ACADIA Pharmaceuticals (ACAD) 5 Aug 202020 Q2 Earnings call transcript

Company Profile

Participants

Mark Johnson	VP, IR
Stephen Davis	CEO & Director
Michael Yang	EVP & Chief Commercial Officer
Srdjan Stankovic	President
Elena Ridloff	EVP, CFO & Principal Accounting Officer
Tazeen Ahmad	Bank of America Merrill Lynch
Cory Kasimov	JPMorgan Chase & Co.
Ritu Baral	Cowen and Company
Douglas Buchanan	JMP Securities
Neena Bitritto-Garg	Citigroup
Andrea Tan	Goldman Sachs Group
Charles Duncan	Cantor Fitzgerald & Co.
Paul Matteis	Stifel, Nicolaus & Company
Joseph Stringer	Needham & Company
Sumant Kulkarni	Canaccord Genuity
Jay Olson	Oppenheimer
Gregory Renza	RBC Capital Markets

Call transcript

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Operator

Good day, ladies and gentlemen, and welcome to the ACADIA Pharmaceuticals Second Quarter 2020 Financial Results Conference Call. My name is Jonathan, and I will be your coordinator for today. [Operator Instructions]. I would now like to turn the presentation over to Mark Johnson, Vice President of Investor Relations at ACADIA. Please proceed.

Mark Johnson

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

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

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

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

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

Stephen Davis

and X. made pillars. Thank Good Please our to afternoon, and turn us everyone, Slide today. X important significant strategic We've on thank you progress you, joining for Mark.

CNS the dementia-related we NUPLAZID; innovative with development in with of year, indication in second and improve disease psychosis ACADIA, on for disorders late-stage on for this the X unmet our early treatments and driving CNS patients opportunity, medicines. for and our new with are At Parkinson's growth psychosis; developing of reminder, candidates by NUPLAZID delivering patients needs our commercializing mission focused a developing As is the lives new to pipeline.

Our on execute enables strategic these that X focus pillars on us promise. to

turn Let's to X to Slide review.

These XXXX, the NUPLAZID in achieved fact of million driven sales, second are the reflective environment evolving quickly increase, net from the we year-over-year pandemic. of that execution. the quarter COVID-XX a to strong $XXX.X For by resulting strong XX% results commercial adapted

a in Our is successfully commercial at care team executing engaging both high practitioners. health with and level and person virtually

$XXX successful guidance. sales our lower As growth to between representing a net We end XX% execution, sales of million year to result of raised be now midpoint million, team's $XXX the at year-over-year our range. the full the expect we've net of

in long-term in market the of NUPLAZID and DRP. addition confident are look forward We driving the PDP to opportunity for

Let's Slide opportunity move the X. to DRP on

The filing dementia-related represents PDUFA by caregivers but a XXXX. family DRP is need, not members. for step significant as the highly of accepted of for FDA the Our a filing psychosis only the unmet with supplemental and April disease next and the for their NDA patients and application date important disruptive was an X, devastating for is also

supporting Please our forward review. their FDA to to to confident submission highly work the and efficacy to Slide look with continuing both and in are We X. the data safety turn facilitate

patients enroll in XX-milligram weeks initiated pipeline. pimavanserin. development evaluate This progress a We've We pivotal continue Phase and ADVANCE-X, the to late-stage in fashion double will approximately with dose XX III for our now in second study, blind schizophrenia. them make negative symptoms of our a important XXX of trial

top line the anticipate study III June. year. second Phase of LAVENDER next half syndrome Rett results patient Our in We in recommenced enrollment

In capabilities. pipeline addition, and and development our leverage development grow internal commercial are R&D focused we on to our business

this through complement With additional long-term MX invest discuss now development highlights. to from the our to year, that, business opportunities For will future example, strategy. we our PAM Michael earlier licensed I growth it to commercial performance program Vanderbilt, that our we will turn in over and continue and

Michael Yang

was Thank long-term you, fundamental quarter our in another performance, would our up commercial expectations execution, setting of like franchise. second volume highlights us I for confidence for Steve. and another quarter Today, the the us growth. of the which business of review gives NUPLAZID to strength This year double-digit strong

launch care Please for NUPLAZID Slide we're the with with patients to psychosis, good progress preparations. For XX. PDP. transform turn continues to making our of dementia-related standard

