ACAD - Earnings call transcript Q4 2021 | ACADIA Pharmaceuticals Inc.

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Operator

Good day, ladies and gentlemen, and welcome to ACADIA Pharmaceuticals Fourth Quarter and Full Year 2021 Financial Results Conference Call. My name is Gigi, and I will be your coordinator for today. [Operator Instructions]. I would now like to turn the presentation over to Mark Johnson, Vice President of Investor Relations at ACADIA. Please proceed.

Mark Johnson

you. Thank thank Fourth us XXXX Quarter and to today's Financial for ACADIA's discuss and you afternoon, on joining call Results. Good Full Year

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

your Officer, Officer, joining Following Steve, our Head guidance. our our Also website. us financial final provide our is on also discuss Commercial, like updates questions. Chief Mark new X and pipeline President, our drug Schneyer, we're Serge for before commercial to point to of remarks Operating then will out turning applications supplement available our up it will who initiatives. results are section then discuss that slides, our Chief Stankovic, Teehan, today opening which Presentations Financial of Steve for I back and will Brendan on using and our Dr. the would progress call and Events the

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

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

Stephen Davis

are pimavanserin completing and To Rett our of of thank strategic early-stage our opportunities new to third, with level; focused wave advance in Alzheimer's joining on to pipeline pimavanserin; or our afternoon, Good us of drive our high we by negative perform trofinetide X. at and growth schizophrenia business opportunities. syndrome; development on franchise Slide for in develop you continue ADP disease mission, deliver the applications in Please continuing enrollment program, for with a Slide pillars: symptoms and NUPLAZID turn CNS First, approvals we late-stage also psychosis X. submitting Thank while to pursue you, for for on strategic and Starting breakthroughs next X Mark. everyone, where today. second, X

For the full year-over-year year XXXX, growth. million, XX% which we achieved $XXX.X net sales revenue of represents

Parkinson's market to in-person affected we and remain we occupancy as rates grew market facilities both disproportionately to neurology, despite compared and approximately outperform and operating XX% long-term remain this long-term approximately Parkinson's total in in the down XXXX, a care During visits patient drugs. share top achieved levels. We care prescriptions continue where prepandemic down Parkinson's, disease XX%,

our Our brand. to the performance time this underscores during strong ability grow

accelerate this PD pandemic improve, we growth. and conditions market poised to As the dynamics overall normalize are

Parkinson's in in rates look looking shortages on focused reduction be care we staffing physicians market, rate but a their person. we the in are be XXXX, both space the turnover importantly, of As for and of more to in settings. patients normalization it Parkinson's long-term also staffing which We'll we'll office to infection of ahead and improvement the see relates seeing the expect at as COVID-XX

minute. a will Mark speak to As in

care read-through be conditions, outperform expect year XXXX, Parkinson's a net and top sales million the the to $XXX to $XXX full we drugs. function pandemic to our long-term neurology range achieve continue be and from of ability this within between the million. and we will For What

Slide X. on Now our late-stage let's ADP. X for announced of for We turn the treatment resubmission sNDA the of recently opportunities pimavanserin to our

our In we syndrome around of the for year. trofinetide the Rett look middle treatment submitting NDA for forward to addition, of this

Our previously the studies clinical Alzheimer's to and proposed treatment provides XXX a the raised indication study in and complete for response analyses intended disease FDA's conducted address support additional HARMONY from of resubmission is X psychosis ADP issues letter. to

first of we've our described, gives important analyses contextual to review treatment to the for psychosis that pimavanserin of case medically to in resubmission elderly in As compromised drugs is motor important this new, compared and ADP. treat Alzheimer's drug opportunity that developing cognition challenge very previously to gives process with consideration a opportunity point studies this function FDA the our be in make historical did patients. population an impairment placebo, additional through or observe should this our us highly not we fully an the pimavanserin, An in approved and and

in are we would they the that recently II We We FDA Having an update third soon, which quarter. and soon X-month point we'll to date. be resubmission, expect a submitted, this as the assign at not the a where do. mean the reach review with should be Class point would FDA date action targeting as action yet an will you

NDA study treatment syndrome. top Rett our at we for trofinetide, positive the trofinetide end III Regarding year, line the of results last our Lavender from of Phase of announced for

scheduled clinical to We've the preparing pivotal submission, FDA our submission format its endpoints. co-primary and Lavender submission. the with the of our for met meetings study to review included already be In will the overall be on NDA with content the Our X data NDA we NDA in based and FDA.

CMC similar The aspects second meeting scheduled of submission. for the dedicated covering March on will be to ground

