- Earnings call transcript Q3 2022

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Operator

Good day, ladies and gentlemen, and welcome to ACADIA Pharmaceuticals Third Quarter 2022 Financial Results Conference Call. My name is Gigi, and I will be your coordinator for today. [Operator Instructions]. I would now like to turn the presentation over to Mark Johnson, Vice President of Investor Relations at ACADIA. Please proceed.

Mark Johnson

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

Stankovic, Dr. on our Officer, would Schneider, third Brendan and quarter from today and a Srdjan our slides, Chief opening will the our results Stephen performance section an also me commercial it and business; using of progress, President, provide that Operating are point Bishop, tripinetide; which our final our of discuss our the our Events who Kathy supplement Chief Commercial, we're Steve Head out discuss our will overview and and our will Financial pipeline Executive Head call to Teehan, remarks ACADIA up and I an Chief to before turning of overview will then provide review back Scientific Davis, Officer performance; on our Officer, financial of guidance Officer, updates of questions. like Joining are the call available provide on Presentations our Chief Mark will website. for for your of

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

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

Stephen Davis

Thank you, Please you to for Mark. everyone, Slide us and thank joining Good afternoon, today. turn X.

achieve strategic investing investment in and investing the Parkinson's our we our With R&D syndrome highest efficiently we PEP, for for last As . ROI long-term mission, to ourselves that business Rett in resources to optimize and positioning value launch success our quarter NUPLAZID we're preparing trefinipat development. disease to psychosis, presented for drive the focused on of and franchise. activities are internal through maximize the the brand demand commercial

of leverage new And for rare our our future most the positive I growth schizophrenia investing CNS investing to we opportunities negative In and we're The XXX continue without a We're increasingly development attractive Rett trufinitat potential program program. of us syndrome, in addition, our to of invest disease. finally, an late treatment business and for pipeline our product. early-stage III need allows launch additional symptoms and franchise in our Phase capital. ourselves to clinical ACP set raise for from second flow cash to Phase opportunity commercial of candidates, our position successful the notably in

X. Slide to turn Let's

increase increase of by $XXX.X is in incremental net the LTC channel. to to of to driven show admissions. the growth of achieved like by were by offset seen we've an prescription steady an rates, demand This increase channel Revenues $X long-term in highlight for new million is related NUPLAZID This current in quarter, of NUPLAZID. improvement. in early in reduction an as starting third segment this driven sales. in inventory items supported but sequential signs LTC care Recently, landscape by occupancy an I'd by X% a the the For growth net in-channel a of impacting million. approximately growth was acceleration and sales couple

psychosis of is admission new potential diagnosis with NUPLAZID. potential and As a Brendan will elaborate, critical treatment a for time

Our to in-person compared unchanged visits pre-pandemic with still doctors as and levels. is fewer to in-office channel by continues patient their be impacted

yet Here, of as observed level we have channel. the incremental in same not improvements the you LTC have

evaluate continue which, business, as to XXXX. our optimize the ways execute look on and has since we and cash maximize to we best As a forward, been positive will PDP reminder, flow

use other the of when favorable confidence the relative constrained use share in Let the couple run. important medicines ability together in baskets the and our patients. total two, of safety dynamics. environment, One, maximize to ability studies of and PDP NUPLAZID me highlight publications a of new of brand since our on us long and real-world scripts neurology highlight LTC Parkinson's, the presentations to to profile in top increase our NUPLAZID antipsychotics, the a the in beginning outperformance give recent dependent to with pricing and of comparing And on the expand for compared

sets We will to community. dissemination these treating the the within continue of important support data

review Let's FDA's review move in We're trofinetide syndrome. We new for in in application on to the our facilitating preparations, parallel the late-stage our of Slide announced programs the that in while on XXXX. only drug the of a X. Rett priority prelaunch treatment Red for FDA-approved If first action XX, granted quarter and FDA date Refinitad PDUFA our approved syndrome. assigned and NDA filing March for will be

voucher. In a we expect party would to addition, pediatric receive review

state broader including is disease preparing team care commercial on team diligently launch, market identification. consumer working education, development, and Our profiling for

negative treatment U.S. impactful therapy in previously FDA-approved of advances our and Today, have schizophrenia as XXX,XXX in And the of to still Phase treatment patients receiving the we negative that described, around with are antipsychotic schizophrenia next estimate enrollment these we III study for no over Next, persistent of symptoms. there complete is symptoms. negative we who drug middle there expect year. symptoms the

advancement not size NUPLAZID where compete about be is therapy drugs. is If Xx in the first-line that the this approved, would approved. as against PDP adjunct context, need market or an replace indicated of to For generic would

Let's programs. to stage our now turn discuss Slide X to early

are pimavanserin, aboard and years in worldwide I last obligation on to rights developed X shares sweet party. and economic to few important similarities explore the to is some the new important mentioned improvement. and any leverage third the a also risks designed no It development. we been Phase is opportunities ACP the XXX with and As for currently from we've for maintains designed XXX which development internally ACADIA ACP to potential past for quarter, working pimavanserin learnings molecule, provides reduced spot. hit ACP nice

business our while In will pipeline programs, including and addition, Brendan. across commercial in excited it turn broad invest leveraging and and our detail. And greater R&D we development, areas. commercial in to to rare internal now remain efforts disease in and both investing our psychiatry other our we and To I'll about discuss neurology expertise develop with early-stage collaboration over our Therapeutics. evaluating in continue

