ACAD - Earnings call 3 2023 | ACADIA Pharmaceuticals Inc.

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Kathie Bishop

Good day, ladies and gentlemen, and welcome to Acadia Pharmaceutical's Third Quarter 2023 Financial Results Conference Call. My name is Kathie, and I will be your coordinator for today. [Operator Instructions]I would now like to turn the presentation over to Al Kildani, Senior Vice President of Investor Relations and Corporate Communications at Acadia. Please proceed.

Albert Kildani

Thank you, Kathie. you third us quarter thank to today's and Acadia's discuss XXXX afternoon, for on joining call Good earnings.

Development, will Chief our Joining from me will our NUPLAZID programs, Doug who Officer, Chief Financial and provide up of and Brendan update before launch and questions. will Acadia today opening who Executive Commercial, Williamson, Research are your Steve our the pipeline Schneyer, Head we for on Operating execution. will some review followed and on will and Mark Steve Davis, our then Chief Teehan, the by of provide Officer, some call discuss our open Head DAYBUE remarks, results. Officer closing call President an financial the the provide thoughts

both Q&A Vice Trofinetide-Rare President Innovation Head Disease of In Bishop, be for the session. our Senior Rare available and Meswani, addition, and Kathie for Parag will Disease Franchise, External

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

to forward-looking are undue of You Steve. reliance only place over turn now on to as are the statements, call cautioned which these today's date.I'll made not

Stephen Davis

Good in X. of to Al. quarter. a joining record the afternoon, growth, delivering revenue Please is you for Acadia thank period everyone, Slide us. third you, and entering Thank turn transformational

higher on highly our executing We our to strategic profitable provides priorities.Let years our complements to R&D briefly Rett third DAYBUE pipeline opportunities of We the and franchise quarter in as our by growing rich capitalize community million opportunity since first robust even and ahead. soon of NUPLAZID rapidly set DAYBUE. in on $XX.X Our generated pleased available. extraordinarily sales levels success to the business, this growth we on me with net as touch excitement plan fuel quarter, high of a launch, are the in first, the DAYBUE became full level demonstrating

across NUPLAZID results results, launch addition As the of we base.Third, and including positive. III we'll symptoms study to Advanced cash to the for access.Second, flow $XXX.X results negative XXXX. reflect top-line expect in share a in schizophrenia, have including and where gain pipeline, growing to revenue were have II these revenues to profitable successful of ability of we be our million. persistency, These in to and indicators grow all products, continue first discuss marketed market deep and metrics strong strongly these underlying our quarter Phase today, NUPLAZID demand, quarter seeing our we're franchise the continues highly pimavanserin

III next learnings study ACP-XXX, our Phase from leveraging NUPLAZID, to have Our month. this where we In Prader-Willi developed commence enrollment in our expect X-HTXA later evaluating we ACP-XXX blocker. syndrome, generation

to psychosis.Fourth, expanded following U.S. agreement DAYBUE's worldwide granted the III patients Alzheimer's program, our disease the our studying the this of us global in success launch Here underscores opportunity July, the have ACP-XXX to will in seamless II, DAYBUE enrollment month, announced license in too, for markets Phase of expand which later commence we asset. we rights in Phase

discuss with significant an syndrome worldwide, meeting new for month Health outside treatments the drug States. as of Rett in for reminder Canada. important to unmet serves United need trofinetide the experience We're submission planned approved medical with a Canada U.S. early this Our no

addition, early-stage that growth. and disease that we build deep, on have we're plans our a opportunities to neuropsychiatric advancing other in current and represent geographies.Fifth, disclosed significant to European rare with undisclosed includes disorders regulators programs continue portfolio in engaging In focused on

in had some we and to critical addition, Rett inspiring continue never in the relationships into for In Rett and for syndrome. further hope seen we've success a success. our therapy. rare X.X communities, continued a build months Slide an and and launch our We've portfolio to CNS the medical remain and approved We've to established the provided in dynamics DAYBUE discuss in and very our with business amazing launch active we've development caregiver on community to DAYBUE provided X. that on expand base NUPLAZID launch, patients disease.Let's and future has respond ways treatment DAYBUE of strong

to medical launch thus has During either to we've in from plan plans, launch, been. caregiver demand exceeded and exceeded significant expectations.Prior the approximately mid-April greatly we've booked this about preparing September, for made million everything in far education, expected in we our preparations, launch time, be in in result, to the revenue.In through the has gone approval and launch, It both the measures, and $XX medical pre-launch or communities, and our according some high. investments

fast exceeded immediately significantly Centers of plans In came pre-launch launch, area our is from demand upon how fact, the one where particularly Excellence. we just

early that significant and We've of depth are foundation their a access will with on written have over demand experience expectations to Centers a you rapid access in sharing of at pent-up this both pre-launch and stage, Excellence very pace speed Another time. and high more which the to medical dynamics, substantial enables physician by persistence have which terms of of that case. we're produced of amount number of on ahead short payers.As from is continue families just with the patients access than treatment benefit gain patients build And anticipated, with plans of pace adopted coupled levels DAYBUE come high therapy, we that of plans. at patient approved establishing speak forward. momentum as as at have momentum.Turning positive this and further previously exceeded of access sooner. be persistence, shortly, launch letters we've us adoption established faster, to which payers well we're reported September have of to on breadth XX.Importantly, prior will resulted seeing, established experiences the in in the that DAYBUE under area A to what coverage plan our we at Brendan these X encouraged formal to us we've has These where have to necessity enabling XXX continues move and they dynamics the

