Earnings call transcript Q1 2023

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Operator

Good day, ladies and gentlemen. Thank you for standing by. Welcome to ACADIA Pharmaceuticals’ First Quarter 2023 Financial Results Conference Call. My name is Corey and I'll be your coordinator for today. At this time, all participants are in a listen-only mode.

a towards facilitating today's end be call. will question-and-answer the session of We be call today's Instructions] advised [Operator Please conference is recorded. being

Vice now would to at like turn Please President Johnson, ACADIA. the Relations of I proceed. Investor presentation to Mark over

Mark Johnson

for afternoon to today's first XXXX you ACADIA's us financial on Thank you. results. thank joining Good quarter and call discuss

our a business; Chief me the of call overview before turning syndrome, Davis, discuss Teehan, Officer, Executive your Chief provide pipeline Operating of on of final today an questions. Steve Williamson, franchise; Officer, results our our Doug recent the of Financial our Joining opening and Commercial financial updates to who our an of of for back review followed remarks our updates Chief call and our will Schneyer, Mark treatment performance Officer, and our update for by the programs; debut on will our NUPLAZID Brendan on from for ACADIA of Steve launch will Head Rett R&D commercial are it our Head will provide up provide

Presentations call addition, of session. available are In our Officer the Scientific Head for section Rare slides which out supplemental Bishop, using the Diseases like on and be our the on Chief of Q&A to also Events I will we would and point Kathie and that available are website.

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

You as on of reliance undue are forward-looking made date. only are cautioned not statements, to which place today's these

the turn over now call to I'll Steve.

Steve Davis

Good you, thank you today. joining everyone for us Mark. Thank and afternoon,

to XXXX start great turn with to slide March progress as strategic and in off our only is received four treatment syndrome. First, Please Rett five. FDA priorities: a for the across strong DAYBUE first approval

Our today. with updates team sharing make execution moved commercially quickly launch on we available to mid-April, will you by DAYBUE our and be

Parkinson's psychosis. to Second, disease we volumes steady continued our deliver in franchise NUPLAZID in

cash XXXX. since Our year-over-year, business has profitable year, increasing flows, turning every in generated PDP

Third, symptoms pimavanserin we results early expect schizophrenia to complete of for evaluating study in enrollment X of the treatment a negative we'll and have for mid-year our around Phase topline XXXX. as ADVANCE-X,

next-generation program. And completed of of development Phase fourth, we our ACP-XXX, X-HTXA part X

plan with meet psychosis. to development disease clinical are steps to next evaluate Our discuss ACP-XXX treatment FDA to as a the Alzheimer's for

to debilitating patients Let's and recap clock of first-ever syndrome lives the approval with Rett neurodevelopmental we've an around XX, patient approval quick of the disorder on launch working rare to been March the a on and for impacts treatment slide is begin Since subsequent the syndrome genetic this that their six. deliver DAYBUE community. of severely our extremely families. Rett DAYBUE

been first-in-class, are to moving community treating first-to-market a diseases are also HCPs quickly therapy. The receptive beyond to having launching is DAYBUE, very a time waited for be excited this extremely an high such need. prescribe We they've unmet drug with FDA-approved and long for excited

first with in payers engaged parallel, our we are post-approval In discussion.

launches, with initial typical rare is As adjudicate anticipate it payers requests. take will we some disease to for time prescription

for plans hub. to to Rett working obtain insurance have are we who expect, our prescriptions would you patients, with coverage As diligently submitted

will Brendan color response the launch, three highly into far only today. we've weeks we are with and launch encouraged and on additional we're seen provide our execution the Although so

seven. Now, on let's slide to turn NUPLAZID

PDP a resulted providing franchise in in Our increase parallel, steady in market profitability business. a the market. significant gain and NUPLAZID meaningful has to continues for and our share volumes deliver NUPLAZID we've a contribution In franchise, expense which our to optimized commercial contracted base, reduced overall

for Our first was as quarterly slightly with the patients traction. $XXX.X evidenced net discussions share volumes of his quarter is year-over-year are further to a market will real-world million early publications driven inventory sales in result increase describe Sell-in in were new-to-therapy that beginning section. on This evidence indicators Mark bottles of gaining down our of of which We're in see by in healthcare initial demand fluctuations, performance year-over-year PDP. by our X%. providers a increase an

we As off-label there three real-world NUPLAZID studies antipsychotics. believe which for atypical and healthcare the I contribute relative are can just our by is previously the the out growth professionals top-line we've demonstrate One, awareness catalysts, NUPLAZID franchise. mentioned two benefits of understanding of to as the to laid that

positive visits to has a for very two these the on which as initial not returning we've growth prescriptions patient far been is in-person levels, medication and to well So feedback as pre-pandemic return Parkinson's datasets; observed. yet

we're briefly clinical symptoms focused this significant provide failures difficult treating quick One, exceedingly to of needs eight. Doug an multiple slide let's treat condition. the on our before, as more decades review detail lots drug in has approved our programs, But with commercial multiple in all noted NUPLAZID and section. no will programs, over now, still programs negative area two developing beyond on DAYBUE, his schizophrenia and been of CNS. A of updates. we've couple And industry

