ACADIA Pharmaceuticals (ACAD) 31 Jul 192019 Q2 Earnings call transcript

Company Profile

Participants

Mark Johnson	Vice President of Investor Relations
Steve Davis	Chief Executive Officer
Michael Yang	Chief Commercial Officer
Serge Stankovic	President
Elena Ridloff	Chief Financial Officer
Tazeen Ahmad	Bank of America
Jason Butler	JMP Securities
Ritu Baral	Cowen
Charles Duncan	Cantor
Alan Carr	Needham & Company
Ben Burnett	Stifel
Danielle Brill	Piper Jaffray

Call transcript

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Operator

Good day, ladies and gentlemen and welcome to ACADIA Pharmaceuticals' Second Quarter 2019, Financial Results Conference Call. My name is Michelle and I will be your coordinator for today. [Operator Instructions]

I would now like to turn the presentation over to Mark Johnson, Vice President of Investor Relations at ACADIA. Please proceed.

Mark Johnson

Michelle. you, Thank thank to and joining on us Good ACADIA's you second call discuss results. quarter todays afternoon for XXXX financial

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

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

made statements, of undue these forward-looking only date. to reliance You are which not place as cautioned today's on are

over turn Executive I'll Davis, to Chief the Steve Officer. our now call

Steve Davis

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

XX% revenue year-over-year delivered in see on NUPLAZID increase. quarter slide a team $XX.X net growth and $XXX In achieved the at previous range the million year-over-year range. of increase year from at XX% this full represents XX% can quarter, our you the raised in our of year-over-year guidance we've and on execution a sales to $XXX as the the sales million midpoint revenue strong performance in million. volume million quarter, to Our to five. This second Based NUPLAZID $XXX $XXX million second a

We continue programs needs as pipeline in pursue very by CNS with to our leverage space R&D capabilities pressing unmet several market the large we opportunities.

second in the patients we with our our have ongoing announce dosing schizophrenia to half plan we line of diagnosis, in studies. in completing related results forward In dementia disorder, treatment continue top evaluating X progress and study, our for fourth year. Phase HARMONY Rett in initiated schizophrenia, predominant to now results In evaluating line of in top trofinetide study look LAVENDER, end negative good half pivotal remain year. the Phase of we for study advanced And year. with announce symptoms this next this and In syndrome X make the of major finally, into our Phase initiate X we to the year depressive this pimavanserin track with expect of to quarter on around second XXXX intermediate both to an

it turn I'll that, to With Commercial over Michael discuss our to performance.

Michael Yang

seven. you, slide Steve. to turn Please Thank

the a NUPLAZID driving of second the a initiatives, commercial as on our our reflection with adoption quarter. pleased team's execution This performance of PD is continued of very we are treatment the of choice. We Psychosis strong in achieved awareness and key

long starts In well care term term quarter, at care as the expand NUPLAZID volume to for and patient growing as facilities. we new prescribers our second continued long new adding and new pharmacies, reach

volume year-over-year volume we result, XX%. sequential growth growth of approximately and a XX% of As achieved approximately

to successful able the were the demand were specialty the milligram increase XX both completion of distribution of transition In drivers NUPLAZID the growth pharmacy in for channels. we and of Principal specialty quarter, milligram the long also care XX growth DTC Patient to a quarter. planning in tools and for contributed during developed term tablets campaign. driving channel care brand the screening healthcare practitioners and

quarter, second on will to established the treatment. growth significantly sequential for growth we of an these In of compliance Both remainder realized new additional in to patients the year-over-year the increase our benefit volume and continue patients contributed starting for patients even very consistent paid we Since further, and quarter, XXXX. continue the we performance. of to to Notably therapy strong launched this a our was NUPLAZID, for increased quarter which who therapy. second contributor on high we seen second saw have compliance during compliance benefits

with Reaching our seeking initiatives caregivers caregivers their According only as research, Psychosis awareness an increased is market approved important and directly patients of have strategy. actively additional treatment part NUPLAZID to the practitioners. Motivated having PD promotional are and conversations and and in and FDA on healthcare of NUPLAZID choice. patients PDP resulted our information

