Axsome Therapeutics (AXSM) 9 Aug 222022 Q2 Earnings call transcript

Company Profile

Participants

Mark Jacobson	Chief Operating Officer
Herriot Tabuteau	Founder, Chairman, Chief Executive Officer & President
Lori Englebert	Executive Vice President of Commercial & Business Development
Nick Pizzie	Chief Financial Officer
Charles Duncan	Cantor Fitzgerald
Yatin Suneja	Guggenheim Partners
Jason Gerberry	Bank of America
Joseph Thome	Cowen
Graig Suvannavejh	Mizuho Securities
Chris Howerton	Jefferies
Matt Kaplan	Ladenburg Thalmann
Myles Minter	William Blair
David Hoang	SMBC

Call transcript

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Operator

Good morning and welcome to the Axsome Therapeutics Conference Call. I would now like to turn the conference over to your host, Mark Jacobson, Chief Operating Officer at Axsome Therapeutics. Mark, please go ahead.

Mark Jacobson

Thank you, operator. Good morning and thank you all for joining us on today's conference call. our of release, for the quarter XXXX. issued update a the we of details and company's morning, earnings providing press corporate second This financial results and the axsome.com. short And website wire release on our crossed time the ago is available at a

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

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

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

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

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

Herriot Tabuteau

and Results thank for Business Update morning, Good joining Call. Financial XXXX you Conference and Therapeutics Second Thank Quarter you, all Mark. everyone Axsome

stage we status product commercial reach. first the commercial Nick developmental Phase of before months to companies U.S. with and sales the Sunosi. our portfolio close well I turning in additional the that quarter. to our sales of we stage Sunosi acquisition a term. of May second report X five near with to net for an on second to proud a the NDA to candidates the commercial rapidly closing end III our commercial few following financial are Lori clinical And We grow quarter. the is update from the the milestone to the transition developmental $X.X update. stage provide as This acquisition portfolio We that programs. update roughly it are Starting commercial should generated to will two as have in on positioned happen intermediate potentially the two million and This for for of

We growth this continue to be potential product. for excited by the

with the to we our NDA disorder, late for into we labeling for migraines. FDA announced regards MDD on depressive in our that have and discussions Moving to for or major AXS-XX NDA With AXS-XX in MDD, stage entered products, June. AXS-XX

for disease The third relapse agitation ADVANCE-X amended III have -- the withdrawal response an Phase randomized, top indication, of initiation completed regards new discussions. third FDA are the developmental discuss we're fourth with AXS-XX The to analysis placebo-controlled ACCORD we data in And progress quarter potential we the approach to support also occur parallel in by to the requested conducting positive pipeline month. we Type NDA in the a from early regards generate as trial group change quarter have the with and continues rest complete initiating this from results quarter. by program, XXXX. of trial, pleased action the progress. criteria as results FDA of the of And this meeting disease withdrawal approach we this of of this our the the anticipate AXS-XX, previously study letter, and in planned order this with trial, potential of recently quarter. ACCORD the the on efficacy the that concluding AXS-XX was for to A data Alzheimer's ADVANCE-X these to informed our -- We anticipate we we our in are the the to ADVANCE-X, agitation. on of following randomized study In the our of Concurrent additional meeting the will been expect randomized potentially NDA. With interactions, the based With submitted we FDA resubmission Alzheimer's to trial. line

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

planned will in for plans of the anticipate the for fourth to -- indication to the treatment a and other update. submission new our ongoing AXS-XX, to will ADHD. I adults ND expect now with call the over the are fibromyalgia, announced the solriamfetol activities For submit of product develop With in our the and recently XXXX. for We who treatment Lori, planned a initiating commercial a candidate product we to trial provide manufacturing of resubmission quarter. ADHD NDA of we to pivotal Sunosi, the turn this solriamfetol to in for related regards

Lori Englebert

was no portion the Herriot from U.S. patients. seamless you, previously of good X completed to acquisition The Pharmaceuticals Thank the Sunosi Jazz was morning. disruption reported, May on with as and transition and

deal and a X. proud amount portion of force. XX completed announced of digital-centric were achieve time significant for productive At conveyed in U.S. significant short plays by Sunosi time acquisition, was the to the already on the this of commercialization in the March employees highly Axsome's such commercial which made majority Axsome May for milestone Jazz role The team strategy XX Axsome. efforts the is Sunosi of completing from extremely are sales a a was approximately our rep. platform on and enabling sales the We

to potential disruptive highly a quarter. As had be such, the QX

during volume new to However, and business. in scheduled and Sunosi reflecting the maintained effective the grew volume total prescription The of the X% quarter-over-quarter, portion EU underlying close second half this was is strength the execution occur prescription of period year. of

