Axsome Therapeutics (AXSM) 1 Mar 222021 Q4 Earnings call transcript

Company Profile

Participants

Mark Jacobson	Chief Operating Officer
Herriot Tabuteau	Chief Executive Officer
Lori Englebert	Senior Vice President of Commercial and Business Development
Nick Pizzie	Chief Financial Officer
Amanda Jones	Senior Vice President, Clinical Development
Joon Lee	Truist Securities
Vamil Divan	Mizuho Securities
Marc Goodman	SVB Leerink
Joseph Thome	Cowen and Company
Raghuram Selvaraju	H.C. Wainwright
Myles Minter	William Blair
David Hoang	SMBC

Call transcript

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

00:07 Good morning, and welcome to today’s Axsome Fourth Quarter and Full-Year 2021 Financial Results. My name is [Candice] [ph] and I will be your moderator for today’s call. [Operator Instructions] 00:33 I would now like to pass the conference call over to our host Mark Jacobson, Chief Operating Officer. Mark, please.

Mark Jacobson

00:46 Thank you, operator. you joining thank conference on and call. morning, all us for today's Good

research release, update axsome.com. and a the earnings may possible agents; These information, on plans short things, providing involve Our plans; utilization press making is source of to subject and may on plans; that are actual results to and XX:XX periodic annual are include that the in and future development corporate today's crossed among wire are results anticipated available call, including reports. the investinational time ago other XXXX statements other of non-clinical quarterly Securities website intended company's Exchange investments. change XX:XX forward-looking intended of statements our from forward-looking to the Commission, for clinical conduct and filings and These differ the During fourth statements. clinical statements. of and quarter at full-year certain our safety the cash a XX:XX our will our financial and cause on forward-looking details and statements and present be expectations additional efficacy, current those described with based risks and in future and the commercial These assumptions, and trials; or and and our uncertainties our data; regarding, contained made plans materially report use plans; we risks regulatory the

first any Executive statements. Dr. call and me milestones. and date, are are and Officer; Financial Herriot the will Senior place obligation on disclaims which forward-looking of Amanda reliance Jones, Development. these an Development; today company and recent President Dr. Pizzie, President Tabuteau, today's undue developments made overview upcoming Nick You review not company Business then XX:XX such on only the Lori Chief of XX:XX Englebert, update Herriot to to Clinical Officer; provide are cautioned of Joining statements, Commercial Vice Vice and of the Senior Chief as

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

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

Herriot Tabuteau

treatment will second the observations, initiation following and in durability that been greater study, to FDA. for study depressive analytical the review consultation not to response for Controls of timing the Phase light In affect made smoking The the NDA. major we regards of FDA Enrollment methods XX:XX trial XX:XX Agitation. will Disease lead Moving AXS-XX, our issues section the living everyone manufacturing update. informed indication with facility on AXS-XX related is any of new in for these candidate required does Thank Alzheimer’s the developed medicines by of prior the action The have you, development is evaluating The Mark. potentially it candidate, update product implications a us to a anticipate of fourth migraine. duration We aware in thank in multi-mechanistic I to was the to of contract Good to an travel update intend Currently, to relapse than and acute completing an and With provide the NDA development Therapeutics' that the update have being of XXXX provide may and AXS-XX launch is of undergoing all receipt cessation, addressing to progressing. would treatment two it FDA ACCORD product conference months. have The joining NDA for not might COVID-related the imply date. been XX, Lori, has FDA of FDA the submitted projected inspection and lead by a of a Chemistry, an design acknowledged due treatment AXS-XX be below with the PDUFA which Axsome XX:XX the and prior us other since to two investigational response potentially XX:XX accepted also pipeline informed continued call. our the we the X of overall for to unable in inspection XX:XX that of PDUFA any on trial which first are with they facility to patients in our the with XXXX. to financial notified for before provide migraine. the trial. target provide of date, deficiencies which complete FDA. NDA for review will Starting This was a restrictions, blinded coming this We previously and by projections. the you position related year-end a turning commercial XXXX morning, on with disorder. business events PDUFA. date previously for quarter for deficiencies XX:XX AXS-XX, progress we depression of a us FDA are these who Manufacturing, April results has year the deficiencies. a put of the

And under commercial rich our AXS-XX advance. active the preparations pipeline continues will review, XX:XX Lori rest launched on readiness. for launch are underway. of and details to Axsome AXS-XX provide The With our NDAs

first turn XXXX. treatment for in product of Lori, commercial our manufacturing the to are related treatment product our fibromyalgia, of submit AXS-XX, half candidate the an candidate we NDA being NDA are of and in For now this call and and trial will I XXXX. provide the for expect over to update. product will ongoing, planned activities AXS-XX, other to Phase the who submission the the narcolepsy, For SYMPHONY a XX:XX for enrollment III developed XX:XX anticipated progressing results of is candidate the top-line in

