Recent ACAD transcripts
Associated ACAD filings
Steve Davis | President and CEO |
Cory Kasimov | JPMorgan |
All right. Good morning, everyone. My name is Cory Kasimov. I’m the senior large cap biotech analyst at JPMorgan. It’s my pleasure to introduce our next company which is ACADIA Pharmaceuticals.
ACADIA and us CEO beyond for expect we Steve present XXXX in is to and what tell can Davis. Here the company’s be the note breakout in please that Steve’s Room. there And following the Olympic session to hall will down the left presentation, a
that, turn I’ll with over to So Steve. it
business all and by Cory. to more of about I to need you reminding development a a for inherent of filings pharmaceutical the business. risks, so Great. Thanks how our SEC thanks certain hear that commercialization has our bit much, of of coming this little and just recent morning start us relate description Good morning each please out copy for to to risks ACADIA. see a most
I’d bit to dedicated a you we like have symptoms. about that why seek see just with do our of of the together we are what treatments slide reminder actual morning adequately we employees. are patients The treatment little do of to because start continue their patients on So treat approved do? some they pictures a not no this with suffer The either approved serve to this or
you we patients all the a just take their that see disease of granted. These It Parkinson’s impairs are disease. debilitating patients Some XXs, XXs. patients. their and that activities daily psychosis in typically have are are XXs, They their movement for
patients And high advanced PDP very they’re time. Of carrying stages where over disease they psychosis burden. course, the already typically disease it progressively gets the of for develop in more worse a
a price, projection, at the with families to just These they’re you not people that a can moment productive people live, faces are These they’re to like people, CAGR. not look we picture. revenue to are people years to I’d ask and So a in help. this stock with not a
out time wanted reminder whom people vision. desire the help So just we start of I’ll about best our That calling seek I to very that’s but the that by to business serve. we and of owe patients our this ACADIA, talking the people fuels morning spend the the to to
to pharmaceutical leading the medicines organization our with NUPLAZID, psychosis. lives with vision company of CNS Our is dedicated only advancement the Today, disorders. the patients of the associated improve focused FDA disease commercial and is hallucinations to and that first delusions treatment approved on Parkinson’s innovative for become
on approved I population current indication if that Our R&D indications are to. Parkinson’s together focused team advancing our think probably psychosis This the five is most three there aspect disease year business. you the $XXX left-hand with for here. clinical million important the where in XXXX calendar what far launch year to second look in Parkinson’s big drug, we million $XXX very in a is at our side very treated. the revenues XXX,XXX are project psychosis with are being to of and we both slide referred messages addressable One the there in and where late-stage is the curve that’s is disease had think on be are we’re I this that a growth programs. in, trajectory of to about underappreciated with going that I represents that patients pursuing take-home think is attractive And we’re PDP a liner This just
XXX,XXX It than depressive schizophrenia PDP. XXx X about it’s very is no which larger There’s schizophrenia just treatment to psychosis. exciting And approved negative inadequate larger In no PDP. XXX,XXX also we Xx larger Xx again response are of approved treatment major where patients Schizophrenia than treated. over Phase are is Parkinson’s response about there in is psychosis, XXX,XXX about XXx than actually symptoms there Now about reported dementia-related approved results, In disorder disease treatment. larger for today. Parkinson’s being PDP. is them altogether inadequate but no than disease
is Point disease advancing So the psychosis, the drug. profile the very safety the indications. we are interactions. know of same drug-drug because Parkinson’s we’re large molecule we’re these and one point them is and tolerability in number We approved of two in know all
As I’ve investments. There this to point we said you these And efficacy evidence three love achieving before, three we make is see kinds to pillars vision. on have everything clinical our of slide. of in are
patients as with grow. the and First care of to only Grow approved NUPLAZID PDP. is treatment standard for
business which disorders Second focused is for referred indications I is unmet pipeline is that in further expand the And our generic pimavanserin, NUPLAZID, high just CNS with in to name to to. development leverage through the third needs.