Brendan Teehan

Please Slide you, XX. Thank Steve. to turn

Our demand a commercial high level quarter-over-quarter. NUPLAZID team continues and delivered to for perform at growth

of demonstrated achieved long-term $XXX.X channel. quarter driven This net demand in XXXX, by As care Steve for mentioned, particular was million sequential demand growth the sales. with the acceleration NUPLAZID in of third X%

LTC. Let's start with

is as LTC. remain admissions been diagnosis to the the growth facilities were the sustained in quarter key of improving new a highest in for time we pandemic. rates with the the selection from have growth XXXX. in improvement increased on newly in LTC Slide that channel experienced pandemic, occupancy admissions. patients new bottom rates Recall resident early treat of shown is As The an More where psychosis significantly prepandemic. our data help occurs modestly, NUPLAZID's This was environment today this are focus admissions, things declines the in the our number the symptoms in critical and suppressed target significant occupancy this one sources growth you of recent period NUPLAZID. graph coupled XX, first residents, PD This segment. on since note over teams the proprietary specifically, of they to of rise the will best delivered which important that to And the market while new of the contributor with PDP opportunities enable in diagnosed us the of have

you see, NUPLAZID's improvements. has this these LTC As growth growth, of outperformed in environment rate can modest occupancy

this are had strongest In the some we've prescription of fact, ever growth delivering we in segment.

a patient This the a pandemic, time symptoms a rate, by prescription psychosis still albeit with of in NUPLAZID. while of for at in physicians. has the for at visits our share market is the office a space we're critical grown of improvements Looking diagnosis channel, slower the in-office meaningful their over lack constrained

our the safety ahead, evaluated These data sharing treatment now of is team real-world Looking from NUPLAZID the studies and payers. studies PDP in physicians off-label with with antipsychotics. versus population

atypical channel, the recently hospitalization, the in antipsychotics. and starting started example, study pimavanserin the share nursing psych-related and of retrospective payers database, Medicare the off-label all-cause lower a fewer presented For visits treatment concluded versus claims of of middle lower facilities emergency PDP resulted to and some third in psych-related quarter, stays in all-cause which with room the LTC we

of for compared profile facilities. fewer important residents decisions In facing PD in psychosis to with pimavanserin addition safety hospitals highlights antipsychotics to understand had clinicians are More on data in These patients physicians starting stays publication with the been to recent we've the fourth symptoms in first-line NUPLAZID early making for in quarter, patients treatment recently, that sharing and when shorter stays, treatment PDP. the a off-label setting. and

as the bottom the our highest enables the invest, focused franchise, thoughtfully on in to which activities. well mindful the line normalization portfolio. gradual ROI top for invest line the continue investments will growth growth PDP as optimizing We trofinetide opportunity and our of of both to on PDP newest We're NUPLAZID market, R&D us

turn to XX. now for strategy trofinetide activities on our Let's Slide prelaunch and

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customer-facing preparing with additionally launch are organization. our rare our disease by commercial team augmenting We for

IRSF-designated substantial Excellence, Today, of disease of United in elements rare patients while our and States team We approximately breadth leveraging diagnosed neurology expertise, existing treated franchise. in and X,XXX of we the for building and are with non-COE institutions targeted at cared leadership seasoned practices. made progress know academic other are there have depth and neurology our the Rett Centers

universe mapping database. are our target patient We HCP already and

So force launch target our our beyond. will field and at know treating audience to where best

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within syndrome Rett support I'd we was across Rett United proud were States activities awareness the educational the month, and to Finally, like community. that and to mention October disease awareness

need, and as ultimate for syndrome access all on turn continue trofinetide establish Rett that our goal. and launch the be to will to our foundational it I'll Our in well now to over achieving on to ensure to treatment discussion patients Kathy objective trofinetide. we're way

Kathie Bishop

XX. Slide Please to Thank turn you, Brendan.

for treated. disorder with have are there currently there treatment. we approximately know, and debilitating a X,XXX which States and you patients being estimate there and syndrome the are Rett data serious United X,XXX Rett syndrome, As indicating We in rare is is patients and no FDA-approved diagnosed X,XXX between

to Child hit Neurology includes for end Rett the mentioned, community, for continue both important congresses As including secondary the III Academy American trofinetide Brendan recent briefly Pediatric results, we and co-primary the present or our at data key Society we at Phase IV clinical point. and positive where meeting. This endpoints and FEI medical

data We also from younger X syndrome X. presented interim DasADiL girls in our study aged Rett to

results trofinetide. in III recall additional the to of of you submitted across As may NDA LIDAR consistent age from group severity been Phase disease. we and the data FDA These our study, for observed support have

the events community trofinetide both with we are these approval. feedback positive as pleased potential a caregivers from addition, we and In we receiving the and at enthusiasm approach the medical are

quarter, priority review. granted filing FDA the application During our us accepted and the for

Our they planning to XX, advisory meeting. on hold XXXX. PDUFA an an continues Srdjan programs. for I'll other our over indicate not And And committee turn FDA update are it to March pipeline date the is action to that now

Srdjan Stankovic

Good everyone. Kathie. Thank afternoon, you,

Slide second social to still in potential burden. can these starting of functioning, today, largest the significant of pimavanserin, remain one for approved schizophrenia negative on our symptoms long-term treatments are there move Persistent of for needs which as and low XX. Let's unmet indication And symptoms disability lead to caregiver no CMS. on

predominant positive treatment . symptoms. but on gap. available We close those experience We are can to symptoms continue evaluating help controlled effective that pimavanserin adjunctive patients believe to this an negative for on be pimavanserin are whose as currently

placebo. the development III Advance on our probability track patients study, of positive milligrams even on completion XX of separation we part to compared pivotal Phase next around of pimavanserin X, X, of enrollment one for the of in the endpoint overall As optimized To Advance program, We success dose robust dosing pimavanserin maximize only the to have XX-milligram statistical we doses. our using ongoing have results the study and compared middle we where primary receiving more the observed lower remain in year.

