Neurocrine Biosciences (NBIX) 13 Feb 182017 Q4 Earnings call transcript

Company Profile

Participants

Kevin Gorman	Chief Executive Officer
Jane Sorensen	Head-Investor Relations
Matt Abernethy	Chief Financial Officer
Eric Benevich	Chief Commercial Officer
Chris OBrien	Special Consultant-Neurocrine
Eiry Roberts	Chief Medical Officer
Geoff Meacham	Barclays
Tazeen Ahmad	Bank of America
Anupam Rama	JP Morgan
Jeffrey Lin	Leerink
Brian Skorney	Robert W. Baird
Philip Nadeau	Cowen and Company
Biren Amin	Jefferies
Charles Duncan	Piper Jaffray
Andrew Peters	Deutsche Bank
Jay Olson	Oppenheimer

Call transcript

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Operator

Good day, everyone, and welcome to Neurocrine Biosciences’ Reports Fourth Quarter and Year End 2017 Results. [Operator Instructions] Please note, today's call is being recorded. [Operator Instructions] It is now my pleasure to turn the conference over to Kevin Gorman, CEO. Please go ahead, Sir.

Kevin Gorman

Thank you very much, and welcome, everyone, to our fourth quarter earnings call. Special Matt Medical Chief Chief Officer; and OBrien, by Roberts, Officer; Commercial joined Chris Chief Neurocrine. our Eric our I’m Abernethy, Financial our Eiry Officer; Today to Consultant Benevich, our

we statement. Harbor going our Jane. have Sorensen Jane Before read get Safe I’ll

Jane Sorensen

historical may limited from disclaim subject that made statements. not materially page to are including to Form contained uncertainties. to concerning in date, the Copies factors made website. risks cause today's the on implied Form Company's forward-looking filings that visiting in forward-looking and actual by today's we differ report release. be Company's statements to not statements but Kevin? these in statements XX-Q obtained of Investor this the obligation XX-K, and be quarterly on Any may Certain call by in or Relations is statements, could results and only filings, annual conference reports the those course forward-looking forward-looking are statements, press which of are the update SEC Company's Information on these any as the of contained

Kevin Gorman

us had drug more did in not program a and of our year we of to The approval the drug It short led a affairs, approved much Thank you headline we than was as we for the This thorough planned allowed actual XXXX label commercial a than done. very along that great an our clinical trials with work label of had also the patients to the team, obvious to Neurocrine. attributes regulatory outstanding special based all time most Jane. clinical such know, was important INGREZZA. And year was with of is, this you for. very from INGREZZA that period clinical reflected many bring that imagine. upon team

our clinical in push and that of a been preclinical able XXXX to number have we to programs. addition forward In

our in what to going from continuing R&D and performance INGREZZA. Eric to speed over also Chris financial those. is with go bring Matt, us hear is being commercially the update to you’re from so our from then today and XXXX will programs Eric on going that on progress update And you on be up an And an

So turn like what over Matt. I’d now to do is it to

Matt Abernethy

our Good Neurocrine call the my glad joining today. be I’m afternoon. team. to you Thank participating call And for as part first in of

the benefitted X,XXX strong continued quarter approximately total product XXXX X,XXX increased prescription over slower price the During also net per were capsules to the show XXXX one higher resulting This above million the largely mg the $XX.X compares net due to volume, which to XX% third fourth period. the quarter revenue, with to we anticipated the mg by than day, from day. to But XX capsules script per our the fourth high scripts expectations previous of approximately month-over-month Net from XX product transition approximately in sales revenue, during INGREZZA with filled. $XX.X million in filled. of product prescriptions quarter

the for a the Importantly, fourth the largely elagolix revenues mg were to mg two in fourth as AbbVie million transition complete quarter from XX NDA FDA's capsules the $XX.X exited the Company for acceptance quarter. the payment endometriosis XX inclusive one from quarter. Total million the capsule we of milestone received was $XX of

the Corporation. million $X.X inclusive quarter Net the XX, of ended same were sales period quarter $XX diluted $XXX.X $XX.X for were was XXXX or Tanabe share December of Company net million the from income of gain for million For and year million, of to our $X.XX and – collaboration INGREZZA Mitsubishi million received recognized with by for XXXX. per was loss product revenue also total growing or per net driven share, AbbVie product net and agreements sales. loss largely the million, the $XX product $XXX.X AbbVie $X.XX revenues net The compared Pharma milestone a in

fourth ended loss $X.XX of net loss XXXX. XXXX to or For of XX, million, activity the share XXXX. Research share, compared R&D. per quarter and Company $XX.X net The $XX.X in expenses during during quarter December increase per million due were million compared reported year expenses loss in $XXX.X a the loss the of increase $X.XX a or development to XXXX, program to fourth million, the R&D as of $XXX.X for principally

the million for the first fourth million were to R&D million BIAL $XXX.X year was to the expenses $XX.X ended Sales, same administrative due exclusive which primarily XX, as to general increased the a period R&D. This increase million payment to million the is of compared $XX.X of December expensed in-process expenses for licensing for For XXXX quarter in $XX XXXX and quarter XXXX. of XXXX, in fourth $XX.X from XXXX. quarter

ended million, XXXX year expenses were including compared XX, For is SG&A the of hiring across activities This in to the sales expense periods same both due INGREZZA, increase for primarily force. $XXX.X the our for million commercialization in December $XX.X XXXX. SG&A period to

positioning as us investments execute to near strategy. December term $XXX cash, Our receivables XX, and XXXX well was Company position of nearly our million

the the launch customers. our ahead and by results look positive, we feedback remain of XXXX, received by encouraged initial the clinical to INGREZZA Now

still QX. Endometriosis not guidance XXXX agreement of milestones are AbbVie early contingent our this are sales net the Revenue to at We plan time. expected formal for FDA cycle be million product INGREZZA in for approval under launch Elagolix to in do $XX provide on and

