ACAD - Earnings call transcript Q1 2019 | ACADIA Pharmaceuticals Inc.

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Operator

Good day, ladies and gentlemen, and welcome to ACADIA Pharmaceuticals' First Quarter 2019 Financial Results Conference Call. My name is Shannon and I will be your coordinator for today. [Operator Instructions] I would now like to turn the presentation over to Mark Johnson, Vice President of Investor Relations at ACADIA. Please proceed.

Mark Johnson

Thank you, Shannon. you First us Quarter thank to today's and ACADIA's discuss XXXX afternoon, for on joining call Good Financial Results.

And pipeline the will Steve Ridloff, Executive Officer, opening updates commercial Serge provide the our Yang, our Events will on Davis, on pipeline opportunities final which Elena our out questions. Chief our who section our me call point Commercial discuss we website. performance. Presentation turning and ACADIA and achievements, our progress. from to Stankovic, for that Joining Michael financial are discuss Financial strategy, slides, our recent before Chief NUPLAZID. are results brief are Officer, I available Officer, it our like initiatives supplemental of would up a will Chief remarks for on our financial with and who the President, overview of today call back also Steve will provide to his using

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

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

Steve Davis

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

their Many ACADIA commitment ACADIA whom walks to This opportunity and patients our to Month. awareness share caregivers, at every in was and to Parkinson's honor we April, for in During day. employees participated were their important charity an and to disease we proud aim caregivers. Parkinson's patients Awareness alongside serve

we educational executing to year addition, not Please of collaborated possible organizations on placed round X support make XXXX just country X. momentum, help pillars. across to advocacy turn to several all the events during We In and Parkinson's Slide and with to come in our strategic our significant April. patient

as for we First, disease NUPLAZID psychosis. the grow with treatment patients sales continue to FDA-approved Parkinson's the of only

And opportunities indications to to Second, unmet we our in need. development additional we disciplined pipeline our of business high long-term in vision to continue third, explore continue achieve CNS. leverage pimavanserin of the multiple potential to expand through

first our progress Slide X. quarter review on Let's

execution net in and have $XXX guidance growth first million. and to the forecast with quarter, $XX team's performance. in XX% efforts sales, We achieved are quarter, increase. a year-over-year and $XXX sales million our extremely revenue net the this NUPLAZID of the between be raised driving strong our pleased end In XXXX now on first of our we sales quarter, Based million NUPLAZID our lower

data both inadequate On an as front, evaluating late development treatment enrollment the expect completed topline recently schizophrenia schizophrenia adjunct stage to we pleased in In midyear. we're and pimavanserin ENHANCE in of clinical patients I'm study, our report that to we with announce studies. our response

year. syndrome Phase in And and our With of treatment treatment a trofinetide that, the pimavanserin III for to year. ADVANCED should finally, will quarter treatment program schizophrenia this performance. have end anticipate for depressive in major as evaluating expected. initiated adjunctive negative Our with now expect program, sooner than pimavanserin reporting around top is evaluating we adjunct evaluating discuss results we turn study also thrilled recently to this this line it CLARITY Phase announce symptoms I'm Michael patients study prominent over we to III to We I Rett initiate commercial disorder. from as an the results now that our as fourth an our

Michael Yang

you, been the Please like to with delivering you Today, Steve. NUPLAZID. to X. result This growth making I would their execution we're response an treatment and update Psychosis with progress caregivers. Slide to provide in we've of establish continued turn patients Thank of in on our the of the pleased seen our of choice key from as commercial the are PD NUPLAZID initiatives we of physicians, management and has

that completed in believe to selling We the XX-milligram the more the in stopped as was starts pharmacy published the Society the our Disorder of due will benefits treatment and quarter international as have patient recommendations Movement PDP to this successfully positive to NUPLAZID and by listed quarter. specialty for transition as new DTC distribution efficacious which showing our out have NUPLAZID pointed Parkinson's our only the believe specialty included positive and business in clinically channels their We throughout patients. patient useful. result We the grow a this we and tablets. PD treatment awareness both XX-milligram campaign, of potential capsule the continue the experience. first In February, built medication Psychosis, updated a for pimavanserin the

served Physicians support these PD guidance review is this told about for care Psychosis. the peer in to on treatment Our have team their first appropriate that important us guidance which recommendations. started as educating the useful with patients recommendations quarter, help

can by see, campaign customer-facing trajectory to solid reflects field and this established base, our Slide our have continued in believe in growth expansion prescriber response continued growth new you driven DTC force. we patient the our starts and a our as to XX, We of XXXX. Turning

treatment and more use for PDP. more see to continue NUPLAZID we as physicians Importantly, first-line

of X.X% overall we achieved business, the first sequential growth volume quarter. approximately the For in

delivered long-term with are specific higher quarter. long-term the this pleased growth rate which We our in a especially response care commercial care initiatives, toward

The XXX,XXX patients feedback market we continue their received over I'll over it in grow population. receive and our supports that in to to caregivers treatment long-term our the provide and about confidence Serge to positive XXXX to are guidance patients to for We continue this the community NUPLAZID. on turn in PD PDP current opportunity now experiences with pipeline. our updated growth the R&D NUPLAZID estimate We having updates from for our intend share and Psychosis.

