Axsome Therapeutics (AXSM) 8 Nov 212021 Q3 Earnings call transcript

Company Profile

Participants

Mark Jacobson	Chief Operating Officer
Herriot Tabuteau	Chief Executive Officer
Nick Pizzie	Chief Financial Officer
Kevin Laliberte	Executive Vice President, Product Strategy
Lori Englebert	Senior Vice President of Commercial and Business Development
Amanda Jones	Senior Vice President, Clinical Development
Charles Duncan	Cantor Fitzgerald
Joseph Thome	Cowen and Company
Vamil Divan	Mizuho Securities
Ram Selvaraju	H.C. Wainwright
Joon Lee	Truist Securities
Marc Goodman	SVB Leerink
Vikram Purohit	Morgan Stanley
Ashwani Verma	Bank of America
Matt Kaplan	Ladenburg Thalmann
Yatin Suneja	Guggenheim
Myles Minter	William Blair

Call transcript

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Operator

Good day, and thank you for standing by. Welcome to the Axsome Third Quarter 2021 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session [Operator Instructions] I would now like to hand the conference over to your speaker today, Mark Jacobson, Chief Operating Officer. Please go ahead.

Mark Jacobson

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

press corporate quarter Our on providing our time release, earnings a available is financial the a on for ago crossed and the at update results the XXXX third axsome.com. of website wire short company's details and

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

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

Senior developments an Vice Herriot of Dr. Commercial President Officer; Development. the Product Laliberte, will Business President, Joining President Pizzie, and me milestones. Executive on then upcoming of the Officer; Senior company Amanda Clinical first and Dr. and recent Dr. and Lori Chief today review call Kevin of Engelbert, provide Jones, Development; Strategy; Nick Tabuteau, overview Vice are Chief Financial Herriot Executive Vice

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

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

Herriot Tabuteau

joining Thank morning, update third you, Good quarter XXXX Mark. everyone. conference for results business thank financial call. you Axsome Therapeutics' all And and

for disorder. months, of update advance our candidates lives first turning candidate, will continued Over differentiated patients. did provide control the to XX the prior application aimed informed on Starting The have take and year. who that a II/III late-stage which depressive pivotal on addressed our in development initiation timing update. proceed the which Based major plan. the Phase proposed trial clinical FDA half smoking the a to on confirming current undergoing Phase And product disclosed, is in of NDA completion the the related positive the to chemistry, the must FDA Alzheimer's from AXS-XX I August it review the meaningfully our previously a the meeting at manufacturing on PDUFA development agitation. improving and pipeline to trends, product trial date to with details will the With not in FDA. an past several developed of as analytical is feedback, deficiencies also of The of we section request two for on is enrollment agency based review received and action syndication regards a FDA deficiencies treatment III we guidance the CNS on action NDA AXS-XX indication with the these be of Lori, treatment on us methods the and to trial expect recently for XXXX. by the provide of NDA, lead the AXS-XX, before the ongoing. a commercial the are an to this we written is Enrollment in addressable NDA. of taking believe plan provide progressing. pre-IND cessation, this next anticipate ACCORD of the the being are We we of first trial to of in disease development

monitor product migraine. accepted our for multi-mechanistic informed The target Moving The patients migraine. details acute depression the AXS-XX, second living unable prelaunch the AXS-XX provide health of candidate, of AXS-XX. prior our the a that launch the rich to on in this an PDUFA situation, due continue you also was readiness travel for in be and date. facilities The will complete the informed action of for as keep commercial on of travel treatment restrictions, two a AXS-XX two in April near lead may NDA for Lori, a term They and position well us for review to commercial with has NDAs manufacturing review, FDA, to for Axsome one COVID-XX they date pandemic-related AXS-XX FDA will XX, commercialize advance. treatments rest pipeline developments of on intermediate to continues With XXXX. inspection to to is to any restrictions, front. PDUFA new as by with we will to potentially public our activities and active under our

XXXX. quarter. our SYMPHONY AXS-XX, is progressing, line developed Enrollment top initiated results in in the for the we being product anticipated treatment narcolepsy, of a Phase half III candidate in the and the first trial For of are third trial

who manufacturing For to other we the treatment activities, of candidate to a on status XXXX. of update. related Based NDA of submit are will and for NDA planned AXS-XX, ongoing. fibromyalgia, now expect turn provide call in our now the these to I submission will product the commercial over an Lori, activities the the

