AXSM - Earnings call transcript Q1 2021 | Axsome Therapeutics, Inc.

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

Operator

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

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

Mark Jacobson

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

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

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

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

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

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

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

Herriot Tabuteau

Good mental assuming on timing CNS all the Therapeutics first in fall will Thank second this the to into for Health of quarter. for morning, NDA groups, people a strides to the Lori, call PDUFA to make treatment of team target conditions. delivering proud filing And living MDD. dedicated The focused the for candidate a a work XXXX. The Financial First of Update Call. with acute late and and of Mark. treatment The of NDA partnering was action the date is of you, acceptance lead submission the up Month we or becoming the for the the serious filings product And approaching we launch joining With the has life NDA Axsome biopharmaceutical with August stage. by to by quarter, thank is with other Health company Results advocacy changing potentially this Mental observe NDA premier target submission for helping PDUFA with set review The decision readiness commercialization announce provide its on And NDA third FDA. on granted some priority pre-commercial and AXS-XX Quarter Conference Mental to coincides awareness May details raise Axsome track major for date AXS-XX resulted Axsome activities everyone. CNS FDA health Business quickly with continued and to In FDAs to depression and is XXXX living medicines expect Month significant XX, conditions. you our August support towards as regarding people successful FDA review. quarter. for NDA Axsome depressive the of migraine the ASX-XX ensure two disorder action our in for

Alzheimer's our in for Phase is continues and of of developed rest an agitation differentiated For late-stage pipeline trial disease the is also III to core AXS-XX enrollment progressing. treatment the advance. being

narcolepsy Our AXS-XX trial the progressing product towards in III candidate third the for early is Phase planned of initiation the quarter.

For feedback AXS-XX plan discuss awaiting with recently treatment meeting. from product our clinical FDA are the for the development we candidates of written we to further the and met fibromyalgia, its

indications under of development Our percentage unmet portfolio a four late that state comprises distinct needs medical representing for candidates large product six Americans. affect

commercialization turn to planned will are We update. patients call benefit a approach. now energized provide to deliver significant by will over commercial who to and the by our I potential their Lori

Lori Englebert

of at Thank on has our been commercial US you, depression rise activities prepare time Axsome Herriot to an steadily AXS-XX as successful in launch depressive morning I many you exciting disorder. for an adults This we will in The it Today, update for readiness. prevalence years. continue everyone. a to major on symptoms is give launch and the relates of good as

depressive adults have greater However, shown of symptoms. one XXXX, almost recent studies than increase that fourfold a experienced That's third in US versus XXXX.

awareness the a of affected. AXS-XX depression. associated approved, living would new important increase and support in rapid health mental personal conditions and many be There's to with undeniable economic with for those need option to associated Americans the urgent an result a an and them. If treatment bring burden As

committed means by about with customer type. fourth DCC in XX. I've or quarter to launch to with engagements the commercial commercialization be this a date used platform across are manner, a anticipate all August this Axsome's PDUFA We commercializing of plan of in to an innovation our year. culture, for innovative purposeful. timely expected the We meaningful the bringing optimize as launch previously is patient strategy and centric Consistent product digital spoken to

digital continues and past Our customers. the strong research indicate core direction commitment in as belief this with our focus has trend a amplified preference a only to year, and to over for in

year, and our platform, and DCC digital implemented. launch a we fully over with helping innovate. effective, Functional across I our leadership our extremely CNS desire physicians I DCC thought and condition. digital am am Using and affected to proud and tools, their of for of with by a market senior And now impressed the marketing, will commercial passion team, with leadership those in a platform continue analytics, all operations, more consumers. AXS-XX Launch to out is and sophisticated AXS-XX a meaningful are team system efficient past with we've our and QX on approved. launch. out commercial include activities breadth and infrastructure commercial for engagement technology a combines launch if access, foundational allow experience that for sales commercial streamlined potential build depth potential also constructed focused enablement Our are building data readiness capabilities. preparations The of place. Along