We priority date and XXXX. action first the a review submission in are expect midyear quarter PDUFA NDA the of around planning with for an

as delusion generally third pivotal pivotal the negative study the to our ADVANCE-X The to negative suffer been successful from symptoms in need study, we that to difference. of the study. symptoms. With This that's today, And this we're positive of is a our identical process largest our a XX at running milligrams no with study. our something is ADVANCE-X have is important revolve to opportunity. an complete, decades. dose of positive observed virtually around our the the second disease ADVANCE-X tested which III ADVANCE-X rare social In that ADVANCE-X, symptoms symptoms, late-stage the symptoms withdrawal study. designed Phase program, hallucination have proved drug and space, have the In we be The unmet receiving for schizophrenia of highest schizophrenia study turn ADVANCE-X treat. multiple the overall Moving to drug-treated our study, X Please in all was negative in the FDA-approved to dose. in Therefore, results very and significant for have lower pivotal meaningful optimal difficult chart than still the be XX-milligram Slide statistically pipeline X. treatment aspects most higher and which we schizophrenia versus included clinically markedly effect well. our doses are the on patients of group, patients

business early-stage Our the programs. pillar grow to next develop third strategic breakthroughs is in our to our wave of

pimavanserin internal to with early-stage learnings never with and II collaborations advantage franchise indications is studies have in well and to early-stage program, acute our X of of X ongoing both studies, in take programs Stoke with we earlier-stage designed pimavanserin. ACP-XXX further as Vanderbilt of get highlighted coming programs year. Phase highlighted leverage Our evaluating from pain pipeline data pain, to our this University X chronic we And by in as additional models Therapeutics by the and might

the Finally, I further over look opportunity development financial to guidance. to and back will With forward CNS, and evaluate turn and we continuing our business to our strong now set execute that, R&D to grow to in our capabilities. Mark discuss leveraging commercial performance

Mark Schneyer

increase with million sales of $XXX.X approximately in quarter XXXX. fourth of results our was the XXXX NUPLAZID discuss $XXX recorded and to X% across net of outlook. I'll to compared Please volume net by and in we year-over-year driven Today, channels XX. Steve. of In turn full sales, QX XXXX strong you, financial our performance Thank year This Slide quarter, growth. an million

of we of XX.X% the XX.X% of a year. fourth part in adjustment net last is As quarter from sales, observed up which gross-to-net

in $XXX.X expenses to quarter the marketing XXXX. fourth launch. Slide DRP to Moving increased $XX.X XXXX, in the GAAP related million GAAP fourth and which down the in in from million of included $XXX.X XX. quarter of to SG&A Please decreased P&L. expenses the quarter million potential compared $XX.X R&D turn to quarter sales million the the to expenses

increase For X% year by adjustment the full XX% year compared sales in an $XXX.X million growth. of driven to in XX.X%. million The the XXXX, for of net sales, we full net recorded was was $XXX.X This year-over-year XXXX. gross-to-net volume

to due R&D XXXX million activity. of to typical PD $XXX.X remains gross higher mid-single-digit reminder, a volume. higher clinical in a XXXX. net percentage was overall This to million development in though from of expenses of this in and XXXB ebbs we as decreased volume, percentage was our As primarily a $XXX.X XXXX flows Capital observed the and

million XX year-end our million Please upfront on balance example, to million sheet year cash $XXX related investments in in acquisition the XXXX. compared XXXX. to financial expenses Slide XXXX, total R&D expenses the XXXX We XXXX expensed SG&A with slightly in and a in to from collaboration. guidance. ended CerSci in $XXX in $XXX.X increased and GAAP For $XXX.X at to we million for Vanderbilt $XX.X of turn our million

improvement in the range demand NUPLAZID NUPLAZID dynamics XXXX, million the last to For PD for million. for level represents we similar The as psychosis and end demand net in to end experienced are The half an of with levels market slower disease the we $XXX providing of low year. Parkinson's $XXX reflects increased this year of represents guidance of demand, XXXX. similar full high subsequent sales in midpoint second a

range, to of to increase an Regarding XXXX this the XX% we XXXB mix. to net year-over-year. of sales result volume higher gross midpoint a as $XX would reduction the million net, of in be range At are anticipating XX% additional to an a

obligation first pimavanserin Medicare we be will donut net our guidance the ranges reset year, the As to quarter of and expect both this of a the D expense need in patients. hole is if treatment due approved revenue Note ADP updated. be manufacturer the reminder, gross Part for highest the to annual for to

expenses side expect to R&D GAAP expense expense. $XXX in compensation million, $XXX On the we stock-based approximately between including for million be million to $XX XXXX,

While does associated January. million related our R&D to $XX executed for it include development in range that for collaboration guide upfront incremental the not we Stoke transactions, business spend with the the does expenses

costs for milestone with cost additional filing have will supply associated we year, trofinetide payment this commercial regulatory [indiscernible]. manufacturing including and addition, a In

in and million in like for GAAP to full of including There expect $XXX SG&A provide expense between reduction an a to $XXX million midpoint range and encompassed X% XXXX. within as We spend the year, represents further approximately compared I'd to be million color that few puts approximate are The takes $XX stock-based compensation. the range this on.

First, we in the potential investments for preparing of trofinetide making in syndrome. launch are Rett

continuing for our most prior to of on to focused third, ADP relative commercial launch to are was it market in spend DRP, potential the a XXXX connection as of date. Second, PDP our while outperformance NUPLAZID in additional pandemic. efficiently And make to PD for of conditions a we related investments ADP, of managing already relates so lot prelaunch in NUPLAZID completed the function as the we need don't with the action work the

$XXX expect approximately range to our be We flows. our XXXX expected upon million operational to $XXX of based year-end balance cash cash million

pimavanserin of look is positive approved and/or ahead, or Rett we plan, turn are for but trofinetide This not current whether ADP under holds business XXXX. cash true we during our over expect As of rates our XXXX. syndrome to flow subject for who and turn future one our commercial will development, caveats to our performance pipeline PDP experiences Brendan, I'll discuss it less-than-standard standard for outlook of to attrition. business now

