ACADIA Pharmaceuticals (ACAD) 5 Aug 212021 Q2 Earnings call transcript

Company Profile

Participants

Mark Johnson	VP, IR
Stephen Davis	Chief Executive Officer
Amanda Morgan	Senior Vice President, Chief Revenue & Customer Officer
Charmaine Lykins	Senior Vice President, Global Product Planning & CMO
Srdjan Stankovic	President
Elena Ridloff	Executive Vice President & Chief Financial Officer
Gavin Scott	JPMorgan
Charles Duncan	Cantor Fitzgerald & Co.
Jason Butler	JMP Securities
Gregory Renza	RBC Capital Markets
Neena Bitritto-Garg	Citigroup
Jeff Hung	Morgan Stanley
Jay Olson	Oppenheimer
Vamil Divan	Mizuho Securities
Tazeen Ahmad	Bank of America
Marc Goodman	SVB Leerink
Joseph Stringer	Needham & Company
Danielle Brill	Raymond James

Call transcript

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Operator

Good day, ladies and gentlemen, and welcome to the ACADIA Pharmaceuticals Quarter 2021 Financial Results Conference Call. My name is Jonathan, and I will be your coordinator for today. At this time, all participants are in a listen-only mode. [Operator Instructions] I would now like to turn the presentation over to Mr. Mark Johnson, Vice President of Investor Relations. proceed. Please

Mark Johnson

thank second us quarter and to today's for ACADIA's discuss XXXX you afternoon, on joining call Good financial results.

the Marketing the Planning Executive our and will Charmaine using website. an pipeline Also turning and joining on up Elena section on before Davis, on Dr. Chief financial supplement I questions. a Stankovic, we're review discuss our like XXXX Revenue me call for today and updates Financial business discuss ACADIA and the available Global Officer, in from Events our Chief Lykins, results Joining operations. and our are us Officer, financial steep President, our point who'll your performance Chief will and of is our call Officer; Customer then performance. out overview provide also us our that Chief opening our Officer; would of slides, progress; who'll for detail our provide to Product our QX Presentations are final more which today Ridloff, and Steve commercial Amanda Morgan, remarks of Srdjan

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

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

Stephen Davis

for updates. important joining to us review and slide commercial some thank to with Mark. turn a our afternoon, Good you of company start like Please today. by you, Thank everyone, X. I'd followed performance,

second million representing of the growth. increase a and volume quarter For NUPLAZID net achieved driven in by X% year-over-year sales, XXXX, sequential year-over-year $XXX.X

pandemic a net, gross higher-than-expected of we're greater for slower to projecting sales result a to Elena the pace her of the $XXX of net a will in recovery gross net and section. As dynamics to $XXX million. detail in discuss million year

visits This the growth Let the are of quarter. because pandemic, a without In me the down in from on the pre-pandemic in-person. first XX% levels. the patients new our therapy were in speak to continuing the patient second diagnosing many impacts impacted quarter channel, hesitant physicians Parkinson's which important office-based is

new starts impacted starts new So, In reduced patient in significantly while down visits. pre-pandemic in facilities currently XX%. we Parkinson's patient still was the the approximately are growth channel, patient the XX% new are of admissions approximately long-term the levels and care rate grew rate quarter, below by occupancy

new patient care the often a population, on The both diagnosis of admitted start business patient overall. in patient NUPLAZID Despite the ability on setting. new these admissions to new LTC [indiscernible] impacts pandemic and our start continue starts our to the patients patient's of grown impact we've our patients many ongoing being occupancy a or For facility and new in in coincides rates to NUPLAZID. reduction with PDP and long-term thus our

headwinds admissions in-person are, and temporal. were by is strong other our less Our course, to performance quarter. to care care has the slowed facility visits, of channel. grow compared the products in despite further our these detailing Patient long-term reinforced relative ability second headwinds headwinds growth branded long-term in These

to expect new sequential our patient starts. including growth in volume these headwinds, to business, despite grow we forward, Going continue one

our expect growth. these for As Parkinson's conditions further improve, we accelerating the to tailwinds, community pandemic headwinds become

several In Amanda a Charmaine growth speak we will that have addition, PDP in commenced moment. and to initiatives

a recently Complete like to We Response update we end-of-review our received slide in that Letter Today, Type that on the discuss share the an move April. program takeaways X. DRP on Let's meeting to the A we'd issues in to key with the meeting. completed raised FDA from

the pimavanserin conduct stated dementia position in reaffirmed an each best in study advised individual clinical us additional First, that subgroups forward and FDA of be subgroups the which their the by to the for studied that CRL should of Parkinson's meaningful patients bodies, we the dementia observed well disease, highlighted Lewy as pathologies. the we in dementia with meeting, population across [ph] the In consistent mixed as individual and clinically with overall, Alzheimer's DRP efficacy approval. disease subtypes seek and dementia path

of the HARMONY potential the result discuss resubmission conducting We're from planning parallel support the study prepare -XXX In we outcomes indicated this they analyses additional come that may a a analyses these to study year. for study. this FDA potential additional with without meeting, discussions, discussion. to meeting may open As the an additional that and later at all will also discuss with FDA that a from this for preparations are

updates Phase trofinetide addition turn of DRP, program recently X. the by the Rett syndrome track in completed and to III We let me to highlight for year. enrollment slide we In deliver results end as to line are clinical top on from our

negative well. pimavanserin of Our for continues Phase symptoms enroll schizophrenia for III program to the

priority osteoarthritis. Charmaine performance long-term key would to growth XXX the study this to unmet I year, third for initiatives. bring to and with reminder, this started with bunionectomy patients commercial Earlier in with high associated our to study a last pipeline like Amanda initiated over initiated quarter study the line Business a quarter, for expect we year. cert, Furthermore, of the second in and top the for needs. As ACP-XXX evaluating was later growth our be turn expand pain new results year. discuss Phase and we a strategy postoperative to to and therapies associated Phase pivotal second quarter ADVANCE-X now evaluating II II call for development our pain a continues

