ACAD - Earnings call transcript Q1 2021 | ACADIA Pharmaceuticals Inc.

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Operator

Good day, ladies and gentlemen, and welcome to ACADIA Pharmaceuticals First Quarter 2021 Financial Results Conference Call. My name is Mary, and I will be your coordinator for today. At this time, all participants are in a listen-only mode.

We will be facilitating a question-and-answer session towards the end of today's call. If at any time during the call, you require assistance, please followed by Zero and a coordinator will be will be happy to assist you. to of presentation Investor like Johnson, to now President Vice Relations would turn over the Mark I at ACADIA. proceed. Please

Mark Johnson

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

opening Officer; call on provide operations. Joining will Customer a Officer, are in Steve Stankovic, our Charmaine for slides, Officer; overview then joining review performance the the our President, point website. your Officer, Also detail we our and performance. discuss to more final for today's of Chief of Product us section that pipeline our are I of will are like from and also back Financial Davis, me Lykins, today ACADIA business Ridloff, financial our Dr. remarks Chief Elena our discuss which call our on Morgan, Planning questions. to results would and Executive financial on Global call progress Amanda our turning who the and Chief is Revenue Presentations will an before up it who our using Serge QX and will Steve Chief available Marketing provide updates and commercial our supplement and XXXX out Events on

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

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

Stephen Davis

Thank us today. Slide X turn to executing to steadfast on create you, for remain in X. Mark. thank mission you our to commitment long-term strategic our afternoon, our and Good joining into everyone, Please pillars We growth.

continued by driving psychosis acquiring disease dementia-related or patients NUPLAZID growth or new second, wave in third, next advancing First, delivering And pipeline development developing for opportunity. psychosis, our and the breaking assets. with therapies the DRP, of PDP. on Parkinson's

Slide Let's review our on X. QX starting results detail, in greater

XX% $XXX.X This quarter in first achieved XXXX, office-based by setting. the sales. the of represents net driven million strong NUPLAZID performance For an year-over-year year-over-year increase, in

were conditions of ongoing first the NUPLAZID relating of post-holiday spike negatively quarter, During COVID-XX to by the sales pandemic. the and impacted

latter pandemic XXXX the part on indicators, we to $XXX guidance As the observed beginning million into related second reiterating quarter we improvements ahead, the continued in million. for and at projecting we of net sales and throughout And our the the based these growth $XXX year are the fiscal first year to of look quarter.

our plan psychosis. the DRP the path, dementia-related Top response complete issued X. our committed or drug dialogue path pimavanserin We our and community. meeting, bringing to CRL on potential regarding DRP later, program discuss in We to update A supplemental an new on application CRL, FDA with to constructive FDA for for approval pimvanserin. we a the forward to we a the look where to April, move Let's the that In Slide announced patient remain

frail and from symptoms. by significant in Current of the risks motor as heard have the significant. made made need this members concerned remains DRP by patient public antipsychotics, prudently often and which of UsAgainstAlzheimer's, scenarios groups are all for use this I statements Body impairment caregivers their of Association patient who that encouraged FDA-approved without DRP the both unmet voices advocacy treatment matter. to planning what and family want privately many learned off-label meeting. an elderly critically worsening the involves treatment, we of population, on remains physicians, Association. publicly such Dementia further We and preparing cognition We burden disease. at carry based important and you recognize Lewy that We're and We've multiple Alzheimer's heard this on the remind for including significant this of

In we our X. as and here pipeline Slide are areas, across of therapeutic new on developing DRP, addition expanding focused shown multiple to innovative on programs

associated growth study pain osteoarthritis. to Phase strategy Phase be results in of bring program key of symptoms the pipeline our continues Phase top plan and to call with continues like track a commercial negative over needs. a II additional and pimavanserin turn expect to through development III the of surgery for ACP-XXX schizophrenia year, long-term an our and first end remains and trofinetide expand Amanda line with for the patients to a II unmet on postop initiated evaluating Our to ACP-XXX, evaluating line deliver our funding recently for priority well. therapies to initiate quarter, the performance Business Charmaine III our we to to We quarter by the obtained program top Phase high new study I now growth year-end. initiatives. a discuss by enroll would to second results and In

Amanda Morgan

growth conditions and our to expectations and continue psychosis. the will growth of starts the year-over-year was Thank disease transform Slide million, and on within quarter deliver in with first to representing sales to an for patients to to net review X. initiatives, of of of standard revenue in In We Performance NUPLAZID our driven you, delivered focus XX% new pandemic plan to for in Steve. our we I XXXX. related quarter, the Please turn us care we'd the the PAP by Parkinson's enable patients increase. double-digit NUPLAZID, performance on the our continuing growth base strong Today, base subscriber channel. in PEP. $XXX.X long-term The first like improvements largely office-based patient quarter

QX result performance spikes was impacted in negatively in post of in NUPLAZID Steve As cases, decline COVID-XX resulting visits. a as office a the holiday taken in mentioned,

