ACAD - Earnings call transcript Q3 2017 | ACADIA Pharmaceuticals Inc.

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Operator

Good day, ladies and gentlemen, and welcome to ACADIA Pharmaceuticals Third Quarter 2017 Financial Results Conference Call. My name is April, and I will be your coordinator for today. [Operation Instructions] I would now like to turn the presentation over to Lisa Barthelemy, Senior Director of Investor Relations at ACADIA. Please proceed.

Lisa Barthelemy

Thank you, April. to Quarter welcome Call. Results and afternoon, ACADIA's Financial Third Conference Good November conference and our available through recorded, is website XXXX. archived www.acadia-pharm.com This being be an call copy will at XX, on

and call Joining Chief Dr. and and of Chief Vice and Todd Head Chief today me Officer; Officer; Vice Stankovic, on from are our Yang, our Executive Vice Steve Executive our Development. and President Michael and Commercial Serge ACADIA Executive Young, Financial Officer; President Davis, President President Research Executive the our

efforts benefits Before we to results. and products regarding you or number today, be proceed, timing, including the approvals; trials, the I like statements pimavanserin; to development advantages implications commercial a strategy, and our would of, we and regulatory that case, remind derived financial first or approval candidates, development of be or making of, including or clinical results future call during future NUPLAZID statements, in each the future forward-looking the our commercialization of from product will our or and other

the we of expressions risks our the found use and of events During from that factors the expectations inherently information, materially can forward-looking associated today, and uncertainties statements. forward-looking project, are assumptions a subject made and or our on of to are risks filings with These statements or based that believe, number and cause plan, potential, change other statements. and in may with intend, current in uncertainty call words to predict, be should actual anticipate, SEC. such to negative terms may contained identify these those those differ could, business that results involve our convey expect, similar as may, outcomes future These forward-looking

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

Steve Davis

on Thank you, performance today. Lisa, and I'll Today, thanks and us discuss quarterly highlights. to briefly for operational recent the call joining everyone our

$XXX our important Following results. R&D. Serge recent in questions. then third open We'll quarter my we for and million. discuss growth will of deliver receiving sales of The call quarter-over-quarter will guidance NUPLAZID then net quarter. and in $XXX Todd continues our commercial NUPLAZID continues our between will XXXX grow XX% third to results, and the patients developments discuss progress NUPLAZID performance revenue are a for strong treatment up million based remarks, Michael review on number to increasing with be to financial the these

continues the caregivers important from commercial feedback on and we to Parkinson's physicians, NUPLAZID multiple community very to strong. positive. the and side, be progress seeing patients remains advocacy are The in Access groups fronts. On

remarks. to make their area. on underway to We of promotional We're in strong awareness and awareness. and initiatives continue efforts patients on NUPLAZID Parkinson's Michael working his hard in this our increase expand psychosis with for progress disease important will brand this with have caregivers increased the

Parkinson's our patients reside. expand where business to in continue care significant number of we disease Additionally, with long-term a psychosis

dementia-related important On items We October. the indications. III note initiated multiple our advance continue pimavanserin with in our Study in HARMONY are several R&D clinical There development side, efforts we in Phase or to to psychosis here. DRP

of approved, important with is the serious which an currently medical This designation results psychosis to is for psychosis. Study Parkinson's our second Phase of part from in FDA dementia-related the Designation the disease granted this acknowledgment The is This of large pimavanserin drug Therapy pimavanserin Breakthrough received disease II-XXX treatment condition no was psychosis. Alzheimer's in together the III-XXX this FDA address by need. potential for for the in for Breakthrough for we our breakthrough upon and Designation Study First, pimavanserin. Phase based

program. FDA are path the pleased an has efficient important this for we development that to agreed Second,

studies. the of And in a Following the with together could an from are It the supplementary we study that with End-of-Phase very design. Boston. study supported on Disease types Study a Clinical Application. higher II-XXX as about in Phase we These meeting Serge basis results call typically efficient prior from is execution believe third, Phase in New with as and excellent of success one Alzheimer's design across the prevention we at the later had pimavanserin are Drug quarter with recent FDA, meeting details excited or summary, studies will of II about continued more data a of design employing relapse probability presentation CTAD share HARMONY. the serve powerful our well In we acute Trials that the studies positive have III company. Study, than strong on robust the a as

financials. our Let turn who Todd, call to me now the will discuss over

Todd Young

provide Steve. our sales and guidance and financial quarter QX last year. discuss net the the Thank I'll of you, results Today, for expense

