Neurocrine Biosciences (NBIX) 4 Feb 202019 Q4 Earnings call transcript

Company Profile

Participants

Kevin Gorman	Chief Executive Officer
Todd Tushla	Head of Investor Relations
Eiry Roberts	Chief Medical Officer
Eric Benevich	Chief Commercial Officer
Matt Abernethy	Chief Financial Officer
Kyle Gano	Head of to BD and Strategy
Tazeen Ahmad	Bank of America
Paul Matteis	Stifel
Brian Skorney	Baird
Owen Drinkwater	RBC Capital Markets
Tessa Romero	JPMorgan
Jay Olson	Oppenheimer
Laura Christianson	Cowen
Charles Duncan	Cantor Fitzgerald
Paul Choi	Goldman Sachs
Evan Seigerman	Credit Suisse
David Amsellem	Piper Jaffray
Marc Goodman	SVB Leerink
Joseph Stringer	Needham & Company

Call transcript

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good day, everyone and welcome to the Neurocrine Biosciences Fourth Quarter and Year End 2019 Results Call. All participants are in a listen-only mode. Later, you'll have a chance to ask questions during the Q&A session. Please note, today's call will be recorded, and I will be standing by if you should need any assistance.

It is now my pleasure to turn the program over to Kevin Gorman, CEO of Neurocrine Biosciences. ahead. go Please

Kevin Gorman

Matt much, Tushla, us very Roberts, thank everyone me. and Commercial you Chief Head Gano, Thank to Head of this operator, of afternoon. joining BD Officer; Chief Benevich, here Officer; and Eiry CFO; Today, for Kyle Medical our Todd you Strategy; Eric and Abernethy, our I our with have IR

Statement? could out, we Todd, you read Safe start Harbor Before our

Todd Tushla

to, are of afternoon, historical in is Form everyone. XXXX made this concerning Information Company's Certain and to be cause conference statements, differ Company's statements third not course in results could including, the actual XX-Q forward-looking contained release. to today's by limited that the filings, or contained Good may Yeah. those the in risks forward-looking subject in call statements factors statements are that materially quarter SEC the uncertainties. from which press and not implied but

obtained visiting date, on may and Copies today's update Relations any statements website. we of Any these page Company's disclaim the Kevin? obligation by made as statements. forward-looking to be are only forward-looking the Investor

Kevin Gorman

Thank going you, my questions. keep brief, we Todd. can your to to so get remarks I'm

believe appropriate growth We dyskinesia tardive significant struggling, and treatment. for will year a in was of diagnosis about educating XXXX the we sufferers are still beyond, foremost, make These and where majority efforts INGREZZA. progress dyskinesia. tardive and First vast providers, caregivers because while waiting be to XXXX in for our a continued of focus of patients primary XXXX year healthcare and will continue another

four have important and in II of five three This to product by took in real compounds company. not year, neuroscience clinical fortunate we're also be our build Phase trials, In steps nearly pipeline medicines doubling the the possibility we studies XXXX, company approved leading will that, single a indications. biopharmaceutical important said having three compounds of pivotal we having in Now to medicines.

from foundation which we'll build. powerful that's Now, a

With Eiry. over like turn to call that would the Matt to said, and I

Matt Abernethy

earnings Good net afternoon. putting we I And over over in our thank second keep will you strong provided quarter full million market. comments sales, demonstrated the $XXX since the of million past INGREZZA for my our $XXX with lot product quarter information a sales in XXXX, conference call. fourth month. year Overall, another joining calendar brief, on just

Full activity our and we'll non-cash of the items, a reporting increased included tables in on begin press performance development our basis. business our reconciliations P&L Given GAAP and financial are non-GAAP release.

million. million with sales non-GAAP QX Our net and profit $XX income of net of translated into results income increasing $XXX

For the the full $XXX net with We securities. year XXXX, of exited $XX non-GAAP year million we finished of in cash million. and with marketable million net $XXX income income and

XXXX $XXX and to our GAAP SG&A collaboration. million compares to and XXXX. of programs and investments registrational in R&D R&D, investment our for meaningful Voyager and three non-GAAP XXXX $XXX The million reflects million SG&A a we on increased increase to in Xenon million R&D expect $XXX million our and on $XXX including Regarding expenses $XXX of a expense non-GAAP range guidance, a basis basis. This in

the in guidance GAAP guidance and that business note during of our $XX IPR&D future share-based reflects Please or approval approximately with current milestones future the GAAP costs expected connected associated associated out of million activities by anticipated are potential reflects second compensation other quarter. INGREZZA of expected with or No investment guidance. opicapone. the For opicapone included pay million the FDA SG&A, our with continued our payment development in milestone and collaborations, $XXX launch marketing a

with the still help educational diagnosis in efforts rates TD. remain the We'll developing patients TD for ability we've while in to only confident to our INGREZZA, struggling tardive our Regarding progress mid-teen. market, are made continue tremendous many dyskinesia more

what providers, continue to remain script in and with XXXX and expect revenue Healthcare we as of understand per realized insurers similar in INGREZZA net will the strong was value access XXXX. patients

company we to is As dynamics. any with payer-related specialty tier the think quarter of year seasonal due drug about QX, first every for challenging the

mitigate We to are the impact working from diligently these headwinds.