Serge Stankovic

forward Today, our you, some progress. Thank I exciting sharing updates Michael. regarding to look R&D

start particularly Slide lack suffer XX. selective a Let's patients agonists. by All who other with Pimavanserin in is dopamine, primarily first-in-class is worked Parkinson's dopamine. from serotonin of antipsychotics which inverse blocking problematic

shown already to results PDP, in categories has are clinical stage in addition currently late In pimavanserin we X all progress. clinical evaluating positive

X On just Slide we Phase in to with a share recent trofinetide III highlights We XX, stage for also I syndrome year. you. are later late few a programs. are advancing to Rett this program plan In initiate wanted total,

late First, and patients enrollment treatment, predominant stage studies, as negative as antipsychotic ADVANCE Steve an both attractive symptoms. with of inadequate schizophrenia in completed for noted, our evaluating pimavanserin for to patients treatment with ENHANCE we recently response an

Second, estimated for MDD. Phase with III that positive third, we Rett Phase initiated II with results our were the in Starting pimavanserin CLARITY depressive trofinetide adjunctive disorder for an as in or published program patients treatment Neurology. And major for for There the of recently syndrome a our which ongoing or will DRP in is patients about to States, half I is affect psychosis FDA-approved more detail. diagnosed. little dementia-related X.X in approximately review United XX, are no treatment DRP. million programs Slide

as in DRP is previous relapse X Alzheimer's disease as study HARMONY in study. study leveraging is a study. clinical observed HARMONY benefits PDP we III prevention patients the pivotal studies, our our well psychosis Phase Our

for get all response those patients months to relapse. time randomized a patients stable pimavanserin to X for additional in primary reminder, continue to pimavanserin fashion and As primarily, with with are placebo or outcome a are only months treated followed X an and off-label is either

FDA the development for this with Designation supplemental program robust anticipate with results of from received Breakthrough submission. FDA, second this We This Reading designation results the NDA We can for have agreement serve an with Interim study final second year. XXXX, in the as of in the the a half that pimavanserin. such basis HARMONY Therapy

Today, Let's treatment to with to or people XX MDD for SSRI SNRI. an in MDD care standard turn of program. the is Slide initiate with our

respond this adequately treatment majority However, do symptoms and initial depression. a continue to of experience to patients of significant not

its our take that the significant treatments and leading profile approximately patients, difficult a these in side therapy. pharmacologic and new believe clinical for therapy significant struggling adjunctive and consequence, pimavanserin patients the CLARITY additional unique compared in exist as sometimes the MDD. unmet represent an needs result trial As approved first-line important treatment adjunctive Slide to carry million XX United high effects needs burdens, States both drugs with decisions. to can Phase II Unfortunately, X.X unmet We for MDD may the adjunctive therapy for people today. highlights and of

and the enroll enrollment standard SSRI United the we are Scale which designed even were SNRI. MDD. patients results XXX with results the primary given endpoints pimavanserin The placebo of including more We adjunctive achieving have or adjunctive endpoint approximately as item X. antidepressant both we either clinically have patients unmet will X-week exists with involve States. Stage on evaluate relative are initiated. an in outside initiated studies secondary to to pimavanserin the a in The potential XX MDD, of CLARITY-X the high positive Phase pimavanserin adjunctive these program in CLARITY-X for treatment patients MDD, United to Hamilton We MDD. will double-blind and in recently primary study, treatment who and key efficacy of and designed, treatment are both III an enrollment in our from statistical XX Slide our Depression XXX need control to believe safety development shows score. for in CLARITY-X response coming as placebo. randomized CLARITY-X of parallel multicenter results baseline treatment has overall results, is important on Rating as will develop and the inadequate approximately robust for that therapy change impressive, the total study States. initiate months the CLARITY seek significance

and at our U.S. X% XX% FDA-approved some no the symptomatic, submission. patients. XX. those Our suffers therapy. from therapy have least therapy, roughly X schizophrenia additional an could Phase adult of meaning with be combined With III patients I'll for population they treatment NDA response, show Slide to response review approximately believe program, requiring is one supplemental now of we II trials, to U.S. basis inadequate population schizophrenia remain XXX,XXX addressable starting but inadequate CLARITY of these the highly the response study, Phase Approximately of on

in announce ENHANCE topline data remain to and enrollment on study completed midyear. have track X-week We our

the design. On change XX, on syndrome reminder, negative graphic of the Slide primary in scale. is and the a ENHANCE study this we the As representation positive study endpoint from a have baseline