Regarding our approximately organization Key adrenal for number post expenses number sales our million. disease enhancing be will congenital syndrome, be programs by one, $XXX expect Disease, two, to investments studies operating to to advance and for operating directed $XXX XXXX, to potential the marketing toward: ongoing internal of expenses million maximize we and for and INGREZZA INGREZZA state dyskinesia. Tourette's tardive meaningfully opicapone of awareness. Parkinson's hyperplasia And marketing R&D

XXXX, commercial and will to in provide clinical insight Benevich IND Eric Chief we another to commercial update. In call right. Commercial when will further the development tremendous these of our progress. We to file a which provide timing Officer, forward one that also now over With I to look year the we is intend who addition and to will programs

Eric Benevich

Matt. Thanks

very Our how commercial team far has in excited our XXXX. launch about is prospects about energized our gone very so and

months approximately As month-over-month noted approximately the launched saw net strong product we ended and year May. growth. We QX million since for sales a with earlier, million net we $XXX strong the eight $XX prescription last quarter-over-quarter in and

dyskinesia. early are very and our We an market entirely launch are building new still for in tardive

health recognition, with and treatment increase Many TD. awareness, now for reasons. focus disease currently of first committed the to state and awareness as medications a drug patients to to undiagnosed But market no to providers with have FDA of patients TD patients in for were approved TD, who possible. prior INGREZZA to INGREZZA. the to many Our order diagnosis TD patients There help driving has remain and treat approved growing are we on care been variety focused as

Our uptake or profile, and no warning label launch. with tolerability once-daily that patients terms regimens, INGREZZA’s efficacy, TD, have to and dosing product compatibility breakthrough profile. with all well psychiatric common since very clinical attributes contraindications we as are who its and any the box treatment simple of taking are that care seen as HCPs robust rapid support rapid product, product of both in attractive INGREZZA is

in As impact filled than completed capsule. capsules is Matt transition be previously pricing QX. will mg the stated to approximately which mg less we our this The have XXX substantially XX transition full from XX%

QX, In including addition, market commercial reset of we The to hole combined will gross of for be payor contribution reset experiencing will time the donut contributions of patients. effect net to annual these co-pay Part from patients Medicare first net. pay-related impacts gross in impact out-of-pocket to D our related factors our the for and

QX, health the Regardless growth And the However, going we expect are time We're of specific since to prescription initial and strong providers these is in gaining continued a their seeing this expand is use demand additional to move it through adopters we're their reflected experience. model we INGREZZA. care as of first XXXX. impact. dynamics now challenging early QX see through

And is very stories feedback INGREZZA. hearing feedback that – of hearing discover, as to We impactful are gratifying develop world many the trials. we treatment did that in performs from clinical Especially with from we real experience. patients of it employees early pleased drug This are with in experiencing clinical who with very INGREZZA. and our is are meaningful hard all the those INGREZZA these benefits to launch so from worked

mission in summary, INGREZZA many benefit committed are thousands to success. with treatment to we can and TD there So our hope We launch out from are realize our early patients. that more those there all delivering patients we are and pleased

Kevin. to over it turn I'll that with So

Kevin Gorman

Thank Eric. you, Thank you, Matt.

we that can you want with pointed that a which and let's can we're our Chris to given you and now that over go more Eric real, best remain of detail to to in commercial of focus And out pleased a financial be up? had Neurocrine has I is the at as Matt turn And the to of on position to spent INGREZZA. And if it launch Chris the next dollar Eiry. success little start is INGREZZA. So Neurocrine, very other I'm pipeline. and think good the to see going as commercially

Chris OBrien

Dr. a and those to our recent that afternoon. great years. Kevin continue unique was get joining I pipeline expand welcome successes enjoyed we She help of and thanks have Roberts really to this which will Neurocrine. Thanks skills Yes. call a has the the set in to pleasure It

has to valbenazine efforts our both are has the years Eiry, am personality clinical for the that opportunity and congenital with lab over who hyperplasia I to Neurocrine to development the an XX the physicians the an XXX adrenal and a and opicapone programs. very as discovery turn helped small large clinic. role Officer provide will provide molecules As in over cardiology, over on I've programs the last who she team. Chief lead pleased after the I and her our immunology and had INGREZZA update is Medical bring update had neuroscience, training to from fit She great into

recruiting with multiple U.S. update Let's underway, an on sites GOLD syndrome. around at goal start study patients the of for is on well T-Force valbenazine pediatric XXX Tourette's The is with track our off recruitment

from to we so-called randomize and approval with dyskinesia. variety also second commit Neurocrine of continues the post last patients This subject for a conduct study INGREZZA of IV half renal more such in this studies of and Phase year, the as investigators, we the Tourette also timing the and they'll getting We have but support are end have We families at the this very as study line top or Association data the of America. on still of with we'll are clarity anticipate pleased tardive and conduct with impairment. INGREZZA Phase the the I year. includes pharmacokinetics

also planning are to associated IV We study factors clinical INGREZZA about which of tardive the be dyskinesia. remission may with see a Phase induced

clinical request an Our update Medical Affairs this And exploratory in continues independent development give of Group this she point I receive our clinical hands to also turn Eiry? I'd INGREZZA to the to will program. trial using investigators. other like over to on Eiry. At back support

