Neurocrine Biosciences (NBIX) 3 Aug 202020 Q2 Earnings call transcript

Company Profile

Participants

Todd Tushla	VP, IR
Kevin Gorman	CEO
Matt Abernethy	CFO
Eiry Roberts	Chief Medical Officer
Eric Benevich	Chief Commercial Officer
Kyle Gano	Chief Business Development and Strategy Officer
Paul Matteis	Stifel
Phil Nadeau	Cowen and Company
Brian Abrahams	RBC
David Amsellem	Piper Sandler
Paul Choi	Goldman Sachs
Marc Goodman	SVB Leerink
Biren Amin	Jefferies
Charles Duncan	Cantor Fitzgerald
Jay Olson	Oppenheimer & Co.

Call transcript

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

Operator

Good day, everyone, and welcome to today’s Neurocrine Biosciences Reports Second Quarter 2020 Results. At this time, all participants are in a listen-only mode. Later, you’ll have the opportunity to ask questions during the question-and-answer session. [Operator Instructions] I’ll be standing by if you should need audio assistance. And it is now my pleasure to turn today’s conference over to Todd Tushla, VP of Investor Relations. ahead. go Please

Todd Tushla

Good our Ryland. and you thank Thank XXXX afternoon, earnings joining QX call. for you, everyone,

Joining me Development Eiry on Executive the Gano, our call is Kevin and Officer; Officer. Abernethy, Medical Eric Kyle Chief Chief Chief Commercial Officer; Chief Gorman our Financial Strategy our Officer; Business Roberts, our Officer; Benevich, and Matt our Chief

materially. to and statements. to certain subject the today’s During our results discussed latest statements actual These in call, you Kevin. turn we’ll that, SEC be are call I may factors risk filings. differ and over to review I making uncertainties, encourage the forward-looking our risks now With

Kevin Gorman

like our with good success the of achievements broken pipeline. a record resilience the sounding Thank and first and living been afternoon, you, regulatory continued our our of any bit I’m is great advancement of this growth a like the quarter full beginning INGREZZA, Todd, has impressive of we’ve approvals, of Company, clinical record, to The display COVID. is by been evident broken remarkable. in organization little I in programs, that this like of sound a measure across a resilience is our everyone. here This quarter entire the but

Now, our this I’m pandemic. that external certain to and that our of tenacity throughout mission of partners all us of our employees fulfill will allow

the entire experiencing. and to and And adds presented are openings the everyone same industry. the COVID the biopharmaceutical with fatigue is just We to the presented the economy, challenge healthcare starts, fits is yes, in closings the and as

caregivers most stronger to moderate This of aspects that any of However, in physicians than have environment the INGREZZA’s is patients, patients telemedicine, telemedicine. now and will with of we by this our this of mix nearly their importantly, is interact But shown demonstrated more we their of are by to unique perhaps balanced XX% a all importance and at Neurocrine. history where professionals in-person and past rates time back continued objectives business are fundamentals the the temporary, high-compliance quarter. of healthcare adaptable.

until But were unique on compounds this as While with the about than see actually touch quarterly about new We we that four time, we are patients and had find I impact patients to impressive to clinic. doctor’s ourselves the encouraged XX our this are discussed position on ago this with in approved from And on call. we I office, in expect four there’s our back were call, Company. in that. call, just clinical starts more of we INGREZZA’s today, talking at development. looked in. seen to we Prior I went later two at years to and last back time. the more in certainly end the want we approved it medicines two actually the compounds that medicines growth

As as try always, we as here a to through so keep your can get possible. to questions opening remarks many our minimum, of we

and Matt each going to the aspects brief go business, turning So, call Eiry, and the to more Eric, Matt. on with in depth now, of I’m starting be the they’ll over into of

Matt Abernethy

good and Kevin, you, Thank afternoon.

pipeline uterine FDA our INGREZZA, of ONGENTYS great fibroids for team for collaboration. the and accomplished approvals with disease quarter has ORIAHNN expanding with what Parkinson’s and We’re proud another two for psychiatry Takeda really on our

are a our opportunities to well-positioned our on company. patients formally strong our make quarter. registrational available biopharmaceutical execute third ONGENTYS our commercial financial leading expanding And R&D FDA in to and initiated to focused profile, growth X the for trial to in become pipeline strategy medicines, approved CAH. With a our preparing Phase We’re neuroscience we we

Adjusting million, we demand for $XXX Regarding continued of quarter, XX,XXX TRx. had existing reflecting INGREZZA from $XXX second approximately which to strong the channel financial results were inventory, sales patients. for underlying approximately the million equates sales

very-low the visitations continued front, in NRx The patient the April majority across the through QX through feared. industry, in-person we the impact of held to less although steady July. step-down and On saw were than NRx initially is

the for sequential This associated the upfront payment to we $XX in-licensing Turning Idorsia which non-GAAP GAAP to income does on includes another not the strong sheet. third quarter balance NBI-XXXXXX, the in closed million. with quarter with $X.X in the $XXX billion of our P&L, paid transaction with had $XX approximately Takeda of include profitability million million income of ended net and but cash QX $XXX of net the We quarter. increase million

Looking diagnosis with optimistic and XX%, what the for term we near there’ll about the around downs be we the ups is In opportunity entire think we estimated long-term COVID-XX, extremely at forward, rates many INGREZZA. TD the with expect, industry. for across remain

I What further patients pipeline. back the the with and advance on Chief For regarding we is Commercial Neurocrine is over proud of to to circumstances. meaningful related TD the we accomplish will to team longer to INGREZZA in the historical and pandemic both, QX our flow the are will Eric? aspect saw Neurocrine getting continue, our to has in Benevich, the to near to be not said ongoing able short-term. now insight levels visitation call in-person challenges impact our add a commercial or are make INGREZZA. as trends These patient at what But we July outset, NRx very hand these acknowledge Officer, an similar to Eric needed in for I in unique more efforts. been quite what difference experienced important disruptions our

