NBIX - Earnings call transcript Q2 2018 | Neurocrine Biosciences, Inc.

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Operator

Good day, everyone, and welcome to Neurocrine Biosciences Reports Second Quarter 2018 Results. [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 quarterly conference call.

Before we start, we’re going to be making forward-looking statements.

could Safe you statement, if Jane read Harbor our please. So

Jane Sorensen

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

Kevin Gorman

Jane. you, Thank

joined we years our our by outstanding So Chief I’d I’m Eiry the Officer; in regulatory like with this done Benevich, to Chicago. Financial call have Commercial particular and Chief Partner an and Matt ago. our several form Officer. since start Roberts, Eric Medical Chief Officer; of, here today by Abernethy, entire team clinical They elagolix partnership AbbVie, congratulating the our and job in

label that is outstanding their III in the of Phase conducted earlier an call week was reflective real it that think on of high label Rick echo, quality by I for the said I AbbVie. the is program its ORILISSA Gonzalez what that, indicative and

up as There a patient drug the is stay outstanding I no through has say duration the patient the of shined on their said, monitoring team. this in no program think complete development warnings, there is here. dosing label so of dosage regulatory while the confidence program, restriction decision that this and to really and there also the that and of dosing. to of into There we is commercial there flexibility recommended I no have the AbbVie duration -- quality forward, requirements I boxed on definitely a label. is in is this a went have label, in physician, is is and that treatment, going can We that this want

with the years, with been Rick a out and two well lot have Gonzalez next has We the that to nearly that, last interacting going work the months. work them the and we’ve several that over you’re say seen talked see for, to of started I’d come ORILISSA, about

confidence launch And have how so but of we nothing they will in ORILISSA. trajectory the this AbbVie, and and handle

gears to Neurocrine. Now, I and like would talk switch about let's

back. go so Calls that the biotech I want this, really is next past for go a three wanted moment very a the This over special like to details And in is the time time company. unique the just we months. over as any into don't take and calls earnings this But is quarterly I get a lost as to hour. said, and I special step

successful are absolutely and that previously with company it continuing a a of product enough. if a the stages in isn't treats was untreatable disease extremely launch We is that a early very that and

will that discovered were second women. We at drugs change of here have a drug Both of these approved of lives millions the Neurocrine.

former for proud position. current both we employees of and that and all in both speak employees I us, humbled this be to are think I the

the start that, great to by and let's I'd he quarter And talk call turning like been. this with to get details. can into a So about over Matt the what has

Matthew Abernethy

uterine approval, conference our opicapone. XXXX second FDA ORILISSA NDA a towards data with positive start call. you green success, proceed for INGREZZA quarter XXXX FDA from had to thank an for and has afternoon to the submission a continued Good and light Kevin. Neurocrine joining earnings fibroids Phase receiving Thanks, III for tremendous

script months of sales product quarter million for INGREZZA approximately XXXX. of $XXX to same Through to compared $X.X the INGREZZA product the $XX.X product million During first quarter XX,XXX XXXX, second net saw This XX,XXX scripts volume in $XX.X first XX, June year. ended for the scripts, the and sales. net to six million were sales compares increase million last XXXX resulting net in in period

trajectory, As during steady made QX and patient uplift trends. commercial off persistence distribution coming quarter X, reflects continued TRx The on available a for was new the flow, payor seasonality INGREZZA positive reminder an May XXXX. in second of related upward

over more longer. We to further win expect persistent we have drug time, as trends patients on

per milligram QX the loss a same XXXX. capsules XXXX a in hole for the $X.X XXX with revenue partially share, quarter impact was was $X,XXX increase single-digits primarily versus to by This throughout in compared reflection of the of being milligram the decrease from lower XXXX. Net million XXX our offset as QX, scripts script share Part per D the filled expect experienced slight was or script in a or loss total continue per continued XXXX. net the per Medicare QX. of net loss Scripts scrip quarter approximately loss mid doughnut to to $XX XXX to milligram during decrease and in capsule. $X.XX of we being The filled per is $X.XX as million for scripts period capsules QX compared us for to from the Regarding $X,XXX in approximately increase

million for that Recall the XXXX, a of loss net loss same the For quarter same per the XXXX. INGREZZA of XXXX. $X.XX months million $XXX.X compared $XX.X loss share to the period XX, June share, $X.XX or in was launched in six was or ended net per

including period also and during our Rx the XXXX, XXXX preparation is $XX R&D filing. comparing a million development across to of being the million when and reflection So expenses XXXX. compared was second of the the Research second XXXX, expenses our half only of during The CAH the increase for to corresponding of opicapone of million $XX.X progress there first NDA anticipated continued $X XXXX. quarter Tourette, pipeline revenue XXXX during quarter in during made were

