Neurocrine Biosciences (NBIX) 11 Feb 222021 Q4 Earnings call transcript

Company Profile

Participants

Todd Tushla	Vice President, Investor Relations
Kevin Gorman	Chief Executive Officer and Director
Matt Abernethy	Chief Financial Officer
Dr. Eiry Roberts	Chief Medical Officer
Eric Benevich	Chief Commercial Officer
Kyle Gano	Chief Business Development and Strategy Officer
Phil Nadeau	Cowen
Paul Matteis	Stifel
Tazeen Ahmad	Bank of America
Brian Abrahams	RBC Capital Markets
Anupam Rama	JPMorgan
Carter Gould	Barclays
Neena Bitritto-Garg	Citi
Myles Minter	William Blair
Joshua Schimmer	Evercore
David Amsellem	Piper Sandler
Jay Olson	Oppenheimer
Vamil Divan	Mizuho Securities
Marc Goodman	SBC Leerink
Charles Duncan	Cantor Fitzgerald
Chris Shibutani	Goldman Sachs
Evan Seigerman	BMO Capital Markets
Jeff Hung	Morgan Stanley

Call transcript

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Operator

Good day, everyone, and welcome to today's Neurocrine Biosciences Reports Fourth Quarter and Year-End results. At this time, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the question-and-answer session. Please note today's call may be recorded and I will be standing by should you need any assistance. It is now my pleasure to turn the conference over to Todd Tushla, Vice President of Investor Relations.

Todd Tushla

operator. you, Thank thanks and and us our on Good year for XXXX quarter full earnings fourth morning, joining call.

certain Chief forward-looking Officer; Joining that risks may remarks, we to me Matt Roberts, our SEC Financial Gorman. Kevin Officer; Development Officer; Chief uncertainties, the everyone and and Strategy encourage Chief our These to statements. for Eric results subject Kyle statements our risk be we latest and our our Chief will actual the hand Eiry call Gano, Commercial today call are remind Abernethy, Officer. in your differ call, Kevin you our over prepared I'd are open during filings. Gorman, After our to Medical today's I questions. to Benevich, materially. will I'll Officer; making factors Business With our review Executive the and Chief like discussed that,

Kevin Gorman

Good Today, we back you, made. Thank progress to the challenging the XXXX look a at morning. we and and Todd. lessons learned we want

will QX infections, significant to shortages years. year was will that in our we believe next by QX for XXXX, us and for XXXX be forward up We that set several tremendous efforts. bracketed a office growth looking closures rising and also the constrained staffing

into with go However, in will a many progress customers and moment. in new work environment. identifying to in we a Eric effectively them make and very did health more care how professional changing detail challenging this

suffering patients events continuing and of focused end clinics bring needlessly more more anticipates constrained of the and to investors in of year our lead COVID, will with to internal external released by on that second half many than TD lower both and this believe specific significant impact epidemic we to this reopening sufficient morning force, ebbs The a points the and founded future. expanded upper the beyond. who by is the allow care and will staff us previously. items growth The Turning is sales We the end flows. on are less these of attention and to the year unpredictable

we compounds mechanism are way disease way schizophrenia these treat we where just By we a in we're be one We the We addressing in growth. programs we historical X/X have to neuroscience challenge disorders each XX of our portfolio reaccelerate fronts, each otherwise side market with approaching Phase specific Concurrent have successful and addressing can this, these made and good major that. multiple we're developing efforts, will being developing pipeline compounds, multiple And two neurology, diseases acknowledge now We this address medicines diseases. of different other of commercial flip from to developed neuroendocrinology. in addressing will But disease we a this have such attacking start and these we depression. neuropsychiatry diseases attractable the diseases. approaching designed believe the and a in in a with the disorders. second as had are

significant turn to Eiry XX will it pipeline and into time, Over of At will the next a I'd over months, more number in Matt. this to have like these go this detail. readouts,

Matt Abernethy

assumptions. first initiatives. guidance, our as factors, current annual thinking reflecting is sales operating possible ongoing environmental aim we remarks billion be as $X.XX sales INGREZZA preannounced good in QX our with I'm providing our billion, time on expense net Kevin, my to morning. going This to XXXX January, and guidance Thanks, focus considering XXXX latest we guidance. is our range and Since transparent INGREZZA $X.XX and trends, business sales and early better sales to

COVID impact TD primary going treatment a Our on directly of go cases environment. impacts psychiatric this This the up, news visits mix to and to to the impact virtual. rates. a decline higher for second throughout good tailwind clear, Though visits first as with relates leading are a But predict The transpire. few external is year. how diagnosis will difficult increase visits combination ultimately that patient is patient the the categories, expect following our and assumptions it site COVID INGREZZA in XXXX, decline, COVID starting to is half cases business to of of admittedly, the we

advertising benefits initiatives campaign be fully which will relates on we commercial force next We rates. bucket expansion, anticipate and our specifically, accelerate diagnosis place second expect these help to from in treatment is the track and The our to initiatives, sales direct-to-consumer month.

to access to per to similar previous to disruption and front, payer We years most XXXX. with the the to remain revenue due the assume rates the net dynamics having reauthorization to QX be the with impact and gross-to-net very expected On consistent seasonality script on typical are due refill sales process.