Lori Englebert

on good commercial that And relates activities and Today, launch our give as for morning. it progressing to prelaunch update I AXS-XX. for readiness will AXS-XX an you activity are Herriot. you, Thank

launch opportunity has stated, this Herriot we the of been depression. from preparing As potential incredibly to the AXS-XX bring actively the and for of about millions for patients suffering remain market commercial the to excited product team

published crisis. been released increases global climbed receive should Most US dramatic in middle a stating we prepared study and Multiple ready mental the have approval. in in the depression remains are pandemic. COVID-XX studies The recently, recently, due worldwide to by Lancet We health a devastating at people of mental XX% of Awareness that the more about high, depression effect COVID-XX rates XXXX, showcasing are an pandemic. is talking issues ripple all-time today health showed health than a and of mental in of ever.

is affected. Given new the an burden with and option support those many be associated there approved, economic treatment conditions, bring would living mental the personal with important health for need to undeniably AXS-XX to Americans urgent If depression. an

approval. patients meaningful We are to to innovation by after product the prepared and this soon bring commercializing a ready potential

purposeful the intent innovative important bring and way. commercial a to meaningful to market new products is Our with launch in strategy

This understand information have needs and We informed undertaken care treat the patients great the efforts who strategy. our professionals has of to health them.

commercialization execution. and designed to or technology-enabled and ready digital-centric is DCC increase effectiveness implemented, efficiency tested marketing for Our of platform our fully efforts

platform efficient reminder, our our I a DCC with use and enablement was a team meaningful and designed physicians we systems have fully to As digital allow leadership and with more and combined for to impressive that stated staffed. tools, patients. streamline quarter, engagement field effective, data analytics sophisticated Last

for complete At have talent to this been the several accepted top a force working positions. our sales offers recruiting on formally staff team. representative field time, Over months, we have hard past they

anticipate are by certified board, having trained all approval, contingent the representatives approval. event and All sales offers of In upon on launch. a we potential

with profile to with team ensuring experienced Our of pipeline highly clinical forward after and ongoing permitted capable access and in engaging continues market We immediately AXS-XX. engage approval. Axsome, payers awareness look discussions, our payers the of to

marketing teams services been patient and have potential all ensure support approval. and in patient and of Our for comprehensive execution marketing implemented hard working are ready that anticipation materials complete, our support services a to

on readiness launch Our AXS-XX. have heavily preparations been focused

launch AXS-XX XX migraine, are for a tremendous along well and for an the also a disease potential million DCC US need However, initiating actively Marketing acute continues debilitating AXS-XX of of discussions. payer to adults. impacts integration we underway, unmet estimated have subsequent are with preparing that and permitted activities a treatment

the dissatisfaction for The still patients close a the about profiles potential treat available differentiated that AXS-XX AXS-XX market with them. a to potential currently therapies. benefit physicians to enthusiastic who bring have opportunity both the AXS-XX significant to are XX% clinical rate bring could that and sees to and We

excited now important new and over our bring products financials. meaningful about it will these will opportunity to an in turn innovative way. potentially I We market are to review to the Nick, who

Nick Pizzie

to in We the remaining million per XXXX. activities the And $X.XX were Today, cash $XX.X a morning, $X.X to share guidance. was quarter from for roughly G&A in We potential loan recently and along capital completion We $XX.X second through compensation XXXX. AXS-XX million XXXX for increase [ph] expense. or XX, Net to loss launches turn loan period The announced we XXXX. million current the trials compared expanded the million period to call $XX.X were the quarter personnel FDA million ended both The cash comparable Lori. commercial operations position $XX per I [ph] operating XXXX expense, NDA-enabling have our at ending for XXXX of in clinical $XXX term with $XXX I the decrease and facility, the now in decrease financial September XXXX facility our believe our R&D by review. quarter our share is for XXXX $XXX third fund million our That of million, results comparable prior September XX, sufficient net related comparable flexibility quarter XX, everyone. term based the the in pre-commercial thereafter. $XXX you, access financial our million $XX.X the the million. primarily plan non-cash in in driven good loss R&D $XXX quarter were to was at the AXS-XX. Mark and expenses million our and that approximately expense non-diluted will that or committed third compared us for upon Q&A ending Capital some lead September AXS-XX provide period. of with million gives concludes discussion. in increase of end additional approval additional $XXX period to for with capital now stock least available $XX.X anticipated quarter, a million MDD along on committed of an Hercules back the was into with $XXX expenses quarter to million for XXXX. current $X.XX This anticipated ongoing to an of million comparable versus net discuss third with approximately will Thank ended financial and the

Mark Jacobson

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

Operator

[Operator Instructions] from comes of Duncan Your Fitzgerald. Cantor Charles first question

