ACAD - Earnings call transcript Q3 2018 | ACADIA Pharmaceuticals Inc.

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Operator

Good day, ladies and gentlemen, and welcome to the ACADIA Pharmaceuticals Third Quarter 2018 Financial Results Conference Call. My name is Christie, and I will be your coordinator for today. At this time all participants are in a listen-only mode.

We will be facilitating a question-and-session towards the end of today’s call. [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. proceed. Please

Elena Ridloff

Good to you XXXX discuss Christie. on joining Financial and call today’s ACADIA’s afternoon, you, for thank us Results. Thank Third Quarter

Events Steve available Research Chief that supplemental on Presentations our our and our point & Dr. me the out our today we on I’d Officer; ACADIA Joining slides, website. Head also Stankovic, of to call Chief Commercial using President Development. of which Officer; Executive are and the Serge Michael and are Yang, are section from Davis, like

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

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

Steve Davis

thank Good opportunities recent you pipeline I’ll today. and announcements, joining our afternoon, a financial today’s Elena. of provide everyone, performance. and Thank overview you, call, for On brief us our

initiatives our then for the quarter provide Elena Michael review financial results. updates discuss up will Serge with our third my Following progress; pipeline call will will on and commercial NUPLAZID; questions. We’ll open our remarks,

priorities. and that on key recent Turning highlight X. serve third foundations important deliver want to will our achievements to as I quarter our to Slide

we pleased benefit-risk were of First, FDA statement NUPLAZID. reaffirming educate on statement. positive public very quickly issued following to to FDA community their disease this well come Parkinson’s the clear to see evaluation, the prepared profile conclusion September were and XX, this the about the We a thorough

XX-milligram benefits physicians capsule XX-milligram going we a is launch capsule and the engaged regarding have form. the in mid-August. launched of successfully very we Second, The well,

financial we on $XX.X in the Revenue for delivered Third, year-over-year. our million, QX quarter performance. XX% was third revenue increase a

million week of In evaluating revenue And year results end of guidance million to are of the the million. X from an line previous depressive CLARITY $XXX $XXX range in adjunctive range Phase lower major our new $XXX to fourth, disorder. addition, announce were excited last XXXX we positive from increasing between very our to $XXX million full top study the we pimavanserin to as therapy

proven delusions We addition clinic its and have now with that has the to in to an Parkinson’s hallucinations in psychosis. disease associated treat effect demonstrated antidepressant pimavanserin efficacy

Rett SSRI Please start schizophrenia the As studies we X of the care we Phase of of of on dementia-related X in the potential standard take moment to I’d unmet our in are Today, describe X a major why with and a psychosis, the programs based pimavanserin our head include on is depressive the with SNRI last in need and or course like study we so excited first pimavanserin announced in therapies. into disorder patients XXXX, we week. MDD X. for to to study the results syndrome. year. total Slide turn These will the and Phase be trofinetide planned during MDD advancing to

depression. MDD and a do experience majority However, these of not adequately continue to respond treatments patients to initial significant

leading believe can carry other literature, available market without treatment patients to is to which adjunctive adjunctive first-line high add sleepiness dysfunction, we a including the gain, treatments motor in believe sexual the and include physicians faster needs Based effect treatment tardive therapy current for and MDD. X.X then approximately and for therapy. X adjunctive associated greater Today’s impact dyskinesia. for our the U.S., response both functions, negative results our sometimes medical on options, significant pimavanserin burdens, difficult consequence, a for Based treatment the there with in decisions. trial, As unmet side MDD people on but research weight unwanted with effects can a differentiated and approved efficacy drugs as be on significant and million Phase daytime troublesome serious of side we inadequate has rare CLARITY potential need

study, early results most efficacy. assessed find improvements showed we In things align study unmet research. The in achieved the market the our significant statistically with in the secondary clinically this compelling that efficacy, see see needs this is of points. primary we reflecting as One closely Phase in X the and end were starting by key pimavanserin and week immediately positive one, we

no pipeline unmet the to sexual reduced and results function. that, I opportunities on in to discuss state a call improvement commercial With large sleepiness expand more and needs. data now weight potential gain, meaningful no Importantly, These Serge update. in function, little will a our disease daytime detail with impact pimavanserin’s motor significantly provide we over in the observed turn

Dr. Serge Stankovic

progress. our Thank with recent I’m you, Steve. extremely pleased R&D

our by Phase X the positive start of Let CLARITY me discussing results study.