Now to operating our expense investment.

focused investments and GAAP INGREZZA programs. range XXXX growth $X.X Our R&D to many our on $X.XX billion operating advancing billion, accelerating with is

Our million SG&A $XXX increased the force in and reflect sales expansion primarily spend investments a DTC.

programs of In to from and advancing MX XX in an addition, late-stage expense reflects also agonist plan Sosei Heptares. are R&D our recently the mid- operating completed in-licensing

better. in sheet, Our us our important to execute growing programs discover INGREZZA therapies for allocation our cash profile and innovative capital strong flexibility deserve priorities, who balance durable allow flow clinical and people the P&L to new investing advancing

Now, Benevich. over to Eric

Eric Benevich

you, Thank Matt.

continued have era. the during grew year. XX% suffer straight and versus grew our QX begin, I prescriptions needlessly many third made external TD. to sequentially and who sequential commitment X% patients want meaningful our a and affairs otherwise Throughout prior pandemic growth challenging schemes. from to of year's to Total would acknowledge I unwavering performance INGREZZA's of marked thousands your difference commercial the Before dedication medical environment, last quarter

that our both to in managing good strive While we it Kevin issues while said, improve see out of growth, was kind through of control. and several as to

specialty our pharmacies greater across likely in a network expanded outlets. for our even care changes distribution of of to as And modest access back implemented. retail led The to First, patients. shift prescription INGREZZA we to their we the health delayed from provide and were providers. some distribution pharmacy in to going strips Walgreens and CVS ease QX, network network some transferring anticipated, in our those to and Recall, of builds prescriptions for of patients order forth saw

turnover from of cases prescription referral with an first, and TRx how difficult Second, variant Omicron volume, the offices, ascribe while pharmacies Staff our sales. we on impacted to an and patient Intrax likely Delta shortages much had rising contributed and impact, to prescription and uptick time cycle clinics then customers know the the variant in care. to and and interfered significantly

to a to total guidance around month over in are the half year. New INGREZZA Year. XX% provided one this going quarters, year. worsening the a of Omicron rates for all, Our into persistence All and particularly QX, INGREZZA maintain the This momentum record and the to level. TD for compliance we in external remains continues XX,XXX by prescriptions range environment most Shifting prior QX, us estimate have XXXX the in on We into is strong, consistent grown of second number diagnosis prescribed surging with now a to treatment variant, the the helping be TD now despite population. brought tardive dyskinesia. over

positively access The one will woods of seen? with and external as our is So signals trend been the encouraged the We've what optimistic to yet. we out environment key this are early slowly the but customers have teams external that sales of improving, be is no of The onboarding at expansion expanded end sales improve. dedicated deployed the long-term force, to effort continues environment our will is Internally, psychiatry, neurology force XXX-plus newly fully quarter. and underway. strong well with across cautiously care

in products, sales and Spotlight-branded direct-to-consumer and is to INGREZZA. acceleration more growth Medicare ONGENTYS to practices improving In the our With XXXX as addition, team feedback we ONGENTYS remains opens market dedicated in XXXX a a on TD Part disorder for specialists. accelerated great both we especially prescribers neurologists, you will campaign ongoing should with doors from ONGENTYS we And Furthermore, making should neurology expect that most plan with to stage gives benefit throughout and believe the non-formulary our plans. are INGREZZA, and conviction movement and highlight time ONGENTYS medication for commercial neurology reiterate, for strongly set I positive D team receive having years not continue strong a while to to fundamentals we run come. investments XXXX. in patients

So an update for with Eiry that, our I'll on turn the Dr. call over Roberts, now my to pipeline. colleague,

Dr. Eiry Roberts

Thank everyone and morning you, on Eric, to good the call.

made Over development. progress the last across months, tremendous all we XX and have research of

for these plan each and set partnership to We in of In safety application for cerebral Heptares, with drug were XX together with data, have my I'll of over follow-up new disease. which studies studies supplemental beginning agonist mid- from selective late-stage from update the schizophrenia for study, advanced X a recently MX pleased the We the investment data XXXX, basis submitting of Huntington's pipeline treatment these with goal the six-month valbenazine, best-in-class for of sNDA a registration status next X treatment the first-in-class FDA adjunctive pipeline initiated the the associated Phase with the be These form potential with we for spend to Neurocrine execution in XXXX line remarks to delivering stage we with study unprecedented of of was, programs, R&D dyskinetic submission. year study. efficacy programs, data the KINECT-HD initiating number chorea pipeline, acquired on submit anticipate the the or with XXXX. schizophrenia recently of data recently sNDA XX clinical achieved this with readouts of results the balance disease, half initiated through a for Continuing and has top year in the KINECT-HDX in our the valbenazine. across registrational significant brief second our foundational and prepared a many and to NBI-XXX, valbenazine months. of orthosteric a novel the Huntington's ways, and We advance and palsy. medicines. the to now a for diverse Phase extremely of

antagonists selective NBI-XXX, in T-type Idorsia. channel to the Moving from licensed calcium

line from NBI-XXX studies two X Phase We data expect year. for top this

data tremor. midyear, we anticipate Somewhere proof-of-concept around delivering essential in

half the anticipate NBI-XXX, in potential with generated ongoing sleep. these the that, during in a year, review of of epilepsy data will next determine our for wave for second spike indications. we completing Based each we steps trial these in continuous Following of on

from studies channel Xenon, NBI-XXX, sodium to Phase have Turning NavX.X licensed in X now ongoing. selective we inhibitor two the

first the we from portfolio SCNXA Takeda assets epileptic XXXX. in anticipate line The in in seizures and to now top Pharmaceuticals. gears a data second from Shifting delivering encephalopathy focal-onset in psychiatry in rare the license Adults which pediatric of

