NBIX - Earnings call transcript Q1 2018 | Neurocrine Biosciences, Inc.

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Operator

Good day, everyone, and welcome to today's Neurocrine Biosciences Reports First Quarter 2018 Results. [Operator Instructions]. And it is now my pleasure to turn the conference over to CEO, Kevin Gorman.

Kevin Gorman

Thank you. Welcome, everyone, and thank you for joining us on our Q1 earnings call. Matt Medical Chief our Officer; Officer. by Roberts, Officer; Chief today Chief our and joined Abernethy, Financial our Eiry Commercial I'm Eric Benevich,

this statements. making During will forward-looking we call, be

read So ask I harbor. that please would our Jane, safe

Jane Sorensen

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

Kevin Gorman

you, Jane. Thank

the very be growth We over on you. and INGREZZA, into with to not Matt continued hard time sharing everything this outcome. Eric to It excited have with and will increase cover has it's INGREZZA be [indiscernible] strong, for we're nearly exited another that with of call, are yet in going to good much first momentum pleased XX% sales quarter QX. be was and going we our a TRxs over very reset, and QX. and QX

future starting T-Force to investing We're only that over. the go expectations, salesforce. going to in which discuss and with And made by study, the our was our its decision we're beyond in to expansion. we're to TD success future we've you, date, PLATINUM As going with the which not is Tourette's in seeing, Erie Eric's its salesforce continued INGREZZA's also investing adoption with expand even INGREZZA's

and III positive this fibroids We elagolix our XXXX. pipeline, in QX. CH in in so very on and just our which two confident partner, in going rest AbbVie, is over. for last elagolix' with sNDA that Phase of INGREZZA. the uterine approval studies is preclinical track filing indication announced all Now And AbbVie we'll planned remain be a is with quarter,

So that progress over the in to I'd brief the to introduction, with go detail. like more to all turn much team over it

Matt, could So if it performance. off you our with kick financial

Matthew Abernethy

you clinically start call. INGREZZA a gotten NDA for Great. earnings and data path thank with first uterine and submission conference fibroids positive first half has joining quarter Phase Thanks, strength both XXXX commercially in continued good for positive III to opicapone. for a a clear to afternoon, XXXX performance, our and our XXXX off sales

turn performance. to financial let's Now our

to in sales volume saw scripts $XX.X the increase expectations. both XXXX, quarter script dollars, $XX.X During This of of million INGREZZA in XX,XXX product internal first scripts net resulting net for These results, quarter our million XXXX. the to product and sales in fourth X,XXX sales. and exceeded scripts, net approximately compares

effect resets on anticipated. patient insurance and seasonal have changes new plan did front, demand the On copayment had and an the significant TRx demand we as a existing impact not from

expect quarters. drug persistence being was the more Persistence now trends previous stabilize. levels compared lower longer, due as patients migrated to above long-term expected, rate remains During as to on refill we to QX, impacting where

be fourth patient levels XXXX. continue similar add for quarter to at new strong of addition, In the

October capsule, of was full QX of to driven priced XX-milligram the script contributor for one in impact script, to by saw quarter For of $X,XXX to XXXX. decrease the which a of per script two XX-milligram net this $X,XXX capsules the approximately in the was revenue QX approximately largest per launched late XXXX XXXX. per transition we higher from The decrease

quarter Net two when was per QX compared net per revenue per $XX.X compared million hole results or resets. million was XXXX. we a of and our share QX loss in to seasonal estimate of what also the was XXXX. of for script or loss plan headwind commercial D XXXX saw these on in second Recall in $X.XX million same Part XXXX. the the had the loss a copayment by that We $X.XX loss for share doughnut quarter affected net $XX.X from to Our programs impact Medicare INGREZZA $X period the launched seasonal

activities compensation nonrecurring with our payment SG&A to well XXXX prior of INGREZZA. million expense XXXX the as is million milestone the when of during trial corresponding primarily there the XXXX, the timing $XX.X in for payment made proceed from quarter to a submission were increase for expenses of in for stock quarter to This program So million first increased exclusive $XX million a XXXX. from million BIAL expenses preparing was to year $XX first million offset spending, The first licensing is $XX.X increase clinical a to for XXXX. SG&A of Phase XXXX by due opicapone. first quarter an quarter due to additional opicapone not was for determination to an in of the comparing the million decrease $X as $XX.X result The partially during to compared first commercialization R&D activity quarter BIAL necessary charge NDA $XX.X III no RX XXXX. of revenue. overall of an the the was

of and company investment was well XX, $XXX us Our cash, our near-term position receivables March execute positioning million, XXXX as approximately strategy. to

rest ahead look we as of XXXX. comments few towards the a Now

As date million to and the earning anticipate third quarter moved you've we for elagolix the that event-based a AbbVie of been our PDUFA approval. upon $XX has XXXX, announced endometriosis milestone partner seen,

of we encouraged INGREZZA, the As it to progress relates launch. as previously mentioned, by the remain

market the of expansion allow for tardive and our XXXX. fourth patients We investment continue physician in opportunity and will greater decided many sales and force to reach entering visits have This of expect investments coverage care make reflects professional expanding sales completed training as expand marketing, we quarter our we to health force, and have recently to fulfillment in dyskinesia the and see which possible. as to the