Slide to X. Moving

a Depression parallel Phase safety, a an serotonin daily. placebo once serotonin a or double-blind, norepinephrine multicenter, All X stage. SSRI, inadequate or end inhibitor, adjunctive Rating efficacy X using standard received Subjects to SPCD weeks the study comparison efficacy to reminder, reuptake selective in dose We reuptake therapy treatment pimavanserin evaluated assessed and inhibitor, placebo-controlled, SNRI. As antidepressant stable tolerability sequential Hamilton the of as XX-milligram as an X-stage either with was subjects primary patients pimavanserin were MDD that had Scale up CLARITY each who study point. for of a the response randomized,

measure including disability the secondary reflects which patients. secondary key point or Disability work, on major social points, impairment assessed multiple a activities, of and end family SDS, We improvement clinically using also burden on relative Sheehan relevant -- additional end and of a meaningful Scale,

the placebo Pimavanserin p-value primary randomized compared by Hamilton results were placebo met Let’s reducing Stage top or X.XXX. study Slide XXX to with all Scale on point of convincing parallel XX-item a prespecified points. review In the pimavanserin week to pimavanserin Rating sustained an Depression the participants line end for X. X a X, and five trial on comparison. significantly starting across and reflecting through sustained at improvements one several effect the period, The achieved independent were Stage early of immediately effect. showed antidepressant positive were end week treatment HAMD

selection of difficult-to-treat patients resulted small a we subset X entering from of a criteria did Stage and Our for the were likely see where separation bit not stringent in placebo.

an Stage originally SPCD Advisory design, Committee of for this traditional only from indicated for As X not a endorsed would be informative. anticipated. time data have take an patients Stage a to which consider of treatment X of SPCD which Last XX a Stage part design the On to address of the a moment they result, half Slide Stage and like to in X, discuss about drug the I as at trial adjunctive comparison importance MDD, XX, efficacy while X, week, specific parallel is they entered a most trial FDA to what only relative was design. was analytical method

X at efficacy our of a look results moving Stage So observed in let’s the we SPCD trial. take on,

Slide Turning to XX.

all potential positive end on rate, reduction results observed sleepiness were secondary primary responder the point, including daytime and points, to provide additional results differentiated truly that In addition for to has function, improvement observed additional the positive and in us robust in of antidepressant. confidence a also the pimavanserin key seven secondary end be sexual which

XX% leaving in we the achieved a also out that the XX% percent XX% this of patients than and Approximately on on placebo, approximately achieved pimavanserin responders and doubling were of would like just Before point patients of I patients pimavanserin placebo. slide, Stage more remission response remission. in X, on versus XX% saw on to who versus

X, and As the at size was end through for can starting achieved to X.XXXX. where on the X, The visits X.XXX. week of was sustained p-value score, immediately total X from observed Slide baseline at all in see placebo separation you from Stage a significant X week we was primary see point, HAMD week XX, effect

size an point The approximately represents of work, we results family in include X, key comparison measures for our plan treatments in and what parallel study study reminder, Scale, participants. X secondary observed would robustness Stage Stage this in we X.X a is effect depression. was of The social in randomized X of considered be Sheehan Phase confidence because as placebo clinically meaningful activities. traditional in end all impairment and which program the pimavanserin a As us study essence, that gives Disability

achieved The was effect Slide the sustained see X, separation visits X, at where week at starting and at X week Stage observed from placebo XX, was X week all p-value a in immediately from of was to X.XXXX. X.XXX. baseline through significant we size Looking

addition, received In who, study hoc. p-value the derive This period. was in inferential placebo accordance pimavanserin statistics with XXX evaluation protocol, computed followed prespecified XX-week either the to patients we continuously throughout or post with

HAMD for effect end meaningful entire Slide As We period of XX, yielded receiving XX level separation favor through total X separation continuously pimavanserin. also observed either with and the p-values observed pimavanserin score; shown a size placebo over or at week X.XXXX positive an X.XXX. on week comparison from in significant XX-week the of the primary point, between of patients