on will along will rep access on focused post hiring medical The And implement access data Axsome focused and to the and of promotional team Our disease education, profile MSL operations now payers team Nick, comprehensive at and market marketing continuing at ensuring and ASX-XX our PDUFA to and engage patient continues awareness DCC it our who group our both leadership lastly, level has with And congresses optimum over setting review planning. and size, affairs discussions upcoming execute has team concentrating launch The now permitted are force structure KOLs. on turn outside of presentations force as engagement commenced. and finally, services. in is financials. is our product of actively commercial sales expertly working vision. determined support design with up sales of to team is I preparedness sales build commercial, with the ongoing

Nick Pizzie

March Subsequent $XX.X related or $XX.X of along clinical quarter period compared $X.X this decrease quarter activities for million expense. million March application million fourth to period the Good our $XX.X Pfizer current the onetime confirmation that $X.XX the by share and quarter in million received in you, million XXXX, of some R&D to XXXX. million the the comparable cash has $XXX X in change end AXS-XX. fee. Net results charge agreement, completed. have net a the ended Thank to we expense and XXXX. of related application were request PDUFA The $XX.X in we in be R&D the to that the provide was ending ending for trials prior million license in business quarter morning, per expenses in our the the $XX.X to refunded a loss loss XX, We been XXXX of charge will or with compared of The with million cash, comparable PDUFA ongoing loss in XXXX, quarter, driven Lori. versus period FDA million ended for several our for the was at XXXX. increase of everyone. G&A we'll share a for small a compensation end has The period for first the NDA that guidance. the $X.XX quarter were accepted. XXXX And March stock been approximately the was subsequently comparable fee pre-commercial XX, million. for $XXX waiver include the primarily due the loss to expenses XX, $XX comparable quarter Today of financial submission net XX.X for from million per approximately first decrease roughly period the quarter, and discuss in were

$XXX which capital XXXX our $XXX in our facility on I That our capital plan both call we have on million anticipated fund potential loan turn based from remains We non-dilutive currently committed million committed to launches commercial quarter us available. reminder, to concludes and sufficient of at Mark position lead remaining facility, the along our cash anticipated now of funding Review. XXXX. back operating first financial loan into our least the the $XXX discussion. for AXS-XX. operations gives to believe $XXX Q&A with will million term current As current million, Financial a additional is This flexibility through a term AXS-XX

Mark Jacobson

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

Operator

Thank you. you. Thank [Operator Instructions]

Cantor go Charles Your comes the Fitzgerald. ahead. first from line question Please of from Duncan

open. now is line Your

Charles Duncan

congrats conducting FDA really quick question PDUFA even the an Has you the haven't, regarding had anything? Fabulous. anticipate - communicated to upcoming in and the advance the Herriot if are Or morning AdCom? team, I NDD. Good for progress Would in prepared on XX date good they an a you PDUFA of for quarter. that? AdCom

Herriot Tabuteau

for Charles, the question. Thanks,

be communication any FDA from there gotten not have will indicating AdCom. the that an We

that let know into would a as regards with being preparation lot we'd possible. change. very that of as changed, as a AdCom, the that goes an for significant you preparations Now when there's And have filing be to soon position time in that work, NDA, can any gotten that if And filing be you be to we know, are review for cycle. the during upon an we happens there the indication review not would so whatever part have that and cycle. AdCom. that would we But for based the of AdCom's expected think prepared potential any

Charles Duncan

that's Okay, helpful.

would back Let the and preparations me Lori XX, I talked of then And imagine question also, then the differences the base? But in regarding ask When the sizing you on highlight quick you're address is hop but a any versus provide think queue. impact that prescriber field perhaps numbers, that XX does synergies in the commercial doing? optimal about in you you any I'll that some how that? haven't also readiness. can those for perhaps, And of how about the can you you color And force?

