Axsome Therapeutics (AXSM) 8 Nov 192019 Q3 Earnings call transcript

Company Profile

Participants

Mark Jacobson	SVP of Operations at Axsome Therapeutics
Herriot Tabuteau	Chief Executive Officer
Cedric O'Gorman	SVP of Clinical Development and Medical Affairs
David Marek	Chief Commercial Officer
Nick Pizzie	Chief Financial Officer
Charles Duncan	Cantor Fitzgerald
Yatin Suneja	Guggenheim
Joon Lee	SunTrust Robinson Humphrey
Robert Hazlett	BTIG
Robert Burns	H.C. Wainwright
Myles Minter	William Blair
Matt Kaplan	Ladenburg Thalmann

Call transcript

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Operator

Good morning, ladies and gentlemen, and welcome to Axsome Therapeutics Third Quarter 2019 Financial Results Conference Call. Currently, all participants are in a listen-only mode. Later, there will be a question and answer session, 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, Senior Vice President of Operations 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 Axsome.com. quarter press of release our time providing a corporate available is financial the a on for ago crossed and the at update results the XXXX third www. of website wire short company's and details

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

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

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

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

who recent begin Joining Tabuteau, Chief will Commercial Nick Development Clinical Dr. Dave me provide our are by Affairs; milestones; financial Marek, will the Officer Cedric upcoming a and Pizzie, Herriot Chief call Officer; Vice the highlighting who Officer on President of clinical Executive call update. Chief our Dr. achievements Senior today O'Gorman, and Financial Medical

I call to would over Herriot. like now the to hand

Herriot Tabuteau

and all the thank today. for you joining you, on Thank call Good morning, us everyone Mark.

candidates, efficacy trials trial including one three advanced for productive evaluated five Phase different in So X clinical six been Axsome. trials, far, very being has stage Phase five product CNS are significantly indications. our which across and X We've XXXX

Axsome developed, the the these successfully existing trials. investigational year-end are results the our potentially these several medicines have for are many of If in with a of It time approaching and CNS patients for as treatments of clinical fast currently for time by line best expected disorders. millions and who important transform class to of by potential studies clinicians patients first-in-class for their highly or lives failed completion active is a top

I an career, the milestones, clinical CNS held Lilly on advertising. of I and he Before at Officer, like the Business AstraZeneca. Neuroscience to Manager in healthcare Commercial programs at introduce Amgen, August. our at where Marek, you Dave from and positions WebMD Earlier Chief General in to he update Executive us his provide who and our upcoming joins Axsome Saatchi was to would commercial Company Dave Prior team Amgen, President both Vice maintained roles and he Saatchi and & Eli in areas Unit. therapeutic joined

Dave? to would it to Dave. I turn over like

David Marek

Herriot. you, Thank

coming and filings excited important to affected medicines, how possibly therapeutic say investigational me a time two such exciting for team Let have people Axsome CNS an join of advantage and the the I bring the year. commercial the to unveiled weeks ensure lead many efforts to the am data It's millions to novel in of disorders. NDA by lead needed our next

everything same focus The at And and Axsome programs. commercial center I'll clinical we ensure on been accelerating in efficiency thinking follow our efforts our patient leadership differently maintaining do. and team efficiently has the our of focused the philosophy of effectiveness,

therapies. access timely clinical my who Herriot? from actually products the as education a physician to of responsibility benefit need will better to proper options attractive matched and profile is payer ensure as fair be treatment patients ensure it As can leader, commercial well our our with

Herriot Tabuteau

X AXS-XX is and provide trial STRIDE-X or treatment NMDA an AXS-XX The depressive novel of two being Beginning receptor antagonist multimodal GEMINI our and major oral on Thank AXS-XX trial in upcoming Phase disorder update active-controlled milestones. depression programs with of you, TRD. investigational our in activity. placebo-controlled studies. Dave. clinical with MDD resistant depression evaluated now I in will AXS-XX, or

completed this to top screening of be Based helping database, this long-term patients XXXX. robust on previous year-end. X of for from line AXS-XX end filing. this are versus in results results included safety now with track in to the approach in STRIDE-X timing, of report We XXXX This expected the NDA GEMINI trial in will before the conclude on guidance line assure the fourth first trial a from TRD study proportion quarter patient the November. trial and to Phase are of top TRD quarter in meaningful by of active-controlled the of Patient enrollment allows

