ACADIA Pharmaceuticals (ACAD) 25 Feb 212020 Q4 Earnings call transcript

Good day, ladies and gentlemen, and welcome to the ACADIA Pharmaceuticals' Fourth Quarter and Full-Year 2020 Financial Results Conference Call. My name is Giji, and I will be your coordinator for today. At this time, all participants are in listen-only mode.

We will be facilitating a question-and-answer session toward the end of today's call. [Operator Instructions] I would now like to turn the presentation over to Mark Johnson, Vice President of Investor Relations at ACADIA. proceed. Please

much. call thank quarter to XXXX results. so us for and afternoon, financial today's on discuss Good you you and joining full-year Thank ACADIA's fourth

Davis, call an provide of XXXX. business, our a ACADIA Joining and who performance, overview today financial of on Executive Officer, the are me Steve review our XXXX our Chief will for from our outlook

Morgan, us financial our Chief Amanda Following Officer, our final Marketing Chief guidance. remarks, Commercial provide opening initiatives. up Customer commercial then Ridloff, and our Product I also and available our your Web on Serge site. supplement call will discuss would updates Presentations discuss and Chief Lykins, questions. results Steve, pipeline Events today for are Stankovic, which Also of Officer; will joining using to Elena then on we will turning and are our the our that for & point Officer, Global who it Dr. our slides, is and Revenue Charmaine out like before the President, Steve progress back to section Planning

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

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

thank progress with strategic and turn We our today. Good you XXXX, Please for five. joining afternoon, a to Thank significant everyone, three slide across in you, Mark. had year us pillars. great

performance pipeline year we us impact our potential financial while prepare launch, innovative advancing transformative strong DRP programs. positions of for Our XXXX, of in our a for as well the pivotal

at the achieved NUPLAZID a our of team, This results XX% net For continues we execution launching year-over-year or XXXX, $XXX.X focused Parkinson's with are a disease the sales linear which patients Since full-year we've million. for despite increase. for growth in NUPLAZID high achieved PDP. psychosis of to of sales to year-over-year in level the challenges the consistent represents pandemic. ongoing perform due These net XXXX, commercial of

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pain opportunities. In science we're strategic six. focused to brought high approaches in We Please CNS potential XXXX, slide our pipeline further muscarinic we Therapeutics, novel within receptor program. University, market through development. us on pillars. turn our We deliver Vanderbilt mission, strategic program. on with acquired to first-in-class the and business collaboration CerSci large expanded brining also our non-opioid a three with Both represent And

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

of our potential Let's combined clinical meaningful review growth. will these drive pipeline with pimavanserin further long-term seven. significant on The slide

We sales outlook, significantly approval in net the DRP, our we're for our XXXX on larger have approximately fiscal cusp providing PDP, and potential market and current a two for years. continue We're $XXX based of for in to $XXX guidance million which a performance NUPLAZID been on to year million. preparing grow sales, XXXX, of opportunity teams

We will execute be ready on Day X. to

significant In neurological indications. programs early-stage treatment unmet clinical have and trials areas advancing addition, separate the psychiatric we're and we our indications five pipeline of on two across with focused Today, in late-stage of need.

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was you, I'll XXXX net for with space long-term full-year and performance to driven prescription the stabilization office financial care fourth in higher at Today, slide Weeks the outlook. XX%. recorded adjustment In and XXXX was sales, our than in channel. in the quarter, increase XX.X%. $XXX was The Steve. end in our quarter $XX.X of the the million inventory to channel, previous of turn historical growth of slightly channel volume QX the year-over-year gross-to-net and Overall, quarter, results, strong ranges. NUPLAZID XXXX. approximately discuss of continued million the but of quarter QX Please This consistent were we in Thank approximately in net by nine. compared QX fourth sales XX% an in

the was the in GAAP increased XX. period compared the quarter, $XX.X in XXXX. from in million same P&L, the R&D turn stock-based $XX.X last of of million the for QX Please compared to the million quarter million slide million down XXXX. expenses $XX.X year. Non-cash increased during to to to quarter fourth compensation $XX.X expense SG&A GAAP in fourth $XX.X Moving quarter, to $XXX.X expenses million in