of million, an quarter forma XX% the of net recorded in revenue sell-in $X.X a million recorded $XX.X pro third For growth to XXXX, compared QX. or increase million of we sales, the $XX.X

gross-to-net Our XX%. in was approximately QX

as securities quarter and a in third perspective, quarter. sales balance operations basis. From for of the $XX press one-time the a a quarter on $X.X today's cash ended the million provided for million quarter. a revenue We $XXX.X As sell-in deferred have item previously our table we that we our cash for of release, each a revenue comparable used last a with In on as from recognition flow result, reminder, approximately net cash we was transitioned in sell-through presents investment of and sell-in sheet. XXXX QX, recognize million

cost amount of goods expense the total expenses, were million. of compensation. P&L, million side of the operating including On $XX.X This noncash stock-based sold $XXX.X includes

$XX.X in increased quarter QX the expense in $XX.X R&D XXXX. from to Our of second million million

was versus million expense $XX.X SG&A in Our million quarter. $XX.X QX last

million quarter $XXX provided to million $XXX net As to million. of $XXX expect XXXX $XXX which from guidance increase we sales an million, Steve of last noted, is year the full

expect range. million million expenses, and QX in For the in we mid-$XX be low-$XX be the range to to million to R&D SG&A high-$XX

our all press reminder, today that, over release GAAP noncash a amounts the in U.S. that expenses on the to I'll include with Michael. And are turn As expense. call call stock-based compensation and provided

Michael Yang

growth pleased Todd. of in third the the with We're Thanks, strong NUPLAZID quarter.

We continue to make as for NUPLAZID a strides significant psychosis. care in of standard establishing PD

and compliance. practitioners we and with same We disease are optimizing to appropriate caregivers engagement to healthcare patients patient to the as brand build our well are with working closely patients. new At time, awareness ensure identify as continuing approach

increase for by prior disorder XX% to PD our market the represents important most as specialists a choice psychosis of for promotional pleased from reminder, line physician Let's efforts report which, research. is considered of our a movement start NUPLAZID. I'm with This that ways first is segment. significant NUPLAZID

objective Another us to strategic important the is close for PD gap. the awareness psychosis

and symptoms awareness accepted Parkinson's Although in a is a is emerge chronic as amongst this related of Parkinson's shows a progressive which disorder condition psychosis low. research actually physicians that over psychosis, and such our patients as caregiver is time, it's well that quite

patients specialists end PD introduced targeted delusions Parkinson's television approach patient our the month We've about -- awareness of right be disease in patients associated information. extensive disease. and important approach with direct-to-consumer and the for are designed to the caregivers discuss by We of condition caregiver An commonly hallucinations and programs as and their is at caregivers. with a of Parkinson's stimulate stimulate with market initiation This programs to and campaign viewed ads to seeing featured associated this to this targeted campaign result is and this executing their websites to number aware research physicians patients commercials our addition and will with Parkinson's. also hallucinations their further delusions more raise a awareness and visiting the by caregivers of conversations our conducted a believe their national of with

education disease Our as as support TV spots additional caregiver their their discussion contain with information will a Parkinson's well will specialist. website to that feature videos guide, conversation a

continues business. on important our an of to component Now which care, long-term be to

long-term focused key in LTC sales is important Our team this setting. educating on care stakeholders

number LTC the carrying XX% quarter-over-quarter seen NUPLAZID. pharmacies have of We growth in

Our channel, and XX% now includes business. about TRICARE, LTC, specialty which our of distributor VA represent

regulatory for an homes, nursing psychotropic enduring November progressive Parkinson's guidance undergo for on an CMS, and enduring for homes required In nursing effect will recognizes is into CMS conditions first drugs drugs. psychosis treatment disease and that go to indefinitely. Importantly, condition discontinue time unnecessary XX, in the continue the reduction may are that dose attempt to need to gradual

the a devoted professional that, However, ACADIA I'm an centers, practice older from that settings, condition prescriber to more long-term disease psychosis The day enduring programs the and to as care pleased of outcomes Furthermore, makes selected management let of gratified allows and the Consultant facilities, continue hospice in of medication and the a row, and the and well the enthusiasm our for Serge. benefit every society LTC X,XXX Hall by report support recognition optimal in in care society year resident patients the to persons. Fame is its hospitals. care to product only is are commitment health of treatment who international healthcare senior with long variety consultant of pharmacies efforts including our patients has commercial we're a being more pharmacists, importantly obtaining all the Award of ASCP as than American of care NUPLAZID the sum, families. the turn consultant improved represents medication. me for on nation's for and NUPLAZID adult recognition Pharmacists receive received. to Society the And serve. and over the Parkinson's senior as impact they and the lives with strong community's In of in the positive second call day