Charles Duncan

Are terms in Herriot I'm a that be our you could if were what us on if morning. that address be experiments address color, with question. or kind if mentioned, be any to team of and need bit months wondering provide Yeah, clinical do for or and analytical the able guess, able there to the that regarding you Is these deficiencies. what the so or you the you AXS-XX more will, it good information are update to that Thanks, additional at? and run non-clinical for you'll that to Yes, would looking deficiencies on so, have timing expected we taking I hand? And of quarters? think you little

Mark Jacobson

it question. to turn to answer Yeah. I'll Thanks, Charles, for question. that the Kevin over

Kevin Laliberte

thanks the question. Many Great. for

that update our communication understand just items So methods specifics manufacturing fully to process will still actively working the note and requested. in the we to are that FDA I that an But they that to to the has we the the they now. give FDA we specific are the to understand attention. right analytical are resolve update, the brought with on

be So in work to for we would near from be solely we And understand what agency to it point term a expect intermediate based those resolution. complete view on manufacturing of methods the resolved at our from this time. on the

Charles Duncan

helpful. That's Okay.

you it ongoing anticipate So studies any candidate? don't product with impacting

Kevin Laliberte

an that ongoing - have impact on any We would studies. anticipate that, not would that

Charles Duncan

discussion then the I'm that landscape? when mental of Lori Okay, therapy treatment about think AXS-XX paradigm and of really wondering, super. about But versus, for its health of increased treatment maybe burdened my that. someone certainly - for wax about say, MDD. How historic challenges chronic role more lots patients. highly the intermittent I has question philosophical and mentioned And team do treatment future paradigm, awareness the you and to how relative guess Herriot landscape daily the on in philosophically in think on an you to second is or the

Kevin Laliberte

that symptoms, those as label treatment and but inadequate the studies We're look response, landscape. have in role both excited know, as conducted about of just of meaning, and XX% well potential with the the the landscape the as if have the populations. treatment in clinical reduce you leaves AXS-XX could also those in improved well remission, shows And rates reduction various and The as of that meaningfully of vast responses. of is AXS-XX terms you majority controlled, as multiple been patients patient parameters and landscape now, of treatment Because That the rates product not it we of at studies the the current with open definitely response. clinical impact depression of remission.

treatment. well And So exited gamut those as we're all a with to treatment-resistant never depression treatment. have from types product the treated antidepressant that equally who've so of in have appears studied of had an spans multiple really patients to with who And far that. lines of breadth reminder, been about patients the totally the perform of the naïve we lines patients

of which to benefit is action, clinical that seeing. the other to we're aspect the notable we which is the think So mechanism our is contributing

you a is health to we're pandemic incidence Lori, only a needed which we're you given as not have anything the the to the know, large timely of that? population, really developing so by add impact on do the is be And company, depression. of a - but increased percentage which to mental product, of excited

Lori Englebert

and But should of these Charles. gets believe bode piece, that what bit need we market onset people Sure, studies, the I based extensive little product off of really only an for you remission has HCPs I'm think love to perform given undeniable discussions durability in And about research a concerned well us. are is based action is amount physicians of always a we lose an [indiscernible] that not really for and of But what is way, rapid of it, patients. with durability. that the about will off I shown sight several state durability our

Charles Duncan

update the Look for forward added Very, to color. the Thanks message. good. day. the analytical on Good

Operator

Company. comes with Thome Joseph and Cowen question Your from next

Joseph Thome

Good you earlier there spurred you that you're deficiencies taking deficiencies Are one, for Maybe have that there. with FDA since questions. Hi, first these resolved the morning aware our only other were deficiencies. and on the thank Or the the that given be just the the going approved how co-label that on TRD resistant be launched, leverage [ph] of? best second, refractory And Thank sets you. then of maybe and data AXS-XX some is for can to MERIT these data, should and you patient MDD? letter?

Herriot Tabuteau

Thanks for disclosed regards Joseph. have today, the With we to these the deficiencies deficiencies the that only been are question, we that made aware of.

the on with be during does working clarity as to exact more could obviously, FDA, the this pieces So that we're that the There be we've only just the stated, could will deficiencies the clear. information or mean of But get are FDA ones, request or only not response. the only to these be these review.

conducted. not clinical we with have we So in TRD that MERIT generated, regards we're that in any not making other And the but study, predictions. to trials data just the

do clear, additional care MDD, and the treat physicians we indication is of mind professionals, see all to make of to how it be patients, because as up will sorts to kinds and patients they come their their so for will we've that's think data that be we the generated, that indication. best under currently who them review inform are applied will The them, up for Let's to patients. other to and we health that all have

once it full which It to is how the perform. breadth MDD it encompass with So MDD. product with is we focused to is be clear, practical the we're that trying with broad, are indication is doesn't the But patients regards of may and answer nice. questions the indication, and to available on

Joseph Thome

Great. Thank you.