We pediatric inadequate study top-line the Anhedonia XXXX. registrational in Crinecerfont NBI-XXX response both class finally, this in programs, lives and including XXX impairment strong associated for muscarinic year. we lead a in studies change with in schizophrenia in the Phase for patient our populations molecule against close, and to X Top-line data anticipated XXX NBI-XXX dramatically and cognitive X portfolio, Phase to potential initiate To for We in schizophrenia, This for depressive in disorder to NBI-XXX. in major have that a staying a Heptares, target. potential this the respect remain patients. with three in the in data has North molecule on study and in of depressive are America we Luvadaxistat built initiated read all for a of R&D of orthosteric XXX pipeline our the our lead the major highly is treatment have neuroendocrinology with tried adult XXXX, agonist And collaboration agonist with selective to to psychiatry track best within Sosei for event be disorder.

now believe business candidates add strategic innovative our internal development, continuing focus pipeline the also drug patients. via and want we the I needs those on while is Our delivery of efforts serve can this to where effective mission at discovery to our Kevin. back medicines who everyone support who treatment options. better to patients you, Kevin. clinicians ultimate in to our I'll now need hand and partners, thank Thank external to patients call us the bring Neurocrine, of

Kevin Gorman

it we remarks, open up questions. you, Eiry. our That prepared ready and to are Thank for concludes

Operator

[Operator Please move Instructions] with ahead. Phil to first go Cowen. Nadeau We'll

Phil Nadeau

give you warrant would development? what would Can of you some A and be of question what concept for on tremor. sense us essential proof further

Dr. Eiry Roberts

crossover Thanks study. we have very certainly, you study much, a ongoing, Bill. which proof-of-concept Yes, is XX patient as know, a

also population We patient the But by study. that primary have that actually in measured impacted we looks measures endpoints tremor to amplitude severely tremor moderate is The endpoint several and accelerometer. of in have patients. TETRA's at

totality. the then hand that, in of be with middle sometime as statistically be also seeing we'll well. interested considering the think that in be significant And were including in I around looking next those regard. data CGI difference successful totality, in data at at a that our in this the we'll design. looking the assessment year, we'll Obviously, crossover But we'll be in data a beyond steps

Operator

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

Paul Matteis

if frame those On demand scenarios you end of were seeing your could the wondering before high what kind and at you pandemic? INGREZZA I midpoint guidance, different was for growth low compares how us in the COVID to

Kevin Gorman

Paul. Thanks

look back a the it, years. you we trajectory As a had $XXX growth call million a couple before nice pandemic, of,

So pretty much XX% growth, with midpoint it puts the you prior to when back you think have a been track about on performing you how pandemic.

the two items think back as guidance access to and I as to into the is the range, the point cooperates, office greater. environment, environment one, patients to biggest I'd the it that relates going customers

to pressure, closer higher that the impacting overall the end us of to the fall demand. of and have put range expect the on bottom course, continues range. If you You would, significant pandemic would to

piece we're And our of which recently. well year. by counts we're second force complete internally. we and the this The what we're sales initiative we've on quarter, with case us optimistic business been underway seeing second going benefit down expansion the expect side, of And the the on seeing in what that is the half to will then with end

to a So, looking forward growth we're for year nice year, nice another INGREZZA.

Operator

to And ahead. Ahmad America. Please Bank next go Tazeen move we'll of from

Tazeen Ahmad

same if their be the to the a else? And something in with be televisits upside, stocking based upper level for psychiatrists that for guidance variable? clarification. Just without for at of continue of Or for of how would And end point INGREZZA? then Is is for much rest a to of impact person, the there the or inventory say, as year? guidance place on is your is particular let's there from reimbursed potential it your

Kevin Gorman

question guidance, do will that first. I'll your of the our that full year. Matt, no we is within throughout that to entire want part anticipate of that? take take changes telehealth the second range there be And to you

Matt Abernethy

Yes. census as shutdown, reimbursement not our the from a that's is be higher open to course, expect but from mix the perspective, on patient is up current And reimbursement person. this likely we, policy of going a as year. front, would But of clinics the there be would changed a COVID is

inventory a fluctuations desire it nets talking inventory quarter-to-quarter. the to strong my out. On front, And is usually, within get of rid year, about

sales. update inventory. really quarter, account underlying our So, I reflects would say any that learnings of end of we'll, our course, guide the around guide thinking to be INGREZZA which demand at continuing for And into each will or take

Kevin Gorman

add sales. actually seen the that And in time, the is year's amount compared a period of that's quarters, thing would net inventory what only inventory over out. other as I now on fluctuations is reiterate rest to multiple over said And we've carried very any small that the of to Matt

Operator

Markets. Please And we'll take with Brian our RBC next Capital Abrahams go question from ahead.

Brian Abrahams

current how that you're get incremental also much curious long-term investments How to dollars year going benefits? pull it I to are to the from towards well areas these is on sounds you're way in? progresses. like like to medium year, the the just curious we your the there? expanded growth as to the on the as otherwise Congrats I'm term hoping target compared additional to to exit investment, going through all challenging as the the about in think in put current revenue Question pursue force I'm what's beyond segments right year. left the care sales do progress translate guess returns an are reopening intrinsic in commercial areas start

