AXSM - Earnings call transcript Q4 2024 | Axsome Therapeutics, Inc.

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Operator

Good morning, and welcome to the Axsome Therapeutics Fourth Quarter and Full Year 2024 Conference Call. [Operator Instructions]

As a reminder, today's conference call is being recorded. I'll now turn the call over to Darren Opland, Director of Corporate Communications at Axsome Therapeutics. Please go ahead.

Darren Opland

you. Thank thank joining and conference on all call. you morning, us for today's Good issued release for earnings update morning, XXXX. our This we press and year of company's quarter and the providing financial fourth results the full of details business a wire accompanying crossed time short today's the call. the available along with ago our section of The website, is the on a release and Investors earnings presentation any via Those advance time at during may slides the webcast joining the discussion. through

intended present regarding, will or investigational be investments. of of future to source things, regulatory making cash and report the During among today's plans, statements intended our data, possible additional other efficacy, research forward-looking and of nonclinical conduct call, agents, commercial and use and safety we plans clinical plans, trials, anticipated the and future development certain the clinical plans, utilization and plans our our

forward-looking and These that These information, and and from differ statements. reports. the materially uncertainties events expectations in made are based the including future and results risks to quarterly annual that of our to involve forward-looking current statements periodic Securities those in other filings are Commission, contained our and actual with described cause may subject Exchange assumptions are and on risks change

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

Nick Executive Jacobson, Officer; me Chief are Hunter on Chief Mark Counsel; Herriot Officer; Officer; General and Officer. Chief Pizzie, Joining Ari the today Chief Murdock, call Financial Tabuteau, Operating Maizel, Commercial Dr.

of XXXX made into the opening important will ahead overview we've XXXX. an rest look to with of begin Herriot the and in remarks, including progress

commercial will financial then Ari update. review results, will our provide Nick Herriot, Following and a

open will the for We order the taken be they will are received. which in questions, then line

over turn call Herriot. I'll that, with And to the

Herriot Tabuteau

integrated its a has Thank you, CNS. years, last leadership and both expanded deepened morning, commercial fully and everyone. good Axsome the and within R&D as In X.X Darren, organization,

positions X products, significant products regulatory indications patients innovative numerous and commercialize to in-market to III stage differentiated and Phase X comprises to deliver today ongoing through us submission portfolio in X product portfolio shareholders. to innovation Our us broad potentially candidates allowing This XXXX, value or trials.

strong another was year for of Axsome. execution XXXX

delivered year-over-year we reflecting for Sunosi. of Auvelity year, revenue $XXX the million, net high total product growth For double-digit and

continued expect completed in our We improvements for force market further increasing in XXXX, access awareness and dynamics growth differentiated supported our second by Auvelity, of sales products. expansion

on potential. Based on the Auvelity blockbuster is track recent reach performance, to

its treatment of its we are received Based migraine. commercial on have With products January on Symbravo we living now represents launch. Symbravo preparing actively an development with important for novel XX, Most clinical Symbravo, U.S. migraine. X and oral commercial-stage recently, approval profile, patients acute representing a for for

and year, the rapidly advancing pipeline financial Before for turning priorities the to call commercial about Ari, expand I'd key Nick who will provide and late-stage to update and XXXX. performance an strong in like the on over on our speak

trials Phase development XXXX was across our initiated III clinical a from portfolio. trials perspective and read highly we out pivotal X X as productive

several deliver important clinical in a this trial. indication, in Alzheimer's X III controlled AXS-XX Last program the of of completed execution in R&D for trials milestones Phase we treatment positions safety III potentially agitation. long-term which Phase Starting in to year, XXXX a XXXX. Our consisted us with efficacy disease

plan in to for FDA the disease the agitation AXS-XX from submit results treatment Alzheimer's an program second half NDA of for positive in the this With of comprehensive we hand, the XXXX. to

safety half to trials plan and from narcolepsy AXS-XX a year, of cataplexy controlled cataplexy. for of with AXS-XX for the Last patients for program X the which also treatment included with the the treatment completed XXXX. trial. these we this results to product narcolepsy to clinical second the on long-term in submit of for FDA NDA on Moving Based candidate, studies, positive we an in the efficacy