Dr. Serge Stankovic

very of Study a psychosis Therapy the program. of Designation you, and Michael. the pimavanserin exciting has Breakthrough III our of the This receipt on with Phase initiation this HARMONY for Thank front time in been R&D dementia-related

the major HARMONY, in of the our dementia-related studies focus III relevant -XXX ongoing meeting Phase on schizophrenia CTAD psychosis HARMONY to addition negative My today HARMONY areas comments CNS schizophrenia our we with recently with will the Study. disorder. large response, and in advance need like design in start inadequate to in important initiated Study continue pipeline symptoms psychosis, findings unmet directly III data at of to to Study presentation depressive data AD Phase In a Boston. in of would on I and few

with very durability Let start a design. study of important effect. This our pimavanserin consideration me in is

antipsychotic And and in see for PD that the in We Psychosis. effect have curve in Study. shape with seen We in the in pimavanserin well. the matter, the previous group psychosis as pimavanserin -XXX of AD consistency durability of this

pimavanserin response severity typical at when attributed We in rolled the in variability and Study the of patients in into in setting. is Parkinson's marked using reports By II Study variable this and contrast to to observed the it may of waxing who placebo getting consistent long-term extension studies waning placebo in study, also world -XXX and patients, the Phase see way, with in our real -XXX we be AD symptoms from in naturalistic this This, psychotic look from disease. as we're shown physicians this response also psychosis.

study, discuss Study, detail So we in these durability observed study symptoms contrasting are endpoint time the moment, Phase essentially on Hence, as patients an of HARMONY greater the relapse is a choice psychotic between in against groups. patients and HARMONY of The waning optimal in I'll placebo. on the Study. The the in waxing of the effect in things. were above observations pimavanserin, we've the III critical to in the two of design primary average for two

antipsychotic In this and portion enhanced is efficiency, enrichment. since randomized is its considered will only effect because pimavanserin design Durability power an population patient study. design for addition, the responders double-blind of relapse prevention pimavanserin the study be of into the of stable ideal

randomized period is double-blind hand, responders to it mitigated weeks portion making study placebo over response of this be observe On the treatment the of other significantly time. as maintained placebo very XX unlikely will response into

meaningful size pimavanserin been Study, effect our antipsychotics size -XXX X.XX that What Next, severe we studies. pimavanserin than and strongly indicated overall the in severe effect has in with was effect data in in therapeutic consistent disease in relevant? of is HARMONY size effect standardized with psychosis. the Study to moderate pimavanserin I to clinically effect Alzheimer's design. was in of more robust and The standardized would with with the Psychosis. rarely X.X clearly like patients greater the size with Study other effect extraordinary, of Study, informed previous to reported other patients in this well-tolerated in moderate -XXX psychosis. safety showing doubled than seen Totality and population -XXX overall how the of antipsychotics is from and of frail size patients general. robust in a was X.XX, the Why to Study HARMONY what studies effect to speak In In AD elderly with safety, be will psychosis, enrolling antipsychotic observed respect the the profile this this and

effect the treated associated placebo. no on design contrast, statistically of Study. Importantly, deterioration detrimental with HARMONY with cognitive been cognition In significant Phase observed pimavanserin III was have patients our Phase data II-XXX antipsychotics to of compared the acceleration Alzheimer's disease. Thus, for led to analysis atypical in patients of

psychotic placebo-controlled in detail. evaluating III Let HARMONY the me little of study, to is relapse symptoms The pimavanserin of now a in review key with of more patients a elements ability dementia. Phase randomized Study prevent

response pimavanserin patients. participants into followed XX XXX The population. With period will randomized treatment withdrawn. reflected meet in will with open-label turn in fashion relapse end psychosis, study, can for FDA. is to patient be the to for treated important for At In possibility will this pre-specified dementia-related time of weeks. certainly this be symptoms. relapse will weeks call Prior they and period. randomization up This approved where Therapy an believe be be Steve. or really that, area open-label pimavanserin endpoint their study who approximately we psychotic double-blind we Breakthrough With treatment treatment for XX-week the period, enroll treatment in continue the we're XX psychosis. be their the period, to option expect treatment meaning, and will double-blind or will underserved Designation said until we in excited pimavanserin elderly the no to expectations in be recently to of dementia-related the to an back advancing pimavanserin double-blind placebo, active summary, is primary in for of I receive from either as the Patients study patients in received the an We occurrence placebo-controlled