In XX% a a XX a XX% rate weeks, for XX% of p-value addition, of observed, responder almost a p-value double rate X.XXXX X.XXX. XX% for with remission XX% with versus placebo, a placebo, delta versus we and at of of of

throughout XX we of had events low durability These the of of Slide observed leading on events a Looking entire On serious SDS endpoint very we treatment. Slide p-value in X.XXXX we on of response. support the of X.XXX. at to achieved study, XX, of the size XX, results the number effect and discontinuations same adverse and note analysis secondary adverse score key that a weeks

events more safety at well adverse Looking overall than in was reported patients. with Slide generally tolerated of XX% no XX, on pimavanserin

any weight study. In not did we see addition, in the meaningful gain

Turning to Slide XX.

Phase our at believe initiate encouraged in X of the of positive states, an half the also as and opportunities. need We indication MDD highly as X on necessary submit program commercial potential Based reinforces of to for XXXX. could representing disease robust pimavanserin studies benefit placebo-controlled the We X CLARITY our pimavanserin are in sizable plan adjunctive Phase data the The parallel results to X and to results, in discuss plan end study the for Phase meet an multiple MDD treatment unmet by to meeting. patients of X significant confidence serve X first this with MDD. studies in to is that FDA of for pivotal the these the sNDA

we which on psychosis, Another dementia-related Slide XX. discuss large in unmet need CNS is

pleased We with Phase progress of very are as HARMONY the enrollment continues to study well. X the advancement

previously As in number the interim shared, the we for half of to in of the second events study reach XXXX. prespecified expect analysis HARMONY the

reminder, a very statistical interim set is there As for threshold high analysis. this

Phase to anticipate completing XXXX. prespecified its Now passed recently highlight focus in enrollment mid-XXXX. let’s the schizophrenia responder second Phase turn in futility analysis, X in line Slide expect Slide schizophrenia our study study negative ADVANCE X top of half our symptom XX, data ENHANCE study on On we we We XX. inadequate the The and study.

rare approved Turning a debilitating life. predominantly months medicines for occurs Currently, development no Rett apparently Slide this is that there on are females in to trofinetide X disorder Rett following for of syndrome first syndrome normal the and disease. XX. neurodevelopmental

look eager are evaluating this initiating trofinetide trial progressing with on Rett XXXX I the trofinetide potential know to discuss treatment single approximately X this This turn in as placebo-controlled is support submit Phase XXX there our community our for an randomized, over Michael in we of options. is girls study. Phase activities If Rett to of double-blind, is study positive, will new We initiation XXXX. placebo now NDA second performance. X the forward a to X study study call evaluate the half based the and in We manufacturing Phase our to syndrome. will to commercial

Michael Yang

add to the with trial. discussed Phase my Phase that Thank for Serge X the you, positive X results Serge. excitement like I would -- CLARITY

this no important and If we positions treatment who Depression As approved, separation in placebo; weight to patients and sleepiness first-line this suffering study respond we the deliver ACADIA uniquely Slide believe our from don’t observed footprint commercial new early MDD improvement findings daytime reduction and adjunctive function, Disability and think in are statistically adequately of millions for about treatments. significant Scale MDD; to robust meaningful Please sustained differentiation, gain. to XX. as sexual potential turn improvements and the Hamilton from important Sheehan treatment to from on the

with an you time NUPLAZID As can it’s activities. see, commercial busy our been incredibly

as families. at the immediate all prepared community, team on We, proactive outcome. very ACADIA, to action patients FDA was outreach XX, by We well all not When September our physicians have able been pleased medical statement field we the FDA. this and we released at but conclusion for the with the to was in our educate spoken have and surprised were the were by take

addition, advocacy organization their community, In patient on websites. shared many FDA their support of in the news

We are that and executing physicians growth the with label. multiple, efforts a our to foundation on exciting efficacy contained that build data initiatives ensure safety NUPLAZID understand on the of

the launch. patient We are the enthused recent improve opportunity experience with to with the XX-milligram

and significant milligrams portion dose then availability While over for patients NUPLAZID, XX-milligram only time has the on XX a resulted to titrating starting tablets XX milligrams the XX in of milligrams. has of always approved been

a and have employed approach. We patient-centric physician

physicians strategy capsule to their scheduled patients at on XX-milligram their the Our next is visit. focused having regularly transition largely

