ACADIA Pharmaceuticals (ACAD) 4 Nov 202020 Q3 Earnings call transcript

Company Profile

Participants

Mark Johnson	Vice President, Investor Relations
Steve Davis	Chief Executive Officer
Michael Yang	Chief Commercial Officer
Dr. Serge Stankovic	President
Elena Ridloff	Chief Financial Officer
Ritu Baral	Cowen
Neena Bitritto-Garg	Citi
Cory Kasimov	JPMorgan
Jeff Hung	Morgan Stanley
Marc Goodman	SVB Leerink
Charles Duncan	Cantor
Tazeen Ahmad	Bank of America
Andrea Tan	Goldman Sachs
Roy Buchanan	JMP
Yatin Suneja	Guggenheim Partners
Alan Carr	Needham & Company
Gregory Renza	RBC Capital Markets
Danielle Brill	Raymond James
Sumant Kulkarni	Canaccord

Call transcript

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Operator

Good day, ladies and gentlemen. And welcome to the ACADIA Pharmaceuticals Third Quarter 2020 Financial Results Conference Call. My name is Giji, and I will be your coordinator for today. At this time, all participants are in a listen-only mode.

We will be facilitating a question-and-answer session toward the end of today’s call. now Vice turn at President would to presentation ACADIA. I Johnson, Mark of Instructions] like the to over [Operator Investor Relations Please proceed.

Mark Johnson

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

on today call provide our a will ACADIA are overview review performance and of our of the Chief on Steve Officer, business. Executive me from today’s Joining on financial our will who an who call Michael Davis, commercial Chief QX XXXX Serge our Dr. Officer, updates progress. discuss who us Yang, will Commercial Stankovic, provide joining our pipeline President, and initiatives; Also our our

Our Chief Events are the using for point available your turning financial before it we our Financial back also are on out the questions. to that section I our call discuss up would Presentations final Officer, like opening Ridloff, then Steve to supplement in and detail, website. will results which of more for & slides, Elena remarks

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

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

Steve Davis

Good slide turn Thank joining afternoon, today. you for five. thank everyone, to us Mark. and you, Please

have significant strategic pillars. made three progress and our We important on

or psychosis NUPLAZID combination best-in-class for PDP activities. growth virtual of Disease patients in-person First, engagement with Parkinson’s driving of the and through we are a

opportunity, Our second the second acquiring pillar And is indication representing development delivering by on and addressable DRP new new XX-fold third, for we in assets. innovative the a market our size pipeline advancing NUPLAZID. psychosis a potential or developing are treatments dementia-related increase

review starting on detail in Let’s greater six. slide

treating third these achieved net XXXX, a of the of a For commercial This testament driven pivot million is year-over-year NUPLAZID of uncertain a importance in by well as quarter increase, our sales, successfully times, as $XXX.X execute to PDP. ability execution. in result and direct to XX% strong the

performance year-over-year net midpoint million reiterating As million, at XXXX, result to of $XXX representing be full are growth continued in our we year of the the $XXX our a sales XX% guidance to between range.

the achieve DRP addition to long-term to the well-prepared look NUPLAZID PDP of market in and the forward opportunity are We for indication.

seven. on to move slide the Let’s opportunity DRP

delusions We are dementia, could of represent nursing hospital pimavanserin with treatment morbidity first Dementia-related only and with as psychosis. for caregivers. high be patients mortality. dementia medicine excited increased a placement, the serious and is of increased likelihood and risk Dementia-related consequences of for of that in admissions the for and burden and and home patients FDA hallucinations Psychosis repeated associated such approved progression

April review will the and in work our with NDA efficacy their XXXX. to safety continue data FDA supplemental and facilitate PDUFA X, both the a confident are supporting we with of We to date

of negative shown our trofinetide Syndrome. with pipeline the with We studies stage slide late for progress the schizophrenia X of as ongoing of on but symptoms development pimavanserin treatment in treartment with and important continue Rett to make for eight, Phase

the treatments. investing the In improving a through including need. unmet we exciting potential and two diversifying ongoing muscarinic our brought cognition programs from approaches focused this receptor investigational remain on an in development program, University. pipeline neuropsychiatric third significant very part spring in of new collaboration our of differentiated are we on As strategic Earlier ACP-XXX In with and by we research focused areas year, program we this to pillar, bring Vanderbilt. expanding symptoms Vanderbilt in-licensed to with

class Therapeutics, Over acute CerSci and the treatment which pain summer is a of acquired disorders. advancing we for first neurodegenerative candidates non-opioid focused molecules stage portfolio earlier in chronic and the of on

update, afternoon. Finally, one to like disclosed later are this share in the be I’d positive following more which we XX-Q will

that its pleased not be of are the to to Justice discuss investigation commercial over company Department it I any to We will recently concluded the now taking further performance of and notified report it will turn With Michael our that, that us has highlights. action. and