addition, we goal in a In one XXXX. at of to invest IND least preclinically with continue

million For six non-recurring of period R&D for were last for timeline made opicapone to expenses compared ended timing XXXX. as first R&D the $XX.X Sales the XX, a $XX to prior QX and general first The in as of charge BIAL quarter year-over-year BIAL million licensing the during half $X of months million quarter offset an the of administrative clinical of was million an to XXXX from exclusive stock the increase second year. the XXXX. payment for $XX.X $XX the of in for second the was mentioned from increase XXXX in previously partially as activity, XXXX, the program increase result of increased well million $XX.X $XX.X to same QX by million of This quarter XXXX, June XXXX. year expenses compensation primarily million in the

periods commercialization XX, six-months $XX.X expenses increase both due were period XXXX, the across million The activities SG&A to ended for SG&A For compared million in for $XXX.X primarily expenses June same INGREZZA. to last is the year.

near $XXX receivable positions as XXXX million, and term our of investments company to over execute cash positioning was strategy. XX, us well Our June

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

our based during quarter With will agreement milestone the for approval Neurocrine event under AbbVie. to of $XX the million revenue due collaboration third ORILISSA the recognize we

In a from upon ORILISSA addition their sales we based launch AbbVie begin their will also of August. earning royalty following net in two

executing the we continued the completed it and are script of patient and sales progress entering our XXXX. increase INGREZZA, our third sales we we net which quarter have be plan demand new fourth we in an remain pertains also Specific marketplace expect As in INGREZZA to to volume. overall quarter how encouraged to force expansion there by product expect to

As with growth all fluctuations factors certain launches, in quarter-to-quarter. cause

of we're through is For include I items items continued key specific with mass into Seasonal from term sales the heading But on expansion. the INGREZZA QX. XXXs. force possibility managing robust. make the dynamics as aware we as of and in to distraction our you potential focused scripts us, The want long being decline to QX filled are always, the

operating With Benevich. to previous $XXX within call Regarding Commercial for now the Chief hand we fall XXXX, of our to million. will range our million expect Officer, Eric expenses I our to expenses operating that, over $XXX still guidance

Eric Benevich

Thanks everyone hello joining to And us Matt. on today’s call.

our team second for of was quarter more INGREZZA And The help suffering launch. TD. I their patients many and proud a our couldn’t be TD to of the great quarter XXXX the from performance effort of

now on a have approximately the market launch been the QX, of exceed to for expectations. we continues year As and

sales have our increased performance, assessing reflected of four said, prior The our which nearly $XXX over XX% net in QX XX% quarter. generated million full impact prescriptions, total And in a metric over previous of As net in representing increase of sales. $XX we the million, launch, to were over our quarter which first the quarters patients, XX,XXX. is key the Matt is

breadth three-quarters patient with all across acquiring and segments, persistency INGREZZA momentum. prescriber remain and perspective, our of medication TD. prescribers with a the is TRx per continues From leader of of and use dispense prescriptions from coming the to with prescribers payer expectations in continues year that both of and led within new first be prior education is market both vast starts see launch line less a as growth coverage in intend Through our New patient realized real build with years, confirming of experience prescriptions through approximately will over to we which we awareness, month. opportunity of favorable than to the remains paying our get INGREZZA. XX% a written affordable out continued see experience expand INGREZZA. and life brand and over TD, they patients believe base, disease ample to for prescriber state on the the We them be have authorization majority steady launch diagnosis of expanding matures. their The to with INGREZZA as coming $XX the INGREZZA depth practices, clinical pocket

track. expansion, is sales previously Our announced right on force

of sales less than XXX We have literally received applications for physicians. new thousands

with currently sales in across team. our neurology We’re interviewing with existing psychiatry the and highly applicants many country, experience qualified consistent extensive

to continue mentioned, team the our Matt to we confidence, force, are in in we’ll customers. significant from QX. on expanded members the Combining existing current measures newly expect market make progress us existing new and ahead. years developing this with our As great we distraction our over deploy TD highly expansion minimize team the sales And that capable team taking gives sales to

the our year, forward Going of our continuing TD efforts. progressed the on executing balance we into have of educational plan

providers loved and place TD, urging them And on identify INGREZZA. recognize with helping patients the helping appropriate ones. to them range and TD their of the that appreciate multi-faceted patients are presentations We burden severities healthcare can of and treat

that option daily treatment The approved first only medication and tolerability TD favorable robust box simple FDA complex efficacy, dosing once for hydration. no offers without the and warning,