DTG ongoing and seeing an in our invest we return campaigns, initiatives. to positive patient advertising half our the from in complement commercial second to DTV XXXX Given we're of caregiver additional the plan

a continuing we deliver awareness new approach on for initiating with cadence initiatives these right would We investment, patients brand attractive benefits anticipate positive with while As to treatment. realizing closet. believe an and we increase the to disciplined reminder, it live for new have associated return

to continue to quarterly patients strong PD to more commercial our benefits the are NUPLAZID as performance will of teams experience the NUPLAZID grow able delivering implement I'd our and of thank Looking initiatives a caregivers and execute their now PDP. on Psychosis. in in to to we like treatment ahead,

provide to over pipeline. it R&D updates turn now on our to Serge I'll

Serge Stankovic

Michael. you, Thank

highlights our development. pipeline have stage will will we In progress. reviewing our regarding which I programs be total, nine I with you usual, in today. provide Slide late programs, four R&D updates As clinical

program our slide Let's or start with related on XX. dementia DRP psychosis

We've X study. half conducted for There no DRP million prevention only the currently diagnosed. United treatment a which to estimated approximately are X.X the Phase is patients is DRP. of affect approved FDA HARMONY, in States, about relapse

HARMONY the for with basis from FDA results can We robust the as supplemental serve have a submission. NDA that agreement

final On plan half We to read a interim an the XXXX, relapse of announce second prevention results we of second with high have in year. study. this HARMONY slide level half top the the Phase the for XX, line in HARMONY of illustration X

for read the As threshold high. is statistical the very a interim reminder,

Let's important adjunctive and slide believe major from depression. to turn patients the therapy depression. to significant to MDD XX patients our disorder continue adequately not with our struggling depressive CLARITY study for respond and to majority study, The on experience new represent an pimavanserin their results of Based positive robust with discuss may do we their treatment program.

for Phase our of development MDD. for pimavanserin attractive Slide treatment program X shows XX

by enthusiasm encouraged CLARITY-X enrolling well. very are for We already study study is the investigators our and this

are In basis supplemental addition, at submission. successful, X Phase study be we of study combined with NDA If our X CLARITY-X. Phase recently one initiated we X a least would of the the clarity our second trials Phase

announced slide we and results XX. Phase top week, These study. Last line X results are summarized enhanced our from on key takeaways

achieve last we significance study endpoint. did primary the not week, As on statistical reported the

exploratory encouraged we by schizophrenia, see effect However, as consistent the and symptoms secondary to pre-specified on were a measured positive and endpoints. negative trend the antipsychotic improvements of of

Currently discuss our available of to of of XX% program for turn symptoms schizophrenia XX% to to the no predominant schizophrenia. withdrawal need symptoms slide Let's unmet social schizophrenia. positive treat antipsychotic remains approved Approximately are This the lack XX treatments and a primarily for cognitive experienced significant as impairment. patients treatments symptoms, negative emotion, there available. which patients include negative FDA of apathy,

positive for adjunctive On high evaluating treatment The on from week symptoms. XX slide pimavanserin XX, a while This an is their study baseline advanced have we scale. study. endpoint symptom as predominant assessment item of symptoms with a the the schizophrenia negative illustration level negative is XX for primary a controlling change patients

results year advanced end. We to expect announce have fully around and enrolled the study

normal six about to females XXXX in excited disorder all Currently, in development this occurs which our slide approximately trofinetide XX. debilitating are is XXXX rare patients for Syndrome approved Rett Rett a a syndrome, following for the first affects no life. the medicines We're in disease, program States. months that there predominantly for United neurodevelopmental parent