Amanda Morgan

delivered quarter million like for second expectations growth of our long-term quarter, office-based In net sales care I'd sequential Please Thank of performance volume review and with turn you, both X. long-term channel. our slide in and across the $XXX.X Steve. we to NUPLAZID X% disease psychosis. Parkinson's the Today, to

performance which strong was by patient driven quarterly patients, patient and primarily continuing demonstrated compliance. adherence This and new starts

Although visits this starts patient channel, slowed dependent are the patient patient correlated population we the left, greater patient remained they that To which confident the demand setting are due patient and are visits have with of graph business new penetration. accelerating were We yet in patient highly physician new at give drive pandemic you NUPLAZID the which consistent as this, that serve. challenges starts patients pre-pandemic new within the the rate. new on will have levels, rates quarter. occupancy patients office-based at levels. starts, as the We Parkinson's being for approximately expected market are resulting growth their Parkinson's XX% admissions of starts to still our know in offices, related in Despite upon will office pandemic. starts increase, new the down, within in disproportionately total on patient and with affected are levels reasons color not pre-pandemic believe long-term physician below shown we further patient business therefore, return pre-pandemic new the to office-based of and The both care impact the continued which to is have

and Please the efficacy graph the and We've right, this identification in execute been our highlighted which safety our symptom NUPLAZID the team's X. to a As able psychosis turn psychosis in accomplish reflecting early. the highlights HCP challenging and to messaging, urgency slide PD on ability treat to environment. through to elevates of

long-term Now turning attention channel. our care to the

As month. see X.X% improving occupancy right, the X% each from have you the been top can slowly to on graph at levels

still levels. below are XX% they pre-COVID However,

hallucinations with many resulting of of patients, a PDP a and often new the may admission. in care and in For resident diagnosis the coincide identification long-term facility occurs delusions,

new occupancy we momentum return LTC within levels into to fully translate As increase channel. growth and expect the our to accelerated admissions normal,

care the a indicates near modest visits, promotional result Regardless as will NUPLAZID's the term, in highlight. outperformed multiple the brand second a facilities. setting. medications, support areas. initiatives, will our marketing we accelerate messaging positions in strong LTC products of therapeutic market shown began this, our well including admissions growing new of growth and Overall, of a face-to-face This enhanced and encouraged Carbidopa-Levodopa now branded foundational performance office Charmaine be engagement. pace us and bottom graph In basket Parkinson's right, ability long-term on sequentially growth within have of increase this care the within across are at to long-term LTC the and new patient which of we dependent quarter as growth to implemented accelerate largely bottles of patients as As growth on recovery

Charmaine Lykins

XX. slide to turn Please Amanda. Thanks,

of discuss other initiatives, important capitalize These will in research second awareness as new Let's safety the it the initiatives our to insights, discussed. patients. indicators market growth us just leading on in considerations light to new to treating profile the of NUPLAZID's and tolerability specifically Parkinson's improvements position year medical incorporate that and which of when pertains well Amanda half

really NUPLAZID distinct profile safety leverage is safety benefits. advantage. Our initiatives growth a NUPLAZID's to available important clinical for data promotion NUPLAZID highlight

concerns PD that diagnosis physicians patients that PDP We new and because receive our Today, associated psychosis off-label than treatment. indicates of And of higher less diagnosis PDP to research percentage also, patients. with elevating increase safety capture a advantage are treatment a of with of XX% delay market antipsychotics. XX%

key addition, In is and impairment. patients is [ph] motor Parkinson's in concern a fault another

for that with warning for events. Cognitive comorbid concern another related to Parkinson's been or physicians, has impairment who've Our diagnosed HCP highlights patients is especially for communication sedation-related no hypotension NUPLAZID orthostatic dementia.

SAPS-PD patients XX scores will materials our study. now subset promotional Our PDP ranging impaired the pivotal of from data XX efficacy to MMSE from cognitively include in with the

there physicians presented than differences messages, that willing and more prescribe with before. they that approximately PD earlier treat communicate now XX% Please slide to our XX. to no also stated After NUPLAZID NUPLAZID with age, safety of will gender treatment. cognition be being to would we efficacy, psychosis Beyond new turn are across safety

of be the that new including without second our Our strategic vision. channels, NUPLAZID impairment, half year. efficacy of the executed all will across The our teams safety messaging highlights promotional promotional amplifies improvement in and field and messaging

with continue HCPs of a at medical branded program strong support QX. NUPLAZID brand engagement for to attending see We over and promotional our congresses, X,XXX high in NUPLAZID presentations

target our care efforts reach through our patients we digital Additionally, efforts caregivers increased to message continue promotion patient We've our with identification. providers. more to health drive non-personal and to and amplify

about psychosis patients and to why important Our PD the consumer symptoms signs programs doctor. your it's talk to and of educate and caregivers

digital patients and to DTC by NUPLAZID Our name. platforms request activate those

identification and and drive year our increase long-term in to well safety, with Our the NUPLAZID. up patient focus new growth of promotional messages prescription accelerate will the us starts initiatives on set half patient a back of

to Now, I'll over our pipeline Srdjan progress. it share turn to

Srdjan Stankovic

to slide turn Please Thank you, everyone. XX. Charmaine. Good afternoon,

dialogue A mentioned, constructive Steve at meeting. our we As end-of-review had a Type the with FDA

present we agency's have encouraged While do and we the the prepare and it we with to an allow would by some the the a still not additional data to a optima's to additional resubmission alignment further without to are analysis the to time will clinical take us on study. discussion us Accordingly, take for continue for resubmission, meeting. support what for FDA FDA schedule

