Axsome Therapeutics (AXSM) 6 May 242024 Q1 Earnings call transcript

Good morning, and welcome to the Axsome Therapeutics conference call. [Operator Instructions] As a reminder, today's conference call is being recorded.

I would now like to turn the conference over to your host, Darren Opland, Director of Corporate Communications at Axsome Therapeutics. Please go ahead.

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

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

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

Officer; Maizel, Vice key of will the coming Tabuteau, as Financial progress overview Mark Nick provide Chief company Head the XXXX well on Officer; Ari Commercial. in Chief Dr. first call Executive Operating Executive Chief an as me the today quarter Officer; and made milestones. Herriot of Herriot of Joining are and President Jacobson, Pizzie, and

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

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

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

Darren. Therapeutics Conference you, for Financial Good joining Axsome Business Thank thank Update and Call. XXXX you Quarter and First morning, everyone, Results

quarter our own market patients marked sleep option of strong depression, differentiated The delivering financial treatment XXXX by for first apnea. was obstructed and products, narcolepsy are and important living which performance with for

product XXX%. quarter growth year-over-year revenue million, Total was $XX in of net the representing approximately

We our will details additional and in on performance call. share commercial later financial the

advanced positive indications submissions, We old our for [ ] education [indiscernible] AXS-XX. top announcing neuroscience AXS-XX and also ] the narcolepsy, AXS-XX including significantly and in trials advancing our in with line disease expanding pivotal and quarter results innovative [ in program new AXS-XX for advancing solriamfetol pipeline working initiating

We expect to continue pipeline the momentum of in balance commercial and the XXXX.

for neuroscience quarter. I track brief update and resubmission provide on industry-leading our acute X Starting a stage treatment [ the of will with pipeline migraine ] products, milestones. on our for AXS-XX now expected this huge year

XXXX. are conducting an from study, top of Additionally, dose multicenter efficacy half the a to the CGRP anticipate we Phase response the single with this and of safety line second a AXS-XX in prior inadequate II EMERGE a We trial evaluating results group inhibitor. oral trial in

this developing [indiscernible] completion. are fibromyalgia, for we the which of activities for the AXS-XX, product For for treatment pre-submission [indiscernible]

We continue quarter. later to target submission this

quarter XXXX. improved frequency March, reduced excessive of safety achieved severity. overall results also and sleepiness [indiscernible] AXS-XX In cognition extension attacks expected trial fourth In narcolepsy its that placebo. reduced SYMPHONY AXS-XX of the with to of the primary reduce in III open-label and compared announced in AXS-XX for significantly we endpoint as trial the daytime [indiscernible] Phase [indiscernible], narcolepsy

AXS-XX the this We are excited potential about for provide differentiated condition. and treatment a to option patients [indiscernible] of to debilitated

program ] treatment a disease to in date, positive This the study, ACCORD-X, the is [ we double-blind include XXXX. education ACCORD-X clinical III launched AXS-XX Alzheimer's announced In treatment trial. of second trials. Phase similar double-trial the the the of development To half that completion a controlled to in trial Alzheimer's placebo-controlled evaluate now the ACCORD-X education. completed the [indiscernible] randomized ADVANCE-X of in of in the the will design study X disease efficacy

the ACCORD-X our of program is Importantly, education time [indiscernible] impacting disease very and Alzheimer's the without overall And robustness around year. further line. robust a expect [indiscernible] we increases clinical our development in competition

disorder expected norepinephrine solriamfetol, With Phase quarter. lead in [indiscernible] first performance, III Phase respect PARADIGM in launched to in the in we to and in [indiscernible], inhibitor in continued XXXX. trial trial disorder our trials dopamine [indiscernible] the Results are commercial both update [indiscernible] III addition the from

in initiate a track on program this We quarter. Phase clinical disorder III to [indiscernible] are

Solriamfetol is also top we trial being second continue year. line results which this for of the ADHD in evaluated in anticipate III in the half FOCUS Phase to

innovative XXX X [ CNS [indiscernible] of more disorders, neuroscience opportunities. affect in product the to had intent [indiscernible] which psychiatric the and for U.S. substantial and compasses the serious than conditions our late-stage billion Overall, neurologic Each candidates serious potential treatment landscape portfolio [indiscernible] for difficult market ] product with transform

will call will turn who to I Nick details performance. our of now Nick? financial the provide

morning. Herriot, financial our and first will guidance. discuss results Today, and you, good Thank quarter I some provide

