Axsome Therapeutics (AXSM) 7 Nov 222022 Q3 Earnings call transcript

Good morning and welcome to the Axsome Therapeutics Conference Call. Currently, all participants are in a listen-only mode. Later, there will be a question-and-answer session and instructions will follow at that time. [Operator Instructions].

As a reminder, today's conference call is being recorded. to Chief conference Therapeutics. Operating like host, to now Jacobson, Mark Officer would turn over the your I at Axsome go ahead. Please

is joining time the earnings XXXX. the press on Thank you site providing quarter a available call. morning of Good and release, ago results morning, us details wire at for update for third of This our you, crossed conference financial Web on a The issued and we and release corporate short today's company's operator. our all axsome.com. thank the

from and in the materially in differ annual will additional During statements. today's Commission, and and These that on forward-looking other making call, and investigational plans; These statements. source cash are and statements report and products; and reports. filings statements our efficacy, plans; Securities clinical and the our include anticipated to revenue commercial including plans; we made contained cause to regulatory trials; intended Exchange among involve be regarding, and These present our to certain of clinical of our forward-looking non-clinical and agents; other forward-looking the uncertainties periodic research results possible regarding those data; statements the may and investments. future development pipeline plans described risks expectations change risks utilization actual safety based information, with assumptions may our and current of are and intended things, projections; our are that our or conduct the Auvelity subject future Sunosi, plans use quarterly

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

recent and company Chief the on Dr. provide Development. Tabuteau, the Nick call and President an overview review Lori will Officer; and Executive Vice Executive Pizzie, upcoming Officer; me developments milestones. and of Englebert, today of then Business Herriot Financial Herriot Commercial Joining Chief first are

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

questions. the open be the the I are then Herriot. in will will Questions received. line taken to We over they will call for And with turn that, order

joining Thank and quarter at update you, have past exciting results few third all financial XXXX conference for Mark. morning been business Therapeutics pivotal and call. thank Axsome you Axsome. everyone The Good months and

Auvelity Our of development driven, focused with biopharmaceutical transformation sleep integrated, now the MDD and has treatment with of obstructive of and and into company adults. associated accelerated a the stage, commercial in for Sunosi apnea, research for fully commercialization EDS with narcolepsy launch the CNS

CNS In broad progress. addition, differentiated our and pipeline continues to

The third the was well initiatives and of on results growth for market differentiated continued Sunosi, quarter performance. demonstrate significant of our potential the potential. for efficiency quarter the Sunosi provide full more approach. Current details and and commercial this the Nick product for expansion of our with bode future sales indication first financial will

a patients major the address mental thrilled concern epidemic. We treatment in is recently new current public to Auvelity, important the this health with the making are have health MDD helping now Auvelity millions adult of U.S. launched to living available given to

in and stage creation the migraine, Type in While some migraine, for for resubmit for the progress, on stage intermediate Based potentially we over comments well we the the still only completed potential NDA progress, as treatment ADHD, XX as results, Alzheimer's very on early for days quarter setting quarter. initial experience. meeting AXS-XX a significant the Sunosi. market, acute to includes for Complementing indication with the pipeline solriamfetol third for fibromyalgia term. AXS-XX broad for of A intend new on long regards our days Lori FDA to will narcolepsy, or meeting the our a disease our the This With agitation, with near, late continued AXS-XX to provide value pipeline commercial AXS-XX the continues AXS-XX XXXX. third AXS-XX of CNS

as XXXX. the safety efficacy As the have have our and by trial, requested disease a for of track randomized FDA the With we Alzheimer's clinical resubmission NDA. ADVANCE-X is on the withdrawal agitation. line Concurrent the Alzheimer's study, multicenter regards from for are initiation which double-blind, now program, results the Phase of for to X, or recently fourth to ACCORD reminder, quarter a been AXS-XX trial the treatment of the of ACCORD efficacy the safety disease additional we planned. trials placebo-controlled, no agitation ADVANCE-X of Top concluded randomized, assess trial with initiated the trial