FDA of they on on therapy are subgroups for the for such, it the DRP outcome and CRL us considering breakthrough - As have receiving designation notified our view individual division the that pimavanserin. on consistent of we regarding with Furthermore, psychiatry this expressed designation has update the psychosis changed later of dementia-related views the year. will have in an dementia, appears the their

medical We the months very PDP, our coming and to the community. the new to well in scientific FDA be discuss further. meantime, be continued and meeting received In DRP the both will in by with publications

slide on Journal study the Phase from further XX. positive HARMONY Medicine. were to published The that discuss of New Let's share III results in excited I'm our England

and patients a that share demonstrated the findings Two, the One, of to significantly psychosis associated a not psychosis. of high of to Association to pimavanserin unmet portion potential a of across pleased was In of disease regarding three, appropriately treatment portion related among PDP our in treating discuss from subtypes with the was awareness main discussing takeaways of at Conference. DRP in for motor data pimavanserin And consistent psychosis in this demonstrates psychosis. pimavanserin International and and reduction and pimavanserin dementia-related pimavanserin The treatment hosted the of three almost well treatment experts studied clearly in sustained in and tolerated management Parkinsonism delusions comes are by it as able importantly, by be The dementia-related highlighted extension further for risk most experts of the symposium urgency was disorders. need year's matter demonstrate symptoms when clearly awareness Also and the reduced patients in highlight in meaningful appropriate DRP. psychosis the study, is open-label response pimavanserin results continuation the published both key cognition whether Alzheimer's hallucinations field in We broadly. to X a dementia of these discussion open-label utility the double-blind symptoms view. The which supportive further elderly study, was PDP. relapse important with times. July, a in were the dementias. in or symposium This decline June, ACADIA with the

an Let's on stage move Syndrome. to our XX, our with development update program starting Rett for on trofinetide slide pipeline,

track Phase in top LAVENDER quarter this of enrollment on completed in to As fourth and study the Steve announce have recently mentioned, year. results are the line we III

Turning to slide XX.

for program includes pivotal negative of two Our schizophrenia symptoms treatment study. pimavanserin Phase III the evaluating

Our initiated a program. study ACP-XXX ADVANCE-X, positive Phase year. analgesic is is our XX for the following is treatment brief year. highlights a of track. orally pain fourth II expect continues being studied postoperative first-in-class bunionectomy initiated Slide schizophrenia ACP-XXX MX we of progress evaluating in pain is which in Furthermore, the recently Please to third chronic from and novel with XX ACP-XXX of study suffering slide II models. both in and a and that quarter and for an ADVANCE-X ACP-XXX, disease. associated of pain well impairment the for non-opioid potential administered enrolling on The program well, our on PAM we update last Enrollment osteoarthritis. Phase Alzheimer's acute results turn summary for to the in surgery we this treatment quarter of and patients study cognitive

results quarter fourth our be Rett ACP-XXX keeping quarter, over with line the additional study notably, study to the As Most progressing year. Phase part in our in to pain. results that, of III some Phase work Elena timelines. of transition, our advance completing I Syndrome look we postoperative ongoing Phase will non-clinical our initiation top top announcing line updated II you our study fourth we're the our in dose development look this program from from for now. call and Slide summarizes XX multi-ascending I We pipeline. to we trofinetide the With and forward a as turn forward will in of

Elena Ridloff

second end Today, our recorded the in Please you, due of X% results sales compared of QX the inventory of was million was slightly The still XXXX adjustment approximately year-over-year. increase discuss quarter-over-quarter inventory the end volume channel net second in Thank to Srdjan. QX our for an gross-to-net slide by QX growth of X% mid-teens. I'll in in Weeks our XXXX to QX. $XXX.X second In expectation quarter driven in turn to and demand high outlook. in we and growth XXXX, of reported the levels updated then $XXX.X were This net XXXX million and compared XX. XXXX. quarter outpaced sales, stable at remaining the flat at increasing QX Sequential relatively XX.X% to of of quarter the range. financial

million XXXX. Moving the in to from million down the GAAP $XX.X SG&A to million was second to compared in period million same quarter of quarter $XX R&D compared stock-based $XX.X expense QX the to $XX.X in the expenses last during expenses year. million the increased GAAP for $XX.X the million decreased $XX.X of second in XXXX. in compensation Non-cash P&L, quarter quarter

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

for leading commercial confidence ahead, us of volume and XXXB eligible driving initiatives payer look our give year indicators half the a we demand growth, who shift in institutions discounts. growth in observed statutory year. From our mix greater a are proportion a we've with the perspective, second volume of this gross net As in QX to from

of now gross result a versus to previous for As teens. year estimate full be expect of approximately our XX% to high the shift, net this we

the We $XXX and to to net. higher the as sales of for of are to the of a result net continuing a $XXX pandemic guidance in million reducing be impact year range the our million gross

XXXX, are be $XXX million and from approximately between side the $XXX compensation the our guidance in full previous for On million for to GAAP expense range million includes to decreasing of we R&D year This the $XXX $XX million $XXX expense. million. stock-based

includes full million over to the $XX $XXX This of the We to are GAAP Steve. $XXX call SG&A compensation million year. stock-based I'll our with for expense. reiterating back between that, And turn million