X to for upcoming milestones. three development our look Rett approximately Slide clinical on LAVANDER We on in forward sharing for Syndrome, the quarter study our XXX to five pivotal late year. evaluate to clinical Phase months stage in our needs. slide Please XX. all remain syndrome XX. fourth turn this of trofinetide programs We This initiate significant will pipeline study track with females XX programs highlights to unmet age Rett addressing

call turn I'll Elena the over performance. now financial discuss our to to

Elena Ridloff

by driven Please In in outlook. million XX% the Today our and financial Thank quarter XX. quarter the we net sales volume of slide quarter which approximately XXXX QX. at $XX.X second $XX.X XX% in I'll XXXX compared growth turn year-over-year our in you, of of Serge. increase to an in to XXXX second net was recorded results million sales discuss second approximately

volume of XX.X%. consistent Gross the compliance to previous growth the The in favorable half at was the was second were NUPLAZID the result XX% to this rate a quarter as net first channel the the Basic was our For expectations established net of for year-over-year. approximately of inventory higher QX patients. adjustment with versus quarters. XXXX, in gross quarter at the end

and to $XX.X clinical increased costs development QX XXXX. pimavanserin. costs due in the additional QX primarily The R&D XXXX increase for was GAAP study down P&L, million million trofinetide $XX.X in for and Moving expenses to of

due quarter costs. QX in in year. XXXX GAAP of versus second million decrease The increase personnel $XX DTC an primarily prior in million to by timing SG&A offset partially of expenses year increased from expense, advertising the $XX.X was last the

the during stock this approximately quarter the for with balance million, during $XX.X in compared $XX.X to cash second million million $XX.X for million in the in million period XXXX. quarter and Non on used $XXX.X entered cash our sheet. was quarter We of expense Cash compared XXXX. the was operations investments based quarter $XX.X compensation to same

million guidance $XXX from turn $XXX $XXX We're guidance on between of XX. million our be sales to previous range to our million. to the Please XXXX net to $XXX increasing slide million

CLARITY-X the the compliance start increased well inpatient with reflects of year. as remainder we the the now This expectations as for increased have and

growth midpoint range guidance XX% approximately this XX% represents revenue At of new the approximately the and growth volume year-over-year.

adjustments favorable net forecast half net the XX% year, to XX% in the net gross the to range of mid anticipate to gross to to the in to and first year QX gross be the Given be we teen. now full of the in

QX than will yearend with of inventory higher the net the and As quarter current gross obligation QX, in fourth a the associated channel. [indiscernible] result to in a as be reminder

expenses, the $XXX expense We're additional of half second forecast and and million million. $XXX products expense between XXXX. The between increase R&D GAAP due to to $XXX million of million to part million we $XXX SG&A range Turning plan be to in $XXX now GAAP in previous be forecasting to continue our $XXX the in ads is from to run million. DTC to

based compensation $XX million stock non-cash million. expect $XX expense to We be to continue between and

with that, back turn to I'll call over Steve. the And

Steve Davis

Thank to for Elena. you, by our and measure pleased turn with the quarterly Parkinson's people's with the our treatment getting we difference their we commercial alone, Ultimately, of initiatives, only Please We're year. Because very disease remainder of improving in outlook need. our don't caregivers. slide but by patients the metrics can but financial true success psychosis more performance Not strong those are are make also lives the of lives. treatment, their they the XX.

to Syndrome. PDP, Beyond caregivers and trofinetide they hope related Rett pimavanserin schizophrenia, who excited psychosis, patients dementia depression, struggle are with and and we their that offer

Please turn to slide XX.

pipeline leverage execution and the execute our focused like employees to PDP, by development. strategic our three NUPLAZID of pillars. and on I'd hard potential the continued whose delta of we and driving company's of our work and pipelines our Grow ahead are continue will all to dedication expand close pillars strategy. our our of success thanking with business in three programs Looking

Operator? I'll up for call now the open questions.

Operator

[Operator Instructions] Cory Your Morgan. first question JP Kasimov of comes from

Your line is open.

