ACAD - Earnings call transcript Q2 2022 | ACADIA Pharmaceuticals Inc.

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Operator

Good day, ladies and gentlemen, and welcome to the ACADIA Pharmaceuticals Second Quarter 2022 Financial Results Conference Call. [Operator Instructions]. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker, Mr. Mark Johnson, Vice President of Investor Relations at ACADIA. sir. ahead, go Please

Mark Johnson

afternoon, of you Financial ACADIA's Good on Results. joining today's call Second and you. for thank us Thank Quarter XXXX

our Davis, Schneyer, questions. second quarter Joining ACADIA and a will call the our performance Disease, out to an Scientific also our provide business; pipeline slides, provide Teehan, your I and Operating Officer Officer, and of Bishop, using Steve the supplemental Head website. opening Steve for would Head Mark provide our Chief of our our discuss President, me that Officer; and to discuss Chief will are Chief are our back financial section results performance; the Chief Commercial; point overview our Rare our of trofinetide. will our today overview will updates Financial review available final Officer, Executive it and then on on on commercial Presentations which guidance; Events up Brendan will of Stankovic, like are we remarks on from Kathie our call of for turning before progress an and

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

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

Stephen Davis

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

late-stage to selectively value Our in business an positioning in from schizophrenia, and to advance finally, Parkinson's plan product and development study allocating is early-stage move franchise disease development, focused cash syndrome, market the pivotal NUPLAZID, molecules of capital for increasingly business and trofinetide into as second the treatment our to on with priorities: second our our fund symptoms by development; complete opportunity commercial leverage we ourselves is our flow carefully business set current disciplined of our positive. balance existing maximize first to FDA-approved sheet attractive Rett following deliver

me detail. Let get into these greater in

on start our Let's performance with NUPLAZID X. PDP Slide

XXXX, net quarter of NUPLAZID $XXX.X XX% sales, year-over-year representing increase. achieved million in Second a

branded continue Importantly, care market to share proud in in top NUPLAZID pandemic. a impacted I'm the Parkinson's in market the the to market continues and facilities. outperform drugs TD long-term the environment, outperform to negatively to and be by of which segment, continues execution our of competitors neurology basket market grow

been current focused managing optimizing commercial continue and PDP be the we efficiently on dynamics, our have spend. market Given and to

the a while in in projected launch grow in PDP. the by a the capital NUPLAZID keep funding of describe maximizing with relatively we carefully continue competitors share market will currently against trofinetide outperformance SG&A gives ROI, syndrome. to is our market, what to to the downsized As our term, XXXX, moment, and while ability brand, gain to to in confidence allocating PDP overall ability in continue Mark us Rett of flat value opportunities Longer highest to expect

I NUPLAZID, want clarity on franchise. some to for our Before provide protection the patent

of at with patent Book XXXX. Orange extension term matter of end the composition was Our the April updated out patent in recently

of taking our October work in XXXX. a the In end X-month should that clinical of autism pediatric addition, extension, in result conducting pediatric we to are composition

we a capsules and XXXX and of XXXX, method additional out NUPLAZID use respectively. have patents to As protect and currently that reminder, tablets marketed formulation of the

X. Slide to move now Let's

our As on secondary older. positive pediatric results submission announced III of delivered Rett also designation line and and on the submitted last on X we our of age FDA. by Rett disease co-primary endpoints been trofinetide top in its the patients and granted based designation Syndrome status The orphan pediatric NDA trofinetide, month, years drug pivotal is study, for it's for rare fast it's and treatment been granted Phase key for LAVENDER endpoint. adults track Syndrome, which and the

in And working action such, diligently receive As first state customer review an NDA approved, launch, this pediatric medical on XXXX. most market a quarter care would priority likely the with and are team review to for priority we disease preparing and Our education, development, date profiling if identification. including we expect teams of a commercial to receive expect broader

with for of method expected As to XXXX, consists patent a reminder, a patent additional trofinetide pending. out patents patent our early of term extension use with

negative treatment to of already completed Pimavanserin study, positive the Moving now of for symptoms pimavanserin X schizophrenia. ADVANCE-X. pivotal has

industry for previously studies noted, we with difficult a been has As and negative no failed the many FDA-approved particularly symptoms area therapies.

top is identical same range approved to important for XX Our explored ADVANCE-X PDP better X than we ADVANCE-X In difference. second milligrams, meaningfully is doses pivotal the that doses. determined with a and virtually of lower study, dose, ADVANCE-X, dose the performed ongoing. ADVANCE-X,

are only we using the So XX-milligram dose. ADVANCE-X, in

the result of projections discuss next year. our a will complete around the to to Serge ongoing As we Russia/Ukraine middle war, extending of enrollment as are

period. this reminder, treatment As study X-month a with a is a

At developed is ACP-XXX now in discuss we previously pimavanserin. And an include is good. plan a evolution further early Phase in compound Let's ACP-XXX, currently this develop disease the potential development. looking One very if of to early-stage I internally we've point, our is which Alzheimer's not the as successful, neuropsychiatric on Phase to X program may is molecule, portfolio. which I builds turn it of to symptoms, psychosis. new Slide discussed stage treatment

around I development year-end. ACP-XXX to expect We complete Phase

modulator decision We're II is advancement development the in discontinuing threshold ACP-XXX on of development of based also Phase a also development. from and early a requirement in the a to to evaluation II. support to study. made completed an that discontinue data late-stage PAM decisions ACP-XXX based not chronic final in disciplined profile previously pain acute on making course, does success set Of the and bunionectomy Phase We've

the investments is bottom investments PDP, slide, being increasingly positioning business of want positioning environment. to we back ourselves Moving I opened just with be what I prioritizing to development will we the leverage point remarks I an to attractive believe in We're in our very that go ourselves are when made focused and by a to my that ROI.