Stephen Davis

front, XX. in the closing, grow execute Please Thank in to to commercial the expect environment continue slide on short conditions. these you, despite In Elena. intermediate continue to term, to challenging we a to turn

from desperately are it NUPLAZID and to PDP Looking the to intermediate in needed. real confident potential of committed the to we're the getting long-term, who patients

Regarding with DRP, quarter with a data business on a to fourth to clinical attractive our potential align discussion readouts resubmission. development pipeline our focused of deals. path continuing two in advancing continuing we look forward development to the on while We're to FDA pursue XXXX, the

I for like I'll their to thank up our Operator? life. would call mission employees now elevate to to Finally, for our questions. open the passion

Operator

question from Kasimov first [Operator line JPMorgan. Instructions] the from Cory Our comes

please. question, Your

Gavin Scott

for This our question. is taking Cory. for Gavin Thanks on

them? Just Or you. what to curious, the what particular be think you needs show clarify FDA be to to Thank do do analysis completed convince convincing? them can you

Stephen Davis

Yeah. question, want Srdjan, for Gavin. the you do take this? Thanks to

Srdjan Stankovic

have of address as looked Type it. questions for this prior opportunity the analysis brought to CRL and expressed a to We opportunity meeting we to at didn't the concerns us in Gavin. A of additional Thanks, as number some an bring that Yes. meeting, we the to the

scales and treatment the couple in the psychosis a of brought analysis, item and cluster relates behavior different among showing psychosis that specifically, as is, bit of and treatment, features essentially before were analyze it could pattern a characterizing following clinical interest subtypes. buckets. be analyzed course clinical very looked did successful of of at characteristics we variety and the as of characteristics of these treatment, the analysis the we of subtypes, psychosis whether a FDA different different picture subtypes. One this summarized to as of among dementia a different analysis, among clinical similar well We of quite the in So, withdrawal to and rating

that's So one of bucket analysis.

The the different meaningfulness bit not patients the response particularly among you among - among the and clinically - treatment, response quite the other subtypes, when overall, meaningful is dementia-related a with a response. bucket of meaningful meaningfulness at when pimavanserin but in of we different response, look of only to to similarity response related psychosis, and look also clinical you that at see pattern

perform So, different analyses we demonstrated of number that as a well.

to So, discuss FDA, those that and performed analysis we'll the as of of were and features presented forward we the with our discussions. continue kind move main we to

Gavin Scott

Okay. Thank you much. very

Operator

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

Neena Bitritto-Garg

for taking question. my Hey, guys. Thanks

indication for think able you are resubmission Or the data, around just specific the Thanks. you for I be to kind would existing the refiling if a be well. a only? the you DRP broad as forward FDA have would indication? of from on or got do it So, additional with kind subtypes some sense of guess, of analyses a move

Stephen Davis

to this? for address question. want Srdjan, you the do Thanks Yeah.

Srdjan Stankovic

essentially down of - discussions boils analysis One for look question. indication. the approval When review three DRP Yes. we we discussion additional part, the potential alignment sufficient the results thanks to broad is with existing they that and that that the data, at data we can and pathways is the that for of data the and have Well, the the Neena, pursue.

that data of like the other we position larger option along would subtypes, Alzheimer's for And Alzheimer's of work clinical disease they that required that particularly clinical remains subtypes for with we have sufficient have approval work. in have would indications, to and study if third then indication data analysis their present, we that be for that without the we an the the data some is would the finally, the subtype forward. disease we psychosis the data psychosis be move steadfast with that aligned individual would with in additional that is sub The that additional - want to to see individual part additional individual FDA

think some we how see. second Obviously, position are So and and first we presented that have And happy or that's we're received data we the to continuing that for the our is have option. opportunity. traction, discussion I the

Neena Bitritto-Garg

Perfect. Thanks, guys.

Stephen Davis

heard Yeah. some this, was This is was skipping but when Steve. I don't talking. know Srdjan others there if

I to clarify. just So, want

this Srdjan So, there's play ways as out. mentioned, potential could three

data a broad is, that discussion that we meeting DRP that that to case front. label. the Type existing position determine and our A We continue First made need we have, in supports our we the on

So that's one possibility.

to individual in study. one Srdjan is subtypes, is data. obviously is the amount where of greatest largest resubmit have disease Alzheimer's the possibility mentioned more Another psychosis It group based the we upon or

very also We had Lewy compelling body. data in dementia

second based a additional or outcome is that work potential again we clinical subtypes. without So, upon more resubmit here one

this third is the FDA, additional on and submit is possibility, that requires that view, we subtypes. work do individual The and current course, their clinical of

they discussion do. Now that, clinical stand possibility potential have are think you a where without things is here willing again, work. your we're see as it. suggest submitting further the path the this with additional outcomes is about We we today, you having said, best forward what we but of this said too, those three to That's

Neena Bitritto-Garg

you. Thank Okay.