Importantly, the unchanged. anticipated our remains AXS-XX filing NDA for timing of

trial readout the the support trials. an to MDD of GEMINI AXS-XX forward earlier looking would completed or NDA are of breakthrough Based the for for STRIDE-X previously the ASCEND MDD. AXS-XX positive GEMINI meeting to FDA results in along with held year, for therapy and treatment of the sufficient We AXS-XX filing STRIDE-X the results either for this from be on

this targeted being enrolled in Pending AXS-XX treatment half top NDA first XXXX. for line anticipated filing trial for evaluated the is studies and of the second trial. and X/X The the is ADVANCE of is half associated ongoing agitation approximately of XXXX. trial Phase data in of Alzheimer's readouts AXS-XX the disease ADVANCE for from with these XX% our is also

of to inadequate AXS-XX, of trial AXS-XX history the in treatments. X novel in has completed to mechanisms for in Phase acute acute oral treatment acute Turning enrollment the action investigational with medicine treatment migraine with of response prior momentum a now migraine. of dual the Axsome of our patients distinct

incorporates required be for positive, FDA of NDA if which to potent trial, of migraine only trial half for XXXX. support for acute the on this feedback, the conducted for We results top is an filing protocol on efficacy the an will AXS-XX comparator rizatriptan. the treatment targeted second before remain line and being track to is year-end. report pursuant assessment Based active MOMENTUM special to MOMENTUM FDA

placebo-controlled a by real-world AXS-XX the month generating INTERCEPT at are Last INTERCEPT to Phase X which is additional enhance the information patients market in AXS-XX to migraine administer sign its of use. on potential designed we of initiated readiness pain. the early trial trial,

it INTERCEPT administer line As the their to vast the sign of pain. Top are at from early results specialists believe anticipated in acute treatment important of is very migraine first for majority of XXXX. patients the quarter

now novel, selective for potent, inhibitor oral, AXS-XX, Turning to our reuptake and norepinephrine narcolepsy. highly

randomized, is trial from before effect We We to trial, Phase AXS-XX the remain have completed year-end. a concert evaluating narcolepsy. enrollment track double-blind, trial X placebo-controlled in patients this line the in with of results on which top report multicenter,

of the line and GEMINI trial the the X X we AXS-XX the Phase treatment top of results trial narcolepsy. X in trial between In X of quarter Phase migraine, in line AXS-XX in AXS-XX summary, in now STRIDE-X in top results and X year, from both from We in the of of treatment end of of AXS-XX the the a year next CONCERT XXXX. migraine, continuation of Phase MDD, anticipate the trial the of first INTERCEPT Phase the with TRD Phase and significant of milestone AXS-XX acute expect expected MOMENTUM into trial

filings half AXS-XX first XXXX. of results AXS-XX in half from We of NDA the in MDD for disease the migraine X/X in for potentially trial two also and in agitation of Alzheimer's top the Phase second AXS-XX and XXXX, anticipate line in

to turn I Nick for Now, to the update. over a call like financial would

Nick Pizzie

fully in focus million initiated I period versus good in some for highlights fully Thank comparable R&D and enrolled were R&D the expenses provide safety subsequent which $XX.X million include the September close in expenses and are as increase substantially primarily CONCERT GEMINI, enrolled. morning, to with to you, trials, MOMENTUM quarter everyone. trial and financial AXS-XX AXS-XX that trials the initiation XXXX along Herriot, key expected to of the studies. quarters quarter are and and or was multiple will $X XXXX. XXXX due the in are ended on trials guidance. the and year, were in for open-label the XX, decrease INTERCEPT The being

XX, the and higher The quarter. compared $X.X for $XX.X comparable expense quarter the due stock were costs. expenses and was second end $X.X with XXXX. primarily to in of million quarter million at ended the million personnel third ended million cash September the compensation increase $XX.X period the XXXX We in G&A with for

current second quarter the cash and fully operations will position sufficient all anticipated funds plan clinical XXXX. fund operating our trials to ongoing that into our current of be believe based We on our

previously any we not disclosed, new our the As trials. from readout anticipate did equity efficacy prior Phase to financings X

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

Mark Jacobson

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

Operator

question your line Yes, from Cantor first with comes sir. Fitzgerald. Duncan Charles of the And

Charles Duncan

to AXS-XX. kind the of this to of provide a be that of quarter look rate our question can guys. Good morning, in assumed? the congrats your sense though if blinded expectation the trial, questions I’m the years how could Herriot, you entrusting GEMINI taking continue terms year of you and to dropout sample and a that Herriot all had at does this wondering And the had and of patient? on and progress relative patient in characteristics terms [indiscernible] as quick you’re for and then looking so. of team Thanks

Herriot Tabuteau

question. you, thank for the Charles Well,

to in we a as study as believe the what of to its what terms ASCEND was look rapidly, do that to studies. demographics the turn the Cedric trial to we've of to seeing try study a GEMINI that try regards enrolled goal. ASCEND, the reminder, the that to sense patients thus achieve replicate it much would we enrolled we've I As far types And of with early. like one design -- between but GEMINI two that with the things he we been the trial possible. I'll in The versus of have quite over if see that patient might

Cedric O'Gorman

Yes. Charles. Hi, Thank you, Herriot.