AXS-XX, product Phase X candidate For top trial anticipated results the enrollment in treatment first SYMPHONY XXXX. of half continue and narcolepsy, progressing of to in our the is be for line the

to over filings on XXXX. financial a which quarter year of progress, in and For clinical AXS-XX, product to the And through expect and of NDA regards of term year. or to update. related of for for activities intermediate XXXX. ADHD, include other to our now treatment the the submit and With randomized, trial will and for X/X will product and call fibromyalgia, Axsome busy milestones, we The clinical NDA a treatment ongoing. in readouts, the a pipeline indication I trial double-blind, submission solriamfetol candidate fourth initiate of therefore this the excited this provide to we an manufacturing this NDA are continued Nick to over planned preparing and placebo-controlled ongoing as initiations is turn we near are in this multi-center, team Sunosi deliver who Phase remainder trial the prepare commercial the

of discuss net in sales. of you, was financial quarter good full which guidance. quarter our provide third revenue sales the Sunosi and Herriot, net of XXXX $XX.X Sunosi. some generated morning, the third of third first results Today, and Thank U.S. everyone. sales we'll Total million consisted the in quarter quarter, of

with of non-cash Net stock personnel commercial full per and X.X million. XXXX. XXXX. in for share generated prior year $XX.X loss The million primarily compensation increase for of quarter activities million period or for or and for the were expense, pre-launch Sunosi, in associated personnel expenses an was third million U.S. increase quarter Sunosi in expense. We XXXX. remain increase so net along ongoing Cost were period. related share costs $XX.X third the comparable in the of XX.X quarter of compared trials. stock in in driven a ended in activities SG&A XXXX. XX.X to for quarter track Auvelity million comparable loss on and to was per the portion million ex-U.S. quarter expense R&D sales X.X was sales loss The completed million of million acquisition $X.XX third and compensation and clinical for period X.X no the the the comparable X, $XX.X May the the with were $X.XX The by cash period. million for product of net XXXX. for non-cash with quarter for the reminder, period at a We XX, to December expense close for million the was the quarter were XX.X equivalents the compared in expenses comparable on and period comparable current As Axsome fourth to the million $XX.X there the included in $XXX.X

million. ATM proceeds of utilized we quarter, realizing third the net facility $XXX our During

turn anticipated to to million million from reminder, with immediately term that the our under commercial Auvelity, with term the Capital facility loan We of a cash operating fund call the FDA believe our loan As Lori current our $XXX is update. on sufficient remaining will to Hercules $XXX available current now up with for capital along operations I approval the facility. is over XXXX based million $XXX into a balance plan. committed

conditions. Nick, provide represents everyone. the full launch With update these commercial I marketed first start of we Sunosi. very the which important good like QX first I'd both differentiated now as and address Axsome you, have morning, product. am Thank to excited with and an quarter for therapies. and products, to Sunosi Sunosi a Auvelity, two two of for recent serious

promoting promoting and the Sunosi DNRI excessive apnea narcolepsy growth first through only nine obstructive sleepiness and total the wakefulness wake hours. is for prescription the proven improve Sunosi and reminder, only agent daytime In a and and quarter, U.S. grew versus first wake As sleep Quarter-over-quarter, WPA to in versus sequential prescription total for was the market. year-over-year third Sunosi WPA the X% prescriptions WPA the XX% quarter Sunosi total growth only for X%. outpaced X% or growing market. the for growth market

estimate increase and of The leveraged of Sunosi growth to Auvelity Centric for also and the is customer omni-channel being used future prior of contributed productivity approximately for in for our for products to pipeline. will treated contemporary, current enjoys treated million adults, the of patients. a whom people potential drug of drug XXX affects estimated peak X% sales narcolepsy an narcolepsy million XX% million. XX substantial, in a OSA XXX meaningful twice integrated periods is industry the to that in DCC, whom performing and sales X% and U.S., XXX,XXX of in Sunosi is that U.S. commercialization Sunosi EDS. average. has close Commercialization, the we all be approach of Our only potential This force Digital continue or affects platform experience EDS. launch U.S. the well of engagements indication to is share And currently and experience OSA share patients to alone

Payer education efforts for to promotional total market enhanced covered. remains coverage XX% growth commercial broad, and increased Sunosi. Sunosi lives of and expect lives disease drive We with for and of XX% covered share

the is by early Turning encouraged commercial so availability October to on Auvelity But It early interest. We days. still are XX. Auvelity. very far, very we the announced of

healthcare Auvelity. Our education provide engaging field comprehensive force is actively to on providers

list vast our our our medication are experience, for channel reached platform, coverage, of psychiatric expected the market. has be of payer more proud to XX antidepressants. with the to sales have days than quality including already of force Guided target the commercial of Auvelity. With majority primary channel on by prior our the XX% whom field prescriber specialists, regards DCC only the We is

have for decide and enabled after decisions protected help that six ensure prescribing commercial and launch, Auvelity, payers support patient productive, blocked perform patients Medicaid the order a on our a by over of with rule, comprehensive program, the formulary a experience Side. therapies antidepressants in to and tools easy we some months we expect on In placement. and an formulary Auvelity access have are In and are clinical As have been while they that suite new Interactions physicians six Medicare services My the class. first commercial channels, months. active have to, payers and generally next reviews

