ACADIA Pharmaceuticals (ACAD) 6 Nov 242024 Q3 Earnings call transcript

Ladies and gentlemen, thank you for standing by. Welcome to the Third Quarter 2024 Acadia Pharmaceuticals Earnings Conference Call.

[Operator Instructions]

Please be advised that today's conference is being recorded. I would like now to turn the conference over to Al Kildani, Senior Vice President, Investor Relations and Corporate Communications. ahead. go Please

afternoon, today's Good Earnings you joining for Thank to and discuss on call XXXX ACADIA's us you. thank third Results. quarter

Katherine and Executive Development, commercial on Head from who by is today provide some debut financial our Brendan me on call strong will Chief Owen franchises of Commercial, followed Thompson, are Executive our Research Adams, Operating Vice joining review who and our Mark Chief on Officer discuss NUPLAZID. update Joining opening remarks our Liz of President, who Officer, the and Schneyer, Chief Dean, will Head provide Acadia today will PhD, an us the programs; Financial Also pipeline results. our will Officer,

thoughts for the closing open Catherine provide before your will call some up questions. we then

using supplemental website, are section. available which Presentations and slides, on Events We our are

may like Reform events, that will meaning Before remind and growth Litigation Securities make proceeding, of XXXX. expectations, potential, including plans, timing financial forward-looking prospects, results goals, our we of statements several to I within the These involve guidance forward-looking Act call Private today, statements, future risks would you are inherently of with the SEC. our business and during expectations in filings are and found information, our that factors on to differ made change the uncertainties risks based and subject materially. to associated with current assumptions cause that These other results several and can be

turn remarks statements for over and on change, made update assume to call as to place as Katherine as no not cautioned on forward-looking beginning date, to opening I'll by forward-looking law. except revise which are Slide reliance we these circumstances or X. now required only You the these statements, of today's undue are obligation

speaking take few way you, introduction, and be share Catherine Al. moments want felt an to a To new explain little Acadia. to pharmaceutical I'm and Vice experience Squibb Adams, of the of it By for their international background and have us. goals, serving a Acadia. in about drawn honor Good and to major Manager aligns you CEO you so over of why with as I and my join it's Thank Owen thank recently joining the everyone, General afternoon, to prior Acadia's business and most of I Senior with as industry, I Bristol-Myers to that, U.S. President XX years how business. the of markets begin, leading

XX [indiscernible] and of U.S. and and X businesses I advancing the years a on people's Before difference involved internationally, and future drug and areas, the number Johnson a to U.S. in including team therapies ] rare career, privilege pharma disease lives. joined across X by years, I've tech to our that, the many both up potential Throughout and because med my fastly rare pipeline put [ make real in including and launches lead the therapeutic launches I both last the opportunity humbled being of neurology. can Acadia EU have inspired foundational was In the and of and the business excited I spent Acadia drugs that disease launched working on had in successful in managed the

to assets incredible I execute unmet assets. with our in opportunities portfolio evolve grow patients including of high we innovations new continue look that priorities I advance commercial I pipeline, needs. potential significant enhance see shareholder future, towards see serving value and current the our and our medical As late-stage advance and ahead our as communities pipeline to to X

to why pillars. of these X a Acadia elaborate core areas and X, Please I chose Slide turn our little to where join each underlying will against I on

to tracking billion together, based front, extraordinary our on commercial in which sales, we milestone for X annualized have biotech of First, are growing size. a now QX company $X franchises over the results an on

flows ] at $XXX financial disease cash commercial [ highlight pillars pipeline our by late-stage balance stands million. than assets is and syndrome to a the handing into our And X Alzheimer's our strength third, leaders, will our which cash I'll growing our psychosis, now briefly who includes deeper and dive fueled promising complemented off Second, positive before robust R&D Prader-Willi now early-stage by and programs. details. many

journey but of lots unique, I situational care are the journey, health new of multiple with some quarters both how parts on Six Daybue $XX.X is to say We've take observed patient's and Daybue with and starts million Slide our sequentially. Daybue with another involve XX% launch important the can have I concentrating and coordination to is some launch is patient rare to to year-over-year we system, this generated high-level generating quarter, moving of focus disease stay commonalities on the therapy opportunity reached with this supported. quarters. complex, now highly while has several and observations based X. Every think especially $XXX we've Daybue. some this X% street Beginning give on results in have I'd within million, Turning key They a had next my like solid up successful a and growing disease sales start sales, context end focus [indiscernible] on steady with date. fully on the on for our launch. been and to this launches experience to share in state of

on insights impact continuing time from to lot in ongoing our generating This of be and experience Daybue ] describing system by and clinical real and scoring study. patients, LOTI life lean our into [ will will trials take bringing and clinical HCPs used data, illustrating breath driven the the has growth to to the

COEs benefit early impact, our into beyond U.S. I'm dose will about continue in NUPLAZID, who and on its We together underlying achieved trials. last also as see debut last focus work beyond. their and to These year's find patients both the potential the now I'll sales patient turn impactful up an confident diagnosed for families can we further doctors the journey the the the Parkinson's net on to of for described part and outstanding now combined extremely the of growth to quarter million, XX% evidence as penetration clarification, label and has results quarter, we disease market. what real-world stable a with had studies basis $XXX.X were with which of from including year-over-year. trends psychosis