Syndrome fund in enable relatively Rett us flat. our launch and appropriately SG&A As I mentioned, will this to

to they disciplined continue capital we've described above. also what will for foreseeable future, joined in Day We it appears I portfolio in as be and the will Markets very allocating our R&D sheet, seen with in like balance these a companies strong of established R&D us. is revenues in commercial the that past tables cycles Companies infrastructure. and favor and in the dramatically solid still the

In across infrastructure you both broad addition, in and we X here an psychiatry disease. across neurology all established have indications and see rare quadrants and

Of of course, good past development. in success business our trofinetide example is a

like for the Mark our extremely established financial infrastructure And position detail. that, to evolving over position, to discuss guidance financial I'd now success. opportunity to leverage strategy well further the us turn in and to strong and development set with call position more Our

Mark Schneyer

Steve. you, Thank

to you as we Slide upon XX. building by talked start me about just turn what Let

without to As expense continue priorities. same to additional our key optimization the the as our it expenses. of a This need ensure At continue we're business existing to the prioritization well the refocus fund base SG&A we our includes time, capital. to able align company, of for with we expenses R&D as strategic our that our

Now additional color. let me some provide

First, with our a approximately to expense terminating. Second, completing XXXX. million. continue expect in trofinetide, maintaining we a advancing, prioritization of to This we as R&D by program upon resources PDP compared and trofinetide decrease in launch from the number expect while continuing, prioritized costs Based G&A means the to we and invest flat to have we XXXX redeploy from $XX programs relatively SG&A to commercial efforts, portfolio our expense commercial base of will R&D

a for remainder to another reduction business cash turn $XX positive. our we million, $XX we of a year expect resources with have $XXX.X this million fund than cash of next million of finally, until current more We approximately year. sufficient And the and balance

course, the this future PD. is scope to of subject Of

we Now of down selling million XXXX. let's turn $XXX.X to million X%, of XX. quarter, net and X% Slide in recorded $XXX.X in approximately were sales, QX demand our Year-over-year an increase the respectively. quarterly and In performance volume to on compared net XX% of sales

During the current demand year-over-year. our first the X% matched X was And over months volume. for our up selling XXXX, volume of growth demand quarter,

XX.X%, are to net $XX.X The was compared expenses far provided to to on we've to improvement Please halfway million the in quarter last last quarter guidance to million market $XXX.X so approval we mentioned in see Gross that Slide to of various year. discontinued, down in balance Our which expense now expenses and that related that was to time, which we beginning from XX.X% trofinetide end the -- as been million. which healthy net a the due guidance investment R&D commercial yet advance the related first early-stage decreased to flat a of in $XX.X finally, has million to the XXXX. GAAP the development half sales supply, improvement for in the through now was significant reflect essentially million GAAP adjusted top cash year. with activities year. in gross that QX $XX.X the the significant range to scenarios XX.X% XX.X%, of for expenses the of primarily And of the year XX quarter ended deliberately I in increase At quarter is programs. SG&A ranges not range we from ACP-XXX, seen year, reflected the $XX.X adjustment a second second year. of net wide for increased is for pandemic. At year. our this compared PD QX last and

reducing of the As sales top range. our net end guidance a result, we are

the to slightly to have Regarding gross XX.X% we net, year. our to reduced range XX.X% for

$XX side, our we R&D guidance by expense SG&A and million maintaining the guidance. are On our reducing

will come be most next XXXX, to year. expect another of million approximately to down referred realized $XX reductions in we cost R&D earlier, While the I

to are guiding like of generate to Brendan We And sustainable $XXX million are expected raising with resources. year-end the cash in now to million. the now existing reiterate, end I'd range $XXX to ability business. To confident our our our bottom to balance turn discuss growth we over PDP cash the call our are of to

Brendan Teehan

to Slide X key address XX. Please themes year-over-year of sales performance. this with Mark. growth. organization net representing team's million, our want I'm pleased regarding $XXX.X you, to and delivering XX% Thank performance quarter, I turn our Today, commercial

the for studies growth PD brand; shed safety the optimizing exciting finish NUPLAZID First, dynamics performance; and profile, new our relative on on for real-world trofinetide. our light and off market discussing pimavanserin we'll I'll next, some preparation and

dynamics start our with and performance. Let's relative PD market the

the demand improvements volume seen which X given date. to grew of PD is to in Our first XXXX the slightly months in market dynamics XXXX, the very slow incremental encouraging compared

the indicate approximately strong XXXX. grown we As areas. shown to of growth carbidopa is branded which has treating up on levodopa audience us support medications, since to increase well basket through XX% market slide, Parkinson's foundational from our multiple our therapeutic outperformed pandemic continues encouraged a to LTC including market this as are despite continue brand This our share, further performance allowed as NUPLAZID's and as has across products and

our to, alluded the the efficiently we evaluate optimize cash spend opportunities from more PDP growth Steve as business. and market have to current flow commercial continued to environment increase Second, in

We PD dynamics prepandemic will, to closer move as market improve the always, be levels. opportunistic when and

when in and comparisons presented with several that Third, opposed been make off-label real-world PDP important patients. or pimavanserin published treating atypical recently, antipsychotics to as studies multi-receptor have patients

the One antipsychotics in American this in to associated moment. The Journal recently speak use XX% These was studies are Psychiatry. Serge mortality important of of concluded findings, was -- pimavanserin was authors which published over rate with XXX other approximately than these of the a study atypical lower days.