So INGREZZA attribute in summary, of great company. a QX XXXX the the was growth into steady our continue and to drug building is strategy. to focused attractive results deliver our brand and an launch, a and strong suffering we year We rest for profile, TD. quarter execution and and to a Approximately thousands also market team most consistent our of great patients team gratifying a of that have we our helped from the me for

hope. are We aspiration of on our up living shared truly to delivering

So our Eiry? Chief Medical to that, progress Eiry call our the over I’ll with with discuss Roberts, now to turn programs. clinical Officer,

Eiry Roberts

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

involuntary possible nearly For dyskinesia. the with of of INGREZZA, on dyskinesia. RE-KINECT medication. for confirmed life real clinician data of Annual quality possible demonstrate confirmed shared movements Study. the tardive had impact Psychiatric Designed in XX% new from the at of Meeting study largest with study we into from world study insight is This antipsychotics population antipsychotic patients clinician Data provide that the May, patients the the American to screening study taking valuable this treated tardive Association

or half body over the experience with patients regions. two in movements In more addition, uncontrollable of possible TD

without meaningful signals. improvement study that safety treatment X INGREZZA at presented tardive provided APA, dyskinesia emergence sustained data KINECT of new the in were the clinically with demonstrating New from also long-term

has Tourette to XXXX. top to T-Force progress The syndrome the data in from highly in Tourette for indication late to our now this XXX remain doses continued patients of valbenazine confident Turning plan in we study GOLD line study, evaluating valbenazine. release and approximately optimized pediatric with

to the in path data meet the of submitting date. recent with we an syndrome these success study for T-Force discuss XXXX part with FDA in valbenazine. weeks first the to In With the Tourette in began to hand, patient will activities good forward enrollment PLATINUM sNDA

withdrawal and randomized line study a As top previously end valbenazine PLATINUM double-blind, Enrollment of in plan described study in at Tourette progressing the pediatric data this to we anticipate is XXX available with is T-Force patients XXXX. having placebo-controlled, approximately of syndrome.

in over and the open-label optimized for the in we months studies, complete dosing roll in extension and required over submissions participation second as in to open-label addition useful Tourette well the tolerability to be pharmacology last T-Force the six of In of final from remain participation in included into for in to the study of children the enrollment this molecule patients. complete Syndrome for NDA GOLD into dosing. T-Force safety study the the quarter, will submission. additional maintenance treatment studies first information commenced clinical patients Subjects we XXXX. extension adolescents, on the GOLD six the of are Plus reports months work completed in this will Opicapone, Of valbenazine. as these doses The successfully and planned an study, about term of NDA period support collect in to providing the longer of note, study data with we with recently half eligible efficacy these track dossier

study Phase Turning deficiency. now to adult of program and tolerability and of examining in CAH the pharmacokinetics, XX-hydroxylase II pharmacodynamics concept classic, NBI-XXXXX our proof with patients the

quarter quarter study initiation As later sites but slower for full anticipate be originally this enrollment. in data from the completed we quarter focused study, now site study our was the have mentioned four. on initial that active last will planned We and this available with than

you for this data hand, in of to to very remain the we Congenital and over Adrenal we -- with With hand path clinical portfolio remarks. look in these clinical the meet with year. encouraged the evaluation that, data adults for treatment now seeing children forward Hyperplasia. call by for a forward the our FDA and discuss to progress sharing development closing to are with plan this We as the Kevin I'll the across some With back molecule novel later both

Kevin Gorman

much very you Thank Eiry.

and So and to obviously track in to and as us. patients continue from on a We're bring multiple Eric Matt very got new you Eiry, indications. important and for quarter medicines productive to

like to I'd do So open to call is what questions. now the everyone's up

Operator

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

Geoffrey Meacham

question. Good afternoon Congrats guys. for on thanks the and the quarter

that point I get can among quarter, the INGREZZA, trends, know this I great. could duration call any if it that Then represent demand. ask so be will commercial always was there for on on psychiatrists physicians Just [feeding] a you as in specific on tipping out or among

the I Just one there follow-up. that. of if is outside Matt, you called but I given trend, anything more have seasonality, sequential know out And some

Matthew Abernethy

you question Can your of Yeah so the duration Geoff. was clarify about treatment? it

Geoffrey Meacham

point Yeah respect just anything that trends persistent with called and tipping demand? out potential to in then the