Parkinson's with collaboration campaign our we in unbranded Parkinson's-related raise August, In and to delusions. [indiscernible] hallucinations Reynolds, of awareness Brian announced

believe impact accelerate in growth caregivers a which in launched detail. will more XXXX. We are discuss help for early patients, of excited these this HCPs. about new will Separately, Brendan us that NUPLAZID and we direct-to-consumer seeing campaign we with the we're campaign campaigns closed

Slide to of now our pipeline. discussion a Turning X for

commercial pipeline is I so brands, reason excited successful addition In pipeline was to is an join the to truly the why believe Acadia's important I underappreciated. company, our as

program. being Phase no our often III currently ASCP XXX that's II FDA-approved for eat that as X-HTXA where second-generation syndrome, drive disease the treatment. pipeline our asset we blocker is Phase -- and in a treatment have have portion Behind called in of an are Prader-Willi the unrelenting while ACP-XXX, patients We rare conducting to evaluated a genetic a with debilitating hyperphagia.

current communities exciting to than these Both allow options asset patient portfolio. will our neuropsychiatry our has of to drugs and with in franchise. us numbers new for This extend larger the underserved offer expand potential patients

I'll also We as remains focus now important forward to me in growth We're their and an for which pursuing our the discussing business to a pipeline beginning performance company strategic to they with of it development, expand imperative this turn these in opportunities brands earlier-stage We look of also assets. over a advance exciting to our development. set have we actively more the number through to future look X. for further Brandon Slide future. discuss as on commercial trajectory

Catherine. you, Thank

X. first and continuing driven both Let's our on business among and primarily take in was growth In That NUPLAZID by of net Daybue $XX.X Starting drive population debut franchises. as rates patients. to continued by a QX, dispense penetration in the demand look measured continued sales. our Daybue at prevalent with million growth increased with we Slide our

in During the received which receiving patients QX XXX in quarter, to and shipments, QX. compares XXX XXX paid shipments

and our longer mature dose each likely on term. average increased will Importantly, the a remain cohorts that number they received as patient of bottles reaching begin patient

QX in discontinuations were to continue quarter QX. patient Weekly to be similar and down the significantly from

Daybue past patient suggesting a Importantly, XX% active of over months we for since treatment patients all on from treatment treatment is base for as on more patients treatment now is This the persistency enduring significant have flattening, XX months strong or time. XX over initiation. benefiting curve out

XX at looking we out and XX% favorably similar to months at higher. compares In rates or see persistency beyond, other chronic therapies This stages. fact,

dynamics. prescriber Turning to

written having for a to unique prescribers continued with . of have XXX expand We approximately prescribers now breadth Daybue the prescription

starts centers COEs, We an large well further practices. institutions from XX and we of as have of as penetration or the our RETT new non-COE community-based excellence, coming see high-volume increased increasingly of proportion

is of XX% all as patients Rett are important outside treated COEs. This of approximately

are care they to those additional debut Daybue. X we or of who where prescribed on We have X focusing benefit their depth also prescribing have under from driving HCPs among know patients who patients can

XX. drive future to Slide turn Please ongoing our adoption. discuss to Let's efforts

do important mentioned, are the their is to as have not patients educating we of COEs further population, more deep real-world expand profile. understanding about and patient where benefits Catherine focusing efficacy RETT day-to-day of Daybue's outside families or This prevalent Rett HCPs are As efficacy to Daybue's treatment on especially the prescribers an of and syndrome experiencing.

and include in HCP population. skills purposeful driving improvement continued reported increased other alertness benefits, use behind the improved are conversations quality among mood, force better of of verbal and These RETT improved life, the penetration benefits engagement in nonverbal hands, caregiver communication more and real-world which, both and of

including was these that excited is a caregivers her Daybue. and been her benefits, ice speak As tangible now her become what treatment. cones. own improving since on ability She recent one to well. like her daily shared has on objects, an X-year-old grab and her our now hold utensils program daughter items her started vocalization can example own with at about and capable as of Her of other I that doing delight now daughter overall to communicate treated of to increase she's expressive her daughter to She cream more much everyday

helping patients us create ability and are caregivers want device. Other just benefits all are nonverbally improved these their very These ones loved a benefits of HCPs about caregivers. their with communicate of [ few examples pursue. iGas Tobi and understand better exciting caregivers real-world ] Rett hear, and the with their and connections Each we to tangible tell to

stories improvements within will the sharing surely Rett these community resonate. are where We types these of

in LOTUS both HCPs their for loved breadth our insights management well about yield reporting of is real-world GI sources number benefits One valuable efficacy observational experiences. of as and our best study their and ones ongoing of caregivers continues families as to clinical that are the

are focus programming, this summary, all with benefits our growth sharing patients. real-world them informed in HCPs allow sharing Daybue's their our prescribing benefits engagements and caregiver peer-to-peer with and demonstrating We materials, data for more is our primary efficacy on In families. decisions to for these HCPs sales RETT and make to