Brendan Teehan

Slide of where extremely Please we another Mark. I'm proud revenue to year XX. XXXX, our team's you, in growth. Thank of performance double-digit delivered percent turn

compared ways half the second our in have Our patient caregiver XXXX, when NUPLAZID This team's of In segment year well total space script outperform growth results campaigns, average levels doubled find the our prepandemic we NUPLAZID's new up adapt continues and underscore which growth growth XXXX. market grew to HCP both prescriptions share. neurology and the and in brand, including positioned ability office us supported in to to setting, XX%. the branded as the to and are drugs nearly levels. In to rate grow continued be of branded for space the XX% current continue

This normal levodopa brands carbidopa/levodopa and under would X% top X% time the be were XX X% prescripts are During PD down when frame, expect Parkinson's relevant were to the particularly down essential X%. and to because up them circumstances, we motor medications. same is carbidopa

long-term Let's turn setting. to the care

suppressed, tells were while We Here, continue rate. carbidopa This even XX%. further actually being a long-term same choice both even growth remain is to us drive up often LTC more LTC average patients. share physicians down our reflection of Most At XX%, may X%. occupancy patient selected NUPLAZID and in dynamics lower was The and XX NUPLAZID. importantly, of fewer PDP LTC PD that time, community levodopa we our further in the brands leading significantly top their with for to and settings patient in an occupancy as suppressed, of in-person the significantly at a rates the customers, be messaging resonating care NUPLAZID lower temporarily facilities. with despite outperformed significantly visits therapy appropriate down

at graphs these indicate, of bottom the the to market slide As persist. continue the dynamics

meaningfully, by patients impacted and a grow same admitted research we visits brand has on years opportunity user a based facility. drive and new physician to diagnosed are maintained forecast, throughout refills will experience come. pandemic, see the to in-person to or those strong patient dynamics. to long-term are Most to most high In NUPLAZID grow for starts our point market our addition, when a care have the significant to importantly, which continue fact often we To that continue not very to are need and the rates, refill market

Beyond have X PDP, opportunities. potential near-term commercial we

treatment Let's start of XX. on for the with NUPLAZID Slide ADP

As for of the expansion treatment label the teams patients are previously we a dynamics very NUPLAZID you our psychosis, market similar. were potential dementia-related for which of ADP commercial are XX% and know, preparing

already will on psychosis, ADP XXXX. extension be market the is the an brand than much of since While established indication indication line PD a larger this

NUPLAZID, For upon established will foundation infrastructure. means our commercial and leverage this build and current we

example, launch, generated significant For awareness. brand since has its NUPLAZID

we teams and community We in for capability in and LTC a And market with extension. NUPLAZID to expand finally, line NUPLAZID and have strong value segments. for and well-recognized a help have caregivers stay service dynamics well-established both access patient broad that support similar the formulary patients field ADP. proposition, will on start enjoys we PDP and anticipate this access experienced and

Rett III Now trofinetide the at developed groups with syndrome. launch. let's focused preparing the Rett of community patient engaged Centers launch. motivated With opportunity in we work have for the Rett highly partnerships the advocacy are patients we successful hand, results Today, from and Syndrome Phase a within commercial with positive Excellence to identify who and discuss we of treatment for are now with as trofinetide working on benefit strong can

to roles We it we existing investing to necessary. further force education opportunities increase forward to patients to look provide dedicated appropriately And an in we evaluating preparedness to trofinetide update. leverage In summary, would turn alike. opportunities genetic patient and support testing are will and now executing identification. caregivers to customer-facing where sales our I for while and and infrastructure helping R&D on prelaunch over like Serge are for both further

Srdjan Stankovic

Slide taking We XXX,XXX are this receptor Today, off-label, for turn patients a to vast the to disease ADP XX States. United and no good Thank accelerate antipsychotics, regulatory treatments proven function. to ADP. no there FDA-approved decline approximately offer of are afternoon, of Please begin you, estimate on majority The impact U.S. little the by of in treated recent the there treatment X resubmission with our efficacy our which to Alzheimer's submissions for which can multi cognitive and are And motor would currently Brendan. psychosis. deeper that sNDA everyone. year. I like dive discuss

highly also prespecified of in the package we and separate, clinically observed ADP dementia DRP population, statistically resubmission analysis meaningful meaningful a support. benefit that where Our from focuses results efficacy HARMONY placebo-controlled in X study, In ADP, overall we a conducted patients. the significant previously additional on pimavanserin included studies observed

As show reported, powered were subgroups statistical not significance. to the previously

which include and in support demonstrating we laid Letter. pimavanserin issues Complete support analysis additional XXX in of FDA and a effect Study However, will pimavanserin and the out observed and of was additional significant benefit show Response specifically powered in analysis, designed that conducted the consistency address we've the results strongly meaningful meaningful ADP evaluate the ADP. both statistically resubmission, showed the In our the the benefit observed. benefit clinically patients to

need, believe and pimavanserin impact for of Given observed the high of the function compared motor placebo, ADP. the unmet notify we that would be should pimavanserin and resubmission with benefit Class lack negative treatment a target in X such, cognition the soon day strongly approved be on and us the that We expect to expect we of will quarter. to FDA third the this as an action demonstration

