study clinical transformational depressive would with enter our the the into their the over adequate the therefore, as five by schizophrenia. thank back company thanking addition, their of study palsy. we investigators, treatment potentially I'll exciting we're an trials. response I the continued at and trials in an more teams impairment benefits end outside XXX of And we number registrational participate MBI of major all and Phase come, and who to our our and to NBI X in each support turn in XX of to in an trials call to portfolio. onset Most programs coming include In cognitive is clinical planning clinical patients anticipate treatment importantly, this in the seizure to adults. now With would time over focal ongoing Kevin? years. look the to depression, for like we XXXX. for across important forward having to a an for Kevin. NBI XXX Neurocrine like treatment Anhedonia mid late XX studies,

Kevin Gorman

Thanks Eiry. all our That up remarks. sums prepared of

So we questions. now for your are ready

Operator

[Operator Instructions] with And we from Neena will question Citi. our Bitritto-Garg first take

NeenaGarg

question. Hey, my guys. Thanks for taking

want regardless all, telemedicine neuro that sounds just if little overall, guess I an the about Can similar growth total and bit that'd scripts First increase great. some talk down because a just from from INGREZZA dynamics, is versus to psychiatry XX% drill you number those total diagnosis into whether is like offices? inpatient could in of of is XX% of more telemedicine you're the from new just coming coming little still rate. psych of a it prescribers you understand versus be visits more coming of more about used I the number in in for that offices bit where kind seeing of

KevinGorman

Eric?

EricBenevich

question, for Neena. the thanks Yes,

So a of it's bit little everything.

have and I extent that mentioned terms significant lesser think environment. adapted are of into use. I in seems psychiatry how of and of we've grow, telemedicine seeing been psychiatry, neurology. this much And able leveled within It still if patient to we as they telemedicine rate terms visits within to volume to before, in the a we've As off of use of,

have the versus person people a those virtually. providers So see things, in who that need to obviously, see of sales they they actually it's would out, figured can are that our combination

the being team. prescribers, at have identifying haven't access to inhibitors our Secondly, MATX those utilize and adept new started to that yet

them look for in to we of And are behind reminder, so patients screening on help them put virtually, environment. that, of the remind overall, I with their adapted just especially resources to and a primarily providers those so. continue everyone and think And TD do that seeing different a and providers fact, utilizing TD resources take help And mindtd.com helps. importance to helping providing for you psychiatry in we've resources and to screening just related them the to diagnosis, some treating number of we've want if there I to see go call, providers this remotely. For a content TD field at in we've that diagnosing that created at of better to been and you'll the hope to educational the educational out become

Operator

to move next with we'll Paul And Stifel. Matteis

PaulMatteis

number thanks so Matt math, the of amount. into by next for would price optimistically my provided you a that by was from Hey, much just conservatively. and that a but patients suggest And for even also net question. think - month somewhat adds Great, guide the the taking small our I by in investors' greater so XQ quarter, inventory, would probably and seen quarter, a guide benefits

we of my in level thanks much. so just what demand So maybe quarter right, exceed confidence maths to that can your could assuming saw this XQ you speak

MattAbernethy

the Sure, Paul, appreciate question.

I is think your right. math

and see on that's to Dyskinesia what continues And has engage a level. go It Tardive radar. progress the and been driving continue to the providers to right to was testament interacts, healthcare below really with do interacts keeping I great to We the able pre-pandemic up. think team

get to really what seeing and competence, we'd transparent So we medical QX will with have what throughout commercial be who the - organization a patients tried said off we've it's to as rest to the and But the the momentum rallying yes, and around we're level have continue in give INGREZZA. that of quarter, seeing, we TD good you expect start in treatment the our in entire is past. of helping we're is came team good a

Operator

to next move will Barclays. We Carter with Gould

CarterGould

some your telemedicine questions in the of the afternoon. on Maybe Thanks for of Good Great. about for expectations question. taking thinking the just terms you earlier guys up how follow dynamics. are

of how would sort Any next reimbursement and onto given that helpful. you're year, insight about thinking into evolving Thank Looking dynamics. front that be the you.