We growing and ahead growth and treatment diagnosed to the of With we journey. a the patients current rate the continue and building and plan strong the U.S. helping to in enduring now a opportunity RETT top of combined funnel We're growing base. a patients HCPs started outlook brand. us we families the over in base to early patient confident patients. tolerability drive are Daybue, of population the growing improve And new of while at increase on continue our better RETT XX% enduring entering growth the substantial of penetration have of to manage the with and challenges based X,XXX having continue

initiatives for let's outstanding the NUPLAZID Slide million quarterly QX Now with XX% achieved turn ever to quarter-over-quarter HCPs. that the This growth was as strong with by patients QX all the growth NUPLAZID focus throughout this driven franchise what the with net we've volume XX. by grown year-over-year. in highest in across have performance demand sales our discussions X We been we've growth market of year increasing active the sales the throughout was XXXX. segments. quarter brand another on key for NUPLAZID on seen $XXX.X quarter representing follows

demonstrating mortality they can of overall cotyopine the most all Parkinson's evidence [ market notably HCPs First, patients psychosis the which comorbid all-cause antipsychotics, lower experience disease about patients real-world published with delusions NUPLAZID, a outcomes, disease the and with last have differential versus low-dose other risk including label helps or dementia. important clarification that off-label Parkinson's year's without hallucinations and ] understand educating treat experiencing leveraging

for choice in conviction HCP increase therapy leading demand PDP, and first-line us their share. helped NUPLAZID levers X as market to These of higher a

of in-office are future Looking resident return patients at as care the broader numbers. measured dynamic census as market, market as long-term growth NUPLAZID. supports a well This continued visits by Parkinson's for we seeing

about turn to were which we see our excited are benefits of recently QX which I'll advance from NUPLAZID's campaigns, to now. Please direct-to-consumer expect We launched results, Slide achieved in XX. discuss the

launched As delusions we the Parkinson's campaign his often we campaign announced education an it and this that disease August, featuring this of can category. focused Ryan the in and on state most campaigns of ever awareness accompany early hallucinations Tammy, symptoms mother, unbranded in suggests disease Reynolds successful disease. results state among is The non-motor

the measures demonstrating Here are early of just this. a impressive couple

early branded of mentions the first patients airing increase encouraging campaign. in nearly In a in impressions first Concurrently, subsequently XXX media and only including launched also media are weeks campaign, Nuplazid.com billion who X.X as Over These nearly NUPLAZID visited the specialist. saw XX% so and the for or just very post indicators. weeks a headline a of featuring campaign placements, approximately PD we just the Parkinson's first with and X X we PDP. treatment threefold disease visited

ahead. schedule majority As in seek to campaigns benefit look months patient for on NUPLAZID consumer excited the with now to momentum the these Liz of XX. of and we're NUPLAZID appointments expect the and summary, be seen that hallucinations Slide over as we're XXXX In capitalize and about and it we a in delusions turn reminder, our seeing specialists in on the treatment growth weeks with in months we'll vast campaigns ahead. with their the to I'll new

patients to Please expansion Slide as turn and from first start global Bren. for like approved Rett good only highlighting front. recently received Thanks, with living XX. Canada to the some Canada for I'd approval therapy news today We the Health on in syndrome. Daybue

is plan next for in the in first launch. EU, Europe where now in focus a of in the of we and targeting the next team Our quarter to submission are expertise We're building our up authorization application marketing order that year.

forward with In addition to much regulatory to with experts the Japan to there. and progress conversations potential very our program. regarding Japanese European look expansion, to We patients productive the to in we've continuing bring collaborate PMDA, PMDA had Daybue agency to

that interest society XX. upon disease included to about NUPLAZID support meeting, data Continuing and of marketed avoidance of of to key the the on the we various for and disorder areas Pimavanserin some of In with patients regarding movement like continue touch the our of physicians disease, with some measures with medications, patients treating we've symptoms we recent healthy generate also a and volunteers, Parkinson's PDP the psychosis. unwanted neuropsychiatric I'd share and on analyses related presented across Slide sleep, sedation sleep. of At are exploratory studies to quality on sedation both sleep neurodegenerative

and other the of liquidation with trials associated levels together, adverse Pimavanserin Taken fleet-related be across data may suggested these low that events.

presented PDP at worsen complete that who meeting, of our untreated, their delusions. studies the site also but about disease Parkinson's literature we The will later. week, of hallucinations tend had versus examining suggests time, earlier little patients left last Congress in symptoms treating and the there's information of over impact Just resolution if psychosis to data

higher after fuoner of was treatment In after complete of XXX response an probability symptoms with was patients XX treatment. reported associated whom with a onset initiated no analysis, receiving dilution and PDP, then Pimovanserin, including later integrated achieving flotation a

Prader-Willi XXX Slide the discuss clinical ACP our starting to Turning late-stage program programs in I'll syndrome. XX, with

living to a U.S. a in X,XXX rare patients are neurobehavioral XX,XXX well. disorder, powder with As the is genetic Prader-Willi reminder, roughly

disease. This to anxiety myriad an lead obesity cardiovascular currently unrelenting XX as life disease, hunger. can characteristic As defining like largely due we've to type in aggression. X old, is before, years very or And like behavioral well early expectancy as is and and hyperphagia, complications which described manifests only is life unfortunately, the diabetes and heart changes around