Eric Benevich

we have little better will we TD and average expected. we used One patients that their seen And a regards populations, would on. be so the on other what is a We medication a that as antipsychotic highly and the and model study fairly distribution it that's expansion the medication bit with on that tends we've keep two that pharmacy And they see are with the medications, drug antidepressant persistence Okay we approximately we persistent more quickly. may being consistent of condition. based where that that to more seen been with persistence and are for But typically other patients know thus the X label what end by contacted into of medications due for symptomatic go we INGREZZA we've is extension to get KINECT medications drug. that got so down. has is maybe the returned at with we've patients as that these in our come they movements went far likely thing off help the the them than pleased really trends, Certainly to think been the when launch expecting open did the that on patient be factors. longer, this where

we're the really as view was a I of it around at think sort a that that a with we're this launches don't speak. really And second point. terms tipping I tipping of -- of seeing stage the of guess happy to question persistence had launch. point. was in overall, around and the so So of series pleased you I searches

so As you identify continue on. and up you opportunities your targeting messaging and and tighten to your

or of to are a growth haul I rate to we the quarter about in from educating So expect long think to identify investment, variability and see month our of helping terms month would expect growth. TD, we like, And to see terms that obviously INGREZZA. making it we the or for that quarter but patients what appropriate looks in continued for from fluctuation in customers to them

So, I hope that question. addresses your

Kevin Gorman

thing I’d only the just and sign very market said we that last force The as potential that here is we belief significant. clear Eric the opportunity the quarter our to invest and decision made long-term add Geoff sales in is, a in the see as to

Geoffrey Meacham

to as you related Matt a just that for follow-up just And for Kevin. and

elagolix looks you side the you disciplined pretty On are on have cost P&L, profitable. been even almost and kick guys it economics like in before the

launch transition to range of forward much And to and/or that pipeline? a how profitability? going will just priority question the business to versus earnings the close of the in like trajectory is our seems is the investments It so the purchase INGREZZA a sneak

Matthew Abernethy

organization R&D then going bring the that the those are we as our and all programs possible as first to to second, to we are Geoff then or bring in forward jump other as possible. and the Obviously to I’ll organization to of we in in our foremost first say our commercial we’re in for make rapidly successful going is looking and into company. programs make And internal and and INGREZZA company. outside investments just Yes, compounds smart so are company be on the secondarily as and also investing

this in it we to So, at from to are coming will us in being flows have ORILISSA, INGREZZA our isn't pipeline. coming we we and is or that develop have we try make stronger just where look in maximize at going avoid the something actually profitability that either much to point, cash that that from able that

Geoffrey Meacham

Okay, thanks.

Operator

Skorney Brian with go ahead. Thank next you. to Baird. go Please We’ll

Brian Skorney

guys, afternoon good taking Hey thanks questions. the for

around Just and in to and is wanted wanted if follow can contracting guess little a to any switching not versus INGREZZA if and of you the around terms you in from are is comment thoughts on an prescription Thanks. bit of seeing TD? any in future. or up And from what market and that we of through population? public there what anticipate if in follow-up pricing are some [training] per patients and to what seeing I share that currently any on failure is of from whether are terms maybe mix think primarily you sort growing any you with or coming commentary private kind treatment share TD penetration Austedo also that market seeing payer new

Matthew Abernethy

Brian. Hi,

on net had five revenue which and take or will our net around we contracting our I’ll I the first the one gross really appreciate. you script in through to per four commentary competition. and take Eric think there, of questions

as state some Medicaid plans see are that. an perspective get for fluctuation Medicaid can mix quarter on mix, as example you because different net seeing we to for gross a from So increasing quarter payer of you

intending provided do not we’re to have versus exact We into mix government private here. and of that not insight our what historical

not the change in to for we change yet. where place we've I’d from a some then not had contract at having at gross are launch. So, been net And we've perspective, point call but this a major

XXXX. on total revenue have throughout alluded that that I as call, us on per expect addition, script. we XXX out the scripts we still down gives our of going bit single-digit percentage net as capsules, go to mid But a In which do to lift a of milligram

is going comment competition. on So Eric and contracting to

Eric Benevich

the thus know, before been we been to think payers. want reimburse value. We of on have so But feel appropriate our launch, in for and about year far, over confirm haven't Matt a this we contracting a a been health said. situation. plus year we're with year it's to the into going our We, a really with TD Yeah, that haven't into is thus and you plan sort launch certainly, we're contracting feel to favorable we -- doctors The We of a that the the and just diagnosis proposition of reimbursements what value happy piggyback INGREZZA good and is favorable with claim. that payers, access. so far,