Kevin Gorman

it field segments. team, to sales going existing we're the and into I So reorganization the the deeper about our with is that essentially, of expansion way think think

more neurology more thus the For of them example, do team we've dedicated frequently allows to us been than to the build-out a reach and far to ramp. commercial neurologists see in able

get-go, in but With against. essentially, from care dedicated the really going one always as essentially psychiatry a this to segment for interested focus a as the next step residential There we have LTC And team, put into us. providers an And of logical way LTC the build-out wherewithal care it's think really were facilities. practice a going is didn't both clinics about to that is a are well in essentially, space. psychiatry into that

think commercial of more Again, obviously launch. that providers. the in sales of identified. tackle in go ramp more it's more So, reach base an about we and what the that's certainly of five And there's is a team where But allowing expansion this it's the field had phase we years to prescribers to INGREZZA are same providers. time, high-value prescribers the our us the early now. us for at within I deeper there's we've of allowing really And than function potential certainly existing

a priority meaning The all an other bit care. this across which note on been I more go and segment assistants what's that practitioners providers, those is is focus prescribers, of nurse to put of thing allows us sites would high practice physician advanced little emerging of

the to deeper new into tapping through long-term as move the we're So a we And segments, the in into year get about opportunity think XXXX. care. we're providing we're way more it into going is and and existing insights

Operator

JPMorgan. Please move We'll to Anupam go Rama ahead. next with

Anupam Rama

was specifically. dynamics bit into I a could XQ in if we dig little wondering

But kind about at which think talked bit previously, I given think per about specifically? in over all on XQ more just going XQ, with is provide of the color any you guidance on want the to I you've and is other color X,XXX little XQ. you script, conference, numbers place. a worried there line would

Matt Abernethy

the ultimately going patients refill through than Yes. a net as quarter. some fill in lower and a you said, first The reauthorization dynamics. always And for layer you has QX Thanks, per that rate process have the results discount, Anupam. to patient gross

seasonality historically script noisy a Typically, to pullback and because a So then the you QX QX down from is of QX bit a it of a net per always yes, the see perspective. to going in revenue impact bit the per get out see a nice Since an slight to seeing, that rate taking going modify account in as QX the of recovery accordingly. we're annual quarter. But of performance of then what a is providing on in year. we we're QX, within sets QX, specificity we've on our the up refill And throughout we'll year. our stay the said, you that some guide and also we're of patient. And guide, we've rest But strong QX. And for the exit we'll be historically as us is that QX a provided patients and QX course, goal in ultimately ensure medication. into

Kevin Gorman

providers just it Yes. that, and challenges on. in clinics as external members our presented we're affected to better. QX, It seeing us affected is sales in team that QX a with. add falling things environment. ill, for an that be Certainly, a deal good with And I'll that the well cautiously quarantine. our surge improving and and staff business. good that in here We're appear to Omicron number our shortages, early obviously, a needing news of with variant getting lot customers chime the so chunk optimistic benefits late having of of team to our The certainly, with additional

Matt Abernethy

to in a said very to with is the starting And be team that, QX thing QX. Anupam, would was challenging looking that put what a to going we lot the actually in help was it of order commercial place efforts prepositioned only like in I add

and said, it I come to cautiously Like to Eric the optimistic put think think to efforts can best we're way help. those improving only are is environment fruition. going I

Operator

Gould Please to next with ahead. move we'll Barclays. And Carter go

Carter Gould

Eiry. one for Maybe Great.

the potential study? the are about insightful be tremor have guys might of broadly we about read-through talked data guess, specific or additional there future study indications. some coming as And the indications? to think Are the signals study about the are have that positive you that might specific back to e for later about epilepsy data the think read-through that ET derisk as in that ET think there always come more year, I you study ET then will Just essential there, from out XXX,

Dr. Eiry Roberts

Yes. Thanks very much.

the the mechanistic are very to that impacted that know calcium wonderful links directly tremor that channels epilepsy we to So that from network tremor within perspective. also a represented channel, look by network. calcium T-type And

we're I and dose-related some study, understanding So to actually, terms effect issues from XXX. medication able in that in using information is the ET think pharmacodynamic generate of the in the of of it helpful

that In to population way study pediatric addition, And CSWS, tolerability different obviously, we be from patients if some upwards. it's age population. will very epileptic you two obviously, it's think about that rare initial our information in a get is a will study, study patient but in ET the CSWS a encephalopathy. The in relevant

different adult so from it is which is population, older And the ET significantly population.

at be totality And space we'll So wait anyway. of and to long data think, initial very I signal we safety efficacy ET looking both actual the to the and from won't in general, the tolerability. the in the profile the CSWS have understand

part out CSWS be Phase XX the the study as the in of from will We X latter reading data well. that patients year in

Operator

of We'll Bitritto-Garg Please to ahead. Neena go move next Citi.

Neena Bitritto-Garg

back of high going versus low having CMS then I'm thinking year previously of in midpoint visit wondering you on a can that, a telehealth the decision every seeing that about whether INGREZZA that first the or whether likely and talked you've having in-person give range? the more patients after end the visits XXXX to Just person of at will how And event. us be just patient sense if proportion their and you're psychiatrists about XXXX guidance.

Eric Benevich

it's of in utilized a what it's bit, in certainly, psychiatry, telehealth about different The in that a pretty rate returned to close neurology, a be than patient XX%. we're lesser Ultimately, it's The thinking Frankly, is for degree quite psychiatry. is quite virtual utilized example. all whereas much, that high about was impacts and much to utilized And been still business seen Yes. to that we've latest are LTC, data it a less half it's pre-COVID. utilized portions visits that differently. our continues at within bit of it has way to telehealth is

baked even lifted, going significant into expectation of and is our public and we've there's health the so be utilization emergency our And that assumptions. that planning psychiatry, in after to that our is telehealth

second of a in-person We're certainly question recognize guardrails at and sure opportunity around have requirement reimbursed. telehealth first be as going your the to of proposed, visit that once supportive that are least of their want see for part such be circumstances, sure place year, some subsequent visits in telehealth patients value The We making a person provides but certain being visits guardrails really having was to in make providers person. in the the that are in to that forward. there

we'll see is XXXX, shake the So things how our of quo. But for expectation status out. duration

Operator

Skorney Please with We'll Brian move next to go ahead. Baird.