ADVANCE-X. positive in rare achieved With this pimavanserin, a we've study something population, pivotal very

are submit XXXX. have So in to shortly we Again, results new supplemental we thereafter. if position a a the X expect in drug study would our this of to application be study ADVANCE-X, positive, results ongoing Phase early

X X-HTXA disease target that and studies I this product psychosis molecule lead next-generation takeaway The work work And our our in we X two, continues plan to our Phase year. Alzheimer's support as we've initiate the later key ACP-XXX, development here profile X for mentioned, Phase in completed program. the is Phase to

I'll its now additional execution insights it Brendan DAYBUE to over and launch commercial on turn performance. to add our imply

Brendan Teehan

to turn XX. Slide Please Steve. you, Thank

launched our are second first medicine the thrilled syndrome. ever Rett to only approved We product DAYBUE, for and the treatment commercial of have

throughout Rett and disease continuous development syndrome a with patients all discussed aspects assistance debilitating requiring program we've lifelong daily As the with is care highly of living.

DAYBUE and ahead enrollment on of available April initial became XX patient forms expectations. our

color today, weeks and launch we specific As into received three we're the our insights but execution community. broader only positive on any from feedback launch, not share provide will the we will and Rett initial we've metrics the

XX. slide to turn Let's

going much our very execution to plan. is according First, launch

the are both has of DAYBUE As label broad to With expected, centers and representative both age, broad Rett institutions patient received Rett patients, sites, the we treatment participants syndrome. clinical trial received for de we back trial XX-years practices. patients label patients, receiving ages enrollment and excellence, March, standalone enrollment above FDA-approved male female for pleased above high of novo see from forms are patients clinical forms well volume a from and from two of both of all to neurology in

XX% total and This Of of the as well the clinical patients, over diagnosed of proactively about Rett of population. which excellence identified physicians Rett X,XXX centers diagnosed outreach Rett XXX% and treated XX% spends engagement of sites, trial with treat includes population. our of the Rett treating today,

have fact, the started extension paid In patients remaining our process XX% from patients. of over of our studies becoming open-label

number represent a of to standalone institutions, the large engaged also And patient we're of the in XX% over neurology the engage community setting. population. We XXX X,XXX offices which high-volume starting have the

including a at and print the In activating digital, materials, too further community Since launch marketing congresses speakers approval, early we've bureau Rett includes and to comment takes the branded community, engaging educate today. medical and a payer both with it's execution been addition, standing actively robust dialog and treating engaging our development up the key to process time, productive the as further DAYBUEs. of in community,

hub engagement addition assistance Connect our managers given with field-based ensure already these In HCPs financial patient's to to access best families support timely family DAYBUE. Services provide meaningful the both coverage to payer the are to options, providing to our along Acadia access activities, and Support

like are highly we XXX forward prescription, Rett above live path of robust seen well internal community over attendees, a sharing while launch, success access to caregiver-focused we our our webinar we've with And look finally, so to response caregiver that reiterate information we're the webinar, I'd our a support about the our to and on enroll sharing loved targets. next all with was following product, encouraged the Acadia's obtain big the approval, The hosted call. weeks services. how into three and We the one to quarterly more far. first only

discuss our grew demand first-quarter last In let's we of first Slide XXXX, the XX. on to X% compared bottles quarter year. performance Now, NUPLAZID

both indicators the Beginning growth new quarter, space now first, for by prescription driven was into share new long-term and patient across continuing new-to-brand of care increase in Our starts in performance have starts patient NUPLAZID. we and an fourth observed early and the in channels. office

may patients admitted fewer and prescriptions the a direct like you facility, during coming patient in or growth into foundational reduction patient as of population, treatments of was new carbidopa and care to PD As a the result impacted levodopa. pandemic the negatively in recall, a overall office being the long-term decrease

real-world maintaining from compared the PDP are presented steady to engagement These NUPLAZID market. for NUPLAZID only off-label their in healthcare highlighting PDP share safety, to we datasets resource with an high differentiate on treatment volumes we further by grow of by otherwise antipsychotics. the to potential and physicians level data are evidence seeing important in the when treatment continuing an differences dialogs Thus encouraged NUPLAZID, ongoing for first utilization and contracted with with mortality, actually Furthermore, option are patients. create we HCPs as

our continuing proud cash in share profitability teams say XXXX. NUPLAZID has franchise focus grow flow new both top growth commercial year turning market base. continued With positive to starts, a achieved to and that patient of the and all and I'm each bottom optimize line, expense early NUPLAZID We're that while pleased grown in on our indicators since to reduce have

provide clinical on programs. Doug And I'll it an our with to over that, update to turn Williamson