We be enhanced by best-in-class year-over-year growth such This enabling innovation in to engagements was tactics virtual environment. response delivered XX%. the identification patient our and net volume have growth diagnosed NUPLAZID of fueled rapid driven positive prescribed $XXX.X pathways, second evolving and driven the million, electronic of quarter, health by momentum sales remotely. to patients we records by and through In clinical leveraging as our

their treatment We conversations troubling are NUPLAZID. and physicians patient with platforms with stimulate utilizing symptoms of the our about PDP to caregiver digital and potential

COVID-XX specialty to improving and strong consistently overall patient facility fulfillment control resident care infection high. new pharmacy managing setting, Monthly channel rates new and quarter. in impacted has We decreases and access health invest for both easing practitioners. remained Sequential terms growth this situation growth services patients process volume fulfillment in new nursing In adjustments performance. contributed in continuing the operations in the staff, which admissions, continue the long-term also in prescription in care for resulted of patient the quarter to to the

market things Despite fact, other have believe in LTC. outperformed of is metrics. directionally challenges, Acuvia, showing we long-term to NUPLAZID in And major improved a and care NUPLAZID well performing brands signals in recently setting. However, these according promoted seen stabilize most we

these as care. and will new established stakeholders demonstrating of patient with believe partnerships disease recently advance the timely in care we space, NUPLAZID of the have key and long-term We partnerships importance further education identification, standard

return The certain growth at XXXX functioning field XX. able have to the initiatives virtual Slide sales Let's areas. environment, on recently been has we high team in review to and a in the level been further our

forward, I'm the the that channel. trends patient returned have in start to pleased SP report Moving recent pre-COVID to levels new

introduced growth, on-demand several to caregiver materials educational the optimize and via initiatives have KOLs, continued virtual programs topics care case including new drive including social and nationally with recognized on speaker programs COVID-specific We and support field tips. patient isolation learning virtual to telemedicine,

patient addition, PD with psychosis In disease integrated and campaigns awareness physicians NUPLAZID. conversations to enhance about to their continue caregiver stimulate we our and

digital requests. NUPLAZID are continuing to social our activate further and platforms We to also expand

for XX. Slide turn Now on let's pimavanserin potential to our indication DRP second

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

We for virtual positioned our scenarios, in-person well are both to execute planning and be and plans. launch we'll

marketing-driven sites education Sermo, to disease and content initiatives, We to including such third-party education on and site our Doximity education disease with engaging continuing market new Medscape prepare leverage refreshing as our are partnering via HCP website, MoreThanCognition.com, from theirs. content state the disease and to

virtual as are medical Conference, congresses, International such We Association month's or in Alzheimer's also AAIC. last participating

With significant additional presented to turn over to of education burden Serge the As dementia you it that, are to R&D discuss aware, pipeline. X an which AAIC an science. I'd data disease on of oral to meeting and the presentation and HARMONY a treat. many is virtual to the open-label of highlight like advancing posters, sponsored our international held extremely some ACADIA need booth, influential dedicated DRP

Srdjan Stankovic

to Please pipeline the good related and DRP Allow Michael, afternoon. you, sNDA. on Thank to me development turn comments start XX. to our Slide with

advisory identified We are with not us any on meeting. forward committee potential filed our psychosis and planning and that an they FDA working issues to FDA of have very our communicated that not are pleased the the has review dementia-related look sNDA application. to hold We for to review

program we negative focused of syndrome. as to Vanderbilt to that on pimavanserin Consistent Earlier licensed new schizophrenia is pipeline. developing our and in University advancing in advance well. PAM look programs program year, and a growing our with the from In novel forward and and strategy, we this symptoms Rett remain advancing trofinetide late-stage treatments, addition, innovative continue MX reflected this we for our for

recall, we happy would study this initiated to the announce that our on negative start ADVANCE-X III have indication. Please with symptoms second for pivotal Phase Slide program. schizophrenia. for negative this study the symptoms of Let's XX be I'm

will the the point the disorder results dose predominant XX-milligram the previous study, results Building schizophrenia XX. is as end of the investigators, previous reported last LAVENDER to learnings schizophrenia The unmet Slide Slide in design end Applying debilitating study of with is patients symptoms of here study XX controlling Working symptom in a assessment able in the where provides on this with robust ADVANCE-X. significant be November scale. XX enrollment positive view the for highlighted in while recommence item ADVANCE-X unmet negative remains the ADVANCE-X on first the design. on evaluating options clinical we evaluating and study, which, study learning ADVANCED The of X from a symptoms in we in of an the study a need year. of high-level The dose, the the from non-U.S. conducted negative negative treatment very primary observed XX-week sites. schizophrenia, pimavanserin receiving rare trial June. pimavanserin their positive of baseline no symptoms. our available. Rett ADVANCE, primary FDA-approved to adjunctive a studies in our we on Similar with treatment syndrome positive need are patients point with change ADVANCE-X now were for is positive

on once in to performance. With be call results Elena into able will We now the to working are turn the I patients over enroll being discuss second a half financial basis site-by-site again our to top We of anticipate to XXXX. announce line to that, the able study.

