ACAD - Earnings call transcript Q4 2024 | ACADIA Pharmaceuticals Inc.

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Operator

Good day, ladies and gentlemen, and welcome to the Acadia Pharmaceuticals Conference Call. My name is Shannon, and I will be your coordinator for today.

I would now like to turn the presentation over to Al Kildani, Senior Vice President of Investor Relations and Corporate Communications at Acadia. Please proceed.

Albert Kildani

Thank you. you fourth us XXXX quarter thank to today's earnings. and Acadia's discuss and afternoon, for on joining call Good full year

Owen will remarks; will Also is of Chief closing Head Catherine update Research followed will and Joining Acadia provide President the Tom and who Garner, and our an Officer, call provide thoughts NUPLAZID. our Development, Schneyer, the Commercial review Vice up by strong open will Adams, Financial call programs; pipeline Officer, some Elizabeth Executive commercial we Chief will then Catherine DAYBUE who highlights. who opening me on your and today Executive for our who our Thompson, before joining some the today Mark financial provide us our Officer, questions. PhD, Chief discuss on are from brands,

available supplemental Presentations using which section. slides, are and We our are website, Events on

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

and statements, or of which unique obligation place to as on forward-looking we required are date, as law. revise statements change, these assume only made update circumstances except no by not forward-looking these to today's cautioned are as You reliance

Catherine call to opening the turn now I'll remarks. for over

Catherine Owen Adams

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

made. my on months significant of have role Acadia, update an as the excited progress to X share we CEO into Now I'm

include my pipeline. first strong reinforced call, my last our for we've our the I and our confidence revenue the at then, in my expressed billion These achieved in only commercial targeted Since future. will both over financial enthusiasm developments with with During of Acadia, in foundation the in growth potential call, in detail we XXXX company's delivering the developments later guidance have the for recent $X brands, volume strong with both brands. results U.S. as

our treatment an diseases and new the neuro-rare in programs, in of exciting XX. held our culminating announcement neuroscience Officer; tremor, up June approval Announcing second application commercial Commercial Medicines Tom Garner Dementia with Acadia outside Lewy new disclosing first new Body by the essential program intend authorization pipeline the for joining our of Agency in diversity and to to with Psychosis, Acadia's adding into depth for America; Day be transparency submitting our as North to announcing greater marketing ACP-XXX, us study on setting pipeline first details R&D leadership trofinetide, neuroscience both more our with we European a providing ACP-XXX our our Chief for of about indication

rare franchises, Acadia's And to plan with and is long-term strengthening review priority sheet in by by further deliver anchored adjacencies sale balance growth neuroscience disease. franchises, we neuro-rare voucher. into corporate our expanding our disease of exploring and the our these investments additional strategy including

later in also and call. XXXX will We which the some to execute milestones in detail XXXX, expect I important value-creating

commercial to highlights. our Now turning

X% I'll XX% growth in year-over-year record commercial volume XXXX. and year Our begin with poised of brands and which quarter, strong the revenues generated both sales sequentially. fourth DAYBUE, with in up revenue are and the $XX.X finished for million quarterly

up sales which was XXXX, DAYBUE's launch DAYBUE For were full $XXX.X $XXX.X year. in year, from million, the million

this grow have in the of continued therapy Tom growth accelerate opportunity base brand, both volume and will and expectations from on detail U.S. U.S. our we our the to key stable, remains our patient in the initiatives U.S. patients in and While to for confidence outside abroad. revenues the initial

sales up sales which of in XX% year. NUPLAZID, the $XXX.X to full of the up year quarter, and fourth generated year-over-year million $XXX.X from XX% turning Now prior million,

awareness by We pleased unbranded launched about direct-to-consumer Parkinson's-related very NUPLAZID more impact growth, driven hallucinations websites, with patient traffic have These strength of in doctor are and continued boosted which to efforts initial of XXXX. as sparking our our were of see we begin to mid-August primarily and volume the and discussions disease NUPLAZID campaigns, delusions.

Turning next our to pipeline.

in slide Acadia's at factor more my robust a a excitement highlight conference, an pipeline observations. I to like month, was the at key we our outset, diverse in-depth join few Last at providing pipeline. investor look As to key company. I'd the noted this introduced a

Our mechanisms III, unique disclosed pipeline range leveraging product intersect. diverse two These significantly areas a Phase discovery than is was all programs disease of with neuroscience, of of stages rare broader from development previously the where to spanning and action. cover candidates

substantial therapies pursuing indications the are high medical need. unmet while treatment with bring of patient in Furthermore, options align areas also our mission opportunities communities either with market representing underserved or first-in-class to to new we potential best-in-class

XX We this at New York. also information look forward programs about for to more our year first-ever Day sharing June R&D of planned our in

Commercial pleased introduce also collaborating impact hit on us organization. significant previously brands. to commercial Bristol new commercial running, like the at ground on joined color a and to strengthened him in quarter, December the making Tom worked be Squibb. together with During again. successfully Tom already of Having our will on once our who leadership, has Myers our particular, we I'm executive commercial our side. provide in Chief Officer, the Garner, I'd additional performance the fourth

Thomas Garner

$XX portfolio the CAMZYOS reasons billion about to led bring Bristol, that in which such truly aligns large X a commercial revenue. at ELIQUIS, Established Acadia I for many of including To well with a and as you, Acadia. you've I and the years rare both excited of Thank brands join pharma XX I'm over experience, and Brands such background, as Catherine. leading exceeding large decades little spanning included overseeing where This my highlighted. share focus business U.S. biotech, my at experience disease launches Cardiovascular unit,

Having and confident in successfully of I'm in a across both potential NUPLAZID, growth long both near for led the brands expanded term. and the significant diverse range commercial therapeutic and DAYBUE areas,