We continue launch for about learn very dyskinesia INGREZZA tardive long-term optimistic to patients. remain this and of prospects through the

will of operating Benevich. range compensation the already expenses over to increase to We momentum Officer, continuing driven opicapone commercial look primarily milestone to we XXXX. I force and mentioned of our to hand stock the $XXX throughout Eric and XXXX, Regarding our $XXX and quarter expense is nonrecurring call This increasing the that, operating our Commercial our charge. million million half to second for expansion million. And now Chief with impact guidance forward clinical from $XXX XXXX first sales are million $XXX by

Eric Benevich

was about to Matt, continued over the prior expected are trajectory good at INGREZZA quarter. another thanks quarter Thanks, point. very where where and we call. saw of be QX great this today's joining on TRx feel us XXXX for XX% strong to We growth momentum the Neurocrine, everyone we and with increase for of approximate launch ahead

or contraindications the TD We drug tardive day a no-box tolerability, one be for are sustained Our with INGREZZA. having these important capsule strong with the product dyskinesia. selecting the success marketplace dosing cause believe and market. and a Product hydration in featuring attributes for the as to in profile a rapid starts in such once treatment simple without combined that's warning favorable attributes good considerations efficacy, reflected when INGREZZA complex label preferred

with coverage, authorization with we simply thus health they payer have majority Regarding enabled access diagnosis confirmation seen TD commonly, implemented to have very far. a most are we of claim. prior require that a of pleased access INGREZZA, open plans approve The policies the to of

market diagnosis work of TD. Prior behaviors success by willingness approximately launch, and many dyskinesia specialty treatment and experience, is hard drug. alone change a our pay And appropriate for long patients of options or helping of And our to educating in at dependent over building is there and the XX% on run, written, INGREZZA, it coverage branded market, the product, approved TD has a per time when a gets INGREZZA's no to this affordable, a prescription years. is the effective In less $XX increasing approval formed FDA still been gets far So nascent were TD. month. team in the filled. let my ingrained XX% for or great treat our Tardive

educational the at TD of understand was and people's undercoded At TD underdiagnosed, regions, decades, TD staff and of undertreated. fully impacts negative the patient the criteria, neurology of variety types multitude our spans lives. appreciate the psychiatry their recognize underrecognized, mission Neurocrine, diagnostic can on variety the For HCPs risk quality and different and of help have body in to presentations

we like sponsor interest we our engage we say, help We in colleagues positive American and medical scientific on continue Academy to had TD in and educational next last continue the commercial RE-KINECT, momentum and a the TD, medical from exhibit will in data real-world INGREZZA York, Psychiatric Eiry the unveil in American highlighting data which of moment. TD and greater current many about neurology Suffice Neurology, to as challenges in Association psychiatry present where is local expect scope detail Meeting sponsor called at and at booths, national Annual for to week week it leaders this to meetings interactions. to of where learning teach peer-to-peer the our strong discuss forums we epidemiology TD New will content did such long-term in with study programs

the stakeholder commercial and are medical It's TD. that even efforts, of and educational have to groups, made, as partnership scratches are barely recent bear in direct long-term these outside starting INGREZZA we progress surface to recognition of it of seeing TD our teams All in the marketplace. potential only fruit with through of diagnosis and the occur we note the increased important with in

coming anniversary launched up on one-year we INGREZZA last are now since May. our We

with emerge, and our year. efforts, to considered allow force larger and be of with in INGREZZA. fulfillment our TD the and our are sales universe. always seen the Physician results and our a TD product TD. about all ahead opportunity to at disease has this high-touch data professionals favorable reach with reimbursement us made have a HCPs receptivity enhanced the as toward helping team as market launch of TD we to care We've service payers health targets, to very patients increasingly many positive and a right upbeat awareness quite insight sales have process, market and become messages call refined INGREZZA required the during that the first the We with has of more necessary It's possible where about to with customer gained We're added our engaged adjustments help positive level clear this learning bit patients frequency expected been all is point. thousands to

planned of to can team market proud development I'm launch, quarter sales we of force deployment about the the of years patients. expansion what many accomplish market very expect can turn growth. the with of Officer. the the with promise XXXX investment of we're leader for XX%, by the of Matt to planning reconfigured become of and And year our I'm accomplished Medical team our beyond. what excited the and our As Chief this earlier, in to fourth We to our expand Eiry rest I'll now it that the This the deliver in first size has year. approximately opportunity, by over hope sales expansion team in mentioned Roberts, believe to to throughout help accelerate field that, commitment next belief the TD the commercial testament waves and prepare and in INGREZZA our INGREZZA TD our the conviction a us is expected

