ACAD - Earnings call transcript Q3 2021 | ACADIA Pharmaceuticals Inc.

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Operator

Good day, ladies and gentlemen. And welcome to the ACADIA Pharmaceuticals Third Quarter 2021 Financial Results Conference Call. My name is Gigi and I'll be your coordinator for today. I would now like to turn the presentation over to Mark Johnson, Vice President of Investor Relations at Acadia. Please proceed.

Mark Johnson

discuss third to results. XXXX is call the quarter ACADIA's financial Today's

Stankovic, progress overview our XXXX updates slides to Officer, call me from turning of the final discuss out is point Officer, Teehan, Commercial, are Chief an more financial today Interim Mark for the our of who and Head Schneyer, our our our and using opening like the are provide on available Joining commercial before pipeline our results our joining for call performance. Brendan our business Presentation that we're ACADIA Chief operations. on President, your us a will performance Events Dr. financial it and will detail Steve which our on Steve Also website. and Davis, Srdjan and Financial back will questions. to Chief then provide supplemental of review our Officer QX section I today discuss remarks will also Executive in of would Operating

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

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

Stephen Davis

our our to recap with Thank everyone us a today. slide you, like joining of to and Pimavanserin commercial turn by and update catalysts. a afternoon, for regulatory performance, preview I'd Please start for Mark. coming of Good X. followed quick thanks a

to Chief everyone last First, Commercial. has take leverage and experience for of Teehan week to position Operating like able leader I'd been moment our a be to of excited has further Officer very team of deep to been that the Brendan our Head strong and and tremendous announcement a promoted his capabilities. Brendan to remind I'm

pandemic. While be disease Brendan of Despite of a say for greater will me and significantly This represents NUPLAZID third take a year-over-year growth. has NUPLAZID to just challenges, detail on quarter you and minute, market a increase as in that in continues impacted a XXXX. update outperformed Parkinson's the level, our let through result commercial in drugs with macro space in million net the $XXX.X volume these year-over-year achieved sequential sales. branded X% the the

brands setting. the with long-term performance has since As care on NUPLAZID in market to Parkinson's the our in prescribed more be be in of basket team beginning sequential left, the continued Similarly, the our continued of year. urology strong graph channel. precise, the in each quarter year-over-year to To the and NUPLAZID disease outperformed shown the and top office-based growth has execute

which launched safety and find it its profile Our grow This branded underscores promotes relates to recently as our strong implies team's Parkinson's relative specifically ability brand. targeting unique includes and campaign performance the adapt our our to ways providers, community. to healthcare

person. PDP aimed new patient DTC process of caregiver one seeing campaign launching biggest front, which challenges, in physicians a patients On the we're not COVID-related of many solving at our the is in and as

psychosis their who to and doctor patients potential a to designed activate symptoms with it's have DTC is are such, campaign at with them of to and aimed this treatment and conversation As caregivers about NUPLAZID. home, their

Our XXXX. will into we of further and initiatives, the NUPLAZID accelerate leadership, performance growth growth that relative confidence strong us give new

to our Pimavanserin regarding our Now let's regulatory sNDA move update for on X. slide

FDA end where you at individual seek clear each made of additional it looking As review the that they is top are stated path DRP believe dementia our at a study, conduct that they meeting, group. recall today they our approval. subgroups X as we rather forward of than Accordingly, best an in single to subgroup

open at to also discuss study in there meeting potential subgroups. on is to scheduled the additional path meeting shared to any them,that they stated, that FDA based analysis, meeting, whether and is having additional without the of However, a we've with This now we clinical expect the another resubmission an to our between When of be very the we have disease, dementia subgroup year-end. XX% which for we somewhere around that it's of meeting in U.S. the able data, data at results to report represent are patients clear on XX% most Alzheimer's all the dementia and look

in pimavanserin OXX psychosis database study Together, HARMONY and studies meeting in in anti-psychotic additional studies symptoms disease in the feedback to in done look meeting. the ADP risk of more will of response improvement provide clinical psychotic Our the relapse psychosis, Serge from upcoming we on this efficacy this of we've our two with these Alzheimer's of includes FDA, analyses providing in patients. the At section. details reduction last opportunity demonstrate sharing forward to study. evidence independent

I'd highlight shown ahead, as near important like some catalysts look we term X. As slide on to

to look FDA meeting the First is year-end. up noted, our with providing around we update an from forward

a top-line in III announce from Syndrome top-line proof-of-concept results results surgery in X XXXX. pain following we post-operative expect first study third, this we later trofinetide Second, Phase LAVENDER, bunionectomy for from evaluating the to quarter. And of Rett quarter in ACP-XXX pivotal Phase our to study expect announce

Company's our further expansion. well-poised for Finally,

call our sheet, the over to turn a revenue commercial active strategy continues performance. growing and priority I and we key a of to best-in-class Brendan and that Business healthy to front. very a discuss like continue have balance R&D be to We in-house base, now be development on teams. would to our commercial

Brendan Teehan

for review performance disease Please quarter to sales Parkinson's the to psychosis. I'd million. $XXX.X quarter, Today net NUPLAZID third delivered X. our turn slide we of Steve. In in you, Thank like

demand stats sequential strong growth into that by I'd fueled adherence patients and macro a represents performance quarterly compliance to the we're and dive operating in. rates. further patient current new a like continuing environment with with start This

the As pandemic affected has we've disproportionately stated Parkinson's population, the previously, disease patient market. the impacting significantly

