ACAD - Earnings call transcript Q1 2022 | ACADIA Pharmaceuticals Inc.

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Operator

Good day, ladies and gentlemen, and welcome to ACADIA Pharmaceuticals First Quarter 2022 Financial Results Conference Call. My name is Crystal and I'll 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

Good afternoon and thank you for joining us on today's call to discuss Acadia's first quarter 2022 financial results.

a call Officer ACADIA overview who first performance the our Steve of on business. quarter Executive our Chief will and me today are from Davis, our Joining of review provide an

Following Steve, Officer, Commercial Stankovic, and provide will progress. our performance Chief President, on commercial discuss Dr. Head our our pipeline of updates initiatives; Teehan, Brendan our Operating Serge will then

website. Steve turning also for questions. discuss Finally, remarks our Officer, financial which it on Events our back we guidance and I point are Schneyer, up to Mark opening the slides that will and before final your and using our the like Chief results for section supplement Presentation are available out Financial call to would of

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

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

Stephen Davis

of us elements. X. today. and on everyone afternoon Slide you our Please foundation business to turn key rests Good joining for three The Mark. you, Thank thank

stage in outperform CNS and next strategic of symptoms disease to continuing where early the schizophrenia Alzheimer's pipeline of negative with pursue three to market psychosis, third opportunities opportunities. late-stage NUPLAZID breakthroughs to the business wave to franchise First second, of syndrome together Rett the advance with development drive and our comparators; our continue we growth develop

net $XXX.X achieved For year-over-year the XXXX, in first representing quarter X% an NUPLAZID million sales, of increase.

go Mark to will key our and the point during quarter. few in performance Brendan components a While I'd more of into out like moment, a detail

in operational growth, by of we million the for experienced driven guidance our assumptions X% net similar performance XXXX year is XXXX. line sales to million quarter demand to of our growth, a also with full first was through level and our which for First, $XXX in what the $XXX

into seeing the starts in Omicron market and Second, overall surge now early exited quarter, whole. second we the and of variant following additional signs we're and with first NUPLAZID new the as a growth both quarter patient the as prescriptions total

beginning a cumulatively grown market the comparison, market this period. bit X% of pandemic In Parkinson's the this the two-year grew Just only Since of pandemic, the has period context disease the XXXX, during two-year X%. early in to here. over prior

for are patients previously In as Parkinson's addition, and fewer treated subsequently disease Parkinson's their being in-person physicians have we for conditions diagnosed in visits resulted to approximately treating down XX%. Parkinson's available and psychosis. patient These reported

throughout back summer. come However, improvement further to encouraging to returning optimistic lifted recently and care the these With into spring see to community both Brendan signs we in mandates as seen and physicians growth. long-term the patients that the cautiously could mask to the stabilizing slowly Parkinson's dynamics will in and speak we office, market are overall channels, of and the we've market

strong to on PDP. brands outpacing year-over-year and LTC has the Finally in and facilities. performance neurology the most grow continued of long-term forward maintaining for We NUPLAZID to top segment, medications the potential in delivering NUPLAZID PD market and the importantly the and look

late-stage turn Now our opportunities on Slide to X. three let's

with our an for our advisory June stand by start to to FDA ADP. that where have week, resubmission. the This providing for overview sNDA First, XX meeting announced scheduled like resubmission I'd committee an review we they of

for meeting, which positive efficacy, unmet three this we profile overall the patient in are For focused on high pimavanserin include point to safety key and which population, need. risk benefit messages the

our For efficacy, in Alzheimer's patients. and that our pimavanserin symptoms relapse improvement package psychosis risk provides supports the the position reduction of meaningful clinically consistent a of and disease in

equivalent committee as These motor psychosis, to about Alzheimer's medications the patients for to the in there business. risk patients Alzheimer's falls, efficacy or Alzheimer's therapies US, in the marginal will these safety upcoming On providers many FDA profile for these healthcare not the patients, hospitalizations also continue to importantly pimavanserin demonstrated sedation, increased of families further to Please and has of is associated acting fractures, to finally impairment treat with times treatment the that and are Slide which antipsychotics of first with safety In either should with Today, has in cognition a And issues. making and with all today need, disease caregivers that our disease this one unmet We condition. challenging case and progression. issue, Alzheimer's patients, psychosis. treat side, large-scale historically to are X. debilitating safety the psychosis of and XXX,XXX ADP endure. no impairment a development with be in turn we've cognition of which disease clinical majority these multi-receptor tolerability FDA-approved antipsychotics year of despite take of meeting the worsening with to known an anti-psychotics motor trials treatment the the advisory in at are pimavanserin function approximately associated study, disease off-label CATIE-AD associated forward desperate increased were look regards their prescribe particularly off-label limitations, function, favorable to FDA-approved being hindered treated off-label

trofinetide syndrome. NDA the Regarding meetings for are the the and for for format our of for the pre-NDA aligned submission with the Rett NDA FDA complete we content fully are trofinetide, treatment on and upcoming

Phase Our the our or XXXX. with X oral Annual We first NDA the plan late and AAM. action positive Meeting top-line be XXXX. Neurology submission this based study delivered Academy to NDA priority which quarter late-breaker in on expect at the presented an recently results in results to American were will Lavender be These presentation pivotal of primarily submit a likely of date review most a at midyear

Our commercial team launch speak which Brendan is will just moments. preparations, to few working hard a on in

schizophrenia. Moving now to of our treatment the of symptoms third late-stage pimavanserin for opportunity, negative

