AXSM - Earnings call transcript Q2 2021 | Axsome Therapeutics, Inc.

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Operator

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

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

Mark Jacobson

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

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

efficacy, These safety, we will intended and other be statements statements. may call, forward-looking among clinical include today's our During things, of certain the and utilization our investigational regarding, statements making agents, plans. non-clinical

involve present report Development and risks on quarterly and to forward-looking statements the uncertainties change, regulatory to plans, plans that intended reports. Exchange other commercial and the differ current to our Our in trials, source investments. the Commission made Securities These information, & Research possible including from or cash and plans, anticipated annual with the conduct, may of based results forward-looking those and expectations materially future clinical are subject risks plans, contained data, and future in assumptions, our periodic are cause of These actual and filings additional and use and are described statements. that

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

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

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

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

Herriot Tabuteau

a date time. for they July of and this NDA, NDA deficiencies that are. review through morning conference with everyone, Quarter make delivering PDUFA to Good major ongoing been for focused AXS-XX, review CNS it Mark. learn update Axsome update, attempt letter we with you, On letter Therapeutics you letter, the to provide financial the becoming preclude that of strides identified nature Since The have have significant serious from provide all XXth, communication in of disorder the an at Lori, which on a premier today, who we XX/XX/XXXX. labeling we to call. a upon joining received undergoing the last as did our and these state the of our Thank will before depressive a of what stating deficiencies update business treatment receipt on an conditions. medicines pipeline thank biopharmaceutical CNS Company XXXX I potentially development is our and people toward lead to of Second results with deficiencies. the part Immediately first Starting not commercial their living candidate, with product continuing discussion FDA continue life-changing turning will to our of FDA update.

that this specific questions can the time. no the has have In and we FDA informed is at Company them. that So address ongoing they response, the review that for their Company

AXS-XX. the not This decision potential the a reflect under Although and a to on information of may development final stated the approval delay notification does letters that the review. lead

trial met AXS-XX AXS-XX X primary a treatment-resistant the six delaying compared P-value also at in key the X the as subjects MERIT progressing informed with endpoint III with occurring symptoms robust secondary Enrollment AXS-XX trial over relapse subjects in as more. of syndication We for from receiving X.XXX. AXS-XX months, anticipated in substantially preventing depression the AXS-XX study placebo, This placebo depression. least Alzheimer's to the is the depression. keep met release, data to in also XX% relapse separate AXS-XX of a is demonstrating morning add Fourth you depressive topline we results significantly this for of learn in significantly The the the we endpoint of with by benefits positive of compared the The time will to of announced statistically being relapsed by a treatment Phase XXXX. Phase of with and of P-value developed disease in results X.XXX. of to small receiving trial, control completion agitation. the core Quarter body for

will this two Moving on provide on its some acceptance continues of for rest migraine. launches the candidate ensure was quarter. The acute details decision the at these AXS-XX, product FDA Lori pipeline Second to filings, And to to commercialization treatment FDA's we our activities commercial our our is assuming approval. With The the AXS-XX for advance. for NDA end to pre-launch announce expect of regarding programs. a multi-mechanistic Quarter. successful NDA late-stage of the stage Axsome differentiated second approaching filed lead filing

Fourth a And Our to anticipate Lori, of now NDA for turn the of management product update. AXS-XX AXS-XX I on Quarter candidate product call candidate initiation track this the for of commercial will is provide the submitting planned X narcolepsy quarter. our Phase we XXXX. to who will the trial fibromyalgia for for an over

Lori Englebert

many middle the Americans Mental for of mental acute AXS-XX awareness give celebrities at good an those the This prepare increased we bringing morning, for spotlight migraine. Recently, everyone. The have for be and may our commercial of crisis, athletes to launch support an update in major who you are as Thank apparent. as Axsome in suffering. launch Herriot. to we the you, time is on readiness. on as is the the need is I activities disorder both AXS-XX relates to suffering U.S. the it continue will exciting health to health treatment an for and and awareness forefront witnessed And Today, depressive and

versus During depressive the adults X pandemic, One of than XXXX. symptoms of in in greater experienced XXXX. fourfold out increased symptoms adults every prevalence depression U.S. U.S. has