Operator

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

please. question Your

Jeff Hung

Thanks the for questions. taking

additional follow-up meetings? whether this have a is FDA. a clinical follow-up where final the resubmission a study? to potential there will Or with meeting the make Just And allow go on that. that so for the to the a this meeting I additional clarify, on to a on agency without could Is multiple decision

Stephen Davis

you Srdjan, that? take to want Yes. do

Srdjan Stankovic

Yeah.

the briefing already FDA data in brought A a of the and we document. information and Just clarify, Type a had And mean, I obviously, meeting. XX-minute that to lot meeting to we that with meeting

will and is already the we have, with with of and we the that anticipate already the that of next essentially extension the scheduled continuation meeting a had alignment discussion We So, started will do to will point they we FDA meeting certain come have FDA. point that at of in along that and this hoping the the be our a data meeting bringing the we support just the and proposals position meeting. how at discussed And necessary that understanding our we to what or pathways are different that will three discussion next certain obviously, that forward. move the of

Jeff Hung

Okay. I Thanks. clarify, then, a more you position, actual little if so color open but can another in they're FDA they'll pretty on And reiterating discussion? out? being position it to can having to provide their their that that on the seem more hear they're meeting? Or you firm more Like, an does was open like

Stephen Davis

color, and Srdjan continuing that. then different more if suggested that that interested they A we're start, weren't for to having refine I meeting we're to I'll you I'll don't think we're and the hearing had did would have a in another of let they the meeting if Type analysis open like. - doing we

dialogue. they're when further think genuine they I So, being have to agreed a

to Type a Srdjan further the have order As again, open further study give I meeting clinical can But in additional cover pursue. do try next you forward That's is having do work only your for to want the so said, that much meeting was mentioned, only clarity. I clarity an each to believe We to that, clear. as to much said need meeting. we're discussion. additional in meeting. get you ground best be to as at just this subtype point. We path A want we clinical Having to that They a and XX-minute

Jeff Hung

Right. Thank you.

Operator

Thank you.

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

question please. Your

Analyst

for on just up This follow Maybe the is for [ph] Laila question. Thanks on DRP. taking to Ritu.

FDA of that potential expected members members it to the you more there now is division? the later FDA with that with. interacting you. is with meeting year, plan been might the that to the reviewers, Or escalate the Thank For be same any have to same the this of you've senior

Stephen Davis

do take that? Srdjan, want you to

Srdjan Stankovic

Yes.

At FDA and have Type as we Let from division Tiffany the along Billy to meeting, the meeting. as office were meeting first me Office well neuroscience. was strong the of the - was for a also all, presence very both Psychiatry but representation Director the Dunn just Neuroscience our pleased present, of say from that Farchione at at we the Division division present obviously, Director A - for

continue from and our as discussion presence So, to to the dialogue. we side continue anticipate, as continue constructive have this we FDA that strong well

Analyst

Thank for clarifying. you

Operator

Thank you.

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

please. question, Your

Charles Duncan

taking guess, question. one Yeah. a the you're patient initiating there on that psychosis wondering color from subgroups. if then any DRP, one that commercial provide psychiatry you is question. And then division for you degenerative wondering given the contemplating additional Hi. I contemplating perspective the these kind of you got being AAIC; differences why can with I'm question on Thanks trial these think in actually across Had a DRP - regarding additional And if a I'm question and is of disorders.

Stephen Davis

take Srdjan, this to want you question? do

Srdjan Stankovic

Yes.

the submitted community HARMONY study results a part regard the overall our of me support supplemental of the medical of address the the question. we that received data Let And out of data and in quite NDA. as part second try from of to bit a the is, we of - the there our that to and interpretation part first

But a the a editorial debate England So in of very, regard data mentioned, there is, studies about within to as a the community and scientific the an community of appropriate also that's and to pointing bit is as the entity and look in fact clinical looked that single I the were received study and psychosis But we We positioned way available basis also to where positive very dementia I we dementia conclusion pleased of psychiatry of have. psychosis. Journal how how the as or the published agreement data remaining that study studying to I studied New guess to we the entity, effect can to data we the Medicine by overall that came dementia-related we way that, indeed, you and are on at by The which way little of is medical them how presented the a And the with it dementia-related to a data is divisional subtypes the at had that subtypes. wider division out an in data. that say. psychosis. data psychiatry had, I discrepancy best that

Stephen Davis

also just asking you would - were outrunning Srdjan. think an I go I about study. additional Charles, ahead,

Srdjan Stankovic

Yeah.

all be and for prepared want but for discussion preparing as outcomes are to outcomes obviously this. taking all would alternative or not are We alternative prejudge of discussion. move actions possible forward we - with We our possible the we do that we

we how at the look that's things. So

Charles Duncan

Okay. Quick wondering agency change just and off-label. any of the a that don't of able result there visibility pimavanserin use, I'm know if then. is that, over there off-label around the detect second to But as even I if if the course the I'm changed know - use of question the you but is, you're commercial I in And that that off-label promote if wondering decision don't quarter. if dynamic

Stephen Davis

long-term that we consistently label our of we sales and digits. look we've single instance, amount the comes peer. know our the track use. bottle, But diagnosis has hub. very when launched question, bottles is know little PDP, final the hub destination on We for the what prescription every that in prescriptions, goes that been don't our for those every Thanks is bottle, Yeah. Charles. come to low into every off through at And From bottle. the had time majority every of off-label our we've can't the in the We of

to get prescriptions off-label XX% are more is drugs. label. drug but So, as It's on difficult. the it possible many than It's of difficult

of That the reason, throughout not today. seeing cycle of our product, are that that differences changed a label. last for any so And bottles on not the and we're percent in high has very

Charles Duncan

the for Steve, color. Thanks, added Okay.

Stephen Davis

Yeah.