As our momentum demonstrated in brands. we strong continue delivering for growth driving today, and both QX positioned well to results sustained are

fourth patients excluding in year. Let's by to was $XX.X for this quarterly begin see forward, use bottle bringing with their us the growth. million primarily in of volume straight the quarter year-end even dynamic, pull record driven DAYBUE. patient titrated of expected the more upwards the Growth recommended volume increased quarter third sales towards We stable doses was it through bottle the We achieved million $XXX.X did per as some sequential dose. quarter,

profile patients XX% of In XXX for who for over quarter, XX An XX% been patients growth the quarter. patients future our growing now long paid total the important remain QX, months group or with having around we patients of third accounted DAYBUE the During and of fact shipments, received DAYBUE which of base unique prior stable volume. current the that longer. have this on factor therapy term, on therapy for essentially is the was with of flat a

improvement in XX% we observed patient a discontinuations. Additionally, quarter-over-quarter

an launch ongoing this individualized product DAYBUE. considering strategy of disease, care is at to forward, observed the for move a important for considerably receiving and our chronic element rare support Overall, or point persistency ensure and cycle. will persistency Rett with in drugs we As these for remain a proactive patient caregivers impressive patients I've DAYBUE's their many lower

about As you see persistency drug here, remains for at overall patients on our XX%. months XX at

regards to continue around quarter. With the broaden to we prescribed about our of at the end having up from XXX prescriber base prescribers, with HCPs third DAYBUE, XXX

Rett our be we is ongoing patients specific This their still our of expansion While we room expansion HCP the be XXXX of this significant important us there to broaden base, to wherever aim they may strategy. an journey. component pleased as DAYBUE continue customer in will with for to believe meet

we with grow executing brand, are we the the review see adoption. meaningful XX% either beyond. institutions enhance to and noted, vast as of community of remainder high-volume currently majority in now U.S., expect DAYBUE believe a treated our and or both are patients in initiatives settings. time, opportunity of other Let's the have excellence, at COEs, Rett to We Starting more we've accelerate strongly strategic patients at U.S. where further the to treatment. the therapy of starting centers Rett being we treated Over COEs receive or outside patients

the outside physicians the and DAYBUE is have XX% to X patient around of our DAYBUE for nuanced significant journey excellence XX% more a of the of identified result, versus additional With have in a almost centers growth Today, deeper excellence, of now centers as a benefits and dynamics field, and opportunities educate understanding Rett we treatment the that opportunity. offers. years representing these in the for about DAYBUE accounts penetration

capitalize significantly reach To these centers beyond enhancing on opportunities, our ability we're the XX excellence. of patients to

we we of treating we're be Most engagement their caregivers a will increasing their these but with journey. strengthening announced more and also expanding treatment for on field and patients roles focus support our month, with by last throughout As force XX% around demand patients. are HCPs new generating,

time, efforts with of stay Since growth. patients launch, which confidently driver adjust helping our therapy crucial partnership volume we've important are an learned HCPs, and support in over in dosage these how and on caregivers is their

also their to we're several key patient, for be both caregiver Beyond to and patient the direct-to-consumer HCPs our opportunities our experiences. patient new expansion engagement, model, growth campaigns initiatives expand launching sharing and and including universe, whether customer it of or drive to caregiver HCP peer-to-peer

bring the clinical life from continue to to and trial DAYBUE omnichannel Additionally, highlighting LOTUS we data our study. data strategies, the data our real-world through

make have ability date. only to With of about tried difference momentum XX% community, to even where in a build confident efforts, we're patients and these meaningful the DAYBUE Rett our to

with Rett begin the laying very XX,XXX for the foundation in Europe the of an year. opportunity to this The also of U.S. by substantial We're to X,XXX excited outside individuals is beginning syndrome. DAYBUE affected estimated commercialization

in and quarter Managing EU General experienced the plans region anticipated beyond. on Germany, Director be Manager well actively in building we we've a have XXXX approval entry team developing a our for and we market highly talents soon building. complement will in our focused a will started will who as team of first XXXX, the as welcome been EMA the With launch These key already

making patients we're to those subject While regulatory await committed for to certain access managed caregivers countries and European markets. available in specific through guidelines eagerly programs, country-specific trofinetide approval,

track year's in Meanwhile, by on year. we're our following Health sales DAYBUE approval the this third first last in Canada, of quarter for Canada

our EU to and evaluating Rett Canada. approach fully patients to more the making select of in markets are DAYBUE we outside widely Additionally, U.S., available

We revenues later this year. are U.S. outside excited of the to first record Acadia's

expected Rett is to look In in half summary, We're XXXX, preferences. to and to while DAYBUE expand as we customer we further the at broaden outlook second anticipate occur as for engage community year HCP majority our with according tactics in the growth, to channels volume the their actively various engagement. the new through we of model continuing deploy the

in patients receiving unique Moving forward, we and the shipments. to expect patients of growth both see number new

We and anticipate utilization number to stable maintaining stable strengthen persistency our and DAYBUE. to of are continuing the growing time patients tactics on increased support over

and managed the DAYBUE, We the and of U.S., patient evidence Rett to and programs lives of impact expect access positive reinforcing upon in continue outside caregivers. value growing to their build the countries in we with record programs and patients select revenues its related will to body real-world named

growth growth sales $XXX.X the of coming from revenue of X% million. volume, I'll top growth the sales with the achieved sales turn that growth $XXX.X which or line important more quarter NUPLAZID. is now note by is to total million, XX%, representing across grew since Overall, half of than all and segments. sales year, annual XX% to rate market is volume highest this this of It's XXXX, NUPLAZID happening brand year-over-year. fourth for

of Taken believe positive to significant that grow NUPLAZID given together, through room momentum the has second we saw the XXXX. we half

hallucinations is I most share previously, atypical continue only patients up and share tremendous that the we performance the Parkinson's-related delusions. brand. in growing is XX% we treatment opportunity for the market about and receiving reported What find exciting a have have those a still This XX% sales antipsychotics about still that to expand have we meaning NUPLAZID from of this