With is As is no we previously bank, pivotal the treatment for positive approved currently schizophrenia. of we study, of negative for and pivotal attempts, study second study pimavanserin, study. that discussed, our in we seen, is a pivotal With symptoms today study decades there positive something the one drug we rarely patients have the file of approval. study conducting that this with is negative symptoms will in successful, if are our a ADVANCE-X ADVANCE-X despite

modification. almost top the in ADVANCE-X in one dose, We around to to is most recall, study robust had previous study. important you ADVANCE-X turn are X. As an evaluating the results XXXX. ADVANCE-X line important the ADVANCE-X, optimal the XX-milligram efficacy study Slide the year-end with this identical reminder, with enrollment In we Please study in anticipate which as may completing

early our opportunities, we are early-stage ACP-XXX, late-stage Phase in also three X. program including currently our novel programs, several non-opioid pain Beyond developing

an build ACP-XXX learnings molecules, collaborations Vanderbilt including and pimavanserin. on program to to our that finally, and with business update X those strategic on engaged we Our Brendan stage And Phase call and compound Stoke in earlier our MX from molecules to additional now provide upon testing lead our be expand several continue further our highly I'd to our development PAM of focused over currently like and potential pipeline. the to efforts. commercial turn

Brendan Teehan

with Slide based $XXX.X representing net on Thank you, Please sales delivering Notably, X% with year-over-year growth I'm our Steve. performance first XX. assumptions quarter, guidance our year-over-year quarter our demand and this turn is demand pleased plan for this our range. sales X% net line to with growth in of million XXXX growth. aligns team's

we and ahead, to importance new up ongoing reaching caregiver As patients, early set continue educating treating and well, and PDP our on the HCP them potential of physicians us the of NUPLAZID. look patient campaigns

PD for long-term and PDP in relative outperformance on care our the reflects facilities know, in top prescribers potential treating markets all community you patients. highest focus our the As the LTC the and

when they is increasing with impact to over made new more a month month a starts. that behavior have contact regular patient in-person metric to measurable especially prescribers, able teams, Our have leading on are overall prescribing

occupancy profoundly confidence to recently a the conditions by have As to backdrop Steve years. of two long-term pandemic normalize. rates against impacted we know us mentioned, should impacted year continue PD pandemic accelerate pandemic. as of especially only treated the the this this three growth facilities to of grown that data Based Utilizing see the ability not measured that in brand remaining impact the we hard signs the in early stabilization, across started care the only hit were good is pre-pandemic was that market over NUPLAZID growth have and opposed significantly to timeframe. by great by market return we but first of these growth market disease gives biggest channels. the it LTC sense COVID-XX on same grew X% March X% This makes XXXX. potential home, as facilities. and patients many entering as The at news overall market residents past by IQVIA, with spread see the Parkinson's as from rate since of rates, in care, growth long-term in The our improve The the many times PD to

up top declined long-term the down top office increases XX%. NUPLAZID direct first share was by occupancy neurology the In top X%. carbidopa/levodopa channel, based up a our almost pandemic. In the just performance of addition, the four fueled since LTC NUPLAZID pre-pandemic, contrast, time, This growth when an rates average comparing which the in significantly brands, market up levels. XXXX LTC NUPLAZID's and of that grew medications lower and declined averaged beginning scripts and to times XX new X%, X% of XX%, down of roughly outperformance of which reflection were the X% in carbidopa the At same XX%. over setting, meaningful LTC the In was XX% Parkinson's levodopa maintained care significantly quarter XX brands were a XX patients,

return to over their encouraged hampered have field that our months, past signs seen physician including in growth we of market in visits of the early potential further the by a few from that and a dynamics heard PD several patients. our growth, have increase PD force are We

normalizes market patient the As engagement brand. regular caregiver peer-to-peer return efforts broader potentially growth the more to with physician, begins and multi-channel live and and to efforts plan programs grow promotional its further programing, we speaker enhance our further to to dynamics,

we have commercial PDT, exciting potential two Beyond near-term opportunities.

Let's review of the treatment start for pimavanserin Alzheimer's XX. disease with psychosis Slide of a on

pimavanserin with of us ADP, of ahead an our opportunity PDP that potential current for significant a times seven approximately size indication the have We is market.

diligently are already important teams NUPLAZID importance, the advisory recognition This for NUPLAZID's if upcoming commercial this demonstrated Our commercial for approved and has at profile. expanding and ADP is messaging meeting and Key in equal to efficacy of population. forward preparing committee and strong for both only for potentially products launch will drug brand the be NUPLAZID safety to to subsequent PDP, demonstrated we patient the especially our first approved. this look ADP. as launch

XX Rett Now trofinetide with let's to to Slide discuss syndrome. opportunity turn our in

affecting of the to the ability lot see of met Phase this long breathe Rett syndrome, impairments with waited announce a trial a for eat of This a that disease to easily. end treatment a to in have debilitating positive results Phase year, has of very time neurodevelopmental to and aspect X for we the positive results been walk, nearly leads Towards last excited severe community speak, life, excitement. were disease trofinetide every the X and

key Today, understand progress trofinetide. and we of and critical for meaningful part our centers are patient With laying launch launch best successful of preparing as treatment particular the the on the year. opportunity are stakeholder educate A advocacy needs with preparation way families. launch are excellence as thoughtful through Rett their groups of well focused and physicians approval investing foundation and engage engagement disease. market leaders the to opinion the appropriately first caregivers, engagement and on positive the and identify, commercial Rett community, we the on collaboration made commercial our potential for to includes throughout external payers help the for both for with this readout, within infrastructure We've this

results patients of physicians their Our Rett trofinetide's in provide trofinetide potential look it it percentage our Many this excited very professionals market now interested expressed symptoms very for Not Serge efficacy core to treat turn for opportunity about reason were post to confidence patients caregivers of ahead also today the from are to high surprisingly, trofinetide's a that caregivers trofinetide underscore who I us syndrome indicates approval. a rare the treating Rett when market in respondents feedback to to in and research and of say establish approval significant healthcare our of in their available obtaining ones. clinical motivation strong as for loved prescribing like patients. interest a prescribing an This in treatment, disease. and presence current Rett R&D would as update. we the over forward