U.S. no schizophrenia symptoms, X addressable population XX% to predominant Approximately cognitive there schizophrenia. symptoms is Turning of withdrawal symptoms which treatment to apathy, potential Slide impairment. negative with FDA-approved provide and negative XX% us include Predominant of experience the approximately lack negative patients. of XX, social of the million for patients emotion,

results ADVANCE have baseline enrolled of expectations Slide study graphic our the We expect XX, have announce items change fully the negative the we now symptom XX and ADVANCE to study On year-end. The XX-week around assessment primary of from design. endpoint our is scale. ahead representation on a

there is the this ACADIA financial Turning clinical following turn to I'll rare females, in an forward to submit If in to a our no Phase Phase in is neurodevelopmental syndrome, XX. X,XXX development life. call XXX plan trofinetide you performance. Rett and for for to R&D approximately a I this based now look Rett is study. X first discuss trial in initiate III approximately study debilitating females on patients on with United predominantly X,XXX of Lavender, the for medicines syndrome and XXXX disorder Rett of States. are our an single X-month evaluate and disease, on provides updated of to This Slide positive, months fourth there over III study first progress. XX, in for X is This to for which syndrome, syndrome year. a our apparent of Phase our life. the our beyond. NDA III to Slide XXXX, months normal approved trofinetide X We XX that Currently, in potential quarter summary updating affects the will Rett time aged milestones Elena the exciting to occurs

Elena Ridloff

you, Serge. Thank

was compared first sales quarter I'll In net approximately million financial net Slide The has in our the to $XX.X for we was the was stronger than discuss growth, distribution in gross million less to performance more $XX.X portion This $XX to XXXX, favorable to XX.X%. this growth due driven to and Now increase our of of volume to million an than the of growth first XX. sales, results turn The Please specialty XXXX quarter net by adjustment business, recorded in the approximately which net. outlook. or XX% anticipated XXXX. of year-over-year. quarter first gross net quarter primarily our XX% adjustment XXXX QX forecast, of

reminder, As highest the of in first Part with XXXX. reset at the to the annual consistent gross inventory for net a typically of Medicare year-end the first the D patients. quarter, Basic is donut to due was end in the quarter hole channel

our period the additional noncash, $XX.X the in down due million quarter XXXX, as as operating and million the on million $XX.X expense, of increased was to million respectively. Moving increased GAAP stock-based used of to advertising compared in $XX.X our due $XX.X in as during from charitable $XXX.X the $XXX.X GAAP goods increase Slide study from included related in marketing to operations costs XX. SG&A first QX R&D These on first the ended million, the with to pimavanserin, million XXXX. Cash and was for for approximately for total compensation balance quarter annual to spend cost campaign, expenses DTC in primarily in in to $XX.X increase million The in amounts development million XXXX. of including of quarter the of P&L, well million year. as $XX.X quarter expenses cash QX XXXX, to the sheet. QX million first costs sold, compared primarily well contributions. We the turn The Please of guidance expenses, our XXXX. trofinetide. million increased has same XXXX, were $XXX.X $XX.X for was clinical increase last quarter of investments to $XX.X

the for growth mentioned, be million the approximately growth of in year-over-year. forecast to have we Steve represents midpoint volume of XXXX, We now and this XXXX guidance range, million. guidance sales lower for the between end and growth NUPLAZID approximately XX% range. As full raised the expect and year $XXX year-over-year net continued this At $XXX revenue XX% strong

expect We to mid-to-high to continue forecast year the the adjustment gross and the full XX% teens. to QX in net range to for adjustment net in of gross XX%

between to program III to depressive quarter. our to forecast $XXX $XXX continue and will R&D quarterly a manufacturing commencement we expenses, up III the the trofinetide of to second Turning and This R&D be Phase million is up in basis, million. GAAP expense expense to disorder related the step major On scale Phase starting for program.

XXXX. expense forecast reduced the million to We full completion contributions. and reduction advertising continue $XXX to GAAP million down SG&A our quarter. basis, year expense to be between the expenses second in is the of we a SG&A This of $XXX charitable a starting step DTC quarterly and due On expect for campaign to related to

I'll $XX noncash expect be Steve. turn that, XXXX. to to $XX million million compensation the continue back We with to And over stock-based expense and between call in

Steve Davis

our NUPLAZID a and in great executing large is additional XX. Elena. indications; call market of hard and Operator? appreciate all are open CNS success. of now work driving development. truly digital our our employees dedication questions. team first, Please pimavanserin disease pillars in leveraging to off Great, second, In our the psychosis; all company's third, XXXX; X start, of up in the I'll on closing, business continued strategic who growing Slide you, thank for Parkinson's turn to pursuing We and

Operator

Cowen. first [Operator Ritu comes instructions] Your Baral question from with

Ritu Baral

there strategies And a renewed on you discontinue Or question to follow-up keep to or I've the about an other given that you keep that the got basically you. to why negative seems going? is first working a My Are for little it growth thinking commercialization going? detail be option down, on symptom DTC ramp the study. would more is

Steve Davis

first. do DTC with you that deal take Let's want Mike, to question?

Michael Yang

and summer. to that through -- Ritu, we quarter it's going and very go XXX. think you already normal people we XX/X, It's will now second that planned awareness with attention run into like I positions, the keep a the be of had website, did that throughout from to through to flow see always which campaign on that. of execute which their first our a go through is create -- campaign the And and bolus have the not quarter, as benefiting it kind campaigns this,

more demand. will way assessments. campaign weeks few ended the just process of a so we learning generating the we're And, be to we'll So now doing the awareness that and along as that pulling again, ago, be physicians through in

the the running see keep don't to throughout we So campaign a need year.