an started we remained at DAYBUE what is from curve disease plan. patients our open ahead over DAYBUE discuss X% XX linear Prior study, treatment date of As remain shortly, to to therapy after up, label launch, initiation, of their rare after producing of Brendan a X This see on XX% rolling continue projected months will to we evidence X since days indicates last and beyond our XX% therapy growth real-world operate refill. extension revenue only placebo patients typically sum after launches. treatment on year-after-year. scheduled in LILAC-X or who In we in are additional starting comparison, months initiation.To attractive growth

the penetration these to and early what revenues course, the the anticipate our DAYBUE in in with accelerated didn't launch associated quarters. is we that contributions Of surge demand

to growth a products successful as strong Slide leverage increase is As in programs Rett we'll to products overview commercial What community.Let's and we our this forward, move sectors for X foundation opportunities all breadth of our of depth of continue our an we current we substantial pipeline the late long-term and and early-stage turn snapshot represent Acadia. see X. pipeline of on that and

to X in record In significant schizophrenia eat. of our in continuing disease gain franchise, Building disease Prader-Willi psychosis, unrelenting program, we study. quarter unmet our to have have a studies real-world where market to we negative As in no the are care month growth Syndrome. drive second quarter. There is a continue increasingly commercial later in channels, leverage be with evident highly treatments this study debilitating first office-based flow. this our month, and team patients rare Phase and ACP-XXX care out our we'll Prader-Willi and will from pivotal this booked we've next DAYBUE evidence robust provides need rarely channel.Our to III is successfully business, to noted, each the and that and indication. the Parkinson's we've cash symptoms this, having in The quarter potential behind negative look becoming continues symptoms on a we year.Later something studies and this NUPLAZID long-term share in programs genetic impact That is be an forward year, results FDA-approved our the commencing year. long-term both positive pipeline earlier and rolled successful the generating is where treat we dramatic another pivotal seen to late-stage we In a schizophrenia. high, of is have study to commence

rich insights commercial over slide that, launch long-term busy with no for and a And now NUPLAZID'S a mentioned, Phase that Here us on program disease of also I've Brendan additional growth.I'll DAYBUE early-stage undisclosed pipeline to our too, we be on it as and seamless us provide there position behind disclosed our have November III II, month patients. X. for turn treatments. as to execution will programs we performance are FDA-approved Alzheimer's psychosis commence ACP-XXX Phase in

Brendan Teehan

Steve. you, Thank

terrific quarter. Let delivered me in NUPLAZID, commentary commercial the both franchises, X provide DAYBUE additional and and performance on our the

Let's X. DAYBUE begin on with Slide

commercial DAYBUE's demand, outperformed parameter has X treatment. to like to across since have launch and execution today, discuss We conversion approval. priorities paid I'd persistency, each

patients since a very great advocacy As unique, who patients XX. with a segment lot surge many DAYBUE, patient us not of DAYBUE on Excellence Steve represents XXX in demand who but as for mid-April, initial start, a just community. and likely Centers strong whom of wave patients interactions with advocacy therapy have prescribed due from September have been fewer a the DAYBUE in we of for resulting patients launch over Rett benefit of noted, to factors, of was a including have DAYBUE. This bit several in yet XXX still demand patient we seen majority organizations.This have can on is of the

and approximately practices. of are Centers treated another in XX% treated remainder of we in are described, patients As Rett institutions, Excellence, previously in community high-volume the XX%

larger disease expect we've of we significantly as next other orphan this more segment engage to the seen look a curve, with market, Rett linear we adoption launches. As rare

bring reinforce market, the initiatives, we larger of penetration will the coming are Rett with Rett loved including requests which in HCP at expected treaters ones and the are DAYBUE.We're on growth therapy participating experience of successful already in and DAYBUE.Our far support especially patient DAYBUE rate on provide Awareness this starts, and looking in so at new the local we coverage, efficacy, to point launch To and and more. experience October, opportunity that to an treatment are Rett market. to high during on delivering segment employing caregivers caregiver and will New bring conviction that a number attractive with learn this those continued our already their the webinars, with experienced achieve Month that together families still together events, now degree in of staying starting in of DAYBUE patients persistency about HCP a speak penetrate

XX%. than better long-term help on we're far on turn best patients we more addition, to initiation.When remain discussion confirmed Real-world based who to programs than a on persistency to DAYBUE discontinuations saw patients on who early refill, of important peer-to-peer our meaningfully measure of we've high is persistency and this is started our realize DAYBUE scheduled we stronger comparison, HCP months at staying seen label at thus not In open next X the early therapy discontinuations, level translate days of of practices in of remaining to Slide When DAYBUE measure therapy us. X have on label to the outlook their believe persistency started extension transitioned on from on other long-term.Further persistency the a the This remained supporting placebo This patients extremely drug high from open XX% is clinical of XX. confirmed newer-to-brand treatment In getting surprise LILAC-X in into XX% last extension past that months. we persistency are on patients end rolled persistence HCPs treaters real-world experienced number does of levels persistency plus on from any trials. study, with commercial we delivering higher since benefit.Let's is XX therapy. based over patients who because therapy persistence on

not specific clinical about our benefits observed We proper patients proven well GI to HCPs from XX. now caregivers experience initiating expect have now medications including caregivers be turn the on conversion a like management, dose to and our supporting have DAYBUE, and did language real-world and in a all the different trials anti-constipation what to as label we as discontinue clinical experience.I'd of to further discussion initial compliance instructs in where clinical that better we prior information to Slide