Operator

Mizuho Vamil from with Divan next Your comes Securities. question

Vamil Divan

and and Great. FDA question around responding about can insights share you like my why have getting I of maybe had. wondering much taking a it's the out just questions. formal more when a any call I'm sort Thanks but Maybe unusual Can just of other for FDA, can that opposed for maybe way the as process an unusual deficiencies far this one bit. it curious the give why a just that more here? just ended seems you're you it to complete you - for that then question how I'm you the more if here if of guess clarify the timing anything these? Do in shifted to an second up so third mentioned. through little CRL and going found And be into you the companies you had – to going sort Agitation why the longer a previously looks on its like then [ph] And on trial Thank path sort that just of has that terms was timing the you point? trial, kind thought. little by of I exactly is bit enrollment the in the are when that's you update completed changed just of you. And out you taking in at of to

Herriot Tabuteau

to the the question on by and that the trial the for answering of how there. of other aspects Amanda, provide [ph] trends who'll unique questions. questions. I'll But some some first the Vamil, I'll turn enrollment maybe over impact trial would Thanks, Agitation start color your inheriting and

the terms FDA from got on of recently when these deficiencies, them. communication In got we we the the of timing

get So of them, since very that details and on end respond. then could October been we to so we've trying specifically

those still CMC including as But is received. So an unusual requests receive information, in details. to unusual discipline of in is NDA the FDA might of review they nature in the ask situation. actually we unique that additional whether for where this and from during you information any of not be have a the process, And as what it getting terms we're process this characterize remember,

as the of unusual this itself. and So we view information request in don't FDA from

regarding your disease and Alzheimer's helps answer hope that, So trial. to it regards answer over will turn to around those Agitation that questions then I question - Amanda I'll to points, the with the

Amanda Jones

Yes. thanks. Great,

a point the great about So Agitation trials.

randomized then where So is is randomized and number as are study, completion this which and actually a withdrawal X-period so relapses, a really upon patients study enrolled it's occur. trial reminder, the a of a contingent

So study, tracking to way anticipating variables, study we first all been are the the those the half. based of complete we've in the upon

slightly a all to different just these we're again is study it's design, So related which that metrics tracking complex enrollment.

Vamil Divan

you. Okay. Thank

Operator

Ram Selvaraju from next comes Your of H.C. Wainwright. question

Ram Selvaraju

taking for much so Thanks my questions.

CRL issued, So would to that's II? just Class whether that be deficiencies to the just what point at at the have clarify without resolved if going be some can the for the is AXS-XX? already not outstanding given currently issued? as, to Class others CRL to FDA know. kind following or And on to I'm I this be Thanks. is AXS-XX that on NDA the you issued, be be CRL, CRL then on to of have I case, a wanted asked. going if outstanding, from about clarity saying the remain issue if fact, the you be of point going matters Or you know you resubmission if in currently classified think a what expect going I don't to ultimately, is But and what having

Herriot Tabuteau

the question. Ram, you, Thank for

not an your action. action, CRL would be not whether the whether is So first is that or to an is issued. FDA question - And or that a a be going thing around

determine we we and yet determine So don't - that. that,

and take one, or NDA our two Now forms. that, they release that could It an CRL. in the the comments, deficiencies must on analytical the a can can in opening has come with be press action. be action as stated to methods tell stated approval in And FDA what we either an will we've before these addressed you regards is

information what resolve is has the must to the prior - those the actions. to and I taking is that us asked to So do deficiencies one that them of that, helpful. done hope be FDA provide to

Ram Selvaraju

the that that the still clarification don't on I it you once kind the still of as issue odds ultimately that a you that to said, a want not see FDA you a still just happening But are. submit is a CRL decide right? agency the FDA just remains to when you clarify just what to possible, possible So CRL. us issue data for for AXS-XX Herriot, of submit? That's this they that what means that the information handicap will us that may whether possible deep not to

Herriot Tabuteau

would your clearly we're agency in you the I be why way is not is and - that has CRL CRL. what the would on not issue negative guess a the action as reason is saying in answering question posted, as hesitating is presumption The NDA. I'm if there just taken they the the a which that

also they've to have are before that's decisions, issued So that have a CRL. - not outcomes. very approved information the their they product. They not Those us they two means the like And indicated which potential that would requested. they they the make clearly

we are understand to We working expeditiously. what needs to exactly that make and we that sure response, that do will go into

Ram Selvaraju

just some CMC opposed that responses Okay. the fact, information characterization And to further pertains of in to this on product information actual on the assuming the itself. product based gave CMC that, in change as is requested. questions to then you being earlier any the I'm

would that to correct? further the but ensure product down ultimately which that other not any line order in approval, for not is may in not in this you indications ongoing would MDD, but studies, the seek bridging only is only clinical affect work So not approvable require

Herriot Tabuteau

is That correct.

