Axsome Therapeutics (AXSM) 12 Nov 242024 Q3 Earnings call transcript

Good morning, and welcome to the Axsome Therapeutics Third Quarter 2024 Financial Results Conference Call. [Operator Instructions]

Please note that today's call is being recorded. I'll now turn the call over to Darren Opland, Director of Corporate Communications. Please go ahead, sir.

you. Thank and conference joining call. everyone, XXXX third you results financial thank morning, our for quarter Good I'm today joined by Dr. Chief Officer; Herriot Pizzie, Tabuteau, Ari Operating Chief Nick Maizel, and Financial Officer; Chief Mark Jacobson, Executive Commercial Officer. Officer; Chief

discussion. this the complementing call presentation time slides our Those at to new may webcast the of today's joining section any we via a Investors also Earlier morning, website. corporate posted the advance during through

and the Auvelity are efficacy, Sunosi, products, company's As pipeline any, and we These the and possible financial things, regarding, be development actual projections, and among to our certain from of cause making certain clinical our nonclinical on use differ those results other plans to clinical based performance statements and plans uncertainties a present forward-looking additional forward-looking safety materially and current of investigational and and and conduct plans, commercial risks that the or trials, projected. to of reminder, will the anticipated our our and investments. future and our may utilization plans, cash intended regulatory assumptions report future research regarding of events expectations other intended agents, are statements the subject source data, plans, and forecasts, if revenue information, future

these Please refer risk important and factors. on filings to details today's press additional release, SEC presentation and for our

only are statements. any are of on obligation You which these or forward-looking date, made update revise as rely and cautioned not company to to today's statements, the disclaims these

to Herriot. I'll over With that, hand it

nervous results lives novel joining conditions. developing and are for innovative Thank At focused delivering central that financial the on system with of and business today's can medicines Axsome, you, good call. Darren, living serious Thank everyone. on we you patients morning, update and transform conference us

intermediate-term pleased value mission the vision year review and the in to important potentially and report progress driving our in this are articulate on milestones. made advancing we've quarter, long-term We

for time. quarter quarterly and milestone excess first the strong as another was quarter million represented we notable delivered in revenue $XXX product third The a of

This $XXX quarters quarterly commercial our as annual to run revenue X year second just a of full approximately translates into an company. performance rate million,

While this candidates. on and ahead progress lies current potential based marketing our significant innovative, even late-stage growth portfolio of tremendous, is more pipeline

In our addition and Auvelity FDA-approved sleep apnea, depressive narcolepsy Sunosi, obstructive daytime for in to sleepiness treatments excessive major X and respectively. disorder and

Our neurology. late-stage pipeline and product development currently X innovative X candidates in on indications across features psychiatry

reflects U.S. deliver medicines patients late-stage therapeutic Our million pipeline to to us developed, than this provide portfolio the areas has XXX continue in with aligns to peak If scientific the the $XX possibilities in important new impact depth differentiated successfully more positions that of over our innovation, diversity potential pipeline to also billion conditions. seniors for in and which and sales. therapeutic patient-centric Axsome's our we mission The approach expand believe

turning pipeline milestones. will will quarter on greater on before update the Nick the over I an strong the provide Sunosi, detail Now it provide in Auvelity and and to and for Ari, upcoming performance who

date underway if migraine. AXS-XX, treatment to as our Class was in resubmission multi-mechanistic II a candidate with development are the new acute action novel, the approved. preparations the key quarter application for designated resolution A our and The XXXX. PDUFA the by product of FDA January commercialization, of was ensure a for drug acknowledged XX, Launch goal resubmission of timely

of the fourth completing AXS-XX inadequate for corporations fibromyalgia, [indiscernible] the will patient CGRP are Results a inform respect from out this AXS-XX track in submission. on trial of we patients the potential to subgroups. NDA III With for Our this utility is prior different help antagonists of in management to the response [ quarter with to in ongoing year. trial EMERGE evaluating Phase read oral ]

NDA the submit to expect We the month. to this FDA

our products, on comment starting to with pipeline late-stage I'd AXS-XX. now other like

development ADVANCE-X a Phase positive ADVANCE-X trials pivotal [indiscernible] the quarter III AXS-XX comprehensive trial a and efficacy and completed X placebo-controled for parallel disease Our group uses trials, X trials. and Alzheimer's in is ACCORD-X of randomized ACCORD-X in consists the design. agitation program ongoing ADVANCE-X

provide [indiscernible] Given both have in are simultaneously track we an ADVANCE-X we look both results top one reached, on line that report positive Alzheimer's disease enrollment these strong filing and a readouts that these trials as been believe ACCORD-X of quarter. We for X this NDA results from addition AXS-XX to trials, to the favorable support outcome in both forward agitation. to or completed from studies, for ongoing the pivotal for from will

