AXSM - Earnings call transcript Q4 2019 | Axsome Therapeutics, Inc.

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Operator

Good morning, ladies and gentlemen, and welcome to 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.

I would now like to turn the conference over to your host Mark Jacobson, Chief Operating Officer at Axsome Therapeutics. ahead. go Please

Mark Jacobson

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

Our earnings on quarter press of release ago crossed providing a corporate short a at financial ended XX, time for Axsome.com. the year wire the is update results the website full fourth available and and December XXXX our company's and details

our our certain other During today’s report intended and investigational regarding statements plans, cash among things may non-clinical efficacy, These our utilization of call additional we agents, the anticipated and plans, plans trials, future of development of forward-looking will clinical use investment. and clinical source include the data, possible statements. be to present and intended and research the making or conduct future safety regulatory and statements

based forward-looking These and involve and current differ materially contained forward-looking to and from cause to information, risks subject are expectations results statements. are those on the statements that change uncertainties may that assumptions in

are risks periodic including annual other and filings reports. our quarterly and Commission Securities the described Exchange These with and made our in

undue cautioned such on are statements. place to the weight any to not and these forward-looking update company disclaims You statements obligation

the O'Gorman, and Marek, Chief Herriot are today Officer; Dr. Officer; and Clinical Executive Commercial Chief Financial Cedric Joining Dr. Medical Chief on Senior me Officer. of call President Dave Vice Tabuteau, Development Affairs; Pizzie, Nick

review corporate the clinical and significant developments a over of and past year, of first the describe Axsome provide course Herriot upcoming will for milestones.

our that financial Nick results. Following will review

will then for open questions. We line the

to the turn over now shall call I Herriot.

Herriot Tabuteau

serious call. for our full generated difficult Axsome Axsome to CNS morning, year thank important transformative year we for Therapeutics and for and treat quarter we're investigational for XXXX clinical Good all a And joining Thank Mark. data developing which of everyone. was you, XXXX disorders. medicines, all results conference as fourth you

commercial enabling in in stage depression, propelling Axsome positive readouts and of towards important clinical included potentially migraine, next as NDA many year. The AXS-XX for achievements trial as XXXX early for AXS-XX

on our X is In candidate based positive Phase for Phase X addition, narcolepsy results. product AXS-XX progressing to

this Phase four expanded fibromyalgia. in for our collaboration throughout CNS all, pipeline have clinical now product the with the Pfizer, early development. of And candidates with year, AXS-XX we treatment differentiated of All addition we in X

in of have NDA, entering of trials, two which All X having demonstrated trials. with efficacy are controlled completed other pre which Phase or two the

These action and candidates potentially greater mechanisms product treatments. to compared available new of efficacy broader and currently faster, provide is

of change standard transform Our care investigational and medicines to therefore with brain these conditions. for disorders potential the the patients lives of the current to living treat have difficult

to XXXX the We of operational, continued expect disorder for or be of planned filing our major in progress. a year are underway clinical treatment depressive NDA of MDD. regulatory and Preparations AXS-XX

activity depression. MDD. antagonist Phase X trial multimodal AXS-XX confirmed NMDA with has and be for severe in only oral In patients the the receptor announced first GEMINI we results of moderate the positive with treatment December, of to to potential from a AXS-XX

the and GEMINI this with primary of previously rapidly, symptoms In from positive AXS-XX compared statistically depression to substantially significantly The trial by an met study file endpoint to AXS-XX XXXX. the as results on placebo. are improving along fourth quarter this completed NDA support And the MDD. in of of MOMENTUM NDA of we AXS-XX trial treatment for the track MDD in in the filing

also to as multi available designation provide of AXS-XX's migraine. therapy compared acute treatment AXS-XX been underway enhanced of filing NDA the our the approach breakthrough is in for are granted has AXS-XX currently treatment treatments. efficacy planned designed for MDD. mechanistic Preparations to of

to patients relieving acute In as inadequate a and endpoints placebo, secondary active met with announced significantly study as the compared response December, from AXS-XX this results of in prior In of co-primary the compared to trial to competitor by a we positive AXS-XX momentum key X rizatriptan. and treatments. migraine history the migraine Phase pain

of trial we The in of MOMENTUM from filing support file XXXX. for treatment acute the results AXS-XX second in the remain NDA and this on half NDA migraine an the positive track to