net million XXXX, For on compared we growth. the was compared turn XXXX. at driven to personnel increased $XXX.X an gross-to-net full-year from from in to on advertising to in million balance the research in collaboration million in ended XXXX This acquisition XXXX, and to SG&A $XXX.X is Vanderbilt DRP related preparation well increase guidance million The to cash with costs, CerSci XX%. compared XXXX. increased to Please XX% our $XXX.X as and in GAAP expenses the and adjustment million for in license compensation million, XXXX R&D and launch the is an related the increase $XX.X We XXXX. with year-end and promotional XXXX. $XX.X net sales, for million in million largely year-over-year XXXX. costs. our to full-year $XXX.X year as to upfront million sales sheet, $XXX.X expenses primarily XXXX, University. expense by expenses, was $XXX.X GAAP stock-based recorded due $XXX in XX% expenses due in $XXX.X million This financial Non-cash was for XX. of This volume slide increased investments to the

the providing psychosis. of XXXX, million. that million $XXX expect For continued full-year guidance for We're for of PDP to we Parkinson's growth in sales disease NUPLAZID $XXX

this the potential DRP, in in range revenues As DRP we're guidance midpoint represents our expectations The for XX% a launch is growth revenue of year guidance. not including for PDP year-over-year.

XXXX, in model we similar as years. prior gross-to-net you As quarterly dynamics expect

of obligation to the from highest first Medicare D gross-to-net patient. to reset annual the due be donut manufacturer the We in holes quarter Part expect

increase we sales quarter meaningful a expect in down sequentially. net be first to gross-to-net first of result a in As the quarter,

quarter expect continue and the we net sales in throughout However, to the PDP growth resume second year. in

million $XXX clinical expect R&D This by driven and $XX expense GAAP for to and expenses million between XXXX, and side be we million. the five expense. is includes candidates in stock-based On indications compensation approximately $XXX progressing

DRP investments our will million similar the in outlook PDP in XXXX. performance compensation We Commercial and to who PDP expect full-year. This This launch. discuss compared approximately million GAAP stock-based represents to new to includes now $XXX for turn over SG&A the to $XX for expense. be I'll XXXX, also a between it related $XXX as Amanda million investment and

of which you, review Thank to solid would long-term Today, positioned our XXXX XX. the for turn performance, us Commercial I growth. like business Please full-year and Elena. slide reflects our foundation to

Over representing $XXX.X through growth. that XX% results. to years, high drivers a developed two have focused like out performance achieved success. year-over-year of the a XXXX, and is I'd past we commercial our culture million several in organization In we on key net sales, field best-in-class point built

broadened year-over-year. double-digit we've to pandemic, our base prescriber leading double-digit growth rates, the growth despite volume First, at

Second, and which is we high our we size approximately and prescriptions, continue segments result of patients the promotional all efforts. NUPLAZID's performing levels X% observe meaningfully In office direct of This share or grew result disease on business. This market market the start a led grew at as to by was for to new PDP pre-COVID we X%. XXXX, NUPLAZID. expanded overall and exceeding across increased of patient education, continuing rates fulfillment of our by our space a PDP

LTC by to as a basket this stable, business to IQVIA LTC care long-term is channel have the pandemic. we As this previously, NUPLAZID In According outperform our has the branded we impacted ongoing discussed continued has products. of QX, and data, continuing been year. enter latest market the remains

numbers be census and pre-pandemic levels, this temporary they below While will we a stabilized believe have remain situation.

growth the work wherever they're as we we're care patients, As for remain our to the potential confident in in positioned we reach whether through XXXX well long-term setting. pandemic, community located, or

to and slide initiatives Please PDP. Now XXXX turn NUPLAZID discuss our XX. in priorities let's growth

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you, afternoon everybody. turn Thank slide Charmaine, good Please and to XX.