poses challenges, and new is patients quarter year. first our INGREZZA the unique on stay Although, focus with help seasonal their receive long-term the patients TD ensuring existing throughout

investment year we existing our signifies to and XXXX expand into programs INGREZZA, grow an Overall, important advance of as continue our increased pipeline. Neurocrine

Eiry to our I that, the hand now With Officer, Roberts. Chief will over call Medical

Eiry Roberts

program trial portfolio, start on Matt, clinical you, will call. and anticipated the present afternoon also the registrational of with across meeting San will at We in good data concept patients Congenital we on with I my the everyone track the for the to the including Ahead Thank today. on adult remain keep timelines all March adult ENDO brief this, in Crinecerfont Crinecerfont year comments Hyperplasia. of of Francisco mid for XX. proof Adrenal

Neurocrine, diversified at to By development three study plan different we multi-stage stage in Neurocrine portfolio indication the clinical early of end in program. programs clinical four -- studies, this and each a mid-phase of to registration including have a year, clinical

by clinical better disease, need near-term, Opicapone, fluctuations potential the is in significantly the has date important with for motor treatment who most program In PDUFA adjunctive the to of Opicapone April the options. portfolio in the Parkinson's Neurocrine help patients XX. patients impacted

the Parkinson's well-tolerated, payers U.S. forward and functioning bringing for patients patients. a to educating inhibitor impact improving motor the COMT and in Opicapone differentiated, have patients on can physicians, that for look in We to pick this

pediatric focus For collaborations, Neurocrine's most epilepsy. my on precision review into of I'll entry highlight two our which through the field remaining recently remarks, rare announced medicine our

announced Firstly which an NavX.X molecule, selectively and in sodium channel. rights first-in-class we potently promising exclusive a inhibits important to gaining NBI-XXXXXX, the Pharmaceuticals, Xenon collaboration with December,

promise to XA of believe genetic this a specifically of channel. in have mutation sodium pediatric the the encephalopathy type could great function for rare SCNXA molecule gain We or epilepsy, short, of related treatment a and NavX.X devastating developmental for

developmental a causes of and with chronic XA first life and very seizure few the complex disorder in often represents months delays.

with XX% patients of can In unexpected to XA. XX% occur in addition, certain death

For and to opportunity the precisely for selective to time implicated provide NBI-XXXXXX improved patients and with a the available its significantly action, the profile target in channel we offer these mechanism ion benefit plan currently relative risk of first to treatments. XA

also in potential the XA, file We plan seizure patients IND in this for of of great XXXX year. including epilepsy. a order middle the second has start focal to in of this range an Beyond the in trial application half disorders, adult to II NBI-XXXXXX with FDA XA in a Phase molecule

that which potent, I is ACT-XXXXXX, clinical channel epilepsy. studies selective, into Phase which Idorsia, and agreement includes in orally-active had to option rare we a Secondly, completed January treatments as disclosed for license a brain an we calcium blocker, entered exclusively T-type potential with the pediatric penetrant

study this of IND in approval initiate Pending later in of a the we rare starting second a epilepsy pediatric this year. half Phase plan II the to year,

across In potential disorders, of pain. addition to this tremor important broad essential mechanism including the application neurological a treatment range has of epilepsy, and

collaborations and competitive. Our not Idorsia Xenon with are

to fact In reinforce treatment of inadequate. patients they are highly epilepsy devastating largely needs with options are addressing and for and the rare forms commitment complementary born whom our of currently available

gene with collaboration II XX two the nearly programs end our It epilepsies research is and Through months. our agreements molecules have through Xenon, with this by of Voyager, and in in pediatric last Neurocrine's rare doubled we've therapy internal Idorsia expectation year. our pipeline the efforts Phase to these over

important make their these the of their has program pipeline our by at the work a on to to close molecules. patients in Neurocrine to I'd many and hard dramatic impact on advance lives thanking partner cross-functional potential Each and for at families the our teams growing like companies Kevin?

Kevin Gorman

you, Thank Eiry.

So ready at take this questions we are to your time.

Operator

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

line is open. Your

Tazeen Ahmad

to you Good you, that competitive not When pursuing made partnered a or the you you talk taking be afternoon. think with programs that do in to Idorsia Xenon say each Thanks be about point -- my a specific questions. Maybe question will programs? so other. much for the and for it one for are would indications both you Eiry, you're of position what with these from a

various be getting general of that crowded with investigated? those of also action thinking And space as epilepsy are the how seem about you're mechanisms Thanks. to being drugs

Eiry Roberts

Thanks very for that. much

currently mean, particularly of old. space; is that very are in in patients more epilepsy a So of serve there still their epilepsies significant generalized -- broad that obviously, opportunity we first actually epilepsy are And the in fact broader all, I environment. the terms of many believe benefit to profile, used in drugs the risk in

more doing we selectively on through blockade that, have address we target If our although very with specifically one approach have long-standing mainstay sodium the the opportunity two the channel of epilepsy and over on been think that about to channel the the of much us and sodium calcium epilepsy. to precise gives the NavX.X a sodium Xenon believe the treatment we're mechanisms symptoms blockade we in way in past, here collaboration the focused channel opportunity and channels of here,

First, in rare the in that, epilepsy. but SCNXA pediatric beyond more epilepsy; focal broadly adult obviously

the agreement more we we'll IND talk With indications more the that and opportunity then about that phase able other the be once we for say to are the about as to the collaboration Idorsia, option of potential still with in respect is to obviously, have collaboration. that approved,

Tazeen Ahmad

Okay. Thank you.