In and surge second converted leaves fourth yet-to-convert on to to a starting of shortening on Compliance continue demand factors helpful keeping compliance quarter, outperforming to has to of paid number our what on progress XX% labeled quarter of payers, well surge let titration XX% in between demand, the patients that third A and to me addition therapy. as executed quickly adopting converted This payers the therapy. XX& paid that date.Now in enabled to take over ahead lives convert we plan turn us our a carrying have of dose, work in in into formal months the the to being and most converting but smaller been plans is range to X through quantify in foundational this quarter. the the time of to with proportion of script dose. and X early we is covering To access. it patients treatment. This almost resulted of dose significant paid to written

of expected, optimal compliance dose at X treatment their up provides begin Most a majority titrating XX% and weeks. over the typically lower by As prescribed dose. period patients to this we titrate of start to X DAYBUE determine approximately patients most caregivers their improvements with a with in can up find the dose treated like their about believe We being long-term of DAYBUE.Please to to insight Slide into from loved XX. I'd seeing and to sharing using so long-term.Finally, benefits benefit are turn patients real-world titration to the matters appropriate most, dose what caregivers turn they're us ones the range

We are or through of patients the DAYBUE are the this the impact representative excited slide. A decreased purposeful more broadening hands. through coupled speech on families testimonials improved speaking stories lives is see improvement placement, first even years, in and the the examples eye improved daily stereotypies improved day-to-day the communication in and the and for describing conversations, real-world patient's and of in of syndrome vocabulary important gratified having benefits on and few gait feet to engagement eyes, hand-wringing purposeful include of caregiver time see with Rett you contact use

able the We experiences the promise DAYBUE move were all also now complete one's loved our we'll the testimonials These a better patients alertness to to like to of they continue to now seeing as we're continue with progress regularly increased being to of unable hear complete. patients XX conversations activities discussion monitor feedback speak to treatment about follow or and with great for franchise. Slide treatment.I'd NUPLAZID in previously

remain million. to provide PDP continue positive is business. the regarding third our drive and these confidence able with have were The contracted of of market.Product a educational to are NUPLAZID year often the important deliver disease studies we to broad the new Parkinson's results NUPLAZID overall emerging the noted, choosing increase speak NUPLAZID and over the real-world datasets customers These greater versus patient we antipsychotics reinforce market continues alternatives. efforts these about observations Leveraging franchise antipsychotics, atypical in to their other a the evidence on off-label we The off-label X sales flow X in of XXXX to quarters for over impact versus a leveraging the by our started dynamics, value. increasingly the overall continues first XXXX, quarter market increasing wide NUPLAZID we outpacing Steve the data, our strong the starts.Looking in quarters cash to grow, that first Carbidopa-Levodopa at flat As continues market see share the evidence while at real-world essentially NUPLAZID margin. of more prescriptions foundation campaign beginning the broader $XXX.X

NUPLAZID the on can increased you X% during where all timeframe, some channel, during we channel grown we've time LTC record continue in also In the in the period, this new other indicating see starts X%.Turning the have in resident XX% PDP this improvement bottle to growing new for delivered other long-term this outpaced to office-based all degree this channel, NUPLAZID, As we seeing quarter PDP have admissions, has X%. recovery. market only class, patient treat products substantially setting care just slide, products of while used a grown while

are both it revenues in on in increases XX. our Research Williamson, patient of large during record Slide given an Development, turn Head patients, by result any significant of new these provide update starting and the quarter to that refills segments market starts programs, majority NUPLAZID Assuming encouraging.I'll Doug are we continuing on the our over pipeline of now to

Doug Williamson

you, Thank Brendan.

products, pipeline providing several In opportunities we programs to our addition have to X our strong a commercial of clinical further us growth. expand with

treatments and with normal, treatment adjunctive program of designed symptoms XX. pimavanserin there productive no inhibiting symptoms a suffer approved start treat for in as and pimavanserin negative lead symptoms.Our unmet their the Slide ability Predominant for on of schizophrenia, is a schizophrenia one Let's of are life. but symptoms, who to patients still these largest controlled, the negative remain positive adequately negative symptoms are potential to today, whose needs persistent uncontrolled from still psychotic as

of to first turn enrollment symptoms we sharing we negative last As of forward XXXX.Please our of results We in XX. quarter top-line second in in stated schizophrenia. study the quarter, advance-X, Slide have pimavanserin look completed to

X developments, entirely compounds ACP-XXX. and ACP-XXX. with begin new with We pipeline programs ACP-XXX I'll also and have

