ACADIA Pharmaceuticals (ACAD) 27 Feb 232022 Q4 Earnings call transcript

Company Profile

Participants

Mark Johnson	Vice President, Investor Relations
Steve Davis	Chief Executive Officer
Mark Schneyer	Chief Financial Officer
Brendan Teehan	Chief Operating Officer, Head, Commercial
Kathie Bishop	Chief Scientific Officer and Head, Rare Disease
Doug Williamson	Head, Research and Development
Ritu Baral	Cowen
Tessa Romero	J.P. Morgan
Marc Goodman	SVB Leerink
Tazeen Ahmad	Bank of America Merrill Lynch
Charles Duncan	Cantor Fitzgerald
Neena Bitritto-Garg	Citi
Eddie Hickman	Guggenheim Partners
Gregory Renza	RBC Capital
Jeff Hung	Morgan Stanley
Jay Olson	Oppenheimer
David Hoang	SMBC Nikko
Kyle Qian	Canaccord Genuity

Call transcript

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Operator

Good day, ladies and gentlemen. And welcome to ACADIA Pharmaceuticals Fourth Quarter and Full Year 2022 Financial Results Conference Call. My name is Gigi, and I will be your coordinator for today. At this time, all participants are in listen-only mode.

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

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

Mark Johnson

call Good results. you. us quarter afternoon. thank full to today’s and you fourth discuss XXXX Thank year ACADIA’s for And on financial joining

the then and from on commercial Officer, Kathie provide being guidance; ACADIA provide Officer results on our of Head our our to Mark overview Operating by a Chief Disease, Scientific review an Brendan Chief Davis, are our Teehan, on overview an and Chief today Commercial, will Rare Head will Bishop, will joined Schneyer, performance financial updates our who of and Chief Officer, provide call private of new discuss Financial before of me Steve our Joining Executive our our Officer, performance business; trofinetide.

and Our Williamson, Doug for programs turning and it newly back our for will provide remarks the Research Head Steve pipeline appointed update of your questions. before opening Development, to call up of an final

I out which would of are website. Events the we point Presentations the and that to available on slides, are supplemental using like also section

of we we you that today, XXXX. of to proceed, like making meaning will the within statements remind be Litigation I a call our Before Reform Act the during would number of forward-looking Securities first Private

change differ results to based actual results current subject information, cause on These forward-looking expectations materially. and involve statements, events are uncertainties including goals, of expectations, risks inherently plans, are may of or assumptions prospects, growth a to potential, future that timing that number and and

filings in business our can made associated found factors These risks and with SEC. the other our with be

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

to the Steve. turn call now will I over

Steve Davis

up five. and thank us Thank you, us XXXX XXXX slide important today. for and our for you Please ACADIA. to execution year transformational Good has an of strategic set to in for be turn afternoon, priorities The joining Mark. everyone,

$XXX.X approved potential syndrome achieved an increase our for a in million the X% in submitted the franchise XX. drug year-over-year. upcoming of NUPLAZID first-ever PDP Rett We treatment March trofinetide, our Last, new for date sales, PDUFA with application

Phase And of of our program is III advanced enrollment and next-generation program middle year. with I this around complete negative currently our advanced the we ACP-XXX, clinical We X-HTXA schizophrenia Phase expect in development. symptoms which to

are With need in our on desks cash four and flows that from to franchise priorities strong well capital. without beyond deliver we sheet, for a and balance strategic positioned shape NUPLAZID the will additional these our XXXX

slide six. Let’s review our business further on PDP

our to the NUPLAZID of PDP. We franchise continue in value maximize

few strategically PDP NUPLAZID past the years, thoughtfully we Over have grown current environment. for in share market the

and We commercial our steady volumes base. optimizing while delivering are reducing concurrently expense

flow XXXX. result, cash As able we it this turned franchise since have a year to every profitable from been in grow significantly

the NUPLAZID performance total XXXX, in our improvement at Looking led our care back by business. channel, approximately was long-term which represents continued of XX%

channel, In full the LTC X% demand and growth year. sequentially the was for the fourth for X% quarter up

fact, LTC a NUPLAZID channel. the quarter record for fourth high the volume In represented in

XXXX, high quarter before QX the previous hit. pandemic Our last of was the

about a this up relatively More an to netted XXXX. business, to share X% makes disease year the sequentially market XX% gain recently, declining quarter. in overall which we demand channel, space in experienced demand decline in This to for out we of impacted office still the In fourth conditions. pandemic market, in steady compared the our by Parkinson’s continue channel have

channels growth XXXX. all across for the compared demand franchise for year, Overall, steady the was NUPLAZID to full

near-term the profitability stable franchise, our current continue environment. volumes objectives optimize PDP for market conditions we and our to demand will expect the commercial spend the Given and in

is of In intermediate the early are We in conditions potential market. situation, the in indicators believe other One related to disease which near we in the catalyze There some normalize point term this future. to seeing growth. LTC to Parkinson’s at are pandemic change that psychosis will temporal two volume is believe the a words, with important we factors a channel.

new And pimavanserin medical assumptions, the a publications atypical demonstrate million, of relative that a further important second providing section. we of $XXX simulation historically are guidance NUPLAZID which community antipsychotics, his net before to which to the describe XXXX is approval. in Mark three benefits of very off-label in used which of will the were incorporates Today, $XXX sales range NUPLAZID’s million

are for some looking Later, forward of Turning trofinetide. upcoming seven, date to are in important an unmet we we be PDUFA moment greater will to key large to with working a for slide need. such detail the could like preparing remind XX March launch first, on. the to much community for take very and drug Brendan trofinetide action describe what a I’d But initiatives everyone a

in syndrome rare you As significant a and patients the Rett families. of know, their severely of Rett neurodevelopmental of trofinetide disorder that lives forward impacts is would genetic syndrome. represent treatment a approval the step The

greater supported by broad across results co-primary III endpoints completed double-blind study. topline section, a review in is will profile efficacy positive her in these from a recently well established as Trofinetide’s extension initial improvements detail provide Kathie results in Phase randomized two open study. label as

treatment protected the patent regulatory Hatch-Waxman XXXX. extension exclusivity provides perspective, drug from and Rett by trofinetide early And for patent which a a has used status IP method of is into expected syndrome, orphan with and of