without other described decisions the last in antipsychotics they mortality educating use leveraging the atypical comorbid published like label and about or HCP the we HCPs influencing X key in important growth all-cause dementia. with hallucinations experiencing association One, past and understand year's clarification, can market Parkinson's outcomes have which with disease Our helps showing treat an initiatives of evidence two drivers real-world XXXX prescribing were years. over patients delusions that pimavanserin compared the key as

drove momentum our awareness patients also QX, campaign Parkinson's positive the these conversations NUPLAZID hallucinations starting of created, encouraging branded websites, traffic and both about initiatives their and the campaign. and we to initiatives impact to began our in and the awareness disease disease. more Together, increased on see delusions Building branded these with associated our between doctors

next commercial strategy for Turning and to NUPLAZID. our outlook

the to to We efficiency we're want and HCP at the at prescriber generic strategy with the to that to Our use to time off-label sales evidence of by antipsychotics educate consumers in-person and the analytical growth NUPLAZID NUPLAZID. campaign continue right benefit field targeted analytics tools continued further gains want the educating and market force share community to decisions. highly impactful our And drive support right DTC We efforts. place predictive about against our is through drive leveraging of clinical to real-world offers NUPLAZID be looking straightforward. activating maximize about other and

sales in long-term NUPLAZID, As market goals, data, real-world data the NUPLAZID growth, including you highlighting that will of see publication value share evidence offers. our outlook for for continued our X-year support more increasing those the is guidance XXXX to further and sales

summary, to excited and see to is progress plan we're the XXXX. on through NUPLAZID momentum that In making build

Liz. I'll now to over turn it

Elizabeth Thompson

then start I'll approval. programs. update XXXX pleased turn submission marketing regulatory Thanks, and begin European for our to first our pipeline brief Tom. later-stage with We a with to were

approval this first Rett trofinetide As of with expect living in PMDA study quarter of to in we with our we third continue announced for In With XXXX. this in we EU. month, Japan, the Phase about syndrome submitted the anticipate have productive discussions submission, a the year. last trofinetide now quarter Japanese MAA and patients in III begin

Prader-Willi licensed later-stage with as recently on I'll Now ACP-XXX. syndrome. the our well programs I'll ACP-XXX briefly start clinical as in comment our program

is characteristic hyperphagia in appear reminder, hyperphagia, years a U.S. early in life, anxiety life an is The neurobehavioral intense Prader-Willi of diabetes behavioral like to hunger. well affecting disease is often which sensation aggression. The largely is genetic of patients a the roughly disease. complications as unfortunately, of X,XXX defining as As due leading expectancy to currently And and myriad rare X disorder cardiovascular heart obesity to XX,XXX symptoms only Prader-Willi changes very XX type persistent old, and like or around

intranasally the more human oxytocin to long-acting a we're ACP-XXX, Carbetocin, the delivery provide direct of developed analog to oxytocin, was receptor. With selectively bind to carbetocin delivering to brain.

randomized, called Phase of experience Our informed and is trial selection. current Phase III III terms prior study dose COMPASS endpoint PWS is placebo-controlled. in by multicenter, and double-blind global, design The both

of shared year, half we fourth XXXX. be up in first we to the month, us to the expect enrolled see this fully last line of top As quarter this trial by results setting

from agonist late-stage second is pimavanserin. learnings designed ACP-XXX our program, XHTXA that's new to next based on Turning clinical ACP-XXX. inverse a been

We focus three have areas specific with of ACP-XXX.

second, time higher doses action. seen of ACP-XXX; enable to third, the to improve and to eliminate to signal testing first onset QT of pimavanserin; with is mitigate prolongation The or of

supportive Our data literature of starting are meetings to at to these We're follow. of the to data these. publications each with planned date medical medical in share

QT example, in prolongation. likelihood potency cardiac the Neuropsychopharmacology shared the ACP-XXX supporting nonclinical For particular ACP-XXX. of ion lower done demonstrated we've College importance, for at some certain lower a with meeting, American December, channels, we characterization for Of of

ACP-XXX to psychosis, Beyond of XXX first publish this Alzheimer's this the is included we nonclinical we over designed hallucinations program Alzheimer's the With the are condition program, II through Phase our promising Currently, ACP-XXX commonly develop are from patients, year. a for Phase course III. enrollment testing placebo-controlled to delusions. patients with foundation, global Phase II We've and Phase I pursuing which program in a of we disease study. seamless indication intend double-blind, the that of about XX% consists

XXXX or second first LBDP, Lewy our most alpha-synuclein living Patients protein with year. mood. dementia disease around first As Body the causes We alone, Lewy a to estimated people which can update brain. by behavior X of the this have affected. body abnormal one is dementia with in those last enrolled Phase and deposits we is in quarter time dementia. ACP-XXX provided program the called plans results announced common indication, the month. to to the line thinking, also of II of a is of ACP-XXX, changes see of body Dementia We've top associated study Lewy substantive a movement, with U.S. middle plan line In on then the have over the are that next it million Psychosis, and for

promising LBDP, subgroup studies initiate provide third II this potential prior with We could of meaningful and small patients hallucinations in have of study there population. with a patient Phase impacted to profoundly suggesting ACP-XXX plan in a the delusions LBDP this the In on pimavanserin, the of to impact were results for that quarter year.