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

received this a date prepared are to bring expected after ready launched We of our approval to product PDUFA XX/XX, on and soon we by commercializing approval. patients three innovation the meaningful is months. potential If anticipate within occur to

efficient patients, purposeful bring to is effective strategy and the meaningful in intent and way. launch an with commercial innovative Our products new to

DCC And implemented. launch the of for commercialization, or platform, is Our is platform underway. fully now digital-centric well testing at execution

systems a with consumers. DCC and and enablement As with meaningful physicians reminder, sophisticated to data use effective, digital platform our to have streamline tools combined and and allow engagement for analytics we designed efficient, more

fully Representative our by anticipate upon their is with now staffed. incredibly team has hiring attracted all caliber, that leadership look I'm talent forward offers the leadership. Importantly, experience to and having We pipeline The payers forward by with discussions, approval. and awareness continues field all being Axsome, permitted profile have after contingent and commenced Field impressed with look and field our the we in to to We payers market representatives team AXS-XX. access ensuring clinical of ongoing engaging board immediately engage of launch. made approval. trained on

preparing a actively ensure services AXS-XX, a continues have also patients to estimated access and debilitating receive up to has potential for the our acute a both is a for team U.S. significant XX support to differentiated It and can that impacts launch treatment setting prescribed. actively profiles note that AXS-XX potential product market is comprehensive to need clinical currently bring are migraine. of important and adults. that for also unmet them. Our tremendous AXS-XX readiness we discussions on patient launch who disease the treat A to of are The physicians easily benefit subsequent patients million although it focused AXS-XX an

I over will now We turn our about products opportunity Nick, are meaningful bring to to excited market. will to it financials. who review the these

Nick Pizzie

R&D Quarter for cash million results, cash expenses morning, increase ending increase the June period XXXX. A in and driven approximately were will stock provide $XX.X XXXX, decrease Thank with to First in of includes comparable non-cash Second And financial in million headcount $XXX the the Today with our for million end quarter the compared an cost We XX.X along I The million and in Quarter. million. to personnel which some guidance. Second compensation Quarter at approximately XXth, net XXX XXXX the an by NDA you, versus in good of was filings in ended XX.X roughly Lori. increase expense. discuss expense, the everyone. support

quarter The in acute increase FDA the for paid quarter million XX.X the the PDUFA due a fee of ended activities for First the in for NDA granting Net current increase for headcount submission treatment XXXX. XX/XX/XXXX, in part XX.X with or increase the $XX.X charge refund from related an to Second the to AXS-XX included was MDD, for $X.X received During loss related and loss the expense, an million was per application pre-commercial waiver. to migraine. quarter in a June ending comparable million million in share personnel the AXS-XX in a was of for PDUFA or million expenses per non-cash primarily the the amount application were comparable includes the in period of a million XXXX. Quarter, us small stock which compensation $X.XX $X.XX Quarter period G&A expense. of the share FDA along to a for which business in XX.Xnd, compared The fee as we the net XXXXX $X.X

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

Mark Jacobson

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

Operator

today. us instructions]. might for like sir. take Certainly, this would At you we [Operator questions any have time

Our from Cantor Charles first from Duncan Fitzgerald. question comes

Charles Duncan

Good morning, results. the team, taking MERIT the Herriot question, folks. for on and and congratulations trial thanks

have being that going their be contemplated full to that if can at by buy-in not However, the speculate is first supported but definitive, the MDD. all as regarding know that of I designs the questions in to in nature Was wondering the trial I are terms agency? AXS-XX to I'm you able that be this you're the question NDA? all of

Mark Jacobson

you for thank and the questions. Charles Good morning,

we not So deficiencies, with know that the reiterate deficiencies what are. regards to we the do want just to

So even the letter to. did or they not what state discipline deficiencies the what pertain

these importantly, don't we period. to receive As questions up has the existence and the this track package the during of now, a going extent an and aware for the will still out, very not letter, know. what reminder, learn any but up as adequately impact that to you a we to from it's situation, application the review application, of hard say, submission deficiencies our attempts soon made this perspective. until as made was large we have did let we've responded that are, point, to point. in prior deficiencies find Since And And we this on We we've has all to to review have of the we up we learned what know. this on review deficiencies current been believe the been the of through

Charles Duncan

then with XXX to were that during Okay. any observations the were review, manufacturing regard And the that occurred observations? there inspections noted

Herriot Tabuteau

we on So of commented specifics the Charles, inspections. haven't the

in been this XXX's aware with inspections. our of any connection so not And to we've day, any of

Charles Duncan

Okay.