Eric Benevich

second I’ll performance Kevin our may QX have of strength of off seen We insight in-office new-to-brand ever, to. happy execution sales with support With provide QX office providers. far from combined it the healthcare important strong not refill the quarter as reflects quarter. impact I of immune than was QX. INGREZZA start starts of in-office select in not in need our so visits. patient rates great the in of update the our patients ensuring saying in they on new estimated a noted, commercial network, the resilience INGREZZA at were an the into to tardive our the to Matt. and COVID-XX, record with XX% results that suffers XXXX entire of QX. and saw our what saw team for have mission momentum dyskinesia patient I’m decline as the nationally continue Matt pharmacy And best Across to QX to teams, QX. into our value is first reduction note, demonstrating, patients proportional by our because were existing note said, declined to field we home of half reduction through and as that seen nobody of a and the starts been visits. to longer biopharmaceutical due Thanks, in industry, XXXX patient persistency for in and patient this trend and carry the We to in, But that levels

With from the adapted stay-at-home engagements. advent of remote orders, our to in-office team education

resulted found with Although quality, overall that decrease, providers. lengthier healthcare in remote higher generally call customer interactions engagements volume we

communities a also Just as with Neurology patients. possible the engagement and remote their as went model, connected stay to providers to platforms, pivoted as helping we to telehealth Psychiatry

of disorder dyskinesia. it between this healthcare a patient and majority to clinic suffering nothing undiagnosed. tardive relates growth our patient, people diagnoses back face-to-face remains vast from somewhat important a person visits rates truly and trend. improve In historical get as movement TD are diagnosing provider encouraging While especially and to TD like is can in-office interaction The a replace to treatment on

continues. access highly our expect region of in field safety care back as we provider and dependent the on customers, QX, the continue protection with representatives Healthcare As setting. following into appropriate personal are And interacting many variable pattern start we with a to stop field enter see now to and guidelines. remains pandemic

on the connect majority methods still to of reiterating challenging worth we’re these the However, times. relying customers. It’s our that time during with virtual

We typically relationships a slower now, been INGREZZA providers, field teams, serving also strong patient due and with growth compliance situation. and addressing for a to vacation patients. have the we dedication dynamics. such are quarter Historically, HCP, experience who exceptional have are summer fortunate has QX to healthcare COVID-XX to and true sales hired And

to refill expect over carry back on we bit. a starts expect patient the and new for existing rates do continued may patients inventory pull into QX, impact we While channel see

suffering in quarter. pleased with and we are the like believe were to and planning to I’m available ONGENTYS by label switch medication approved about gears I’d and a has fluctuations. help disease motor ONGENTYS, a Now, we to from the clinical our the very newly patients which make end Parkinson’s regulatory talk able United movement States with teams opportunity this disorders, lot of tremendous now for secure, to to patients of our

weak medical FDA-approved profile more on has pill and witnessed broken Our INGREZZA. and nearly only a patients day, daily capsule promise the on launch live and the It which launched up expectations is to due can COMT convenient the motor with entire COMT to ONGENTYS symptom at dosing, to teams affairs ONGENTYS patients. something It’s tolerability side our of frequent lessen consistent help achieve burden first patients effects. fail to of efficacy by for as medications, rate once for for once perceived the limiting safety of that’s success excel and/or ONGENTYS that It’s our may community with deliver efforts that which education, the is focus previously taken Parkinson’s will Parkinson’s inhibitor Parkinson’s demonstrated continued for a control. one disease belief need also and commercial levels the attractive. people

movement and treating near reputation well. in new in disorder phenomenal the with the burnish this and give by Despite leader extremely by practices, will believe movement promote well-received time pandemic and the bring compelling. to to more as remains the in INGREZZA in the challenges long-term neurology customers. benefit face movement in INGREZZA excited will ONGENTYS on to disorders opportunity two efforts ONGENTYS us as community TD disorders. will our We’re be brought opportunity term, We and therapy products our a both Parkinson’s our with Having many neurology

Eiry I’ll pipeline. over to my colleague, provide with the the Eiry? who an Roberts, will our Now, on progress turn update call

Eiry Roberts

provide afternoon Thank programs. clinical happy I’m an you, update Eric, the on our and everyone good on call. to to

Europe, or serious half healthcare care neuroendocrinology visits psychiatry. range and and of of health professionals. XXXX, work COVID-XX and of our These of include manner our of that enable who adults efficacy re-initiation announce status form dose ENDO or at portfolio authorities I since in dialogue Europe We to evaluate the hyperplasia, this trial patient in followed approval with have to study results to investigative study Before a approaches treatment the to will the and though, that industry, and clinical impact randomized of single for in the crinecerfont. year CATALYST by period. It’s that study across many has partner productive clinical of as underserved and assessments and congenital milestone safe pleased the safety years, study global of diverse trials a X endpoints in and participate be the the placebo people The extensively now efforts registrational this Approximately responsible invested measure subjects a of remote changes XXX a outcome with first-in-class open-label adrenal the over over and the address a doubled qualification across followed safety The daily of global excellent previously-posed treatment screening of congenital clinical trials final impacted weeks. and for led exciting in passion clinical virus single in subjects has the size the in the America Phase our change June study of in X where we X-month primary to classical just and resulting CATALYST to in the crinecerfont to pipeline, all a from in all with trials double-blind with want beginning to potential sites, Neurocrine an in adult organizations continue U.S. which needs designs and of the first double-blind our know remote the the Phase best-in-class achieved placebo study. is participants by in of significantly telemedicine and the from percent XX. July, control hyperplasia, trial home appropriate. called on successful from study, development candidates is monitoring for period we amazing neurology, and of will patient week online data, at in enrolled controlled These one within study the the continues execution adaptation screening progress evolve, with informed the registrational baseline R&D the glucocorticoid for I’m one The adrenal across approaches CAH. I at time. few randomized at North in includes now have research reflect presented past to regulatory begin conditions classical designed crinecerfont thank Neurocrine to the our clinical