XXXX, in million net the $XXX,XXX which first Total million product growth in revenues year-over-year the net XXXX. comparable $XXX,XXX million of comparable sales revenue. and first and period $XX.X revenue for of product $XXX,XXX in XXXX million, quarter in quarter with consisting product received and product for revenue $XX.X Sunosi revenue territories. million revenues consisted of license $XX was of the were of quarter million. million, $XX.X product in Sunosi in $XX.X territories. out-licensing of sales revenue were sales the in were for $XX.X product ex-U.S. $XX.X product sales net This and consisted revenue million Sunosi royalty royalty associated certain net product net revenue of product for and for of sales was period $XX.X XXXX million product XXXX, from our $XX.X Auvelity in sales royalty the the of Auvelity onetime of period licensed comparable $XX.X representing million XXX%. in sales net first of for Total consisted million, were royalty of $XXX,XXX. of $XX.X the Sunosi

Total cost for disorder, period comparable 'XX related million comparable $X personnel licensing million in XXXX. quarter of was million compared increase Sunosi $X.X manufacturing fee the AXS-XX XXXX cost Total the for for higher costs expense. the trial AXS-XX, Merchant associated FOCUS commitments solriamfetol XXXX. post-marketing for AXS-XX, the which of ongoing million of to of noncash advancement was major PARADIGM revenue in for sharing costs, stock-based period the ADHD, primarily AXS-XX $X.X the and the the and expenses included first trial $XX.X compensation. transaction The of the revenue NDA with million, trials of for to in $XX.X including solriamfetol Auvelity was for disorder, quarter were the and development of Sunosi trial for solriamfetol initiation binge-eating the the anticipated depressive both ENGAGE and for first

Selling, to compensation. comparable Auvelity force administrative and period organizational general personnel sales was of the noncash growth, The to in expenses and higher quarter compared were and expenses commercialization increase $XX.X for million million first Sunosi, primarily related XXXX. sales XXXX to for activities costs and including marketing including to $XX related

included in for of to [indiscernible] $X.XX XXXX Net per is loss expense. out-licensing. included majority which the net compared first noncash Sunosi the million in approximately compensation of noncash comparable million stock-based quarter of XXXX The the $XX period from The $XX comprised loss or the XXXX period quarter gain in $XX.X for of $XX.X the net first XXXX. million net comparable million loss a per share of or in was share $X.XX

both Auvelity QX the typically Sunosi low was has prior GTN negative a we in quarter. Sunosi saw and was versus the effect mid-XXs. Auvelity discount on QX GTN in [ the GTN seasonality ], for mid-XXs, and discount on to which

cash the fund ended cash in into flow operations balance million plan. believe compared XXXX million that based of operating We the of equivalents our first quarter We is as to sufficient on cash current cash year-end. and anticipated to positivity $XXX.X $XXX.X with current

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

in representing of new growth of of once XX,XXX elevated patients Thank in since and the performance number unique launch first the growth bringing to QX Auvelity rates competitors total quarter-over-quarter delivered the you, quarter with prescriptions to XX% Nearly outpaced compared the again for Auvelity market Axsome quarter, brand with quarter Nick. XX,XXX XXX% the first an demand solid [indiscernible] XXXX, trends approximately treated in growth started patients more the XXXX. XX,XXX. than

cyber demand prescribers psychiatry performance and first-time attack. compounded illustrating Our treaters than primary sales new seasonal the continues of product among in strong activate the care proud especially more by and QX, were care for health with at team expanded in dynamics, industry-wide a offices. to both of underlying Auvelity We're this in change light consistent [indiscernible] rate, which prescribers X,XXX use

XX% stable Payer Auvelity coverage representing remains of as lives. to was patients QX covered accessible in approximately

in for plans X now the coverage a with our we Auvelity. on of of contracted covered Axsome terms. future able for release organization agreement, based under now contracted With just this this potential potential contracted managers press the in EO for for purchasing with and benefit the to Auvelity lives. formulary of morning, health coverage increases are decisions make is Auvelity, this largest X groundwork GPOs large laying Pharmacy noted As group a