KevinGorman

There's that to to on come that take that. do. CMS Yes, week going day to out guidelines be sure, be saying keep new And still by We anticipate reimbursement. Carter. I'll put are any now. going their any or we we

place rules is start public stay in year. the the basically whatever what transition a guidelines starts under emergency probably will the if health current will time remain in But telemedicine be in - pricing current be emergency those work all going health of with that the in to might before While still construct after public everything public relieved emergency the is associated we we are is new They'll all most the place, again health the be or will next new, again. same in environment for place. not

Operator

And from our of America. from question Ahmad Bank Tazeen next

TazeenAhmad

you my Thank taking Hi, good afternoon. for questions.

try of to doctors, mostly the the to place to from now would for you had into decision to beginning efforts So, the of $XXX providers now at Kevin, relates minimize home. you investment the I make $XXX working why as think the because long-term it time you of and that neurologists feel the right talked put care, investment, do million about year, is effect

think So now at And those your put that place into to time? trying are you these outlets? Are the work do for been current for all additional market you that you maximized? going looking has be you to on same of efforts

KevinGorman

a couple in. there. up a of address I'm to then Eric going I'll Tazeen, Yes, brought And you number points of chime And - let interesting it's them.

by teams there's go was call ability be still salesforce our we point psychiatrist, is reorganization, the The heavily fully into of we to psychiatrist will more psychiatrist will current - we - we base focused with far we think neurologist the think increasing primarily going first been on we've which psychiatry, the be psychiatrist up is Do have deeper don't three with do penetrated? all. do even close. not we that go into, it offices exhausted that at on and The so prescriber you largest brought not that the no, we yes,

You is like here. of we are of do the are wanted beginning to so harm we do QXs year, right difficult the at kind no because to that

QX. into go we As

of had the Eric these in take will teams really, said, QX. As new place rollout

and adding QX you that Eric, we're leaving QX. our our are throughout to? up do have that territories to we to So we so not disruption the salesforce want intact coming don't

EricBenevich

piggyback your I'll Yes, on comments here.

well clarify, couple the a as of for full advice, million was partial to in So for by salesforce as things $XXX this DTC, both the increased just year Tazeen, a SG&A of only by expansion. is year year driven spending keep mind

that that we neurologists, educate well prior So it's cover this as line all there's we in TD. the resources continues believe it. prescribers of psychiatrist. getting TD recognize we then high as driving as different be prescribers we an we time opportunities to there launch back that opportunity, have for at treat sort decided expansion actually, and and as the did to at what's And one. and those VMATX well to bottom to the the reach, a And combination an And that XXXX, LTC two prescribers potential analysis, looked market, the to that INGREZZA day to have we as then had The of INGREZZA opportunity from motivate of is back TD didn't developed initiatives. or more

we we essentially is so time feel have that invest along our got to done on deferred opportunity further to to And resources opportunity. focus the market dedicated in to for LTC the decision we more and on right until and focus LTC us develop

and growing So structure mostly need it's the size of the really better our a base. our and really, by are development market, more the to driven diverse of customer salesforce the changes and needs to meet

Operator

from Cowen and our Nadeau with take we'll next question Phil Company. And

PhilNadeau

taking for question. Good our afternoon. Thanks

XX XX trials one clinical when to are It's in read And events release exactly the there actually, that likely going on the out. you of to know are some are us year. by important the over pipeline; unclear a have little be the trials mentions XX that press months. data next of to end those programs the We to

next in read out So Thanks. data ones likely in trials produce to particular, year in XXXX. likely And which to are XXXX? more which are

KevinGorman

basically be first going of is read and read the So this The be after is to to to Xb study next we'll going read that last Huntington's that going in out is to to that going then to study, CSWS going in Phase one it's be the that's reading going the out. out the to that's year, And going tremor. a is trial out central year be next December later

PhilNadeau

and the Great others in are XXXX.