Importantly, patients XX-milligram a our initiated we capsules. vast are majority be of seeing new on

is team to and field this strategy. transition Our energized well execute on positioned

capsule burden, market that across research we Following recent our our of are physician were statement respondents respondents, NUPLAZID are the of patient were to see these and The the aware improved launch XX% three the moving capsule. about administration. use FDA’s good the The capsule universe. and right recently expect on on the decreased reasons they XX-milligram of findings principal to compliance, future with in the Of we of patients execution. indicators NUPLAZID, commercial track the completed target next the pill XX-milligram ease an XX-milligram stated convenience for XX% months. listed the increase over of

they increasing the FDA XX% over aware, who statement XX% Of months. were XX% profile next research, use that this of positive During aware of anticipated the the benefit-risk for were respondents reaffirming indicated the the also their NUPLAZID. three over

hallucinations to the fourth direct-to-consumer with our by with their with caregivers. and associated conversations NUPLAZID. we programs viewed a Parkinson’s patients campaign disease to physicians commercials be commonly new and ahead, plan in launch further featured will and stimulate branded, about Looking caregiver and introduced campaign patient targeted This quarter in their delusions television

to was campaign. is Our successful. awareness new on a converted branded was disease starts the campaign right first previous in very a this the that awareness patient This direct-to-consumer NUPLAZID quarter of year. into increase in this large believe time initiate We

basis provided metrics As several you recall, last current quarter, share business we trends. temporary on a to

and growth. of metrics these give you about an We we you how to turn are XX. with the will future few reiterate of a today to idea why business Please Slide has optimistic stabilized

We actions are confident the to in growth. accelerate we’re undertaking

However, these with benefit important time are full impact. next visit, are a in they prescribed patient when their start to will take regularly they for new a results more scheduled it that period. counted to patients of at NUPLAZID when achieve remember actions start. a This to as the sample lag it’s their Typically,

messaging interval. time a to their it of it repetition or with at takes takes and as they many X- of see whom patients, initiatives, see X-month commercial addition, In all physicians

see, of the of you left the thirds the As can of stabilized we’re starts slowdown signs new patient to side saw channel, our the very in in slide which pharmacy represents has specialty we on and growth. sequential revenue, starting see early two

refills we quarter, our as disclosed addition, In have remained last stable.

care the side. to long-term on right channel the Turning

seen the demand growth continued we’ve through that You see quarter. third can in bottle

here the over to a growth discuss respond initiatives in the upcoming us we to contained Elena deployed, and feedback DTC Psychosis. sooner a gives The physicians, between that to performance. financial including Our more and long-term caregivers. care have now loop tends business patients the given channel PD the initiatives quicker opportunity NUPLAZID’s call our our it’s with I’ll long-term and to in turn branded XX-milligram confidence launch campaign, observed

Elena Ridloff

Michael. financial our you, and Today, I’ll our Thank discuss QX results outlook.

$XX.X quarter sales, XXXX. million XXXX, $XX.X year-to-date The increase million to million in $XX.X available we the growth or QX release afternoon. for financial are Please in approximately of of to the third of an net recorded In the XX% issued net third XX%. was turn gross-to-net of XX. sales quarter Our the compared rate this Slide in results discount we press

in the at end inventory QX of QX. the was channel Our from unchanged

The XXXX and North million XXXX. $XX.X payment related largely in expenses, timing million. million increase related the stock-based in to in a period million expenses third year last quarter upfront DTC was Neuren XXXX. of cost in the $XX to are from flat operating in in of same respectively. of QX QX and increased including $XXX.X The goods noncash compensation of million fourth the expenses third $XX.X quarter which and million to compared of down lower-than-anticipated sold, R&D quarter our million P&L. Moving million the of a of third for incurred $XX.X $XX expense, trial quarter. the commence Total $XX.X the costs expense to $XXX.X SG&A to at included were These of guidance to amounts below in rights trofinetide. compared was XXXX increased clinical campaign, to in million $XX.X million result for change the will Pharmaceuticals American the our planned XXXX, $XX.X costs