Serge Stankovic

review for by three to on upcoming Thank afternoon to late-stage you, sNDA like good dive At we actively committee And time, preparing Slide advisory a begin XX opportunities. everyone. our meeting this Brendan. would our on resubmission. I the taking deeper are

have several to prepare with help the advisory months, we working in upcoming key the multiple Over for disciplines us committee external closely leaders been past meeting. the opinion

refine continue case are of opportunity to standard and this approved active And as for ADP will disease with our marginal with well We Steve unproven these reiterate for of discussion demonstrated efficacy the often an patients and benefit. pimavanserin We risk multi-receptor of Alzheimer's that be ensure off-label the that should an like psychosis. Alzheimer's safety This in for would patients its to anti-psychotics, critically pimavanserin first acting I safety real frail there important our made benefit to current disease psychosis. use who is finally, to make significantly the be we the are for care a remain profile drug the presentation context increase on see profile prepared community to at with the elderly. point the which of risk earlier, and the concerns best

multiple Beyond we clinical have across demonstrated studies the endpoint. efficacy, and

a support of post-marketing pharmacovigilance of data favorable have tremendous in to studies clinical on at-risk both amount We this also data placebo-controlled pimavanserin population. well-characterized safety at profile six years and pimavanserin's

this lose XX. X,XXX a submission FDA-approved and for neurodevelopmental on in patients me is estimate the There which States. discuss independent disorder, Ultimately, Rett syndrome there on no to ability daily United require basis X,XXX are serious NDA functioning a treatment between disorder. patients their Rett upcoming our Slide maintain support. syndrome around-the-clock rare for Let with trofinetide and debilitating we is and

symptoms from as study co-primary Behavioral efficacy placebo Our positive demonstrated results from Questionnaire, the assessment a syndrome benefit on Rett a as Impression pivotal of with Lavender meaningful tool and tool. assessment separation physician statistically core endpoints, across clinically the Clinical significant multiple of well Global Syndrome Improvement, two the caregiver Rett

Importantly, age disease. efficacy consistent were of results and all groups the across severity

to FDA meetings in midyear and We submission. the quarter first PDUFA with format content with have pre-NDA the XXXX. most completed the review the plan NDA a We likely of aligned and and upcoming of our priority expect submit date on

XXX,XXX have who lack such are patients debilitating potentially there and among treated affect There but schizophrenia, Now over still no treatment. are for let's persistence on discuss and United symptoms negative symptoms and for in withdrawal, currently schizophrenia program is as emotion negative social FDA-approved XX. of Slide blunted our of which others, States

As receiving part have of pimavanserin. on statistical where one and our patients already advanced XX of positive results study robust primary we more program, pivotal endpoint in even the milligrams observed overall, we ADVANCE-X separation

the ADVANCE-X. in Russia of everything potential in we to optimal impact to And the on all in minimize evaluating are we pimavanserin now are monitor that and and we can wanted second continue our mention Ukraine conflict pivotal doing such, ongoing enrolled. to study As XX-milligram I dose briefly, any

of enrollment top-line achieve and based completion Slide our XXXX. our of that projections year-end XX in study, we available the multi-region on around still current multi-country we target can the design opportunities. highlights early-stage results believe Given pipeline

evaluating acute and We pain both ACP-XXX are chronic in model.

evaluated. the pain Phase As not even a study one trend on previously primary in was our two-dose achieve acute the of endpoint, statistical observed regimens announced, X though did positive significance

As data appropriate such, step. we to are analyze continuing the determine next to

chronic ongoing of and in X half osteoarthritis study of XXXX. a model to in first Phase pain complete is Our expected the

program our dose now pimavanserin. advancing turn multiple developed compounds, our the internally the collaborations programs, PAM we from we lead results. I'll and our from Phase multiple Stoke build with Therapeutics the upon And HCP-XXX with compound currently to early-stage are discuss have MX are in financial learnings ascending which addition, study. advancing X to In call over compounds we of Mark

Mark Schneyer

million Thank million XX. In you in increase Serge. $XXX.X net XXXX. quarter, Today, quarter first I'll an X% we discuss sales compared Slide to sales, net $XXX.X XXXX in of recorded Please turn results. of QX approximately to of our the

revenue performance Brendan reflects demand one of the full volume regards consistent and we growth to XXXX. our our flat during in of guidance X% key year our This first As volume sell year-over-year. both offsetting observe result is growth our This operational essentially of the two for XXXX range is approximately full XXXX. assumptions In with Steve year the of to mentioned, underlining the dynamics. is demand and recognition, compared quarter

by grew mentioned as First, demand we year-over-year. X%

However, this of QX year as compared was build year. this a larger to by in in-channel offset inventory last