XXXX in a pay or MDD, have disorder, no services is HCPs, in recent and adults XX samples, with card $XX pandemic. increase Our and among health patients, support month of authorization prevalence major Major more than a prior support million as depressive a concern U.S. eligible for diagnosed patient savings for significant tools. publications include reported per the result other public

I MDD proud make We patients discussion. physicians. the living to available are back Auvelity and with will Mark to call turn lead now the to to Q&A their

please questions, size of could if the Thank you, fantastic we queue the per first that that's Lori. we have questions you please have. to that of can question? and asking you. just Thank line two folks based would three Operator, on are person, mindful be the And that our be on

you. Thank Instructions]. [Operator

first Charles Duncan Cantor Our is Fitzgerald. coming from question from

is line live. Your now

Hi, taking our quarter. a for Herriot on and Congrats Thanks team. nice questions.

a to limited days, the what? mechanism with think commercial. is few had you talk -- clinical question for only a lines commercial. think what been The the know you pipeline to you for And it's is about differentiated along When effect Is but of regard or or it a profile? side question or prescribers I then what attractive most Auvelity, onset I Lori do first do

XX with Hi, list. interactions has reviews announced have Charles. all want I are I of availability. the field question. have and market, interactions Thanks been product sure they -- been for our days clear, very, full the active the our been the make direct HCPs. of These HCPs Auvelity target with to since just XX% their clinical Only everyone's above. with in force Like very of It's said, we

exciting physicians It's hard the top. are. hear It thing. and active varies So to point all engaged rising physician to of to are one are by how above it's the just obviously, been really they how to very but just

Okay. for quarters. color later We'll more look in

kind study Herriot withdrawal I'm the being ADVANCE-X you to being in I of visibility gating is has on year guess just but interpret XX, able NDA able study what give withdrawal. on resubmit then now started. the to agency mentioned XX regard Thanks. gotten pipeline, one double-blind the has a from one randomized or to I XX. And really have to you quick for you factors with concluded, the migraine? that What On randomized from been is advancing guess feedback wondering on

in also that design. do Randomized for what FDA if And it regards the Mark. though working AXS-XX, a does provide withdrawal study specifically, With relative And studies evidence parallel same I'll at the studies, you Thanks treatment but look they to feedback that not over control. randomized been is randomized information from your the to to clear. you not is group provide, that design or effect. overall of not would withdrawal studies and information that on whether Charles. question, to include turn question psychiatry, on have the provides approved, with a with regards products that the design, just That's very withdrawal drug

Good Charles. Hi, morning.

year? one number stability data to that made asked are had why there on batches being been recap already us So next new things made. the including just of FDA with from of year respect or a XQ for CMC, So or approximately

protocols And brief can on data stability or various product. there an room so typical temperature and but data, accelerated approved right. just stability cannot those run, are be that conditions, sped And background at That is of be to guidelines ICH up. shelf and the a inform and life assess used

month, cetera. times typical months, months, so zero, six et And one are XX

through going it's that those generating So data. just and process

it. Got

Thanks. questions. really chart. it's So you Gantt Nice taking Appreciate the quarter.

Thank SVB today coming you. is from The from Marc next Goodman Securities. question

Your is now line live.

Yes.

bit. about Sunosi So we talked little a

the gross just with inventory Thanks. I your to feedback net net changes. on a first product, us throughout the is can product. give full you behind scenes maybe of what's the payer the but know quarter, this talk and to Just coverage year, on how the your about going just sense just have just and gross been physician

Yes. the question. Great. Thanks for

going take behind will and scenes, the net the will on changes, comment Nick Lori what's et think cetera. to inventory I question gross on

Hi, Sure. Marc. Good morning.

to the It's we QX pretty steady around been seeing. on build it's gross sales Essentially, with type the to beat to So inventory as net, consistent. as I to on or really think million, -- channel. and the by then expected it's first we impacted of not kind said relates the inventory, net inventory any is we're QX which your guess question we gross for investor pretty it call, XX%, are load had quarter then And X.X obviously of to start channel I in of channel the for though, the a state. what

So really no inventory impact during the quarter.