Michael Yang

would I quarter and fundamental to for our the business new in NUPLAZID Please strength Today franchise. gives slide confidence us of which Steve. you, a our to XX. expectations review turn performance, third Thank long-term like highlights the

sales prescribers We new of momentum we have net driven quarter, both of positive new our of channels. growth year-over-year a driven million, this quarter, $XXX.X and base by delivered In volume XX%. in the third growing patients

growth interactions. appropriate with was and result our of of in-person best-in-class COVID quarter’s virtual layered This opportunistic mix tactics a a

to have well office all of programs, in for received in We promotional have well. which return instances an to offices several as able been been as physician visits,

PDP stimulate about their is we our commercial solid treatment patient continue Our physicians NUPLAZID. and foundation to with digital as caregiver and to with leverage platforms conversations

remotely. has overall Especially continue strong invest the in to contributed pre-COIVD new as at pharmacy ability remained prescribe performance expectations. to patient channel we NUPLAZID Importantly to the growth

rates the for In quarter continuing consistently and remained new fulfillment patients high. both in monthly addition,

their care third to get LTC from on the In on COVID months seen related quarter have observed of care now mentioned standpoint over past we temporary long-term As for impact a the the open couple in growth have an able new we back call, that we were doors our channel. to long-term facilities prescriptions and last we the admissions. the NUPLAZID in operational stabilized. track And channel

build and range records broad pharmacies. We health a to professional and partnerships organizations of electronic continue with national systems

products Overall we serve located. to continues wherever on to basket other well-positioned well a perform according relative LTC a IQVIA. NUPLAZID outperforming the patients needs result, a NUPLAZID with to basis, they are of PDP As promoted are of

psychosis on XX. slide related discuss our initiatives dementia Let’s

disease DRP awareness preparations recruitment are on Our track. including talent launch and

are on market initiatives the stated platforms. education We disease focused through preparing and

unmet For over we website quiz leader views X.XX exciting launched a with disease of in for MDIQ since the opinion focused our The including a and on several million have education capabilities virtual enhanced key panel updates example, MoreThanCognition.com, introduction DRP. videos dementia-related neurobiology generated our psychosis, webinars. we and need new lives, expert

more sites such syndicating third-party also are our Casts Medscape. content and cognition We than from Health Doximity, SERMO, on as

presentations and DRP. active with PDP Congresses be very Medical theatres several We continue to at and disease education on

better a data reaching we for to of in dementia-related all doubles almost of were generating psychosis. psychosis annual diagnosed Managed payers. with psychosis showed are the understand year poster average patients, the completed administrative evidence claims and month. newly of last Pharmacies DRP recently impact the Nexus cause from costs Medicare a that that of presented during nearly analysis compared addition, We Conference an perspectives Care In their These Academy first at patient a dementia-patient $XX,XXX to without results the providers

to Dementia. sponsored Wish released a Dementia and partnership Battle to a film Lewy and Williams I from SPARK Robin’s film symptoms. dementia Additional update Body is titled academic this Lewy length over development our and and will will major association Excellence we will education with to who be full its disease turn pipeline. his drive adapted provide Center awareness on on research the SPARK-Robin summer awareness it Body Serge with education available now institutions opportunities include and an in of

Dr. Serge Stankovic

to slide Please turn you, and Michael, XX. afternoon. good Thank

First, well I am pleased would review to the is of expect. progressing going and as we report NDA supplemental our psychosis that dementia-related for

We the Xrd FDA to are are date. working the the timely review and in with fashion track on PDUFA facilitate for April a

to from study need that progressing clinic innovative Rett them earlier enrolling with year. the studies are for is and two enrolling is CerSci treatment we We growing ACP-XXX advance promising in also assets in half high are reflected next ACP-XXX unmet X the negative well. Phase on in the site results of for ADVANCE of The for on treatments schizophrenia new the X treatment year, of patients. and acquired of our track pipeline. topline and our and developing well on next focused clinical and working with Vanderbilt second this is year. remain advancing The and Syndrome remains Our symptoms diligently bringing new study strategy from Consistent Lavender

to four at week’s RSDA exciting I estimates of dementia-related acute XX of clinical ACP-XXX, chronic a first trial ACP-XXX moderate pain problem and and neurodegenerative which the will neuropsychiatric the non-opioid Now acute in in including one-third several and in of both the CTAD. presented clinical has X the slide in or This Exeter with chronic impact Conference of discuss with cases. a represents with our University which the Clive promising and species School on the of pain. new analysis about initiate half have Medical U.S. disease prevalent of X it brought studies in Alzheimer’s this or CDC shown data and pimavanserin of cognition United models like health testing consequences. of in data highlights affects year animal team we would to is scientific is Chronic of compound acute adult seen from favorable have Boller being that severe on both approximately for in Phase in major Slide pain is first-in-class present investigating on the being next on the models ancillary acute treatment Friday, and will mechanism significant CerSci related accelerant the new pain. is decomposition the we from program of vast and Furthermore, pimavanserin reactive acquisition Disease and patients psychosis. pharmacokinetics we tolerability and economic Dr. extreme XX. pain. symptoms chronic ACP-XXX with of or Therapeutic clinical some to the results In studies, population clinical compelling placebo-controlled present more following Phase pain majority surgeries States about XX% severe