Unidentified Analyst

This for approval a more in gradual loaded impact expectations Kermann] rate? for And in your an or indication for you a in growth on how disease front the to discuss do could pace? that is be you Could sequencing Brian. just chorea INGREZZA's uptake [Lou of bit Huntington expect

Eric Benevich

Yes.

get need TD, So of XXXX, experiencing to patient we study because opportunity patients to the to that assuming INGREZZA that and process, uses. label bring INGREZZA this is successful Huntington's the excited our finish that of proving and open-label chorea. any patients it's it submitted. We're a expansion The emphasize specialty is all giving to a prior for population, way essentially we they're to first about and But any but product all, health essentially sNDA now. a very about -- incremental in think plans, authorization we're those we're those that new a it's The not the with other for not want get are business. to Huntington

a of the when really of with to get this of the label. be opportunity VMATX have what going a your a chorea a patient treated within So this need. group we're little medical look opportunity the I that sense the to Huntington's to patients chorea Ultimately, we would front-loaded we around that the would are And the more further labeling be as was we or forward XX% patients provide the have down will inhibitor. bit with We Only like. view say currently about second road can looking ramp. a is question gradual of color Huntington's part unmet and expand more

come there's differentiated many INGREZZA Huntington an for product patients more certainly, with a to and thousands in potentially So like opportunity benefit to chorea.

expansion. for more as tuned progress in label stay make we that So pursuing

Kevin Gorman

thing only being having their that that, of the approval INGREZZA and you. to the with add force ask focusing Thank that base. I is dedicated now treating they start help obviously, efforts these a time sales neurology would patients TD can on will with can And update,

Operator

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

Myles Minter

heard on over back Just be the I've have of that you'd I sort to around expecting previously, time. that projections? been for $XX sort steady creeping with but number, of growth new state channel inventory around think INGREZZA. the forward the What's moving seems your million the showing

what is inventory? for new point there set wondering the just So our

Matt Abernethy

about you're stocking for... you inventory typical be levels asking could Myles, would clarify what

Myles Minter

forward Yes. time? growth And change over going your also your with to rates, projections anticipated is moving that

Kevin Gorman

of from, three grown call And there between our inventory at two account to it, on in volume it think on see take growth hand I No, about weeks from mentioned, from and look Yes. a hand. two of channels, -- now. have we're any you three typically weeks perspective, into as our which you somewhere weeks, to right would and a we in days

three-week is on So number variety a stocking less to And our distributors is somewhat really product off But earlier, quarter-to-quarter. hands we it's I think two- what are days for become a of we you a hand reasons. meaningful goal don't expect. as channel with should our influence Kevin said

annual major a you think part there's as about transparent we'll year out guide, perspective. some net the if course, throughout always. Of most on days fluctuations, But end be for it as the should from

Operator

Schimmer And Joshua Please we'll to Evercore. ahead. move next with go

Joshua Schimmer

larger this are? year? And what what reasons. you deals? distributors for those then, share hands a indicated variety your Matt, appetite business some activities is to of Are And inventory you additional of Can planning with just you reasons respect your for off with

Matt Abernethy

Yes.

causing of to sales One projection of them sales volatility performance. the our just purposes reasons or -- sorry, for in our is

influencing incremental some just think whatnot. we're incentivize our provided are really why whether stocking, have sales practices the discounts one and reason They and primary say giving place TRx. discourage be buying. we've I the which there of in that results. demand, speculative is would want where overly number, to don't more We a try towards that talk we to or underlying just target I a always

Kevin Gorman

And over Chief I'll development, Development. our turn that far Gano, Kyle as Business business of as to

Kyle Gano

at are and things, we priorities of that, side valbenazine at second broadly just development. franchise recap and business BD would investing the pipeline and On heavily here be obviously, to and to of in kind the our two INGREZZA

So, looking into there looking we things bring sense. and if active they are still to pipeline make out the

long-term more our think continuously from mid- ranging licensing on and traditional objectives, I all things of deals opportunities that co-operations strategic. we are assess from types to

So to we you've if currently the in we for work the and have us that can that find with been pipeline the at those seen look the assets things in late-stage that I think bringing in, development. sense and make few years over past

Kevin Gorman

constrain did We not ourselves.

Operator

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

David Amsellem

-- volume you quantify And how based? potential about even about of just the to that? think and opportunity, here, think this. should talked how talk just long-term about new sales I may long-term TD opportunity, about this the can not portion should So the Can extent that market being care you is care you we but what a have underlying, you missed regarding potential

Eric Benevich

Yes.

care it that the few long-term is But that haven't treat expectations of the are we around cause guidance what long-term way that given patients the blocking for represents care to that think residential sales any types the is dopamine with it care. and way about the about residents really facilities or a think antipsychotics drugs different or -- We specifically TD.

include homes health would disorders, with care that or those intellectual so facilities And would patients behavioral developmental might that geriatric that conditions. facilities treat living facilities assisted include or nursing with include for that residential

and could be U.S. ultimately, in individuals subset several And so are people somewhere obviously, look any represents a time, And the and million up, those antipsychotics to you you at that roll at them XX% that of of if that given facilities. between XX% TD. expect on those having across

population a in the significant population on into early have be So and segment resources that size patient on feel that are launch. certainly like the the interested to of prevalent earlier, believe the But going focus in we the I versus experience that like space incremental out LTC where wouldn't that it. capacity to the and in a they it TD the we TD in addressable said it's opportunity of overall it's we seen. with have in remains based and shakes early terms But

be couple you'll perspective color we're getting getting progress. for and that But will I really, that up more ourselves think opportunity deployed the get next as better and doing make XXXX quarters, set be lot lot of So will we'll be for exit characterize we success really just QX. and team exit And and as a we as a I to trained into say we hired our XXXX.