Lori?

add Yes. Hi, payer on Marc. coverage. And I'll just

when back payer what no Our was acquired There's changes. the May. exactly coverage coverage has product in it maintained been we payer

Thank you.

Our question Securities. Lee from Truist Joon from is coming next

line Your live. is now

taking for Thanks our Hi. questions.

are and Veeva from IQVIA. that to clients due is with certain supplementing the you to are Veeva IQVIA, efforts addition litigation services understanding by In Our your provided between Veeva Systems, ongoing blocked services from IQVIA?

share year and differences data on end? And of the Just wanted we the to you. there you the material X? DCC of of efforts? of between will kinds understand your any designs And terms are can ACCORD ADVANCE-X for in Thank expect pipeline, the flexibility what by

Yes, Joon. infrastructure recap built just Thanks Hi, then so the for let IQVIA. our question is from can I around and question. DCC your answer me how

limitation additional stated with that at we're offerings. So by and actually our different use it as of platform IQVIA, really data. in AI not several Veeva is machine the DCC The built Veeva impacted analytical supplemented learning and we've We SYMPHONY foundational as tools by and is past, all. off

interchangeable. feeds And the so system. through they're is that very And Veeva what

what our in us So impact look to there's like. terms offerings really no of

with top from end the Joon, will be by the to expected line data trial. questions, regards results your then, And ACCORD ACCORD Right. year two other that's

that as this the study to unblinding the activity results population. forward it regards to you information provide look reporting in will to and additional we the patient with So of product

order stopped positive As the it a events going we ACCORD a the reminder, to ADVANCE-X, on think could question while of because the the the very the us provide the trial, initiate activity there in to ADVANCE-X no the do the of studies. information And we study powering of trial differences while to will and reduced, that that trial in those ADVANCE-X was -- design With be is support material to that product. study. directionally, regards possibility terms of are results there the which is

designs. much pretty they're So identical study

Thank you.

Jason America. The is of Bank next Thank you. question coming from Gerberry from

Your is line now live.

six gross coverage commercial of sort Hi. questions. Good nine morning. just early have first the talking been for to say out Thanks the my taking about days. you talk insurance bit Wondering that how I can in a the impacts you know challenge little if Auvelity’s with in and months? mix to about net guys

can how of antibodies script Lori, that's So capture of basis? utilization you that kind of right And can And CGRP time with of gate, just on free to model effectiveness Amgen wondering just of Thanks. effectively script like then the the the and to the kind kind the awareness program DCC also with sort early amount assess Sunosi, if pertains of leverage pre to anticipate you what's in of of sort marketplace? if it out on revenue DCC of get Auvelity Sunosi? you as maybe comment the something

lot for questions, Thanks there. packed Jason. Hi, in a the

start the just So let beginning. me from

authorization class, mean after reviews the a period therapies as and And are clinical board, blocked channel formulary a This prior perform for not does to make new So commercial co-pay card that support our that payers generally -- on place on not fill placement. this that well they of expected if Auvelity. therapy. decide appropriate a across while those be we Auvelity patients channel by HCPs rule, for of one regardless our My to sure access is payers affordable is to That time have primary program during approval, the that system of commercial reasons cover patients time as the patients therapeutic for out robust their as paperwork. Side they the have will why in

the very communications the do in a very productive with since decisions expect there so and some our the of made announcement reminder, And payers. months. after providing are we're even volume what and/or more to not that's Medicaid over class a what Amgen that to be through next protected We is been I'll And -- those playbook not active some those switch we six channels. question commercial approval of or in set have is that up channel over will Medicare, that That be comes around as the launch, the have been -- Those we're those formula to free doing. scripts. your launch. of do

patients payers out We Sunosi meaningful coverage. that getting would need DCC co-pay affordable we to that inform the assistance like rate asked a card have then and a are drug at their patients I with on and the a filling so you to paperwork are we believe physicians providing there. to are effectively appropriate impacts very see can and program how and question had while

my I remarks, Sunosi already prepared we of the with seeing in are As DCC effects the force. field mentioned

quarters, half prior really of by continue Sunosi. field we roughly prior this, our we're encouraged size maintaining same relaunch those a have the and productivity force efforts We're We of as quarters. exact the as

additional have appropriate And are incredible process experienced patients and as the our are for focus reps disease to reps avenue of additional education growth. coupled see promotional ensuring really are leadership with sales We with team. And highly the targets an sales we meaningful on our our in growth. enough targets really drive spend that appropriate that who