With on year. to transition is track planned to early as potentially stage as NDA filings two these Axsome next commercial

And we narcolepsy. top attacks treatment cognitive in and have quality and out results daytime trial this capabilities. sleep reduced sleepiness our cataplexy AXS-XX Phase to In function, and improved that the from sleep end, also In we of announced related been AXS-XX December commercial INTERCEPT positive building significantly study, the symptoms. line excessive X of

point AXS-XX on profile differentiated Based key AXS-XX clinical scheduled results symptoms in half this positive of address to enter a X year. the clinical of to second to narcolepsy These trials results, is these potential narcolepsy. in all for with Phase the the

AXS-XX. the We AXS-XX license with result agreement as intellectual and ingredient of Pfizer, covers January. announced agreement U.S. pharmaceutical in accelerate nonclinical of we which our reboxetine, an a exclusive expect to active for clinical data, development in This to Pfizer's property an

exclusive expands CNS X demonstrated the treatment to previously fibromyalgia. statistically develop commercialize us a in in by in candidate and in the stage treatment fibromyalgia. pipeline X product AXS-XX results AXS-XX rights new positive or and also trial the our agreement Phase for has esreboxetine of late providing This of a Phase U.S. and significant

function, for plans on condition. and In treat the symptom FDA effect Excellent with addition this meet development further to effects studies, but to to demonstrated fibromyalgia. its to AXS-XX these fatigue, on of year discuss clinical in AXS-XX an of difficult the this of pain both

early trials before migraine. of top-line both results our recently resistant of trial and month. treatment the treatment from the these randomization Turning trial completed now STRIDE-X efficacy remain We ongoing our into of for in our We track INTERCEPT this end of to into depression AXS-XX on in trials. AXS-XX the

the Phase trial treatment of top-line third now enrolled. results trend, AXS-XX is from this ADVANCE-X agitation we trial in than on the of this X/X with disease based And three Alzheimer's associated quarter. Our in XX% more expect

fourth filings for Including AXS-XX In quarter. NDA the the we in year, the several summary, migraine in over the AXS-XX balance to important MDD, forward and of anticipated in look milestones.

of trial in quarter. AXS-XX trial the the quarter. INTERCEPT in Alzheimer's in from trials narcolepsy AXS-XX And this disease and initiation TRD agitation trial the the Top-line in results STRIDE-X year. Phase this the of in second the of third in AXS-XX with AXS-XX the half X of migraine Top-line of results from ADVANCE-X

recognize Mark also since of Senior like XXXX. member President valued his been Jacobson team appointment as to Mark a would and recent the served on Operating congratulate Axsome I since Vice Chief as Operations has Officer. XXXX. And of

the call to I of to provide for financial full will Nick turn now XXXX. year update over

Nick Pizzie

Herriot $XX.X in Thank million morning, XXXX good XXXX. financial the and ended highlights provide focus key quarter on December period XX, for $X.X and the the you, comparable quarter guidance. some I everyone. for versus expenses were million will in R&D

during significant was to the AXS-XX and the studies. AXS-XX increase trials This safety a prior CONCERT, quarter due of as the including that to compared label GEMINI, MOMENTUM, along the were open new conducted period, clinical INTERCEPT with number trials,

progress ongoing the the ADVANCE-X trials. to addition In of and STRIDE-X

were The quarter for personnel was along G&A mainly functions. stock million of out million in change ended commercial expense, primarily the the compensation and period build due higher the expenses $X.X with XXXX to XXXX. for comparable December the XX, $X.X costs, from

approximately an gross $XXX proceeds as running underwritten In aggregate managers public of deducting yielded the that expenses joint acted offering before December, Stanley and offering for book Morgan offering. million. we SVB Leerink completed

our As cash sufficient the of in operations at cash that million result, compared two the third operating plan years. with with end We $XX at ended our position fund for based our a we million believe will the quarter. anticipated on to quarter current $XXX fourth least be current

turn will fourth call concludes now financial the XXXX quarter Q&A I Mark to our review. That the to lead discussion. back

Mark Jacobson

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

Operator

[Operator Instructions].