XX. Turning to Slide

million the increasing million $XXX to of year to million new prior to end $XXX million. our guidance a from are $XXX low range range full revenue the of of We $XXX

advertising DTC SG&A in to range, for and expected our related the includes million QX branded expenses million pimavanserin, trofinetide the $XX the program, the the opportunities side, preparation includes expense preparation for we for continued our low which campaign are which the in program for pipeline to investment for On Phase mid-$XX be for NUPLAZID. be QX, X additional expenses Phase in expect X to range, R&D in the MDD. investments

cash. to on Moving

balance approximately third We the $XX in quarter to QX million compared approximately of We and the XXXX cash million on will of the that, anticipate our $XXX cash Our net I’ll $XX million turn end our quarter and third Steve. of year the $XXX over was sheet. $XXX between cash operating in ended balance the million back burn for investments XXXX. to call with million. And at that be with

Steve Davis

Great. we the In you, achieved a past months. deal Elena. great Thank few closing, in

advancement Phase of statement With to in towards With profile for our of benefit-risk of a FDA successful results opportunities the from trial and the future. MDD, launch I’ll exciting we Operator? positive X up see reaffirming momentum the pipeline, the clear positive continued the XX-milligram open a and very that, NUPLAZID, now the look great late-stage as we R&D commercial on build questions. our CLARITY call

Operator

Instructions] [Operator is Our first Cory question Kasimov from JPMorgan. with

Matthew Holt

Matthew is on for This Cory.

I’m for one front. quick the terms NUPLAZ dynamics safety commercial if patient in Just late announcement FDA qualitative you September. on perceptions one any can review color or provide in wondering the of following

Michael Yang

seen NUPLAZID really had mentioned, been that has websites up, did I put only those we hallucinations groups. and both We the as conversations As community FDA a helpful quite the on And physician of and and caregivers approved patients awareness statement it delusions. the we grassroots a picked number patient positive. were and for for have the and it advocacy as survey, medication results and local believe has very for builds this caregiver with

Matthew Holt

you this, patients the sorry if then XX-milligram say And did capsule? how converted the I but XX taking many to pills missed guys

Michael Yang

percentage the high patients have we converting patient XXs new office start, into would in the new are basis. we’re existing milligram, a on on they XX the majority the opportunity that We the XX cleanest is not. starting of the the as which regular a and come a did starts, when say high I patient

Operator

from question Cowen. with Ritu next Our is Baral

Ritu Baral

in talk Stage of follow-up. patient you have so a ended requirements that what you for times the you had that’s you and call patients the Serge, X. why you stringent where conservatism I the and profile? of have will on how those and Can with changed put screws previous this CLARITY, about patients mentioned up were? few call And re-randomizing sort a in very criteria that And on couple might

Dr. Serge Stankovic

the fall have Different into into SPCD less the Hamilton different then criteria as category is use than for XX% a criterion at dual re-randomized minimum less or as X are Hamilton labeled for criterion single X. on more Depression Hamilton and XX% nonresponders; X and the trials Stage a Essentially, a categories. or that into on threshold X. other Scale where than on patients One reduction the improvement Scale Depression that they they is done we a Depression of week say Stage they are Scale XX are re-randomization

we the So randomized patients and is that smaller re-randomized more who in actually resulted second criteria stage. second -- a were of that group use in are stringent this

Steve Davis

higher I’m I in but reduction you’ve question, be sorry, have XX another HAMD in XX% Ritu. order you to both to just we be or to know use re-randomized. got clarify, and HAMD a on

Ritu Baral

any I concerns especially about, designing be for And may over couple then nothing else? changing the years a severe paradigm ketamine, programs do you if the of X I Phase refractory guess, and have depression, with guess, couple when running if depression, next

Dr. Serge Stankovic

all No, actually. not at

to First people perspective, inadequately hospital a the trial. in SNRI. Sage or SSRI that From such of are development really ketamine responds in that patient Phase or all, patients background affect targeting X program short-term as would a with we that intervention the not severe compound be population the continued suicidal treatments, we our very potentially, current will this doing for

Ritu Baral

if from excluding X? them had previous Phase So wouldn’t somebody ketamine be you experience,

Dr. Serge Stankovic

treatment other appropriate appropriate for or SNRI. treatment, to What are met, that dose those us they are on be the at with adequately Once need -- is the cannot of same on currently are duration do and the conditions patients antidepressant be respond they treatment SSRI and important they of not time. for those treatment. on, that course, When to

of candidates the category would in that that for patients So are exclude the esketamine.