in major Phase PARADIGM EMERGE The we quarter. Top of it III readouts Apart and depressive the to anticipate inadequate NDA in of results Phase activity AXS-XX for related we all fibromyalgia, line Symbravo from for solriamfetol near trial for CGRP several the submit submission in from publication this X include III III first ADHD stage XXXX. these prior in and of to studies NDA quarter III of to evaluating the patients to trial inhibitors. relates the in our the NDA these FDA trials the As on the top oral trial the Phase response term. solriamfetol submissions, of These are with expect FOCUS line in are Phase track disorder. to

solriamfetol of of the study XXXX. ENGAGE line the for disorder SUSTAIN binge progress in and with both eating to work solriamfetol top for continue disorder in Enrollment shift studies in results anticipated study

from across to Phase X portfolio, development I transformative NDA months. an forward as coming we in all, pipeline. top our as in another of look excellent and and and All candidates advance the for am upon trials our CNS build success III progress we made commercial X expect year submissions proud organization readouts we've the line product our

that, With to hand I'll Nick. the over call

Nick Pizzie

XXXX revenues quarter in and and morning. and royalty comparable $XXX.X million Thank of and the $XX.X financial million fourth guidance. full $XXX.X the representing for million and year-over-year were you, of of revenues year, $XXX.X year consisted were periods product product fourth for product growth sales full $X.X XXXX of million. Herriot, million million, and for This our $X XXXX and and million fourth milestone net revenue Total quarter and million $XXX.X results of respectively. the $XXX.X we'll quarter and and XX%, provide respectively. good and discuss XX% Total year Today, full some

for representing million. full XX% were the net and XXXX Auvelity were sales product $XX.X net and product XXXX, and quarter growth. for comparable $XXX.X XXX% periods million million sales million year of and year-over-year the Auvelity $XX in $XXX.X fourth

and and consisting royalty associated growth, million for and in milestone sales product of and million $XX.X net million territories. XXXX, year million Sunosi the $XX.X XX% fourth representing year-over-year full were $XX.X million and revenues in revenue and $X out-licensed product in sales net $X.X million quarter Sunosi XX% with and $XX.X of

onetime milestone million. sales QX Sunosi $XX.X which million, $X.X certain license ex of the periods includes $XX.X year for XXXX from revenue million territories. Sunosi million million comparable Sunosi and was regulatory-based Axsome. for were U.S. out-licensing the net $XXX.X earned revenue in Total XXXX a in by of full includes $XX.X

cost QX million full onetime XXXX Total a of achievement $X with to expense fourth revenue cost were of related million the of included $XX.X sales. received a periods of for full Sunosi $X.X the includes milestone revenue Total revenue the worldwide on a comparable associated in U.S. sales-based Sunosi $XX.X cost million for of onetime million. Total million and XXXX revenue were for of out-licensing territories. quarter XXXX. in year the $X.X revenue ex million for of cost and the certain and year of cost $XX.X

AXS-XX, Research periods ongoing advancement noncash stock-based ADHD, $XXX.X was binge costs, organizational million and eating quarter and increase work as million AXS-XX of and year as of associated trials growth. manufacturing to expense and well the in AXS-XX full MDD, disorder of compensation the were Phase development with costs the primarily for $XX.X compared XXXX, of including for $XX XXXX. and III AXS-XX in Phase company's million respectively, disorder, for to shift higher III and trials solriamfetol the and comparable The related personnel million fourth $XX.X

including XXXX. force to sales and The was for $XXX.X Sunosi, administrative including higher $XXX.X to and million respectively, XXXX, with and $XX.X noncash and general quarter million commercialization and growth. compared related fourth $XXX.X and expenses Selling, full million stock-based organizational expenses the periods and the marketing in increase for were million for year of Auvelity personnel comparable compensation costs, associated primarily activities