Lori Englebert

and excitement burden crisis intense morning, I to the by year commitment, the to The like remains am article have patients. of [indiscernible] world two moment the deeper XX:XX opportunity XX:XX efforts demonstrating preparation associated immediate is an of was and a for leadership their health XX:XX I'd therapeutic article by Commission, potentially need many depression, serious bringing depression. and commercialization stating Our and the therapies is force. for remains execute and new commercial united the global Lancet address data to if urgent depression for to Recently, Thank crisis. good Psychiatric powerful is and increasingly to options innovative the you, deeming the with one substantial. the support launch of XX:XX published global prepared field purposeful, and an The and to That appreciation approach Herriot, reduce help my affected to everyone. excited sincere and preparation, undeniable to to for continued provide tackle global approved. sustain of burden to that Lancet those achieved over calls of express take extremely and by a depression, action XXXX points, Association past new passion, AXS-XX bring to team fully proud we Field a this disease. affected are failing recruited patients World year. article the

living need experience XX:XX prepared and for permitted strategic services XX:XX to join Distribution and Axsome the turn Despite awareness Americans ready launch and team I support will for new with available recent label. deployed, for ready acute would to payer commercialization Given many XX XX:XX for are of pending ready there All in migraine strategy we Axsome, product with to be the the access of option dissatisfaction acute therapies, AXS-XX close this on at be bring will the and patients. AXS-XX market the sharing adjustments the important ready high approval. demonstrating immediately to engage to highly are migraine Americans million discussions, treatment meaningful of continues patient to upon rate to market our and whom final shift If preparations innovation, profile. who to in continues migraine. targeted. currently now materials landscape, and are gears current are XX% marketing be treatment launch for address for unmet approved, be The XX:XX to innovation migraine. an depression,

of and terms salesforce will well with AXS-XX upon Consistent are offers tracking discussions payer planning rep the have Permitted the marketing XX:XX underway launch is commenced all accordingly. underway. offers, and AXS-XX In preparation, force recruiting be efforts contingent sales approval. sales and made for

is for DCC platform platform are to another is effective, the remains more any ready Commercialization tools, use The Centric and and combined to The potentially with We for patients. systems commercialization a implemented, data to strategy. a engagement market efficient, execution. our or allow streamlined fundamental XX:XX designed enablement analytics tested, from with fully and option Digital to and Americans digital XX:XX platform platform, suffering physicians Lastly, the migraine. to DCC enabled the about sophisticated meaningful excited technology opportunity bring and for

excited is Our about AXS-XX have commercial both important launch potential market profiles and the to the intent clinical products a these our opportunity over them. to to turn patients will I review important to and the bring potentially Nick who market. financials. meaningful with The significant way. purposeful XX:XX products and We to now in new innovative XX:XX who benefit physicians treatment will bring to for new strategy remain it differentiated bring to AXS-XX

Nick Pizzie

XXXX G&A share compensation the For to period and quarter morning, quarter non-cash and our personnel XXXX in with at proforma in of $XXX expenses clinical expenses expense. XX, for I the period $XX.X three months to were in QX period. increase $XX.X to primarily in charge $XX expenses for $XX million. will the $XX.X a license along for comparable decrease The build-out December compared million of was good XX:XX XXXX pre-commercial activities XXXX. and were as prior related $XX.X along the of the increase in was million XXXX. million for year, full-year per $XXX financial Pfizer end XX:XX which We a Net balance ongoing conclusion to compared $X.XX $X.XX $XX.X stock cash, of of $XXX.X or in share The or net R&D to the R&D third expenses provide XX, $X.XX were December XXXX, utilization was Thank everyone. you, loss expense $XX year the the approximately XX, were comparable compared an of approximately facility of versus quarter, XXXX. million stock is one-time agreement. fiscal the $XXX.X trials, comparable guidance. the results XXXX, compared a the year loss million, included million, year-end ending quarter ended For loss of year and XX:XX for were G&A ended comparable million. commercial XXXX to or Net net net was loss XXXX. for function the XX:XX ATM our decrease $XX.X year the XX:XX XX:XX with December of the million The million period cash for increase our fourth $XX.X Lori, to compensation in XX:XX million $XX.X due in some million R&D discuss during with period approximately to the for XXXX. an of share the in due million primarily year, expense comparable related Today, a million fiscal Inclusive the per for million the increase XXXX. or million roughly ending for compared million several $XX.X per to $X.XX was expense. at $XX.X

financial position FDA both XXXX. XXXX a discussion. million up in review. $XXX our AXS-XX million with current million to $XXX in access XX:XX full-year proforma of to As migraine term cash MDD approval financial loan Capital AXS-XX QX Q&A million and from our to operating we the expanded $XXX with back sufficient XXXX, This with $XXX our I facility, the into through based loan an anticipated call XX:XX will We Mark committed us launches is capital the quarter and in capital anticipated gives AXS-XX to commercial That additional additional facility the AXS-XX. operations, Hercules of turn upon along fourth potential concludes believe our for year-end of on fund now $XXX reminder, and committed million to non-dilutive plan thereafter. to remaining available and term flexibility lead

