ACAD - Earnings call transcript Q4 2018 | ACADIA Pharmaceuticals Inc.

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Operator

Good day, ladies and gentlemen, and welcome to the ACADIA Pharmaceuticals Fourth Quarter and Full Year 2018 Financial Results Conference Call. My name is Christie, and I will your coordinator for today. [Operator Instructions]. I would now like to turn the presentation over to Elena Ridloff, Senior Vice President of Investor Relations and Interim Chief Financial Officer at ACADIA. Please proceed.

Elena Ridloff

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

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

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

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

Stephen Davis

our In of Thank thank Good for pillars. our strategic you, in XXXX, joining us everyone, X afternoon, executed team you Elena. today. and all

to First, grow.

patients treatment with or FDA-approved care and Parkinson's only standard for psychosis PDP. of the is NUPLAZID While disease

is And and again, potential of leverage, focused pop of unmet with needs. with need. is the disorders, third, expand in through unmet leverage high our pimavanserin Second CNS development quarter the to business additional indications on

each Let's progress on take pillars in X. Slide advancing a at these we've of made the look

to and year in benefit year, leverage new in depressive patient by to providing positive NUPLAZID full the sales development Net as we're XXXX. for in PDP $XXX for achieved CLARITY and XXXX, grow full the in in clinical NUPLAZID of to continue seeing period major fourth indications. XXXX. on net the XX% We growth quarter of of XXXX Phase Based in starts million increase were net year $XX.X $XXX XXXX. the for the a XXXX same pimavanserin over million, to our late which we expect additional year, XX-milligram launch was we was $XXX.X including CNS results direct-to-consumer a our the enter million launched execution guidance highlighted the our we continue fueled our represents million are commercial adjunctive Last the sales November, treatment in disorder. in ad II This growth of we TV campaign This In August. in increase initiatives, XX% and year-over-year. by capsule sales

we'll of this be In half FDA, first addition, trials meeting completed the Phase recently end-of-Phase-II we with III the our and two in year. initiating

trial trials with pivotal submitted confronted FDA the can II as to our NDA our in Importantly, end-of-Phase-II CLARITY support filing. a supplemental be that Phase meeting, we

conducting, will for need will which of Phase least X trial positive. X we III be also at So the

all course, most safety see the how in positioned I experience business. of approved $XXX I also of evidence to we either and our pillars burden On in efficacy disease balance these think very underappreciated interactions, XXXX over all We of we indications what the In that the of probably we markets X slide our know PDP of business psychosis, here. the the existing are X patients advancing Point treatment single indications on ended drug the #X therapies. on successful with quarter. inadequacies know how X executing forty-fold approximately currently are point population. or pimavanserin with the approved important Slide molecule with cash profile strategy. each which of the of million markets an for Parkinson's the well PDP, represents There FDA-approved same our in continue disease sheet three are strengthened markets. in represent it. make and these We fourth we're messages is and aspect We the approximately X of have indications. to think tolerability is with know addressable already additional representing And is to significant are all that the in the population clinical indications are together of you large These we're slide, no the in this due are indication, advancing in, other pursuing we see both continue drug. you is with aggregate, increase addressable Point the to pimavanserin.

turn we love now performance. So discuss to that, of kinds over With and can address Michael said substantially these these we I've programs, it to commercial investments. our I'll before,

Michael Yang

Please the X. activities growth commercial continued you turn provide would are that I are to with Today, we to Steve. progress Thank our of NUPLAZID. like update driving you, an making with Slide on

with of to form PDP to in for capsule dosing done patient a XX-milligram smooth was The has and adoption the introduction and transition well. are team The the and has of treatment we the XX-milligram provide XX-milligram this more transition once single XX-milligram recommendation the experience. the of commercial capsule, is NUPLAZID. to to patients the capsule completing tablets. health with the daily XX-milligram very resulted facilitated patient XX-milligram dosage achieve believe care professional successfully positive in we First, single the capsule from single a process launched The

commercial benefit of the the the are across leveraging introduction and new business, on XX-milligram profile. initiatives of We the in risk capsule driving the QX, reaffirmation FDA focusing positive

the launched extended direct-to-consumer branded notice one. to end November, gather we of at commercial positively along forward their important campaign time a in revenue year starts mentioned, We changes an to look expect our families in this seeing Steve other As would impact XXXX, together loved when and and the patient of new with initiatives.

conclusion safety recently the Disorder efficacious the This level of as for try and treatments of Within NUPLAZID. confidence these treatment their is XXX,XXX Beyond treatment who adds received with the without non-motor to specialized a for this out like having with percentage Society double to first. recommendations disease. efforts, psychosis. Of are of NUPLAZID taking an acceptable an that through I'd establishing suffering update the that of both treatment point symptoms Parkinson's for listed update, have PDP, Movement we only the published risk currently NUPLAZID patients roughly should for patients digits PDP been monitoring physicians low level