are grow shown levels. over PD markets. pre disease broader rates continued compared facilities is X%. the throughout neurology XXXX, for pre the office-based grown has top of visits the are brands past long-term care the two In X% PD we as the down office and LTC of how channel, NUPLAZID over down carbidopa significantly up XX%, the the has of Despite As top period have time that care top on slide, the trend. This And during XX% important clearly 's has long-term XX% from relative down and with are the NUPLAZID -pandemic prescription Carbidopa Levodopa specifically, decline and the products and are pandemic. these points Levodopa market been following. at up Carbidopa are down overall Parkinson's strong to occupancy trended the the Parkinson's -pandemic marketed XX neurology they still period. are meaningfully is compare the performance challenged and More we These the years. when see to performance and Similarly, recent XX%, average this, quarterly NUPLAZID XX while are average disorder fundamental down fully Perhaps in and period. all setting, medications down levodopa signifies same most with while the time XX that data X% PD movement on brands total just on performance and

new However, We've backdrop had novel in us grow to analytics to continued future thoughtful of patient starts. new to growth. opportunities tactics the both of has channels, have adapt NUPLAZID and against giving our and implementation this environment, found our confidence in utilizing grow

improve. growth strong months channels not working underscores performance all Furthermore, to environment resonating and team confidence our for ahead. the around in us continued our commercial Our gives will and tactics macro are simply that execution continue relative our Is and waiting across

even to with PD and buckling ensure we physicians, and with caregivers are working psychosis, an interacting down We on that educating NUPLAZID. harder patients, their and are treatment

that and on educates discuss to further it provider what the campaigns. patients of second like brand or half platform and to To the community new HCP of on HCP NUPLAZID, Slide audience, and the grow principally the brand. in have the community. Parkinson's focused the caregivers. other as year, continue focused important I'd drive turn healthcare on treating Let's On slide, safety choice messaging to focused to specifically relates the X our discussion profile the doing unique One to growth on introduced the we're new engaging this to continue we to

research messaging experiencing and medical goals channels promotional function. including with all of campaign motor being HCP's avoid insights other focused and amplified treatment on the tolerability the desire resonating psychosis, This impacting on field Our consideration, to and market well patients HCPs. Parkinson's is most light important across is profile safety in our NUPLAZID's teams notable incorporates specifically for

Our our safety goals important messaging demonstrates a NUPLAZID's by data physicians better treatment profile. to efficacy leveraging deep and of understanding clinicians clinical educate on

home patients resonating PDP to which further highlights moving out capture Slide treatment and roll drive help therefore NUPLAZID. a campaign, new options. their XX diagnosis their physicians COVID-related to patient of and and of patients messaging this increase percentage have should new NUPLAZID direct-to-consumer with our of symptoms campaign, in the early intended of and not for with discussing caregivers and While at home reach to at their new This we adequately and is this higher biggest them the treatment opportunity physicians conversations see symptoms is and forward. physicians our about one staying to or in-person, not campaign psychosis their seeing solve challenges:

ad includes patients with and patients ad caregiver potential to since disease. benefits been disease an of The PD about NUPLAZID Our and component of symptoms families. has important treatment patient mid-October. their in help understand on psychosis the psychosis. both story of a to patients prevalence critical recognize also and air introduces centered signs and living tells The It Parkinson's impact the awareness campaign its and

centric NUPLAZID With has doctors to the on executing the team their message this patient newly patients the is commercial new perfect educated - the platform to doing, new HCP drive campaign, been grow the side, work a brand. and introduce on new time our

in patients quarter, these of need disease. the see the in we better Parkinson's And and to expect campaigns in realized patients fourth recognize symptoms Of treatment and The traction NUPLAZID bottom the caregivers while connection need as mostly year's complementary it's growth. benefit full will of to next psychosis caregivers such a to of be are and options course, line,

accomplish Serge. campaigns to it We will I are confident this. over now turn our will

Serge Stankovic

afternoon good and Brendan, you, Thank everyone.

had and mentioned, are FDA Steve forward As our have meeting. the we with dialogue a upcoming looking to constructive

a as dementia-related potential psychosis the for we Pimavanserin FDA evaluating that as understand to analysis dementia believe to treatment the position continue most subgroup. appropriate, additional by we and While 's support indication a is broad preparing are treatment Pimavanserin

with dementia. Let's an mentioned, data, at disease start Slide the of discussion form is overview prevalent the of our the specifically subgroup, most on looking XX which Steve as Alzheimer's HARMONY

side is as left portion of anti-psychotic of double-blind in the of observed subgroup label the open efficacy outcome portion. the as slide well Alzheimer's efficacy the On the the and overall, overview the an primary in in Pimavanserin disease study, HARMONY

we not powered significance subgroup. show As noted, statistical HARMONY was previously by to dementia

on shown showed of relapse XX% group, hazard we approved reduction compared hoc Alzheimer hazard symptoms who the with those XX the a where However, to exploratory dose ratio of a treating analysis ratio Alzheimer did dose Pimavanserin subjects XX% of for placebo, milligram subgroups. we of patients, currently Post disease dementia about risk subgroups, Pimavanserin, less planned X.XX. experience with disease analysis the about PDP X.XX. of likely In on as efficacy with psychotic remain that see prospectively

for context, in design effect what of such relapse as psychiatric Schizophrenia this drugs with in For indications, been studies in line observed approved depression. various prevention numerous of or magnitude is has comparable

well-tolerated endpoints which on efficacy responder this severe the primary complete supported efficacy within that conclusion. right demonstrated right share positive the Pimavanserin number potential Pimavanserin the with support conducting to To analysis negative patients. will Furthermore, patients. set has of Alzheimer clinically positive slide. show conducted this conclusion than The equal clinically value to several addition, data to has cognition of in these of clearly severity we -specified provide and the motor or response raised equal in Study, treatment of that of Alzheimer magnitude ADP in clinical demonstrating analysis in analysis p-value placebo-controlled benefit efficacy across more study we sensitivity complementary disease was been demonstrate Pimavanserin of the efficacy will symptoms, and, ACADIA of studies. and addition hand Pimavanserin more benefit analysis, is a for and, a upcoming psychosis. a higher slide across further subgroup that of Note additional treatment recap, the antipsychotic for These support analysis that the Pimavanserin treatment meeting substantial Please patients to confirm had with on also efficacy, pre evaluated In antipsychotic responder meaningful which analysis utility of Pimavanserin Alzheimer our in supportive the in and subjects and with the further Alzheimer the with primary listed even dementia impact disease with by observed across potential turn on additional different meaningful is disease importantly, outcome next disease our FDA, analysis consistently clinical randomized side also doubled has of benefits the also in of are psychotic of a studies two the some The subgroup, positive of letter, function. shown a overall treatment order examples psychosis shown response in has the Pimavanserin demonstrate of efficacy X.XXX. thus effect to In resubmission with not of independent discuss in the to examine for the without evidence issues symptoms psychosis the ADP the and the XXX X.XXX Alzheimer's all the those In P XX. further in the psychosis. slide in patients greater been FDA multiple In meeting,