Ritu Baral

And it. -- then go Got ahead.

Steve Davis

question. Ritu's please On No, On symptoms. ahead. go negative

Ritu Baral

the on data? scale, difference? these clinically like upcoming What's good comparison to we as data constitutes landscape? Phase minimal What clinically And in negative meaningful would especially symptom PAN's patients? the constitutes What the to about good look here, II data important truly what the think to

Steve Davis

to question? Serge, want take that Right. you

Serge Stankovic

about inadequate Just negative you Ritu, study? -- are the to are clarify, predominantly ENHANCE for you study asking response? Or negative asking symptom about

Ritu Baral

Predominantly negative symptoms.

Serge Stankovic

this and what that been meaningful. be will there exist sizing design may we used are in toward -- the writing symptom study regard later the and has that disclose is negative of specifically reading symptom very year-end. out endpoints. are the are assumptions clinically clinically be and effect of of as the meaningful we one are the trials a the sizes negative few we comparable assessments out didn't certain made scale that very to assumptions considered we But year the assume. This this for We study, will We effect our the we that validated accepted that made sizes and for

Ritu Baral

Delta powered around? that you is that What

Serge Stankovic

Yes.

didn't disclose we said, I this. As really

assumptions meaningful around the we not our that. appropriate, But in trials. That's are We usually details. clinically made disclosing course, of

Operator

with next JP Cory Your Kasimov question Morgan. from comes

Cory Kasimov

Serge exact you one of summer. size, was study responder feedback And not but gotten to the guess I asking, the to Ritu had run enrollment but And the Is the be for you're then the Phase terms, already you've for least well, online on can what these first with from there will just schizophrenia disclose trial a CLARITY, and front? U.S. glean probably all running. speak for on pimavanserin? bringing and first, to is the the in Maybe expectations this from curious actually study? as trials my this effect what you curious, anything in, potential up second other that's for you're at especially one I'm studies, you've since very, upcoming there can front the and kind sites your was this I and inadequate going III for looking in in general MDD KOLs similar

Serge Stankovic

Yes.

Let me start the that. and around the with assumptions ENHANCE study

study, With a the a ENHANCE because it's little and is of in there products studies inadequate this. response, different our approved plethora

majority wide X.X. is there currently of with range X.X. X.XX saw of the with A X.X a between treatment they approved somewhere monotherapy only few a this. that going to we sizes And from So is that of starting exceptions size, effect and range in effect above

obviously, With that Phase we we of the of There trials, in are treatment. So for sites imagine, this so deltas regard no on all the as that for to the worked a that is again, is, the are U.S. scale, don't the that related we therapy, but number to comment the trial, to sizing assumptions I adjunctive MDD. in in X.XX the our trial. our assumptions, II have just assume more of X.X make the of the want MDD, around discuss trial on and schizophrenia are trials monotherapy here you trials. other in we range we specifically this CLARITY benefit really, one to were an in treatments when adjunctive

results, a process. study terms size, engaging the quite to smooth bit with quite from And of perspective, a the in participate trials, of very sites of participation had So there positive we was was that we, interest. for of bit interest the so of a recruitment a

on with trial, even a interest, little reflected have that as to we CLARITY. indications across to Compared a our have and higher other We expect, probably a smooth to now, obviously, there going pimavanserin say, how trial that well, fairly will in mean and -- for we I result, as the be the similarly, timelines trial, ultimately, is like you fairly were because the bit that we -- way recruitment follow able is asked level of will better I have recruitment. CLARITY our in of positive all our different we projected recruitment of in

So no that. depression is to exception

Cory Kasimov

remind just us how to you it Can II recruit the CLARITY Phase you long took trial?

Serge Stankovic

than more X It was a little years.

So it trial this to expecting be X the X.X complete situation, will in trial. about years a to singular we are that

Operator

with Securities. next from Butler comes question Your JMP Jason

Jason Butler

or campaign on DTC, mentioned the you the another from this up commercial, the it before one, impacts bolus last you how can you us got First frame to impact compares for on the follow maybe positive and time that DTC the year?

Steve Davis

to on want just what? clear you're bolus sure to The I referring is we're question. make the Jason,

Jason Butler

this the versus you of pull So got through the you're through therapy. you year DTC to patient now with bolus and in -- to the answer mentioned of process campaign that on this patients inflow looking out going question the last into year, a previous year in that

Steve Davis

I Michael, don't to used we bolus, I Michael try and but do the answer want the it? term get to so question you think does I too, think Yes,