ACP-XXX. for the of addition from worsen essential X to newest first-in-class, It tremor. the to which turn we voice a alpha our potential chosen develop now announced license highly our all include body. treatment tremor Essential head, Saniona and exclusive mainly ACP-XXX, positive stage a in I'll selective clinical In is that can for over of last shaky we to an shaking uncontrollable year, modulator November pipeline, have allosteric nodding upper of characterized the a movements, time. by hands, using difficulty may and GABA

to impacts, with patients impacting functional is its tremor reduced some social can therapy. receiving and U.S. to the of roughly kind avoidance tremor million in of currently Essential X quality addition common, of them million lead X a essential In life. roughly

as ago, years improve and with treated look approved a U.S. more The XXXX. as II than literature came study I. in We market estimates to tremor Between initiating product then, to for treatment. collecting we're now the Phase essential in don't and of that forward XX half suggest data only many more the patients in Phase

an plans and focus to needs population. account elderly particular into Our take the cohort of is that dosing the our potential patient ensure development full

conclude, a comment our quick I upcoming June Day on Before on XX. R&D

the stages. first the across a beginning indications, Day time last members at our more to As of development we mechanisms disclosed R&D the Catherine month, some our of mentioned range R&D opportunity a time of in view call, spending as forward the Acadia's some showing shared and for programs team. the breadth additional of expanded action of parts of pipeline, newly We our to at pipeline well on of as introduce the look

I'll now to Mark over a it And turn for update. financial

Mark Schneyer

Liz. you, Thank

Let's year full now quarter quarter review fourth fourth of our from million and fourth XXXX, quarter we up recorded the total in XX% financial of last year. XXXX In the revenue, results. $XXX.X

For prior XX% $XXX.X year. the of up XXXX, year full the million we from recorded revenue, total

price Fourth quarter up were year. volume sales were and to X% up sales DAYBUE the growth. from net net sales gross XX.X% comprised year-over-year. million, quarter, up compared for XX% XX% of Full was Sequentially, million, DAYBUE net the DAYBUE $XX.X XXXX. year the year X% for $XXX.X full X% to product third were $XXX.X DAYBUE growth million

year-over-year, were million, XX% for sales quarter year were net Full sales gross was NUPLAZID split the million, $XXX.X up evenly sales and NUPLAZID net the NUPLAZID Fourth NUPLAZID adjustment gross year in price. The in essentially $XXX.X also to XX% split essentially net year. was evenly year for product was net to product XX.X%. net between quarter up the full price. net to million volume and between for The net volume the compared $XXX.X increase prior XX.X%.

XXXX, from from decreased R&D to due payments in decreased XXXX in in to million stage expenses $XXX.X the by programs. XXXX, development mainly costs for partially clinical increased full business offset million year $XXX.X

to U.S., and brands in of increased increased costs $XXX.X transition. XXXX, NUPLAZID DAYBUE XXXX $XXX.X costs SG&A and expenses driven related DAYBUE the onetime CEO year to the U.S. million from support to to outside commercialization for in investments in marketing the support primarily by million full the our

voucher on and the $XXX.X priority primarily the XX, for cash from driven million, in at million, the million balance review flows $XXX.X cash XXXX. QX XXXX, of sale December XXXX of up our from operations was resulting by Our from $XXX our net substantially cash balance end proceeds of

guidance. XXXX our to turn Let's

be revenues total U.S. Beginning XXXX $XXX net million. XXXX DAYBUE, the be in in the range in to range $X.XX of to billion. of expect We DAYBUE to $X.XXX to in we expect with sales $XXX billion million for

new assumptions XXXX. While approximately the and number funnel for referred range top patients this into more At the many XXXX XXXX. of are influencing expect the takes who to referrals we scenarios, compared is during as new of guidance the DAYBUE into the generate factor patient range consideration range, primary in the the XX% midpoint to of

to and net DAYBUE volume year-over-year anticipate total net X.X%. of growth as price XX.X% we to gross growth the terms project anticipate range, across of between XX% we approximately X% be to only In We growth XX.X%.

to XX, part accounting the related Part Our as our DAYBUE to expected year-over-year the the impact specified is the August Inflation D as does qualify pricing January gross rebates for early launched accrue of as net of redesign well action small increase for was where to after it we as XXXX. Medicare not manufacturer Act, phase-in as additional Reduction

I'd expect insights also progress year how share some like for we on to to DAYBUE. the additional

price the three, is and sequential of fourth to sales DAYBUE three D net $X.X DAYBUE, QX. expect typical in approximately quarter two, primarily one, We QX; accruals decline in seasonality sales; bottle is the to attributable Medicare for net of beginning a year in a Part mentioned. be net estimated just that sequential I which due the This in million the decline redesign to per pull-through the of factors: product

As a year, to we we expect price quarter-by-quarter and in QX, progress basis. volumes on through the net starting DAYBUE increase

sales Net to ex DAYBUE guidance. our addition program-related in for ex not a total or expect U.S. included sales markets DAYBUE, from net of access net revenue amount contribute are certain In in in revenues managed U.S. modest markets to U.S. we sales XXXX.

Moving to NUPLAZID.

price. split range expect midpoint $XXX roughly to net We million. volume the in At and evenly million expect between $XXX the range, we the to be of sales to net increase be net of the XXXX sales

XXX phase-in reduce to expect small gross other to in reduction of and points Reduction Inflation for We specified this to part by the increases the approximately be basis as offset by to manufacturer Act gross partially to NUPLAZID net net due channels.

to project Medicare net fluctuations quarterly Part As be gross NUPLAZID D such, XX.X% net in due expect Furthermore, we year. to no NUPLAZID full meaningful between gross for for for to XX.X% redesign. and the longer we see the to to

expense expect is and million $XXX to be increase our million. XXXX costs and an R&D between in expected compared broadened advance clinical to to R&D and $XXX R&D We spend The as primarily attributable XXXX we have in increase in personnel portfolio.