Ram Selvaraju

to yet evidence program. follow determined in to And from then see be long-term program, of specific the up, this quickly the very cessation agency parameters including, Or to just particular, Okay. extent point? does long-term FDA smoking of that still on information you which clinical design at smoking Have on wants impact cessation? remain received regarding the this the

Herriot Tabuteau

was smoking plan the to of development AXS-XX agency's entire cessation. get input guidance the point pre-IND the an for fruit the get on to So clinical

trials the the of subsequent pivotal would that database. include So trials out the also design safety of and on

that trial. based a why information's, proceed we into do clear that which of out that is guidance on we we pivotal So stated process, very coming can have

do AXS-XX we're able think data that, been well the able about And very short-term and with long in can leverage, are both in term leverage excited of that. setting. the as indications. I generated And to the as to other we we have so been all we And has that

answer the yes. is So

and a I believe on think we lot to do the of smoking that that long-term AXS-XX able we leverage cessation. AXS-XX, information be have we'll the information of development safety in of for

Ram Selvaraju

And smoking it approval in an respect just that the And Phase cessation? before cessation has Phase a you be whether that to Or the if Thank for smoking study more a on of to of results already outcome is that have II/III the with smoking XXXX cessation program, positive study likely clarify, file of sense XXXX? to this end you. to yield FDA in agreed II/III the you would do event? be could able basis a the data

Herriot Tabuteau

going of trial - we've next the And is guidance two Phase filing We incredibly NDAs, more studies. will and of year. II/III of lot a pipeline, rich is these the just an we so purposes, the lot filed, part of guidance of and on be we for could which given exact three that looking initiation the a NDAs timing XXXX, that on we're provide planning that have further the depending on, we potentially, at outcome are currently

of scaling sure advantage in take of our going lot on. up terms capabilities can that these a make we We're there's of opportunities. to So all

our when can we'll that precise with to start do around and in, sure pivotal on provide next in like a trial. that we that that and And would regards confidence take have we would would make two be guidance guidance indication. that's And very the trial so that why time would the year. can to we And that we studies you these nature the we pivotal of need Phase believe the with II/III based we studies, trial guidance

two So one II/III will of trial those Phase studies. be the

Ram Selvaraju

Thank you.

Operator

question Lee Your of Securities. Truist Joon next from comes

Joon Lee

the for updates. Thanks

offers been near expiration mentioned And months midterm. Can all be approval. there stated Thank have on but You force, is Is that means, contingent quarters? that that then made you that resolved for to the the those or could that you offers? an what define you. they're deficiencies upon weeks, date sales

Herriot Tabuteau

let second Lori the question. take Sure. I'll

Lori Englebert

Sure.

so through the contract current upon extended the we're we additional is FDA, the been able how to thinking and their already caliber force impressive. offers that the So June, depending outstanding, as to their that clarity we've incredibly have states, - leverage from field are it offers

we so keeping in of timing would like can the really but able decision. before them, additional we to make terms need be leverage, to from that And FDA clarity we

Herriot Tabuteau

and waiting And what year months. feedback with further from that get to depends on regards that then it's Great. we weeks that the And means, to to the really midterm FDA we're on feedback.

Joon Lee

Great. then deficiencies? And to will have responses submitted release those you you once press

Herriot Tabuteau

are is still agency and you and it review. provided back imagine, of information balance a during the for with fluid we But we review can stakeholders in a the investors, we situation, that you, have also the NDA historically, that situation. want forth can not want to details So to as the AXS-XX. much fact the to to unique we given provide undergoing as the because to that And the situation we to fluid remains we it as with are with regards

and want to So balance we do disclosures also expectations.

be a play process the not giving review that We that process, would with do that, So by expect benefit play. don't agency. we'll the think the IND

do definitive intend Street the we developments. update However, on to any

Joon Lee

All you. right. Thank

Operator

Marc Goodman comes SVB question from of Your Leerink. next

Marc Goodman

I have questions. Herriot. Hi, of a couple

and efficacy off just on signed three think safety even or on has First simplistically don't of have if yet? about an those and the signed sections, the off all, FDA NDA portions you safety CMC, efficacy, the you with

Herriot Tabuteau

The be sections. as review. The the But - it FDA reviews the not that it the process. ask so process, does its if you those sponsors necessarily a which information think simple for for the would about simplistically, it main needs unfortunately, agree and I is what it just is does NDA, -

we've the which right we to. and discussed, around that's what is - now, requested, has information, So been and responding CMC, which are