Mark Jacobson

XX:XX Operator, our Nick. you, may our please we have Thank question. first

Operator

Our Instructions] the Cantor of [Operator first line Thank Duncan XX:XX comes from of you. Fitzgerald. question Charles

Your line open. go ahead. now is Please

Unidentified Analyst

XX:XX Hi. morning for This Good all is on and [indiscernible] the Charles. congratulations progress.

has steps FDA with about anticipated provide or timing? relating or anything the next is there with First question any else? the And the XXX, for been any color FDA can safety dialogue efficacy anything and on you other

Herriot Tabuteau

Great. you XX:XX for the question. Thank

regulatory interactions to with it about So, the communications the Mark to FDA. talk I'll turn and

Mark Jacobson

Good XX:XX morning.

made in responses. snapshot current those they you're of them our ago. current two and is number that's of the particular We told has and addressing reviewing pertaining XX:XX snapshot. So, months still FDA of to we methods, analytical responded were subsequently deficiencies as So are the aware, a receipt to has acknowledgement those CMC confirmed us receipt efficiencies

of not have We anything you any continue that. around keep we'll No efficacy, like made updated. been or proceeds, And things deficiencies discussion to aware other safety, that. or as that like

you any of don't terms we we're how we’ve thinking received. specific guidance for have In that about timing, or feedback

there that, planning to processes. is, during purposes course using just kind planning major major of XX:XX guidance. that framework PDUFA three of months, amendment a our if submitted a by that accepts to the typically a our so, the again as normal in amendment the total. we're for FDA review, expends reminder inform review And doing clock is that's we're what to So, And

haven't what using we're that just FDA process for the told We that's or procedures purposes. but by using, they're that's planning been

So, that’s solely helpful.

Unidentified Analyst

And you can in there you. going us COVID? a give agitation, for is Alzheimer's any Thank enrollment sense by of Yeah. XX:XX been XX and impact how has

Herriot Tabuteau

take that and release XX:XX the results. in track Sure. first to us terms reporting question. proceeding expected when guidance designations able the did the stop FDA it used also in of be to we of on is XX:XX we that XXXX Therapy of agitation is the meet We pioneering it to our Enrollment number than thing morning Thanks at AXS-XX. design of half well events is it's excited very the been fact durability and this the we for and syndication Breakthrough discuss this our first of this puts this in make is that of design are projections with syndication implies of the would in effect, actually want that We're the greater potentially study with but trial target – disease the look good them. this study with consult for which are determines it those events, does because work, time Alzheimer's the that conducting has lower which a have us and the that than advantage

very looking want carefully. we're And to so, that we make sure at the study

Unidentified Analyst

XX:XX monoclonals the and [ph] treatment and share positioning? last and residual given the as migraine well need with switching product you CGRP the for XX, Alright. question gears And oral landscape for CGRP help us taking drugs can understand [triptan’s] from the unmet as

Lori Englebert

I’m Hi. the to for Yeah, take that. question. happy XX:XX Thanks

treatment are therapies. triptan’s recently still that XX% clinical XX:XX least year It's isn't survey, performed Nick as high that that market And that patients great the point are on that the survey unmet year revealed that that at needs I there's that a migraine We that XX to And extensive And ago, for share, driving have and cycling So, point cycled a XX% fairly a our mentioned therapies sure high a think lost Champ, a just profile, migraine therapies me very Recently, was pointing give different the I through is patient continues have to dissatisfied need. available. as dissatisfaction. was you also given landscape for home of product. recently with as that through XX:XX landscape. a organization that many advocacy level data well-known patients of again, a which as want, continued that XX% a current further think the shows point there's potential – the that a still that out in ago. current do of

Unidentified Analyst

Thank Alright. XX:XX taking you for our questions.

Operator

XX:XX Thank you.

question of from Truist Joon next comes Lee Securities. Our

Joon Lee

questions Hey, updates. and XX:XX for our guys. Thanks taking for the thanks

month just is can correct? is that you a summarize what share references PDUFA, the based question, framework you So, assumption? prior under you're to to any amendment assumption And major response three your working supporting a call on extension that

Mark Jacobson

Mark. Joon, Hey, XX:XX it's

to given FDA don't the of data. clock, if that additional to that timeline like for the is, review the the you FDA's manual they like X-months Because months play it's about for X-month in the written to us assuming And PDUFA desk if we're the planning a course during you but think months to because out why So, why on and And that's take addition that, the and be guidance, XX:XX order purposes. go do say their stone, XX:XX to have things accept So, a has given triggered content. they depending additional website the or a you review categories the normal determined, substantive review, we're that? on it that X gives it etcetera business submit, amendment we’re to extension in what need purposes, data time what reference something So, a to that run that analysis, for off we the if planning say, right, at accepts allow using X-months that just extended as amendment. and major it just or X-month on here, similar of depending FDA by, the nature X there's can review, that's check then a clock. just typically no you clock assuming we're that of again