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we are In high reflected unmet trofinetide program that in indications. our treatments with slide on like and on XXXX, advancing more innovative growing I DRP, is XX. now with new pipeline. our we have starting would Beyond in across will ongoing programs clinical progress our five detail, pipeline focused developing to discuss and need,

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X program, ADVANCE-X FDA the have pivotal the our only As pivotal treatment be ADVANCE-X. could negative positive, for symptoms are If the now enrolling indicated our study we already positive and part approved schizophrenia. Phase study one first of of therapy pimavanserin second and of

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year, and near-term, of approval upcoming we look forward PDUFA to programs ongoing DRP XX to Also I in Slide potential April We the our Steve. are we first-half program. turn initiate And with Rett ACP-XXX we call this before to we studies of results the back expect for two from Phase the Phase top-line end of I'll And this over that, trofinetide X To in updates continuing milestones. X with a this forward look development. provide date the progress. X. X will on as highlights program study Phase syndrome. in recap year, the

to and we to Serge. allows were to deliver executing caregivers. Thank It second slide number with PDP on while in turn you, greater DRP. for of patients XX. NUPLAZID indication their potential Please a promise help to preparing a patients Today, us our

franchise addressed of momentum disorders need. unmet our of continued strategy broad growth long-term NUPLAZID which of reflects and high pipeline, progression Our our the

of development open mission and questions. our Additionally lives. to their deals I passion expand remains Operator? commitment, for thank their pillar continue critical would will and closing, execute call to elevate In our pipeline. high a science now continue our strategy we employees we business that in and XXXX accomplishments I'll our for continued as up to like

JPMorgan. [Operator comes of line the Cory Our first question Kasimov Instructions] from from

Your line is now open.

to more you initial guys. to maybe biggest your to as around you initial question. you afternoon, DRP, my Thank and see you the of Good market much. what intent wanted the about Great. what kind taking and I expect to impediment would you ask for Thank be uptake? research prescribe, very

Charmaine, question, Yes, for want Cory. the thanks take you much to that?

to to research. because And Sure. KOLs we've I'd able advisory Physicians to the be it chance off-label efficacy be from the up the psychosis. patients out for less vaccine from prescribe we've it when it's say overall, on [indiscernible] differentiates NUPLAZID approved. had symptoms of compared are profile market. the that And one or good excited ideally times very in The as of there's study, is market until dementia-related used feedback there had relapse safety well psychosis three of through once now, the boards to that HARMONY are comes agents placebo

say would I in feedback very we've physicians research. that to market with overall, to So spoken regards positive

Great, thank you.

you. Thank

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

is line Your now open.

question. those taking would Thanks your disruptive, What steps and are about retail? guys. it environment. that long-term the take on you COVID-off Hi, care the Could first is for into moving for what sort centers first wanted that to dynamics, care a as and center relates launch long-term be the it of seeing to DRP you launch, will how back the patients activity? I ask fit into especially potentially in are

question, Yes, want that? Ritu. Amanda, to thanks for the so you take much

throughout be will What and availability We the question. vaccine the the the share and the I'll is like is, that of the you really to temporary linked of the regardless is and to the has a is, is distribution pandemic. key NUPLAZID vaccine well market share for you remind of that and of, LTC Ritu, outperformed pandemic. believe thanks, What that with Yes, situation returning done in conditions. the very element XXXX, to I'd to pre-pandemic

of the experienced And you declines. look compared market XX to products so when basket, XX at it

just XXXX, at situation, to we'll looking and that leverage continue So how foundation. that performed in looking we into looking at XXXX,

that's patient, -- at homes. We [Multiple remind directly drug to just distribution so so always everyone. model, their to directly it speakers] get our shipped they been

and So care we've home. ability they're think that, the at learnings as through And ability through DRP a seen into is to the our pandemic we reach pandemic, that facility in carry patients we've do out to the well. we to or our of through to garnered the launch we long-term as what expect I work access patients, challenge there can whether that their

Helpful, thanks.

Thank you.

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

Your line is now open.