Charles Duncan

morning. Good

Cedric O'Gorman

was far has know symptomatology we trial. keen the mentioned, to worked sure similar are the of was been strong, we discontinuation distinctions. confirm that what severe. So to trial that diagnosis you we they pleased to ASCEND that the MDD a we and study the very the similar important some trials to wanted as to in of terms GEMINI with so that we’ve make to example, of very are had -- their with as the moderate say that for But content very design you And ASCEND seen

that’s the we're So I it. happy design and content with think and about

Charles Duncan

a arguably AXS-XX, in trial a follow-up that ask dextromethorphan with of if dextromethorphan, with a you and I agitation. impact? think I endpoint because would've of conducting on make Okay. studies a dextromethorphan. out anything just deuterated deuterating patient of regarding mindshare then or there think I'm contain -- unexpected Alzheimer's results advanced that the There you deuterated could just did. an And drug agitation what that form, a that could was meet competitor that form drug And anticipated wondering even different about Is about its Alzheimer's didn’t a in kind says an containing either one -- it

Cedric O'Gorman

compound it a way that works referring that a with different DNS indicate That deuterating non-deuterated may its So an of as study components. used deuterated is are of out somehow, dextromethorphan. pathways is by unintentionally part difference There the metabolize, pointed dextromethorphan. pharmacology way is that dextromethorphan than the candidate, you as either does which the you the deuterated was to as been dextromethorphan use data non-deuterated whole point published, receptors. change of interacts that did their or one the which because has AXS-XX know with product preclinical biological And be important you to that maybe

pharmacological differences be basic those important. So may

The other we're length with that doing the different that is reported the was what is of aspect from dextromethorphan the recently deuterated trial. most of study

studies over So non-deuterated a either metabolic our XX-week and that trial. trial did a non-deuterated X-week Interestingly a or X-week dextromethorphan report X is dextromethorphan positive was mixed previous and conducted enough results when results deuterated with those dextromethorphan or with dextromethorphan dextromethorphan and deuterated inhibitor with studies period. study study very were

results been with versus So reported in where they also, pretty which always for might considered be the dextromethorphan Alzheimer's we half rationale the for we differences methodological of the AXS-XX we’ve first interpreting study, our AXS-XX what of looking seen confident forward deuterated should are are year. the agitation in be which and in results versus expect in to have to disease next

Charles Duncan

on questions That’s already helpful taken enough had time. but added I I’ve color [indiscernible] on Cedric. AXS-XX,

hop queue. will I in So back the

Operator

Guggenheim. line Suneja And comes Yatin with the from your next question of

Yatin Suneja

for morning, good Thanks Hey, taking question. my everyone.

patients, a of tell rapidly, Charles earlier average cut similar Just the you that that we I that you notion sure do Should us about and GEMINI what following trials for to is a question steps asked maybe enrollment. so enrolled on population up enrollment? given maybe [indiscernible], taken professional MADRS about these you was talk off Then anticipate maybe mean talk MADRS ASCEND? are in there the terms might you to you have some the make the the about enrolled [indiscernible] follow-up. of patient then for the there And that the right GEMINI could be the could steps. or baseline have I to the that

Herriot Tabuteau

Well, are ASCEND patient proud for is control, confirmation the including implemented things which And having agree thank the just regards we trial the for trial, question, in really that of the first paramount. who controlling where a high-quality your one the we question. your you, quality quality, quality to high-quality in patient of do part Yatin study With and that enrolled speaks conduct of to patients were we of having the -- trial. was the of the high diagnosis

out patients the Now are U.S. patients. professional that’s the professional can they with problem and clinical which minimize there, are especially enrollment in are various There of the be taken which to all trials mentioned, you measures as

did the to And were GEMINI had diagnosis And with For patient is but are in difficulty] example, implement the replicating general we're some a enhance those in a of way have other of further for trial. control to of because databases, we to kind able experience also trial there control just to third-party to we confirmation ASCEND, measures. these and [technical not which but for we in in it I procedure the that, help the even think ASCEND patients. such patients help,

quickly. So very aware GEMINI We enroll that enroll quickly. were it might did

Cedric. of measures And put it lot the of patients with the in we that scores, demographics a turn the maintained And so along enrollment. trial of ensure place with regards quality to to in just I the will was GEMINI baseline speed over to from MADRS the

Cedric O'Gorman

would STRIDE, the is site. Yes, thanks, study with ASCEND Herriot. relationships I positive through The points add established experience few clinical our a we’ve and with

judgment call a there's was same what done based the in our that of and on make would we’ve lot confirmation diagnosis to prior of and there sure we GEMINI previously. approached symptomatology you for experience. study And way as So good in adjudication infrastructure the wanted the

Again, gets Total cut well-established as score points was patient that off, third-party off recruit who confirmation response. allows done XX one and us the similar seeing So allows the placebo moderate [indiscernible] know on the in demographic Ascend. severity. potential we And terms to identify of readings of severe to MADRS can to same make previously course sure or we’ve in we cut the [indiscernible] professional patients on the elevated are that group, age contribute and are higher to the to in patients which of

coming measures a prior [indiscernible] implemented number of that maintained. is trial, this we to there been So of like have one of the patients trial the the the Herriot and as quality ensure the integrity that into just mentioned

Yatin Suneja

was a the it have one like if more was to timeline safety comment get what a trials is a to ongoing to these But the STRIDE-X, Got the Do like you on to on what in set it. the the you you just blog is also push have into on the gating to patient what you. just number on maybe Thank a And label it you MDD needed you broad needed? required more. filing seems can earlier to of an if the what May. the or then reason FDA factors, NDA agreement QX have agreement positive. finally main Can then would you hit an And get be comment MDD two like enroll build the label, database?