As demand, our quarter, achieved will and know to ultimately from but you we in-channel future quarter inventory revenue growth wane drives in growth. which wax importantly,

our between was XXXX coming Year-over-year volume portion the XXXX XX.X%. QX quarter gross net and the compared XXXX in the adjustment on, second Medicare was higher gross of XXXB to greater to as Moving accruals for XXXX. first timing to from to a of net and institutions of

difference GAAP SG&A dollars CMC the in year the of $XX.X the The also projecting stoke decreased XXXX, XXXX. in year. XX%. increased expenses prior QX quarter GAAP compared the cash period full largest the last and increased was driving upfront from million quarter difference from to factors between clinical the first $XXX.X balance quarter spend expenses to and R&D end our gross finally, in pre-launch primarily $XX be to collaboration due expenditures first year and payment And still million $XX million costs. QX DRP was to in of in for million XX% made in XXXX. million in $XXX $XXX.X the the for related the we January the at are to to The For were to net quarter million.

Now let's turn XX. to Slide

previously slide, now of call And remarks. As closing for announced on for are reiterating the ranges. like year to XXXX, this see can our to Steve guidance the you turn we back full all I'd

Stephen Davis

Please to we clients and grow to XX. turn promise significant is Mark. with on continue you, to Today, Thank where executing deliver Slide brand. the long-term new there are PDP our a patients opportunity to

the ADP. In advisory addition, as for on with upcoming committee review FDA continue sNDA the our their we resubmission are meeting focused of they

opportunity schizophrenia year. on are We submit would to X with for our to now open third the expected to to for our ongoing elevate with and up their of mission accomplishments late-stage a trofinetide And drug for results track midyear. I'll commitment I negative as of their symptoms thank new we our and life. questions. Operator? application next the for preparations our our continue ongoing Rett we like continue treatment In passion with syndrome study employees closing, the call in Phase advance

Operator

Duncan comes Instructions] Charles from Our [Operator first Cantor Fitzgerald. question from

Your line is open.

Charles Duncan

and would changes for thanks is given I'm guess, the then that And is PRV? it perhaps it's you going should our in the able really the question to extend question team, first-in-class trofinetide My that really get infrastructure to upcoming it multipart, then And commercial to NDA, to for challenging good and to a environment. to be be approved? approved, you taking to related, ADCOM would if despite then on ever? I relative and result hold one congrats anticipate looks would it drug an like since Steve a quarter Yes,

StephenDavis

Thanks for respond three. Charles. questions, to Serge subparts Great. to two, ask Brendan much and the one to I'm going to and subpart

Serge Stankovic

the priorities a of thinking of that Advisory occur. not controversial any I would just the least chances of Committee course, saw this with situation Advisory a that do little issues our that lead the XX-XX though, there an think In sort Yes. I is relation we even maybe what Thanks, it's eventuality. we and Historically that are in I Charles. bit say diseases, about more these chance. advisory rare say, say of having on always to anticipation preparing we such Committee, would we not substantive from us, we for see that the immediately would committee. on would have at that would records But just half-half

Brendan Teehan

Thanks Serge Charles, for the thanks and question.

to it ACADIA. about us fits program and us when into brought means to excited trofinetide very into had Just overall our nicely. what footprint taking We're back we very the

As you know, experience in we already have disease rare health.

will sure a rare closer from into leverage on internal and we'll we the to adjustments address get. expect go for synergies We also make operations neurology we to thoughtful infrastructure the community further but details I'm pediatric disease

Serge Stankovic

and there Steve, a you repeat that just was Could Charles subpart. second part?

Charles Duncan

it that granted Is would be Yes, you I'm is approved? sorry. possible a trofinetide if PRV

Serge Stankovic

Yes.

Sorry designation, about if anticipate we do voucher. a would pediatric that. receive pediatric orphan approved, it having we Yes,

Operator

Thank you.

comes from Bitritto-Garg Citi. Our next from question Neena

open. is line Your

Neena Bitritto-Garg

there taking Thanks. differences for or of for Alzheimer's of kind expect June. wondering you versus to to question. expect you up PDP any you in can ADCOM just be Thank ADCOM? coming in do I pediatric the this channels thoughts versus psychosis any about share be of ADCOM terms you that the the guess typical a how I was my historical

StephenDavis

the you want question, Yes, thanks to Serge, that? take for Neena.

Serge Stankovic

the Yes, is the saying and not This as been thanks response Response would along. What Neena. resubmission Complete all say, application. your Letter we've I to is typical our

that We very case -- following following a while. its making development has are for having fairly been complex a course a a

our of a Advisory and as do are the positive we present to not case perspective, in and outside are way would really any trying supportive substantial date. Advisory of we are manner we of And comprehensive really efficacy usual of I the is as the this core are for committee would application our Committee them in say and prevent of to data evidence be the but to the the present expect mechanics historical Alzheimer's making, spectrum offer any the and the full in typical context of trying well way. So the context benefit-risk I Committee significant fairly disease in that psychosis execution what

Operator

you. Thank

Our comes Cory JPMorgan. from next question from Kasimov

Your open. is line

Unidentified Analyst

there's to NUPLAZID go-to-market terms commercial different treatment Tiffany strategy Cory, disease one be more Thanks for for is for wondering in on We're the than might ADP. just This just psychosis Parkinson's the question. how on and wanting any I'm if preparation synergies and in PDP. of etc., relates of get to take kind the just Thanks. as centers, your on it readiness physicians, launch

StephenDavis

Great. to the you question. Thanks for much Brendan, want take that?