You Charles. bet,

Operator

you. Thank

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

Your please. question,

Tazeen Ahmad

don't Srdjan, that who's committee it And I to clarify comment status. maybe breakthrough? it just - when breakthrough wanted another next you the going have in that the the of There's determined be chance your let's let's and might regular in breakthrough future press be status it's breakthrough case go best review, going revoked? might what determining you as is have why in meetings up a guess given say path say, involved the to going statement I these anybody now be kind resubmit. that make for made you case, that if be And as decision is be meeting, to that would reconsidering can study FDA the to your on a status? you do a would to be,

Stephen Davis

sure. Yes, you want take Srdjan, do this? to

Srdjan Stankovic

Yeah. A here. of couple things

reason cycle prior believe that a just all, otherwise this A with consistent the an breakthrough this our And clarification. substantiate CRL of to this from the their the the that point impact is position meeting. does with at data development, of the very their life the notification would consistent received as it's in at did First for breakthrough designation indication. is - we FDA Type it designation, And really particular not have approval point not this this therapy have. the We

data, in which in its breakthrough review, depending take division on the see. we by of point, a the the makes either is labeling your and regard resubmission from levels to - that To recommendation important something resubmission designation it's a or this is in surprised probably review And an therapy which agency. So the to with case, perspective, X higher approved would question, this not are be, to months case resubmission, the then that that for additional cycle. would whether it's goes

So it wouldn't doesn't a go in submission. - manner go like it original

Tazeen Ahmad

the color. for Thanks

Operator

Thank you.

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

please. question, Your

Jason Butler

questions. the taking for Thanks guys. Hi,

seeing relating ADP the II on discussed? any of study the case study closer on remained better to it levels physicians' of the occupancy just return you things Just was that discussed or normal? have FDA's country? a country? offices you then rates in all seeing still across the are commercial in that side, is CRL the or the LTC the DRP, geographies And where Are across to Or lower. in depressed Phase COVID to Are comments at different

Stephen Davis

question? Srdjan, first take the why don't you

Srdjan Stankovic

and II The data additional and analysis. we meeting conclusion positive the that goes the Yes, to the Thanks, FDA discussion Jason. is - point conclusions the The as ADP brought bring of far to as in issues us invited the regard quality on. division independent so wireless study Phase in the to any look data analyze on of that concerns study data you study with the expressed single-center some how that study, that at and and remain

bring overall analysis perspective, because validating it study us in additional they we study an data did of overall So to that the important and data from the that invite conclusion that is the of package submitted.

Stephen Davis

Right. Amanda, question? do you want to geography take the

Amanda Morgan

second take Steve. the I'll Yeah. question. Thanks,

a pandemic. across have to say U.S. see beginning differences our patient reps year from well pre-COVID to, the we seeing return as face-to-face the year, we'll visits. levels And until But physicians. regional U.S. our across LTC differences specific admissions we seen continue is seen of our we've the to still do And and PD the office are that grow, as we we've it the at this although as new of relates engagements seen So with

So HCPs indicators we'll navigate as with continue pandemic. and engagements track optimize with continue we leading the those our to to our

Jason Butler

guys. Thanks

Operator

you. Thank

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

please. question, Your

Marc Goodman

Hi, guys. Thanks for taking the questions.

need if So, you saying, FDA up ends Steve, another to confirm the study. okay,

another do subgroups. of to confirmed? in that willing You're X study these Is

Stephen Davis

appreciate I question, the Yes. Marc.

the need honest had point an And not matter, would approval we the think generally. just required of answer is be we're to that we - subgroups, for or individual for at haven't yet. what the know that for I in discussions DRP

be an we if enroll very, we to like to thing It into we If take with further or is and that time path it. very take then discussion a that Obviously, clinical like. need and asset So FDA. next like to X of have feel to steps We eager approval, patent to that next additional valid. what want work be need that we still pursue lot understand not if scientifically you that have we is path get to life determine that to forward feel X the looks it's appropriate, long next it's very the enroll, path would feasible. we'll if is is difficult an we to But just ultimately consideration. the need a do

Marc Goodman

meeting, So would be. study study any subgroup what at of that do basically, you give no they on was There subgroup, get should particular in that all. told you they the it type that a guidance about at but didn't another you discussion to

Stephen Davis

of have do correct. That's look clinical said, had word analysis that We the not as on additional spent and like. your we done I clear, is think a again, what the be did work. said, I a really want meeting would had And they we best discussion majority new to the dialogue talking that to path about We around that.

have you discussion analysis that the further to with to a However, we're willing further consider done. you've

Marc Goodman

your term, And comments Right. Srdjan, got some We traction. you the somewhere in comments, - the used traction. some

that the So of part some you was discussion just I traction? it what was curious got

Srdjan Stankovic

of but of space encouragement that information were I quite that directly were the I analysis I with interest. and to to that data of the quite both reason is that discussing both analysis we the brought sets that a a continued of more bit described a new would interest buckets a discussion. traction, And we This bit discussion analysis, that characterize But that. was just really buckets finally, new say of received there was see that and in and as new analysis.

Stephen Davis

clinical get just very we into meeting that A meeting, additional a Type should comment. might do you clear would because and CRL, would this time going you I Any be that you add work. a X issued about just that view CRL they were the expect before additional that Marc, their

pleased opportunity constructive as a [indiscernible] at we meaningful And dialogue. Srdjan that we the did. that And think to was there analysis, So the meeting. we mentioned, the had I in would interest an I say both present were we're and analysis had very very very

Srdjan when referring like discussion, think a further we continue coming some the to I traction I to that discussion warrants out then that got feel he said, with we and need of we dialogue. So this have and what meeting productive recognition that is think is

Marc Goodman

Thanks for the guys. color

Operator

you. Thank

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

please. question, Your

Andrea Tan

This to pandemic can us is maybe gross to lowered impact Andrea on guidance due X the for and you. reduction With help to versus from is expected what proportion continued respect of there, for that the Salveen. Elena, you net?