Operator

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

open. Your is line

Tazeen Ahmad

you of done of that guess, which survey pent-up all lot the you’ve a indicates there’s demand. about work talked I that physicians, Michael, for

XXX kept million your You end the of guidance have at year. the high for

safety? of -- can the you that as acceleration result came in And on so a now FDA a give quarter, us that of formal statement seeing fourth perhaps of making of color I the we’re on a terms what into follow-up. And have you’re comfortably then scripts some

Michael Yang

Tazeen. Yes, thanks,

can have slide, new the patient We as see acquisition. of on seen, sequential you early signs

mentioned on period But sample to call, solid a building between do we due that between in that there I believe we’re foundation, and the is physician coming their will the starts patients office to the the a the that start. As see timing new converting that lag and lead into future I a the new acceleration to in in months. patient patient efforts

Tazeen Ahmad

But in the long-term I care, think that seeing said you acceleration you’re was pretty robust, right?

Michael Yang

Yes.

As see the channel, long-term I more immediate on mentioned care we a impact. much

didn’t dramatic quite a also We downturn in see care. long-term

very good, seeing in We’re response care. a long-term robust

Elena Ridloff

quarter add year-end Michael’s a with to in the additional to inventory in channel. Just of one hole guidance that’s is anticipated in fourth our associated comments, donut accruing the in for result increase obligation the Tazeen, gross-to-net the element incorporated as

Tazeen Ahmad

XX Okay. Did mg this dose of you sell quarter? the any

Michael Yang

Yes.

Tazeen Ahmad

And us have have you might some you been? what can give -- color percent scripts that on of

Michael Yang

from channel as have percentage, think XX a detail we XX. we from don’t a a fairly perspective. on the But It’s but milligram some a low It’s small perspective, a I percentage. script good very stock did

Operator

Jason Our Securities. is Butler JMP with next from question

Jason Butler

compare one to Can how you campaign on couple both and will us visibility campaign the contrast of and to starting efforts? had maybe give will last of you’re January’s some consist brand into just the Just going that what that months. be next that more in

Michael Yang

question the Great for and question. thanks Yes.

psychosis. treatment really disease campaign patients of Parkinson’s campaign more and designed conversation caregivers office and This in physicians, around awareness with benefits is Our designed last be to remember, disease NUPLAZID. painting to campaign, stimulate be the of designed solutions-oriented, picture a as between a you the was to

on the So to be of will with it treatment campaign and really be will benefits specifically be on a NUPLAZID is designed focused the that solution. largely

Steve Davis

have question? Jason, a follow-up you did

Operator

is from with Salveen question next Richter Sachs. Our Goldman

Salveen Richter

phase Just in reading you next details Just the initially were phase enrolled to wondering of would that year, second study? the us you and what the data that’s provide half or the provide get number for dementia-related year, -- psychosis patients that will the the study qualified how withdrawal of read. then many regard around that we’ll of before out in

Steve Davis

said is fourth do question? just to what to The answer, want rest would second to you read year. the of study. said before commenced X.X time, for interim the half dementia-related years point I’m We we’ve the the going would expect to study, in in next psychosis ask I The study answer clarify at do. the Serge quarter that it but take we the of we to of that XXXX. X Serge, in

Dr. Serge Stankovic

What around can I share I of the same exact of analysis, interim Yes. and when specifically to we make number of say recall, going we adjudicated half not did pre-specified was reached relapses, clarification, we the the numbers the patients. detail

criteria, bit week terms completing both criterion rather is -- are enter for in rate, and stabilization of little running and I In open-label stabilization. week patients are the ahead the successfully a of you the we meeting stabilization stringent X the our that patients a treatment that XX, tell period can of that which assumptions of terms proportion

more So we we than are randomizing more patients anticipated patients, what initially. slightly

will or latter we case. the of which going any stop do we be, the is I that remind Now at till interim analysis, will the case rather at threshold, trial, is end either statistical in not the in stop details the trial interim announcing in but announce of everybody terms and interim trial to with the analysis the of want high. point, trial be to continue threshold, the we that analysis positive, results to point the will