measures daily metabolic change mass. fat glucocorticoid clinical related outcomes androstenedione including subjects a of include in with XX, weight X, at proportion of to Secondary week achieve baseline week at from able of and dosing to physiologic body the levels together health, variety

lifetime. their discussions initiation the parallel study a valuable patients glucocorticoid, the pediatric hyperplasia. every continue in differentiated control of pivotal their our in CAH begin With the progress registration a to the reduce and study, study day regulators significantly excited to adult subjects. of in need the a needed to option adrenal study with course successfully take added congenital this Europe In reinstated patients pediatric benefit that in with proof-of-concept of the we much U.S. of of provide and We’re screening with the X single in underlying will enabling of amount for Phase recently and treatment in over hope they crinecerfont this to global of initiation support the important

valbenazine also registration patients. Huntington’s patients chorea to X Phase re-enrolling in with now the crinecerfont, is of disease Beyond study treat

NBI-XXX expanding precision pipeline, medicine Phase year-end, by treatment we Xenon respectively. pediatric in two and continue in-licensed of the our to and good make initiation X assets of rare studies support progress for the Regarding mid-stage Idorsia, the of from distinct for novel epilepsies NBI-XXX

ovary AbbVie partner polycystic to for our syndrome. continues treatment elagolix develop of addition, In the

of formerly proof-of-concept enroll Finally, efficacy the Phase known study the in in X half to from schizophrenia. Results NBI-XXX negative program patients year. of to next the as in our of designed expected continues control newest and this TAK-XXX, study, are symptoms global tolerability assess second

and more Neurocrine that today have removed We development. have very By it development to Phase previously about current mid-stage the pandemic to inspirational conditions. continue notice all for by mechanism. neurological in this to on I’ll bring VMATX their world you, remainder pipeline. and patients this for as broad suffering enhance relieve the additional the research mission this to The and dedication truly VMATX time keep believe thanking a class five was knowledge, we clinics. that a an for will clinical range to three registrational progress. the about challenges, VMATX will to It’s to spent instructive with predict again, committed reiterate what potential You taught our exciting to forward the molecule intend impact ongoing Neurocrine’s remains back on we we be inhibition remain despite in close and NBI-XXX build addition can chart our programs. me you we’ve of on to will these let efforts R&D the neuroscience target that candidates patient With programs once follow-on psychiatric X across bringing colleagues our difficult With my have But plan us with of lot incredibly that lives. unchanged. about year, the at value XXXX, XXXX patients’ Kevin? molecule and and excited and time we year-end programs for our remain to pipeline continues firmly posted thinking the In of a

Kevin Gorman

Thank Eiry. you,

corporate up sustainability Before efforts. open like to it I’d first highlight with Neurocrine’s questions, I

our our this fundamental communicating to sustainability at can ESG environmental, said, lives. our Eiry relieve The we the have large. first to we our our and to our we society And Company social and light, issued that most disclosure and found in customers, report mission to be simply connection mission really between the corporate suffering website, step impactful enhance is As strategy. on responsibility marks which the report governance shareholders in is to patients, partners, in And programs this of our and highlights first be just Neurocrine’s society. believe that

strategy we engaging on deliver to ensuring our matter we most look drive evolves, value. to issues on -- help long-term shareholder develop to to with that the forward As you mission the on to sustainability mission and continue and patients our

So, with that said, up I’d it like please. to for questions, open

Operator

first our go [Operator Please Matteis. We ahead. from question will Instructions] take Paul

open. Your line is

Paul Matteis

inform to to try better quarter. a parts, I guess, couple guys on understanding lot more steady a of this you patients you second, the sequential moving for the rates And do maybe where and estimate? questions of then in patient drawdown how can my with next of And bit a and to trying happening of phone refill are quantify add I’m And to say, now. going one, three a months? state that added should of works. foresee I’m how increases little still and And how get over, compliance going you relative much a ask six just there’s you many our to hopefully what’s inventory? Thanks.

Kevin Gorman

Paul. Yes. Sure,

the couple So, led for increase. a the second to quarter, dynamics sales

back from quarter. gross hole the First, where came doughnut in were in first the we at net

staying as testament that INGREZZA. step-up on experienced on specialty did get in it year, team the by medicine ensure quarter. element, effort in taking level pharmacy our really ultimately stayed last an think, we is have network incredible from as that I was we to rates. to drug value as a refill patients second of The and the a well patients patient And And that the

into get to the going not we’re front, there. patient ultimate new the On quantification

down XX% But, near did wasn’t due in out As did anywhere the you of on patient to in-person or that you drop April visitation. -- it we in have NRx coming step saw we QX inpatient, a described COVID.

know because that INGREZZA, you’re brand remarks, We both confident to very reach the INGREZZA But do So, quarter. rate Kevin like for a We and point its place weren’t very to a I discontinuations. prepared weren’t reach term long-term, NRx than we potential. where stayed natural was for -- as you in your NRx its in the ability where big discontinuations. long less throughout we’re and our steady at to said when potential a have INGREZZA