Eiry Roberts

Chris. just here the delighted of with the underway Well from data ongoing the Neurocrine of for And provide trial to hand would our patient proof to team here next of currently XXXX. and data adults program academic thank development the QX determine the an of of I'm part study overall those plan be The as year. sometime is concept second We in at congenital program the in half and With to Parkinson's with meet later clinical for CAH a anticipate you adrenal pediatric screening and to hyperplasia centers number U.S. disease. update to able FDA for in study line this we development in on of for with excellence. And steps top be

Parkinson's disease, would discuss for Neurology of at an trial met as ahead FDA, with this the be INDA. in program, Turning we next for the whether January, another Phase the to III to filing planned, necessary opicapone steps on Division including

meeting III the expectation comment that not the III with however, a required receive base we've study tremendous study until If we will it a accordingly. an planning compile required take have data XXXX. into filing still to of the for our ahead the has, We The been and on FDA provided work a company FDA minutes. which that a Phase required, Phase previous may would guidance likely is date be discussions not on is we filing amount determined

We meeting the later of will the FDA minutes. with report we the the month official this outcome receive meeting once

package I the the As These part planned on the been hand additional that track Thanks NDA submission. we of for With regulatory round Chris. for be requirements. studies Phase to data over and they're some out submission initiated part to back have of opicapone I’ll have and our data Chris. U.S. NDA identified it to need meet

Chris OBrien

you, Thank Eiry.

year has its closely advisor. this continued opportunities with the closing wanted growth and clinical our an few as part that to really and at to to I with thoughts. opportunity to and Neurocrine see entire up And a Neurocrine. Just are XXXX currently programs of to the We’ll been my be honor success. on these in look enhance of forward working it just been Neurocrine see closing and topline for company of me is I some Eiry colleagues challenge. are In continuing what its team end a place say great from about to an and internally. And

turn to over it I'll back much. that with Kevin. very Thanks So

Kevin Gorman

caught from to a And work think be be much of without Neurocrine you integral to Neurocrine success. and you're Chris. in as Chris all things and future, Tim. as of Eiry us off fading into Chris and much we can now there By to also he's lot has also very without Chris come. the sunset. will do not he have an the Chris you them very with on We've never moving have you with And years from going Matt hearing I Board. We’ll been be changed, touch in that forward part Thank and for continuing in but know here we

couple just reporting will of data on anticipate Elagolix and quarter line Elagolix trials before two AbbVie fibroids. along that Also all fronts. things for next is uterine QX. A questions. been program that job III turn great for goodbye. a Phase a of it I doing not over this is this it be each Endometriosis date XXXX with AbbVie PDUFA quarter. So in QX has top clinical the We at moving the

on way I'm that. not in So you And we that last well can seen in XXs a the It on it hits And launch or prime AbbVie. is have print, taken forward affects look nearly disease is advance bringing million is awareness their through a think that have that a the up one of of the responsible that menopause. radio that that attention it one advertisements been there. by women their X.X drug. activity very place undertaken life, of to of in number is it – in women XXs deserves their sure that United I endometriosis is has of in all that received many the that important yet that had the this of sponsored in television, States, and out they've

very loved forefront campaign in the So it this of from I to their suffer to physicians the is and think women their bringing and important. who ones

So open with for that questions. I'm going your it to up

Operator

Please ahead. Meacham first go question from Our with Barclays. Geoff Instructions] [Operator comes

Geoff Meacham

have guys I clinical. commercial one and Hey thanks question. for one the

it’s I respect it big holiday much launch, the then there pretty baseline and persistence early matter? clusters there been to but a follow-up. background discernible And PD or I'll can has INGREZZA is trends? do you it with meds talk obviously whether drug know if For the is about when and in

Kevin Gorman

a things for we more time. all be inconsistencies talked you've little a in drug too going haven't Yes, think, we It's hi is there. early feel have or early any seen persistence holidays us pattern run, for I Geoff. about yet to the reference in long launch. With to regards like bit the And and good to are to it with how any need

Geoff Meacham

your next endeavor. you Then see Chris go. sorry Good luck Okay. in to

Chris OBrien

Geoff. retirement it's you, Thank

Geoff Meacham

I bored know pretty though, think, you'll soon. I be

Kevin Gorman

busy. him keep We'll

Geoff Meacham

about asked is When front you I for about I or T-Force, of terms and potential what guess like the an you lot you're is times be of in – mean in you've design of give I feel view. the you the I you're registration study I – a you've you been know updated dose the and the the just have mode? in think still – Tourette's, been like the want may sort you a to that fileability do million I feel [ph] know the it just finding outcomes, are do what regulatory enough, think, asked

Kevin Gorman

in going It's data the comment well down we high a robust Until study designed it. for psychiatry to that is really that the perspective study have Tourette a division she higher in a respect would well selected would I obviously robust, that doses premature that as were finding, steps. safety. it response trial study FDA. to that that is been study be next placebo-controlled But we the about think until have My has decide a based say study. out the to Those that both yes to Eiry the quality the clearly sit exposure how and have efficacy had the very that of and depends with careful about on designed the conversation could previously But is in works sense on a with in stand trial. not they're With and data used the and study But exploring dose we're hand registration this to doses very modeling. results

doses I’m that these designed that additional in that. necessary. was confirm So we to would quite be with that. doses And these just work this not the the think exploratory the the to mind And extent is concept that that comfortable are are right obviously study right meant with

Geoff Meacham

a Thanks great. lot. Okay,

Operator

Thank you.