Operator

to go you. Please Matteis with ahead. next go we'll Paul Thank And Stifel.

Paul Matteis

Great. much for questions. my Thanks so

speak past, to preferred, getting you was Maybe seeing two wondering this foresee a is ORILISSA could what continuing? you rate-limiting INGREZZA, little INGREZZA In being access. but comment not you the certain INGREZZA, on for you're just one you picking that talked if plans, about is of what I year? Just could dynamic on respect bit with contracting, the that for

with thinking down about Thanks inventory all it risk fall could over are a Is actually quarter? maybe XQ we as relates is color. at inventory seasonality and How that a there see to potential so second, once a in out or then much And going then million for $XX being you any time? that sequentially player quarter that? to also a headwind, this

Kevin Gorman

Paul. Yeah. sort questions order. those reverse of We'll Hi, take in

first in the that million $XX million about inventory think your point, quarter, product we reported included as net in So, we was sales $XXX what in build. QX to

$XXX the QX So right would off for jump be point million.

translates think that really would at how for thinks QX, everybody make consensus to we expectations and QX. dynamics Now sure there's to about about play as that want three you informing

assistance. D to growth period co-pay largest one is net being because hole QX first always and discount, our gross net to Part the The commercial of Medicare donut discount

you you what that QX. people think versus many think last X% and of the X% as sequentially, about about could be I have between estimated said year, And impact QX as

number. So, directional that's a I think probably

that piece, first their to beginning patient second to each with at ultimately a has occurs for occur go cycle in a existing is their of a piece it's plans. patient. the And leads rate is, lower the most reauthorization get that The refill time and an with extended what process year per which the just fill through delays material actually to patients as do

Now, but very the year the actually doubled you significantly rate this this greater, on year, maybe compare year. if last be patients to the dollar similar we've time number of INGREZZA will last compared to now as because magnitude

the -- between out And average if illustration, of just just by a quantification of would scripts if patient a TRx. frame first is of X,XXX and had that reduction that way quarter X.XX headwind within X,XXX to and you a have the sequential on

through clearly So, you the are challenge of INGREZZA. impact. unique reflection just and our it It's fulfillment purely that now. It's hard of This is medicines, for teams many demand a underlying work the specialty it not could working through, be tier happens us. meaningful to not a right and to a

And inventory third you the up. is then the brought bleed that just item

as that be build. should it in million to the will on it's your quarter, expectations. predict that It's far something setting surely materialize radar hard $XX but We as that have first

it reflect although just for help XXXX sure I'm the just here quarter, say, dynamics, our belief we to but real more patients make first people highlighting understand set not these the the appropriate and long-term I And to many opportunity emphasis that and INGREZZA. all within QX is have expectations does with

a that We're receiving treatment. fraction of actually mid-teens in with of the diagnosis

sure else, we and lot through Anything of Eric? us, but opportunity to working a make provided complicated, of we're adequate color. we this We QX have very wanted dynamic ahead but

Eric Benevich

have if and XXXX? launch, related we've first to contracting and access part making the to that activity patients remember important for significantly Yeah. off providers coverage I'll patient I was Paul, in correctly, of start is your by critically and the us the sure open saying invested sort INGREZZA. question of throughout course of So, really for access that and expectations relatively

the of early an with we've success written a per all specialty really less times, can being affordability days and very medication, with been plan through This and of filled, of month from launch But require before the prescriptions virtually paying pleased over up that prior all perspective, is XX% claims XX% the those fill. per are the prescriptions and way current treatment. the $XX the through the initiate authorization we've patient approved to than patients had

more the phase selectively recent contracting from gather become payers of said terms to in engage of certainly, the brand. we with larger attention a And our in that more as launch, plans So, to activity. we INGREZZA started we've started has previously

word And I will to secure been course we formulary, patients INGREZZA. are of approval on launch, we've selectively, re-emphasize found over We're not successful that on for approval. securing the because in of in whether helping the regardless of the formulary and need we

landscape year. coverage We we're looks that, for a good month is quarter INGREZZA. a into what the month like about and the approximately today the into feel stand we where So

remain XXXX. be Matt in net script in strong And as well. XXXX per remarks, access in as we was We to what that said XXXX to expect in expect prepared revenue to it his similar

Kevin Gorman

And thing many like patient only we and with QX. about but challenge to professionals, as we start The twice that acceptance XXXX, population leads it Matt as what customers. the is as It patients that downside have started the said that's Health the in the that is, and XXXX is is of also about, of to our I news that to the by good shows Eric add great. the nearly in INGREZZA talked we've Allied would and

we that an before it's talk seen have flow. the about as in ebb and past and you And

we a QX QX we as the out have generally of come it ebb, So, the flow is year. and is strong

color and to wanted year this So much be -- to is that call. we to just this to able the we quarter could as as give on

Paul Matteis

very you Appreciate thank much. detail. the Hey, Great.