We year. U.S. expect to SG&A expense due to in be the NUPLAZID, million primarily in SG&A support outside is U.S. and the full of of costs support between an $XXX for investments million year-over-year to DAYBUE to the and to the continuation in DAYBUE support growth $XXX The DTC commercialization personnel increase

was regard profitable cash, expect basis, in of approximately on priority in attention totaling with XXXX payment include to million, we to. are both sales remain plus the to from that milestone of your a our to net Neuren's number operating achieved the DAYBUE, XXXX review of while the These voucher. Finally, QX which the cash like outlook outlays proceeds sale of reflecting an initial in XXXX, Neuren payments to there for for call the $XX.X I'd share

invoice a the payment the outflow Reduction netted related of cash $XX of Act the the of rebate million first NUPLAZID. timing anticipate We Inflation rebate for approximately net also accruals to under against

turn And call I'll remarks. Catherine now for the to over closing

Catherine Owen Adams

commercial the billion, need. and to for intend business patients in $X substantial drive where era new we of benefit our our globalize Acadia, over XXXX in advance to marks new Mark. brands a innovations growth for Thanks,

can XXXX. you achieve of on we milestones a number expect to slide, As XXXX see significant and this in

programs MAA trofinetide we we our revenue ex-U.S. that XXXX. in for ex-U.S. filed generate anticipated be QX in certain first through await making available approval of will managed soon access we will countries Now Europe, Europe as in actually our that have in XXXX

For end this to have with of expecting ACP-XXX, in by of year fully III XXXX. Phase enrolled line the a first top expected half we're readout the

year Phase enrollment in II ADP Phase in to II year. line we in of of In this mid-XXXX, our initiate next also complete quarter the top in study and study terms around expect results ACP-XXX, a LBDP third expected with we'll early

sales, We'll billion first at From a to new era corporate it's have our expect in $X R&D we Acadia. our can of excited really to the companies with guidance, biotech. from progress you made share Day. as annual select And group recent joining year as standpoint, the a in net see exceed a you unfolds. ever we've very more months and in with I'm pleased

I'll the it for that, Q&A. With turn Operator? operator our to over

Operator

Our Ami Company. the Instructions] [Operator from first line question & with Needham of Fadia comes

Ami Fadia

you Just to you over more how evolution future as this the sort of with drug X DAYBUE, years? the X about should we And think of regards to next gross net or the of do sort to peaking foreseeable continue over growing see where invest behind the product?

to the we next NUPLAZID, net that obviously improvement an How do think this over to of years? be there just couple year. regards to with in gross And seems about

Catherine Owen Adams

a helpful Yes, Mark that definitely going Thanks, to gross Ami. you net to there's both with I for around. think few to details it's be more some things give

to So DAYBUE NUPLAZID net peak the as talk talk gross to Mark I'm about sales. to ask maybe as and to the well going

Mark Schneyer

On helpful to to was we some Ami. starting give Yes. year, there are net, felt changes Thanks, DAYBUE, it gross more year-over-year. color some with as specific this color

but in point it's DAYBUE, redesign -- impacts does increase less to add of us a year-over-year, in factoring XX% it DAYBUE. is it primarily changes gross X due to of it's the net. the see, you volumes than or Part Medicare Medicare of to As to as going kind D

doing low remain As but of it may actions due kind fluctuate over or we going inflation the of see as range, to mix of and rates XX in course, may evolving next future to to going pricing forward. could this relate year, probably it's it fluctuate to

Medicare D we the NUPLAZID, change had, Part redesign. to a to year Transitioning due again, this

year, benefit We of And to gross XXX for does that that to qualify as do point other small expect handful gross this benefit we net in for NUPLAZID. for due There manufacturer that. price are years. NUPLAZID basis the next net changes over the to overall a starting our unwind mix influence

over net several you'll NUPLAZID's next gross inching time So to years. up over see the

thanks specific it's growth beyond And to not achieving this that far We for give where are and over to sales, year, point here that. peak -- come. to meaningfully as as above a is from DAYBUE the been question our But on sales. look and we to expectations our we years policy the peak

Operator

Our JPMorgan. of comes question with line Tess from next the Romero

Tessa Romero

XQ? DAYBUE, patients the that a to active have think for on So way to expect is about in XQ decline you therapy where ended correct you from

target there And number end here? been is be on a the by as you year of think drug the patients follow-up, could a have treated by or that

And the long-term can you in get think terms penetration? to of what is you target

Catherine Owen Adams

question. talk thank but Tess, going the short to you. the Mark answer the decline I'm is appreciate QX there dynamics on. no, I patients but in the on that about dynamics expecting, let we're are going other

then just So you can Mark ask that you target color we to through I'm taken to a talk dynamic. he's give after And going there. of little treated the to numbers

Mark Schneyer

Yes.

there at of Catherine patient the so base time. this kind stable hit the -- on -- the think point I is

don't but for of the we'll and it patients share so continue And number in a unique is served, our We first expect to the meaningful quarter on report stable. decline next sequentially. number call, patients the we'll

first for revenue mentioned the kind sequential the the forward anticipate expect caregivers of does sequential last prepared overall that net families through quarter remarks. expectation fourth quarter. price. gross year. a and things What's go some the back pull do of the renewal net we our of in a do as my quarter utilization process between I And due I driving that are number year's and the in to seasonal in into decline their mentioned the last One, have insurance early revenue That in have decline first also question in to on to changes in impact we of

to those So factors an not sequential to drive on really due decline are that patient a the going are a expectation decline. quarter-over-quarter, revenue

Catherine Owen Adams

Thanks, Mark.

the the then for just of earlier So ask vision the I future. you've elaborate sort some to terms up target I'm call about and of overall of think to in in going the the on Tom points brought already talk treated, numbers

Thomas Garner

the Thank you you, Thank Tess. Yes. call. for

Rett #X there's So estimate be our preprepared still per tapping think expansion mentioned, going patients the the as I yet our into priority. DAYBUE. that try year and to we XX% strategy group And of around the is for are that about remarks, as population ahead, to of we

about think of XX% Again, those those with sit excellence. where of especially center we treated know outside think footprint, we you as of that a are currently major strategy, today and patients about our our broadened expansion patients commercial

us as understand expand given or is a our goal, with patient reach, our Rett going low those have the the that focus they there our XX% Rett of DAYBUE rates value a around to so we for discussion So relatively customers offers a frequency expand a be key penetration that when family.