Hi, guys. Thanks much so question. taking for my

a So, away, are not understandable. expect to could that cadence early of and that sense we some the so scripts for of being should we just that of see specifically right written guys least do how the DRP, at to about least detail guidance pickup, have in do think But the in modeling? for start going early you be some have that detailing on get assuming sort parts we at launch, indication days that approved Thanks. providing you you a expectations so of we

thanks you much. Elena, Yeah, that? take to want

Sure.

excited metrics, at and approval. on our Tazeen, premature will little do as what are as on insights into eager early -- launch we'll provide this to provide we to And comment a into dynamics launch. but best launch and So, the far it's to we point

you. Thank

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

Your line is now open.

probably progress for said know that X accommodate in the can challenging color lot PDUFA in that the if year and were to to you track a you date, wondering and case, market. how you for on it's then I is label, label, regulatory to a And question taking of I know you and for had imagine But team. of progress, of April an provide how on any you provide patient demented label on are discussions? I'm kind a Thanks relative population? DRP the you're a going good the not you color. approved Congrats use despite my Serge Steve question. Hi,

be there, them? two mute. I think on you Serge, may want you questions to Serge, take

thanks I'm for the I question. sorry, on Charles, was mute. Yes, and Hi,

As the there really providing is review, it not the customary, are on is or we commenting unless, obviously, ongoing something details material.

with across track the we the all, But commenting So as we label, that anticipating had the the indication regard meeting. to our PDUFA had not interactions psychosis, the that we on X we also day-to-day of earlier, are going FDA. for the we with X but beginning, are we we the end pre the details into not dementia are, the agreements interactions from with FDA been other or everything, on are the April broad subtypes. But that starting the dementia-related have date. based to only types and broad on on sNDA extent, we label, basing In are and of Phase meeting --

that perspective, submitted that reliably on NDA. part a So, broad the the we with receive anticipating as label it based we are will from study supplemental we however that the of

good. Sounds for the Thanks question. taking

Thank you.

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

Your line is now open.

thanks guys, my Hey, question. taking for

the and potentially Elena, So rest year, curious to drug had for and some detail good about just how about Medicare out But large about first through it kind I'm how DRP launch the guess around And this gross-to-net. settle coming we I quantities. just the fourth in second gross-to-net patients the giving should us I the quarters thanks, could year. given Thanks. quarter question just think of the about and of in think a new the where of the like on for dynamics

take you Yes, Elena, want to that?

Sure, thanks.

maybe context break So out DRP. it the for a dynamics little give versus just more you PDP I'll to for

the patient a for heavily rate there'll proportion donut population, PDP. a more So, for as obligation gross-to-net at as as is DRP, have and patients, expect different this will of well we very dynamics mix as be we'll hole there you teens similar us. higher high a new PDP, XXXX, When be look Medicare so since for a a

over because mix, gross-to-net, likely so have the of in So, the the and DRP change. it'll time that will would mid-XXs, higher proportion again revenues a of patient be

Perfect. Thank you.

you. Thank

Butler question line comes Jason Securities. from the JMP from of next Our

line open. is Your now

for question. thanks taking Hi, the

care idea DRP the between is long-term overlap can the of outside here subset essentially, what one setting, And of you just of already give data. us that prescribers is? our of level long-term prescribers just Just follow-up an it PDP return any pimavanserin has of awareness assume does level guidance a growth And to setting a relatively the a care in XXXX? DRP PDP in quick Thanks. high then your and for and

the you want take question answer on Elena want guidance? the Amanda, Sure. you and to first to question

Sure. Thanks question. the for

prepare to So DRP, take leverage current our to compelling care and as we LTC, we're psychiatry, then and physicians. Elena, going point. for then you we'll focused the expand into primary further CNS our second want

Sure.

are, a we've they're range can before, our So, incorporated home within care Amanda And mentioned importantly, patients they and of long-term or a Steve in at we setting. scenarios reach wherever guidance. as whether

be a incorporated to growth versus care long-term what returning partially determined we the end see lower our the range throughout to guidance and in and year. long-term the as census with of confident So that will as based end we're upper on towards regards scenarios dynamics and range in the improves of there's care, far the the rate

for question. it, great. Elena. Thanks Thanks, Got the

Thank you.