Doug Williamson

XX. Thank to Brendan. Please turn you, slide

up Firstly, while for to Rett also generating scientific medical community. important continue support of information, and to the for exchange we DAYBUE the launch set new opportunities efforts, sharing data important

affairs team information and already medical clinical scientific about Our to community. have delivered the Rett team including Science running is our important and who Liaison Medical DAYBUE education off

to well presented central education. meaningful Syndrome in AAN American Conference which data April are AAN, Academy congresses we've as the presentations the a June. at of medical Congress disease on International Rett included Foundation have surveys clinical At as to continue that or upcoming posters, and Neurology the We and in several including community, key Rett presence important

to approaches should Phase the a X the of management In the with Lavender two months. coming paper clinical publication on and the white addition, important best is other available be in which results for GI is very we're publications, excited the associated trofinetide. One

Finally, real-world to DAYBUE we'll in the large-scale so, in initiating month naturalistic setting. be a is or about best how prospective, next more a study learn used

our largest treatment Let's Persistent clinical with of to programs, unmet the negative negative today, still needs move treatments negative are starting of no symptoms schizophrenia XX. symptoms for symptoms. in on a as or slide are potential there affect. these of characterized pimavanserin one lack remain schizophrenia symptoms The on social emotion, schizophrenia, approved of of and withdrawal, as for flat by the

Our is whose symptoms life. still psychosis patients their hallucinations, designed a from but inhibiting other uncontrolled and U.S., controlled, the approximately positive ability productive in to treat to pimavanserin normal adjunctive who XXX,XXX are lead negative delusions, program adequately persistent the suffer and the symptoms,

identical Our second study, ADVANCE-X positive to is with almost but differences. our pivotal key study two ADVANCE-X

trial First, XX-milligram ADVANCE-X. we're a dose, and pimavanserin of the dose dose optimal was the symptoms the ADVANCE-X from this evaluating was of schizophrenia further is therapeutic negative evaluation in learning the for clear and indeed

well it's the in in less well of by second, decades. responses have couple the that FDA schizophrenia industry understood past trials And our become as US placebo as reliable over

our our of in trial. ADVANCE-X this observed also We US sites

results occur that so is the mid-year the enrollment, ADVANCE-X And topline US XXXX. is need, we which outside exposures in ADVANCE-X being early in with have around close we should US. solely sites completing conducted now to

program psychosis. and Similar X-HTXA Please XX. on potential We to blocking X-HTXA. an this turn next-generation ACP-XXX pimavanserin. to ACP-XXX mechanism by treatment as molecule build a populations believe are on learnings provide disease Slide is lead pimavanserin, like to Alzheimer's seeking specifically from developing update ideally ACP-XXX, for our the elderly works with and primarily suited we're which to I'd our for

demonstrate tolerability and we elderly mentioned, Phase work in focused a the X completed on and Steve to evaluate exposure plan adults both studies, ACP-XXX for ACP-XXX. and and doses these In profile. we've safety favorable optimizing As we occupancy receptor in healthy have Phase our development. continues very volunteers, X to characterizing

into In days, faster days so half to than around steady pimavanserin, potentially translate addition, onset state we've confirmed this that compared ACP-XXX five could in action. with and time, XX reaches less roughly of the our

completed to-date minimizing QT the product of appears to work target Our profile support of our also risk prolongation.

are next the with FDA and steps clinical discuss the development Our for ACP-XXX. plan meet to future

financial Now, I'll for Mark turn update. it a over to

Mark Schneyer

Thank you, Doug.

Let's quarter the recorded In review of on first our first quarterly quarter, XX. up in performance net $XXX.X slide million the X% year. from sales, last we

net up across XX.X%. approximately demand gross patient quarter for driven was was increase both adjustment the to the new by an Our channels. X% Year-over-year in in growth starts quarter,

of million of volume an decrease X% which for $XX first declined upfront XXXX. increase decreased recorded we expenses to million in-channel QX in inventory related in-channel collaboration, R&D XXXX. Stoke approximately in a quarter from first in $XX.X As in as payment declined QX compared Steve XXXX XXXX. million to our in to in is year-over-year sell-in XXXX, the the The QX $XXX.X inventory quarter mentioned, of

million SG&A $XX.X slightly to from XXXX expenses in XXXX. QX increased million QX $XXX.X in