III currently the been on with We've study selection. terms prior experience Phase multicenter, double-blind randomized, and placebo-controlled. and pleased global, Our We endpoint enrolling. truly called PWS study dose is we both This of built are Phase the II to is specific and COMPASS in study. advance clinical to the community, guidance enthusiasm seeing look them early we through year. next on anticipate I timing and we in work as more with providing continuing Prader-Willi forward experts

to second Slide Now turning XXX our program, late-stage on clinical ACP XX.

to strong dose approved steady equivalent Here, potential we compound range, expertise and approximately particular, half NUPLAZID, wide product a of NUPLAZID. the than for the have In develop projecting NUPLAZID a seen in date, utilized our QT the dose onset potential neuropsychiatry to we've for understanding prolongation build earlier at and upon less achieved study, extensive the of pathway the no X-HTXA of to activity. XX-milligram dose year sign an of of to designed next-generation twice supporting dose time PK a profile the

a Currently, as studies. program disease and ACP-XXX treatment over placebo-controlled master global patients. Phase that and contained includes a The potential in The development [indiscernible] randomized, is is for Phase is III. in Alzheimer's a protocol X II psychosis XXX Phase double-blind,

which underway. on Phase a plan data financial to I equivalent now also studies Phase report be the continue on guidance study time providing program I'll over timing more that to look Once And We studies be specific XX. by Mark are we'll III Phase early X this update and results forward to turn already Slide next III will will it beginning year. of for II the analyze the collected, X X. roughly

Thank you, Liz.

sales volume were quarter, the total recorded third third financial the of third comprised comprised $XXX.X Daybue net X% sales XX.X% from in and was growth. $XX.X year. of $XXX.X third review in the from X% product the QX. volume million performance the second were in on Sequentially, quarter X% year. in NUPLAZID X% the price our quarterly $XX.X in net quarter, price year's of from Gross third million XX% NUPLAZID quarter net of product to up net million X% sales were up versus growth. last the Let's up quarter sales up In quarter XX. net net we Slide Daybue third growth for last prior million XX% and growth quarter,

business the quarter. we in G&A as to the expenses decrease decreased last American $XXX balance million was and increased payment quarter of of $XX.X third North million [ million million of related The which to for XXXX. a transition. ongoing upfront the with onetime from development a as the of ] QX $XX.X ended reduction mainly in to NUPLAZID third research from in XXXX was in expenses cash $XX.X as to quarter in Neuren million CEO $XXX to ex increase XXXX expense in the related rights expenses development the R&D in quarter made due trivinatide $XXX.X QX $XXX.X prior the to third campaign XXXX. our consumer activation quarter million of We versus costs increased well The year. million,

share the priority sell an have also rare entered for PRV voucher. agreement an to our on disease into update we to review Yesterday, I pediatric $XXX million.

latest the We [indiscernible] a agreement from fourth transaction. to turn will guidance. we this discussion licensing as XX of Neuren expect Slide of net with the own XXXX this , financial Neuren as part And of to reminder, close a our for in transaction proceeds Please received X/X quarter. our

range and debut and of our $XXX for to described, now upon to million end of Daybue, million. sales our are third Brent previous of dynamics the sales and for net guidance now high the based $XXX net million. narrowing we to range narrowing expect $XXX our results million our expect For are quarter $XXX range NUPLAZID, guidance we

will from campaigns, earlier, on recently which impact said be XXXX. this rely benefit in achieved not does launched Brent our DTC the meaningful a guidance largely As of

also are our year narrowing guidance guidance We to XX% net XX%. full to our range new NUPLAZID gross and is

million. expense million we SG&A reducing R&D guidance to $XXX million $XXX increasing $XXX the On and upon guidance year-to-date results, million side, our are based to to $XXX to

net performance. are over raising to for expectations our PRV. remarks. cash $XXX I'll does $XXX from guidance our our million Lastly, we Catherine our of not proceeds to operational reflect now closing This sale range And reflecting the for turn range anticipated our call the million to

to Slide now Let's turn XX. please

I towards and head drive end on year, we a today and beyond. foundation, the of As to is further the built am excited strong XXXX us business growth for our in

will continue significant on of and to Nuplazid that for in growth. that remains execute opportunity both front us Daybue to We the drive

as We potential well will enroll programs work to also for deals. diligently our pipeline our late-stage trials X as development business and

to from fund sustainable be cash pleased to generating growth. operations future and We're flow expanding

believe over the With company, potential for I that the about our turn As dive incredible enthusiastic I upfront, Operator? into the more growth. deeper I'll operator it future stated I truly that, am the Acadia's for Q&A. to

[Operator Instructions]