Eiry Roberts

and I'm programs. an afternoon. to update very quarter progress to able be our provide across Thank pleased good this you, clinical Eric, on

demonstrated detected. Kinect both well the of III INGREZZA, in the treatment weeks. subjects of receiving tolerated shared tolerability and that blinded, with the study recently from the with and milligrams, long-term portion with was dyskinesia XX new data milligrams at the we for medication patients efficacy safety open-label study INGREZZA, tardive Kinect INGREZZA long-term describing to American XX from Neurology treated XX extension IV signals Academy meeting, generally and/or For no up in Data of study,

XX in XX-milligram the the TD for condition weeks measures improvements out sustained were both and patient-rated demonstrated In treated subjects. addition, based to on XX-milligram and

of XX In of goal XX% or Change Global very Impression Global of Impression fact, much participants Change improved group dose more much each and at in improved INGREZZA had weeks. indicating Patient than a Clinical

impacted had shared data XX% long-term results than phase, to by that the including extension which region greater study, each disorders. health III screening Kinect in increase population, the or in Phase by for were to of XX% also in patients to our III We data from body showed of confirmed of of of professional This the our antipsychotic proportion regarding disorder. from the equal perspective approximately to INGREZZA we ongoing moderate RE-KINECT TD help dose. note, movements at baseline continue XX significant who participants to had assessment. symptoms patients XX with with a treated used no severe an treatment with or movements a or level abnormal weeks at of whom included study, mild, treat neuropsychiatric real-world XX-milligram dyskinesia patients awareness improved study, and/or also Through RE-KINECT TD clinician generate antipsychotics after the TD, mood minimal Of

addition, body in regions. two over half affected of In patients, more symptoms the or

data And from valbenazine. Turning evaluating continues pediatric late now on optimized with Tourette valbenazine remain indication to release to patients study progress study, The XXXX. T-Force in syndrome, we doses for approximately to in GOLD the this Tourette track according line to plan. of top XXX

GOLD to direct part a based data the plan discuss to path submission program initiation PLATINUM in Tourette our with of in confidence to at tolerability a the to randomized NDA in to T-Force it supplemental effect recently with T-Force FDA, with we XXXX In with instead in or the hand, current parallel valbenazine. with not our the in valbenazine. the XXXX of a meet double-blind, on initial syndrome. available who and to the this Tourette in Tourette's data valbenazine is of study in pediatric of open-label withdrawal in these syndrome any for was requirement from of of patients of and top first clear, FDA forward With completion with placebo-controlled, T-Force understand initiated QX interaction line patients, the this XXXX. reflects expected longer-term end therapy we study, approximately systems Enrollment XXX be To the begin to but desire study responds PLATINUM, pediatric begin

additional the to NDA in we remain We with our division of not written to disease, and announced I studies of fluctuations. did of opicapone on For January, in with studies patients the track work other for submission FDA complete and opicapone, we The adrenal previously as II the Parkinson's met submission needed for or received NDA require I pharmacokinetics, highlighted, the highlight feedback male and the III patients in February will motor prior the the continues for CAH hyperplasia The previously with and the that will XXXX. tolerability Neurology division Phase pharmacodynamics confirming study treatment the to and our XX the data proof-of-concept last of summer. deficiency of half in program CAH first is with program. congenital today NBI-XXXXX progress. classic Phase in that adult this anticipate female We hydroxylase examining from study later be available Phase

this for encouraged as path will will CAH. the data treatment to in year. now hand of the are clinic for these we more call development evaluation the over to remain one all to we remarks. across a novel that, forward with hand, Kevin at the seeing closing With some the back for discuss progress to meet look With the of and NBI-XXXXX bringing least our FDA patients compound programs clinical forward very with We by I

Kevin Gorman

Yes.

we Q&A, And go I it's excited everything going like so on. to the said, with hard before be not that's here to

So to that, I up open for with questions. said, like it would

Operator

our [Operator Meacham Instructions]. from And can Geoff first with Barclays. take question we

Geoffrey Meacham

your that out extent answer trends you early what persistent under know typically what but trends? the Tourette. over a have the you discontinuation I'm just launch, relative it, mg Kevin one first have that conversion seen vis-à-vis the the have Eric, in I almost guys maybe also from to and with to belt. is or the you your help how And initial mg, XX I do the expectations, played us follow-up then I that seeing can quarter. XXX on And year to on or then just