However, interactions, including the we increase quarter, the overall of and returning an which are levels, in pandemic. all of rates. face-to-face we in observed to an conditions traditional visits exited vaccination to as related increase improving

impacted pre-pandemic in first versus a average XX While temporal continuing face XX-day patients the of reverted bottle policy the fill. refills temporarily and we QX our net sales. continuing per ability guidance unique to on NUPLAZID reversal as This a remained high, interrupted quarter to payers dynamic our obtain patient

after in stability, decline quarter, first care observed channel, the several showing we incentives. Within of months long-term the additional an

and However, now importantly, into we see admissions, in April. improve more and to starting March are census

For the leading long-term the channel, office-based market conditions both our and indicator, and improving. care are setting overall steadily

recovery patient land we the and XX. XXXX timing fiscal interactions, XXXX Slide and As to LTC of our in business year pace in to out of to PD be million face-to-face guidance the net pandemic, our turn Please where new driver $XXX and million. admissions will office performance reiterated we of come $XXX a key sales

including to return an to modest The see We a following early channel, in towards points pointing LTC growth and the growth this have admittance long-term indicators observation. key incentives. care highlight increase recently in new started

And first new visit major care. the First, both impediment has within ones, which family led staff, previously high rapid which a and admissions. vaccination was admissions vaccination other and COVID-XX loved care among resident indicator to residents our a finally, in that more facilities There drop is XX% to to starts December of group shows all leading channel. residents second, long-term XXXX. provider rates are LTC new highly now allowing large since in quarter, was correlated prioritized shared the patient data new are And than members greater over the a of of resident small areas cases

improving on the the support We market focus turn are our growth long-term growth. PDP sustainable for it Charmaine return the overall to care business. a within to that encouraged discuss now conditions market I'll to over by

Stephen Davis

on Charmaine, I believe you are mute.

Charmaine Lykins

mix Thank the maximize Slide Amanda. emerge begin marketing you. underlying Please to we conditions to response market channel to to pandemic. the from tailored XX. as We've turn Thanks, our

digitally professional promotional we virtual booths several key of of expect year. Academy drive virtual campaigns, engagement American we medical remainder April, our leverage our the with will amplify In this Neurology throughout of We College and leveraging across both of And person. continue the the in health rest virtual these at congresses throughout American at theaters very strong country. growth the to means will to and our care This Congress presence continue attended, [indiscernible] well the the initiatives and Physicians that programs and year. CME were consumer and Virtual speaker and product

request campaign that online to on-air patients that, are NUPLAZID campaign, activate to an caregivers and we and to in specifically. addition DTC executing to DTC In order support

our the exited observe see share and is supported started is market new social and growing of significant key weeks, patient other are conditions. symptoms. reach that In April, Our carry and market safety to for This to risks, Most off-label penetration. growth potential market, and exceed quarter which and grow current opportunity large. care exceeding started motor long-term of continues recovery including is for the we digital on which NUPLAZID media and prescriber importantly, we of visits patients into antipsychotics, focused TDP face-to-face remains as our patient campaign prescribed to share. breadth a today to with our indicator new by recent the base. worsening future targets the the overall in a we out across have our depth tactics business, we The the We're interactions, share there, in-office improving And DTC admissions. working have of our and growth synergistically

us positioned ability future Our to it. well, expertise grow the commercial as from performance strong team's emerge and the we with pandemic business has during

NUPLAZID now turn positioned Serge our And pipeline drive to of to in prescription We growth are over PDP. progress. it discuss well to long-term I'll

Srdjan Stankovic

XX. the provides a request meeting. on discussion Good complete which study interactions HARMONY you, SNDA, the and regards has Charmaine. is Slide been and In package, DRP, now for everyone. perspective positive future briefing with be a in our a afternoon, team preparing turn Phase document our results for to will to outlines the diligently Thank Please This almost template III A FDA. included and Type

towards approval mutually CRL path the Type objectives Our discuss with FDA. identify for A meeting a are the the agreeable to and

the to make confident patients, to in DRP, described and data active pimavanserin sNDA their NUPLAZID in and DRP. benefit and are families in suffer FDA profile risk from our and caregivers science, are the of We approval available committed who

As prospectively of as pimavanserin program that a way agreed and HARMONY before, design of to most believe study and for the the treatment is the development safety pivotal appropriate we've scientifically we efficacy said the evaluate DRP.