Lori Englebert

thank hear me for you Can Charles, you you. the Thank okay? question. Hey,

Charles Duncan

Yes.

Lori Englebert

bit a the under I'm weather.

hear everyone clearly. I So to want can just sure make

Charles Duncan

great. Sounds

Lori Englebert

as planned terms closely behind execution sales DCC we've Yeah, quick up that an as to enable assured in it's always as we're of how how follow everything includes standpoint to able very potentially from for from XX force. and a our platform, question. great set AXS-XX XX structuring AXS-XX our planning commercialization, an being been and well for we Rest we've

call our quickly ready So depression migraine is launch. quite physician. being so physicians pivot on originally will be and Sales prescribing AXSXX able depression in force There overlap bit a obviously terms we to when of and of is to at constructed whereas to anticipate our do

Charles Duncan

back to I money Nick, you the perhaps, know of could from here, last housekeeping. for we're sheet Nick we that getting assume US them when dealing and the the Okay, back, second government question agency. on quarter? anticipate just with in congrats that balance hit But actually this it kind would come

Nick Pizzie

that's Yeah. question. a Yeah, Hi, Charles. good

as in accepted have you the remarks. the waiver opening heard they So

So are reimbursement. now, waiting for just we

shortly. been I has X.X million be a that the process specific we to would back receiving should the receive be back. we and give receiving So when on it back started can't time

Charles Duncan

Thanks Okay, for Congrats sounds taking good. the questions. my on progress.

Operator

go Please Truist comes question Joon the next of Your Securities. from ahead. Lee line from

Your line open. is now

Joon Lee

on the congrats taking questions Hi, our progress. thanks for and

be the So that's sources. question that imply many by and many depression you necessarily fourfold But does of curious just people diagnosed are up. there be first are that Thank if medically as pre-pandemic depressed I'm is patients corroborated the prescribed follow - patients? is and you. I more claim that other than could of MDD say, who prevalence And to ASX-XX? actually diagnosable those who be represent level have pool a

Herriot Tabuteau

for the Joon Thanks question.

you we US or of adults major depressive at to about patients referenced, data, roughly symptoms disorder. which If the percentage at corresponds X.X actually the MDD CDC XXXX. you percentage That of of look or the with which that they've or measured, prevalence was look the X% in depression if

with XX% depression. or the then those same so the level and patients adults CDC of symptoms or of it's So numbers and US gone that to up have roughly

question these or the the well would correlate be So it to with MDD. MDD. prevalence point we - the of individuals original with did answer whether pretty with starting pretty diagnosed did of correlate But all don't not well the know the

Now like over I'd - to if see to to anything so more add she's to turn to that. got Lori it

Lori Englebert

Thank we obviously about X%. that that watch are overall prescription through something the what we question. do to drug either treated. It But grew know market to and is watching is the diagnose you. Thanks data XXXX, in X% for actively

indicate - would the more So are that that coming patients into

Joon Lee

clinical does the Okay, you and forward importantly, it's site. inspections And but for there. great, that and the question the shorten progress that the of the more looking the is sites, priority to review, numbers time manufacturing then that got great second

CMO? recently tell not? are? you. inspected level experience Thank And So bit been can you their disclose maybe whether Can if us you your a who about little they or they've can't, you capabilities and

Herriot Tabuteau

So expected so chip maybe get inspected, they they - our CMO had a a once is CMO least year. an blue expected regularly and at so

Joon Lee

Okay. Thank you.

Operator

Leerink. line Marc the Goodman Your next from from question go of comes ahead. SVB Please

Your line is now open.