March, for positive reach in expansion enhanced to as an performance, foundation of NBRX campaign and a signal with to pleased sales both weekly of option commercial inflection the sales of We recently expanded Auvelity commercial our adults are continued new our major created very with HCPs. patient targeted capabilities footprint, marketing psychiatry impact Of adoption or including [ to go-to we have digital depressive support ], treatment Auvelity strong and disorder. a maximize observed the we team, a optimized starts in of both, and

the XX,XXX, More Total a [ during covered XX,XXX coverage agent lives activated representing treated total first XX% QX growth channels. in and in evidenced ] Sunosi just patients Sunosi treatment market to X.X% now were quarter, XX,XXX prescriptions with of the observed cumulative of prescriber weight-promoting Demand in decline this X,XXX typical by versus versus approximately were the Transitioning base seasonality launch. than XXXX quarter QX Sunosi. across in as new in XX% since XXXX. than XXX launch. was QX impacted over Approximately remained Sunosi X% bringing by resulting more of the for total unique the [indiscernible] number decline patients market quarter. new Payer in started QX, to EBS the a since

was commercial very with QX and new prescribers, with as reinforcing closing, as in for performance our Axsome both deliver positive and will activated newly such starts leading strong company. trends patient that a indicators XXXX year commercial start a Auvelity second Sunosi, confidence to In our

the in care compelling And in Axsome's having space proud We delivers are feedback to impactful reputation products for our as impact psychiatric a patients professionals receive leader of and products real-world positive serious from health are the neurological CNS and continue settings. about we that and differentiated growing conditions.

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

Thank our you, have first we Ari. may Operator, question. please

first Charles question with [Operator Duncan comes Instructions] Our Cantor from Fitzgerald.

and quarter then great a a appreciate you on one questions. taking and Congrats pipeline. on the question I our commercial had

the you sure rates fast. speaking of if for Ari was question, new-to-brand refill a Regarding not versus I us sense commercial heard it, I'm Can give Auvelity?

Thanks, Charles. a to that's prescriptions, at moment, brand roughly to accounts moment. the Yes. XX% at for the weekly healthy Due number of XX%

brands expect We [indiscernible] feel should which persistency grow, and rates, comfortable and point, seeing the We're this obviously just continue on generally. but new base based we outpace to -- good the existing at with. very to refill patient TRx,

So that your hopefully, answers question.

follow-ups. specific know me any Let are there if

know do with Auvelity? Just a about more probably how so far that too little I persistency. feel on early, color you it's but

good. Yes. I feel really

to In And a out, don't have We but what of is group we roughly have historically seen they're -- this adherence clean this KOLs which specific feedback. ] receive prove bodes the well as brand. for engaged [ data with anecdotal. SSRIs, with recently fact, very twice they were seeing to

meaningful the they're of is for it patients entry and impact the sticking with the other that showing past. longer Just profile than depressants from clinical

study? feel that Would brexpiprazole And information changed of those the you the frontline? development, guess, of out then AXS-XX anticipate [ Okay. you part you would a you, percent to use of responder for it And then sequence would perhaps in rate how the sense ] it I provide in on patients? any of need. after Or first -- anticipate terms that become unmet you brexpiprazole has Herriot. ACCORD-X us Can

model With rate regards in want the in ACCORD-X, be response what included don't misspeak in to X. to the is criteria inclusion of but exact terms quarter the I rate, responder it will the exactly or in

sale So the ]. effectively able and very studies [ designed ACCORD-X -- are the a similarly trial and to the reminder, detect very was

view don't that unmet of and has terms need, long-term brexpiprazole treatment In disease changed and for [indiscernible] the need safe agitation. brexpiprazole a we the effective

class. as fall [indiscernible] were So into reminder, does [indiscernible], breakthrough result patients a that necessarily with as treated

And opportunity data [indiscernible] disease their materially online based [indiscernible] [indiscernible] assuming the so we we in ACCORD-X expect approval. in in will that treatment changing that for a And and generate be is terms of to could got upon for [indiscernible] ADVANCE-X treatment [indiscernible] view AXS-XX continue and usage, also frontline that be that replicate frontline [indiscernible].

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

the about you gradual with that of in be the you change? we Congrats to the X the more X on the And ]? third you'd price to GPOs latest an out progress expect with net hand, expect it talk quarter. about from of major can would then impact to scripts that, Or talk made? incremental, GPO Can the term? add some related volume And this near just guys maybe you've acceleration impact should gross [ maybe in in

Yes. Leonid. Ari. is Thanks, This

trade-off, able So terms through the the ] premature volume gross to contract obviously, we'll appropriate. there expect effectively but net is of for particular are updates [ of regarding talk the right do GPO we about the with pulling to on are it's to the now to to price to be ensure on once little growth and PBMs agreement. part we're that a that impact the gross net coverage effort this impact volume provide expand underneath when its umbrella, we And

what growing important [indiscernible] of around major fruitful having GPOs. term is negotiations. plan payers need And PBMs these for be that long I'd also question the we're us, to very portfolio all coverage and GPO, Regarding to not with the your discussions but Obviously, only are complicated a including the we over for. profitability we of third expand the mindful say have because

of the good negotiation, updates. So -- nature but the no look details about very specifics the the and feel on future we to dialogue of forward

question next Ash from UBS. comes Verma, Our

progress. the on Congrats

on why I lives this percentage XX% agitation, what then You you like study had a already have study So that you have something successful coverage you study And is is this, believe. thoughts prior the Can win. regulatory this do study about that on be to and sufficient? that X. just new do versus package? need this on, like second, last AD just you that elaborate would for GPU? randomized now another through can comment ADVANCE-X going Or the GPO this you had One earlier? withdrawal you remind wanted Like study think your you covered I us regarding maybe a have commercial So to get are for that.