We have FDA on and not gotten any other other notice from deficiencies the disciplines.

not got... have we So

Marc Goodman

that yet? studies to on something from they you that, don't whether don't know that you've you placebo-controlled know that second the of whether feedback you're know are with part Your good you do need efficacy, two that good Or enough, like respect it? FDA, got

Herriot Tabuteau

the is product. before review once I to their is is that that, approved that them. And our sponsors when think job the the they've is and respond fully job, to NDA, know FDA satisfied which are to they doing

Marc Goodman

and just the understand. that discussion about studies stuff discussions a - of I'm to been and aspect, the besides you the safety whether I trying there CMC, understand any there's had other yet? - that your the

Herriot Tabuteau

been has FDA the reviewing Well, application. the

the So NDA. well was know of your specific off until signed the they sign have have we whether off, application And it. had on they safety process and question the certainly portion of been any specific approved any not reviewing don't I the of they as efficacy think whereby or as aspects they

Marc Goodman

Right.

Of safety the been is, FDA back course. forth on interactions there have the better data? with data the and And question maybe and efficacy

Herriot Tabuteau

expect agency, with been has the review. as interaction there Well, of discipline all to the the would stage given the one the NDA of

Marc Goodman

We're in forgot, needs. I the methods. we're to I And the I exactly I but woodwork you were the to thought did just here and out response update the okay came to secondly, kind too, to have CMC working CMC first the out in think that what we surprise okay. been was trying us? analytical that of there, flip presume I FDA Q&A was And section. question, the to it the then thought might so still figure of had what

that comfortable needs? exactly with feel FDA weeks the what you you're months still can it's how when comfortable to So not

Herriot Tabuteau

the medium is the to so or then to the reflect that term go other into near started get and it we get ongoing And particular around job ongoing. months at job requests that to regards we them, months along of review, they - is to actually, occur weeks more we're terms fact of the FDA need So really complete we respond the of and review depend And requests the what to as It said typical to the sure weeks reviewer our to for on part is it as to the is term, we specifics way, that complete. which when sponsor, And depends information can't doing. the your need why is is would and on we - in depends, to the will from the to what does the that predict the rhythm reason or so it meant what least CMC, review. adequately work the make response. And it to sponsors our are. us for with then is we question those

Marc Goodman

good a it you to these needs it there? in characterize better? analytical are are Herriot, little the two as method manufacturing to an What deficiencies about exactly And be? what talking that willing demonstrating you is as are Is help

Herriot Tabuteau

So finished analytical to relates methods testing of product. drug the

So we all. relate at does mean our process not to tablets. manufacturing the This

methods can those the you make would are we And we narrow make pretty are can and do. analytical we to range sensitive, it can more be less sensitive range. or think less can more are we things or have addressable sensitive totally responding or that and And request, those more or you the what sensitive. FDA that the And robust, to robust so and less a you broaden robust believe process, we

Marc Goodman

you. Thank

not is quick question able sites you say both was the can off confused So of on understand, have signed be I the might migraine, a that enough? us comment. Just you the be filed? to by manufacturing be on be help by little date? to you're one one Thank implying just your Do PDUFA two that one did could and you. one you

Herriot Tabuteau

Yes.

respond who to Kevin, sense it terms to But there. So give I pretty the over is trying that. a FDA it's what straightforward on in - it's I'll to think of turn will

Kevin Laliberte

Thanks that question. for

FDA required manufacturing that of So specific States PDUFA The an inspection United the sites AXS-XX. location for us is in there based that because be involved that us them, as obviously in may review notified in one prior to multiple are to is process. that the COVID-related process the part manufacturing And notify before restrictions, the did of happening then they of date. jeopardy have

States United notified that the in specifically of in based manufacturer they us communication. one their this just it's So

Marc Goodman

you. Thank

Operator

next Your Vikram from Purohit comes Stanley. of question Morgan

Vikram Purohit

taking Great, Thanks for questions. good morning. our

side. our from two So

going to for MDD. back XX First, again,

one wanted just around clarify next I question to steps. So basic

looking the So are you've a in to hear to is waiting you're which questions preparing take response feedback submission got, submission, that now after clarification question then a then get And some agency for around Or secondly, you and initial be submitted And I and beyond on the months? the for? fibromyalgia. to you'll might on what weeks some the back? agency, clarification specifics could just you XX, to situation basically that more had AXS-XX

happen is just between needs Thank of So wondering filing? if kind your release now to and enable in was walk then could through a what you. NDA us And expected to mentioned submissions I you XXXX. that

Herriot Tabuteau

Sure.