Steve Davis

Parkinson's benefit Serge. Thanks making patient progress and ACADIA's with our In performance care it. I'll NUPLAZID the every turn the with over And standard with Lisa. very disease for call much, closing, pleased that, this towards psychosis of would we from strong quarter back are to who

Lisa Barthelemy

of April, the our point, please questions. begin this the Thank for you, Steve. Q&A we'll At portion open call. call

Operator

from Tazeen Instructions] [Operator And Ahmad. Please the of your ahead. comes first line go question

Tazeen Ahmad

to benefit, far? there Alzheimer's? couple indications that or more other but a indications, what there have that to clarify again be let's for wanted of indications, smaller the the on psychosis say, II. based explanation learned trial patients things the chance lower just reason mind from pivotal for on Is believe of the pimavanserin working I a for then Serge, potentially the potential I relative in design going you Would any has agitation just to have your forward so Phase seen in, follow-ups. could albeit and you've results And that

Dr. Serge Stankovic

indications, you Thanks, just your referring the I want smaller question. to question… what are for clarify to Tazeen,

Tazeen Ahmad

Lewy of that example, smaller terms would body on the guess, to of Is relative that in be population, patients. for dementia. right, say, Alzheimer's? based Like number I addressable

Dr. Serge Stankovic

is are with is between psychosis underlying in meaningful dementia confirmed all Right, psychotic no I of a antipsychotics differences neuropathology and same or of of The the in differences evidence response down symptom symptoms by are psychosis. the to said, in practically scientific all dementia yes. symptoms, treated for, And terms you. types the a understand. atypical different simple there different to body subtypes. currently, Thank not I fact response literature way that -- in treatment as that a secondary and in neurobiologic clearly times the that after last psychotic points between really

So in we different significantly do not, these response dementia. differences in of between short, expect any subtypes

Tazeen Ahmad

then they And between? or more little in the detail? just be you'll first XX screening Can where Are be bit Okay. at weeks the patients. with intervals trial a for screened you to frequent weeks XX effectively us give in going itself

Dr. Serge Stankovic

Thank you for question. that

clarification. think I important it's

will We will to four Everybody that's adjust but start clinical on this throughout opportunity of In a they XX-milligram, -- if their will basis clinical period. to have XX-milligrams back opportunity to will judgment. the physicians be actually warranted. evaluating weeks, adjustment pull have clinically first the patients dose with

randomizing They Following for Meaning, response. those a periodically overlooked the will everybody patients dose. be at be week points But phase. criteria question. and we fact that evaluating week your four the randomization on in a at weeks, we little X be stable that time double-blind important very gets for looking often our XX have patients bit response improvement will will I will to criterions only maintain evaluated. is both hope that a stable that and and meet are stable clarifies that

Tazeen Ahmad

sales quarter. moving make for the does. you you putting look note Yes, environment companies bit a up increase. you of ACADIA a that I And NUPLAZID with put of maybe insurance to that. price for of visibility results us in took to Michael. hoping what risk comfortable that potentially back price on give Maybe for just did slowing I'm a is down the to barriers. kind signals little question for that a guess, the price or then can increasing increase doesn't this the at good understand you took you Maybe launch I

Steve Davis

free crack if this take in, Steve. Tazeen, you and jump Michael at is like. feel I'll it a to first

price upon our is that think objective of drug, to delivering. in always value that, pricing is I we're the to based the make the first terms the point drug

I that commercialization payers And the drug drug of is that, did of are the we even antipsychotics so that. been launched, and approved. throughout we've atypical understand picture. as to add understand approved would X.X feel before and nothing we potential we preparations the was the as off-label the throughout tangible before more well have for delivering. an They value understand we're the into the get mode the launch, the of They as think that they of value the course sedating years they're there's I use for now far, very get therapy, with drug. through They interfere to

this we time. price that the think point at very is I appropriate So feel in

Tazeen Ahmad

did percent as I I care? my into gain now you question leads traction are I'm long-term is, say coming so, sorry -- it, what long-term to try next if to guess, sales And that but me you from care of your missed

Todd Young

defined and care, long-term VA, TRICARE as care Tazeen. by XX%, Long-term

Tazeen Ahmad

keep you do And expect that to increasing?