We two, This continue result DAYBUE. of commercial is and right to our base; to the expenses of successful a and making expect versus investments essentially be one, optimization execute SG&A a NUPLAZID flat the reduction of XXXX. for to expense launch XXXX

We cash to million, ended balance the $XXX.X XXXX. million of quarter of the at with end $XXX.X a compared

strong with ability and resources. existing our remained business sheet are balance Our current on confident our cash to we in execute our plan

XXXX, slide As gross-to-net, including you measures on expense see are and guidance ranges. we can reiterating sales, net XX, for all

turn to Steve to like closing over now for call I'd the remarks. And

Steve Davis

Thanks, four Mark. I'd across remarks today's focused our XX. on to end our prepared turn slide to Please priorities. execution like strategic

to the call. quarter net launched for our First, forward three recently earnings providing was DAYBUE on approved next only and metrics ago. weeks sales and first appropriate look DAYBUE We performance

forward share Second, franchise, look NUPLAZID. and to we profitability driving growth in our to PDP continuing of commercial

expected schizophrenia enrollment ADVANCE-X with XXXX. to our plan for topline Phase in negative of we mid-year complete in results the X Third, study symptoms early

plan we for to the finally, plan with development to FDA meet the soon And clinical discuss ACP-XXX.

employees accomplishments life. mission thank our As and to we like and for always, to commitment our as elevate ongoing I'd their passion continue their

Operator

Thank Our Cowen. comes will from line [Operator TD call session. this Baral you. question-and-answer conduct we Instructions] your a first Ritu is Ritu, At time, open. of

Ritu Baral

you the payer what those on Good Thanks guys. your I ask requirements seeing any open I for DAYBUE, for they give or restrictions patient are color unexpected will the X guess us are any afternoon, taking age, on discussions a question. requirements more focusing patient new you per specifically, just -- certain one, pre-authorization to patient on can it’s to pre-authorization label? population, Phase size, say are prescribing Thanks. or to

Steve Davis

for take much want Brendan, Ritu. question, you very to Thanks do the that?

Brendan Teehan

question. with our yes, we Sure. been ever They've got Ritu, the we And have engaging and thanks been very for encouraging label. final discussions good payers constructive since payers.

process I rare they've for would products. that disease following demonstrated the they're expected think that largely -- for rare disease have we

get necessity patients considered that according would or exception be and process, to medical a medical we a precisely letter them with plan. access expected early what going is working logistically of are to what is We through

in have can We happen seen short yet you of relatively policy do not -- a time, Those decisions. as period know. happen

working to we're in identified patients to Some XX days XX therapy up while range days XX more take period policy and take are get now, that take days, made. as can really in being can those But some of days days. on those XX to XXX first decisions interim will to put the

Ritu Baral

admission inclusion And versus to I the criteria? -- openness clinical is label sorry, to I'm reimburse, trial there guess,

Brendan Teehan

again Thanks Yes. question. for the

standalone way to thus enrollment different payers of seen -- breadth the to pleased we from And -- of forms the I that enrollment I early with of of the label all, of are think -- all the to each those the encouraged over we've trial provide say gain also from of and access are practices. working from gotten closely breadth through settings we're patients. we've I'll well the come forms to clinicians by that age to have us first patients types that We sites treatment of from very by, are clinical we've received guess, far, neurology patients youngest XX, the

We these early have not days. seen a meaningful in restriction

Ritu Baral

Thanks. helpful. Very

Operator

for a question. Please next standby

Our Charles, Cantor line open. the at Duncan comes next Charles Fitzgerald. your question of from is line

Charles Duncan

Difficulty] [Technical

Operator

low very you're Charles, sir.

Charles Duncan

Okay.

turn [Technical me Thanks. Let speaker. Difficulty] to the

Steve Davis

sorry. on ahead, We Yes, Charles, We Charles. please Yes, but can't our -- I'm end, hear we you. we out you talking, can't better. go can question. much make hear your

Charles Duncan

Okay, sorry that. about

call. in from the taking for Sorry

Rett the two has and diarrhea? will use that there help DAYBUE the on management well you. you for Thank been registry, to In as terms the of publications, of drive a how adoption upcoming with of pushback DAYBUE

Steve Davis

for let We've heard it you Charles. Thanks take I'll question, Yes. Brendan, the this much time. that.