Elena Ridloff

Andrea. Sure,

pandemic recovery and half reduction the So of the half pace to of due to net. a to due growth result about it of about is the is slower the

Andrea Tan

Srdjan, ACP-XXX clinically data fourth one for what quarter question you of year. you're is the And that frame on Great. help And in that? expecting this Can meaningful? expectations for the

Srdjan Stankovic

Yes.

year. primary XXX XX over intensity measured surgery, the study, just that the bunionectomy as results a patients study In measure in expect conducting are study the pain is reminder, We about and the postsurgical of outcome before pain, hours. end

highest testing the study. are of We And placebo-controlled kind regimens it's the dosing level. study at to in dose a

very pleased separation pain with in intensity or reduction be would in we a see So significant intensity to the pain treatment.

Andrea Tan

guys. Thanks, Great.

Operator

you. Thank

of Stringer Our question from Needham Company. comes & the next line Joe from

please. question Your

Joseph Stringer

First one, commercial on PDP.

sort following difference. of question Just earlier up on an on regional

vaccinated a dynamic. if returning office data bit PDP know curious any it it's care, to different visits? info had Just you amongst little I in patients, or the hesitancy long-term be whether And

second occupancy points? new mentioned those? clinically expect meaningful RSBQ you And a change end of each there a and for in the down. question us CGI again remind effect But Rett. were to of what admissions different You is is Can sort just for and on

Stephen Davis

and want Yes, second? question to sure. you take the Amanda, do Srdjan, the first

Amanda Morgan

question, Thanks Joseph. Sure. for the

patient and the answer prescribe question my we to kind they willingness effective HCPs or with visits to my it and to new business. or rep face-to-face the an the a visits, visits. product X of patient think and But So face-to-face differences - we and distinct of boils physician an more categories is and it's interactions. increased the separate are X specifically important know about really when physician face-to-face X psychosis, have patient and during And think this we position regional let in-person how down diagnosing kind things, either me into because about

level. I below And in-person are so currently, XX% pre-COVID visits, shared, about patient as

this, we've of So starts though, pre-pandemic. regardless our new maintained patient

at both interactions. look as look nationally physician rep and when and regionally we we thing second The at face-to-face

when HCPs that than know our were be virtually. we what we effective is more with we so engaged And in just interact we'll are person

And from levels. of so still is beginning physicians is currently, of interactions in it more the our pre-COVID free at which and person, are significant the rep but year, than two-third improvement a

but tailwinds, perspective. into both do to we an are And at those a those turning NUPLAZID. headwinds temporal for expect we increased from the to of vary ways initiatives, growth expect kind look do see and demand it we the our really national throughout regional regionally, So

Srdjan Stankovic

read study. trofinetide Phase the III About Yes.

has symptoms questionnaire co-primary Global caregiver a completed Rett questionnaire, which across rating a the Rett and physician the is As syndrome; behavioral second Clinical scale. reminder, two of which Improvement, study One is a measure: of is is symptoms Impression

internal with of whether So observed their that scale in characterized on are patients improvement on scale. the in validation study the correlate itself, of has changes - physician the sort individual scale the improvement that rating rating meaningful the

whenever from perspective, as other and that both meaningfulness I of there there well validation of that reach was the an internal that positive, as meaningful on primary broad study separation are placebo will to symptoms we measure, And Phase of since particularly reduction results context from is point. was Rett we about the no at obviously, was in separate II treatments XX% that the need the the our scale. of placebo. you the separation, Pogo a So syndrome assessment remind this that in across broad available from there

Joseph Stringer

Thank you, guys.

Operator

Thank you.

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

please. question, Your

Jay Olson

provide see you share an data read thoughts for and should potential any across and to pursue you when please latest MX with any about data? thoughts your wondering could update could see I their that your MX to PAM? to expect if we indications MX was on PAM Phase And maybe on PAM your might if [indiscernible] then you I

Stephen Davis

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

Srdjan Stankovic

Yes.

Let me PAM for that start developing. what indication MX thinking around we are our currently the with potential

When acute symptoms mentioned, of schizophrenia, pursue negative schizophrenia. also we are looking a talk symptoms obviously, X stroke, symptoms can symptoms at We in and in and the about schizophrenia but we and are as cognitive - broad a schizophrenia, cognitive dementia. taking we of cognition

different, are I our much because we there we those II the Phase listening be successful believe MX and more symptoms We the PAM. and and of we we successful are also in will in would the it more as to - suggest with be, evaluate what treating is that toward we as some of MX like there - move cognitive the that believe lower, indications following are as as - targeted the while acute symptoms. developing we would that conducting may MX are the some I development say, molecule, further molecule there that say would that treatment to data in -

MX short-term far the in of data data. As positive symptoms say Cerevel, acute as looked of It it's would data. I from acute is an that treatment We impressive at schizophrenia.

do all, treatments we for need better schizophrenia. of First

such very, in see So development we are also would have also seeing very for pleased validation positive that and target, pleased to as in are a we results of muscarinic are very a schizophrenia that we as reported. I receptor seawall say But a that a program that as area.

Jay Olson

Thanks, guys.