Slide life for United the no X,XXX between patients treatment. starting XX. for relentless loss is and basis require trofinetide ability estimate and Rett issues, our of a a that maintain States NDA, of of to round-the-clock communicate, and are and impact X,XXX impact there very support. core The patients daily gait symptoms syndrome autonomic independent is repetitive include syndrome turn and significantly which Ultimately, which and lose GI in daily a on nonverbally, movements, abnormalities motor functioning and serious Rett and rare their FDA-approved and the on to hand we Rett verbally ability to both constipation. Let's there disorder serious patients especially

placebo Our of Lavender the from demonstrated statistically positive on syndrome. a improvement, separation physician behavioral and tool impression assessment core multiple questionnaire, benefit from tool. clinical global as endpoints, significant the syndrome Trofinetide co-primary symptoms results the the of well Rett as efficacy caregiver demonstrated study a meaningful assessment across Rett pivotal

all RSBQ. domains across improvement the showed of trofinetide Importantly, X

interferes their assessment has significant ability living. addition, to efficacy with many and parents on its key statistical whose their a of placebo This study potential patient's to caregiver fully outcome, ability children address secondary lack achieved daily another for focused to on the challenge In the the significance versus communicate aspects of communicate.

has priority drug status, it's review and could and overall designation be the approved, to rare format consistent content priority a which results disease pediatric pediatric severity of included across review all designation, NDA met granted We disease. if of submission. and be the data voucher. fast eligible for efficacy clinical awarded were age with orphan review been rare track to disease Trofinetide and groups FDA in the Importantly, means recently our the

dedicated March NDA plan our around We have and midyear. to in a CMC review meeting submit

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

the As program, clearly ADVANCE-X results study positive this part pimavanserin. PDP end dose of is recommended receiving showed Lancet available year last in recall, of on commercially robust Psychiatry. which the most our in for advanced results X dose and primary already, we the observed published have finding where most patients study and ADP. Please we were the results pivotal as point milligrams XX the ADVANCE a in serve for robust

ADVANCE-X. dose the pimavanserin evaluating We are now only second our of in XX-milligram pivotal study

in by In addition, conducted and opportunities. XXXX. Enrollment in on trial the expected ADVANCE-X non-U.S. our our top learnings results with building line the complete available highlights previous well Slide being going in is end to pipeline early-stage schizophrenia, studies this X is clinical sites. XX year, of of

for that ongoing for evaluating bunionectomy pain the for Phase ACP-XXX to pain, acute XXXX. II ongoing this surgery II or quarter study we have of complete the early we the we Phase of with results associated end have of ACP-XXX treatment of is around And chronic treatment postoperative following expect For evaluating and an an study quarter. expected by osteoarthritis pain end the next pain,

ascending ACP-XXX from multiple in is lead we has that compound, Our a MX program PAM trial. Vanderbilt licensed currently dose that I Phase University

multiple it including that, And remarks. collaboration severe are to the with Another upon and our for Therapeutics genetic back Stoke different focused diseases multiple targets we such syndrome. which is compounds, of Rett I'll learnings exciting to have treatments pursue SYNGAPX turn finally, molecules opportunity neurodevelopmental closing pimavanserin. early-stage analog build With on for and as executed RNA-based Steve rare which recently

Stephen Davis

ADP. while XX. Slide for NUPLAZID second promise preparing to our a turn Today, potential with PDP on are to patients Please Serge. we you, in executing Thank in indication deliver

third in In in and studies for Rett trofinetide I'll submit enrollment call syndrome. pivotal advance the opportunity early-stage to to the III II have XXXX. to our expect of with late-stage of their year, a I pipeline, we the Phase ACP-XXX and to we up for in questions. schizophrenia expected middle commitment negative mission life. this as Operator? the continue addition, continue results drug application study elevate our our of our treatment In with from of open for Phase now with we year. closing, symptoms And our new results completion we would thank for employees ongoing X expected And accomplishments like passion the continued for expected their

Operator

Instructions]. [Operator

question first Citi. comes from Bitritto-Garg of Neena Your the line from

Neena Bitritto-Garg

if that how of about kind SG&A all. about assume that, were be reps ramp number too. you a could that there? elaborate spend bit have back I adding did talking commentary at know SG&A we and was should previously talk a some the of spend. the I cutting you what know just I wondering could changed around XXX would reprioritizing And good you're guidance. know has approved little more little if on in ADP. It if kind you to of specifically on But is bit you if pima maybe then more kind

Stephen Davis

Thanks take want to for the these? Yes. do much question, you Mark, Neena.

Mark Schneyer

Sure.

mean evaluating number kind we a from year, have we the that spend. prepared the limited depending needed commercial there what return trofinetide. our focusing SG&A reduction to remarks, I the investment spending could but highest the standpoint, are mentioned know and the PDP it. question kind right? On is within date. investment in dynamics how we're activities investments. asked we And takes, of have this overall And prior an of as progress you action market of ADP a on I exactly be there puts yes, as range over don't PDP. The and on, mixture mentioned, I range, of about We in we a support a disclose upon in

guidance for will expenses If ADP. potential that and I positive revenue approval increases later in to think the appropriate for of a as time. guidance we we'll reflect of how give get and year, kind in kind at reserve

Operator

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

Tazeen Ahmad

Can Is see it see prescribe I guidance? that would hit ability to sales? in therefore, they in of XXXX is to What need need upper that terms ask upper about end the guidance you the of you driver end provided the just of for to major to it scripts? than you doctors doctors to more the person, additional more leading already to patients do? prescribing, for Or them

Mark Schneyer

Steve, I think you're on mute.