X-month keeping on this our duration. updated forward We a study As reminder, is look you progress. to a

on program the is new let's Now ACP-XXX leverage is XX. from to discuss which our XXX ACP Slide molecule, learnings designed a pimavanserin.

serotonergic today investigating and build other are on of we a upon our work thought on franchise favorable pimavanserin Pimavanserin DX market predominantly For blocking profile. system. to through all dopamine, work have antipsychotics serotonin, and molecules particular, several to years, focused tolerability sought in can safety the developing through by the the dopamine receptor. Remember, virtually different and is provide entirely and start which the very to

a mechanism, and ACP clinical the of with high have Of in development, go especially with in molecules, course, we and XXX, have rates. are we chemical not early small to But a known attrition go to space. good working where understanding where

risk our to is some So extent. profile mitigated

the the risk prolongation. potential opportunity XXX, efficacy we have while Specifically, to of maximize an ACP with may reducing

We Phase in I are currently development.

preclinical range may covering the lot a finalize data I disease support there dose to vitro studies. Phase on of financials. With Mark range indications our that, plan our have to call to this allow advanced additional potential top date to to being will III also We in data. the the II to higher vivo order psychosis based and list. of In and are in and to respect to Alzheimer with discuss in over doses complete exposure. I evaluate, Clinical in evaluated turn be that work opportunities targeted additional at Phase exploration I targeted Phase the We dose of studies

Mark Schneyer

Thank you, Srdjan.

the Slide driven in reviewing In XX. quarterly recorded million we sales, quarter, X% the third net $XXX.X by performance financial growth on in by demand our sequential second start Let's quarter.

reduction While to of million. the within historical sales approximately during levels a quarter inventory be our we impacted which averages, continue inventory net in-channel did experience by $X

a gross the will last these XXXB in is for to compared moment. Our due our to primarily of primarily due quarter were million, of third GAAP gross XXXX, which compared were to commercial are On million in upfront X gross an supply expenses XX.X% X% expenses net to SG&A approximately quarter balance a $XX.X the with and expenses prior as the the more to million Reduction in cost speak last million end at a acceptance of was to with $XX.X in-channel year. expenses PDP quarter last adjustment of the we third Increase increase milestone R&D in $XXX.X up approximately and primarily million and the associated commercial the to year-to-date essentially NDA quarter the the expenses on to down of to classified inventory the trepinatide our the increased in ended inflation from a due million million GAAP milestone XXXX, $XX.X of -- million unchanged to $XX filing than to continue balance rebates the optimize increased And in as in spend. to to of which quarter R&D The I tripinotide QX cash supply to million to account sales the quarter build. during tripenitide two, cost the adjustment $XX and higher year. X% were approval. commercial from decreased $XX R&D $XXX.X cash million SG&A finally, to the we million, comparison one, quarter. factors: collaboration, higher net a increased $XX net for $XX.X for accrued payment $X XXXX. volumes; in net increase of XX.X% to Act third of

generate of subject and in the existing with strong, balance to size scope continue and cash business develop. future our be to sheet sustainable our growth remains to confident we ability Our resources

Before I update Reduction Inflation an on address Slide Act passed let's the on give XX. newly guidance,

the focused that XX% approximately a unitize population payer a Medicare patients. reminder, mix than XX%. is on Medicare whereas has includes As mix IRA and Medicare have payer a expect less to to NUPLAZID beneficiaries we

did of inflation-adjusted impact while in Part of the takes financial overall several a various pricing our phasing. are we as ACADIA have D summer, NUPLAZID, potential the the the to assessed we in on from We small have remainder as legislation, from puts to aspects year-to-year, Medicare Reduction redesign, Act impact all, in recent implement completed and XXXX. implications the initiated including relatively manufacturer modest the All August of mechanism of price be on late inclusive pricing an Earlier well the for Inflation action on the process increase decade. X.X% August. expect which there most the we

approximate As net be our went rebate, net the pricing a IRA, price August additional realize The updated against change be between the X, XXXX, pricing X% result of investment. accounted inflation-adjusted from of as this which will our an price will end to October will action. will Medicare through it which the difference price of which we nominal during this third from last reassessed for in the pricing will effect result an an XXXX. and action approximately net of to after time, latest X% increase X% quarter benefit The gross as into benefit a net

our move XX. on on Slide financial to Let's guidance

for million that assumes midpoint Regarding have of continue the of million. similar guidance XXXX. of remainder for to we a for this NUPLAZID the $XXX net for $XXX The we now year, range sales guiding demand range are to

and addition, inflation this reduction. impact reflects of the In quarter XXXX inventory drawdown we it the experienced the