Operator

is Duncan Fitzgerald. question with Cantor from next Charles Our

open. now is line Your

Charles Duncan

pivotal Serge sizes, question I the regarding large. the doesn’t to steps. recent with know I MDD that for given next need like that to program the had Congrats a on have you all the be meet still results. effect agency, looks but

what sizing And what could right size, sizing? effect follow-up. about you be us sense, you assumption the I if both an had now, a -- had just beyond of So those Xs? would the to guess Phase give a else would Then drive

Dr. Serge Stankovic

if exactly will that were effect a the trials looped the Phase have I we even a of the some And in trial. discount do size say luxury effect a X. comparison still in that achieved X just Stage in X, size indeed a parallel -- as smaller for we considering we X we trial, rather can large can paradigm that the -- Stage Phase we

trial absolutely So will the give of advantage trial as which usual, that than careful carefully as that. be take well, the this not again, of conducting consideration of be a trial we additional and small this sites. X mean, -- The smaller right, hundreds I would a selection will regions selecting Phase numbers trial. patients. well as the will but you’re trials in advantage we smaller really us of And is a

just what refrain of good have we will we Phase doing course, and sharing settle Phase I say X the of from we of the envisioning than But larger we until trial. that we -- -- what the we what we FDA a with fairly So can not publicly did much, have size are much would in but what X terms are discussions the would program. on be be idea that in of

Charles Duncan

this understand practices it’s sales the trigger compliance place that on practices, could new have guess thoughts That something investigative that -- to makes this has and that even Avanir I marketing. not ACADIA bit went a seems I in it’s wondering same, received question reminiscent Maybe years wondering me help related you through could information. consumer though if a several you’ve little And force Steve. ago. I’m you sense. A quick saw demand to who us marketing but of if any for this

Steve Davis

No, thanks the for question, sure. Yes, Charles.

document received with We And course, the from DOJ. fully we’ll them. of have cooperate the civil request

grounded and board and to it’s comply people and committed and practices fully worth that laws our are we aim and all with noting responsible ethical to business I the are of that of management encourage a culture think to in compliance regulations. foster team behavior, that

the obvious, employee, Of it high that is principles course, helps to assure responsibility very hold adherence the state to just these we to very of and this standard. ourselves

I think -- point, comment a at comment any to time. at premature on give this further this this it’s

Operator

is Brill next Danielle Jaffray. Piper Our question with from

Danielle Brill

be Did gross-to-net you what will I said this say heard, quarter. in quarter? increased was Elena, you that it fourth the

Elena Ridloff

this quarter, XX%, was Danielle. Yes, it

Danielle Brill

growth? the what sequential And And one was I quick then have volume follow-up. then

Elena Ridloff

third approximately the X% was quarter. sequential The volume in growth

Danielle Brill

for MDD, about Should that here. already for think now a with can would keep be of quite pricing? give helpful. what’s I color And think How on in we PDP derisked. it modeling premium at Any should most available? I’m is pricing we then us, so And line about just you to now, thinking

Steve Davis

question, the to Michael’s that. answer Danielle. for Thanks going

Michael Yang

from the there opportunity everything on discussed, significant we saw or need research really perspective. a as that, we the MDD, has had robust. the a an and positive wanted and we market agent. As best-in-class Based to pimavanserin that be saw that adjunctive in It adjunctive unmet is trial were we very, results that believe very

profile, differentiated. there’s lot to it’s early really dial talk potential and pricing. Phase of is the little up continue the in what the excited about payers to is doing of X going seen X, and So about we’re research expand in be and opportunities the a Phase partner pimavanserin. for We’ll we research lots been We’ve of but believe access to to with profile planning, a to appropriate we’ve

Operator

Paul from is question next Matteis with Stifel. Our

Ben Burnett

Matteis. This is Paul for Ben Burnett on

just quick to X first, just ask burn. about -- I I about question a Just cash ones. guess, wanted

and X follow-up, about we you single financing? XXXX I have you that runway? expense you the are if Phase for don’t top anticipate do And in for how line range. slated So the need mentioned Xs Q-over-Q a guess And like mind. with you should think low growth that I have digit a

Steve Davis

want do you take question? that to Elena, Sure.