And and other not visits it’s your to and have channel many I to it of levels. disclose Then, that in difficult number, reflect an the are We number that I is build. in-person We to historical the And unique similar near a this dealing last to that’s straight get very sales so inventory, way, you sales very think, something can results to think patient to see back we Neurocrine. more represents had piece that with predict. adjusted underlying sales the Company. question companies for our tried normalize that relates three to quarters

inventory around be I some a sometimes weeks channel sets distribution your in at be So, inventory. do stocking is drawdown example. it’s reported hand. nuances two get It’s expect the in we a was example, over our baseline into would it expect the into -- there to to XXX get should levels long-run, the point I drawdown be to Paul. site this last for another for would why inventory, think -- hard distribution, there XXX, But I quarter, although around it on was for of XXX. because in And that occurs, right quarter, up to want

Paul Matteis

in Last And on Thank follow-up, reversion patient to per you big say you. anything number to per quarter, can underlying helpful. of you patient is? understanding benefit guess about saw script snapback can figure Matt? average I the XQ trying there sort Is significant. just as ask to said this patient as That’s saw script out issues a you XQ. this in context seasonality sort pretty a Thanks of broader the any QX on lot. you here one in one what the that And average relative I year, quick weren’t year,

Kevin Gorman

patient the Yes. per from up Like authorization or year-on-year QX. And a net and revenue big team as we or step reauthorization had great patient. better people a average in job QX you script to said, from year, went QX, revenue a script process this through -- per actually -- year, did in last was back

you’re right. So,

patient. significant a as in You from wouldn’t have script this QX seen step-up QX to of that per year

Paul Matteis

All so much. Thank you right.

Todd Tushla

a Ryland, we’ll take question. next

Operator

Phil next ahead. go from Nadeau. question comes Please Our

is Your line open.

Phil Nadeau

maybe questions. afternoon. And you. in Thanks me on first for great Good Matt, taking my add congratulations a let for performance my tough one circumstances.

us number Looking are the QX out up you’re Can QX, they what at the weeks in QX, you the looking a calling as give disruptions five or four field? in project we into trying what more into just to of I’m to you better first than qualitatively, is same? QX, it some help just we to understand of as that experienced the come try you’re qualitatively seeing revenue and with is

Matt Abernethy

and to good an question saw would similar to June. is very Good Yes. from hear perspective seen What from in April, and we May you. have what NRx July we

a seen down a level much stabilized. from the and would were I very, shut of had once a medical still very we pretty existing hope to helping patients started access with then, when similar think testament COVID, So, our professionals back very then absolutely we in again, I getting up. it’s a here are at that us as all And we’re things compliant. But economy looking people remaining are society, that a the going it’s people dyskinesia, INGREZZA NRx, new better is opening bit which down sales that into step and tardive say are team, field to

that’s a do job. higher cautious we think the to back hear any above in-person get that statements have patient occur is insights? for levels. forward-looking, job great and I team a us to to on see doing continue you that or expect up the level, visits NRx Eric discontinuation naturally medication, great any to other we significantly an need Kevin, them But So, to

Kevin Gorman

open-close -- that. back want does it the we are as things just givers sure statement, hope said keep like you my that I society’s with opening different. is Yes. it, and don’t, and no that a to like does, and patients is and in one But, feel -- care snapping I there everyone getting add goes in as thing I’m certain there, we whipsawed I fatigue for don’t and sake, forth that, there guess, that, Phil, I

And so, a is you off doing, it see every field again job, just and a two of, at in they that’s and delivering to But, testament terrific our is they keep a that that where team sales really caution coming is to what quarters know each sight well again, quarter. don’t lose it we’ve in keep our want that had a these bit things, get close. while nice of and we or things as front what of thus just far because we don’t to team curve to of you And his Right? amazingly balls, this, almost weekly. to Eric expect adapts seem open that voices you

Phil Nadeau

could I just questions. up with helps If pipeline two lot. That follow a Right.

BIAL be something ONGENTYS, or according to results, you expect therefore, will completion XXXX. resupply they’ll the And they’ll when The ready February is tell when first primary Phase ready be to be endpoint second Should on half missing resupply clinicaltrials.gov? do the the in that first clinicaltrials.gov, primary the the reasonable XXXX, in is there of X market? is we CAH study, when I’m sense from to then, you ready to a on have of or market the

Kevin Gorman

chain the a launching order. supply issue confident job going this not done point. drug great whole And Phil, in the we an that are at a take So, of BIAL getting did first will and such there. supply to because job, part is this chain good be we I’m they’ve

Eiry Roberts

of pandemic. has there CAH up COVID-XX impact question, to how from research with our really I external With all like our enabling respect I worked obviously, around mean, is partners started. this of the team to proud get efforts, the world the I’m in and mean, the

give a are took as months soon in of to are able we dates we’ll respect you with kind and understand enrollment get be current much the expectations, our better that trial, a to consistent. enrollment we update. As ct.gov that to trial the relative those the into few estimates into But,

Operator

next the Abrahams. We will question ahead. go from Please Brian

open. line is Your

Brian Abrahams

My congrats the talk curious taking about On I’m guys. quarter approach detailing well. can a course has telemedicine evolved you little for the bit my maybe of if on INGREZZA, the Hey, over how and Thanks your questions. pandemic. as

regional And, help comfort are utilization. can drive shifts the new linger? seeing maybe there to growth telemedicine that you movement pandemic to ways diagnosing improve via disorders continues in some patient We’re if

Kevin Gorman

Yes, absolutely.