Michael Yang

first. address me second let the Yes, part

this a very was awareness. compare campaign to disease think year course, did ago I two we in the is regards it's first brand-new And of that hard a impact. The to so campaign,

very healthy is phase with et the campaign -- seeing the digital bolus, is In I campaign. lot websites, believe designed the our rate the a of we was awareness and interest campaign. request getting brand the regards a attention awareness. into generate and fact, properties, better what interest is first With rate we're, we're That's stimulate to do, cetera. and was referring the to what we obviously, really now branded rate interest to a with of What that original

an ensuing become, revenue patients to the We're So quarters. after attract we're patients level. appropriate trial, on generate Those and both also doctor anecdotally there. go are good starting that engagement in some will data and process hearing paid they the getting in at

year, we'll So in we the beginning the benefits XXXX. of the that phase that's why the of get throughout campaign so

Steve Davis

little a color there. of just additional And bit

process the X I walked kind months, sometimes sometimes their see of on the Parkinson's patients -- of X more becoming months, of the every patients aware think last doctor through drug. every earnings They frequently. a we bit call, typically

drug this then a create messaging a right a they appointment them to a free that in patient have by months and process and full full an prescription of and start of of awareness, quarter it's repetition started going times, drug then that after a beyond then some all then increasing paid later getting we from benefit from a many and So through that of you revenue get the quarter awareness. you full the

the the for we'll earlier I So of done DTC over benefit the we've some period of think expect making months, was time. to that the Michael last in that several on point continue work is,

Jason Butler

one the enroll into the trials. the built worsening expect you just about happens? question if background And on protocol what at anything to And symptom Is the Can in during positive a symptoms any positive negative the trial? study? just symptoms point has score talk there patient you

Steve Davis

question? want Sure. that you to Serge, take

Serge Stankovic

a In for the the fairly able. patient the well symptoms to be negative requirement symptom study, that controlled there is are positive

So negative studies. predominantly it's symptom

certain the to positive enroll are to the a be of study. So minimum at symptoms in capped able severity

what are that or the throughout seeing. apply their antipsychotic, in positive saw It's but change be worsening should potential something trial we and clinical patient's they in symptoms, continued of we therapy. continuing happen, discontinue trial good investigator the that's express trial a symptoms, have of In frequently and terms the to anticipate most there physician so is patients whether background decision obviously, they that the that to symptoms, by of it's a if the are the something still control not for want because on part, we negative positive

Operator

next question Sachs. Salveen Richter with Goldman comes from Your

Salveen Richter

responders So patients. you specifically benefits wasn't demographic risperidone trial, symptom and patient in symptom II NUPLAZID score subscales. your negative and inadequate used saw and the PAM Phase negative some in schizophrenia in But or positive you

So should two think to readthrough how the these about patient we here demographics?

Serge Stankovic

we that Salveen, dose you're somewhat in other therapeutic that's, of words, that correct, a was it versus X-milligram of therapeutic on saw alone. with while study, in a dose risperidone yes, efficacy is of risperidone that In trial. was and used the study of tolerability X-milligram the was paradigm risperidone the And side doses sub-therapeutic full bit we with we X-milligram saw what the than saw improvement some pimavanserin, aspects, In that the what comparable risperidone. in risperidone and and we better the little combined different. trial

effect of is a paradigm, So we, looking a but atypical are trial full are And for between are What trial little people still this efficacy that looking demonstrated atypical the synergistic response. pimavanserin. risperidone antipsychotic don't with have obviously, we in different obviously, enhance that synergies to on that the antipsychotic, we of adjunctive treatments.

hence, name ENHANCE. the So

Salveen Richter

benefit than Are awareness much a strategies long-term commentary DTC provide setting. there to other the could undertaken be that here? just your that care didn't maybe then on second And question other

Steve Davis

ask So wanted Salveen, here. the and I'm going Michael, point to to you first just clarify

Michael Yang

we an was there campaign, said the awareness, believe first are Maybe we that branded don't I first disease to that actually, the see I dynamics. care in And of that when our long-term our in from campaign. campaign awareness part quarter. seeing sails benefit long-term are in not specifically the did conversely, a expected that No, did I care. compare in point wind We is campaign, the believe long-term disease which you the What first benefit with misheard. in the see impact not we is And branded in we in LTC. was an mentioned campaign, different care to fact, did

benefits. seeing So we are

care we just over be our that impact with that we'll time, have that that. is campaign But very whether branded evaluating sustained finished. that with pleased our air, Now with in on disease, we we're saw long-term

Steve Davis

We to just not ago. crystal an I'm back of awareness impact. ad, did see just disease the long-term be year year, ran care. which Branded a see much in sorry, clear, this campaign finished we

Michael Yang

That's correct.