Brendan Teehan

question. so for much Thanks Charles. Sure, the

real-world to to the profile being in So in clinicians We've privileged of to able proactively with do of that able communicate and position with do setting, the benefits families we've and DAYBUE. been tolerability as been we've the well. able been that

well say I been appropriate received. So the plan, with GI very management would it's

fact, would very that positive, the to clarity FDA fit put has In itself saw discontinuing we especially the label in label. that shows say on reference medicines anti-constipation I as the been feedback the can when the

And surround support and the we both guess the families that then type much with able that, to clinicians from Phase X beyond so learned we're they I program need. of

for managers, access we've We that have are sure the the and of of plans. best patients and specifically paired make to our expectations caregivers with them XX field-based family treatment set that HCPs the right

piece speak real-world or if know about evidence Doug to side. don't Kathie wanted I And the -- real-world

Steve Davis

that. want Yes. on comment you to Kathie,

Kathie Bishop

I'll chime Yes, I in something. you can and miss this, if Doug, take

launch. offering option the if to. their parallel to out as into and the it's In patient Rett want as we're Charles, a So choose study. can they the option real-world enroll that, evidence roll an Caregivers patients I on mentioned just call, we with

Just we mentioned as deal great learned conducting Brendan clinical trials. through a that the

study lot in are both real-world learn over clinicians is the business to in diarrhea would like We the terms placebo, you're confines this are things think to to used manage choose real-world, caregivers where additional in trial of a DAYBUE the easier launching long-term you maybe on about that. clinical outside how study the I how as be [Technical also well confined and which Difficulty] and do the to the information what and of

patients of for an study. really the sort job. who purpose It's that's So add-on commercial on of will optional go the

Charles Duncan

and for the Very congrats the recent Thanks good. taking progress. on question

Steve Davis

Charles. very much, Thanks

Operator

your for Please question. Thanks standby.

we the on bring question. next While stage our

Our next question Tessa, Morgan. your Tessa J.P. from comes is of Romero line open.

Tessa Romero

afternoon, team. and taking Thanks Good for questions. our Steve

as beyond Street revenues metrics the think metrics net areas key those launch? So Thanks And of will qualitatively, today, what how from of what to or key to much. are health we should of you kind about you you see sales DAYBUE, gouge cannot the so most us providing be valuable. provide the that buckets the if the

Steve Davis

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

Mark Schneyer

Yes, and thanks, Tess.

reasonable on you that but insight going the find progress provide launch. net we not and only only today is As we what just we be we revenue launch. on weeks commit the metrics and constructive to will it's time investment or this think we will specifically share mentioned, we're What metrics you to forward in give don't that And our sharing a next our call. just the next provide community to can call, even -- at will or set meaningful stage, three to into of at we share on will

Tessa Romero

Okay. Thank you.

Operator

you standby next question. Please for Thank very your much.

question comes Tazeen line of Our Ahmad America. your is open. Tazeen, next Bank at from

Tazeen Ahmad

you can guys, hear Hey me?

Steve Davis

Tazeen. can we yes, Yes,

Tazeen Ahmad

Steve. Hi, perfect. Okay,

ask Just about wanted to you ACP-XXX.

expect as expecting we X level should what of to exactly data, see the that? And data when see? far Thanks. Phase should be we As to

Steve Davis

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

Doug Williamson

Sure.

explored Phase plan we and evaluate and to the in and the characterize in basically doses optimize exposure use X, Phase receptor internally So we that data occupancy that to X.

of So Phase decisions plan important data, we and internal and the share going beyond it's the those X really don't that. details for X to for plan more Phase

a agreed So release on FDA plan the that after once issue meeting. press we've we'll release probably information and a more development with

Tazeen Ahmad

meeting a requested yet? you Have

Doug Williamson

have. We

Tazeen Ahmad

Okay, great. you. Thank

Operator

next Thank you Citi. your of for our much. is Neena, Neena from our question Standby comes next very open. Bitritto-Garg line question.

Neena Bitritto-Garg

for thanks guys, question. my Hey taking

just Can So just the to patients you mentioned about that on launch, paid process commercial over, expected of initiated trofinetide roll are the drug. or to you on the get of through have timeline the that haven't overall XX% And Thanks. extension of walk patients? expected is they initiated us the completion what now why open extra XX%, been that for rollover yet? label then

Steve Davis

do to take Brendan, want you that?

Brendan Teehan

And -- paid question. become Sure. patients. Neena, eligible we clarify, thanks process say of begun open-label would patients so I have XX% extension the much over just have to for the to over

their soon needed of reasonably we're investigators. talking to visits patients additional a ACADIA and So the engaged with process At of with course, pay adjudication of them point, with that with trial are completing as is and family the about help patients handful support their also possible. completion the that plans, we'll converting as end-of-study where insurance

how decide over. look And take pursuing to spend of we for that three take we All them proceed. benefits to on be expect eligible months. process bit patients two that, to And in those moving handful want then that all, of average of and that process, will for families in support will those where time XXX% just best of they're a some seeing with clinicians, the their sure of they're a I'm at still little

Neena Bitritto-Garg

Got it. That's helpful. Thank you.