X% benefits or narcolepsy As the with a patients. who suffering only The the reminder, both patients dual-acting Sunosi is FDA-approved, sleepiness, in are daytime to We that first patient excessive and for meaningful adults for results Sunosi drug-treated has for or differentiation I patient the share Axsome's EDS. growth believe earnings with X% drug-treated OSA. narcolepsy our in in a Currently, a to clinical Sunosi OSA treat provide during patients substantial QX EDS, forward first marketplace opportunity of and quarter Sunosi call. share DNRI and OSA the remains full of communicating in and look narcolepsy

AXS-XX in team remains launch Regarding preparations, anticipation the potential a of focused launch.

We have review incorporated DCC to I prepared including commercialize, if will to learnings financials. our who Nick, and now ready from Sunosi, approved. will utilizing platform and turn the commercializing are it over

Nick Pizzie

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

million. facility, net pro a and million, $XXX $XX.X receiving proceeds resulting forma of During in balance approximately to subsequent existing our of QX, cash ATM we accessed

Sunosi Moving quarter for to United the the P&L. was States net $X.X the sales in million.

related the the were for relates stock for and the Net compensation $XX.X the pipeline The for million with to activities the and months for reminder, XXXX ongoing personnel $X.XX in activities our or of and the ended a three $XX.X was expense. clinical along May or comparable ended the June increase current period. was share, included million in net through trials. and an non-cash loss the associated for sales pre-commercial with the $X.X period months comparable territory million expense, in loss and increase stock million Sunosi share, to for $XX.X Sunosi, completion June XXXX, $XX.X $XX.X in period in net As was the June XX, period XXXX. $XX.X for per on XXXX. The comparable XX, net the SG&A compensation XX, compared U.S. of expenses The for expenses primarily of XXXX. three of driven June X completed was time for costs million non-cash three R&D in million, of per acquisition months the million loss late-stage million to XXXX $XX.X May by a commercial comparable XX. ended assets the personnel expense X period were $X.X expense $X.XX to period million, for compared increase

combination. date, To to later determination from of acquisition Sunosi values in loan of with discussion. value no cash with AXS-XX completed will be includes review. along operating the commercialization the preliminary Capital, development based date. anticipated financial now plan and Mark analysis fair current accounting on than the the lead quarter turn included pipeline. I acquisition, but statements. a we XXXX MDD, of XXXX Hercules current preliminary second the to Sunosi our concludes final the That capital these will from our The with Q&A have Regarding remaining of which business financial our back one that facility of balance, Sunosi of the $XXX potential million approved, fair QX possible soon sufficient committed is our call believe year fund performed the of the We continued along if operations as in term our the to acquisition XXXX is the launch as into

Mark Jacobson

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

Operator

from first Our Charles Cantor Duncan Instructions] with [Operator Fitzgerald. line the question comes of

Charles Duncan

a with terms about to can regarding but and I progress that should for access I negotiable AXS-XX. wondering if swan any first I are all, happen before Sunosi what’s is or quarter. so long. to term But to about granted AXS-XX, talk wanted call guess need within and, is about Can I therefore, I given ask that suggest black I’m there’s that, get because to taking ask facility wonder the that the, capital? on you Congrats it, this of of you loan you AXS-XX, kind the you and that, that Hercules CRL renegotiate there Sunosi

Herriot Tabuteau

that interesting to for actually the some tranches is term Hercules, Charles, With facility you million your the a as Sunosi of $XXX are question. the company it's regards sales what's those for sales-based. loan know, acquisition facility. And with base, thanks

additional addition, there So the Hercules. proportion of at to some still in access facility discretion is which potentially loan And significant the a of we'd have the is tranches. of

for I'll our together more say accurate. I -- guidance that referring in color the financial it Nick to but turn that put scenarios. to that And characterization, safety. regards the I event to black in does be will all it Now, terms you're very swan those package of with to and confident think incorporate provide and that the we're is AXS-XX efficacy We in we would --

we that therefore, AXS-XX, we've cash scenarios go launch our in would But spend that. away do case to that for over needs. comment. then which for and, a of all be But lot naturally I'll However, happens, we plan to Nick and the currently of ready turn that, the the would for operating modeled reduce it

Nick Pizzie

Yes.