Herriot Tabuteau

as an the trials. NDA out, two filing, are positive Sure. you pointed to regards the requirements for With requirements

conjunction be be So GEMINI would should positive. file STRIDE sufficient Those ASCEND positive an to results either the or in completed with trial NDA.

of the So which on. therapy which that previously the we result we reported had was breakthrough meeting and

the one we continued TRD that stopping target, That In the enrollment capture success question a we’ve have STRIDE-X the filing, to we of XXXX. trial, in database. terms the was filing. a to NDA regards the patients beyond assuming the of screening timing are into why beyond screening by in STRIDE-X timeline is the the With who trial requirement for studies around the reason the of for reminder, as the these end an with targeting NDA finally of target safety NDA

open-label So open-label come have to trial TRD the safety the capture driving of in an an recently STRIDE launched a We interest proportion are of increased the the TRD number number, the to to very as STRIDE-X was into the July and get gone was without those that patients extension. open-label queue, factor and And capture the in number to it sense in assure we affecting in patients NDA who the the prudent have to possible to who the of filing. as a patients patients given robust and those NDA safety good who out patients we’ve extension. of package felt safety a trial extension now with of target timeline target

Now the bit of regulatory over about this team thought. the clinical you team gave a color it a safety and bit should to just the meaning of And we in TRD database. give the the proportion I'll turn how patients thought to of terms team, Cedric little quite in be of

Cedric O'Gorman

Yes.

that in general as So a to appropriate of patients the approach that capture what see that filing MDD was an wanted to possible, the ensure real world proportion we proportion -- you NDA as population. robust TRD

achieve the the real real-world said, randomized patients, enrolled this reflects XXX approaches again the of proportionate population. approximately MDD And which in subjects end TRD until world enrolling representation screening allows of to were study Herriot as the [indiscernible] in by STRIDE. So November, us we

half timeline not in And second more it making in XXXX. filing for robust. NDA it, importantly of change Now fact our only the the this strengthens does

Operator

Lee question your line And SunTrust. next of comes the from with Joon

Joon Lee

Hi. Thanks for taking my question.

in the given quarter the the study 'XX, that end of improved also does plan, the in continued through recruitment now as into this the negative, us any the because original from that’s of it month the MDD -- tell Can you TRD of the an of STRIDE study database proportion study study, impact reach you. but that's database amount legitimacy STRIDE-X also and on just of way? Regarding significant and the study database to the Thank the a STRIDE-X largely about of out because now STRIDE-X? important compromise compared coming powering reporting and first in the way if part. safety And this has filing given NDA does that for the is safety safety the ASCEND, GEMINI any of

Herriot Tabuteau

question. for or either file STRIDE STRIDE to should as would negative, a NDA Thank that reminder, regards MDD. be what you, Joon positive allow the were With us GEMINI would happen to for an if

in that would are be there pretty would position in advantageous The STRIDE course, be regards that we to of the would be a product included included, So with be the data should label. difference, optionality. positive

to MDD. for scenario either the under would -- be However indication just in either clear, be

Cedric enrollment that in But with at that safety have sense STRIDE about and of safety you to randomized the the into many extension entered subjects regards percentage out the open-label could not are yes so currently the potentially the that reached disclosed a fact are have of second the to thing that, we’ve Now XXX out GEMINI, proportion -- that trial. patients that the of of one exact in who back so mentioned, think we STRIDE -- And you quarter. had versus is how STRIDE-X And we the in open-label coming come yet the guide as can extension. flux. of in I target give are -- should XXX is who trial, patients subjects and you

first very question, your powering. to Now around

STRIDE-X safety in be that One results patients fact patients more enrolling of are study to additional open-label of there patients the into TRD the will over that analysis. the database who the in the the capture study is efficacy or

trial. so power the yes, have of the increasing would of the that So, effect

Joon Lee

that wrong, to MOMENTUM what but have that is couple open-label XXX. you enrollment percentage a for Correct safety AXS-XX migraine into you with talk of have study understanding me of patients the Could the rolled open-label on me -- as are the completing well. expected my have study? I if had over And ongoing up I'm an to

Herriot Tabuteau

have the exact patients, an yet, the I capturing the exiting MOMENTUM don't safety number number fair of a who we know if but extension. are we open-label trial are into

not So an we’ve I significant going not we’re you a percentage exact those number. done we're the of give think But patients. capturing so calculations, to

Joon Lee

exactly the difference last notice -- And soon us understand take as they encouraging the and symptom the Okay. to AXS-XX seems of INTERCEPT, specifically question, between have what it as help is like very you’re symptom MOMENTUM patients migraine. they

between migraine onset of before what's in So drug if a lag studies, the both symptom taking typical goal? that’s the

Herriot Tabuteau

Yes.