Turning now AXS-XX. to

Phase We quarter. complete, The conducting AXS-XX study. and trial treatment in ENCORE XX-week are report to this period. trial a long-term of for period called of we the narcolepsy top in track evaluating the III line efficacy a continued double-blind, the trial reboxetine consists with X-period open-label is a are by X-week followed withdrawal Enrollment randomized currently and results safety on evaluating

additional trial a for our NDA provide study registration ENCORE support AXS-XX. as was conducted to The for planned

completion planned meeting Following discuss the plan to submission. FDA our trial, request of pre-NDA to the a we with

pipeline [indiscernible] depressive to binge MDD, eating disorder for our ADHD, III X disorder and in represents significant expansion development opportunities advance solriamfetol. which Phase will believe work major our out Rounding we shift ongoing continue trial disorder, with

placebo-controlled first Phase anticipate expected as of a the and adults complete evaluating XXXX. Enrolling solriamfetol III in efficacy we our line the to quarter safety top is trial, December, of the in in results in in FOCUS result, ADHD Study, and double-blind now

patients solriamfetol anticipate in nicely, Phase III complete without the examine in trial the of XXXX. line and results progressing top disorder expected also trial depressive Additionally, to this the from PARADIGM MDD We effect in will is quarter enrollment quarter. now PARADIGM with with major first [indiscernible]. the of

binge eating and ENGAGE XXXX shift to and results disorder XXXX, in line trial anticipated Phase sustained disorder the top respectively. in Phase trial with Lastly, enroll III III a continue work in

preclinical and previous impacting conditions, to broad million norepinephrine over clinical with of in along highlighted reuptake the evidence, as potential U.S. pharmacology a a range people inhibitor, and supports X-HTXA we unique XX and its dopamine TAARX CNS solriamfetol's agonist, in As and calls, treat

With drive solriamfetol solriamfetol long-term to the multiple have the for value-creating alone. under for catalysts indications potential study, growth potential new deliver we to

In path includes a milestones. shareholders. confident to regulatory of excellence, and ability strong significant closing, clinical, and ahead long-term we Axsome in the a With our near balance operational for are and deliver robust focus, strategic sheet, commercial for patients value series

that, to With Nick. over it hand I'll

Thank you, robust million of product share the quarter third results for net compared the provide $XX.X financial another year-over-year delivered $XXX.X growth Herriot. to total yet prior momentum compared sales XXXX, quarter, strong XXXX. financial $XX.X guidance. increase. with sales million Today, net XXX% revenue in growth and I'll We the reported third our period representing some and quarter million QX versus period same representing in XX% XX% continued product year to Auvelity's increasing an and to sequential

to with a We're the continued compared XX% for in the increase for of in quarter to and million same Sunosi. pleased also XX% XXXX. Sunosi, performance which Auvelity the $XX.X approximately XXs Gross net or low net period of delivered revenue the in product was

products, growth. and by Our in for personnel QX were costs, controls higher clinical compensation $XX.X compared XXXX. well driven pipeline as including chemistry with manufacturing noncash AXS-XX associated expenses programs same increased for for as was R&D million stock-based primarily and and costs associated solriamfetol our period increase million with ongoing to organizational The our $XX.X the

The million associated investments stock-based the for quarter Auvelity was the for result with same $XX.X organizational third personnel compensation higher XXXX. mainly $XX.X compared of along the costs, commercialization growth. and million to expenses increase including in of were Sunosi for period SG&A a continued with noncash

for a for was $XX.X value quarter contingent million third per $XX.X in share reflects this charges, share the quarter noncash for loss million XXXX. market $XX.X loss $XX.X $XX.X million Net consideration in $X.XX or adjustment comparable The which compared includes the period to fair of million. or $X.XX million per

and September million equivalents $XXX.X Cash as XXXX. cash totaled XX, of

assets of we and the efficient capital the substantial committed years, in AXS-XX returns allocation remain has principal As we late-stage to potential date. approach our to coming yielded in approach migraine to launches that other

we is on current operations cash plan. our balance cash current based operating fund sufficient believe anticipated to into the flow such, positivity that As

to Axsome's provide call on I'll Chief the Officer, turn that, Commercial commercial And our over with details performance. Ari, to

in Thank quarter you, performance robust commercial delivered the Nick. third XXXX. Axsome of