Roanna Ruiz

let the the how for question. a the about of activities thanks the Mark, little your you cadence is Hi, scope what plan taking for XX AXS-XX. know line that payer us this and detail you're bit launch? educational of curious, for engagement is - maybe was the more on of doing launch programs Roanna the Could I the ahead

Lori Englebert

Hi, question. thank Roanna, for you the

from permitted overall are standpoint, on have payer the profile. as payers fashion those well and to producing really clinical Axsome on So Payers a extremely been a continue them engagement we as engage with interested. educating AXM-XX

system. understanding a there's As mental happening interested we obviously, causes crisis and America learning products are economic and in may that alleviate in efforts. personal health mentioned, more tremendous burden Payers, and the that about to very the help

Cedric O'Gorman

development. with are presence programs, educational for medical sponsored And had raise where product awareness sponsored based American And opportunity on significant metrics there's the of then the a clinical Association, we was directions that we attended received need the Association future recently around that terms conferences theatre the depending at regards American that on based all Psychiatric treatments the an to theatre programs conference. product to upcoming, with Psychiatric by a excellent from best amongst of And the we the have MDD, current and the state. educational unmet in within limitations accounts

more So can there's promoted. those of conferences where have educational many kinds we programs

Roanna Ruiz

to plan I do many yet. Got it, more if how you initial launch target accounts if can. the curious detail you thanks. one this XX? sure But of I disclose And wasn't at

Lori Englebert

DCC part for is was can reach we our sacrifice with tell of structure our but to platform. rest size assured, forces' it has target either great force DCC sales will a [indiscernible] been I maximize and/or question. developed The not set, sales Yeah, platform our for of quality long the it's position. help the now, and impetus that efficiency, you really what actually was our

Roanna Ruiz

Got thanks. it,

Operator

Your Vamil next Please from question Divan Securities. of comes Mizuho from the ahead. line go

now open. is line Your

Vamil Divan

Great, had filing around curious I'm two exception if if the thanks AXS-XX accepted just for the you've at just taking with FDA you I the trial. one review. Maybe all questions. discussions ASCEND that the could, priority and further got

that I then maybe of updates any been sort the to enough, of I around there's pivotal. surprises can just I the you assume saying you're trial if robust some seen big think from can recently, concerns just here. some would be XX, you we've on given regulators considered your And maybe file to second know, you're conversation just give quarter further us. just on be in update helpful. going the enough

you factors what I Thanks. in of into think the it's the year, FDA? maybe earlier pushed this remind pushed bit. Again of a can gating that getting little got are terms us and back submission

Cedric O'Gorman

we With is to it well, NDA, you Thanks granted tell priority - was Vamil review. the The regards AXS-XX was that obvious. and can accepted, questions. the what for it's filing

the in order to has substantive everything FDA conduct therefore, that clearly So a it review. needs

communications course, Of the trial, comment regards breakthrough on that also trial. remind a previously isn't another. on I there and we designated - FDA timely, in we're you we is considerably a disclose product. of AXS-XX, is we - on our one ASCEND federal sure update track this file to very And make did we've that trial working with or a there. specifics diligently this quality was have the specifics can't a the very that With to but way with any meeting to do The ASCEND we regards the stated, the team the And to quarter, filing. really as after much previously NDA declared

Vamil Divan

Okay, all right. Thank you.

Operator

from Please Yatin line go ahead. the Suneja of question Partners. Guggenheim next comes from Your

Your now line open. is

Yatin Suneja

little one. to So a the study? got that understand for that's time narcolepsy program? maybe it you bit, any factor number us It III Phase - seems timeframe the taking you thank initiating guys, the for Hey, Can like pushed help gating my enrollment question.

war for might market below that could can if the little sensitivity price have you help pricing do you you research? regards bit to tiers And do on point Are there you or where XX. keep might with seeing the is specialty could you a done what you you are Thanks. second what price certain would the the in comment provide? The and and copay

Herriot Tabuteau

for Yatin question the the thanks So - with questions.

it answer on we trial quarter. to pricing in regards the track third So the so I'll start to the narcolepsy question. are to early turn over that to Lori study, With

month into start guide will the initially, quarter then was So the the second roughly to first III we've trial slip third frankly, the Phase that quarter. and given that the of

that's a complex expect you Lori normal a as And well for study would III to with the regard within variability, planning with which So Phase trial. pricing.

