Axsome Therapeutics (AXSM) 2 May 222022 Q1 Earnings call transcript

Company Profile

Participants

Mark Jacobson	Chief Operating Officer
Herriot Tabuteau	Chief Executive Officer
Nick Pizzie	Chief Financial Officer
Lori Englebert	Senior Vice President of Commercial and Business Development
Amanda Jones	Senior Vice President, Clinical Development
Charles Duncan	Cantor Fitzgerald
Joon Lee	Truist Securities
Vikram Purohit	Morgan Stanley
Marc Goodman	SVB Leerink
Vamil Divan	Mizuho Securities
Joseph Thome	Cowen & Company
Ram Selvaraju	H.C. Wainwright
Jason Gerberry	Bank of America
Yatin Suneja	Guggenheim
Chris Howerton	Jefferies
Matt Kaplan	Ladenburg Thalmann
Bert Hazlett	BTIG
Myles Minter	William Blair
David Hoang	SMBC
Esther Hong	Berenberg

Call transcript

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

Mark Jacobson

Good us operator. issued thank all you press Thank today's morning, conference joining on we call. for releases. you, and This two morning,

the corporate Our a of quarter short the are the the the and and providing AXS-XX press to and results available a time relating website action earnings details the ago release XXXX at of on wire FDA's company's release first NDA. financial for crossed axsome.com. update our on These

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

statements. today's which any and disclaims are only You the place to of such reliance to forward-looking cautioned us date, update obligation are these undue made as on statements, company

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

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

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

Herriot Tabuteau

and Mark. have Thank update productive financial you, all incredibly thank The months for few busy results Axsome Therapeutics' you quarter Axsome. Good and morning, for XXXX and past business been everyone, conference first call. joining

a commercial FDA update have a we progress the and of NDAs, provide this of With an on status the update. provide acquisition morning, migraine. of AXS-XX includes both and made the from We rest to in regards CRL, of financial complete agreement the NDAs, pipeline, AXS-XX and pipeline our reviews Nick, fibromyalgia. or late-stage AXS-XX, transform before Lori pending who disease Alzheimer's entity have advance the NDA we announced FDA acquire the announced in potentially rich Axsome in the will team's of the a results our acute execution. I that the focused continue turning Sunosi of it direct in to received for month, our our rest into and agitation, letter, to treatment AXS-XX a to response poised over will Sunosi as to which for our commercial and narcolepsy AXS-XX of this as is early

addressable. and the the manufacturing drug safety reason not in to efficacy data CMC product pertaining CRL and CRL The chemistry, given manufacturing additional to new CRL believe about or considerations. the the in relate that all The clinical any approval did clinical not the the the We issues process. for need the or identified raised CMC AXS-XX. identify any controls in FDA CRL raise trials are principal request of the Importantly, NDA, concerns or did the support and to

so make on approval the to data It with information prospects to With millions need new a the to that provide this important excited with previously the possible. and We with deficiencies the for following AXS-XX closely believe of the migraine. offer timing clinical the quickly NDA people driven as as would potential CMC option available our from FDA, medicine is of work multi-mechanistic is needed the treatment AXS-XX. strong the This to The provide new we the excitement disclosed are by have them FDA review that is AXS-XX, they been consultation resolved. much resubmissions progressing. living can goal a intend to of AXS-XX. for regards we for FDA. patients by Based of feedback product We profile with

recently the of the we in post-marketing AXS-XX we proposed addition, NDA action this progress. to in ACCORD anticipate the the on regards second commitments in and AXS-XX. Phase requirements continues XXXX. III Based of Alzheimer's agreed agitation FDA on this interaction, received In With trial quarter our by disease to enrollment the program, and for FDA indication potential

the study with previously consultation the and update provide evaluating As following will we an the disclosed, design FDA. of are

to waiting acquisition XXXX, acquire in on Moving we to to dopamine Jazz Sunosi improve now excessive to with adults a into daytime or expired. from apnea. a is agreement or acquisition. definitive and sleep Sunosi March period entered Pharmaceuticals. dual-acting reuptake norepinephrine wakefulness the obstructive sleepiness for solriamfetol indicated In The has due the narcolepsy Hart-Scott-Rodino Sunosi inhibitor

late-stage and of patients to acquisition on to FDA our poised action so medicines a continues in for new close coming is closing to available in we to Sunosi, expected the with potentially CNS of serious this depression make two transaction AXS-XX month. Axsome advance. important of pending the living The the And expect pipeline disorders NDA our Between rest our months.