Operator

you. Thank

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

please. question Your

Gregory Renza

for steps? I striving changed there. on curious, into questions. though just an Thanks taking what the I'm just next just alignment really secondly, if and separate firmer of as topic meaning that for with understanding to FDA you've have And kind appeared for of were you that, understanding Steve, forward, know now, Hi, means alluded good the coming then of their coming meeting. path A on getting you've footing to you the with position out Type them a just that as on why felt reached that the morning. related the to, BD.

approval? assets as maybe plans wider the your of rethink criteria could following and you has prompted on [indiscernible] industry the if curious sort Just update us there, development to been especially

Stephen Davis

Yes. Sure.

take this indication, look DRP the broadly way at way it indication feel Look, the physicians to where in to medical is the Let think differ. additional at we in of any can is data And response add X to most and color. [indiscernible] situation them and then again, think answer the believe reasonable way this I the treatment. by a free Srdjan question terms in of a in literature the I'll terms and the time, X as it our way position me presents first supported about importantly

from got that position. think case study So feel strong data We our and very our we we've there. like a supports is consistent

is open-label withdrawal at mentioned, you the portion portion look similar. also in study. Srdjan of As of drug-treated very between randomized subgroups, response the study, the the in the the similar very It's group when

fact however, to different So FDA, respect or than the And that a the this position right just different not or vice that division is psychiatry a wrong we're we They we particularly the have position. say versa. has do.

as as group desperately to our the recognizing benefit two is who to fast to objective to One can it. possible we get that and patients win patients from accomplish to this broadest need is So things. get that, drug to of want it

we're a those objectives, we forward, you So opinion. to that? can try on recognizing alignment as anything to of where difference we want that going Srdjan, find to scientific accomplish just to we to two add focus go reasonable have

Srdjan Stankovic

well. quite think I did you sum that

Stephen Davis

to in, then second you up I Could key that? repeat you of your broke a regarding part question question. And think, Okay. the BD, second

Gregory Renza

Sure, Steve.

Just and programs, I'm to the criteria curious well? applying the sector to applies prompted if others of how maybe you when as it's rethink us if assets that on by to the that you development curious and if could just external update you're at aducanumab approval while look in you look assets just at

Stephen Davis

for neurology say both would and strategy unchanged. question. built our much Yes. a in business Thanks presence psychiatry. on development the I We is

to view I full. and I'll continue that. impact and not of medical of There's is about We stay continue development, on press. Having and difference. or the impactful most on medical top and a that not accelerated and is probably the things very step say there's sea that. to had when view would point pursue a I both terms to of think the pathway, I does on that business about strong of a great to franchises view really this specifically this R&D say fronts, development aducanumab, are - the significant topic not meaningful we're create would back said discussion our that, and has and in relate approval have say that point of we'll currently in much as thinking the general a to FDA of the very But social going commercial how there the affairs path on point our well obviously of as - to view assets we is strategy change a political There's

Gregory Renza

Thanks. Great.

Operator

you. Thank

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

Your question, please.

Danielle Brill

the follow-up but the Steve. It having asked, may could good be nothing morning. a another questions. maybe This clarify taking a you the to X meeting just Hi, just Thanks bit, there's like FDA. gating if with for to seems

us So here PD are any steps office get guess, insights to that more than can highs? when all-time as were you then the I XQ commercial visits at curious why walk XQ side, in pandemic from down for just to was next exactly meeting through what the And you the if scheduled? I'm have on

Stephen Davis

answer Danielle, Yes. a the to question? in I'll I'm to - as repeat it first you question Amanda second the But second. ask sorry. the could relates

Danielle Brill

what like discussion wondering follow-up just steps I'm are Yes. with the having FDA. here that to from the

Stephen Davis

Yes. Got it.

Okay.

Sorry.

cover first. So kind let mechanically me just of

be meeting, C B So meeting. or to a mechanically, XX-day days depending it the then XX or And it's request. A, will whether and briefing the XX- submit we then submit need to need a meeting the document before we clock on Type on

So that with FDA. in place it's just a are mechanical rules

and clearly included will be We are sights we needed their request. in making material hear working document, our that have the briefing that very on the to diligently before that be we within

we've that's of little And got until CRL the an unfortunately opportunity didn't the FDA's as to reported we the previously, just context, say, bit would CRL. coming. to DRP learn of get led that a So I as we additional concerns

and to very respond and those So a top we're thankful to have opportunity concerns. appreciative the the of meeting had we

dialogue we this to want responsive we're And and continue that to certain are so as make we dialogue, responsive concerns having. the we to their very that

had now get order those an as do And so right It's know discussion initial that well. in them. to concerns, next important with discussion we this that, to we've the for

want take I'm question? you So that's, do to of sorry, #X course, the our second priority. Amanda,

Amanda Morgan

Steve. population Yes, the office I'd we that sure. that serve PD for visits, Thanks, is a question. Thanks, patient to Specific elderly. just PD Daniel, remind

patient elderly serve. that is So the population continues, as we this an pandemic

Danielle Brill

you. Thank

Operator

Thank you.

the for Divan comes question Mizuho Our final Vamil from Securities. line today of from

please. Your question,

Vamil Divan

Hi, Thanks the taking for morning. good questions.

as the So, year net. But guess, you gross just know one Maybe I you'd unusual around gross this year? speaking, of higher back Elena, or an next What and give you is year just kind commercial comments of sort just we beyond? expect for Is talking net too on generally look side, the the forward? early talk about about formal just to the of guidance of it's maybe range going to things? settle sort can more for XXXX this at situation I Or of kind down to this sort of more beyond. this again, as were

Elena Ridloff

the So is we this low this grow single year mentioned in seen from - trend high pretty single volume the as digits. remarks, mid- I XXXB a in more institutions to stable prepared seen the It year. the industry. been in we've increased broadly to last digits, it year and This that's was

I expect So it to wouldn't reverse.

And for our we for frame. - in the I year mentioned XX%. So on guidance the year, in gross we'll call February this about XQ be time as next net expect to to provide

Vamil Divan

you. Thank

Operator

conclude any does I'd back to management the program. This question-and-answer program remarks. to for further of session today's like

Stephen Davis

forward. of to you thanks for look our so on today. forward each move Great. Thanks, to us We operator, we as progress joining much and you updating

Operator

Thank program. you, for the participation conference. your ladies does gentlemen, This today's in and conclude

now day. Good You may disconnect.

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