the for Thanks question. Sure.

there. turn to So answer Ari then last first the the X and questions I'll to take over one, I'll question. it

do to the while regulatory submission. So is affecting for timing [indiscernible] not a regards of an for at we program [indiscernible] with also to all us need the opportunity trial, the submission. [indiscernible] not it of This increase

to important want also going It's most And in generate submissions, of just review. indication. additional which strongest publications this a also future -- an NDA into but [indiscernible] is have we data, package the to useful of the such not perspective. So [indiscernible] is commercial in from may [indiscernible], always terms robust package, terms

the this [indiscernible] allows do. of in patients to responses It's thing So It trial. a us leverage we experiencing to stable is very think the large number right efficient.

Yes.

Ash, this is Ari.

lives incremental the covered give know, different around that make XX% Your the of of pool Obviously, has is specific decisions, new GPOs the own stated is so we publicly percent because the we you number PBMs but a their lives of question PBMs each and GPO. today. above of a with and represent -- lives you it of as percentage of to number meaningfully have covered, coverage can't the ability I a

majority of moving that forward [indiscernible] agreed the part the [indiscernible] to our GPOs so focus the are are is And that ensure we've accessing to. PBMs of

PBMs with So a were all successful of [indiscernible] is the we it umbrella. percentage if increase meaningful

from Our question comes H.C. with Ram Wainright. next Selvaraju

the you GPOs existing in if I this if And are indication. the what for that a of was largest you comment with X expect quickly the on then relative going could sleepiness positioned to the front. most third is discussions be might secure specific to approved are to if be? profile competitive commercially AXS-XX factors And you on on you for Herriot, the way was the on that maybe the I side, on to Auvelity impact AXS-XX if agents. very commercial in And development point. cataplexy whether significant looking factors And to marketed with? that is currently the selling the impact be wondering, sufficient wondering likely to impact contracting of so, Just you anticipate there believe those be

Sure, start I'll question. the with first

growth of impact the discussions the we're and access the focused we've demand factors driving generally coverage. negotiations brand the best is So the on in are formal the access so And way secure to of growth marketplace. beating is in growing quickly that how all that absence fact, volume to had, show really recent in

to primary support the and to brands existing within driving it's and think of for demand our we in areas of factor that and has our a plans with continued up focus drive ability GPOs in services to I the And know reimbursement optimize paradigm. is note access patient coverage as support growth rule, with PBMs, interest PBMs. to savings to major the while major been negotiate one growth

And December. to my XX% I compared opening weekly access proud we've a growth new in that on existing of we've March with patient year. the the that And we seen that's starts comments to we're have. increase about start really seen mentioned so off the

the ultimately discussions strengthens only ability and with companies. negotiate have meaningful insurance that our So to

so, extent? Auvelity? what ] DTC started doing if Have [ And of to promotion you

largely at the DTC consideration a the had moment. we running, digital at do moment, that that's something not is is that We currently video updates share when or have in ad under Well, the appropriate. we'll TV space but and

So your Ram, the with and AXS-XX on regards profile. question to

the saw we cataplexy. the it -- on in an we a important trial, in [indiscernible] saw pretty application So impact significant what was was and study

at were percent So which you if in cataplexy. a the our But only large elimination, cataplexy, there results looked remission is is very stark. total not reduction

in a of of So the third less than room. cataplexy XXX% attack patients the had patients placebo reduction a versus in XX%

did also well see on we as And as an severity of excess [indiscernible] cognition. impact

profile the on it are is to relates market that like are profile the we [indiscernible] not and favorable, we that as market, that tests incredibly [indiscernible] So on all patients. currently the is know