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

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

Lori Englebert

good employees ensure are life-changing focus of Axsome. prevalent transition are focused and commercial extremely commercial of and efforts working we Sunosi and the team of to Axsome remains verge into need. on the commercial Axsome Axsome for is potential our the we opportunity have unmet the forward substantial and Herriot, launches of am smooth welcoming about to you, addressable Jazz near-term hard morning. potentially excited and team simultaneously upon immediately a proud The preparations The infrastructure. the the look becoming patients. to a from deal been I products highly have bring diseases therapies for to on entity, close, Thank entire to

differentiated will their to markets. profile if clinical approved, bring respective products, Our a

associated affects positive executive experienced close an to whom XX narcolepsy prevalent reminder, treat continue patients on US, and condition is a the of condition Sunosi or OSA hand, and them have continuous effects serious XXX,XXX airway XX% of excessive a the US memory and Many is EDS is million EDS. a sleepiness condition that with or with dual-acting that OSA with other despite people As can the in highly adults, all experience experienced of attention, the EDS. affects FDA-approved to is of or estimated only CPAP. is in associated impaired function use pressure on OSA an orphan first an DNRI narcolepsy functioning. daytime that OSA. EDS neurocognitive Narcolepsy to adults estimated

one continues an MDD the disorder, XX adults US number year. [ph] mental health each with the illness feel, crisis negatively way they to has and serious the studies how AXS-XX impacting the affects major estimated Regarding of how cause and and due COVID-XX people And the estimate million MDD worldwide. medical pandemic. likely number increased MDD depressive recent threefold that is they disability US act. a that also experiencing common think is

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

experience of Sunosi, if approved. are rate Despite are base major Regardless for high approved. on disorder on prepared near-term and highly AXS-XX up for in depressive to complementary so launch commercialize, current to currently is been launch who to Americans for acute our AXS-XX for efforts the planned migraine. migraine prescriber actively have delay therapies, sales to preparing with weight-promoting the available a to XX potential ready for for if continues and made the AXS-XX. of will be We XX% do allows be neurologists to and with combined in of and force the due we million Promotional agents psychiatrists dissatisfaction any AXS-XX. unmet Shifting primary market, innovation XX% efforts. close of there demonstrating recent CRL, AXS-XX need ready targets

As are approval. a offers force upon all reminder, contingent sales

first-in-class digital-centric our commercialization DCC to strategy. our fundamental platform Lastly, remains or commercialization

engagement for the DCC content the meet and with and want promotional our goal augment to how efficient designed was The platform be and where right meaningful efforts highly time. is allow effective, DCC with engaged right more patients. to of to customers to they at Our physicians

to launch purposeful forward market I to I commercial commercial to market We AXS-XX near important discussing who Sunosi, who significant innovative will Nick, important the after AXS-XX products strategy turn plans way. the to intent of to review for potentially financials. patients a potential Our to and the excited opportunity potential it to close these is the bring profiles detail them. greater in of the the now products about differentiated with bring The bring will upon and to the transaction. over new clinical in treat Sunosi the look and AXS-XX for term. the and remain our meaningful new approval physicians have benefit in

Nick Pizzie

and year, financial $XX million decrease guidance. compared Today, and to the results the Lori, cash morning, at a end I the million approximately first our you, everyone. with some good roughly We provide net in approximately of million. of will Thank quarter ended discuss $X $XX quarter

compared of related XX, for related million in the accessed net first million. three increase compared loss in compensation $XX.X Net March $X.XX the XXXX. net expense. months period were million the receiving $XX.X quarter, to million stock The comparable share the along we expense expenses of stock was XXXX. $X.X expense, XXXX, three ended period for current compensation in share the million period for XXXX. March non-cash to decrease proceeds XX, period in per loss The in ended net was filing, per XX, which million months the $X.XX million by or an our includes increase period. and was with for and the $XX.X and three non-cash R&D expenses or $XX.X months comparable loss for prior driven the million in million primarily XXXX, The ended pre-commercial the $XX.X activities personnel $X.X of comparable the to the to a $XX approximately facility, $XX.X period. for for G&A ATM expenses occurred During March were XXXX, comparable comparable NDA

which AXS-XX to Regarding the in the lead balance, acquisition, the anticipated the through of investment That remaining current million Capital, first fund XXXX the plus MDD Capital. with on capital committed with believe from of We our sufficient will and facility existing along Q&A and operations turn being $XXX our to funded launch additional financial back commercialization concludes acquisition I operating $XXX current includes Hercules Hercules Sunosi an Sunosi. term into that review. call the is quarter facility Mark million loan discussion. is based equity acquisition our to potential XXXX cash from now plan, the our the

Mark Jacobson

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

Operator

open. of Thank is [Operator your Charles from is Duncan Charles, question Instructions] first Cantor you. line Our Fitzgerald.