Unidentified Analyst

would provide Phase Gavin but anything for event data study, We shot, be is QX. just can the – on it's on you Any can long And then on the one X on like on as granularity provide i.e. you timing helpful. versus far the Congrats this rates? Corey. Hi, quarter. color know qualitative a Thanks. had as HARMONY QX on I

Steve Davis

will Serge both sure, questions. Yeah, take those

Serge Stankovic

Yes. Thanks questions. for the

study. of providing been of label have success progress First we on insight rates and – some terms open the in the on in recruitment question, just the

haven't that independent from event it's indicator relapse the because We so a providing trial, very an the very details it's change. and no not rates that's been really driven perspective, because on in variable

as, well around We said, enrolling progressing mostly, anticipated, most in very as in as somewhat are have rates part both numbers. better what patients well been than trial, we our always I've initially for those the success the but

say that. can I all that's So about

to referring analysis? interim Your analysis I'm sure. Are you second would, you clarify the quite granularity please higher not or that? around question, the final If

Unidentified Analyst

in as provide far the QX Right, any talking you XH or 'XX. Can of about was QX? granularity as the I interim terms

Serge Stankovic

Other in not commenting specific that, year. we this Well, than the will been have half on second that. it on timing of definitely happen

Operator

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

line is Your open.

Tazeen Ahmad

the good whether taking follow to compliance Hi, Maybe a you improvements my little you particular talked how DTC half Can the improvement much that ended prepared is campaign expect on think on which you why I And going of quarter? a on compliance? to quarter. particularly in remarks, improvement any DTC believe up granularity had questions. you in year, was a this different afternoon. you seen planning might that your in from to you the couple more would secondly, the I Thanks continue bit Michael, you are for just so last to that curious second trend new continued for and then occurring I give you mentioned or in us be as that about think campaign rates, start

Steve Davis

Michael? Sure,

Michael Yang

the Yeah. Hi, Thanks question. Tazeen. for

historical So patient's historically, commented are quarter, compliance consistent increase when that a We've patient notably in bottles quarter for lead believe the referring in compliance, And high physician those the patients. And a mentioned, norms. the the an established on from patient past and I how and experience. number to of around a very XX talk milligram patients. continuing about as and specifically saw that's as those to this takes going specifically mentioned, and I we the rate in we to I we've better seen I'm

if one, think that of it value closet. think I I then the attribute the endorsement of So we and to also were the number the milligram XX strong new proposition and profile

you'll the part of think all for look campaign. of in and start things our see I of the new that had of In be base. to And coming with those totality, you're feel to think year the the I year. kind see the and we've rest benefit DTC, think I So to regards in base that'll going same prior that

very end the tactics. learned be back of Of mostly you're I a the on think campaign going lot those the and course, and along learning's consumer other see implementing similar perspective. from our view, we've way we'll But point in from external a refined a to

Tazeen Ahmad

DTC? why restart And are I to guess you choosing

Michael Yang

ongoing all when Right, education. yeah, time. there's and a we media, we to patient awareness number of factors initiative we evaluate support caregiver the And TV look an have into and those are on

the to In consideration terms element take the more weight of our the we intensity fresh behaviors And pivotal, actions is into for to and and cadence those to campaign audience. target our in TV, importantly, reach creative right themselves benefit totality compelling have that it our things the the and general and believe media time how we the in obviously manifest as In the we brand. approach. takes

Tazeen Ahmad

Okay, thank you.

Operator

JMP of Jason comes from question Butler next securities. Our

is open. line Your

Jason Butler

congrats Hi, you give who any new A or trends versus quarter. questions can the on thanks couple to on again, for patients around trends early go ads more those the taking the of in granularity longer? stay that in off drug on drop the the the for Michael, us changes questions therapy patient and

Michael Yang

Jason, Hey, great question.

the the think patients, duration to care take can't added mentioned plays see what on regards But obviously, borders the improved we dynamics, drug. benefit added more experience pharmacies with to to new quarter comment have ordering in how ready We as milligram. we're say therapy, benefited to the I therapy. of before that seeing the dynamics long to have has physicians, of regards we patient going out. we're intra term duration new we're in rate, I to In certainly XX So continuing the from that

in lot So but yet. I dynamics nothing offs comment cetera think regards a in we really more patient to regard to penetration, still have drop unusual intra to et just

Jason Butler

size the second current about thoughts Okay, that of for how half great. year? investment thinking DTC, And field structure force you're continued on any in with the of then the and the the and

Michael Yang

sales I'm DTC heard question not I the the quite and a force. was sure

Jason Butler

driving size to of Do continuing and you force sales the that? invest the on driving have product. feel you like end? on capture structure you're to interest in back right Are you the Obviously, awareness, more the

Michael Yang

term so the great this, past think – on organization Yes, of added commented the kind past question, we've we've or our Great, year we've so function. we've yeah, right. care In capabilities the increasing I in of the over on a and added example, key account long for footprint focusing group. increased

So will. continue the commercial, make we make in you to sure best to the the all adjustments going sales, wind capture we're I say that to if

So think the a at operating moment. very we're and I I high at think level we're optimizing

Jason Butler

thanks Great, quarter. congrats and again on for questions taking the the

Michael Yang

Thanks.

