Earnings call transcript Q2 2023

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Operator

Good day, ladies and gentlemen and welcome to ACADIA Pharmaceuticals’ Second Quarter 2023 Financial Results Conference Call. My name is [Jeda] and I'll be your coordinator for today. At this time, all participants are in a listen-only mode.

We will be facilitating a question-and-answer session towards the end of today's call. [Operator Instructions]

to of presentation Investor like Tieszen, to now Director Associate Relations would turn over the Jessica I at ACADIA. proceed. Please

Jessica Tieszen

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

execution. who ACADIA our launch Chief R&D Mark on our review of Williamson, the thoughts our Executive our open call pipeline Head Operating will will Chief will before some Officer update Doug from provide an closing who and the Steve up by followed Head Commercial Steve will Officer provide results. opening programs; Davis, Schneyer, and the Joining for some me remarks today we will Brendan are then your and DAYBUE on financial provide Financial call NUPLAZID questions. discuss Chief the Officer, Teehan, of our

of In session. Diseases Rare and addition, External Q&A our Bishop, will the available Kathie for Head be Innovation

supplemental Presentations the slides on which available We are section. using are and Events website's

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

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

over I'll to the now call Steve. turn

Steve Davis

we Please Slide turn Thank you, of as all today. growth ACADIA Thank entering a joining Jess. for X. transformational to strategic to priorities. continue execute is afternoon, everyone. us you across period Good

financial foundation is to flow cash franchise our an is NUPLAZID positive First, business. the and increasingly

had impact Our beginning studies new market, off-label the positive and contracted products starts over a to share antisec PDP patient rolling we at gain market disease year which evidence a world used begin new out starts on other in patient Parkinson's the continues NUPLAZID despite real market. have of the outpace and

Second, to the is launch DAYBUE exceptional off start. of an

seeing are commercial since and XX. on demand We high broad U.S. reach availability April

distribution We to of addition volume all broad prescriptions types across excellence. continue centers account see to including and written a community practices of institutions high in

discuss section, caregiver pleased are are further Brendan highly seeing. they As his positive benefits feedback regarding we the in very will be receiving to

we Connect healthcare support regarding In and positive receiving into from sustained through addition, are feedback providers services our receiving of are these seeing ACADIA efforts translate are caregivers the demand. we and they level

rights successful now opportunity we to worldwide Third, and last agreement our to global for trofinetide launch strategy. expanded month we in licensing have DAYBUE U.S. execute the the have asset. of The announced we underscores the our

medical Canada to will a and need expect Japanese soon. unmet the worldwide months a is trofinetide submission next XX United Rett There syndrome for European drug no We for regulators and in in outside we engage new the States. treatment and approved of significant with file

expect between Incidence rates and the and prevalence be Japan mortality U.K. data, to rates, rates the X,XXX XX,XXX in between estimate in world birth in those X,XXX are on Europe to We to X,XXX prevalence Based around U.S. combined the and patients. patients. be other similar we and

negative study of we XXXX. now programs multiple including schizophrenia Fourth, the with completed hemavansarin enrollment X Phase have where quarter results and of we symptoms in and expect of have our near-term milestones late-stage top-down ADVANCE-X first

world more disease support submission. expected about quarter. Later seamlessly Doug fourth psychosis will ACPXXX Phase in section, study NDA into X to We begin two have discuss studies, potentially and could study all his Phase which three of the of Alzheimer's in an will is that how X that a

Phase Prader-Willi expected and disorders deep start programs neurosaciatric includes Fifth, disclosed on And also to we early-stage to is year. business and a have our syndrome portfolio X and active quarter portfolio. in ACPXXX that we undisclosed a trial in development of and further focused expand the this rare remain fourth

an As business reached the DAYBUE the through side franchises, important our flow note, success our NUPLAZID cash now in neutrality. of has

Let's and results The been flow and bottom this by year reducing to positive over then million of expectations X. our since increasing NUPLAZID cash line, has cash NUPLAZID franchise XXXX going back on from when franchise we've both focusing turn inclusive slide each flow to expenses for $XXX top generated by XXXX on to comparing XXXX.

was performance quarter across driven sales patient performance long-term an million by care starts LTC. with $XXX particularly second new in of office-based strong net both channels in in and increase Our

and believe laid we which we've there real-world understanding the three professionals As healthcare is previously, contribute demonstrate benefits answering off-label One NUPLAZID franchise. the two out antipsychotics. studies can compared awareness atypical of growth dynamics for are by that the top-line them of our to to

section, these share no further significant in continue improvements by As studies market our ability to disease of share patients our Brendan gaining in for despite Parkinson's traction that increase will his dynamics. it's grow an to new PDP. market in is to clear second evidenced are And this elaborate therapy as

discuss to highlights. our to seven slide turn Let's top-line

we our picture commercialization leadership programs. disease and nervous big for our medicines a the system in to commercial central of top-line two late-stage and numerous early-stage these long-term opportunities. new our of of development overview and shape Here contributes have Each and growth

symptoms Prada-Willi underway programs We and have schizophrenia in Phase negative syndrome. X both in

We in that that, of quickly and disclosed have a behind also early-stage Alzheimer's getting we program position undisclosed X rich And a underway long-term for programs psychosis. pipeline growth. slash disease us Phase have

launch starting to it turn eight. commercial execution now slide provide on DAYBUE additional and I'll over NUPLAZID's our performance to on Brendan insights