FDA-approved channel. trends only these long-term for important physicians the an in part addition NUPLAZID is validation recent of highlights paradigm. the therapy care recommendations the to in our growth of PDP, Slide treatment As XX the

can from roughly seen throughout XXXX. XX% continued As demand you growth right. pie see long-term represents total the on business, bottle as you chart channel care of A see, in the total our can we've

the long-term commercial to delivered has the create care in and care initiatives momentum. a gain Over This growth traction two channel specialty pharmacy past our seen rate as quarters, higher channel. our channel-specific long-term we have compared

on as would our a and shown growth seeing quarter. represents are recent compared channel, like growth new return turn pharmacy in sequential X/X this patient quarter to third the which and starts of I starts business, trends now new channel fourth to nice attention we're patient Now your of XXXX specialty our and the In to we Slide why pharmacy to specialty encouraged by XX.

have The of well starts starts year, the into campaign. seen statement XX-milligram public this We supported the patient the profile capsule with of growth patient as both new launch PCP new positive our [ph] weekly branded benefit the of the up is of and average continue of as NUPLAZID, sequentially. launch the FDA's quarterly momentum with new

achieved business, total in overall growth A X% sequential the approximately fourth the of we For quarter. bottles in

compelled On day In time, we addition, to to with recognizes symptoms motivated their consistent. with our starting action. typical has journey, visit to that remained typically patient it are caregiver treatment. with physician rate Slide feel take action take the the our weeks Once patients they they physician XX, a to next or have take when about talk their and to before refill seek months symptoms outline their

growth Serge We on revenue. we have commercial turn a will time, of believe lag several increase now are to prescriptions reimbursement years. start initiatives new updates patients the majority provide period of during efforts over to penetration back hub, our the then on taking contribute we we market which in result, I'll these to with the hold are significantly and promising The marketing appointments, a authorization these and current a and trends is benefit, to patient typically that sent and new starts trial track when there typically NUPLAZID this our prior next starts over majority patient our the lists as our patient patient between on observed and free R&D it process. our the to Following access pipeline.

Srdjan Stankovic

ongoing will results a XXXX. quarters I'm really Michael. from I'm reporting stage clinical late you, several our looking number next pleased in forward progress R&D our Equally, trials. Thank the with we of extremely to as be

Let's and the Pimavanserin by Antipsychotics from is lack problematic start dopamine Slide first-in-class who selective Parkinson's dopamine. were suffer inverse then agonist. primarily particularly blocking of with patients XX. seratonine in the

efficacy we has data our its near to we IGF-X in Rett total, II share rights amino On are stage Trofinetide are we pursuing you. a that like addition programs. late CNS, is X advancing XX, of novel Trofinetide programs of clinical are that late In to in the synthetic trofinetide license syndrome. stage the development drug expertise positive of in growth tripeptide currently factor. categories highlight terminal pimavanserin of term indication the Phase X few PDP, Slide are have reasons target Furthermore, year. shown the indication for the to In all already the I insulin has we August. with evaluating in this just [ph] in wanted that

agreed FDA submission. that adjunctive therapy for expected, am the pivotal X major First, meeting end-of-Phase-II the our the pimavanserin would CLARITY trials we the NDA as of serve discuss as FDA that, for disorder. with depressive as recently report to trial happy X supplemental we to our I completed

We is year. ultimately review. subject program As matters the in the this first III are to case, of the always NDA initiated our half Phase end-of-Phase-II planned as

schizophrenia in with our little second track on Starting remain States, half ongoing to Phase response and we III programs more ongoing of ENHANCE which and the stays we affects our in dementia FDA-approved Second, XX, about and our FDA inadequate patients results increased in trofinetide, we initiate will top third, of rapid announce the repeated home including very will a There no Phase Dementia-related morbidity an consequences, design now discuss psychosis for from III we has with United And DRP. X.X hospital trial more trial confirm care, Slide study mediator. treatment the with and of for XXXX. progression serious is nursing to risk mortality. progression early in million detail. line

As program benefits Slide psychosis studies. in the we process is XX, on two highlighted leveraging dementia-related in our previous observe

study, Alzheimer's study trough our in psychosis. Phase PDP as pivotal II well Our as disease

represented two on and agreed our Phase had end-of-Phase-II an the with meeting the FDA slide. it's plan, Following III we on next these and studies,

program development Designation received FDA. this reminder, a Breakthrough As also from Therapy

Phase a is Our HARMONY prevention relapse study. III study

with XXXX, read as that final needs in the in anticipate There serve FDA depressive here with from as the on XX. disorder Slide of robust an major of basis study single are this this unmet submission. substantial this interim can today in SNDA the results have study results treatment for the half We second of an We agreements outlined the year.

side testing the right-hand our from are CLARITY therapy an SSRI observed adjunctive On pimavanserin SSRI Phase or for SNRIs. study, as the results II to

study promising results. very have We overall a

XX-item Our Scale with point Hamilton was Depression primary in of achieved P-value X.XXX. Rating the the improvement end

the in represents disability significant that the disability X.XXX. depression. well Our was known p-value achieved key through And it's secondary for patients scale, improvement point, end of with burden a

We observed positive results X also additional secondary in prespecified end points.