comment I lead patients moderate will and reaches Cedric in until some color. provide to off trials wait let typical overarching So, their is pain that or will are severe I dosing. prior to required intensity One acute migraine

is being how trial INTERCEPT is case. that the so trial not MOMENTUM And the conducted and the that's in

in patients required or migraine to at trial treat their INTERCEPT So the earliest sign migraine to, the pain. instructed of are

that setting. treatments migraine in patients clinician And to is acute take their the clinicians so another who enough interestingly treat real-world patients how a instruct -- specialist now and

turn more in little who of terms give gain will it what would will bit to can I over expect So -- you who we INTERCEPT. from Cedric, to color a

Cedric O'Gorman

Thanks, Yes. Herriot the and question. for thanks

registrational trial the And purposes for distinction real we an a retreat what filing need the of study MOMENTUM migraines. we that’s positive, prior being treatment quarter only But here to of would -- see think real sign want that the NDA. migraine is pain patients recognition to [indiscernible] that the with one are and severe. real-world in moderate [indiscernible] survey I to And till physicians don’t believe becomes to fact earlier speaking key in treated that term wait world, real is is patients are who their pain. of if the

the look in fully kind wanted what earliest it the of So utility we data see treatment offset patients additional thing, in AXS of real-world would are the at to order and have of exactly like interest we excited data generated the are to their through input. to of the generate additional treated in that who migraine, potential migraine understand to kind

Joon Lee

you. Thank

Operator

the comes next question SVB your of with Marc And line from Leerink. Goodman

Herriot Tabuteau

some Yes. company. obviously about your from migraine about I wondering has if be going jug the how Good this joining it's morning. And comments company coming through make could curiosu migraine a was positioned. thoughts guidance Dave that and a our to

David Marek

Yes. thank Well, you the for question. morning, and good Marc,

I of all, join think, Axsome. first I couldn’t be more excited to

I work a And who think and of accelerating when we day need. professionals treatment depression. at of experience look experience CNS proud in I’m that surrounded you that of out be in within other do, of I all kind meaningful to team in category prior day by the kind migraine, certainly most the in has including for been options recent areas have my CNS service in people work

migraine. elevation continues to the are expectations. point expectations, of And treatment when what year when context physicians you that’s when we with we years patients the marketplace, two the only excited. we've And at that greater not but on tremendously AXS-XX, the in potential think in consistently focus treatment past it the migraine And is are improved for at certainly well-deserved treatment efficacy. looking look place clinicians. both with seeing also for an acute I I’m patients of the and to those over I look seen to And information of

designed improved degree longer. only the ability on not but So at speed look that when to the and just with efficacy it deliver AXS-XX is that program with to of onset fully of response hold you onset,

So sustain pain freedom.

make a been at than acute to had trial a looking we're more MOMENTUM solid is is evidence when clinical so the have agents done more And migraine acute efficacy that’s rizatriptan. be look at excited viewed we're clinicians that comparative is having the a decision, trial one looking them give head-to-head and against for who a needs improved really of serve where what more specifically a in going effective and response the therapies, much as suboptimal prior head-to-head past. and or I what and we in have we commonly AXS-XX about really opportunity, sufficiently And program to patients to couldn’t are hopefully what’s that putting

So about very the excited opportunity for AXS-XX. I’m

Joon Lee

end you putting thing on next us other Are studies here, tell TRD come planning a before how MDD year. out the the plan the press out and going just then same One press given not separate are you at of the the year, of Thanks. with can early really to TRD that And releases? MDD on release the is kind on the time.

Herriot Tabuteau

are the from MDD the year-end an confident The line results towards GEMINI in in top we So and by the it's very is in that, trial completed team. hard very trial. team working enrollment

the as acute of just the we're phase trial and the in not treatment X the but well confident GEMINI timeline, migraine. with very in So trial, that as also CONCERT trial AKS-XX MOMENTUM narcolepsy in

that by trial screening. We studies, Allowing from we is upon when data sometimes imply our stopping would who middle know are STRIDE this also quarter first we we're screening, with we're study is go they completed based the the last enrollment So STRIDE the confident that data in TRD, in after. would come quarter put will which are regards the year-end. and put will those in of read to currently That in exactly visit the which are first through out out all to in patients been last first we goal. fact quarter. patient, has out the And confident the

quarter. the of second the half in So first

Herriot Tabuteau

Thanks.

next line comes BTIG. Hazlett from with And the your of question Robert

Robert Hazlett

guess just more is Yes. This online follow-up, I Hi, I the guys. If one Jake on for question. STRIDE-X. for Robert. could Thanks

in was and into open-label the Just wanted rollover expectations? patient to confirm If accrual with line your

Herriot Tabuteau

in and with our Patient into Yes. accrual open-label expectations. line is rollover the

Robert Hazlett

on next Okay. manufacturing maybe and taking with two Thank comment just this but in commercial can Thank second where little early, you. you’re just bit a then NDAs year, half a chain?. is the establishing And you supply you.