Elena Ridloff

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

promotional largely in during to XXXX. the and same advertising quarter as Cash quarter million $XX.X and compensation the related for during the costs. period QX to for million was stock-based is $XX.X expense with GAAP This was $XX.X increase GAAP compared $XX.X operations The well to compared decrease due $XX.X $XX.X in as million of Moving million quarter million an increased spend personnel year. used Noncash is the in million due DRP. XXXX. lower second associated SG&A in quarter in compared $XX.X in last costs the development schizophrenia P&L. increased down to and R&D the million QX $XX expenses the to million from to quarter expenses in decreased to pimavanserin second largely XXXX. in

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

lower and growth year, of the expect million growth revenue be the guidance midpoint. for year-over-year now continued range For We The full XX% the have NUPLAZID end $XXX forecast XXXX range. million. the reflects net of sales we at between $XXX strong approximately revised and to raised

Our to the and assumptions range a of net the incorporate guidance COVID-XX of to duration impact sales pandemic. continues related

GAAP reduction are with to to reflects reduction the The to We associated $XXX $XXX to guidance reflects million of adjunctive from our MDD. for On for DRP decreasing GAAP of expenses now previous in between million range million $XXX expense million $XXX to This $XXX be range SG&A of from $XXX a we $XXX investments to million prepare our million between side development launch. for timing $XXX to previous lower the costs XXXX, be million. expect million. reduction R&D

between in million continue $XX noncash million to and anticipate to XXXX. $XXX stock-based be compensation We expense

$XXX We our from will strong million guidance sheet with approximately million. I'll end previous XXXX and to million the turn be $XXX $XXX balance call with to our million, that, And back over of balance to expect Steve. cash to a $XXX year-end increase

Stephen Davis

the $XXX to in in Slide for Elena. Thank first the the net NUPLAZID sales Since you, XX. in year, Please million achieved PDP. half turn beginning we've of

April commitment from III with the In and our FDA program the for Phase look syndrome, programs growth. momentum like to DRP our X, depth sNDA date to the as position our and continued we licensed for thank I'll and for open and pipeline filed we business. breadth schizophrenia and advanced the of Rett keeping would in our long-term continued of now progress PAM updated symptoms for ACADIA Operator? of closing, passion I employees up call has for the their forward questions. on PDUFA of NUPLAZID been the XXXX. We Vanderbilt. Our negative you advance an We've by MX

Operator

Instructions]. [Operator

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

Tazeen Ahmad

strong a on Congrats quarter.

you on seeing get way you how basis. your can't moving pandemic on Obviously, any kind is thoughts provide? through But comments different in far kind It quarterly XQ. you're to just guide the wanted that seem of of can activity thus Just a general does its geographies.

offices on have at pace some new uncertainty you're ability open it then you closed with? a again. rest the you that a physicians thinking did doctors from of that seeing We item? comfortable particular How keep can give to sensitivity for that of for And for the heard of bit us guidance patients sense the terms in back a about year your just are down and the of

Stephen Davis

adapt been what in you this a soon the past and facilities, irrespective we've we think doing extensively seen we're their pretty very we're which again, pivot that dynamics? in have living the new remotely. we've does, through very think you I'll is reflection just year. quarter dynamics we're have or we seeing that's in Sure, the simply Tazeen. in the pandemic person want as execution comment to quick made, in core we're I the hit. of to long-term mentioned, do And to this about just strong in just broadly. kind that that remainder term he the in guidance terms is, else today that to the relationships pandemic. But we're offices Michael, person, And world And reported of strong the of seeing that care talked as add say guidance, ask anything able on in to the I confident I all we've that in updated to we before as the testament of just of how a of that I'm doctors quickly we've going with Michael whether

Michael Yang

Steve. Yes,

very I you from look setting response the strong I the think setting. it saw if to at of tactics care in a office perspective, we outlined

levels any discontinuations. in haven't mentioned, We brand. recent seen terms our we I of in pre-COVID to increase as see, And new to trends