Auvelity sales increase for our dynamics the in and for for quality second an brands, addition Auvelity for the and quarter, consecutive of in lives commercial to including continued covered market saw both QX access strong improvements strength Sunosi, In execution. performance reinforcing

quarter. Auvelity this X% year-over-year and total once and XX% By third Auvelity prescribed again, started XX,XXX year-over-year second the antidepressant number the patients the new nearly comparison, in branded XXX,XXX. compared quarter, prescriptions Auvelity, market outperformed since competitors bringing approximately market sequentially. were in launch to growth with quarter, the growth to sequentially XXX% new patients XXX,XXX of grew the on and representing Nearly

and ], X,XXX MDs, continue than more penetrate quarter activated the among care primary to the [ patients markets for who the care successfully both depression prescribers team sales PAs and third U.S. Our across of the psychiatry majority new and in NPs

market the access lives from starts landscape. XX% Auvelity across total Negotiations access new and of covered PBMs and claims. and of payers evolve meaningful announced resulted and Auvelity for with the continues our ] now payer across expansion Coverage patient are front, On of expand, XX% channels. lives covered previously increases covered in [ in has commercial and to advancing lives

to increase year approximately our attributes of planning Auvelity To of outstanding as build the positive in expansion the launch, force is and provider Axsome. sales strength we first pivotal share expected XXX success and representatives, further will for XXXX. brand of and in complete with the product position quarter patient for The of enter market another to are the which growth sales voice, second combined access, we Auvelity on with a psychiatry experiences Auvelity

and to prescriptions with to patient ] ] [ patients X% XX,XXX performance XX% with the prescriptions sequentially. the during the while once year-over-year XXX agent [ weight Sunosi. quarter. Sunosi quarter drive initiating market promoting Sunosi's quarter, grew new activating X,XXX again representing treatment in approximately the as By continues new with Sunosi strong in also new growth. Total approximately more X% prescribers year-over-year team writers were Turning existing sequential and in than depth comparison, the X% growth QX,

to now Turning AXS-XX.

of them with being mentioned and million date Herriot in his to affects is the approximately PDUFA disorders of their for we neurological XX cause satisfied Migraine treatment. due January treatment As leading fully anticipating among suboptimal XX% efficacy. disability XX eagerly not the report current Americans, innovative open, this are

Launch are has multi-mechanistic If the a of XXXX. commercial well underway, the the address distinct including We anticipate team. sales unmet build-out to AXS-XX potential first approved, this in AXS-XX's of the pharmacology half need. preparations launch

future as made patients for a have providing a payers, trusted launches. foundation as Auvelity in for XXXX, partner have product and commercial and solid as progress full Axsome providers, company significant established we and firmly performance Sunosi our commercial well closing, year In a as second for continued

call I will the Q&A. Darren now turn for back to

now Q&A. Ari. to it operator Thanks, over begin the to I'll turn the

[Operator Morgan Instructions] Our first with question Stanley. comes Purohit Vikram from

This on is Morgan for Vikram.

you the from expansion, how that. on a would And how expansion So a you force And expansion? sales then have take? would after expect to full sales I this long expect lift much Auvelity follow-up of the

is question. Ari. Thanks this the Morgan, for

As completed we expansion of mentioned, next we quarter expect year. be first the in the to

In build expansion, would ramp terms course we the our of year. the the guidance last that gave lift, would of I over suggest the was that

I think started over why it's of course impact we brand the the and so performed we of the in to of this completed that this as you reason January been year. well straight saw part has year, the away, expansion see

the for would we impact So similar second expansion. a expect

you would of Okay. potential in move driven -- desire be for then would to That's expand ADA versus helpful. the how as preparation well? MDD And say by this much launch

it, first Yes. primary as for potential rationale market. This about and market We've MDD, the promising for or recent the wins also in really the expanded seen Auvelity have second-line access growth treatment. care is

further forward access and care. growth in continued expect in improvements market We primary moving

But to we sense makes your potential dynamics. future point, this those see the do So synergy to is capitalize for approved. if ADA on

that share so more And on we'll the appropriate at updates time.

America. Our next question with of Bank Jason comes Gerberry from

get going it option target there. a I for technically Auvelity. of antipsychotics new considering fair but adjunctive, the tension that Curious approved your the to is to these to market, just versus thoughts a be considered think atypical patient that [ likely monotherapy as ] that with be there's new [ year might adjunctive. competitive a an on next that are of ] mechanism on are different segments different on First, sort

tolerability better wondering somewhat I'm way there's just So profile a my like to any competitor new first atypical if question. Auvelity.That's with of be might [indiscernible] a

And just follow-up. then a as

profile. I On past, the you you have you in ADA a marketplace, differentiated know feel have like said, guys the