In actually tolerate patient fact, I know them. the

conduct that So did there that conjunction showed to continue what on We a narcolepsy XX% is of treatments, even of very patients significant network a survey large current [indiscernible] and [indiscernible] in experience also [indiscernible]. with cataplexy. was

if generated, impact it relates the whether also severity, that on that around [indiscernible]. overall of saw because saw what the be enough data also clear As product. AXS-XX And overall your in question severity. we a will think clinicians narcolepsy reduced improved [indiscernible] for study that about [indiscernible] its life. quality without we a clear to [indiscernible] we on [indiscernible] to -- was severity impact and narcolepsy a around in The

clinicians when available on it's is the clinicians the think So and would profile it global impression be should the very patients the outcomes. that way treated apparent patient-reported outcomes that based and patients this and product to what to to we about clinician be

we the like patients. this profile an treatment important really think be and will we So for

next Marc Leerink. Goodman question with Our from comes

Like anything of about you talk may gross next AD about Nick, this this half, inventory -- that's second second, is Herriot, in in label. by for that be put quarter, place? the more net? -- can being going in second little already of for the then half about you should of you're X half just about that there the now of And last just years? of this the to we into give going early year about this not are with you're a that the second? you Or but to can the can year? year? How completion Maybe in contracts And you How color late we're Auvelity that just something happen back have and the couple the [indiscernible] these here, it on you talking who've new is over to sales? any helped the thinking talk agitation just are was there? that confirm the Is us study we Obviously, be thinking delay rest track? can ADVANCE-X. about and gone to open patients unusual And second quarter, through talk not

not competing So really against it all, it's at right?

Nick. it's Mark,

So X inventory, at weeks. a for channel inventory remains

at was around DTN discount And low It's nothing for in the inventory [indiscernible] the or remains in So X for the continuing changed specifically Auvelity then for was quarter. Sunosi, an has Auvelity weeks. mid-XXs to QX mid-XXs. the discount

seasonality As seasonality you a [indiscernible] the effect on GTN, [indiscernible] versus typically in Auvelity prior does quarter. have saw both Sunosi and which we

right fluctuate in it GTM vary Auvelity, did mid-XXs. For expect the no forward. we now, March ended QX with level from significantly that And to to quarter moving in reason and the have being

it Mark, the agitation. questions relates around [indiscernible] as to

this We The second So starting that with guidance guidance comfortable. [indiscernible]. of year. comfortable remain very We're very half ADVANCE-X. with is

that is relates as it with study very not is with And to is how seeing competing the regards to then we're ADVANCE-X. proceeding. positive what So it ACCORD-X,

you are correct. So

a of [indiscernible] have responses. do are we label experiencing open who portion, number in stable are who So the large

So that allows us very enroll efficiently ACCORD-X. to

And expect for that the reason the more is that ACCORD-X around along midyear. terms in study enrollment. So fall enrollment of confidence very to is complete in we the

months, over And ADVANCE-X X really picked and past the just up to you're that's why so for understand confident? enrollment

also far and continues at is on and we're pace. in to it where very a predictable along, enroll [indiscernible] So confident been. Enrollment based [indiscernible] has enrollment

comes with David Amsellem next question Our from Sandler. Piper

pipeline. questions couple of a the have I on

on completed gating in an the Or forward? there time narcolepsy/cataplexy? you you expecting other First, Can plan? path you that us a just other pediatric can and ADHD. in words, ADHD -- you So filing of to can narcolepsy, are any that's to remind study the items for I extension? filing reboxetine you to talk filing? are file to your In talk your your to gating about line believe a reboxetine item and NDA after

it be priority to to which to that. And is that the helpful lastly, then product big that? and going fibromyalgia, you're the would of what's need And commercial expand organization So to extent how to esreboxetine to commercial talk the support commercially?

you those for Thank questions.

[indiscernible] think the X then Ari on I So comment I'll first and esreboxetine.

the factor. in to the filing [indiscernible] spend legacy And terms that then to a is of So time of factor together is new take gating it for us so completion to timing the in filing, AXS-XX, year. complete the the of for trial, this some which we expect half be the but will second NDA put

So is will be once file we that the then NDA. study able to completed,

As it ADHD pediatric plan. in study relates the to solriamfetol,

the that, you the is part but trial, be in we've which terms guidance, will FDA been start not in the this to move on exreboxetine. And provided correct speaking with to we've is to that precise [indiscernible] package in of place. regards that that working are of can the You in and in yet targeting get to that, as And imagine, study we year.