about eagerly prospect excited and of our We date. await very bringing trofinetide to are market PDUFA the the

need programs significant withdrawal, living symptoms next social The of to our the characterized or briefly for is with schizophrenia, discuss slide flat Let’s by eight. people referred of negative emotion affect, frequently schizophrenia. lack most on unmet two as

delusions designed and paranoia, but still suffer hallucinations, patients program whose who the those to adjunctive uncontrolled from is are treat and symptoms, symptoms. persistent controlled adequately positive Our negative pimavanserin

developed of With pimavanserin, a Negative symptoms pivotal study. something area positive ADVANCE-X study, in rare exceedingly we failures this very been has an multiple over decades. have industry lots our achieved with population,

in middle the study, around expected of We our ADVANCE-X, this expect with second in year, results enrollment to XXXX. complete pivotal early

novel we a for disease in program, blocking targeted pimavanserin, or Alzheimer’s our ACP-XXX And by molecule, investing primarily Similar are psychosis ADP. works X-HTXA. next-generation to ACP-XXX, finally, in X-HTXA

with frail completing to improve suited further this elderly Currently, into Phase for ACP-XXX, the believe populations, from few seeking and mechanism is Phase to learnings pimavanserin. we in and this working are to I development are ideally later on a We ACP-XXX speak advancing further on look minutes. we year. will Doug this studies II and forward

Mark I our it will and to financial XXXX discuss now over guidance. XXXX turn performance to

Mark Schneyer

Thank you, Steve.

X% and of performance quarterly our last reviewing year. recorded the fourth In fourth by XX. million up start quarter, $XXX.X year on slide sales, the full in from quarter net we Let’s

quarter the Our gross to net XX.X%. adjustment for was

recorded million in sales, up we XXXX, year X% net year-over-year. full $XXX.X the For

to unchanged adjustment This compared Our net XXXX, adjustment impact the was the excluding gross XX.X%. year IRA for legislation. was of to relatively the

for relatively was in-channel at full XXXX the year XXXX demand the inventory mentioned, end over of XXXX end of to and compared Steve As unchanged XXXX. was steady relatively

was our undisclosed $XX and there spend $XXX.X payment to partner $XX to in XXXX as commercial from supply for in in collaboration, portfolio to BD million our $XX $XXX.X still increased Stoke included of in build. approximately expenses trofinetide Investments in Neuren million R&D of million XXXX, in million cumulative Also million total milestone our payment a GAAP XXXX million in related transactions. $XX a XXXX. upfront payments a yet

franchise decreased flows by year-over-year. we considerations There significantly and $XX XXXX base PDP here. optimizing expenses in franchise. the are million XXXX, decrease million $XXX.X SG&A One, to X% in increasing million two our reduced expense XXXX, from the from a cash important $XXX business approximately GAAP representing from

$XXX.X We well launch. for ended the And to a investments the at upcoming million with of have been trofinetide compared of end be we to two, XXXX. prepared making cash the balance the million, right year $XXX.X

Our our cash and we generate balance sheet to remains our be to confident strong ability growth sustainable resources. continue with existing in

this our guidance slide. for that for are sales Please next while assumes guidance the providing review XXXX XXXX potential expense on trofinetide year. note not launch, guidance Let’s a trofinetide we our

providing As cash guidance a also not our we future result, on balance. are

For PDP range for The a $XXX middle and million the NUPLAZID net business, providing are and X.X% $XXX X% volume in this net million be of approximately our about guidance assumes increase year. price sales between XXXX. NUPLAZID to we growth

We related gross the between the and net given to the for XX% need to are to to year accrue IRA. rebates full Medicare projecting be XX% for

is QX year. for the the net gross reminder, a As quarter highest

time to be expect our providing gross net year full net, and to we the which to XX% year, of first gross are on we impact this between the IRA guidance Given XX%. for QX

remainder years, QX with the QX. seen QX, As an we for for in to and lowest the quarters being relatively of have prior patterns consistent and year, anticipate and be net we gross in QX will increase QX our with QX

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

guide Our incremental R&D does not business transactions. for for spend development range

in and million $XXX approximately be to the expense year, million million SG&A GAAP compensation. including $XX full expect We $XXX for stock-based

be by successful enhanced franchise. to will relatively expected reduced reducing same since year-over-year, from have be a XXXX, generation investing significantly $XXX PDP of time, spend while at commercial is million. launch the we approximately by franchise expense our trofinetide, flat an to and further we optimizing $XX PDP additional this In SG&A cash aggregate, fully While support million our spend flow

turn to Brendan. And now, call over to I’d the like

Brendan Teehan

I points. to slide return will Mark. after brand Please now our launch later to going our am trefinetide turn Thank speaks discuss we commercial and to you, Kathie discuss XX. NUPLAZID

steady share drive growing PD volumes we delivering flow. growth cash continue to smaller NUPLAZID, For a in and market,

optimizing by of the brand. goals We are promotion accomplishing these

Steve optimizing been since mentioned, continued profitable franchise expenses. has while As and XXXX have the PDP share we

to that are the efforts, conditions related change growth. two One the in areas there could these PDP market. pandemic important is future Beyond catalyze

channel, Both to of to identify levels and improvement signs in have further levels early with the opportunities to the and census with already LTC improve. returning to continuing some and We PDP new treat seen symptoms admissions present NUPLAZID. pre-pandemic

visit down not digits In represents business, this as improvement to prior the remain pandemic. approximately of total versus have we our the type patient observed yet volumes XX% in-person which community of setting, double

have catalyst conclusions the for with atypical potential and key presented they as been recently off-label differential important real-world benefits promotion that patients which second in treatment are already studies the initiating opposed the is demonstrate pushed, have for three I of the to on pimavanserin slides. PDP of antipsychotics. The evidence discussed

creating are to still data an engaging patient a data are with focused we and early facilities are NUPLAZID. of is critically by differentiate payers level healthcare we important of message with new further important in treaters care sets, This these and HCPs, us seeing. is giving the dialogue days or we and While important professionals the engagement encouraged long-term

recently space channel, our just office progress. forward to begun we top look we the We these on very slide sets of to the data opportunity HCPs. sharing will with only In the discussing data and these share and have important you at this update sets

the of slide received care et. facilities, the compares of NUPLAZID al. the long-term study have shown sharing visits patients resource latter antipsychotics. the other around we portion In since S., The care stays been in ER nursing Kumar versus health the off-label utilization paper and bottom who XXXX. specifically from hospitalizations, at home conclusions

data as directly the a make These been have and well ratings, real star impact they may you update in care use of business. improve could suggest pimavanserin on Again, impact their important will difference patient our facility outcomes progress. favorably which that received we clearly

our Now discuss second slide to I’d like to starting XX. on trofinetide, commercial turn it potential product, over Kathie to exciting