Operator

question with of Beatty next Joel Baird. the Our comes line from

Joel Beatty

arrived your of on about Could I is The and confidence patients estimate last discuss first to between from been before at to kind number the you one noticed there's -- since earnings how you increased that? now. an X,XXX in of that X,XXX U.S. call, X,XXX diagnosed

then year? similar And fail somewhat has II you which compares question saw on think we essential different last ACP-XXX. second with I tremor but how a a discuss in that SAGE-XXX, that Phase mechanism, Can is in as and

Catherine Owen Adams

I'll diagnosed then Joel. take to we'll Thanks, Yes. over patients Liz. quick, transition and real the

as in X,XXX been we we've that. know, last So diagnosed as the launched about now we gone and X,XXX years, we've X,XXX. monitor And U.S. you And patients through of X talking we to DAYBUE, were sort the up when to continue around

in sources of data sources. terms of various that have that We number the we codes, at come in ICD-XX a cetera, different from et look

track So we that. keep

of -- also especially the diagnostics product. to in, diagnosed rare in drive first an the It diagnoses, in-market tends sort patient. increase to patients, it's patients see say each a clinics for I And normal up but tend as for around for disease it's tighten ask would to payers specific

we're how the expect And increase. but tracking XX% will data. what to plateau, of typically sort that's start so to getting that's for a would a around to now, That XX% we probably

don't question? Liz, So the why XXX you take

Elizabeth Thompson

Yes, absolutely.

really think insofar that containing you GABA across So GABA, is different to I are for XXX there's potential us that the gives and distinction program this receptors. in the like the tremor which here, opportunity we side receptors. we that to the program best the with as the what dysregulation question. very on see this alpha And effects. of essential they important really And XXX has focus in are -- dysfunction really you really opportunity safety targeted X the had target in system was at is GABA part sparing while both the some containing The SAGE thank similar impact and but of a SAGE think

Catherine Owen Adams

Liz. Thanks,

Operator

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

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

Basma Radwan Ibrahim

Basma This Marc. for on is

cycle question is to first XXX its and Our life strategy. related management

if Given and psychosis? opportunity psychosis both disease bodies, going to a that Lewy trial basket be proved in Lewy the with in you trial would back whole to initiated maybe other new in bodies, Alzheimer's FDA expect the you and dementia drug dementia-related efficacious the revive recently

And on awareness. we the regarding NUPLAZID product have question another

to campaign from You currently. XX% current mentioned in X% that? awareness goal achieve? is in time to the before for need what of that And the it's you level with terms the XXXX down your unbranded line gone what of -- is What

Catherine Owen Adams

So the NUPLAZID the tackle and question. let's XXX take then we'll first, question

Elizabeth Thompson

you. Thank Yes.

as for psychosis sorry, So we to dementia-related Alzheimer's in future. going bodies Lewy to investigating a are in in the FDA get trial our body disease type And trial and approval Lewy with as in planned both try -- ACP-XXX, well upcoming psychosis dementia. currently our to ongoing not anticipate dementia would of we

consideration. it's learned very that we've through over disease I in to specific what interactions important FDA our to think see is under time the impact

with those two do to separately. So continue we plan

Phase see Alzheimer's Lewy that psychosis, Phase approval, the consistent to of in Phase III the see we for the body anticipate Our disease looking to we're data package need currently we we would trial the with existent based out would program. see results is on program assuming results going we be II. to support we the And II that design

Catherine Owen Adams

Liz. Thanks,

And call I back delusions terms the we awareness which about the treatments. to come to their hallucinations was reason conversation of and the that the last unaided us awareness where DTC referring to and think campaign campaign, low levels encourage of a start into about ask NUPLAZID, to doctors and talked them raise you therefore, was were caregivers. In reason for the around amongst for launching

we so that now at higher have we level. awareness, see been And and a measuring much

wonder also for if metric. seeing little you now Tom, bit other But in DTC the understand sort more talk could to the we're coming patients help I of to some a about team of the

Thomas Garner

Absolutely.

branded the both We're run is ensure and goal campaigns be as into means our remarks, should doing kind opening unbranded ADP actually patients symptoms that are and and raise to during with traffic Parkinson's, they seeing campaigns, we behind of as So uptick to also in the from to both through the as the the branded mentioned our disease. awareness but aware what what of engagement our both they nice More unbranded terms really some campaign, to associated nuplazid.com. driving --

of to encouraged went we itself, seeing, in mind in discussion by may the engaging the a Remember, really making around this also behind primary we've be is discuss caregiver, doing metrics the we're goal bearing NUPLAZID. suffering only that have and a, disease delusions the to hallucinations, live this with been then from campaign have sure that but middle QX. that patients And who their really early

again, So that us more momentum into XXXX. are gives what as XXXX with But we move this good come. is sense we good a leaving to some

Catherine Owen Adams

the was NUPLAZID, behind seen of to market from that, to Tom just that in the increase jump our talked and XX% in period that by we've share that NBRxs. think And XX% year. in we've I end put last earlier the a about seen

awareness now new the that show come is action, to not just and through. only scripts but driving actually, again, campaign raising So we're seeing

for the very we're So encouraged by those question. Thanks specifics.