randomized the evaluated age study X as co-primary Rett with CGII, physician XX is Patients behavioral would caregiver I The and Rett syndrome to for for Now, through placebo-controlled a a Rett phenotype potential XXX global of are XX. pivotal approximately impression Slide clinical endpoints Phase a to study treatment RSBQ, or LAVENDER which on or like females syndrome. weeks. in double-blind discuss evaluating a assessment. are improvement, our syndrome. tool; XX X a is young questionnaire, assessment

LAVENDER, efficacy safety be study, II currently are previous announce top-line addition by with track are from FDA to in the a We to new the to results we results have support importantly, we And supportive agreement sufficient year-end. on positive data could from the drug database Phase that application. collecting and

nothing is burdensome let the Rett Finally, me for treatment Syndrome. approved their support. remind you the Rett devastating and around-the-clock that requiring often both disease there and caregivers, a is for of patients

study of We summary significant near negative of for ACP-XXX the a field. treatment our overall X opinion X we which our Phase the experts evaluating in modest studies: could look informed includes their turn symptoms have the program to XX to the for the last future. of the third had X, of Please on key announcing ADVANCE Slide improvement initiated two and of ADVANCE which update slide our of pivotal difference an in forward meaningful the this even very quarter the XX They for a functioning. Pimavanserin shows program. patients with year. results discussions make for and in and study leaders us and that schizophrenia, positive a care to We symptoms several ability in the

evaluating of X following nearing surgery Phase study completion. ongoing for Our the enrollment XX is ACP pain [Indiscernible] postoperative treatment all

slight delay the Delta of during with elective slower of now we to Variant first XXXX. quarter surge. results summer surgeries in is expected than many of postponement the However, COVID-XX the the expect due This enrollment

initiated of as summary athritis year, program. ascending study pain a this pen program dose with X suffering disease. patients and of for a the cognitive from in we earlier an Phase treatment study a plan XX I multiple brief continues reminder, this a astro year. to as ACP impairment provide XXX initiated next Slide our work Alzheimer's and Phase study for potential addition, for update schizophrenia recently We associated this our highlights In on MX

to to at XX, in committed needs CNS. ACADIA, Turning we're high to unmet investing Slide in therapies address

III Our early multiple late-stage clinical call acute QX, has pain have Phase clinical initiated ACP-XXX study. and we in chronic multiple to ACP-XXX well the This turn in studies, pipeline as multiple QX, year, Mark. programs, ACP-XXX pain I'll before With that, dose development most X in in program. over as including the stage recently, ascending

Mark Schneyer

to an sales, to of discuss in Please compared I third In Today million will results. net you, the XXXX. of turn approximately QX net in quarter XX. XXXX quarter recorded million X% increase Thank XXXX, Serge. third of $XXX.X we of Slide sales $XXX.X our

increase The at XXXX adjustment for third XXXX represents the sales gross QX the of in quarter end slightly channel XX.X%. QX to was was Weeks year-over-year. Net in inventory growth X% Our the volume down. of net

demand sequential growth growth X%. approximately higher slightly was than result, a As sequential of of X% selling approximately

expenses XXXX. down Moving our quarter upfront costs in GAAP, R&D included $XX.X year, the decreased last $XXX.X the compared $XX.X in million to expense third $XX.X R&D to during compensation SD&A related of Recall P&L, $XX.X to transaction in million quarter acquisition expense for last relatively in compared the QX expenses quarter consideration million GAAP to flat XXXX. the the to $XX.X therapeutics suicide quarter were year. million the Non-cash GAAP the million same million period was $XX.X of in stock-based million third at compared

expectations Please for additional was of XX. on slide Our the some $XXX.X year. color our remainder at cash the I'll the balance million. financial to ranges and now turn the end quarter provide of guidance

channels. with strong growth we well commercial relative deliver continuing performance team our previously, is mentioned execute both in quarter-over-quarter and As to

from hole accruing the a obligation As the fourth inventory year-end much to gross in a result we associated a for net in expect donut quarter with as impact the higher reminder, channel. of

recall full we last addition, gross net guided In the somewhere being for year. XX% that to quarter around

As we of the the guidance $XXX range top the our of end we the get narrowed full-year have $XXX previous range of million. to closer end to net million $XXX $XXX million sales to from year, million XXXX to

of in guidance, to saw little leading X PD guidance sales of provide the in in the that and like rates,has commentary approach remain net presentation, on assumes net first the Our as year. year. Slide inventory half more flat we levels As indicators our end occupancy improve a of sales to I'd of office relatively visits channel our we the LTC Brendan's started bit the

However, quarter, or This is third in off surge in experienced COVID-XX a have to the variance Delta they seem summer. leveled of decline. reflection we the the

Our net sales range, flat to relatively remained grow. they indicators long scenarios leading how versus quickly that guidance on how factors, and are returned

slightly finally, Moving onto full for be have from million with $XXX the $XXX million the R&D GAAP between $XXX end $XXX SD&A turn our back and have I that, $XXX we be million to And top million narrowed our will million year to expense range $XXX $XXX range full-year XXXX, GAAP to million. to million side our over the to And Steve. lowered million. between of we $XXX the guidance for guidance to call previous of from

Stephen Davis

this teams you, closing, I XX. In to proud Please am of execution year. our to Thank how like remark for on turn I Slide their Mark. would

less all delivering suffering Pimavanserin to psychosis. push with achieved commercial year more Our from families symptoms the the worked They've has pandemic and of continue are conditions. Parkinson's to more team through and patients their on who tirelessly

look Rett regarding pain. patient clinical time We're study from during Trofinetide executed our the R&D of clarity postoperative difficult. results results syndrome, X andn to additional key enrollment on from study ADP Our course now around two And providing Through is out your forward year-end. to our LAVENDER, has Phase report in in studies. poised ACP-XXX when we team

employees to Finally, I all for to I their call questions. our to would open mission commitment our like up elevate for now the line. of thank will Operator.