Operator

next from Our question comes Sachs. of Goldman Richter Salveen

Your line open. is

Unidentified Analyst

This Hey, question. is the Maybe a Andrea for Salveen. thanks question taking on for for Serge.

trial? if Gavin's of of the you When that to double As if to eligible how the study. blinded on a follow patients to to therapy, to patients the you are come question that Or responding number to large say HARMONY due perhaps more of trial who that's are the on portion? the enrolling, been up has then can reflective proportion on think are that's Thanks. the about rapidly continuing

Serge Stankovic

is. and to in are with hard the been reporting speculate involved. Andrea. the much that's that treatment – a the active kind akin and is There three think And about months of patients I both treatment also practice And trial little what I for that's it more open and we is due significant patients. design had standard in think starting of families large part clinical investigators to where to the is trial by bit Thanks, –certainly the of interest we've and

trial that's and high throughout definitely we of my interest So had the and the saw of a interest reason the a probably from kind steady in so perspective we very – in that a enrollment a participation trial. execution

I that definitely for the believe population inclusion dementia, the there with of patients participation. do of other potential in of the side, and reflected On trial also candidates that also itself that is a all subtypes large study

Unidentified Analyst

Sure, what the and so is population to of terms is, of or the I the large just I that maybe understand of pace maybe that, to if on because follow like patients we're could in so right, that of people because enrollment patients, trying that guess, number guess moving second who responding portion. and have, you're the could to are progression many on seeing where driving me responding rapid of the portion, that to label you are open factor drug up be

Serge Stankovic

so Well, disease rates investigators trial. that, be what to on probably Parkinson stable a we we XX say to as after approximately what population. is huge anticipated is encouraging. that in a it the I may to conducted. of say seeing rates just the response extent that the to based of pure slightly and would this that psychoses and would design I But response we after – part play want of I a not is response, my were patients enrolling we not response treatment, interest continued what are on trial in are role the is speculation to that that in the patient And that's trials by overall higher the the seeing certainly in rates weeks eight And said, say the extent extent

Unidentified Analyst

color. for thanks Got it, the alright,

Operator

Baral Cowen. comes of question next Your Ritu from

Your line open. is

Ritu Baral

indications? sorry. I More you for is payers MDD guys, through on the And pricing guess, broader. Alzheimer's, negative do discussions you flex DRP? and either DRP How to that done goes goes goes little, price have any How symptoms think have current what a question. or into about the thanks do data – first for the PDP? means traditional how think guys question through. Hi, through relapse you I'm My proposition? clinical And about assuming specifically, talked might value current prevention of actually for you taking payer dose the

Steve Davis

there. to try enough Michael. to several in there's and them this. I'll going over you I it maybe get I'm Great, honest to questions think keep turn to fair

Michael Yang

Yeah.

studies, have is the we've that from we or DRP, junk negative don't high start to weight place studies. a in really value we're first seen, a is the symptoms, the evidence needs guess these But the these perspective of it's going the I the whether unmet of obviously, commercial after, recognition into the of research, patient that all do and clinical MDD, of we are approval need when So innovation. we've the value going there the commercial the see done results that unmet

innovation, call it. specifics, research Broadly those payers multi a what match would there's into if indications mix So and speaking, of you're We're business insurance doing, we're of that planning. with lot companies. the We've I indications scenario recognize on a many done mixing having each that. without getting books too of

footprint has know wait profile all is a us larger we is current on and in that schizophrenia appropriate entirely going way So a an to entirely. find is and cheap our any very for for there commercials. new x not partner to be indications in to of do with example, MDD up or PDP the access regards payers those we're way of for similar DRP going Despite course, against generics. of things, to the bottle believe

tiers criteria are are to new see. the that us and We looking that playing affords payers specialty and appropriate