KevinGorman

Yes.

Operator

And with JPMorgan. we to move next Anupam Rama

AnupamRama

here Connect this guys. Thanks Huntington's the On to a profile are the from is so question. if the or share based you market much the how on disease, there? thinking the guys. dynamics about TD market Hey, Like HD so much. for of for they've taking and market Thanks you expand potential INGREZZA, take

EricBenevich

want Hi, the Anupam, on guess then take question to add Eric. Eiry I'll it. I it's and to if you

safety, answer We've with Chorea Huntington's including VMATX So patients tolerability, concerns day significant from a both. little and of multiple that for a of to associated times around are I with the moderate convenience don't noticed inhibitor bit could a treatment benefit there reasons, various is with a of even dosing. number around symptoms but think or concerns that severe

inhibitor. they if there's to of will opportunity we to it patients the be also believe treated Huntington's the we potentially switch there VMATX to find trial over for that grow be. with which the emerges profile from So patients have And proportion is believe, some opportunity attractive, our us,

and as towards those share it's our being to data about two the complete to think XXXX. opportunity move combination this Eiry? able things. and I commercial more of So end is, We're the forward what looking into thinking a we the of about to year, trial the unblind excited

EiryRoberts

patients I Yes, in on mean, Huntington's the with Eric, no, to disease, patients think United couple he I I I XX,XXX the there just said just point. mean moderate of that, VMATX those States them And only have a it well, Chorea severe of spite about XX% build treatment are things. in inhibitor. make XX% with that more of we treatment. of get have of know merits and a that aggressive Chorea to of XX% form

particularly very have medications with really believe also improvement the that there. flexible take that Huntington's we simple, And many, may be with could day patients potentially reason treatment many lot these important and for so And room there's once Valbenazine swallowing. being for disease. difficulty we patients patients oftentimes, think a the The of

very be black important. And so the numbers patients obviously, important to the tablets in Dyskinesia complexity currently for of complexity treatment this very can space. Also, for The and of the numbers warning. of INGREZZA And the be no patients the taken. regimen box needed be of Tardive has can

to about of new results Huntington's as Eric interested disease. see further for able be so mentioned, And hopefully, and this end to and to get how very discuss our successful, a going we're if year, of at the forward VMATX be Valbenazine treatment approval to able we're regulators in the of to thinking approach

Operator

next And take our we'll Schimmer from Evercore. question Josh with

JoshSchimmer

Thanks the question. taking for

this quarter you So you it's where ever your branded it where Thanks. that market what do VMATX share at to looks been, evolve? the and end low see of was this attribute like

KevinGorman

same. I Actually, the think basically it's gosh, that stayed

XX:XX dollar is for I market think competitors as what quite take it's which a sales it a has share that they by if them, that still split, out Huntington's amount, been describe now the while. you

Operator

Abrahams next Markets. Capital move to Brian RBC we'll And with

BrianAbrahams

Hey, Thanks my for for on so me schizophrenia. there. Valbenazine, much pipeline question. question A taking

wonder if you talk design more You Phase talk upcoming influenced what trial a little X I design. about about the bit that there.

of by other be or patients, is little other we've Valbenazine level? a what's curious than of are guided there? activity. XX then wondering time on Thanks. evidence one and was anecdotal that week XXX of seeing the just think schizophrenia if data - a studies, will I What you're in powering dose full other for your seen to guided not expectations the And for effect some your endpoint terms longer bit

KevinGorman

Eiry?