Got thanks. it. Great,

Cowen from next Thome is you. question Company. coming The from Thank & Joseph

live. now is line Your

journey? do weeks Auvelity is are Thank that demand these first to of updated Maybe morning you licensing? in U.S., change our their just is patients I treatment your within couple approved ex-U.S. on coming for Hi, time? here, but questions. where at only it's you. on the where know initial thank what expect that a approvals been are over And thoughts or now the And maybe kind taking there. Good from, -- and of you a one

Joseph. Hi, the for Yes. Thanks question.

in would So again, what very expect. But XX early would days these exactly expect, it's is on only what we're you as seeing you days market.

has psychiatrists handful patients the groups. clinical treatment the are is supported that place. robust over scripts the patient a And profile primarily the nice terms that are of PCPs. with likely So of their of it's very Where by data in and in coming Auvelity from from journey, a broad all fact subsets

therapy if really So board, for we're a across physicians it are And Auvelity. on. Nick ex-U.S. candidate turn over now, the to to are a Right patients little too early it's which tell the finding for of bit I'll concentrating they lines

Joe. Hi,

for comments. we ex-U.S. right partners. stated. always And be always That's how then opening Auvelity stated standpoint, stated, as we've an for we're now Sunosi our ex-U.S. we've will looking in as consistently So from for

We quarter. ex-U.S. this are expecting of to close portion on the Sunosi

one Great. And on can pipeline. maybe the if I do just

In for for AXS-XX, Phase all work Thanks. completed be upcoming an to there this is of of that additional submission terms is NDA X CMC would submission? any data, this regulatory need you need therapy ahead

a It's for is well that custom oversee we that APIs reminder, work AXS-XX, as -- there process that's Mark. just drug for as product. the ongoing synthesis is CMC. a Joe, And a

the registration et So cetera, underway. of batches, support all is to work

Great, thank you.

you. Thank Suneja coming is from next Guggenheim from Partners. The Yatin question

now live. Your is line

guys. you Hi, my question. for Thank taking

a of me. from Just couple

How like on part. the also you pack? is are somebody on how are doing you the a on then work? reimbursement starts first So sample, one Is whether sampling. if And it sampling? a setup? just Can on First comment pack, two-week sampling the comment that's maybe weekly

If around how entail? Should just can accurate you does finally, to tell that we that what data is? are the available is then data the revenues? to that's party, Rx recognizing use TRx help us how the launch? Thanks. that you third or model Second And

Thanks, Yatin, for the question.

the Nick also revenue handle the reporting recognition. and question will sampling the handle data will Lori think I So and

morning. Good Yatin. Hi,

shipped so the that to or distributing But is into happen the physicians order or patient in hand HCPs then at way is file when office, now online the are rep samples to hand most through can the They and will them their a so it that are same -- script EMR obviously sample, HCP. to samples. script varies So samples we the right regards when EMR samples what are they immediately. likely, comes system. time the will the Typically, by electronic

terms In a bottle. it size, two-week of is

Great. a in to the revenue, as And title then are it so model. relates we

once at title our those losses is warehouse of such, is point, are passed sales. net And as distributor, gross is that So, accruals transferred. then from to sale risk gross inventory the transfers booking associated to against recorded, we

And the side. I'll answer data reporting

to and So is rate capture in capturing both SYMPHONY what for them hard early IQVIA, predict it very national especially all scripts. the days, is in terms of

So there is always a factor applied.

they gets We be both of to coming have they'll very found expectations. their why get capture as right in But that -- the better reason the and see weeks trending direction. the close We are data rates it's no next reconciled. over tweaked course

Got it.

the What the How target, are comment? in queue. be get you there a in managing like Just the inventory? may. if need that? can back Thank one you I'll you. I range, about quick, to And just you Is two-week if

correct. that's Yes,

channel. in title pretty is the So easy the with it's model, that ensure to supply