Operator

Baird. next, Brian with Please Skorney we'll And ahead. to go go

Brian Skorney

thoughts I maybe walk trial program, ACT-XXXXXX development envision us everyone. taking if and mechanism? this your guess, how you used my good you and clinical thoughts Thanks on on ask for could through Hey, Can afternoon, question. about program. I your of kind just being drug the maybe design

How you of but being in comparator II about placebo-controlled specifically and indications, GABA, neurosteroids you of the or overcome calcium have are recent T-type recent others some developing to thinking also channels? drugs the epileptic difficulties kind a study study? had envision that And can would block Phase primarily this

Eiry Roberts

the for Thanks Brian. question,

dose without because as able treatment many relationship the that the that target doses in really effect and of epilepsy of their challenges of a antagonists statement to calcium required believe just very respect can side think I So with the been that to initial of and form those produce cases the very effect brain the of well. quite fulfill have the potency as past issues promise Idorsia an and mechanism channel highly the on has to – that haven't off inability mainstay efficacy is extensively molecule, the mechanism channel to potent been used this the action low that in we side and penetrating antagonist. calcium And

terms I there a alone, to the plan demonstrate this And opportunity believe is really that development comment so field in of can't on of mechanism molecule. for we through this significant value epilepsy. the in

the areas say tremor more in to those I molecule such potentially pain. move a lot mentioned forward broadly epilepsy, mentioned initially in IND this that Specifically, opportunity the very in earlier move excited as and option later with earlier, we'll subsequently space hope essential be year more to becomes forward about and we're and the as able this this but as but pediatric that space the we to rare this I our intention are we of in approved phase still collaboration about other

Brian Skorney

Thank Great. you.

Operator

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

Q –Owen Drinkwater

Owen for is This Brian. thanks guys. here. – taking Hey, Thanks on for for question my

for me. two So

in CAH First on coming program, know I the is the data March.

Just have or the should whether of little there, a what patient-by-patient you whether we on, you analysis give wondering absolute in to more biomarkers? maybe if sort versus could expect responder reductions color report you'll a see

drug and could approved is with been And wondering drug general about has one U.S. approach is then population, the that cross Just how Europe opicapone, on just talk potentially Thanks. drive the the in familiarity that the some given with the actually there? launch? physician second there maybe the familiarity in

Eiry Roberts

Owen. Well, thanks,

the study. we all reporting First be proof-of-concept CAH, data with the will four from the adult cohorts of

think the mentioned molecule in CAH the with As in I schedule adults. dosing that we've design at for us Crinecerfont before, study – allowed which the to study, of and look an both adaptive program dose optimizing

of terms that the treatment, study. XX-day of be presenting, In is we type proof-of-concept data, will a obviously

different of the be measured will individual several approaches both we So biomarkers summary analysis and to around data data. and the those presenting

I March ENDO Francisco at presentation will be XX that, I the in meeting. on earlier As presentation, mentioned an think, oral San

that, in pediatrics. program, both very Beyond we are are where we the CAH adults with and with in pleased

of forward both in be this the Europe, make progress on of continue the global path we're we the in registrational trial, pediatric which Clarity program registration will middle implement adult last agencies, end to a U.S. trial, the at And and the adult ahead with to starting moving and as year year. well. the from

With has with date for affairs educate to respect in COMT. working help to the our around PDUFA of the opicapone, the preparation neurology in organization role hard April community, been medical upcoming

with been the deliver U.S. opportunity believe currently there right inhibitors that the available of on little has We that available to promise COMT now. in are COMT

fluctuations. to interact their another we hear opportunity patients bring And motor prescribers so, potential excitement neurologists, as option those from with forward for we with about the

risk forward benefit States. for to In we very It's clinical particular, forward bringing looking very profile really demonstrated the in for much program that United by favorable are extensive patients an we a see straightforward with profile. treatment trial opicapone. And once-a-day we the are very that a encouraged that

Owen Drinkwater

you. thank Great,

Operator

ahead. Anupam JPMorgan. Please to with go go we'll next Rama And

Tessa Romero

in Tessa for disease. this you taking from for morning is one the questions Hi. here, us our and the Great call on STUDY Anupam. good on maybe today KINECT-HD Thank Huntington

for review might study. factors us that to gating any initiating you Perhaps

I in this comment the space? think half year. overall pursue that guidance competition there Thanks first given this you to rationale of is might on so And then, the maybe much. indication

Eiry Roberts

Thanks much, so Tessa. here. Eiry It's

of all, in at a initiate the we KINECT-HD the of actually clarification, last just end year did First study, November.

a subjects population. a of placebo-controlled as comparing disease, that study valbenazine is in just XXX reminder, Huntington's placebo that Phase to with in Korea III And

subjects XXXX. of will me to year. have sometime And we your you second anticipate respect The with -- we Tessa? that, in over -- this can XXX data that enrolled Sorry. the be And will of study part the that remind question,

Tessa Romero

Yeah.