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

Charles Duncan

year prove commercial a very then I Good to Congratulations on pipeline wanted interesting morning, Herriot a just ask questions couple very and could what one of on this be and maybe one on the year and to and build. you team. quick a good last year.

of drugs either to for AXS-XX regulatory of relative clearly TRD results. impact be the couple a drug different scenarios the be drug TRD? the the not and working working I the lay about strategy For the you're guess commercial on or wondering and/or out I’m in the what you that may Can could AXS-XX. thinking scenarios working, upcoming

Herriot Tabuteau

to it that have about with in our clinical is patient targeting that regulatory With results is positive nice of a What's commercial strategy demonstrated and population we MDD is you, in about Thank great that regards nice product treatment what's profile. is now Charles. need. efficacy very strategy study which TRD, our differentiated the

our is trial mixed, is any the prep very it And positive, impact filing the If if commercial assuming approved that or will negative for TRD or product track our also MDD. if strategy. on our much And it's underway it's have filing we're on to not NDA. gets

of package. indication the NDA included be And the would believe study the It in it positive, trial not the be clinical for would the included should be still package that the would change our in section MDD. would insert. indication it be we product, However,

In in trial is order resistant TRD. get a the a second -- understanding label to it treatment our depression, we would for FDA formal require that

control we before, could as said be Importantly, that study trial. placebo a

positive I positioned. the under very scenarios, or study is vary think the if So, if assuming we're the that or in well middle, somewhere it's it's negative,

month. we to of We the will very could not internally. the the on certainly before And what scenarios readout have the be. But forward much speculate results looking planned we're end

Dave. Yeah. it And to just from a turn commercial perspective, I'll over

Dave Marek

Charles, the for morning, Good you question. thank

out build As TRD. relative we the to commercial think about

As access already to MDD. news us that broader physicians, we've gives with a that of talked broad the we to is the MDD, patients good with indication have range

data high towards enthusiasm given of that a when talk there's And degree already clinical we physicians, AXS-XX produced, the quite already. to we've

question with does change. So that we TRD, the positive if is, how results have well,

their greatest view talking seen they is with And appropriate of I the for enthusiasm for AXS-XX. clinicians, that terms we've for single that would it the in factor increases think patients

in that So MDD, if for at already of tremendous you look general. enthusiasm there's degree a

for the further would this patients would even perhaps appropriate AXS-XX. range they patients either around of conviction that or consider more deepening And strengthen their

Charles Duncan

Yeah, that's consistent diligence well. helpful. as That's our actually KOL with

a is So like nice it It's have. TRD to doesn't seem needed.

to Moving XX. on just quickly

'XX an release said I it the Herriot mentioned was you think XH in I filing. And for NDA press XQ. read

just is it actually is slip AXS-XX the could for in that yet possible NDA come or that third So a the quarter? filing

Herriot Tabuteau

It that the in is quarter. coming possible third it's

for quarter XXX year, factor we gating do ongoing. guidance the the label treated And that database, an one trial to and is our safety needs extension safety which include filing patients the formal fourth is have though. to open Our NDA

the to XXX in the at so file patients order to point one we And year need will that NDA. anniversary

Charles Duncan

Okay, final question commercial capabilities.

although built, the to two on need you'll markets that You size somewhat and have mount have of will thoughts of any you these And market timing. to prescribers? you've same in are being terms Do them the say I you what been force really do field what somewhat doing, maybe instead of the guess sizing different drugs? effectively for

Herriot Tabuteau

the appropriate sure want our a we're build appropriate you're When commercial And potential think correct. out we building to about we solid that resources coming. we as adding foundation make the absolutely have Regarding towards launches team, we out of stage march kind at the commercial now.

we around looking clarity MDD to of force sizing terms both think in et a been of allows prescriber think highly migraine of field structure, of And efficient mentioned benefit variety us cetera. our as the force having around in have When at you a scenarios field base. and we way,

think using is prescribers data sure ensure that also at could launch. and who prescribe efficient make the to we that a of prescribe we are we contemporary been way have given analytics believe those what the in to we kind to and be. that I highest looking the targeting do have using one environment we've we're of payer very Where ability willingness very tenants how a

launch open scale as very targeted envision and could very and scale quickly. quickly up. a We be you ability very adoption ready so with access And would efficient to the prescriber to

and presence beginning force of quickly. scale very that can one think sales efficient So an at the