period per XXXX XXXX. $XX.X The Net expense. to share in in loss noncash net million the of the and or comparable million quarter stock-based share $X.XX loss million compensation was or per in of net consideration charges, expense of for million contingent fourth $XX XXXX acquisition-related for million includes primarily $XX.X in $XX the of quarter comprised a loss $XX.X in compared $X.XX fourth

million, and $X.X charges loss was net expense which contingent full in million year $XXX.X $X.X amortization year includes million for total $XXX million, loss full includes full $XX.X full compensation The of approximately in to share in consideration million acquisition-related for of per or stock-based loss $XX.X to respectively, compared the $X.XX intangible year share compared $X.XX $XXX.X or million for a noncash of XXXX. the the the expense, XXXX. of Net million and year $XX.X net per XXXX of for $XX.X million million,

XXXX. XXXX ended effects be and GTN of negative discount Sunosi cash in GTN approximately in our cash compared discount cash the December QX, to plan. and based to We equivalents Due flow that Auvelity current million Auvelity into on in in XXXX to XX%. to million operations were sufficient Sunosi seasonality mid-XXs. current balance at we cash operating the anticipate is We $XXX.X that believe positivity both for fund $XXX.X and QX anticipated with XX,

the will over who to like call I now commercial to a Ari, turn would provide update.

Ari Maizel

awareness another delivered successful quarter of of medicines. demand off quarter of and Axsome for Sunosi and Nick. a Auvelity capping increased in fourth strong you, Thank year XXXX, of growth the utilization our

impact and life For positive and report measures. continue quality symptoms both providers to both of patients significant products, a on

poised Axsome's adults dynamic consistent which testament our growth impact for treatment platform, XXXX Our and in months. of is coming launch migraine a across enabled as Symbravo to the support of the an throughout performance portfolio is to the digital-centric has commercialization acute

in grew XXX,XXX compared again the growth new the once comparison, and of XX% since patients to approximately XX,XXX the new demand total to with started on less prescribed Auvelity quarter fourth market quarter representing Auvelity the were Nearly XXX,XXX. fourth prescriptions, Auvelity XXXX. led the the bringing the patients and of sequentially antidepressant X% in growth than quarter compared for quarter-over-quarter launch growth XX% number XXXX. quarter, total X% grew to of approximately By market

care Our activated providers in primary of X,XXX sales QX, successfully new providers prescriber with the representing greatest source growth. team

of increases in lives Auvelity XX% covered positive channels improved commercial. Auvelity in with total in access all QX claims. of experienced is lives of across dynamics coverage impact and meaningful XX%

is our and to the access access improve payers Importantly, landscape with actively team in expand engaged market across payer XXXX.

Sunosi with was were channels. in XX% Payer started nearly health providers of the sequentially Sunosi. and quarter in Sunosi Approximately QX By the to XXXX. waste comparison, on Total bringing writers versus XXXX. patients on care to new fourth X% prescriber cumulative coverage X,XXX launch. since grew launch. of approximately XXX Sunosi Approximately total were in XX% market X% QX grew growth since resulting approximately for quarter, sequential across of representing of stable covered XX,XXX activated base new the growth agent XX,XXX QX, total promoting Moving in compared new lives started patients the number X% to prescriptions and a XX,XXX,

Finally, their neurologists treatments. We sharing look by the to for migraine specialists neurological excited headache the a first we Symbravo, for patients more Feedback plan months. from frustrated our soon. innovative and remains represents XX have than migraine for leading million details the than compelling Symbravo option the Symbravo migraine of the discontinue in limited conditions forward third sufferers commercial XX% product, differentiated launch coming treatment disability year an impact launch Migraine are highly to position additional been the cause as our and acute patients of of treatment. treatment in existing and U.S. more clearly treatment in among migraine. who of of

with and successful and we XXXX closing, year Axsome, our growth a are full of the second a both enterprise, year Auvelity Sunosi. for as In was pleased commercial very very

platform commercial Axsome those our robust of by and promise pipeline to improve commercialization CNS deliver on of innovative impacted position conditions. the lives the Our digital-centric capabilities and

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

Darren Opland

we for Operator, may line Ari. the questions? open Thanks, please

Operator

[Operator of Instructions] today from first And the the Wainwright. comes with line Selvaraju H.C. question Ram