Tazeen Please with from of ahead. go comes America. question next Bank Our Ahmad

Tazeen Ahmad

us follow-up. from the the because tell mg on option you're you the are mg/day so doses most And XX thanks physicians, or viewed couple INGREZZA. initial a as there preferred docs then getting taking switch A still prefer by my I to guys, some much physicians who like the that’s what dose? XXX for Can on Hey questions. feedback have

Kevin Gorman

Yes from feedback in a more The hi X with they're from to than by regards to lot perspective. it's capsule, by convenient going a which recognize message same the XX a the sense is is that actually day, one physicians that not to previous. even physicians most X equivalence bio once the XXs now

due when already getting them they're by Essentially patients new for on being first of for that the their capsule relatively maintained And once for are refill then for a capsules they that's XXX on and INGREZZA to patients day. process it's happened. So a were after transparent on course milligram that XX week. switch when X

So from it's process that been perspective. a smooth

Tazeen Ahmad

And I’m Okay. and still salesforce do you as a your as in do year? as far you've you’re opportunity, still figure out feel out progresses early you right sales drop trying to like anticipate this launch this market launch the more the but sized,

Kevin Gorman

We that invest I do about a products for as and feel like And certainly we size some need put that our in if downstream, place the then to sales to launch. have optimize good structure appropriately. the and And INGREZZA for for indications to at new to adding But of terms and speak feel especially results the of means quality in now we're do everything force. new we so. we obviously changes we good potentially prepare understand we'll that salesforce look hired. continue we making that market testaments to and so going team the We��re the up we dynamics far, think, that

Tazeen Ahmad

Okay, much. thanks very

Operator

you. Thank

Morgan. with Anupam Please go Rama ahead. from JP Our next question comes

Anupam Rama

thanks so for much guys the taking Hey question.

first through generation XXXX, of program much. CAH different of than first be the update the For us here the a is compound? XXXXX win Thanks kind you how half just would XXXX update. so walk And of what remind first for half in scenario can the

Kevin Gorman

recall Kevin. I'm on it's you because this taking the is here. so and main that Yes thing and that different this comes question contacts in all of The if historical

first we the put The compound clinic. dose a single into

just in we dose had they all a recall you If patients adults. we one of significant with that endocrine on impact that were their treated profile. And handful

then single running it meaning our into long-term we mechanistic? antagonist, moving what juvenile with then this compound-specific, go back, about XX in was our place to into the dose never was understand is years, into adult took the that vast tox saw it it that antagonist. this another tox and there have tox, compound been that of long-term that specific, very and found because stop, the see taken library We so of that juvenile animals. wanting decided same seen had compounds, we an read field put with clinic the backup been multi in was to adults it And compound then we ongoing one it determine a of is children signal we CRF it for look clinic. species-related were was to we which we just our That's phenomenon CRF preclinical dose the is when that signal preclinical pretty was out we if then went we've study juvenile in And drug-related, could before had that the out. now program. were through in model tox we a or As And was tox, indeed clean and

Anupam Rama

should the it. how I'm there? thinking be the XXXX update, And first we scenario win Got about thinking half about

Kevin Gorman

a in X-hydroxyprogesterone what very going levels be in we we single one did those win that study Yes, and scenario for to lowering see dose a there where looked androstenedione first I previously. Much that we of like think, is patients.

Chris OBrien

Anupam? it got You

Eiry Roberts

completed All year. dose single Kevin’s in those points that data subjects possible change that would this markers and we in also with of a I potentially then who the this the we if add in clinically be compound And last And bio the And XX-hydroxyprogesterone. see study would adult. them take the for we the in primary molecule study points to the a is are study, could on a measuring with potential is agency treatment what we anticipate in meaningful this multiple dose. a ACTH dosing Also end we're levels. study for is healthy to children discuss

Anupam Rama

Great, guys. for questions the much so thanks taking

Chris OBrien

Thank you.