Herriot Tabuteau

with So in excellent we're manufacturing, shape. to regards

conducting are with supplies. commercial our Phase trial We X

file we be And NDA. So already has scale the up to in need commercial there other occurred. once will manufacturing no words, transfer

Robert Hazlett

Thanks. Congratulates on the progress.

Herriot Tabuteau

Thank you.

Operator

Robert next from your with Wainwright. the H.C. of comes line And question Burns

Burns H.C. Q with - Wainwright Robert

taking Hi, Thanks for guys. questions. my

one. first my So

Dave, like sense programs payers applied as to deployment? you’ve a well as drug AXS-XX ahead the a AXS-XX authorization probably physicians as [indiscernible] feedback Just, might little or frontline prior prescribe about to the what got be of of kind and willingness from therapy

Herriot Tabuteau

an MDD. on excellent in feedback profile we’ve thus So, AXS-XX the of far got

from you various the scientific know, we results at been have presented results conferences. Those did trial. As report out ASCEND

it that So KLL broader feedback it the comparator. based and loud upon and the fact onset versus also conducted was the AXS-XX from and the the that for fact community rapid active community study has a has that did show a physician been an action [ph] very positive of all

So uses action, by which that a the Clinicians is an that. fact AXS-XX of also antagonism, receptor new it the we're is like differentiated mechanism administered. orally really fact encouraged NMDA that

of seen the need do in candidate. turn So some we on actually need there excitement replicate the think to think just we the STRIDE-X bit trial. looking it payers trial we before will we're it's to the data thoughts. and With of have a premature is now will portion have at who the data full and to Dave and the a GEMINI what product have and line give quite who who that looked in those regards do also those over it. But the I from to is, And discussions [indiscernible], top clinicians we findings to I

David Marek

is in sorry, that there first-line payers When the the type of a the payers is populations I'm used which therapy alluded, to understand excited as first-line think make time we be foundational really and in our population really make information fails sense AXS-XX will robust we're the with to working after types and thank think coverage clinical coming also with as think weeks. profile. about those the we patient given And access but AXS-XX first conducting certainly the there that specific payers, kind understanding -- of perhaps perhaps the the decision. depression, fact and way in clinical could for the utilize the clinical a is would provide of XX% the a as therapy where out And AXS-XX question. in Herriot And element then might to about use working you patient first I I’m appropriate Yes. much line. will AXS-XX still therapy, be of it one trials that seeing that we But data why determining patient

So into work demonstrate in specific we with always pull as the of effective population treatment we and to payers well. those utility, of discussions realities directly the then would the economic course clinical patient

Herriot Tabuteau

add have of decades, the the I if existing antidepressants just And that fact same the could mechanism action. for

we the AXS-XX, novel into be a of with would NMDA the potential So action. which first first oral mechanistic represent could mechanism potentially in the antagonist approval of new

a mechanistic treatment MDD. So I a for first-line compelling case agent oral new in would also be is to provide made to a think it have place

Robert Hazlett

then And that. on more. just you Thank Awesome. one

enthusiasm So guys pre-commercial of you in potential given that undertake that launch, any anticipation [indiscernible]? [indiscernible]. have What currently the of this AXS-XX, sort of if for you’re preparations

Herriot Tabuteau

to sure best those fulfill that of the would would of that lot pre-commercial we we appropriate look patients. the at Yes, think the I those need. terms a understanding specific unmet have appropriate I help of think the we efforts, to the I And position sure need, most appropriate are there that of make that benefit, efforts potential not in making marketplace, to types AXS-XX the proper patient the a education for around understanding the understanding mean, be when in of but out to that want only there's position serve the

that key think of would some the would be So about. those we things

Robert Hazlett

Awesome. Thank you.

Operator

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

Myles Minter

the for guys. question. Hi, taking Thanks

that you on or also much to specifically? curious that class bothersome in symptom, docs response trial a in bothersome that in be trade. patient that few are reaching sort the most rizatriptan enrolled of that heard for documented a them as a any from response, might inadequate this the mean does have to had an the general its to patients that symptom MOMENTUM, difficult most tends triptan actually to nausea population inadequate of And know Just that whether I��m

could So be there any would that population, might anything response you helpful. reaching tell actually inadequate [indiscernible] in me

Herriot Tabuteau

you thank question. Myles, the So, for

Optimization are confirm And a an we using prior The the Questionnaire. randomized a have patients. amongst the inadequate As vary to of -- reminder all acute the the enrolled, must MOMENTUM Treatment trial that instrument treatment who Migraine treatments. will that history acute response the called are patients into who prior

of I to and not it also thoughts. nausea for many patients And bothersome or whether then it been with been around question in symptom, patients have turn so could enriching be for will over most that on will Cedric but to any their triptan And will treatments. migraine response those triptan, inadequate we to and other of acute are terms the

Cedric O'Gorman

Thanks.

in that enriching to your is specifically response. who are patients but having So bothersome sometimes adequate most we're observation we nausea the around symptom agree experience I not nausea, with fact want

think trials. [indiscernible] [indiscernible]. to an element in are we Obviously, still [ph] that the the we We looked I are observation that into to tacking contribute it's inadequate haven’t forward But may looking response. nausea way. And patient astute of that running