Operator

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

Tazeen Ahmad

I Prader-Willi. Great. a question had Okay. on

the are to going look for about talk to secondary that looking endpoints think those those you we about us with important and at, of to you what some be can be As should secondaries?

like about not, the And does to are And you pursuing same treat what there question if about disease. your the one advantage overall the a curious be? with approaches in different think is what of I maybe companies competitive twists approach? Prader-Willi. was just seem approach landscape could right And It few an if

Catherine Owen Adams

Thanks, Tazeen.

more the about So trial. let Liz I'll answer specifically

to Soleno just especially think multiple we're high like Prader-Willi, at areas that are action we very I mechanisms level, at in looking different be unmet is. patients, that there medical the fact a going are will able than confident to of of targeting be that areas need treat

you the to of the more why Liz, don't trials? specifics talk But of maybe specifically some

Elizabeth Thompson

Yes.

of I in landscape. think the we about So and trial as context about think the our overall how that

I say really of is and So family think believe, and is important what that experience itself the of appreciation hyperphagia good in I'll is we the in a portion that and there here. patient community

study And patient that so I that as on is the think we've primary our and overall of we the family focus that really, and in experience. designed hyperphagia terms this fact important of is to reflective endpoint, the think

which is contextualize that impact we is which going important are might our there, extent to people an continuous think think I just be the an impact at help defined looking expect they on really we not of levels, variable, the responder ACP-XXX So seeing primary seeing treatment. have also with -- endpoint, I to but benefit

of evaluate I our at endpoints, to be we going physician looking those that is well. assessment in that to are think there in terms how to XXX primarily are hyperphagia as trial. meaningful. assessments secondary able have Certainly, But impact are those the being assessment. I be other in very caregivers and important And important we think success there our going

that a reflects terms that approaches with echo different just different says number And are that the of I population we fact there. needs. think this out I'll complex think is patient there a of this what Catherine and -- in

For the programs that's other example, sleepiness. daytime in one on the out there of is focusing particular

think this patients. lot population. in patient for a the meet is that that goes different there on again, room agents echo, ways that in multiple to we individual of So needs there's And work

Catherine Owen Adams

Thanks, Liz. Thanks, Tazeen.

Operator

comes Our Mattias the with Paul line next of question from Stifel.

Julian Hung

Paul. for on Julian is This

swing NUPLAZID uncertainty? be could guide, little just about what incremental driving provided bit years talk you there a little in Can the On wider what it's bit the potential past. you factors and than a

will the just of in reimbursement continent. you you that allow with opportunity gives large a what the prevalence I obviously, data generated thus favorable EU, the Rett you've in that the guess region? confidence achieve for to then far And

Catherine Owen Adams

Julian. Thanks,

ask for both is to achievable, year. aimed I'll through thinking. I'll ranges some the say versus slightly and we've for year. So pragmatic with take brands the yes, guidance wider guidance outset with the we've at to guided very feel set we've Mark this NUPLAZID year be you I our last of this comfortable What that and

Medicare a the But going little there dynamics that landscape particularly new specific around on NUPLAZID, bit. with Mark are let some to just talk I'll

Mark Schneyer

Yes.

Tom highlighted kind of our think initiatives. I commercial

typical about of of that this of put the volume. D range which there's it kind that, your more price could new impact effectiveness net I Part So volume redesign to I range question talked be our of can earlier. is What's possibly would out for as would come year the Medicare to impact a NUPLAZID.

So some tailwinds there's potential as as well headwinds.

patient As this you out-of-pocket year cost know, less. the be will

be will volume, on So the on while increasing. that incremental their payer benefit can provide side, costs

headwinds be So there it's could that possible there. some

broader expectations have this in they our years. been thought year a with and than range be just widen prudent a it was So this the being previous to as new little could uncertainty, environment, we some

Catherine Owen Adams

to think to we narrow through it understand the quite Medicare the the the it's and understand fact as but we'll our to of year that to move that start wanted year look guidance. we is say fair guide see impact to to we before volatile, I them those nod wanted narrowed dynamics, we and with we landscape the a really a And start to range, better we

for So with that, next I'll question. ask

Operator

from... Our comes next question

Catherine Owen Adams

Julian apologize. question EU, did. not temporarily I I've which but forgotten around Shannon, Sorry, another the had

what So Tom, confidence we're to our doing EU talk don't and why you there?

Thomas Garner

Sure.

for the which we're from carefully during We opportunity we've mentioned about Europe. handling I had a already, very believe that already asking requests the say we're the in prepared remarks, and exists can as of that drug excited rep So caregivers number judiciously. we

an that a really QX same make of in demands the that year. experienced Zug also at we next see tenured, the to European be focused referenced, market we And we're can building going as time, in sure based of team meet the approval quickly that's I as highly anticipating to but we're

KOLs leaders, patient to good we're where So seeing encouraging. community going. I sense really, as engagement think the been also gives the from which a us we're and that has really thought

obviously, us time. more through I really of our think LOTUS year all and data as additional from to data, a it as generating are European that's this our the the We'll comes go we will we continuing, opportunity give of to supplementary the this that kind we have discussion. data believe bolster filing

confident very feel about So DAYBUE's we in outlook Europe.

Catherine Owen Adams

Thanks, Tom.

Now we Thanks, next question. can open up the Shannon.

Operator

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

Gregory Renza

quarter the where optimal with technical congrats now? speak Team Catherine, Acadia's current respect of, a of looks the even to of where out, Perhaps color than different on rightsizing vastly area I'm the success or ago. progress. the aptly the that pipeline gaps as just build you've noted stage, additional that whether on even you exploring curious see And getting in the therapeutic it's that investments state, and right are dimensions you Acadia's to interest. you a across external pipeline little portfolio those

Catherine Owen Adams

Thanks, Greg. for pipeline. the Thank you acknowledging

both about and also excited and deliver and in color Liz within additional excited at milestones promise. at we're very Day. the going to possibilities And the 'XX the all will 'XX our the be that are on R&D that looking We for to team be we're sharing there our

focus That's how built eye strong to a had there. always company, we our we've has Acadia say, you as But to continue and BD.