Operator

Please go Matteis We’ll Leerink. to next go ahead. Paul with you. Thank

Jeffrey Lin

taking question. this for Paul for Matteis. Jeffrey Lin is Hi Thanks on our

So you I schizophrenia? happen have INGREZZA the couple first patient who have with guess hand, question mix disorders on are to versus one the update do mood of snapshot a like quarters have is percent what percent a on

Chris OBrien

capture that whoever prescription the physicians our see from the treating TD data is what of should. don't in they're what that through their We psychiatric they however, hearing process, with we’re anecdotally regardless we're underlying

the it appears general neurologist So mix in clinical probably too from the psychiatrist. or whether trials, function a practice I is but not think of has a they type of our disorder are patient it's certainly dissimilar that the physician movement

Jeffrey Lin

Okay. XXXX. at product in perhaps guess, recent And you're some I can have as other, for internal of CNS guidance you looked know impact? I what not your the assumptions launches giving the us But gauge like sort QX insight you give

Chris OBrien

Matt. ahead Go

Matt Abernethy

in to still product. perspective. continue launch to really early out guidance obviously our able a we're this we feel from going come Yes comfortable assess. of we're When be And to to

more your persistence. out Eric a That's able mix from into looking asked number can is payor example, And to to shift one And some the commentary regards which add questions guidance. second from overall here. more then side would And of we're piece to to market potential. formal was lens patient in We trajectory mix. was a of a payor first revenue the continue that huge aspect can for then the quarter-to-quarter. one, assumptions build on items So to the what be be

Eric Benevich

any anything But going time. part you to mix and mean for the when predict most the much as be what future as in we're out to at the first we launch. we've that for the and seeing And about good the give early QX to out for helpful corner if persistence about very us be just And is through like. in we’ll where analogs, with still we able product. there I asked through add. about looks strong dataset further look there's the is terms see patient Matt the trying like understanding future demand bigger been what that to There’s going talked try this we’re are the not guidance have We're of these continued just payor for at. to is going variables in there

Jeffrey Lin

thinking on is should And the be then of context sort the along finally half program Okay, the with the sort data the differently with CAP asked was come I the the of about guess out in – XXXX, same lines disease? great. asked how asked I should data of first that we

Eiry Roberts

So little I earlier study, the are the the a is we’re long-term to at mentioned proof-of-concept disease I that with disorder. think the associated clinical dosing, the biomarkers and context downstream looking this as the that impact in to of mechanism core

very are the context they so And the relevant in of measuring disease itself.

be towards So the data relevance agencies we then would terms the initial interested those doing their engaging access be need what clinical population. And we in completing to do to CoC though have of with obviously expectations that and once in the what agency. with is understand step regulatory first interaction is that might the the of patient they data other those that relative study, to

Jeffrey Lin

Okay, thanks a lot for taking questions. our

Operator

you. Thank

Brian from Please comes Skorney question W. next ahead. go with Baird. Our Robert

Brian Skorney

just of scenario kind I another version BIPARK-II? you Comtan be or something comparator in like of or just point do be are look mean do think here? opicapone of the about U.S. mean, for case guys thinking terms controlled I want would four-month off consistent appropriate we’re study, an that Would when over you also or we for the And that about we base what study your prior to end of He questions. how think another would guess study thanks or to a BIPARK-I be taking the three should context approval. do think time I of placebo it like? period?

Eiry Roberts

to that And with consistent treatment. reduction study. and an most United include States those time the the believe relevant the off controlled points with with the need believe that that the you application. in part end potential amount we BIAL to we we comparator would The measured study in together this active placebo we time European in be patient not think mentioned the associated believe improve I levodopa end study of to setting. And in dyskinesia would points troublesome was a outside setting the time with do the are of to that the are off similar

be go been the looked So a that the U.S. would data our very level the generating it consistent FDX. NDA. to agency that just that, we’ve and has under would to price case case base be scenario If support requires into of

Brian Skorney

to Thanks. if to you approval? if a ask European follow-up, I could any with a as pertains AbbVie where just of I is And just have regards wondered concept Elagolix it

Eric Benevich

any any not concrete aware of. AbbVie not work doing Yes has that Europe over plans with they're we're in actually shared there us

question would appropriate So a probably that for AbbVie. be more

Brian Skorney

Thanks Great. guys.

Eric Benevich

you. Thank

Operator

Thank Nadeau go go to ahead. Company. you. Please with Cowen We’ll next and Philip

Philip Nadeau

And INGREZZA. Thanks for afternoon. the questions. congratulations especially progress Good taking my on with

Kevin Gorman

Phil. Thank

Philip Nadeau

question patient versus INGREZZA the any in of many talk says. to about hard have in it really QX bit how trends may per have model you what QX, unknowns a fewer so QX. it's patients looks like starts the model compared it rate QX. guess confidence starts QX new One there's in But could new been some I our versus month the

Kevin Gorman

also continue from into seen that throughout with Yes, quarter-over-quarter the demand numbers. we're pleased seeing we've feedback that be with shared the basis. from very we the and to And that very launch, both TRx And pleased a demand we've month-over-month previously we've we're stated physicians. the

Philip Nadeau

Okay.

the last on of the And started so program And first of on the guess reported sense the the quantitatively the maybe impact impact sampling similarly Drug quarter you I that launch Free or you uptake? Program Teva any quantitatively of revenue? have do

Kevin Gorman

forms requests regards With into building seeing. focused means our roll of we free with on a did continued out with program competitor have said having treatment themselves. we what really Obviously pleased free that the then the Yes, we're do we're and strong QX. trial. need so of to we've diagnosis to the in demand starting to results we're raising treatment and come And have INGREZZA in for that associated letting awareness majority market speak that October doing terms and and you're the trial have the for had the we

Philip Nadeau

fibroids where data be this we actually see actually, quarter. the a are then have I when one quarter. Do we thought is for thanks of would had Great in and We it? guess, the and information. just AbbVie question uterine Elagolix sense last it earlier might anticipating you And it

Eric Benevich

only left we more have weeks Well quarter. the six to about

in only in So completely is to control. releasing way be the And know that be in as going more those weeks you no we’ve six it behaved past the advance. about we XX will when hours and they're that than all sometime the data know within AbbVie’s wore

you So with until share guys it. just anything us get before they don't

Philip Nadeau

taking Great And on thanks the questions. again congrats progress. for my

Eric Benevich

Thanks Phil.