like really even educational model their and I remarks, as And clinic, reach As prepared GoToMeeting, became a my looked in necessarily or engage our the about existing through to TD supporting via And as new what move a remote to moved existing the adapt forward have this in mentioned customers patients, we Matt longer to content refills. terms essentially a engagement platforms, understanding too a psychiatry remote neurology environment. or had about model to those of as and we’ve engagement to INGREZZA it that on platforms, and lot with patients to early telehealth with no talked was And that we prescribers. more engagement taking discussions in lot like in people for went remote were QX, FaceTime. proficient Zoom, to adapting either how them we how of

a isn’t and they’re to community, widespread remotely and believe the resources from been been trial into And we’re forward, here. we’re lot going to practices, in This a we’ve basis. in to thought Going out We’ve educational movements capturing have that those and best rolling to assessing past, new TD I done about their that’s course, that learning blaze been leaders integrating the recently our in them customers. patients. how a more and done tools prescribers from as diagnosing content develop an something And of we’ve new to on there’s assist opportunity remotely. certainly we’re

and health it So, we’re I and going ways. in-person this posture, what to between environment this, be after going with patients. help at a HCPs steep that gotten a course, appropriate, telehealth ultimately, the we’ve is adapt get a was provider credible whether adapt that patient make relevant, previously. when new telehealth content is here more return and is this that But, educational continued many INGREZZA. And level them just offset seeing to in than even to higher ultimately, crisis normal to and interactions think or this we’ve as a decline we stay learning sure the will to to that the somewhat diagnosis in Certainly, it’s lunch, regardless patient past choose remotely, of make of

Brian Abrahams

then, little for this COMT it. engagement give MOB really other ONGENTYS step launch was for like later for you Got I far, expectations inhibitors? color access. through the as pricing more bit could That’s was Would classes, announced. prepare your thus expect the edits any other quarter, payers you on wondering if Thanks. inhibitors helpful. a us with you recently And or

Kevin Gorman

Yes. Sure.

So, on And want threshold is we is Medicare specialty month, ago. our say, for price, the XXX WACC plans. announced tier below I weeks two like, which or three to price per

only element us field previously, reimbursement company. team choice in plan. have critically the that place. we patient is access our Obviously, So, we as said as with of a mind. in access And patient made we Price access important isn’t for our

other elements we We ONGENTYS out patients are need time that patient want our it. make get ultimately, support have sure that of to program. be will available the to can there But access And built launch. at that

of the other to the understand treatments engage other started to COMT for inhibitors is labeling adjunctive ahead adjunctive there to them that beneficial products -- in actually category, may treatments classes our they and make And how with they’re to payers or be through not commercial the and to understand the start we’ve goal managing price, of currently to announcement introduce to Parkinson’s edits of the launch. With step sure patients. -- and

initially, we’re formulary we so, a on ONGENTYS as be to to gate go going And this is exceptions we and get Obviously, through have it’s the a good drug. INGREZZA. to the of end at this. had out and into going very with to be QX And approved QX, at non-formulary process,

formulary be publicly available we’re to that sure made, to as it’s initially, decisions As understand for value payers process. with the be see into and the we going well. will gate, you to bringing they we’re a XXXX. currently with But start Certainly, get engaging out exceptions formulary And make ONGENTYS of those we’ll

Operator

Amsellem. David. go from take Please will our next question We ahead, David

line is open. Your

David Amsellem

Thanks.

crinecerfont of So, questions. couple

So, that if type on it’s receptor development. that CRF there lost anyone antagonists X other are not in are

the that that’s your then, global take with I What’s commercially the more And what’s So, guess, alluding products? question anti-CRF Phase in X than I’m product. bone is, take mind, X market’s points something the or to color mass on on to is study. the here relevant which it by commercially mean, the Thanks. secondly, how your of end accommodate you tildacerfont, more ability number along thinking commercially lines steroid body like burden? Is terms are I endpoints, endpoints? So, the Spruce my of I on to appreciate all one one. most you’re us density? it indeed Help that specifically direct think relevant? clinical in understand

Eric Benevich

David. the question, for Thanks

questions few there, a So, in actually.

start first me with question. let So, just the

over First lead option absolutely very terms really unmet what be of will doses, crinecerfont that side initiated. the development delighted adrenal I entering study we’re stage need now clinical hopefully the to that’s With to clear effects. that we’re of often a Patients’ last glucocorticoids in is themselves lot absolutely a now the medical program. registration hyperplasia. treatment in right respect of of in just in very we our only there is which course congenital at lifetime mean, superphysiologic issues of is significant global high thing steroids,

find important think trial. dosing. ourselves the situation clinical to reduce of overall study and itself at that, the based we program, really really so, know the their holistic at on we when I ability really in a is end But, CAH any is relevance on that patients levels points the manage the look day-to-day. that becomes glucocorticoid in we disease about important time us like to steroid more our problem we a involvement. previously of very to from our it’s lot they a respect the within endpoints potentially different And valbenazine the the little it hormone terms study of designed for looking competition. programs, Obviously, that managing much how elagolix with this bit that from the our in design of With of think learnings And from

payers months program safety professionals, the world. the very-important six to healthcare that the set tolerability our patients, then with a and of steroid ultimately order we in data So, endpoint serve the on the focused and reduction gain around will regulators, efficacy caregivers, designed believe we stakeholders, and many including

we access set and to very study, have previous the the as clinical we exists with ability and believe in a order for to get combining it’s the crinecerfont data think, to come ultimately to of I will so, medicine, completion data, medicine. of this the this so, in the we doing patients of that registration robust And this support

Operator

Our Please ahead. next from comes Paul go question Choi.

is line open. Your

Paul Choi

on Thank quarter you. Good the afternoon, progress. and everyone all congratulations the and

of this advertising, recognition your you right over sort right the TD. now intermediate just maybe in about about to our driven a diagnosis if elaborate think, being of maybe term, as the any up. think a on And a is terms just I physician should is And just of then, if factor, during you in the about seeing you as increase earlier diagnosis talked such of for do short just or step you wondering think modeling? was that? comment I by follow rate maybe we here can this or prepared I you sort remarks, XX% particular up you could think on are had