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

now line is Your open.

if in of or that's seeing curious Just the update levels differences on kinds last region the you in-person Thanks Can an provide and Thanks. months changed of over for couple channel? time. just taking question. what activity you're by

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You line. again? you Could the ask on were breaking up question

Yes, sure.

on if differences or time an I'm update over months, region by provide and in-person of curious level So channel? seeing last you're that's changed of you what activity was could and I the kind in couple the of wondering if just

want Got it. much. Yes, on thanks Maybe the to take in-person you very activity? question

Yes, thanks for the question.

just we're we in-person in-person this and face-to-face some on pandemic, we dynamic but virtual market or to throughout market's XXXX have and the we'll hybrid. from interactions, XXXX adjust continue the So to to as return navigate seeing like maneuver to

you. Thank

Just to things side, there, shift on more and towards the are in-office we more in-person visits. Amanda's thoughts echo seeing

Having And that long-term on getting are side, the things care patients situation to said more in see all reasons, press where more temporal care restricted understandable do long-term pretty in elder I the we'll care and front getting and broadly, think visits much is facilities. to it's in particularly the in-person have It's is very just additional call to more be a This at for On facilities. that unchanged physician's want distributed on thing vaccines the and that facilities. focusing care several we've clear before, care being on we'll a long-term nursing there's and the of staff a course one than to in remind different of office. pharmacy a director calling care need long-term little or point prescribing constituents that care, you bit -- engaged just long-term of mentioned more we're medical physician. the I long-term long-term facility, ability care of

not them with us relationships many do of have We relationships in to and those all of require be a facility.

since there, the business profits gross of to to that we care. same So, there kind as continue back come we pandemic. drive return had positioned indicated in as numbers before, long-term we the this before well to And feel very we the expect

thanks. Great,

Thank you.

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

open. Your line is now

with view including what the can with partial your factors, out PDP give differential here footprint, COVID color helpful. recognizing DRP but saw on provide you you Could launch you versus us existing trajectory any playing would launch be you and how see

Sure. Elena you want to take that?

Sure.

we what of a expect but much course similar observed with scale. So, PDP, we've larger very dynamics on to

PDP, we state said growth. progressive there's as then is And more in approved you recall, getting really these the and expect If of prescriber physicians a on the you're base as depth just familiar when kinds your because of the particularly of before, space, with of but new drug. this entering grows. two that's a And prescribing as disease primary exactly more factors, well with type both to we sales educating familiarity, nothing we get should been what one And linear prescribing of that seen grows new start PDP. when with you we've launched drugs,

the So, for following true we to same expect thing to PDUFA. looking we're the much launching be very forward DRP. in And

Thanks.

you. Thank

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that XXXX are adding the from the Are that respect XXXX Are and XXX going plays to the of you with it of of Elena, pulls. in can we're reps? and in to year? coming kind coming how coming up number to is in the event we're I'm reps of PDP just the beginning layering as dollars of mean addition obviously, the doing, advertising about you year how curious DRP in DRP. you're the moving middle promotional adding, they this, increase talk kind of as year? or out at mean, dollars roughly I down, to I I'm in PDP around curious we With curious just SG&A some well? thinking push kind about I'm guys throughout year-to-year they the are

hit drivers. on of you've primary so Sure, the two

just So driver first so primary let the first, DRP the launch. sure is for me

spend are year-over-year increase drivers PDP very key field is And to the the similar. expansion. Our that

we a unbranded for And to medical DRP Phase You XXX.Our have implement for similar MSL affairs with investments, DRP. and to from investments, which DTC XXX And marketing plan and and the be we expansion. success numbers, right, include on PDP then of strategy new our we're both campaigns. will lot lastly, which launch think our plan, going DRP had important, studies brand a we've X

expect primary and are throughout should the drivers So you quarters through grow for SG&A the far the cadence as year, as to the those year. the

Thanks.

Thank you.

the next comes from from of line Our Mizuho. Divan Vamil question

open. Your line is now

over because question. take on weeks the Thanks thoughts for they'll the taking my next for six so. all or us thanks Great, DRP

there's be companies shift from on at year trofinetide working maybe And syndrome. coming frame out have the the end of could for the you meaningful what also here. data then gears, of trial? just would Rett think just sort I Can thoughts on clinically several products results your that maybe you So I

where you Now, huge product unmet obviously, need. differentiated Thanks. Can you there's about maybe talk this just from the a being others? see

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being Yes, I'll question terms start terms are thanks in Vamil. of first expectations the what most your of part for by of results. the of in our