So that's very good.

long-term setting. with think our late. nursing seeing facilities I But peers long-term that, period the to stabilized had with turning stabilized. of were, again, in deal Recently, lot. to dealing quite We're was care, they I a the with staff care frankly, where things that as in we're relative said, there over a that have was had control. They infection pleased performance

of you look a the if journey, treat still at with high these disruptive the very need to and So patient have patient major that's burden, the degree symptoms that issue. are caregiver a

place. put a doctor so And patient we're as or care, And the help the the diminished the by from the not office NUPLAZID the the result whether has nursing patient that we role in home, been -- some in in positioned pandemic. any tactics by or of of frankly, well telemedicine situation have it's it's to standard whether for of in

think our in said to it I you confidence the establishing guidance. our regards So well in

Tazeen Ahmad

Okay.

to you start, patients us ease give about physicians to color that key can then them virtually As first time patients diagnose their of about you any the new have patient kind for or comments and given being of drug? it on get relates able

Stephen Davis

Yes. Michael, the...

Michael Yang

sure. Yes,

that's patient I likely is the obviously, that, and channel. PDP But with Parkinson's. that it's optimized across diagnosed with already a is adopted think think thing being I the telemedicine been

a relationship a So with in case, there's this already likely physician.

reimbursement, that's NUPLAZID. for big directly and diagnose, And the so to advantage samples, the a ship really for the verify home think to and ability we get physician their insurance

feedback hearing on to that well on So that. very and our response I for positioned -- we're one. not good tactics think We're we're

Operator

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

Cory Kasimov

of started data based One if And online, from strength on course, investors. stays is have something patient there? comes increased you. And for stable it's the pricing more have get the NUPLAZID is them not why know on I opportunity two we within the second safe that's FDA any assumption time a seen been question gotten only review? to assume few assuming, the additional there's a do something from did we've have, the you for you that whether approved? accelerate potential population, Given it's the any of should of addressable I that And you color DRP I once to have weeks, division? Is sometimes believe then priority it's this line? get that you agency but

Stephen Davis

second Thanks, Yes. the first one. answer going Cory. I'll to answer ask the Serge I'm question. to

enjoy in premature from that very how said, there a is need extension an we in to the currently off-label wouldn't necessarily comment So similar provide access and would it's very we terms patients as little on above at we have. pimavanserin treatments before, the as believe we've important One, can DRP. price dynamics be and where cases, mix And pricing are what that it's NUPLAZID. it And standard as PDP assume in for of DRP, would currently such the approved pricing, we are caregivers this Two, similar. finally, for care value of seen we But demonstrate for DRP beyond today. already very to we see payer important we that no change and juncture. between line and said to payers I good

value anticipation proposition, already developing which very As budget health we well economic deliver DRP. prepared to deliver in launching and such, we're be impact we'll to of in our payers, survey modeling,

that payers. progress, labeling said we very we in seeing we're the be have. feel that a to the with final we as once So data And dynamics about firm position have dynamics, kind we we'll I've and up good language, before, very good set about the today of as

Cory Kasimov

Okay, great.

Stephen Davis

want do Cory question the to second take you has? Serge,

Srdjan Stankovic

Yes. Yes, thanks.

reaffirmed the with review, that color really the communication we as and in are they we previously, In the review we occur back review prior regarding few to it and their working day. cycle, preliminary any focusing for on our are hard to appropriate FDA Considering whether view very details facilitating that But don't time, action additional the be where for they review the date. on at review case case. engaged not their as on FDA. additional based speculate toward the -- a standard discussed filing April they complete us, that that anticipate did Instead, provide receiving occasions, it's their in As we And us. early and this did classification. yes, mentioned, to it's action may to with you us X

review are we facilitating of the day focused on So X. and April on action

Operator

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

Ritu Baral

little I time, a to preparing think, DRP to extra you're launch? Michael, hires lines. of to are time the how question what talent recruitment for you is And then looking make? you you've talk bit you got sort Elena. alluded about some Can the that for Given follow-up

on lower a component SG&A could launches? fact As launch of you DRP you costs virtual given than spend, that see XXXX? classic think a we net forward be shift the should actual of to savings took down it there larger sort into as do just Or

Stephen Davis

do want go to you Michael, first?