EiryRoberts

of haven't some Yes, the of context trial. along some to we in the the of information released reasons, actually the

study in the just endpoint question primary in answer Valbenazine onset point just So and one is first movement, effects Tardive front, terms in up the of environment, as the choice. Tardive Dyskinesia of thing, to patients. to right One the see on about many rapid impact the you very all, Dyskinesia design make the of

any rapid neither we or onset of effect so generated, complex in onset And in and needing we have for other to setting. of we and we've longer titration. preclinical the we ATS of don't in seen effect that have that's data that a also, of some certainly And so needing do anticipate this anticipate effects, And setting. form longer to need get terms not the case in rapid

the look see in In primary study have the effect if somewhat of are, out trials many agency's circumstances actually variable. the of you longer to terms of - there of the in treatment, are is to endpoint, done duration This registration terms the quite at the endpoint. been the to duration they seems primary that out

being upon that as And to of land discussion able this adequate we the endpoint a failed the patients particularly for evaluation primary agency, had timing from treatment anti-psychotic get so were with alone. appropriate setting, who to in in

that in it So you'll the trials.gov total is very randomized, reduction do to from score, say, schedule of this And the The detect this clinical program dosing isn't this question, size size deal an us But final in we the power for study. in first allow the the terms the of readily as that's if clinically meaningful now. and posting, great the treatment piece study, is right an is to then group to that actually pans we your see talked appropriate I'll believe parallel study. about effective active placebo, versus setting. haven't a the

Operator

Morgan to Hung move Stanley. we'll Jeff And with next

JeffHung

taking the for Thanks question.

palsy, can XX% of adulthood? you've And about How that X Dyskinesia. the from for bit For into population specific focusing you Dyskinesia Phase rate Valbenazine early you pediatric experienced different year, adult you're diagnosis little that age studies? more patients change range? would and specific in of a versus up the versus childhood split sub you're that starting talk does palsy this cerebral a about on as such And Thanks. indicated cerebral the about

KevinGorman

Eiry?

EiryRoberts

Jeff. much, very thanks actually, We

We trial actually haven't about design as the yet. talked

indicated we includes adult both that trial and will pediatric have Although the subjects.

palsy of You're Dyskinesia occurs about correct in to XX% due palsy population. in of that proportion and persist into that cerebral a adulthood cerebral

think important individuals of it can we medication is persistence suffer cerebral cerebral that palsy into or into continue adult useful who so to an to not Valbenazine the with whether given for have the palsy And or population we adulthood. medication important establish be Dyskinesia opportunity the

In terms talk much design. of the we to this obviously start trial in clinicaltrials.gov, prepared be remainder intending about the of later to on trial once design, posted And are is QX. trial we'll the the more

Operator

And we'll move Brian next to Skorney Baird. with

BrianSkorney

good taking Hey, question. afternoon, everyone. my Thanks for

data well on sort numerical of in good. Just TD basis trying of of look for in idea the terms Chorea what a and I'm you perceived advantage to an advantage efficacy, upcoming. as know have to get you over as in to maintain I Huntington's that steatosis due dosing, both safety

the history to steatosis for inhibitor? a account we from in same on you're we to drug the sort VMATX patients market in Just any see I that's to this considerations should just at do the we we looking when and that with advantage the two you accuracy how particular, when a Or baseline, a take about Are have going of in could efficacy? a patient be here the there see PD. here excluding XX.X improvement to be population think In be X.X improvement given think I been from here? outcomes at pivotal, showed they're who look while, they thinking

EiryRoberts

Brian. you, sorry. Very, Thank

KevinGorman

Eiry. go No, ahead,

EiryRoberts

like with you ahead Kevin. to that? Would me go Sorry

for thanks Brian the So, question.

will the totality tolerability the the potential that, be the once profile both that I think and flexibility the HD, the restoration it benefit efficacy the trial we and of MHD important that the we and and in a elucidate overview think tolerability we've of to a designed that and combination associated of Valbenazine is fully benefit, designed and day dosing the will data. of be with see