And two agreement of with FDA, X in remind outcome actually other of the initial symptoms Phase Syndrome. the being the a outcome behavioral of by to global assessment improvement, of for measurement Just is is Rett you caregiver Syndrome a our assessment trial symptoms improvement the separate impression clinical measures, is of one the which questionnaire, primary the of clean symptoms. overall which Rett is validated

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our Rett Phase first that's of trial goes. to the of data that Phase one second that of as X point is core distinctive initial from the in Syndrome. characteristic to far benefit replicate So regard have we areas the X the the trofinetide of anticipating symptoms we're addresses In in the as question, multiple that

As nature symptoms, are ability to neurological occur. you important well in respiratory Syndrome that symptoms multiple the motor, its Rett articulate seizures as know, the affects system other as

other the specialist seen So, some nature. with development what that is from characteristic trofinetide symptoms, is either addressing different respiratory distinctive that seizures, to like have specifically from perspective, are or one targeted of of symptoms these multiple of things that we area addresses that or we're really programs which somewhat

the symptom to to to this from we with anticipated the is trial. be X thus our data the and important through demonstrate of core address improve able functioning Phase ability are So, that feature patient overall

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

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and thanks April, is agreements, approval for much pimavanserin can my and Since the May, market them how a ahead question. I least taking know you you semi-formalize what do of formalize guess well, at in on insurers reimbursement or June, lot that think Thank able and to could period of reasonable get we months time? be that like? the after away be a a it from the write think access pretty will on this patient soon will Or you. Do physician look PDUFA? Hey, within you

just Sure, I'm thanks going second to for the to part the question, question, the I'm early answer answer going and the Charmaine in ask part access to Paul. of regarding going.

assume and have very that formularies I say before, and payers. is enjoy atypical drug for based Used get use already with problematic payers similar there when approved. today. DRP, PDP, cases value very, price access is is access in NUPLAZID we provides we'll caregivers, any priced with I and DRP in the PDP, there the very change as off So on And enjoy those we mix, was We're good in in no indicated very we expect drug with antipsychotics we've population very no very dynamics, we've similar wouldn't approved, that with payer payers good of DRP use populations. their very both Today, always we label on you and I similar with although PDP dynamics wouldn't than dramatically expect there. a expect, larger patients as know,

to happen So what and little make of I'll let will a we mechanics bit Charmaine approval access, adjustments the as payers and about talk move past just their Charmaine?

thanks sure, Yes, Steve. Sure.

So will extension to it market, has that approved a of product class first already the protected all, as DRP and be well. on part of line is for recognize NUPLAZID a a we have

criteria situation. So, related add simply of both existing because additional NUPLAZID's for important psychosis here. Payers of of are those information pieces an dementia formulary the to will usage status

Medicare, happen is to or considering days demographics, within for so Now of course, the largest XX that the payer of approval. expected

well the On we're up I interim, it support patient Acadia to in In or may programs up payers. before, where with they matter payers, equipped year, and of to they no with set taking payers. setting long we as different types commercial a but care mentioned to it patients anticipate also the be, it and be don't community may the with long-term whatnot commercial Connect got we've commercial services side take happening that

you. Thank

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

now is open. line Your

Hey taking my guys, the all for and thanks the for question. Congrats progress tonight. color on thanks

and a how how you assets could and back, follow-up just higher those to very development from if you of using reads bit beyond essentially you through forward a that from going you're at [indiscernible] external characterize beyond initial perhaps thesis build finding Lavender looking model perhaps and efforts wondering see and case growth as taking level, around as readout study your business suggests just it and it to a how next on important perhaps pimavanserin, the the step Just Thank just much. waves for wanted your breakthroughs the just to pipeline?