Lori Englebert

Hi, along while for with a Yatin that question. can educating thanks engaging upcoming disclose observation, tell adequately are earlier, value clinical and of you make we to to congresses as obviously, I to data supportive launch. really additional as for working use with is profile do we bit sure cash what AXS-XX. payers. of for present premature that It's capturing that you us use that plan details And current in the the - the that around ensure we product. to pricing, to is that we closer information the hard any we But will are and - can the mentioned are payers timely But but continuing Cedric fair The

Yatin Suneja

one Lori, question sorry, ahead. more - go

Lori Englebert

to was just I answer and going copay questions. your patient support No,

easy services that sure Just we product receive remarks, fashion. as assure in I mentioned support you in prepared to to want we preparing patients to are the make that an - that

Yatin Suneja

I question Systems. is it. - have the on partnership with Veeva Got The Veeva

What and understand others successfully you that Are leverage talk it? bit, launches a launching what using can what this to platform. system the Just do? the edge gives done the successful there have you. going Veeva companies you little trying it you If in - this been have other maybe used the that how to product? are exactly platform does just Thank

Lori Englebert

for Thanks that thanks. Yeah, question.

them component. So all critical have the have platform, to in is are partnership keep we foundation our with world the with Companies now setting that important been in not leveraging the DCC a the mind of over pleased whereas extremely it's that it's we and component Veeva right DCC. only - Veeva for foundational

fed to add to does promotional working and reps, to be call. out real complement analytics to Veeva to effective back an to with the systems also sales that are sophisticated digital systems efficient capability and be We time data enable make fed a so and

Yatin Suneja

Thank it. Got you.

Operator

the go Your ahead. next of comes H.C. Ram Please line question from from Selvaraju Wainwright.

go now please Selvaraju is open. Wainwright, line Ram H.C. from Your ahead.

is Your ID muted. open. caller And now be line may

Mark Jacobson

don't we on question the why move So to we'll get Ram. back and to next

Operator

Thome Certainly, Please from your next Company. go ahead. Cowen question here comes Joe and from

now Your open. line is

Joe Thome

Hi, my for there, thank taking and good questions. morning, you

the touched this MDD diagnosis. in seen thinking been And about you The depressive then on increase the little looking at the they the difference can the are that what kind us or Do the certain first bit on trial expectations a base or here a formal the FDA is symptoms versus of you one, over or one symptom expect you. enrollment just case the are know I you past TRD you that that year my between a remind have of patients how MERIT impacted are most that? AXS-XX, carefully. Thank and second have

Cedric O'Gorman

Sure.

to the that as the a depression. - with study resistant Phase trial So MERIT to in remind regards enrollment, treatment trial just is folks II MERIT reminder,

a So randomized uses approach that study design.

the our to about that trial and And relapses enrolled. the heavily we AXS-XX. asked in waiting of for pretty rehab. then are determines that that's you occur Currently, so And timing question the

So more this AXS-XX? be for product is our know you specific like fibromyalgia. terms what Could in about just to candidate you'd of

Joe Thome

steps, of, kind most you. Thank there will was do on certain whether enough? of the III base next that your about Is expected terms then conversations the drive pain that another are in with And Phase what current they guess, package? guess benefit or FDA, it's appeared think I sort expectations. what in you your case a symptom filed of were I fatigue, Yeah, getting concerned

Cedric O'Gorman

symptoms to get the like so for we XX the to the get final minutes. meeting the we'll minutes, as feedback had we'd planned around FDA second more and pointed once but quarter just prior - in pain, the to written such for currently, to have participating with we incorporate We final And and met regards And say with waiting do we are general, fibromyalgia, items. current regulatory petite, symptoms Fibromyalgia for providing other endpoints other does studies, fibromyalgia details. you those [Technical any they to And Difficulty], but incorporate fatigue, out, it pain, in accurately as symptoms. but the not

there that is functional pain, But regulatory is obviously, symptoms fibromyalgia. a for other one which regulatory is So endpoint. endpoint, another incorporates many endpoint, example, of