Operator

question Thank for question. next our next you. Standby our

Marc SVB Our Mark, Securities. line you're comes Goodman of next the question at up. from

Rudy Li

talk Thanks the population? current are about Mark. is on for product expectations Thanks. peak for your This my for taking in a the the And line maybe Can Rudy question. PDP for this penetration NUPLAZID. current I you question penetration? of have what

Steve Davis

of you let first and that, the part Sure. second. take the Mark for Brendan,

Brendan Teehan

Sure.

our we of those our to the patient over in in and believe quarter. well that move -- overall populations. increased setting. question. starts of that So remarks in north. both increased continuing we community penetration also the the community-based starts care thanks the on we don't we share and setting, That on was new both where in know long-term first for we're our setting will But year-over-year in XX% provide the in And patient the that We ultimately, prepared new have reported do guidance be. necessarily we

started As care in in you community we long-term the know, after setting. we started

So the rapidly, a up we're entire business overall, over that across channels. growing kind still NUPLAZID space. of and share that XX% is growing is but more making And for both

want I add. if you know don't So to Mark,

Mark Schneyer

you I the of both parts covered question. Thanks. think And

Rudy Li

Very Thanks. helpful.

Operator

Thank you. Please by next stand for our question.

next question line RBC Renza Our Capital comes of from Gregory, Markets. line Gregory open. the your is at

Gregory Renza

afternoon, Good the approval. voucher me Steve, team, thanks. quick Great, and for you've the review a as Steve maybe one just on progress. DAYBUEs congrats of acknowledged the priority award on

Neuren, you update us on you external wondering value if far extracting harnessing your the as Clearly, there, the but either latest Thanks value I with or Just are accelerate have their own you parties. looking out and as could so much. sponsors Any shared FDA. there would there voucher color the of programs for to the thinking for before great. who be effort also

Steve Davis

remind of a can for little that bit with Yes. a the terms just Greg. start. question, the to with of that is we running I'll But I how us. of utilize in much take Thanks voucher rests that you value entirely Neuren. decision the share

share market use so we'll and or we we If it it, proceeds value established of an in them sell to share sell. for internal value these And of if determined we based things. from the whether And upon it, the haven't pay programs. it sell their there's Neuren their our use have we one pay then yet we

have determination These obviously, haven't ultimately the it things to of are we quite happy a whether determine or we but road. factor be it. valuable made it we're will really firm will that use So sell down yet, for programs one and our a

Gregory Renza

Got Thanks, Steve. it.

Operator

question. next standby for Please you. Thank our

Matteis your Our comes is open. from next line Paul line question Paul, Stifel. of the at

Unidentified Analyst

Hi, just this development guess, color James you're your you plans, I our move as you studies? on thinking for just one Thank to be running guess on expect guess question. to Maybe great. I be into studies right And clinical about pivotal about one, for on or subsequent clinical taking relapse two, is do I Paul. quick development a in plans any acute Thanks. studies? prevention able thinking are would ACP-XXX.

Steve Davis

Yes.

based enough the a the opportunity of space what. drug, We well. space is aggressively related well, closely So with That to know stated this the position to puts us earlier, which chemical as pimavanserin we've space know that where to the we we profile be we program. a in said, know move in upon the we have biochemical as

So quite greater as ready mentioned I'll simply we're X prepared looks go his in that the Doug like. we've describe to that much beyond not into a we'll exactly program with remarks, be what in in to to once position and FDA, met Phase say detail.

a in Doug as And product mentioned potentially action goal continues issues target as tolerated. having to onset profile is to than The the pimavanserin. drug well set therefore, and call, extremely this a No Phase of -- behaved, completed in we now X, clearly to on state Phase appears X steady well the our very get at point, we was very look this that safety faster that attractive.

profile we based some issues XXX with indications in upon with forward at plus no QT the a of of this seen design features our carrying that We've with appears lot we benefits or see that these blockers X-HTXA that And this be we set see to providing the ADVANCE goal. as point.

to point with next greater meet talk we that, So and FDA is detail. into go more the to we'll to step we're the can eager but about get the then

Operator

our Thank you Standby very much. question. next for

open. Jason Our is at line JMP. question from comes next Jason, your Butler

Jason Butler

the for thanks question. Hi, taking

dynamics. PDP the Just one market on

space context where today couple growth bit you quarters for office stand? of think setting, of you more a patient now early just starts. that would or seeing in pre-pandemic us little the there said versus signs normalized level a you're where You've in new think of a give future Thanks. Can we you stand maybe

Steve Davis

take much to very Jason. for that? thanks question, want do Yes, you the Brendan,