X-months And thinking don't it it. that's we of the is and And to be so, going know.

standard they're our in references that's So, we XX:XX normal besides provided in processes because and no commentary submission. course in procedures. the that what of but haven't absence it's FDA that for not from we using terms – direct of we're publicly action going FDA like haven't that review. of it any other That's We think that, is, specific information what feedback received X-months again, to a you that's has take

Joon Lee

love you Understood in to to ACCORD study lower looking And And event more Alzheimer's much. that a so that having fair. implying to effect. you're be Regards could That's drugs agitation, one That's your what for [indiscernible], superiority of your you Is And hope did elaboration kind than dialogue so interim analysis FDA [[ACCORD] then mind? than trial And that due amendments, greater that of interim potential projected. amendment question. Thank then XX:XX FDA with you you're with seeing the an then to have we a possibility a you. on hear for this with relapse have thank of helpful. a meeting you're anticipated look what on and accomplish an to you [ph]? in at

Herriot Tabuteau

XX:XX Yeah.

for thanks Joon, the question. So,

is might So, randomized you X-weeks the the stop a timing is design the why of year. group that the study It you reason when growth of depends on to be, duration. conduct number where mentioned when in let's as and [indiscernible] parallel study events that we design study, of kind or X-weeks standard opposed say

do the rate typically we that in approved. are is the precedent. terms particular case out prospectively, in is set Alzheimer's XX:XX so, is that currently watch on And indication carefully. so, a it's XX:XX also, of way there's with information prior parameters little very that event the based agitation, product of those And there And no disease

given sure that look that very at we we appropriate that FDA we blinded So, make actually to study an the we design. want dialogue study know this carefully sure is is the with on, and that design and make I what's sure to going want make don't to that the

Joon Lee

XX:XX an that? Thank When update you. expect can on we

Herriot Tabuteau

This provide to Street we expect XX:XX the fairly something quickly. is to would that

indication. the dialogue the the is know, active, is study this do open an as ongoing have we and with So, on FDA you

Joon Lee

XX:XX you. Great. Thank

Herriot Tabuteau

XX:XX Thank you.

Operator

you. Thank XX:XX

of Mizuho Our from Securities. comes next question Divan Vamil

go line is ahead. Please now Your open.

Vamil Divan

the questions for and Okay. update. taking for XX:XX the Thanks

a way because the just to the we get lot are [Technical initially not events question expected. one Difficulty] So, and thing this on ongoing clarify accruing

pure point, So, if obviously in good. of or the just in no or so events [indiscernible] at just arm this be events you be in know. placebo both, arm we sense But to fewer don't right, know, the events clear, treatment clear, don't just it's to it's potentially given pure whether that's

on an of clarify want been second did And questions of XX just sure all clear. with there’s sort stake I official it's the been dialogue. just that that's for question we're because if I and So, confusing, you but to getting that a think for discussion can think couple make MDD, and CRL, you going the then my XX:XX us, on sort of back not I where FDA forth you receive of back

other why gone official any maybe So, push-out I’m is the from just and unusual place [indiscernible] there? the the wasn't if action. wondering does FDA, taking as for helpful should [indiscernible]? Why of other why announcement it’s if path you we've I'm further or then you’ve seen received be insights so any your pretty curious planning as on insights It probably just purposes have what well [indiscernible]

Herriot Tabuteau

Sure. second answer XX:XX address I'll then and question Amanda let we'll question. first the the Sure.

Amanda Jones

Sure. XX:XX

So thanks for the question.

that So, blinded. it's we're the looking rate at, relapse

So, study this fully that blinded. study period is

So, don't which arm that know recurring relapses in. we are treatment

that's… So,

Herriot Tabuteau

we in the the to happy we that NDA. to deficiencies were allow sure the that in wanted possible them review review And that on and particular with of is was to the at they to regards team prescriptive that. able other constraint the there was know, has as we very our been respond is terms publicly which of been the reflective So, do to possible, continued what's continue contributing the also FDA is see discussed making with what PDUFA a to best And to general Perhaps they why that a are regards what focused happening we're with the the CMC what then situation? industries – that NDA. is, further to quickly don't resource FDA be in Could capacity, XX:XX XX:XX to this as delay? the is, of to FDA. in know have really FDA fashion into insights respond We gold the

that. Mark do to continue we'll there as So, are mentioned. items Currently, no open

Vamil Divan

you. Thank Okay. XX:XX

Operator

you. Thank XX:XX

question comes from Leerink. Goodman Marc SVB next of Our

ahead. go Your now line open. is Please

Marc Goodman

on know talk yet, Yes. questions. morning, if a date, inspection of done I the has the XX:XX of done manufacturing everyone. first you yet? couple a all, just have those, XX, it told about if I haven't FDA that they you Good there's Can got they