We we and to product that's know focus the lot indication. reformulated a words, was And I and is patient. that win, part with or thing make hear our we of our for that's the for for fourth physicians on your do our of Second TD same we're a market customers education. the don't there from the think that's the of also sort motivating We inertia piece. competitor other it and We frankly, actually as when competition Tetrabenazine the customers. nothing. and it. view on But been the diagnosis that's question in about guess, of historically, with sort standard main that And, a healthcare apathy don't professionals treat win that, other about care changing patients, a

we're that results we warning, those thus the of the we're far. And complex we really having reason The So, we're seeing pleased strong with that really and so box the profile we're the our a we reasons strategy that of along profile execution, tolerability the are And main that's once that the customers. we dosing product our delivering are daily that titration, seeing far. educating main think uptick facing with on have. efficacy, all with reason have really no forward, that the we're lack

and with focusing possible let the business, to and INGREZZA. on product, we'll patients giving the patients best company regards bulk with they're So getting new of their comment they experience on the we're think the but existing other adding them their where

Operator

ahead. go Bank to go America. of Ahmad Tazeen next We'll Please with

Tazeen Ahmad

give Good me. for you a How force results? afternoon, update where I of might questions. A how And being that have then is sales couple you my and to complete? your strong couple of much talked underway. contributed thanks on follow-ups. that But much about have taking now an Can us quarterly for expansion your are, of you

Eric Benevich

Yeah, so hi, haven't my are We're Eric they of -- it's board remarks, and been again. It's their midst now. candidates, right interviewing I in we on haven't it, started in prepared as mentioned and the training yet.

So reported the out QX, don't expansion. results for we sales that force reflect that

we're focused on in In distraction fact, candidates minimizing to addition and best the any to existing what factor is really customers. our team identifying

So light as in the really imagine, for some of from distraction was expansion. you can with the coming results possibility especially I that QX, of pleased

hires the And to field bit to obviously new to meet into for all a in the We if new able holidays, early expanded to be team the the get little in time around expect that's going QX. heading of to the put customers. it's take

bit the into be quality time see so the the pleased really interview to so lag so the team good when place process. to new between in to with of start going And we there been and impact I've been of far is we've the candidates put and a of attract that field we that. able But when

Tazeen Ahmad

place multiple your is that, to doctors of same are targeted contacts related and reps to have in sales the you per to focus areas? plan have fewer area on Okay, trying or

Eric Benevich

Yeah.

have it smaller even way institutional through territories, to the the so the everyone number that going nine-months targets other and the target lot that into first the or cover perspective. of I them to will an though ACP we're from characterize the appears targets a of So pulled words, is be We and In more targets INGREZZA don't approximately physician to have same. universe. launch, have the our we've valuable attractive bandwidth be identified would

that's more rationale is before And field originally in there opportunity for expansion, what customers. we our the there calling team out sales this the that so of anticipated is part we had had that

physicians institutional and number be similar of those and professionals allied they'll covering geographies, that territories. smaller So health in accounts

Tazeen Ahmad

what Kevin. assuming year-end? Okay, the release On top-line by thanks see data then to for to steps positive? guess data And if And would that the when could you remind Eric. what do expect GOLD is expect one following you we that us T-Force I be next information

Kevin Gorman

Well I to baseline we'd is the the compared guess I if is start primary endpoint me Global going done I'll to in score change to grab we What show do past, to Eiry have and be we placebo. doesn't what by sign from as answer than Tic finish. Scale will the Yale throat YGTSS expect Severity the

p-value. And get you'll that magnitude and by so

Eiry Roberts

we in first the And prepared talk data take to to That's as that study correct. I mentioned order in in year remarks, take will next part then with FDA to submission. and understand from the the entire set of the the path the NDA supplemental

Tazeen Ahmad

could this your your the is that serve as data if growing pivotal? positive still assumption is it that And

Eiry Roberts

the study, a is we're pivotal we to going strategy that and It forward. intend be that

Tazeen Ahmad

Thank Okay. you.

Matthew Abernethy

Tazeen. you, Thank

Operator

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

Anupam Rama

thanks Hey much taking guys, question. so the for

opening trends level the [gate you follow of guys relationships of in commented penetration or you the much, kind year, for into type Are of strong accounts? out is on Just within of uptick your there describe you room you there? one accounts those longest the kind you What initial of any point] last to would the plateauing ups. so seeing think effect? How how Thanks those are much those about comments, quick grow me, accounts? no but in have when where maybe INGREZZA this

Eric Benevich

to considerable accounts still staff. there say in So these some grow. expanded of and that is reason I you is the And would providers room have multiple

staff, team, in sort so is care to but therapists and and model educate And includes also the go integrated the so of managers to our case typical and the on. prescribers nursing

the screening to so you these and still requires centers and to with bringing understand these of attention of certainly mental number is of to treatment in some to of what TD of prescribers. is to aware are And INGREZZA. with and And different kind TD, be rates prescribers really in the TD, bring them that from could symptoms everyone for community recognize patients along health there multiple benefit this large the in clinics

lot So already gotten there a still I think we in accounts, the is contraction. even institutional of where upside, have