Pennsylvania on the a of with present function motor Dr. in from multiple of data, safety in pimavanserin populations. with with the In pimavanserin elderly addition, University role Weintraub Daniel patient patients to in across remained presentations support will the analyzing Pearlman’s poster impact supports dementia-related pimavanserin continue studies. Medicine at the these especially the of treated patients The vulnerable overall profile School psychosis. We at in clinical clinical the CTAD potential breadth of which encouraged of

Kaplan-Meier to September turn Medicare patients Parkinson’s cohort. that pimavanserin another was in antipsychotics Finally, takeaway or supporting disease that International cohort slide I patients curve and a conducted the financial the now the the an study and in interesting described of was The primarily pimavanserin way view University members days of of were Disorders pimavanserin a Services of and Movement separation to mention you atypical graph in These this with compared mortality the to before year’s on survival with atypical associated With homes. call Virtual U.S. antipsychotics findings higher data this reduced the was Congress and poster not in XX. XX% who retrospective treatment atypical atypical group on safety is survival growing year of the antipsychotics. outers either body and pimavanserin for profile. Stanford in presented Medicaid is performance. treatment treatment Medicare through pimavanserin line the The in I among over with slide key of includes pimavanserin The during discuss with is which exhibited Society’s like This are the treatment therapy Centers specifically that one and the figure the encouraging to exhibited describe would nursing our XXX FDA, to for that, to concluded from will treated Elena antipsychotics. It Parkinson all-cause contribution we see probability compared [ph].

Elena Ridloff

Today XXXX quarter That’s $XXX.X Thank increase XX% This sales. compared XXXX QX you, quarter an XX.X%. of to for with third XXXX. I The our were of the net to Please XX. at recorded quarters. consistent volume adjustment net by million XX%, QX end of is in gross discuss turn million to Serge. the channel driven financial previous the approximately $XX.X sales of inventory results quarter, in of slide net we updated growth outlook. third approximately will year-over-year. the in our Weeks was and In

due expenses the QX, P&L, XXXX. the increased $XXX.X to expense increased related to million, related Cash R&D Non-cash $XX costs, million, the quarter million included consideration down in is SG&A XXXX. stock-based and XXXX. CerSci and year. personnel well same acquisition in $XX.X during $XX.X compared XXXX. increase million million in $XX.X compensation in and transaction to in period quarter, advertising the third the $XX.X the for QX R&D last promotional during an compared million $XX.X in expenses Moving the upfront to million operations Therapeutics million GAAP in were This expense expenses compared as as of for to quarter third quarter GAAP increased to used the of in largely GAAP costs. August $XX.X of were $XX.X quarter to million from

Our at the slide to quarter the million. turn cash balance of $XXX.X was end XX. Please

XXXX in of full be For $XXX range this guidance year-over-year. revenue between the net XX% and XXXX, represents year million. to our sales $XXX the guidance are midpoint we reiterating approximately growth this At million

the as quarter obligation in As a of a higher gross associated for sequentially result holes with donut accruing fourth the to inventory net reminder, channel. year-end the is in

side be between $XXX Therapeutics. of guidance $XXX primarily of GAAP million $XXX increase million. XXXX, associated previous and transaction the This the CerSci from expense increased have to to result expenses a On with R&D of upfront acquisition million we the is $XXX million for our range to a

million SG&A reducing million expense guidance XXXX. to to be Non-cash million. of million million to in $XX $XXX previous our GAAP range million $XX between are the $XXX $XXX compensation anticipated from We stock-based to now to is $XXX

call Steve. We sheet year-end turn And to balance will with our cash $XXX over that, million of with end guidance $XXX a to XX reiterating and our I the million. will of back strong

Steve Davis

capabilities XX. with advancement Today have patients NUPLAZID a we are built slide At commercial executing opportunities. our fully best-in-class neuroscience promise in Please Acadia you, Thank with organization and strong turn to to leverage R&D PDP. to on Elena. deliver the we

larger the grow the a their to and continue much ability PDP, patients and for caregivers. magnitude help in while a to in of We opportunity potential DRP indication preparing second

our are employees updated Operator? questions. for passion ACADIA for the keeping progress, we growth. of call now depth to In on breadth long-term would will for the We forward to will brand our open and our momentum and up like look our as of continued I you franchise, of business. we thank continuing and their NUPLAZID I advance commitment closing, position

Operator

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

Your line is now open.