Operator

the Instructions] we Q&A [Operator compile Please standby, roster.

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

Your line is open. now

Neena Bitritto-Garg

my and quarter. taking congrats question for the thanks on guys, Hey

then sounds for at commercial just have like of just also you quarter dynamics to question QX, the on now, comment of kind a we net is just assume say the during similar actually Thanks. Mark can 's and quarter-over-quarter. a gross to guess, on it should all should I patient about versus -- down a starts it us higher be new of commentary of -- kind could some and I Just QX, quarter? expect that performance from QX NUPLAZID. of pace can guess the

Stephen Davis

Neena. Yeah, thanks the the answer Brendan question, first the going question I'm for ask Marc, to second.

Brendan Teehan

regarding question we in Neena, the a levels. approaching starts quarter, new the are thanks for patient pre the question. seeing -pandemic patient starts third are that The a new

the in quarters. comparable largely So between

we and would into campaign.We DTC the quarter growth XXXX. head expect HCP As continue increased with our our into moving with efforts fourth in to our

Stephen Davis

Thanks, Brendan. Mark?

Mark Johnson

question. the Thanks for

net there's I I is think put net out of an full we that with fourth growth bottom gross out the what range. the the are net lower But quarter end volume got fourth expected third to that point with would I that reported than range the sales of guidance has reported quarter there's the -- scenario want quarter net sales. across at -- for range. be think range implication we end lower The sales, of for the net yes, for higher adjustment of sales at

Neena Bitritto-Garb

guys. it. I Thanks, it. Got appreciate

Operator

Thank you.

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

open. is now line Your

Gavin Scott

We broadly about the from Cory. setting for Specifically, but agency for about have invest their as to the case? independent DRP now would actually got Phase view a to DRP, to for to question are regulatory on drug the it next planning in to thinking -- help you on year Gavin development was are increase relative feedback X I'm launch this a your components had expected they candidate how seem [Indiscernible] DRP any ADP

Stephen Davis

of Could part? repeat that second the that you hear part Again, and I didn't question.

Gavin Scott

seem development case. said help your just this that to I would

Stephen Davis

Got it.

our to subgroup basis. on are other based a by with to a that can't made subgroup they clear Well, it what we Thanks. the just people's is the Okay. this I'll simply correctly FDA. assess think reviewing that obviously on have upon us data say comment population interactions they

focused we're what what be next the on. focused on in That's week. we'll that's So

Operator

Thank you.

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

Your line open. is now

Ritu Baral

Hi want on last to up the guess I guys.Thanks different for it slightly that taking I way. a ask was did to going I follow question. question,

discuss As specific this treatment immovable, mentioned, far so does trial best to as XXX, well-powered FDA can through you quote an come far address remind to I study it. DRP think XXX the the like and you And of then you us meeting ACADIA's -- further, And the Thanks. Can I believe on you was well-controlled out as plan versus the sort FDA controlled of interpretation conduct sort it study? the side, they next they whole, have effect, whether would the us study. is XX% quote, that of just of in what well XX% clearly was if take as you remind approach around you on the changed its aspect considered mind ADP option administrative population. a of of and are single-center overall to a

Stephen Davis

part, patient XXX do. first the the I'm going take question, other we to you regarding any I'm of the the question, have well. heart for Serge the to going portion as Thanks Yeah. if have comments answer Serge,

we the broke to meeting, of placebo-treated XX-week what components, the And recap consistency the very we drug in suburbs. our patients patients. clear are psychosis used treated patients top irrespective during X-month second A process -- type to for during placebo which by the was At individual a control through briefly, when very cluster I versus on response we and made as presented of broke throughout it intended a again entry on on used individual down them study. to it was or we randomized of [Indiscernible] portion saw also subgroup April. ago. was our consistency that was the components Houston period mentioned scale, that study the then down response a data And that basis meeting, demonstrate enrollment of a the that in of analysis underlying subgroup both looking FDA Just response And criteria a at dementia-related A received and CRL they that

until the infringe then of patients came responded of during So each group and in co-morbid disease when that see pretty in is more group, portion randomized elements, similar in dementia. -- a difference period they In very across way a area those rapid subgroups. similar we look the study. same loved that wagering the both drug they was placebo much we for responded relative very in patients open on the label patients they that placebo sub One They saw patients relapse responded study, a on dose the where in to other have that in did group Parkinson's we --

that psychotic of to to dopaminergic So known we back their that's attribute who the patients motor these -- are exacerbate taking And function. for therapies can symptoms.

population subgroups think think conclusion is is forward bet of your approval. your -- made the that to a subgroup basis, we way study the the the subgroup we to in think seeking meeting, that an we study get at and points. FDA additional best this you points, said, So on reiterate, we you some valid We run each best to are want

the However, didn't get to conversation. complete

with And they to said, dialogue having another without we further open discuss hour one potential of the back before additional an if course, meeting meeting. would very be would the you to like forth meeting, clinical for and resubmitting So study. we you

And so disease doing the the we're where the the is Alzheimer's, XX% represents you in our we a XXX starts the second, dementia population. that also and patients, of our had psychosis population is in is great XX% about that to we where about potential what have is -- that subgroup we think today That's we're study, epidemiologically, positive psychosis. of where in study, also dementia group telling speak result to was HARMONY there a very that Alzheimer's