Kathie Bishop

those to tomorrow, worldwide Brendan. their million and Rare you, the for a begin to change XXX generate care people like and of mission support would disease, awareness Disease ACADIA, living by rare behalf Day. we families with February Thank for On XXth, them. that noting the who is I raise

of very Rett community been and have trofinetide. as develop and support for the grateful We the involvement we disease touched

to normal an is unable use debilitating patients, leaving slide the a There their only not loss their turn a extraordinarily disorder child of typical of is to development or syndrome walk, speak. eat Please but XX. caregivers followed a Rett by and hands, period families. affecting skills,

deficits of movements [ph]. set including in repetitive breathing, vocalizations, hand broad a or serositis, eye and behavior, affects syndrome gaze behaviors, Rett symptoms, nighttime facial move expressions, core

symptoms and their require but need. no this There as of treatments the complex core Rett care very is for approved this entire for are unmet Despite do involved tremendous into adulthood, live with syndrome, one-to-one disorder, FDA lives. Rett individuals many such, the

involving Let’s here. is potential discuss LAVENDER, starting double-blind on study, study a growth young We shown robust in XXX trofinetide Rett III women trofinetide evaluated in with slide as The treatment a XX-week XX. syndrome. design Phase clinical

physician of co-primary assessment and Questionnaire Please met positive XX. III tool. compelling profile statistically caregiver study a of CGI-I, significant The patients. on the the demonstrates its Behavioral a turn placebo assessment from The benefit Impression slide for or both overwhelmingly to or Phase the study Global RSBQ, was Improvement achieving and LAVENDER Rett both Clinical endpoint, Syndrome separation

The RSBQ observed was positive XX at baseline. patients and a improvement group X.XXXX was the compared in weeks to effect an for mean X.XX. p-value of with trofinetide a X.X of size Overall,

In of RSBQ, the addition, was trofinetide favor array eight in placebo. there There a in improvement of to broad are symptoms. eight across capture which domains domains all the directional compared

endpoint, CGI-I, an efficacy consistent The and severity also X.XXX age p-value of of disease. of groups co-primary a across The X.XX. was positive effect with and all results size were

endpoint, key communication which LAVENDER, in was also was to positive. completion Upon continue the secondary addition, non-verbal In patients to related LILAC. of

we trofinetide XX shows Slide patients in continue LILAC, Upon and XX-week available study this study from LILAC a into design rolled open-label until approved. can recently if LILAC-X the LAVENDER. which XXX them transition completion study, study product over is for the to patients extension to commercially of completed. that could remain

the on LILAC starting review of some study key of findings XX. Let’s slide the

that are both improvement of we for LILAC. a the endpoint, sustained co-primary continued LAVENDER efficacy, pleased and observed in Regarding we

RSBQ, compared than improvement baseline. the caregiver we LAVENDER the of points the X For an observed assessment, to more

of Importantly, the who LILAC magnitude was study. trofinetide also this to observed from effect for placebo for transitioned patients

the slide CGI-I scores review XX. Let’s on

by a Likert than an note on score X-point disease, as than As physicians no improvement, the scores indicate the of physician improvement. is saw less greater scores a indicates CGI-I Thus, do of X a reminder, X worsening a X assessed scale.

the end meaningful Recall next patients improvement of in average demonstrated And very a study a patients score half in full and that in score caregivers. all of who trofinetide reset, over almost XX improved at X and their the These a patients are study, the and point for were and completed RSBQ approximately weeks, both the mean XX important LILAC point to baselines of with X.X XX in weeks of on LAVENDER, weeks. additional findings the CGI-I, X.X.

the XX-week topline study, study. the slide observed review and we briefly LILAC consistent profile to to LAVENDER findings like the adverse tolerability event XX. a on I’d safety In compared

findings tolerability Importantly, no safety new or were reported.

the Over consistent were reported rates the or mild Diarrhea of course vomiting with from in the adverse those study events were all common vomiting COVID-XX. diarrhea, and most moderate LAVENDER and study, were the almost nature. and

study the the to an when diarrhea XX%. is rate rate and event to were approximately not XX of over discontinuation XX% weeks. open-label this studies. no to reason in the contributing was related uncommon other There compared adverse Discontinuation discontinuations single overall was The additional long-term

only span For this context, patients of continued management GI overall a towards the of study of and data the difference completed much LILAC added several the end would years. over were plans in collected. a and not have made

patients However, no the in and rate discontinuations so discontinuations LILAC-X, therapy. diarrhea. on discontinuation the a in have to much by LILAC-X had This decrease smaller far evidenced notably, extension, did longer stayed is ongoing due further we

launch to I will Brendan our initiatives. now back to it outline turn

Brendan Teehan

Thank slide to you, Kathie. Please turn XX.

treatment on novel first solutions. the Rett potentially ever for families are and excited of the HCPs We to very be to verge syndrome the patients, bringing looking of

significant making are and successful for we the expect, investments preparing of trofinetide. would you As progress in

disease of patient support. three identification ongoing down me priorities areas to Let awareness, focus, break and our