Ritu Baral

Thanks about question. guys. I wanted Hi growth. to taking ask for just unit the

could quarter-over-quarter the the also And volume what are You growth. Can guys retail channel give noted the unit just had that seeing channel? separate have unit by long-term you and year-over-year in XX% you you growth? us Thanks. growth if you care

Steve Davis

Sure. Thanks Ritu. Elena, you want to take that question?

Elena Ridloff

Sure. Thanks, Ritu.

driven growth SP in was was and by quarter So his the sequential the Michael volume approximately X% as in that in remarks. channel, growth largely mentioned

stabilization We have third SP in channel in sequentially. the seen quarter

Ritu Baral

question. queue. for Thanks into will it. back taking hop Got the I

Elena Ridloff

Thanks.

Operator

Thank you.

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

Your line now is open.

Neena Bitritto-Garg

now that just Hey, the Thanks. probably a not an where question to wanted is of on kind timelines DRP going point that the guys. we previously taking to Based mind their question. is the are quick holding for I you about safe Thanks to AdCom? the the ask change at discussed review. say on that FDA

Steve Davis

the accepted not advance the think could give change advance AdCom how contrary Serge, not you work we we But that would and could could we their second. in at Serge, that, you where start. say, that, when to are me us don’t kind could to information about out to time the the when point FDA at a juncture. I PDUFA us do it much just are as they their change they an at backward an mind. rule go the submission say jump plan anticipate mind. have Serge of answer But yet and then having need be not that, do at have is they you ahead you they do Let any for I want that indicated reminder, up wouldn’t filing, date AdCom this this may possible to the that and we AdCom. a of notice to And from they if indicated an they mute? juncture

Neena Bitritto-Garg

Great. Thanks.

Operator

you. Thank

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

open. Your line now is

Cory Kasimov

is this? all outreach suggest I new your even is of this market appreciate I mean, doing probably comments DRP awareness level about education guys. question you in afternoon are what disease disease potential for from launch. and Michael. the I Good like am what curious research you for kind learning anticipation or on made preparation in the guess This are you I demand the for plasmid in Hey. DRP of time? the pent-up at

Michael Yang

Hey, Cory.

Steve Davis

Michael, go ahead.

Michael Yang

Okay. Hey, Great Thanks Steve. Cory. question.

great So is that all associated part on areas the have EPS, in I them treatments cognition, that particularly compromise they understanding in see side, enthusiasm, of motor the think there with practitioner that we things. other some disease market the more because there’s is a research have healthcare surprisingly

rather with efficacy were without new as that physicians able important the really the and mechanism safety that that function plans, well that And potential know, well, safety profile together the then into in trying to motor efficacy today. that’s socks you profile to are we establish they have the to which impacting knocking impairment. to ability and So are I our think PDP, is platform cognition into that really safety the We without fits -- off do of deposit. don’t with do regards is

I we So are think a audience. reaching good

with help will doing I are think of we their well the lot awareness. on the consumer the think I the engaging on side. in a Spark Film really terms physicians But in

Cory Kasimov

the question. Good to Okay. you Appreciate hear. taking

Operator

you. Thank

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

open. is line Your now

Jeff Hung

and hear Thanks. starts of trend persistence you seen the talk in as changes wondering what over new COVID of so any we increasing? have month have last cases seen was if you and I question. the for about patient Thanks you taking on can or if

Steve Davis

want to that? you Michael, take do

Michael Yang

No. Yeah. Sure.

based persistence on seen office side, patients we we Long-term high see prepared mentioned have where consistently as not new if our I mentioned any starts care a pre-COVID stabilizing. a remarks level and to or we in As impact add neuroscience and have fulfillment there. performance my

a as are basket mentioned. We I of products, outperforming

of the start important have wide to patients and provide the to I a it’s in vocal really obviated and mechanisms prescribe that a I environment. they symptoms PDP able think of to been think treat NUPLAZID think for hasn’t we more I even digital NUPLAZID thus variety pandemic become remote and

in in are or think whether we are home the office nursing we actually remote on or So side. they patients catching the even the

are our patients. really capture about good to standpoint, I we the think, So feeling potential from the

Jeff Hung

All right.

Just to clarify, did or that last well? was XQ then month as so pertain strictly that also to

Michael Yang

Well, I in care would the seen last for stabilize long-term say, we few the have months. market there

and starts at I side quarter the for new fulfillment third retail the think were side. the neuroscience persistence on of

Jeff Hung

you. Thank

Operator

you. Thank

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

now line Your is open.