X.XX. the meaningful and are patients high XX, achieved study the MDD. pimavanserin we exist and a given as stage of where were we our treatment unequivocal efficacy treatment the results of In p-value endpoint, observed X.XXXX X CLARITY commercially all of study, for are potential with develop results MDD impressive very best-in-class today. We these adjunctive that in here effective shown of need size as seek clinically the believe primary and unmet to on result effect Our NOI, Slide

adjunctive end-of-Phase-II we in and an Phase III disorder. our with CLARITY shows substantially III the our the mentioned, thus depressive the FDA major our would of week, for as MDD as study the two confirmed treatment As for placebo-controlled submitted derisking, XX MDD. meeting Phase six derisking trials, our that support Slide one expected, be FDA to X subsequently of studies completed I plan We development we parallel of program pivotal program. conduct designed recently fNDA

combined at CLARITY these with the trials for an NDA Our one study will Phase least of be submission. III basis

inadequate principle doses would our like with provided of in risperidone, further for early to response proof study I evidence on, pimavanserin from schizophrenia program. Phase Moving of development this Data discuss indication. low to our and pimavanserin of supportive added II

XX who that they're and baseline and ENHANCE in Phase line background Slide from data XX are negative remain a ongoing our design receiving endpoint this we The patients is treatment for study top antipsychotic syndrome an plus patients and scale evaluating highlights from antipsychotic therapy. trial primary announce ENHANCE is positive to therapy with initiated change total our background have or trial. negative we in for the plus antipsychotic pimavanserin a the placebo This such, III the response on study, mid-XXXX. score. X-week As track treatment either on schizophrenia study

of the XX. is Slide to FDA-approved Turning negative There treatment no for symptoms schizophrenia.

conducting We half study, year. to expect complete II Phase in this a enrollment the second are XXX-patient of and

XXXX, month a neurodevelopmental United in recent the disorder this occurs interaction is rare After that on apparently Turning disease, aged three design Currently, Rett life. females we X have following normal XXX first X and you there beyond. call trial and our to approved Slide the syndrome for milestones medicines Rett there It our finalized XX. financial syndrome If will submit is to of for summary patients the trial X,XXX updating This an I approximately development performance. in potential III a on upcoming forward going that, time, exciting single progress. discuss be turn evaluate Phase with syndrome. this study. based predominantly which affects XX is a to positive, our XXXX in over will the I approximately now to months trofinetide. look Elena and on for With no XX for Phase with debilitating to of III Rett X,XXX to our States. study our are to III now Slide NDA is Phase trofinetide provides females clinical FDA, an to

Elena Ridloff

you, Thank Serge.

fourth discuss an channel our QX fourth of million net inventory $XX.X the at The of to consistent $XX $XX.X with Recent compared of or Slide increase million QX. the we XXXX. turn million XXXX will I In So XX% in adjustment end XX. sales quarter gross-to-net net and for the full was of fourth QX sales, XX.X%. our XXXX year to recorded quarter XXXX, quarter outlook. financial Please results the of in in

of sold, These $XX.X of $XXX.X of fourth same including million for the the advertising will in our Moving to costs, of million primarily compensation timing the XXXX decreased QX increase related Total The expense, GAAP million expense cost million the program. due GAAP first in to the included marketing R&D from increase to expense in from stock-based expenses, fourth last which from P&L. certain million of million in expenses million were million the Fourth compared XXXX. amounts $XX.X year. XXXX. $XX.X be to now XXXX respectively. noncash SG&A branded $XX.X goods direct-to-consumer quarter operating in XXXX realized to in R&D quarter of benefit increased QX and expenses in an $XX.X period in $XXX.X QX quarter clinical XXXX. $XX of down trials-related quarter was