Joe Thome

you. thank Right,

Operator

next Your ahead. the Chris Howerton line from from question Please comes go Jefferies. of

Your line open. is now

Chris Howerton

much taking Wonderful. the Thanks so for questions.

with I think is a to just lot - learn move does how forward? of plan question expecting it we're what MERIT more of us is them respect trial and have efforts kind would and The team I an of for been and key about that team asked infrastructure trying moving the when will obviously, the to the information the a as metrics more get in is have they've at the guess the to second the and devised might I the kind commercialization around have this soon, be give of the and point. PDUFA we we commercial But that August. towards all plan understanding So readout, commercial structure solid that? color XX

activities the at commercial that it in setting, might Thanks. that how information time? if So is alter your approved

Lori Englebert

Thanks Hi, Chris. for Thanks. the question.

you your around we and when prepared can that of where we'll information. size structure, expect typically launch, to in at that's disclose terms would reveal that So be

recently, at the rep been level, the of efforts we leadership applicants. the three overwhelming has response force our that weeks, is have amount quality in of the the The level. you field the of past well sales tell for can as as I as within applicants as what well terms started the think, hiring I

it that we'll response we be then to of pleased that have great insight timelines we've our quite as set our we to received, and vision. also right make well that meet. the that sure we're unique people able meet approach the given the in type us So positions as at gives And out

start In can that will metrics to launch. the around to - you measure of success us we at to going how rolling launch, thinking about expect terms closer we're

Herriot Tabuteau

Okay, and trial. your you question with METIT thank on regards to

Cedric O'Gorman

a So the launched wide to data which the spectrum MERIT Phase goal a COMET is our of sub-studies, of trial, the we patients trial, studies, other that - time was MDD. the COMET studies, generating same launched at example, this which provide clinicians with to for is had across II a with

was trial. the launching that reason So for that

terms impact a it And out, that provide types patients will the its data - clinicians us be that performs MDD. will of launch of additional of impact will on so once how to in potential with in be to allow different it it variety on reads and publish AXS-XX

Lori Englebert

Thank questions. very wonderful. much that's taking you Okay, for

Operator

from Your next question comes Matt the Ladenburg of go ahead. line Kaplan from Thalmann. Please

Your line now is open.

Matt Kaplan

Hi, guys. morning good

to the a up little wanted Just your follow with interaction more on payers. bit -

other then of payers thoughts the maybe as I And AXS-XX? Lori, XX months But Specifically, to your respect and are six us AXS-XX - the with and on kind you on XX and to guess, heels, well? time or also, what commercial in potentially you initially, we filing can with can close sense approval. give then of with coverage interaction about maybe rollout first the coverage how over a terms of should think

Lori Englebert

Hey, Matt. Thanks.

I've a of this call. coverage, ongoing. terms it's it But it I is us our in So too really know, said discussions because that. - to on also premature lot But premature, really it's for are disclose

services patient terms we product be support that covered. so that that so offerings, will thinking a And anticipate patients we're the of covered. that we do are sure But through in make

payers in profile. believe product we be covered. do And the are confidence high have that interested extremely We the product will that

introduction. not those with payers Axsome overall In of of - discussed we that specifically outside market terms portfolio discussions but AXS-XX have - ASX-XX we've research, just an have performed

Matt Kaplan

terms and of kind program the III can about next you then agitation Excellent. good. - smoking talk cessation Very where steps And indications are progressing next is maybe then and it's how XX, little as you in Phase of for for a Herriot, bit well. how AD

Herriot Tabuteau

Sure. programs. over Thanks, to those I'm Thanks. provide Amanda to I Matt, for color questions. to turn think And on Jones, two going those it

Matt Kaplan

Great. Thank you.