Marc Goodman

Serge, first kind of about have what concept data look give of you you you RSDAx at, in I us little confident a so you talk can proof we seen, here. ACP-XXX, class, something mean of have sense just could maybe what did how

Dr. Serge Stankovic

do the or pain seasonal and clinical so. models pharmacokinectic of in in shown pain, results models a has pain. inflammatory a ACP-XXX in Yes. robotic displayed animal pharmacology promising we X the saw evaluating tolerability favorable Happy Phase variety pain different properties. also studies, to what And

be that as studies. well -- models, chronic pain drug particularly, are of fairly we variety our Phase on So can acute the as X animal addressing and pain, the properties confident as one well both as and as the animal models of that in based

the into pain planning both X current of next program to X and include very in development. the And it and Phase stage development. study year first are as human -- half now, models of move plans we in next chronic initiate right Phase our acute are a is to confident for We

Marc Goodman

assume models these And that… standard are am so I and pain these models I animal sure

Dr. Serge Stankovic

Yeah.

Marc Goodman

model curious, of of lot a do, was from so is just I the… have you data what … opioids animal kind

Dr. Serge Stankovic

Absolutely.

Marc Goodman

advantage? the just a an play we are obviously better here what that’s are Is but opioids we opioid than good, huge or as

Dr. Serge Stankovic

in the than such in acts are of strong analgesic it a the study. multiple -- primarily interfere it data animal the The that with to its ability obviously, has a with opioids that you do will manner the opioids saw in ACP-XXX impressing studies. of comparative we action mechanism based that we Well, And very preclinical pain on is different obviously pathways. based impressive analgesic periphery compared Yeah. properties but displays in and potential

forward. level that confidence a gives So us optimism that of move and to

action So of analgesic but a opioid mode actually pain with interfere properties, pathways. stronger and properties multiple no that

Marc Goodman

Thank you.

Steve Davis

the animal echo found the results just consistency Serge’s would of the that very we things say, thoughts. I the is Mark, I’d one models. of compelling in

we at, saw two, that the others. were happens try in animal because they comparators some for humans consistent, the I the all running least what and looked results you models But information or comparators results and relieving model, get agents. were they those would than than predictive against equivalent other in say, run pain more Now states we were models and opioids equal to disease in opioid in that that models animal are the we predictive those when know other very produced better at against that to to were the models one,

think too animal that just addictive better you play ultimate to I be an say not was into high or simply with X. very consistency compelling we hopes in it’s just whether relief and would relief say the saw of opioid pain opioid now So have would models the the get qualities. the the data launch pain we as does I a us that very than Phase early But that gives

Marc Goodman

Steve. Thanks,

Operator

Thank you.

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

now is open. line Your

Charles Duncan

Steve to to for try rule. quarter I here Thanks be Congrats and team. my on brief a respect question. and good taking Super. and thanks will the

means? aspirational that what to then revenue. am I you the perhaps, I for penetration? you of any have have for guided triggers guide? I $XXX for to for million market consistently And high Michael, And million $XXX you Elena, color think on of estimate rates. happen do mentioned fulfillment wondering Any guess perhaps side For what that year-end

Steve Davis

take to the Michael, then do will question to first go Elena. want we you

Michael Yang

Charles. Hey, Sure. Yeah.

PDP, I share fulfillment, the our would are terms that to in And your is which in full the of and that’s product regards part market is get first patients in say, you three question of patients close there month is to for high-teens, the great. a rate. obviously bottles know fulfillment in a is the that The taking

seeing. gives it of what we you sense some so And are

the We that it to seeing and rate very fulfillment per on want are we based number call per take we of high potential bottles rates that. the patient quarter track

So consistent throughout high really that. XX-milligram and we since have that’s launch been very the very year past seen the that

Elena Ridloff

around there higher range, occur in high trends we regards do -- QX. And us what your Michael would with mentioned, end in of for end guidance end the guidance us range. are to to QX his would basket seeing the need will seeing year of we our in question revenue require to a channel, prepared LTC the and our guidance outperforming about stabilization us the sequentially in peer have remarks the on the higher And that the of we to seeing we improvements and high achieve products At when beat just to guidance. as LTC are growth would of full you a improvement to think net reminder we

headwind So fourth that quarter. is a the in

Charles Duncan

color. Thanks for added Congrats.

Elena Ridloff

Thanks.