Sorry. the relative know now that too may it the to I'm has rationale -- realizing thinking the about and how indication, competition. right. And differentiation wondering clearly AUSTEDO within I initiated given overall is indication? same you're maybe study TEVA's then, initiating overall

Eiry Roberts

Yeah. Okay, okay. fine. That's

are have the about So patients disease. that XX,XXX XX% chorea. United States them to troublesome XX% there in Huntington's with of population, Of

mechanism with But patients though only even proven the a VMATX still has population, treatment patient about VMATX in inhibitor. with XX% that it's that chorea received been those of

from in that benefit titration so perspective, patients opportunity there's the is simple left and valbenazine of with and what significant interested to we favorable we're these risk its particularly profile. once-a-day we And treatment, serve have believe profile that

Tessa Romero

much taking Great, thank our you so for questions.

Operator

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

Jay Olson

more What on there on you taking could comment should with for did of types gene we and And on last timeline therapy? for was could Voyager congrats Oh! make in how separately, you any next competition you that do disease the Thank the the expect Hey, wondering readouts up? in thanks collaboration if BD are comments and data question deals your shaping year? Parkinson's the I the then plans of on you see you some all you. the business to development XXXX, the activity XXXX. for

Kyle Gano

goal for front, considering Kyle. Neurocrine a one we great be and going is global And question of there's studies on and to this the various with that. the Hi, on markets. the leading right BD the products here appreciate lot is now, Thanks our of a outside a neuroscience company here doors long-term in science and

to both Neurocrine It's and invest here our externally. internally at goal

are continue we'll a to aligned the And our we we'll with So if in-house. look goals and objectives project and that strategic thoughts for look projects fit, at here. good find bringing

the to they programs is, in party sense. make here I and be So, development that continue into to business we word new if the looking think bring company, active

Eiry Roberts

with towards gave the good On on which program that That ensure collaboration, for a the got protocol end clarity last clarity year, registration the the Parkinson's agency forward that the the amended disease. on Voyager interactions we moving had us trial to RESTORE-X registration study. now. we're as We and of how that with we right an implementing viewed protocol quality involves could and amendment was RESTORE-X

will year. starting be will global thing actually up the at later The data In we the RESTORE-X, trial releasing pivotal be months only study, that the was parallel, we'll trial, also be from second is, we are a which XX study this the I'll this add and PD-XXXX AAN year. starting finding dose

Jay Olson

very you much. Thank Great.

Operator

And Laura go next we'll Please to you. Christianson Thank go ahead. Cowen. with

Laura Christianson

CAH. Great, with what you'll on be taking endpoint FDA, will comparable that ENDO the the that the data in planning I in presented? of same a an cohorts March that planned dosing if the trial, important looking how drug it to registrational primary you're back going trial? alternative the sense then that in whether steroids? curious reduction if thanks interactions your to Thanks. the And will expect analysis of for question. for allows at part secondly, we guess, be presenting will one my have can be a include you to in of that show for And is regimen, I'm

Eiry Roberts

the where study proof-of-concept outcomes biomarker the a that dosing exploratory of subject. two-week Well, And at study is in adult levels. hormone looked in the study initially,

will to we to for the the great respect presenting obviously, meeting. trial, at with, together And registration that. on full the commented extent we profile tolerability haven't ENDO what any endpoints the so that's be With

will we soon and As the as on up trial post clinicaltrials.gov. is running, that will actually

impacted size be part are that the that in of be could of a that and a very context clear, we hormone to steroids important will understand the new will this and it's core endpoints us novel dosing that looking also sample a mechanism. the of is at. the levels we're by design patients study and also how the the forward. managed how sort novel obviously, moving though, description And include of disease this use full of that program treatment so steroid non-steroid It's and And

Laura Christianson

thank you. Perfect,

Operator

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

Charles Duncan

and growth? Hi, highlight it continued be you and INGREZZA growth. see on plan to executing additional taking for your year is such Kevin year diagnosis, one overly this to team. as business change? prescribers happen want penetration existing simplistic, INGREZZA pricing first thing key the What that and year? growth good you additional or My or in drive increased this Thanks you a or of would as to but be new very questions congratulations wondering to important my Would to if just question to is you could INGREZZA I'm related driver point not that one

Eric Benevich

actually is Eric, give This you Charles. two. Hi, I'll

Charles Duncan

Okay.

Eric Benevich

mentioned earlier mitigate et switching the cetera. of and et require reauthorization these or plans We we've got QX in the a in that all patients fact place a the to impact that patients are plan cetera, that payer dynamics

in that well these one to executing the impact team year, driving make focused have treatment new disrupting on minimize sure really can dynamics So plan, the for patient starts beginning sure we're as make QX. executing all that priorities that and against as of of the that our that is payer -- we're on

tale You back lapses, that quarters, focus may were experiencing making to half treatment of year, really able was that QX patients of recall on the last was that two on first strong a were sure a get half QX treatment. any

we quarter, in half starts. patient surge the new Second of a real saw

And in so, want rest against the to of make setting that for our plan nicely the we're ourselves year. executing we sure and QX up

mid patients yet, Matt in rates are to years diagnosed. vast diagnosis Dyskinesia teens. of the three Tardive We that high mentioned yet the have into launch, this And with be earlier, as then, as think to majority almost