Brendan Teehan

Tiffany, the Sure. for question. thanks

a year already for undoubtedly getting we a going Alzheimer's were of is very have broader terms will and much in that in expand our ADP you deployment. but a will our audience just XX% As and that in to psychosis disease as to audience. is of we ready right been of physicians for thoughtfully target place, treats are launch subset know, targets a psychosis at tactical and of our well, execution both psychosis plans we dementia-related for PDP dementia-related some targets this DRP were as disease strategy, psychosis Parkinson's ago reminder, would absolutely be that post for point which,

event, audience. Alzheimer's be to their address treatment prepared we to demonstrated to We ability have and and psychiatrists in are their more there ability any demonstrated and physicians that for primary write cover are psych-like care importantly prescribe in broader that the atypical antipsychotics that will to will in medications and expand have

Operator

Thank you.

comes from Capital from Renza question Markets. RBC Gregory next Our

open. is line Your

Gregory Renza

outcome, color June. the team bit and you light some I'm that the curious, vote certainly a mechanics confidence just especially endured Steve Steve, and the leads on once of up Yes, of is to be taking question how congrats throw the or could about Thanks, also hear typicality subpart, situation the color well. some if potential history helpful maybe a following -- about until about think in maybe how And August? in and as differences for one on provide you And in outcomes you the a having very Maybe thinking just view led based CRL. the scenarios progress. maybe Very the ADCOM recommendations initial ADCOMs just panel, in not. on related related and package on of to may the unique you're and approvals just just but Thank go scenario the that the I'll that the planning it. much. you've to from to from that providing that maybe June and just important that how vote Great. respect the of you on some and of to of to

StephenDavis

to Greg. much potential question, the Thanks of take Yes. the the I'll first confidence the Serge, regarding for so want you second regarding importance one and take the scenarios. of ADCOM part

Serge Stankovic

FDA. Advisory Statistics a out along goes usually the of the with although thank not for vote Committee a on point binding advisory very the Advisory Without committee recommendations cases, the the that in the you. FDA of the Yes, is doubt, of important, great this is vote, majority the Committee. is outcome an

overwhelming drug, the and Committee a disease you significant Advisory was report certainly from reaction on Parkinson's psychosis approval on favorable. experience previous ultimate received own respect positive had the the as the initial of And in Committee. support Advisory Our from from we vote, the impact the of FDA know, not where as

So certainly Advisory or Advisory obtain we important the the from that from support Committee making. we it case and that a strong receive that is believe for perspective, Committee case we are for make the

StephenDavis

it think are buckets. there think question, buckets to bit way Greg, response principal the a we Serge. Thanks second I three And maybe about and your three part of the of the is, little in space between

meeting significant an very with of can Committee You opposition. Advisory out come

the of So heavily is math in non-approval. favor

the between. spectrum the mid-point approval of the of end votes then are come with course in of out that out favor a and something math opposite variations of come then can You where that's more the is, you some and of heavily

for us the think not I us reiterating just would the approve FDA tells the ADCOM. during significant that fall don't and majority so Serge the history but does again as And we in does, caveat that drugs, ADCOMs mentioned

too timing about it which that of think that after we ready a earlier. that's we and this preparing will neuro We're We've how very for an action the an work to did and have in ADCOM. got far I'll advance fortunate on has in impact us, is work the is a good somewhat very, said just of the on and shelf. of X, buckets terms We're date ADCOM what the it precise that all in the those scheduled so not news And launch. road Brendan position. DRP off function We how August the of on and that for be of down lot repeat we benefits three pull the planning

so ADCOM of depending scenarios, where launch. how goes that prepared be and we of be in to for we are a And on eager will spectrum the kind

Operator

you. Thank

Our from Partners. comes next Suneja from Guggenheim Yatin question

line open. Your is

Yatin Suneja

one me. Thank taking quick question. you my Two for real for

by First study as ADCOM X the a one the the and had formal was requested is part HARMONY and And Phase different could you confirm dispute both XXX if that endpoints. FDA? study proposed the of resolution design it you or part then is second

different? and and the both how can of So question are they answer trying supportive studies and each to a I'm completely endpoints just trying be to a Thank understand you. different other when

StephenDavis

one. for question. the second so much respond and first take Serge one I'll to the Thanks Yes.

consider receiving FDA their we terms having for In premature just having did of FDA. it's an think the an simply they that discretion and to entirely I us AdCom to suggest Early in our AdCom AdCom after CRL, that. response comment set was requesting of discussions the about level with the

now Serge, they're discussions. question. these any advance we then second answer want discuss the them. all And as Anyway Let's know having determine they we AdCom. with further didn't have you an it

Serge Stankovic

me part studies asking as make our little. broke just the two sure with different you different Were up I population this together fits in let that about Yatin, you question how Yes. resubmission application? and of understood being the in XXX a and patient a studies that of outcomes and XXX

Yatin Suneja

for but the patient the are That Yes, is both endpoints studies. not just correct. different the maybe population, very

Serge Stankovic

any same in and in one more measuring and Yes. and hallucinations the of actually do recurrence have we case I symptoms. are symptoms using studies they But from in think as in sense and because than studies and the a delusions, terms of how more case that other That in terms been measuring we of we in measuring psychotic breakdown, of is primary data fairly relapse would correct. both them compare But the case, complementary have, in differential rather we are, of the from can more same reliably of disorder see. symptoms both perspective, severity we

patients matter are about demonstrated that experiencing what is the a you term think in treatment of of in if psychotic acute in pimavanserin fact, paradigm. short symptoms As weeks we is efficacy six acute that of XXX, study

other within hand the effect been treatment. of Study symptoms On XXX that respond to the durability same in patients has evaluated,

there bit perspective is quite that from actually, just a studies. complementarity So of two between