So there's at the weeks that's And how seeing it. two channel. roughly basically in time that's currently we're any given

is question next Vikram from The Morgan from you. Thank coming Purohit Stanley. today

live. Your line is now

Hi. Good morning. taking for questions. Thanks our

two, about in the use of of early duration have to you've Auvelity the learned both related what phase We launch. for

secondly, you full And current use, launch think many more average one, in currently of question you think prescription could the do bottles how would how state? bottles blown once your do is year the of thoughts Auvelity one So And launch once how again, then represents? are this of evolve steady a patient treatment state? steady what the in per kind many Thanks. you on of broadly, more a think

able little it's of We've so credible market the think days, Hi, provide clear. the the to on you the use regards Vikram. to with what for maybe any you Lori, represent, and of Thanks With pretty to could been answer the be it's early bit clarify? But use. I scripts duration to XX a question. to also duration

PI Yes. clear we I dosing, XX-day so the on And too again, us too any little fully would intend for a It's But by two do have expect say. That's should -- exactly script early we bit data very and early. a now. be to is for it's what bottles.

-- we're Lori, that's what seeing

we're seeing. exactly what That's

you. Thank

Our coming next Howerton Jefferies. is question from from Chris

is line live. now Your

the Great. OSA had questions. guess commercial Thank the Sunosi much. to a of revenues in what sense respect and the One be quick strategy that, with just us would maximize two follow was Could narcolepsy? so up to you success way, in to And launch. between you I agonism assuming the Any I in narcolepsy, just just give split Thank interesting with curiosity And then the TAARX about XX? capitalize had the found Sunosi. that was question to the you. respect plans that molecule? the on for second mechanism to a new or discovered an is finding you any I

Great.

question. the on between So and Lori, comment could other the in you and maybe OSA split narcolepsy terms scripts, of take then I'll

Chris. Hi, Sure.

EDS The market, premature patients narcolepsy. grow versus scripts how room But bit is Sunosi So from for is it's only. massive OSA to is narcolepsy. indicated in in narcolepsy to XXX,XXX about in right, XX market XX% And about a XX. million with XX% a definitely right suffer now, split current OSA, OSA work the we'll talk both. There's

sure present will of narcolepsy one the we so symptoms early that capitalized first for is that in is treatment And the usually make since diagnosis. that on is

With regards that narcolepsy. AXS-XX in remember versus to in your AXS-XX, around thing cataplexy to question Sunosi one for being developed just is narcolepsy is

Sunosi indication -- regards cataplexy. sleepiness narcolepsy. with is And is to been daytime with the patients So seen no has activity in excessive

TAARX that for it the differentiating shown so I the that to is mechanism which realization be there this of mechanism relates new action the agonism, think is mechanism secondly, And So for TAARX pro-cognitive. as the thing important? complementary. And are to could how is Sunosi, solriamfetol. has products be been the first

as OSA in were was it the to the as And results a And significant on in who to or we patients cognition did of potential like also this effect showed drug a cognition. with compared cognitively robust on do track We therefore, and quarter. relate does Sunosi announce to initiate mentioned, EDS. in relates with effect ADHD. with quarter, it to potentially mechanism X/X on -- fourth it the study of the we action of trial X placebo. ADHD as is Phase the Sunosi trial impaired statistically which So, SHARP Phase this we And are what the of a indication and solriamfetol

Okay. it. Thank Appreciate so much. you

question coming you. The David next Hoang is from SMBC. from Thank

now Your is line live.

on much I so couple. a taking questions, the for Thanks the and had congrats Hi. just quarter.

indication study there? for walk So the approval scenarios you that based there ADA for positive, And plan you possible then to different pathways? can on us any do data still is those ADVANCE-X So again, just data? the through Are it's with remind the alternatives are filing? the is AXS-XX, need file randomized if would that withdrawal then if ACCORD other you us the intend support to that not, besides the

way package. that NDA. an approaching to that intend the to that have is we We So it file want ensure we robust we readout have we are ADVANCE-X a before

now, would are As assumption implying, a the an is we'll once trial right there serve are But we of working out lot ACCORD different the trial. for as you that our a positive more NDA. read ADVANCE-X know lot factors. And second

think regularly of as lot in I be products? for just into of prior you patients the of of most guess I it of, belt, deeper metrics terms in launch several addressed any in I questions of see. the provide terms guidance there scripts, full And numbers earnings -- and our a then to calls, But revenues a lot the helpful. plan quarters you launch, that had would treated? Auvelity are on get That's have under the terms it. And report of we the of

what first get Nick. so and definitely obviously HCP be I'll will kick then well answer into scripts Yes, writers will as as to quarters. the over as we report adoption But on the it I'll and one, deeper we

Yes. to to And add obviously reporting payer that's would just on that, because of that and we relevant be think we coverage also interest.