Serge Stankovic

add just may – not to to order just in to thing one everybody. I If remind

term parallel which In that have done we term trial, prevention positive are data acute addition to trial, trials design. a is treatment also relapse in two a short our long classical in

and than data, is at usually have approval. perspective looking actually a So you package overall, from that payers' I from have fairly think the comprehensive we complete the at more

Ritu Baral

across enrollment is background is case the shifting? first Got that year different recognized earlier had you this on by of sort You'd tracking my you the four just about that enrollment Serge, mentioned parts characteristics of it Design. question on Mike, can or comment the still diseases? it, HARMONY epidemiology,

Serge Stankovic

of imagine, a trial. the and qualify qualify respond of as randomized people it's you We can double both blind for for enrolling follow open case. that well the Yes, stage that people essentially trial the in absolutely then as that fairly as the terms label continuously. in And

different tracking the We are epidemiological to of very data very, close proportion on subtypes.

Ritu Baral

if did missed your say in precisely it open is? your what the you I'm I And over role to label rate sorry, prepared remarks,

Serge Stankovic

we the firmly at above say not. specific were steady. a I what same, about did No, But it's remains did anticipating. we number. they're slightly not – It

Ritu Baral

all for guys. questions thanks it, Got the taking

Operator

next Charles question comes Cantor. from of Duncan Your

Your line is open.

Charles Duncan

Steve and Hi, team.

at Let page my to Ritu's But on book My what me a going nice look add driver the or to one if to that, a very out ads increasing, guidance if base guidance? going it be quarter. would question a new first be What congratulations kind it multi would identify would And related increasing forward, driver call patient be be we're of to pricing? to it question. was the of would it you take ahead particular prescriber of be guidance. looked it I'm and would ask main increasing, compliance – pronged be

Steve Davis

Charles, going Michael to answer to ask question. that I'm

Michael Yang

business all both I the of created lot I as long Yeah, the to levers thanks new existing out depth question. Charles, a across new we've think the care channel patients, forward, going in Hi,, adding physicians, pharmacies term and deeper affect, looking momentum, the the new our adding in Sure. penetrating mentioned pharmacies. for of we're that

primary out to and So patient would new say growth also the existing forecast. the to be just the of volume to I starts continued adding drivers patients

Steve Davis

second the to uptick existing said, patients. take from Michael reiterate what in just in one quarter the a significant maybe was saw we rate things the And of that

through as Michael into the fourth see third quarter well. carrying as so that we and quarter mentioned, And the

that year. guidance But impact the than remainder obviously at different reflect the in we of at on rate that rate our we Now, didn't is have base for compliance the those the levels. of higher growth, those

Charles Duncan

clinical XX to think migs. be Because us the Xs, more of you CLARITY-X understand maybe sites one that Phase That also or two I absurd, program. entry you one question I Xs Phase two and that probably Xs between Phase CLARITY-X could If Phase for different criteria two CLARITY-X the help makes sense the different ask or differences especially SNDA. value with to the MDD anything? using you X? just relative Could mentioned of would but between those given be the would sufficient Are related

guess Phase I probability two for so if different And Xs. of I'm the there's success wondering

Serge Stankovic

the X two in done to identical is CLARITY done studies in and CLARITY-X sites, obviously, study the study. United are those in Europe. the performing United The sites States with naturally In done CLARITY-X two study, one and that studies, And X in Phase the previous Phase well CLARITY-X CLARITY-X was our exception, in is we included CLARITY-X States. the regard were