Auvelity co-pay eventual for high seeing applicable defray to not a really we're Rexulti whatever with a be costs big But has through I Sponsors costs heard high are one program. Medicare an out-of-pocket issue assistance patients because launch. SKU. the been we've So thing to it's may guess those able is

hurdle, That's how ADA my which intrinsic So follow-up. the marketplace? do you overcome more that seems to

Jason, Great. Yes, do for [indiscernible] question. monotherapy is questions. of distinct atypical as we marketplaces. is I'll although addition see And adjunctive [indiscernible]. there the in Obviously, slightly start these thanks, monotherapies, with different the use to than atypical

As we stated previously, believe line had the to atypicals later is response has when or we've a Auvelity inadequate firmly will fourth treatments. in line, come Typically, patient that second play treatment. third into first or a monotherapy

profile, related would profile, about I say, is believe, I in our marketplace. strong atypicals comment tolerability capitalized other very safety Your to is tolerability because this

our competitive some there noise, that's we're how is level to commercializing set ultimately, the and believe key SNRIs, SSRI, we expect we product. So while of monotherapy with be

As ADA, patients. the very for launch always ] for been following the across Auvelity Part working those expense I it we tough landscape and out-of-pocket on carefully. is and branded develop a for have as to agent think relationships strong relationships providers to Rexulti the develop strategy is expand And continue of [ marketplace, Sunosi. and with relates and any we coverage payers PBMs concern we our

benefit expenses up ADA launch, for mitigate should We a set time. patients out-of-pocket expect over to us the for to those there be which help

on co-pay [ patients? guys out-of-pocket have you ] costs wouldn't So borne kind to expect $XXX of these

that the coverage the rebate we Jason, have with the plan. and agreements depends on it really

it's a the access is every premature our to So ensure out-of-pocket But goal that expenses, it's that And for comment to on appropriately. exactly expense. there's little patient. out-of-pocket managed

Timashev RBC Leonid Our next from Markets. comes with Capital question

Congratulations quarter. on Leo. It's the

the have what simple your then to and you one ADVANCE-X event guess, that reached a you've expectations? both Just also the compared On target to talk I ADVANCE-X you me, how expectations And compared rate enrolled I can about enrollment would from and in patients in now ACCORD-X guess. ACCORD-X, ADA, for both ADVANCE-X your been?

question. the for you Thank Sure.

So have as reached you we enrollment. mentioned, target

As patient they're it to very the similar. relates population,

thing very criteria ACCORD-X. So the you the and exclusive we as and an make studies to ADVANCE-X to same with And would goal say The ADVANCE-X ADVANCE-X similar. I for do regards ACCORD-X as are well was studies. ACCORD-X replicative

readout expecting that rates, will all the to rates we're event what to them And a confident the to ACCORD-X as why study able this relates it both be. event are we we're be quarter As the is simultaneously. study for that have the ADVANCE-X

question with comes Fitzgerald. next Our from Duncan Cantor Charles

on regard potential Auvelity, is say, all ], in AXS-XX Rexulti, and congrats upcoming a ADA? team, read With if quarter. driver terms on shows approved nice traction lots I had pipeline response follow-up and the are the on PCPs could is questions. think And Herriot the relative differentiation then more you kind couple commercial that, psychs of on. a its and One going a that readouts. drug or for rapidity I color of a getting effects with on of to and to [ And do the you appreciate of and pipeline, that? profile is the to,

a Charles, much really which in care question, this psychiatry in market. the Ari. To primary answer question. clinicians segment, is That the doing care is quite for primary said, fastest-growing both we're Thanks signal. your were the so QX, and well great

of about grow. the we market expect to historically Something that that to talked we segment continue

the the care really we're with that segment. So making we're pleased progress in primary

in utilization is education top market. be a our rapidity part very launch. rapid core on depression the we with about think early KOLs of market, yes, spot And conversations that the attribute that story It Alzheimer's on. a the will is our acting response is compelling drivers of of comment in Your one based brand at

slightly Ari. Relative smaller AXS-XX than upcoming looks size to the ADVANCE-X. readout, is Helpful, ADVANCE-X sample like

us can So in any concerned you into you does or then rollover observe what that you of provide size? the of open-label study at terms about terms And all ongoing effect then and on persistence? extension enrollment make color that in might there

Great.