Charles Duncan

It on closer on we later sounds or as like next this into with more get that the year year filings? NDA

Herriot Tabuteau

launch. that approach Yeah, make months force We our the options in period, that to help as hired, will solidify about to that structure mean, field and looking being six sure as latest final advance. if want our and the I size about data, you analytics, time closer active we're at think and get correct. we the we keep latest a sales us force little

Charles Duncan

my you questions. Thank good. Sounds taking for

Herriot Tabuteau

Thank you.

Operator

comes of question line Please from Selvaraju HC. ahead. go from Your with Ram next the

Ram Selvaraju

SBA And of going this juncture? program. Can much very I this? from with could the you us whether was have a large seek questions. taking the the trial wondering Thanks maybe start to scope clinical pivotal we program be is expect narcolepsy give if If to of the in FDA setting? an of how for a the my you you that sense at sense regarding

has then whether the have of a center possibility file at around to the with on whether discussions you are being And point the esreboxetine. I this to was able going Pfizer they're data fibromyalgia? wondering with sense work FDA development also the already of before that clinical additional an center in potentially pivotal if that to around going setting, for for you're able generated or to candidate in need the submit product the application

Herriot Tabuteau

the question. for regards narcolepsy. With Ram, to Thanks,

already We we have narcolepsy. we're from actually trial the the X with actually X plan. And gotten trials Phase thinking feedback initial X Phase regards with two our interactions or to launch before FDA that Phase

make refine sure not plans those to the changed. wanted and We has that thinking FDA

reflect results did that. of the approximately arm this or XX had I large regards a that clinical parallel been with is, to the treatment assuming with at the even patients equivalent per tuned difference What pretty trial, you would say trial. results stay our design the if So, of look

regards has cataplexy. With registration previous in what trials, sized to for been in

example studies to in For arm. those been per XX treatment XX around past in patients range the the of have

that sleepiness numbers daytime from the excessive So, studies. sense. to there adequately And power up order for go in a you gives do

Phase we'll clinical to discuss regards those mentioned, you, X the with launch do coming as be With to the esreboxetine forward. esreboxetine, we as designs going meet I FDA we for the plan before back But, to finalize we development to intend studies. trial

I symptoms it regards product treat. said can fibromyalgia We candidate, with of is breadth think that a the as this of very differentiated especially to

a As are in only treat the there US. currently to fibromyalgia three reminder, that products approved are

of trial So, like as at to generated has those for Certainly and data discussions. we discussion to an relates may appropriateness Obviously, those view the we the any that'll been that as looking it to we're of discussions, that trials to to forward important part of the date will clinical conduct. registration. understand clinical of those point be potentially FDAs have least further

Ram Selvaraju

thanks then for indication. that AXS-XX target I question for wanted clarity. regarding Okay, ADVANCE-X And ask to the a

was hoping maybe what is assuming I for perspectives the ADVANCE-X AXS-XX would could positive? So, forward be path you regarding comment on

Herriot Tabuteau

results, assumption, one our that trial disease assumption Assuming Alzheimer's we additional would need efficacy is trial, ADVANCE-X generates in positive agitation. working the additional one

is As need. agitation. approved an a of medical treat currently area Alzheimer's disease high product reminder, to this is There unmet no is that

trial. And the We're trial happy of is clinical this progress with the far. thus a pivotal

so make extra obviously And There trial we sense the an that in from FDA. it would feedback the to need get has order would approved. product also been the

So, that working that our is assumption.