Our awareness is disease core education drive first state Rett. priority the about of symptoms to

laying An of stands important symptoms the the deliver. build of and unique part to Rett the core caregivers is to are are so that awareness to trofinetide better foundation benefits the recognize now equipped physicians poised we continuing of

of trofinetide potential and It and the efficacy receive the and ensure of on expectations is to benefits up for right both equally full caregivers value set educate HCPs long-term treatment. the therapeutic patients to important to tolerability

centers excellence, diagnosed States. advocacy cared patient are second settings. primarily principal who in to of characterize X,XXX treated by designated patients Rett in in is XX% treatment are priority patients United Rett three as of for foundations. identified the patients About fully currently Our the are

centers with There of are more the in currently of XX that excellence, the designation. are process receiving

for these COEs, other of including majority Rett institutions, a significant academic current cared hospitals. Beyond are large patients

hospital. the And sized have percentage with associated leadership cared in out for seasoned force a offices commercial out disease finally, patients rare address field small to a standalone launch setting build audience. preparation concentrated of HCP we are not of hired community there neurology relatively the significant with as to experience trofinetide, highly a the this team for in In

for priority critical support the and in the families, support develop their And and continuing services to At community. of we have to our patients third this launch strong leverage is is best-in-class the the support Rett hub, Connect. Acadia center

have we provide Here, developed extensive HCPs patients, need. support with comprehensive that soon will they caregivers resources and the

managers, members will based our families field on as they access as benefits at hub. model, people service center team caregivers our Our implementation These pharmacists with of well well as on-call appropriate as family and GI the at be should care our plan. are observe and the coordinators educating of nurse treatment, our including management

we best are from are XXxX to ensure day support trofinetide we be ensure partners we every one. patient it to community, Rett best journey can in To the on investing be the the can is

to and to in are March launch eager We we get to XXth. great are shape

appointed it Williamson, And Doug? with Head of turn will over to Doug our I R&D. newly that,

Doug Williamson

slide I’d front just Thank you, we to programs before turn taking some Brendan. myself exciting XX. in have Please potential begin introduce sharing of some the thoughts on us. and moment to ACADIA’s of to by a like R&D

large and training have I by years in practice psychiatrist spent academic almost spanning development following development all a and phases medical clinical and am clinical XX spend and few drug neuroscience research. of small in in a both affairs. pharma, years I

antipsychotics, other importance drugs. receptor NUPLAZID much for time and target which like important already so them, differentiated to We and X-HTXA I reiterate selectivity have too would to other in approach the and I antipsychotic receptors. spend an of two contrast the NUPLAZID represents trofinetide, on discussed but won’t to dopamine treatment these

of poised psychosis. meanwhile, by to only treat and to approved the first being has Rett effective of thousands and well Parkinson’s a potentially treatment Trofinetide, families safe as this as is commercial ACADIA’s affected become for second tens product. syndrome, provided And therapy disease

challenges. full is drug Neuroscience development of unique

demonstrated a to We the long and the as it to huge have main is need joined understand require the because throughout the the persistence the and will way rest unmet the achieve of one well cost ACADIA brain, and understanding from history. as But qualities disorders of are to reasons consistently brain I we is still of body. beginning focus society And are company’s we success. those

two of help of psychosis lead very negative and Rett to disease need, and Alzheimer’s schizophrenia other syndrome, symptoms programs. excited PDP Beyond our development unmet significant I areas the of am

Let’s slide symptoms negative of treatments the negative in and today, of continue the for symptoms. with these remain program schizophrenia, one Persistent needs are on no XX. largest approved symptoms still as unmet there

symptoms which Enables psychotic crippling the often them it living to of the caregivers take to prevent relationships, returning energy, schizophrenia mood, lack and withdrawal which for have instead. often with acute the been care after we employment opportunities and for looking passes the Once is granted. from blunted motivation, low controlled, of social life, burden of those the quality themselves,

We people step available adjunctive currently believe take are an the living has the next in U.S. are schizophrenia to potential symptoms. negative We pimavanserin alleviate XXX,XXX as fulfilling and the to positive who negative symptoms estimated a today to on controlled antipsychotics, continue enable that to with them whose life. but symptoms more evaluating adequately that pimavanserin for predominant experience treatment

ADVANCE-X. have XX, one positive program, Steve study, as of earlier, development pivotal part we our Slide mentioned as

had ADVANCE-X, Our an next modification. study, important

clearly dose PDP. dose, more some commercially observed dose, the results the for while who shown this efficacy Note included available took endpoint, primary on is robust which strongest we and slide. in that ranging the study demonstrated ADVANCE-X XX-milligram patients we same as the The the achieved

well, updated to occur ADVANCE-X and continues midyear. all forward topline should should XXXX to look results to is early around you we close our in keeping go on now have we progress. If which enrollment, completing

all ACP-XXX Now designed the and potential, an our we efficacy risk a With ACP-XXX which of faster build let’s but experience QT optimize have prolongation with of opportunity also the one pimavanserin. is with reducing while discuss may to on onset program. a novel molecule, action. is potentially to our ACP-XXX,

development once complete, Alzheimer’s plan Phase We for work, FDA engage for as are we our treatment currently the I ACP-XXX a and will our psychosis. disease finalizing potential

the with FDA, this trials II to discussion year. plan Following initiate we Phase ADP patients later in with

novel leverage compounds prior characterize to aggressive this be pharmacology the very familiarity We to it anticipate entering late-stage with still of III. important being asset in but Phase appropriately class of able development, to to will our be this

turn for will to I remarks. Steve that, over closing With it

Steve Davis

key to Thanks much, a Please end like development remarks our prepared today’s XX. turn slide Doug. I’d with to slide milestones. outlining

weeks First, trofinetide for PDUFA two just our upcoming is away.

we pivotal year, patient ACP-XXX advancing of with our complete plan in of topline this the second symptoms the XXXX enrollment middle negative Second, around the ADP study later schizophrenia year. results should we early on into trials and expected in for

the cash to need the strong we cash PDP given additional the finally, our raise plan without current and And flows franchise to ability our operating capital. from execute our have balance,

and commitment to always, passion and ongoing our As our for their life. employees like mission I accomplishments would thank their elevate to we continue as

that, over now turn I things will with back Q&A. to operator And the for

Operator

Baral from [Operator first the of Ritu question Our from Instructions] line Cowen. comes

Ritu Baral

Good you I recommend question. resemble think for little just diarrhea you describe Connect help the support trofinetide, the you management discontinuation you in today do nurse you afternoon, guess, on the taking Acadia guys. are bit what care the diarrhea LILAC? can going and Can will On that coordinators and is manage? to in a program, that plan Thanks will to alluded rate on-call featured you assumptions Thanks. then what for what more pharmacists elaborate the your