Gregory with from Renza Capital comes question first our RBC Markets. And

about Acadia Great. refrain Acadia. Congrats the but you of maybe Good the aboard. Katherine, rationale and asking what interesting afternoon, progress. you joining on Catherine to Reynolds, some the attractiveness Maybe welcome from and start, I'll Ryan question color team. us on just a gave saw

the early-stage is development You [indiscernible] certainly and interest of us. to pipeline, I'm mentioned sure

fleshing if pipeline you as for that of assets strategic color nominating as out to you. a add just those how was sort the of well in what development really of and Acadia are wondering more the business down Just welcome some capabilities to early-stage little break interest about framework, the could

for the Greg. Thanks question, Great.

about Brent business on So a yes, I'll at talk focus to more But development. will point. ask I appropriate Rhines

is So play to terms our important I of development yes, in in business company, the going the growth role believe of for an focus future.

footprint think continues strong, the important I We up strong our additional under areas area, business with will now our belt, know, possible disease. in neuropsychiatry a that we for of it's X.X rare development -- ] as and be have continue in that be so in focus RA that to played the company. around. Obviously, debut framework believe part our and and you future launch [ to successful a And years drugs with develop you the very role trofinetide. As asked we strong and of acquisition growth about an have now until

cash come position, areas business at strong outlined, forward Beyond the the and feel are next to probably position we in further as we in just very development we of as date. deals But we'll great financial that to a team later months. interest, slightly look working has that, I'm at discuss be strongly are Mark that confirm a sharing with few they that and to

That's helpful. And a maybe question for Brendan.

on utilization some respect visits be of latter us the and and it about and and and about XXXX the Daybue patients holiday you holiday of patterns the on from coming the December XXXX? to families, we comes with Just should to the it reflect to part to as Daybue Thanksgiving transitioning season, think of into thinking January patient and to some how we when entering how relates to December season February,

then. question. our for this changed second since as Daybue lot a we Thanks first And much head will just Greg. so as franchise has be the Sure, quarter XXXX. just transition in And reminder, the into a

of And closely all, of that's our working out and process team patients. those but our for very access of family understanding much built the we a reverification have our we've within also transition. manager better First families during both that hub each our with requirements capabilities

patient a different XXXX. difference think which of the is into first mix mix than quarter important heading the XXXX, very had we is our in I quite

patients wasn't possible XX% even been quarter over Daybue XXXX. have than the on we for first remarks, in were prepared which our in obviously of far less XX long. mentioned at debut that currently therapy treatment of our patients There current or on that months I XX% had that time of longer As

think I of first provides more demand. business for dependable base much So that quarter a

as in In terms in just tend think patients disease, don't of January. schedule many patient dynamics, that as that seen I appointments we've I think would to Parkinson's

be surprise period. to me. in patients wouldn't XXXX to grow over and expect fully we a But longer the that So otherwise, sales

And Butler question from with comes Citizens. next Jason the

campaigns? seeing the a of or terms the I the and in therapy in the the older branded initiating also NUPLAZID. on early you now a of patients -- in of us on of change. patients in context Are are guess quarter. earlier extent are unbranded that and Can to patients give you the label profile therapy initiated more guess on symptoms? diagnosis board Congrats just versus seeing the you I sense come what -- psychosis on couple

Jason. answer Thanks for Brian that us. question, let to for I'm the going

Thanks, Jason, I in campaigns. tell for the and of launch say, see for mix of very still for we're both third seeing what we -- in from those far, can patient the first, what would from dynamics quarter. we're you early the saw second question. I seems of reflect thus days prescribers post we But to what

number that a So physicians the seeing same are brand. of the prescribers our kind are and we're targets new similar of that to new

In age been it's our largely patients, expect. would of terms of the we what

substantial But caregiver change to of subtle the age patients far. think seen helped I I our connect we've more think campaign ones. families has so they're to a identify help the in loved perhaps readily changes that seeing don't their in

from Needham comes with question next & our Fadia Company. And Ami

on is This Puna for Ami.

be You've in $X suggested that having sales billion in you'll XXXX.

like Daybue you the decline sales to X Just is of any the products? relative wondering in anticipating are XXXX? What mix

Yes.

clarify So the me just for let question. Thanks that.

right is equates we're we in million billion. have what in the quarter a sales to rate now, think and that $X of $XXX saying I run

we'll not, we're growth suggest rate year growth and this into run So guide full time, at to that. then this pleased the at yet But point, guiding year. and over billion, over franchises expect XXXX. next can we of both milestone kind that certainly, in that's we're a $X have share for But

with Marc from question next Leerink comes our And Partners. Goodman

for is Basmo on This Mark.

Daybues. We have regarding a question

assume color what us the if treatment patients on the the it Regarding is And wonder to discontinuation patients or that responders of lack them demonstrate profile? the with Or I we factor flip key the of effect? are with the we the remaining from XX% at respond clinical benefits? the Should benefit who proportion treatment point XX% on all share discontinuation know more basically therapy? is Is could on it the of drives really and of and therapy data. provide do side, you -- this actually that therapy? and the the us of

Bata. you, Thank

think I through us going take to questions. to X those ask Brendan I'm

you No Sure. the And question. thank for problem.

which First, that suggest have the patients we that the of and would the longer. just the to cohort in very XX for is to on encouraging. of us patients they're we're we found there And at, months what What at is have latest settling and journey that that treatment through see looking yes, confirm, flattening months XX worked over XX% or curve persistency out to are dose have benefiting. is the

the our would benefiting at clinical family patients are team that nurses Our and manager confirm these home and access continuing.