United be slide, with Prader-Willi represents efficacy for currently the to global excited and ACP-XXX this about. completed is program neurobehavioral the safety III in patients. laid HQCT, X,XXX III approximately This that the significant Phase this Hyperphagia by or Trials, If steps States eligible The the is all improvement extension patients approximately affects syndrome endpoint from necessary of approved XXX study. the to ACP-XXX to will the are we evaluating to drug patients as the to of genetic enroll the as Prader-Willi in complete multi-center XX-week rare hyperphagia a turn plan the Prader-Willi treat to of unmet in measured we've efficacy treatment have Questionnaire long-term XX,XXX a placebo-controlled syndrome initiate out characteristic a Clinical the Phase working study positive, evaluating patients for We need. very who Those the hyperphagia in in clinical therapies study data the is and scale. a an hyperphagia new open-label study forward of development design is for in of this program.Please submit and XX. advance We continue we There III Prader-Willi PWS to the Phase Slide syndrome. no PWS.On application study look treatment with randomized hyperphagia double-blind FDA. to we're of community primary experts to

We to developing which potential a treatment next-generation as we're advance disease continue for compound, psychosis. Alzheimer's ACP-XXX, X-HTXA our

As inverse an as agonist receptor. of primarily X-HTXA the we ACP-XXX previously works described,

and and product to supports seeking I program future.Our we're for has experience low on very elderly tolerability pimavanserin medications, those it profile concomitant is with ACP-XXX, well with with comorbidities and drug-drug Our attractive work profile completed interaction With a our for to suggests target liability. efficacy date comprehensive believe Phase exciting that ACP-XXX. antipsychotic and a includes suited build an this multiple mechanism very learnings populations providing

you II, see weeks. to significant I, data strong a slide, our preparing the III XX. Armed can in the turn Phase coming ACP-XXX's profile from with product ACP-XXX strong Phase program this Slide Phase to we're over seamless already profile pimavanserin.Please for an start could on As represent for improvement

Phase plan, considered from designed if move finding sites designed be continuously into can could which registration Phase X the sized II and with that study plan seamlessly patients, study development a with with XXX III this reminder, we in same Phase initial eliminate way study.As directly and pivotal an dose Our enrolling Phase been Phase This patients. a such over X to includes roll II III it into studies. II is studies has accelerated a successful,

site the into complete, move be of study by Slide an their Phase allocation, Once our III we've underway. financial will it one represents allocation grow provide studies. patients the for update business.And program. we're for report aligned ultimately studies Phase component plan, already progress now, attractive completes II for and a the over patients II This III Phase each XX. to with on on will we FDA, the of turn X they is the for results, As this with pivotal opportunities our full provide I'll X Phase will site studies submission.Overall, potential continue very to to strategy directly which recruiting analyze which a important II Mark will of of excited time to Phase It

Mark Schneyer

Thank you, Doug.

in-channel to for DAYBUE, inventory million increase volumes review was quarter of compared of of as of $X our XX. NUPLAZID Reduction increase net primarily the significant NUPLAZID to Inflation full the $XX.X product net compared the last Act, quarterly XX.X% million not million early of in prior offset by In quarter, to due $X demand offset in The year-over-year million expenses by to reduction and with other of XXXX. increased in stronger-than-expected earlier rights million expenses $XX.X with the excluding to to in million from XXXX, in ended upfront Steve in $XXX.X On quarter by commercialization, Slide third the partially Neuren quarter Brendan. on expenses.SG&A cash offset partially described gross performance QX net reductions million. sales on XXXX, to spend was payment demand XXXB partially trofinetide, million adjustment by net upfront R&D we was QX with associated revenues. $XX.X were year. million Pharmaceuticals rebates to $XXX from increase trofinetide, flow and growth.Our a the just mainly $X company. as in to for successful in driven increased total million XXXX. the increase $XXX.X prior the XX.X% QX were the the result of gross I mentioned.Turning we the to year $XX.X costs performance neutral million increased comprised excluding cash $XXX.X volumes, QX the XXXB launch, and R&D attributable payment payment. to by a third $XX.X The commercial were commercial X% strong year. $XXX was reduction trofinetide for also first in million worldwide a associated rights recorded did reflecting this that in the as worldwide to attributable launch a positive in year, our our The third basis, million recent a lower quarter, million the for flow Let's $XXX.X DAYBUE were our sales in NUPLAZID. quarter, product in cash quarter, upfront a We the reduction when we recur balance With DAYBUE, year-to-date The is

scope subject $XXX term, cash we the we long is size to our the forward, over and are bottom net XX, positive business million to our future flow the expect NUPLAZID of $XXX.X sales full-year to be to and of range million. guidance Slide new raising end Going development.Turning

also gross range is new net of guidance, bottom XX%. are full-year NUPLAZID the We to and our our end XX.X% raising

net fourth-quarter million sales million. guidance we to Additionally, are providing DAYBUE $XX $XX.X of

as ranges are narrowing expense we close year. the the side, guidance our near of the we On

range. Our $XXX to to million million $XXX prior of full-year our R&D of the guidance narrows middle

remarks million to over now, the prior call like million to XX. $XXX on of to upper turn the of guidance I'd Slide SC&A to range.And half Steve narrows our $XXX for full-year Our closing

Stephen Davis

a thank and continue for their the to our Q&A. Thanks, turn and we is period employees I'll Mark. I you to start their our mission life.Operator, execute like would it transformational accomplishments of Acadia to as growth to commitment as across strategic continue ongoing we entering elevate our priorities, passion all to and over

Operator

[Operator Instructions] TD of comes Cowen. from the Baral line Ritu first question Our of

Ritu Baral

[indiscernible]

Stephen Davis

Ritu, muffled. you're through coming very

Ritu Baral

I'm sorry.