Steve Davis

families for much answer then of to part the to last very ask stood and will your it care the in take of I activities Thanks Brendan very Ritu. terms question and am the question. that how going as patients and your to comprehensive offer will we Yeah. up support we their have question, to relates

Brendan Teehan

the Thanks for Thanks. Sure. question.

critical that start, on and help to our is known to patients and remarks, not both As treatment only therapy are caregiver stay patients Acadia our hub, caregivers and to patient we but around and prepared also This the Connect. we support said in do ensure experience. building end-to-end to comprehensive support optimal it’s as intended our provide

-- and family the supplementing managers and clinical are XXxX have stay nurse at face-to-face as they intended access in coordinators also start family we begin then will the trofinetide. to We to pharmacists with be coordinators, on are then field, access clinical hub, that that families with

Steve Davis

your Thanks, regarding rates. Great. of to discontinuation in part diarrhea Ritu, question Brendan. response the last

any I practice. be can in sometimes see what you there and see drug clinical differences between think with studies you real-world in what

And I in think subjective early think endpoints, way you I see certain as the therapy. symptomatic months of that drugs of would that. on see have will consistently, and discontinuations said lot, this, that with and relief have amount the about that we very we We you neuropsychiatry will have with a so a in NUPLAZID see

population components. in I this prevalent population. would think of the One is two

there’s sizable drug that population prevalent that will first. access So will we the a --

population through then and We will work an beyond that. population incident that there’s

therapy. And that no the so for the it’s see so disease. we with access approved to a think There’s this to be and that of hope dynamics a first think as benefits trofinetide we very there I about will debilitating highly there’s time motivation molecule, The very, families high therapy. we offer recognize -- the these

normal then then rates flatten population, months cycle. early lot of the and And where work -- much going as a in more we over into prevalent that discontinuation the the we anticipate is in of out simultaneously, through the will we through -- will settle therapy have patients what settle a time

helpful. I that’s hope So

next We the to will question now. go

Operator

our next Thank moment question. One you. for

J.P. question Tessa line from of the Romero comes Morgan. Our from next

Tessa Romero

so Thanks for much our guys. Hey, taking question.

on trofinetide. So one just us from

can your with Rett respect key academic in of physician centers So much. treated, of remind prepared remarks, to we different your any healthcare about? here. practices thinking from bit so a you trofinetide on to just patients number your us, hospitals of little be of kind your How characteristics Thanks other community or practitioner awareness excellence centers average you compare about to distinguishing talked your do audience these should

Steve Davis

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

Brendan Teehan

a to groups where community. would with your do for group you expect the a be that find is Thanks Thanks. question. a in membership the This into rare in times it disease, see well Rett on thousands. well-organized advocacy have little not the lists challenging Sure. patients. Many that you We

identified the already diagnosed in for have or States. already We United and the patients so cared X,XXX

perspective, locate we don’t to our as limiting. from where finding patients So, that see Rett

in When do, the as three you out, community going break you into find of terms Rett principal are and prescribing to groups. both pointed patients, they those we think where

The those which there XX% in those the roughly first population Rett and currently treated of would of excellence, XX be centers are are of designated there centers.

treated capabilities. And a of vast hospitals practices. at are patients are children’s at centers neuroscience then percentage strong The majority high academic institutions, volume individual principally neurology smaller and with there’s patients of then that treated

principally audience the breaks that’s So how out.

Tessa Romero

be expect of And cadence of to on kind then dependent do patients as treatment you the starting different of type practice, just a follow-up. quick

Brendan Teehan

things. of fair A couple question. A

we of that that younger given a think on results group would the of end families with see the of patients program motivated we are I the expect LAVENDER the would spectrum.

early So for surprised families towards in we if treatment. I be younger skew days younger patients the wouldn’t and

expect to early the seeing where treated the and days. are Also in institutions, majority given patients at principally be at with the volumes to opportunity be trofinetide the that of we we high that’s volume of these centers with excellence

important That simply is, I getting an treated. payer the still -- understand important working organizations we is family of to in through a think, to facilities of be will be have to that each to high to the access and with opportunity interest it’s these there logistics be treatment, while

Operator

next for moment One question. you. Thank our

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

Marc Goodman

like a you or so. number just have I all using That follow-up year and that market, years past diagnosed would these Just just cared as are kind was been I more a for the you you have patients. that number [Audio in as dug just on for would the using the you same patients it is X,XXX this and over just conservatively Gap] you of seems seems be to curious that are finding have number or into past look as

Brendan Teehan

and to to are access we with have so patients databases, track, able diagnose treated We Rett.

a prevalent diagnosed a there’s population older of first-to-market have As could there genetic test. in in on a been not be and therapy to is earlier in diagnosis there of uncommon the it hasn’t particularly prepared been the X,XXX clinically remarks, that mentioned in may perhaps introduction an who confirmatory increase which for patients but rates, after life, X,XXX

time. than available claims so the those to incident the X,XXX database us or United will an in States. over roughly the while that population still be using Other diagnosed in there and is that, range is introduced for treated It’s

are the seen pandemic. had by think, refers of you drop on know care as fronts. to more function the the the and had a Frankly, residents entering The One, that’s in early steady of steady separate market and residents new long-term census patients a two increase question signs we we over trough but passed saw XXXX we by encouraged have profound slow NUPLAZID long-term a seen time, portion and we LTC, the care from I and in that facilities. middle which have of we been that away driven

it’s and as so where the is is The be opportunity of great signs time a treatment. for important to Parkinson’s disease reason psychosis the a symptoms identified, NUPLAZID chosen to that’s that are NUPLAZID

the a those some from for strong a really other with voice the the coupled the logical in half the et that that basis in real-world provided study and studies first-line NUPLAZID That of fact is of Kumar the second have introduced for residents. why al. being have the are setting had setting, of community evidence in dynamic, S. XXXX that sort preceded we

in as the create volume our coupled -- in of Steve long-term highest quarter two XXXX, highest of noted, The those for bottle the have long-term the care. since, care had history we of fourth to

When led I say at still down setting, the we way. double patient has see that, look digits. in-person that we visits to the in-office think that it’s segment fair

is, same the see if the using want face-to-face to logic, a therapy. a are So prescribe challenge there branded to really patient physicians going they

I anymore. not of we in-patient frequency and like much see we or that’s that telemedicine to helpful. just are in-office So are would dominant increase. encouraged those We visits the hope seeing are visits

Operator

you. for our moment next question. Thank One

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

Tazeen Ahmad

think time about of the initial to or should of should any you two uptake? for what’s be have How nature for announcing days Code lack are identified, secondly, do at closer? range about Okay. Hi, the know we trofinetide meaningful the So of thinking And but as we of uptake, for purposes rare the won’t that you question need Thanks. J approval, pricing matter? appropriate of you Maybe guys. and or get a got you me. will modeling therapies, going because patients that the thinking be we but I disease then be another

Steve Davis

take Thanks do Brendan, so want much. questions? Yeah. you to these

Brendan Teehan

Sure.