X% about to And Okay. being time results, call or responder versus relapse one with psychedelic-oriented XX% ask to the they And I Which the focus important lot drug control, there. do when and intrigued of unmet over work if rate the trial. in done KOLs, are talked question the stay, to, MERIT companies I'm efficacy generate endpoints wondering as think relapsed a then to TRD arm, on? you the need the response two by having of what most or could X as TRD. you you Very it months having on there's know,

Mark Jacobson

on Charles question merit. for Thanks that

relapse So as we the is at. prevention looked study we relapses, just of at endpoint our designed, -- looked look the This and is -- way also prevention endpoint a to very was endpoint primary for the at that trials. times And that a endpoint. important key for but we a standard relapse secondary

a drug symptoms. a to for But thing delay relapse depressive actually relapse period. of bar one it's prevent to actually it's So, higher

relevant certainly the something MERIT And of very clinicians And that's relevant so as the be think that would result X very at for. and minimum. I is if but the clinicians, both possible to that endpoints preventing -- treatment, is would and relapse least it's show over trial months in look

Some year. No [Indiscernible]. to treated out that relapses a observed of were these patients were with

Charles Duncan

mentioned. Very Okay. sales question assume they're contingent how importantly, approval you of you number you with timelines, good, Can last that last. Lori, long share offers on the those the offers. do as for I and contingent think have them out, I us

Lori Englebert

Charles. Hey,

size made sales of they And being are And revealing so contingent still we're approval. the force. the upon sorry, not

estimate just So that I yet. give want you don't to

on that we the launch everyone on current will well timelines. our ensuring we on board of stay by have are We way if

Charles Duncan

for Thanks questions. the taking Okay.

Operator

you. Thank

next Our Goodman SVB comes with from question Marc Leerink.

open. Your line is

Marc Goodman

the about bit can you kind Yes, how Herriot, is pre-NDA boxes call detail. to FDA the meetings needed a for those pre-filing, can meeting, understand us was us say you? take then us good little your thinking here more the like what help morning. the FDA, asking the process. little talked a checked that's back anything in along talk filing you've just maybe CMC. in your you're about did about previous What and you of with In So, FDA you bit question, and give feel

do CMC issues we not it that are no and done here your trying to is just what is Obviously, understanding going like, you to I was everything mean, like there there stability, everything completely were we're just are -- the happened. with too, out So maybe understand assume. find color you until meeting, have more Or you've I guess requested there? have you us Thanks. wait a a PDUFA until with you -- meeting and you've little to them give to requested a date, I

Herriot Tabuteau

you Marc for the Thank questions.

just aware to reiterate With are? very I to point, the not made the the to want has been deficiencies So smoothly. we process going that been have what of process up this regards

this gotten agency. And felt only review. very along accepted was As the the it so we've and product, feedback is therapy-designated a a it filing was including we pre-NDA step as meeting. that close not accepted, the was breakthrough every reminder, our reminder, priority way from a but granted

feel So, And have CMC agreements. been indication was that and the boxes the Prior regards to adequately to be the All all With the that all an would CMC, checked. of application. review, we've work the during answered the complete per meeting questions the requesting smoothly. filing you And can to the the meeting. letter, as of the going has nature learn terms a what been in process including receiving a made agency, we've upon we with efficiencies requesting of are, that attempts imagine,

clock. PDUFA time time there's Admittedly, the the it's on dwindling. is still Now --

any additional are of know. However, of or as details, deficiencies the first what to learn you'll soon the we as be

Marc Goodman

been completely, I box concerned far probably manufacturing you're is everything the like, belt that mean, is is -- issue. plants. as a talk they checked, as this about Just Have inspected manufacturing not

Herriot Tabuteau

you So inspected. But Mark can that the being at some more a a on commercial is as details provide reminder, gets manufactured blue-chip product regularly CMO that.