Todd Young

Well, of opportunities we're early sales optimistic in as been in the the know about the We're months. growth still you in channel. that innings They've our future force. expansion our very with market only six

commented are of who a with who where psychosis. lot past, in we As place this have patients is a there's Parkinson's

I'm channel be for that yes, very the anticipating us a So in important that, future. will

Tazeen Ahmad

this gross-to-net And then I was missed this. what Okay. I'm sorry your quarter? -- But if

Todd Young

Yes. Tazeen. It approximately was XX%,

Operator

Your the next line question comes of Duncan. from Charles

Charles Duncan

kind was XX% that bit of I one And little business, if will. clarity development. is asked. follow-up regarding of XX% on is So new that, And that a of just you one you question that believe to a commercial. on one revenue, Just one on The it Michael, said then of that commercial XX% is patients? is more

Michael Yang

of thanks revenue. That's Well, for the that's -- XX% Charles, question.

Charles Duncan

keen of it drug? new durability or Is you that been What you've is increasingly Okay, value great. patients mention think, initial of starts? And reimbursement it authorities I responses the are created aspects to on? the that patient it really you and that. attention paying then on have Is are value Steve,

Steve Davis

Well, you've mentioned. it's, above of all that the frankly,

a get on too you clear home we're appreciate. they will I we number -- gone levels to had medical have have center. that of home NUPLAZID, benefit want much for they the make physicians the real drug. that the patients the I and It's nursing they got high nursing like but homes. went from and anecdotes, satisfaction back go have tell we we a who think visit of community, with I to out a very didn't don't They to that as delivering poll

and fronts, very an high of it's feel very that like strong we we we of -- can So have provide of across indicators value. example all just the benefit kind

Charles Duncan

That's arm? reduced endpoint for of kind design. neat to do for like question be assuming what or the pretty couple needed a you change cool. Therapy But out risk in you much just What create relapse of you of primary a development. that ask And just If weeks? Study, the terms in of would Breakthrough time for Designation then study are Could it I consider trial? the you and clinical as real the could weeks control Congrats see to also to think I'm wondering, Serge, HARMONY how is on value?

Dr. Serge Stankovic

Charles. you, question. Thank A great

because that most studies offer more a me First, say doing study it variable -- customary this outcome primary time continuous is primary in way and to a relapse let of power. is a variables and analysis

the However, look between XX in very end. We of period this over difficult it's predict study, because the the follow-up. and at of on of the the active this will Kaplan-Meier to proportion treatment how weeks powering curve study this relapses powered drug

So certain you're the number number assuming total of certain and relapses, difference. a

on our not sharing just -- I'm are assumptions is less an prevention trial. all is assume, over of trial XX%. we how our we on But difference -- the treatment based a that need the number the actually that So calculating when And we Because -- do. events and way the between specifically and can the trial determine at the are is is to when in case, on this the standard observed difference only the data. we giving disease we that's of on as that not is for similar power considered data are as difference own we detect this psychosis where data in the there's sufficient drug it the the Alzheimer's looked meaningful. modeled in in that And relapse then assumed that than prevention usually difference placebo XX% we we usual and trials power to We difference have -- we active relapse based example. assumed placebo a assuming.

Charles Duncan

Last effect That makes question, the size. on sense.

have a moderate study, robust X.XX in about arm you of or pretty patients. severe might effect the at must size like think control saw moderate makes almost less talked look kind control you to But seems about that case that that of which arm? if in severe I much psychosis. been guess, it and in variable for waxing -- was XX% sense the patient less the when to the or waning You you that the previous

Dr. Serge Stankovic

and responder looked saw impressive and is the going in is percentage we rates, responder on from for we XX% population, usual overall and of What what particularly the the we scale, moderate XX%, the cut-offs tremendous too, saw when severity rates, that at to XX% population what decrease severe to responders. on we the increase -- scale, saw severe

XX% seeing to rates XX%. are response even above We XX%

however, when the we at group, we parallel that see So placebo increase. looked don't

that arm. a arm, the arms. the response response, seeing somewhat mostly active are comes in to increased a difference difference the XX% two is tremendous, from in XX%-plus larger groups It pimavanserin but We about between between treatment actually

So you right. are

little are We seeing less.

see and Although this would in general, placebo in group, waning. waxing you

Operator

And question comes Butler. your next from line of Jason the

Jason Butler

Again, I'll clinical. one commercial, add one

just percentage Just proportion on Michael, a the to had in terms new facilities this talk about And contact amount you write you center to taking time prescription? to with what it's talk or care then of at could care. point? get of average and long-term what NUPLAZID you've or even effort commercial a the if can talk broad long-term

Michael Yang

force, more we very a the sales the recognized not to thing And, to get heterogenic It's we're They're local impacting doing better control span care homogenous. of to a challenging therefore, larger was question. at that more a kind of needed the insights when standardized that and long-term tighter facilities. a facilities. answer channel. on Thanks Certainly, regards we as for expanded in the Yes.