So that's make. to the point first

the Secondly, way able of in trial the detect, design, program the and meaningful is the was to order to in similar steatosis terms designed designed. trial the clinically to in of be sizing reduction, which

point, failed exposure to to patients is who clarification a and of to inhibitor that are small are of VMATX exclusion a previous one we is VMATX such that mechanism Since ensure the little Just a proportion to VMATX inhibitor trial in to in different. unresponsive may who be done respond have don't patients have order patients the of action. there that

in clarify profile that tolerability so our And includes study. which in we're the I primary the seeing discuss to And that. disease. position successful and looking able going we forward efficacy be regulators totality if really patients this we of the we're wanted in the endpoint, obviously to registration of treatment will reaching think this the generate how I Huntington's just should to But data, with as to forward both then we're

BrianSkorney

Eiry. Thanks,

to inhibitor saying who Just previously previously it are - including criteria? taken have patients VMATX says about are trials, that exclusion have on just established you clarify, you because clinical

EiryRoberts

is adequate exclusion and inhibitor, The of titration them effect and aware, probably tolerability profile with have response deutetrabenazine. criteria patients deutetrabenazine, the an fail to get one to patients issues reasons as who many for is to to outcome because of why and the that of many to use acceptable those have associated are the side with failed meant eliminate VMATX you of

then we're So a inhibitor, short they have VMATX criteria. a meet of necessarily excluding if if those other people trial had all individuals, not

Operator

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

ChrisShibutani

much for the Great, question. thank you very

only would XXXX obviously subdivision the services quite to of being appear programs? reimbursements between expecting to that reference versus mental strategy? point a there expecting on particularly in INGREZZA. are commercial proposals your just scenario health, imminent, that changes on just can be important for psychiatry, that you. the I audio an if combines The execute for far Medicare you're any have ones would you by particular video impact? there some clarify for being as very is would you think about reviewing how video. Can is impact payment the In is that made CMS you Thank particular, a You decision the what in as within you're comment

KevinGorman

also today. Also doing plus there audio one were level secure there there. in number video the a that practitioner. changes changes telemedicine and minimum person were that are of would in a person that a of to having is or that reimbursed you Yes, visits. Health site start sites that there, audio it would has which having be is under are there were nurse be another be They've so continue be health out release only, Public in number of from relieved same I'll There relieved from nurse the or the your Emergency, all at from to at professional and other that

of also and the state medicine So for lines. allowed across practice

CMS to those all to what with. they do on looking see take So come then of really and we're out

alluded seeing to we adapted INGREZZA we've before, growth As we're public health emergency. very now, good to the with right

well that to as is their as going see is going Fee what really I'm us. publish it's soon for But final CMS appears imminent. Physician tell I All So saying too to that Schedule. it

ChrisShibutani

has psychiatry the ask just telehealth component I the you only in of as Can mix video what audio far and know do been? audio as versus

KevinGorman

Do you Eric? have that,

EricBenevich

mental only our but patients I and can you about of only. from Yes, at I video telehealth once psychiatry, half only providers we be data, I then, to the hearing plus audio excuse that, for audio And TD advance created from help how least see an in tell materials a the claims to are more What can if screen for about and that settings. makes of certainly community to audio the process. to market plus again, website and you'll audio that diagnostic And or health customers more TD that and isn't. are more predominant recognize be you challenging being video screening because for go it research, me at and in can't mind.td audio regardless visits seen tends is it are video, it's to that call, half whether anecdotally our report adept

give will post the telehealth us Kevin physician that schedule removal. is Kevin those and publication temporary So expecting extension for change will of health the waiver because temporary XXXX, waivers described, of health what fee status next the the as will And emergency when public into into and lifted, quo point, at some the environment said, some look the insight we're also of year. emergency public post pandemic upcoming likely then CMS like

Operator

to move next we'll And with Needham. Fadia Ami

Ami Fadia

Thanks. quick efficacy X tremor, had of Huntington's with Good essential the question. in study? as that a proof-of-concept then looking evening. What superior anticipate with existing regards study. Thank X? treatments for you for I the taking the a Phase year? follow my to Do And possibility positive you to on up Chorea disease next readout study we should Phase be

KevinGorman

Eiry?