Amanda Jones

Hi.

nicely. progressing being It's overall regards just to the responding So nature involves - second which it early and the to a us randomized on based smoking then give cessation? the still in question for was and design, formal study around the status on And guidance stat bit relapse. little the AD to then program, on is any of patients agitation going

Matt Kaplan

Yes.

Amanda Jones

Yes.

provide planning FDA So in based program. with the interactions then we'll on meet third our on update with we to that quarter. the are And them an

Cedric O'Gorman

to Alzheimer's Disease I regarding if add Amanda's may And just comments agitations. all

trial, the initial metrics - of is internally the XXXX. So we're out half while data the the seeing collaborate that progress is early made in being the guidance while addition - in of second read to it in still our

Matt Kaplan

Okay, thanks detail. for the

Operator

from comes ahead. Please a Blair. Myles of go question next Minter line from Your William

Your line open. now is

Myles Minter

Thanks questions. the for taking

and that one to Just technically probably therapies. it on the reasonable And few time population. for is payer going prescribe to to a trying the clinician a MSL a landscape by fourth applies it's through seems set this XX, product

have this over potential your I'm the And we So guess those launch? what's line positive seen case, running clinicians to through wondering, to that current I get upon endpoint? there. that's haven't from prescribe data message this got to the start pushback clinicians controlled if you're that you any So necessarily them educating

Lori Englebert

on I'd some your to hearing Hey, Myles, I'll Cedric what the But turn over it answer terms certainly are lines. questions. in like MSLs of of to those

Cedric O'Gorman

and and responding happy MDD nature treatments. to Myles enrolled I'm in center clinical that the Yeah, who actually clinical trials in people existing for trials typically to share of

coming a placebo, in realize to are been degree after in that a coming people because but that the resistant. MDD are of proprietary I profile, treatments great tend treats versus to and the hasn't somewhat the with brand new essence, patients differentiated action, Difficulty] also to There in patients of in we've clinical pushback [Technical of study already are So data who early the think in life market and generated both sense fit of in onset MDD functioning. terms rapidity shows that versus quality improvements new

field to clinical the So difference out drug, is compelling from what I hearing think a as of authority this differentiation in we're they from AXS-XX - is even see they why and overall, the there. profile arguments use

Herriot Tabuteau

the a hearing in with lot sub-studies, in MSLs is evidence example, in the trials, the patients showing too have actually the all as that based patients recent sub-study that that familiar things profile and which that that as rather KOLs lines works TRD have the who multiple been for drug other are hearing who Phase Right, failed the very now, general, may in COMET just and positive. the has - of that COMET emerging to those we and if is upon TRD that compelling from who field, thing we is it from treatment, of who I treated frontline. in our well experts then essentially our there's field just in And are from of on is the presentation one add TRD, data and the we're of depression III impressive is with actually had four a are

at depressive week look you at clearly symptoms was higher if two. using And even So control evident and from the that a with in the TRD, active dose. drug seen one to trial the was regards effect week STRIDE-X an separated

population. TRD important significance it's also than were in week only with seen and was two, patient at at in other agents. much life, not in have the that, remember achieved higher in been and And one as So disability a improvements TRD quality week to of that trial,

because getting population. very with around expected have STRIDE it's [Technical been positive into - overall, it's of in actually, what Difficulty] positivity its the lot variability, of So is happens and a MSLs a which this questions patient been

Lori Englebert

as Myles, Hey, on pile third just I'll your comment. here

by just population this what was to entire we're in are we and question, population into and taking conducted account. question that consistent payers Herriot well. on They the Cedric as So with what the study patient for your very comment both hearing is - stated

Myles Minter

Thanks. one, that's all as along trial But for I've you've cash does Fibromyalgia? the a think another just potential Maybe provided with what of well. commenting for in clinical I know them. hearing the quick been that actually that waiting you're include not minutes guidance I because today, Yeah, you're AXS for for on provisions additional

Nick Pizzie

guidance spend certainly AXS-XX. for cash our includes our, So

know as since we that to incentivizing this entity. So registration. would as necessary do you is for API, And a we previously have chemical - make we new supplies sure stated, be that we want are ready,

feedback questions. is thanks next the plan, a With development the agency written from so any specifics making necessary Fair for it's enough, any of a await So regards the step. - for getting will clinical before that we to potential pronouncements. spend

Operator

from the question Please comes Holmes next David go of line SMBC. from Your ahead.