regards the ADVANCE-X, for sample with to Charles. size So

in sizes slightly presentation, are slide that see our once sample differ you enrollment. enrollment numbers complete these And our So you target always the actually numbers. the

numbers. You never reach the exact

or -- plus minus. might usually, You it's

wouldn't use the as into too look is except I powered. at number to a So read much study that to and that guide how it

the studies and open-label extension terms or In nice a usually, of precede seen open-label how that's the of open-label expansion, extension a we've And very a study. patients study, from or high rolling in terms product. percentage over very of control patients positive caregivers those sign in the the

happy So that. we're very see to

open-label high which And safety positioned. move our ] us ICA enrollment that in a target NDA studies very an filing. does [ it on rate we're towards of an extension are allow well numbers, the front, from to benefit that exposure perspective enable Another is to needed

Our with next question Wells comes Chen from Cerena Fargo.

enrollment. want Congrats I if sorry, in any on ask you and pediatric FOCUS is readout? your was competition now study? to 'XX. kind still pushed planning or adult the in wondering -- thinking to with data the quarter. I of there about to then after to a potentially just the strong running or on solriamfetol out study XQ what ADHD start slowdown Are that And is prior

Mark. is This

that's the So kind screening what timing, and final funnel with we're to of simply seeing. respect

enrolled, patient take. enrollment XX% So long the is just estimate of how study is to our going it's already over final final

pediatric basically So to and all plans works with we're as as along. in And going able. we're -- as stay those soon moving the that's study, then And to the tuned. respect are that launch

so for se. on But FOCUS not the stay tuned that. predicated it's And per also study

Sandler. Piper with comes Our from Amsellem next question David

not to And I'm about for thinking guidance But to any of question XXXX. want you're about broadly the down as next know just think on I lot that? spend, think R&D not studies year, about speaking. that, up of asking year. I particularly ask how did should sort next How drill wanted So beyond with a programs, structure a for lot we about you of cost but wrapping

next regarding you're I support force in have and count be extent say, support us migraine beyond. then to to is are secondly, going which the I expand Alzheimer's of year and about, SG&A mean thinking to opportunities. expansion adding sales know Help the and head then promotional But you And the of additional how spend. to how these Auvelity. going understand you

I'll Maybe comments that But more the the in then thought whether of or I'll other provide just the detail. members to just overall, it's let rational approach give team some R&D way. very it in of for commercialization is overarching just spending and -- about we've a way terms for

So the return capital. intense is focus there culturally in on an company invested on

we be thought in way. well that done a rational everything be very do So will and will out

maybe differ to may what we're that Now with seeing from companies. used other

However, we way to run business. think that's the that the right

this David, And we've Nick. capital in Yes. on end at just since I of say -- ever QX, the Axsome points. been Sure. that is now, he the position are made just inception. right the think at And add maybe strongest I'd to key to we, Herriot, But

had OpEx specifically operating decrease to investing a AXS-XX. reminder, we a and As We saw with R&D how execute cash our flow spend. of And QX expect from as in launch should quarter, our We then mainly that the the furthering the QX. just our for in a all on fit to are it have the R&D Sunosi, in and SG&A were increase ability to in due QX and on our Auvelity, previous -- this just about positivity plans, quarter. that's PDUFA in of current including we think would relates we priorities slight AXS-XX pipeline. And maybe and we QX, further get in cash our hand, on to

then migraine just that shortly. So again, we're SG&A, launch. potentially increasing the we prepare as following slightly And for

Our comes from with question Marc Goodman next Leerink.

just First how is sense of that's and of can how give used the all, you evolving? a Auvelity, being on product us

has like sales add? again, to are going been but asked reps just that I when times, approved? are going the expansion the a the have to for migraine question it's the that's But about to leverage expansion be question another Auvelity. know the the force, you're Second for used just in I'll few is are -- we ask it going to for these migraine how we Or launch? reps

And study, lastly file need give to on have then running this just an just the another you product? you positive reboxetine. Can us on You're you update study. what

safety? there need more issue the to Just you do this Are looking patients for we So be study what long-term file? to positive is. curious for gating

it's start with Auvelity utilization. Ari. the Mark, I'll

around incremental use in and remains line first It So second QX. or second line we, XX% first in increase saw again, an use.

to So incremental the product. pleased market build, that with we expect sort to online as bring we for particularly more and of continue growth, access the

[ addition, but increase In adjunctive about use, remains XX% we when ] again, think in use, monotherapy around saw you or an it monotherapy monotherapy adjunct.

and that the continue to trends time. expect overall, with we line are So expectations in our improve over to

migraine As for this think to targeted market the Auvelity When relates Auvelity. differentiated expansion do migraine a the it leverages [indiscernible]. experience enter that we launch, in about is way our with you to the intend expansion,

So over of with if we've additional you representatives. our sales significant the there commercialization year expansion, model. be say digital-centric would will past an I progress that made will,

engaging and cetera. experience headache to centers, will at large XX from treaters launch, with be expect but we migraine benefit clinics, top et We this neurology

bit share a additional details closer. little as we'll So get we

Great.