I it. think, you Herriot, commented on majority of the

to available $XXX $XXX baseline everybody, is upon approval. -- give million to Just AXS-XX the or tied is million to there's

$XX sales-based a Additionally, months. as three of to measure tied Herriot it's and trailing there's tranche, million tranche a to tranche performance is another debt that stated the

what us And the So to spend event decrease. available that of swan our CRL, mentioned just in as Herriot black Charles. to, well. you're In a event would obviously will that the be restate referring to still

to As obviously would tranche and right away $XXX would AXS-XX. that the spend spend away. not we launch would million That for required you're there's aware, access go significant have be

still we cash our take into us runway will However, believe XXXX.

Charles Duncan

Okay. swan generally not guy. I’m black a And

to term, alternative able is end by market year early be that would of that, marketing and So next are this approved launch overlap a reasonable reps give many Sunosi year? within the to or forgetting near in how would the period AXS-XX of sense it time, considering about currently is be of even as of which the you well? the say, here us have a And let’s could able you AXS-XX then

Herriot Tabuteau

Yes.

are I for think Lori. questions those

Lori Englebert

Charles, thanks the for questions.

the a are who and both aligned XX patients within so So XX,XXX and product are HCPs will suffering And really launch before overlap sales so are synergy, regarding reps the for the of due drive as we've our to have now, narcolepsy is of reps, mentioned pretty potential provide as for and a potential we'll currently territories approval. focus Sunosi. about high about sales with conditions. adoption we at and of alluding EDS prescribers guidance upon to. to that I'm separate Those force at XX keeping you're adamant can high that there are who force covering approval right those launch AXS-XX launch but we OSA quarter in lot and

will time Sunosi force keep sales when everyone right, the But sales AXS-XX. points. continue the focused turn sales call want two really start is So overlapping, overlapping for up of I we forces want drive really terms and focused, consider a to to to the same with in –

Q –Charles Duncan

that data Last a quick later of time point? certain analysis, that question the regarding additional present at year. in will Alzheimer’s what us could that? give you Or this at a say, Can this on agitation, might a included milestone data yet year? would be drive it potential sense that a patients And number data be on of look really you

Herriot Tabuteau

the withdrawal to remember, analysis, with randomized a this So regards is milestone study.

would milestone-driven of time from be a perspective not the point. So it it's -- not

So in at we relapse placebo. the groups, the rates or time actually relapse look will AXS-XX difference to between two the and

announce For results. the patients of disclose who will that the we analysis, the we in that will that be at time number

Charles Duncan

reminder, us the once I – for include to launching percentage of you’d patients Herriot. of a what can it? sense numbers like you that? actual Thanks you But in give without mean, would

Herriot Tabuteau

the All are included. patients

Operator

with from Our is next SVB Goodman Marc question Securities.

Unidentified Analyst

This Rudy for [ph] for the Marc. X-XX. line have couple is questions on I

I want in about So depression. ask first, NDA the to

ongoing since weeks. for the much more post-marketing and labelling and this there respectively? I takes Just been typically three discussions than has proposed proposal months, four weeks wondering have back been how six two mean, all the to on forth label, on

So with specifically, and what pushback issues the the are the FDA’s continued now label? application and

Herriot Tabuteau

the state, four I weeks discussions, control average. any of have The and maybe provided done. folks that that to don't have for responsive guideline it control however, typically part make to And you which what that's collaborative, know we process. labeling we're we that is six FDA's think over that's the that So can sure of that I we an

with way an look negotiations the term. in As that have the far I pleased been we're forward have we very thus to ongoing, the FDA near said, going action and been

Mark Jacobson

and Rudy, you had for have those ongoing. commitments about here? Those Can I follow-up months. one asked the and are requirements not three post-marketing ongoing

PMRs with As PMCs FDA. we previously we mentioned, reached the agreement on and

this the by just clarify So that. wanted separate those just I to two, to And Mark, is way.