Your open. now is line

David Hoang

asked lot great the update for questions thanks Hi, questions. my A and of taking already.

So I just have ones. a couple of quick

lot first, expect would primary prescribing AXS-XX there the be population prescriber you care that MDD, like the from a versus do for is on primary of side and So care would physicians you how the much of of prescriber hydrous target bass? say

Lori Englebert

David. Thanks. good question. Yeah. a one. Thanks Hi, the It's really for

look versus the or either PCT. prescribe. not many health not are are as as to There I'm look to some the are tend at there out and sites. as first tend it and level it at mental or prescribed We propensity sites PCT. the same who categorizing at PCTs to we highest hydra a focused So of site actually

the consider for will targeting along with to the encompass the our high prescribers, most the ones potential So be trial. we that best

David Hoang

of That's then to Thanks. US, or ex through a just it. products the XX own commercialize your plans XX, both helpful. are And US terms those Got partner? of on and in any geographies, there either eventually outside in really

Lori Englebert

publicly disclose we ongoing. answer So is US. - question outside that there partners can looking And are well. that for as those the Yes, discussions are I of we

David Hoang

Okay, thanks. all That's me. for

Operator

from BTIG. question the next ahead. Robert Please Your Hazlett go comes line from of

now is line Your open.

Unidentified Analyst

taking the on Terry question. for thanks the Bert, for Hi, this line is

question an Thanks. terms and brief a trial, and so, on point at if of analysis Just Alzheimer's efficacy in at in potential interim analysis? point of data on any color AXS-XX expect the terms should what interim we some that timing a can agitation we for Disease expect on

Cedric O'Gorman

for not is interim there of - currently trial. analysis is currently a this There plan an

study terms the of upon incorporated. However, in we so based see designed what be that is that could one rates event

by So events randomized how that is are number and are powered. the typically of withdrawal they studies driven

what a it's relapses. in will the one No has be So as of earlier Disease done in mentioned cadence Alzheimer's to remarks, the right now, know too early agitation. we study like before this

for very - out forward right have seeing to an are now, analysis. this while plays how - in not So we're but planned looking and we not we much thing

Unidentified Analyst

just Okay, color could bit that. AXS-XX, on the about you in then be will talk including Thanks any a endpoints more potential thoughts And just for thanks. timing, helpful. on one trial

Cedric O'Gorman

primary endpoint of the study the the of AXS-XX in So frequency for change be will the cataplexy attacks.

So that is the same Difficulty]. [Technical

Unidentified Analyst

congratulations the and progress. perfect. Okay, taking Thanks for on questions the

Cedric O'Gorman

Thank you.

Operator

And from your here ahead. the comes go last from line Please of Ram question H.C. Wainwright. Selvaraju

Selvaraju open. question. Ram again, go now is line with ahead Please Your H.C. Wainwright. your from Once

no queue. in call for back the will further management the I Okay and are there questions turn closing comments. to over

Herriot Tabuteau

you thank again this all Well, call for our morning. joining

We to rest advance for are move as pipeline with the We serious the progress of the living people many in potentially and as you forward our the conditions. benefit updated on excited our we towards of months look commercialization we keeping ahead. CNS

Operator

today's concludes you participating. for conference call. this And Thank

now may You disconnect.

Axsome Therapeutics (AXSM) 10 May 212021 Q1 Earnings call transcript