Rett commercial ACADIA of our company's on focused is the commercial syndrome milestone now launch to preparing of product building the and another a in to second yet Let's disease important turn Slide for launching preparations reach trofinetide treatment organization. XX. history, a for the rare

identify awareness to already as therapy the our Syndrome Our health and launch shaping their have on providers. generally engage goals developing building for care resources care be achieve we to Patients prelaunch activities team, upon approved Rett a and patient trofinetide the as In support further of have generate caregiver, Rett in family Syndrome. near dedicated the are includes order for their Rett to patient. ongoing, several usually the what and term, educational which best-in-class potentially including families and teams working first with will treat market well

to Secondly, care strong and partnerships our and build to engage And we impact for advocacy to our increasing education through groups leveraging best understand we're continuing presentations trofinetide's with are clinical awareness, community establishing the including finally, disease community engagement. needs outreach KOL Rett perspectives. team publications, scientific and

objective foundational in Syndrome ultimate established ensure I'll clinical Our to launch discuss need. now patients trofinetide and turn perspective. be the will all treatment to Rett for from it Rett and trofinetide as a access Kathie to over

Kathie Bishop

Thank you, Brandon.

Slide XX. on start Let's

gait symptoms serious treatment communicate As which Ultimately, of of United a X,XXX rare abnormalities we are for nonverbally debilitating including and patients GI you no severe round-the-clock who Syndrome patients and for the and in Syndrome There daily Rett Rett loss know, impairment, estimate the between verbally basis new Rett to in a X,XXX and on debilitating severe include maintain disorder Rett Syndrome ability independent and ability neurodevelopmental U.S. including both of is motor require lose is their FDA-approved constipation. to functioning loss Syndrome issues, States. The there and support. and

LAVENDER XX, with Let's for for P recent our the RSBQ, an the prespecified on week of which basis XX study, results the endpoint. NDA size submission co-primary FDA. value the observed LAVENDER review At X.XX. X.XXXX the were to was the positive of Slide the results formed In

known X XX of to a validated behavioral scale, in week developmental reminder, baseline rating improved Rett X neural is average, symptoms a patients from a on at completed wide this impaired the As core points range trofinetide meaningful. scale, is be RSBQ and caregiver assessing Syndrome. which neural on very

is the the an or individual with was scored and was In Furthermore, separation also endpoint improved addition, size This skills communication is using significant the Syndrome. completed was quite much This meaningful study, that of baseline, is size divestment patients standardized the in Rett for key the these clinician to of the statistically on efficacy to X.XX. placebo X.XXX XX with value has clinical week worsened to the the of CGII, a P their illness achieved. designed at a families. relative how from patients. CGII endpoint effect important specific assess secondary

disorders an these for patients across endpoint the for of at ability to size and designed for week Rett XX, their initially age to P been consistency disease Rett with a value neural infants such helps Lack was and The and of Syndrome. and skills as was is Although this observed trofinetide's the This older in the study. with meaningfulness patients applicable patients all Syndrome. verbally groups nonverbally has groups reinforces applied with effect challenge families. and of of developmental to potentially significant communicate all in results X.XXXX, age X.XX. severity Rett On

our Phase Serge update II pipeline on other are In over also an previously addition, now it in turn I'll observed to results what these studies. consistent for with was And programs.

Srdjan Stankovic

afternoon, Kathie. Good Thank you, everyone.

evolution the on CNS portfolio XX. discuss of Slide our Let's

capitalized the are place a whole. and Steve existing to we Mark year that over believe more important right and and to the opportunity expand. and portfolio continue favor discipline said, what companies that next each attractive have development set and the for in well decisions Therefore, to ours transact reiterate program investment stay get and business like and will as more course it make infrastructure the the is to First, of

lead and we of our MX As discontinued pay; today, PAM in ACP-XXX, announced and program. ACP-XXX from prioritization a development we result our of efforts, acute that molecule the chronic have

molecule we we to the is expect ACP-XXX. Phase ACP-XXX learnings neuropsychiatric year. of internally hand, development investing of complete upon this I being end molecule This the around an in and treatment in developed On further I, Phase other evaluated the of the are in symptoms. pimavanserin

investing in among collaboration also programs. programs are We the with ASO our early-stage

a like off-label couple pimavanserin in the to Building with to Now that symptoms with I treatment upon would pimavanserin multi-receptor discuss PDP Brendan studies atypical and compare of PDP patients let's discuss on antipsychotics. in Slide negative real-world stated, schizophrenia. of XX what

of atypical presented pimavanserin days. of Psychiatry; publication mortality with of the with comparing recent first antipsychotics made the PDP claims the risk associated pimavanserin Annual in mortality is the the during The a similar the XXXX that all-cause use, were described Medicare proud thereafter. disease than other retrospective lower in Clinical other publication was XX% than Psychopharmacology and The Meeting. XXX poster and and Journal encouraging, of the second, and this was patients pimavanserin Society other with over were an lower risk antipsychotics patients public antipsychotics American the risk analysis Both families. of conclusions their in the June year. from with approximately in psychosis. Parkinson's to to was associated atypical publication continue to make First, recent American of at approximately versus treat The findings with out use of This atypical patients XX% is presentation while available very team days NUPLAZID XXX data our mortality to