Tazeen. thanks the So question, for

days early we access. be for treatment the establish treatment trofinetide will as let’s of working ensure and to launch, to terms the be outset want the clear, Rett from of the definitely In we foundational syndrome of

If disease high to mitigated that’s issues would be access. at of other there one will that demand that rare you by tends some look you launches, handle, see logistical the particularly

time for to second to physician. it their patients the being get The takes appropriate

drug. medical they We high before in receptive So a of interest have perhaps proven made for an opportunity prescribing started patients there to decision. us, and payers be coverage the We get have know know that those will exception to letters a counterbalancing. are

But expect we access patients, Unlike be diseases where might program a some bolus here. still create not of an what where uptake there rare shaped you we early might be linear that’s there had to really a curve. other

in to by access payer be majority of individual but of the an and As LILAC-X geography. Kathie over expect their transition patients described, we open-label extension and those going that’s function do time subject drug, lines commercial there to a to is to

I around think was your pricing. second question

are that that there several where to bit a add With of established an and tend are range to we levels context. little approval going rare of contribute there prices price. not products be disease therapies, before we pricing to to tends to elements So to disclose can tend

The disease. first is the of severity the

The to of And second those product ability needs. relative the the is the level itself. is the medical then rarity unmet address of need and disease of a third,

is devastating So who a a of if and and care lives and substantial the patients causes provide very disease. It of caregivers Rett families disrupts syndrome then to about we it in the thinking are round-the-clock essentially Rett particular to patients. disability trofinetide, syndrome value

The that critical be to void to creating core high syndrome, symptoms approved unmet neurodevelopmental available equally of need with address medical filled. a needs therapies Rett no here the is

it for Given potentially is trofinetide, the our in need. robust address to III response Phase studies poised seen unmet that

population to is so at the patients. currently estimated X,XXX or in and the small the States And prevalent treated relatively X,XXX then United X,XXX finally, with there diagnosed

who ensure that you So background, access think from stand the need to of poised as broad families to I with address high level treatment. and price unmet trofinetide should only benefit expect for to patients us and first and that to therapy

Operator

Thank you. for our question. moment One next

question Duncan line Our Charles Fitzgerald. comes the from from next Cantor of

Charles Duncan

that the with Yes. and/or regard wondering LILAC formally actually the and discontinuations anticipate guess to to for afternoon. timing did Rett? today. do with and had I sharing you guess, I information I regarding patterns recognize specifically am regard you that diarrhea Good severity, with you if any, engaging you Thank you agency

Steve Davis

that you Kathie, do want question? Yeah. to take

Kathie Bishop

with to that will very discontinuation Charles. after Hi, about very the LILAC a due discontinuation say three smaller rate first for then within trofinetide due a diarrhea pattern question. pattern the -- was LAVENDER the to I discontinuations of similar that. have similar in trofinetide, and Thanks regards associated in we months With rate and to the that that

have a low mentioned I study, to-date. LILAC-X, the do very subsequent none as rate in on and call, diarrhea the discontinuation And the we

So to the that in that it. is on emerges longer pattern stay able trofinetide, one this longer you are you are from

years not trials, of did in notable, over As these place. the years, I several that we plan management though, extend mentioned, the early have also it did in they is diarrhea

diarrhea we think and to manage provide able the to drug. to caregivers as instituting there Brendan them we to patients the resources So plan many to on ahead and to launch, are give that is be

Steve Davis

Yeah.

our standard in engaged. Charles, But we back agency. to is on have response not are have forth the I very they been with simply think, we comment registration that, and when I say just

to day, We don’t things we otherwise. PDUFA on but eager get are comment our

diarrhea. to have to and can constipation and hospitalization. important contextual cases it point, we can it I sepsis it’s before, a even have They associated quite of It I get few due -- with a said XX% mention have them really on impaction, to know infection. average terms want death I just in of constipation important lead just have about one point, of though. patients reported Rett significant severe.

right this So community top in as physicians, as is the very of caregivers. well with mind

some of a the trofinetide be in all sertraline. that respects, And somewhat so Rett type diarrhea we also And were have these with where garments see patients diaper situation can effect trade-off. of you a almost

steps XX-week took already a diarrhea of been that, that significant completed in we mitigation some mentioned, we well. as patients study late that around as program context in had and or lot majority management regimen just so of LILAC late And LAVENDER additional time, that the Kathie developed that in

the manage we is outweighed we we Brendan continuing So finish lot to tolerability will put trofinetide, see to as to that line to of and get will families which have see, which -- grow study. help LILAC think significantly we that bear the sustained earlier, very of And the resources significant through described are by a benefits eager continuing bring we here. to that the

Charles Duncan

Kathie. and Steve Thanks,

Operator

next question. for you. One our Thank moment

Bitritto-Garg next Citi. question line the Our Neena comes from from of

Neena Bitritto-Garg

Hey, my guys. Thanks for taking question.

on the on discontinuation. a Just the impact of diarrhea last follow-up question and

that diarrhea of discontinuation what implement management did to on discontinuation Did rate? comment lower the when about the I the the see open-label study. program rate? on contextualize patients did were can happened have how earlier just the think you OLE you who in the you management to extension am impact Thanks. LILAC diarrhea in a if curious Just maybe trying