Ram Selvaraju

a in updates point, believe in just Is monetizing I any about it or evolving in the then of possibility regional I and Okay, intellectual the of that one complex area property very situation Axsome that other quick syndrome. you the the at see of any there remember talking some holds that on pain were near-term? that ones. way was couple you which

Herriot Tabuteau

not other that, have are are assets, assets. core correct we which You do

is assets, now product pretty right clinical active CNS we're development. other candidates in about. of And focus four our consists core these our So, excited pipeline which

And we non-dilutive potential of funding. they that sources think are

been And so to a facilitate order placed currently business not We We immediate development have took separate update business on business any negotiations. those have that unit. unit. into do in

However, on as we anything is certainly things you progress, updating if there will. worth

Ram Selvaraju

indeed lot a question data And juncture XX there. just a was also AXS-XX if then this wondering for at out of perfect. since this Okay, efficacy clinical for David. is I is the and

might are at become part people Axsome. interest receiving and of from you sales marketing the If inbound who potentially team

this these qualitatively could on CNS you that marketing confidence as a what you perhaps drugs you caliber team in some background establish And would best if and industry, the neuropsychiatric can to promoting their of were people, it in extent approved? spaces? be sales potentially just XX and in of the gives are the And and breed XX that as of when potentially comment and

Dave Marek

Well, thank Ram. you,

programs, only And gets but think out, I as couple really regarding I that not think itself. excited. there more those things are people that you're right and comes more information a the company exactly

happening in as we and of can have our can the of excited the are around prescribers of or terms who you're how are the out we a watching serve there are lot of commercial what potential depression as migraine you the space and what's in people therapies. in If been potential do patients. just the There new evolution space marketplace

Also, commercial about I are and a excited the launch. highly think there individuals are who idea very of efficient contemporary

function within types that's or marketing data And kind disproportionately so of those analytics of the and the attract we function. whether talents,

in receiving, have feel confident to So as to we that about commercial contacts We able strong that to going of very, industry. feel other through feel very as and but be very also interest good talent. we're we force well the we're type that the relationships very unsolicited, sales

Ram Selvaraju

Great, much. thank very you

Herriot Tabuteau

you. Thank

Operator

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

Yatin Suneja

question. role. new thank Hey, And guys, you for my the taking on Mark congrats

Maybe Just non-responder are about few a STRIDE a with you bit how start the little couple Plus. TRD a and questions in talk Can study? qualifying on you we'll things.

what terms And the randomized two using phase different follow in then and there phase, is dose using the in might And phase? dose you a label the have might believe I you be open ups. be that label of then be should a randomized open the reason in that to

Herriot Tabuteau

that. question. the it for over to to And Yatin Thanks, turn I'll Cedric answer

Cedric O'Gorman

thanks. Yeah,

of think that of to all, depression resistant asked with first So you'd resistant it depression and -- was the regard treatment the definition -- treatment I about

Herriot Tabuteau

non-responder. In

Cedric O'Gorman

right. responder, Non

standard to the open is if randomized. approach within label period, fail as And with that being a they the the they're just there's patient respond, bupropion. reminder So, a treated

we start, to just do before will of regards measure to top-line or we and end by disclose the dosing the month. both the criteria with before which once the non-response data, that Now have response we be which

track for on So that. we're

Yatin Suneja

again the own then the you dose, commercially commercially manufactured this so in bupropion like dose. the and for terms a I -- you on that available, have or study, your to of to Understand, remember in use had in ASCEND your you own available? Because dose are dose have using not you the used make is study Okay.

why So Thank you delay? understand help can was reason pushed And us from to the what move agitation here. up the got then on QX? side And maybe for comment situation you. the first to it

Herriot Tabuteau

that clinical So, additional clinical to a With reminder, questions. in is trials, product the require regards yes, which thanks be as for do blinded. drug trials used products

And the have to and for the that so appearance. made periods be drug match in various product therefore various treatment the arms with they in

to updated our regards agitation, With disease, and Alzheimer's guidance.

So, half our previous not guidance have as you are wanted potential we build factors. year external changed to of some the this first there has and we about significantly. was roughly What to mid-year. know do was talked some buffer in That

do of And the given corona that do disease something be to about too not in that guidance, potential we elderly. impact the to eventualities. now, of range virus, make impact. it it talk any is sure of patient not into our any take is that which we've seen Alzheimer's prudent is Right a that targeting account mindful agitation but much population, we is that But to think have we

Yatin Suneja

Got into the back get you it. thank I'll And queue.