Kevin Gorman

Sounds a to would. and answer he's actually in, Eric, questions going going but here of them a let good. better I I'll take your I'm you, lot to maybe of than both bet I heck chime

Eric Benevich

bit, for patients with more we Hey, time. having above ultimately have we regards think to it down to really be still over function drug it of tends expected on we where where trend that's Geoff, certainly a so and but a to to seen And persistence, expected longer. go I see little

by just X function yet, down have And So population we in Matt sales a the have by days a regards it's the of with early in the but the XX, a drift XXs the seen to net But XX of belts. XX. that, seen treated reflects of treated. as the transition from patient little being with his the from but size with comments Still there coming that that X under the then transition that now to patients we this under impact most are milligrams, belts. like we've day, feel number our are most a for some part, quarter are full our an is for or the adequately prescriptions to

Kevin Gorman

Matt, you anything have that? to to add do

Matthew Abernethy

impact we No. as highlight in portion the the two as the that -- We Eric from my the discussed to I large was in a prepared per point. at said, prescription. this had XXs. transition shift some from and during had remarks, largely step-down revenue we as the that But $X,XXX, about belt quarter just of net of our our under script still XX-milligram a XXs as I'd two

Kevin Gorman

Geoff, have you a question? So Tourette

Geoffrey Meacham

you going to enough large start logic duration just last want you there the talked, ongoing a Yes, but now to was is just registration time thought -- get for I think Phase I on serve as the to that your because, formally really sense you're we I registration. is exposure? the mean, from feel learn get potentially the trial, of guys, better there see something a to IIb that you T-Force longer us a sense a to PLATINUM, from like just wanted

logic So design, want go I and that about that detail of thoughts maybe bit to into things a on little just dosing your initial with more the and nature.

Eiry Roberts

very It's understanding efficacy Geoff, around core the to tolerability Thanks, us with of and We that the those is and NDA. the we plan that to help of question. confident the T-Force And remain to Tourette after data in study core will the well, FDA the talk GOLD end efficacy appreciate the the Tourette supplemental valbenazine. that study. by parts is of -- and enrolling the have the year

generated We also treatment withdrawal in IV that responded data of FDA of type also randomized this of this from other setting long-term describing that people of context type are know very in who patients asked to Tourette, prescribers of the and and tolerability trial the persistence the that therapy, for approved the molecules for in Phase has themselves. the trial, important, for for and terms and

were do be happy this And longer-term controlled very proactively to so answer time, believe initially able because valbenazine to respond to we important questions for persistence that we tolerability trial our given additional that of and a environment. who to patients at in ability around effect prescribers it will the do in make investment the

Kevin Gorman

that Phase second be and at end with, an that we're extended just doing we to initial plan data as with that. now out the based When IIa look next the our the And asking all this don't longer-term on our months which file that and from of data T-Force very year you those said, T-Force trial the sufficient trials, We to of we being sNDA with them for GOLD if we've this discussion was clear. as the which, with dosing, year, here. kids, with at Geoff, clinical plans have from we do the haven't this data GOLD, changed the with a again, pivotal six know order positive on in did we FDA go to agency in having

have is these Now further But but launch designed in said started in agency the to closer started you the Phase would Neurocrine financial to it the Eiry pull trial in of to we to years things Normally, so is of waiting And right a ability now. have then, the this be say more and XX drug also, talent understanding increased look is it. a that, very you're throughout. this the not drug, tremendously and be goodness would if if IV our for of setting, as what way it's for depth and physicians. the great at now for that thank we forward now. months, we've situation past situation all this X.X at of the really In the or company good --

do INGREZZA if now also just in been some future and RE-KINECT and have the serially. wait And would at we study. in data didn't we're to that It not able just have can have unfortunately, like of to into things of of the now great so invest the TD had we time the that. launch rolling the do this, we wherewithal cash out But the be and to

Now do. we

doing is we're next INGREZZA. we we were dollar what do, going best the So spent to said on

future, we're You in planning force for now, sales with we're see invest to right the INGREZZA, the invest you in now, it see future, now. the to that Tourette's going going planning for expansion

Operator

Anupam And go next JPMorgan. we Rama can with to

Anupam Rama

me the and innings you're types agents? in of and [indiscernible] between one patterns. and a early the differences with psychiatrists? terms the the similarities neurologists Just are two competitive for terms dynamics of Any physicians seeing of physician here What in prescribing prescribing quick