I answers that So think question. that

around we still see second And lack fills be happen first consistent -- diarrhea early and the that is vomiting in the discontinuation not discontinuations of the The treatment sales. in a of of on tolerability reasons really majority much to treatment. of so for effect. or the or the X terms in X question tends It's discontinuations, that

Romero our JPMorgan. next comes And Tess from with question

is Romero with Potter Caroline This on for Tessa JPMorgan.

flow. forward? now starts next will few has you this patient state mean the just grow So it the or had a you changing curious that steady patient strategy strategy new in fundamentally the of pivoting going this net anything just if that of to there to are launch any steady quarters. accelerate be debut changed were your statement. facets then first, focus over could prepared adds? mentioned Is and is And launch new clarify the you We in your mentioned remarks, you Does at considering

terms weeks. with Caroline. the perspectives that some in I've team I'll the that over the of take X developed last Thanks, of

go So just to original to back part the question. of the

unusual that's steady after of the launch. disease Daybue state, launches. in state a terms strong rare not very to steady And the ads we're a patient start yes, In seeing of

As unmet medical of you coming looking you that sort growth. that a recharge with see door big patients the But strong and see driving that phase. to can more are a we top start of high to tend is there growth of see funnel. the burst to the to how out go more we the and know, of we believe need in then plateau And possibility a patients

to order we're what you achieve that. that let focusing the in me areas And tell on just

they trials, understand over that debut to change scales use handwringing. and changes be efficacy. that physicians, we to first that for change we've their the The communication, X life can the promise What in they for in RBI they their in impact is clinical cognition, patients brought our to the last them they for quarters learned is need need the -- in

Daybue So this starting and on to the them as enhance longer-term the physicians life our we're and their bringing ensure LOTUS efficacy well to patients. that first impact the generating focus helping around real we're message amplifying data as of understand the study to is

when rare just which surrounds persist. The start need the second the diseases, to patient patient journey, with patient Brendan of mentioned, we on managing as really the continue thinking that therapy they journey is all sort start about they to and

the of we're on the towards really has cells But Brend cohort start first we the that those treatment right end families strong going throughout patients as into our now process. journey. patient indicated, out finally, things. And ensuring focusing that penetration through diagnosed Daybue now that of also, population of XX are of the beyond that to to currently talked patients ensure have then are first mature we've few guided and And about A couple XX%. supported of whole months a

obviously seen all, more XX%, the Daybue. which of go increase the make we've since diagnosis by opportunities rate patients after to us seen increase them allows First of and launch the of that aware with around Daybue. We've

our treated of patients outside our XX% secondly, And COEs. are

excellence. our [indiscernible] strong see of So we a outside growth opportunity for

driving enhancing those XXXX. factors, very our the patient beyond move strongly growth the into So we and feel if I growth efficacy at I as will focusing Daybue that we then on journey compound see COEs, strong beginning X the the really

from next Baird. comes question the with Beatty Joe And

think the that on started of unique patients been point there's do looks you therapy who and ratio to patients of unique What about the therapy of I X,XXX mean is the guess about what at I XXX with prescribers. have some number prescribers like

would I it concentrated? have little little a So to be and that's expected X less patients than bit perhaps prescriber more bit a per

looking Thanks, we've a that at. observation know That's great and Joe. been I one

a that? want more Brend, bit So to do you little share about

majority may area, have continuing or Daybue In Joel. they vast it X patient physicians a also high-volume have penetrate And see X community, is mover a have sure, for I referrals disease that first X think right. gone to is -- still that patients we're and the uncommon the institutions a concentration that or more rare centers see those. in to a frequently. of excellence I are further concentration think for less one not it's as we've that have referrals into have the or For for long been written and position written a that a of the community, Thanks have the that and further of And question. tail. prescribers There multiple

there, And tail anymore. of a necessarily not you kind of pediatric long neurologists see

some and likely offer. will to have physicians one care pediatricians primary seeing You're patient who

those focused patients X we X physicians have or are, they We on that for know have prescriptions Daybue, however, and for additional written follow-up.

from Markets. Capital And Keith next Tapper question with the comes BMO

Welcome and for to Cathrine congratulations Acadia.

but drug would know I Anything in talk your -- similar can And share all which remind a and indications? debut, revenues, Canadian rights versus strategy then terms in itself? gradual of there. helpful it data, revenues to and I well. his in it's what And goes 'XX the approval 'XX have separately, expect early, [indiscernible] have from neurons Daybue, know in impact to you you could So timeless Europe then for maybe the if about partner you is expenses to for obviously, Japan. interesting you us different in can you XXXX, guided be launch