to look Let’s each a milligram recently, we’ve taken of the on need patients diluted didn’t for the the physicians titration XX was XX This more simultaneously, in of is from often we to take important importantly capsule tablets of NUPLAZID lead provides it of dose launched these drug. That but how at they Most the a much couple perspectives. quarter scored two a although more onset delayed with would action a of milligram because convenient launched advancing drug. titrated quick One many third and a pillars. is with XXXX. drug
be and experience recently disorder, of that I the result programs be We’ll earlier, progress our from about milligram more second. referred pulling we brand In in large milligram doing year. We’ve that next much read recently XX we’ve there. dementia-related and drug. that year. half from advancing say treatment this X should Rett and results a half the in American out schizophrenia launched be the Phase system syndrome psychosis, major to dementia-related I’ll X in ran. we’ve inadequate we in second a a study, initiating trofinetide results study positive to X negative single in Rett first fourth highly initiating this fall of X a the Phase quarter. campaign of syndrome response year. in for second we other the help a launched will excellent to better the – X that the in In in We’ll Now very a capsule symptoms. as speaking have rights have in we’ll that CLARITY interim the a this the one of Phase in half we’ve Phase but the in depressive I study trofinetide, rights DTC psychosis I the XX capsule, And study recently made program the tablets And acquired we’ll we’ll mentioned, be year, two we be advanced North an for have in Phase
SSIA. growing I mentioned, the a is treatment NUPLAZID, the as first but not inverse of is agonist first it NUPLAZID sales. and only So let’s only focus serotonin for a approved second on PDP or selective pillar for
we’ve they of each For burden. can in blood drugs cousins very dopaminergic about side very have one These life-threatening hypotension. patients they class gain, And lot other experience psychosis dramatic been of result significant are very dopaminergic – heavy in disorders. particular XX orthostatic sedation, with function, a motor molecules. they have of molecules, these and serious things One years weight experienced commonalities, daytime treating sisters result can potentially in impairing and brothers, effect all including drug
from far perfect they’re drugs. So
non-dopaminergic Our drug first only and is approved. is not antipsychotic This the dopaminergic.
its targeting profile exclusively with drug Our works by X-HTXA receptors. SSIA
the unique hallucinations that our nothing this that’s in about psychosis reducing improvement And reeducate exactly of curve as PDP. kind significant and we shaped in expect great pivotal you with When we said, delusions of in we’ve this fact that We’ve in drug approved. the seen. So psychotic the approval, of rewire launched in first to they disease patients has think profile of in served way there’s a we resulted study experienced their medical what the kind been and linear XX% class, in basis the efficacy should demonstrating drug a saw drug, was community opportunity Parkinson’s and got a its symptoms.
to to revenue As represented quarter, $XXX million growth. we’ve the million quarter. year. In third in of year-over-year $XXX I in million for this recently reported our revenues XX% reported $XX.X guided most That we mentioned,
so there patients do the that them question the in over to appropriate And go is market of about So I here? PDP? million time an to are have are I mentioned see as do we from in course point about XXX,XXX What ask the disease. them where U.S. in their being opportunity have it’s any the Parkinson’s Well, is disease; moment we prevalence X think At XX% question earlier, psychosis of about the experience XXX,XXX XXX,XXX PDP. – of of treated. them
before XXX,XXX only until treat, times of or be habit very are is because the reason out XXX,XXX they developed Now drug to it. there was being waiting to of many disruptive no a XXX,XXX when treat the got physicians symptoms the treated
efficacy and grow market get in patients as favorable we with experience that see think that paradigm. approved a profile be more treating we’ve treatment some of and the that we’ll physicians the strong that. fact with begin we tolerability to able begun very And drug new earlier likely have in will and So to more and the
were motor in were of disease An as of the underscore hospitalizations patients result and for to six-year one additional that illustrated all of a need, hospitalizations study Just complications. a XX% over XX% psychiatric period alone. for Parkinson’s psychosis
our we start specialty our Focusing we care moment the business. which is the with is specialty on pharmacy on at business. our long-term where We side even right-hand stand business kind time, business. this of have two-thirds side left-hand more channel of in The pharmacy about