Let's significant debilitating approved treatment. to on There for others. among and burden, currently are functioning, potentially indication XXX,XXX but for potential there and Slide who These blunted lead social currently of the still and XX. negative in affect, low pimavanserin lack move United schizophrenia, as is have second our symptoms long-term starting persistent symptoms no withdrawal, on are treated States to emotions patients social disability over such and FDA

in have X optimal overall ADVANCE-X. and milligrams the observed I our Psychiatry. Lancet pivotal robust pivotal are The to the the more pimavanserin. in receiving only for of As positive XX of Slide appears patients where patients dose, study therapeutic shows endpoint which XX-milligram evaluating want XX-milligram we graph focus second published which positive the part even group, dose results of XX of program, results on received advanced primary our study, we pimavanserin. the separation were on These we be results Today, who to on improvement in statistical

can effect as an increase size X.XXXX, to of unmet our turn period. this back with updated see was with progress significant from Steve of X.XX. And remarks. look separation need. I will that, keeping You unadjusted at that X We p-value continues began achieved X-month XX call observed improvement week the week closing you which to with an throughout forward early high in The placebo the to treatment for on as

Stephen Davis

turn executing on Today, to you, Thank our XX. deliver PDP to we Please to an brand. where there's promise with to Slide the long-term are to continue grow NUPLAZID patients Serge. opportunity attractive

like In addition, business for the with program next launch our for strategic year, developing fashion and commitment In trofinetide, their employees ongoing long-term for up thank early to their several questions. schizophrenia, well strong Operator? our product a our balance commercial would our we development. we closing, the are as the mission of open sheet and launch positioned of projected III call programs advancing now preparing negative our while I'll are symptoms we to I With for second Phase pursuing accomplishments growth. and product and additional continue second

Operator

Instructions]. [Operator

that with line Cantor Duncan Charles Our first the from question, of will come Fitzgerald.

Charles Duncan

today. update Thorough

guess, you relative on trofinetide. to product the feedback multiparter prepare gotten try on then And is provide trofinetide Kathie. far on profile, payers if Let's given color that for can what's and say, a or maybe perhaps to it that whether could X and going will part if question, that? he so to share drug probably I anticipate Brendan, any be an further ask she not I'll target first-in-indication a you've from any is I'm wondering for for first-in-class, second

Stephen Davis

the to second. you take that Kathie, the part want first Brendan, of do question,

Kathie Bishop

question, Yes. Happy for Charles. And to. the thanks

that about day a mentioned, our of since NDA July. hear in the we is Steve priority as the are filed will XX we As At rare we filing, And severe Rett announced, NDA. Syndrome anticipating pediatric disease, given review. we acceptance

in is for worked the is advisory meeting. advisory about anticipating that that not that having date we experience, FDA in so officially committee leaning committee say In PDUFA first I are it years, so and case, my our straightforward, case an be meeting. happen. in a a I indication So on given for data time hearing they at think are going committee and that, where that preparing disease have there's is are necessarily in But drug XX that would meeting. pretty they advisory is September, have would the potential to about will not in we

Brendan Teehan

that we've your Great. to Thanks, result. thanks And chance Kathy. being treat engage that us, question of trial of like would since Syndrome. trofinetide They think, diseases payers to Rett Yes, I Charles, Brendan. an had in are this with the for core line understanding a come in project very see as LAVENDER the they expect be understand the also other able will understand Operator Next They space feedback product need. on area to across devastating favorable target the to given Cowen. they of from product expecting of trofinetide's would the had rare of high profile, pediatric medical category. Rett that in symptoms have They the importance being of nature that Ritu profile. question, unmet a same They And the that -- Baral chance Syndrome. see have well.

Ritu Baral

a of say forward XXX? and of about Phase strategy Is pimavanserin, statement that is this you II mechanism learnings wanted ask or is upon the that to the strategy? I an ADP ACP-XXX. agonist on building When year also

Stephen Davis

for the question, Thanks Ritu.

regarding on strategy, cohort I'll ask part comment me ADP Let the of and to part take first then second the Serge Serge? question, that

Srdjan Stankovic

Thanks, Yes. Great Ritu. question.

are from and but internally different pimavanserin. with and ACP-XXX We pharmacology developing a compound similar developed differentiated

So in potential it stemming some system, compound from pimavanserin, the similarly and molecule. of has are that a advantages a properties as differences in as target

efficacy, area important thing among so differentiation related is potential looking as the deploying I in symptoms. the is compared of Alzheimer's development here we of properties a after Obviously, and aggressive are work. others, perspective, there the add again, molecule which second, that the -- we QT as pursue data Phase in the And terms the that preclinical our is particularly that the have but higher the well far terms be. of whole that compound I pimavanserin. to this successfully One -- anticipate pursue of may of molecule the work So our and disease to to would through at we differentiation lack this this that liability into from preclinical is which liability, and of different is compound

Stephen Davis

Serge. up Thanks, line of Did hear was Ritu, bit. On his end breaking my a little the answer. you

Ritu Baral

I the pharmacodynamic heard about I about exactly differential portion. wasn't sure middle heard the the about QT. I

Stephen Davis

Okay.

Let me just sum up.