Stephen Davis

that. Thank you. about Sorry

Let I'll me at it high very Mark. answer a turn to and over level, then

as move continue revenues prepared the to you conditions and mentioned by So to outperform remarks, sector. undercurrents. normalize are the second then the how see we we ability pandemic drugs is in the And is the they our range driven that other year. One through in our X as really

particularly I is as timing we so that revenues normalization confident clear. to of that the investments we reflect ability the to precise Parkinson's that And forecast mean as is that. that forward. continue less And we'll rate the it that what community the our medical in [indiscernible] our and to level latter and is is community we're just and And in things go But very making those have pandemic, to the in relates something SG&A. of on assess to and the ability have we're normalization to the do the our the of

guidance let questions -- the in the that end me, that things particular reflect specific that that were conditions. you may or excuse Tazeen's think pandemic would add I upper of drive end I'll detail pandemic in improvement an color. additional upper and about of Mark, So our

Mark Schneyer

the while really have variety is think as a our is principal that range, the Steve reflected what dynamics. the assumption really underlying underlying comprise always, assumptions market we of I range

Steve of it earlier, as range, and recent year what reflect I So an explained the higher we've just think market I well the improvement from at last seen mentioned and conditions in months. would end

Tazeen Ahmad

market Okay. physicians? But by interactions more you seeing are with conditions,

Mark Schneyer

in facilities seen in it's patient their increased in improvement right? because both and in in-person At care I a think inpatient think I physicians to ability it's office staffing, recently doctors -- continuation person. More settings. we've and visit our visits long-term -- with

Stephen Davis

think that? do mute. Brendan, add else to to you on you're I have anything

Brendan Teehan

better Sorry, driver LTC the a to today. for thanks. Yes. we'll just as important question. pointed Tazeen, new of market out, we is the dynamics grown opportunity that. our that visits absolutely pandemic to patients which thanks for market abates, census. starts those that returning wanted we Both The patient that share biggest With message Yes. as have face-to-face said, than is increase I add for XXXX, have Steve are have suggests in throughout resonating.

share line We are of gaining more and first more patients. setting

really those it's residents So in the opportunity show for care for new the or up office long-term facilities. patients to enter to

Operator

Kasimov Our of from Cory from comes JPMorgan. line next question the

Cory Kasimov

you that is think, something been a at already? expect for of FDA NUPLAZID in committee a you? the resubmission I wonder front step Is about for of advisory an as you've you from if taking should go back, you to favorable just you to when get I opportunity look that to FDA in development communicated your kind insight have an any the yet XX ADP. after, expect Or agency to to learn not would whether or days? response you And would the ADCOM

Stephen Davis

the for much question, want Thanks Yes. Serge, that? Cory. do to you take

Srdjan Stankovic

that at to of we'll Thanks or speculate and would advisory decision safety in would will for treatment to review FDA we in our toward communication I XX-day cycle opportunity submission. pimavanserin fairly about to say not in psychosis. will every FDA that we just the it. they the respect In we whether advisory But Yes, this time, advisers the to case say committee, us should would be on for soon, our to request advisory learn for a can really as make We case or for unlikely, it's to they the to It when regard well. I not the we the is a and move But look efficacy the It's unlikely. Cory. learn of is that of following return FDA X-month regard the decision committee, Alzheimer's about the disease very the whether is make this difficult that. anticipate FDA for of committee. will wait question. ultimately All ready in considering

Operator

next the Our line Baral Cowen. from comes question of from Ritu

Ritu Baral

CMC analysis It's aside as just you had unblinding And FDA meeting the gating part as on the of trofinetide link of the Rett. the discussed part data? submitted are functional can what on guys you then Have the for you submission? Or further, items statistical was from that through go for it analysis plan? that

Stephen Davis

questions, the for Serge? Ritu, Thanks

Srdjan Stankovic

Ritu. Thanks, Yes.

for briefing a the the results from our information on documents our -- part trial. submitted from meetings, a pivotal and of the we of detailed As results the trial the have

So a the the safety whether not was in information your the was full discussed, is to answer the FDA. this contacts with meetings no. potential available -- meeting. did To both preparation question question unblinding efficacy That for the complete and was not and we that had in the and functional FDA raised

we So did that at not discuss all.

Stephen Davis

Just to point. on that done recap the analysis this we've

Ritu. Sorry,

Ritu Baral

Go ahead.

Srdjan Stankovic

were I'm both sorry, speaking. you

Stephen Davis

a maybe analysis of on done you that very Yes, high-level the just we've recap Serge, can that give point.