as earlier, excited at to our I year neuro-rare announced outlined some to but look earlier which additional core also neuroscience strong we're sheet, this Mark we at think our look balance spaces in spaces. might to and core fit areas, our with also Acadia aligned expertise adjacent cardiovascular, allow endocrine, areas beyond us those as in of such competencies neuro-rare which immunology, and rare capabilities sort into under therapeutic our expand the areas,

at to move opportunities. about I of think looking pipeline we of QX, into earlier any of very several fill as at looking investor out the the sort end we're diligent We're stage. this year, our come team meetings and

evidence, to potentially where us medical win need best-in-class. clinical that's we bar where at the think high can scientific strong looking high bring company play market a first-in-class our and importantly, like I for for key something can Acadia is to unmet and or areas either of

hold I to It been with DAYBUE. keeps will we the the and held written And continue that's that Liz will be we that XXX bar that's NUPLAZID to and high think for and will XXX, and on. and XXX that same focus

the for question. thanks So

Operator

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

Charles Duncan

being in you appreciate guidance. on But wondering all refreshed enrolling and had 'XX age not I the pipeline that persistence communication. Congrats, I'm of if And of the or be big and new. not commercial see that's specifically Liz X a there a an team, going, there around able XX, has has is whether in a been HQCT But to extension question expects noted Catherine terms ACP-XXX, are to range there on call and and the range and in signal. study there a she execution open-label thought I on to an that? age-related, it, is impact if I rollover? dynamic And

Catherine Owen Adams

ask I'm Charles, to that. great to to going Liz hear from take you.

Elizabeth Thompson

to So Charles, great from hear for great you. question. the Thanks

try start sign which extension continuing program, the an I'll seeing to not are to to is, in one I do open-label and open-label at that's always the which with have are neutral good we rollover but for interested As that, positive we that least usual, extension. the overread, first, patients on into yes, easy a

set patients. to this impact is do tremendously age age, that of range dynamic to data have the range. I that we there and lifelong the us generate we That disease think don't we're said, the out that for understand in the We important a as that far across age up across think As range, information this these strong helps it's know well study.

make think I population. patient the across So it think we that have that to understand that answer, we impact the is important sure do don't the I but perfect

Catherine Owen Adams

Right.

I think question. definitely it's Thank Charles. something right? through the to learn going you, study, Good that we're

operator? question, Next

Operator

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

Chi Wen Chin

on Athena is This Ritu. for

Some questions on DAYBUE.

noted patients You XX% the of titrated drove currently improvement strategies And improvement? your rates. is You in on this out drug? recommended what been stable DAYBUE? going expanded patients that utilization discontinuation What have of also there sales maintain all a mentioned force does represent and the stable that the was What doses. to are to more who to deploy try percentage

Catherine Owen Adams

those Thanks, Athena. questions. on to I'm ask going Tom to color some you give

Thomas Garner

Okay.

for the you thank So question.

to consumption begin on focusing So with.

continue see had we consumption on moment, of average, So seeing target to label. we're on about a complete slightly since launch, XX% the over cohort we've actually time. patients upwards yes, treatment At our the tick with alignment for

But the XX% kind their is year that's is saw of tick end their on of that we're of of fact the So getting per kind that reflective that up seeing, XX%. we we what patients towards through what know they're and do potentially occasions guidance dose that from slightly the titrate HCP.

So we're that like. looks what encouraged by

In was regarding terms which XX% of the discontinuations. your second question,

great Rett we've journey, know, launched you about as product. have DAYBUE we patient the So deal also but a since learned dynamics both about the

as DAYBUE to what we they we obviously with journey. have And of really family And understand sure managers, care starting they our one one-to-one a learned a DAYBUE that expect they thing begin that patient that making is they make requirements of well, Acadia we get their dedicated the Connect as have and start access through team, team sure can treatment.

one on they that have and patient is see the great this going sure DAYBUE, that to that value able ensuring DAYBUE a and XXXX to the that understand appreciate sure benefit make message, for long needed and hand sure be fully of going the on just they we're lot through manage that deal they large. they're with we efficacy expect product to a both everything education. the thing around to our as So start that's making HCPs writ focused because make for term It's what the is they consumers with to that how be to that that is

we for this and patients. longer. months that and I our XX this or now group mentioned on than The is we patients now remarks of have my treatment that other during mention, greater would of stable prepared have thing Mark, to want XX% been do think both I very

we ticking over that So have stable we're And patients. see given up that, and again, time. actually consumption do base of this growing our that rates dynamic, we encouraged

that So I question. hope answers the

Catherine Owen Adams

We'll Athena. take the Thanks, next question.

Operator

next line Kulkarni from of Our the with Sumant Genuity. question Canaccord comes

Sumant Kulkarni

of bit angle. specific has picture bigger Acadia-related a but a It's question, a

might terms high the the forth changes FDA Given program any back you make generate do what different things into a with of indication? versus agency III data expect you're in well Phase in at your you Prader-Willi, on is a the what might that in unmet currently potential that you need foresee and

Catherine Owen Adams

Thanks might ask question. FDA interactions. about thought for somebody the We

that? yes, So to want you Liz, would to talk

Elizabeth Thompson

it's to a speculate mean now. hard I Yes. little right

that potential across a evolving risks. this obviously about think know was reorganizations agencies, out all is today space. there quickly I and We memo came just that that large-scale potential

on and the of else far to time So specific say either broadly eye changes speaking, what -- like we or everyone the say I'll not is I are over have yet carefully we, tenor an those broadly that of we've have time. we generally, But PWS. And carefully our interactions. in interactions space, regulatory so would this speaking, seen in watching tenor not seen impact But on to interactions. in be going keeping not

Operator

to Catherine the turn Owen closing over to like now back for remarks. call Adams would I

Catherine Owen Adams

everybody interest for and for Acadia like forward all connecting and in just look the Thanks. in their to I'd with today thank future. their you to questions

Operator

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

may disconnect. You now

ACADIA Pharmaceuticals (ACAD) 26 Feb 252024 Q4 Earnings call transcript