Operator

Please go go Thank next you. Biren Jefferies. Amin ahead. with We'll to

Biren Amin

for my Yes taking questions. thanks

your more Medicaid you on in seeing comment commercial are Just regarding s mix, payor patients shift prior you patients? over government

Eric Benevich

place think on I get from launch through a to to increasing moved we've really payor more comment it we've shifted that wanted previously and the And has we've before a seen Medicaid. where state in mix said times we're what Over looks steady that quarter-to-quarter. we we of like. can

Biren Amin

minimize the to in efforts what what hole it. efforts you the undertaking are are donut And impact of Got QX? your then or

Eric Benevich

medicare switching going they patient Well patient the part year to is I there really of the of it’s that same to our going Is re-certification on just any prior whether plan not but end are to any the And part the That's to require have network, that the is strategy to or maintain the having of not a INGREZ, going of like to Medicare have. patients limited that we part to treatment all specific you so for plans? that tell staying to benefit like reach administrative procedures use out pharmacy determine be for specialty in the ascertain and patients place they but said, therapy. they that be are pharmacies can pharmacies on patient on? of I and or their that’s steps medications, what interruptions distribution on not, avoid proactively so that INGREZZA, whether the are do in

Biren Amin

the specialty Is you pharmacy have reason provider there also a why added third recently?

Eric Benevich

more that would towards I attribute No, to want growth. I actually

Biren Amin

And there maybe on on chorea? last comment pipeline, developing the then INGREZZA are Huntington's it. thoughts for any Got the

Eric Benevich

of indications to been that we review are various planning number There‘s they have a stages. in

announce so any new on to going out will indications that And on But reps as pass appear indications those on we our those comment indications, to we're which go clinicaltrials.gov. they not are. any probably

Biren Amin

my questions. taking thanks Awesome, for

Kevin Gorman

you. Thank

Operator

Duncan Charles to next with go go Please We’ll Jaffray. Piper ahead.

Charles Duncan

an as to on spend feedback of then first quarter Chris for your efficacy Hi guys additional to comment on and my provide is you for I’m And another of or of a drug is perhaps efficacy, of of pursuing first Any on wondering the Eric of perhaps could is couple information with progress. one real in a in Chris your trials. further regarding performs to that that? if as Eric that all, time it follow-up? opportunity there congrats hobbies, more two the colors question good from And or kind longer-term questions one Eiry. and And INGREZZA rate, on information world kind aspect clinical any response the or regard

Eric Benevich

comments Yes bit I’m happy Charles. my on to a call up

market expect clinical trial have like trial mean in gotten is that does have Kinect into necessarily new this from introduced that X study. the they the So what initial what experience doesn't really feedback INGREZZA we've match to the it physicians a their data. In we feedback when their by physicians work I adoption from that often drug the is had that that up is from did gets it gotten the personal the instance in of clinical

tolerated. You're seeing their meaningful reductions back in patients coming with it's symptoms, TV well

treatment. continuing For response their to earlier their show to in patients meaningful started that were launch,

patients think that have pleased whole simple to is very are really wide treatment a inappropriate And to on they And real of regimens. very really one who prescribe INGREZZA And range about of it's that it's appropriate for treatment study a so psychiatric they things across a like they're patients versus variety the because world the of with been and that a underlying a their with TD wide setting performing. how lot is don't product take.

top a workflow. in taking. can fits right And they can of is layered be are their with antipsychotics it practice medication patients this prescribed, the that it that these on So

in what that's clinical so And I did mean the by trials. performing as it

Charles Duncan

any Chris clinical and/or had on Phase insights design and helpful. trial, if then trial? Chris the provide or with I'm opicapone? any for Eiry, point induced it's I’m or provide more of on if that. mentioned that Excellent, the timing the question I could IV remission And a intrigued you And wondering perhaps then INGREZZA

Chris OBrien

they said a think important have was predict it you time been approval is we we factors might in And the that TD us the could on doesn't That than to question information study have do small for both in back. not from percentage clinical INGREZZA of were about we time what that I the to where in Sure, a discussions clinicians profoundly post for on go had this trials patients to do those time understand and gets trials. that better, better. And for little observations. we the in really like period some advance. approval we reason they And a this the That world remission, come see remission. patients FDA alike, drug. that in associated in who and with we'd couldn't whatever post our clear patients off clinical TD saw clinical our be for of And that could with who a

us have designing who protocol in are patients a we which allow randomized would period of the the So clinical follow imposed. to process withdraw

on on who follow blinded back So drugs if randomize some extended What's placebo of after continue the nuances then on the placebo. drug, underlying and to protocol indeed What failed other who the factors And we come with study some the of may and in patients? are doing that go some well starting period TD them to in patients their the associated design those additional, so time of to the we workout are symptoms that FDA. on to clinical then with remission? diagnosis? discussions a so What patients concomitant And an to medications? if are and fashion are their for some be pending take with see plan on and would

to but next year maybe even in early expect start into moving see later or not I year. early this clinicaltrials.gov So something year, this

Charles Duncan

I'm now XXXX on of you like in Phase data previous that would to III very for perhaps and study But or Okay, opicapone what My wondering you great look end at your what's have and could by cool that point? last the job of the a XXXX did to anticipate protocol anticipate question. would a you this timing, Eiry start question a outlining, you analyst’s could thoughts hypothesis.