look secondary while view key and endpoints, of pimavanserin The informed to the We with highly following: align forward symptoms benefit-risk position the results. Our met statistically met on in across on study, division's pimavanserin response meaningful its patients position hopes further would criteria, portion pivotal measures symptoms like keeping The of We prespecified DRP. significant notable study in with updated and subgroups. and rigorous separation results, an you for demonstrated Consistent a pimavanserin on study, demonstrated of the HARMONY by assessment. these in this on our informs can psychotic the is very over meaningful study and placebo the double-blind HARMONY described of primary pivotal the on portion of understand our we meaningful results patient with to efficient hallucinations Furthermore, size. psychosis, profile XX% towards the in open-label or the such the as treatment delusions, from And plan the in above that of on a our consistent clinically all of progress. global resubmission. severity of clinical consistency effect sustained reduction better

areas need, our on X unmet innovative we ongoing across trials with for DRP, of Beyond clinical are -- pipeline disease treatments areas. advancing high of

hand syndrome. including sensory review with the on rest Rett Patients purposeful motor emotional, a lose leading briefly impairment. neurological symptoms, severe and and disorder is spoken XX debilitating independence. of Let's our communication pipeline, rare loss to syndrome Slide use, starting cognitive, of with Rett often a

the continues II top core which symptoms with uses expected that well, endpoints the of in Rett III syndrome. the progress study on positive LAVENDER our designed show validated this are LAVENDER to quarter to results as program recall Phase of same improvements from year. study the study, the Phase fourth Our line Please

caregiver who burden. to the These Turning over are lead to restricted of significant blended symptoms, and experience There United treatment debilitating schizophrenia but in effect. Slide can States social for disability long-term patients negative including are withdrawal, XXX,XXX XX. the lack speech symptoms still receiving and emotion,

schizophrenia. the Phase more we well, look progressing the ongoing results As pivotal continuation XX program the our study III the of we we development I Slide year summarizes initiated we expect to line we we update the patients quarter with to is The associated our this suffering that highlights to announce Phase day for by this positive ACP-XXX from In for negative postoperative osteoarthritis Slide pain rating study study in a of Slide evaluating cognition our call of reminder, ACP-XXX pain administered, which numeric measured acute XXX the dose X being We the safety of top II and a before ADVANCE the Phase in a enrolling through intensity first-in-class, third hours. for future. for Phase of quarter, the Elena. keeping a chronic postoperative a line Rett and symptoms ACP-XXX. Phase study from Phase with summary the with schizophrenia score of pleased study forward III study, program year. The our following is and for top program for treatment currently the surgery XX for X, quarter. as Phase initiated the and ADVANCE-X pipeline. program. And double-blind, primary first is look novel, Please endpoint study treatment pain the second plan program that, of that both to of forward and II ACP-XXX advance turn II you enrolling providing initiated potential of syndrome. am on a we study, initiate bunionectomy brief detailed XX ACP-XXX average results lines. the last over Furthermore, from to scale efficacy this pain. an for initiate fourth quarter, XX randomized, II to plan on pimavanserin we updated evaluating ACP-XXX and We an is time a our of is recently turn first patients. updates anticipate In in announce from to Transition of surgery. osteoarthritis. pain. trofinetide quarter, our study evaluating is end on approximately non-opioid ACP-XXX studied pain placebo-controlled orally our treatment additional I'll the study analgesic study includes later associated for I to subjects and in and of And

Elena Ridloff

XX. XXXX Thank you, Serge. sales to Today, outlook. million to net I'll of volume X% discuss our first driven quarter in XXXX of quarter results growth recorded This Please was and financial Slide increase our XX% an year-over-year. XXXX. of sales, we $XX.X of by approximately the million net QX first compared updated In in XXXX, turn $XXX.X

this, comparison year's first increased this challenging prepandemic. we was Importantly, is demand year-over-year. because last Despite quarter delivered

average driven the long-term demand bottles quarter, of second several as the the by levels in XXXX, decline described. visits office in the by census was of the facilities office-based fewer patient in channel, declined per last In the led performance Amanda growth following first year-over-year Our patient a impacted and by with further decline year-over-year, quarter care year. in half in of months channel, LTC stabilization in

for quarter and XX.X The started the as census and into in demand office-based office we we improved and million XXXX adjustment levels -- our first visits LPC QX to net However, gross channel see X.X%. exited to was patient in increase April.

Medicare year-end. We highest slightly of the gross-to-net due hole Part the a channel saw D the the reset the in to in As donut the the first reminder, is quarter higher quarter first end were patients. at annual than of inventory typically for

million million the GAAP $XX.X XXXX. expenses in compared $XX.X $XX.X decreased P&L. quarter the the expenses first in compared first during compensation Noncash, to GAAP XXXX. quarter quarter in period to the stock-based million to million down in for $XX year. $XXX was million Moving last to the quarter, QX the R&D million SG&A increased $XXX.X in of feed expense from