Operator

volume, turn you Could up your please?

Ritu Baral

[indiscernible]

Stephen Davis

can We you hear Ritu. understand saying. talking. what sorry, I'm We Yes, can't you're

Operator

up. and questioner could we'll in get next the You bring again, queue try our but again

Tess line with the next Romero Your comes of Morgan. question JP from

proceed. You may

Tessa Romero

Congratulations on all the progress.

to quarter? looked might Our starting specifically how of off average? could, cadence XQ with that exiting in around And question second I respect is that of the type if patients trends patient the and than drop earlier question, then any DAYBUE, the

Stephen Davis

you this? do Brendan, to want take

Brendan Teehan

prescriptions early had that that families would of to that our of to a see Tess, early. continued We think that in many which important to have the highly quarter third in got the way to engaged part the that the started came we demand in be Yes, third would in quarter, then in many due sure. It's first second simply think of is to demand then the on in pull I quarter. early the right group about forward note a place. third quarter, And see the conversion. surge, the of filled were filled quarter expected

Some also I think quarter. will carry over fourth into the

that rare early stepped have already number on a to some very is and quarter seen. in the disease to didn't the same of the familiar of of of is growth, up patients leaving more basis And we what launch we've up would brought on those step I therapy. [indiscernible] slope, see terms other sort seeing to third but think what linear we're we've the So launches, expect and families though

Stephen Davis

think the of difference I Brendan, second any regarding And question in that patients part the discontinue. we was terms see of

Brendan Teehan

of No, say what been would in we terms would discontinuations. have that Sorry, question. great expected it's I

with some rare therapy. with to on product see aren't to patients going disease launch As any stay benefit enough early subjective endpoints,

across age will to and that tolerability, due we've seen weights. Some ranges but discontinue

Operator

Suneja of line from comes the with question next Guggenheim. Our Yatin

Yatin Suneja

particularly Very impressive today, results DAYBUE. on

So the is constitutes the end? question low lower, of to the million guidance be drivers pulls you what into that I Could higher versus on a high maybe and end, what $XX of to that push guidance. $XX.X help you comment some have are the million, what end on some can closer the of the like the

Stephen Davis

Mark, do take you that? want to

Mark Schneyer

the discussing, the kind demand, come those we've conversion, that we've we've to forecast, a towards Christmas the end, all lower through you end. to the higher period I of access, think lower of to lower on potentially key together and kind persistency, all kind been gets and end, the Yes, up higher looked other of go financial so One build at kind thing with DAYBUE. yet of range. towards as together the Obviously, holiday parameters of

So fourth last the of bottles and impact quarter we don't could end if of of weeks lower couple the know on the range. sales the

Operator

Our of line Baral the next Cowen. Ritu question TD with comes from

Ritu Baral

series a quarters. about ask So I to coverage. wanted obviously, insurance congratulations on of consensus-leading

denials is denials. As it about coverage hear the know, the of on conducting we one Despite numbers, tracking sure patients over the I'm been And good launch. you left surveys there's seems things of table the complaints around long from and again these doctors we've like guys still DAYBUE letters over denials, And it are what seeing hearing now to this, what we're see around that. around you exception efficacy, months around that for We X takes were how come denials through. out, wanted on denials to you maybe reauthorization?

Stephen Davis

Brendan? Ritu. Yes,

Brendan Teehan

Ritu, what published seen that is helpful. been we've Sure. have very coverage so policies

early the in. there's bit in the to days, we'll prescription going obviously, backlog patients Now get a be because in of a

We the prior probably compounded by this audience. the disease-treating rare And of process. authorization is have through bit the to a work size

from hub prior with That's and of say can can further the of be, authorization to into in have why assistant much with that accelerate seen specific now as behalf. approximately I generally XX-month we've that They most moved an coupled their our consistent XX% other even for X and single continued covering reauthorizations, at much process Excellence, doing is those rare a and the on these we've some clinical you specialty are DAYBUE them the been of work launch, we've the lives.For As and do so a this approvals that those benefit products. What are around with is of question support of we've that receiving know, reflective this Centers what require seen provided expectations in period. physician reauthorizations your maybe physician patient our attestation disease coverage have very work. tends to policies or a

patients. annually have and of a X then Some reauthorization for any had are But we DAYBUE at a thereafter. denial them not months, for final far, thus

Stephen Davis

Just are that on to point, are maybe annotate and there last denials. denials there

in policy initial have a place, doesn't prescription when a if particularly a uncommon, to coverage not comes it's plan in formal issue denial. So an

doctors of of that deal of the plan that, is denial but as noise do the move time, much terms that. And we in kind them. neuro with denial have as in ] ops does so other is system of where [ is That terms very and just the still kind of -- a not mentioned, But Brendan off a supporting in rare. to

does the and subside it of as place. then so administrative does bit plans and get create in system, more And policies in effort formal a more which noise little

Operator

from Our Gregory question with next Markets. RBC Capital comes Renza

Gregory Renza

on Congrats Greg. for Anishan quarter. the is This

your potential DAYBUE even interactions be should from thinking ex-U.S., also, physicians region? of by about on for how stratified diagnoses, should value could, seasonality with Rett, perhaps what if unlock expect by Firstly, one treating specifically we And age? I availability

Stephen Davis

take ask first Baswani to second the going the to Parag question I'm and question. Parag?