Mark Jacobson

Marc, morning. Hey, good

and prior FDA not aware we have as also -- U.S aware that the the we under So that available we just mentioned earlier are that, -- product comfortable DMF open North may drugs facility to are here so any commercial our a lead of facilities this. and the so any to substances and not reminder, have or with we that or That any has that sources substance like of a in ourselves made have we're And drugs mentioned, the Aereo our are substances from engagement. with are done inspected multiple terms drug inspections audited Ariel we that's that America. And of makes and regularly major is is is CDMO numerous inspected inspections, in the as been mentioned. may drug and issues products, not preclude of as by in use facility development

Marc Goodman

this positive trying Like have patients studies. accepted, said I might numbers understand I be you appropriate for unequivocally, the you've mean, know got studies you the at had the of a question to were you two basically where I'm FDA, but basic because safety, just is. two problem just

Herriot Tabuteau

We are communicate as aware and deficiencies are what too, soon of made you. as we the we'll exactly to them are,

Marc Goodman

All thanks. right,

Operator

Thank you.

Divan open. from is Vamil is next your line Our question Mizuho, with

Vamil Divan

taking these my the one as last Maybe other companies just more letter of few we've few for on Great, in well. a thanks months seen this now question. from deficiencies

during to only manager maybe That a and -- was data. get I'm process. of few trying because there's played we of some process. in late the that's and Acadia project speculation, curious then think TRD anything it if coming along being or maybe second very and thought managers just during may changes think this Again, sense, weeks to a of just notice question also your project strapped your process And were different the with but role. the months your a separately or just deficiency in So personnel, there of the kind and way, COVID the is now maybe I led few ago to FDA review I with saw my have that out that to review sort

curious, Just again.

be get medical able you am the described we as me do an TRD correctly? you've think you that ultimately indication in more label and you will Or I I ultimately Thanks. for remind anything think, indication. you're to before, as if a And expecting not of can education verses just or that well? thinking as is it around try TRD purposes,

Mark Jacobson

study is and in those with of current MERIT We'll regards to AXS-XX approval and and ensuring our questions TRD, order focus MDD. two launch the reverse take

So thinking we the very that COVID MERIT an be what to do by we do results there's we is other from overall source the obviously additional the about with excited those of results And that this mean the are the to of any know a trial, every will as data. for our plans. is process, particular to organization kind the currently point regards is changes of during recognize definitely focus With FDA the agency at to review so AXS-XX future ensure we MDD. that -- in globally the But of as it and long-term that. approval COVID the we as resource-wise With FDA But has you our strain. dealing can application, been specifically. and nothing That pandemic. relates result stressed that pandemic also, like comes resource's do

Operator

Thank you.

Vikram with Our next from Morgan Purohit question is Stanley.

is line Your open.

Vikram Purohit

morning. our Good taking for Thanks Great. questions.

Just for my side. two

if back just progress plan available one? NDA? is commitments. secondly, mentioned And become deficiency NDA from incorporating about the just exactly So some study in data near-term, there is for things what the the AXS-XX, and on your that efforts towards specific the release with and to the color to available clarify, commercial think the assuming some clarity does going letter, of from topic Was language any area press I the there additional the that post-marketing FDA MERIT around

Herriot Tabuteau

That's of put letters. to So from part the press it around post-marketing commitments. in the the we with identical the release regards that language language

it as we So to just we wanted got it. to you provide

MERIT, you you mention, the that So what's and we agency to over was imagine, should so us. specific, we of been to regards either the was The And -- unblinded provided are or regards weekend. so there provided exactly have as said then to results. identified no the with study made can with aware, we specifics nothing there

And turn course, study which it not as might for focus to MDD. we our to And Lori commercialization. over how is the file indication relevant is TRD. is, indication clearly I'll depression that and And to of so it MDD, general we an -- impact discuss so, in the

Lori Englebert

relevant The will only patients reuse conversations. given data we'll having in are expressed to to treating validation there Yeah. body data, durability, the our a as well. that I patient further physicians highly just relevant that provides just are has. Phase data that AXS-XX that that physicians population was be work is from a and The in to the believe supplemental time difficult the very II this the study, of do

Vikram Purohit

FDA AXS-XX Understanding you the for execution of or impacts follow-up. well. relatively on plans your how quarter? this then you meeting later have were any on a whether do is thoughts news with the And outside program But have that's lever new smoking for quick you MDD, that supposed deficiency this the NDA current to that as the with