Brendan Teehan

Steve. you, Thank

of provide me of both performing DAYBUE our commercial NUPLAZID, Let each on commentary exceptionally franchises, are which well. and

excited that We're report expectations. exceed to slide our DAYBUE nine. to continues on DAYBUE with start launch Let's our

first improvements in to important real-world to of are like metrics this caregiver launch most with DAYBUE element day-to-day get regarding testimonials on date, describe families through see I'd us. use into illustrated of sharing you slide this that these the the Before I important

Just about launch, the XX makes the is on of first-ever these DAYBUE for more Rett families having examples the value impact all treatment tangible weeks this meaningful. into and important patients hearing syndrome the

A and few broadening in for describing speaking are in time in families conversations. improved examples benefits of or years, include speech the improvement vocabulary, first engagement

activities alertness, These patients speak proof of increased hear to as regular those treatment. the all able promise slide to and continue about which this better complete, complete experiences share the and and continue also were previously points with patients stereotypies. monitor DAYBUE to We feedback in unable as or treatment hand-wringing on testimonials they decreased conversations to follow will are such and

demand all availability. prescribers community This Let's sectors, date, centers prescriptions and from practices. DAYBUE. Slide we're XXX now the of well high-volume received I'd all coming over metrics prescribers. to like is of written first five excellence from significant on prescriptions to prescriber XX seeing designated XX. speak for excellence, To within to turn of demand We centers from breadth weeks post-product have of the first institutions, the

from forms prescription, prescribers pointing who breadth, broad of of than increasing encouraging prescriptions this at territories. we're also XX a from written not In one each and seeing We're but distribution of across point the have more of enrollment addition DAYBUE of country to the every seeing our types, significant prescribing only region of also to account number launch. depth

the respect with With opportunity the to prescriptions monthly. remainder advancing to pleased The to have and broader ahead. paid market. to written therapy, to in seven and expect we we're from there prescriptions scripts out rate penetrate While converted, is both the second Rett of the improve XX of to to quarter paid conversion syndrome about convert depth weeks continues prescribing, breadth of still date, significant the these

come of patients terms centers vast syndrome see during process, treating Rett planned they of clinic In days. to them are majority the as

centers Some days number Rett clinic and the accommodate increased to families. have patients of

number patients a their dose. above patients age, demographics We're with mix age of such XX. as seeing see that are the degree including gender we a and high the the male label we community, broad are reach have Rett that characteristics pleased at Looking early patients of and optimal the and of to help weight, to on, of meaningful the patients of titration consistent

While many this label. now early started titrate are continue will starting patients from reaching added the launch recently by our more treatment at point. broad encouraged post-launch given patients to are their of we're dose, very their who stage of seeing we most up appropriate Overall, what

on discuss our next patient support Slide XX. services Let's

our We continue to a the providing very strategies to services about providing HCPs emphasis GI of educating and range plan. support a on and benefits for proactive DAYBUE with in management caregivers of special wide be

medical the both of One team caregivers ACADIA feedback the programs. from from has underscoring our benefit excellent received and Our community

this on click double me Let briefly.

as fully have access managers teams is As caregiver we coordinators from a as at of prescription and are care our written. well the staffed family nurse patient paired each moment reminder, with the who hub

family strong authorizations, office prior field-based develop to pull-through, relationships physicians with leading or reach out approvals. access the Our prescribing to FAMs, proactively to managers, faster also staff and

are to all of staffed highly volume and well team sales Rett on our program DAYBUE are well They disease Excellence, label is clinical Our as ensure smaller with supported. as well are institutions, high as educating services the engaged practices. rare community the as with the support who that practices Centers package experts

timely our insights information healthcare instrumental approach community field-based to DAYBUE. based our Our clinical science further ACADIA they has One disease supporting provide provider Overall, on treating as rare liaisons for start the patients Rett with success. medical been early requests to

somewhat written have have, This that process approximately expected, Rett XX. faster patients of the and on Since discuss formal At slide launch of progressed one-third their has policies that than clinical covering understand commercial severity families, been accelerating. syndrome, coverage access the the we launch, as the impact supports payers stage approval. DAYBUE this underscores DAYBUE's stage, this payers as on policy Let's written policies has of dynamics and lives. well evidence for it anticipated Rett adopted as at

we plans up XX%. coverage, with of Medicaid about about XX% As makes covering additional an commercial projected,

other is programs. The rest Medicare of federal the mix and

yet patients through payers are of exception that have medical of not two-thirds necessity. medical DAYBUE a adopted formal those or fulfilled prescriptions who For policy, have letters

months, our with what has been six disease or seen prescription generally are some reflective months, at at with of then and are XX reauthorizations other consistent for annually at Most products. three specialty thereafter. Looking expectations these rare reauthorizations,

Slide now Let's on NUPLAZID turn XX. to

and after noted, year. significantly Steve cash year NUPLAZID the so franchise flow is As positive increasingly

simultaneously We market. off-label have cost lowered that increasing a in our disease introduced while share versus Parkinson's overall have market contracted our efficiencies antipsychotics base operational atypical

PDP, Driven starts. patients by new increased

We the preference brand NUPLAZID at studies overall most evidence importantly, are educational the segments broad Our net year-over-year. an market pleased product sales across and second see of both million, the pandemic, of $XXX both available campaign in beginning NUPLAZID quarter beginning has up contracted significantly. the year drive real-world newly were these to our began in increase X% to leveraging and efforts and, long-term care Since disease of community beginning starts of the patient new business. our Parkinson's the the

of half grown half prescriptions this to Carbidopa-Lividopa same of at versus during XXXX, over against NUPLAZID's Looking Despite current significantly. second continued we have starts the this, run the continue XXXX to timeframe, we performance new the patient first trend. the has and see

products As new slide office-based X%. patient other in this PDP while grown on starts you have can see XX% timeframe, during this channel the all we've declined

other we're in seeing all the products Growing new PDP has period X%. in are of the admissions, to we and channel long-term these the revenues setting XX% patient patients, increases the segments treat quarter this during in where result record care new refills class. market NUPLAZID large to used in during any are encouraging. just LTC fully have outpaced significant both Understanding while NUPLAZID, substantially given Turning the continuing starts improvement by grown majority patient that of

development, update turn to on an Doug our our starting programs on and Williamson, of now pipeline I'll research over Slide head XX. it provide to