Eiry Roberts

were that as compared, XX about NDA timing XX need if study would possible our the we add Well it we it that are of as the for required. [indiscernible] not We expeditiously hard working to it this stop and if to to months hoping if anticipated to data.

of push maybe And beyond. so next even a a would latter part or into that really little year

Charles Duncan

I it few you you I a you albeit, know were if and what have do more won’t will is questions but betting answer, think be that required? person

Eiry Roberts

person. I’m not the betting

Chris OBrien

when F.D.A. the everyone. share those we have Yes minutes, to going we're with

Charles Duncan

my Got yes, taking questions. thanks it. for Thanks

Operator

Peters go ahead. with Bank. Deutsche Please go to We’ll you. Thank next Andrew

Andrew Peters

for thanks Hey question. my taking

commercial efforts competitive their out perspective choose guess. of of from be can scenario kind a Teva case? landscape, sales they spend marketing you their you of on side, then one on areas Austedo a you if I the little singling of as And more or what a just of period could on in planning best expect just So the provide planning comments around key mid to the that sort sales on dollar just imagine you. particularly transition, What if spent kind aggressive Thank of question kind the a increasing effort? with there on color marketing question What next the wanted the scenario one related to effort? kind and could Kevin's of to you see and can around of focus do

Kevin Gorman

I’ll start out the one. with second

for is they're said We going very on concentrate don't time from preempt the INGREZZA even on educate The today. based we sales your competitor. care And said. standpoint, a talking about dollar very a question a be attributes first dyskinesia. any to to a sophisticated, true spent. may have on with all bit of little professionals actually do of lot ultimate the we success from had what spend the best on Eric I about being for from beginning able respect they as is very our capabilities. standpoint party is What of have competitor, We tardive physicians next the we've our enormous health marketing drug But

they diagnose can action easily have and a patients. that these called recognize treat so And to

And we move to you Okay. really as have to Eiry, add lie do forward. so our where that's that? efforts anything

Andrew Peters

thank you. Great,

Operator

you. Thank

go to next We go Please will ahead. Jay with Olson Oppenheimer.

Jay Olson

remarks the I Oh, opening INGREZZA a on you allocation touched question and had and all upon hey, you for questions. my this about taking the in thank investment products. when progress the plans you guys. can capital in for Congrats us and you development prioritize and with $XXX that and on – into frame business prioritize fits your for other your would pipeline XXXX? capital how in how how you your allocation sheet million balance But particular

Matt Abernethy

is six what highlighted product in to really from one call company indication we to then long-term four as four our begin own earlier and investments. value and a become to is created INGREZZA. able significant investment those now believe on aspiring is be the through there and creation to be just to years we're going on on our And number to to investment our is Kevin internal Yeah, pipeline number spoke that two

it how that $XXX as million make distract number we it on the we our on from desire well making not opportunity the advancements relates pipeline. utilize as the with balance to maximizing could one to sheet the So would INGREZZA as

it at financial INGREZZA flexibility So time, well focused we as on executing as our internal some this really have pipeline. obviously but

Jay Olson

Could NDA that. had from patient XXX filing that how IV on an to opicapone. of And for contribute comment may it this have up you trial on opicapone? you Thank looks according results study results that I a year Phase clinicaltrials.gov. follow the to for There's OPTIPARK will a like

Kevin Gorman

in VI the over so, OPTIPARK BIAL trial Europe. by Phase conducted is that's a trial really Yeah, being

to that agency as is safety that that’s then post-marketing the And of is all of the pharmaco so safety we important see a economic having study. would having has database The – OPTIPARK our I the at the existing basically and that being that that's part one the say more all wouldn't submission all done. FDA. to BIAL

Jay Olson

much. very you Thank great. Okay,

Kevin Gorman

& Thank Carr go you. Please with ahead. Company. We’ll Needham to go Alan next

Alan Carr

those? kind of that Hi, how and them contribution much of are guidance. thanks OpEx from R&D. us in SG&A for III potential and distributed you Can program your Phase on taking my a questions. sense of R&D of growth sort opicapone how couple between A the is on And any running – give essential Thanks. little that And that I And also can those for also us there? updates program then trials any that a then us bit about tell developments that opicapone? you more you're give a tremor Phase new of you sense can what

Kevin Gorman

go first. Yeah, we can backwards

So of the Eiry programs wanted opicapone. Phase to about I talk

Eiry Roberts

Phase performed U.S. for it’s the trials a they're and the I and assess BIAL impairment. hepatic the in impairment doses molecule opicapone. to So medicine appropriate it One we think is study the was study And patients mild listed pharmacokinetic ongoing data safety to we important have the no several also therapeutic included mild labeling in behavior in for submission and – patients. actually with now is in was in of us hepatic hepatic BIAL in has clinicaltrials.gov moderate Parkinson's impairment. in that there There the exposure

the submission well And very density interaction. the profile transporters well. the was with our tolerated of – again, two studies, from that potential shown the low are part so a for that drug And drug, for approved a as interaction will then BIAL drug, at NDA in that patient would PK drug be And other study interaction transporters. at was we the package very III a the Phase dose – molecule around completing drug looking study

confident move we the fully package these forward the small continue profile to in just as that but to NDA, in address order requirements to FDA. fell we're needed that be we so, the to And gaps the the of in will