Michael Yang

Yes, sure. Thanks for the question, Ritu.

adjusting been that preparation now to our the but Obviously, virtual begin PDP. disease for So and well already We've We're sales the a leadership out, of done and that's start we leadership in prepared good I because of lot now, the leadership moment. to build talent in doing when at of to shifted expansion. for be We're date, and level. a we've team to and have be market We team. we'll to and hiring. hire has is and expand education talent, begun this obviously, preparation X slate to expansion footprint a what mentioned broadening how also that place first identify team we're April

for in benefit We're getting prep this time of so already market. And thing we're place. we're already we have to just loaded So the of NUPLAZID, about things think is this I market the the here one really a think and is other the payers. lot in extra to on

support successful very services patient We team. have a

we're launch So be extra time prepared to prep extra the this market. really and getting to

in or virtual shape, good that April. in face-to-face, see we're think we comes I at whatever us So

Elena Ridloff

virtually. Yes. on Michael year. in a this mentioned, early of been hiring shift. savings team And to PDP The engaging year question, the Ritu. of the part just very field the SG&A result next And as well timing moving is the We've

investments And we're a of there's we'd support we team to successful the field so expansion regardless on to or in-person a virtual make whether in launch. want environment, think key

Operator

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

Douglas Buchanan

the Jason. the marketing if have percentage earlier. more It's materials little you Roy with in mentioned new interaction in-person efforts, been then to a the wonder with start able you the force patient We've And for COVID-specific had sales the could couple on actually interesting of discuss I strength. what a has providers?

Stephen Davis

for Sure. question. Michael? Thanks much the

Michael Yang

Yes, great question.

been out but what programs. been received. to really what is or is sheets around load some algorithm the telemedicine and in say force's percentage It's face-to-face system that of, have not. diagnose caregiver to So on is to disease a We've visit I computer fairly to or social the we engage sophisticated enabling into a how as release Those engaged, able tips material, educational well lot mentioned, automate do we've virtual and them put sales is them what difficult field especially we that exact ed a have to environment. isolation, do a and obviously medical promotion doing been

that So spits for risk that case-by-case, our on we've county-by-county out on the levels executing successful, been think, depending a COVID I and very algorithm varies basis. team, the that

Douglas Buchanan

Great. Okay.

reps by well. varies actually as it So

Michael Yang

be can one rep that it county could the rep be territory county the even in So could inside and green. have red by vary rep's by -- they one

Operator

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

Neena Bitritto-Garg

Congrats on the quarter.

kind of to levels talked about come starts the of pre-COVID So pace new has you how recently. back

of up remain physicians the what trying is offices, around comfortable we getting some just get kind down new shut continuing just we much think could to physician of And you versus sticking of to to longer reopening telemedicine telemedicine. a if starts is, do with should see really at is kind and actually end period wondering at I'm of offices levels? how time to of more for kind Or of I'm there due expect of that do So patients if reclosing things see drop of pre-COVID kind or a again? does

Stephen Davis

take do to Michael, that? you want

Michael Yang

a great. great Sure, question. That's

I is very to and level and answer disease that disruptive very, it PDP caregiver. on of think is significant at a I the set symptoms really that really patient the would question start causes a burden family the and

And treat. I a it need of an so that, think, into puts kind urgent to

So really physicians mentioned to think I open. happen. nursing and I of earlier, if to we could is response what be in try is. think paradigm enable be could telemedicine, that, going think treatment it process the starts to urgency I do to I setting. ease with think or it And that It abate as I could what the is face-to-face no be capture the that office the speaks diagnostic that just aren't in is really as setting a asked, patient-physician, to home, new what the the we're matter you to our to And seeing And treat. don't in

situation. I still always a treatment. think This choice. is many In a a mandate going clear cases, that's there's not for be to

Operator

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

Andrea Tan

personnel as you've DRP Elena, look a follow-up And as comments Salveen. still in to for given I on previously you question. efforts to mentioned? XXX have expect do team maybe about XXX Andrea the towards there, the grow as your then is you the to follow-up a This increase prior launch, to virtual

Elena Ridloff

Sure.

and range we be we're believe of will get scenarios -- specifics and launch, exact as of a we'll both So to of closer. preparing sales will a supportive provide person we as mentioned, And far for DRP we sizing expanding be as more strong the force able virtual in-person. Michael as -- and

Andrea Tan

it. that, given wondering And that penetration into the to go thoughts you Got drive you growth have to and outlined back that updated if to just PDP PDP, on the maybe then continue to just market. the efforts

you I think previously, mid-teens. around the saying were

to that. updated just if you an thought So have on would love hear

Stephen Davis

that recently high to case. is said the and continues we've what think be teens most I

Andrea Tan

Sure.