Slide the balance million. $XXX.X at was Please end cash the of XX. turn Our quarter to

of For to placid million. we million reiterating the XXXX, are guidance $XXX full revenue new $XXX our year

impact the guidance could of of Given in first lower end range. quarter, we observed the pandemic the in the land we the

be timing office Just recovery function field the a face-to-face where and admissions. and interactions, patient visits we finish LTC new pace of in will of

expense to This in optimization we reflects the expect includes On expenses compensation R&D $XXX and expense. GAAP be previous XXXX, now million. $XXX side in development for full our stock-based $XXX million $XXX year, and million between from for to of the $XX million a approximately some million range

full to GAAP the in between reducing reflect launch. delay expect million are $XXX to for in We million approximately with revised a turn SG&A call of associated Steve. range DRP back I'll We $XXX year includes to the expense. $XXX that, reduction stock-based from potential with to million. the of be $XXX a million range million expenses and previous guidance $XX guidance And compensation our The the over SG&A now

Stephen Davis

turn confident In Elena. long-term are in DRP. Please you, we to outlook XX. our Slide for closing, Thank commercial

to committed are call to open our like struggling up caregivers and for for are investing our in unwavering patients to opportunities. elevate to and to passions We questions. on now we with I'll employees and the our bringing would DRP, life. business thank clinical mission Operator? development focused I Question-and-Answer their Session\ programs pimavanserin

Operator

Instructions]. [Operator

from comes the line from of question first Cowen. Baral Your Ritu

Ritu Baral

I a those those address A has is, then and meeting the for issue kept way that Type discussing at broader is And question. are potentially that, with forward main XXX study to with DRP. trial records around record-keeping this any do Type quality the you records first, beyond? of ask housekeeping the wanted to point? the clinical or worth path requested if to issues about I here sort there A quick the I guess, very two, Have the guess formally at question

Stephen Davis

of Yes. for question, Thanks to first question. the second ask to the Ritu. I'm part. going much Serge answer the your answer part I'll

have is, submitted answer yet we the not So the request.

A template provides as request. And briefing almost A in diligent foundation is counsel to before will discussion. So soon. position and this with a which reminder, complete you included believe the for formal is to XX of future lay do FDA Type request your A want And request meeting, prepare you advisers. first and and a Type interactions. it's will to we very days of -- for And this the to document, input a meeting outlines very Type the want our Ritu's right the have strong template and to the order from a submitting get the the right be and have second preparation to scheduled arguments FDA Serge, important benefit our be includes for in the outside document We and also The take be expert in question? of meeting request. part official again by within discuss

Srdjan Stankovic

of to understand a all can hope that and were just those and Steve manner, to that. in the I'll the point Complete our be raised Response to first you address the concerns in we of what of a issues related briefing really division is and document, objective will 'XX Letter. point the the by provide addressing is Ritu, that context by in the that to concerns mentioned, Yes. that be those letter, additional meeting understand reiterate in information part we that of this and in to were issues raised our and complete extensive mentioned principal detailed the certainly, that response earlier, a issues division Considering issues that in will study the helpful

Operator

the of Cantor Duncan from comes question from Charles Next line Fitzgerald.

Charles Duncan

you jumping diagnostic more DRP wondering on criteria? follow-up limited the before a is Or I learn the more you gun, to some top a maybe I with based do had quarter label resolution? to you guess dispute indication. question I'm if imagine you on refiling willing Good strategy? a determine line. are the Yes. And but this could pursue on need information

Stephen Davis

Thanks much Charles. Yes. the question, for

FDA appropriate FDA process if that meeting, the towards think this information. don't process, can't At -- appeal resubmission. an agree get There path appeal that have baked the to on time, a our productive So is pursued. we actually the the sensible speculate into official could following the -- meeting had Type it's until on we and A process be with we and

be that. the part was me your So I'm question, focused of Charles, there the And now. escaping on That's we'll next step, second it's sorry,

Charles Duncan

Yes, some that a regarding makes diagnostic sense. limited label based Steve, on criteria.

Stephen Davis

look, to meeting. I, a to about the have lot And there want scenario obviously to there. Yes. we see meeting planning, learn speculate data top but avenues learn need No, the I what I remember potential need don't X we of we this We've We now. done meeting. can first. to beyond too, have

Operator

from from of comes question Next Kasimov the JPMorgan. line Cory

Unidentified Analyst

for on Turner is This Cory.

what your potentially are ERP latest about the to possible the European it impact, take U.S. curious, to Europe? you strategy? Just your regulators delaying think And about how the Is European PBT? on thoughts is this package

Stephen Davis

much the question. for Thanks Yes.

the indicated, just drugs we this. United And filing versus reflection we've that is difference -- very States. a to very, answer in our this as So is going Europe unique this This not drug of in the like pricing previously like to the frame-shifted in European strategy. dramatic really

is multiple the pie to in was indications a different, other try drug out to doing in like of the that words, data felt indications senior to other the tend and we're in into And get for vast play we because this pricing States. the a majority exclusivity. work So important so common dramatically United the value it it is

secure to this say continue more at sure wanted of make the So forward. at to we jurisdictions. just this value more have every of U.S., the with we in I about but filing the We'll is in buys we have anything U.S. don't But to other to we we go as and outside There juncture, timing say pimavanserin, assess juncture. value anything bit of on that want certainly to

Operator

Butler Jason Securities. of from line the from comes question JMP Next

Jason Butler

those a for midterm moving just headwinds. see the looking Just little COVID about do we future the -- had the has exit thinking long-term opportunity as today opportunity one PDP into could you growth views space I channel that in growth? the just How channel, the remind X opportunities in office And for versus the you deeply guess forward. on penetrated context? your market the each larger which size in EQR care, in on if you how

Stephen Davis

question. for going to I'm much you Thanks Yes. answer Charmaine, ask to the that.