XXX perhaps more our question Brend ask Thanks, in Canada, strategy ask and to we'll Keith. little take about I'm the to and a for Rett. elaborate going Europe Liz bit then Japan,

about We're longer. payers private to the tends We're population. For public forward in U.S. into an process health and much patient technology that talking excited obviously payer for serving and be with we stakeholders looking Post take ex have approval approval, through We to limited Canada, negotiations assessment a public sure. to coverage approvals. to having bit then enter Thanks. with very going private reimbursement. XXXX anticipate

we RETT their to patients generate for reimbursed approval. interim, opportunity a the Canada in have interest great patients and begin have In have we in work up with when do the signing to centers that

we to soon engaging as be very can, coverage. to are doing we otherwise, making as interim. that Daybue forward necessary patients the looking while we're So those accessible we'll to much And stakeholders get actively to in

XXXX. And on to a comment little bit

start obviously commenting find serve but out new think to by first treatment I generally. a that think to great we've are with I'll in with interested got We community. for ways Daybue patients living continuing

this At that other commitment population. probably about point, XX premature you future us may clinical what this from patient too really show it's the from come see and a in talk our about to thinking So specifically things to we're perspective.

data Neuron I'll that learning to from think that this set as own compiled putting so with is necessary information their RETT just together and asset. that of have say interesting as specific have are generally far our well strategy a we they we

than future. So in more be I'll to about able the talk

And on and just, PDM. Europe available looking are slide, only and for not and Keith, to launch, to, patients and discussions as our already referred build of but to Liz the started in Japan, we product We forward it preparing making the with Europe we're terms out of beyond. has Daybue was to the alluded Japan, Canada MAA prepared achieve our to our Liz that in Europe in support in remarks. terms And in

those currently are all active ongoing. and So discussions of

Ahmad And America from with our next question comes of Securities. Bank Tazeen

European be wanted And talk ex aware your about think U.S. handle thoughts role, you that it can forward can in that rare share to from your thumb how about in Cathrine there you to welcome me launches Are in launch the rules of as your launches. of plan general And region? you previous as I did disease with to about Europe us to us get well. relates to today?

Tazeen. Thanks, Sure.

next we preparing MAA I've our early for said, are just application in Europe. year as So

know, there's set normally Europe. to take to the in and in that document It a of clock normally and France, places launch we Spain. then online HTAs Germany and Switzerland then would our for clock like first be to authorities -- national come with the countries takes we after start regional negotiations a long reimbursement, Then up both As the assessed. time year in some depending as each that, on you expect Italy national of the how as with on and other local other well authorities company

of with it's rare our countries less my once single dealing case-by-case little to U.S. relatively terms rare managing it's bit in The that. in to a from Europe, have we is In Europe of medicines a patient easier. in of sort access We're is ways, on with a disease launch experience, system similar in care involvement accept not lot the launch a the easier managing a a disease In journey. prescribed all because a some basis. payers in health

making around and But that we slightly have of while available that terms to looking very approval, so team support of registrational the up in and Daybue just And looks to the we confident journey. it and built that need will feel wrap experience I individual physician forward different post in we're being Europe, with patient, my patient launch as already well. successful

Morgan Jeff with Our comes question Hung Stanley. from next

have remind your just if the any regulators can to you protocol? strategy whether agreed on For of master there's us wondering AP, just update And there?

Liz to ask take one that I'll for Yes, us.

Sure.

is particular. That again, slower little protocol, Phase the haven't portion, in Phase in there about starting III a potentially terms -- Phase up master III the data anticipate more into is reengaged of all a II Europe interest. running the Phase is We So and the on further a in the which means of this II little helpful may said, them always of the portion position investigator on But with from that III be advantage of that III portion portion in Phase with the doing protocol. on the bit we getting study. up really hand Phase the portion the master that be of we'd

in we bump a the this time or on of overall don't bit little but strategy implication see a it's road, an line. So having

Ritu And from Baral with our question Cowen. next TD comes

you physicians high-value This applying are Daybue titrating had on of and are to folks? here? and another I Ritu. rates with the forward stages it we practices. how learnings about on launch from these what is academic Athena Daybue's should your How for comfortable centers these adoption think when earlier comes conversations follow-up community to And

that. elaborate Brend Thanks, Athena. let I'll on

Yes, sure. the Thank for question. you

launch, them to contribute we've think COEs further high-volume there. what past to alluded year. physicians with find continue the ability to pleased and have penetration in prescribe our community get and the for growth they that I early RETT institution were to driving still of over see with prepared I'm and my I continue seen to those part start in I'm instrumental As to similarly the patients Daybue. remarks, pleased the we're penetration into

clinical Rett of we're what do from discovery the education with have visits what and successful programs on very where launch early expect a on experiences several to experience and infrequent that's a caregivers in starting the like been as lot their they're them us. of seeing combination get successful Daybue to to real-world more a particulars the COE, those doing product longer-term they a have in pair those clinician more for patients had as performance the with of clinical loved for and in we'll these and that tell Daybue, to ones, Daybue well you profile because you're further Daybue syndrome part the The leverage champions, the that have

And our from question Stifel. comes with Mattis Paul next

is on This for Julien Paul.