Operator

ahead. Oppenheimer. Olson with Jay next go is question Please Our from

Jay Olson

addressable your XX% total now diagnosed, you the you TD U.S. patients the Since education is of can with talk progress. XXX,XXX on diagnosis and the And growing? level fast that all ultimate you as is the TD initiatives? about could continue for of on market in Congrats how population patients, your awareness comment goal the

Eric Benevich

Yes.

as based growing estimate data, the this. rapid and literature of our at the with And is and U.S. people use analysis This population, growth in et claims the the it's looking conditions. as in around really met especially antipsychotics, we well So reassess cetera. a of tardive XXX,XXX dyskinesia, on periodically is of of a function non-psychotic that's

think about And used number treat anxiety. to of uses There's off-label in treatments in used treat antipsychotics they adjunctive you are bipolar. their of so used antipsychotics. it, a to schizophrenia, They're widely if

use so size time making seen have progress And been have population. of patients we of of spans, those estimated in diagnosis. a a does that the as have get yet that diagnosed. At we antipsychotic TD. the them about with And over the reassess beginning those percent the of so importantly, estimate We'll to to diagnosing, more individuals continue helping we're launch population be we unfortunately, diagnosed. given our of the in Today, back single-digit quarter XXXX, the

a that inhibitor. get about only even are patients a today of Importantly, VMATX half diagnosis offered

and the population go gets for making a prevalent these with disease terms diagnosed in that in as and is long gap making and we're is get bridging that, progress making the of standard as there's way diagnosed coming we So And terms between to regardless setting. of reinforce that screened population the sure guidelines everyone the the that lot the to that can well care expectation is that sure medicines. I'll treatment. antipsychotic we conditions last the higher thing But treated the that psychiatric routinely going goal certainly the But effective care to gets of The Well, years APA realistically, with would you especially TD with what's is is about patients get know diagnosed. diagnosis say a is here of XXX%. asked a leveraging goal. really being that be offered everyone the not in

Operator

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

Vamil Divan

last Maybe Great. the quick one just question. follow-up on

that's little I able I'm curious think are rep product know it's a if be lot I INGREZZA. you selling having mean you of product hundred for at better a I in sales million commercial think sort assuming looking people couple that again, I'm consensus of alone when a look realistic. think are as you access numbers. what might several us could for growth. a us growing synergies like to the question delivering like market my see It little just But opicapone. synergies, get of population. is TD you give trying just for you you that a quantify I'm with of out more someone kind if a you be know that bit a sales. does think and sense that you as of can more we years said Or smaller maybe overall But And value. along you from just you of the if I a better that should on now. get of when the don't sense think how may there opportunity and see just to we

Eric Benevich

Yes.

the of in the then question your address OGENTYS. and tackle me I'll growing clarifying question -- question the population your about about Let TD,

use So expand. of -- of the to million, XX me, a antipsychotics yes, XX been said reason growing excuse over There's that continues I it's population antipsychotics is million million the prescriptions the year. XX past that

in more expand as pandemic to expanded this continues people health environment for especially uses are where that being and more the so antipsychotics disorders. And treated mental for

tend though time. of patient greatly antipsychotics lower even to expanded population leading have what's a is the over TD to TD, antipsychotics a second-generation use So growing of incidence

update is monitor, it's we estimates. once was with estimate closer that you might TD. people we XXX,XXX. to again, to that, recall years So we our XXX,XXX and And continue five And our something ago, that around estimate today,

Matt Abernethy

prevalence TD correlate with antipsychotic use you if quickly going. is the how So

is You have X%. X% antipsychotic market growing the to

normal is it's the give of know an it So faster you exact it's than on you patients exact but hard the growing TD, population, to segment. percentage growing have general what a but number

Eric Benevich

majority they anti-Parkinson's a And non-formulary in especially Medicare seen will of branded primarily that ONGENTYS The within the Part point with question and because a treat to made of great D expect for medicines I a across really branded other Medicare medicines, of my that, non-formulary I plans, that's your products. as plans, the was ONGENTYS it related part is dynamic prepared acceleration the a tend product. remains we clarify that XXXX, on coverage. shouldn't in remarks sales all

formulary So to we'll our to process. exceptions get help continue customers access through the

will a ONGENTYS. do dedicated I'll that believe is that thing neurology other we say having sales benefit The team

our earlier, and, more customers reach As I neurologists benefit in value to us see ONGENTYS frequently. of tardive INGREZZA will course, dyskinesia. And more highest allows to that mentioned

Operator

We'll Leerink. Marc SBC Goodman go with to ahead. move next Please

Marc Goodman

about the selective talk Eiry, can agonist. you like you MX why

you maybe the the MX, about we will taxes comments the just the forward? just the how tax why clarify you have companies in the and cash on tax curious just what on NOLs actual going press different should we I'm And taxes just pursuing like could to and we Just context, income release or are rate versus just MX about these MX. this understand going when so be and statement runoff think one?