Charmaine Lykins

Yes, we're sure. and growth Steve. means. effects for when growth NUPLAZID and positive those there provide Thanks, that caregiver commercial about patients channels, demonstrated this initiatives of And Parkinson's all we're Well, disease first to to overall care, patient through channels to our only base for all, PDP, have in committed opportunity accelerating as also our both and you several we're to long-term office across to across look request the time. out going to activate information do resources NUPLAZID FDA-approved the that over going deliver psychosis. caregivers, establishing continue and treatment and to to Namely,

long-term the bureaus in community, we're business and both in and data the promotional impact that, year. an the the NUPLAZID several pimavanserin has on virtual speaker already setting which of educating at virtual and congresses booths the medical office-based we've care participated throughout that on actually benefits through Beyond important

see is side And strong to platform, continue of the both and consumer, to addition and got across the HCP side. executing awareness consumer setting. digital integrated we've fully program, on our both regardless results coming media, social In from we a that, the which on consumer HCP

we continue on further these that or the ourselves basket tactics effectiveness of actually products basket benchmark with we today. that executing overall, the underscores against, to market care, which say, long-term would of outperform I I in we're perform think think I market

but office-based So very the we're in of our long-term growth channel, the in not optimistic channels. care prospects, also only

Jason Butler

Great. Okay.

Operator

comes question Renza Gregory RBC Markets. from Next Capital from

Gregory Renza

I thank for touch the end an team, encouraging and Steve little focus if metrics full I'm first the I near-term Steve, and a of exit, on quarter a just that to could like just I outlook of wanted the lower sounds range. year bit update. the bit had you those guidance. maybe think indicated the It reiteration for you you If more on heard a Elena curious correctly, factors. just PDP. you

market? lowering of if narrowing opportunity could curious just this light for you the or that commentary guidance what year that, any, to just PDP a penetration that in lastly, a in maintaining the perhaps versus potentiator related then if bit, was you to curious, that degree, And just unpack So just maybe it the added? DRP potential

Stephen Davis

Yes. to then the question. the answer ask going question I'm to to going first Elena second and first, I'm answer

-- we and we So percent had we've every hub, deviated. been label, come XX% are the off-label see in That and of our through time it's this the exactly but launched from use. in majority scripts We low always very, high significant drug, channels, range. we've all can't very scripts bottle the of know hasn't that on the

impact first any see don't I changes in PDP. So percent from quarter on the in off-label -- of off-label use

very have results Parkinson's very, a patients of overall in were the in compelling. that super compelling. And dementia, with patients results that as our disease also course, DRP just were addition, is, reminder, In obviously, psychosis PDD,

quarter to PDP So between DRP first connectivity I take any want just models. question? the and first don't you see Lenny,

Elena Ridloff

Sure.

to So did with the the new remainder patients the those the in remind on has patient to low guidance range, regards folks lose through are in an and expected, Greg, just you our confident the the bottles quarter, that of of comment starts range. for you I first impact patients end have continuing we than fewer when that year.

to continued channel, March care about April expect channels. in office-based and setting talked those and the and the the, we in both see we seen have growth both both in long-term trends improved As

we the So that confident we guidance in are reiterated range today.

Operator

Next question comes from Neena Bitritto-Garg from Citi.

Neena Bitritto-Garg

or from minutes you to would meeting. that is to what's steps Type guess can the plan a DRP. you guess, you that'd the be do if that So Yes, have on, I elaborate in you wait kind meeting, great. the of I the more I or that about hearing something just bit outcome guess on just could until of meeting? A right a of And you kind communicate more question bit us next after talk that, another after time little little line

Stephen Davis

the for question. Rich, Thanks, Yes.

their we days. meeting under most should within XX in the are well. in have speaking we store, whether in pre-sNDA and XX they wait it's our of or following typically the meeting public meetings of as CRL, this happen right So do meeting the a FDA's Phase II at we usually the the the meeting, get meeting plan Once days structure the request, from Type would meeting this as or case loan, and case, in that's until we would minutes A

Operator

Jeff comes Hung Morgan Stanley. of from Next question

Jeff Hung

go early, can there you are should was DRP, that from highlight the the those pimavanserin you companies really or highlight process but any cases similarities down went any For And where DRP? it's precedent path to through the differences I and would CRL in know cases of overturned? Otis, appeals you