Matt Abernethy

from and new will what a we’re as generating think hey, seeing he’s as Matt, where Eric give I it you is Paul. a to demand. bit insight customer and perspective then Well, more -- little This

growth QX, For flag. patients the driven movement net patient discontinuation. change modeling to and gross just purposes, the of I new QX level some persistency, by The and growth there less and compliance from to the largely of was to then net out also, want then

been the it’s to good, much going which is to because relative and levels sequentially, we’ve remained QX to NRx that our So, is than forward, talking have very-steady, about QX that. visits, what drop higher in-person patient

to we’ve when what diagnosis front, insight none going go he’s seeing However, patient to seen predict visits talk to through that’s we on similar from need can with us in-person that. our of growth normal, where can closer to But, sustained to occur. back and XX% get what the to here rate we historically, Eric, that customer which have

Eric Benevich

Paul. Yes,

So, I now important it’s about the and population four of about have with that’s prevalent years patients to been think note diagnosed that there of that estimate push estimate after of started TD, that we this on When we tardive low-single-digit Company. effort part percentage with patients of that dyskinesia. market, developing the educational been of the was actually and had XX% diagnosed

over the time, so, a we And get around And XX%, year, middle is have given estimate been our we’ve of as to of diagnosis. increase. percentage now seen this that patients

that is said, remotely. a diagnosis HCP I’ve flowing also being function and help that in Matt patients largely pivot patients more be happening through of diagnosis and making likelihood clinics decreases Obviously confident As interaction we’ve dramatic diagnosis education made and decrease the And about spoken that with with hospitals of diagnosed. remotely. comfortable is in TD the the providers to that

these the in in not patient foot been traffic INGREZZA with we’ve decrease clinics. proportional or Matt decrease that As with patient said, new the seen to starts has commensurate

terms or our of patient is and what educational diagnosis it So, get what is new diagnosis is our providers The make our people of a continue efforts, be starts. engagement with those the in whether that TD remain the -- here remote will impact in-person patients majority and to takeaway them short-term on that started. help vast belief in undiagnosed, disruption be this and that commitment to it’s rate

So, more provides bit a for little that you. I hope context

Paul Choi

you there. And with one Thank for which to mentioned, Yes. That’s one Phase you enrollment that Huntington’s, in color. great. quick regard Eiry, for the X has resumed

given potentially you thought the Thank incremental about from regard versus gathering formulary points to potentially here market competition, that you with Huntington? other second positioning will outcomes, the technically be to that you’d that have any clinical might As with you you. trial with a think about be data help

Eiry Roberts

Paul. Thanks,

designed chorea chorea the as endpoint an valbenazine endpoint as primary obviously important The on So, trial. important the the score. trial is terms the the part of of UPDRS is outcome. score is of And determining a actually impact that registrational in the

important of We have Huntington’s quality the as we in life to moving included that study, other seek support appropriately forward. we measures patient most believe which chorea are

label In straight blackbox and study respect this occur. is relative of all best with by of addition, day the -- we’re terms would to being The and dose we’ve the competition, warning the a for differentiation to those that of in to INGREZZA. blackbox a this up say a believe us in study, any profile that differences once to absence therapy We point valbenazine I the warning to seen of differentiating. the the context address very-encouraged give our order in fact, we’ve difference relative escalation with are obviously as a titration. opportunity forward designed of they in in And

Operator

Our ahead. question Please Marc Goodman. go from next comes

open. Your line is

Marc Goodman

is question inventories. about First

Because amazing wondering I else. different a just, guess, right a come just Can it’s lighter of why could relative why other I these just everybody be little I a is patients me you all -- patients was? they you now? you’ve you would and having just -- you you’re such dyskinesia you success there the to will expected just I to new tardive of believe us. are which special inventories talk question down, You figure reps two-week obviously, but I lot mentioned you’re have seeing we’re is mean, out, tough that And stuff? do think environment you or about was back is where seems us if Parkinson’s tell I adding to attributed And new the guess, sales down levels. it’s Can product? than that about launch quarter. in such that tardive on to dyskinesia anything the persistence telling Second to just things, it mean, is third, in really for will there, then, out there relative your therapies of And SG&A,

you if more So, I was on give curious, some us just that? Thanks. color

Matt Abernethy

Mark. Hi, tardive the then first questions it dyskinesia. for I’ll hand two and the Yes. take off

but said I And this like ever to three front, think earlier, weeks a time of hand. bit do on over little of it I inventory first one phenomenon been the with the On has we’ve warehouse. is partners inventory now, they’re levels normalize Historically, that. And they weeks. stocking will tried keep actually weeks, new actually our I’d our over expect of we’ve two to below two up a that

that sales we’re measure relative in people So, this that far results quarter, is. that’s at TRx inventory-adjusted is down. to there our has see demand to going quarter, looks I underlying to on an But said, us bleed best the to true pattern every continue I’ve what what can And and something ordering July way like basis. so disclose like so it look slight on to the even demand, some think, underlying seen I been

concentrated the front, SG&A decline one is aspects QX really the seasonal from typically there’s two that sequential led spend recovers you then Number that’s in to in On QX. QX. and have that that a

have -- normally is piece been the we the same as aren’t that was field-based that what that spend to do necessarily done down, second being spending it of were. slowed some we would some The level COVID-XX, have relates they at activities weren’t behind, as

investment trials It’s We in pause. just on well as did going in lot shook aren’t out as as near-term things out here a have trying of front about SG&A flag, much people down to profit R&D how R&D the slowed spending. would to the a I in as the just where forward, we’re want squeeze we possible. as place think

as spending the other have up well But, lead have mentioned, believe us number to think We when excited from going XXXX. step And that’s running so And for big and up clinical up perspective, of of that what have we’ll more in as now. we’re really Eiry Takeda collaboration, ahead a that you positions running. programs then a product from future. about spend in back and to us and programs Idorsia the well the getting we Xenon, all about the

about a ability part the over hand or or -- to makes drives Kevin. what what the I’m So, environment, TD or Eric this next to question TD of -- going in to physician to diagnose our diagnose