Raghuram Selvaraju

expect respect those you activities, Auvelity with order strategies optimize on you And might to to for you With the what Symbravo, cadence be are can those to buys? in initiated? the comment promotional efficiency of employ DTC whether or which DTC

Ari Maizel

Yes. Thanks question, for Ram. Sure. the

we branded outreach sufficient drive intend think previously, the about is patients the awareness to in to media ensuring pretty this it and market, broad-based depression discussed a plan is the Auvelity are our in of spend months. year way coming that And amongst broadly. we remain we've agents advertising competitive the where for launch As most

investing level. take there specifically, in In and calendar high terms that during where year are when on of it's commented are the of that sure we plan, we'll some haven't that a just considerations seasonality in but of sort that time flow account make is HCP that year the a into offices media makes sense at patient media we

yet, plans but our Regarding commented to we commercial expect Symbravo, share coming details on more the haven't in go-to-market some months.

Operator

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

Charles Duncan

nice a on year. Congratulations

regard the happen? the a the not could Auvelity. as create well whether color synergies question sales provide size as wondering future had that the or is to relative I'm that productivity, with pipeline then base any for and I change Symbravo commercialization force to you and prescriber with for the how for expansion products might if For on base, or prescriber going

Nick Pizzie

Thanks, Charles. Sure. Yes.

is synergy to particularly migraine that believe we we as approximately XX yes, do advantage we about the additional think treaters force we'll XX% to increase Symbravo, with able Auvelity So in team. size. take overall the mentioned representatives sort of the previously, about added That's overlap primary And you be sales your care when question to sales about there I of. in setting, think some XX% that

that. our of of on high depression across comorbidities we're that indications the the one come overlapping is But to aspects more portfolio so the all studying. of key with And

And efficiencies some so synergy certain providers. does with create that or

Charles Duncan

That may pipeline ask makes a sense. quick that's If on question, just I AXS-XX.

You've I that's second believe of that, for test. submitting And NDA. by stability the gated a mentioned the half year

So analysis ongoing.

quarter any have NDA in you color, you that really you're busy quarter? third I if with a know would fourth greater of or wondering I'm lot So now. submissions anticipate

Mark Jacobson

Charles, for it's question. the Mark. Thanks

a the thing, So it stability the -- step for And us, rate is gating you can priority organization. submission. clarify that's building It's one updates a it's expect not just the half, second time to from limiting factor. point is but top the

do to the provide but get in we closer. looking granularity we'll half early we'll second as as be possible, that as So more

Operator

next from of Joon The with Lee question line is Securities. the Truist

Asim Rana

agitation pre-NDA the what Congrats of AXS-XX or and NDA narcolepsy sNDA? This the be leading Rana some disease for on is Asim for the on meeting then had Alzheimer's an Joon. filing an Will have quarter. And the are over scenarios? you

Mark Jacobson

first is Mark, one. the again. This take I'll

not-too-distant filing So sorry, the that well? from we us haven't could as I'm communicated the the to yet, hear repeat but you you in question just approach can expect And future. second

Asim Rana

sure. Yes,

AXS-XX just you have for meeting see? some for Just had you narcolepsy that scenarios pre-NDA the might and leading

Mark Jacobson

that the as around planning, hypothetical, I haven't share scenarios, meeting. strategy. with we're timing to scenario We the we or I yet so close as all. think so share with the not-too-distant have we'll think look I specifics to But we outputs, the confirmed close, on you can, think the you commenting that soon -- to we're different And on in future,

Operator

next question from Joseph of the TD Our is line Thome with Cowen.