Operator

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

Marc Goodman

and little Obviously, view about about I and a differentiating it the was could how one thinking crowded pretty out? wondering your about that's market, product Yes, already that's how changed doing morning, well. you players launched Dave. talk Talk in the some you're comes coming you new bit. space market with, when how migraine if a

Dave Marek

for it migraine get clinicians. And of will migraine time. those patients. for when exciting with be look think good associated been you. for a more I really years, and for a it's we couldn't And at that's good who've the many more. us market, market It Well, more Thank

marketplace. in to more migraine. this in So for what I manage options patients the certainly and look the really frustration is and the provide When long wanted marketplace, we solving terms you we clarify often place help the for say at in we have are have to or go the of really to unmet first need to the better them frustration

what to we patients physicians efficacy. by clinicians When patients therapy in and just the is consistently setting, and frustrated are talk acute pure

was was a of there that physicians rises improved out While our there, out of efficacy variety are need. and XX the research, their in needs one the greatest to X it unmet top prioritize

clinician built we And really of so I'm issue it with day. together And clinical single MOMENTUM, question clinical proud on we really a around because program of solving focused I answering how every a faces that we efficacy. program the put the can think improve that

who's had acute that prior unmet are start that therapy. the one at in the And population have and enrolled failed, were those who patients the greatest prior therapy. patient response So, least those types sub MOMENTUM. experienced those are you need, with treatment right and with Those to of optimal their we a

tell treatment And what well, are faced dealing MOMENTUM, rizatriptan, the effective certainly took okay, said, options are the options and head-to-head we day-out. went what and one one that in treatment there, the then again, largely with. effective those would patients and viewed with most we next And most day-in that as us they they out physicians which step are against triptan. of be is of And their

they're right the helped the And allows looking think data will showing that And are data really step. that superiority, the is where is we've that patients, those think for. right be can we to by most think what them treatment in patient next which with, we highly have we understand for their deliver clinical best the the dealing marketplace clinicians marketplace. difficult that we that make a decision The with efficacy, better differentiating

treating migraine think their be really we think should why enthusiasm towards may to superior of that's AXS-XX, survey of for and physicians, our our you mindset rizatriptan? in we enthusiasm tremendous is we I there the recall And AXS-XX. And degree differentiation core asked

majority would physicians over we've the treatments, over also but where prescribe they think, currently of say well. available results I as AXS-XX And those the emerging talked vast about treatments

strong to very patients with a opportunity So AXS-XX. we commercial see benefit

Marc Goodman

study INTERCEPT And into it? how the does play

Dave Marek

and it greater in is a until they wait what know inform world the in setting. treat helps is We think foundation trials to does to patients direct the for clinical moderate severe. and need Well, real pain we typical how INTERCEPT patients provides I their

And therapy, first those patients sign their pain. helpful migraine they take for processes we it clinicians When look data say and to registration their of administer how cetera. typically at the tell very et are at acute

provide we in think for INTERCEPT that so setting will to they'll will instruct kind the patients that how world this of And real information think a manner perform product likely we administer.

think required additional we So AXS-XX. the NDA filing, we for is as that's will setting information but not of educate it be the important utility the in around physicians

Marc Goodman

force, question, separate last you're be and this both And sales it sales it thinking progression is How one? as to two the product that one overlap there? Will about is force the much going ones? products, be sells

Herriot Tabuteau

earlier, at around options depression both structure as of will how looking still that we -- -- and at the Well, mentioned size force. look and migraine and we field

do So work around of that. landed, we while we'll we have haven't specifically options, a more variety

mainly the migraine look prescribers both will across we There care and some is you high imagine, setting, in overlap efficiencies of can both. promoting and physicians, with who are though, depression. say primary for some will I as

advantage we at our would certainly as still we which take degree The options. And to that look of evaluating synergy. we're

we field greatest for do on decision what one we we the look glean. force So that efficiencies as or we haven't make but two, landed that will can and

Marc Goodman

Thanks.