Eric Benevich

product Yes. I we're we And like with There generated like our are the momentum, say reflected in strong for we Well, lot had Certainly, of I focus current all, really with psychiatry, first the into And carrying got that's time the conversations felt TD We feel question TD it happy disorders, to we've really movement saw who how on the a which specialties. the thanks is The that, moving XX% a data various quarter certain -- similar to about we they patient cetera. INGREZZA. profile, is spending -- want very and growth. the -- two with it really new of that for education, labeling. et in think we're preference understand so drug-induced starts and are we've product, to QX. quarter. And can product to the most certainly, about we body tend think, presents, differences, neurologists, that experts, focused amount those the between some attributes. making to it In TD and the from of more the teaching manifestations, occurs, when more we're distinguish where psychiatry. sure other that I of regions of comes

are some But differences So going to both momentum. we're can between I the received to specialties. in there psychiatry. say well very And continue that and invest INGREZZA been across has that neurology

Operator

go And to Ahmad of we Tazeen next Bank can with America.

Tazeen Ahmad

in you then follow couple to sales take And per-physician force, market? almost over your that that wondering you if past of the it that about that the current year much of does share your before the they're example? Maybe in decision a on basis, sales current to physician data about, does saturated you've how penetration many terms you're how getting up have do reps have a And accounts collected some talk script? for I a you your could on the I increase feel with with was general, rep you can contact a follow-ups. also of write points sales

Eric Benevich

Okay. Hi, it's Eric again.

to of physicians. was or a X mental of thousands of to universe months opposite. adding the in sales uncovered Health we've team few accounts our of launch additional customers added customers, about of Health added your across community question care actually, of actually question we've was lot potential would the actually also that say, health. our first uncovered during and first types, lot Your professionals we it's saturation a of was neurology psychiatry, frankly. X And What the our I part Allied call first professionals institutional and we've --

number conviction With that response we So that quicker you regards forward marketplace, reception look your was really bandwidth. in the which more say I've a opportunity set I talked question on the to, momentum specifically pull generate think in been our investment, really about. a increase about happens And when really to I other it that as seen given of really than us the we've to other without emotional associated I the growth the the uncovered guess, that the comment prescription, a drug past, calls has corresponding is product the at won't and this in with lot than Kevin heartening. to it, really the and

Tazeen Ahmad

give the And proportion can idea scripts Okay. then from you revenue versus continuing of that patients? an came as of renewals, new

Matthew Abernethy

new a higher Tazeen, I'm as not But progressed, going the I is of Eric this compared coming you launch Yes, the the exact give as has I you'd overall base to guess, both as mix. call Matt. existing and alluded to have from, to lot percentage NRxs. your it script patient

go So we up. overall similar versus have to continues QX NRX adds, QX, the but weight existing of the

Tazeen Ahmad

from coming us Okay. proportion Medicare? scripts of are And can the you that tell

Matthew Abernethy

going called saw those headwind to impact QX. I can to QX questions. is out the to that that specific, as the we from some doughnut what say that, specific we're to in add $X specific color of just provide to No, not we What million as compared hole,

understanding type -- RE-KINECT demographics eligible. underlying recently mix, be as a representation our those a poster would presentation and had study, and relates could far of who in the to the of you considered we it maybe give As patients patient mix that as of

Operator

Jefferies. Amin go can with to next Biren we And

Biren Amin

about Can you're on you particular And focused a are on a to planning hiring? little how talk bit channel? be these going reps reps many

Eric Benevich

question, Biren. the for Thanks

size. identified, a a territory to there XXX everyone boundary. have publicly, alignment said sales going QX approximately in force about our increase and comments, my deployment. and trained expect now. adjustments the there's in mentioned to I XX% territories We're for time to out But in some We've So ultimately, final be we doing hired

continue versus terms their we're outpatient we're all having they'll to going not groups neurology psych within focus. of neuro both to team separate In focus or and into customers psychiatry. role, a institutional or the and splitting versus the their Everyone's geography cover

Biren Amin

the reasons X? persistence noted some you then to are are the just I or dropping Do what for on patients trend therapies? that switching top And you're think are they X discontinuation, off. other that And know Okay. seeing, the you

Eric Benevich

don't larger No. I of function information. having that just kind a But we number trend it's the have mean, data, people of really of on just at longer. drug been a looking having

Matthew Abernethy

of of And medications, function drug their not se, with. average of understand it's time patients to caveat, on that Biren, I underlying these begin we XX% XX% dropping to take per I, would the patients the a

around that matter. it, of efficacy become naturally lower. it percentage people a existing patients, other to our are persistence causes overall stopping of patients a as It's taking our due it's persistence as be new comments some So mix overall just not a just to or compared to statement of flag whether higher more

Biren Amin

Got arms And then entails? can the do PLATINUM. a you just just How dose evaluate? question little a you randomized bit that it. withdrawal T-Force plan what to and design on about And talk many

Kevin Gorman

all That will be clinicaltrials.gov, on Biren.