EiryRoberts

Thanks.

comparative trial head a not to study. So head as is designed the Huntington

to terms a so setting functional we the versus efficacy This are head question, core, forward the in be we ourselves I data and of built the those that no hand, will particularly successful we're to the trial. the with move a of other generate we're head in that study other of placebo data, Huntington's if is will And controlled way claim not answer direct endpoints profile that controlled that the we also designed as held be said, haven't the interested in trial understanding in trial. And Chorea With inhibitor of data to that or earlier, totality of order that VMATX in other in on versus a mentioned both obviously treatment. that tolerability there superiority, registration - are able in any that study. but into

this Tremor the study, Essential actually a study. On proof-of-concept is

arms tremor. a patients treatment for the from XX two treatment And tremor change placebo be of so to XX amplitude baseline moderate individuals the it's and outcome with and frequency study each into will peak controlled in measure essential primary day with crossover period, postural at increased

across the looking in a placebo, between comparison in we the or be. determine quality to go full at that, active I findings step for dose whether the able of and within terms next with treatment am subjects, we'll registration to XXX forward subject and hand, be X So Phase

Operator

David And with next we'll Piper Sandler. Amsellem move to

David Amsellem

thanks. Hey,

in to position So, regarding XXXX guess, reason provide INGREZZA the think floor, a sales net a earlier be XXXX Thanks. do least in per on to at revenue I or XXXX. of stand how range you'd you given regarding commentary direction that about versus call Would it provide a that? TRx your And sales guidance?

MattAbernethy

will of the impact and a the will XXXX guidance for intend to advertising do our and would we definitely environment step call give up both Yes, And well and salesforce in reflect do direct-to-consumer number QX call David, guidance. and the so INGREZZA provide to also, range on a an for we include course, come us as time for our that well, has our as annual thinking expansion. February campaign the latest

market. gaining those continuing something having So understanding we're of forward and we that February. look And that's this progress to conversations in to

Operator

And Shi Jefferies. will Kelly with we move next to

KellyShi

Thank my question. you for taking

for of do for it exposed on Thank point inhibitor So including the clinical end placebo three Chorea of far reduction. patients to that Connect two the is the wonder from inhibitor how total showed HD a maximum trial in also, baseline, the to the approved change impact VMATX And over trial? the benefit think Huntington you point on connector primary benchmark is I trial. if pre kind this the What previously VMATXt disease you. a time? score effect

EiryRoberts

of the the Chorea that and what impact as Connect is we've of previously of primary kind change is total score stated, relevant terms the think HD So deutetrabenazine score. in articulated endpoint I in indicative a you the for trial

has powered to designed able score be and other of identify as we placebo reduction score in change believe adequately in this conditions, relative to Our time. to such to this have a placebo, over Unlike elsewhere, to be for the will treating little response and no in obviously time. meaningful and believe appropriate should study of that to think associated we terms adequately the schizophrenia previous able sample change over exposure about is disorder I with reason clinically VMATX a the to the significant that that effect size, placebo in changes where in there disease. be the Chorea Huntington's And been I a us Valbenazine detect earlier situation clarified in response population inhibitors, for

terms again, they effectiveness reiterate, of both we're profiles the of from interested and this the at also in to the data Just use. ones tolerability the associated in generated with totality trial, looking medication, the that and the of

of end have of the to I articulated think functional a as totality we for as successful. the in if the potential out go forward we're decision making the year, of the also looking endpoints at for at earlier. We data, study, be we'll terms this registration that And read I data

Operator

move Mizuho. Vamil we'll Divan with next to And

VamilDivan

a only or it's in year about a as a $X for about launch. million taking see Thanks my maybe questions. what whether about doing catalyst it's per kind going think know ONGENTYS. you payer how of I talked smaller quarter year product you Maybe that might more should going trajectory. just its or, maybe get Great. just related it's changing I'm of we not one forward, but be so about anything of kind seemed the curious much COVID Thanks. or that product sort to access