Joseph Thome

data the AISRS meaningful what Congrats of clinically on progress. Maybe just Supernus' given ADHD, upcoming for? in on the their comp a good that particularly looking of, in progress package data the is is Qelbree change the you're that solriamfetol sort here launch? the with that I helpful. Anything you be sort And would terms point be can might and guess, overall of differentiated of out different

Herriot Tabuteau

results Sure. Thanks, trial to for We're III announcing the ADHD. close in very Joe. Phase

what So will show. the upon lot results depend a

and of you the as excited profile as clinical to learn rest multicenter open in the a just study. we're about So the envelope

to we for, the study positive what with be is to looking meets study, for specific what first not And study This we're solriamfetol ADHD. its between a a the for with we're would looking that treatment is in endpoint. we're is it are primary relates which this looking that conducting trial, regards any As arms. difference the it

Qelbree, be to that it comparing seen. question, your to relates it as And remains to

we'll soon. have we'll the to So and at know look data,

Operator

of The next with question Deutsche is David Bank. from the line Hoang

David Hoang

expectations of would fiscal successful if about for little on in scripts seasonal point? could talk if some Auvelity might year. pull you for we Congrats the for bit you and I was headwinds. a quarter guidance force forward-looking where How sales at wondering cadence efforts providing comfortable typically expansion product XXXX, just a revenues the see and through and some feel the QX particularly

Darren Opland

Yes. Thanks, David, for the question.

of the a from QX In something somewhat seasonality experienced growth a terms quarter, we than of back we expect growth in but to what half standpoint, do -- demand year. slower the be

last see of We if patient initially impact terms We've sales growth seen another when expansion. of started good as had very the the team year, already up showed leading that NBRx of activity, the incremental in or starts. we recall sales And the call expansion, end we from are which QX, new impact force optimistic you weekly towards indicators activity. of to in of

something So we would expect similar.

you meaningful think depression overall growth summer look Auvelity the course expect will dynamics market be throughout when but others at somewhat drive the is the overall historically, will of brand, I a QX, QX market, to some we slower the experience. the tend But to than growth the market. that and months be there year, for

Nick Pizzie

Nick. David, it's Yes.

providing currently. nature we field of dynamics to and relates force plan fluid include the factors, impacts, been the many and that filed, have MDD in billion payer for $X guidance, market $X which it sales could to are reference promotional shared, we unpredictability provide Auvelity range. is in material sales As guidance expansion have other and don't Auvelity, What sales the of billion you can the that efforts with to external deck alone of peak for coverage, that's

Sunosi indications, in $XXX to For revenue. billion its to million $X.X billion $XXX then for $X current million. in Symbravo, And peak also

to ranges. So we further commercialize, guidance. can we we And in remain as these provide confident continue

Operator

from Amsellem David with line The of the Piper Sandler. question next is

David Amsellem

question this. one my So is

good So place? commercial in ability runway assets your an asset? you're development leverage even infrastructure you about let know a us Or or that bring in philosophically. can Just thinking how stage the have you in terms where would for you with the about to Auvelity that alternatively, with bring significant up generation, visibility asset exclusivity shored willingness of in M&As/biz dev are thinking and how cash and to you

Nick Pizzie

Nick Yes. again. David, it's Sure.

we that commercial But pipeline potentially in are very we pipeline, We're earlier something for open with are stage We and looking can assets. our are satisfied something obviously complement late-stage always with to. where opportunities. our our

We radar. that have opportunities, to something resources our dedicated a evaluate is on internally and now that's

Operator

The Leerink line from next Partners. of Goodman Marc the with question is

Marc Goodman

Nick, what expenses AXS-XX, the gating you think this half can can how us help filing? factors to give you just filing, wait for about us on second are that year? And with secondly, to for just

Nick Pizzie

it's Yes, sure. Mark, Nick.

in the So well as and the bit XXXX. quarter speak about little as a I'll OpEx

R&D quarter, Our the the given trials programs. XXXX in the closing we spend in spend higher concluding the other to continuing expect slightly were moderate progress R&D peaked during the was anticipate this conclusion out R&D and of all other quarter on to X trials the trials ADA as to spend QX, and QX. and We ADA

As do it we see versus QX. expect relates to increase to an OpEx,

However, we us OpEx, expect We're positivity. than the a P&L leverage flow excited super cash about. on sales which to faster starting see track sales putting achieve increase growing to we're at rate, faster to in and

Mark Jacobson

Mark, so we AXS-XX respect the share plan we a the have and with pre-NDA NDA, with did FDA. to meeting to

is rest So building a the But The the that's just program done. is modules clinical the building component. submission and itself.