Srdjan Stankovic

of did the with for data without we very both analysis, either and I co-primary Yes. detailed diarrhea outcome measures. patients a mean efficacy evaluating the

looked looked at at We scatter We analysis. the the also plots. responder

raised in -- regard adverse did and did all was bias to diarrhea is point question was on no we there I meetings. So terms at them as not any there conclusion consistent and the detailed the that the a in no said that in assessment all as analysis of of perform of of question But very same event. discussion look we indication that efficacy in

Ritu Baral

of Were and those the statistical analysis were part those submitted -- prespecified Got it. analysis Serge, plan? analysis as

Srdjan Stankovic

is will analysis be always NDA our unblinding Those submission. statistical obviously, prior the data. plan submitted of But to analysis part

the there wasn't were because which So wasn't -- there analysis information part plan you based not of on these anticipate statistical analyses could any analysis. or those

Operator

Our of next question Jeff comes Stanley. the from Hung from line Morgan

Jeff Hung

population For patient may treat could Stoke us Rett, you than trofinetide? can on with trofinetide from that differentiated the that how and you might remind be be different your how with just collaboration those of

Stephen Davis

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

Srdjan Stankovic

of addresses about Stoke technology the -- genetic The hypermorphism. that that Yes. have X/X display patient

XX% is about patients. on rather based population, in to this of performing that of protein actually potentially suboptimally. that the technology XX% on entirety in but intervention, the not population the said, that's difference the increase that I gene So overall the -- not the of And as the is is is the

general completely than with it's from is trofinetide. what different a So in approach perspective, approached that

Stephen Davis

just to is a think that add maybe trofinetide short just program. approach the modification. with collaboration there. for -- and we're indications greater worldwide in And I are our there's with of potential couple taking Stoke that then have rights rights disease North Stoke, collaboration a in version with to is America to One with the we

with potential an more that greater even for of or type effect So profound approach.

around So that is we're complement -- we think franchise program nice very, very building that trofinetide. we're to the a

Operator

of question comes the Marc line next from from Leerink. Our Goodman SVB

Marc Goodman

in XXX And was bar and in way study are what's could both to about out second works Yes, you the about get going going Serge, we such whether kind sense is the the for talk report to to the later if acute this about wondering would and how move acute the upcoming of I a us that first the product? mechanism What chronic same in talk give forward you data year. the pain. excited of good see and just study then

Srdjan Stankovic

a for Yes. of the II bunionectomy. bunionectomy following Thanks, -- study evaluating This Mark. first Phase study is pain treatment is ACP-XXX postoperative

just is reminder, a an placebo-controlled, acute randomized, model. patients. double-blind, study, The as about XXX a enrolled it's So

of patient from efficacy powered. analgesia. appropriately population targeted and question, of the really safety But of take compared tolerability of pain to a separation to terms would control and drug. the have the safety study profile the in and study to it's and ACP-XXX pain complete. we control Related acceptable a longer if consider we placebo is the statistically model evaluate for that your we this to success That So have osteoarthritis evaluate efficacy And perspective, in placebo from will study. significant in little objective doing study are to in chronic

The success perspective, the that active models model obviously, but potential per molecule mechanism success the So be in theoretically, on other pain. from acute animal in in both the year. the be was active. control se preclinical also our of model. results was would X basis will should models, anticipation But the of And that indicate of and drug next sometimes chronic

pain the the interpreting And that I remind difficult in sensitive everybody always to from read-through into are placebo perspective, automatic, very is will should be However, and think translating that studies model to I conduct. notoriously response. careful and not They're we X of results another the model.

Operator

line Olson question the next comes from from Oppenheimer. Jay Our of

Matthew Nirenberg

on for Matt Jay. is This

time PAM pimavanserin. your MX The corollary, or lines. ever a imagine would as first terms combination with of a your doing And on if plan data MX question of just PAM program, we trial was you in had just

you hear If of any sense. be about opportunity to And feedback synergies, really driving there about terms would currently we for Lavender rates. so gotten in far and combination what the interesting terms would just you separately, then after indications That trofinetide of could thinking could also of make and the physician how diagnosis have results market were Phase might helpful. you're curious in be any imagine III that about

Stephen Davis

an questions and Okay. throw -- sorry, I'll in for then further talking answer answer Serge payment it the I'll and MX on trofinetide. me. the A just on PAM on on to the with watch I'll color is over I'm turn an few start program then combination, to Brendan my there. --

interest the I'll terms So that or that just as we reasons, things early doing might pursuing. say are additional talk don't for opportunities of in in have we relates pipeline combination, lot it to about simply an competitive a in things we're interested a we're

speak learned potential and think that So that very XXX, we applications interesting. the there of Brendan, leverage you going further pimavanserin commercialization to I'll just take new are we to including Serge, development insights us do then, through XXX. the want with want trofinetide? do combinations to forward. more that the molecules, things for simply And we've you say And find to give

Srdjan Stankovic

Yes.

reminder, impairment Alzheimer's our and in potential negative MX PAM cognition, ACP-XXX cognitive and cognitive treatment symptoms disease Just is as for in of schizophrenia. impairment the Matt, program a

been on engagement Phase updates we ascending we additional study. Phase study. It's year providing study in year. studies, And this initiated multiple I later announced, dose last we look As this currently Even multiphase early to I forward that the ongoing. that the to of forget to study. question far, I we physicians to from treatment on treating regard level can there data. feedback considering excitement where potential better and said, to I to But are benefits on pleased and I so with for target updating in you syndrome, our the what haven't be some seeing XXX. mean of -- with year not forward to the this for experts and are understand the understandable, say try syndrome. are on may that with evaluating successful progressing quite address in just we out of And as the that we be it's, late-stage receiving programs further whether development look the symptoms enthusiasm later we Lavender a Rett results there Rett to It's the extent, of will are your we the development.

parents the also the So and from only not quite in perspective, community, caregivers in in community a there is but community. excitement medical and scientific big that the

are and excitement enthusiastic the look and NDA we So and forward see the enthusiasm to approval. across bottom very line, of level to