Alzheimer's those the focused we've on the now as all taking this psychosis new very on last that So we're meeting next focuses done analysis meeting disease for in since we population. reasons, that said,

Obviously them want So address do meeting. about further to step the steps. next able we'll to study? have, that's look the need to give as we next have having and to guidance the forward XXX meeting, be Sir, as you we soon

Serge Stankovic

it just study, -- XXX a into that to them reminder roughly to in to the response the to care issues UK. be letter was homes psychosis and makes a Alzheimer consider difficult FDA study adequate that FDA of related study. homes others that conducted concern of respect study are no product design, certain the In the study. expressed or respect second issues is deviations This disease there X is we they the design of and address you. number was One, were air two for thank these study. our Yes, can outcomes. complete single-center control one care outcome concerns, emphasized. particularly, were the secondary in for the related by or the We to in the and study that this in the raised that categorized study in a on to can buckets: the for perspective of the and understanding conduct the that that requirements type non specific secondary we are that measures, intend these In of well-controlled study; the the in reported X this from adequate issues is and believe and well-controlled a recorded

reported the not that by or down area. a said, only I London throughout the UK, we the the deviations they this single the conclusions from is specifically detail, reported. are results. the to the se, that it investigator the beginning to sensitivity perspective also as conduct, impact elaborate deviations specifics discussed But nursing -- address, in study way, and will impact to also, in of And intend that of study broader we was protocol a From in ability intended the their under per analysis this are further protocol of additional and But we in number reminder, done way. on did study are a not timing and of number a study the very this any provide demonstrate care in homes the interpretation Just coordination report will we overall UK. homes of that, would of that and

in a short, meeting, of as we what And be the adequate of the exactly address re-submission. the that disease intend in of as -- we that are Alzheimer's level we can concerns our in these the well we FDA. and do and data independent to overall Pimavanserin this is So comfort an consider psychosis. in well-controlled that believe can that, efficacy perspective, And from study in as following eventually the study we evidence by have supportive raised and in -- that should

Ritu Baral

it.Thanks Got

Operator

you. Thank

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

Your line now open. is

Charles Duncan

and Hi. team. Good afternoon, Steve

First of on question all, and thanks wanted for taking congrats one solid our commercial one ask to and question. question you pipeline then quarter. a I

would in guess the and thinking Regarding two goal.I some be HTPs percentage you're campaigns the And where you question, at I like PDP I commercial diagnosis on say, the suggested guess wondering brand new us if think and I'm XX months? color provide you'd and about direct-to-consumer. to of could that be higher today I'm where for

Stephen Davis

go Brendan, Sure. ahead.

Brendan Teehan

Excuse me, you question. the for Charles. Thank very much

in their Parkinson's campaigns. The say because principally excited First, We to on motor that both HCP that and it. They very demonstrate focused story improve their weave about the telling campaign. And see our function. way. We've the to HCPs we're campaign disease, research about Parkinson's to higher story not patients are I'd need favorably going HCPs of disease. know impacting NUPLAZID the function is responding in to interest the to ability psychosis a drawing market done we the attention on treat. are prescribing of while to a psychosis, as need

and focused on caregivers. patients more campaign second The

and experience You this that first bit patients the to Parkinson's their to disease HCP's story, NUPLAZID is all, attention. is highlight sure to can disease bring that which caregivers to DTC the of psychosis. it's make normal part and those to But understand solution importantly Parkinson's important thus that of situation as every as a in their see

patients the now complementary of that has how treaters again that been campaigns up and caregivers will conversation, that very proud using fashion. those their So DTC to here. very We've engaged confident are and we're happen we and in that with

Charles Duncan

around would mentioned a for in and population. lack impact to if me little Brandon safety? just Serge And Ritu's as the provide that us analyses Are more color just the conducted. have it wondering the second then, on this I cognition but Okay. around ADP as a be well in I'm motor would efficacy? they important Are primarily they of mean, seem on on function Perhaps question new been you pipeline. bit that you addressing is answered could question,

the conducted a by be what this? in So kind would have Would to able this would when end you update update analyses to or year position of you happen of and you meeting secondarily, be of the then the end the by or year so?

Serge Stankovic

and that let or I'll questions also efficacy dementia in a related stating patient group one-by-one. first where start way as be by is to or evidence as should to says, Yes. complete efficacy raised dementia in response the, regard evaluating patient the all, what of the something with as the get the by letter subtype. previously we psychosis, -- that appropriate how new a the whether Thanks, in stated, just Steve that analysis, derived, me of way Charles, In population

can that efficacy start is of where are of is And comment any and I also, of specifically have So certain want to a a specific that and submission. specifically also providing to with for the in related analysis additional analysis. course, did a part second, And is psychosis regards to was benefit motor new not designed -- supplemental that we lack And It's well negative specifically safety safety of is open clause that this looking reduction this is functioning. of the regard and in in your ways upper substantive. a preparing a Pimavanserin psychosis, that primary providing debt this negative calls the a are discontinuation analysis of impact variety different NDA in is population were subgroup the grouped can provided that supplemental we in to related in And the cognitive Alzheimer -- clinically the that as Pimavanserin dementia, demonstrating in three relapse, specific of -- as with to is where discussions question in information of safety we as on in a providing of and population. and have be part Pimavanserin, three additional in and imagine, of in cognition, questions subgroup, respect. as that reduction -- in our any that to you all that into the in benefit with largest a the loop a the that say disease the in disease just part group that to groups. Alzheimer's evidence, profile who address broader safety most outcome, data One that it of that where there for the to of NDA meaningful I'll a related and the the around discussion is we the case, the function. patient we naturally In number in are patient evidenced are additional where this we're well because is secondary safety about and but unchanged we and issues certainly is that don't