Brendan Teehan

in-person if at of PD the if relatively still for visits patient look think is setting consistent question. Thanks say, community a flat in in-office dynamic this we see we're point. Sure. market And context to, of at terms carbidopa-levodopa. -- market We I'll in a I fewer it we use see in that is there yes, and the mid-pandemic, that

essentially growth X% So year-over-year.

we're atypical exists additions think, stated in differentiate discussion we've data focused from the clinical this NUPLAZID calls, of antipsychotics have evidence previous that important As on to, other been sets terms to the help Those real-world outcomes. I whole data three category. us on of

And they've in long-term audiences, very both I the received and by well in think setting. our community care been the

encouraged otherwise us, starts is starts to had new NUPLAZID is for to of increase of pandemic where describe market market. best increase early a what a part in down, contracted market. ‘XX. to the a little share the that able new in and PD and in patient with starts this, along sluggish results new think, for from been the the So midpoint has me, slowed We're for on patient That, encouraging that I see bit way we're the

Jason Butler

Thank you.

Operator

much. very Thanks

question Next standby we as queue it up.

Hung comes Morgan is Jeff Jason your line question next from open. Stanley. of Our

Jeff Hung

versus Hi, pipeline, you Jeff. updated flow thanks M&A? your How business taking talk say, cash for is mid- thoughts to Can is it important positive question. you with further late-stage to This development? be expanding my about to your on Thanks.

Steve Davis

question. for the Yes. Thanks much

important very previously, of So business be our business. part development a continues as stated we've to

leverage neurology and disease to established to an do now franchise and and we have an have in rare franchises in opportunity capabilities, continue applications, psychiatry, broad We both that. and established those we'll

continue and But do company top an much that also continue than development, prepared we're And became franchise future time answer with throwing and as the as heard Mark we're be environment to an prioritization we'll franchise it both. for more particularly in say question terms the profitable you've year in his recent of any very have every going to that XXXX. as -- to profitability going us is of example, in become priority. The remarks We're the investments and build mentioned business that in we today before, executing cash has been continue a is off as the to profitable then, judicious more since continuing will versus PDP in about in making. began on is history. attractive It's the to

both well fronts. discretion exercising investment as forward, continue So move on as we see to you'll opportunities us as

Jeff Hung

you. thank Great,

Operator

you our question. much. for very Standby next Thank

is Our your Goldman next from Sachs. comes question Salveen, open. line Richter Salveen at

Unidentified Analyst

is for keen Hey, where just on docs using Salveen. more This a DAYBUE. group on there Matt thanks We were specific guys. patient is are interested,

with ones. doctors late-stage patients to a in early-stage of the preference checks our use Some versus suggested stable drug

was So you a to seeing. that most And could lot. see you the what then if I with you're Thanks share the in presentations. what wanted line as takeaways from just important view

Steve Davis

sorry, we part I'm Yes. question. the the hear of didn't second

Unidentified Analyst

view the from important you what your AAN Just takeaways as presentation. most

Steve Davis

it. Got

want you take do Brendan, question? Okay. to this

Brendan Teehan

means that keen go label, we're what that seen of and see improvements, this forms enrollment are with the the interest that Matt, audience a the say, disease or encouraged think, opportunity have to look what of question. I broad to domains Obviously, individual show patients individual back think help clinicians with three of patients saw you to we've it's Sure. and in their And patient for prepared to age and improve an would we've to breadth very I been address. look of watching seeing. in of been study, caregivers to regardless I'd we're that remarks, our the going both that there's RSBQ, we at LAVENDER thanks by populations severity weeks the demonstrated and which the indicative, however, across situation. eight

type, said, in that a encouraged XX. We've considered the well I of particular that very I've severity but seen of as are we're for terms patient above being there's and age wish disease seen point patients. as across So and female you broad are that could two spectrum. young patients a patients range DAYBUE I both as male We've to

the can to looking early to that maybe intervene in others as a as patient end population. and with the patients scale clinicians of they Some younger sicker looking are on start

it's So we're not very, very of in still in a subset, the see. early seeing feedback days particular a of But Rett patients. that for interest example, clinicians, from we've gotten to terms

you And talk Kathie, can about AAN?