Brendan Teehan

The echo, on Rett specifically, your just want of very the comments. Lavender diagnosis. feedback results. Matt, to has seen us address I community they've encouraging given treatment Rett around question what But And to Serge's

already increased time. for a number high Rett. There diseases, with a a rare As pretty of dramatically has over pediatric the of diagnosis is rate diagnosis pursuit

that of of So testing numbers and looking work Rett genetic diagnosed suspect patients also have and a recent Rett. launch. potential we pursuing post to educate they will are are been with organization, that us avenues partnerships MECPX And an at patients on for databases show to to access and MECPX in testing as that years. we, will number diligently a testing There's already significant have increase then physicians have confirmatory in

Matthew Nirenberg

Extremely Appreciate all it. input. helpful. Got the Okay.

Operator

question from from next Ami Fadia Needham. Our the line comes of

Ami Fadia

had I two questions.

talk we PDP see or Firstly, with market for patients able then to some can to a time? of the approval, get just structurally on market to for you NUPLAZID. opportunity admitted you you Can long-term that your care And indication with of Has to PDP? into relative the regards being the which comment being should indication, regards in for quite sort to just the patient And on something that? not market tap recovery to separately inflow because changed may there? ADP expectation

Stephen Davis

start? to want you do Brendan,

Brendan Teehan

a no, restructured I My thank Ami, you that so market. PDP, questions. In anything don't think much apologies, for as there's both PDP fundamentally around

has seeing we from PDP more that already We've our in will abating that trends, quarter. some they would that taken expect type seen in dynamic top see readily not place. are of Patients December to the improve. physicians of first Omicron were the visits With in-person patient beginning

us. as suppressed. selective staffing will So is think When had suggested, to census potentially there new headwinds we're in the improves, as challenges that Similarly, improving. pandemic-related seeing environment, I those where long-term improve been residents are improvements in staffing facilities. for abate this to in Again, available rate staffing become care, us. care Steve you spoke has long-term

would near return begin we that call the abate well. are conditions so in adapt pandemic for will I term, to again, as So to temporal but as these types of these hopeful to changes us

existing they and similar also treated brand NUPLAZID -- PDP. types well-known back The are in to has Xx a Your is already opportunity treat was have PDP. an of reasons line second question the very of in very in number for extension we an today. that XXXX. treated overlap launched that have for patients around there's are are XXX,XXX core of And us. in for ADP. there a We've tremendous treaters about a number about that ADP patients are quoted PDP. This This addressable the It is addressing as

to broader would audience that But the We this will address that significant to to is and market first with be psychiatrists treat a by a will expand, also [indiscernible] for of be PCPs first ADP. product to an a obviously, address us ADP. opportunity margin

Stephen Davis

on to just add thought Brendan's PDP. quick point one I'll

we So do of change the in a the is market. -- question there evidence see was, structural any

office but space It's the an mentioned, as care as we're shortages multi impact seeing, indicators, plasty both indicator setting, well Brendan long-term not As of principal in the well staffing. as but leading is staffing staffing it's staffing as that in both the infection turnover. significant principal leading rates,

other care, where results. new aspects of so turnover staffing very, patient the solid just seeing in down, to, particularly impact -- the all occupancy on to in very an And franchise, rates both In long-term addition starts. continue we're the are have see

have Our wavered. not refill rates

to continue rates. very So we high see refill

rates have quite it as conversion patients. this seeing in their climbed relates it scripts impact Our person, as during to relates an more rates particularly and Parkinson's are frankly of pandemic written the staffing starting But of on when to physician new the time frame. impact patients

as to an those we will new start that's we as grow And and Brendan shift, opportunity to as so conditions this we say increased time patients. we normalize share see why mentioned, dynamics continued we And -- see during frame.

lifter as growth conditions So they these or rates. significant normalize, expect get we will that

Ami Fadia

the would of So if you've you trends seems conservative? I your in guidance. just comparable sort it as that mean at up. could year to of And volume your assumed I sort review a midpoint Is follow sort Is of last that -- the you which you flat of of it's I the Or of think or it? is sort range which evolve, guidance you've see guidance volume sort sort to is you there guided were of giving a that versus where because how something year. else seen, a last think of should about about that.

Stephen Davis

Mark, want do respond that? to you to

Mark Schneyer

Yes.

So similar not flat year. over is clarify, midpoint volume last volume last range year, the for just I guess, of the to growth

range hopefully as there and we high over getting of underlying past, not and of we've term, through just higher as above. trajectory coming towards the the and is the and back out long is is living end then that So still pandemic as growth, higher that live the the growth in the seen -- pandemic and through

I stand think in I now. listen, will we're wouldn't I of -- the say, where year So kind third we just that's of the pandemic.

I the wouldn't I living the in pandemic. just still we say would confidence we're have think conservative. at are use the word better I getting forecasting. range. We in

So that and term range. and brand. to on with in that hope the and is continue growth in But the near influencing we expect then exit investment this

Stephen Davis

end. upper to the And range the Mark midpoint and spoke the of

besides there. reflecting end the of Just we for a predict things Omicron we're a model guidance At X. another variant that could we we at will to of number end see of that sake there impact expectation. recognition And range, the That's or are completeness, other can't we the range, today going low the of lower But possible range, flat the be our volume just what, not have it the it's of that provide course, when were Omicron that do us. you scenarios.