So of now it's is as AD a order the the And agitation. then this date. that really division other work I'll filing to consideration same lot get is mention just in back that to office

So you might and expect that that. of things control working choreograph terms how we'll be workflows running some air to in traffic we're like

Operator

is question Graig the Suvannavejh line with of from Mizuho Securities. next Our

Graig Suvannavejh

past progress year. and Congratulations in the on all the the quarter

to positioning Auvelity? in especially a just PARADIGM us study vis-a-vis and Just if X on me. that the quick MDD. positive Expectations for product, readout there? for the just see MDD, of And were solriamfetol remind you could questions positioning you the One,

most rizatriptan the on just I least drug prescribed for think can think a Symbravo, you provide launch and then you trajectory sense look like? of at second And might what like generically, migraine. is uptake the

be gradual would do so could more expectation given some And it education product? uptake? Or you the think maybe the relatively around smooth a be

Herriot Tabuteau

the take one. Thanks questions. for first the Great. I'll

this -- to with solriamfetol As the the PARADIGM first it and PARADIGM relates expectations, that study MDD. will be study is in conducting we're

So a we're close to very having learn we'll that. readout, a from so lot

And to comorbidities between positioning, treat relates is is of sleepiness know, to and it excessive you in a terms daytime As depression. excessive there sleepiness. potential solriamfetol lot overlap approved of daytime as

if product X would patients So an be natural look a to were X at this it in MDD comorbidities. to those natural to fit position who or it have way a effect have

who So one we've we've and disclosed look conducted MDD study have those EDS. that patients MDD versus that to EDS also the ways who of have without at the is

some relevant, works product action, us so And population. think appropriate translate nice all patient how the will of information clinically very the that to and very we which provide are about would an how mechanisms

Ari Maizel

this Graig, is Ari.

impact market. Symbravo So Symbravo we're recent the migraine uptake, the launches regarding more very at believe analogs, will the obviously, are have on you there -- the look When optimistic acute uptake. we product CGRPs. as The terms probably referring to I'm clinical the both the relative have are accurate in oral does triptans as oral to the more a of well unique CGRPs. profile about

product. very So a think we for do that there's position compelling the

practices of that said, the we up market. is on you very the targeted, modeling one when and of roughly about that make very overall are should being specialists branded But things that headache Symbravo think neurology focused XX%

And than launching competitors CGRP with we'll be something so large and smaller out the there. -- X oral

what the it I But closest think are do like. assess. probably seen exactly that the to remains analogs be to uptake will those So look

Operator

the The is next Morgan Vikram Stanley. question of Purohit with line from

Vikram Purohit

X We on pipeline. had the

the you filing know help strategy, I of versus us to one about second versus So sNDA? specifics ADA What the on be you're guiding guess, into path the kind could factors but feeding of the commercial regulatory some to of implications thinking of year. first, going how other? the I could understand, NDA you're filing practical plan not and half the for back the

then that AXS-XX your XQ the for on for track 'XX release secondly, is And I think submission mentioned fibromyalgia. NDA

as soon gets if you as about a you could just see patient there? potential and I be it bit a was the commercial AXS-XX what which within fibromyalgia segments talk fit So could good for approved wondering as

Mark Jacobson

for property, considerations. the functional, access There to and agitation. filing the respect intellectual branding. are market regulatory to respect start right? I'll for considerations the some about with considerations AD There considerations cross question strategy strategy are with It's different with

and element able the So be I in we're future, which taking. to we'll launch. it comment touches of development think And every path not-too-distant specifically really on

Herriot Tabuteau

Yes.

all of that multiple the those to treatment adequately relates fibromyalgia, of address has the aspects As And current disease it one of not do the symptoms. it symptoms. is options

So function AXS-XX reduces does it and reduces but also what's multiple of profile that is it fibromyalgia. reduce not the it it -- nice about date to of only pain, improves symptoms

of impactful could the be does One patients which that to be has symptom data consider fatigue, one their that to really have And to X on symptoms shown disability. treat. fibromyalgia result key the is of and in very AXS-XX effect top is patients it difficult an of fibromyalgia that