XX% over means, diagnosis of haven't that that out been there for treatment So been people given TD and have it. offered haven't a

and will been that for has undiagnosed prevalent the focus quite population patient population. the between time bridge gap the some to So, and remain

focus and to going out have symptoms. as the to ticket awareness been in diagnostic our been conversation our of a year this TD year continue And so when are what one probably their this disease there. to that We've -- you're the aware, helping improve also prescribers may to them TD Talk and to recognize we're helping acumen patients investing DTC items disease on they're Or the recognition, in be of campaign About with has And doctor. plan TD. into called encouraging year unbranded big experiencing last

in that The QX, going going continuing what the quickly TD payer and we're in the clinical TD. of to what raise good We're involuntary mitigating us are to driving of and our diagnosis benefits disruption continue to continuing of and for getting execute be in then XXXX. plan. the INGREZZA on movements isn't on So, seen to a educate impact key to start But data. are providers awareness is have worked and our reductions TD of

Charles Duncan

the the appreciate opportunity neurology Eric, for color. on question increase share or opicapone will within be One helpful. taking when you look there, the PD questions. opicapone, set for it added That's by at measured the community? in that one Thanks quick I Perfect. initial the mind prescriptions is community

Eric Benevich

established all will bit Sure. to an little receptivity options, planned I the dynamic year. Eiry time given later that, about us thus the people it's a thus the role therefore, commented bit far we've launch of is to of preparation that seen far for a levodopa earlier had remind studies, clinical going take This and little this for here unusual the outside our in in of treatment clinical therapy. say experience the about that optimizing U.S. COMP a in is all the

enthusiastic they neurologists of to the leaders average Parkinson's I having about patients, that, treating or familiar key specifically in disorders, FDA or available that are the that's movement are with though may familiar leaders, not Parkinson's other be the an aware them generally data for option thought So, physician new approval. side treatment on with opinion community and this opicapone. will say,

recall, work our organization So, started levodopa to launch year. the the of we're and treatment. mind, as the role XXXX, optimize was doing medical to mentioned, field for but opportunity, when has sales Certainly, an dual team it as in the we team later COMP disease. also eventual of Eiry TD that expanded eventual for with important launch prepare of now end Parkinson's prepare optimizing the And in reminding this may the for people the about towards goals you to process

we've got specialists things there. place. on launch We to launch, out movement that so can disease as So we our be team like after and we team to our the of we're approval. the on, prepared be we well all data get that going training doing cover so in towards additional And progress FDA are disorder

Charles Duncan

the added for color. Thanks

Operator

you. Thank

we'll to Sachs. Choi Goldman with Paul Next ahead. Please go go

Paul Choi

had you questions Thank on for everyone. good I CAH. and two for afternoon, crinecerfont

First, comment just European clarify used global can on purposes? -- us and on company board, Europe Could whether potential about I Kevin, selling and being a think, that? foray if in it have the for pivotal be maybe you can you sites this if on registrational and in this the past for And your you trial to trial global just design. Eiry you've talked you'll becoming

plan line just, to is the but And I see is, in pursue this to didn't the pediatric pediatric year? it to development also could those you regard still in the as and that's ongoing. with CAH, Phase second speak the you. top path population well? whether the II it question have slides, I on you And Thank to the maybe intend in patients younger results later

Kevin Gorman

Yes. Thanks, Paul.

we Phase as look We've Regulatory contact in III both at adult that your the FDA. European Agencies this as recollection study global with, as correct registration are study. been a in You the well

And what year, little the all that being throughout so, doing is a we're States. to later that, with able sites do and Europe this as United

we resources these of And and level have a that it we Europe. will reached situation the in be sophistication ourselves over commercialize the company can that in

about And, the would be second want not you a into first half would that global there seeking talk Paul's becoming of we be So question. pharmaceutical our company. and a to Eiry, partner foray

Eiry Roberts

Yes.

the regard In Europe, the with determine is trial is the though, So study both study. pediatric the and previous now, registration for the That parallel the respect to program, progress regulators, adult right be continue are study, make which to trial engaging first adaptive will with in with proof-of-concept to design step U.S. we the that that global our that. ongoing we obviously with to similar indication, pediatric and an in program. proof-of-concept a also

go certainly we more we And clarity more year on can so, that as this information. and gain we provide through

Paul Choi

as patients younger of into that go to in II? versus the plan Phase the teenagers being currently well is sort studied are the And

Eiry Roberts

Yes. That plan. the is

Paul Choi

Okay.

Okay. Thank you.