Unidentified Analyst

clarifying. sounds And the like more have Yes, It for provide filing? that another that trial? pivotal got ADVANCE-X. Is starting line And for trial agitation. study? a it. Thanks follow-up for for FDA color you we're trial, I required time Alzheimer's can on Did ask for that the

Herriot Tabuteau

trial, agitation. when that as reflects we for of that strong the have our make submit sure starting package to disease possible So Alzheimer's as desire we a data NDA it

approved As you been yet has know, indication. for product no this

we we get what where So make do that them. can we can sure is incorporate learnings

with been FDA another a psychosis. there's know, disease in on Alzheimer's symptom, you As recent competitor neurobehavioral action product

very that into try program. learnings clinical our carefully watch there and any So we to incorporate

this that say, would than is positive, parallel goal so disease study, filing be not other. that study we have let's that technically an studies, NDA prudent both agitation, required replicate shot randomized it's in want for we have the -- of to to one to Alzheimer's think that make on which new assuming withdrawal while So two sure would and group are each more

Unidentified Analyst

wait ACCORD study going ADVANCE-X, the then We say let's too, So to for is we're file. won't positive, right?

Herriot Tabuteau

what the and tell should the we’d file. we after do would FDA a whether or able that have that believes we package is that think assuming FDA. then And meeting, have is be you go a not ahead with So pre-NDA to that meeting we data adequate, we

Operator

question Joon next Securities. is Lee Truist with Our from

Unidentified Analyst

[ph] This Joon. on for is Ausom

patients interaction follow-up. to to they I AXS-XX? on Our given standard need first patients before you with out drug-drug be bupropion, do antidepressants do of And washed you question is, known a think transitioned be on can could drug And how on AXS-XX? have currently will envision antidepressants be existing

Herriot Tabuteau

receptor Thank interaction pharmacokinetics AXS-XX. of It's Drug-drug antagonism leveraging we the the to are a AXS-XX. unique to drug-drug you just for are that not improve the of NMDA question. particular interactions

antidepressants with. of And regards advising package it able out typical in have also them washed are interactions This drug-drug have patients make lot a the are is is clinicians, of that in to those clinicians to are drug-drug treatment to interactions. to do navigate that However, do. something And something that it's Other familiar interactions, and sections every before with that. putting are clinicians insert there drugs another very how treatment. particular, sure psychiatrists one on drug-drug

Unidentified Analyst

disclosed have since interaction if REMS items labeling so, FDA as then, And the discussions labeling you discussions? Okay. any such that more had part you first of on discussion? for XX, And were with the just

Herriot Tabuteau

have additional had We interactions.

As discussions the been of those regards will comment labeling in on we we aspects part FDA. negotiations, discussed mentioned, And we've has other with been what to of as with not that.

be imagine, would As at can it stage. you this inappropriate

Operator

from Suneja Our next Partners. question with comes Guggenheim Yatin

Yatin Suneja

with the sort me. guidance for then abuse if how -- give on XX. provide the to the you work. some have on a Could terms in sort of that? to might talk of abuse in definitely abuse of comfortable think should that's about other read lack launch going they of the you little just drug, and CNS is a question data? you the in liability with one. And for performance be Could FDA for at you the provide liability point I your bit Two is liability Because we -- what require Are some color Sunosi guidance more a you able position So about forward QX?

So some sense get to there. just trying

Herriot Tabuteau

Yes.

question. answer I'll liability So the abuse

drugs required to are assess abuse all You are correct of drugs the those that liability. active for CNS potential

been and signals done depends really compound had in clinical the if any seen However, trials. how that's on

we've Nick that as NDA, in And turn your have to our over the did past, to Lori do of regarding done. questions Sunosi. been part and as to And I'll answer assessment. that has said we it So

Lori Englebert

of Nick quickly the some in terms give some color acquisition I'll just you to performance so of around over toss that then and kind I'll give from Sunosi help guidance. far So, data points it

So we're And I the XX now still force. sales as currently are the learning territories promoting are really out and mentioned very market much earlier, that transition. the aligned the they generating post believe high-caliber from that we've are as momentum and underlying reps We incredibly they assessing forces the productivity as DCC. sales now. has a right being levels with Sunosi X.Xx to that lot effectively of do the able size Xx to through are well execute of to And that