XX% the XX% with account a XXXX to Medicare Reduction guidance gross our year associated to additional increased Act. have Inflation fiscal to to for for We of range net rebates

expense our addition, remain to In unchanged. the midpoint tightening ranges, but we are

the million. for Steve turn remarks. bottom our cash also year-end now to raising $XX like over I'd the expected are tightening call the balance We And range by of to closing

Stephen Davis

the we PDP on Thanks growth our of much, deliver patients with are Great. Mark. focus and Slide Today, NUPLAZID franchise. promise long-term Please on with a so turn XX. the to to to maximizing value executing

developing program In sustainable well the our of addition, line a and while for long-term top strong and commercial business launch, our additional to Phase programs, symptoms With positioned and value. III opportunities. are ACP-XXX, a We're we several product negative focus attractive advancing second create growth, on are including pursuing preparing we Vinita. balance bottom for development and schizophrenia sheet which

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

Adora we our regulatory skill to moving Srdjan, significant as you our a mention expand set executive board its to asset ACADIA Dr. clinical disease is nicely our biopharma and real finally, And as Indo in those year. Before Directors. current announcement commercialize I'd be the experience. like have retiring has appointed Adora that Q&A, Combined rare to complements extensive membership recently Board end and background last be for our of seen with and a at of further us will will our pipeline. the of a week, President, to may with in

stage Over been as X and disease. you for commercial and and proven the been to biopharmaceutical ACADIA, today, great a Srdjan, a have and capabilities community, will him Personally, it great CNS has their pleasure families. distinguished hope in with ACADIA we most patients in work exciting alongside thanking years, into me importantly, of an and a what to the company fundamentally rare partner service portfolio late to programs early-stage scientific and join past transformed is Srdjan his I it's

experience. to open now his forward, vast advisory and I'll transition insights call the Going benefit will Srdjan for team role questions. from and to an up Operator? will continue

Operator

[Operator Instructions].

from line from Duncan first question Fitzgerald. Our the Cantor comes of Charles

Charles Duncan

do PRV you date, the anticipate be done? think that? been And but particularly be I this one to limit multipart package? may the are then trofinetide. And have or Or or anticipate not able finally, detail, yet with to manufacturing question was regard answer I'll before that you was I'm now, it NUPLAZID, submitted from and wondering they guess my inspections a to that the package? you the all secondarily, right monetizing question on submitted I internally Appreciate Kathie submitted. Was with using Or on would Rett that to submitted but was pimavanserin done? data then after additional with and mentioned the or it PDUFA

Stephen Davis

Thanks Charles. so much,

me with what Let the middle the the do say it's the us third to would Kathie then pediatric with review and first respond third, and we question. ask just voucher. Actually, just to for take to one, one the I'll starting premature

I think regarding your in terms of question inspections. the manufacturing

we've say our the not just the on period. and back we're to policy during interactions a though said get will and eager appears to from all What As previously, to is date. track I is day-to-day comment review or forth indicators PDUFA on have, exactly review that be to we

Kathie Bishop

study just the submitted I'll the was as second Charles, original And extension as part the girls clarify well That from NDA filing. -- regarding your long-term data the interim data X. for aged to X the younger interim of as question from studies the NDA in

Operator

question next the line comes Bitritto-Garg from Our of from Neena Citi.

Neena Bitritto-Garg

it's And what sales I think back care now long-term XX% but still will NUPLAZID. about all? going do up know lagging? you I rates just if on the changed visits channel into comment . ask said the And you proportion and at think coming in-office then historically, in-office from of patients in LTC, get are the if coming take to are want about it admission channel. can you been you've to that's why

Stephen Davis

you do Brendan, question. the for much to that? address want Thanks

Brendan Teehan

seen for signs that's gradually When and residents are say of increased driven important is have showing we've to encouraged an indication increase that last in-office thanks seeing I new there's new up, over growth we're a the had the element several Sure. quarters. clinical quarter-over-quarter, takes I prescription contrast early And channel. an Hi, place, a most of in improvement. us, a by occupancy up. that question. long-term in what that it care the the of that And by rates But should on market an that and the that sense for that shows We is gives the think of that's in important of think for I'm in outpacing evaluation are us the NUPLAZID's pandemic. a a channel. resident advantage. really -- Parkinson's The patients that's in with XX difference the beginning working which rate NUPLAZID channel of the identification there We've It's of proposition is a also is for neuro PD NUPLAZID. space. symptoms in-office decline a carbidopa-levodopa. great top quarter-over-quarter in-office that start dynamic time was LTC clinical to visits the the growth the both ideal disease outpacing chance our the that XX the the and brands top number psychosis at brands

we've I think encouraging seen is is that stabilize. what that

for So are to -- levels on to disease, secondarily, continue decline. to compete rate level, patients more readily it's return first-line and continued begin we to marketplace, a would it expect but going use. -- lower hasn't lower One, it's we at encouraged for a at Parkinson's X to to I'm is there. the there an incidence fully office. And in this

previously. prepared As remarks, clinicians evidence differentiates NUPLAZID we to have off-label that think atypical my other that further don't antipsychotics available us the we in a in mentioned that way with seen real-world I from have