So – there they're sites in more has had I that considerable CLARITY-X identical sites because a can say also but respect. and is overlap that

just So of regard with parallel the Phase two between X there trials to are difference sort is had Phase there design stage that's X remind Phase trial. design much differences also one, trials, are one you exception in so X that not and design, X of of Phase was phases. SPCD

are continue not And in Phase – no the certain of more than do then the And difference X. close to XXX we can a do and Phase X we patients here, are trials results robust on is Phase relatively X fairly Phase trial. remember, essentially but had – are in that is the a to differences had trail, stage of we trial minor XXX trials, – counting in which plus there we and quality. able were a So in Phase on size X you where that of things little XXX, differences about basis really there X that other in smaller to they're learned one between as trials terms the with these we the these for identical regard to in will the control the

Charles Duncan

clarify that an is regard to X upon And parting US trial just only. to with CLARITY-X

Serge Stankovic

yes. Correct. Yes,

Charles Duncan

on Thanks great taking questions. a the Okay. for quarter. Congrats

Operator

question from of next comes Goodman Leerink. Your Marc SVB

Your lines open.

Unidentified Analyst

the overall to quick to of certain add and line on on main were a at their color all In question. wondering those want XQ you as making Mark. from past, what Roanna initiatives the do are we I is sales? you what ask any Has et cetera? you've for highlighted to could on Hi, goals if this contribution them just focusing XQ that LTC. changed percentage such see And

Steve Davis

Great, Michael?

Michael Yang

the Sure. question. for Thanks

the As believe tools, term in that and in contributed plan I my patient mentioned screening prepared care. care we long remarks, we the saw to growth

you're long of electronic an Importantly, algorithms patient facility level. facility in the are institutional kind of processes, treatment channel care Resident records health where with very kind term and of management dealing more approach, at important. the

and long setting of a documentation et we the we've So meet different practitioners and we've the the healthcare a screening, to algorithms care based identify more them helps our is and just business I is identification. two in them establishing as we're community That our historical number to not tools facilitate to and staff two a distribution pathways. of and related done treatment the a setting like regard. business patients specialty have these that patient In well our think in which fit cetera mostly as And care. existing patient designed to on of environment. physician term into reflects channel it is reminder, in see of heavily their regulated what segments education, tools we that thirds necessary that what regards term specialist with channels, care or advocacy of pharmacy third splits any one that seen thirds of two shifts the We've are the appropriate importantly, facilities to helps and long helps way SP,

Unidentified Analyst

thanks. Great,

Elena Ridloff

Just and to continued quarter both Michael's growth comment, channel. this SD in and SP to add in including seen we've

Michael Yang

good Yeah, point.

Operator

Company. from comes Carr Alan question next Needham Our & of

is line open Your

Alan Carr

perspective have grow? the XXX,XXX do had concerns Hi, for Couple my about you Do said one again – call, and on the you think other numbers of kind updated do And of any the you Because What in effort more trial, that I the is, for remember had which past, your on for to XXX with last last said thanks of CLARITY respect the the trials, risky? be XX% Thanks. that of patients. these you US then you've of hundred you bias any after can mentioned think depression? are in you penetration European terms I two might that week one them, taking biases over sites versus have schizophrenia questions. some sites.

Steve Davis

take So going Serge to to Serge, question, I'm the first ask Michael.

Serge Stankovic

is is, answer a look other reason one with depression. response when different the disorder, study trial trials the the and or with in to trial And versus then and the condition. way. a probably literature have short schizophrenia condition are major at bias and do schizophrenia higher not a the The participants picture Alan. do placebo depressive to more rates United States specifically we that related any Hi, major being more the as has that I for just And the

So it schizophrenia it sites, depends as the is then of country, the more trials circumstances seen is on uniformly trial. in the

Steve Davis

Michael? Right,

Michael Yang

I the number will market. PDP to Yeah. go for up the share Thanks, the up with forecast, VIP teens updating bogging that and I as if John. Good had XXX the in memory. be you market you the we're patient expect now, mid think right populations the in but you XXX it update regards Those have market would the PDP. in anticipate metrics are, of We'll saying model,

Alan Carr

Great, my questions. thanks for taking

Operator

We for have two time questions. final

Paul question next comes of Our Matteis from Stifel.

open. is line Your

Ben Burnett

Ben Burnett for Matteis. much. on Hey, is This Paul thanks so

the on academic Do that events long or wondering anecdotally have term care more you into patient adoption compares about community any per or anything you've clinics here. in like how and bit one mentioned the you was compliance Just script heard? little PIM window term or a that I versus clinics and centers. long