Doug Williamson

our the schizophrenia Brendan. progress I'd on now clinical Slide of you, XX. as for negative on a starting continued treatment Thank to update Pimavanserin programs, the you symptoms like potential of with

study second for mentioned, high-level we've schedule the on symptoms on XXXX. our track first advance Steve results completed negative As Pimavanserin are in of in of in schizophrenia quarter and of enrollment now two,

are Predominant negative symptoms. I to program. remind one of today, this remain these there you for the still approved want opportunity unmet no of the and we're as treatments largest of that in symptoms schizophrenia, needs pursuing in

distinction the and negative positive understand treating first the schizophrenia. of Let's symptoms between

hallucinations, and characterized positive schizophrenia delusions, of symptoms The They can Negative psychotic long-term social persist symptoms are symptoms to by poor treatment or appropriate typically occupational with characterized to of social worsen greatly blunted and disorders. anti-psychotic burden, are symptoms functioning, discrete by disability. increased schizophrenia psychosis outcome, and over often period in episodes. a thought of following often lack lead of acute motivation, and occur negative The affect. resolve withdrawal, caregiver diminished episodes. of continue between episodes These and weeks

treat the acute approximately drugs negative treat the to including patients that fail U.S. Drugs may during and treatment negative but affecting resolve positive XXX,XXX schizophrenia also chronic, symptoms, thereafter the persistent, symptoms a symptoms to benefit show approved in the today, significant on phase,

ability time, control for of study several for Pimavanserin negative is late-stage patients to this positive an predominant these FDA adequately negative in who program designed treatment productive Our usually positive a treat lead necessary order are and whose symptoms still to whose under population with and to In and obtain normal, symptoms sufficient symptoms patients approval a suffer but it's are utility persistent Adjunctive demonstrate controlled, period negative inhibiting their from psychotic life. of months. uncontrolled to symptoms, symptoms

the turn to Please slide. next

few me positive population. ADVANCE-X same the ADVANCE-X, with ADVANCE-X Pimavanserin, are study, of study following as proven positive challenge, now with we highlight a negative study something ADVANCE-X, our treat be fully-enrolled our drug industry an decades. probability Negative success. symptoms key to difficult aimed which schizophrenia. our Phase clinical Let over Therefore, pivotal of of multiple with this very exceedingly second key just in the achieved improving schizophrenia trial, have of the failures previous elements differences, our rare two symptoms several development to of of at both X we're design In

the patients ADVANCE-X in milligrams, we dose meaningfully on the met, endpoint a patients XX dose approved improvement that response, First, XX with XX patients on trial, we to and milligrams of all while a same dementia. XX so range is NUPLAZID for flexible as for the dose, in patients the the studied milligram primary of stronger which treating a without Parkinson's in clearly was result, only patients ADVANCE-X, had we're saw

FDA, in Secondly, sites treated ADVANCE-X of are understood in well decades, because the over trials U.S. the industry, the our separating largely past placebo solely from more of that in It's run and remain schizophrenia results on as Again, U.S. way patients way well is outside trials being conducted announce study is differences the enrollment, become in we solely from outside the difficult the by in of has here. US first XXXX. couple as clinical the U.S. we the run quarter already top-line recently Therefore, ADVANCE-X have having because to schizophrenia being patients completed this we are all need, track

no our treat discuss syndrome increase the PWS. are characteristic Slide in or footprint patients turn currently XX,XXX of approximately in ongoing ACP-XXX, of neurobehavioral hyperphasia to There a approved Prader-Willi PWS. therapies the XX syndrome significant hyperphasia in PWS rare program patients addition a Phase unmet we in rare X,XXX our to Prader-Willi in announced June, with development syndrome, disease. is the Prader-Willi States genetic Please our and the treatment early represents that for United need. strategy candidate, to affects to to our reinforces syndrome. X ACP-XXX In in

analog carbatocin, ACP-XXX behavioral a Oxytocin hormone is as deficiency is a increased oxytocin. PWS, in is particularly which an intranasal believed important of to such role and naturally appetite the of resulting in anxiousness. play symptoms formulation synthetic occurring

eye by accordingly and not PWS. short a or viable However, is treatment for a injection, oxytocin is intravenously administered very half-life, usually has and

receptors as drug risk greater for off-target improved vasopressin hyponatremia. allows anti-diuretic effects compared daily three receptors, has activity also including It reducing a greater Carbatocin the oxytocin, seal dosing. of such qualities times has to much which for half-life to relative oxytocin

to effects. intranasal reducing for and systemic the reduces administration brain of delivery of potential addition, the provides direct the further side greatly exposure, In drug carbatocin ACP-XXX's

of group of Double improvement ACP-XXX and On placebo. compared III the Randomized in hyperphagia was Questionnaire significant will same Levo we've Clinical study, efficacy statistically separation ACP-XXX Hyperphagia or Trials, achieved out placebo-controlled in by Blind this approximately conducted for of laid the Therapeutics. HQCT, to In study XX-Week primary prior-release is XXX primary This milligram milligrams by which of measured endpoint the slide, design dose Phase a from endpoint the X.X Phase III patients. efficacy study previous we Global the The Multicenter X.X scale. on this evaluate as placebo the safety evaluating