The in amounts in XXXX, year on Total R&D from million $XX.X $XXX.X For reported the goods of quarter XXXX. of of of primarily million Neuren expense XX, our to $XXX.X due and $XX of XX% net the XXXX. Please to The guidance compensation sold, well was in GAAP adjustment an direct-to-consumer the increase the expenses XXXX. trofinetide compared we expense, in year in net clinical $XXX.X respectively. marketing to of in sales, included in to for These Slide full primarily an million an additional increase million our $XX.X XXXX increase for million million program. to related XX.X%. costs $XXX.X to $XXX.X Pharmaceuticals additional million sales operating full XXXX $XXX.X that in million compared pipeline in expenses on from incurred XXXX was turn payment gross-to-net for expenses, XXXX. increased cost Slide GAAP was $XXX.X $XXX.X noncash were increased to programs invest advertising in upfront as $XX.X million the including XXXX we as The studies third million increase million SG&A due or XXXX. stock-based continue in XXXX million to to XX. in pimavanserin,

year-over-year year the growth $XXX As in an strong mentioned, net $XXX million and Steve this full XX% for growth volume approximate growth represents NUPLAZID we guidance midpoint this range, the approximately of revenue for year-over-year. expect and million. XX% in sales At XXXX, continued the

be the in increased a result XX% the We XXXX higher XX% the of there in factors to previous With to regard to three obligation year XX% gross-to-net than consider. first [ph] the XX%. We full the from range donor and adjustment year. for of XXXX adjustment projected manufacturer full expect the are an quarter, to as to

First, XX% we to adjustment of a are XX%. gross-to-net forecasting

Part of reset donor to reminder, a patients. manufacturer high typically obligation in annual is quarter gross-to-net As Medicare for first B the due the

DTC the a the and, inventory realized largely partners second reduction XX-milligram in as it they transition the third, experience this and And XX-milligram a possible XX-milligram partial benefits channel. inventory channel the we therefore, the year for benefit towards Second, temporary quarter, tablet our be the is as to initiated our capsule last quarter, remaining from may campaign in during that positivist those end of complete of the volume fell QX. ongoing

On the million results compares X-week expense XXXX. $XXX for stage increase XXXX, to of plan clinical progression XXXX's and side R&D for $XXX our be to The GAAP expenses in million. we of programs expect between

of the these bulk XXXX. expect XXXX to We in recur and investments

cash $XXX expense million to XXXX. million expect the stock-based expect year offering, XXXX. million ended with equity between in $XXX $XX and will be approximately between over million to $XXX.X GAAP turn be compensation Inclusive Steve. and XXXX we fully and for our million $XX We SG&A And I and $XXX with model full investments. diluted noncash, we expense shares back the We of year, million call the that, to for in

Stephen Davis

Elena. XXXX. XX. In turn of Slide team pipeline is executing two, our Parkinson's disciplined you, through in in our on One, strategic leveraging the CNS pimavanserin, NUPLAZID three Please Thank closing, indications; expanding business our additionally to growing three, pillars large and additional psychosis; disease development. and all focused market

dedication committed for are disorders. will our of Operator? appreciate to now improving I the all up and questions. employees we who always, caregivers of As and of patients call CNS hard work the the the with open lives

Operator

Instructions]. [Operator

JPMorgan. the Kasimov line Your of comes first question with from Cory

Matthew Holt

EU the II criteria? might CLARITY the and on Matthew patients on question Phase MDD My U.S. is in is for other? study irrespective the program. how Can This And this you Phase both to trial the terms prefer each discuss an III run decision your on on of of and first Cory.

Stephen Davis

Sure. serge, take want you that? to do

Srdjan Stankovic

matched just stage we in trials Both essentially II Phase identically our closely that Matt. Phase III and performed. to Thanks, identical Yes. X very design almost are trial

we similar the it's terms are patient the in measures, the addressing, outcome in So of measures, very design. terms a that of population

Matthew Holt

ENHANCE it. to up read possible either out study. level with get are curious of with dosed then to Got to And far turning going of the or proportion Curious what dosed your seeing general dosing. confidence down patients so schizophrenia. this the that and to you're

Stephen Davis

that. level very always high Yes. trial would every confidence I do otherwise to say have a do, not I we'll we have of probably with

the have, we have benefit paradigm. in I So patients can conviction do adjunctive that an a bring to schizophrenia with do pimavanserin treatment

been in course, it's clinical Of to business long I've own know challenges. this that actually trial its

in optimistic of From of ending we about of would outcome say I the that also nice that of the a up in I'm in lower can that the quality a trial. are trial on say terms higher thing So dose, I the are proportion this with of and terms on perspective trial. see trial confidence the the majority dose. say the of patients blinded quite on a dose, of patients what dose, XX-milligram we would of reasonably fashion, the in execution a with a smaller of the bit retention that I one seeing

Operator

Our Baral next question Cowen. is with from Ritu

Ritu Baral

little the probability success Serge, study? had the we given how about HARMONY for have reached interim. a at can But the feedback about the I [indiscernible] that know a of you And of discuss you gotten should the bit think discussion of especially positive from conduct [indiscernible]. interim, the