So XXX is similar, but not identical from a biochemical perspective.

a but important binding very very give other profile That, us from compound, of properties the differentiating pimavanserin. factors together give from So perspective, think of similar, with important That, properties not similar, identical. compound, with the identical. not we we think potential perspective, together us other but

this to out clinic. continue compound. get has it course, very it's early-stage the given the eager all great about compound, We're but to has we in that Of think and to it -- an we're advancing play excited potential,

study pimavanserin. This study. it in considerations. longer potential there's than product the against its we go-forward of population stated, ADP we as kind would plan to partly another it is amount multifaceted. of with where and do ACP-XXX. always time And that taking previously life would. case, -- our rises Juxtaposed this that It on the a otherwise other another the and in PDP not cycle of terms also That is conduct strategy, included In take to pandemic, for decision the run is

the it the patent that a early consideration. into have but consideration, was will ACP-XXX life will XXXXs. So wasn't go it a certainly only

get not need compound And indication the with so and definitive study point, others with At -- high Phase very but and profile I, not priority it to a forward, if you back yet that determined be of will was full wrap we pimavanserin. development be one just running we're to ACP-XXX, this We've us will to going for consider. up certainly, we another a plan. we more will

Operator

line from with of Neena Garg That question. Next Citi. will come the

Neena Garg

Maybe can I you some net, the of kind quarterly describe if of should great. clarify you the was drove clarify the drop-off in you to year. And if for be steep just pimavanserin discount specifically. on would gross-to-net what what if wondering full the the gross could That expect there. the we can dynamics then

Stephen Davis

Sure. to Mark, you want do that? take

Mark Schneyer

Yes, quarter comparison quarter accruals sure. -- question. of Thanks second for last The difference XXXX. the the to was of for the for the first in a second timing quarter in really decline second just between that the year and happened

bit has up. been of little to XXXB we're a in net so XX.X% less growth to kind net that's gross that's guidance X in range I we importantly growth from of look gross our ticked and we and a driver XX.X%, forward same the dynamics, months of noted as commented are the bringing essentially has full to we're year, kind And last for So the just of the as seeing I which the to of announced net we think year-to-date, main which flat. the kind or or year why to gross that is as basically for

Neena Garg

maybe about of it of how helpful. of and sequential starts then quarter the the because Got seems we I you should kind second in then guess, to net. in a the pace was kind just gross That's little new most talk of just the bit sales if like dynamics about growth by it. can think driven the

Stephen Davis

go Mark, ahead.

Mark Schneyer

we we to remains Yes, it now. last I are that be kind think as flat continue but guess, of, period, growth this where forever, just modest to in won't I

and which we So the that growth that hard favorable of as in environment outperform gain return share a timing has expect, to market more this long period continue market dynamics we're to environment, to that to PD over of greater predict confident will normal a going return to is would kind we term, as market.

the top this a remainder just range, reflective of that market year, lowered we that been for guidance of think was I have the of improving. significantly would end dynamic PD our

we mentioned, yet. haven't I that As seen

demand year. So positive year. be range expectation for to than year our as this A time. Selling dynamic be that and will kind little demand sell-in growing we growth. expect wind demand current necessarily we this in would had that negative slightly continue up exceeded the of of growth last our brand to less And to that look forward we'll bit range we kind is to of the slightly see over is and where growth, don't increase

Stephen Davis

than echo prior that Maybe than Mark's smaller that it comments. market One other quickly thing just note is We the when we see to pandemic. the to see to PD environment just is was the cetera. carbidopa for today long-term see a rates growing patients rate, at in-person of very offices, slow in levodopa lower occupancy part much et we the in pandemic facilities, was scripts that care it it

a lot. we've those So about dynamics talked

today what smaller a share. throughout despite again in is we've pandemic, -- we market smaller will gained XX% market, Importantly, grow a future, the about the which

market share pandemic today our gone where prior to up has XX%. about seeing we're the So versus

terms as that the So rates conditions to us is share that grow continue that historically. that back consideration only kind improve, that we've to another go to seen we'll in market and pandemic growth able confidence we're of gives longer-term

Operator

that Jefferies. next Our with question, line come Howerton the of Chris will from

Unidentified Analyst

of go is here. physicians antipsychotics maybe get are about Are that? sort as out Do on following A.J. if atypical you This for it any and Chris willing holdover today? for Howerton you to differently NSS see thinking preauthorizations

Stephen Davis

want that? you Sure. Serge, to do take

Srdjan Stankovic

Yes, absolutely. the question. for Thanks

indication of results, we I on the see And in that symptoms that point say, very pursuing pimavanserin social it's all, treatment withdrawal, withdrawal a very from pleased to on treated that is scientific in very it we this indication leave of in for symptoms and therapy First from negative schizophrenia, a option we with how are would acute treatment -- long-term to all another negative negative condition. is schizophrenia different under symptoms, But on there the that's where symptoms that potential schizophrenia, the would a frequently But are that that. are is with schizophrenia acute with that. short-term I it's symptoms pursuing the perspective, of requirement serious studies. remaining exactly most program is of probably adjunctively I'll symptoms authorization the and Although and pursuing control so and are terms schizophrenia say, emotional are positive

will thing treatment for other acute not because negative with context the treatments for you, a are on competitive seeing paradigm and Karuna from something acute no a our reduction add schizophrenia, see are negative symptoms. PAM than subscale are in different are some or data I are multiple symptoms, will as is we that movement remind treatment it's that the we the movement you is seeing I the a schizophrenia we in short symptom symptoms negative approved there the X read of through while of for there only environment movement So pursuing. acute trial because the what well. regularly on direct symptoms

for symptoms in that's only So X-month and schizophrenia. efficacy. as symptoms symptoms in context regulators stable is of the an -- efficacy long-term of The of accepted of treatment paradigm evidence studies by improvement of as for evidence but appropriate negative a not -- the accepted negative positive