placebo in patients study LIVO X control and to not Phase two Those conducted label demonstrated the additional eligible achieve evaluating compared the enroll while it open extension the like complete acquisition, be significance. placebo of doses and The X.X dose. X.X who placebo. to eight-week multi-center, I'd study. ACP-XXX, randomized, some underpowered ACADIA's milligram improvement statistical versus double-blind, provide milligram milligrams, Prior X.X an was study to study will long-term did perspective regarding dose a to milligrams X.X

from milligram However, top-line open-label With clean we followed. ACP-XXX ACP-XXX adverse X.X significant no the treatment PWS results hyperphagia statistically study regard drug plan X to events both the the profile new in with showed for this study X.X safety very Phase concern, of and application a positive, tolerability, in demonstrated LIVO extension efficacy at that study of that and If dose. serious submit an of a milligrams the X had to data is Phase FDA. to

We their experts as advance the of continue to this families and know program. patients to We with are community look Prada-Willie for forward and we waiting development a clinical working that treatment.

next-generation shift we make psychosis. XX, future. Alzheimer's let's ACP-XXX, developing X-HTXA to which and exciting ACP-XXX progress compound for a excellent a as continues treatment On disease to potentially our has we're now Slide potential believe

agonist as the receptor. primarily works inverse an X-HTXA ACP-XXX at

comorbidities multiple tolerable anti-psychotic with time interaction Our highly concoctions low and very a for suggests efficacy safety experience a liability. is with drug-drug profile that populations and elderly this of suited mechanism answering with well providing

learnings. ACP-XXX, on seeking With those build we're to

completed involving including X as early ACP-XXX Steve for XXX comprehensive effort elderly late-stage volunteers. and ACP-XXX development. a we our program to Phase reflects over have As in accelerate in both development of Phase as fully This possible goal characterizing mentioned, adult subjects X order

Our an profile already strong a target work a date completed represent product for profile that to could Pimavanserin. product supports over for XXX, significant improvement profile our

Firstly, we with Pimavanserin. dose signals prolongation goal studies our This risk that important as To-date, QT QTC planned of the wanted seen we've signal. it was of to of mitigate or in no a eliminate doses ACP-XXX. limited an

mg the through Next, taking Phase are we believe mg of ACP-XXX development of XX We we mg represent of than to to explore doses higher twofold wanted dose. and Pimavanserin. ACP-XXX up doses equivalent XX of X that the to XX

ACP-XXX wanted action. we steady Finally, half-life than shorter has than state it in half days. reaches to around a five ACP-XXX days onset of less have the time, roughly faster to XX a compared Pimavanserin a and

addition, ACP-XXX for low demonstrates drug-drug tolerability a our favorable profile and to with X interactions safety In similar studies, Phase in propensity Pimavanserin. very a

to preparing Please turn this pivotal X, strong X designed data Phase X Phase it successful, to fourth XX. Armed we're our study. patients if be registration of study start could for in considered ACP-XXX that Phase Slide over from XXX We've the a with so quarter.

met described, As we to from move X X the Phase accelerated from Phase seamlessly recently continuously to our the into studies. Phase development Phase X on Phase two this to able With patients. plan with get alignment X with and we FDA seamlessly enrolling sites we previously move be plan, studies same development X-X X can

complete, and full directly will one X of the studies Phase ultimately will three for results, analyze be underway. pivotal their patients which report Phase patients by Once This for studies. into provide the completes potential plan they study site site already X X will is studies Phase two each time move of we allocation submission. the for Phase allocation, X will As X enrolling Phase

a inhibition cycle this and very a excited of will progress Overall, indications life significant exploring begun plays with program, X-HTXA we've for we're role. plan potentially already which comprise other XXX, rich the where

a And financial now, XX I'll turn for it Slide over Mark on to update

Mark Schneyer

you, Thank Doug.

second on million, up last sales. net quarter, of our $XXX the we second $XXX.X recorded Let's sales million review were year. total quarter In X% XX. performance the NUPLAZID quarterly product net from Slide of

particularly up for driven an new the the adjustment channels, for by selling long-term approximately was quarter. and patient NUPLAZID and XX.X% care. starts demand performance quarter, X% growth grossed-in-net care the were in with Year-over-year in both long-term strong in increase across each Our office-based

were of Turning DAYBUE, $XX.X the in million quarter commercial product to availability. net first sales

consignment to As a reminder, single directly our specialty partner model. DAYBUE is sold a distribution using

pharmacy is the orders Our to customer to which before essentially is recognized is revenue product shipped the filled are right when patient. warehouse,

there is DAYBUE. inventory no However, stocking for in-channel

XXXX The year's QX last expenses second R&D inclusion in million decreased trofinetide quarter. mainly the expenses of was manufacturing in decrease QX to pre-approval for to due from supply in $XX.X million $XX.X XXXX.