trial reasons they've So there there. the the lot going is actual that's about beyond like just than we I we're clincaltrials.gov. then to that. we'll be in writing. to there, elucidate won't until elucidated And other until be to but of for detail a giving doses talking more out we we designs hit -- other competitive be generally wait don't usually happy than like But --

Operator

next go Company. with Cowen can Nadeau to we And Phil and

Philip Nadeau

what a one hit prepared couple you per back, that an your in quarter, for we you'd per about $X,XXX the we prescription. of net [indiscernible] million prescription get future was noted you in about that quarters? $X,XXX the then that because add should assume Jeff, for then on revenue Jeff, a also like questions. a hole. doughnut million question average of but $X $X First pipeline there's If the Is mentioned remarks

Kevin Gorman

looking going before answers start I'm named the to to that see CFO around is Jeff Matt so... call, if Phil, Hey,

Philip Nadeau

made Sorry, I comment that who misunderstood have must before.

Matthew Abernethy

of the Yes, $XXX product caveat said, $X that problem. of did only about we going like difference. thoughts some at to what capsules just two would expect were still forward your the versus XX. impact is XX-milligram No shift around to million, The the you make I the

that a offset per have would $XXX you headwind. So script would headwind that

with get to we've to i.e., we're in net a But tell movement those and that. where aspects the the from about. as on that's underlying well impact items the think our are key see contracting, some I not had I'd we've Medicaid. of an to mix, caveat into our you make payer to had would in So to as continuing been in along that only gross of increases future, And much we've place, into not

Philip Nadeau

Got it.

of Okay. Then pipeline That's a helpful. couple questions.

are respond? what Or therapy? going First be? the on portion. what of response I patients, expect assume is open-label believe any then have discuss design meaningful randomized -- Do that of response a there going into therapy will rate do is gauging way the be release respond is you in to to press people actually trial, proportion put PLATINUM the will you you to that T-Force discontinuation Can the the most you to entered you patients have who

Eiry Roberts

we the becomes -- that part. question, number to alluded fashion study I study, of Kevin of number Kevin for a when into on thank such more entering sufficient as of the randomized in the study subjects to posted Well, the be the randomize you in the number we size the will think, the there'll subjects need detail alluded achieve designed it to, be withdrawal around have to believe there we that the then open-label And clinicaltrials.gov. included

talk included you for of and the the me wouldn't to course to will it but be think what anticipating see the we're response appropriate from the -- the see trial. in I expected in rate about numbers study

Philip Nadeau

randomized? So the the the the in release, portion is the entering XXX that entering of number the patients people, who or press open-label are people

Eiry Roberts

open-label people that the the the withdrawal randomized eligible randomized into And valbenazine to study. the to deemed with respond be will of open-label treatment be of are then in at optimized beginning entering be part Correct. treatment those study. course that of after Those the will the the

Philip Nadeau

Got it.

is on then the question And Okay. CAH the last market opportunity.

broadly, And you I a you've in markets? appropriate said accurate some would proxy still per what patient for sense there patient an think be when therapy. what patients, revenue could is pricing One, are those So that be? two, we that can the could who then to assume about past size us XX,XXX we give number? of

Matthew Abernethy

the suffice to that CAH. a significant as it drug. the tremendous see early said far value But too It's what as the have put patient with mark could We've to say, us Matt. is drug XX,XXX. could on we from for ground our patients about the this in is potential dealing impact this coming be. And pricing coming we still Yes, population it and see from value

Kevin Gorman

that is what to just number other Europe, footprint. the plan thing Neurocrine this put There's And said they that and U.S. only have in the ex we Phil, at add, good registry to -- over on being approximately opportunity I over over a global at we believe this could an development Europe. Matt as would plan we patients of would commercialize We look and CAH there. ourselves a that we being look for very same the as in

Operator

And Brian Baird. we can to Robert with Skorney next go

Brian Skorney

to data. guess the elagolix I change up little, a the have and a FDA some request maybe liver question just on from it for

what anything or can thoughts, to you that I'm terms there just data, on elagolix you And out on think wanted your can see internally. here? speculate And of even FDA kind with to you high-level you're sure speak effect review when the the for FDA? looking be an maybe Just the you all get seeing could of if reviewed data LFT, and we what the in updated you that's had on

Kevin Gorman

anything Journal, you advised and response, liver, Brian, can there, this speak that Google go of signal. to bilirubin, never that in to not AST, we the liver thanks to that are a New asked put this AbbVie is the question. anything than again for England being don't go England that too, and can standards database, all AbbVie response of it And us really on more AbbVie together see if rigorous the article never going we, an peer-reviewed into thoughts an ahead really find We the that I entire handed FDA aspect pages updated Journal Medicine powerful have quite importance. Neurocrine, long X,XXX to had you when and level expert -- as well. we by had by There you're we is that's us had rose gone think, the any most LFT, and of into entire and I this, try this, completely of including do had the and, no our having and back think independent can go it you go is Google and New