mentioned group, and or PDP the a the XX% dose, in approved also providing we disease, psychosis. are dose but prepared in that in not also XX and DRP recommended and overall received in recommended which patients we where Alzheimer dose As the the in Alzheimer I larger is of specifically the group reduction, remarks, dose XX% milligram, between -- only

treatment Second in continue the or switch Pimavanserin patients placebo. to ways and severity to of randomization, is group following Pimavanserin -- analysis symptoms of to severity, this of psychotic placebo the all either also following measuring with different continue active

continue also both of the drug the X that with exposure, at symptoms. treatment on of patients, remaining that and in time of severity with another relationship We of improvement are for dose the exposure, seeing the pharmacokinetic the and of way psychotic receiving [Indiscernible] finding. as FX over symptoms that that scale Pimavanserin symptoms, where following hallucinations demonstrating Pimavanserin [Indiscernible] on in benefit drug we through the well benefit the looking -- real delusions, control of efficacy and and clinical as is these that groups seeing change of are [Indiscernible] and on We're effects not terms in are of looking in and and we're looking +of of prep psychotic we're the patients continue overall, is

of broader a really we're is is evidence different of following seeing not types treatment, are the what that characterization the group related and dementia sub evidence to to that that to the is overview benefits symptoms psychotics that the across supportive purpose psychosis, treatment are I And XX this with the response a and subgroup is third The and demonstrate of one a patients, presentation real we of of across we prior seeing psychosis evidence in again subgroup also response different at just effect. group Alzheimer Pimavanserin. of in milligram disease specifically that both disease confirming and the in a benefit patients in looking categorical with substantive categories Alzheimer is finally, across treating will mention overall

broader So I hope scale. this a helps on

Charles Duncan

the of Definitely. Hopefully, when they hour you the just it. to will the about agency. Look forward response response we an hear the and than forget from hearing timing hear allocate more to

Serge Stankovic

Yeah. mind. sorry. slipped address -- just that. my I'm I will I

-- we meeting this that are We schedule. saying

We just end, we after confidently us therefore, receive the we're are year-end the year minutes around end little that talking a bit will have It's the difficult meeting the just maybe to minutes holidays. will meeting and or whether anticipate And because year state of year-end. NDA. characterizing that that that we for about will from the receive before around we

Charles Duncan

color, Serge. good, Very thanks for added the

Serge Stankovic

You're welcome.

Operator

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

Your line is now open.

Yatin Suneja

for Thank Hey, you guys. my you. Thank questions. taking

questions few a Just on Trofinetide.

XX-week question or us are if enter on FDA -- both the not decided you you that have show one you looking treatment you you [Indiscernible] the and portion a I or aiming comment period? the the? RSBQ agreement CGII? or guys So at sort enter what confirm the on there have exactly co-primary patients to know hit Could let all with to if study on to could to also after are who what patients are of entered And have us is endpoint. [Indiscernible] you X second any and the of

Stephen Davis

want to Thanks Yes. those? question. take much the Serge, over for so you

Serge Stankovic

the Yeah. Thanks, core who data Yathene of actually disclosed, (ph), the as first the we measure, primary actual in from terms study. are having

scale. into good and any are would focused for on and are all for speculate I what different of is be preparing purpose scenarios would hit scenarios would questionnaire a the we may would speculate Rest to Obviously, don't clinicians the result different certainly think statistical background. syndrome I the on us But occur. obtaining serve on assure, be we Rett happen what rolled think -- numbers, specific it positive in what separation if had scale hasn't that to it I the -- hesitate safety both for been happens. but course that of perspective on point, --we second majority open label extension the think exposures -- I of again, the the patients From patient vast patients patients where of over I in the the program. this the from further of study. can an provide, issue the -- the therefore, of on don't vast say majority And the that's

Yatin Suneja

get sense question clarifying long know completed? if more the just maybe to take Just that let us how a Could these trying January. the on for data is analyze you to One data could get it timeline. the to trial you might once pushed

Serge Stankovic

are the been in that respect. that change I hasn't can to end-year. a just study There line say on top track we results from the before report

Yatin Suneja

Thank that. you. All right. Good luck with

Serge Stankovic

you. Thank

Operator

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

Your now open. line is

Marc Goodman

slides explained Alzheimer's? FDA to even curious, when subgroup be nicely to you couple new data do with giving on a data, going I'm Has of seen data that that what that FDA the over you you today. are you there the meeting. the us But went Serge, just were

Serge Stankovic

Yes, for the Marc. Thanks question.

previous some the meeting, have in We discussed of this.

seen they So this some of some be what in terms providing general some of discussion of been should have hasn't. on the of the discussed. outflows analysis the But have we beta

much that providing good they idea a we of moving And and but So regard, meeting in specific respect. have color in them in outflows data. -- have of next in direction provided general be we'll it's terms are the that with what more the sort a we mixture

Marc Goodman

separately, changed give Just how sense fourth-quarter's a us reps past the us office in that's give of quarter to just question, sense can and four third just then you has the and changed. just how a then And changed? the quarter, Okay. in months how relative how the of commercial second

Stephen Davis

want Brendan, Marc, question, take to good think you I that?

Brendan Teehan

Sure. Marc, thanks for the question.

both improved rates setting. our have for and community access representatives, seen in We LTC the

in reported visits LTC. very line face-to-face. We're and community we're what the previously encouraged early I much in we've fourth far bit we're It So a what varies up quarter. by think little being in of But XX% seeing with around the between seen industry. so we've

Marc Goodman

And were ago? three where we months

Brendan Teehan

So we in XX% were range. reporting the XX% to

So it's ark m up to continuing

Marc Goodman

you Thank

Stephen Davis

at very from more, in bit up the it's continual the of little those we've really And on the and and very basis. meaningful A month-by-month beginning seen the low going numbers industry us of year is what everyone else. a this for were beginning year,

With the slow Delta bit. a quite variant, down you saw that

the the guys through, is see Brandon we'll as the approaching seeing are I seeing we're we that pass pull what well. our are you So as all the are, details we're now, for way Delta of virtual. point variant same mentioned, Delta in-person that we probably about And think today price about variant the impact of XX% the and all XX% of as see, impact

Marc Goodman

Thanks.