Anupam Rama

our so questions. for taking Thanks much

Operator

We’ll Olson go with go Jay next to Oppenheimer. ahead. Please

Jay Olson

prescribers psychiatrists? program April? guys, psychiatrists just at Hey and for could wondering breakdown TRxs into the back could comment impact you was the mix APA the program my just on And NRxs has if thanks congrats on that and maybe and questions. you I XX,XXX the for taking in the talk refills of your wondering and quarter then had also neurologists I out also that you if about educational rolled between

Matthew Abernethy

this thanks Matt, question. Jay, Hey for the is

the providing you what see, and it persistence than new our breakdown are have NRxs patients. aren’t we it as in from we patients a refills. said good sequential drug trends -- comments, that when had show our of up would in a And trend can we between expect been perspective, long-term once But longer. would We flow hopefully higher

a well our the perspective feel adds, similar what From refill in have to both we So the mix we both really on good said rates. Eric. new educational sales patients as we’re at, underlying with reflective what see psychs past call script it what of that’s or hand point, prospective volume. would you an neurologists program to in I XX% pretty and From will over XX-XX, and our XX% as call

Eric Benevich

so speak of those such audience for presence we that medical but with audiences and professional national psychiatrists having And, say speak just AAN have bringing prescriber peer psychiatrist our to a helps, to to in peer example, a to very as doesn’t lot our active and universe the to so of been terms bringing go speakers neurologist of education, meetings. the bureau I’ll meetings bulk a on. and to psychiatrists certainly work in a doing Yes, at APA regional we’ve been

there as some that’s about And started overall activity, physicians so been new untreatable that at experience new treat really a a strategy. to a peer medication the the stage as to valuable experience clinical learn and to of our They of of peer so get this rely a previously and others launch, is part on condition. lot of have way

Jay Olson

question. Great, thanks for the taking

Operator

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

Philip Nadeau

quarter good taking for a on question. thanks congrats and my afternoon, Good

those put the serious the the prior year dyskinesia one tardive you’ve understanding First are to with more in in dyskinesia for in you of and has find XXX,XXX on that moderate so there market treaters that changed treatment. XXX,XXX that market particular figures suggest patients are for as and the a as maybe been your and appropriate launch these you U.S. of figures to How tardive overall physicians the the who believe patients? size of maybe

Eric Benevich

publications in into medical understanding we've our industry same these undiagnosed. to us were is Yes, Certainly the as this market. on that overall what Certainly I was it launch, think the the the multiple of prevalence the going our patients size help majority was. relied of it belief

I is focus should healthcare other under is the -- we really pool, the But think not immediately of physicians physicians opportunity, only is care say. of reach we which considerable. market what's that our which growing are professionals can that on and So size the diagnosed overall the patient that patients accessible

in pool, near-term, So as that opportunity we're opportunities. we're near-term both increasing patient addressable the focusing we that expand on penetrating and the

slice for a the two-pronged pie us. take pie. and So, of Grow the of sort a approach

Kevin Gorman

with so to this. And on just a the thing, that correlated isn't I at would want from really of There on dyskinesia and as treatment be the who seen patient follow-up and have populations the their tardive of are dyskinesia. by patient for benefit categorized gone both appropriateness we by mild significant found treatment physician the have tardive drugs. have the one severity Again

with to in that. So, I just wanted jump

Philip Nadeau

Go actually to effects. pricing pricing mentioned due another it. quarter-over-quarter whole second up seasonal That's helpful. doing our you on And a picked

the Are per other effects be the that Aside forward. we would to go the aware of should you there from in affect two that year? seasonal pill to change price script expect remainder XX milligrams the times the to of

Kevin Gorman

No point, really earlier, would where I a point not have I at to place could an primarily of And being that XXXs. that yet have this Eric think the we're driver. as biggest be mentioned in something as the it's would impact. the we're XXX sort probably some But a contracting

Philip Nadeau

last one question And okay. it, on Got then ORILISSA.

early know? likely the you the will stay restriction. to is really payers beyond with what payers those not too the are Do just on think give I'm think want duration that patients is that to you hard they so is that mentioned You recommended it recommendations? the Or to label curious do a recommendation time a duration?