AbbVie, So I responded the to my in FDA. I have partner, think great that well really they've confidence

I And drug. this in so say, confidence approval we the of have undiminished completely all, would

Operator

Jay And Oppenheimer. Olson with to go we can next

Jay Olson

was Did of just find have is the can you guess, surprised at I the on maybe high at that reaching AAN I And I atypical tardive around XX%. at patients XX% that guess by of about question were maybe think some And presented of a within penetration about antipsychotics along data we was AAN. I surprising those how it context, percent are dyskinesia sort where of then, patient? curve that you number? of that physicians talk the experiencing

Eiry Roberts

Thank I'll the start. Well, for question. you very much

I tardive the population and current Eric help further because in up I it's think dyskinesia think there obviously, RE-KINECT to think beliefs prescribing prevalence. of are lot the until community undiagnosed extremely a in study recently. And need patient the perform about understand mentioned of we were because really as this real to earlier, important untreated fairly very I the

professionals little a in Now It their prevalence patients it but we better was in believe in real important patients of question really we provides of know that not that that was occurrence symptoms information for understand this terms that in clear directly, do it that address XXs. study high the a to will setting. world health care

the The only it important in was patients patients in mood schizoaffective very with other that but with of in seen context thing that not the that was study fact was disorder also disorder.

there information. believe And important are so I think we

that it's the ongoing at continue will with We moment. study,

information at APA. new to additional relating Eric information maybe over generate And your shared be study, for to comments hand additional from will continue I'll the We question. to

Eric Benevich

the just is published TD. about additional are with of that the study Jay, couple of of findings the a the consistent Yes, in actually prevalence points. very literature what's One RE-KINECT medical

the estimates, at antipsychotics you are estimates, teens in first-generation low-XXs. the mid-XX% see range. that low most the you'll of in data second-generation neuroleptics, If estimates look are around prevalence Prevalence and the the for to

actually So the findings estimates. prevalence in line where patients previously the RE-KINECT prospectively with strained reported from study, are are

However, most physicians, do research, estimate when you would lower. market

community a of with they're all a in of neurology, with And setting them, caring so And to the suspected gets in to the patients certainly of the into TD these a diagnosis in it's message every different either value little TD, is data of where part were paradigm think identified I And our symptoms. for than TD bit presenting it's important patients how neurology, many psychiatry, a the to it context. or patients day. screening, put at where that look in referred

at we're It's next the and our week. what additional So to presenting neurology more is going to be may data And believe. than prevalent. you TD psychiatry APA is both message common diagnose and there's there, in the message treat. TD you're our And what important is community do. when is to lot of is out implemented and practices, Certainly, going a thing screening

Jay Olson

purpose in syndrome Great. just and But sales for you just maybe treat which term, thinking also tardive reaching being longer caregivers, It's I you who the for the then Tourette on force you very helpful. one of Europe? as can expansion, question launch had preparing is opicapone comment And described on of follow-up And dyskinesia. I opicapone? additional are how performing guess,

Eric Benevich

the the is answer first of force future is opicapone. rationale which yes, for the to us I'll part sales of the that, the for prepare of Yes. expansion question, part launch

when And did so would some need to within of on gives Frankly, neurology. already on we the But opicapone. call neurologists us we it additional bandwidth for called we most that bit. there expand thus it's little in And to our do the additional work, that regard we opicapone then footprint recognized early days. of performance a to far, Europe, with we need

Certainly, work in the in it commercial may neurologist our uptake. to feedback so disorder Germany, have about existing to started movement say, place far this recently opportunity partner, from and very here U.S. you the product England, excited available imagine, the them is we've the that they're as Spain. seeing should BIAL, a And inhibitors. They're COMT markets, Our in launched in with pleased the they're I few the has very displace, in to it --

Kevin Gorman

are I'm private that, to And BIAL, a and disclose that the that's our add partner, to I'll thing one going not is confidential obviously, to they anything company.

forecasts don't BIAL's to they Suffice has were, completely opicapone responsibilities. they're it outstripped as Europe. that outstripped has our have internal public that reporting really what any INGREZZA in So experiencing internal say forecast

said, the launch as always same the of the opicapone of they're over of INGREZZA. Eric future use talking with in when for we'll So Europe. INGREZZA, we and the just very with launch that about very pleased pleased them, use We're

Operator

& Needham can we to go with Alan Carr Company. And next

Alan Carr

come can to CAH. we back Maybe

if a I into middle of think wondering quarter, you that, then all reminder that at, can to second also of for that going talked looking you many about later, how you're of enrollment's and the year And this, on give comment on thing? anything and I'm be much going? maybe us data there's having but sort in design how doses