to reboxetine As the question. it relates

So This Mark, trial. referring what I think narcolepsy. our is patients to Phase trial is the ENCORE with you're in III

study to in this to positive to NDA. be So we need not file able do be an order

the studies, that we support AXS-XX. our regards X or reboxetine claims make So to we have with to want efficacy already which will

withdrawal randomized the trial, III term it Phase the trial, incorporate -- extension safety a long does Phase period. III the However, X-week long-term

design on always it. just not beginning. has very And there from it's the been focus study been that that's the So of the much

additional did fantastic, an make efficacy for a near we positive, package. for And is, fact, point in it's readout should the provide that to out this if that even So it data. want that's we study, stronger controlled study, will as it and

anyway a But study? you're with without positive or filing

study, a it open-label ENCORE periods. the the safety open-label has That's X One And X-month period. extension trial. is Correct.

So the original for that was the running study. reason

leave to So when our which AXS-XX efficient And the then of in did in we is to which study [indiscernible] we versus is using used placebo. file. part we that sure include that that a strategy phase, we've everything the we past, designed that the do make in order do, we're study,

Our Thome comes next Company. question from TD with Joseph Cowen &

before AXS-XX doctor? on Alzheimer's indication, it patients? Congrats referred are you're solriamfetol of on about Kind an when where in I patients? the can Is a these study? has you on a of care that here Is And find first bar given that Alzheimer's psychiatrist? What what Maybe enrollment then the the physician? program? for setting? last different point second, agitation, of we it Is sort it the set of the progress. the finding in is touch it sort thinking investment in one commercial guess MDD. Auvelity in the sort neuro high area you're into of where additional primary being that consider looking for to And the differentiation these

Great.

So for question. thank you the

in disorders, we studying it to As without solriamfetol with MDD, sleepiness. and major are in excessive with depressive relates solriamfetol daytime so both patients

we've clinicians pharmacology the will which you in is action brand-new drug the action, Auvelity, from So that provide patients, the mechanism mechanism has perspective, that population. agonist. and marketplace it mechanisms receptor novel action marketplace. by mechanism received with is patient have novel that To a different That been has And its MDD, a with MDD of action firsthand and is given at look a of of useful. of if [ and and [indiscernible] ] very seen how pararogenous very a

other to of differentiation. relates it As points

is clinical comorbidity aspects daytime its one aspects, of major the with excessive of and sleepiness. of depressive One association disorder the

that to So the look PARADIGM that we study. will of is the areas one explore in

forward And So solriamfetol from profile much stay the potential learnings we're about of tuned. that MDD. to study, in very looking

companies Alzheimer's with and related that agitation we other psychiatry. in and the partner which from. is The run are coming question are critical And you clinical specialize trial disease to centers patients where those other studies asked that way

the So relationships that go works go and way It to is clinical there to patients experience that in them. general centers care the to although not taking trial enrollment advertising. is population, and enrolling to is have of these specifically

So are the that's coming from. patients where

commercialization, to And patients. our translate how that with one of as it community dwelling it focused I program is into might on differentiation think relates is that point

in patients. be So disease And is, home. AXS-XX benefits to developed patients one of should your potential the in these of Alzheimer's agitation [indiscernible] of the are successfully not fact, nursing keep out

Our with comes Truist Securities. Joon from next question Lee

This quarter. Congrats is [indiscernible] on on for the Joon.

year? increased on seeing XX of million you're from the X? earlier inflection The inflection you remind would study coverage ADVANCE-X then on say Or the new lives us the side first a sort me question of is, due more have for this you FX sales And some than as powering additional can of seen August what follow-up is? Auvelity, to the force expansion you from

powered powered very similarly a Well, to it's treatment to so is ADVANCE-X difference. ADVANCE-X, XX% detect

the talked detect have about that exactly size We effect to to it's is is, powered not [ size ADVANCE-X. ] effect what in but the size effect the similar

And inflection. the on thanks Auvelity question for

driven the post market with that we've We the access expansion. are very demand pleased

in meaningful covered We seen patient both and claims. starts have new growth

covered we've those In rates in rejection addition, lives. seen a for reduction

So overall, with pleased we're performance. very the

that, win I think during keep seasonality in mind summer month. that occurred the

So we to build to over time. continue expect that

make the very fair more the course given the and don't has And we've obviously I been that inflection. more year time think impact, expansion comparison of impact with force to the in earlier seen But expansion the created so pleased sales was over to say the we've had which fact year. it's -- a the