We difficult. strides wouldn't have it really, it predicated it's GPOs, on penetrating very good There's cycles in want way. variable. to the of lot sales and facility But the and a quote is really and are cycles of It's we're shorter-term a I better making how these long on with sell them contracts very access channel all -- every of to and dynamics. longer-term are some takes. some physicians day,

to I from is amount pharmacy timeframe. long-term growth and of carrying or in supplying mentioned care number, So drug NUPLAZID. earlier, who wouldn't Yes, one challenging have Even that want just of I we to We quarter-over-quarter had in may a really pharmacies facilities. standardized -- regards multiple growing. statistic the the be we're quote are XX% to stocking regards

is -- it's one-for-one So hospital. you would in even not basis that a difficult say as a

So looking NUPLAZID. in anyway, penetrate months. deepen -- of places broaden objective but and to and the we're our look, our coming That's carrying penetration

Jason Butler

then for And Serge. Great.

Phase using For ADP Just studies for the just how of II trial, the the you're terms moderate severity you the and severe trial clarify different psychosis NPI thresholds scores? HARMONY can in for the us defined what you to psychosis two are?

Dr. Serge Stankovic

trial have version either or delusions, or that of the for We on the of -- hallucinations we to has the a X, And score obviously, in that Home patient the qualification. Nursing assumed X. in ADP trial, NPI we combined use score

hallucinations, requirements a things. or or for study the combined So clinical population I And severity sorry, of We severity, score other of qualified of one we of assessment terms require is into incorporate category HARMONY there and other the the of X. severe a did not or would did we symptoms delusions. severity on whole global on mild that patients with of requirements really is of that In global delusions, item total by item we the in -- of patients moderate the about not say, the or four in global I'm or the let's described that the more -- other, overall any SAPS say, was, patient score Study, of hallucinations that psychotic list score to fell was presented. the as X/X than

clinical patients to is moderate and psychosis enter of of patients impression global the clearly the combination defines what that only symptoms and qualify patients as well And severe that would severity. trial. mild with exclude As

Operator

your question Kasimov. the comes from next Cory And line of

Cory Kasimov

One commercial and one clinical one.

So commercially, NUPLAZID PDP. for

XQ good sort expecting you're curious seasonality year. growth if impact implies around of end into of the guidance the any the Your continued I'm holidays?

Todd Young

year, last it by individuals. with Cory, pull-through we some -- saw of scripts we're

Now our QX. inventory the assuming in QX in on-hand held clearly, today revenue are terms saw the with the at line demand, as the distributors. of be going amount inventory a year. generally end be QX, they But to holding stocking would sell-in with it us grow, the more it of stable could And will generally of affect days by the we over range end into recognition, change at We're at pretty QX. of small

Cory Kasimov

Can double-blind you for Okay, HARMONY qualified the would the II how criteria? that's Study from I'm that talk into responder as III kind a percentage for different then regarding patients portion? high-risk entering the helpful. of on XX-week Phase might And curious lead-in the have relevant maybe be. Phase about of period. based criteria response what And the just

Steve Davis

Serge, do to take want that? you

Dr. Serge Stankovic

Thanks, difficult look absolutely. assume it's psychosis period order our -- We applied response more psychosis actually I patients that. data Parkinson's disease response at be over did criteria And responder. anticipated period, mean, we directly did that XX-week will these And to the disease Alzheimer's have. a found particularly we to -- very as than Yes, certain well about and there that approximation the -- on we model that Cory. respond be would the we ADP a we had we'd but trial. to the qualify apply of XX-week for for certainly in where criteria, apply XX% of it would the

no misunderstanding. make sure there Let that me is just

was And the HARMONY patients you patients moderate X/X X/X the are that about that to of applying these qualify would had of for required, be that that symptoms a the Study. the of severity terms symptoms. there know In are probably would symptoms we severe of we

is this to two for of there would is qualify many actually elements responders after qualify randomization considered XX-weeks. and One and a patients those another how So question. how would many to are be treatment as

Operator

And your comes line next of question Salveen the from Richter.