Herriot Tabuteau

XX:XX So, an be XX, to they inspection the date completing by regards have issue. with us PDUFA will is the not told what that

Marc Goodman

have XX:XX done Right. they But yet? it

Herriot Tabuteau

Yes. XX:XX

with directly typical during situation. refrain NDA the of in back the forth, from unusual So, have conducting in that that of course might PDUFA providing prior us the the we date We issue. the AXS-XX in delay exception review, inspection, has a an if told an but their warning an made facility delay there a because be the FDA we and that is no disclosed longer

Marc Goodman

that labeling you Have started XX:XX discussions yet? on product

Herriot Tabuteau

be we again, back So, XX:XX won't forth. the commenting on and

give However, a PDUFA at valid, typically, labeling occur and reviews, the April timing XX those which rhythm date. of PDUFA is date to approximately prior one-month is typically, a of is just of discussion the sense to still you NDA

Marc Goodman

X-months Well, you when head? XX:XX your just response know can you the that exactly know XX, head, to in flip you maybe your clock then FDA, can we so file and in to when started did your

Mark Jacobson

Mark, it’s XX:XX Hey Mark.

acknowledgment where like if say that something could that's mid-January. Speakers] was and year, months, year-end, in thinking think but I receipt of I occur. guidance somewhere not received around potential how X-K’d we're range I potential the so add again for And there, could when think time range, you from potential review, was three us, that's like around that's about, guess just you [Multiple part the we're we tethering what that, which And is, and confirmation that's we of the to of first

Marc Goodman

XX:XX Right.

this there that on product, will you been type any comment label has negotiations So, of and on either? not or

Herriot Tabuteau

unusual XX:XX are sought situation, that So, updates provide we have AXS-XX, Mark definitive. given the for the street to with

situation, provided we update get an lack review. situation FDA, an PDUFA with anything unusual a from the the ongoing of we unusual whenever but So, being definitive have given date, the

would So, and once street we we definitive that is be currently you that that expect definitive, have do we could to look so on know. think the would front, something let that that something that

Marc Goodman

a question, so they and definitive? else if back And happened you actually but that any the is definitive something came you your asked would XX:XX yet? would FDA anything follow-up responded asked be also or [indiscernible]? you receipt, that acknowledge have for They basically and Like, be,

Herriot Tabuteau

Yes. XX:XX

once So, what the is we know the anything clear that's from said is been doing We've Street would there let definitive that FDA. and that. we

if there you have then is anything And nothing. heard so, not

Marc Goodman

Right. XX:XX

program Okay. the And of smoking the planning that you're can type you cessation, then just completely different that just subject that study the planning? you're in describe

Herriot Tabuteau

Yeah. XX:XX

I'll to that over Amanda. So, turn

Amanda Jones

Sure. XX:XX

consistent with treatment practice, announce reveal once launch we design study design short to these observation to whole speak we'll the registration will prior periods by be generally, treatment designs cessation our just it, personal to products, study followed the other incorporate typically of So, [indiscernible] trials, but similar free period.

Marc Goodman

XX:XX this And is start going when? to

Amanda Jones

XX:XX to study the We initiation within of provide guidance on intend further year.

Marc Goodman

XX:XX Okay. Thanks.

Operator

Thank XX:XX you.

from from come and question Company. next Our Cowen Joseph Thome

ahead. go Your line Please, open. now is

Joseph Thome

to the middle year, XX:XX highlighted for Hi line taking a data thank to you I FDA question and have morning And follow-up. I know at there, of last provided first the agency that's additional the on top good and for you merit my any have trial? my data questions. Maybe you the AXS-XX that review, would

Herriot Tabuteau

the make – that FDA. result the provided did made and And of not trial. additional we from have results information to the we So aware XX:XX of information provided the not the apart study we the have FDA of

Joseph Thome

XX:XX AXS-XX AXS-XX that did is Okay. AXS-XX, with And specific review, the that make then the on or to to popped you there applicable AXS-XX? to any changes have are concerns analytical up

Herriot Tabuteau

XX:XX to AXS-XX. That was specific

direct So see between two. the we connection any don't

Joseph Thome

Are how without your now have and how patients relapse hitting have patients are where too most then an Alzheimer’s agitation patients? update, XX:XX between or of is symptoms treatment, too wouldn't long on it it's a we disease just Okay. one maybe you're common going for consistent had [indiscernible]? Perfect. guess agitation this that And can have agitation to just kind been last I just that of maybe many

Herriot Tabuteau

the There’s of – is disease. XX:XX the symptoms in definitely variability there

agitated, So, patients have disease who they who have they of range are symptoms. have a Alzheimer's

for symptom common example, XX So, one of the acquisition has inventory scale, [indiscernible] items.

to into of And and groups. each those behavior. different those behaviors a XX:XX separate items So, cluster corresponds

variability so reflects the And the that in presentation.