Herriot Tabuteau

any it don't impact We other believe indications. on the that has

Vikram Purohit

you. Understood. Okay. Thank

Operator

you. Thank

from Our Wainwright. next Ram H.C. Selvaraju question is from

open. line Your is

Ram Selvaraju

Thanks wanted they to to not my beat they Again, from petition had AXS-XX? way letters the citizen dead feedback for received whether to regarding taking to any a was very as ask the an that much FDA horse, you questions. whether had may I have any any related spent

Herriot Tabuteau

We are have to any behind cause the is deficiencies. not don't We made aware details what or related they of is. know been what's the what or them

information, As let you we that as know. we'll soon learn

Ram Selvaraju

meeting then able regarding as the deficiencies you follow-up be arrange Okay. clarity to date? or or the PDUFA with you anticipate will to likely do think And do only PDUFA the before scheduled this a scheduled these as more a is date that, that obtain you to FDA be

Herriot Tabuteau

speculate. It's hard to for us

obviously but developments. PDUFA of of as right given them. imagine, on clock with as information, information, we're possible, time or is any other the with as you you and trying or the the that soon As meetings our as nature goal the learn let soon are [Indiscernible] can goal we that any not to now, within that is and or control, we'll still that as is there we're And to quickly addressing something do, now whether not our know deficiencies get

Ram Selvaraju

potential complete the And you Is go date is resubmission some be by determined. clarify and scenario to is that a response is the would approved yet be. correct? through letter process. yet PDUFA to there might One scenario time, drug period And to the a and the other that extended of third that have by then that gets is is actually Okay. date scenario what scenarios just the PDUFA

Herriot Tabuteau

Those possibilities. are the

Ram Selvaraju

on know perfection had thoughts six and quickly detailed MERIT very could just then reported, this finding frame the you And the within is, over TRD more differentiated how study, I AXS-XX that just this wanted how was relapse make time if some of Okay. context? to month the on significant the

Herriot Tabuteau

a a finding. companies not one And the the in actually prevention because prevention do delaying do endpoints as relapse. relapse, to have important lot very it it's it's me drug of actually work -- relapse not but prevent may studies, of actually in think We maybe relapse another thing to

that So that is a bar. higher

it So Lori mentioned. relevant drug. it as very of durability activity also the the speaks we think is of to

then patients, reminder, were long into a As for discontinued. prior as some had enrollment them drugs, And on to of randomly XX MERIT months. as been they

So, to at X remain or least. another months, they on X discontinue they either AXS-XX the AXS-XX for

So durability of period fact patients that that's demonstrate product, long relapsed to so very the none a the time of significant. is the of

Ram Selvaraju

you. Thank

Operator

you. Thank

Our from Company. Cowen Thome is with next and Joseph question

now open. is line Your

Joseph Thome

taking for you questions. thank And morning. Good our there. Hi,

from FDA. manufactured point, how to it them to as data is the the scrub a correct? more to that's the same fashion, thorough clarification, based of the you notification if a of would take little is of it the maybe that second I And information the of mentioned the kind point you to provided on sort submitted of Herriot MERIT; maybe you think them? additional Have in is Just AXS-XX? timing the AXS-XX [Indiscernible] facility results necessary? And then any give maybe in in long

Herriot Tabuteau

Mark question. So I'll question the I'll and then let second first answer take the

I weekend. data, MERIT regards we the to So the mentioned, as data received with over

have to of We agency top-line results provide see we it to they study. from the them. aware If the are additional made request the prepared data, to

Mark Jacobson

its Joe, hey So Mark.

and actually the facilities process also product. open we utilized -- there we available is drug a the them in AXS-XX, the are for used the And bit product drug that is same manufacturing, DMF that too of The of the used that for U.S. for one of under AXS-XX. we facilities for two the 's the two for manufacturer So more that are complicated manufacturing API drug

Joseph Thome

switched Thank it be more it that we Great. MERIT quickly initially And towards would one in seeing, did just is helpful. telling six-month totally you. that can data on How patients write end been placebo was follow-up Okay. period the that the be or would relapse. maybe on the were connect has that pre-rapidly of the result

Herriot Tabuteau

Yeah.