Stephen Davis

Serge, did question? you hear the

Srdjan Stankovic

I understand of question, Ritu. the not part did your last

please. repeat, could you If

Ritu Baral

Yes.

did how depends good things you are and the probability curious about I've it confident have at Just say pimavanserin the outlook? seen to interim that letting all recently we that indication. how the on of success the

Srdjan Stankovic

general are couple here. in There just pimavanserin optimism of Right. take about that I we couple has comments this considerations to the my of a mean, in read to I conducting treat respect. one Again, are potential will of trials a that indication. and

we mentioned is that threshold our high. analysis we As -- previously fairly the interim of

want spend not high a analysis. did to have we interim the So at alpha

the So although possible, we about at quite analysis. probability consider success thinking when the high. rather to interim put that threshold something And of it's

with the this, agitation. the risperidone depression and psychosis of is, second rate lot prevention relapse with and of in terms prevention XXX consideration with or is, psychosis dementia This psychosis course, combined high. analysis, area precedents fairly is the are in trial trial not trial, there were trial patients. only The Although Previous psychotic there are second and success as too not a the there interim of in of precedents? schizophrenia of which

of don't I trial historical record So a is that of chance fair said up probability that, a there that reasonable to to perspective, expect from with all going Having end long point. it's we at is success. that think that have this

Ritu Baral

conduct trial so out drop far? And in

Srdjan Stankovic

trial we nice see first we [ph]. and thing well. of as And open organization three stabilize pimavanserin is is because for meet seen patients, can had in The and progressing one a success terms of ability you trial, quite the the very certainly to months their know, these label ideology the then criteria to

with to we terms those quite So trial are that, results. And enrollment, pleased in due planned is progressing as quite well randomization. of well as

Ritu Baral

going DTC And on follow-up is of are the it. we Got get program? measure the guys you DTC any my metric Are the program. that success to or tracking will

Stephen Davis

Michael, you to take that? do want

Michael Yang

the significant for websites. traffic I Thanks of physician really our say a reports by I requesting are and in our think pleased the and consistent patients with we're really and And would increased seeing reflected earlier our NUPLAZID guidance. on just amount indicators name, seeing, We're we hearing that we're that Yes. the question. consumer is that are

So tracking number a are we early indicators. of different

brand. starting Of reflection [indiscernible] see you're course, the of some perhaps in maybe that to

Operator

of next from Our Tazeen Ahmad with Bank Merrill is question America Lynch.

Tazeen Ahmad

from you if is or your second on any give regards impact And you're articles? media question. insurance from don't coming color year's I Steve, physicians what is know a you're force last seeing sales what your then with that not comment have us providers. could whether I you in hearing and And from first, The any can questions seeing to some

Stephen Davis

the Yes, Tazeen. thanks question, for

on drug said to go have professional. we best media taking of that as no is keep reminded XXXX, at profile had the you're when evaluation of two, thorough patients FDA One, And would back asses if a to for did care it said effects the not the they we think very reminded I I that available aware treatment three confident and in safety articles, we the additional saw three, the the drug do drug, long-term health your The just think things. they advice taking brand. information anticipate any time We they the PDP. some that should that patients, the that. safety of concerns; year. you we're under concluded everyone approved And of last if we

-- in our thought as what So [indiscernible]. we XXXX

We the see throughout expect launched we continue drug. high of confidence what to course we linear more of have growth brand. of generally And to that's When drug, progression. the the in the we've said, a the seen

our suspected already safety and And we junction, knew. as reaffirmation Are not confirming the I positioning confident in payer really on And the mentioned, want highly seeing growth. by the any the the And change very some sales call, and received FDA of remain and status. longer indications well that's in sales just the the physicians and at are this prospects of are we force. the your in really I force, call our term as question is obviously, to being of drug. new on discussed encouraging payers around we address last profile, of we finally, terms they So what seeing

in no the attributed guidance So nor by change physician, the of payers. the

Tazeen Ahmad

Okay. one for another Thanks, be Michael. you. And may

like look you the have are And drug shorter? have preference what rather you longer? need at making you see some a be certain don't do doctors of patient to multiple and many far, you becoming based on on you of targeted whether changes necessarily to patients? prescriptions as guess their progressing, would possible be physicians Or prescriptions? your had I would more as prescribing is to they from know are to prescribing coming it they physician a launch time trends. the And As so you to any is take

Michael Yang

Great question.

prescribers. we prescribers, First first-time I all, the think, fourth growth saw and seen new of time in quarter-over-quarter, we have of quarter in a significant

physicians to now, There's are into seeing want have think to priority, where with we kind dabbled line. into deeper and and get we we're to these to confirmation a drive of first more through of more I are we situation That's physicians But get as of where help the are. but still additions to many just reach, So working NUPLAZID like use It's we a deeper still brand. period we starting people NUPLAZID. cohort product think, moving usage a with where the our guidelines about further we'd I moving a first-line will depth. talked

Operator

Charles question from next from Our is Cantor Duncan Fitzgerald.