Elena Ridloff

Sure.

programs ongoing XXXX. planned, ended X our that us XQ business to are with our including our investment million $XXX securities. current So and in into cash cash And based we take we Phase plan balance and expect on plan, approximately for

Steve Davis

Ben, follow-up have did question? you a

Ben Burnett

Yes.

So we’re just that of other. studies. we succeeds the if studies should the guess assume understand read-through there’s schizophrenia any to I onto if your one trying one on just

guess, of inadequate you do negative what I population, speak So poor degree to between in extent terms in to therapy i.e. just and patients patient to study who symptoms? response the their ENHANCE overlap because could the are of ADVANCE study so of of control experience the

Steve Davis

Serge?

Dr. Serge Stankovic

our symptoms. to question. negative the of for are, antipsychotics. Yes, background of experience and case patients, are and feature studies antipsychotic, is background, would the the absolutely. in common their experience spite treatment In positive required on both ENHANCE both patients that The yes, Thanks of with study, -- atypical

negative but in is symptoms patients of case positive of no to negative are symptoms, symptoms. the not there really certain So have -- severity a required prominent

So that’s the difference between two trial.

trial, we symptoms trial, two on Phase the population. the low-dose trial are ENHANCE is negative what idea subscale would the and in So in that were background that in trial, to our saw able, X different the the perspective the to action of also that, positive probably the these Phase symptom negative patient and did to what of trial symptom improvement see We we see expect both patients with obviously, these that subscale Risperdal there. that. ENHANCE dual will able due results to we a the I subscale, so but improvement improvement be from on be was read-through, see impact patients better in and X in that symptom the negative schizophrenia on in get did that treatment say

Operator

Alan next Carr Our with is from question Needham.

Your line is open.

Alan Carr

TRICARE then sense And you Can and long-term proportion terms of think prescribers was picture, that you this of potential where give a a bigger in of quarter? here? you penetration stand do care

Michael Yang

mix in care, low our long-term digits. business. a heard not our XX% part significant the total is your of correct, was your I single correctly? of Our business for Did question TRICARE question answer I if

Alan Carr

quarter sounds Yes. if I changed pretty see it’s was to like it trying that proportion just had from quarter, but to stable.

Michael Yang

remind me? And your can you if stable. question, pretty second Yes,

Alan Carr

here potential room stand Do to of to grow trying a feel you you -- here. prescribers I’m like of in where question still? picture lot here Well, about bigger terms you a think penetration of you have

Michael Yang

yes. Oh,

terms ways; the mean, it opportunities two look the in I lots and penetrating at prescriber I in in universe. prescriber of base, of targeting So

patients, decile more to good in XX% the right positions. coverage of We have around terms the of relevant we’re importantly, opportunity. But XX% patient of

a the penetrate market So have PDP. we in opportunity lot more to

Operator

America. have question more Ahmad time Bank with Tazeen for we from one of And

line is Your open.

Tazeen Ahmad

on your clarify to balance Just sheet.

take that of you into or that that that on to does cash assume your on next you’ve whether trials beyond? they’d couple the the to in about talked DRP XXXX, be have fund years, and MDD you you hand enough Before, comment would also able be

Elena Ridloff

program, in MDD have trofinetide. Serge obviously our includes assumptions. And made that some to plan, that DRP specifics, MDD, as With the finalizes and cash more we’ve schizophrenia we’ll regards So reflect which will consumption. assumption

Tazeen Ahmad

question then on just any all the inventory? And at one from quarter. there Okay. impact Was

Elena Ridloff

No, inventory was flat quarter-over-quarter.

Operator

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

Steve Davis

Great. operator. Thank you,

work progress with dedication hard you to forward disorders. of quarter. We on always, As caregivers are committed and the we who updating employees appreciate of patients improving the look and to next our CNS lives of all our

Operator

Thank conference you presentation. in your call. participation does for This today’s conclude the

disconnect. now may You day. Good

ACADIA Pharmaceuticals (ACAD) 7 Nov 182018 Q3 Earnings call transcript