Charles Duncan

our Herriot question. XX. couple then morning, taking have and on for questions, Good of XX team. Hey. and I on Thanks primarily a

CMC of I Regarding can additional with us address CMC, color met in on the or it how received and you provide your gives CRL you this ability with guess, terms not not is XX if confidence in but issues at to but of the I CRL, this haven't what any the the you subject, only related XX? all, you to but know it? CRL, that agency, And the CRL

Herriot Tabuteau

the who it I'll more no with Charles. relationship. distinct. The also have XX, to regards provide question regards XX Thanks been relationship, to XX, that for the resolved. to With and maybe there Mark and some issues Hi, addressed turn the and did deficiencies between then comments some over also announce question. details. CMC-related And can overarching make then I'll is are the we

NDA. concerns important CRL data any that efficacy or XX Now not to the or safety CRL, did the reiterate clinical of raised it's to regards identify the around the the in with

to we of And think So about affirmation we great at feel very that. clinical our data. the get from a it's with good the regards FDA review to end that

to good it's think and So We product. a incredibly it's it's - exciting profile, to the the review. get we of an love end

regards Mark. considerations, the turn Now and to over to with CMC questions I'll

Mark Jacobson

good morning. Charles, Hey,

product questions principally and manufacturing we related mentioned, for they process. additional information, the as drug the request the So and

technology incorporates So AXS-XX Axsome MoSEIC just that reminder a that novel developed. with our technology,

of that And the the technology. so does increase the process, complexity manufacturing MoSEIC

understand give more you questions, detail. we for to And and other complex many that and may is a result as was we many of molecular be the the there just do relate just that informed address is that to addressable. is of one we so we question, of no our and completed of to and have that, shared that. that And basis elements helpful of inspection. previously was little believe bit different And the impression technology bit findings that were The the facility were required try inspection they're questions system a buffering information the a inclusion that your

Charles Duncan

So you us like it's you addressable and that distinct Do relative they're it a set really with XX, sense after the you feel a like agency. provide you'll be? of issues sounds of – but could when have meet to timing

Mark Jacobson

So – we how and share that will with we to approach we that's plan that be take that, an folks. correct

[ph] a to We all to sense expediently. timing, we take we to granularity know. computations resubmission. as So to have sure do make a II and that of timing, as this our And time soon for we'll expect prepare that we do we related you want do to let And we then expediently. for Class be would will want the

aware, is so that everyone as six a review. month think that's I And

Charles Duncan

incorporate And be it. include And lot detail XX, that XX, communication And treatment, anticipate that. a changing hear or the on one demand Thanks. Serene therapeutic great the that provide Got for does intermittent you of color? you've the I'm initiated and filing. is But Do to any can received I'm sure post-marketing on from the same landscape opportunity two-part quick it be on their second perhaps is, you part you provide so, you you Biogen, with seen question a post-marketing of that for if example, AXS-XX? of requirements can't had set out of the kind wondering to some should alone to then then when program kind REMS? agency the given more [ph] requirements. if that approved, that Sage, there with

Herriot Tabuteau

PMRs over that treated Lori around there. question the to intermittent the those REMS. some have regards provide for additional details intermittent is I not part Charles, it we're PMCs Thanks, that With comments some Sure. might treatment follow-up just or questions. been to overarching depressive REMS was the on are discussed before the turn major overarching question agreed the of your some around he - or with FDA. disorder And to able that, way treatment. But can always to comments be

clinicians course, of episodes a medications. once been while, to major taper they've would and patients and treated, for then better better are off get their they depressive So many them

not should should depressive lease their receive of patients that that, be symptoms, but here from important that maintained. a aspect The is only treatment

really shown significant long treatment important. a is period. AXS-XX with durability And So durability we've over

treated patients year. out So to we one

So we as better prospects in MDD. feel not if as for about ever good the Lori? AXS-XX

Lori Englebert

Hi, Yeah. Good Charles. morning.

middle You health right know, we're the in And of to up million US crisis. we now. as MDD the estimated middle patients in prevalent there's all know, XX the

compelling clinical their physicians, given we're thirds So Herriot achievement at our What to not to XX available durability with know any And with for profile treatment. see action, of we and this it the onset two patients as market, fast we the believe therapies, differentiated new achieve of we do therapies ability excited and coming about a remission. for current is all. was mentioning, don't and now demand hindering fast as do and the remission really of the get

Charles Duncan

Very Congrats on good. Thanks taking for the questions. my progress.

Operator

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

Joon Lee

the Hi. updates. thanks Thanks for And questions. taking for our

you started have on discussions – for yet? So XX, labeling

Herriot Tabuteau

for Street we soon we the labeling as will question. as now. the that said enter into discussions, Joon, we've is thanks let What

Joon Lee

can Suno Great. under funds XX? Hercules you the us loan can of it remind from require you [ph] And Does conditions facility? which approval draw the then the

Herriot Tabuteau

Yeah, sure.

that there - is AXS-XX, approval tied for upon is to So of approval. that million $XXX

However, Sunosi later And that we and to had an fund up becomes upon accelerate that do have amendment tranches of executed signed the we will $XX million transaction. the transaction. Sunosi to the

I the the $X also direct it's equity close Hercules think to to that important a upon committed note $X million of has transaction. in also investment million

Joon Lee

And is any discussion agitation with to the regards AXS-XX, sort the quickly, you. the to you're with depression related last for Alzheimer's Thank then in the amendment contemplating that FDA of for that question trial way study indication? having you're the

Herriot Tabuteau

related It's that. to No. not

Joon Lee

for the Thanks questions.