Eiry Roberts

study up of dosing. performed excited very in The We patients in to of really molecule study this study XX patients days ongoing. for for in patients, to CAH still XX two demonstrate CAH. classic in potential It's a has CAH. with remain total, patients the value The with XX is to cohorts adult

ongoing it's effect pharmacodynamics data very tolerability. couple a to And complex it throughout and of stays. efficiently, the late on able And the obviously continues our for on molecule, the overnight molecule pharmacokinetic, able requiring then study and and look CAH. based of a of next at to we we're be summer. that share potential path treatment data, discuss to With progress So the hope we dosing multiple to for agency the of to steps the pharmacodynamic go effect will of forward understanding submission those to

Operator

Peters go Andrew Bank. And we can next Deutsche with to

Andrew Peters

see I just to or newer sense in you've But down of a a some patients expansion. far info these I when so of bit newer I on start start drill wanted a question, of know lot prescribe guess wanted force and accounts prior to you the INGREZZA. to given on more get sales to a could expectations

on your experience likely understand to develop that's patients far physicians impacted how the the something are is take potentially the of and identify something time already? on Or with timing revenue and with going accounts as well? expansion. familiar be these it to to relationships kind is by it could based Just this new so cadence the the launch, want where Just

Eric Benevich

Yes. the Thanks when deploy to actually going for deploying team, And new there's in to be couple our we QX Andrew. and training, engaged we're a new think on-boarding, about. things of now screening sales question, Between and identifying, the team.

for of great, relying Our and really keep the the thus performed, we're they've far. is existing way momentum our up to team that them proud distractions and And we're any minimize on customers.

So think our have that new the can there. and some trajectory. launch disruption more is accounts us so I Ultimately, such their of new in to them any transition be importantly, existing to And folks and big new some tactics, customers, existing get to as minimize of a the but customers orderly term, focus employing mix going of folks, relationships. those a using out so on, more being able really to for hand-off reach to an to then near be some frequently. We're we're teams, customer the going of it's to we new introduce the

neurology we able been and the team. with a psychiatry so can And team have go to than in place, deeper existing we with in larger

and the those patients brought as right as that the reaching possible earlier, year we're right of with and mentioned customers we customers. value support, I of launch, that the sure many of INGREZZA. of first can we We with so As we the want in thousands recognize help in level the them to frequency make

kind going to the So year, and end new between look expect and starts what like I lays to is team plan of what gain as this think the the now and hits then some of kind field out to the of traction. that, that

Operator

you, And we back turn it no go Kevin, additional ahead this I'll remarks. at appears questions it or closing have to further time. any and over for

Kevin Gorman

to the there that to all just how APA, We questions This is to several you his terrific in continue fact see to place. competition this many INGREZZA, heard with interact the meeting a you've me that's health we'll to going have here. team and about be this. on this this is and taken to to that initiatives next are that KOLs that in, on see about, that the throughout that That to RE-KINECT see in our how and will at position what great with surface don't with do, from at you're pipeline, isn't we'll is proactively the the going and a little Affairs a on last, what seeing and years, said, There continuing very pipeline. And that and and doing the of indications partner, of job are you between patients' what are have and to expanding is of and pleasure with just Eiry the that with there. with. is and I future this. everyone's why number surface really are I APA. going and I'm marketplace that. more scratched going the we traction. just is enthusiastic fact over if leave incredible huge gone forward through as then And a about there. across think holding And seeing in Medical we exactly going educate marketplace, again to is again, scratched it think INGREZZA, do very with her X be I a effort everything you a we've do. -- the much, who impact continuing is up Neurocrine X educational know look we've team, seen INGREZZA us to theme yet that's because I on. building that in be call. continue just with entire is that begun in talk And add study real that's And study, you're ourselves an have I'll have that's and I over that what Thank now, that be have, the only invest, extremely gaining once is in us earlier, and this We're that appreciate events the current has that we But invest, in ability We're Neurocrine her professionals is now based the we we to be going I important our launch to us. as out the of is we compounds team on the a We're really that's going by AbbVie, exciting we with with and the information one agree Eric can INGREZZA everything, reiterate care us, marketplace. surface. going reception business. everything there said you an you lives performance you're commercialized that have just says the reason And invest in scratch are going putting we we've we for would we going at number seeing date, to our to you And just look time. leave four have and this invest we to right

you care. coming and look New I very you York weeks. to much thank So attention. in forward for I all Boston And over meeting Take the your

Operator

And this does participation. conclude Thank your today's for call. everyone, you,

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

Neurocrine Biosciences (NBIX) 30 Apr 182018 Q1 Earnings call transcript