Operator

Thank to you. go And next Please ahead. we'll Seigerman Evan Suisse. Credit go with

Evan Seigerman

high to couple was you question. guys. when so question level, Francisco. significant of see just a the And about you is, that you much to INGREZZA? on a and in It -- my great how or pipeline a you question, do specific get opportunities had portfolio One as do in you be weeks net see opportunity San your what you that for that impactful and think taking Hi, net then Thank mentioned, or could the as of expect second ago price the basis? increase on

Eric Benevich

one, take I'll second the Evan. Well,

that we the several -- more effects to are as there children right that I be patients, think these these like epilepsies because compounds these pediatric impactful can These that even we need babies see. and impactful medications now. devastating have of there of

of forward urgency in We in have going with a forward going tremendous -- sense those.

decades patients a for these I it been there. day, again, sounds Also, could that, the the of within the and, end say nothing at seen be that would there's now impact But CAH, going for we that trite, unless that for impact real wouldn't program thought preclinical there but work was a molecule a research a mechanism program clinical to is or on there. we or be

there's so, millions that. have in I fibroids all there. work women now, programs And as we know bringing whether here said, Neurocrine. they going you from of think diseases And And that you the working talk rare talk that's our about opicapone, about I that but deserve uterine suffering everything Huntington's, pediatric right we all partner to attention. with we This something these don't that is Voyager at rank that on on our that with bring talk about our whether whether forward, to you we're market and that's prioritize

Matt Abernethy

Evan, Matt. this is

we've you you exactly in So, November. tell on the I front And large the but price a much would of majority net middle but sticks, a pricing if disclosed through, XXX%. recall increase not took just of how we that flows that of not it's at

about price would in increase quarter. benefit quarter's first get of you So that half the a

Evan Seigerman

guys. color. the much so Appreciate Thanks Right.

Operator

with go Piper And to Thank next Please ahead. Amsellem Jaffray. David you. go we'll

David Amsellem

Thanks.

So just couple. a

and first the the as INGREZZA, question the through the more longer-term regarding on is of landscape footprint the in that things and of you're reauthorizations quarter. of grows product at First about given the commentary this a some working least payer

we up INGREZZA more As about as in think do Or of the beyond a should you put that landscape? grows? are more number payers XXXX, going expect volumes product one. payer about That's to restrictive think we roadblocks

opicapone, two about can out will net and think your gross also number regarding auths bit of and edits where but talk Thanks. then to prior shake And this, you maybe you early on a little expectation product on a is on for sense step to us that? that give you

Eric Benevich

Yeah, David.

we've to need access access rate about that going a so. to patient high it. continue that been versus and heavily prescriptions over we're coverage patients prescriptions. So we're very the two And of about for the got make thinking earlier care written on can INGREZZA. actually We've little do INGREZZA future gotten we've sure great And of market the to sort perspective and a a I now. pleased years I'll We deal how payer filled get we've as comment invested said with in from that to

through request the INGREZZA providing that evaluate to authorizations to necessary the and coverage. steps has reality in patients been we've order to INGREZZA stated willingness get heartened providers But grown. doing of health product profile the the also require the grown You that plans by the for rightly is information for a of to the very their has the that as prior access go to

that is reality step get and to terms it. to next The prescribed access reflected INGREZZA that's extra the in their go is go I think most to VMATX helping of the And length most in of the to the to preferred to patients inhibitor. providers willingness the and

don't want I to So never. say

that homeostasis But in the to of making plans we're plans think also in that always continue of patients these state medically at this complicated understand sure reality TD. that looking be of It's populations where value with time work I we'll the changes evolving going and we make is are coverage criteria. that that terms for INGREZZA their remain over are appropriate that to appropriate and with to criteria patient them to somewhat the now a to health their provides treatment help coverage for develop

So that to we've for invest sure continue because going We're coverage good patients, responsibility. been our that's to successful. there's making these in

really kind on think the part asked I what And second recognize the the are experiencing I'm for say opicapone to fluctuations. with we net there be your for INGREZZA early that today. patients opicapone maybe provide critically around gross treatments are like of question motor just regards Parkinson's not to that of -- coverage and certainly will that might piece, about out will was to disease But to think I comment net. also and you look we there patients Parkinson's that important going gross on I on with on to INGREZZA access with detail levodopa like don't with

in specialty we that's to really it price possible a make month. the this for criteria patients. be our field part help what our the lack We'll the strategy support access access previously our and INGREZZA we a understanding are. the have patient resources a coverage that we've In said be sure learnings don't to medicine. infrastructure would able that developed to from below to that other our of some such And as the also is of price the use launch words, expect customers We've $XXX in as best team which

launch not to be reality is But going the early formularies. on it's in the any

And for them for but going be will have opicapone. understand we're patients, a to get help prescriptions formulary exceptions approved these process that to to so there

to in and everything everything because prescriptions launch providers that filled. opicapone it get to So, power our we're sure going remaining going in possible we take for as those as this unmet significant believe apply learned there make INGREZZA population. can is convenient yet that for a make written to to and we're patients and from patient we've to the do it as here And we need that

significant are experiencing can that product not-too-distant market hope those per with got hours the patients. a a A that lot we've And of in and to not of are difference off hours that people therapies day optimized that their future bring for to levodopa make time. we

David Amsellem

Hey. Thanks again.