Operator

Our of Stanley. is Purohit Vikram next Vikram, question your is Morgan from open. line

Vikram Purohit

from my the side. pipeline Great. Thank for you Two on questions. taking our

the first, of ACCORD topic study. The staying on the

So you projections. been did mention below previously have that relapse events your potential

in to an provided sense just wanted design also, you could point And any then give you when I able been last do us about might So update? you be of to update those you how this that to an since if have trending with have on the amendments see mind? at speak us you on study might FDA the timing have

Herriot Tabuteau

I'll that let take Sure. question. Amanda

Amanda Jones

Thank Sure. you.

relapses not to line granularity, NDA, have the discussion as we intend to will we do disclosed in it the data soon and so any study. so rate And we top currently, any haven't with numbers, of when but disclose the towards Regarding we we timing of regards this do provided provide possible.

Vikram Purohit

submission? NDA And know I in it guided the to an or you've second that for in follow-up, and between Okay. What one needs for to expected? event NDA half Is XXXX event? do might fibromyalgia, XXXX. in more happen first be submission that specifically a know And as then AXS-XX now you

Mark Jacobson

It's Mark. Hi, Vikram.

the granularity haven't yet for XXXX. timing on given So we

closer, is As all. ongoing. do is to we manufacturing narrow you guidance get have recapitulate step now, And from process manufacturing the stability. and and rate - limiting work - continues we'll for that We right that the are be to the the prior and

Vikram Purohit

Thanks. understood. Okay,

Operator

is Our from Marc, next line is question your Leerink. Goodman SVB of Marc open.

Marc Goodman

Yes. affirmation else I safety. that same XX? to that you comment have is related that Herriot, make when Good XX efficacy you to morning. think there to I Can you respect comes or nothing with it say heard

Herriot Tabuteau

NDA to action. to to us for impossible that XX It's any like regards comment with an make prior

regards the formally So we're with the what outstanding us, that has completed completed, to is FDA because and and NDA provided the with the make determination officially comments review able to now XX issues the are. is

So with XX, on are with the with as and FDA action you we're until are - the our the developments package. PMRs encouraged while over we to we positive the very soon. looking get review and we And regards profile very efficacy latest while by not the on we and PMCs, much process to - it's understand, the action, forward the FDA hopefully, can in

Marc Goodman

seems XX, just dextromethorphan there of be a this that with how Yeah. problem a because And thing I the on there just gets component. that out it's assume be there to labeled. could concern

will dextromethorphan? up that's that you out other don't no there news. You at mentioned be there issue there think going REMS, Or to labeling regarding be a seem end specifically all? any to so FDA that's the Are being that with issues great

Herriot Tabuteau

metabolic Well, to to can AXS-XX is metabolism the all And the using of as inhibit is dextromethorphan. technology with a inhibition we're we reminder, product. is our just speak

did why in is of So safety require therefore, and us a study conduct thousands to to also large to different, FDA patients. open-label the exposure the very pharmacology be have is extension going which

action. of We're that, conclusion We confident the and data, done those is we're in forward we've fantastic. So review the released which the and NDA looking the to data.

Marc Goodman

Thanks. we seems products be you what? are kind just Okay. XX, the with picture it these And same XX, to using big lastly, here Can have respect you a of or companies product. manufacturing just manufacturing. a about to going us, to just remind issues of same I XX? Obviously, discussion every then mean on on are the all of

Herriot Tabuteau

some natural as amongst you vendors. There is imagine, can overlap,

mention, other the I then a thing mentioned is issues in and more to the - CRL, globally, one the of do end that to other industry, you NDA related think I have rate around the the CRLs, the that the way. in of to least versus And not CRLs XX% we far while of to compared be get would at does receive the an NDAs this However, But thing XX% the it too, year - be is of percentage so look or other there those that at review and just all increase the related related example, to historically, any disappointing, XX while most at seem obviously, is a in - that - for especially may of of this indication roughly has first that been to for at an climate if manufacturing half the FDA. are CMC. sorry,

want sure fully any that understand new vetted. make we the to fully why the manufacturing So would reasons agency technology, is process any new

Marc Goodman

on now XX. Well, you're for manufacturing right working

issues So some will from from before? manufacturing same the who people these it are products? the That's just this you needs other the things what FDA the ends learn of question. with kind really Is of question the learning

Mark Jacobson

Marc, candidates. Hey, CMOs program, that commercialize to think the are best we product each selected have we suited so

own its product and drug involved facility, an multiple entirely - companies, has are its And facilities there. that with API AXS-XX, own different so that's there AXS-XX,

a one As and them of inspection had findings. we our there no that mentioned, were understanding required

case. - then. is there not about the there underlying And question with that overlap this CMO. distinct So aware the an is generally, programs, We're that's each in the is some but issue with

Herriot Tabuteau

least fibromyalgia, for another every FDA we would of increase question, are those make way experiences time with interaction we learnings possible. maybe future. sure your answering Marc, the probabilities yes, through NDA every from by of is file the And that our we at is have from Yeah, that NDA the will every mine in filing. And lesson we that the take to three NDA. success two, gone We'll there

Marc Goodman

Thanks.