Kathie Bishop

Yeah. Thanks for question. the

Steve Davis

ahead. go Kathie,

Kathie Bishop

management to keep we constipation, really which be implemented context that XX% Steve mentioned, severe. as plan, these the into can of which very it’s important patients as So diarrhea have

medications anti-diarrhea on or plan such and measures as to your in in of over-the-counter taking increase and of the stop in and those implement step diet three these over-the-counter many patients first fiber The the anti-constipation loperamide. is are two then to

plan out the the keep rolled by to later then trofinetide. in implemented became helping that patients hear physicians in the the those trial, control the feedback on and and certainly as that we So and are caregivers trial steps diarrhea

not not does weight to talking is I are we lead nature loss, should lead remember diarrhea a concern. the almost not it’s in safety to to mild also all or not It dehydration, does moderate as lead about and that add, hospitalization. does diarrhea,

and hopeful better intend move this So nurses through to towards I that’s study working with steps management of help manage put we to clinicians, really is what think, we and do commercialization. a in as some place the the it issue and trials and parents we

Neena Bitritto-Garg

it. you. Got Thank

Operator

our you. Thank for One moment next question.

Partners. from Suneja from comes question Guggenheim next Our the of line Yatin

Eddie Hickman

And restrictions for trofinetide quarter. to to on impact review or expect Eddie on Hey. after filing on This Billy do Congrats Dunn Thanks. approval? the any departed? now have complete any you potential the or expect limitations or post-marketing any that has studies on have is you Yatin. the Do label

Steve Davis

first expect, should Yeah. on Billy today, of they FDA. -- Yeah. part don’t We we should and that leaving -- take impact from the I not that. any might any will not the FDA have out We this as Dunn our we anticipate reached expressly back application. impact confirmed you heard

for the as Buracchio well some of of Division. the with Dr. been Deputy Director time as Office X Neuroscience the and role, acting of has Director that Neurology will continue

for asking think question, don’t understand have but it impact will the reason on the I So any we application. our

Eddie Hickman

Okay.

Kathie Bishop

are requirements we talked think, post-marketing Since of respect with question under part second this that don’t on point. to, And and comment we the at about labeling. you I review,

Eddie Hickman

on you Got you. have think you many currently Do clarify could drug? you how patients LILAC-X

Kathie Bishop

Yeah.

is the study So LILAC-X ongoing. currently

So remarks. the this time specifications I we in rather further any at can’t than what into get mentioned prepared

Operator

Thank question. you. our One next moment for

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

Gregory Renza

have input it’s to it to trofinetide any patients, I you to ASO as at others patients? foundational premise the a on PDUFA for the on the Great. of term about and curious approval for program Thanks Thanks, prioritization longer the Steve, market, are question entering my your much. how potential looking and so or maybe your Steve, question. and important think trofinetide that think certainly on even post on Rett whether congrats or progress. Thanks pipeline least March just tack as Brendan perhaps serving taking of shape the a these when mentioned you to does to comes that you externally trofinetide, if and just am on maybe or

Steve Davis

relating part -- what the heard have question. hear would second hear the I didn’t it portfolio the I of I first just, impact sorry am our I didn’t Great. on to part the

Gregory Renza

Yeah.

external, your your to and there? in thinking how are an Just ASO about you. shape focus approval how pipeline prioritization with the pipeline, would the what’s you respect and program Thank and

Steve Davis

Yeah.

much. Thanks Okay.

it So is the wouldn’t. answer short

-- we have I both from always have a with viewed think trofinetide data where very unmet we since endpoints, recognize study need. we dramatic that have co-primary

with felt this of have high We like drug a and approval. that’s needed a is lack

we accordingly. find So our business

assets we have other have continue and will we Stoke We our including that about including to. partnered referred Therapeutics the very you programs excited assets we are the -- early

as strategy very the a development same, From couple -- remains a that business. is part perspective, the and important last described years it’s of our have we our for business of

that, of to that described opportunities revenues do, have back have capital improve, and don’t go we capital seeing leverage that. as works advantage markets positioned impacted are recent we to in established like that us, business most well so those are and versus continue a As the sheets, in to to to significantly consequence the but and we companies the of companies opportunity that the really the markets quarters, development have balance set strong fluctuations

Gregory Renza

it. Thanks, Steve. it. Appreciate Got

Operator

for Thank moment One you. next question. our

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

Jeff Hung

conversations Thanks for surprising? question. from Thanks. found you my your with is anything us there of the some of hearing that with trofinetide, share current Can -- have you taking you payers feedback recent been

Steve Davis

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

Brendan Teehan

the Sure. Yeah. for question. Thanks

logical with in address. year payers are we program discussions have since this had a that say recent I context, the we questions over even payers would Just But to really have that, back at very able acquired we point. conversations, dating more

many payers is what know first Rett is. The syndrome don’t simply

this outset. describe and the it that fact from a We them dimensionalize it the round-the-clock support devastating as for requires disease, a have to

that They proceeded only individual of are some FDA different of of than is it the that trofinetide well the the core be treating that symptomatic approved Rett would for very aware have it. medications drug may in types symptoms

disease They difficult expect very aware are is pricing come have that to like a that of this positive that that education products space from with for and model and understand a and rare risk population. rare this profile our benefit trofinetide, a now is they this

to going near-term -- access given that patients if are we So, and an enough lucky to to to appropriate that, able to the in have ensure we confident be their families we patients approval feel are

Jeff Hung

you. Thank

Operator

our next question. moment Thank you. for One

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

Unidentified Analyst

Hello. Paul. Thanks [ph] taking Catherine for my is for on This question.

approval approval trofinetide thinking on side. patients? and the you risk about at are the start Just greatest Thanks. What point how the on and do the if post any treating expect to can this cadence regulatory you how as soon on see launch, after to then you

Steve Davis

the for Brendan, -- second Yeah. question first? you two Thanks much for the questions. do take want to

Brendan Teehan

the for Thanks Sure. question.

are doing we approval. launch quickly a go in expect, would to we company you ready first-in-class everything that expect a As of to after rare would and getting be you pretty will ready product a disease

and of from finalization that some product obviously, also a There perspective field to time. a force But delay sure that because to drug things takes is the it they want waiting. we label, that prepared reasons availability, our training that prescribe that we families those implications started. than and One make for to the know get lots community simple support see are want no other of is are about physicians to logistics, XXX% the few a really just other has logistical the