Operator

Your from Tazeen of America Bank Ahmad with Lynch. comes Merrill next question

Tazeen Ahmad

question ask wanted to just the guidance. a to with Steve, regards you

good enough feel leads so you ready with the to call on that that wind have. down the you on far, bit that focus and all DTC So that you're you a stated

think had long-term I also in you care. mentioned you an uptick

the more So of then what to I raise end? order you well see follow-up. end as guess I higher a in need And have would to the guidance lower as

Steve Davis

going to Tazeen, Elena let the question. I'm answer

Elena Ridloff

discussed first of midpoint much with At we the -- that's quarter, of we what's our included our as full in on track growth. pretty year-over-year the had the guidance. year, guidance, pretty XX% the midpoint in that's for Tazeen, volume

point are we our in against the this will the the we executing So low-end guidance at increase how and, we of year, pleased with hence, feel very range. why

we a number of Michael track DTC, appropriate, with seeing how we'll we it commercial and adjust initiatives guidance. in pleased As what versus continue and full and future. as to are the year will we're far our with tracking we're so mentioned, And have that

Tazeen Ahmad

go just -- ahead. So to clarify

Steve Davis

saturation, it going it mentioned we as certain the I'm just the so through DTC that to stop that in actually earlier, campaign you a expect order planned, seen exactly planned of clear, as beyond say where campaign, televised the the poll run campaign where ran to to the portion point -- do television need benefit. -- to of reach benefits the do we've conclusion stopped because on it's we television be not to We of a but we ran you campaign, result. that. And

good the So really that campaigns. about the we in returns early we feel have

Tazeen Ahmad

How your drug changed? does a how long give color just more can that Has program? you free many patient renew? bit it can then little last times a And and on

Steve Davis

Michael?

Michael Yang

Yes.

the for they is they come our standard XX-day the if another program re-up needs can a hub trial through services. and So distribution when for patient it. And that free XX-day

if hard we a get an get of days, rule, we but not, the the, it, XX needs days. but hold are majority someone extra patients as XX we that hold So don't

Tazeen Ahmad

Has And has the use stable? Or of that program? that been that changed?

Michael Yang

It's pretty stable. been

Operator

question Duncan next Cantor Your comes from Charles with Fitzgerald.

Charles Duncan

all, congrats I two, and of had First a pipeline. good and commercial one quarter on progress one

the comments the at you rate The what XX-milligram about could that and tablet than on you positive contributing first impact little wondering persistence regarding a on versus long-term care had expected. else long-term care XX. the commercial, talked least if is X with initially. DTC, growth you and of the growth the some I'm by And was touch you perhaps now to higher

Steve Davis

Sure. Michael?

Michael Yang

very care SP. pleased long-term saw Charles, both we what our we in were with and

specialty to we and new the brand the demand, of in unit care our want pleased are clear, with channel. growth I pharmacy very So our bottle long-term be demand

campaign Specifically, have. commercial what really we long-term continued around benefit what us drive in a it's the long-term Basically, see I care growth and systems, through accounts addition, is up access that to mentioned this helped we awareness generating of disease capabilities, And our is deeper that on a followed identified system have in we demand process. up we care, of nurtured setting. where identification the the pharmacy, that's to that patient think what by starting deposit PDP account focusing and set a with doing we've in you're we're maturation a at the and further in then system champion, system

by aided the the that by pay pay on in to you're long-term awareness to part And That see what driven also that's started So off DTC starting care. in think campaign. our with execution. I is dividends commercial

Charles Duncan

for my second is then question And Serge. perhaps

ask ENHANCE terms do unmet even to negative care laid greater of versus but potential you inadequate number asked value you and, pharmacoeconomic assumptions, step patients, patient just is of the think and response in the I to and been have where and back make questions impact on need ADVANCE, the et two versus size and, out clinical pipeline a therefore, specifically, several think effect symptoms, about you perhaps, indications? of the the wanted the But on you, cetera. when On design

Steve Davis

Yes. Serge?

Serge Stankovic

actually, great on, lot these is, that beginning there trials adjunctive provokes both are one that's is in and no adjunctive the make approved any of to interesting thinking schizophrenia. point here Charles, currently, trial. I And a one of question, at wanted antipsychotic a for that treatment

time, be symptoms. grail. There able at numbers nothing demonstrating symptoms more that to but practice would same vary that it that widely, X Now perspective, the there have of using XX% advancement more they psychotic also truly the, holy benefit X it are control time. nothing both that antipsychotic And trial, in because adjunctive on in or negative focusing adjunctive But that schizophrenia. is more is is the ENHANCE general, and the antipsychotics the I that with is in one though it paradigm. that is a while positive symptoms approved, the medical therapy. same not from demonstrate would of we even is are And on schizophrenia syndrome perspective, of antipsychotic negative a to adjunctive are treatment symptomatology, efficacy in at treating scale, from XX% patients say treating trial, true in on negative many that in the Obviously, patients could a go there patients are we or great that the in great ADVANCE the on from

on to they it are issues positive producing do of we also the when about advantage a would interesting I this. and are kind here. therefore, we rather less adjunctive very more expect same So using you than receptors a talk and antipsychotic perspective, producing benefit safety benefit, if the and see that hope on efficacy treatment, and effects the same they some this I a great from And, brainstorming not at a hitting just neurotransmitters. be looking for to are side more of tolerability see. demonstrate would is like that and a I even that, It's advancement if question that myriad or

Charles Duncan

That sounds good.

if request, onboard? it, little or or them have I of equally perhaps a than or the seemed other you quicker kind I'm and are for to wondering, taking just that appreciate had a ADVANCE Sorry study, more -- and one enroll interested you clarification expected that in we physicians less enrolling and is is