Operator

Thank you.

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

now line open. Your is

Gregory Renza

respect to that you just regulatory quarter update the that's to that's that's European with If to proceed with the on -- of that FDA, the forward. disease, enthusiasm the the subgroup curious with as much. quickly of Alzheimer's very going level to starting can all evolved. with subgroup the you indication how changed meeting. or you're that on subgroups. respect the Thank just meeting your on way if right going the and other into And and a Steve, my Hey, team. has more you disagree the good Congratulations versus past know position totality thanks the stance expected of question. as their Steve afternoon, with taking the that's engaging agreed I year just in characterized for have follow-up on and I'm you comment DRP proceed an the

Stephen Davis

for Let question, me thanks -- the Rick. take the

treat running of start dementia-related approved psychosis. drug approved is to There it. no drug Let There bit me to treat psychosis. disease take no a is at Alzheimer's little

in have patients today safety largest -- We psychosis disease the patients. ground. undoubtedly psychosis or breaking we're Alzheimer's So dementia-related database

how of treat done we've really addition, In to these groundbreaking determine work in trying patients. terms to

that best The as psychosis them view the population is still Our not believe dementia Reasons this very at thoroughly whole. study changed. underlying to is relevant etiologies before. a looking for has described relates to They We similar. as are to similar it way but very relates population. psychosis, as the very is And these we in study to symptoms way. a that the best dementia itself respond think way it

area that not in FDA does we we things differ, by understand at and where on could Their at basis. they that subgroup on, very and should looking However, little lines this share data subgroup go should things that the there's reasonable looking view is view. a groundbreaking be be to

as time, of have division just So on the the well to meeting that well. topic topic been very come this this them of engaged. focus next pivoted important have the FDA And described our recognizing It's very simply in us point as we And to dialogue has meeting. included to course, we've the crl neuroscience at history I'll conclusion. to that a it's expect a very for had. say important as that to next a we the psychiatry, I've together,

is that, but utility at we that. in decision a they utility that said to a see patient I the have are We as has way alignment meeting where I need prospects been from virgin a will that point, make We safety they before, case of if both when as tolerability in for forward. is again, this this for well with encountered that perspective very population, if psychosis. and look area the that have good, Alzheimer's efficacy say, eager territory to engaged to are there's strong to lot find a a in around ADP up Disease we data our having the And simply of and Pimavanserin that think we an can FDA not remain the data move represents new think

Gregory Renza

Thanks, appreciate call. the Steve. I

Operator

Thank you.

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

Your now is open. line

Ami Fadia

Phase the FDA the adequate of DRP. my not disease Thanks of package? If view could had study your the the give or And the on Alzheimer's or is as I best us be way. part question. as Is whether then taking you there question one viewed for in of can acceptable And II a have is that. with not different data on I'll follow-up whether contention slightly different point populations, registration a or question. the

Stephen Davis

give Serge, you then additional in want you bit to add. anything feel color. with try little might jump a free I'll And to else of Well, to

when about psychosis. think we or aligned the we study designed that and around was how Lewy pursue aligned Phase a psychosis, with III program, to program, that with subgroup Parkinson's not we study to group, of FDA I should perspective FDA all Body basis. that's design dimentia psychosis, and or to they the FDA disease our to Alzheimer's ran. has things or as are a we a as was that subgroup on at one Phase so we III looking Today looking described, subgroups by at single program the just be It the things mention the

where group that a on was now not in But the described, have, bit And a a in little have multitude that Serge to do. subgroup consistency from we're results is we've typical we a did a from if we meaningful to not cross-sectional And because of we perspectives so perspective, we're show things talking basis. about statistically see have we in very very subgroup. data a thoroughly we study Is clinically that looked at think significant situation design I there.

have. also We

Our have that patients. disease, on Alzheimer's study positive there. psychosis just focused But was XXX study

of just perspective being an well-controlled Serge described, we did study. the that FDA around adequate, As further dialogue with have

very the to align if to can where that on that's see have. board eager around data So the next the FDA have pieces We're to data the are. we the meeting we with

Serge Stankovic

and that subgroup. for is we in are And positive having DRP positive specific This think a studies disease subgroup context in that the that context on of actually in disease completely the at important from taken everything and then study that psychosis overall a study Alzheimer two to that we of now said a or If that is look benefit you seeing not study remember failed looking persuasive and These analysis at evidence robustly any very I or subgroup lining primary as Steve whether study. subgroup One be positive much add, in evidence. And second very the study. different Alzheimer's positive evidence set did I if perspective, subgroup are more is out on terms just that but to other specifically, group that the efficacy. of may the the different, that it's to the subgroup, it's looking out is XXX you with convincing and there us in has would more a of situation benefit studies. the

So we dementia. separate believe to there demonstrating that of is evidence in particular X independent this studies, subgroup benefit

Ami Fadia

very clinical improvement was a understand the those. the this helpful. any you be question trofinetide on population. second type meaningfulness of earlier would That patient that Great. answered co-primary about My question in is endpoints and the and of welcome I

supportive it requirements approved. the for think get pricing chronic drug about However, the the these think treatment and of about other would nature of as we patients, you should care possible how

Stephen Davis

question. the for Thanks

to the of value we the delivering. that's be file -- important comment just open say disease forward. and pricing it's will the to step results determine the very lives their much results, simply a the course for application, will unfortunate would question, to the to very, as as like can if think patients on seek we we'll of be look medical envelope, an population, And In of I'd drug is case NUPLAZID, we're caregivers, rest answer from this the I that, that we support help the with think perspective. I that if have it very and The improve to there and program that moving in an just forward the those price we it as a based improvement burden. that next on at if juncture. situation I where extraordinary high would premature us think

Ami Fadia

Got it. Thank that. you. I appreciate

Operator

Thank you.