we the to regards correct. that - with So is question, first

reason agency. to We what it sure And CMC. of exactly to want their is to submitted assessment that is with NDA we that the when the we the to response and need make continue regards is they have the that adequate that respond questions clarification for

exactly don't looking want have and and a we not to experiment submit response an what So rush to to do it they're for. or be submit

fibromyalgia, to So needs are you manufacturing. what AXS-XX so is that And primarily right - now regards correct. for happen with CMC to

chemical a AXS-XX reminder, which also the a new stability synthesize then are we is have to material, we working and the entity, As so do do generate data. to

most the the do in filing has steps with determining certainly and to manufacturing. So the rate our of work NDA

Vikram Purohit

Thank it. you. got Okay,

Operator

Ashwani Bank from Verma question next Your comes of America. of

Ashwani Verma

for Thanks questions. taking Hi. our

think you So your there's I handled consultant has to deficiencies, be specific will on some first your or that or able a such team have that lot my have team us you this? that seems which regulatory question. partners of me. any through external you give navigate can any before? situation to Has That's or I complex wanted understand, to a discussion pretty I mean like confidence

or that? on here just from redone? characterized just downstream Or findings does you method to anything analytical need you deficiency second better some of need be The that in to that? so mean one, that terms specifically, that the this needs the in method, Or experiments resolving that be to had would what the Would redo it? of

Herriot Tabuteau

are the answer is get as we sure reason this why making the those to FDA we that possible. So questions, as from much clarification

- that's doing. we're so And and what

back with all, that get believe of want And just clarity from they say - So you are so themselves and we to the that step first we the deficiencies did we of FDA. if addressable. then regards kind actual to

of lot that. So right this confident type of - review. unusual why if requests in situation. But an now unique PDUFA and very request we're discussing given you is it past we're a NDA The and the these is back, because during step not or only we're reason

But other of during much review to unique the nature are which review request probably as guys is So during NDAs think types the of a provide cycle. we sponsors the These up to themselves relevant normally, that year normal want as possible we come unusual. this the situation. requests information are you not of would

Ashwani Verma

different market, focused to a prescribers. on or lot up like reps prescribers the or build be? and the I - said, market? - you complete, I Just many Are is a What's of this we so follow big a mean types you how going your force subscribers cut is ways of other dextromethorphan to prior quick approach had talking? branded field are any

Lori Englebert

Ash. Yeah. Thanks,

HCPs will From promotion when will in also personal don't that's will promotion what to of high a disclose be you additional to we prescribers that basis, will more I the of the to the algorithm they promote high-value we complex to I are, want prescribers cover greater size a what the But HCPs. launch. nonpersonal targeting speak get XX% I'll determining tell be believe value but right marketplace. a sales very So now. we personally basis. that of on force And will we than prepared XX,XXX

Ashwani Verma

Got it. Thank you.

Operator

Your Thalmann. from Ladenburg Matt Kaplan, comes next question

Matt Kaplan

guess, bit deficiencies more going on a unusual Hi. process. Thanks the for taking little this question. the to I

deemed or CRL. could issue beyond of either be FDA given going a date? to new guess You they FDA just a the a specific with be be we're major could this questions going the process a mentioned that, situation, issue that PDUFA to would you product I to date? your the of just there's answers running amendment? kind unusual the you're new - without CMC the Or And action action - potentially approve the through

Herriot Tabuteau

- date, The is which there an question. the issue. misses the so PDUFA date, when for PDUFA no Matt, is FDA Thanks, a new

Matt Kaplan

commercial question a guess I And helpful. That's with to preparation. respect okay. Okay,

Given what's or the profile unique your what's your and feedback XX, about of thinking what's of sense at terms potential potential payers coverage - point in this from the pricing?

Lori Englebert

Matt. Thanks, Yeah.

not and have once frame. previously the final permitted April And mentioned, time payers directors discussions all payer in discussions national have highly but a I field until we having account approval been discussions we've So encouraging, will engage label. in since our had with we the after about

that product is at launch, sure prepared In our value that market. make that terms pricing, of brings but patients we'll those to to the goal be reveal access but capture receive that to we

Matt Kaplan

Thanks taking my for questions.