So we of you data so which look we results will will provide of of relapse forward curve, [Indiscernible] including providing curves, the the be at the full Kaplan a there, the presenting the that to Meier conference, some so all information.

Joseph Thome

All right, you very Thank great. much.

Operator

Thank you.

is Our Lee your Joon Truist open. next Securities, with question from line is

Joon Lee

for thanks taking questions. Hi, our

this at weeks given of just is So the produce a [Indiscernible], couple away. point,

that who a the most others is. And for reason disclosing not is disclose the think on who Just is You outcome who to another CMO CMO, strategic curious. think would a and is is. What there the of you CRL? out is likely through not the CMO We've companies is question seen CMO choose And most disclosing the outcome? the find you when what then deficiencies are? likely

-- any wondering the strategic disclosing who disclosing So on competitive [Indiscernible] what if versus or is. you. that's advantage of based not Thank

Herriot Tabuteau

will disclosing something policy. our is have who are. different that policies, do. that Kevin do to typically Kevin. companies is regards with Different to answer it not That our question. turn we I'll And your who vendors but Yes, first

Kevin Laliberte

don't agency And for based deficiencies available as potential As There for mentioned is is that PDUFA If there possibility their letter two and a of that options MERIT the third earlier, are. remaining approval have review. option, which point. and proceed. can then also until today We now what this are are a the know possibility couple time, extended that Those at actions example, the relevant could really on PDUFA response that complete is is date. mentioned, is data know possible, the is the There are we what PDUFA. date for different the we between labeling the weeks still occur

Joon Lee

the But follow-up. to Maybe those terms regarding those the there deficiencies of away. facilitate resolution of with the Are periods? two PDUFA just by FDA tight, the companies, to the know what level sponsor deficiencies. and of again hope short FDA disclosure what those interaction a in given, best times I periods curious or very achieve quick obligations are any you in is of weeks time communicating two could the are only

Herriot Tabuteau

of comment We that our to the kind curiosity it's any what them. can't trying on not learn It's and internal the Yes. addressing with part. guidelines are but we deficiencies on agency a goal certainly of has are

Joon Lee

Thank you.

Operator

you. Thank

Partners. question is from Suneja next Yatin with Guggenheim Our

line Your is open.

Yatin Suneja

Hey clarifying. questions Couple just from guys. me,

the understanding that them with like a are legal So doesn't you think our have to that after some because reached but seems you out implying letter engagement. is and might is a I issued it FDA sponsor of engage such there be implication, it

you the you Did since letter from FDA can So that hear been received? anything has clarify?

Herriot Tabuteau

Hi Yatin.

we've that with since informed to the And the we've been you try review. and is to out letter, made ongoing, agency has that the what what on in us review is deficiencies has we've response, clearly, still the agency So, the what that reached final are. decision no shared the learn of gotten is

we'll And can know. and so deficiencies know, once what so want you them, we that are we know let we obviously still the address to

Yatin Suneja

factor? will then pretty said, if to after And the like be launch, the month other what's Okay. regard that the approved you with question the ready [Indiscernible] like, is you [Indiscernible]

Lori Englebert

to the first given this clear of distribute just So, to being launch Company, the are administrative there have that to we hurdles general that is product. prior our able

reason so the only the for And delay. that's

Yatin Suneja

agitation status enrollment? is on study Okay. you narcolepsy in guys terms what And update then the and give ongoing, that's Thank the study, could any you. the of

Herriot Tabuteau

this narcolepsy a With track on trial with regards quarter. study, to III Phase we are initiate the that program to

planned. there So with that. tuned disease the stay so Alzheimer's agitation enrollment regards as is trial, to for going And

as in us the study We previously guided of XXXX. are enrollment quarter complete puts which track to XX% the nearing and fourth on

Yatin Suneja

Thank you.

Operator

Thank you.