Absolutely.

early we're the days right guidance, revenue for days, as now. of And launch the embryonic in obviously extremely

to access progress expect and sense we So have evolve, and able we'll as grow to where of better we we be land. see as

guidance when or sort any guidance would obviously the yes too of down So road, given. potentially be to but early way of give expectations

question coming from The you. Graig Mizuho is Securities. Thank next today Suvannavejh from

now is line live. Your

morning. a right now you've with But on Thanks color thinking any question are lot works has I do other my the additional on just success about direct-to-consumer marketing of in kind to with and campaign, plans taking of congrats my for the there quarter. advertising Great. a for plans Auvelity? Thanks. know had Good question, DCC. for and

Hi. Thanks question. the Yes. for

of the ask a the the into were prepared are for product gate of launch, to aware office the walk if and So make sure and very to patient for HCPs out we the product. want much prescribe that to coming

are to strategic We media also very patients. HCPs that doing targeted to spins and through but

And believe to into so we that to upon And something that is approach we we sure deeper continue media important up make days will that we how a deploy launch. in thoughtful very and it's the we have that ramp early as expand to to consumers. get and deeper

Thank today next from is question Ladenburg Thalmann. you. The from coming Kaplan Matt

line now live. Your is

Good Hi. morning.

that year. you program up your Sunosi follow quick on plan Just this launch later ADHD to a

the guess that saw any I to study the impact in incorporate X/X for you for Given cognition are study, Phase SHARP in those ADHD aspects of Sunosi? going you on

obviously, Thanks for be providing results the on relate the study to details And SHARP launch from the exploration considering product are it ADHD. Matt. the it. of we in question, as We'll of the study once design might exact we the

that in how we ADHD. measures to do whether part and may at. to We'd But that So look at could best of increase look sense that. makes The cognition be an we something obviously, have concentration to are to do an important is want there that different. might determine it or or

All question. right. taking the Thanks Great. for

from next Minter you. Blair. from Myles coming Thank William The is question

now line Your live. is

taking Thanks questions. the for everyone. Hi,

launch first have of lives one, any proportion And I are the them those the major of since Auvelity payers have represent? aware you and through their that say what least at Thanks. meetings guess [ph], payers or Just would covered progressed pay scheduled?

the for Thanks Myles. Hi, question.

for mentioned blocked for only we be the that as active progressing. class, channel, will Medicaid covered. they're given But as right and time But the So period discussions channel after Auvelity. they general Right channel process. some it's previously, their of mentioned commercial we earlier, complete is primary the now, Medicare, are a can usually that so those launch protected rule,

have you those after then to Okay, quick give do clear just program, on their have sampling to path is two-week up those to reimbursement cool. And free a if finished? the follow patients, script patients Thanks. end

No.

the are the patient. the physician to samples up to provide So to

his physician script. a is right write within and patient decide well his the So to samples provide to and to when how

Beautiful. Thank you.

Thank you.

question Bert Hazlett coming from today from final is Our BTIG.

line is live. Your now

ADVANCE-X One on XXXX or trial Thank the question. straightforward. very upside conservative? to the the taking you Is progress. all is is timing and congratulations for there you Thank

too decide information timing granularity we gets to the think initial there a leeway timing to in on but be us placeholder. in study study readout. reflects further that We is that allow could more then of timing. the it it on early that underway conservative, terms it's more And is as of And So overall is enrollment, clinicaltrials.gov. think much how I and have will provide as the what

you. Thank

question-and-answer floor the session. I'd further reached like or closing over the We for comments. end back have our of to any turn

joining the today. living for are CNS life-changing conditions. again we people potentially you Axsome, committed thank us Well, bringing with to on call serious to medicines At

tangible With great our pipeline the to late a and to broad We commercial the stage providers. Have on is commercialization over Auvelity, progress. forward the team patients Axsome day. continued launch look Sunosi, meaningful of translating hard of and and our you work months the healthcare and development pipeline, benefits into of updating their the coming

teleconference Thank webcast. you. That does conclude today's and

have for You at your participation you your this day. time, and thank line today. may a wonderful disconnect We