LTC of our setting. And share I you'll overall confirm yes, in about and sorry, that see So focus first-line still of our more that XX% also for I'm looking can is use gain NUPLAZID is bottlenecks. on roughly

Operator

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

Ritu Baral

you review cycle with request just things what had on given but division, information on meetings guess, next-to-last different to track neuropsych And you Srdjan, has the with comment than for from like different and XX now past. with and for the next happened or speaking for you wishing this review compare in DRP, from had during this review I you that stage. color give pretty comfort Steve, period. interactions no just the know guess, of the And with that that level but any contrast some us and agency, great to with years working the all the you in best been that want day-to-day XX I and is side. where come any -- is almost passed may investors the the question It's you guys is original something years have differently Steve. or your I you DRP that guess I mid-cycle won't much that us just cycle can communications going show I'm

Stephen Davis

for thanks the No, Yes. Yes. question.

things And One an X much it can can think X of I and I I can point things is an give is was -- NDA. sNDA. I'll color with course, as DRP/ADP, out. I this as

don't just And so much with sNDA, the structured milestones. you as have

And it's looser. little a so bit

an earlier, And in through have can all, the is appears milestones. do that And from see, given process it we NDA you of because is track. advantage, structured so FDA course, the -- I more on right mentioned as going comparison we and

thing because is mention much don't many application. sNDA communication And we you second the and have The have you also don't much milestones, as with sometimes didn't just review have very within during that structured cycle. I'll dialogue

the review. We communication, continued we've have and have significantly a very more had to of with we appropriate had but appropriate productive the last than dialogue it's level the throughout application,

Ritu Baral

That's Got very in. helpful. I'm squeak one it. going to last question

announce you XXX some for For may Srdjan, XXX. might mentioned when those -- update for of when X formally announced give you additional and us additional sort on start? timing you Can indications these

Srdjan Stankovic

Ritu. you, Thank Yes.

and my just you I broader with to equally it thank your group. pleasure words. this want And work to you say was work First, for it's that kind to

thought-provoking and pleasure You great the thoughtful you guys of progress a periodically it's been very a on always -- our program. have and questions update really to

in part future the as a that -- among for period. premature indications. In talk HCP-XXX, miss it's little to us regard will bit to many a the about that's I slowdown will things I So

news the I. of imagine, As little Very The there the a to an complete look that to potential based work completed, for I already bit is preclinical a disease for our list work said, is there is exposure, our us opportunity based in you Alzheimer's on data than number psychosis can indications. targeted. to we us we as is that good high and Phase the -- target is higher assigned ranges of there on a we on doses

the always And great define neuropsychiatric in as range. to a it's that's So broader know, good indications, a news. you

We yet tolerated defined not have dose. minimum

complete potential to more of a And we to bit that opportunity for a great we discuss open work. expand that, will time development we to that are it's when about. take and range, would So indications and the to that, complete us like plan we little following thinking that more

Operator

question the from America of Merrill next Tazeen line Ahmad from of Our Bank comes Lynch.

Unidentified Analyst

a different terms opportunity play XXX just and also Daniel just landscape is ADP. what MX thinking on and We into MX for question moving Tazeen. the you're maybe indication. quick how the about We're any competitive in comments space. might for And line with the on that mechanisms This wondering of action that on had the into on of

Stephen Davis

much for Thanks the Yes. question.

you so Parkinson's use better disease and to kind patients elderly drugs between -- alternatives lot distinction a profile you so for have a we very medical They're psychosis an to like Alzheimer's burden, . draw What to schizophrenia these psychosis They psychosis because is And yet. antipsychotic have the psychosis. Alzheimer's side ad schizophrenia for -- frail are like baggage. an approved reasons or or those I'd for disease to And to -- psychosis. disease of drug of in used drugs of significant. drug we that When population have, drug have elderly treat, think in disease much need X obviously, to populations a deal that patients more treat or don't antipsychotic and -- dementia-related suboptimal that drugs. that with and the patients, works. I or Parkinson's in not that's high more effect matter, antiseptics drugs is get but have treat and they're those

to have extremely a Because well a is the a and but it higher. have is effect, that need important lot tolerability safe just very for bar You tolerated. issues very, is equally drug strong antipsychotic to

with emerges a how opportunity pro in I It's very I'm profile and thing a and implication We'll those excited and working And very drugs about the assess very well how have areas antipsychotic and more we it there's in see they'll of the muscarinic so positioned typically to that the we're with -- in schizophrenia. we're know where different very some is to I'm hopeful I evolves will that on this exciting going mechanism kinds antipsychotics. is of lead area profile well work to serotonin we elderly pimavanserin the is the improved think of drugs what in One think XXX And working about have profile that populations. tolerated. through the than we be see the area. by the that greatest today.

element be to anything like else the think as will safety and I tolerability. but again, contribute. there key So also not only efficacy I'll you'd Serge And ask

Srdjan Stankovic

on are add of and bit use quite our in as competitive development our HCPXXX. through second is this population. we with one I and And experience of element, patient moving to experience Steve to trials that we would mechanism this other intend everything Yes. the that side, a we knowledge advantage have, just and designing I said.

Operator

Hung from question comes line next the Stanley. Jeff of Morgan from Our

Jeff Hung

my something congratulations expect again in-channel should drove just XQ? on I your go that appreciate to upcoming you reduction sir, might Can prior Or the you happen inventory? is talk in provide? can of retirement. this levels? about too what inventory the we back And to color And any

Stephen Davis

to Jeff. Yes. want Mark, Thanks, that? take question, Mitch, do you for the

Mark Schneyer

the Sure. Thanks for question.