Operator

you. Thank

Sachs. from Salveen comes Our from next question Goldman Richter

open. line Your is

Unidentified Analyst

This is [Nel] for Salveen.

expect acute better could First share occupancy pain, do And you Or pre-pandemic do view on on NUPLAZID, to you in a unrelated? are ACP-XXX, that this levels? a visits how in relative then care saw Thanks you results in office is lot. long-term you trend given chronic? in-person tracking rates

StephenDavis

the on the want Yes. Thanks question XXX? on take and Serge much to NUPLAZID Brendan, questions. for you

Brendan Teehan

there to Sure beginning we happy seeing, to XX% point data facilities, going have visits patients most recent their said, are visits reflects they a fourth rates nursing that about entering telemedicine question, that ask the where still for seen rates levels. is to we so to by were community inpatient that on. skilled see care slightly returned we And return that those driven With in your pre-pandemic base, new be from over late. just about quarter proximal to that And occupancy they've I are understand to that. that admitted the LTC of that. long-term favor to for because in for facility. are to PDP trend in their for we're Thanks. occupancy clinicians to up increases the us is patient and were encouraging slight continue for then being XX% From tend if two further to being not do quarter. they things are LTC the to visits patients customers, residents below in One see think What which identified I the in out in want first we've the in-person answer

Serge Stankovic

from model as we saying the our from read-through and chronic the potential we do the to study. regard a not results been acute have acute throughout, in to Nel, Yes. studies, model of direct see pain read-through of

direct would would have signal we a but there I love than we results positive of say robust observed, course, Of is to a see connection. very acute no rather the that study,

we of ACP-XXX a models and activity both preclinical those as and of models reported positive positive acute the animal far pain. that see on we've in previously, the has As chronic this the data

point to and the perspective, osteoarthritis best. to that at any regard in from not conclusions So the show premature data jumping us will we this the study

Operator

Thank you.

from question comes Kulkarni next Sumant Canaccord. from Our

open. is line Your

Sumant Kulkarni

question. afternoon, for my Good taking thanks

or of FDA the on how for not XXX, of convention has for than the ADP ahead already external other consultants what meeting? specific the putting expressed together many what of the package having Study they'd subgroup ADP, or the your statistical some ADCOM for are significance KOLs any, key might and So, pushback, sources of of nitpicks the specific if data that on have be

StephenDavis

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

Serge Stankovic

we bit for Yes. Advisory are and studiously but from order looking in we the challenging prepare to the question KOLs that ourselves Actually, to circumstances obviously would of points Committee, the feedback over getting, are best and I terms forward the end than our overall, quite say Alzheimer feedback data the we preparing across we are of across getting and studies, specific have from of psychosis consistency the are and people that meaningfulness understanding a data a disease the time. in and support

think be that put the which that that of meet us and will perspective, can into probably not situation challenges all for providing. think point, I preparing of specific that are terms getting and scientific do very appropriate I are details the of we arguments to we understand, that really without this to at in us analysis you the So data front most from it's in

Operator

Thank you.

SMBC. Hoang comes from David question from next Our

is open. Your line

David Hoang

LTC force that confidence anything gives the then you and recover sales Is people should the much taking maybe a you you're question. mentioned as that a give from what more little recovery so your happens. the hearing this potential allow -- and happen just of little time terms for bit there year. the would Thanks recovery a maybe the color in the that spring-summer PDP that bit in faster? talk I on just to more and both recovery market and see potentially little want Can of frame office more dig field the channel you we to in which

StephenDavis

sure. I'm the But then just let question me little Yes, pass it a reframe bit going to Brendan. and to

cautiously more the seeing and sections that the been of both setting, There said to you that we able in a is that we we these what these Brendan, said are seeing will that to the build in but We're stabilization on than are will LTC in slow we period completely? question course be beginning what bit want see see do grow to indicators of we slow is has So of more some evidence and we're little we're some and optimistic spring-summer. a of see evidence growth. the now in growth. answer office-based

Brendan Teehan

entering very that's Sure. of the Steve. points A is for that increase slow And to over I of are but guide couple the facilities. are seen steady all the couple Thanks, months prior We've residents encouraging that us think the appropriate. new reframe, a encouraging.

with HCP in quarter possible. them both caregiver opportunity see is practices some and a led the to the their our This our from changes hesitation. I population in-person Secondly, are our and to an open both as there to face-to-face of means in hesitation the where visit, coupled for coupled come HCPs that where to becoming patient said the tell before, in return country also story is What advocates in HCPs patient those representatives, to the saw an forced which have the really we the of falls subtleties consultations. patients first and terms told Omicron in of are PD and asking want with us we concern for experience face-to-face to offices, elderly seeing disorder winter parts any more what neuropsychiatric our symptoms movement make to to causes have face-to-face

both at is of as improve So, least months ahead, your will face-to-face. in clinician normalcy cautious the some there things to in those seeing be there return that and optimism weeks

key So those are really elements. the

Operator

Thank you.

next Securities. from Our comes Marc from SVB question Goodman

line Your open. is

Rudy Li

question. It Rudy my Marc. is taking for on Thanks for the line

quarter. in the have congrats first regarding on a question So, NUPLAZID I PDP.

use far and in market off-label including provide you talk So PDP color Thanks. so in rate the can ADP. so maybe other far more indications, about on the penetration

StephenDavis

Yes, those? want sure. Brendan, to you take

Brendan Teehan

question. the for Thanks Sure.

the very of remarks I talking did in and market foremost, a years. and prepared PD the First over it's Steve job past about think how impacted nice couple and

fact continued we been I despite the medications, think what's grow motor is impressive pre-pandemic to written fewer for there inpatient prescriptions dysfunction levodopa, the over have principal NUPLAZID carbidopa visits, that levels. prescriptions have fewer seen and total

psychosis side and in and message encouragingly we in community Parkinson's So that's more on both a treat and starts care to are that disease chosen that share new being that number us increases X, seen long-term patient on often great our evidenced position line is and the what the in gives first confidence, we've resonating by facilities.