Operator

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

Matt Kaplan

morning, Congrats progress. good Hi, guys. the on

little near-term more a of on bit in there. readout expect STRIDE-X wanted the results to given zero Just

fact powering sizing of the Can guess, us that? to please that you us the can safety of a give study? the have So given of and you sense you remind database. continued enrollment your I build the

Herriot Tabuteau

the Matt for question. morning, thanks and Good

had we patients. the at was randomized update of So that gave November. end That was in last the XXX of terms the that approximately study sizing,

the so number north will be final And XXX. of

work which terms detect was been the X.XX, the of the currently XX% of at to sizes have between the study approved. powering effect to an powered they in been shown is level somewhere that effect with In X.X antidepressants have size of of line trial, and the and

Matt Kaplan

both TRD update you. can Great. extension an and extension? patients. many that's of is of terms terms the in for progressing give how you study Thank open the And and open us patients enrolling you that in then XX How label label MDD expect ultimately in

Herriot Tabuteau

progressing study That well. is

treated a As build patients an treated And for gating XXX for one to filing a months safety database you of NDA. and that. us know, we're We to that track X on is need factor do year. do to patients XXX

So that we're that meet is our a will way It the of enrolling the to an with enrolling. pretty end year. allow us currently before pace of is happy filing in the that NDA guidance

Matt Kaplan

up going Okay, the questions guess we to just on give thank us AXS-XX Can back And terms esreboxetine for you. forward a for I paths fibromyalgia. potential some -- and following you fibromyalgia? that on had esreboxetine in regulatory sense of

Herriot Tabuteau

Yes.

So, we first want to meet with the FDA.

and And a size. was reminder trial As a significant patients. XXXX that One positive. trials though, Phase enrolled over esreboxetine X has randomized efficacy of which completed two was study

a which randomized, controlled the trial also was was there these positive. And studies trials. X double blind, were all Phase placebo of Both

those to will get certainly And so on want we clinical feedback the studies. FDAs

Those by Pfizer. studies were run

NDA. terms of order what we to file else in want we make FDA get the sure an in required be would from to feedback So that

We until what we we and with speculate meet could be will on not until those the requirements agency.

Matt Kaplan

helpful. Thank and Great. you luck Very good forward. going

Operator

Your Bert ahead. next go from with BTIG. question Please Hazlett comes line of

Bert Hazlett

you. couple a of quick ones. I Thank have just

plate of corporate the set of and AXS-XX on terms of Where you Just in your with urgency, that indication cessation Thanks. different number terms have in lot priorities? a smoking a with does indications. --

Herriot Tabuteau

question. the Thanks for

to that ourselves the indications, have the is on and that the the focus number do of correct various the need a lot have of avail a potential one time mind facing, that we're we same AXS-XX So in we're our of pipeline. you are keeping does was and challenges opportunities plate. while in at It

NDAs filings those a to in of are So, are file year quality. clearly significant that also timely our sure our priorities manner that, this make and we

that priority based our NDA into Phase upon X, advancing which is very candidate data. filings. beyond the is top that positive narcolepsy product our X So, in Phase our is And then

of be with a efficacy cessation year understand then course, a forward the indication will getting there FDA for will AXS-XX, this So, we regards there. I'd two. what delineate on say that's the priority further to like. clinical then And path positive the and absolutely And given development to smoking meeting look that number what development, results clinical very feedback the with

Bert Hazlett

at Could characteristics remind you or or just of XX thank the Okay, point? status progress us [ph] CNS you. of this

Herriot Tabuteau

the AXS-XX trial AXS-XX So, for trials scale. have at commercial material clinical been for our made

-- also of supply. manufacturer they've are very manufacturing they've the So, will which specifically we're registration NDA. in be submitting an be the that there good made the the at contract There been at been and for made batches shape also purpose must made commercial

And is so underway. that work

Bert Hazlett

Thank migraine. just it Does long commercially therapeutics with make one acting CGRP on combination in have a an with and such that at all? acute XX? a as Does to with you have you sense study migraine then [ph] make sense any

Herriot Tabuteau

types eventually be We see therapies. how reason armamentarium. any not it focusing of see ASX-XX their of certainly choose why administered Right don't product other be to clinicians with it could And approved. to part getting use the will we're interesting now as on