Yes. question. the Thanks for

patients, are room overall and in for the profile of I for offers a commercial for profile meaningful of approved of X do opportunity. about think fibromyalgia, as this a optimistic there's patients. we but feel AXS-XX agents clinical very view we for lot There improvement terms AXS-XX

this a effectively our is impact commercial structure of products. to of part sort will it of portfolio growing analyzing and size the how relates we're sales footprint, to force it year how to what accommodate As

of influence a our not with thinking. it's fibromyalgia, overlapping depressive Although product, there some is of comorbidity a that major psychiatric will lot disorder

want how putting the too of how additional you the on to market. promote think to Do a AXS-XX And reps many products it. would plan or so early while attention we into plenty structure it's to the on efficiently a we other way say is build there also would approved little that

Our Yatin Guggenheim Partners. next with question from comes Suneja

study. One I ACCORD-X regard a have clarification one. to X the quick ones. With is

have [indiscernible] to package study? completion nice this then within And study from quarter. or And that that's Auvelity, Is to regard So that study that's So ADA new of randomized NDA is that [ a the the do withdrawal the you a study will that umbrella. very study. I one. and outcome FDA contingent ] upon requirement of be then the mean, to with

or [indiscernible] Any providing on you. So the a for yearly quarterly maybe guidance thinking on about Thank that. not basis? product, thoughts on

question, guidance the Nick. given for and fluid early external the sales nature too could in different It's of market the provide unpredictability just that thanks Yatin, have of [indiscernible] the impacts. of dynamics some factors

have believe $X billion are for in to and peak its alone for indications. MDD [ Auvelity ] We range we current that $X $XXX shared sales million to the Sunosi, billion and $XXX million

is FDA Yatin, with requirement. regards not to quarter X, this an

and it does it the a trial. [indiscernible] However, pivotal package, is increase

So We studies. we like that. like having different X

ACCORD-X So X randomized are studies. basically, if you in and think studies about it, ADVANCE-X and [indiscernible] [indiscernible] ADVANCE-X or ACCORD-X X

with generation [indiscernible] about those from X [indiscernible] nice states. very a So

the with filings. to regards then And

We completion continue that study. on of

It's it's So really not contingent. required. not

where things do that are upon based of we that enrollment study. we However, with

to number sense but relapses, assets formal just That's ACCORD-X for a the timing new trial, the expect read we but based give and might of will midyear was enrolled and to study positive, there time it of study the of out it. is that be around So relapses [indiscernible] the [indiscernible] think be guidance the to upon also potential about year-end. fully in which how you and a we

way So able product. we're [indiscernible] important happy of efficiently this to increase with that really the very the for program been we've

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

the chance better if did data the really a has mention you ACCORD-X the and marketing given trial? opportunity in ACCORD-X label, to the guys kind is was the like for cyber as it that it a ACCORD-X, motivation pool ACCORD-X on don't such just with I you is an then that And know XQ. sounds getting about a there study. of attack like think of study those into So so And lines, along small that

So of your I some from kind of know peers material wasn't a numbers. had really impact indicated it

So what revenues to did attack extent affect Auvelity XQ? quantify the cyber -- can in you

Sure.

used for be just is marketing, a with product. to be registration So can ACCORD-X, obviously, It regards but it to clear.

-- we that. So we're like

it relates done studies combined. source something of does to that new objective provide and ] in packages. a that's it revenues typically definitely could is And X [indiscernible]. [ So be The design very [indiscernible]

on Yes. attack, weeks. end focused of And prescriptions at Auvelity regarding the a on Change XX% to X Healthcare Basically, really of the XX% roughly what weeks couple March. the of for for cyber beginning was those we impact saw February, was impact weekly

our it's During stable trend. And bounce that and saw number quick We been then, of put back stable time, a optimizations. since savings we technology since to very optimization a demand mid-March in to for in growing then. patient early

behind at this point. it's So largely us

it disruption. brands, We were market, for just the that nature. patient related Healthcare to impactful [indiscernible] time and savings whether cards expect was switching to more Change And to some tied

And put but so transient the feel really it us, good [indiscernible] We it why we growth. nice nature. seen really about and into was that's in impacted place, we've

Our comes Joon from Securities. with next Lee question Truist

[indiscernible] Regarding and [indiscernible] to in on in to which X, I endpoints quarter [indiscernible] ACCORD-X? [indiscernible] randomized behind success have ACCORD-X the trial? that in rationale appears the [indiscernible] what's get are those trial,

thanks, So Joon.