So mid high teens -- teens now? mid- to still so high or

Stephen Davis

That's correct.

Operator

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

Charles Duncan

half Congrats, intrigued in Steve know that's really -- if a new progress with commentary persistence. the figure deconvolute to there And I'm bit just ask out the adds? team, to then that, into on had patient line. going then you but the Wanted and quarter or And new if a if say, good the you of, of of patient patient commentary. quarter, and the trying second ad adds little And year top really can I don't a kind for versus, new I was pipeline. good follow-up I'm

Stephen Davis

start? Charles. Michael, Thanks, do I'll want to add you color. Yes. any

Michael Yang

Thanks question, Yes. the patient sure. quarter. the Yes, those for No, Charles. were new adds in

related I business. to the the business, the it I strength your on forget So think SP of the of speaks And -- question? especially your I side as to what was of second part

Charles Duncan

contribution current Yes. patients? or the was of what And persistence Yes.

Michael Yang

Yes. Right.

consistent fulfillment and rates. We see continue high to

from that, really seen actually the consistent So I since think, launch. XX-milligram that I quarters. prior was think We've

that, think, And so I was continued.

Charles Duncan

And do feel... you

Stephen Davis

to add brief a annotation. just Sorry,

that in And the we last new as mentioned, just last we to on the is stabilizing things discussed now and And quarter, we what the we're starts kind -- seen So at of level the return. beginning at beginning back now, in pandemic. to indicated were starts of we've we of seeing Michael weeks, were the saw few the decrease as the pandemic. and that prior new the we same patient patient

as mentioned, a of burdensome in I reflective where, disorder symptoms position that's just, patients this we've are have on et and adapted, very have now burdensome. again, Michael They're adapted, adapted, So cetera. the of the fact we're think physicians caregivers, that patients,

or defer that can of something you a So time. ignore significant just for really it's not period

given fairly pandemic, better but in expect, more that of did we we in that and and -- we we quarter. a fashion physicians during to forward, than a we operate patients look So at the fluid as second situation this were still beginning a will be with expect the we we're position operating normal in the

Charles Duncan

color. That's helpful added

If any as And new this process easily April? that in to I could do one agency, additional the that across analysis, question a regulatory Serge. such ongoing, universally is between As safety know, the for can that and information anticipate patient you nursing. milestone now I to not PDP time have occur in the you'll is relative current but been thing else be DRP. kind the understand during anything that you providing of or ask adds just environment

Srdjan Stankovic

days, your What accumulated the all safety is information. and of we a and standard data for which as safety original XXX-day the for as includes, a for between cut-off course, the to date application pharmacovigilance update XXX the at anticipate new the information, the you're providing of essentially update data update date well new cut-off which

it's a a process. for any other comprehensive safety the do than And anticipate for updates providing I that, it. additional standard us So agency. not information That's

will -- course, but Of terms fairly would we process of a that anything the is information. standard in additional providing this require, FDA provide the safety

Operator

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

Paul Matteis

PDP then of volume? Great. June. to regulatory PDP, price for and you I expectations had increase just you a I guidance appreciate the speak follow-up. of one and just think at your on couple it. can kind guys I just a quick On end took

year-over-year any the can or you which a final bias PDUFA standard data, time more I weeks, this that update? But lot that be then they'll that if know I X on long-term did given anything that -- And regulatory in showing to, there decision into interpret. be of curious, date for scripts the or was think decline? drugs factor there always drug panel? FDA hard IMS more how frame Wondering a a script past given just on telling it's I to is review specialty So -- and biased Second, should the is less on is not a general whether in holding side, certain or the else. with its the under be time X is line, care than channel

Stephen Davis

the Yes. for questions, Paul. Thanks

you Elena, Michael, then then to Okay. want go, Serge?

Elena Ridloff

Sure.

with the the regards take guidance previous range mid- question? volume question, And volume the Michael, which guidance on our year-over-year, growth is to you So teens consistent high assumes script to want to range. with guidance, pretty

Michael Yang

question, Sure. for Thanks the Paul.

channels. Acuvia does call, SP prescriptions channels. we So not and, our the XX% in non-LTC capture business those the is of what SD in

of channel, capturing So long-term effectively, XX% our is the about they're only and which care volume. projecting really

Acuvia probably you're sequential single digits, us seeing you showed lower So us in down growth. the that report saw volume and

the long-term that in modest business of we a you growing, our tells that was So decline XX% care. saw and

Srdjan Stankovic

Typically, regulatory expectation hold timing that will the it no notify of of the their what workdays to general sponsor is here, question FDA the decision is. That's committee. committee tackle from the expectations Paul. advisory than XX I'll advisory later the

puts February, somewhere So the end in would and January, they think advisory vis-à-vis, about time action change for advisory then XX that beginning us committee November the workdays, about agency latest as mind notify of the the our of committee. about where pool us date if their if you

a essentially, is. happens in expectation is reality So what is this What different thing.