Operator

And Leerink. next go SVB with we'll ahead. go to Marc Please Goodman

Marc Goodman

I you about could versus talk give was you Matt Or basis and to pulls from on talk even just and want Thanks. about and SG&A Hey relative to the absolutes? a push color don't any spending if wondering if the to more us R&D? think you're on -- how year-to-year willing just

Matt Abernethy

question. I Marc. sure Yes, the appreciate

the research So, particular, and is Neurocrine to going on another investment and in XXXX for development year be front.

increase our where As place going portion R&D. we mentioned a of going in pipeline we're have earlier, to spend doubling puts us year-on-year a the larger towards

addition three earlier in up the some sets that fund well. then Xenon CAH, as like of programs; program, to the to us up VY-AADC running. stage disease as the registrational well funding getting the as trial really and Huntington's And And the and programs program that

a of So, behind going R&D. dollars lot

On cost the SG&A front, dollars launch. well really then behind invest to preparing the focused INGREZZA as continuing opicapone on as for with the associated marketing

the to up So, going our that like pipeline it's going set be next position forward to we're looking future. really in feel year. continue well to to us We we're evolve and investments into putting the us to going place really

Marc Goodman

year-over-year? both Are items line increasing

Matt Abernethy

items percentage say from the dollar both line going faster a rate. Both are increasing year-on-year, perspective a would but Yes. R&D, we'd and at up be

Marc Goodman

Thanks.

Operator

go from final Stringer come Joseph our And question ahead. will Needham Company. & Please you. Thank with

Joseph Stringer

Alan. this is for Joey our Thanks taking on for Hi, questions.

Another share options could market for generally share about available? market given COMT just talk one therapies opicapone. generic the Maybe -- on total you

on are of terms you'll of give maybe comment treatment-naive to therapy And maybe the a if -- you patients targeting just patients patients use? that the where that the patients standard-of-care then a -- expect Thank who you. you current of maybe maybe in most discontinued on therapy inadequate in versus responders initial have terms and are breakdown be could who see currently

Eric Benevich

Yes.

treatment total of the to U.S. utilization the So, in COMT about market. adjunctive is X% XX%

so so currently XX% there's those of not broadly are XX% of about patients U.S. with is are in another levodopa. used step back, in And And treatment. or a adjunctive the COMT U.S. taking those, taking a roughly Parkinson's million an on the

promise on the of issues tolerability COMT regimens. historically to the of deficiencies to frankly dosing the COMT safety convenient deliver failed existing because the inhibitors think in and have due treatments, of the issues, I current inhibition

especially patients medications adjunctive relatively including a from we often drugs also other MAO-B about agonists their classes see example of taking seen agonists. concerns and inhibitors. certainly Those from have our in do limitations you also utilization from for a advisers dopamine standpoint loud higher So heard and dopamine impulsivity clear tolerability

treatment for COMT in the currently would to of opicapone. or terms expect patients our that are with So inhibitors previously market, approach be obviously, we been treated natural that have candidates with

mind that physicians stack switch up them to to The keep is The to tend from another. patients other this in thing in category usually don't adjunctive one particular sequentially.

and they to second winning results they adjunctive then a and start add a third. see one agent potentially then on go may they so And

adequately add a significant movements about an increase they're time helping no that and the us adjunctive their expect their MAO-Bs. to COMT patient and considered Ultimately to whether they're for truth levodopa experiencing and to physician longer and a are off class treatment. having displace the other treatment of go-to to to time, classes when we of successful a we is be levodopa to from the or of that's want be moment a that decision displace dopamine not those only existing making COMT also to conversation adjunctive So control over agonists regimen medications controlling, but dosing inhibitors expand that

that of you start drugs the having Given other optimize the levodopa treatment. before mechanism of it action don't levodopa escalate or the world optimizing use the before makes in from around that to with you opicapone conversation all the classes sense dosing,

this difference opportunity really to get many here approval we patients excited the from about once of later we're make year. a So thousands

Joseph Stringer

Great. Thanks detail. for the additional

Operator

queue in have we no time. this questions further at And

I'd So Kevin Mr. like Gorman. to to return back floor the

Kevin Gorman

do I statements two members and Norwalk Leslie you the few I and a newest Sharp. board much very with and really to I'll appreciate everyone's closing call our in want Thank start welcoming participation make today. Shalini

our analogy I'm here sports a in of an going Bowl a following exciting a Super bit moment -- game. to use

good We this had have years. now for very and have a a board board of together number

player. time has for we over deserves great there. we've What each years looking have well go a new the had is over that welcoming And us best to we're that worked the we're athletes our and board, two we members very years. out board. have to bringing a athlete board this for in There Leslie. credit And success that from of certainly we're Shalini We the to and lot or the position not time time. that that looking is brought And generally expand the looking the out for

the medical I on lines year to every a in is What and for commercial affairs and the and there also that organizations absolute impact advocating for the with have like are the fourth our also direct they each we've commend they teams had quarter also front would our day. because INGREZZA out on and XXXX stellar of here patients results that

curative driven we are bring about. and Thank very INGREZZA, hands. what Now partners discover, truly to and finally the patients' patients. fortunate know this ultimate ORILISSA goal is for you we targeting speaking therapies them now in Together potentially bring you all with Xenon, devastating to and to to diseases are of that's opicapone forward potentially to our what life-changing been And Idorsia need right in And at medicines in develop us and patients to precision much. soon who what have industry to Neurocrine we look now. we previously and therapies and have the future intractable Voyager

Operator

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

day. You may disconnect now wonderful a and have

We use cookies on this site to provide a more responsive and personalized service. Continuing to browse, clicking I Agree, or closing this banner indicates agreement. See our Cookie Policy for more information.