starts. seeing So in here what is very sequential growth new we’re nice patient
us. not new patient or a for revenues an Just early this precursor These revenues. is to of clear, indicator are with be starts
quarter. But the we’re time sets in translate. as lag. enter a We side. we XXXX. There So these nice benefit up it the on full late particularly the There to fourth period this see very certainly pleased revenue before us is see of growth well is very a
long-term here. the bottles. total side On very on are These different care, these right-hand represent bars
of hallucinations; continuing to a growth last having through so campaign. do treat caregivers milligram think, resulted year I Parkinson’s benefit to that we is dots. growth on physicians is sometimes physicians patients really that not we’re patient as of is leveraging already delusional. coupled the we awareness both that One mentioned disease. stages time. patients to of could God later the seeing ripe significant that on the we campaign are And these and not disease that in a They the now historically these are to developed the I Thanksgiving Parkinson’s that This of began much And nice for the don’t objective discussions channel occurs experiencing simply bars branded refilling the layered see earlier of a address a follows that occurs then campaigns waiting that capsule reason, vast connect disease that issue in have I’m way they to top many result an patient branded in the their having associate both with practice seen The in the earlier with therapy, psychosis And initiated things disease in exists times that become typically we a That’s I we’ve of is and the new disease. So now addition in the we’re when drug. important that lot starting XX necessary the patients time campaign majority that think their today. PDP that get just the where with fact is that we’re progression. the long-term sooner for my well. this has on addition in about on are DTC or through – therapy They them a launched campaign unbranded Day. described care
disease significant as the of as target that address very campaign this is today. So awareness the well to campaign need
and to go shift second gears the pillar. Going now to
are mentioned and Dementia-related wanted increased and a Just this treatment that you of provide programs X.X late-stage an disease million of hospital repeated U.S. are approved progression homecare, for earlier very to approved are et them patients dementia-related psychosis as same pimavanserin. not in of representation are cognitive for physicians. of year; that to today has decline see including morbidity label, are way I the in There we patients. stays are the was approved the progression psychosis label Parkinson’s And have about insignificant. They not nursing accelerate can affects quickly, The large these equivalent it it’s occasionally They in is no four treat pipeline we’re other year five approved disorder, mortality. progression. option advancing to rapid dopaminergic graphic used as when bipolar of treat no demonstrated And dementia Alzheimer’s serious very there’s It’s more risk consequences, approved psychosis. and dopaminergic study antipsychotics used for It actually to that one that Parkinson’s they and about not in off disease to antipsychotics treatment they’re patients schizophrenia, for the off psychosis patients. disease cetera. because
burden In addition, same side they that the carry I described effect all of earlier.
is these psychosis we also value we It’s study that with in this And the of program well studies dementia. on is what Our we’ve reduced in a showed disease improvement symptoms we’ve had disease Parkinson’s pivotal symptoms in P psychosis. psychosis psychosis leveraging our had both in here side dementia-related done as in disease that left-hand note study the patients of as some by in – Alzheimer’s see that XX.X% Parkinson’s patients important a side also you that X.XXXX. psychotic to
dementia patients patients P in we a value X.XXXX. about XX% the of of also this similar saw study with results So had and in those
right-hand we we Alzheimer’s on a We similar are results results side XX.X% disease where the saw efficacy. ran On an of the improvement. saw study
to saw Importantly is And reason cognition. the actually in we this patients was weeks could on we for timeframe. study XX we that study dosing impairment we long if so patients an of endpoint dosed what in cognition no enough was weeks, six also the XX dosed primary had for patients And the that although weeks. impact for we determine
no dopaminergic So drug options to this be like antipsychotics patient that an population unlike today. feel has the treat ideal could pimavanserin we treatment
here a with and meeting FDA Phase studies, two represented this plan Phase our had X in we X agreed it’s on an slide. – on these and Following
a We’re study. It’s prevention running a relapse single study.