Salveen Richter

in to HARMONY of Just and patients. the regard severity the Study these

at about patients. have MMSE which include If I you ClinicalTrials.gov, would XX, look X to score you of an mild think

I patients? exclude severity? mild going to going a are the And the also you are So by study, stratify to you of in have follow-up. those portion

Steve Davis

Serge?

Dr. Serge Stankovic

factor. qualifying Yes. Status score One clarification, Mini-Mental not is Exam a

cognitive measure treatment the of as Exam. before, Status Status to impact is cognition. safety that abilities is there a primarily demonstrate, a once from not measure We pimavanserin negative are Exam demonstrated of Exam is Status a symptoms, again, measuring we as of psychotic no of Mini-Mental on indicator Mini-Mental Mini-Mental perspective it an

on qualifying assessment impression psychotic is for the hallucinations determined the here patients SAPS-PD, and for with severity our for which global scales symptoms. symptoms, are clinical symptoms, of study positive delusions domain We psychotic and of

Steve Davis

severe patients, Salveen, the term talking is for on not not not we we moderate realized moderate Steve. much to question psychosis, about -- were enrolling Thanks When I've moderate using to mere this enough. we're maybe Alzheimer's precisely about patients. talk because to probably so the severe

So thanks clarification. very much for the

Salveen Richter

my question are here? To just Are we looking schizophrenia around depression is stratifying should the or going severity to follow XXXX. in for And be get then data up, follow-up read-outs you data? by pipeline we any

Steve Davis

Serge?

Dr. Serge Stankovic

subtypes. trials Yes. Certification subtype, on trial basis dementia that between in is we're -- different balanced that of assure a these the these a doing randomization so we

the the expect trial continue the of to the first ongoing and depression in And start half terms XXXX read-outs, major In we the second sometime read-outs then of to will XXXX. to trial, in our be read-out mid- expect we trial. from

Operator

And Baral. from of your line the Ritu comes next question

Alexandria Huynh

question for feedback, Ritu. the regulators on Have One plans on of design is your they HARMONY. relapse trial provided on broader withdrawal to This inclusion What EU or indication? DRP the engage here? either are any Alex the

Steve Davis

do want take Serge, you that? to

Dr. Serge Stankovic

or referring Yes, you absolutely. Are U.S. regulators, ex-U. to S? FDA to

Alexandria Huynh

Ex-U. S. regulators.

Dr. Serge Stankovic

Okay.

next do we the to position our get scientific in EMA our year, feedback that. and their We to procedure the win of to and on on approach are discussion half -- program that first through the plan the advice

Alexandria Huynh

seen increase you it. And guys ahead that October? the took question of stocking Have price one any on in you then Got commercial.

Todd Young

we in not no, give Alex, up any to the or headline pharmacy. front did the distributors specialty

So no, nothing to there stocking was with price. related

Operator

from And your next of Matteis. line the question Paul comes

Paul Matteis

And one if clarify wondering of couple then commercial have question. was you I a quick I just could items. clinical

kind in is improved influenced of price could visibility And all that that this wondering how gross-to-net? you've by into gotten long-term second be substantially. at separately, quarter gross-to-net, you've I the far the then might the take On so it's future? the increases the or better where of taken trajectory if really was

Todd Young

factor, get the we has the basically Sure. distribution low for And QX, into us at -- gross-to-net to With obviously, the where which is the is bottle donut is given of given enters relatively price respect on donut variable as less a for basis. to being in just a gross-to-net the the a patient relative liability when fixed. cost we're QX, biggest hole, hole

of is a liability, So the to the factor patient. range general XX% is in we're dollar price, donut each as hole because I a of expecting which, XX% mentioned, amount again only biggest the to fixed same for QX. in totality be in obviously, is here The

dollars a going the drop from extent have ACADIA have we'll So of otherwise, to forward. or drug they more bigger through

So reset. again, the QX have full will

Medicare year, patients D, the our that end start the are drug are over. All at Part of on who will of

XX% not in for NUPLAZID. QX, this higher certainly So XX%, despite occur range price will a

Paul Matteis

first from Okay, of new sort relative today, of all you're the Seroquel starts of terms say what few mix you the growth? they could talk I'm right. if And as wondering then to quarters seeing switches comprise launch, patient of about the in pimavanserin and

Steve Davis

start jump to Michael, free feel I'll in. and,

no new news on switching. So

seeing past with better we're see refer to which get is quarters I of the on of once that a internally, the satisfaction degradation of than levels is that, time. the think -- often I continue again all the little the this benefit one get or in And the month is very all delivering bit that's ago mentioned earlier, in doing. the thing probably and drug, we're today the kind of would surveying clarity Once or We as have we stickiness indicative natural -- we strong drug we drug. the three from is seeing good stickiness very you first X. two the have that all to drug of The drugs with very sort a you beyond we're what

didn't a of thing that of little drug couple quarters we as have better So limited have clarity -- stands the good a clarity didn't wants now. had that that's really and any out on who bit really one had ago, but