As factors to I we a overall of speak inventory reduction think there channel levels. in in the number partners, influenced are our

due First, therefore in the in cost inventory And decisions. stable has needs Medicare-related price NUPLAZID moderate the capital future interest more of kind this predictable of become recent as purchase influence also of timing and with pressures. for growth The drugs, volumes to their remain for period. predictable continued rates to increases increased inflationary IRA, may the to increases become our partners third, could and more

from Going channel to over always new sell-in demand fluctuates forward, we quarter-to-quarter, purchases. match inventory respect the term, inventory expect and with our to long

Operator

of the Marc Our next from line from Goodman SVB comes question Leerink.

Marc Goodman

of what sense you you to kind taking spending, given It SG&A, respect it's us of With and give appears pop a down is on. that can going again then quarter guidance. your were some next just this back

give DTC? plans sense into SG&A And should sense you're year? and out because a flows that? about what very next any doing of How looks we it there doing with are of ebbs think just us a the there Are for so more NUPLAZID? strange. you And Just give us

Stephen Davis

you take do want Mark, that? to

Mark Schneyer

problem. No for question. the Thanks

have that being our our potentially I forward. fluctuate. principally we a Quarter-to-quarter, campaign see move to reduced selling haven't we positive of seasonality spend in expense. that, marketing to we we some There's that not kind the does done and ROI run But change you as a expenses. our we as course informed mind think year. We've date, investment. by year, some and SG&A over it look if we'll the the this in a of as keep DTC We'll to reduction look future of we

you're that's seeing. So what

budget the we -- guidance clearly, continuing earnings range launch We from a we'll holds for second next which we spend expect optimize our line for SG&A continue is during to SG&A kind for spend net use year we do And this midpoint. just just our it total as as overall certainly be reduced also with efficient next when quarter guidance as just mentioned same true to go the in be spend, give on to year, at and it for expectation a trofinetide where will have just our year today kept our call, approximately it that PDP. of our successful to we call of the the next while we year What is ensure the we'll we year. fourth why quarter

Marc Goodman

also will up. step a next do be R&D Or flattish for year? Will be that you think

Mark Schneyer

just payments. of a last think, bit just quarter. different share what business I did again, development I'd impact little of R&D we because is So the And

So R&D is $XX of take that a kind expenses payment upfront of PD can payments, fluctuate of out, that for And year-to-year. if million from $XX the year-to-date of reminder, largest within you as almost kind about which for of still which million.

an spend the continuing with of approximately reduce ongoing year. have portfolio kind So based $XX and we just the taking kind that are have programs next of today upon R&D expectation that million in will new that aside, we spend do

Operator

of Matteis Stifel. comes question next from Our from Paul the line

Unidentified Analyst

with of But path I I would now. of, kind sort ADP. on productive a thought James about and course, ADP, about color Any kind of forward in is future of a for, forward? would your guess, the for path it you quick gotten be Of I guess with in anything clinical a Phase in guidance on as ACP-XXX. your you you're have or you of most This on how any design guess think I relates I thinking development trials, there interactions FDA just experience kind as Paul. be going guess, given about one you've I guess, and development to learned Maybe pimavanserin are that kind rapid great.

Stephen Davis

Yes. Thanks so much.

indications certainly of possibly psychosis and consideration then XXX. clear, where but of leaves alluded on today running where of that to know a not in little development I'll and that's that up your in one autism have approved is of And to ACP-XXX, want a approved. consideration, Let possibly schizophrenia we be X list, We the to disease try me consider we X. only top Phase With we lot where down focus the exit pediatric pimavanserin go we're indications in to will -- we'll then want be open question. you It Parkinson's average to, The just now. think will only, once precise multiple absolutely negative and studies NUPLAZID bit be symptoms as is not the I will ADP. terms with

know profile this a we through So it And We as us we That for gives lot to forward. mechanism. about reduced potential relates chemical know space. space us a the risk the ADP, in. moving about the operating a move lot aggressively more we're as that gives

a know also ADP. We lot about

feel treatment, a for patients We antipsychotic et cetera. respond good really how to have

as that as things have in anything add? Srdjan, think mentioned, position to ADP we I pursue think aggressively lock put you we all prioritized I to indication a very indication. us position together where those we, in put to us our a want So move first in where can else

Srdjan Stankovic

little generate. quality, data of patients that right the of but provide quality lessons of the and bit we and the working our perspective patients valuable in conducting population sites of only these experience this patient selecting can from not with the trials, recruitment terms for a additional also right also all and color a speed worldwide, and us in of Just sites with experience selecting trials in

Operator

Our next question Olson of line comes from from Oppenheimer. Jay the

Jay Olson

and expectations your clinical to talk Serge you advantages. the on of leverage compared the preclinical ACP-XXX, add those for for I best want to you your retirement. how pimavanserin to advantages when my to Based demonstrated be potential to that about all you could congrats plan and profile XXX the of can

Stephen Davis

Yes, Serge, do you want to go ahead?