Eric Benevich

day, I TD, question. think, INGREZZA It starts about that allowed this is there the aspect us external good with the terms every of it emotionally, appreciate real in circumstances? many many don’t few is their a so off it It’s be that factors. factors it People that’s with then despite willingness community. people few what lives Yes. about in others of internal are the in disease is experience TD a is there affects with here. functionally, significant and to to and What it a is burden successful different is TD just living ways, a their that really engage

as strong INGREZZA. disruptions pandemic. And the that where network that they addition, the people to benefited about field often get they’re patients really despite these are the has get helping of society both select to our individuals recognize think, these the having an us we high-quality I in very we’ve patients hired second the The and on and INGREZZA thing is it really diagnose HCPs is out meaningful then, that have And they which years, but that’s not clinical treat that are only saw we also, two they to providers many the in gone it as that and the offers trials weeks, that motivates seen factor, patients, in patients. treat the committed overlooked, by in talked very that external offers significant caring a trial there, are psychiatrists, through professionals, frankly the based benefit, that is well office a important patients meaningful internal them and allied for note terms a and the improvements that been are home caused access adoption perspective, pharmacy and the in few last a that the passionate being these health as additional -- and frankly, refills, third over quickly stigmatized. able to about From benefit, to see several in try in

that success I So, have QX. seen, all certainly with refill in persistency together, things and rates those added very-favorable the up of think we’ve to

start it’s all and more it pattern or around the in-face on, level be especially seeing longer helping our remote long despite to But, to treatment. stop interaction it As we’ve an And in different mentioned on expect this certainly, that at started committed pandemic the we’re whether and near to the makes even providers, help goes haul. county in this remain challenging we a successful get patients before, this with states continue with that the term the patient. over the to we country,

Operator

We our will Please take next ahead. Amin. Biren question from go

line open. Your is

Biren Amin

XX% IMS there TRx from IMS, where guys. But capture was you’ve failing script Hi, compared think my discouraged just taking the decline on script second sequential the do is XX% what why sequential to data. kind of IMS start data you in reported for What is today, in collect sites reason the just I I a using quarter know they data? Thanks to Maybe could INGREZZA. us you questions. at growth. from

Matt Abernethy

understand our Yes. IMS proxy been And as for it a conversations question. Biren, data have definitely around to not our your sales use results.

our door specialty I as periods. other of think, pharmacies it different pharmacies be close captures or data, sometimes representative it and can’t as

So, which hard increase different TRx, adjusted, strong was than sequential had it results this a we what very were. think, we’ve said, in was environment. determine to why inventory of our I X%, like But about

Biren Amin

edit know payer a entacapone? through then, And they’re ONGENTYS, had step discussion, Got expecting with I some we on payers. engaging be you’ve Should it.

Matt Abernethy

as have speak. a currently said insight as very payers next months. three the Eric or meeting But, more on earlier, that that’s are we And that very something relative good account that to But, ONGENTYS So, conversations we Biren, have we entacapone. very wouldn’t, early. to that our upon based base the is expectation hoping -- see we with team a payer get is over just four -- value that in good we payer we’re still

Eric Benevich

to see going Medicare And to appropriate to to throw this six these thing only or Majority appropriate The class process. patients the that to Part medically months be that’s how have shape the something going product. and one to not have other are decision review But would -- medically that initially and up message products. this be the we’re over the I’ll necessarily in product and Part a bringing certainly, year entacapone. to D. we’re non-formulary make that payers a rush exceptions step it We’ll is to through that of is through conversations. is go next And certainly formulary that pricing wouldn’t our our to policies liaison up our there this those position necessary would payer Part payers team that patients or medical is new D so. Medicare coverage until manage plans science of And account our force towards. wouldn’t be

Biren Amin

up a biomarkers? biomarkers I I primary if X is it pipeline on How XX. maybe on at algorithm it CAH then, androstenedione? taper? with improvements could have the normal, certain limit of And question on, guess, you these are patients improvements being the Is Phase setting trial the for on endpoint it steroid steroid the come like, upper with baseline week the on on is reductions And based that to based or on in of reduction

Eiry Roberts

how I competitive on we about of amount very call. very not get can going to to much the finding I’m in everybody we’re perspective the appropriate else by we the doing here, important actually patients at data. with thing not -- most and time talking about point. that regulators external a one do really this that design ensuring trial obviously, talk You steroid and from from as asked able this robust the a and we’re reduction And Biren, have be question, spent mean, most experts here right that set just field huge can of to to a imagine, the you the

Todd Tushla

see, let’s sneak two if can we Ryland, more here? in

Operator

Okay.

Charles ahead. from our Please go take question next will We Duncan.

is line Your open.