Parag Meswani

Sure.

and so weight I'll so range, of what DAYBUE points high is at that of interest, a physician regardless gender, outset and encouraging So say on forth. age, is regarding the to overall feedback level caregiver

view we the of very So about feel product their profile. confident

rates, we when patients are are of terms see assessment. patients What do to any diagnosis follow-up when don't really In or differences coming in differences see are their for variance as diagnosed. we

One we more become there patients more accelerate of different when the familiar things in clinician. are is and as DAYBUE's that profile. his of cadence see a that going in is to And their over and DAYBUE with patients that expect product prepared remarks Brendan mentioned to time,

Stephen Davis

Parag. Yes. Thanks, ex-U.S.? Brendan,

Brendan Teehan

Yes.

to audience. are So for trofinetide able a outside to about broader be the opportunity we obviously United the bring excited to States,

will be in Canada. Our progress first

As the months. with in conversations to XX taking prepping also bring for our we've began next in conversations in Japan. in are described, We've advice scientific regulators DAYBUE Europe to and we're already also Canada

rest global opportunistically of the for We opportunities world the from for look well us our continue to as expansion at will there.

Operator

Your question from comes Morgan next Stanley. with Jeff Hung

Lee Hung

You days. said clinic planned that are centers prevalent existing patients during treating

So I trajectory existing clinic forward, expectations decrease days remained through the linear or more centers starting work of prevalent of have stable they going guess patients? with number to are as

Stephen Davis

that? take to Parag, want Jeff. you

Parag Meswani

that to question. happy Yes, take

would number days We of their approval I say consequence as that Excellence it's that of clinic the DAYBUE. have So a increased of Centers actually of a variable. know

day Some day infrastructure a have don't from have gone a Others a month yet. week. to the a clinic clinic

access X payer who payer question, may are on X for issues there responsible or Brendan just As visits managing before clinic be to clinical mentioned everything clinicians well. from as the and trials

through clinic We're are well. new to that's they're Centers being demand coming and and the as of muscle seen, treated days patients in added. as a through the that more that are many and So and of clinic community meet those clinic seeing more through days more encouraging learning the doors. over facilitating added being connections time, to sorts being flex And is we this in are Excellence ways. But

Operator

line Duncan comes question Charles from the next of of Your Cantor.

Charles Duncan

great DAYBUE. quarter for a on Congrats

commercial. think the questions couple I of questions other the been on since asked ask on have I'll good a pipeline

their the On question later I'm that to there of for are the of all, And issue would this to in Can journey. context I that give us primarily on regarding that terms Alzheimer's be you etiologies? a anticipate first Alzheimer's is you sense other of enroll? study? the number there how study patients pipeline, going confirm a versus that an quickly not helpful for of conduct of you patients you are guess disease in will are patients. ACP-XXX, for assuming Or that And ACP-XXX, how

Stephen Davis

first the actually just tempting it's enrollment Charles, some on projected comment question. answer We experience. don't we get typically until enrollment to

And have patients. to answer back question Alzheimer's we'll So ask on to Doug you second get to that. then the I'll regarding

Doug Williamson

that's with of the group conversation their Yes, actually validating assessment increasingly a And a interested had because Charles, and question, diagnosis the are in great FDA. it's outcomes we Alzheimer's.

that to into agreed of we've blood-based certainty the just with diagnostic procedure getting correct. conduct extra add an the diagnosis a biomarker, So level them we'll we're a biomarker, that

Operator

Verma with question Ash next of the UBS. from Your comes line

Ashwani Verma

over like, And of wanted any on a be think the DAYBUE, trend get So you granularity. how the seeing would thoughts it's and how are XX study? or of persistency in to type real at, get just representative see updates in time. terms months? data might to world? that this this this do could But X, more And I on your X-month think we X, LILAC-X encouraging look this you on data I very point what for mean,

Stephen Davis

I'll question. take I'll first ask the take to Kathie second. the Yes,

do amount including with we've now to parameters, of respect persistency. mentioned, still. So data it's so on we have, as multiple therapy, early XXX have patients question, meaningful We first on a the

So update. continue we have X have and of we completed strong that patients forward, number we'll monitor months a to of as therapy. go And this

that look We X But I we data we months what the obviously, X would and with et that separation at this cetera. many seeing at as between not have, patients months as at and those which, as have world we think knowing X the in as starting therapy we X, say have, starting we're to see real DAYBUE, clinical the are we're we seeing what open-label again, and best comparison because said, they're LILAC-X from this on we continue trial the rollovers, patients separation. at is

And as updating so highly we'll go seeing. look forward. encouraged to we're But by what you forward we we're

experience. investments We expect on to able it in improve to be it. We our clinical put significant

And want we the second take you are.Kathie, to so far, question?