Myles Minter

Okay. then, for Thanks on follow maybe question for And that. Dave.

what use the you I’ve and very save some marketing that not SG&A in neurology doing, prescribing potentially they’re heard if looking very, also that’s just the did are to might a company the of GEMINI opinion negative. you And whether massive not or of got you that analysis? Just capital -- that history positive Have if STRIDE-X market just yourself? XX to from paying about at a us interviews in to efficient some if doubt to looked be skyrocket, thinking on going of could probably you’re clinician you [indiscernible] that give no unique the they or company difference top-level scenario strategies sort going depression have into when as

David Marek

very much thank Myles, the Well, for Yes. question. you

certainly commercial number are look think, consider. factors sizing the and when efforts a of our I of that all, first efforts we of at will there commercial

around can the only you opening through is to keen will receive that promotion. patients that reaching these to CNS we specific those a then efficiencies be kind first as really that where all, portfolio mentioned. prepared well we perspective and commercial of addressed mentioned in to physicians TRD, MDD of and well. And geographical at will from the environment non-personal kind was of it indications, right reimbursement implications dollar When audiences, for well component the every what be would look as of then understand we target at would then I comments as what’s the my at look that make of portfolio focused look one patient the we can also audience, also course the of and therapies. the think is what across of directed that efficiency. very of a drive potential spent or promotion kind as therapies looking And also benefit qualified that’s So the but we the clinical things that are starts whether what’s products those at with of starting to as look we some really reach have other of are. key kind And adoption then sure not the sales professionals, mentioned actually benefit that towards then mix have ensuring prescriber patterns prescribers the greatest personal that appropriate we've target through that And highly of we I of also at

we potential the the number reach but effective customers understand level can, target which most up we reach can ways most size I for, general are the when there we what audience, to tenants in our the be and really of factors them. that to that opportunity So our then look to greatest and will efficient a will their

Myles Minter

for Thanks questions. it. Got the

Operator

your Kaplan Ladenburg. the Matt line question from next with And of comes

Matt Kaplan

Hi, guys. and on the morning congrats Good progress.

of narcolepsy. on for you’re wanted terms unique little events impact of design crossover in bit looking of that study? can Just design, a signal of the in give terms CONCERT terms cataplexy in sense a the to in in into study, for AXS-XX given dig you us type what

Herriot Tabuteau

the Thanks, for Matt, question.

So in placebo-controlled as is a AXS-XX narcolepsy, reminder, a trial. study the it

a trial but it's design, study. a design. provides it double-blind, trial, because randomized, of using XX a a So it It is power crossover the effectively patient patient placebo-controlled uses crossover XX a

-- Now XX in words, the per so patients treatment roughly arm. other

One in looking there a should thing treatment had XX in -- cataplexy. with patients point we the put us forward are those with you and the the of do good an patients, effect XX to what the is per sodium depending data on position design if to effect, which conducted to that studies at is, the oxybate to that but see We measuring arm. if inserts, were package show, on regard cataplexy, magnitude prior trials around in an effect you XX look

we’re the XX per is size, although treatment on patients while our effectively trial small So around arm.

of in the some to know don’t I the able would is position sense, if on you depending be a [ph]. there that magnitude the physically us to good gives it So but if that effect, demonstrate effect put effect, an

Matt Kaplan

That’s Herriot. Okay. you, very helpful. Thank

Operator

comes from Charles with And your line next of Duncan Fitzgerald. question the Cantor

Charles Duncan

with, differentiation regard key the follow-up. Hi, and thing you lots like but have do guys. of magnitude migraine for [indiscernible], I What a in you space Cedric. probably Thanks of the land, for migraine on follow-up AXS-XX Would monoclonal that response wondering is in of you relative it activity market. terms see see of which think evolving experienced or Dave With the the show? kind to had and antibody where taking obviously be of to maybe for also to base coming generally, to you I’m potential or speed the just durability? like onset XX? you placebo, efficacy that to orals

Herriot Tabuteau

just So -- -- just further the make over comments trial it I sorry then reminder some thoughts. for Dave design a of some for will to will and overarching turn some about the as question

way enrolling MOMENTUM treat. to are is are designed, As we who patients a trial that difficult the reminder, the

active the a for that endpoint secondary component. way in to comparator is I think that's second have important. is is freedom rizatriptan do the the of study really that rizatriptan. key meet the combination the sustained -- we’ve the we rules order designed point And products pain And FDA's

So superiority of order we in based pain to have on rizatriptan to in rizatriptan, other show freedom. words, AXS-XX to to superiority show sustained

we which rationale Symptom sense long potential pain-free And recurrence, just think has So patient have a upon to efficacy. but two not of be does be in the gives it's only secondly, pain a plasma That the it AXS-XX, meloxicam reduction through the hours. maintained hours, based generally of benefits freedom of has you to component. XX increased half-life one the good that a is

think So we that it. about -- that’s how

and it will to an do treat success, study be So have population what show AXS-XX against coming out we will a the of comparator. of patient in difficult potentially efficacy active if the

to So Dave will to might turn marketplace. that it mean the over I about in talk what