ways different in depending So, the be on can manifested patient. agitation

Joseph Thome

XX:XX Okay. you. Thank

Operator

Thank XX:XX you.

of question next comes of Matt Thalmann. line Our Ladenburg Kaplan the from

is Please open. line ahead. go Your

Matt Kaplan

to morning. and XX:XX as XX wanted and front? bit, commercial discussions topics I on payer XX prep Hi. your a Lori, been talk can how shift for about Good little with little you bit a for specifically just and maybe the payers interactions have going you

Lori Englebert

Matt. the Thanks for Yeah, XX:XX questions. Hi

now. continuing that is AXS-XX to discussions for that remission permitted action as remarks, We by know plans. two to MDD there's We encouraged prep commercial forward So, by two-thirds in have we are we see and way the terms ready XX payers as in of payers of is, XX:XX April need of of recognize clinical And almost for permitted look as had one-week with payer payer get I all clinical profile profile. they and as payers engaged XX XX do for – covered. diagnosed patients the impressed prepared amount and XX, novel the introducing the XX weeks. payers, five that potential anymore symptom we given Axsome, tell right So, making well can of representation the mechanism achieve an and in on discussions last tell the data What since not tracking potential extremely MDD, accordingly and fashion had early of engagements, with well clinical we've XX that in profile of payers all stated XX:XX year. commercial in to achievement decisions. great we you associated to the of to I’ve with there the increase. we've In a covers that the majority once its lives launch number So, in XX:XX the do remission XX:XX that recognize engaged of is the is compelling we're as are have that go unmet trends they're and approval. reduction package with Again, we've

Joseph Thome

will guess XX:XX showed this the the X utilized how you AXS-XX Right. I positioning for then do triptan, And marketplace? superiority to be data, how are given which Phase think just and you

Amanda Jones

XX:XX Yeah, question. great Thanks. It's a

payers with how and Those really around question answer you So, going? ask, have discussions ask last are a just one you in I'll did commenced. didn't the recently that's discussions although the

payers on what but on bit to cycling market] in meaningful XX:XX And we be that speed the and how premature patients to we’re the of that But now, hone continuing with know both speak will speculate right our for dissatisfaction therapies, current absorption [ph], it's come with so, patients. to fact the positioned more the we’ll that payers. [ACP product specifically is, the is a on accelerator do continue ACP’s and To recognize of to and in to the action that.

Joseph Thome

Thanks for XX:XX the Alright. questions. taking

Operator

XX:XX Thank you.

from comes of Jason Bank question of Our America. [indiscernible] next

is go line open. Your Please ahead. now

Unidentified Analyst

Jason. XX:XX is the Thanks [ph] [Peri] Hey, taking on for for this line our question.

trial? this to on be question could time? get Thanks. how that a change a how impact potential to seems or timeline design this Just at, been and guess trial at in AXS-XX current relapse trial patient want the the on perhaps enrolled sense of of quick less the us Just will you based rates, where the patients how has is enrollment many ACCORD tell and generally I

Herriot Tabuteau

XX:XX Hi.

enrollment, So to Amanda I'll that trial, not over answer change. Amanda? regards the a questions and to with anticipate of timing we going before to trying off that number to but specific is the do of the events on of get start completion to

Amanda Jones

Sure. XX:XX

the So we of on based alone, mid-next year. just on planned readout track enrollment for

have we're relapses of on So, assume the is the we obviously, on key the know based number thing projections do at that happening be based that should we study looking design. you

with are FDA. number the consultation we below currently, what's for our of since so And triggering kind that desire

Unidentified Analyst

Thank XX:XX you. Got it.

Operator

XX:XX you. Thank

Herriot Tabuteau

as just second a we that, study, the add part reminder, portion. is, of to to to the referring remember happening in the randomized and Sorry, what's just are XX:XX just this

and these AXS-XX randomization. AXS-XX to prior stabilized received been on of have previously have All patients

Operator

question XX:XX of Guggenheim from comes Suneja Securities. next Yatin Our

Your is ahead. Please open. now line go

Unidentified Analyst

is this taking on hi, Yeah, for XX:XX Eddie for Thanks Yatin. question. my

respond And we market you [indiscernible] XXXX first like, then assuming to would terms to when precluding can looking the those under that were In ever guidance label And think XX, discussions? provide that in would plan that year, an Thanks. how you depression? those the approval you you in half should if you disclose revenues? the can have you're given are deficiencies get penetrate How label of their may of you influence begin, ongoing? and launch that assumptions preparations revenue the for about the that and discussions this

Herriot Tabuteau

a So, of lot XX:XX questions there.

to label, with would to in turning before piece do to So, of information provide it a regards terms we of the Lori of that to definitive that around to the discussions, assumption disclosure question think to labeling answer able be be Street. the

premature and guidance the So, for that understand And that. the with that revenues you making XX:XX which approved. labeling on label And question that the want that over terms us regards providing yet to really into revenue what to for aware us not Lori. is we asked be of assumptions and guidance leads our it's also, the product, make regards current is, I'll turn to to then for to is XXXX, we thinking with of product guys sure in you and