million ended SG&A of increase million offset sale. the NUPLAZID. $XX the related $XXX.X to The in expenses $XX increased commercial the by with decrease the of was XXXX. launch, end quarter to commercial milestone is support million, DAYBUE XXXX. in We by in with balance million QX, The million associated first to slightly of $XXX.X costs Neurin from at compared to primarily a DAYBUE's cash XXXX $XX.X efficiencies driven QX, due our commercial payment to partially

a million we balance As $XXX considering trofinetide approximately related our agreement for pro completed payment forma rights our million worldwide to $XXX is licensing in Neurin the that expanded reminder, with July. upfront after cash

cash has neutrality. as as whole mentioned, flow business existing our Finally, now Steve a reached

positive the flow each year expenses comparing midpoint generated focusing expense XXXX over and back cash increasing since flow PDP range. by we've going results SG&A both the on been cash of top to reducing then of has line, million XXXX, inclusive and our to this Our when XXXX bottom franchise guidance by franchise from $XXX

quarter Slide sales are third Turning $XX net XX, million million. guidance we to $XX to of DAYBUE reiterating our

gross and unchanged, XX% full of be also net NUPLAZID $XXX guidance range to remains in of to year range the the $XXX to XX%. net million with to sales expected to be Our expected million, in

between expense XXXX, million the Neurin as quarter. million to expenses upfront R&D to the in payment record On adjusted side R&D $XXX for the million expect $XXX for we $XXX expense be third that we and now will

costs million. guidance in The a expense an performance. is result due $XXX increase increase to to We range as favorable $XXX operating business to primarily million raising our of are SG&A

turn like I'd now And call over closing to to Steve the for remarks.

Steve Davis

turn much, end Mark. priorities. strategic reiterating like where started. I'd to growth transformational Please is execute a we XX. I remarks all entering ACADIA to as Thanks by period continue Slide of across to today's preparative

over that, with to the operator Q&A. turn to I'll And the begin call

Operator

of comes Thank question go ahead. Tessa Please Romero from you. [Operator Instructions] JPM. Your first

Tessa Romero

for Thanks question. much our Great. so taking and Steve Hi, team.

So to question Thanks month you informing what can patient you sense can you'd the that our the July is, the new are And starts be a like that Any to color helpful. give extent us point into be looking so month guide, out? qualitatively? would of trend provide much. any directional may

Steve Davis

question, for much want thanks Yes, the take you Tessa. Brendan, to that?

Brendan Teehan

Sure. Thanks, Tess.

So revenue we there we patient input the we make know the we're point time a of instead the for doing that a start quarter. think principally are at realizing this on because fully of providing We're from output provided to with number revenue. I so of guidance adjustments focused new

the prescription. that optimal to that isn't which There's it's prescription. know, find written place takes weight-based titration also reflective you dose, of As always a

guide to So metrics in of that give we're which of we patient positions we when well revenue, have share into to a I that we quarter. variables insights strong written, sort when the demand we'll rather this as for account get them. those than have metric it's the the and more the help surely out seeing on number If and mix that at those we each dependable think takes these of But point surely initial patients, are believe productive reliable, outlined to think we're we'll today, we've into and you, breadth seeing, months post-launch. for as help of single

Tessa Romero

our for Okay, thank you much so question. taking

Operator

for question. One you. moment Thank next your

of from Fitzgerald. question Your Please Cantor comes Duncan go next ahead. Charles

Charles Duncan

Congrats quarter. be just team. one. great for see uptake on to that questions And trial. and Lots is on Steve limit Nice negative to a of team afternoon, I'll schizophrenia DAYBUE. to mine answering the with symptoms the but of good Hey, on asked,

be And with mentioned I discussed on call maybe of how in that's was with symptoms secondly, in negative a probability conducting solely we the you EX-U.S. different think U.S., that agency about regard understand why study gauge success just assume and to Doug that us advance? symptoms, the a different EX-U.S. versus bit for the might or can that Can bit positive help little that this the to trial? predominant Thanks. little

Steve Davis

Charles, I'll that second and I'll the ask then first Yes, take the Doug of part part. answer to

this entirely outside means So of States. United the of in to terms running study, it

understood probably it's to in that community As Doug as of that at last separate Doug mentioned, just placebo that over upon the and to certainly it's it's few become referred things increasingly mentioned, FDA Doug also the to difficult the some go here. and based need well decades, the from we into

We have enough today, to States patients in so more. we need don't enroll the United

terms database enough Doug, enough second U.S. negative the to but that In with we patients have today. of in the discuss at schizophrenia, patients, part? for want you take plan yes, of early broad symptoms we the the stage development did that the FDA, we're confident

Doug Williamson

question? you positive and were second can your U.S. between symptoms asking Charles, Yes, and about You negative clarify the Europe? between difference the

Charles Duncan

predominant the results that if in paradigm negative the it in seen mentioned asked I'm wondering something or guess you there that I Doug, would that is symptoms treatment you in different study quickly, was patients, just and Yes, that? have you important states as to

Doug Williamson

separating said No, consistent positive outside schizophrenia and and the of Steve conducting on negative the placebo regardless is. I rate, of placebo gradual couple for U.S., the in studies. for as of is as last U.S. and it call, pretty decades symptoms what lower said are the the over The difficulties of region reason the

Charles Duncan

symptoms? large usually that in Not, a positive know, isn't I seen database you don't But have symptoms. on negative

Doug Williamson

We first studies, not and our actually this in a fact just all negative schizophrenia ADVANCE-X in pattern. psychiatry in did It's we similar studies, a finding saw general across symptom see study.

Charles Duncan

taking Okay, question. for my thanks

Doug Williamson

No problem.