So And of is quarter. a potentially the Nick remarks, it really team what quarter-over-quarter the could a what do have really I’ll able impressive to of as in in happened during quarter. guidance. disruptive highly facing was proud was to X% mentioned I given disruptive which very terms for over prepared growth toss

Nick Pizzie

as mentioned have quarter, Yes. could earlier, extremely Lori Thanks, disruptive. The Lori. been

As million we I XX% opening sales. year-over-year $X.X in stated That had in remarks, in actually growth the scripts. net was

how highly transition's so the taken far. with place So satisfied

not give to won't At of very point, this million we're the far. guidance but reminder, market As rest $XXX still range. able Sunosi our year months had that OSA in a the obviously just ago, to potential have positive million learning we be we EDS -- the as a has believe $XXX of peak the sales a on for in couple transition thus the webcast and to we narcolepsy we're

Operator

comes question Jason next America. Gerberry with of Our from Bank

Jason Gerberry

question. the confused. back I’m a to little come cash just wanted I to

the So like access it sales to maybe where triggered facility. more Sunosi point at sort you’re seems threshold of a unlikely Hercules some

you understand, $XX – quarter. to a trying you’re just think I burning million So like

kind seem Sunosi numbers that up. would the going of forward, like that’s the With fully in going

another understand the Why of the I’m fourth update, of update, So before dire, the could on existing AXS-XX work if kind curious, then not study? that randomized could facilitate in sometime AD guys? starting new can see dynamics. trial year end randomized you through withdrawal cash absent just update to not just is the approval to if cash you And withdrawal for or the the trying approval, on and quarter why the facilitate how – approval that just dear, presuming you start the wait study after agitation

Nick Pizzie

Yes.

in the previously guess and on maybe to that So related feel so we we do Sunosi. to is for I next And for then year. this loss that. guidance we're little Sunosi comment, sub sub based state Jason and stated small pretty expect performance the The on of a a excited Sunosi actually period accretive that the year, QX, background bit about to comfortable be

relates actually a that to be we're approaching the three Hercules tranche, down the where month it able trailing $XX trailing months taken or would we've Additionally, our sales, three we with and anticipated for sales, million. the as and to utilize tranche debt

question. actually, the to be I'll potentially to that around Hercules And you over access year. one other last one facility available next had Burn, comment somewhere the to related to I So it -- would made mentioned yes, think Herriot turn answer burn. you other million. $XX

Our cash months $XX closer million. burn average actually four been has to

just clarify wanted to that. I So

Herriot Tabuteau

with disease around start trial. then, the agitation to And regards of the question the Alzheimer’s

we want our history what do make sure continue rapidly candidates. that So that do we of way developing things the product our we is we – to

later. So it sooner sense that to start for than rather us makes study

quarter. So we We’re to and track actually start this the study made guess on that what? determination

remember, study a of of design positive until we proud repeat that will information waiting which in quarter, So of terms launching a that. lot have our the a of the is we’re to that trial. guide be And ADVANCE-X essentially us the fourth of parallel-group this And to very trial, are we study.

the we’ll that allow So tweak of will study needed sure study. design of we new the that – where that from make current take learnings the to and the us

Operator

Ram Our question next Wainwright. from H.C. with comes Selvaraju

Unidentified Analyst

Selvaraju. [ph] for This in is Boobalan dialing Ram

questions. of couple a have we So

could sustainable development? anything AXS-XX there with in other respect with to competitive firstly, clinical stages a antidepressants versus advantage So later of that provide is you the

Herriot Tabuteau

III it's important think Well, AXS-XX, it's compare product -- data data important our first AXS-XX actual to to Phase compare to candidates. with I to in all, of that other

we've What out it's comment. and data generated clinical product year. is other for with now about that clinical to goes we to extent the improvement in So demonstrated have improvement in one one. effect different statistically by can symptom at data, What AXS-XX That GEMINI just of significant by that also highly hard to also seen? in an trials, that quality four which that week a remember profile trial. candidates rapid have but we've we one that least the of significant the week speak was was which not is us at not there's What seen long-term antidepressant was with life statistically accompanied

drug better helping is the before So making them seen that's been an patients antidepressant. feel to better also not with but it's oral And rapidly. function very