Charles Duncan

certain commercial Quick in the of With then I'd goals points them. with could DTC, to like R&D. a or share determinants like to what the you have million regard of range? hear that X $XXX then if kind that with you'd are guidance, pressure and that around you us key sense And question to any $XXX give of versus million, success branded

Stephen Davis

the Charles, I you think second DTC? we question regarding heard question. the repeat Could first

Charles Duncan

Yes.

you if any with have could those. say if goals certain you that, So success outline

Stephen Davis

Sure. it. Got

Okay. take question? Elena do the want first you to

Elena Ridloff

obviously, So range, to regards year. the Charles, the early in with guidance

we previously, midpoint. around potential of we to incorporate XX% about to well provided in expectations scenarios year-over-year with care specialty specialty considerations We as as So long-term mentioned think the volume and with the assumes and the channel, mid-XX%, it growth, our pharmacy range. for the number end We the growth, regard both obviously, regards range mid-teens price. today, and at channel account possible annual a range distribution as a low high-end, at within of I the

at the price first I year think the you time for XXXX. in end know of December increase a we the took

Stephen Davis

Yes, Charles.

at question Just DTC. follow-up your a on

targets we when we a the certain frequency that that and campaign So have So media do the first can evaluate media the reach and have? of we is execute is we wave. step amount we

audience, awareness campaign. building the called and into that on with our then move That then with that's action. executing target are We the

investigation. our the The that's where action call is to traffic first significant referred we websites had And the properties. on with intentionally and digital our of to

actions. component Importantly, that of is an what we high-value important call

then who into than patient And in We just mentioned, action but convert by more et office, people measure in NUPLAZID there, So as that seeking more name. I that their from guides, of physician, we downloaded action that hearing, are terms patients and regular cetera. for the discussion have asking physicians we're indicate videos, support. hits,

success to just way. is terms kind be goalpost evaluation this are ability starts. those in So of our the of But some ultimately, will arc paid the along the of campaign of business business

Charles Duncan

if clinically to you to quick seeing the could schizophrenia on of practical the implications Serge. in would effect the you of would really What for. inadequate share look DRP of year. why meaningful? we'll kind you'd study, share like size just also, us out do And wondering of a interim with is that? of forward us Well, what kind just And an then that question with the that the trial then be see I'm response Okay. course read?

Srdjan Stankovic

Yes. Thanks, Charles.

sizes On effect all the schizophrenia, of anywhere the is meta-analysis from the that paradigm, all the size you in for effect if look are as current monotherapy at treatment the antipsychotics a being effect above exceptions couple low to majority at Those of the for with sizes as we X.X X.X real. see X.X. of the X.X, about are exceptions up to going that of

patients benefits us average where quite of So would benefit for often exciting a on one are quite that that be I combination, because effect we this there in design. the already anywhere adjunctive determine around some the the depends if and to ethical withdrawn tolerability looking of see not are active side execution data half you in of see that the evidence the be between excited benefit if we the reached implementation that's paradigm, because may then is overall don't of the and side, we treatment of between and and you the be considerations Obviously, on level treatment trials trial the at in where of overall will discuss of FX be and other results to when and the the this and safety of and that of design, all we trial. for something that of all, the X.X that look looking trial some withdrawal that also There efficacy. the the nature see many of are we overall concerns its least stabilized randomized at results is an the X.X, patients DRP will will to elements, size. particularly of the on combination, prolong of first

withdrawal often randomized I that power from of mainstay the least at trial, of the this happen And a trial. in mentioned So relapse is secondly of the that, such or trial than is prevention perspective, more interim trial depression not. as earlier, sort and the the schizophrenia the analysis is in design

that, lot sense. also So that a historical, whole expectation interim makes perspective, from of that analysis there's

Charles Duncan

numbers such as there patients of are changes analysis, with changes? but Okay, statistical or could that interim the no involved occur plan analysis

Stephen Davis

be interim will occur will to case, changes. and done data analysis committee, stopping our performed, will were that the before trial they and the report or be unblind, safety not. continue analysis that and results, not for firewall efficacy met, and is will monitoring interim without interim you data, if Absolute by will will group are stop whether the What us data for provisions the analyze inform yielded in the analysis will positive the we the any which trial

submission. If stop the has as is will executing of that, the we'll studies just at to mentioned the positive of Serge is The read, small as alpha study, bar that's for of right course study interim We'll right think than don't read. a is course, I continue got high over. trial power the on studies part the we in bar stop much there. If the there a only about to end the So we very reason at planned. read the hit the interim that. of earlier, the inter-read, the interim move think study reading we lower very And the way fine,