thanks for Greg. the question, Yes, much

risk profile that should is the liked that any is any XXX% nothing opportunity, any program, would environment so an with certain with the as having we program, we case, benefit that clinical we program by we then certain, we if opportunities. we when brought in of where say, cost can a drug, that, types treatment where mean replicate with pursued. more data of make particular those first a trofinetide, really we would have should find development and the In I for drug X situation said that those in case program, we and profile recognize there's we liked profile, Syndrome. really I have operate Phase a we So, those in the that, investments, of those in same intriguing we the And very results X, Rett of the Phase we're

and investment the doing we made that investments. like given and have since So the kinds of made, we'd that deal, those opportunity,

risk important wouldn't the it extremely very we're see it of a the us, is if we've deals we're doing population before, it's development in of both that to needs change strategy, from positive described And as our the of negative, endemic three front. move wouldn't our that treatment. forward BD a on effort as and you'll our indicated it's we to If have to negative, putting lot us. So, And more desperately foothold business quite question, unfortunately, into your to to thrilled. this it, -- have psychiatry. what it were or neurology our that to in try anything the If case, wouldn't we'll change we'll on is business that activities, pillars be would one right? have that BD we're any, our which it business, a a we've out medication strategy; frankly, response positive, just turns to get that's impact

We disease. opportunities. indications well lot agnostic, expertise of And We're fairly a we have really, a broad in of array modality going now. of a interesting as foothold the and really things, are in want lot CNS we think across space, are internal things both are other broad there as rare things CNS science to of there own. really the on lot a There some right are and have wouldn't interesting, that

So by very the about development. we optimistic plan have fueled business we're that growth

That's great. you much, very Thank Steve.

you. Thank

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

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talk around the the have provided question. philosophy larger whether NUPLAZID you might And your Thanks the and on Good much potential for to and And magnitude is to frequency increases all relative about for my dynamics. thanks any again, net price afternoon. on that changed of taking gross you way, the details and that actual DRP in payer PDP? given is corner? approval that of could But indication

much Yes, thanks question. so for the

pricing, indicated in the in earlier, but very, very comment forth wouldn't, or get there's we've offlabel As that problematic approved anti-psychotics assume the nothing that is little had we'll I of it's they are very the use far DRP similar indicate pricing I would that they in change payer it, to so population. if and interactions understand so and I this concessions make a premature other on words, even dynamics price

this price as very move understanding DRP, of value today. get the medication us that work would it's treat you bringing. we to populations go disorder of general. and alignment be feel a has that even we very population would strong that might larger based the I we're across kind with done to the in the nothing to consistent so large what and And we've payer so, the as as And into very this forward, proposition been on that indicated, far, the that pharmaceutical course, as from go industry extensive. increases forward We I expect there's we're eager see see and of you'll like And, we probably

Thanks.

Thank you.

Howerton from Our Jefferies. line next question Chris of the from comes

open. now is line Your

I color frequency Great, would and pain on X the little in evaluate trial Serge. for more duration this Hi, XXX there. Phase going thanks and a have And maybe multiple much could for be? I'm treatment the what guess the know question. to program? if we dose strengths you're for the particular, taking interested to is If so designs just

Chris. Thanks, Yes.

well have acute the based conduct potential program Phase preclinical pain chronic as are ACP-XXX clinical on Phase in of model data pain benefit our and the the that to models acute everybody, the pain of Just in X of X chronic both to planning remind in both pain in model. and studies as we the

a dose be as We results obviously from And will regiments. results anticipate year, dose XXXX. year, by initiated year And the Both over post-surgical osteoarthritis are for we that, that beyond have a shorter, of pain will study, and pain we'll will to the the by I and in middle controlled pain. in be little at levels be well on but evaluating the that this of involved. starting will chronic For will we later. to the patients this the be will And end study of regiments. detail of pain neurectomy. we there point all much this hundreds be conduct couple study that different acute top-line we of will approximately chronic following evaluating for planning the we studies this. and range study that wouldn't into levels pain second of treatment the have go the study acute being placebo different dose the top-line study, the This evaluate quarter

we are results recruitment. study anticipating and obviously better update the we'll the XXXX, once we and in sometimes So the initiate start

thanks that. look study start. we'll more both and for as for well, right, All appreciate details out I Okay. it

Yes.

you. Thank

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

is line now open. Your

for is squeezing Hi, on [Ph] [Eddie] the guys. Thanks me Yatin. This in here.

negotiation the education box how of what done? there be uptake? on Or that can Just for that Box mortality patients, is talk updated the may the your as on label, sort in Thanks. would and the be any black to follow-up Black an ideal can elderly quick for to about label with looks needs that respect wording a done there any increased warning additional in Is be question what previous you affect that to wording wording like?