KevinGorman

Thanks, Yes. Paul.

it's those the impacting year, a movement has of certainly especially and a And Delta a disorder ability think the important obviously, of the the face our we've new I So seen combination this been of to of pandemic launching terms variant challenging. especially downs surge access, the ups medicine of in things, course in over specialists.

in terms and the positive, has experience, seen that gotten very feedback adoption. the we've by and their from And in so, back progress to we've been steady terms of that's And read of being trial certainly experience the patients. them prescribers

of forward between in And customers able so we're foot initial terms trial I ONGENTYS. to in continuing to put we of there driving our remarks ONGENTYS adoption in and with prepared and on that mentioned my neurology forward. terms synergy And best INGREZZA access going is believe being

that's both team. to we in are we think to things. neurology And that dedicated benefit drive continued ONGENTYS building going few One, going those that INGREZZA growth Well, and product? with a what's out neurology practices. a So

next year, we believe that ONGENTYS. for have do into going will Secondly, access better we

reimbursement we base based to continue that our on that and the the we core is those And fitting for we ONGENTYS and for launch. learn behind Parkinson's then the the as INGREZZA, field put and continue course, we team, continue where resources so the practices, market fine of So will our to patients. about built to approach tune into ONGENTYS programs, to we'll

well. the like better, certainly in direction about environment if a feel that'll there's impact the it's externally, reduction benefit ONGENTYS it good moving, of feel and COVID we that gets as So the

Operator

next we'll Myles to with And move Blair. William Minter

MylesMinter

question. taking for the you Thank

that of was to the that have of that Just might you endpoint of of like INGREZZA, Thanks. their FDA the the data also, a week sort six And the back useful, open trend, we trial? absence symptoms extrapyramidal balanced enrolling that that see patients as the and in label with is an you for term be five in are therapy? schizophrenia, on the to pivotal extension the XX trough kind folks mentioned wanting longer need part

EiryRoberts

that. One and separately of the will who there have and encouraged the INGREZZA patients in into and time indication from the and no at that safety been parameters obviously the with patients associated Tardive one are that schizophrenia exclusion in of There thing number is will are Tardive things tolerability for of so safety and Dyskinesia included invocation. is Yes, that and we schizophrenia. made context looking data a for us say necessary be the would syndromes other our about we with And extra treated be of trial. with potentially I was long-term new Dyskinesia going a strong. Tardive Dyskinesia, And - long program, tolerability significant periods our very have with we schizophrenia that data

Operator

with Duncan to Cantor Fitzgerald. next move Charles will We

CharlesDuncan

along patient Yes, Kevin question new good Congrats team. the pipeline question. seem the the adds lines I in for Thanks Connect HD. on this particularly Bialbenze had on the taking afternoon, and of a quarter.

of the I'm more I modulate a guess bit that think you if you to date color talking I a provide sNDA with data on HD it's think to we of at question Eiry positive then the data, kind filing something that simply and assume could regarding an taking that about Connect timing year be I that possible you'd for enrollment is what could schizophrenia, next back or little look totality wondering Valbenazine else? Myles' heard but

EiryRoberts

the the On application the we if the positive to that in regulatory as we'll to for successful, the indication. with to first hand, read US rapidly being in disease, this data forward at consider as question then with submit of we're out possible, associated Huntington's data end And go agency year. able will the

understood I can asking? side, ATF repeat the the were you you so make On what question just sure

CharlesDuncan

to timing am I Yes, trying better really data. just to understand

I I it you said 'XX. And complete was think in think late 'XX. mentioned

biggest considering so what just that for I'm the wonder, you're that And factor time? trying is to