Secondly, is remission AXS-XX our in with at the so to magnitude at Week placebo AXS-XX. there more also with over increases the and treatment of large effect where as important to a in look remission very It's than increase that six study. it's was -- two-fold compared time data difference

also So tolerated durable. which objectively, well effect onset you of the that is and drug that a lastly, incredibly And mechanism then have a drug works with is perspective. has novel action. this of a from incredibly And to well, rapid our was remember, magnitude regards

that mechanism of be current reminder, to as who are And is treat treatments there's really not something don't have current So percentage clinicians, action clinical that action. tells should benefit, But a nice to when it's translates actually then it new mechanism of of to considered to respond hey, novel new the well in patients nearly trying XX%. who a to treatments. patients responding

Unidentified Analyst

detailed for Thanks color. the

on your do to respect thoughts And to the what activities, of you plan optimize your updated ex-U.S. how with So this? commercialization assets? value are

Herriot Tabuteau

our objective focus out been stated our always markets on ex-U.S. candidates product it's to So license we the while corporate U.S. for

did and With that not use yet some now closed the development of whether on may ex-U.S. a portion on the our are or we Sunosi of have which because the acquisition. are going robust more business of the quarter acquisition, that we We not become we Sunosi actually ex-U.S. global though, inform forward, company have comment ex-U.S. infrastructure biopharmaceutical sales this that have another we now business growing. ex-U.S. do there strategy portion That tack

Unidentified Analyst

question One Great. final me. from

So ADHD. you're into stepping

As decently a you indication. may know, is crowded this

what proposition you're So like the are what's with of address that unmet to Sunosi? just hear thoughts, would your value your to And planning here? needs some

Herriot Tabuteau

it Sunosi we’re a or – potentially So profile in the effect of clinical very to potential relates ADHD. as excited potential by –

here. we However, clinical results are. to what don’t make that to and the see we want want trial We run sure gun jump the to the

In lot of is terms what is, the a in unmet ADHD. proposition of value need there

of drugs. As know, And most have ones currently effect. a scheduled that are available drugs are do scheduled highly large that the you treatment are the highly not not

is you So, should match potentially I think is mean I there EDS. is treatment in with effect value EDS, ADHD results And results at by the in in what Sunosi, large. results the Sunosi the here that if look the for very

wake-promoting larger it’s fact, In agents. than other

you effect size. so And this have large

see quarter. in might we that hoping fourth and in the So to ADHD the that trial we’re looking forward initiating that study

Operator

Thome from next Joseph with Cowen. Our question is

Joseph Thome

you bit agitation. the release then mentioned you? just there and on waiting any Maybe Are or any on decision, this. thing what’s the on waiting hear they First analysis inspiring currently that I you or potential I’ll or the then going kind before is steps would What of for one provide that of constitute progress And kind encouragement? are depression to the we’re of sort a data the from point? review? next a intermediate Alzheimer’s current you’re FDA, to part Is that for investors a review encouraged last can of you But of follow-up review, the have on the know little context labeling discussions. on with a disclosable from

Herriot Tabuteau

we've regards and has an action. been FDA enter the that that into interactions disclosable we is negotiations. of said there progressing. negotiations. anticipate that be And we I next label progress So the with labeling And the to pleased -- the we're we're with those that pleased did would been think pleased We event one, FDA we because with

Joseph Thome

agitation, that Okay, give perfect. something the parallel the FDA then was how able criteria Are of a bit And something amended in be the study. little that would Alzheimer's then to to profile? context thought or out PR that mention the with disease you the it as you relapse the And helpful does that to ACCORD and on control the round you the changed? this group trial, team suggested for

Herriot Tabuteau

we in to Yes. in at be thought of of look were the at with FDA, we neighboring would results suggestion with at from be what positive helpful do, that the there able scales. data which the in meaningfulness It’s to look of lot development with a the were the at relapse criteria Alzheimer’s was And question, something looking would regards the clinical one experience to the the context looking at ADVANCE the mined indications of disease. and how was to various the particularly there drugs trial and

And with that informed consistent results change the criteria they’re in so of the relaxed the ADVANCE-X so trial. that the

Operator

Our question Securities. Suvannavejh with Mizuho Graig from is next

Graig Suvannavejh

if in OSA is could to there me And and I’m prescription an And you and is a and ADHD, to and branding different, could for dosing position AXS-XX you the new separate expect remind on As just how is just for then alternative TPP narcolepsy? especially it’s you name, relative that what that the to Sunosi? just me relative remind Sunosi potential strategy? the relatively narcolepsy, EDS to what on