Dr. Eiry Roberts

certainly. Yes,

at The excited the space least MX validated that have So our have you're correct. are in opportunity the And, agonist. two about in-licensing for this part selective we're the modules in that very we MX through clinically There yes, mechanism in we were acquire we several direct of in the a gives reason agonist collective like benefit that MX, to psychosis the here us is ways. this and treatment is and that of schizophrenia. that molecule able

effective mechanism -- it's pursuing muscular in be in that acetylcholine treating doesn't patient portfolio, be because an indications require those the is it it all, one in many in certainly, of the brain a doesn't deficit space not our is modulator, of of might small acetylcholine the is, populations. asteric we in First interested which And patients. competitive to with this substrate

likelihood And in medication so would an effective say. I presence substrate that is the requires that of having the question, of

study be we with a so And direct better year. understand clinical schizophrenia best to the within believe the we in that be target. the this Phase And this agonist in we against X will to approach, later potential starting then have opportunity last

Matt Abernethy

Yes.

noisy different drive your tax will always the when you tax volatility front, it's on and rate. have in So low items permanent book your income, effective

Hopefully, would I then a NOLs would the year, in where I've of when tax a tax tax this here through year through that us remainder of just to that expectation effective does burn midterm the provided everything is that, that cash is previously R&D, is deduction guide portion capitalize as be then think later cash over of say be and is rate going somewhat a paying taken federal XX% change now. to to position remainder but time I to this puts it the the But that's minimal. we'll On you basis, causes would big So we're A your our burn year. legislation the that NOLs just that cause change. gets our tax that us around have this normalizes. legislation

the equivalent bit then will say state for year, would federal would for than cash that income side. X% a full I to guide year our of little rate. you tax And a next cash on this gives and the So tax a tax more likely be effective payer to be X% somewhat

Operator

go with to Duncan ahead. Fitzgerald. move Charles Please next And Cantor we'll

Charles Duncan

very deployment, wondering, I'm new two guess the I of questions, you But weathering you month. us of that force ones this end looking have sales the key one I if look the if end effectively would us of give weathering, the field patient you're Eric, I'm 'XX. for predictive on I points Eric, wondering, by color on different time? in I'm for for metrics proof-of-concept revenue challenges that over said XXX, you value then success I question related versus congrats more perhaps could sense to one essential clinical you that could studies? investment? Eiry, about the CSWS, tremor team, Eiry. provide is And guess and Kevin Yes. really those wondering for which beyond quarter. populations. at But to quick And the gauge And had for guess for the a

Eric Benevich

learn has going With as to regards roles. we psychiatry looking of neurology, in are gate I'm make and going indicators what to leading kind be average, looking members, adjustments sales year. we I'll care and the their experience effective about leading members sales either go the call the get team how that indicators team become we're of of as in quickly are considerable at experience. that years new really long-term to talking the out new XX The hiring Everyone certainly we into can and related about to

However, before they INGREZZA. medication they TD haven't sold haven't sold

bit a of learning And little so is there a curve.

field tracking front like of And like here to There's how that. of And leverage members we've will the off key things training a of hiring and get team our on. things new work in-service doing in new so been ability their at programs, component. resources to relationships in in effectiveness as starts handoffs are of been able existing as and get lot a them happening lunchtime include they look of the right to generating start, been that a that's warm customers, we peer-to-peer help we sampling, be patient the ultimately, programs, along so some key customer terms to

about And excited half especially expanded field the impact year. going sales second have, of So, to optimistic an the we're having really team. the we're in about very it's

as further more get for stay tuned into So we it.

Dr. Eiry Roberts

Okay.

and to both They're one entities against So The trial. adequately on would in the is primary it's that whether the are the But in informative endpoint for CSWS, not into the they obviously, Also helpful both with primary detect have. are endpoints in very the the XXX, to CSWS ET trials, altitude medication the of the and although say impact clinical the the CSWS. trial clinical themselves the these and in EEG treatment first have or trials, respect ET are be aspect ET likely they trial, the trial. signal themselves, could one trial. we we able both built each X one a Phase clinical that the powered to I short-term trial do endpoint relatively

endpoint. trials medication the So clinical of whilst primary impact these beyond we'll get X an initial the to Phase as the indication from

that. so I could think require it registration to validate larger scale much would obviously

Operator

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

Chris Shibutani

questions. a large response there. about talk essential very the have observed Eiry, little the if are could you in for on Maybe Two your tremor others placebo placebo press what further bit expectations XXX I effect. study

fairly with the I for were XXXX specific period, think time If from in second treatment can us annual either or you terms on response of So to first the perhaps to be you question bar percent then I Matt. percent appreciate of in quantify a And guidance. responding back the think hit you an what unusual revenue basis. in quarterly terms patients of would amplitude? a granted helping decrease tremor guidance

comfortable an So interpret the mean should revenues this quarter? terms general not currently as where analyst seasonality we provided we have, of with to that progress, specifically in to is about experience as that you're thinking this in you first INGREZZA seems consensus the to have with particular commentary beyond

Dr. Eiry Roberts

tremors, at But endpoint population. response, have studying treatment, would an In And treatments anticipate you material to impacted in treatment Okay. steroid placebo any been essential EEG severe there is said. low. on is trials. we The to the be two response them it's mean, question, as that that where is EEG I the there obviously, such great In for as EEG extent a low. variable, are XXX think placebo that looked population CSWS, patient anticipate we that very I very think haven't I in endpoint