So we're very in given excited large AXS-XX for especially population. fibromyalgia, about the potential the patient

Operator

question is The line the America. Jason with Gerberry next of from Bank of

Unknown Analyst

is on ] Congrats couple for this had the We This on Jason. year. [ Dina just ADHD. a progress on all solriamfetol for

one billion sales at did $X.X regarding like Phase efficacy estimates to peak XX% profile. your in maybe then $X around stimulant what the And in should can if trial, to are your remind be in we share? that the And follow-up XX% just the market clinical which the III Would versus of plans change we us see AISRS endpoints? maybe size of Just opportunity is billion all on adolescent adolescent for you how terms benefit placebo-adjusted about the adult population? PARADIGM thinking

Herriot Tabuteau

sizable patient be think the so solriamfetol available underserved treatments is still will should we positive. opportunity large very remains a studies be various ADHD Sure. for that the and population The are despite market that

So data we're having very close to a readout.

the the in potentially profile about more of efficacy forward drug we look to So ADHD. learning

in pediatric pediatric population, reminder, submit population data FDA in As order generate able for to to the to as NDA we must a an relates ADHD. it to consideration the be for the

that we is to so something And that do. plan

FDA to So we've plan, pediatric that feedback need and get that, is do that progress. talked study the on about initiating to study. launching order that the In we in and study from do

Operator

question next from of RBC the Capital with line is The Timashev Leonid Markets.

Leonid Timashev

peak on progress. to around it bigger assumptions in deck does some the sort ask Auvelity change Alzheimer's I you XXXX did I I Auvelity Teva. of end additional what versus then settlement MDD for And how deciding wanted guess, first, XXXX, color just forth foundries? you on around your with and how the patent picture. maybe agitation? on both the maybe put up the slide on Congrats guess,

Hunter Murdock

this is want question. I'll second Nick, you is This take the first Hunter. take part first, to and for -- do the thanks then part? So the

Nick Pizzie

Sure.

Hunter Murdock

Great.

just at Nick, was to? a sort the the a specific negotiated It arm's length do tie just negotiated were was resolution. or [indiscernible]. specific you It event want a So dates transaction didn't what of to occurrence.

Nick Pizzie

on Yes. LOE, the having the the guidance our do progresses. day launch plan And help update developments recent the And with that to refine as will we process. and facilitate LOE

So tuned. stay

Operator

next the Fargo. with Wells question from Chen line of Cerena Our is

Cerena Chen

to ask wanted I about Symbravo.

around to there? high should differentiated about the anything oral Just could And given rebating how environment impact CGRPs, Axsome we doing think price? net that factors is compete

Darren Opland

this a prepare the high category. lot is Yes. Thanks rebate to as mentioned, for obviously have commercial share We'll more question. you we for the launch. a as But

CGRPs market. launch the free goods with oral We saw in the significant also

of profile the been study confident clinical with plan and the to payers. so engagement of strategy And We formulate those in we've feel very, able to our very dynamics Symbravo. launches for

from we extended freedom most Symbravo. very a engage have hours, or bothersome And X our very XX do rationale for with brand. at compelling strong the freedom data that The potential discussions pain in fact data, and pain in there's providing see access to clinical relief the early symptoms discussions for hours, payers, across intensities, we

as share of one we mindful profitability the of also that's and more closer we maintaining So for building key to able we'll our the areas long-term are brand, get focus. of to very but be access while launch,

Operator

question of from & with the Needham The line Company. next Ami is Fadia

Ami Fadia

And how think with this how assets to we the about maybe operating X launch that X, specifically, should over of With you operating late if on be several philosophy? well can in as some us evolution talk would give color think years? stage, year helpful. your can granular expenses, about just you margin the next more just maybe for Symbravo, Or about

Nick Pizzie

I'll with I'll irst. the handle. start Sure. question second

as time. Symbravo Just and investment we take to plan approach we're a going assess successfully continue in strategic to the to over launched Auvelity, launching