Michael Yang

of would therapy strive sourcing patients. our who also or to get switching for Yes, of another both and just we and dissatisfied more Paul, lack other products. all on efficacy either mix in That's are I a from -- the question. as the treatment naïve that also we're products thanks treatment goal. of patients are add we But naïve patients mix

gives Just mix kind the of deeper move We ones more where up recall, a though, switch for see that, more that physicians mix and all who process on therefore, end the those any as at is. newer naïve have the there drug are treatment treatment switch beginning an new and, base. into physician more light. in individual of vary the getting most of people penetration Those maybe moved get armamentarium of versus doctor those it level to product dynamic trib then we that's of into and of And you a their naïve. we a rollup -- can

Paul Matteis

was And wondering safety far CTAD, this pimavanserin, question clinical for what compared this has adjustment decision population. the The in option Okay. dose the the into I dose good in atypicals inclusion one of the for especially definitely then about been study? mean, so of Serge. just -- I'm went at the to pretty DRP talked for

the So thought what there? process was

Dr. Serge Stankovic

that, on individual in pull really of didn't have that lowering some favorable mind the may we've efficacy-wise specific pimavanserin. the reason with any some this that The Paul. patient is two option profile but Thanks, would see from the On experience tolerability elements. patients from for side is, of much that. know back one seen basis, step including effect we we Yes. still in benefit very that, effect We benefit dose regardless that the side to don't may One because an dose.

success attrition the in we in element course the patients why of trial, is it important the trial. more the of the Second, is the wonder that of interests of

to want more the continue in double-blind. XX-week have responders period a and them then we successful into So

really in patients a eight dose with achieved, down interest will for lot believe that, stable dose. That's and beginning. We we the a and that. that actually be that allowing of in of So is step whole allowing this treatment the a expect option not are at there do still rationale we that the will weeks that of have require

Operator

of comes question last your from line Alan the And Carr.

Unidentified Analyst

think your relate back to the lower the wondering, of a you suggested I direct-to-consumer also, It the that. some opening with call. it missed on costs associated about Coming did maybe does last conference on changes I'm more the in any promotions talk and gross-to-net. And for Steve, rest than comments. come in I little here then thing? year And bit you and the could that to sort in a of awareness program more building of

Steve Davis

want Todd, first one? to do you the take

Todd Young

Yes.

seeing are D where the long-term patients income low lot of Michael the we're Alan, subsidy Medicare we in care gross-to-net, that Medicare. those A the have On increase liability for Part about. don't the spoke

faster spoke as as well. have drug bottles, new that creates the outside side gross-to-net. have continue on added drop if more certainly the they're to on and the to well, stickiness helps patients donut that So as so Steve a and we our patients there, hole The of through that about patients the continue gross-to-net staying we on

Unidentified Analyst

your starts? drug for or part, stable? is changed get that have of free that thing any at promotions, to you you that and Has of the second changed Before sort all

Todd Young

in our prescription. not care without long-term prescription again, No. goes initial setting, charge. advantage that's actually patients of the We're that many more continuing to take that, have straight And XX-day of VA a

I that proportionality And patients the there less the But is, grows side guess, important a started from to as there's coming that to through be little drug speaking, continues free faster, so on program generally XX-day. an quickly out drug. a get

Unidentified Analyst

the And awareness the I around direct-to-consumer. see, then and okay.

Steve Davis

Yes, question. a Alan. great It's

television I that a, campaign -- is excited mentioned, a about. we're We very as have

I you The think know, have campaign to hitting be and and that's in levers. as to caregivers right Parkinson's to got going marketing But audiences. think is all the it's million such, X is be approach. patients The be though, very a you we campaign. think reach our responsible targeted don't to of a concerned mass about as that I very and, you thus, it's total campaign so, know, targeted total we in kind patients can it's our as audience,

Operator

to proceed please Davis, remarks. Mr. closing

Steve Davis

forward progress. look support. updating call on We for everyone us continued future today's Well, Great. on your you to our and joining thanks, for

Operator

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

You day. disconnect. may now Good

ACADIA Pharmaceuticals (ACAD) 11 Nov 172017 Q3 Earnings call transcript