Matt Abernethy

expense from when from have So commercial a to of that one, from made in Number investments a financial year year-on-year perspective, the couple we we're XXXX. comments. a whole you a of look going perspective, spending

R&D addition front, for to the a a investment obviously the expense year And like company. big for XXXX year-on-year was clinical that's in on really So increase. that driver

INGREZZA to a said aspiring it opicapone positioned I that take become you an But when to product earlier, spend indication So become now. years four to the highlighted the earlier, really as aggregates well Chris aggregate, like it we’re post-marketing the Tourette four increase. from CAH, had program, studies company us significant six

Alan Carr

very much. thanks Okay,

Kevin Gorman

you. Thank

Operator

We’ll Capital BMO you. Thank Markets. Somaiya Please to with next ahead. go go Ian

Unidentified Analyst

on taking XX I of still on Yeah, of have Is the metabolizers characteristics should the patients INGREZZA. there in milligram of remain XX% is This XX be expectation? XX-milligrams? is the that one a those regarding I label hi. impairment guys And remain milligram. patients liver Thanks everything just your to label, expect there in would In Steve the of the captured know Ian. aware of think that for dose for question. you about past, you mentioned, other on that we and some or is be remaining patients reasons stuff that XDX

Kevin Gorman

This is in first that and a can in. Kevin, I then take thing can Chris chime

you're that III be anticipate on based Phase looked on program we you sales patients population at XX%, XX-milligrams, that label quite go system the really there patient XX-milligram we recommended would that dose that would that be would that the we week past that XX-milligrams the would So well. one around had for in the said of satisfy correct and is then the the dose XX% on and

that end way ballpark, but out. within yet, how to it's know Now, don't it's going work see we just that early a too tell what up – was what well in to in clinical going is setting, to trial here that's we

patients an stable want dose. to have that? the to vast add the you you So on anything XX-milligram Chris, else are of majority

Chris OBrien

that the that go go are ballpark. XX% it XX doing somewhere to is and either they or world in too that start that you’ve I captured XX%, start so clearly back well XX. on XX%, you and the is But there XX don't down know think real know in it it, on XX are early patients to up to it's

Unidentified Analyst

speak rate, corporate reform And forwards. the existing carry impact relates tax to but about can specifically thanks. your tax Okay, use of to you your obviously you NOL ability

to I think XXXX. your federal in expire NOLs start

full benefit ahead. Yes. Go you still to those? are So the able of get

Kevin Gorman

was prior that created be full access NOLs will realizing of the of to XXXX prospectively end those benefit the without tax to able NOL On any yes. limitation. to reform have Yes,

any prior that to of in created NOL gets profit. XXXX utilize So subject post anything a the that XX% created taxable be to NOL I any able to future to was being believe given realized XXXX fully to able of of income. But year those you're the will end limited have

Unidentified Analyst

access XXXX, Okay, whether into next? thanks. many you I predominantly and quarter last made can just XQ that you're formulary for or expecting mostly INGREZZA, be enter And and left maybe think decisions to how completed be just around are is you this where on on comment there much should progress you

Kevin Gorman

plan. has vast be cases provider requirement reimbursement particular submit the their the of is tardive What should it should been to majority been we of the far I gotten and doing And in I they moving a that in we've will see authorization review. seen solidifying with is patient. there saying the a to coverage diagnosis is that for that a for the to the pleased patients the plan What some case our formulary some with continues health the and so the that reimbursement forward before what are thus is plans approve of is coverage documentation case a for from transitioning launch. dyskinesia making prior requirement we've Yes. that say most decisions in we've is decisions, confirmation full does interim coverage that that cases without those

seen some data that on published coverage utilization have a based doing in essentially they've criteria cases them. we just we So their plans without the review to and for the INGREZZA that provided seen formal formulary

Unidentified Analyst

Thanks very much.

Chris OBrien

you. Thank

Operator

this further we for at additional appears time. remarks. It Kevin to or closing no it Gorman you. Thank any I’ll back have questions turn

Kevin Gorman

much. very you Thank

and hope once progresses front partner start year you for things have the milestones minutes. we all in of that have us. enthusiasm We'll the we're of important uterine Elagolix Phase data lot CAH the quarter clinic. share year important the year end novel out way we date, have announcing and course have as be had said FDA PDUFA data the forward quarter. with for this and So then We’ll to And I spend will the the just Phase INGREZZA be which of the AbbVie from Phase commercial near IIb fibroids a the the be just providing the path very we'll this out kind our our Tourette progress goes very program of next of be the III II, you as is they then term later to continued that year on. There's a we'll lifting going as our obviously new opicapone in compound to we’ll will of reporting have

quite important our of a our readouts a to XXXX forward that plate a bit and we're XXXX. matches So lot on looking having

very I over that Thank for what to you Chris very in attention. the time are and So contributions want your much they thank made thanking for last decade one then And thanking and last Tim much. they you more. important

Operator

you. This appreciate today's does Thank concludes conference. participation. your We

and a have disconnect may time, at any day. You great

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