Rudy Li

Thanks.

Brendan Teehan

to in terms a Oh, continues number very, of still question for very small be that the use sorry, on us. I'm off-label very,

environment And indicated as other we low disease psychosis. authorizations, of why prescriptions know, As which specifically careful indicate about disease. of single-digit vast you through Parkinson's something the put than prior used you very still a see to majority form in you that go want Parkinson's are probably potentially be hub, NUPLAZID a our payers a to on product very the requires has numbers our treatment where where for patient

Operator

Thank you.

Jefferies. comes from Chris Our from Howerton question next

line Your open. is

ChrisHowerton

conversation one taking to I groups was for Thank you respect to with in the important Excellent. as you quick wondering potential for Committees believe clarification so about XXX,XXX that of how ADP trofinetide, you questions. I Advisory a patients be And if for would antipsychotics influential follow-up, do the entertain the guess how advocacy and treated much derive patient atypical and they ADP how what the part you. both the with population? you Thank might be?

StephenDavis

to back we'll the be you the one. first take then question second first Yes, and want to sure. Brendan,

Brendan Teehan

When similar reason have of Sure. population treated being and population, of for but to There consideration anti-depressants for our antipsychotics. be that in also for those patient Thanks still other off-label two-thirds are mood patients in been speak atypical of addressable XXX,XXX about the for ADP. question. is would the ADP, we a used that stabilizers expected

StephenDavis

Chris, line. that. And the you hear didn't up question were I repeat said ADCOMs, after you Could around, heard on your you of breaking what I first part

ChrisHowerton

advocacy sorry the groups maybe think one I totally important for your I'm potential for more are Yes, how either or concisely say patient the you trofinetide? guess do is Committees ADP Advisory

StephenDavis

active patients. well just and cases, groups advocate are so very the I of I Rett need and every and nothing we they're day But important, there Thanks psychosis reasons think living think, us. space so Yes. approved both and with of drug is I they're they there's as the Alzheimer's eyes making syndrome, the in very in advocacy they advocacy sure no say circumstance they're very patient and passion FDA. this as in Well, that for see groups experiencing disease where where therapies where mean, for that approved particularly independent elevate them that's let So Right? the both being in me unmet first, much. in strong the in in pushing

Operator

Thank you.

comes Securities. Our next from Mizuho Vamil question Divan from

open. is line Your

Vamil Divan

taking think confirm I questions. approval not your in seeing to still in through it be this event that ADP the by used XXX then your the data, asked, clinical just of December, year-end? chronic in to SG&A in a been this it XQ a cover is but around the XXXX side, just to not on assumptions or sort things, side guidance, one And mentioned slide. year. have assuming just the to clarify, on of I'm to I assuming for ADP, my expected trials thanks want specifically still Hi, of that anything related guess, sales couple on so I but Most great, them you're expense on

I if in your apologies So, it Thank you. missed comments.

StephenDavis

Okay.

Let's the second. the to for question and Mark go for Serge first

Mark Schneyer

us? Hi, hear can you

StephenDavis

hear you Go can ahead. We Mark.

Mark Schneyer

is happening There phone the something sorry. Yes, Okay. here. in

expense related the we there just our time. question, on previously, guidance or in revenue is to said as guidance So this nothing at ADP

StephenDavis

Thanks. Serge?

Serge Stankovic

in spite to complete in the to top-line or year-end the all studies year. in regard the as enrollment data of with of around that results to experienced, the said COVID, we year particularly we these in headwinds osteoarthritis first -- next related first to study of the next In continue expect the we types the half the half beginning of

Operator

you. Thank

from Paul next from Matteis Stifel. question comes Our

line open. Your is

Alex Thompson

for This for our taking questions. Thanks is on Alex Paul.

little Just Serge you ADCOM. guess of should the outside position you pimavanserin? concerns it risk is FDA's of be no about Thanks. ADCOM at discussion evidence ADCOM. to unknown alleviate much one was ADP on wondering sNDA a How PDP have of for more maybe maybe could the potential I around the sort class. a approved in mortality this talk your I that there on box the importance the black

StephenDavis

black for meant Alex, you Yes. say presume would no I advocate we that to box. think

Alex Thompson

Yes.

Mark Schneyer

no Yes, Yes. worries.