Operator

Richter with Our Sachs. next question is from Goldman Salveen

Unidentified Analyst

This is Andrea for Salveen. on

pricing? I the the of of of in guidance, us year-over-year growth? is a consequence of one midpoint, help couple reflection drivers but you've first a mentioned the Our your on at year of increasing fiscal duties forward or about true think 'XX light about reflects organic XX% which growth the can more know

Stephen Davis

that to you do Michael, want question? take

Michael Yang

this growth. of see as a organic reflection we Yes,

Unidentified Analyst

Can the drivers? a you bit speak about little core more

Michael Yang

Yes.

see mentioned, great our care levers. ability Of we're and we traction drive course, great one and that enthusiasm with to those and channel, the penetrate seeing greater I on long-term that continue to

The and as reaffirmation message, other external being launch, which itself, by put and in drug a statements with FDA would for the but resources XX-milligram category the in the fueled it's refresh of of obviously, choice way is, the benefit safety combined be efficacy up, NUPLAZID a PDP. the to extension now citing

be symptoms. And to we're is the awareness doing of DTC with educate gap, which things we'll But number to tied PDP them of which course, together reach our it. a lever, levering on So closing one then of the lever is that. patients consumers around large and other

greater those so in of the for 'XX. And are organic growth kind core drivers

Unidentified Analyst

Great. And just a follow up to that.

that care this For had target how to the a case? the for that Is observed your direct-to-consumer were your I you better think, mentioned you campaign, observing. there And effect still channel? long-term greater specialty was channel previously,

Stephen Davis

hear quite part of didn't your the I question. first

Unidentified Analyst

just direct-to-consumer of was mentioned have specialty terms So previously your observed in the there you of a your effect channel. effect campaign, greater that for

still that the wondering is is And that channel? long-term about just if how you the targeting something So go would case? care

Stephen Davis

memory, good And question. Great Right. yes.

had is disease that awareness campaign first The campaign. the we with

distal research that. didn't really see long-term effect that still channel. side, care the impacting we care of later lot We're there assess have evidence can now has much evaluating that we be that Our be indicated data may a and But on the might share we from channel. long-term that the branded

largely as institutional of environment. NUPLAZID long-term education increasing for and networks penetration treatment into at care, terms Our regulated we care integrating protocols of level. in are and a delivering mainly strategy highly is the are is systems These the

selection a for to those And patients so the NUPLAZID as regulations of get agent long-term working PDP to increase care. we're a in within preferred

that's going to things in other long-term and doing to more in kind regards education we're an be sell, So education of care. of patient system

Srdjan Stankovic

gap gap significant their long-term channel differently. office May Is the there is PDP this the NUPLAZID. between patients educate channels and with on for and community There's continuing care discussions of having other the that normal mechanisms the less in recognizing to the specialty symptoms physicians. One in the be just of large in doctor very information very is business. opportunity stated pharmacy

Operator

question is Piper with Brill Danielle Our from Jaffray. next

Unidentified Analyst

if covered this. DTC four for place? when [indiscernible] advance the bit specifically to information But Danielle have little of on I how, a to? should already have in And running effect it I get wanted a just then Brill. be you is campaign, will one, joined Apologies taking be This little about the late.

Stephen Davis

Michael? Sure,

Michael Yang

we is to Well, the I the first mentioned, running day. be Yes. campaign campaign going on as our And Thanksgiving quarter. launched through

the So we've of on program, a that's the effects, campaign assess given the to and kind and it four it's believe, stop we're month we wait where investment. very a going significant and large

Stephen Davis

of the going pursue the for determine pass we the going Just some Michael's finding to to And campaign when we're the that options campaign. deal. campaign of now of do of that assess, on to of investment as end we'll it What from is the and get course, we thoughts. that assessment return that will the will we remainder will the what complete closer are is end echo the forward

Unidentified Analyst

Got it.

sort Okay. That's this great. myself. of and And the had, just last is I question for

the trial remind is to be Just expected? when myself, will ENHANCE data

Srdjan Stankovic

schizophrenia trial? response ENHANCE Our we'll [indiscernible] trial, midyear. report

Operator

Alan Carr Needham & Our Company. question next from is with

Alan Carr

new them. starts your couple of the pharmacy. A One, with specialty around pattern in

then more more data III with first you strong past I a Europe, data comment quarters in if to you wait And think wondering little indications. particularly said for Phase respect on least had that. to wanted and that had You indications until the and while, you also I'm at can more

indication? make one? a third it Europe? point decision what around you Is Around at do So second after

Stephen Davis

Michael second Yes. to the ask of one, change to Alan, question. your the in With no of outside for plans there's first question, the and our respond I'll respect following take to terms then second U.S. I'll

the As is we get are try on more indicated data objective to earlier, indications. we to and [indiscernible] filing