Bert Hazlett

very Okay, thanks. That's all much. for me. Thank you

Operator

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

Myles Minter

on guys. the questions Hi, Mark for and the company. at the new Thanks taking congrats position

currently the third in your the at new question quarter. first on the the with that patients cautioning that highly whether wondering to trial moment enrolled, you're ADVANCE. gotten push to risk given, population. unfortunate into out enroll slightly XX% Just proactively, susceptible [indiscernible] is I'm physicians

timeline, also in wondering proportion you of what at the the And where arm. enrollment. were bupropion trial discontinued that patients XX% alone I'm into enrolled enrollment mentioned December XXXX you

Herriot Tabuteau

have they sites, cautioning But doing The clinical monitoring regards we're So, any or they monitoring that Currently, what currently we're the physicians any trial. around mean, the we're have -- is not into of but it thanks for Myles. to that. hearing is situation questions, trial is the doing information with that to from pretty we that concern, closely the that concerns are very I regards with enrollment. closely. enrollment might anything not

And point. the conducted analysis of with The a interim of the the XX% was enrollment analysis. percentage time regards the patients as at at interim reminder to

the what of to get allow So it subsequent sense after enrollment you that that was was should a enrolled.

trial and of size XX% XXX subjects So enrollment remember total. was the point the

Myles Minter

question for relation eight weeks maybe Thanks specialty there. using that. of six those waiting centers, been sort response early in for, That's improvement. an trying two they're XX% doing And some SSRIs to Dave. for response rather with for a that a we've maybe diligence and To They’re say suggests drugs, then to helpful. weeks a than

patients their going both of GEMINI specialty your I'm and looking truly and are from to response focus data a with behalf those and PCPs. in rapidity clinicians, whether down on the ASCEND is at effects. the response. of the Whether in Just predict have conversations centers in a the early on track? rapidity wondering To actually

maybe quality focused of on mattress the in are maybe And are they most products so is, some [ph] used this more routinely not excited which hearing community? life. clinic? patients the What case? but those much about from on of What Question you are

Dave Marek

Good morning, question. Thank Myles. you the for

for. for And looking data front the what research about have light around one up current of We same put in are rapidity are really they hearing around that the is effect. things of in of the when of specialists, we physicians XX that we some our the

get that. go But you they gets that pathway, the of another the way. for a that plus SSRIs, of of for And also at what looking look really be SNRIs would round when and them in the kind and very different patient delivered friendly off they're multimodal is potentially the one activity, believe hungry a they're NMDA to reason pathway excited kind about merry

they to them this at the when data. the certainly effect and start for that robust as earlier with, struggled experience, look moving to therapy. earlier up treatment to see but they also are think our nature rapidity look who start they've they where it patients quickly and of sit And and very would up effect move that's foundational of where rapidity So to reason want as then really of gives at that that patients about effect up they

good We profile. more think And response there nicely excited in going that that getting the the for good the unmet very focus very effect on about we're is to think we're it's So we're able is clinical we for to rapidity clinicians, be need. and of fit patients. from

Myles Minter

PCP change actually a and six likely their that just patients between are treatment up. not that most later, logic specialist that follow a response period just monitoring that So described. versus monitor centers over that early come early consistently weeks then back Does patient's on. Marc And

Dave Marek

the might that see I Yeah, we types the But out it see think in intuitively, I care specialists of rapidity who question. of in that those urgency that data may of be the of have effect they patients I terms different be might don't centers that that answer actively mean, with we could to sense very makes primary sense field. seeing are very and monitoring

wants treatment. better I think is could curve two different the that the think areas same everybody adoption of be sooner. the across to patients desire But their I those get

Myles Minter

for enough. Fair the and on congrats year. the Thanks questions

Herriot Tabuteau

Thank you, Myles.

Operator

There presenters time. further back call for are I closing at questions remarks. to this turn the the will no over

Herriot Tabuteau

changing call all you the today. on is and the accelerating committed over of of invention, forward our progress. look people you year us facing on on adoption for We we satisfactory joining thank medicines Well, diseases. CNS development to milestones balance the for updating a life and anticipate important to treatments the number Axsome for of many

Operator

conference today's concludes This call.

You disconnect. may now

Axsome Therapeutics (AXSM) 12 Mar 202019 Q4 Earnings call transcript