Lori Englebert

XX:XX Yeah. the Thanks Eddie. question, for

which preparing based can that best label, to could commercial we be the the fast but that as for will to we to prepared label, do label substantiated based [ph]. so, adjustments made are that. XX:XX get of from the And negotiations that we terms off labeling results. clinical any tweak, to the is I obviously So, imagine prepare the draft as you on FDA, preparation in trial are submit is we [there] possible major highly

Unidentified Analyst

us that remind is? proposed just you Can XX:XX language what label

Herriot Tabuteau

the [proved disclosing specifics on be the what with we’ve in after as treatment MDD would that the not label. So, it Obviously, XX:XX we is be you are know the [ph] first] to call. regards disclosed going that indication is that the of to graphed

Unidentified Analyst

XX:XX Thank you.

Operator

Thank you. XX:XX

Wainwright. Our next Selvaraju of from question H.C. Raghuram comes

ahead. is now Please line go open. Your

Raghuram Selvaraju

questions. taking much very Thanks XX:XX for my

clarification you assuming approval Firstly, us both for availability timeline would expect drugs, the you on and what clarity the lag on and of additional receive give whenever for announcement the preparations XX actual product? you occur of launch XX. commercial those sort just some the regulatory approval quick two between Can to of

Herriot Tabuteau

XX:XX Thanks for Ram question. the

take to want that? you Lori, So

Lori Englebert

XX:XX Yes.

Thanks for Ram. hey, the So, question.

likely we’ve we within that after disclosed, will quarter you approval I know one discussed previously be it and So, think will launch.

Raghuram Selvaraju

XX:XX In both cases, for both XX XX? and

Lori Englebert

cases, yes. both In XX:XX

Raghuram Selvaraju

Okay. XX:XX

definitively on clarity they just Secondly, data hoping positive top-line the points that was could the of did you from front, there, two clinical indicate discussion One in smoking the provide. the whether, cessation a additional FDA, with is, would sufficient positive study, even necessary a support top-line they to data indicated supplemental be NDA are that of be currently second or in envisaging from context would this you study confirmatory smoking trial in if the I cessation?

Herriot Tabuteau

required. separate smoking positive are cessation indication and a So, two is XX:XX trials

Raghuram Selvaraju

is control, with XX:XX And And active they if appropriate preferences an from if preferences to have what Got any their an get constitute control? what did it. regarding the color agency would respect this any? you

Herriot Tabuteau

the has follow combination FDA's So, product XX:XX given products it, two in APIs know as for AXS-XX, rules. you profile it have because do to we

would we have contribution. component so, And demonstrate to

So, the would to [indiscernible]. have be one of likely arms

Raghuram Selvaraju

the or recommendations But that. provided XX:XX correct? agency by no Is additional requirements were that specific beyond

Herriot Tabuteau

think XX:XX I Amanda so the design details we will earlier, the we're the can of and that’s as in past a speculate design study you practice the of the looking to launching launch as prior to and your and our been able know, Ram, mentioned design study the launched trial be We we provide finalizing because we change. details. once the to to study, we'll then provide once like don't it, forward

Raghuram Selvaraju

potentially if NDA is, question you able last trial, the the respect would away? top-line that from SYMPHONY have right constitute to circumstance indication, narcolepsy to which the be then a you And would the data positive file with Understood. XX:XX under

Herriot Tabuteau

to XX:XX that. I'll that So on comment turn Ram, over to Amanda

Amanda Jones

that has [indiscernible] label of If have an for Yes. well. study NDA. then our Study thanks. be the positive would the do efficacy as ongoing Sure, basis We XX:XX SYMPHONY also results

to that approximately X anticipated study of is the after conclusion months So, SYMPHONY complete study.

Raghuram Selvaraju

you. Thank XX:XX

Operator

XX:XX you. Thank

Vikram next question comes Stanley. from Our of Purohit Morgan

open. ahead. is Please Your line go

Unidentified Analyst

walk DCC on morning, have What This the been works? you setting? are world [indiscernible] metrics guess, in you on testing everyone. taking our for if I how was I the could us real for will the platform Good its Thanks XX:XX wondering monitor utility Vikram. is that question. you to how

Herriot Tabuteau

XX:XX Yes, please.