Eric Benevich

Rick the about up and with far payers So to to by Phil, think reception I them that thus actually talked work be it encouraged very seems their Gonzalez leading from their launch. And good, it. very he's

to they been are had But where debilitating that endometriosis from is going going payer of years. you've honestly, they and environment think for anticipate hurdles women suffering the in put can. to who have would the You pain payers change

product effects such two efficacy. believe getting payer substantial front after put has that time that they continuing first a be patient able they're in few side that oral treatment. for relatively a can that It hard of would relief on to years an the would to be take, Now hurdle and outstanding of

Philip Nadeau

for helpful. my taking you very thank and That's Thanks question. again

Eric Benevich

you. Thank

Operator

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

Biren Amin

question. Hey the are percentages think INGREZZA, quarter. therapies patients coming coming percentage new are what label guys. Thanks and are off coming percentage what my from on patients? the And for congrats taking I from new over Austedo, guess I what

Matthew Abernethy

mix. are percentage any from And would do very do, Austedo Yeah. label. Hey From that that that and hear obviously. very low We we other Jay, do and very NRx off between Brien a we've around be do instances that that not be provided switching a in market of that little told question. very, then some for this We us careful incentivize have done our at the surveys could I that been our occasion used we off-label but not surveys point. and of business thanks it use, a as the on regard

Eric Benevich

and would comments on only are treatment that INGREZZA The our our started thing add recognition majority customers on with is that other started diagnosis to patients their on for that newly Yeah. Matt's helping I TD. focus of with the vast again

Biren Amin

us are on volume large any what guess coming Got that tell can versus color it. us from And I centers then or you percentages give small community clinics?

Matthew Abernethy

on No, you that heavily Very not when we straight see dig but what customer we concentrated into are base. scripts up. our have commented

Eric Benevich

the these group practices. and And is are most physician small. Small in psychiatry that practices reality of neurology

bulk And we're where our the getting of so prescriptions. that's

Biren Amin

maybe up enrolled, patients with and [GOLD] T-Force on you randomizing follow Yale Got many Severity see phase? Global And a a then to the the that on patients you And it into just randomized score expect XXX in of Tourette the enroll how okay. INGREZZA? patients which of response Tic do are half I guess

Eiry Roberts

question. the for you Thank

We disease we anticipate the the based what patients number anticipate rate. we would weeks improvements. what what obviously That physician response in valbenazine assessment area. rollover. exactly really is will is we basis study But at rollover we of clinical first number you We favorable treatment. haven't actually we be more Tic the haven't powered over. clinical is actually seeing And of the least of as not necessarily are the in actually released response of exactly XX to from is assessment think seeing randomizing Global being believe patients And the score we seen believe that on rate of rolling a Yale that to Severity this an the

Biren Amin

Got it. Thank you.

Operator

Needham We'll & ahead. go Company. Alan Please go with to next Carr

Alan Carr

could go point for cash you here. your Wondered is Thanks bigger your taking strategy this if NBD over getting and balances Hi. at my question.

strategies So work also, evolving? And INGREZZA TD timing effective I'm doing us if is BD the Mitsubishi in your then when you is for wondering that can give effects?

Eric Benevich

for same take that strategy remains the larger. means opportunities look years. It have that we at size as that BD So past Alan Kevin. has the couple the of this of just question, gotten I'll it

of and our incremental [me just meaningful bring. value looking would that not changes. a and say will or products we brings transaction for a priority product to appreciate bringing possibility the meaningful at would So the investors patients two very order of that in are good I that science health twos] not And

great need and and there a is to I a right where But as America's at. to looking be deal of that be of work deal. just outside in creative just very at active order in broad think swaps the of we you done and that’s as look gave lot the we’re has four be So, of it walls all we three being do to I we’ll

Phase III currently. quickly. partner they is that of now expect read don’t in a have nice As when have they considering Phase are our clinical from trial the they towards been very to to diligently working in and Mitsubishi that so far yet, but have as I out it’s trial timing III

Alan Carr

questions. my for taking for Thanks

Operator

We’ll you. go ahead. Kulkarni next Cannacord. to Sumant with go Thank Please

Sumant Kulkarni

essentially are than [indiscernible] of results scripts around the our dosing other that clinical sized Hi, shrinking could highly thanks hooks to generic or so what appears of a be IMS what for key taking start to market, an opicapone, questions my schedule, view? is the are help penetrate questions. My point from

Matthew Abernethy

could Right, repeat. you

Sumant Kulkarni

other is generic on are so product to schedule, Sure, from what hooks shrinking scripts what help this the key could seems highly opicapone or than penetrate that view? be dosing clinical point [IQ] of sized that market a an

Eric Benevich

in jump now. Everyone wants to right

Eiry Roberts

and the here. start then is clinical going that on attributes Matt of we elements patient think be me important view and from some let with the Eric So, to point a will of have comments