Steve Davis

second question. the take of part will I Brendan. Thanks, the

said is, in just are we before with always agency I will I review, and think we policy. in what comment don’t we forth under it’s terms standing just start and of just risk to back that on been the our an approval, repeating and

this get as are will we we with we XX. not have confirmed we we they March eager to this appears are are Having a to ago, impact had Billy just point. second track as happy -- very that Dunn’s to and The have any at FDA morning recently noted to engagement and of Everything level so this FDA, as XX. the have get on be to said, departure eager said that, with March

Unidentified Analyst

much. so Thanks

Operator

you. Thank our moment next One question. for

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

Unidentified Analyst

my is Maybe Thanks on question. Hi. [ph] Good on taking Ami. PDP. Cindy for afternoon. for two-parter This Will just a

whether reacceleration and then, you. XXXX? XXXX in does sometime in range take comment of guidance of volumes growth of a longer franchise the on second, And or trajectory we inpatient year? assume the you could place kind of see this term Thank improving to First, kind could your whatnot

Steve Davis

guide will question. I first beyond year. briefly We the current don’t answer

will much we we progress take of year, can second continue as question? So want to to offer part this as color do the Brendan, you as we appropriate. feels the

Brendan Teehan

I look channel. are. our improvement the think, some XXXX, prepared we at things care the in for we see and do think question. in long-term thanks remarks Sure described where When We we

on will to continue We look certainly to that. capitalize

and starts. In focused on in-office new are we channel, patient share the market

that by off-label antipsychotics real-world see further that differentiate us atypical from evidenced as help studies use You us. preceded the the NUPLAZID of evidence that

in operating dynamic that. guidance terms in market believe and market So of our I we that are dynamics, reflects

are two areas see we where catalysts There growth. could for

to disease see patients to the and to going those see frequency back psychosis in if first can because which just visits is, the in patients in-office increase, treated. there who case, The of addition, get preferred their see front symptoms being the Parkinson’s of route is we for a clinicians, we a know frequency to and signs is need doctor

a confident to opportunities patient be for environment. just We for story more NUPLAZID in want identified. in are the We that

and Lincoln a Mosholder come The Study Study of really is, form could until Mosholder catalyze quarter introduction evidence article late the the real-world Study. out December. Study Lincoln didn’t second, really data which The the growth and the in the was fourth

describing that. in So to it’s really environment in-office early the days be

audience much say and anecdotally the will interesting, information found focused. that compelling very patient has I the

year early So market the further we about kind dynamic again, as that’s progresses, of the that in. days, we talking to forward look but operating are

Unidentified Analyst

you. Thank Great.

Operator

next question. you. our moment moment me, question. for our for Thank one next One Pardon

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

Jay Olson

Williamson Oh! gaps taking wondering congrats the vision ACADIA you question the Dr. on for talk and R&D for of could was about pipeline there like to in and you. the would at the Hey. to Thanks you and pipeline any joining the know? I ACADIA. if for that future ACADIAN’S Doug his are Thank

Steve Davis

Doug? Yeah.

Doug Williamson

the Thanks. I question. appreciate

now. I have here think I weeks been seven

pipeline existing you look to I areas alone very let potential career -- excited to of still difficult clinical I that and ACADIA. development. neuroscience the think most the it’s tell am research its the I understand I I to be future. of am in the spent at one time have of fully can drug So and the most taking my

the that there’s I of appeals of think, the in this So novel disorders things where, developing persistence treatments course, significant for always ACADIA challenges of people and is shown on, to the taking about one the focus brain has me from need. suffering company unmet

over So I clarity about be can’t don’t more or now. the direction any be into future, right headed, what will I -- detail you really we that are headed, in we that we the get around but except want detail will we developing more developing to gaps are give shortly where on

Steve Davis

Mark remarks add there one we Let in me disclose. that that done that, his just Schneyer some are Yeah. have annotation. we mentioned deals don’t

we course, do, from it. deal, perspective, to So of do when we we we disclose we need do it, determine SEC disclose a an and

take get we before we and to want sometimes on don’t, to talking we certain If destination or programs. those certain publicly question programs get from answer a a

yet. progress So, more will we as as we we disclosed that programs about Doug haven’t those alluded talk to, this year,

Jay Olson

great. for the Thanks That’s taking question.

Operator

moment One our Thank question. next you. for

the Nikko. of from Hoang Our next line question comes David from SMBC

David Hoang

update and Hi. Thanks for the my taking question.

do just you before the those presentation think in what becomes that any or to of from PDP. there -- take any long and channel I feedback end estimate the patient of any how evidence patient are script And start have do decreased think have extent if for visits seeing to the NUPLAZID prescriber long you on you two any they follow-up to on or volumes? the So in-office rebound? do of sense number expect visits, How you real-world they in will had reflected the a is as

Steve Davis

Brendan, want do you to take that?

Doug Williamson

Sure and question. for the thanks

very still since seen, paying telemedicine, you inpatient think setting. to volumes to the As what we that’s to are leading for visits. a rise in-office but we been indicators the of beginning attention we is patient however, dramatic We pandemic, we have we are in in-office obviously, expect, ever -- for largely close return digits gone double would of down saw What away. the have

in One, during think was carbidopa/levodopa in population function pandemic. the of two the surrogate mortality marker And scripts. We things. I that a that’s there a see PD a patient for

would as in One to just community. an carbidopa/levodopa treatment would rise expect a you as with broader the incident population

top the X%. patients. the of use carbidopa-levodopa of That’s of sort about down pandemic, Over still funnel the the was for of treatment

visits. for So are to is is I started think in-office what those what see in some stabilization and looking we we have

time days [ph]. we on us they with physicians, want ways. differentiation we to to evidence, I getting atypical believe, What see two is use it. the opportunity we find platform us real-world antipsychotics early know for ARISE One, and ARISE in versus do helps of but we an as there’s the preceded that that as the real compelling for are that a NUPLAZID said, information

to audience combination think, I for more can that term The very longer and return the NUPLAZID if in we second patients is the to growth. helpful is to get and the office, midterm treat

Operator

you. Thank