Operator

you. Thank

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

now open. is line Your

Tazeen Ahmad

Thanks Hi. taking questions. my for

SG&A. give First for a us on of one you can maybe bit Elena, little color

DRP. secondly question physicians have going a about expect we as targeted updated physicians you for higher prepping be Michael continue for maybe going you And in You that for then that about the for How forward with to much general are in you Should weren’t target information the PDD? DRP to Thanks. trend XQ. overlap there is up the launch? picking

Steve Davis

and Okay. Michael. Elena to do you first want then go

Elena Ridloff

Sure.

Tazeen. is So, that right, yes,

quarter. We a the will in There’s in see drivers there. SG&A increase fourth an few

investing on both shifted we to and costs are as activities And in-person commercial more Michael we field mentioned, you mentioned are has DRP the of it. side. As associated affairs recently more which with higher launch our medical and ahead --

year will currently things. In well. fourth our DTC towards on talk a you we end and year is about in investment to as campaign look And provide as that addition guidance air next on quarter so call, with few that we but are qualitatively the our

We our we including first next team marketing next as well these increasing education, will brand affairs investments investments be the as launch. and a expanding year, for the DRP year with to for also medical investments field well in of both part as as launch our be the support DTC will

Michael Yang

The question good In on answer have And targeting couple fairly ways we many ways. a is footprint. hey then of that -- a Tazeen. way already I’d

and example. For an care. with area deeper in in we care the example geriatric example some Parkinson’s And PDP. go patients will disease call there are long-term and obviously specialists facto basis we location. the physicians patients for also centers to be long-term and will magnitude specialist into a and Lewy pseudo within are we key are highly de their that their on the going physicians elderly physicians be to a would and with also and academic I the would good perspective, have call treating an care versus of of specialist a Body dementia which are DRP we we LTT act expansion what psychiatry as lot academic from are obviously, in in facility like coverage psychiatry specialists, have a care that And be facilities, That an dementia neurology. then mostly to general be there and going more who say expanding

facilities. will opportunities care, are terms units a we key to of larger. the care to those and LTC long-term have But patient a in that within have facilities long-term bit these on already around and group expand and centers the academic memory going focused care specifically do So be are audience we they

Tazeen Ahmad

you. Thank Okay.

Operator

you. Thank

from comes from Our Salveen of the line Sachs. next question Richter Goldman

now Your open. line is

Andrea Tan

is This taking picture. question a a big question. Andrea the for for Maybe Thanks for Steve everyone. Hi, on Salveen.

to Just as likely you ones on about stage asset? thinking forward similar you is are about last transactions additional the outlined, how this be it or you think first and PDP

Steve Davis

Yeah. Thanks start am running for Great. to it. of take question. going -- at bit start I little the I will a

kind is So our of an strategies. transactionally important part going of to

we is commercial in area. and a built competitive It’s CNS both have we therapeutic I for in in think space R&D important been think the I really clear. the the a couple One space reasons. capability highly really of

So capabilities we We to to and done. take But judicious opportunities wanted we see be and that’s deals I more be us. We and a want infrastructure have. to clear very advantage make from certain to that that coming will started that further have we reason. you leverage we of we able started strategic have those what been early for early,

the of timing. it precise we that luxury You with know sometimes timing that up have don’t able pick and to match for deal being the always profile a precise

And simply tell in will far. whether late-stage so -- program Phase but you Phase we have have X early-stage say, so both done can’t deal a or Trofinetide, X. next with deal I we the will I Obviously bought deal, be

With in a Vanderbilt program bought with we we have a and in program X the have already. Phase CerSci Phase collaboration got X

So more I be far we will drive the criteria will that have so with same is, there decision science. deals driven deals. start will just One simply and to deal our say continue additional

a a even of when early-stage be So very all doing projected products scientific assessment do and that lifecycle for infrastructure good job Two, assessing to course, I to cradle then, a case. way the grave of assets, strategy. full at of very there medical looking through a and fit we we has it be we very compelling and has assets a of to do think commercial analysis are good our

Andrea Tan

you. Thank

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

line now is open. Your

Paul Matteis

David much interesting. Great. the Hey. guy. and and to that all-cause you of these my Thanks authors Graham question. do a poster FDA Thanks. DRPS with spoken DA to thought that mortality pharmacovigilance of the correspond in involved drug authors a is pimavanserin Are typical taking senior also on kind super poster any you still comparing know I them? I was any the of Have for review? so

Steve Davis

you to do want Serge, take question? that

Dr. Serge Stankovic

To group. FDA Yeah. from drug involved pharmacovigilance, the people would our understanding, from in and safety the come the result their

the involved the this aware is in division We in anybody any are being not involved these. of group applications. of But obviously review from

no, question, did basis. the not is So on reviews your has to of did been any as on well the ongoing we as direct the they group certainly second in And safety and communication. involved have involved pimavanserin this

forward. We are looking

how for find interesting forward into a We and methodology with better we where would very looking a in or the apply this. pimavanserin. of the data and safety are maybe have obviously understand insight publication certainly line it’s But and manuscript we to little encouraged it

this knowledge our from poster presentation. at point comes So simple all

Andrea Tan

helpful. it. Great. Thanks That’s Got very so much.