We have It's study. in study single allows designed site against response. this which within to the power crossover It's a subject. placebo us study, look try order a to a to mitigate

so And we have that take be that look we done we'll we response. think the see. what we power everything topic our a to in to data, as midyear get I at obviously, And mitigate the -- then within able

Matt Abernethy

Yes.

recovery pullback guide, the can provided. that for you dynamic we effective of the outside earlier, being said top get were like regard. through this working into on how comfortable the biggest very really QX. as somewhat And which QX. reauthorization process. And would treatment be feel the of every think from normal at time, ranges I I annual a And that then hard seasonality how of with we QX, and we said say QX look the to I I As keeping XX% to in improve type Chris, down environment they reflects we've mentioned range back are comes you see in of Kevin patients earlier, on low really on and that to and that Eric earlier, when quickly to sales on

dynamics to predict, lot are know. fairly the I of am what than for will specific more QX. there on know be to think Hard I a But I be desire So me I clear.

the as would around revenue on XXXX. raised clarification, then per coming and to gross On to And QX, it, wane net we call our front, would discount In similar the just be gross year is I have script which of out X,XXX, to the it be to per it. net revenue we average, hole. will around, to and net our throughout think $X,XXX, script net the expect a donut expect improve Anupam

Operator

next And Please Markets. we'll move go ahead. Capital with to BMO Evan Seigerman

Evan Seigerman

incremental not for investment? any investment? you've the the the investment drive $XXX ROI there to specific on million from looking what made So discrete Are And organization do in INGREZZA. hope this this Can here? the the the commercial time what you're at of metrics us is you first effort was remind you prior

Eric Benevich

Yes.

investment. may As And frankly, not last the this life we the very move it for first cycle forward it's the product. noted, not as you've long be a with over course

prescribers, in we decided were frankly, fact expanding people the potential XXXX previously, in As pull that get sales the with we an that of learned in about excuse update do exceeded in last INGREZZA sooner. prescribers trigger field a growth team. and to we've been launch, a territories we able to the had we it's the -- force that that that of that place force than an and raising sales reorganizing we've to me, had a larger of for looking the terms the do with both fact that for rate, progress team were frankly, psychiatry. help quickly And and expand terms diagnosis are of over in there in sales reminder, expectations. needed number initial the of were in our seeing, the the early of several XXX we field number high being The force our made with being brand, years the right much and thing covering to launched now as of territories. we it's and XXXX neurology initial And effectively accelerate to at thing able they we to because I market, large rapid treated of development has the early disclosed diagnosed where the sales on XXX right the and little think

is not patient So to with to needelssly our aspiration suffer TD. allow any

neurology, neurology. from untapped significant can earlier, think LTC XX% color a that as of that largest the this an additional we forward, of essentially comes be are prescription So psychiatry with It's there's able only remain segment we going is our volume. resource. terms things and will to expansion. Certainly, has We we the our of improve provide more going opportunity. how grow I will to in mentioned like portion and And in with opportunity about feel business

insights the of know providing ROI we'll of business assessments, but been certainly, from sources phase get the don't business and So I provide to we'll are has growing in where down growth. if how this next coming

Operator

Please Hung our we'll Jeff Morgan And take question ahead. with from last Stanley. go

Jeff Hung

trimmers kind tremor would I to peak that a this look said totality need Eiry, of But the of to bit For postural data you patient clinically you XXX. more could the in beyond what I if meaningful central at frequency the ask in population? in the on look of and little change would endpoint. know you that be primary apple

Dr. Eiry Roberts

to I that. answer think approved think I'm a used. only correlation now able you for deal, really, being that since just there's nothing think don't or been if not enough the medications able the XXXXs. about be are effective there's work And treatment I off-label to that is this treatment

the the ratings well-controlled So in includes frequency. looking daily appropriate that what to a believe we at living. more activities at ratings, addition which and we'll that, assess study is clinically relevant, we're endpoint looking a obviously doing this TETRA in study, But very be to that tremor is

treatment the is tolerability critical a of type of forget for be so that the successful for initial not And totality unit safety [indiscernible]. that to to clearly going be can this that in proof-of-concept the data,

Jeff Hung

the or clinically mentioned since in be And CGIC meaningful? TETRA you specific that would changes TETRA, are there

Dr. Eiry Roberts

I for is crossover. the study this two-week of dosing a mean with each element XX-patient crossover

regard. interactions in said, discussions I and that think obviously, don't And pleased very that if so, program. we'll anything a further for And we for further be see registration

Operator

like Gorman remarks. closing to And back call to I now Kevin turn for any the would

Kevin Gorman

you Thank thank for much, and everyone, attention this very your you, morning.

What getting have seen returning ahead today, to I'm growth is heard pre-pandemic and -- As to busy return to to year quite us. a INGREZZA of looking forward year the levels. we this you've

looking very very at adults NBI-XXX, ready the to and year. pipeline look I CAH the going the X this studies tremor think do I in NDAs. forward Phase and Phase a And in in sNDA. the CS with we for be both that and both committed We're to they're finally, about also we'll multiple enrollment both at important, also and this And U.S. then we when And talked yield those the pediatric finishing robust are that's milestones, confident and X programs. we've able look year, in essential XX specifically to then submitting next submission yielding data Huntington's two that. year getting and I'm disease, to

is said, even as year, and So a be following the I busy year jammed going to milestones. more with

and forward you with in you person today, So really getting looking much year. meeting very care. I and we're for the out once your to throughout again, attention of all Take thank

Operator

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

You may at a day. disconnect any time. Have wonderful

Dr. Eiry Roberts

Goodbye.

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