America. question next from with of is Verma a Our Bank Ashwani

Your line open. is

Ashwani Verma

Hi, questions. thanks our for taking

AXS-XX. the on one a Just

in So, of I the discussion it see second And my here requirements. That's are think I there one. the topics other says fibromyalgia in that on is not the language PVR, precluded? drugs. first any and the Are then preclude labeling post-marketing

elaborate filed you you it's and think So that pending in Thanks. mentioned There's XQ bit? I that some activities. other manufacturing to Can 'XX. on a little be going

Herriot Tabuteau

being topics first With questions. that precluded. may the be thanks question regards other Ash to So the around for

specifically said. all post-marketing So with the commitments, regards letter that's it labeling is to and

the first the it's in to exact the language the fully is interpret but from letter. put without agency hard details So, getting what additional we've it release from

you what the -- sorry, So to that question? read the as into wish. you fibromyalgia, I'm regards was can With

Ashwani Verma

to trying there's that think completion pending Yeah, mentioned you and successful of I'm some understand, manufacturing just I other activities.

want what, to filed understand what can I be year? So it does be done what needs before to -- next

Herriot Tabuteau

Sure. new this there. is Yes. reminder, could details entity. a additional some a But Kevin provide chemical as Maybe

we manufacturing to active pentent and the And so are API ingredient. the pharmaceutical actually (ph)

make have scale we details to launch additional and filing. want that a sure clearly Kevin, ensure there? enough So to we'd any

Kevin Laliberte

Yeah.

API -- would We're Sorry. stability drug and we application. the data of an typically facilities to file own our and we production dating support the that establish starting product need exploration limiter is the to of product collection of and both for the for establish rate as the course,

file So application. is that of for just it before be accrued a we lot to waiting data can stability

Ashwani Verma

right. All

Okay. Thank you.

Operator

Thank you.

Jefferies. with Howerton Chris from is question next Our

open. is line Your

Chris Howerton

Good Thank questions. for Great. morning. taking you the

had letters. healthy we've a think the discussion on deficiency I

So narcolepsy. just ask maybe I'll about

I a setting, in is the guess designation with then And taken as can guess differentiations? a first anticipating do you in Thank you Fourth that design, positioning that you. some breakthrough of label, those of you're achieving the as features III how program that the narcolepsy I going second cataplexy, how any respect question highlight saying that Phase to some there Wakix was that result are Reboxetine question I within to Reboxetine think that the Phase study see you're of guess back, the the Quarter, all. I III in the have so to So that of so positioning questions that the I do the there's been is, significance soon think we're of see is and

Herriot Tabuteau

In this terms is medical still of the narcolepsy, need. positioning AXS-XX of it's and high remember that unmet area an important of to the

that in And also so now treat cataplexy. label cataplexy, means for with only having are a that two the products approved [Indiscernible] you that to have

salts. oxybate the being one other The

of an where scheduled. not medical treated. unmet high patients most are still And adequately most still need So area products are

the also AXS-XX, not that So set, But profile only positively it it profound rapid cataplexy, we daytime effects looking excessive rapidly in product did were sleepiness. impacted which is all at on have

is fact symptoms those just addressing the speed the onset. of key two it not of also So but the narcolepsy, that

we cognition, which X improvement with to the did by significant that a in symptom the is is narcolepsy, a in differentiation Phase concentrate. of show trial, rapid in is and to ability products. important show very concert our patients point improvement did highly important Another complex, an which not which is targeted statistically And we and

we endpoints starting X Phase would As program in studied that you trial can and forward order. short our be all to imagine, in look those of

Chris Howerton

very great. Thank much. you That's Okay.

Operator

question Thank you. Kaplan from Ladenburg next Matt The Thalmann. with is

line is open. Your

Matt Kaplan

for questions. thanks and taking the morning Good

package the Just bit towards a or I were NDA, where studies complete to an beyond well? little about the pivotal term the the little studies, have studies guess, your you of letter. part studies wanted about as did bit can of you interaction to and safety talk studies part ancillary that long those drug-drug a likeability talk deficiency

Herriot Tabuteau

part we studies likeability complete interaction not were the and So have of definitely to did studies drug-drug package.

studies. So of pharmacology would interaction an a fall drug-drug studies into the included array The truly package that. clinical

so And complete very package. it full, was

Matt Kaplan

Okay. congrats a just MERIT to on little you results. talk other that saw TRD And months treatments up durability compares in the saw? study of about for some six Thanks. durability available to in are how general, you Can the that MDD you terms bit then