I think for that's Lori. question a

Lori Englebert

for like XX:XX question. you over answer excited We're very arguing can here, to If you tell to answer, Thanks who’s ahead. going question. the go we’re the

all, DCC. me of excited first about let with we're just start So, we why out

the research was then Axsome platform and well engaged be So, audience understanding do is we believe of now design, what or that the have research how a and that highly believe sophisticated and to why, enabled is we about on we because higher really systems for did they that then once points data of start believe engagement and impactful. approval will with believe more physicians a any to call our with to patients. be we in terms point, this ACP’s deploy – that collected have as platform are do XX:XX you that, salesforce get will we for, extensive machine as approval did or And both When more came it's KPIs points give that that order integrated. XX:XX that meaningful patients, with ACP XX:XX put together. will close platform impact technology we that is whether that the to we're engagements different that, additional developing metrics and metrics I or and patient of we tracking. on discussing fundamentally, and efficient. that the can reps be it, to data achieve And planning be want we we touch size, around it we'll to synthesis the that's but what more. with And technology. latest we goal details uses It any we a In to be that incredibly analytics, learning, way digital nature that's the several given integrated is how platform And that fairly and seamlessly AI, it and meaningful

Operator

XX:XX you. Thank

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

now is line open. Please go ahead. Your

Myles Minter

XX:XX questions. the taking Hey, thanks for

whether have now call I also randomized and is how Just study portion on the what's have than [indiscernible], wondering the into that definition relapse? on what and withdrawal event whether lapsed be rate you right different very the it's classifying just you are stringent criteria response disclosed is XX, I'm less driving for what a scale maybe of the here predicted? or you to not

Herriot Tabuteau

XX:XX Sure. Amanda?

Amanda Jones

question. Sure. XX:XX Thanks the for

note standard make want Alzheimer's disclose to top-line the that that, this study. we do include of We measures yeah, study the we'll response results does of release So, when the agitation. rate,

So, similar of with are programs ongoing. that some the

Myles Minter

Okay. XX:XX

safe say agitation? of event just a it So, [indiscernible] the that to is or is but it it relapse is measurement, like an

Amanda Jones

by date. is XX:XX driven definition formal definition. a definition Yes, so the we'll just driven formal – later at data We're there which be releasing is full

Myles Minter

in then I And Okay. obviously press the was not to all and did wondering is? FDA, are XX:XX why got on you've got review, you the reiterating Cool. as XXXX I we of timing change that first talk And the your to guidance we release, but I half just maybe so expect messaging but restated it guidance that's I'm know when that don't than yet. we that that as to life, point just rather you withdrawing here? curious just won't too, the why to just go change, changing to

Herriot Tabuteau

XX:XX Yes.

giving I prior is guidance. incorporate try So, We did for our in some reason think that buffer. the to

active is appropriate, appropriate, change change update of guidance, don't our reason for do did fact see there our but and in this but change any And that but as you XX:XX that is reason want guidance until – yet we it. formally that coming to to it process sure providing to terms any the we we advantage that want want may to with FDA. dialogue guidance. we We to will back now, We and is currently, then make and the have take guidance, we the be to an an see so don't of design guys fact that alert it to the study may folks

Myles Minter

Thanks for the questions. Cool. XX:XX

Operator

Thank. XX:XX

final of Our Hoang the line from comes David of question SMBC.

go Your line open. now is ahead. Please

David Hoang

question just you on that launching managing XX expect of And guys. successfully how support to the sales Hey necessary expectations just then numbers the of unusual MDD? offers given with I in you, sort fitting with you launch in are contingent situation force there us for force Thanks a can for MDD, AXS-XX the sales had XX:XX here. the remind me review? are would the

Lori Englebert

Hi, Yeah. Thanks XX:XX question. for David. the

out couldn't sale of we're will have cover there more our out of size, that yet. In personal that we just will of physicians promotion improve our roughly that is reveal space. what Well, XX:XX to of XX,XXX are the X% give field, the field we we acceptance statistics just rate applications hired to a on – you So, that field operating XX:XX than in to So, MDD were the have physicians. that in leadership equates the less leadership the we we reps salesforce disclosed high the the delay of several done not them excited months engaged HCP’s highly tell number is have but contingent sales team, to past XX% the that what over only best and terms with best of keep really extended I we the prescribing and get to I and the can the proud the about hiring the you they've be their But to in not opportunity. offers, launch. the also closer build we

David Hoang

the XX:XX so much question. taking Okay. for Thanks

Operator

I team hand management concludes closing question-and-answer now the you. to over today's That remarks. session. Thank XX:XX for will

Herriot Tabuteau

call leading today. you the for with joining new the thank advancement product depression distinct of and approvals our on potential migraine, again CNS year for Well, Axsome the two is us rest a all for potentially XXXX XX:XX also and the pipelines. for industry pivotal of

year. the forward or potential great late our XX:XX you development. all-in-all, four bringing committed serious are conditions. these people are changing developing continued in six review CNS progress FDA stage So, look being We under candidates we We throughout to to keeping on a with day. indications, to which have in living pipeline live either medicines updated Have

Operator

This XX:XX call. today's concludes conference

You disconnect may your now line.

We use cookies on this site to provide a more responsive and personalized service. Continuing to browse, clicking I Agree, or closing this banner indicates agreement. See our Cookie Policy for more information.