Serge Stankovic

are, of approximately clinical months, There are the they with last many competitive reflection continuous is as the always because contributed time. perhaps the on essentially, trial. a caught say it's trials is You same -- a maybe study. that's that same recruitment wouldn't an We wouldn't the factor that I is X-weeks time. that. ENHANCE factors progress are dynamics that out several there know, X-month countries trial sort these interest, environment, ADVANCE influence and in to ADVANCE also don't that, And the at would doing there the much I X we where the And up as trial. of much in delay think just interest. expect trial The at the us. but versus this trials that discount actually only I that, but

So the readout be X later. will months

Operator

Carr comes Company. question with Needham Alan next & from Your

Alan Carr

is A antipsychotics being at around are most follow-up most often being often previous are and ADVANCE one, in X contributors. any meds with baseline ADVANCE on all and background run-in those And ENHANCE. in there Are of the one stability which there is respect used trials? used that disclosing then which to you The on period is last particular, sort charitable around symptoms? ensure to positive

that. If you comment on could

reductions think would I you there be said Can elaborate? you that. in

Steve Davis

do take the first questions? to X want Serge, you

Serge Stankovic

Yes. In regard to...

Steve Davis

the if first think. Maybe I you could part rephrase

Alan Carr

meds. background The

Serge Stankovic

yes, secret Background that a is prolongation meds, been that, QT to do we've warning allowed saying trials. all there atypical always related no antipsychotics in that not have about are our

the label is a So and that of because indicated some the prolong and was antipsychotic without label excluded not their we of drug combination QT only our allowed. reason QT that prolongation

should that antipsychotics. atypical from all, we consider So all perspective,

is there secret no about So that.

Alan Carr

of disclosing do them are in you specific terms trial? the enrolled dominate or I which all drugs any the patient of in wondering if was

Serge Stankovic

not course, of top somewhat of we results. the antipsychotic. of the didn't, fair depends there what is line out where fairly, we fairly are But there. review also countries But the on mean, are. know, naturally, have most, the will the representation you we approved. antipsychotics different I time of countries, these a Well, this use accurately we some that approved In obviously, at follows drugs This, and

in into on, is antipsychotics used that most But frequently that most our regard. we in we trials. didn't the the see So go specifics

Alan Carr

see are… like they that run-in a And in ADVANCE, is if to anything there

Serge Stankovic

a of the Well, entering we period. phase they same the first is weeks. we, run-in patients and in evaluate a screening trial for X, may need baseline over is where screening do trial that the criteria period There qualification and X meet to there know, the up period, the then and at go visit you of all, to that

that's one thing. So

symptoms background seeing antipsychotic the that make levels that of In actually to addition, results antipsychotic these also are both trials. a sure are of That's of we patients to particularly confirm careful spite relevant have in and are background selecting very well, that's therapy. in for we blood their relevant, they in

seeing noncompliance sense, symptoms are, stability are we of So some we're treatment. both rather and looking inadequacy results with the than therapy, the at in in

Steve Davis

take that Elena, as contributions, Charitable about you question? asked well, want Alan. to do you

Elena Ridloff

medications charitable commitment to of part ensure need to provide Alan, to contributing access and that to our prescribed patients treatment. help is have their independent Sure. in foundations assistance patients

portion the in the of year. For donations XXXX, quarter greater occurring are a of those first

Your next question comes from Jaffray. Danielle Brill Piper with

Danielle Brill

on actually think the had you channel usage and a on previously. of patients was I on question you just what PDP with XX% be quick percentage more of mentioned question some able it a specific I to are distribution. Would on NUPLAZID NUPLAZID? provide color that

Steve Davis

want said that. what Do going let first to clarify was Michael previously? you answer to I'm

Michael Yang

we're, said previously penetration digits. double the I regard. low treated patients around XXX,XXX there We and in that Currently, Yes. are our that the would was say, mid-teens in

I how the that's question. would So answer

Danielle Brill

question has caught growing some are was okay. channels specialty trends the between to if the had able you other helpful. faster, LTC specialty volume color and I would guess provide and Great, on would color see. of which I sort And Any I be be up? growth

Michael Yang

is see way have generally about different wax and of long-term the they're business space about always dynamics. we've think And is about So business, FD, way of wane. more SP depending trends. of to that different X/X. been. kind just of we pretty much care is that FD different represents In the wanes, represented on has specialty is it roughly side, independent X/X it it, channel, where part which the X/X of waxes which component, about And distribution, is of which It office it's the and things makes been ecosystems dynamics, X/X. the a There and way, our our our that

we didn't said of that is were that of more things the as a to note, channel robust care, though, that growth underpenetrated launch more in recognized volume we with that we have a specifically, little ahead One it and the long-term the that, beginning. that's kind of the that rich because efforts has we -- just in we're always

force you commercial there. model and evolve we our sales know, we've as continued So expanded our to

as good also well. is SP So we're to growing getting be of that, results out but going

have of X/X channels opportunity to grow, a lot X/X, both split. So the be would

Operator

Your Leerink. Goodman next from question with Marc comes

Marc Goodman

bit? added about a business to Should opportunity expect year? get we little trofinetide talk development of another this pipeline you to type Can the