Operator

question, Capital. that Our Renza with next RBC from will come Greg line of the

Gregory Renza

I just this should and the to it's certainly wanted across profile. are changes just to provide at or on mark know what made CRL give the recent today means Great. is from a that on forward? that certainly communicated the you perhaps how as say, over can on a feeding meaningful But that I pipeline How perhaps going for it loop you some company, point chance close time. telegraphed recent into and punctuation the been with you disappointing looking I final you're the a team pimavanserin.

Stephen Davis

Greg. very it's disease Alzheimer's of drug Thanks there's treatment dramatic approved a Look, for much no Yes. psychosis need. for the unmet the and question,

Look, given we So going ADP. forward, with we continue up be didn't a in we course, positive our the that have very of haven't outcome indication. to disappointed on resubmission

given very population, very in lot think one And need. key of recognition the a and frail that they clear a the maybe still I elements this take in is a of just of success today significant that medications. a ADP is elderly we've remains signal unmet other

And an least so psychosis, treat lot or one them of ideal also but the without to baggage. or at does it that the a drug side resolves tolerability -- effect mitigate is

And so approach system. working of that's of through kind been a our hallmark the

more trying in XXX,XXX interested are that And with we a baggage the and their atypical taking so to than help see what our have currently patients side that families to continue be lot approach. effect we'll antipsychotics

we'll multiple helping fronts. forward today, interested. press we'll prefer continue but be very continue to we these So on to to much Obviously, patients be

Operator

from the of will line Leering. that question, next Our with Marc Goodman come SVB

Marc Goodman

on you before strategy pain thinking product then is for just data? still your it kill can get NUPLAZID chronic at us tell Europe Europe? what all? we the Steve, pain to And killed, you the that Are bringing why about we

Stephen Davis

Sure. I'll let -- I'll Serge let take take I'll the first part of the question. second. the

is pricing would pricing So very drugs to outside or The changed. like difficult this, in make is different. profitable many And States cases, environment is even terms in for it's the of United get has Europe, even not venture like of the breakeven. our strategy the that reality NUPLAZID

it's challenging operated whole of if any have And environment very structures, And course, wouldn't a drug. Europe. which with in just so similar the pricing world

very -- So for drugs terms but getting of were difficult of I appropriate today in wish different, situation pricing a it's States. outside of United lots it's the situation the

we in and there We'll NUPLAZID been that of symptoms take indications years at exclusivity. advancing have XX and of do strategy negative come to has beyond as We of our additional get consider data above Japan, Europe PDP. back a when with So schizophrenia. well look as the results

So the governed by be not would product life patents.

take at it us environment And launch challenged down indication, to only But today, in. look so a a we'll with makes very a the it just road.

Srdjan Stankovic

Yes.

first, just question rate. second development our about me be a to small therefore, the And data. the approach drug with very On has consider that attrition find important ACP-XXX, early-stage it's molecule we high let disciplined that

just with for candidate, positions spend ultimately, of that study, faceted, decision And analyzing efficacy bit a quite and meet data threshold The more future discontinue as when that's we not high ACP-XXX particular internal time investment. a have we the bunionectomy but to was as safety ACP-XXX, well We did in investment it. to we the molecule. reach threshold battery tolerability this development. said and be their will evaluating a with overall, earlier-stage focus molecules further of Having will you profile, further and did of acquired molecules remind in for of action, the our mechanism totality not our we and that realigning and data that, say observed this the data I

Operator

will from with come that question, next Raymond of Danielle the line James. Brill Our

Unidentified Analyst

Alex on is This Danielle. for

little for want happening. Forgive trofinetide just open look of I the are me at studies to and that some label a getting

So about anti-constipation unblinded meds, of the given including LAVENDER, in that some when spoke an line you administered removal strategies, mitigation top you fashion. could diary be

of LILAC anti-constipation patients stopped So studies we meds not of anti-constipation who the were percent taking what diarrhea in open-label and rates curious in meds. also on the what patients in LILAC were

Stephen Davis

the you Kathie, for Thanks want do question, to take that? Alex.

Kathie Bishop

Sure. the Thanks, Alex, question. for

extension issues LILAC-X this continuing, Syndrome, -- this with which as to difficult previously, we instituted diarrhea to we are who of and nonverbally, severe verbally a and GI So open-label LILAC-X patients about Rett is physicians note in in these plan deal XX% we hospitalization. diarrhea. is which very critical which the both enrolled unable their to to is through patient as to to management the patients we that It's that have had the studies, the talked severe very and help constipation, communicate patients severe be about in can parents these leading manage manage patients, constipation and important population

medication. anti-constipation multiple on are they So

anti-constipation as we addition, a along in that medications a fiber think we this that severity we as we're management with to and terms to planning trofinetide in and don't but suggest as for And in Also, imagine remind a or diarrhea And be start they it we are mild plan, medications is them well the what very we to with that have the diarrhea management think have is and as remained as manage about we the with incidence medications patients percentages, of on contribute I over-the-counter them diarrhea launch towards So using to to diarrhea supplements. modern those see now optimistic for this you trofinetide that reduction commercial which severity, we would of ask trofinetide asked long effective the diarrhea. could as we have taking in plan to stop hospitalization. on will trofinetide. going not what those time that seen diarrhea specifics work launch you we implementing management provide lead we in now. strategy does dehydration diarrhea managing the commercial

constipation you compare the have, when could that So preferred. patients that be to the this