We so They’re they me. symptomatic. Patients haven’t, an If highly their eight study and can straightforward. with very exit go both reduced an week time drug the study for symptoms stay with They at robust in have week study. this the the serve XX we’ve the that basis excuse our pimavanserin. If treated agreement And a in submission stable submission, weeks. have that XX, on FDA both at results for study. from they response they – as NDA points, they significantly single come is all SNDA the
who half the And highly the on to average patients then in For two it stay were quite our them study Half time between response move to patients stay those our is significant the relapse drug, drug the the they symptomatic, randomized they’re into and to study and of groups. of placebo. showed simply placebo. of endpoint pimavanserin
XXXX. results So it’s a recent earlier, very this have year very straightforward, results very highly statistically powerful of design disorder, an and the this study indication. we of in depressive will I Major in some year. in we interim as also half this positive do mentioned have We’ll highly read next second
is standard not is start XX patients a in an disorder, A of this. set over to MDD the alone. SSRI Just respond do to adequately up it patients depression or The very SNRI. U.S. quickly, care million in on to pervasive majority patients of
about but million the So very treated or during can of molecule U.S. top That on with on development in highly symptomatic. in significant see there SSRIs adjunctive market patients unmet did slide We amount respond this they’re and of this the results of X.X of still substantial the side are needs therapy left-hand research the today. SNRIs. you being they
study. results side through our right-hand the I’ll the On of go
SSRIs two top ran X.XXX. on ran is parts a achieved value of P studies, We results. drug endpoint a very we study of on study; study Primary or And SNRIs. with two of the X this So SPCD stage top had adjunctive a was design study. was the so Phase therapy to so successful we
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Here our was X.XXX. P value
on We also seven had pre-specified positive results additional secondary endpoints.
results. Importantly, is early. in not efficacy saw this these we saw study only what significant them very We
today. you needs in at action of onset slide unmet is If the you side look key faster the left-hand depression the see of one of
So dosing. we had results week within of one
worse, an dysfunction. sometimes we seen is of sexual you A improved which SNRIs did make SSRIs addition, in adjunct therapy, actually function. majority function these Not sexual sexual add In patients we actually or on we patients. saw only not that when in experienced improvement
no the of no had daytime saw some SSRIs issue a on therapies, reduction significant caused significant top meaningful both had the cause reduction dopaminergic with The a sleepiness. available also the We did together We very another sedation. motor impairment adjunctive today. adjunct used sedation, That’s we We of them of in weight sedation sleepiness. actually therapies gain. a daytime in had Not with antipsychotics function. combination, we only not daytime in
of positions the the results. head pimavanserin to thrilled important MDD of the standard the study, therapies in parallel tried if with adjunctive think very, to I to it’s So is We X.XXXX of a two-part P with X.XXX. high mentioned move study in adjunctive and a kind It’s design class Stage study. and value results an which the really for of note care X this of we very we of treatment. potentially of size a efficacy effect were approved be and had true
many because this is as of Stage use the Phase is the in more times we’ll of part in saw design to effect put study it’s to an of important in context point so antidepressants The is X.X often strong X. X size Phase the done strong into part to study in this the in X.XX type the is, mentioned, standard I X the this But this exploratory. out study Just ran you to we very with the reason Phase addition study, effect study here. type range, very efficacy is the see we X
studies same So two run we’ll the using design. Phase X