David Marek

and you you, Herriot, Thank the question, Charles. thank for

that in when standard don’t many the overlooked using but acute as in many at today. we lot need survey understanding patient thing tremendous new against that prescribing unmet need, deliver mentioned greater comparison would difficult degree population, high we not of patients the there the overwhelmingly a confidence give they’re data that may unmet look their I satisfy only is is, therapies a marketplace, administration it I'm care. from consistent that variables a one consistency times greatest the I most by will is back clinicians pain don't patients data physicians think looking be today. while as And will when our have you one of have information delivered start talk there's the is therapy one freedom very of and what what the And Clinicians to lead marketplace think all clinicians, be of the treatment have current gets that percentage we potential whether about launched, unmet that patients largely more for in we also overwhelmingly in to with of think think improved need prefer. can clinicians, and efficacy we look thing the being success, for is engage head-to-head is And patients. that at is pivotal payers, of for how that much from fact effective a because route I when head-to-head And compelling even that when or to we better to will data that be are that for treat on roads Herriot, get to the of this considered the design versus efficacy. trial meaning of what

type that of So in efficacy is something you that can not the only we it as that can you standard it's oral profile, improved we high. I makes administration. get again the current of prescribe tremendously potential very against but a And of compelling, an oral for to combination their efficacy, to not as administration physicians see an engage do this care with improved when think surprising AXS-XX think well and willingness

Charles Duncan

you generally And hour Wondering and cardiovascular if suspected excuse could say wondering one that to or if months, you regarding is with development the like X XX triptans consideration label? the Right. don't if risk. and should up in durability, would differentiator, have or measure I’m efficacy final used [indiscernible] X do or that you with anticipate clear that but think a in program intensive XX that months known about question safety And be a months not dosing they that still has me surprised in then patients be for I’m little multi-dose a study, a been

Herriot Tabuteau

Sure.

So, for question. additional Charles, thanks the

absorption meloxicam does be with so it meloxicam, MoSEIC of technology just AXS-XX So our MoSEIC along rizatriptan. combine the would

XX%. of factors, did cardiovascular for should survey percentage -- With conducted is as we comforted[ph] are and into against by the terms of what rizatriptan MEDACorp because So think which [indiscernible] the regards a because the in are that approved. warnings of well the physicians, on that of patients it -- currently survey it since of I firm, approximates survey was by seen contain rizatriptan we and contraindicated would And label current have from it that XX% believes your clinicians. was contraindicated migraine conducted the types triptans I recently percentage label who survey to treating roughly for expect make of that as with commission the it you product AXS-XX, neurologists the that were in by that risk around profile a many are number other might the any does be patients we also interesting rizatriptan who would triptans of factors,

a And single regards So other dose are is trials, efficacy pretty with in our words, so consistent. the question, those trial values to the MOMENTUM study. multi-dose

to for long-term which July, to of the However, ongoing. are That conduct are beginning up launched study was study, and patients safety so required is treated in we a X-year.

So for period. they’re that being treated attacks over multiple X-year

Charles Duncan

Thanks questions. color added taking Okay. the for That’s all helpful. follow-up my and

Operator

the question final of comes Suneja Guggenheim. with your And line from Yatin

Yatin Suneja

a Hey, guys. you Thank allowing for follow-up.

real could by end quick to patient how And you’re comment have that on GEMINI? validated are can have many a confirm you as investor, question to you we the that the conform you. enroll, did in independent a you been MDD Just up able Thank many diagnosis? how maybe assessor enrolling getting patient from of

Herriot Tabuteau

approximately XXX the So targeted GEMINI patients. study

say is completed that we the we surpass did with And -- target reached know. number that never you number What we you you up the reset of it. the exact can patients so and -- enrollment end study now as

did we over So somewhat enroll number. exact the

in we terms few course, by the and trial when will assessor. Of of a the independent who of provide we of results weeks in evaluated announce the the percentage patients were

every the quality is that's important of patient randomized, component very is that that process. it evaluated through And So control the trial. through -- of

answers that -- hope your so And I question.

Yatin Suneja

Wonderful. so Yes. Thank much. you

Herriot Tabuteau

you. Thank

Operator

to I now back it And Herriot. turn over will

Herriot Tabuteau

Thank be us will November joining having key conference the and just all public on webcast you. Well, leader on migraine XX. service we today. thank announcement, upcoming an call We you opinion for a call --

team developing it well unmet presentations as focus that Axsome That Stewart We medicines as join of look the Richard Lipton to that. from in results needs reporting committed to our And will us event on clinical and line Dr. is And forward Dr. The the difficult so you'll top year. feature balance for will disorders. migraine. to treat over we differentiated for CNS hope of Tepper. treatment from acute trials AXS-XX the the

Operator

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

disconnect. You now may

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