I I'll try and interpreted said. the You necessarily but the not were somewhat question answer muffled, what so you way that

other what and ACCORD-X design the around was designs. question the was the versus think I for rationale But

[indiscernible] to advantage already So patient like therefore, of that -- and [indiscernible] so response. assessment take would fact had stable the was the an which a we study rationale allow in was fashion

the all randomized that is label they our [indiscernible]. a way made [indiscernible] is that trial lot extension [indiscernible] So same of sensors essential,

the that So was rationale there.

of terms the is as compared ACCORD-X identical. endpoint to in And

the way learnings is and for this be to to able this additional ACCORD-X take a imply generate to from them ACCORD-X us is -- So data. to

Beatty Joel from with comes question next Our Baird.

the And Auvelity. earlier therapy use line [indiscernible] therapy? at users second line be provide could on Can large [indiscernible] one all? is impacted and contract, you the earlier breakdown an between the of with First in

the Yes. This is Ari. Thanks for question.

We line increase in we The or a have last roughly in is really seen since quarter use. first line nice second increase of therapy. X% saw increase

that we're So continue. are second a at of Auvelity trends, prescriptions first to healthy very and line, this is expect which or XX% point, around we

access or line we the the with when speaking, along around for patients. of [indiscernible] question second Generally PBMs, impact Your contract we negotiating and therapy. negotiate first are GPO for

pulling ability through the usage in terms successful we're in patients. those if of that, earlier or contract would expect would we that so further And increase

on you going can And kind of trajectory funding this any is, looking is last question context provide how forward?

question? were hear. you to the mind you sorry, Do repeating hard I'm

does on? SG&A so How for look spending and going trajectory just forward, R&D and overall this spending

Got your question. it. for Thanks

our expense million, quarter as slightly ticked for R&D, the previous up from $XX which was the So for quarter.

AXS-XX. We submit III as will by fibromyalgia. expect trials completion to quarter continue QX, NDA reminder, starting offset commenced work. increase plan we do and trial [indiscernible] for in a [indiscernible] in -- during R&D spend with to Phase the the third the the as the These be gradually as we the And of to QX partially SYMPHONY X for

we will for onetime So the have charge NDA a filing.

as the $XX total quarter for anticipated than than I in force really anticipate be was was the million, to mentioned quarter quarters. previous SG&A the remarks, higher as expense would it for in in As to a SG&A, expense sales this few the opening that expansion. related range We

with Hoang David Citi. from comes question next Our

to negotiations ask in in on want of I GPO Congrats increases lives. terms on about covered any the of quarter. number the the timing commercial impact the of

lives you covered And as Just meaningful up like? in in look of towards up covered potentially quarter number the I cadence pick next that the step can lives. we a seeing guess, what's look

Thanks for David. the question,

we timing. first way is think which parameters. effectively which to difficult is are predict PBMs GPOs for securing the gatekeepers on contract increase, it management to but is [indiscernible] the So the towards terms, agreeing expect rebate utilization includes it, access to The why step exact and about

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Our Suvannavejh next Graig comes Mizuho. question with from

Auvelity thought about agitation? about just here the the a Have This the I had Congrats for under and brand? keep quarter. And AXS-XX Graig. is AXS-XX. it [indiscernible] you more for branding if AD question you on

Thanks for the question.

as So -- one one just disorder. case consideration, That whenever is [indiscernible]. is it's not lot depressed new that always the and versus X and which you it a especially of just we in it's have different major of indication [indiscernible] a something a requires is that thought good and

think it and really quantitative work. So require do to this would some about us

we obviously that [indiscernible] time, we're something not that stay working or ahead So on. announce communicate but tuned would it's of

you anything add Ari, that? to

the I in think work going to that filing the is of of through I spot a you're the road. are [indiscernible] having maintaining an advantage And No, the and alternative now brand anticipation right disadvantages there down we're name, or either think reality on.

Our Purohit with Morgan from next question Vikram comes Stanley.

Auvelity, on We One one had X. on pipeline. the

kind scripts would the the second you can for be study [indiscernible] readout what you of for helpful. you talk sales you expansion the help would expected is completed just there you'll indication? frame bit that year on be to of how the of the going And potentially over of us, III readout Is visible then you'd filing can for Could more metrics And ADHD, a of force secondly, So based you couple this think you solriam throughout and to inflect this Phase those a next the if acute rest either reporting that and a out about then expect lift the kind recently you year? whether quarters? here, confirm, inflect be Auvelity. kind of for of expect sales submit kind successful and be the of could in to what which in

start with I'll question. the Sure. Yes, Auvelity

customers. impact activity XX% expansion, and roughly seeing seeing certainly we with So [indiscernible] a effort customers. weekly are an We're levels to on increase calls in

comments of prescriptions -- able is prescriptions impact are XX% demand the to a We that patient care with opening a but is that we that that of sales early with audience. the sort primary demand which in that would for seeing starts in seeing first additional broader I in care, primary we've phases team. perspective, commensurate expect that early and increase we're days continue is we the engaging And typically increase the time. the expanded seen of in the a providers ways, includes on total and from it's growth a many new indicator referenced new a that are reaching to inflection been weekly an still provide say from with net growth meaningful group focus, we've

about the of to we has that the force So sales and had thus far over build really expansion optimistic impact feel the continue course year. to expect the

with regards And trial a [indiscernible]. Great. to [indiscernible] free That's the solriamfetol and studies.