Steve Davis

Sure.

focus trofinetide that is So we we and in great to of yield way that really We expect fruits strategic think a very disciplined clearly this business it's calls, we way, that the a one to that previous the as process. very that from of on continue kind call important development on our is on example X and said of many pillars. have, disciplined we

Marc Goodman

from early ask the Maybe you So perspective? that a about late right? to I as III expect are you you're practically way, in I ready, question trofinetide looking curious what phase, at? was phase, in thinking Phase just different bring guess, products How we was should about

Steve Davis

Yes.

say we is into think dependent. I asset have case them. I policy, much don't specific we specifically So a assets or regarding -- detail too talk of just would as every categories. just about we matter get do priorities, but We specific don't simply

big we Of what a NUPLAZID, different did launched additional and blip and the then before a more time assets for at in small about a that is launched at so year that's earlier just assets, than reason longer see And rather we're about a judicious and very drug their look just doing. helpful profile saw screen stage if we assets. any and have X period I'd it's assets a and what additional be year color, to more course, we when when companies survey would I launched acquire say risk-reward on some wait. late the first over more stage radar strategic blip didn't NUPLAZID, would three that we I

Operator

Stifel. with Matteis Paul from comes question next Your

Unidentified Analyst

Paul just i.e., include you schizophrenia. symptoms study, response and to be this have the wanted question expect would be regulatory just one to are negative needing guess I Matteis. file Addon] anticipate schizophrenia for enough to the is follow-up. This additional on I on path you symptom positive, negative quick able for you then in a would study studies? both inadequate indications for like clarifying to both confirmatory on studies the I ask would [Denver real or And that if

Steve Davis

Serge, question? take want that you to

Serge Stankovic

certainly, for but with as for requirement know, depression, But What in would are similarly us as that adequate the once premature speculate on well. the it paths confirmatory we regulatory variety two regulatory until response of trials. looking we just that options, see major will Yes. and is the for of course a the be approval approval potential with results we will of and FDA and trial we certainly address we at to results, have we address

Unidentified Analyst

guess And the I had is And can, DRP into question the study? how treatment disclose run-in at seeing this, just on I HARMONY willing through it? one this you or what this you're in expectations if get program. going point, if to of the comparing proportion you your are to patients

Serge Stankovic

over shared that much stabilization XX-week I I period that's being X-week continuing, than study bit X-month seeing the are that what patients can larger phase achieving label X, a I, of randomized pretty and of is number in we and that say and we are some, before, are open the and stable, anticipated. which treatment initially

previous trials and can this that, seeing we specific than we in made other assumptions bit disclose or are that are, little So did that. the we say, better I a on numbers, we pimavanserin not but than of around what saw basis with

Operator

Sumant Kulkarni comes Canaccord. next with from Your question

Sumant Kulkarni

I a couple. have

and coming first question an your but but is continue. was we important know patients agitation. up dementia my one, enrolled year, discontinued trial on related in in trial were the October HARMONY interim SERENE trial in psychosis that the to XXXX, later We allowed this The Alzheimer's-related study have read

think do March HARMONY? about there? Given expectations you data completed into late SERENE interim read of heading up now should ClinicalTrials.gov, showing your as the share on as is how according Or we to any to plan

Steve Davis

agitation Serge, You did On it? you Alzheimer's-related question? hear got the trials.

Serge Stankovic

will That's reasons data the from trial assume as, for will were as trial well and were that shared required results point at the that to we we data. see from necessary we further that information is I the as ClinicalTrial.gov we fit, trial when we with a the in business the will that it -- and, share DRP. stop obviously, moving

some the really trial. with obviously. forward we So as there trial, core of available, the incomplete it's The are already that is learnings move data but we applied

Sumant Kulkarni

approaches, might therapies, you And that in second question to is the other trial. from relative competition enrollment on like syndrome be How trial coming your Rett expect potential up? gene do that

Steve Davis

do want you question? to Serge, take that

Serge Stankovic

to developments all syndrome, bit a take in time actually for more to it's specifically of therapy gene get stage. following little going Rett to little question, And them the are into clinical we your probably is a behind. Naturally, the the

that So our terms Phase do execution I will interfere. perspective, competitive trials, of from the not of that, in see the III

Now in II say of some we of -- of there interest on basis a syndrome, addressing the groups maybe don't second in trials. Rett bit the to trials that there symptomatology with but closely quite of symptoms that and Rett, trial participation on core rather are positive the specific Rett have syndrome, our from going specifically be in advocacy than Phase be see very I working understand that is other data may a overlap. will we there

a not significant competitive anticipate do pressures So recruitment. on we

Operator

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

Steve Davis

our saying thank progress next on today to for forward Great, look you you, thanks just and to updating of we by you us joining want close to operator. I each quarter.

Operator

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

day. may You now Good disconnect.

ACADIA Pharmaceuticals (ACAD) 3 May 192019 Q1 Earnings call transcript