SG&A efficient cash we'll trajectory in For the factored does Symbravo, growth always approval, take has in ability into build DCC as confident long runway. term. flow cash and positivity. execute an spend leveraging us into we're And Symbravo of The cash over our to current needed consistent with our our launch XXXX reminder, our invest a approach, by subsequent been to as

Auvelity about ensure the next As R&D to ROI in mindful couple same very focused over of on line. each get we've the invest dollar with SG&A as margin years, that the function strategy well always within we operating of ROI as that Sunosi, we how the think the and have top had as being we we well as

Operator

The the Yatin with next is line of question Suneja Partners. Guggenheim from

Yatin Suneja

all the progress. Congrats on

Just on have you how a you've narcolepsy reboxetine. the hear mixed given feedback AXS-XX an KOLs, But Phase that SNRI. III we Curious thinking or are it across generated I market about general? from multiple have the specifically very definitely is that to you programs. mean, gotten in interesting question data

So this thinking there? how orexin impact you program, indication? should could And about you have that how that on are from of -- the sort opportunity any

Darren Opland

it XXX,XXX treatments the generic some optimistic very, in terms of dissatisfaction. of the those patients suffer there used for We're this But response is and narcolepsy, of that Thanks have opportunity, a mechanism market very Inadequate about approximately AXS-XX, unique high. market, education that the and from with very the is some and cataplexy very compelling what of the historically. suffering be been will product from existing XX% SNRIs impact to makes question. recognize relative and Yes. we around

little our share marketplace. the see AXS-XX on we we'll to filing. for we bit we'll as And get this opportunity some the more in real that on take details approach thinking a closer a So

Operator

The Myles Minter with line next from Blair. the William question comes of

Myles Minter

material any years? few Nick. X I'm for Is next versus through Auvelity took D Medicare revenues? of commercial And are also impact getting the to is ratio wondering the system Maybe restructure is that of if Part there change effect on Auvelity Medicare the going Jan patients one over and access what that that the payment to mix

Nick Pizzie

Sure. Sure, Myles.

at overall, change don't we this relates how a impact. evolves a it be As expect might a to anticipate don't throughout we just bit little D, point. of significant impact the year. Part in There GTN an But

Darren Opland

to Yes. Auvelity related currently, Medicare. roughly so mix, And XX% the is

Obviously, expect there XX%. be Our much product, significant that. heavier on don't agitation, is and for focus Medicare potential AXS-XX for that a TRx any that the disease changes volume indication. Alzheimer's to with We will

sNDA. as plans finalize some so around we have share to NDA, And we'll our more

Operator

Our the final from of Baird. Joel question line with Beatty is

Unknown Analyst

Joel.Just [ Chris Chen not for on is ] cessation. This AXS-XX, on a ADA but question smoking in in

add And between are versus of the wondering little you color specifically, more a in more cigarettes if differences could a maybe incorporating then -- users you potential Just e-cigarettes? XXXX? just any timeline traditional on

Herriot Tabuteau

for question. Thanks the

where now, plans of this will we III that trial. We're terms right Phase in So very the study the this are for we're, confident year. start

patients we're But So in at The study of terms And more the with later registration forms date. trial be looking look our cigarettes. to initial design. who in will of come nicotine, you of who smokers. will other trial, forward details use for the it that sharing patients at smoke of will a

Operator

floor remarks. the hand questions. no are additional I'll At this And management closing time, for back to there

Herriot Tabuteau

all for to today's with you the our XXXX taking across company of join portfolio. Thank time busy a aspects was call. continued success the for year the

alone. forward your progress continued a our year. than lives people deliver As here to conditions X look on poised today, business XX, in great day. we XX on serious XXX commercial in collectively neuropsychiatric late-stage to an have sit February advancing innovative updating the potentially of We more throughout and pipeline products expanding you, you reflects that rapidly million neuroscience Thank the impact and our rest the of enterprise U.S.

Operator

will today's conclude This conference.

You participation. time. at may lines your Thank you disconnect this your for

Axsome Therapeutics (AXSM) 18 Feb 252024 Q4 Earnings call transcript