Stephen Davis

of you one just There's to first, overturning to the per set. no -- just sure se, level resubmit. of have because CRL all CRL, get once make Well, we're kind a you

some question do The So cases, you do application. what need additional this to doing resubmit. SNDA drug cases, work. is, you the other supplemental you do can was clinical to in new need and in always And clinical to -- work without or resubmit additional

meeting. division made with So division, that the decision on the by psychiatry the whom issuing is we'll have a Type CRL A the was and

comment meeting, as be. so we'll further that the of then next a had and view for we steps our will And course, in as inform we've to -- will plans earlier, I what position, indicated be of it about once it

Operator

Salveen Richter Goldman question Next of comes Sachs. from

Andrea Tan

opportunities, there's some for look maybe believe a drug on any chronic a bit questions one action I of of acute you ACP-XXX you more Maybe on more if more versus effective Salveen. in speak if pain? have reason then to And fruit, low-hanging at for on X could may pipeline. Andrea mechanism second. is the and a the the be if those is as This Serge, and

Srdjan Stankovic

very action. The Yes. of interesting mechanism

First pain, of mechanism restricted a compounds. particularly which all, about This is is And development pain of we accelerate mechanisms. of paroxy compound peripherally attractive. underlying also what particularly excited nitride, really are to is having mechanism elimination of ability it's non-opioid the upstream in an action. sensitization multiple for has that's This of

risks liabilities So any of dependence, the potential present. not is abuse

the to acute the are models. question about anticipate whether we very we drug. from benefit chronic regard So pain a that excited better In in versus perspective, the

preclinical or have saw far, models, in from quite we whether some different those a in the of are extent, variety we with saw better an have in acute chronic. efficacy that displayed single bit opioid. pain efficacy And And quite a we data pain indications we the is -- we models, So par or have. only of mechanisms, the on that

in So perspective, well forward II pain in benefit possible the of in trial, are that anticipation, that's confirmation. Obviously, why the models. demonstrate both as for of models. Phase from our chronic of ability to both acute to the as quite are looking pursuing we terms clinical models we data And bullish the

Andrea Tan

just on MX nature Got you of -- Phase could what when the data be the right it. what And would if is that emerge, with could see then that I, to and helpful. the speak PAM, that start now status some your we of

Srdjan Stankovic

Yes.

plans, are appropriate But I right Phase And we expanding providing as from exposures -- transitioning and progressed the in we As we the now. work. moving is actually humans, continuing I doing the and are I can -- -- toxicology I. the both we that's where we as of continue be need covering reporting, Phase already this We we as to we well future said, the process of exposures Phase be is the the you in are move this have we that obviously, the a will right perspective on the We updating forward. human those compound increasing complete in forward. as -- work, through so And this in quite now, stage the work.

Operator

The comes from Financial. Stifel Paul next of question Matteis

Paul Matteis

I of can changes of last had we of quarter the in drug retail compliance try now the the do of cadence rate on at and than a an machines in first reopening And I guess I more it. things year? end simplify exit are for and terms at the of parts there's to rest half? what know patient you from about XQ, lot the you rates. first moving guess, you see of kind patients of I Did that to with wanted

Stephen Davis

that? Yes. Thanks, you Elena, the want for Paul take to question.

Elena Ridloff

the Thanks Yes. for question.

about and the office As see the we growth we both face in are QX, did -- channel. ending we setting care long-term talked

it's reverse receive strong also XX-day in place. of just where the And in portion pandemic. started I the X% QX, we fills, to patients X% which So about bottles Amanda we was back pre-pandemic on about spoke a our of good historically had in to now and was patients. single-digit for about want in exiting saw comment majority QX her are continued X%. April, prepared bottles. in remarks, to We that that a It that to to There continuing X%. the small grew percentage

see bottles expect, continuing normal starting QX trend average as So a far we as more in to for patients.

Operator

from comes question Brian Miles of Next Jefferies.

Unidentified Analyst

in a postoperative maybe on acute few XXXX, follow-ups pain. So

rescue or allowed profile, dosing the can half-life if speak then dose, needed? know to you And as handled action? a high possible, could estimated PK and then once the maybe a finally, about of a low can strategy? follow-up, going you the in you as is there's endpoint. and are onset to this primary its outline and medications maybe So but And what be daily talk that's how I

Stephen Davis

you those take questions? to want Serge,

Srdjan Stankovic

Yes.