Our their expectation staffing is those in physicians coming Parkinson's importantly, correlate The as to comfortable as person timing rates them, directly that from lift to more infection that. as subside, of and the of get patients most the that stabilizes, magnitude changes will we've scenarios get modeled.

Operator

[Operator Instructions].

Stifel. Paul next comes the from of from Our line Matteis question

Alexander Thompson

Paul. This Alex on for is

as you ADVANCE-X Just Russia the as and from if study. sites timing one could study. question on Ukraine potential relates the in I to as impacts well wondering data comment of it was integrity on

Stephen Davis

take do to want you that? Serge, Sure.

Srdjan Stankovic

Yes.

Western me and multiple Let is South Eastern that remind is XX you conducted Europe, a ADVANCE-X being study across just America. Europe, in multinational regions, first countries and

I we that call will remote country pandemic would there certainly the geography data, Ukraine, have, adaptations in in impact we prevailing study. the collection number impact of the on the some perspective -- became and from it, of geopolitical data So and expect the regard study In terms overall impact interruptions although recruitment or a considering the, made situation the be think to programs. conduct of of to the through in locally, have or current that a of the Russia single no of that setup the

resolved gets through to Having Ukrainian -- unprovoked with do we going, they do as as I But we fast the as attack. I want situation possible this the have people Ukraine. resolution as to concern place of expect are the impact. express mechanisms said as that will far suffering also is far constructive as for dramatic our obviously, our to the wish well. and this, with of trial for a So in going But I sort not deal all and say, an great as situation,

Operator

the from Renza RBC comes question Gregory from next Our Capital Markets. line of

Gregory Renza

update. quick in Stephen, nearly if just that I'm the current you the in a what Thanks months seeing bit and I with just this comment just for could missed, down. a one, quarter X Maybe curious event about you're

exiting PDP is extent. far dynamics in as but the exiting gate in on And some that just for comments that recovery I market appreciate January to not on those I'm some thoughts of general and certainly as Just the XXXX full out of and with the February NUPLAZID of interested concerned. as year, also your we've come recovery while just that

Stephen Davis

much, Thanks Yes. Greg.

just don't to start by need quarter-to-quarter. we I'll saying guide So

to for in play. And marketplace. guidance to in we basket that gave year very LTC what that the top a so information the drugs, reflects us top be like terms we're of is are of for factors seeing stress thing I the much we the responsible the neurology, top would believe up-to-date today continue And outperforming Parkinson's, very at

strong So performance we're elements. on continuing to those see

We continue in terms strong refill of rates, rates, et performance see to very cetera. our conversion our

out to outcomes to we've we've and say I the just impact we of pandemic. as see now year. what as at kind time we're the the where relates the anyone with to be, for today But as the just business be take just of as seen the And around on so bit the that I to Omicron it society, the the both consistent forward this where as know through little impacts out our year, to the as that, from sector. of don't PDP, scenarios year. ability do particularly now it will move coming think And tried behave undercurrents fears kind and And well we is a We're highly And can we're just normalization a society. the the timing, But scenarios then in that informed are out continue of to fall run. a requirements again, a that of of we've confident Parkinson's mask precisely, a in range the that precise in reduction that. way will determine in underlying relates cover reflected the this range wave. coming We for right X as we of play point we of the would of drugs we're outperform up And our right to simply community. specifically everything magnitude

Operator

Instructions]. [Operator

the from JMP Securities. comes question Jason next line Our Butler from of

Jason Butler

drug? the infrastructure from wondering I perspective, Just into prep in towards and you of education just will a that medical But work, doing for outbuild can you're us can assume get Rett going if Obviously, the next. to mainly through be year the commercial end be work you year. market be walk ready to doing this the the to speak the you'll the

Stephen Davis

you Sure. to Brendan, want do start?

Brendan Teehan

the humble for very the III Yes, trofinetide Jason, preparing Lavender And obviously, we ongoing the about and we they're size need thanks study patient the My X,XXX we're with of as obviously, of sure was even apologies, question. population, the for The favorable work the Phase to want excited illness, make in to opportunity. a again work, burden initial roughly of patients. result. community understand payer medical that been the aware unmet have X,XXX to

community, developed time all on. services that and area not as Rett prior from white are but going which caregivers, to the to broadly, care support. the that only on focus support support of on patients, we'll successful support we're that clinical where families, assistance clinical to started and has a to getting helped we're authorization with us We to another understand also patients support perspective by as have then our time going to of be find glove need the prepared with a over the patients so to trofinetide, co-pay and experience, And want launch, have volumes foundations they that health strong the relationships of our well

probably product. are areas So those principal relate the to they the where focus as we'll

community. a For of a awareness There's this syndrome. the high disease is Rett of state, knit obviously, tightly level

We will that confirmatory be available of any HCPs. patients will with Rett also suspected with make MECPX the work sure their at for necessary where to community tests

Operator

closing to proceed remarks. Mr. Davis, please

Stephen Davis

your operator, you updating today. each we and you, to go we and to We look of for forward appreciate support, and and time thanks as you attention forward. joining Thank

Operator

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

may You now disconnect.

ACADIA Pharmaceuticals (ACAD) 1 Mar 222021 Q4 Earnings call transcript