Operator

you. Thank

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

Your line now is open.

Roy Buchanan

in for Thanks Jason. taking for Roy It’s our questions. Hey.

broader field, hoping, interactions level have characterize of that have Just but you current opened missed not could healthcare necessarily your offices heard patients, you compares providers? do but to in-person up for a how we I reps. And it think it the with bit maybe for

So, can just around you give that? characterization Thanks. little a

Steve Davis

to to Michael, do that? you want speak

Michael Yang

patch it the country. conditions for question. Sure. hybrid Obviously, a is Yeah. Thanks of the throughout different

our medical leverage sophisticated So facilities We the with offices. with team at practices algorithm these a to local going we in on look look at that COVID exposures. are

physician depending characterize we channel. say, by probably, long-term varies as so ranges I channel situation And another it And channel the I one region between, XX% XX%, I only by would is on care just that I general by in to it would then that channel. be question and that and would at. territory facilities answer would offices say And look to region allowed

Roy Buchanan

Okay. Great. Thank you.

Operator

Thank you.

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

Your line is open. now

Yatin Suneja

guys. question. my Thank Hey, taking you for

some if harmony refresh then XX-week have data seen consistently the that equally with not guys, double-blinded might I you think not or pushback to performed the one of the the think some we look really well wanted data all of you we hear portion. is that things subset at and say I Just dementia that,

that you you could randomize the the particular of open-label confidence in that for and broader for dementia subset? label see talk among about you perhaps subtype this gives So a different Thank both consistency you. effect maybe a

Steve Davis

Serge, do you want take to that.

Dr. Serge Stankovic

that Yeah. overall The larger dementia Well, you are as particularly, we or presented, weeks data year’s sheet with individual subset XX head data of subtype different fairly response we are look as the cohesive and Oh! consistent the the treatment. data open-label presented that last simplest actually well to a we Absolutely. and rate, response the at over of very rates consistent and when response see meetings. pimavanserin subtypes

well the variability. the decrease fewer the do as terms of of disorders response, represented strong based and patients consistency. pure sequence you the look on we little just aspects XX-week you as of overall look But epidemiology whether that or in some on proportion on obviously, the over score the responders So, the on bit based of that a subs In H&D period. overall the both affect are there of subtypes may a high that consistency a level with the is

the are In in rapidly at psychosis. obviously on the do it’s of the subtypes in conclusions. as subtypes becomes we actually stage, very and terms first is fairly that you numbers see dementia for to that consistent to overall represented prospectively better the the -- related small when But well. response the of difficult very -- the all, defined section analysis But double-blind double-blind spar but those draw a some look

disagree we the with would variability seeing. I that So are bit in is a that there characterization the little response

Yatin Suneja

Very Thank helpful. it. Got you.

Operator

Thank you.

Company. line Our next question comes Alan from from & is Carr the Needham

Your now line open. is

Alan Carr

now and taking so your on what about COVID-XX. to is for which spent Yeah. Michael budgeted, what bringing changed your XQ, the Coming the how And -- SG&A marketing this for Thanks has back specialty Thanks. wondering COVID-XX upon related changes to am I guidance going am open. curious to some drug I much marketing, down in year. extent still is permanent? for or perspective of that’s your

Steve Davis

go Michael? to first you want then do Elena So,

Elena Ridloff

Yeah.

in due think we So engagement be the fields operating extremely engagements returning programs flatted to are you and and other of the to while the do Michael, largely environment the speaker as are possible current virtual. question? continue second when in-person and the Congresses piece our

Michael Yang

Yeah. Thanks, Alan.

would describe really a building leverageble way I up are COVID think so digital I engagement I the that remote muscle think it future other environment and the environment. are capabilities many to in companies going standpoint the a and is in and and sustainable I shore opportunities think ACAD from

that’s we our a in we part response speaks getting the drug seen to and benefit. So in have I that am pleased think and pre-COVID certainly and of expectations a the organization we that get I to upon is have using a brand the expand when that that I and DRP. back that without think face-to-face think to be tactics value -- to we to I and will environment. marketing our and stronger is But I loyalty exposure question commercial think a in leverage

I clear. think that’s

back And tactics engagements think other digital us mix getting and so will we of virtual and all the But telemedicine on leverage forward to be to I remote through or web leverage with I into think the more interactions. looking tactics. face-to-face enhanced are to and

the commercial put. But is think tactics. is our is don’t from I don’t think I So I I best think think don’t that mix where shift. promotional that’s not think away foot going face-to-face I to going --

I think we face-to-face a off are with interactions. better

Alan Carr

for Sure. Thanks my taking Great. questions.