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

line Your open. is now

Paul Matthias

is lot heads guess had thing re-powering data reconciling couple just questions the much. had DRP trouble DRP higher I similarly. our around on X.X one a one Thanks of to just of that kind going I in to speak is patients we've presenting and general. the in subgroups, just so around to a hazard similarly strategy related and and you Body. wrapping for back the forest But in other with Lewy the and except ratio responding it's plot, Parkinson's is,

on statistics or to view. in quantitatively then the ADP you of in case. the upper second was I hazard speak can And So kind talked kind just biological almost relapsed I around ratio is know you is that the just disease differences driven curious that anything that by how not that your your explain but you bound of can subgroup, a in bolster about X.X. reduction XX% sense

FDA of to so sort that's p-value view it? how think do So you tied that there's much. or Thanks if speaking will quantitatively any

Stephen Davis

for the question, to Thanks those? Serge, you want take

Serge Stankovic

Yes.

faster response Paul, like question. versus other what And the psychosis characterized dementia point biological the in really all say, faster of placebo It relapse disease going that group. out to a principal than the just look you when the Pimavanserin groups placebo rates where really of difference very the what patients that on on well, much at is see will randomization, on rates that types similar of are something are striking -- the in we is, first the versus or address the rates other you the a that disease I in subgroups think see question turns difference in dementia among randomized me to rate first Let Parkinson's Alzheimer. I from discontinuation too, else Pimavanserin. reason could the sub all about think in patients after question and relapse for relapse ratio for the I we observed out patients Where the patients is the relapse on is hazard difference we patients there Parkinson's treatment. in actually in here

sub Parkinson's talked are that the unique realized sub it's on what Why is talked Dopamin these patients is happening? Because replacement Dopaminergic unique on. that we active So stimulating patients types. fairly about is rates thing is not therapy that. disease that or in type. is treatment, It about actually therapy One that are similar other therapy. about present among is the different And

are X happening additional are that they we steam treatment psychotic wasn't. this look that sort you the you additional in a of that just in whole promoting while just relapse virtually when in of on them All sample And once have symptoms their what patients, the that, there close have is discontinue are is antipsychotic controlled, these at is therapy. and concomitant they faster there because that, elements

very because is few patterns. related So are seems but are seeing that these subgroup. we other it's to this when therapy we Any the that, presented effects about patients in stimulating there intend what we the can hypothesis in and we some the at about our samples. to it look on small that that is confirmation data biological so see we Parkinson's not look some are data, we we at concomitant difference, -- farm not Obviously, look additional that therapy, FDA of that -- there confounding that in the -- are it regard this are in is there have

ratios. helps regards mind to I you So And this, my bit please. and talking it house second I can part question I'll the this you your hope escaped while remind of about of little if so your with that different in ask [Indiscernible] me, now was a reconciling thinking

Paul Matthias

you worries super-interesting. was that for thank thoughts, No Yeah. and the Serge,

mean, from the the you I really just away far the we which see is data but I in we guess, XX% at to this you, reduction, relapse I'd or almost confidence see suggest how the XX% ADP bounds would relates it X.X, there's As about a think issue that. also curious interval. be statistical least subgroup, account ratio sample right? upper the your for there's ton of and size The significance, has

Serge Stankovic

said, we each in to that As to the Steve because order the in subgroups statistically patients see have of the designed study is in subgroups a as needed to test reasonable separation power. not more

the actually of are the number were we seeing we body is size a Alzheimer are what you about. related disease that But presenting, is larger confidence different evidence the sample to that analysis. a as intervals confidence a -- talking So are Smaller of size, that have. intervals a simply sample psychosis you consequence of

is, reached consistency them of of is, reduction effect. approaches, doesn't. question sum consistency is demonstrate seeing and important we're XX% nominal of question clinically effect. But is a statistical because Some finding of significant, or The is one or sometimes consistency. significant time it robust. is different the these nominally to is is risk argued, point nobody that it's outcome I'll -- analyses not real and [Indiscernible] point, say XX% a or out point is too are And these some significant And analytical measures, not are the [Indiscernible] true different is The way Type that to spurious look you what a that is point to spurious you for different a if that actually but chance that FX and through control the some see than something through rather be X convinced you benefit consistently, is, start sometimes finding. it meaning

Paul Matthias

right, you All thank so much, sir.

Serge Stankovic

Thank you.

Operator

Thank you.

question. time for have one We more

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

open. is now line Your

Jeff Hung

read for thanks first taking complete XX, would enrollment you the question, out? March. the data in when on the ACP went can when need you the quarter of and might in for the have expect I guess completed And to data more versus data in enrollment you January provide for granularity to

provide. Just Thanks. you appreciate color any can

Stephen Davis

to Thanks the question, so do Serge, much you take want that? for Jeff.

Serge Stankovic

sometimes happy our I'm Yes, by that some is toward slight therefore, that first of expectation. that's type we the in within to. should a elective a What of uncertainty, before generally we the That's this the But have are again, the is is Jeff. end the by should as the year say always it's results. first saying, enrollment end quarter, or year, will be of completing and we there I we certain surgeries the -- experiencing level a I of delay, quarter particularly enrollment of Thanks, but end as and of -- we top-line the -- dependency, said, anticipate are we of the context sensitivity headwinds.

Jeff Hung

Thank you.

Operator

like closing over no turn back At Davis this time, to to questions. would showing I'm Steve the I for call further remarks.

Stephen Davis

Thanks We our joining Thanks us updating for look forward to again, next progress Operator. everyone you today. much, quarter. on Great.

Operator

today's participating. for conference Thank concludes you This call.

may disconnect. You now

ACADIA Pharmaceuticals (ACAD) 9 Nov 212021 Q3 Earnings call transcript