Blair. Myles Our Minter with next William question comes from

here. you force that, know more force is ] it is contract GPO that you I from expansion. bring on that level on further still the next we think expansion got required? contract, large GPO access back you expansion you've sales that you year another if sales of [ get Or could that have that? And get Just Is the that a potentially you XXX incorporating one could execute now, expansion?

of sort of to have is just secondly, benefit something you started age jives having and AXS-XX, price? them then And with potentially that unique a that you cover engage therapy see might with on that payers on fatigue that and branded

X market experienced efforts. sales it Myles, primary It's have the a year. time so future access to we've and expansion, capitalize in add second the specifically of in win. the we on why care regarding today access this also are sort primary was that selling right the access tied the in to seen believe it's reasons we and force increase first not the additional really But we've market growth to line XXXX of

any wins additive to further would So and additional access performance. this be market expansion accelerate

Yes. asked about whether question AXS-XX. engage as or not to And with we start payers relates to it a you

Yes.

are very resource improve are utilization. treatment recognized breadth of to So there's talk our term of negotiation. to it's significant room are life, impressed relates only quality interest are more as more payers pipeline, on that options, that also are that existing although do payers obviously, near plenty there And the They've not but to of our That fair these to to rebate generally sort it say of or portfolio. with launch payer still of symptom the of think And areas need. unmet we health regarding things said, speaking. I improvement,

and very good we others feel get we profile launch. have once constructive and believe of the so of the XX to strength we'll about And closer negotiations

is this Myles, Mark. And

do product element of is to observation that important fatigue think profile. particular, in on an Just we the your

Yatin from with is Partners. next Suneja Guggenheim Our question

on Eddie quarter. Yatin. is Congrats This for on the

then pivotal as sense rate getting and the especially coverage, discontinuation, hurdles from branded up range? on the real-world the looks the of it you of to of other coverage that on relates are Auvelity, of the in antidepressants commercial access sort to terms And coverage, market. of studies For channel you're that it XX% seeing to commercial are what beyond you're getting sort major broader creeping but like terms in XX% what

Yes. the for Thanks question.

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Auvelity and internal In that persistence fact, our outpaced SSRIs suggests one of SNRIs. analysis of that

pleased in we're trials clinical impact marketplace. been from with ongoing no So really there's the and the that,

we're with confident expand the very management utilization negotiations had term. about see outstanding in In terms on near to evolve it's of that expect And the in the and hurdles, we've and really rebates access final aligning plans. and criteria

comes question Our next with Ami Fadia Co. Needham from

[indiscernible] could for how the number prescription [ Auvelity for do quarter migraine? readouts and holidays? in Alzheimer's additional the data on disease timing the quarter us to of fourth you question ] is, Ami. is some provide for of fourth the you in This My color trends And agitation expected first with expect the differ

XX? lastly, in regulatory the impact And any decision on study EMERGE the does Jan. way

the question. this Ami, Ari. I'll is start with demand

branded is that there's from and we will in this seasonality difficult I there to point do the which a which some Quantifying QX. expect both in also So and Auvelity market, QX, time. little both market, be would generic a the at impact seasonality outpaced effect cases.

the do we continue be to so able to impact expect that And feel grow seasonality brand, we'll but optimistic QX. we in some

to respect the and now me, end excuse the year, right With the the of cadence of between corner. that's around readout --

provide to not there. we're that we but for forward I -- providing didn't haven't and you and looking the right it's choreography, -- corner, guidance stay the updates can So on exact again, think around morning, we're this we tuned

with that a then resubmission the EMERGE, or is, or to NDA respect perspective. regulatory I for think from is And submission question the heard I needed

just needed so that, the read whatever a potential expect and we the we AXS-XX -- a to potential from that and medical that that is perspective. And Instead, communications. trial that inform marketplace and will commercial reminder out, approaching from learn as we'll not regulatory

comes Our Baird. next question with from Beatty Joel

more how expansion, force file? you then be sales many allow that the would the to for expect And docs give to does for that does able ] you cover? is when is [ question second how example, Like, to for question ADA, reach you? more First much

reach. the Yes. be also there's There will frequency But increase Thanks, some I in for question. Joel, play decile providers. think for high here importantly, a

good in market of more also in feel at really capitalizing moment, we front in markets it those so we're And that And specific on the getting a but doctors more the access in those And expanding you for have doctors. of markets. be think number frequenting sort dual which ultimately I the strong a benefit regularly. about will

see Great. is package readout timing ongoing takes get we disease we then And meeting. But that in is we to for the a the in general, months it will pre-NDA studies, of the the roughly from [indiscernible] it completing filing about choreography order the ready that agitation, as X have for to studies the think Alzheimer's way once X filing. after it relates to

next Our question with comes from Mizuho Securities. Graig Suvannavejh

trial on various III I In AD Phase earlier AD provide that the and potential progress hitting I words, other agitation your, on in on feel the please said on you take Congrats think the Could to like quarter. would versus ADVANCE-X of either about question But [ AXS-XX got My you outcomes? is positive please. then guess, sufficient X ACCORD-X agitation. you a if trials, enabled support filing? ] follow-up, to hit X going on of you're I've one, the we filing an how And enabled X S&D think a should only the a filing. be primarily