Herriot Tabuteau

not a that we to rapid We trial, daytime but regards that in sleepiness. demonstrated other study CONCERT had but improvement was was for cataplexy was that the showed cognition. Thanks questions. there AXS-XX With AXS-XX, measure profound those that cognition. excessive on a in effect our And interesting that in just also

with patients reasons, treatment it’s – to So With in regards who TPP. interesting for comparing Sunosi, patients has the to for approved as while a patients very those EDS to for Sunosi it treat reminder, Sunosi narcolepsy, – narcolepsy. the have of approved is a AXS-XX

– it no an does not is on there cataplexy. effect So have

the difference we ADHD, in that the the with to disclosing of in to study. not we that’s And the we Sunosi the So announce between but look dose regards going dosing initiation X. forward that trial that are have of the be III we once disclosed to Phase studying

Operator

Chris Howerton Jefferies. is with Our from next question

Chris Howerton

contraindication warning were sort second previously, any about already a to example? what question for anticipation REMS? the mentioned is, me. antihypertensive, the an approval, medications, the that first blockers thoughts the Alzheimer’s beta Lots again, there respect of like great for or I on disease question so interactions if And or around relapse. label far. or drug-drug have to label potential those With of The would potential and One, think be the likelihood two are XX. of related restriction company's you of of

that One indication designs. was the of the concerns brought neighboring the respect autocorrelation in within-subjects with up to was

you around data comment the could randomized that of of the perspective from opposed your of to just design the you FDA withdrawal if parallel the the curious view as clinical meaningfulness announced. So

Herriot Tabuteau

you for the Thank questions.

as the reasonable are label we the question the refrain the with with indication? in -- around repeat questions you given are to And ask. those we where the all to will regards those labeling answering questions discussions in are we think relates FDA. -- And it questions from where could I the given stages neighboring to

Chris Howerton

Absolutely. Yes.

the So design randomized one was clinical the the of concerns of interpretation meaningfulness the of for the within-subjects withdrawal.

comment discussion. on if of parallel And And the of type curious you was to clinical of could so that I’m a the robustness if design. the relative design meaningful driver that

Herriot Tabuteau

That's of randomized design. really limitations that good the of withdrawal one is Yes. question a a and

answering a randomized particular regards it control is good So and does demonstrating But of very a job that parallel-group so question, that with drug that design. you best -- particular design answered design. the with works to a question withdrawal the is

approach that make want sure has given which filing data ADVANCE-X FDA it does again, approved. new typically no to we have Now of we is see in with the trial. not indication because initiating we're -- is that think for like demonstrate product parallel NDA The an absolutely this to We especially been this strength, trial studies. needed. position -- But group the that two a now we we we

Operator

Kaplan question Matt comes from Thalmann. with Ladenburg Our next

Matt Kaplan

Where just do a dig to NDA? could you are you with addressing the little into wanted you detailed bit. questions I AXS-XX the And when to resubmit in CRL? the CMC respect think

Mark Jacobson

it's Mark. Matt,

to the there a this is it's nuances we timing CMC the in be and -- now, -- which we'll in would provide to So be did that last what meeting that. the is to if as team it's and quo this to held to with, to of a expectations morning, prior A we've that it work our for do everything the our, the we'd But think The able in you expect is or resubmission. FDA. we'll resubmission doing position addressable the And in position the like to update anything then is held information on quarter. held, be a status a provide requested any this expect where clear we around and plan meeting Once is with are for we we right able once package it its about connection following we or update quarter or its can our submitted are work announce of request Type CRL. terms that -- imagine, have either in a team background. And hand doing

So in not-too-distant future. we'll more have for the hopefully you

Matt Kaplan

that for just Phase NDA? could Okay, study Is Sunosi. ADHD quick filing great. your That's in a helpful. that plans a And very indication on pivotal then, your it single III follow-up expectation supplemental suffice for in a

Mark Jacobson

will that anticipate studies We two needed. be

assuming study And first that, conduct that then is study. the is in a study will positive, pediatric adults. So we

Matt Kaplan

on Okay, congrats the great. Well, quarter. during progress the

Operator

question Purohit Morgan response. comes At there is next Our no with this Vikram from time, Stanley.

to move question. will We on the next

Our the with William from Minter comes of next line Myles question Blair.