Operator

Thank you.

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

is now line Your open.

Gregory Renza

we you Steve launched thoughts of trial question Europe potential curious Steve, how side? focus now And taking potential schizophrenia quarter, COVID-XX that value just in with XXXX on Hey, had and progressing just of the much. analogously moment that team. perhaps cases congrats unlock a are it’s pimavanserin closer refresh your DRP just approval Thank with just and thinking Thank that any if on perhaps is provide here very for foresight just there? any given the the about this on latest about views state for the the to impact you and the to you that quarter. you wanted Europe to and plan and getting could

Steve Davis

will second I the let Sure. answer part. Serge Yeah.

view to element as There say, want this comes U.S. to for years I up, exists. of we start the to things to the always frame relates value Europe, and it make will a the relates U.S. opportunity is to -- made I that value ship period the that weighted more a heavily our that outside we sure has get ago a of same there, couple pimavanserin to within it when pie in topic that as So like the get to been exclusivity. try to decision better to every value we is And leverage of launching indications

I described expands of you we will back as to launch certain that at global a to simply at And we point that say global timelines We doing we the Serge, a more would sequencing it. specific say and -- just this have progress in frame are want that more strategy have juncture, Europe ready and beyond just simply and are submissions come a coordinated to to a But this for strategy that, yet outside anticipate going this and more we quite U.S. do take not shipment that global talk through. where would question? reveal schizophrenia I we speak for plan that with

Dr. Serge Stankovic

Sure. Yeah.

in trial progressing negative X pivotal is second ADVANCE well. Our schizophrenia symptoms

in in Now it’s We mid-summer. study. early initiated the the it

the good done these initial interest So seeing to months. are early sites involvement, well in It as or are But question we And trial. your is very as the up than scaling Europe. to what it’s generalization, to certain COVID related extent. because approaching are of obviously, and difficult although level there very variability from make a it’s they how to any is country-to-country, -- COVID,

things trial, pleased overall we I are progressing far the think progress but in how so the down, overall obviously we slowed -- in it’s are countries are some making. and

situation the with the generally that’s So study.

Gregory Renza

That’s guys. great. Thanks

Steve Davis

you. Thank Yeah.

Elena Ridloff

you. Thank

Operator

you. Thank

James. Danielle Our the from comes Raymond next from line question Brill of

now is Your open. line

Danielle Brill

question. Hi, guys. Good for evening. Thanks the

Box if at just for point taking you had the was that initiated you provide some wondering do any DRP think the addressed review label start I might on So those Thanks. discussions and color the place? if yet with be agency or been how warning Black those during haven’t conversations process could you have might what the

Steve Davis

you do address Serge, want to that?

Dr. Serge Stankovic

of we when course, the process discussed. for of review the sort The of process -- early is -- review to -- in toward Danielle. the Hi, that labeling it’s usually end a discussion, the Yes. that,

is comfortable repeat included that patient that I both safety supplemental specific data it’s very the safety will package the database efficacy to the largest in discussions that that we feel want -- do we database in and NDA discussing then them and aware overall of. were in with and are definitely be there -- we this we population here than other the and confident safety there us And NDA. including the warning FDA supplemental in the of any Box So no to extent our related

are we those that. with discussions. it’s too But comfortable obviously of mature kinds and So early for

that So towards the we video. didn’t the expect expect end that, but of

Danielle Brill

the for question. Thanks Understood.

Operator

you. Thank

time more for Kulkarni have one Canaccord. We Sumant question. from

is open. Your now line

Sumant Kulkarni

Thanks for taking my question.

is a competitive any modifying at the year and pimavanserin you if pipe disease reimbursement disease for impact product for the on market management all a commercial next of approved for when DRP? do you dollar for allocation So Alzheimer’s from such products payer as perspective the foresee is market, hit symptom

Steve Davis

the Yeah. start? Thanks question. want for to Michael you

Michael Yang

Sure. Thanks the for question.

that waiting to important related important psychosis for and no very note stepping an the need for medication. back time. approved unmet to it’s patients really think that some a with dementia is today innovation It’s remember been in caregivers I long have dementia space

Biogen are be available the so view we for that attention different would on a And take both frankly treatments pimavanserin and in products this space thing. good increased the But and caregivers treating the indications. very patients

underserved been of so, time. as view disease think, don’t a And take We long view we attention it a this positive a I state as a to market that away. net has for

Sumant Kulkarni

Thanks. Got it.

Operator

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

Steve Davis

Thank you, Great. Operator.

on again progress much look Just We appreciate and to your want updating thanks to quarter. time our forward next very for everyone you joining today. us say

Operator

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

may disconnect. day. Good You now

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