Operator

is open. your Divan of Vamil is Question Securities. line Mizuho Vamil, from

Vamil Divan

for all my for and today. the taking Thanks info Great. questions

questions. couple a separate just maybe of So

updated - sort from on that we're think newer probably $X product give what of sort product. on I sort of closes. somewhat kind have questions I I the your and products. Street has there think deal we because two the mean you're hurdles sort a of sort new on go know sort if but what the for limited I bit still assume to think what investors since you you approval Thank little payer the it's wondering of into. approved dynamics product for But more one still here lot what may here, Obviously, if waiting a thought terms I'm is product of indications wondering officially generally billion So sort here got of of other beyond [ph] quite before this it's can a XX, old expectations before above you're question of to thoughts the you Sunosi, out could of they any are just to had on product. can of how this on patients share I'm just for? will at any product this this payers that to into already looking then point how open respond move through in you. And there's indications for a to there this you get of expand you

Herriot Tabuteau

the excited and announcing before expired. take the about the payer morning the an on X-K Sunosi We the two. for it were I'll did Sunosi to with question, take put Lori HSR, acquisition. we're waiting XX. Vamil, Thanks, to question this really turning dynamics Yeah, out period now has over there actually, question

some the that new So of And that, to take announced shortly. market the need investor we we expect and acquisition. we plus we kind of transaction get to close having what the signing outlined - indications do timing the of sure when are to potential, that of anticipate steps the timing billion making what $X first we we forum the we the do to that to very discuss take which

anything and excited that really to she payer to Sunosi. we're want it add Sunosi. to the to turn about talk more dynamics And may I'll Lori add about So over about

Lori Englebert

And the question. Sure. thanks for

market. a So express on continue we year continually started permitted need unmet - back Payers more and the they need their to AXS-XX MDD, to and once in They their a discussions with bring for to action and nothing's a the and engage onset potential we - about action more changed. payer you the those look forward there's it. And that payer comes, fact also durability fast of will we recognize of that mechanism approval recognize patients. novel XX telling and for understanding of ago rapid

and In were transition to in the for that Last that will current have year, time excited the is this narcolepsy highest been terms a during has there of prescriptions came the believe potential transition. the brand, about really - during Sunosi, current also excited Jazz especially fact, OSA. untapped is of week, about Axsome, we of how working the do come over period. well. indication second EDS, We that in incredible indication as with MDRX or [ph] so team to new We're are

Axsome about So to of the Jazz are caliber with really the excited them on welcoming and we close. look coupled forward deal employees

Vamil Divan

Thank Okay. you.

Operator

from is line Joseph, of Thome Joseph is open. your Company. Our Instructions] question & next Cowen [Operator

Joseph Thome

and out interim, the AXS-XX what to the year able to FDA? Good find in initial guess during kind that What's noted discussion, the the guess, I of Thank happened review. agreed were post-marketing cadence taking announced you July of thank been there. you It's letter And you of morning interact maybe last with Maybe sort of you. the just deficiencies I for interactions you Hi, this? around be? the to the you on I question. do in continue weeks commitments. to a our think, now couple that almost, since

Herriot Tabuteau

question. the for Thanks

NDA As you can imagine, there are during this phase interactions. the review, multiple of

us, as we've deficiencies And to have other deficiencies, stated, any we deficiencies those regards and not aware addressed and are been with we are deficiencies, were what been the made they continue. And communicated or those those aware to initial CMC. of resolved, have the all So that deficiencies. of now we've and are

Joseph Thome

get you'll you do follow-up. marketing? you And you. discussions Maybe those are in you AXS-XX, decision How those take are something to that think on AXS-XX one about yourself? How And when thank Great, Is in in far how to you to want a the with and thinking quarter. third that launch just Europe obviously, you overall? about about before here want hopefully thinking that Europe?

Herriot Tabuteau

a Sunosi multiple in an our has The on us a and marketed and additional into strategy new Europe, is Europe markets factors in which is way which product also European gives currently approved rollout European it now that in the product roster.

the corporate acquisition our to potential of you greater us So that strategy only to our US. imagine, out-license outside which a prior lead as it product partners. to announcement, as from much might position. to stronger was Sunosi puts This can interest the And overall in relates candidates

Joseph Thome

you very much. Thank Great.