Operator

Thank moment question. for you. next One our

of Your Please ahead. next comes Leerink. from Marc question go Goodman

Marc Goodman

together. persistence, patients what's the quarter plan, us going are all price the kind titration sense Can and on selling of the for staying happening and Yes, wrapped drug there. just on just and how Thanks. the hi. It's you a the what's a DAYBUE, in give happening, us average sense give drug, of

Steve Davis

thanks Yes, Mark. want take you Brendan, that? the much for question, to

Brendan Teehan

thanks, Sure, simply what and by on I'm persistency, relates with as encouraged we're going seeing that we're state to to persistency. early start Mark. it

DAYBUE learned be X want care outset an the family to comprehensive health from staying a We critical. never acute took on outset. know, the of care long-term support approach DAYBUE, you from is As therapy the a obviously, and study, treatment. patient both from have we Phase so the intended and the was patients long-term to to benefits lot We the professionals

lot a worked of and To start communities. make that they'll but directly to caregivers also see strategies nurse journey. families certify DAYBUE, the with done both GI with We've the the end, comfortable HCPs we've they education management as care management with medical benefits caregiver these with and with coordinators the them on essentially GI

family do and are team, with treatment those caregiver them family with managers, further the very clinical way. and with all our start our HCP DAYBUE. benefits step every the patient with to of reinforce to timing paired Our each thing they before access teams And then and be every same

expected persistency, and comprehensive the in us, on. certainly early we're and seeing for early for caregiver-focused programming that to benefits deliver patient was So days that

individual to more they and to from to want your dose families and we're The question derived which therapy get benefit on to optimal to also obviously happy say long-term nothing was each than see. find that make I be around the treatment. want that for second of HCPs stay part titration, sure can patient

from essentially all a to trying physicians the treatment world, highest long-term take can the of clinical of in lead success those define into learnings the rate. can the the trial and translate unlike real plan where trial you're families treatment and benefit And product, the to that those

then would varies expect patients so dose hand as that a a a we the of function I obviously monthly titration with on scheduled don't period payers large on titration approve would a there. of they terms tend settle titration of from do that. patient of time then that and to in experience, dose their varies we weeks. should the dosing basis, two optimal their expect, six ending with with dose over in see That say as about about the and of to excesses product And of a schedule say on while target up consistent should and of over prescriptions area in reflect from you physician families time, actual starting it create XX% to rate separately patients, from to patient or period rates,

Mark Goodman

does mean pricing? What for that

Brendan Teehan

good Yes, question. Sorry.

So are what described titrating, prior said based of is we Many expected higher for perhaps than said. fundamentals same. launch, pricing as patients the to on DAYBUE remain how the average elements weight largely The slightly we of net titration, label other over dosing, because and mix meaningful and for the realized expectations that, of age But of of price. broad our our both the a number we a support patient XX. than patients

Mark Goodman

Thanks.

Operator

you. next minute our for question. Thank One

Capital from go Markets. Renza Our next Please of question RBC ahead. comes Gregory

Gregory Renza

and I to taking for schizophrenia. Hey, good and Steve on my one progress, afternoon, will team. maybe thanks back question. again keep negative Congrats just pivoting it the and symptoms to

readout, what get just helpful it about and about to bit unmet the characterize as the Doug, little opportunity, thinking how commercial hear be that would maybe, you're readout closer would the certainly there. the to to need to additional on But like, For be about you that maybe a Thanks hear flow Steve, great Any in population there direct you the color as would look leverage business so existing infrastructure, what especially like base pending looks leveraging positive positivity. now cash much. NUPLAZID the and opportunity the great. and

Steve Davis

would Greg. much, any Doug] very [Brend feel thanks and free add. for to start, to in Yes, like additional color chime I'll you

negative on these many that prevalent States positive from described, control. despite patients times fact XXX,XXX under control transitory received have already about United benefit and the under any that getting that they've continue in So as got Doug symptoms symptoms have, the

no disease. significant is Parkinson's there five the and need, of is a unmet approved of symptoms times about the the treat population It of very size are size the drugs negative schizophrenia. So to

and currently where So when about pricing in penetrating difference negative psychosis. the symptoms than treat priced we on market, not any anticipate we pricing think to the do disease at Parkinson's we're

needs similar. approved. are the Again, drug very No

back that. similar. No approved. to go to Very drug So need. Significant we're going unmet

think with that to a PDP, have treats have predominantly today, by the NUPLAZID neurologists. So drug we leverage that about obviously when capabilities place we psychiatric in written how are and we symptoms

of predominantly by are a neurology have symptoms schizophrenia and psychiatrists. strong franchise, we psychiatry. treated So Negative in both

not footprint. that same would having we force of So size. expansion We it to separate an force the that have to the broader would have we would expansion, sales We stand would, anticipate our that field much cover a force anticipate would to cover an be up. would that expand Territories again slightly we territories. different be

that negative We of neuropsychiatric there's the manageable. it's few move as franchise did stand opportunity are up with decades very drugs, all significantly today, And of other in ago. commercial we And a into to an industry the all franchises schizophrenia. think of components course, leverage than we our dramatically we the symptoms what smaller

anything think potential So we're like on about to very very, add? it. a approval I And well very you'd capitalize here. to Brendan, excited we're positioned

Brendan Teehan

Yes, going reinforce that I I agree. was final to completely just point.

the are internal have [C&S] foundational of space. that indications. are lot We in across a And we leverageable capabilities

addressable marketing management, population, have services, field capabilities internally, would our of we or we current footprint lots augment are team our the patient physician So shape. leadership beyond to account those support good were which support, in whether

Steve Davis

sorry. I'm Greg,

Just one of. is I important everyone that just other remind to think component

Doug mentioned, to patients. As treat therapy for we're population schizophrenia the first not is line seeking

approved if than patients, on a symptoms, drugs positive those For particularly more are they're that the relatively They're now there dozen generic. are inexpensive. focused

symptoms. not those be persistent would the are So those to to of we displace We adjunctive top on as therapy drugs. adding negative treat trying drugs

than we first symptoms different a therapy. if from pricing positive dynamics seeking the think perspective, to market we little bit the as about were treat So it's way would a line

Gregory Renza

That's great, Steve, thanks so Appreciate much. it.