Herriot Tabuteau

which And for show to treated make hard I It durability It's very to new. did up the COMET very is in is impressive cross-trial comparisons we trial. the Yes. this patients are their we months. mean, by durability. but up -- excited XX not were is

at but XX treatment. out So to rapid maintained not it in of months was depressive was the only reduction symptoms, there a

and up did months. new relapse even is information additional what's stable is that, potentially this not not so remit still and for XX to patients that not beyond did new were -- an So

certainly So, And a was at patients, least randomized fashion. X this [Indiscernible] X months, months. in

lands So data it the since data. credibility is to controlled wait, obviously which

Matt Kaplan

Thanks for there. right. the added All detail

Operator

you. Thank

with is Minter question Blair. William from next Our Myles

Your line open. is

Myles Minter

previous mention the range and up thanks of any broad for agency with of but a your not Gemini. product in and interactions wondering guys, questions. I'm efficacy the ended made taking just demonstration depression ASCEND in Hey across filing just whether patients requiring started of that

off the label. the subsets Acadia want back page agency to that that efficacy multiple dementia in CRL of across the road Just day where asking seems our

Myles Minter

deficiency if towards now a technically use and secondly, And being you actually kind negative. you response of it STRIDE-X did presented deficiency the up? as if to pointing Could that as showed we're target come that a up sub study recently that

Herriot Tabuteau

in we the So, hard with speculate know the for discussions what it's the come that us up are. has since to agency. answer deficiencies don't not is And prior

Myles Minter

STRIDE-X at medical maybe then to of what that to later period And XX MERIT. in day just saw in months drug be we response on running Thanks. is that going presenting right you're that the or a up similar the was to that conference. Was

Herriot Tabuteau

leave analyze. to at we Let’s have it

study also we the prior when only So, at looked to data, it patients not included treatment. but comet so who had of that with patients lines included other TRD,

so it who into and TRD TRD -- were who remission And were the had was randomized MERIT. in had patients stable who who

date to fully you providing to we can So presented. answer that the which we'll have calculations do that. we when provide would the are exact anticipate to do some information And

Myles Minter

Okay. for the Thanks questions.

Operator

Thank you.

line SVE. the question David with We of from Hoang, our last have

Your line open. is

David Hoangr

for you Thank morning. good in. me fitting Hey,

of just quick questions. a So couple

this little bit you could study have the you is again, do just of event there's about realize -- Would to supportive meeting? look supportive can a CRL, think application? little MERIT So -- bring to talk that of what you is there? sort be you the you were that anything the here, forth receive would as this be in bit potentially to in be you a next I to but going And schedule steps with speculation the a

Herriot Tabuteau

meeting. is So Steps a that with regards typically CRL, after to Next requesting a type-A

exactly it that possible. the in With to and difficult any deficiencies as what quickly as what regards we the MERIT and are. we to do eventuality, know that scenario, very would it's do would of we in is since speculate So usefulness do under not

David Hoangr

Got fibromyalgia. on it. just one And AXS-XX for then Understood.

maybe -- understand but So, remind I with development for time. molecule us originally if some molecule the originated Pfizer just the correctly

proceeded fibromyalgia? for just saw with curious never and for you an approval Pfizer as approval So filing know, what to in never the drug they

Herriot Tabuteau

was was it you tell that is of part can we a made decision which portfolio as decisions. What a

but trials. by it has tell of product. it of with made So Pfizer, the or do the the nothing that product that we was positive do decision can efficacy to was And before the importantly, had of the to III safety with disclosed portfolio the -- you Phase readout nothing that

David Hoangr

taking helpful. for the Thank questions. you Okay. Really

Operator

to turn back Since no call the you. Thank are I for Axsome's there CEO remarks. any will concluding questions, more

Herriot Tabuteau

advancing living the call all We on our benefit product disorders. Well, joining as committed thank with differentiated to always patients CNS you the remain for of us for portfolio of today. candidates

as for We keep the rest the you the of of progress learn on will our as AXS-XX updated as NDA more, pipeline. well we on

Herriot Tabuteau

Thank you.

Operator

you This concludes for today's Thank conference participating. call.

day. may You a disconnect. now Have great

Axsome Therapeutics (AXSM) 9 Aug 212021 Q2 Earnings call transcript