Srdjan Stankovic

so QT Thanks, we are Thanks that with we to is evaluate far, a actually favorable development. us have several the identify for seeing say had the Yes. tolerability principal on What pimavanserin the wishes. that have profile the And with One, signal efficacious those important can range through which with pimavanserin. would to levels. and certain I liability that clinical is by the we Jay. that's the advantage ACP-XXX good expand that seeing with and limitations opportunity that to we a potential in doses, mild provides eliminate more potential evaluate better efficacy been we and that

with evaluate is that this the for population patient us to, with in a earlier safety, which important opportunity overall to tolerability I very said, addition, as context In efficacy the overall provides and is good mentioned, . Steve

Operator

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

Salveen Richter

of to a about sense channel in PDP trajectory beyond, dynamics the you've noted? for XXXX you're . just and get that given thinking the Just wanted how

Stephen Davis

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

Brendan Teehan

we which environment operate in environment envision. we current then the There's future Salveen. that Thanks, the and Sure.

seeing early in for those terms individual the of our indicators seeing for I I and we're performance. like care. If itself continue, NUPLAZID the trajectory So in think long-term improvement we're me, market of both

gives in there. PDP after prepared clinicians share that the stability. my leveraging setting. to we market we're favorable and setting, that environment is which community the inpatient approaching the that evidence right the we're hope returning the us, pending begin the of delivering both see to business in side, will Similarly, I that, said think have growth what my top me has to XX a setting. As improvement but community in-office the the way And have real-world I also is LTC patients carbidopa-levodopa continuing confidence see first-line Regardless in our message environment we brands that go outpaced quarter-over-quarter that in remarks, on we is, around you the

posture to suggest physicians putting of in So use material setting. pools patients higher see of for outcome and NUPLAZID the demonstrating first-line a have the think I front expect the that should a real-world you us, should in deepest of that differences of these

So more for and you'll community. community, in us, I see competing for share more us the the think in

Stephen Davis

everyone evidence Brendan, you're do what of are the that just and to remind want those. publications the to you real-world timing kind of referring

Brendan Teehan

the question. for Thanks Sure.

for demonstrating of avoiding residents long-term looking reimbursement. obviously, It's NUPLAZID attractive brought the antipsychotics. appropriate and to which light, So other X NUPLAZID for are multi-receptor facility. care off-label nursing significant our in It's the these that middle looking to the evidence for best the emerging levels. important body visits spike being I the clinically visits, information share use is that versus supports because, differences an opportunity on antipsychotics. you're all economics third atypical attractive also of for looking that of the which in had stays, are, quarter facilities first of versus all decision call hospitalizations a attractive of from That's would are advantages to at this rehospitalization are home make We've all-cause ER

that, discussions quarter. think I until on So is resonating. that early data, start third information in didn't the the very middle really of Again, that we're of the

generally of quarter and important a neurologists early in Journal sharing also because Journal Psychiatry. data publication the second don't recent that's of started the set The We get very American compelling. the It's American Psychiatry. in fourth

It's their NUPLAZID that patients So with Parkinson's disease would all-cause a compares of necessarily they other risk it's with not associated have antipsychotics all data used atypical the on psychosis. versus analysis claims retrospective Medicare mortality own. off-label in seen that

an instead antipsychotics importantly, of the low-dose quetiapine, -- the might that therapy XX% conclude mortality subset atypical authors principally than days. over important approximately that associated otherwise large The lower with and are other there's a receiving that just used was XXX be pimavanterin The NUPLAZID.

as the it. make compelling about community's of Again, to early residents. very very For information, treat and by we is are the that we're their they very to decisions but HCPs encouraged to how informative patients dissemination that data, us, response on into

Operator

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

Yatin Suneja

I it's going that given focus a to think have Rett, a year. next couple be I on

maybe us there understand give you how there? X,XXX sight frame about We can So of should for might or line pricing? diagnosed. some a I label think early, about. us How understand about we the but launch a X,XXX and patients think about on? we think you the or ramp have comp to maybe a are many should How

Stephen Davis

well. Brendan and it to as I'll then on ask I'll Sure. start, touch

of Rett So of be the is, we launch think linear as anticipation our it on about shape will a I kind progression. syndrome, type of think the curve in

programs you Sometimes a suddenly large in patients have where of that access rare commercial disease, you have bolus convert to pay expanded patients.

reason, we did do good that think, I here. very not for

as bit process. so little drug get to take we does a the to it the does a and launched, time of on of little get And bit time formularies. approved It take work through access

early ramping Of bit in but scripts course, up. everything a necessity, to of based take that letters of will little time begin you lot medical get place of be does it a on the so

linear in for anticipate reasons, the shaped So all and but the days quarters launch. of very a attractive early curve we those

you to a will provide the opportunities as to we sizable let I go an beyond we fairly and have then population prevalent then think attractive We other beyond part that, over address we population as forward. continue the question. do it and that you incident -- growth move of turn that,

Mark Schneyer

question. Sure. thank Thanks, you and Steve, the for

and target HCP us alluded my able to, of Kathie map are treated encouraging remarks, being also being said in as I to think treated. where As database, they're we universe and that we've I know what's and already to been that is been very prepared patients the already

we excellence. at these time as of an to So IRS that to the launch of have be at know where advantage centers

through number where point, with their from be they will does go that their big these feedback processes neurology trifenetide. non-COE us of rare targeted will patients that that normal payers know largely are to practices academic of some we suggest treated. patients treated at and the feedback been they similarly, Another diseases, institutions, the Steve's and To has treat

expect absolutely sort of trajectory So comes normal Steve when early I a you'd setting. drug think that right to it disease in in like a is a rare

As view I price, in past. tolerability access We the the product and unequivocal treating you trofinetide match well trofinetide we for and value community. I sure and meaningful think ensure to having make absolutely we're ACADIA of price to has say We we a that premature price families. the received. lives us that the we're mentioned, you very is in their efficacy patients I we imparting. as the the think with know devastating discuss would looking it's to but of we And to is symptoms know how make would viewed profile difference core a disease, know want

disease product As range to expect pediatric that a other would sense just price function rare we'll the the of of you that, some I in of products give direction.