take for want Yes, first thanks do take question. part part? I'll the question. second the you Serge, the that of to

level to I have a NDA. supplemental saying by we warning, safety that of start with confidence submitted the that data we Yes, Related high absolutely. will have the in box our

have that, post-marketing particular with have this application, larger in much years all, as of of to deal experience addition to safety now we elderly safe pimavanserin we a compared terms in NDA. population. First [indiscernible] of our initial And dataset both

So, level when confidence warning, here. that also it's the and the a very the about warning of in we're particularly that safety with realism as we that submitted, box remove black case it's we have to difficult however talking the data box

the I decide minimum really share comment that we FDA what at cannot be So, but ultimately will will in there warning. of regard, I anticipate this the box that in some will wording modification

you warning is with so-and-so and approved dementia-related with consists psychosis, do population class with psychosis. drug patients remind patients risk to box dementia of of such, that currently, in states and related elderly two the mortality so, death one black increased this in Just statements; stating for is not in the sentence and dementia that second clearly

we psychosis hallucination second Parkinson's be a the for dementia. we received for to had modified sense. some delusions that sentence in when disease and So, disease the had Parkinson patients And treatment that obviously in with approval carve-out of hallucinations

do specific We at treatment pimavanserin anticipate look of box in carve you second approval if contain that with out. the So of centers that obviously case hallucinations for the pimavanserin wording the of included. be and will delusions warning sentence removed related wording be psychosis. to to some and in second box dementia patients associated modifications That clearly to with will that have the overall have

quick. all running we're know short on I this sorry. time, I'll make I'm try so to Yes,

be because two So we to second for would removed as in symptoms be Serge would mentioned need DRP. approved symptoms,

just point, were would The and but where come that, it's remains it on first sentence symptoms, that unclear remain if would out this to FDA the we in if whether at that suicidality. similar of the be where take box anti-depressant have are a very depression people young warning who rates to every at situation has in and that anti-depressants today higher indicating we suicide

that when assessment to so a Warning Box positioned in we that is to looking are physicians when evaluating thing patients, anti-psychotics a warning and not well is patients - in make determination addition, DRP that in Physicians for in variable where position atypical class that indication. not talking actually risk there about very, mortality, individual that. DRP today same drug higher the that well-positioned benefit approved are also have they're of In kind class very to are the about the do being DRP And true physicians that that off-label today, make that XXX,XXX we're PDP are they're risk indicating taking do approved and have of

patients and that we'd treat value we're think relates to clear well be if that it's DRP and even the very we judgment. that HCPs that, same mortality make we very to I be positioned approved So well think that to some if box have would label in positioned warning we're approved to

much. so you Thank

Thank you.

question. We have time for one more

line next from & Our Joseph Company. from the question Needham Stringer comes of

open. now is line Your

Hi, our taking everyone. for Thanks question.

similar a seen For and compliance long-term do and DRP, PDP? would rates as expect Thank you expect in a care PDP overall persistence also and for DRP percentage to you similar of scripts to comprise relative you. channel

so Yes. for Thanks much the question.

question In range terms to will of the business of XX% represents long-term the of in it XX% PDP and today, care, DRP DRP, was? long-term believe in business. sorry, XX% care about second be we And our the I'm

It rates Thank was and versus you. on gap. persistence DRP and compliance the

it. Got

you do Elene, want take that? perfect. Okay, to

more And DRP in clarity we'll the in as as compliance. off-label sure. market, largely able what persistency DRP we It's be would premature what launch. dynamics a provide color comment. see far we anti-psychotic to into the similar be on to we're expect little once to and of and based as but PDP, see Yes, greater we have able There'll in market to we these get the

drug. just sticky a a PDP, in really this And reminder, is as

months you drop-off have meaningful a type. the get of So passed therapy, of drugs we this first once couple all of with

mentioned, fulfillment Our would as of get once we similar through a we'll in in rates launch Elena have And anticipate DRP, adherence. type we a PDP. very high are

please closing to Thank Mr. remarks. Davis, proceed you.

for forward again, it. progress. Great. you, We Operator. Thank to on Thanks our appreciate today. updating everyone joining us Look

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

day. Good disconnect. now may You