Myles Minter

know to you’d I XX. on the filing. commitments when a agreement post-marketing you one first the in the on guided, quarter expect Just you decision the second announced

guidance. the You then coming saying anything call And this on and now about month. announced it that didn’t a label be you’re you state could that received timing proposed

Or first in more then? labeling or what that initial a something proposed therefore, moment is, – you there that’s question received is regulatory gets pleased line and, my think maybe was between you’re you’ve that your this you just it’s or and back So that it you’d coming disclosure on aha had happened the an discussions since time a month?

Mark Jacobson

Myles, it's Mark.

we current process we on So we we're think and the of here the sense of the or of related is are. overall our that, to did estimate action potential status providing where the guidance comment pleased And status.

though, on told a FDA not clear, be date. certain action has to Just us they plan to take

of available us So totality you. don't on what and based read that's that. providing our we're the have in to we that's to It's information

Myles Minter

Okay.

the wasn’t guidance. the totality of kind in It’s timing So just going confidence event like discussions. those more of gives a forth it how this your sounds to back that give you specific it like discussions to clarify, and are

Mark Jacobson

Yes.

and where it's is, there things where of course, back our like So are. of forth of -- and we holistic choreography our a there's it's that. read And read

Myles Minter

Okay.

Okay. use just designation in therapy FDA, the be was think XXXX. able after words, that product trial reviewed a you as That's breakthrough additional to and pivotal helpful. that that indication requested the you’d then, in the And back study. was for way they by they on the analysis I ADVANCE-X your gave And that ADVANCE-X in

information did after the all they that and request trial you what designations given trial looked additional they’d So at these initially. from

Herriot Tabuteau

approved there are disease because ton a agitation, product Yes, the isn't also lot on that scales of there of is the the of in no used being treat Alzheimer's to a that's been data disease. assessment

therapy information can the pioneering analyses data. therapy that perspective, valuable lot from contact allow mined that of where found right; guidance designation. because from is the a them pretty be work designation, we their ADVANCE-X And ADVANCE-X of which think the great, for those trial thoughts the suggested from it's we and and was with And you're situation lot been are welcome. those to So FDA trial a source does in special the basis the get a And from breakthrough with that's the doing are the that of data and have useful. the breakthrough I so us and especially there's is

Myles Minter

is this discussion here. Final one endpoints endpoint, for Cohen Is going we’re about the me the as the ADVANCE-X having to Okay. meaningful I clinically just, guess, have CMAI Mansfield?

Herriot Tabuteau

Yes, it will.

Operator

from with question SMBC. Hoang We'll David take our final

David Hoang

had couple. just I So, a

while would This for label? think on that been in Any label the qualifiers was case first there XX MDD for specified a broadly. major think any the have base thinking populations be be one now? based there that a on ago narrower, think trials, study thought I XX. I pretty in was or or to reason but such be depressive your Would population differently the enrolled could – any disorder, the may me the

Herriot Tabuteau

the we've label What question. major the label, at And the anything inappropriate regards we for disclosed be depressive disorder. us in the is as for NDA about will what discuss that this it'd we stage. stated was with Thanks Yes. to before, filed that to for be

David Hoang

obviously sales then milestones. the different that think based heard that attached just have share? Anything discretion. some XX just approval. last I on lender’s Okay. or it If one is from Can based sort tranche, I Understood. There’s around to And And your loan. tranches one as then the comment And are – stipulations I had is there’s the if I one term of correctly, on can more you amount there? is you what the that? at covenants what to correctly, another

Nick Pizzie

that at actually Yes, ability that that option It's general have is on Nick business tranche we this -- a would tranche the a that's general lender's based to just needs. the I'm request is sorry, speaking.

Operator

I remarks. closing for session. ends would now That our question-and-answer you. conference like Thank to management to pass back the

Herriot Tabuteau

exciting and five NDA forward two stage joining our we thank for is have product continuing us and today. call on stage transitioned candidates This programs. clinical momentum again to an for as Well, this time the looking with commercial stage to III you Axsome Phase are

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

Operator

This may your you a concludes and for and you disconnect. today's conference participation wonderful Thank have day.

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