Operator

question Yatin Your next from of comes Guggenheim. Suneja

Yatin Suneja

you. Thank guys. Hey,

labeling - more required inspection, Just that's the physical with - they're couple discussion enter maybe can or the you related then this could you the there me, that at addressing anything no of deficiencies? I a the satisfied submit is question. the the once questions visit and only more So any is to first FDA by but these we And analytical deficiencies CMC Or sure CMC you enter once to section, point? understand or for enter? analytical are okay you FDA prior could if into the when clinical method,

Herriot Tabuteau

preclude Yatin. your characterized us the for been The with regards questions, have Thanks discussions. CMC Sure. not as to by agency ones labeling would deficiencies to that

the will prior has if in Now AXS-XX. inspections, are done regular made inspections approval know commenting just And answer inspections, of been labeling of were question, we inspections when use be discussions. manufacturer any for to at or pace would need information of we the I terms rhythm be Kevin there of And which AXS-XX. in the to aware that rhythm which these that labeling of not don't terms the characterized not be as enter to ones But to on deficiencies are into preclude clear, your that not we discussions. we've

Yatin Suneja

it. Got

I - question. one think, more I Kevin, did a have question you -

modeling progress - color making price? the of and should field How or Can mean, you for the terms think commercial should give we in you with to the terms we in some you're maybe So a about obviously, approved good be Any it's of price in the in of how comp I once get consideration launched? see discussions? terms of in us launch. payer - terms

Lori Englebert

Yeah. Yatin. Thanks,

been was we we So had the until - the not have we with the to in discussions them a what with final will once and date, discussions profile, where discussions engage Axsome, permitted encouraging AXS-XX, those specifically mentioned, very in approval fashion but have payer in formal we consistent have some label. clinical introduced after

do a an unmet payers recognize bring that the benefits could terms that also does can the market be mechanism that recognize novel have price, In I need of great. marketplace. clinical of AXS-XX product think and They in to action the

mentioned we, of price goal approach the price, that product, that and I easy in announce a to capture way as our company, sure but approval earlier, patients be it, at that we value position will to the is that of access as we'll base. terms have in really to make a the the So product is

Yatin Suneja

you. Thank it. Got

Operator

time do have questioners. We for more two

of Minter Myles next Your William Blair. comes question from

Myles Minter

it, just labeling missed that that but for might we're deficiencies discussing the thanks the say Hi, questions. did you I not preclude discussions? have today did

Herriot Tabuteau

That is correct.

that right. So is

Myles Minter

Right.

preclude letter still that love labeling that discussions, but you're labeling makes difficult discussions? deficiencies the a question, received it the exist you or stated they either for clarification Sorry So that that in I'd the did that. around currently question

Herriot Tabuteau

Yeah.

through to do get parse possible So the provide we've to trying the what it. and no, we you get we're soon thank you you information that trying after as for the as we done is and And question, what do to situation. appreciate we

And have so we received. that's the information that

prior And we've now the some disclosed the gotten on deficiencies. we So we information disclosed letter. have also that fact

this the information now that don't are So deficiencies the the those previously of past. if ones if know we are is have. to deficiencies were these thing referred or But which a we

ever all the their process. we NDA help that And we've encouraged are ability a so that that's to done questions will that review is FDA the in have actually because as information wanted whatever address sponsor we're this there

Myles Minter

is current that filing? Okay, level the does cool. XX on the XX, filing just one Final for in the me the measures carry NDA analytical as for same manufacturing

Herriot Tabuteau

Kevin?

Kevin Laliberte

with distinct not over necessarily different Because active XX would the molecules carry specifically. the they are into components, products application

Myles Minter

guys. Thanks, Cool.

Operator

Truist Joon Lee from Your comes of next Securities. question

Joon Lee

the of Well, been product analytical method some relates questions thanks further for I've taking my itself. the the is investors, follow to up. not product I but clarify which getting from just characterization to that wanted that

can said. you this that's the that did what whatever means. about is, mean How Is nature confident second the be clarify itself, the related disclosed FDA is deficiencies you think what to you October. And itself? you product got the I August, Or you not the that not that know you not Can letter from that or but question by the late product let in earlier? deficiencies the FDA the until of correct? were happen

Herriot Tabuteau

So comment the the around analytical methods.

to So we the -- methods were finished analytical the and process making manufacturing a distinction test goods. which between the

the was analytical so they The analytical distinction. what and And so tests. method process, the it the that's that goods, that's what test, finished

regards is to do - with then tablets other the itself. are laid correct. that these not out, timing In how And deficiencies that the made. relate So the words, manufacturing you've to process the

Joon Lee

you. Thank

Operator

now to Thank conference the the will back over you. I CEO. turn

Herriot Tabuteau

keeping life look progress. a on to the indications, thank CNS again, built for in Have conditions. day. We're potentially with pipeline industry. working forward to bring these the to live focused serious you CNS updated continued medicines hard And who the are FDA changing we X great joining we pipeline people us believe our foreign being call either today. have in development everyone, candidates Well, you review, leading that which developed six we With leases on under

Operator

Thank call. you in for today's conference participating

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