Operator

next from question Ram, open. from Selvaraju is H.C. is line Wainwright. Our your Ram

Ram Selvaraju

Thanks very my questions. for much taking

the just the AXS-XX. regarding that to be Since this you this is could for Is I mentioned resubmission. Class a at II approved time line in AXS-XX wanted Firstly, to the juncture a be would XXXX? assume in it likely clarification US potential considered that for approval earliest appropriate of be us

Herriot Tabuteau

prior likely exactly words, get sure getting we meeting. what what resubmit position expeditiously to the to Ram, updated do the We the in have go is question. meet for success, can from thanks we requesting guidance which that we to review. expect Once other do ducks we as want Class that So agency. a and to make is FDA that row the once What we've looking get possible. and would that That's leading feedback with meeting in In to our Type II provide a a we as resubmission A said, date. with it is the we're be meeting a we be we'll we as that then you Apart from have resubmission, on six-month treated a a timing. should already that confirm into resubmission that that to

Ram Selvaraju

in force in just comment comment could then sales a ones of And AXS-XX me. And is have of anticipate the that for like and area, you. any Great. or very to in anticipate over also the transaction? And either two you on deployment meaningful deploying you then if plans on you how AXS-XX that Sunosi promotion Thank Can idiopathic the you may Jazz ultimate of additional sales hypersomnia? you for representatives with Sunosi role the those quick AXS-XX? specifically respect if drugs coming acquisition

Herriot Tabuteau

mentioned, specificity. to indications always comment now. right regards sales about to on it force any with indications the regards we I'll you thinking that the backwards with those to And the have you share Lori additional with to taking question. additional to are turn specifics don't So We

Lori Englebert

for thanks question. Ram, Hey, the

Sunosi very I this sales somewhat need potentially periods. on They a coming to their So think especially as stay viewing case, in And this for of targets. to over during forces, for re-launch it's important launch priority focused us.

the you the high-prescribing, they prescribers in targets. Related primarily have respected believe know, so the force, markets, will to for be AXS-XX, high-value those on potential focus to we'll where and And we Sunosi. will market's, AXS-XX same high-potential, the deployed the sales highest we

those leverage as high However, synergies. we we appropriate, a know do prescribers and that is will between there overlap very

Ram Selvaraju

you. Thank

Operator

is of Our next line America. Jason question from is Bank from Jason, your open. Gerberry

Jason Gerberry

guys. taking my One clarification. Thanks Hi, questions. for

of launches Just discussion? via something there's more requirements? the that it is that expectations. something some you have exceeded neurocyte what in Or label recent post-market learn that you been learn terms about their investor then is that about And REMS,

effectively, challenges you at [Technical So there read contracting Thanks. cycles? I'm just if all there's across think any curious caused Difficulty] is structural

Herriot Tabuteau

Yeah. Sure.

question are REMS that to is we that Just first the first to thinking the - this the with of these product our going needed not through. is anything be REMS, on would is regards actually. we NDAs candidates. two one with NDAs were this These are regards

know, over. PMCs, We findings But And are and of the or communicate the we more us. can and decisions you is not or Lori? assure been FDA's of PMRs until the have really which review to you included And to have the REMS. the which agreed they requirements. can't never communicated have though. You we to

Lori Englebert

Jason, Would faded mind sorry, second question of your and kind that out. question? you in repeating

Jason Gerberry

expectations. [Technical Difficulty] Yeah.

guys you're seems you're where what seeing, the if payer or online So don't non-issue? a launch. of at XXXX mean, effectively little maybe terms AXS-XX it challenge coming there's curious be faster like I a know mid-year like think across will in than that contracting coverage from I expected. you will read cycle in if have you a is

Lori Englebert

Great. question. Yeah. Thank Great you.

highly payer committed are discussions the AXS-XX. [ph] far We by will thus with reacting the are product to how that all had payers we - encouraged that have we profile we've a and of

happy and we'll get that we be of then. once approval So expect timing approval, the what we we standpoint coverage know more around to discuss a from payer

Herriot Tabuteau

that, Yeah. And if to add Lori. I may

launches, launches, part have launches, there recent environment and is of something time, a the reflecting we product to hard in they relates if just neurocyte individual health are Jason's There broader underlying. crisis. of underlying it which on. think that's I one in broader is to though is which neurocyte worth anything is It's of mental exceeded recent repeating, middle to even related as that performance the which know expectations trend, coincide the going in question

increase, disorders. think COVID related neurocyte that has think a there significant scientists been increase it's the So an We to in - pandemic.

has that know depression, in but not that has in the depression, in who migraine, up migraine So is COVID-XX. gone patients of but example, just that even We have for been backdrop occurring. one that's incidence example, case, across, the experienced certainly, for

a in about So And why what neuropsychiatry think is excited unmet I that's there the Axsome high need it doing. we're why that general. aspect broadly medical to company, That's we're indications to it. more is CNS-focused is and really in speaks what

Jason Gerberry

you. Thank it. Got

Operator

your Our from Yatin Yatin, is line Suneja next open. from question is Guggenheim.