Operator

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

Joseph Stringer

This on the Alan. quarter. is on Joey for Congrats

Just two quick ones.

looking to BD In front, are terms in terms expansion, a some other of of at indications forward? going And more indications at assets in the acquiring in taking for you there of are you be terms of pimavanserin, new looking terms look label active additional additional perhaps?

Stephen Davis

Thanks Yes. question. for the much

are indications In indications indications for the with pursuing discussed we are terms we've Tim. that pimavanserin, additional of the

the to with with that a indications We that profile. have compounds this tolerability there with haven't pursue of are the there it, but about with kind have we the just we're we the it, pimavanserin efficacy have given is pimavanserin additional with do battery talked seen may never from be leverage yet, those in we program pursue given that do we've pharmacological a but are forward. None molecules certainly molecules of it we And pimavanserin. would of advancing. clinic want learnings that well very to bring lot -- other a that to get think, profile those indications compounds, that you to do will favorable I and we

some we So get with molecules. those of may additional to

and business commercial and grow the but important with front, as capabilities just We've BD as organization that, development said R&D for very a of we transaction. the also want strong leverage company's very opportunity, not pimavanserin to I is say the the we've On a would that strong strategy. only before, part built

to do continue we'll So that.

will business. As It's said our part I've before, additional important deals. see an of you

Operator

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

Sumant Kulkarni

companies about positioned drug talk for first is programs other to recently, be DRP, approved in to their well the seen be we NUPLAZID some have well. but as pipeline DRP

assumptions you competitive the the to product only on runway DRP? as have approved So are the for alone dynamic, your branded what might given be market this in new-ish specifically

Stephen Davis

hazards anyone And start. add. Two, I'll like of Well, way in say if free the else. Serge or to to I'll first, know we're jump Michael, feel industry. you we all this additional ahead you'd have But of color

progress, don't get cleaner. compounds They you usually As dirtier. get

more dementia-related large schizophrenia. we're progress, field continuing generally, multiple that psychosis, and have terms I'd cross. advance very, of in Parkinson to of hurdles with also all that are These large drugs. in you'd And room markets disease for you the in, more operating very symptoms to negative say As psychosis,

from to think guys or we add? strong position. Serge, anything continue So Michael do a you very perspective, very, competitive I enjoy have a else to competitive

Srdjan Stankovic

these To are stages clinical of efforts our early in development. knowledge,

clinical So product, if market. we still of this reach development have before years successful, the actually would

plus, think, are data, as anywhere work way I a of accumulated that's population. tolerability amount we said, of we in And really So aspect patient significant ahead. and this safety vulnerable and critical clinical Steve

Michael Yang

untreated the would both significant the I a Steve, there's still a to -- that DRP, very PDP is market add thing and on only in large comments population. your And

So and disease patients treatment. the there are have could benefit who from

these grow large So they not to only potential are large markets markets, existing are into. but

Operator

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

Jay Olson

the was other or for study schizophrenia for you pimavanserin I quarters. outside the on share U.S. any any I if wondering indications. on your ADVANCE-X. sites have you're U.S. if seeking planning Congrats to curious for latest was ex And approval could thoughts

Stephen Davis

Yes. take Serge, you question, the do I'll first want the to second? take

Srdjan Stankovic

Yes.

be second the symptom United trial, is negative the pivotal outside our ADVANCE-X, U.S. done all the of the ex sites of For trial completely Actually, will States.