Operator

from Kulkarni the question. will next come with our for line Canaccord Sumant of That moment Genuity. One

Sumant Kulkarni

against potential On in? balance mentioned advantage situation to And that stage Parkinson's a in the business pipeline of quickly for sweet potential development stage recovery that? product that. How you that the do how What's would in take market? the would environment, the to you terms of the your disease you

Mark Schneyer

question. is the Mark. for much This Thanks Yes.

joined the had sustained this becomes partnering for these or just engaged kind all of just and become windows closed like -- in we've the as it's the past. biotech in a more quarters, quite X what in in companies the and markets quarters, reflecting a X programs since cycles of been more is in just to me their let capital going independently. fund naturally by So just to start in and seen we've significant X on capital for them What markets difficult while downturn because seen we've quarters, it industry. interested more past And

guess, to earlier as so of for were that now And maybe the stay markets in beginning of signs around X, at to attractiveness or some like in capital quarter the that. this in more this we another really meaningful or turn at it anticipate the this companies result interested change opportunities soon. But business X not to for doesn't joining in a see We're just but look anytime is early that's engaging. to which happening. anyone's talking time point is going what

as us said, what happens companies PD respects, difficult so in dramatically for infrastructure. And a with a favorite for just our the industry, and net while tilt of us like companies and in some because the time positive we resources table, probably kinds is it's ensuring why

forward. development challenging X we we most X far, go forward, very as markets. we're last capital that. the today been poised business had The go for And So very, competitor most dynamic the the as a has -- advantage by that's take in to of to we've different years

Operator

question, the that with from of come Next will Paul line Stifel. Matteis

Unidentified Analyst

This on Paul. is James for

or learnings specific should with mentioned they forward anything You communications running can around indication. or FDA carry any example, guess did prevention like, your as potential you development you guidance indication that that around potentially pimavanserin, studies for provide what as acute for in a look I relapse any ADP pursue versus I ACP-XXX. guess the recent

Stephen Davis

free feel the Yes. jump if question, in thoughts. have to additional Thanks you much for Serge,

we of yet late-stage So discussions had development that a of the disease about learned first part of me I be But all, with just about we've development the the would not pimavanserin. Alzheimer's awful an course. lot throughout psychosis due will of let what say FDA, with course, in ACP-XXX, is, say, process

And so we'll leverage those learnings.

We appropriate profile to safety run studies, tolerability to cetera. very have these be, the and et a good what needs very, how for what feel

in able ADP we've very very, knowledge we're add? XXX we'll the in -- have of we if those indication, think to leverage all certainly well positioned institutional to if very a be Serge, course, which we indicated, learnings. think anything attractive ADP. we've to I And that pursue So we leverage you'd then ADP, like as

Srdjan Stankovic

different have do are us acute chemical in in just associated psychosis psychosis agreeing Yes. and/or withdrawal I circumstances FDA that into with randomized behind that, new trials you that X were around at would ADP in would development In -- any briefly different entity the doing pimavanserin that add development. -- than We to disease. neurodegenerative trial. a and neurodegenerative were already with contemplating time bring

paradigm to different and was obviously, treatment for symptoms. of would new So we accommodate have circumstance would acute already evidence bring than program there Any circumstances. the that development molecule just to have of be you in the efficacy psychotic treatment a designed those

Operator

will with next Suneja question, that line from the Our Yatin of come Guggenheim.

Eddie Hickman

This is for on Eddie Yatin.

identified those patients the you terminated given many to And expect if on have sales so related why Or of that patients hung of of approved work temper we U.S. a that, you should after drug launch? bit a except of MX trofinetide, And you bolus therapies, lack program? to or some X,XXX can sort ramp? quickly, far? just on do the how education then on comment X,XXX So to the quickly more you

Stephen Davis

Sure. everything I'll Serge, MX take the ask you the of down Brendan, want you that. to question, then do portion you let take to to

Brendan Teehan

been is for that excellence and or of been high-value have treat. aware make be make is centers to population -- as institutions for studies to be to patient that see very rare our make ready trial said, The sure of Sure, readily our speaking with launch question. would drug we're as early seeking to we to Thanks that. sure to the of high very to research, other payers able commercial closely an a already treated. to where, to to every make available wants is opportunity of work there will possible, that but diagnosed With done HCPs desire part post to will with closely that anticipate you're of months be at in with on relatively therapy best roll analogs able to we're access about that to launches. There And few patients well patient market be doing we that to pediatric high. look trofinetide, the will seamlessly. our Eddie. families the that expect working whether we've have stages of work sure product said, is that you be first a And of we the disease, do all course, level enthusiasm over we're In sure

Syndrome, people post available. treatment aware will rare would it's families case aware databases multiple already how is more as are for therapy lot that your overnight, a obviously. more to think the many already And and But question products we that additional that we that to as I diagnosed. of. I lunch, expect are of become increase I X/X seek the And of patients there's be would diagnosis patients are a likely a and people X,XXX, that roughly these second disease X,XXX there novel with diagnosed that aware rates of when that expect, done diagnoses. many of is say of around was Rett don't very to We've population. Rett identified work confirm

Srdjan Stankovic

I move and threshold molecule of the will PAM a the a I we backup first will similar we with story discontinue we ACP-XXX you to the MX on program, not very MX were the PAM did be there early a molecule. decision just data certain that that did high for make basis level to animal preclinical MX We to me as evaluating further competitive of the our the we reaching additional let Phase anticipation I what And development to regards the with In these that discontinue our data. rise anticipated of molecules we and remind start profile not just described in And ACP-XXX. molecules clarification. is forward. have a defined made program. of that collaboration we But the

Operator

Needham. the next Our that line question, will come of with from .