Yatin Suneja

for questions few A you. me. clarification Thank

with warning other What see AXS-XX. box expect on wellbutrin or is for you first expectations labeling? Do to what your So similar are we the antidepressant?

Herriot Tabuteau

label. program that - the we would XX aspects label since of the component reflected would be we AXS-XX, So in bupropion a of expect is

Yatin Suneja

are mean satisfied with submitted you the bit your trying does resolved of when to a been that here, say did Okay. that what an they And when response? again the FDA XX, then response? you get resolved, have acknowledgment CMC little related that clarity you is has here? that you Just the the reservation this say from so just Or issues it get to been have

Herriot Tabuteau

to us the the clear communications pretty also It's that that the PMCs. PMRs is been on based and resolved and

Yatin Suneja

then finally, to how you. Thank Okay. XX? be able might once approved launch And you quickly for

Lori Englebert

we approval. launch Yatin., within Hi, of to a quarter Yeah. expect

Yatin Suneja

should we of pricing? to sort about comp for of How recent you've in at pricing? price? done? us What think look the the Any on terms work comment Any

Lori Englebert

Yeah.

do We upon that haven't communicated we when price. price yet, approval we announced will and

price with product access. providing - the appropriate this the but We to of expect product, clinical patients an to approach eye the differentiation recognize we towards also have of

Yatin Suneja

Thanks. Okay.

Operator

next is Jefferies. Our open. Howerton from question Chris, of is line your Chris

Chris Howerton

for your was this you I I you guidance? XX [ph] a there curious could questions approval the extra launch Great. on into just if how taking Really your might me, or comments [ph] if info to was XX, for non-approvals and the current plays you. runway sequela appreciate and all affect a And any So that, color runway? think the stated morning or delay all cash cash provide how as Thank that

Herriot Tabuteau

Yeah, question. sure. Thanks, Chris, the for

XX So approval, approval again, tied with million Hercules upon that facility. is our $XXX to there

cash upwards So And XX delay for bridge we in quarter. $XX ATM the the QX launch opening very period. good for as to stated tap that planning for we have in feel over million our And that facility a sufficient of a approval… we the this in remarks, We did we in to the are are month position I product. do

Chris Howerton

clarification. there your maybe might how guidance? to affect And cash was that If a quick kind as Okay. runway XX, of a just current further delay

Herriot Tabuteau

have But earlier, to of So fund hand at of cash we there's further north a if operating as it I current said time. plan. delay, our that do XX on months we'll reassess

Chris Howerton

much. Thanks it. Okay. All so right. Appreciate

Operator

Our Matt, line open. Kaplan Thalmann. of is Matt next your is question Ladenburg from

Matt Kaplan

you. Good Thank morning.

to detail perhaps on wanted a CRL. AXS-XX Just have little the more

detailed Beyond be CMC that to addressed? CRL questions, in there the else was anything needs

Herriot Tabuteau

information, we we just Matt, was with item believe our principally there which all to can provide. one CMC, so non-clinical, additional was related which quest for

[ph] is real is us, this CMC. is for a stand focus So focus the

Matt Kaplan

of Thank of good. the you And question sales XX into I us dedicated a guess, the very the terms give Sunosi and launch as products sales terms some here for dedicated kind you're the more us organization for and some how several of Can XX go in you. how of metrics and around interact... they're metrics Okay, forces, then, about in of Lori. size thinking you

Lori Englebert

sure. Yes.

think in keep to things we of couple mind as through you to a plan So how structure.

the forces to sales But revealed target plan yet. haven't for least to which We XX% you the is can tell that more of We prescribers, is I AXS-XX. at high-value target than we XX,XXX size plan of what HCPs.

our help force platform to high-value prescribers. also intend those sales have reach to optimal place, not in DCC that will we We only we but will also ensure leverage a to and intend have

high-value the close, in extended the on prescribers size. talking you the targeted, the the force For be our focused. I of similar will of DCC. the a will that force, to on XX, AXS-XX, employees we that get we be slip virtually we plan all it to decision-making, were it that reach, Jazz approach same structure to highly with high-value And augment then structure focused kind in highly but with how strategic, have those of XX. [ph] more will forward prescribers XX% highly we about to sales with and accepted deal very exactly on - We terms to look highly mean sales XX% We to Sunosi, sure of make the coverage offers

Matt Kaplan

detail. for Okay. that Great. Thanks

Operator

Bert, question line Hazlett your BTIG. is next of Our open. Bert from is

Bert Hazlett

regarding quick you any with that And is Or to to you Yes. the to you. specific I've A MoSEIC taking question two more is Thank for follow-up additional other. be for the the XX, related additional ask what Thank can got CRL ask? one information regard Matt. Then or for technology?