Operator

One you. moment our for question. Thank next

Please go ahead. Ahmad Tazeen from comes BOA. question next of Your

Tazeen Ahmad

my initial go to the does how aware for communication of doctors as that made to right it? get that to the to be managing question. are the to go is they so started? to diarrhea, Or best about severe back Thanks. work signs treatment it Hi, DAYBUE, diarrhea And of having way thanks that patient away? a much found Maybe relates how have it taking topic

Steve Davis

Tazeen. Yes, Brendan? thanks much,

Brendan Teehan

go learned work three. for we we what so I'll thanks Tazeen, as the from did much question. function a Sure, phase back preparation to all of of the

X Phase of gave So us DAYBUE. the product for pretty the a image clear study profile

with have As a that GI management us been you've written. guidelines that, seen function of

We and journey label you And HCPs. treatment. patients advance same of families about all medicines for discontinuing prepare DAYBUE have starting information the includes in a hub with so best We that do the ahead. that educates can treatment we're for also anti-constipation the grateful the patient

of that and they to as they run both care on and health with tolerability, might into physicians, looking families professionals any their best terms In with alerting sure, manage are interact how our that. family for treating their issues have they access the they're guidance ways for managers

titration I think, as terms seen of I with in we've both and said, pleased persistency. we're what

would choosing optimal think to are about providers a thoughtful patient. between I adjustments the to the talk constant to journey and families finding intertwined, that approach the dose, to individual get best I the those their appropriate and treatment say, for interaction, dose then

Tazeen Ahmad

Thanks, Brendan.

And that providing patients accurately You for pretty guys range what already symptoms management out? felt you a all for can sales drop XQ because patients? more the is diarrhea are to similar comfortable initial DAYBUE. going Is predict of the among

Steve Davis

like right the more to we're that's the get we and felt Tazeen good conclusion. the a what gave to various And QX else it to handle to this people like and exactly opposed everyone we overall. on in as seeing more was felt useful reason have that get inputs call you we is productive we output on guidance hopes

reason the guiding on for So that QX. was

and starts perfect by. we're these of hearing, have we system line once we're earlier, particularly As seeing. therapy, what would repeat very, access very just encouraged our and what therapy, It's on by but still what very to information, through we and of sight encouraged simply a don't have we're is patient FAM it said early, continuation and relates that good I things to we're we persistence very

Tazeen Ahmad

Steve. Thanks, Okay.

Operator

next you. moment One question. for Thank our

Your question Canaccord go from ahead. Genuity. next Sumant of Kulkarni comes Please

Sumant Kulkarni

endpoint Thanks trials ACP-XXX Alzheimer's and Could be for the two primary study specific be taking for comment how prior pimavanserin will three what on using psychosis our afternoon. and Good for phase to you the question. in compares in might that you DRP? for disease the

Steve Davis

the question, thanks want take Yes, you Doug, for to much that?

Doug Williamson

using same the Yes, the outcome we'll measure, be SAPs primary HD.

Sumant Kulkarni

Thanks.

Operator

comes question of The our Butler Please question. you. next Thank for next Jason ahead. moment from go One JMP.

Jason Butler

in Hey, a Phase trial ACP-XXX thanks there with follow-up X question. for design. taking I'll the the jump on X,

improving run-in the in the go If through eight use last at that the clinical same marker efficacy that improvement still endpoint, And the XX% three threshold a Thanks. least you're saw in six-week decision a symptoms relevant endpoint, significance? for what you the weeks phase to for for trial? responders is using given drove in you

Steve Davis

want you Doug, to that? Yes. take

Doug Williamson

of even significant the improvement may change, generally we XX% had though six the decided with for treatment a mean, kind clinically though Sure. sticking we're past data existing seeing, I even as weeks is continued so weeks, was optimal we looked the improvement see when you And we're six at pimavanserin, regarded that. we period.

Jason Butler

Great. Thank you.

Operator

moment you. our for question. One Thank next

Guggenheim. Your next from question from Yatin Suneja comes

Yatin Suneja

taking question. Hey, guys, for thanks the

long-term regard be NDA comment PK perspective then to XXX. younger, roll Because tends some in just going consistent from of that an Could with over gating for indications. running, patients to generally these safety you a studies Another was one to the are the And elderly? Thanks. to mean, study? on new factor these versus I volunteer healthy how the on you the that are

Steve Davis

questions. two Doug, Yes.

Doug Williamson

you have I I'll because back Yes, it to second hear properly. come the one, on to couldn't

So versus the elderly how with elderly based we PK And adults can did young with again? was consistent studies adults other many study. slightly exposures was We It the in question But elderly? repeat part of the we've consistent on doses the population. our based elderly. see second findings you that the chosen the of that, on young volunteers comparing in higher

Steve Davis

And don't patients put question roll in the extension? yes. is second will the was, answer in over Yes, label

Doug Williamson

Yes.