Kathie Bishop

those Society we had a Over them had very, few therapy. patients as drug at to that patients rollover presenting We Epilepsy But month, we Yes. results those in therapy. meeting. was of now those LILAC-X, commercial just onto we early the on With the we will XX% LILAC-X very completed so continue opportunity therapy and about study in plan commercial hand. in I And until actually study, the American did on in have dropouts. they December, say go the directly had regards to approved on

long And to DAYBUE. or as of is LILAC-X. they trofinetide through on if that first think that's consistent stayed as in they what I them get think period, with they then we LILAC-X, enrolled sort Brendan we can in So mentioned, stay continue

Operator

BofA Securities. Your next question comes from the line of Tazeen Ahmad with

Tazeen Ahmad

topics bit. for a Maybe I'll switch

study, remind to readout in at expect what to would that data data? of you type just ADVANCE-X be upcoming can top-line good what the you us consider and XXXX, On

Stephen Davis

Thanks for that? Doug, to take the do you question. want

Doug Williamson

Sure.

see, using well-validated in NSA-XX. And top-line negative NSA-XX, and data So the overall the symptoms. a the is for the we is outcome the assessing we're scale expect which change accepted to very primary

of at we what terms in look ADVANCE-X around XX-milligram data about the size like, that saw does X.X. effect good In the was dose

size. the coincidentally. was I X.XX X.XX, think effect it was

constitutes consistent that's think significant I with generally a studies. what in So change clinically psychiatric

replicated, think So regard I that we'd if data. good we that as saw

Stephen Davis

next Operator, question.

Operator

Our Ear of next the question from Uy Mizuho. with comes line

Uy Ear

NUPLAZID, program on guess this the drug. good Congrats switch quarter. I'll you benefited you from quarter. that mentioned I the XXXB On

you Just or wondering going thing, this if do this benefit persist one-time is expect a forward? to

Stephen Davis

to take the for much you that? Thanks want question. Mark, do

Mark Schneyer

Yes.

the of growing. slowly has kind as generally speaking, volumes been of So mix XXXB part our

one-time year. saw kind what this year increase was I happen you results this that in the a artifact of think the last quarter of didn't

provided net that benefit the comparing So quarters. change you're and of kind a revenue when

of forward, the as we we'll as think expect go in to slow years. we've modest I last seen growth to XXXB over volumes continue the couple

Operator

Our in of Partners. Marc comes question line Goodman next with Leerink

Madhumita Yennawar

the on Madhu is follow-up couple us. A questions on other for This line Marc. DAYBUE from

then tolerated you whether on anything specific patients might in better for community to like patients? see side patient are been in that? of seeing any hearing identified the you numbers versus diagnosis are in who or older effects to First, rep And the younger you rates have are when expect or increases overall the start side effects, subgroups

Stephen Davis

the Parag, Brendan, question? you you why don't want take to the do second? first take

Brendan Teehan

you forgive repeat Can apologize. the -- you I question? me. Can first Yes.

Stephen Davis

we increase we did see rates? was diagnosis any in point The or seen -- have

Brendan Teehan

Oh, yes.

Forgive me.

rates, yes. diagnosis So

as the in so We And are changes quarters seeing look X drug. -- diagnosis at we're at we're into this rates. we not of about data the launch point, meaningful

it's to safe it's early think I say on. that

obviously Our or U.S. treated X,XXX the close in patients and that population, so to the diagnosed first goal gap know X,XXX try and is between is which X,XXX, to and prevalent we the

drug that see as diagnosed you can and to approved, think We we'll over see share first-to-market continue is track to you the insights will closely. I very We time. increases in tend increases population, continue those -- know a to

Stephen Davis

Parag? Brendan. Thanks,

Parag Meswani

support encouraged the lot both patient informed at I'll of really a new with second an with say every providers we designed and Remember, is a inclusive services goes single footprint basis perspective. education post-approval. single We've program, and very educating paired say tolerability and would DAYBUE, And and well. both extensive team the from real-world efficacy approach to caregiver, from the very that that's what caregivers a experience, our And question, family that from that that Sure. at the comprehensive of been a that favorably. every that outset, new with a as supplement learned Phase I on received to the is we we're providers III outset perspective

that at So better part they experience a core from that's seeing arise, we're well. launch. that any as a prescriber and that tolerability diarrhea point, a started and tools and tolerability remains in perspective It much with day or communication whether as caregivers, is our because caregiver is mitigate of from the issues a other of both issues perspective and to out, providers with experience and with hearing that, day

Operator

Richter Your Goldman comes next with of Salveen line Sachs. from the question

Unknown Analyst

This is Matt on for Salveen.

you And is for end flow us? and You cash of we're the term? all there have litigation of you that litigation, the headed update now highlighted right for on NUPLAZID have the Could you margins you the expecting then where update longer patent think increasingly positive. NUPLAZID, what any share I kind by month. Do an see

Stephen Davis

Yes, the I'll Mark to and take second first, one. answer first I'll question the ask

before, court We the for and issued year end nothing highly There's our confident really said the that court will we of and yet. the believe position. of is on have our at law side, terms it's point I'll just the think that just or And that not we're by to we is in in litigation. this likely what update than sure. has commentary, decision say other the we a highly So district say

to a decision you get we're want question? So eager the well.Mark, to second as take to

Mark Schneyer

cash franchise. flow cost the on $XXX approximately of we fully profitability cash of the allocated of basis a million Yes, generate on NUPLAZID,

being cycles decide basis near-term growth support continue to we'll our and through that both and year-over-year, budget top-line on the as plans on profitability. time. over for the expect investment of a and we Obviously, to for a We focus franchise year-to-year the on -- grow level go to with investment

Operator

the Your next Kulkarni question with from Canaccord Genuity. comes of line Sumant

Sumant Kulkarni

successful is the product thinking think negative Salesforce from pricing and do you given pimavanserin resourced symptoms already about market, you're appropriately on are potential is how a that Assuming the in of you schizophrenia, perspective?