Charles Duncan

It Thanks been expanded. of great Most progress, notable this of Congrats for commercial and years on questions how terms in questions, building Kevin a taking team. couple my my in the progress. last asked. have pipeline quarter particularly has is

the programs? to When pacing can read So, of patient I couple the of help the you understand did of to want program you to with kind enrollment of would those CAH, pipeline data valbenazine kind what us out program the And versus first? crinecerfont in questions. a ask you timing just two in consider anticipate

Eiry Roberts

Yes. much. very Thanks

initially inhibitor. significant need we trial very are responsibly were pleased and to unmet still, people treated that and we in see able enrollment safely reopen Huntington’s the VMATX obviously, HD because the currently So, were so with few disease

the in be hopefully, there. if so, signs enrollment relatively that forward that situation that kind And screening we able are anticipate in and will we good of given are we And stable, think we registration seeing -- COVID-XX our I the with global to is will as clinicaltrials.gov And in estimates of And X initial trial. we we study. move the to of Phase that stays crinecerfont, previous initiating effectively our enrollment. just question, your I see estimates That trial. are mentioned, that a response

how see to need will trial things progress running in We overall timing. gets months that few next and to the understand up as the

difficult really it’s moment. to So, at the predict

Charles Duncan

strategies is you two Help take of understand, obvious for It’s to the when say, versus mentioned But, or to helpful, to valbenazine tardive How the really there then, different what either differentiation dyskinesia, a competition. me for or understand or me in the about Because this INGREZZA Eric contemplating Huntington’s in to are relative perhaps drug? which is valbenazine dosing And whoever Eiry. a help I chorea, appreciate need parity you valbenazine they products, to think that. you could see or will pricing? you dyskinesia, wants Huntington’s me thing? it, that be? tardive in differentiate be you’re

Eric Benevich

Yes.

question. I’ll Chaz, that take So,

that treatment that that things majority moderate an VMATX particular with advantage think, that with are example, us perspective I could in for there’s unmet is option that that issues, chorea. give inhibitor. titrations, as the medical there dose But, may reasons challenges being are that exhibit starts to, of untreated currently severe chorea safety concerns significant need varying relating like an treated. approved benefit market. patients reality majority or it tolerability from still And that not The for movements people of still to yet our with Huntington’s in with are

feel target be that the on we’ll treatment points based data we have profile, what that to another differentiated to the in like But, market. way differentiation certainly similar perhaps look there for we option, the one the of that are will So, TD product like. see multiple room there’s think we

here. But, we’re for in about complete about us based know what like opportunity the confident excited to INGREZZA in looks profile that to there’s what the we that study the meaningful a market. Huntington’s and So, on opportunity TD, we’re see the emerges chorea

Charles Duncan

Okay.

Todd Tushla

Let’s take one Ryland. last question,

Operator

will We go ahead. Please last Jay take Olson. question from our

Your line is open.

Jay Olson

the the decision I of questions. discontinuing any indications you might VMAT if gen impact quarter for inhibitor. focus one could. was for the I and lead And curious And I’m I on your about additional follow-on, other second and/or Congrats you cycle taking quick had to valbenazine Hey. management thank wondering increase on strategies? that life if your

Eiry Roberts

the Hi, for Jay. Thanks question.

we’re be the of I from molecule what the of even broad patients. VMATX we forward in disorders, to looking there would for beyond had as we is follow-on research that candidates development. bring neurological as I that into the next valbenazine a So, mentioned, of psychiatric learned Phase apply all that able experience across different great a significant a we and clinic, inhibition think because think learning VMATX And bring we deal X to do that range opportunity to generation

on focused then, into those very new in we understanding and that. be move update we’re indications be as forward very-focused to And also to obviously the clinic, valbenazine. on get parallel you. potential So, any for And of we continue we’ll sure

Jay Olson

emerged potential any innovative molecules? new appetite deals to business for you your then, the new portfolio talk where as advantage, gaps assets as portfolio, Thank can may to And like your an about development since add you great. competitive and for team you important has you your Okay, that. in more add

Kyle Gano

on continue and we’re then shortly. funding terms that here focused success to That’s to INGREZZA to that a pipeline. pleased taking Yes, as to is in And have I way going we’re on transpired think ONGENTYS XX great over But, with quite Kyle. in focus the as those past things This our question. our commercial well XX months. we’re business with the interest of development, the

it’s disease by modality been If by you diversified the look stage and at by state. portfolio, and

things bring time. out make the need pipeline get to continue played ways We us the for building and neuroscience to us. in are it over also to of running, look If So, nicely the find execute to assets, studies attractive at sense lot that happen. a we on to those clinical have additional off to we’ll but it makes

Operator

I Gorman. And back it will to turn over Kevin

Kevin Gorman

very we’re sincerely, you Thank way for much. but up this in us. before, shaping We’ve is this that be said in to we position and fortunate year the the feel very that

in to medicine ONGENTYS. go on in in add appreciated a outstanding an we have have get our as another it’s that’s here, that is pointed yet this now so Company. We medicine going years, important for population. And all And through just is coming patient medicine out of driving to INGREZZA. and you so And needed that

looking appreciate forward I bringing And pipeline. last the the and so, in do particularly, And really to all questions that had that patients. part we’re today you’ve our to too about

but just at beginning, you those programs As pipeline when it’s of XX we it. I look the at not number said, the programs, have

of programs two the more. They’ll end development consists early-stage. mid-stage five pivotal then by pipeline be and Our year and in in three

really So, pipeline a it’s now. well-balanced right

years And medicine. neuroscience said significant medicines an we’re with we and developing gene not in have by audacious hope therapy. beginning. that to of out modality. as developing loud stuck treatments, and it we’re constrained neuropsychiatry. Our the you’re we’re the neuroendocrinology symptomatic areas molecules we’re started dedicated what Currently the that a we’re We offer and is modification, we -- neurology, is Kyle out ago single seeing company. goal said, that’s small we’re just for in The and now a number leading and world’s with being and disease therapeutic And precision

your do participation care. So, Take your for questions and today. I really thank you

Operator

for your today’s may concludes you And Thank you participation. disconnect any program. This at time.

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