Yatin Suneja

you. Thank

Operator

question. moment One your you. for next Thank

Your next of Fadia question Ami ahead. Needham and Company. comes from go Please

Ami Fadia

Hi, taking my good evening. question. for Thanks

advanced can if in you milligram remind between the negative saw you. of the you in just U.S. and study, your details of dose? patient study could XX ADVANCE-X powering analysis you Europe disclosed the talk size patients and studies. any Thank the about out us the the the around if you've talk subset effect of symptoms of back one schizophrenia magnitude population of Going to to ex-U.S. And

Steve Davis

and level high chime Doug free very to a at start maybe in. feel I'll

ex-U.S. what It's Doug one schizophrenia. we sites. see as saw We differential all did see the very sites time this we a consistent. the advanced U.S. in between So and mentioned, in studies,

an pattern when opposed a saw it, also symptoms. treat a study We we as higher there, and U.S. to to patients to earlier did outside similar treat saw of difficult We the by the with response positive U.S. way, negative

the dose, So population dose it's milligram Doug about an And total were the effect were saw to I And mentioned, to result size of anything consistent highly with in as you flexibility see. improved where XX milligram XX dose Doug, milligrams. else think XX add? that we a down over want were X.XX. the very you the we results allowed asking we

Doug Williamson

the think No, consistent really size from the was effect It I was across regions. that separation differed. placebo

Operator

question. Thank you. our next moment for One

Olson question next Please Jay from comes of Your Oppenheimer. ahead. go

Jay Olson

therapeutic away area, curious you of for what the since you about you been taking you. size the that's Can should opportunity notoriously Thank commercial probability take the studies describe previous thank learnings And question. We're of the syndrome? success? ACP-XXX. you in challenging Hey, help that a Prada-Willi increase from can

Steve Davis

Brendan, that? Yes, to thanks, want you take Jay.

Brendan Teehan

question. the for Thanks sure. Yes,

a for there a is the prevalent opportunity. unmet the seen population I what life-changing medical similar Rett approved to we've call, need As in put would higher syndrome think, Prada-Willi. a noted is no This in we, type There community. I of prior treatments. are

PWS. us, would in that's approach XXX the way we For

Jay Olson

from increase? previous will studies learnings And you help

Kathie Bishop

there. can help I out

it previously, some longer the full And which we're we that has inclusion quarter exactly that as one Phase bit very this benefit in data see and XX-week Phase in So fourth retreat think be made talking carbatocin. LIVO's gone the X over plan to the exclusion about little with experience. be we've the the all we data, we previous detail, to because trial trial. start I our about We'll have clinical from access based X We starting on learnings made as studies trial and is with us intranasal we do great we've, product, talked design, carefully I is But this we greater a think, think, advantage a tweaks And to helped going the that here. criteria. they do have data I that the conducted longer, exact trial. previous that

You're field a Unfortunately, quite exactly There's quite there. done in been clinical right. no The approved trials. work to date. Prada-Willi experienced treatments is

field. we the And think think, because very an able But also that's sites. trial. experienced in execution some the those of disappointments do to advantage, in I the some they're use of trial also So I have clinical learnings,

previous with experience. working as we're So that mentioned, you CRO a experienced sites Prada-Willi experienced to, in trials and tap that's into

Jay Olson

you very Thank Great. much.

Operator

Thank you. One question. moment for your next

Your of next Please question Danielle comes from James. go ahead. Brill Raymond

Unidentified Analyst

This Thanks for on is Hey, Danielle. taking Alex our DAYBUE. This for guys. question. question on

expectations. benefit, were know you reauthorization physician reading it policies, attestation. I requiring measured the said But requirements the not us, of within stringent some to So documented seems more just the on the enacted side, when requirements payer that treatment reauthorization are

what basis, reauthorization just So year. how over of curious were DAYBUE you at by fall Thanks discontinuations roughly six first so a the quantitative point whether to six-month months time one much. the on throughout thinking off rejections therapy, were patients percentage may we

Steve Davis

that? want you take Brendan, to

Brendan Teehan

coverage characterize DAYBUE question. Appreciate and I what seen approach thanks. them appropriate the thoughtful to to ensure a today seeing take among looking payers Yes, as we've would use.

to them therapy. continue work able that families be only on regular with these their closely elements basis at are on and stay approved make not sure to we so And to meet that very a to and get payers coverage going but policies look to are to

are claims the clinical valuing the patients. we address challenges, bringing are bread paid published benefit needs, syndrome, the large, to that is the look that payers those we and and at So senior criteria, by DAYBUE coverage and when are unmet the believe, recognizing

Operator

Thank moment time have only you. one next question. do for One We more for question. your

by stand please So that. for

Your comes Ritu ahead. Cowen. go TD question of last from Baral Please

Unidentified Analyst

question. the for This Thanks guys. on Ritu. Hi, Athena is for taking

it one on DAYBUE a child? work do chance Another benefit DAYBUE. determining to caregivers show their before give for How doesn't long

Steve Davis

you want to Brendan, to this? speak Yes,

Brendan Teehan

Athena. Thanks for question. Yes, sure, the

the this families a lifelong we're giving and the a we've forward make are and to to illness treatment in to of some weeks relatively here. Rett that the caregivers the improvement guidance But physicians with weeks what worth six look see. LAVENDER approved. is initial would that course, to set appropriate that drug treatment the are DAYBUE. sure to is by It's gives of expect study to sense looking is been seeing are signs first-ever Obviously, I they treaters, see XX caregivers benefits dealing to short think community, they for be people should expectations. months the that encouraged duration, which many saying, look, out encouraging and XX they're

our that caregivers period. in before said, that day-to-day remarks, well prepared occurring that differences, note already hear time we're are encouraged very with to Now, improvements

is the it's two, those So time the give period balance a of to of a I drug but think thoughtful given at work. least to guidance

Unidentified Analyst

you. Thank

Operator

Thank you.

please Davis, to Mr. proceed remarks. closing

Steve Davis

again Thanks joining for our look updating forward on operator. next progress everyone Great. today. Thank We you to us quarter. to you,

Operator

today's your you call. for concludes participation conference Thank in this That presentation.

You may now day. disconnect. Good

ACADIA Pharmaceuticals (ACAD) 2 Aug 232023 Q2 Earnings call transcript