Well, question. your thanks for

X studies, reminder, program the X And which So just read of we've as consists those pivotal of studies. out a already positive. are

And filing. a are studies is us into possibilities. readouts, leave are words, efficacy are of So those studies support of and or other And either needed statutory X one both In But is to there ADVANCE-X one trials with positive. those several is that more would going an ACCORD-X possibilities. that positive that or positive. well, than there that more regulatory these possibility situations, perspective. from In NDA is X X

good going readouts. So data these we really to feel

the the provide the population. safety terms the that product this in profile profile have program in will and lot of is of fact about like we that of of also the a X information we studies terms it in What product and

could net. maybe gross if Okay. I then ask just And to the

quarter. the was the net? the for gross XXXX Auvelity missed I quarter. on think fourth comments perhaps Auvelity to third any fourth on it comments just in into I the for But around have might looking expectation XX% quarter and specifically

impact quarter improvement the quarters. We we that's seen slightly the mid-XXs in we've Nick. Sure, low to deductibles. prior to of from GTN the similar industry you're was [ range would And That similar seasonality in rest approximately sees, fourth in previous QX in then similar throughout the expect to Auvelity XX%. for pharma years. in that previous that for Graig. would that remain due improve quarter, Yes, And year, the approximately to slight to XXXX, a to the and typically, negative the year. years the the previous of ] and reset correct. XX% that was we It's would anticipate again worsening it expect to

X time for have questions. more we appears It

with Selvaraju Wainwright. question comes Ram first Our from H.C.

Eduardo little the [ to could the that of and in sales eating competitive for landscape to question Ram. if is the if a it you that, if disorder indication. market hire I specifically, give to nature asset. ] you [indiscernible] fibromyalgia This had on a And regarding the expecting And color were approved? also a were binge of sales the force promote

Yes.

So targeted that I'll market fibromyalgia a way start we've broad the seen AXS-XX is team primary and XX, really the The similar market represented group differentiated with across by of prescribers the in to we question. with about And comments experience my market intend rheumatology care, enter a leverages Auvelity. specialists. -- to

don't particularly on. distinct our where for there large potential force. segment sales in think which I a will selling, of those specialties is with the care, currently some say that is there Right existing it's synergy likely call primary we provider to now, group, in But fair be

to little And so we'll share additional details launch. as closer we get bit a

Yes.

great. As relates to -- it

and U.S. patients is And disorder very one There that population. market there's large approved. are only have relates in is it that, the currently disorder. eating As binge million eating product who the patient a to this binge X for

And so [indiscernible]. that's

needs that a respond think to of developed. to clinical lot we should of So that need clinical a successfully there's it be solriamfetol lot and opportunity with

one. I if And Great. could last have just one

U.S.? how outside or doing on the had is you any data background of Sunosi If

Sure. continues Pharmanovia, the U.S. of outlined perform prioritized and a you'll Yes, that outside it's been received couple that Pharmanovia the be in increasing able well we countries. that's to European last revenue see do the been to We at further from royalty quarters Sunosi over as the

last Thalmann. today from Our Ladenburg with Kaplan question comes Matt

Just as a in or Auvelity current in the the ADA launch plans in of are terms market? readout as near your thinking term. respect data new what's -- ADA What AXS-XX brand with filing with to the the

Thanks, Matt, for the question.

AXS-XX application NDA [indiscernible] we So or an is nice various freestanding FDA benefits either NDA. to thing to the ability it each And the are file have forms, its there under approach. as about an the do

tuned we We take. are that. still exploring Stay will the approach for that

thought-out is will decision. However, can what we very well you tell it that be a

question-and-answer over floor the end Tabuteau our the to session. I to now And closing Herriot back of comments. turn reached would have We like

posted conference shareholders. has for multiple for Axsome late-stage built spanning and outcomes to indications to look thank singular, Well, us neuroscience differentiated the and compelling call of innovative, on which patients the deliver potential forward you psychiatry portfolio, keeping again progress. has returns a both millions today. neurology, We you joining our on to in

Thank teleconference. your you participation. today's for concludes This

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