As study dosing questions want what a the is, we important is of right for now, optimal fact, of the to this one we the answer matter are drug. that regimen that conducting

dose regimens. we So essentially X dosing but daily testing in are the same different

you that understand, to and the I'm X has perspective also question, sure we part trial better pharmacodynamic not of behavior if drug coverage arms, for respect. the but that want. because want analgesic from addressed the pharmacokinetic the So of second that's arms X second essentially potential I -- active objectives definitely for of your would X one in and placebo the and us both

Unidentified Analyst

be handled allowed. how and Yes, they'll it's for if medications, the primary they're about rescue

Srdjan Stankovic

are of the -- terms Yes, details we is are all we that. and in classical level records. trial very we -- and with make And there go the into design. we are interfere do protocols that there terms this intensity, it's of There in in pain are the restrictions pain acute of -- some are this, measuring -- of don't rescues. are of design medications but course, a that is prohibited, very, certain that the obviously, But primary we measure,

Operator

Next from question comes Guggenheim. of Sinha Yatin

Eddie Hickman

Eddie This on Yatin. for is

differences weeks, LAVENDER you weeks when and you're Phase the those upping patients, that or given enrolling that drug that II then to you data you clinical still the and study arm severity XX of you're Phase add the any led II, the study, is decreasing age benefit X II on it So additional the with get in think that III, endpoints in added time? Phase older was in that slightly do on Phase much the there only disease-related to girls was can study? older to And stopped, how

Srdjan Stankovic

Yes.

Our actually as the additional did view the experts been had change display opportunity the with us trial action and would time on the data vis-a-vis based provide as potentially of benefit led symptoms on trofinetide benefit of a discussion conclusion to to not the the well shorter we mechanism and have obtained. full that a symptom, the that over in

that is the trial to the designed. it do benefit verified. way And decided be So design the have in how we therefore, expect we will additional

that trial. this the right period for we we want extended Of of but we timing not a to did at trial, overly the for believe the go duration are course, with

patients terms we that with the particular specific school that population have a patient where may this point span these have course is patient are receiving maybe age, of the that population of older stagnating rehabilitations the different or than a also and that applied important mean In characteristics, number I measures a within that the are the is that are from perspective. that more disease patients in of

did this include very not trial So similarly, young in we patients.

this not terms expect we be to there clinical group I that always be that that But variability significant is do the for but present, group. across We will in some significant in not symptoms in do anticipate of are we doing the a variability trial. the separate trial, is and mean, including it substantive.

Operator

comes Olson next question from from Oppenheimer. The Jay

Jay Olson

follow-up profile potential prepare you're for trofinetide. thinking you for about the a Can ultimate any the And on work you're doing trofinetide. about just for to the that how talk launch Maybe trofinetide. and market product target

Stephen Davis

want you Sherman, question Serge, And the profile? preparations do you product to want do take the launch. to target for take regarding

Srdjan Stankovic

Yes.

patient something And of been the deeper or from symptom like I cost underscore that, or that relatively is we multiple think is talking to know, as here, know disease, perspective symptoms targets this point that that the unique treatments that symptoms overhead clusters. in population. is meaning as the multiple, and far tested I trofinetide important would have we about so trofinetide applied

others know, so were targeting we where you some and development As people symptoms, seizures were respiratory have programs targeting on. mostly

distinguished broad symptoms out targeting obviously, most programs this of syndrome not on nothing least there characteristic a that's at that rev what trofinetide. the point, And as So I par of trofinetide. at target else are one array core think for are salient broad certainly available we of of that's there I that think of is the -- treatment, symptoms this is and characteristics

Charmaine Lykins

commercialization we you disease. rare launch, a is from this prepare as for And to perspective, look a do see

very, is to patients important is be those caregiver launch. with Of also very for and course, in the going caregivers important very a high-touch those relationship

things might an looking to relationships understand diagnosis working manage rhettsyndrome.org of journey at initially, those and particularly for or with the managed advocacy, is the help then course and launch, how rettsyndromefoundation.org disease. strong on to as patients their find we're as Some throughout and where of the the that to patient are opportunity trofinetide patient well their disease that we rett

early types this that disease. So a rare lot on is of extra a with working the foundational caregiver that of patient, an we're brand on strategy the and core the deliverables emphasis knowing

Operator

Mizuho comes Vamil Securities. of question Divan from Next

Vamil Divan

but would to Steve. sort to could get be the be kind through you of thoughts you've some are with your business is you deficiencies? one's there curious, around I outlook other the you DRP, strategy? previously, A overall there. just of updated notification steps anything for the got and as here may story couple think sure development get thinking guess asked or you that that really first what thoughts just order I to the about over this want But how clarity take that given the in of diversify impacting more helpful. Any meeting this I'm delay the your has question you corporate on evolved last in months type or since

Stephen Davis

It strategy. in patients, the revenue meet for in a and growth have having much need in going a obviously to of the strategy. here doesn't DRP forward very very on of PDP. Look, question. to equally Thanks have change opportunities development We're We're key Yes. unmet DRP. capitalizing will our continue attractive in be business pillar the we the determined we disappointed to we're setback committed

relates the it more iterate deals. case. be make you development, business to that this it, to and As will well, see want we said I just to previously, sure I continues

Second, in a and today. we neurology foothold strong psychiatry both have

as in both as presence a well rare significant need, unmet chronic have with indications We disease.