the see sisters a in results well. XXX to many the of the We Phase with – polypharmacy highly robust our delusions of Schizophrenia first of this middle phase given study don’t of about that a in other a in respond experience response; earlier two mentioned And study year. both CLARITY with we’ll as pivotal meeting aspects are these the has serve can early lot schizophrenia us that initiate believe we disease of and U.S. X is poor early and it’s one as positive treated as of adequately patients steps respond. prominent and and on results. social adults required and the that half this and meet trials X XX% cousins development as a study as antipsychotics symptoms ran dopaminergic same and which situation. end experience using that more submission. withdrawal respond, we’re adding in again X without of approximately about globally third drug, a X inadequate the That lead subsequent of of again on patients the that with hallucinations terms top we’ve ran kind the we about can are substantial affects drug XX% in I increased of we today negative antipsychotics data an FDA times one of relapse. happens Phase And positive what side pimavanserin a of are negative each the next about to seen, in X% And an Phase a third for to patients brothers, very XXXX Phase mid-XXXX. schizophrenia still effects, very of Our SNDA in of and symptoms study for a the but we in the led with positive similar symptomatic of Schizophrenia third today what approved, That’s is the dopaminergic adjunctively, of running focused top a a to Without and third drug circle respond to there, on partially compliance negative symptoms the here. use patients. development particularly symptoms. expect are schizophrenia drug are Schizophrenia well
symptoms we new of drug therapy we also be treatment and unique second with very very of the XXXX. schizophrenia a is as And where half the currently have important drug can approved. adjunctive with in studying We’re in we drug expect no profile enrollment it our think negative complete of this this study
population many on the we all I’ve say that programs Collectively pursuing of just the by I’d – probably that need heard opportunities four Today in indications if fold. But completed of them we’re of these We began starting win saying so recap increase the betting in just don’t of investment. kind of where in pimavanserin me pimavanserin, worth Now again. and one XX, like if we that’s kind we additional when of these, way successful, it’s successful to approvals for these it is we’re XX X-X, with all a in the that won’t the by regretting I’m that. reiterate you we’re simultaneously, getting of we’re thousand, to everything. process if stand the would successful of all addressable
Moving pillar, expanding. to third the
development CNS focused strategy is unmet on business disorders Our need. high with
we’ve begun Phase We’re highly highly CNS exclusively organizations for American of and trofinetide talented of are organization the independence, R&D of Rett X,XXX Orphan X,XXX clinical up positive emotional Global drug Pharmaceuticals, leveraging primarily of Impression last the the half this the at spoken trial XXXX. Trofinetide approved In in treatment. sensory, their whom in and a second we loss both results initiate of X X,XXX a core on Fast had from the the is function. has trofinetide treat of It Scale. strategy Clinical We with Rett by of about almost scaling syndrome supporting the fall Track Today, status impairment, the It IGF-X. hand Europe. highly, of syndrome young a company licensed, agreement loss communication. North syndrome Rett after Rett occurs on There’s Rett designed debilitating patients. and very for loss females Neuren synaptic for recent This most U.S. is It’s registry neuroinflammation motor material to analog with of Phase novel in a we and on and reducing syndrome to in in Syndrome symptoms and study U.S. year. no the U.S. disorder. finish our results Phase patients purposeful patient tripeptide to in cognitive, commercial X executing Again, license Questionnaire ages. movement, and Drug the X there’s Behavioral Designation efficacy in there focused study, active plan
X also Looking disorder In in the the year the have the also in expect year. commence next that the psychosis, I half. a In up, we’ll read we’ve depressive in of holistically enrollment XXXX. response In complete at mentioned, year. schizophrenia X interim we year as second clinical half we major milestones of our And coming in Rett first In initiate end this of have expect this got We’ll an we in I Phase in our lot. results half this results the that second Phase we’ll as Phase of program we’ll to this schizophrenia have symptoms syndrome, X dementia-related inadequate middle negative year. program mentioned, in XXXX. study of We’ll do finally meeting.
committed So priorities XXXX. on in our sum, we’re in key executing to
on NUPLAZID continuing number in one grow commercial the priority grow NUPLAZID to we have that and initiatives Our is to executing PDP.
trofinetide. leveraging and also pimavanserin advancing the are We of potential
development. a strong through very advance X two pipeline expand Phase sheet mentioned, during to have studies, balance the readouts starting X with business potential study, to this Phase X potential study I Phase and five year and one we’ll our we’re As
in very So I look to your much. thank breakout. forward the questions taking you
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