EiryRoberts

I global enrollment think possible Yes, are we month, on this for this trial as trial opening starting mean, rapidly this be we as just I to will possible. enroll obviously moving and as rapidly as

on I think that guess around enrollment. the as date you And the is we'll our is late go clearly XXXX update first we trial. through

Operator

to move Suneja next our with We'll question Guggenheim. Yatin

EddieHickman

on this on for And regulatory talked we what XXX the me. sort on in for indications guys. versus about about? are Hi, you squeezing sort successful, gating both Yatin. the approval here? are what's And of path forward optimal see Thanks factors? Xenon and collaboration, the and thinking there And Huntington's, the pediatric which for US then is quick sort EU? asset of if you Just Eddie really the And a follow focal up how Thanks. can for and the filing other quickly prioritizing How of that are haven't we

EiryRoberts

opportunity there. once handle the at to at much respect forward data I'm regulatory data very obviously, to those And focused HD shared and been of - yet, respect of as with signaled comment the think on that, of the and the much this I the end interact year. with have on With very to we stage, have regulatory the haven't and XXX about on of a to the approval, filing path on trial will approval path data better obviously So we we've sorry. the really don't first; timing we much the timings authority had release generation this after

MattAbernethy

be If be would clear. filing Eiry, make be our next yes, just the sure to to data assumption be year, just positive, to will were specific. sometime we sNDA that's

EiryRoberts

patient pediatric inhibitor of clarification, highly opportunity in we're MATX.X in STMA. that respect We, for trial, I design the excited With program for this And with potentially Thanks focal count. you. onset to XXX, thank every in both we're also seizures. to rare epilepsy SCNA of the making the about selective Matt. think Okay, respect this

trial the outset. the this of have to a provide that our so first regulators. a we're if placebo to controlled effectiveness setting. to forward appropriately be demonstrate at able is even look interaction goal able And And would we we're able that demonstrate And path trial be agent, hopeful from towards to rapid to a is designed that's us the this this in efficacy, with

in treatments. Phase we're currently obviously, fact unmet adequate of focal really And do the not initiating that in need get the a both very is it's focal On lot a cases, study. patients onset seizures significant. of And onset, I the because X available think environment, response the side, to

do to it for outcomes And so about way excited opportunity in the it's selective, efficacy and a successful more as to bring this us be a into for that agent here we're space. enables in patients. well stack as It's And delivering focused to selective rapidly delivering possible in program, a really be indication sNDA site able the little but we're that early setting. on as against both Phase X the on that to how to but, see data would up

KevinGorman

one quick take last we'll Chloe, question. Thanks,

Operator

We'll Wedbush move Chico lastly to Securities. with Laura

LauraChico

challengers, term necessarily it I not generic investments strategy have generic at a obviously, that one about generic me INGREZZA Hey, come of regards competition, protection, all future could patent number indications. with and thinking INGREZZA an number, and also challengers. filings pricing seems much like comment for you're for you're question steatosis you the respect just how Valbenazine maybe wondering with end I I'm in just environment only with in if the recently, longer of making to through upon fitting but to have very here. but a guess thanks to not

at sure if to all terms in kind of talk Thank So that. confidence I'm your you. navigating not of you could

KevinGorman

is So, have business. unusual; course This filings nothing both basically that normal against Laura, been handling them made is business of as of usual. end the we're the products in

that a the about protection out patents goes longer a us of than book years minimum, many green I that patent XXXX, take say that. with on at have have We we to but out, some INGREZZA would number extensions, can in

our all. at on horizons business to don't challenges we any see near So

Kevin Gorman

progress I We challenges year. hopefully that look the and there. adapted everyone, INGREZZA like I as our next at for of to you can closing, good our would think with seeing as us forward to in early today, very to both several So, in future. forward is thank in the from having today. even upcoming and year, And joining and this you person meetings and see that even more pipeline, the This making we all we've out against look have we're amid in existed something goals that progress rapid to, later

thank So you, everyone.

Operator

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

time. any You may disconnect at

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