Unidentified Analyst

next for visibility our on of it the you like increasing year in question One looks have light Ami. Do likely side. trend from of to XXX On how

Stephen Davis

I'm question. couldn't I hear Could the you again? sorry, it ask

Unidentified Analyst

visibilities you light -- do like trend how have So XXXB on to likely any GTN of is into in for NUPLAZID the increasing mix?

Stephen Davis

Got it.

much. to . very take you that? Thank want Okay. Mark, you

Mark Schneyer

Yes, this when forecast results. time, sure. guidance year at We'll Thanks the next out quarter we we'll for release don't -- of we kind fourth our question. for publish

seen is thus of we've that this in XXXB is what volume moderating. think growth I year the far

year for as year. that is to through of guidance gross net, the to this So we our that for year this I sweet continue consider for kind share why we've proceed as we'll guidance that and the of next monitor component and with reduced think we

Operator

the from come will Oppenheimer. that line with of question, Olson next Our Jay

Jay Olson

just with these potentially about programs combination. Therapeutics. in Syndrome then with Rett talk trofinetide be a two have how other X Can complement you used each Stoke would Since and for and you programs collaboration

Stephen Davis

Jay. . do Thanks Yes. to want you Kathie, much, that? Sure. take

Kathie Bishop

X we other because we mechanisms, the that nicely. programs different Yes. Sure. complement each And different think they have very

with that foundational be program clinical goal these increase the could a not is protein the a has different hopefully each mechanism approved very other. trofinetide in is to in next Stoke patients. compete in But year. The So MECPX treatment,

Syndrome effect. the established even patients undergo that Rett is Brendan as of all us disease. as trofinetide work also I an doing therapy well And on his having leader kind that could that launch the a And for add team in now so just of trofinetide and potential think additive maybe the I'll and

to learnings follow-on use all we'll and be the second those able program. program develop any as commercialize So we

Operator

And line Ritu we do one from Baral that and have come will with time for the of question, Cowen. more

Ritu Baral

despite stay stabilized launch. won't pulling relatively I wanted that of mentioned Rett should SG&A, capital the PDP And you that discuss about be to Syndrome connection guess, some to you're You flat from ask from? And it Can dollars sort your guys indicated you franchise. I of the where redeploying the the Rett. which PDP

Stephen Davis

start? Mark, Sure. do you want to

Mark Schneyer

Sure. for Thanks, Steve, Ritu. and question, thanks the

of each resources are modest confident forward. growth And as drive resources drug right tactics of trofinetide, putting results want an and how the wasn't -- the we of and to consequence and that in of is flat SG&A to I that do target. period best of SG&A, product. of in I think on investment have out find our we're resources and independently period, into kind what launch, we cycle budget and and of put the trofinetide, -- year modest to value figure the sure did forward importantly, PDP, we flat develop PDP as are the we make we just investment achieve drug next And of and get think the wasn't move we're deeper that us, we specific this return to and a to And for evaluation we kind overall and -- we kind to flat growth for look itself it on the we some both what growth a right kind remain on that to for on life as in

Stephen Davis

in echoing I which but bit current patient market, on a add this is right more things precise. are on little thing investment Yes, is The Mark. to instance, try for kind if With produce return going advertising the mentioned business be like are of just their -- PDP doctor before, -- again, XX%. just down don't DTC television, only to we smaller, a would the same patients to now

digital DTC to however, effective. be continues So very

about of now very that exposure pandemic directly the and new in what good patient for a physicians, the environment. with far driving patients, have pull are long-term enough to care, feel are what good growth, admissions, kind talking rates feel drivers the are we're into levers physicians to this of So at

consequence, how published impact help The just I underscore with mentioned real-world test some don't last to being that's that because earlier. dollars. been that launch nothing thing there, And benefits think the that we so pimavanserin. just you do new to want I'll investments as add a but invest there important just just or Rett invest about out the disciplined that, pass our to Brendan does having in is, really There's I of information just something

investing And questions so thing, affairs the and that's equipped the are heavily it. when make our kind of that they very team that about to physicians data in differences to well course, sure medical we help those is describe of have understand

doesn't. pressing we're consequence in purely in mentioned, at environment and one the a So investment our and warrants this and time we're dollars as this of -- I right the all resource moment are, assessment of feel buttons like what's Mark working on

Operator

closing call Davis turn Thank any the you. over Mr. back I like would now to Steve remarks. to for

Stephen Davis

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

Operator

for the participating call. This gentlemen, and presentation. concludes thank Ladies conference you in today's

may disconnect. now day. Good You

ACADIA Pharmaceuticals (ACAD) 9 Aug 222022 Q2 Earnings call transcript