study the So AD NDA in this along an that enable a with agitation. filing is study would

the So from efficacy and a of that's required we do data include kind patients for ADHD pilot. to need data pediatric in

the the trial So [indiscernible] we're looking of forward of FOCUS results half the in the to year. second

So we're for on that. track

As looking it we're relates for. what to

I that we're in demonstrate think to first studies. the large thing the for is first looking efficacy multicenter in [indiscernible]

study. sponsored the center that's trial. with has for. one stable There been of -- That ADHD, was solriamfetol product. result that a [indiscernible] that of site was we're profile the looking what initiated prior The So will inform an in which

the this first focus study be be will that multicenter trial. the So will

Kaplan comes with question from next Our Ladenburg Thalmann. Matt

quarterly Congrats results. on the

for you, adult ADHD program Just pediatric in readout the a starting for Will the on the prior study solriamfetol. quick the guess, to of follow-up study I wait ADHD?

not. No, we would

practical. pediatric is soon as study the goal to as Our start

more X time have from We analysts. for questions

with question William next Our from comes Blair. Myles Minter

Alzheimer's the on agitation [indiscernible] program. Just

new the from expansion ADVANCE-X enrolling open-label this ACCORD-X study. of into You're

went imply is that about the that, that for of is that early. protocol required believe first pivotal And one it it some wasn't. is you've and the for So that got that messaging the concluded started, safety long-term have Why messaging required. really ACCORD-X that if was second And think been I amendments it already I pivotal turns is indication? was that all the through be then a does study it potential could then the a data when obviously may ACCORD-X case out when that filing

So I say to there guess, changed be and that what ACCORD-X ACCORD-X has wasn't? pivotal would

the enroll continue question. for extension the trial. open-label to the so open-label we to With study, regards Thanks extension safety

patients treated [indiscernible] As a or what to XXX we're X to accomplish treated months patients year and requires [indiscernible] guidelines on goals. X reminder well and for do we're track those XXX that trying for

So not the ACCORD-X to are course, then [indiscernible] and dosed. also who then And do go on patients completing be continue that. also [indiscernible] affect of

patients. to we're number So very of [indiscernible] comfortable with regards

As also it study to ACCORD-X to that relates is pivotal and comparing ACCORD-X.

completed Cohort we So what's X. nice ACCORD-X, about

we're And [indiscernible] necessary of FDA ACCORD-X could which study we design. the all of the a in also in we able terms have based the trial be on this so like the that prospectively. to registration received a design have from could endpoint, this, and be of very so around And out content feedback

we So benefit for I the ACCORD-X [indiscernible], knowledge with have a benefit which in ACCORD-X, think that it's the it case. of fact is designed and that the the this

question comes from Cowen. ] next Troy Our with TD [ Langford

And the then color feel III FDA all On for the on a the trial to approve Phase from would application? the perspective in on confident quarter. efficacy that additional this MDD? powering provide need do Sunosi, how has any you assumptions AXS-XX, clinical Congrats it just you can

is XX. I'll Mark. This take Sure.

here. we're complete. that's So content, in this quarter substantially And targeting of terms

building that. complete. is we through and just going we're submission. being out think those as possible, get to robust So are finalized substantially tend but -- We're that as really work things the it's We the

it studies powered to that As to of power to progressive in solriamfetol the [indiscernible]. we've MDD, similar that way -- similarly in other relates major study the had our we

So you bit the as -- and have Auvelity program. superior know, of you a quite with

there's So precedent. well out, which expect would in lot a on sizes, very think of about think with one general, effect the laid I the And powering drugs the and these studies, and similar. is

So [indiscernible]. that's how

an the effect To summarize, to effect which size, in is XX% program. power side, to [indiscernible] which detect detected similar we

remarks. turn back concluding I call there now CEO no Axsome's for will the more questions, to are Since over

time professionals of the the Well, look We thank patients, pipeline a progress with to of execution for marks for delivering and to of us investors strong [indiscernible] Axsome. continue throughout commercial innovation balance taking join to and you and of year the goal alike. value [indiscernible] health today's care

of day. great Thank your have rest you, and a

participation. your conference. today's Thank you [indiscernible] for This

at lines this your disconnect may time. You