Kathie Bishop

AAN. can I about talk

data LAVENDER So point. from especially on with communication communication, from on on observed study our Phase X data. end was nonverbal view additional our we the the main clinical side, clinical had presentations benefits the One X trial

gaze to talked eye syndrome ability what speak disease we key to Most and would patients of with the like like Rett even really non-verbally and that about, lose one out communication want. cannot is As the parents of with or see things previously communicate caregivers improvement. aspects pointing the they

a compared to of X both communication indicate had Difficulty] secondary communication, asking an key with endpoint to [Technical surrogate actually non-verbal endpoints functional these saw placebo. LAVENDER we then them CSBS in included task trial, for benefit a assess DAYBUE in to the the we So nonverbal and a for we Phase as additional preferences communication. non-verbal And

at together presentation we we're have publication AAN a on focused actually that, that data. on the putting will So

safety study, in saw clinical with year to the And discontinuation Phase over girls very now. diarrhea AAN we've patient second is outcomes the new only been open-label was data, tolerability who've rate year. to no that X due compared DAYBUE younger one [Indiscernible] in aged for over we two to a even a safety all with that, The a for four study. on profile lower or consistent tolerability at the And discontinuing the presentation which had

what endpoints addition, we hints to in steady there's efficacy ability, of period regression that initial they exploratory a on we lose and included they outcomes harder variability some of study as DAYBUE. efficacy. are And younger is in but because in where looking individual then improvement at are lot very as seeing some a variable, girls efficacy far are of The

of these outcomes that couple and In burden presentations addition to these those have showing on patients two, syndrome the we disease economics families. in of did other causes just a Rett health

Unidentified Analyst

Got a it. Thanks lot.

Operator

our for Please question. Thank standby next you, Matt.

question Suneja Our comes open. next your of from Yatin, line Yatin is Guggenheim.

Yatin Suneja

With the question. you regard should to of real we one. Thank Two duration That's DAYBUE, on you quick for could how comment my ones. therapy? model taking

on NUPLAZID. The second one

look Past quarter. key the quarter stronger let's years or second couple year how a is this last and versus, -- are past the generally any changes Or last quarter there say, to should the Second of like? Thanks. year? predict we at is look going

Steve Davis

the you take do one. question first Mark, second want Brendan, the and Yes. to

Brendan Teehan

on be I'll for I persistency, to because estimates going Sure, providing your really thinking. range, We're as what internal much to but and we're a much so not as question. color is, Yatin. give as can Thank you this of concept course, of there duration

as an And to as LAVENDER. X a Phase and known function awful said, learned what First we we've study, the from we foremost, expect. of lot that,

the of support calls where You've systems been heard about extensions benefit long-term in stands the and and obviously, the talked that's to for of open from in couple done work see we've in hopefully we in label all beyond. the we've And the that want to put families additional work been place. last nothing more than patients offer done LAVENDER, the that's DAYBUE

those to there -- that of to the believe setting we're things to be So that can a are in outcomes. couple real-world we get lead us supportive

But discontinuation first, treatment us important. outset. pleased very clinician allows were with we very That's up and from the medications label It both anti-constipation to with to The of label. expectation the the sets speak right obviously family.

have is we DAYBUE. set to into family we then treatment second hands patients folks manager appropriate caregivers. the The journey, of I Both the be move for in hold patient support with well each we audiences that educational And HCP families been work that the treatment the are the to on efforts and for and to of which this the so parents family up could with audience they outset expectations field access on with the proactively and positioned able with management. discuss beginning GI their from these said, both team, as them those those

the for we benefit patient we're So for the to early sets And in the us, experiences, to of believe up DAYBUE. the get long-term best days, feedback again, very while looking all that we've treatment positive journey. more that gotten both begin having the very on for and stay setting them importantly, been appropriate families support has necessary but the course, from to and clinicians about

Steve Davis

take to seasonality? Mark, NUPLAZID do you want

Mark Schneyer

for question. thanks the No, Yes.

don't but will be which color, me additional I some share just guidance, we know, provide think you quarterly let helpful. As

I this go QX. process just later for to process all patients year. as be think tends seasonality in reauthorization that they move in as patients quarter, -- happens as discussed on patients Medicare as on for we for the patients the some on we there new that It's through just happens

to tends forward positive QX. So more QX going that have you'll be dynamic through

process for the the to and will quarter due again to primarily fourth our and net that have of quarter, in Inflation be lower also We higher the for little reauthorization in the year, the a in that you, Reduction do you've patients. gross the seen have quarter, first the all with impact second just I'd remind years. third obligation in of we this past quarter Act. kind typical seasonality higher the That

basis So just our annual will quarterly consistent guidance. year-over-year overall on our a gross net and be higher with

we obviously, And we'll just results through. then quarters, as far seasonality as between as report go

impacted the impact a volumes, so of sales our throughout the results obviously by on year quarterly volumes, how are the rest volumes revenues Our patient will patient basis. of

Yatin Suneja

Thank you.

Operator

now everyone. remarks. This turn today. all closing Thank to we Davis, is the you, over Steve CEO, for it time have I'll for

Steve Davis

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

Operator

conference participation the your presentation. today's This Thank concludes you for call. in

now You Good day. may disconnect.

ACADIA Pharmaceuticals (ACAD) 8 May 232023 Q1 Earnings call transcript