Serge, to So you want question? that take

Serge Stankovic

with and What not balance the hundreds a the data day the category had we reported controlled frail, data, to we much gradually and larger, at or in to of are every Committee toward years of the and but is considerably day and all the of mortality application regards also without six the previous this data previous that previous toward thousands with patients, trial in will respect a compared elderly going that with added indication we previous post-marketing additional Advisory that surveillance that Yes. about submission. the balance XX,XXX we from approval moving see is ADP and only I accumulated within patients details the to which the the say in with better

Parkinson's So when we are reports and pimavanserin some mortality seeing the perspective, to from favorable in atypical we other profile definitely favorable the see psychosis. antipsychotics more as studies used trend are are also we we recently that two as had a Medicare data terms and off-label based that in compare real-life what actually well in reported, seeing disease on where of

thousands as very seeing it question than you from that patients for we different mortality we perspective, numbers for is from in clinical with because sufficient atypical the specifically on interval the antipsychotics more may have included what data know that a the that confidence be analysis trial. much box we So still, the the from we all is perspective, that whether narrower are we this pimavanserin. pleased data warning, are removal with seeing of of And are

are in So, numbers we I seeing, just box may of we total data in are will and repeat not respect. the amount of confident that seeing, an warning, the the data opinion these numbers profile the are warrant favorable the that because are very of we trends evidence this but of we the of and removal pimavanserin that

StephenDavis

mentioned beginning the to ADP I mentioned set clarify thing of he previous the want previous Serge Serge referred the answer, PDP. this data as and and to just one what to at application

a forward, referring he higher to gone that back initial imbalance small has imbalance approval we've is now studies mortality in and patients mortality at in numbers, numerical placebo. a that and very now showing small drug So little time, away. there our done multiple placebo-controlled was bit frail, very on then Fast elderly

having referred drug fact Serge have So pharmacovigilance studies, on of we and also now those when on the of populations. kinds been data is we look market at placebo-controlled mortality to years. the for equivalent that in a our several lot placebo

of members that over in two antipsychotics two it supportive Stanford to those in by and statistically paper pimavanserin very to that by year of significant a population. maybe relative FDA, University, highlighted members continuing used so mortality rates had other a very, is be in And data is CMS two of ago, improvement academic also and demonstrating published fact, members little

that to So that substantial it typically warning that today. have is the is Serge that Class with requires I than your body making very, it's a warning, data is this have a a antipsychotics think the from class and the controlled, drug larger of remove evidence, we however, placebo-controlled final placebo to a very aggregate X not box was X, so all point Class a pimavanserin

to more that mortality. risk have favorable as today of it Serge of data relates as that all approval but continues to time So, until we look the despite mentioned, PDP more the of and from our

Operator

you. Thank

from Olson question comes from next Jay Our Oppenheimer.

open. is line Your

Jay Olson

where had the discussions feedback early Thanks the the can any see And whether payer of state XXXB you to then payers has you. be you trofinetide, you've reimbursement, not to would about PDP from for regards talk gross With longer-term or stabilized? in mix taking net Thank for great. question. steady on, which for NUPLAZID and

Mark Schneyer

much. Thanks to take the Great. want Brendan, and Mark second? first the question you Schneyer,

Mark Schneyer

the question. sure. Yes, Thanks for

think part I a, the yes I second answer from first.

So from growth and moderating. see growth is still that standpoint, a XXXB we

then think as for trend far basis not we an to forecast. on evolve. as go to I long-term year to annual and how So as do we'd forward this We net, we'll that gross continues for and it something years, that's we continue future we'll to moderate that continue so. give out see And

Brendan Teehan

about for emerging much the that is to view payers trofinetide and question results trofinetide, perception Jay, be been obviously of value their with population. second what is in the treaters, given it the jump impact excited medications. we community with Mark. budget your half caregiver prevalence to overall of Thanks, surprising and rare see for the shouldn't and they see very like little with of we've pediatric payers Lavender the There and talk anticipated

it terms access disease results. the treatment gamut looking expect access what is patient community certain product and will sort And at on some the drugs of clinical early disease and make at similar expect would medications. that to Those sense We was study appropriate can are rare priced issues the potentially broader like in that that other trial population to Rett based that be have get rare of findings. for the would you they look the pediatric of

Operator

one Thank Hong our comes last you. have for question And from Berenberg. we question from last and time Esther

open. Your line is

Esther Hong

for thanks taking my Hi, question.

on trofinetide. just I wanted So, to ask

details on are observed. been provide what's can on label continued and on, that open about could any patients you Thanks. If extension the going studies you who if speak maybe have treatment

StephenDavis

you Serge, want take to that? Right.

Serge Stankovic

Yes. Thank you.

particularly experiencing we As including effect from changes maintenance imagine, patients new the of converted continues treatment. application, double the part beyond. presentation into study label a in our for that the as of well of data study active for are studies, both in improvement on over from patients weeks that In overall data saw improvement we perspective the label the or short-term in long-term open the cases, the you can in open-label XX are direct in and for as as the from and the from are further treatment the study blind former we that of drug symptoms we placebo analysis open and to improvement latter

dropping lesser your be we are label those label from a expected, in perspective, larger many and are eventually pleased study what of what very in that that, to we from including that So people seeing in second somewhat of retention We blind that terms open will account, double-blind In take double the good the patients, in retention the perspective, the which are a results long dropout we while for see continuing question the weeks you our around studies the open to with part studies study? even to of with of submission. are period rates patients data that XX though is that relatively aspect actually and from in more weeks have longer in out saw extent.

So, and of from both the part data perspective, our that we submission. are will be data very pleased with

Operator

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

Stephen Davis

operator us Thank everyone joining you today. for thanks and

plus updating forward our look progress. pretty the months calendar a full have over the to next of we course you on We XX

Operator

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

disconnect. now may Good You day.

ACADIA Pharmaceuticals (ACAD) 5 May 222022 Q1 Earnings call transcript