Operator

of Our from next James. comes question Brill line from the Danielle Raymond

Alex Nackenoff

on Danielle. This is for Alex

you I the know you mentioned not, But a And Daffodil asking you those data? and for conferences. LILAC studies? to if LAVENDER presented basically row. me question Forgive the quarters present same Did at medical those in do open-label include two presentations when some expect

Stephen Davis

Kathie, you want take that? to

Kathie Bishop

Yes.

LILAC-X year. study, end will near of first So the for study be the this completing self-enable that

that submitted spring. for process, the we mentioned, end year. data completion at at of I the medical as of the And anticipate As the interim likely an presentation but is in cut part most submitting this NDA, we then study

Operator

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

Sumant Kulkarni

retirement. to on Serge best my wishes add upcoming I'll his And

resourced positive capitalize the the issue or you of of So ACADIA the on visits, Parkinson's terms driving market, to for company's the a other larger related disease potential simply products normal on Parkinson's for think has in office do a and issue to that's novel optimally a excitement outside is fewer pandemic amplified or innovation control return to example.

Stephen Davis

Brendan, take do that? to you want

Brendan Teehan

question. Yes, Thanks for the sure.

temporal, the has for that are be demonstrating a I favorable. have think seeing preference over care the competitive differential to been And but a long-term what somewhat is NUPLAZID we've we're in early set. seen they channel indications and continued

off-label study. placebo-controlled now in very the clinicians really use some there contrast it these that approved find logical look placebo that that antipsychotics community every have because out haven't as that bit hasn't are existed therapies. pimavanserin atypical I me, for When real-world There of for the that I was seen between those think to versus really a to at any to treating previously evidence is available they X is us, encouraging. So

for market us the to brand on, have to that we our but and a around meaningful think of moving quarters share I forward our plenty there or I ahead. growing a is for really at and enthusiastic provides early real-world room I body in opportunities Again, scientific evidence Now there's grow us. states it's the difference, am continue XX% about platform think with that on differentiation a of nice that that

Operator

Renza Our next question of comes the Gregory from from RBC. line

Gregory Renza

Steve, wishes well. as search to me add also let my well

those at an development. reduction update pipeline all the Steve, investments has to inflation a was how on input latest curious, if accelerating or gating Just on thinking you're looking you one I could and wondering to quick you And on and just even catalyzing any business us about externally. factors external of and the evolving IRA if efforts?

Stephen Davis

of I the turned in impact like question, earlier, we've X cycles stable. We've in Trefinitide seen it thanks, X have development. usually is -- for Mitch, the But whole as successful business takes It enormous capital business kind usually years. supportive We a for markets. an quarters last on Look, that. X Greg. think of as and this else, that this. everyone and is that been or takes indicated had X competitor be to development. for markets prior capital example the to we've great will a to Yes, the the realize And while. does read-through a That less it of and have we that. But

don't -- we capital. need we as don't we So indicated, raise to

a in less business capital competitor us. for markets really So net-net, -- -- a and positive it's of development some we is becoming respects, just the

those flow business, see some and finance we having balance from who And think harder business development in have revenues just cash and achieve sheet particularly all to business a X. have across to don't I don't so are landscape their the their strong beginning confidence companies a need and

companies I which And grow. business as And to the choppy foreseeable well very the consequence, for more positioned these on development, be think so if I then capital on we're the I a is and think grow stay aggressive markets beneficial to future, of think that. pressure get

attractive think more as applications, a those opportunity, So and psychiatry, neurology, growingly and more attractive to opportunity capabilities both there's forward footprints we in through rare we BD. to disease our broad look leverage

Operator

And I'm what I sorry, it I'm Greg, was was Greg. there there was. at your part to question, think to recall trying the two question, your a

Gregory Renza

Reduction If Act impact... whether the will Inflation

Stephen Davis

the Thanks. is I Yes, made on it's pretty Look, over point. a Greg answer significant going think the think, our have industry, impact I to time.

sensitive versus so, we mix. payer people see that to some be -- conscious think a much molecules the I large so I of just from in think right? And molecules, more over begin so or evidence will last and they'll And more week to time, modality, be of small

also and have impact therefore, assessments. on business I so it it have an development will impact And on our industry, will think an

Operator

that of Thank you. proceed Davis, I sorry am are Mr. out remarks. please time. to we closing

Stephen Davis

Well, much, you updating and quarter. all Thanks you thanks listening, for Great. next for . to look of much so we operator. forward

Operator

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

now may You day. Good disconnect.

ACADIA Pharmaceuticals (ACAD) 3 Nov 222022 Q3 Earnings call transcript