Stephen Davis

second mind? the them, if Brendan, don't take why don't of don't you Actually, why question. both part? Two-part you you take

Brendan Teehan

Yes, sure.

where both focus of discuss for the across expand about organization. at the are that think core allow on logically our portfolio to our of symptoms treaters company, between on this So we negative point of tends a resourcing, not of When the we of fair a pimavanserin obviously patients CNS-focused us value we footprint to resources in at than us, cover are of amount will will we're capitalize population have psychiatry certainly locations to will going and we crossover looking to be stop terms we kind which there's pricing, other we say to and schizophrenia, to within treating these the negative But broadened patients. these indications. symptoms'

Operator

Needham Your next of question line with comes Ami Company. Fadia & to the

Ami Fadia

one that. if be more really diagnosed? will this DAYBUE. about strong here better the for of whether under the sort sort a do for plan time Can get performance from and to sort follow-up And insurance from an in Maybe on indicated to the you been already whether DAYBUE, or an more under of to you've blocking, any impacting, waiting approval the and can about the patients, the be bolus it's put Is me. getting talk where more are where of launch, on linear. I'm they on on new of trying on DAYBUE exemption you are sense DAYBUE with growth has as you to just that they initial formulary? color of of Congratulations are now patients give getting patients So

Stephen Davis

take you the Two-part to the second? and want Parag first Brendan, question.

Brendan Teehan

seen, great. in quarter initial medical have letters Sure. and to What was unsurprisingly That letters quarter. other of very similar the be somewhat exception. approvals second come rare in through launches, and medical would necessity, of the the That we've third disease and

the we've have a seen approvals third that over place. -- same month month into basis, seen pointed approvals, for month plan DAYBUE. written almost time as more plans as coverage almost gone on now I've have in too, we XX% lives we've And month-by-month approvals, of As second have covered planned these written

by we those I at few end and December. are we'd published to of piece, would as most end year. expect the the we the are last a prescriptions.Do pleased have pace think increasing forms year, to the happen that coverage and the becoming already enrollment see now want end between second those of But which before going more our take call, of we with the Parag? the to We you the are policies So be on to said of expect

Parag Meswani

Steve, repeat repeat the mind don't to second do or Ami, want that? question, you if Yes. you please,

Stephen Davis

DAYBUE it quarter the opposed was of of what's linearity as treatment think dynamics surge. to the the function of in for adoption or sort happening fourth of a I

Parag Meswani

Yes, sure.

closely smaller At stage, this our aren't stage, that providers, as have first his through So the clinics the to of the Rett of and had visits to is growth in community of Rett pre-launch degree in with uptake as as patients led well, the for step year. plan a Q&A at the really in physicians quarters. this patients in quarters number mentioned the remarks of with having and frequency that of identify had during couple and patients they a up same prepared a really connecting the effective education in of and we first Brendan couple

number experience high of of that faster than significant patients depth much in a our has physician expectations. demand, So experience in far access marketplace and far, a a happened positive breadth sharing to moving that foundation goal we've is forward families pre-launch terms which establish strong our had so is and of initial and the so

we're So fewer or demand, that beyond have this who well day-to-day providers regularly basis. to aren't efforts looking as physicians visiting as families on reach clinicians given Rett Rett as ahead, a expanding COE our early patients to their connected

Operator

time have which We with Jay one Olson question, for in Oppenheimer. of more line the comes

Jay Olson

the quarter. are could dynamic compare commercial does U.S. please ex-U.S. Congrats the on you sales the far, peak on your opportunity latest of the so longer-term what impressive value achievable DAYBUE the potential of terms commercial how in share on Based launch thoughts to the and opportunity?

Stephen Davis

the for you Mark, that? want question, much Jay. to so Thanks take

Mark Schneyer

DAYBUE, excited we've as what many so very far launch the we're times. Jay, experienced we've clearly, said Yes, in about

there to sales size size U.S., the our Rett similar in to little meaningful a less policy be be just just The pricing little population come coming the by product Japan U.S. a could U.S. in could don't in the a opportunity this different, be in are discuss It patients this, regulatory in U.S., terms the very, markets expect of through to estimates. there peak a as We just higher, those are very more than to in so in The matter Europe are we in out the still more of of, we're matter a that company efforts, towards in as advance outside dynamics there the we years. pimavanserin, and our than of but put as working but

Operator

Mr. completes This to question-and-answer session. proceed our remarks. please Davis, closing

Stephen Davis

updating for Thanks Operator. again, Thanks today. everyone, to our us Great. look on forward next you much, joining progress quarter. We

Operator

Good today's your This and concludes day. for again you the disconnect. presentation, in may Thank call. you participation conference now

ACADIA Pharmaceuticals (ACAD) 2 Nov 232023 Q3 Earnings call transcript