Herriot Tabuteau

around and drug it we process Hey, I the to product. it. MoSEIC and mean, much characterize relate that of does Bert, think I

Bert Hazlett

goals of the goals study and in like discussions of change the What just a with the evaluating FDA Is Okay. a Then just to to the design? the design the second. powering? are it agent? do study the for an with What the with you you might shifting What issue regard can interaction cord are where study? with

Herriot Tabuteau

registration prudent So trial. it's to have Bert, as reason This much is possible. feedback the as why a

designated a feedback. And so we make that to the ourselves want that to that right take and fact therapy steps sure breakthrough the of this we product get avail is

Bert Hazlett

you. Thank Okay.

you're pivotal year. smoking a can regard in to think two going cessation you talked you other Or about away me. one for Smoking you is that with II/III for later with to Phase Do XX? one? pivotals cessation, sequentially Just do Thanks. this for something get

Herriot Tabuteau

need studies. would would two And currently, the those we that do plan to expect sequentially. pivotal We be

Bert Hazlett

taking Okay. Thank question. you the Thank for you.

Operator

of is from line Myles next open. Minter The your William is Blair. question Myles,

Myles Minter

Hi. for taking the questions. Thanks

timing that I'm quarter. guidance was XX the gathering upon agreed on Just were said some PMCs put that PMRs by but that directly was the you precedent the how Obviously, sort, from was based you out this when the consultants of labeling and on that and triggering work to discussions you communicated from the just that done? you've that that regulatory agency seen stage? from clock, month wondering Thanks. got clarity one PMR, but streets you've Or timing? your the that that PMC

Herriot Tabuteau

you Myles, for thank that So question.

to no new be is Just clear, PDUFA date. there

not has actionable the do FDA we information. What date. provide to to beholden is with try particular street So the any to

quickly as possible. So any change in of as our internal estimates, terms

the the are what drove - So PMCs. statement so what our and PMRs

those regards timing discussions, there are to with sometimes So to tied those. elements

formal And date. this it's allowed But is tied and our us to so estimate, PDUFA again, not has to a focus estimate. our that

Myles Minter

they then in PMRs required might XXX% if are at Obviously, there net we not be to might like about that so and PMCs. of nature them. language the there, antidepressant in on the or talked PMRs FDA encapsulated Okay. populations? Thanks. that maintenance be for the and are Or the are guidance product documents? were certain Thank - But PMCs within that be the post-marketing certain guidance those look in guidelines, - studies development, those just disclosing you. to dosing not the safety And job in would documents

Herriot Tabuteau

Yeah.

for we be as PMRs that items required PMRs incorporate – that NPE only both in PMCs We can the do nothing that for is might to necessarily guidance, and PMCs happy that that say there expectations, items specific expect product. of any AXS-XX are and surprising. them included me, them. was the not were that can an as with as consistent the they are in and What to, the So are you would well way, which consistent indication, [ph] We're imagine, our discussed commercialization MDD. agreed have with and to individual excuse are are

Myles Minter

the for Thanks questions. Okay.

Operator

final Two questions.

David is is Our next David, line SMBC. Hoang open. your questioner from

David Hoang

Yeah. questions. Thanks taking the for

Just commercialization force. and sales on the had one

of to that, to going you a the potentially reps be would sales would something of terms consider force level high board? this level your there, bring plan confidence down your digital supplement that to able expanding number component that current And have you ore the that's In the you at of the on confidence size what's line? is of in

Lori Englebert

Hey, David, thanks question. for the

engagement really So have efficient platform, was that our that ability the we ensure it to are with HCPs we DCC the and effective efforts, have commercial efforts. to designed but way patients also meaning, promotional optimized,

you can efforts. tell that So going have what promotional I is not those we're sacrifice to effective to not

showing level physician are how historical target are patients continue physicians engage, on how our not, of remains virtual the only data, meaning physicians' how engagement So of data extremely in offices high. therapeutic still at not based physicians to research, areas believe, or we up engaging, preference

very confident the that force. feel [ph] augmentations our we So BCC in provide will sales

David Hoang

lot. a Thanks Okay.

Operator

Hong is from of Esther, Our final question is line your open. Berenberg. Esther

Esther Hong

Hi, morning. good

the one, number this Thanks. on wondering, occur the CMC two, I find this did and then did And So FDA the issue? was AXS-XX after inspection? number issues, facility

Herriot Tabuteau

Hey, Esther.

sense the is, we that were of we're mentioned as of. our So, good of morning. aware during review result the course there a cycle. inspection, don't the from the I know that finding is it's review findings their that And no this

But they our for give when additional information. so didn't us feedback impression. identify these they And needs that's

Esther Hong

so Okay, got Understood. Thanks it. much.

Herriot Tabuteau

you. Thank

Operator

session. question-and-answer our ends That

now for any to to the closing management would back conference I pass team the remarks. So like

Herriot Tabuteau

again you today. call us Well, joining on the thank for

great potentially medicines to CNS commercial We conditions. with progress. and look on day. continued the bringing over Have pipeline to our serious committed We are forward updating people life-changing coming to a months living you

Operator

That concludes the participation. your for conference call. you Thank

now You lines. may your disconnect

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