But So more we'll to as get that. frame we've our in we'll outside continue this said, the to and more as U.S. time, data, reassess strategy shift at point continue of

Michael Yang

it campaign ran family us with I to that we first a except leverage year to first regards fourth ago, when think say any quarters, associated the quarter don't magic to In we gathering ran in the for this versus other is important campaign, quarter. the quarter, that last there's the

to campaigns. a create our patient identification more that when And tends more think, enthusiasm to, go I so we opportunities

campaign we've into the on quarter. So quarter or the the first outside like of got late fourth

has to quarter other it can't we're obviously, how the because affect in benefit a important impact really is nature positive the But the a chronic comment basis. in to would I year, that business, So quarters the on comparison super first our in revenue. the more more early business patients acquire going in this in

Stephen Davis

I understand.

bit Just additional little of there. a color

to we've we've that we're where made to number those seen year. we to look, of And seen not some adjustments a XXXX, the in really quarter to bit previously early I quarter little I leading in we later have coming of to the were of encouraging the seeing of second we're and we of the because think early adjustments, growth first XXXX, XXXX. the last year, are the indicators last we've the different from which but indicators surprised think adjustments, first we and half a of XXXX, quarter that spoke little quarter, the first situation that. a first It's made indicators bit

Operator

Stifel. Our next is with Matteis from question Paul

Unidentified Analyst

can on about first potentially is price to these the Paul. much for How Nate This you are you mentioned as for of you May be you took thinking in this time first, approaching increase indications? think a start move larger I pricing December in year. some

Stephen Davis

take to question? the want do Michael, you

Michael Yang

we let's be indications Serge profile best-in-class commercially, could adjunctive therapy these subscribe. the if the, you take And for DRP reasons And that believe we Obviously, think the the clinical substantial. MDD. benefit Yes. great is or the like already in there and NUPLAZID is potential can provide patients given larger that MDD, say,

that is If unmet psychosis not with there's you [indiscernible] DRP, need no to approve is have asset going impairing there. therapy. take patients There cognitive a to significant for

ability profile point we audiences find payers be with potentially. conversely believe populations, would payers, DRP to categories, that to to that players done mechanisms from in sequenced both So looking unmet we're with price the talking at our MDD that that and situations and with those in use patient our the about significant right then and we we given believe clinical can for pricing believe large need, different we early PDP

side, be In an work expansion MDD of with for the more they negotiate Medicare of believe in note, context access points will So population. population. get It's commercial/younger the having a to important right payers populations. setting, ability patient on the patient audience the that to can to that more we have our a not those we to

a that's nuance. different So

Unidentified Analyst

bit then, how alignment on discussion of end-of-Phase-II design particular, one helpful. a In Got then I'm getting the elaborate it. of as maybe around much That's the terms and, little specifically, in X results? was its kind a comment there on CLARITY more. And And just SPC interested, pivotal? Could FDA? the stage with

Stephen Davis

in knew but designs end-of-Phase-II as of drug. the of the trials. already the the meeting, efficacy to looking consider trial they into division the really the how evidence we And position specific elements particularly are and what are they of the regard the going Well, important an of

advisory committee meetings. All that very of in came the clearly

specific the design, I we overall, There So discussion, for and as good meeting. had their the design. a the the very with FDA align considering trial especially was well as the as that really X, before one drug positive Phase in stage is sense II of in almost exited context very which our pivotal. of our trial, efficacy about little as real trial, consider mean, of actually, is, where position evidence very that of use a robustly positive

a of any exchange. So wasn't subject that particular

Operator

Our JMP next is from [indiscernible] question Securities. from

Unidentified Analyst

Jason I'm Butler. in for

X hopefully question. Just quick

how negative you of one, and guys are schizophrenia? symptoms regulatory thinking the Just about fast-forward

Stephen Davis

Serge, want question? Great. that take do you to

Srdjan Stankovic

Yes.

Phase based terms the in our II determine exact particular fast-forward. this lot As will regulatory for for a is paradigm our in we nothing we there point, forward that -- variety out of and the strength nothing But that. in a there obviously, on will of schizophrenia of at of we regulatory negative data and results and path shops of is approach. adjunctive approved depend symptoms stated, We're when data, And that the considering on actual read terms trial. a

Operator

Mr. remarks. closing proceed please to Davis,

Stephen Davis

each you forward progress We us our you, quarter. Operator. for today. you thanks look next to Thank on to joining Great. And of updating

Operator

conference you may you in your Thank the Good participation for concludes day. presentation, disconnect. This today's call. now and

ACADIA Pharmaceuticals (ACAD) 26 Feb 192018 Q4 Earnings call transcript