XXXX a for demonstrated are Just for ROI in quick really XXXX. DTC in campaign one. What Obviously, execution strong your expectations you've the NUPLAZID? on

have you more Just provide for any next year? can commentary if curious you

talk Brend, you about direct-to-communication want to do the so campaign? Thanks,

thanks question, for And sure. For the Julien.

of So as their disorder and relates the we just initiated this middle specialists. its to momentum we initiated see it pick in or starting it's to patient visits this, movement neurologists but really campaign August, up

our the extend beyond majority reminder, and the value patients -- community but as in the long-term NUPLAZID XXXX. And begin the of XXXX. will of a care in So lifetime see vast think will both we'll I benefit

XXXX, value patient throughout So we'll perhaps start to increase see continuing 'XX, beyond. in also and both an 'XX new their starts

of enthusiastic think don't the 'XX. I what returns. so And of early about realize fully we're visits But some value early we'll seeing all about in in its we're

with question comes Charles next Cantor. Duncan The from

release or XXX, of whether Phase any but protocol, be the protocol from cetera, the on you'll I'm IIIs enrollment of of of efficacy, guess II quick information regarding in confused Acadia. master the ongoing. had a Phase data releasing bit as little enrollment, I et ACP as with congrats Catherine, I terms are the terms not a in to facilitating question new in I the opportunity terms appreciate

So please provide a little color there.

to question, for Charles. the answer let I'm that. going Thanks Liz

Yes.

as appropriate current modifications that time. II expectation use that releasing make Our expectation III some to an Phase is at needed. we was always to would the And data be could data we Phase the

And our next question Oppenheimer. comes from Jay Olson with

For then Arcadia. contemplating your Where Catherine, you your longer-term as also And the you of and at could maybe go in talk company would were that you considered considerations please diligence future? Acadia? any key on about to role taking CEO due on vision this you for elaborate the see like

Jay. you, Thank

things. an approach I X of looking terms looking for had, opportunity, you're was combination in the at really the I So of

years. experiences, First, coming that I commercial with in was grow value XX very brands the exciting what years business. of core NUPLAZID look the where develop pharma and add commercial side far I could and based found Daybue, in base my so to over the on can And we come that's and

a which pipeline. was able psychosis. position, I and the the diligence, the in disease I at strong I very also around strong to investors. finally, strong board I'm due trials and by was really and that. X was really by, position, that Alzheimer's more And was The in second looking and the still bit was really important Acadia area And clinical but then cash as into in late-stage excited financial obviously our has it little Prader-Willi a pipeline, with a I especially terms see got of excited

more Diego. San very strength about future and Acadia in, excited first that me weeks the believe I in this attractive X tell And only I from when so motivated go you, very was than door company to has can exciting really I strength. option. made in the walked And things to here excited I'm those together even X for a and I'm and

from Sumit question comes And our next Kulkarni with Canaccord.

of may on to starting patients levels? And excellence an new at current variable to be preventing Daybue that the being main of sales not, debut review? from you the patients Another than focus what's on on from see need versus your bottleneck understanding other centers one what's key inflection

fair Sumant. question. Very Thanks,

to answer going I'm So that. Brendan let

the much for So, thanks question. so

focused some setting. centers once academic education, in I centers the you world think real get COEs we're on beyond of efficacy the excellence of much the very like and entirely are that on

families able on combination a CGII, of therapy having it over a that so peer-to-peer of had to their their RSBQ are year,s, focusing X or see them daily ones into through that X seeing, programming time. And what and really we're improvements explaining which the of in they've for combination ones have as loved physicians well been as translation doing loved is what on talk caregivers to about

and both from see of elucidate those are clinical that so we age And already those X are audiences. the programs loved I teenagers similar X, expect should to speak XX, in XX the on. for look number X really experiences preteens, the caregivers really caregivers caregivers to need on to of what focus the can one, the leveraging then those And for that well that primary be sidelines started of to have that know some that benefit similarly, between patients at have and efficacy more speak ahead may experiences their of Daybue areas language to and what of they over our of ages a of the about we X patients and can

the comes Raymond question James. Brill Danielle And with next from

Continuation Alex patient This on Danielle. is numbers. for on Daybue that on

have is back strategies of to discontinue potentially to adverse learnings potentially Just tried effort level from curious the Daybue the given and your events? mitigation ongoing getting to what real-world patients treatment who on

Brendan you. Thank Great. Yes. one I'll do well. as Alex, let that

it's mostly contact their engaging tolerability also they and GI to educate their are discontinue both we're themselves make they dosing realize one are have further more understanding you strategies, to stay to that because more to could looking GI but on HCPs checking a after and or families, work as due there know sure just management around and in see be a with will there every those pointing treatment patients that that Great and dose family and about strategy question. X like. be their journey could probably some what sure. we to to here, approaches in For would important tolerability place, challenges. effective. them experience out fills alternate With was where obviously

on restarts certainly -- still overall And something continue terms patient to will base. of for the be so say that Up I to time. patients in restarted, over that than significantly have focus now, we of XX% would that less our it's

like would turn closing the to this Adams remarks. Owen for over at to And Catherine back I time, call

Great. Thank operator. you,

again, today. me the on Acadia look Really in next joining to you've everyone, for thanks the progress us welcome forward further community. appreciate updating quarter. into the our We So given that you

Thank much participating. you This today's so does call. conclude for

may You now disconnect.