Stephen Davis

As or a during number to XX-year -- that U.S. single pursuing of order could your on we we're second filings the data ex optimize before, position question, where we our be to a in better in framed indications accumulate we as strategy said shifted exclusivity period.

changed. to of course, little forward. population with of bit. a not continue So We'll adjunctive at that simplifies looking still forward it's has moving Obviously, DRP we We're as MDD the assess schizophrenia, and calculus the now that symptoms that PDP. in broad go not negative --

Jay Olson

review, for you if Great. you the then a months standard your That's to about time additional DRP launch since the have you may in education that could very And can from benefit what virtual promotional needed? unexpected have learnings virtual helpful. prepare plan leverage and strategies past DRP you to launch captured how time talk few with that and extra

Stephen Davis

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

Michael Yang

Yes. Sure.

time So I can the a because leveraging we think advantages one have disease of more bit we that. little of do we bit the We're do state education. is to little the a -- have pandemic more

virtual like lot with training future programs AAIC We're speaker MoreThanCognition medical As a disease state on virtual and on education. you with website. doing also our heard meetings education meetings, of

doing So on could we're, more this and I offices market. potentially educators be with think, a who the the lot profiling market, physicians profiling

So as And commercial strategically our we virtual prepare are we're general we taking our in -- on on very launch. today. get earlier, the more in environment operations it, I doing as said well guess, for details I've to time more more

virtual we're that if going through face-to-face, product in be we've well a to this to environment But leverage if would PDP. learnings a had great. and that not, in launch positioned be again, we're So the

news in So market. in story a I think it's us regards to for the good NUPLAZID being already

putting leverage, of lot just to a to existing and that best have use. We infrastructure we're

Operator

for question the line Capital final from Renza Markets. of from comes today Gregory Our RBC

Gregory Renza

MDD in just could commentary and to if appreciate perhaps earlier introduce to especially could simplify I'm some multi-indication program? on DRP establishing up strokes, approach value pricing in potential the broad would quarter. wanted PAM comment follow on for now out of direction or the for prematurity. the on how -- bit wondering, that of question Congratulations some and pimavanserin picture, you of a being either just how is on an DRP, a light you I MDD those I dynamics in

Stephen Davis

Yes, sure.

Michael, to I'll start. feel jump in. So free

we've very drug They of approved. similar. to use Prior the antipsychotics. dynamics They're and in as the complicated disease in pimavanserin, are to they can indicated no They generation of the In The PDP function. think used of only can very drug dementia, previous between case off-label populations. I the cognition. before, dopaminergic case are kind impair impair Parkinson's. these primary motor of symptom undermine DRP the

have and those so And -- we liabilities. don't

So and they're very between dynamics DRP. similar PDP

dramatically differentiated drugs entire as we've said and to as into -- relates development the looking a that be in to adjunctive approved there are that other through where along order program, for generic. we it profile they're As MDD, we're break said all market would

didn't signal, but And wasn't antidepressive replicate we'd highly saw so didn't it what of we -- is that -- we kind an profile the expected. it differentiated

calculus XXx of is of that the consequence it So adjunctive a of MDD, the more -- PDP. DRP not dramatically size in a there straightforward size same does, little as large. bit the make phrase, or again twice forward of MDD we'll because, it use course, moving adjunctive does the It's

those patient operating So very and forward DRP. simplified populations, similar very delivering X PDP dynamics, that we're indications very we think as unmet with pricing value moving in about now in it similar significant more need, does in make

Gregory Renza

I'll color on of if in. stay are are wondering just for the the It just wheelhouse, I could was on that Steve. assets Helpful but just helping valuations just commentary And some provide those your how not quick BD, one one landscape, a sort is sneak sounds and competition potentially evolve. it. with that tuned Got approach. last of dynamics like COVID some the in of drivers you

Stephen Davis

respects, In us to industry, the some Yes. have we our compete too. of looking in markets, against assets, those for capital

I've have. competitor capital indicated before, biggest you as sometimes, are markets the the so And

it's the in this with companies. owners doing. that created capital that very, knockdown pandemic markets, effects assets of consequence in those we're so operating are in a of calculus private more is has that and particularly for very And And today, assets actionability uncertainty all tragic terms of

think we're are that's that in for I'm development, generally seeing sure we're already some of well. I good that thing interactions others having, as a So the and business speaking. And

capabilities built, with think well our as we've comes we've access are arena, development shareholders. every large got the opportunity, business to very we've strong capital, that I as capitalize So in from I commercial. positioned in we well balance our team, continue a our to we recently commitment management that both challenge R&D got in and on more But strong got to think Board, the sheet,

it's at part I I an successful continue to of it. our business, well mentioned, as be very and we're And positioned important to so think

Operator

does This you. program to further for the of hand back Davis, Steve today's question-and-answer remarks. conclude Thank I'd any CEO, like program. session the to

Stephen Davis

today. next Great. you, to it and greatly look operator, on Thank everyone, We quarter. progress us updating and our for you joining again, thanks appreciate forward

Operator

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

disconnect. day. may You now Good

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