Steve Davis

has that I question. Parkinson's that disease has the will a or advanced long care and psychosis great patient Parkinson's stage. and characterize term just Yeah, is who more identify really later disease,

of turn long we fragility in part community, complications term of term and that because than patient you that And Parkinson's the in the long though, With facility care, is see so the being is if it occurred. say concentration of in but shorter. times And disease at the therapy, will, duration in in with general psychosis part mortality, neurologist. a said, morbidity, care a the patients also higher has amount

little penetrate a So depth in market. it's offsetting more they're also us duration of and there's element, in perhaps, therapy, a less there's terms greater kind big an patients opportunity get for very but to but nonetheless, that of

Ben Burnett

regarding there. there studies. Okay, that Are details Phase powering had the I the on okay. design for Scale? the the of Thank you X study And question one guess, other the you HAMD I I CLARITY Rating any just the of provide, can get the just color on

Steve Davis

take to you do that? Serge, want

Serge Stankovic

the assumptions, we powering terms same the assumptions in and our similar that Yes, that – of was of very I Phase think were –there terms design in with there made we trial. X

So powered are the XX%. only difference X is trials this Phase at

two And one and in on To role that this back you use other the why we for wonder, The reason made that is there I important. question it. is trial. that's another the mixing ex we that add symptoms going done it for this US, starting is of the opportunity would than may Otherwise, United and assessment are depression significant and the want do play to trial prior one to I thank schizophrenia? So the simple variability. may impacts MDD trial. in did same depression, assumptions regions of that rather like thing a with in cultural People trial plasticity designing really States

the well and go that's setup So that for the to staying Phase in why what's reason within region with trial. respect is chose X this we the advised

Ben Burnett

it. Okay, guys. I Congrats, appreciate

Operator

from question Jaffray. last our And comes Piper of Brill Daniel

is line open. Your

Danielle Brill

response you powering rate an with utility to I can of MDD Hi, the the estimated data. can I'll just me going for expect component correct? we first. missed Wondering then to I anticipated and if clarify, based enrollment questions. And there's guys. sorry, guess a timing And back update the during stick in is but DRP, Thanks before, on that an when remind on this is lead interim? the wanted Thanks. to if

Serge Stankovic

there. three try I'll Okay, questions

try I'll one by So one.

are are seeing any the helps I then for data But a in always very very X this going enthusiasm in months well. earlier, interest On we quite the started trial, are and were make to say, very the Phase with at would MDD early we further, more it's we top is precise better timing initiation reporting are trial, but United of be just going two more well. that bit kind years, of would a precise this we and about be a two as always But predictions take in will for results. stay position will on we and and recruiting years. – when we we recruitment that of this point, of say States, In early positive And half a we general trials we line trial the expectations as estimate. of we

of that DRP on difference in relapses core placebo number the the the the study drug. and on were the assumptions powered the study On for the on of and we actually the study, events proportion versus powering

a the there it's in So in label assumption the stage, what response arms treatment power be power but rather blind not really on the of relapses difference of the the in the double will between stage it's open study. on

Danielle Brill

Got then yeah, component. and utility it

Serge Stankovic

there is interim that done is interim analysis safety included that efficacy, as to No, the – want or analysis. part conduct always data no of there certain around trials in in and to we analysis trial stop ratios inform the outcome one need trial is like monitoring a independent committee other had or variety is a analysis analysis is has say for do reasons stop the analysis. the and Yeah. futility reason, ability values monitoring to is that analysis is futility data being here. a of interim threshold there start of statistical and Obviously, that us the designed this statistical committee statistical the hazard other you P for would of a the also no trial of to this that will but efficacy. efficacies order demonstrated I reach declare for there designed But an receive

Danielle Brill

clarification. the for thanks Great,

Operator

Mr. please closing remarks. proceed to Davis,

Steve Davis

updating next thank our you we of look progress in operator. and today you Great, quarter. for each on I thank listening you forward to

Operator

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

Good disconnect. day. now may You

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