opportunities psychiatry likely do forward, As very, we neurology, and disease in specialty we well very broad will deals we still doesn't disease. -- therapies the and types and a on symptomatically go that more just evolve very That front. be this shift in see interesting on more rare interesting neurology opportunities rare as chronic completely there's as of clear, the in in

So you'll direction. that in see things evolve

business. And very, I've as development see before, from us. will important a part So to very again, said continue of you will deals be business more our

Operator

Raymond Next question from of James. Dannielle Brill comes

Danielle Brill

respect I've and got outcome Could year, meaningful endpoints, for data exenatide with to the consider the be RSTQ co-primary what to CGI. should looking the be do X behavioral this we a question. you us for in set remind you another clinically what lavatory the later

Srdjan Stankovic

little of X of measures. that in bit, a describe It's Yes. sort difficult co-primary to the context

that's As Phase smaller of or trial to separated we itself, both order the in because threshold, of have changes. to we questionnaire, think or outcome, assessment, -- positive. And both achievable which assessment symptom have separate a assessed which threshold, then these declare clinical the mentioned, II the global being trial. measures you I high these in and clinician a significantly is but behavior in of We obviously, co-primary, parent red is a improvement, our statistically measures on which

that treatments So These are we reasonable and we would I II, be will substantively measures. able absence even of the that trial. we the on a would to And not in -- valuable the expect repeat of would the these the or size be win robust to disappointed of improvements we even beneficial see we measures relatively both on of replicate. be a end will tremendously difficult scales, with that the out the have there, say expectations Phase in results both primary that lower is, on patients although we to families. have effect on primary

Operator

from Next question SMBC. comes David Hoang of

David Hoang

a So precedent, my couple.

bunch you Is decision? DRP. get So use wanted to on kind there to of of and CRL the -- a the or I to Have did Is FDA's prescribe talked a to KOLs hesitancy there willingness just you in any one. agency's first talk issuance the sense following DRP? of of their part? still excited after conserve a to

Stephen Davis

Yes.

add feel answer, you please take to. free if the want I'll So on,

wanted we've is time after of study. even this kind is HARMONY I take those initially to the interactions like talk KOLs and issued. continue answer yes, of what from describe start have the the announced been a the of the running at CRL little results to to we bit So

and they that we meeting went announced them, data has the changed. and the see extraordinarily So XX results, the not when convened all panel of a around KOLs about That those with through time to data. of were we excited

right continue they impressed the broad a the to So believe to with regular we this population. We through in way both in get this community KOLs And study. medical all strong very observed in we've the array of study the is dialogue the that had done they support this We've space. that with efficacy data. be

are There's XX% the It's and associated diagnose. misdiagnosed to -- subtype diagnosis, they're look get at often patients very frequently a of don't about etiology. sometimes that. mixed challenges with very tricky And dementia

excited in cognition, say On what you the see does would very side integration, way, drug general KOLs, fact consulted is and the antipsychotics. that's have clinically, about the not the community not -- the dopaminergic this impair I with along safety observed we've the of that and with the we've medical that been

psychosis, they population, situation so compromise, you study, a patient not may in when cognition. It's they Is It's large because X-year using an have that see force. -- very it those make But fit actually about progression, this in whether use very unfortunate they these disease cognitive You a that well that very insignificant. in you impair equivalent you it's drugs. get on help established very can you although they in see there. patients the -- impairments to certainly debatable that

continue very dialogue our to experts have our sort in, with of in top feel scientific medical as So broad confident continue continue very, a and we array of data. to we and to

David Hoang

X quick Got follow-up. it. you... [Technical Can just Maybe Difficulty].

Stephen Davis

back the get can queue. maybe in Operator,

lost I think the connection we've there.

Operator

open line your Sorry. David Hoang, again. now is

David Hoang

to me? you Are hear able

Stephen Davis

Yes, we can. Yes, go ahead.

David Hoang

great. Okay,

of which quick hold you remind second of arms. subgroups the us a Just terms in just Can great magnitude benefits question, there? the

Stephen Davis

take to want Serge, do that? you

Srdjan Stankovic

we numbers, magnitude the patients could was late while with was placebo a a dimensional there but no relapses Parkinson's abstract Yes, Owing, psychosis. not disease, day you to of if X in course, it that greatest [indiscernible], there, also body just observed on that the patient was was drug. simply dementia because calculate due relapse small

meaningful withdrawal with disease Next in in and from is patients And that of aware results meaningful. the which Alzheimer's XX% results line observed in line, the with relapse, the significant all in reduction randomized of approximately data psychosis of we same are different is statistically that sub-group. sub-group, risk clinically clinical number we trials. very of, And

Operator

closing Mr. Davis, may remarks. this further no there time, you on at question As your proceed

Stephen Davis

to us our much updating Great. you thank for each We so you on progress. operator, today. Thanks look of joining forward

Operator

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

now day. may disconnect. You Good

ACADIA Pharmaceuticals (ACAD) 6 May 212021 Q1 Earnings call transcript