Europe and profile, off program when in significant the still very the and BIAL III that with favorable that currently they the context patient benefit of also and know of tolerability profile damaging is believe the understanding Disease a our for the there particularly in tolerability that the dosing a given day Parkinson’s these risk on is the hands do or times Phase population, actually clinically that available improvement motor the with we of with a opicapone have given know can is of you medical partner [COMT] We look on demonstrated seen and comes context fluctuations that associated at and has be efficacy of need as that are the for in also already you As differentiator in what associated some inherent fluctuations critical of Disease. these class. very safety class available the once are treatment we Parkinson’s our of inhibitors currently risks unmet that these how patients unpredictability Parkinson of the in burden patients with that very

patients. to can new bring and valuable excited We we and data by very the that best the value package have our partner believe opportunity was we’re dose about together clinical put the a BIAL. So opicapone

and make had leading those performed the to is direct I that obviously Phase comment other is comparison. very [indiscernible] programs III of the favorably include the addition inhibitor In one in a COMT comparison

So clinically, in that we’re excited very regard.

Eric Benevich

to are I is with. from drug made options COMT When heard looked this which this at classes profile neurologist that class add tolerability inhibition. importantly out essentially we favorable delivering with molecule view promise was commercial of points that consulted within a and on have movement disorder Eiry Eric. would as what have The that dosing, perspective. Robust opportunity, efficacy we the from Yes, a that on currently we that and there are we certainly a issues other day the COMT not once the and the the

the a opportunity entire we that to And strategic unique think innovative our coverage it's therapy current with of INGREZZA. for addition, is platform movement an we for offer that nice in disorder there fit neurology patients. So the essentially community. And have with these

demonstrate prepare with for we second do launch opportunity our that what to NDA to we continuing an to application next this our forward file be our team as look can But product. we exciting going the So we is think year. for to

Sumant Kulkarni

now you pricing close could thoughts are that [decarboxylase] latest share the your filing potential of you on for a and opicapone? Thanks

Matthew Abernethy

we're No, yet not place to at a that insight. provide

provide we'll closer. launch Thank closer we get insight to you. we As as get

Sumant Kulkarni

Thank you.

Operator

Jaffray. Our David Please go Piper ahead. comes with Amsellem from final question

David Amsellem

Thanks.

Just a couple.

Tourette, have can label? neuroleptics for T-Force the Thanks. the related, about payer given you it have Tourette? talk have getting to you off that disclose or how -- on from approved then Tourette's are willing study? And to valbenazine data be you could much powered in more restrictive tardive statistical secondly, lastly, landscape the how specifics So first, do of perhaps you GOLD are patients then regarding And you also many relative

Eiry Roberts

address and me this Eiry first the here. let So, is

for basis the study the that say treatment the Tic will Kevin around group calculation and which about primary have FDA on I compared study. endpoint pivotal articulated Yale baseline deliver detailed this to power We about change and our the it's not study a is articulated to on the for from thinking given with provides powered for the the Global the adequately as the discussion Severity sNDA score strongly is placebo. --

Eric Benevich

think all we've But we're treatments of antipsychotics available utilized the initial really not use simply your half in with the talking to could of. currently the be to related recognize antipsychotics safety some payers. what there's are Tourette early had the in they I payer be was the for indication. and yet, I discussions the children say being of used that and well It's because like, all might about environment because Yeah, being extent reluctance they to can issues And that a that question aware children. days second we're that

making So, think we're a we as of to action on safe sure that patients we terms different least And at expectation about an with our have effective bring treatment. favorable have mechanism profile. the the safety that far excited a that the access product to to we in interactions a patient opportunity that population of reasonable, based plans to so and be think will

Operator

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

Kevin Gorman

Thank you.

pipeline being program. one coming decade, is that now each a INGREZZA, just indications. about through ORILISSA a and a the And over we've and first For fruition as talked and TD endometriosis is

with future addition stay indications ourselves ORILISSA those. even tuned additional robust those, And moving NDA opicapone the be which INGREZZA For for next in we're with and filing both CAH fibroids. will on comes next that uterine our Tourette year along. to and the AbbVie for we and is pipeline to in And

on at have we least about from this active result you, call, market as told But say it's just coming as group. And in just the four that this we've stayed four in our And in static is the if on not static. on business going going more R&D six compounds indications year. very this front. -- the a it would you compounds coming to development If short anticipate We're to we're continuously I've years. pipeline still more one talked

one never with position an we'll we we'll time. get and now, is position but enviable work thought but continue ago, as it I that just and believe years and at enviable XX right gosh, to it's So position be in better this better we

are in and partner successes would to our for AbbVie talents their I our our like So forward It's really the future. reason that and do the thank dedication I again to employees. success closing, to thank look Neurocrine we more all in of and want many

you So everyone's thank for a been attention. speaking today. It's with you very pleasure much

Operator

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

And may any You wonderful a at have disconnect day. time.

Neurocrine Biosciences (NBIX) 31 Jul 182018 Q2 Earnings call transcript