Axsome Therapeutics (AXSM) 27 Feb 232022 Q4 Earnings call transcript

Good morning, and welcome to the Axsome Therapeutics Conference Call. Currently, all participants are in listen-only mode. Later, there will be a question-and-answer session, and instructions will follow at that time. [Operator Instructions] As a reminder, today's conference 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

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

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

These assumptions risks forward-looking our subject the and contained may filings materially the forward-looking those annual actual risks and involve These and results Securities expectations current in Commission, uncertainties cause reports. and from information, on change quarterly and Exchange are to and to in that are differ with are described our statements. other based statements periodic that made including

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

as first Development. an review Officer; milestones. Lori company, of Vice Executive made are overview Herriot and well during fourth Chief Financial upcoming quarter of Nick the provide XXXX Commercial Herriot Officer; the Pizzie, President today on as Chief and Executive call will Dr. me and Business progress then Joining the Englebert, Tabuteau,

We'll with are Nick and Questions taken commercial financial line for quarter second Auvelity, quarter then including questions. Lori will order a sales of review results, will our the received. update, they provide Herriot, on open our Sunosi. the then, will and details be first Following in

will I Herriot. that, to with the turn over call And

Well, end XXXX thank transitioned XXXX for and biopharmaceutical and everyone, deliver a thank business call. we Axsome on become conference transformative all goal and to Therapeutics quarter year Axsome as CNS-focused financial year two commercial you, Mark. for results update Good was joining a leading and morning, fourth company. you stage our successfully

to to differentiated position, strong advancing Now Auvelity and a and early patients commercialized, metrics and well late-stage with products, Sunosi Axsome shareholders. encouraging financial launch of and value Auvelity, deliver pipeline, significant to continue is two positioned abroad

milestone Total with The was it product Lori provide fourth at important Auvelity $XX.X quarter an is the net for and and our details on performance. commercial both further for Nick financial the quarter Sunosi. was quarter will strong in Axsome, million. Later, sales as and sales first

seen Lori repeat To Auvelity been about topic to improve brings taking a we prescribed by than prescribing later. which updates, patients. quarter, that more I'd patients difference additional will these start In have the us HCPs and like of refills by -- is just perspective for has provide by here, a making X,XXXs and already patients. by talking all

patients. unique to for the is impact half difference But of a meaningful having Furthermore, treatment the seen be which a for largely current Auvelity clinical the just U.S. a sales Sunosi we've Sunosi growth. of the on in of for is view making We that observations and both efforts, steady excellent the year contact future that mechanistic suggest with and landscape these indication depressive in leading overseas. for room significant will and potential potential profile the positive growth lives disorder MDD major

our certain is countries the the rights Just (ph) for treatment suited a platform strong excitement providing for commercial for Africa. Sunosi formula commercial worldwide Europe Middle lead of and our the this licensed maybe expand via, region. to Sunosi’s maximize last deal important to in partner availability and to licensing East important in week, we potential of Pharmanovia Sunosi well patients announced commitment North and an shares an in access

In our seen advance, to late and clinical to creation as further positioning pipeline addition continues to broad beyond. us progress, our drive XXXX value significant stage in

AXS-XX ADHD. for of Our AXS-XX improves leading narcolepsy, cessation, for for AXS-XX AXS-XX pipeline Alzheimer's for disease CNS for the for smoking effects for and agitation fibromyalgia migraine, solriamfetol

on we and development AXS-XX advanced In cessation. including Alzheimer’s made subsequently, in feedback the AXS-XX agitation for disease ADVANCE-X ACCORD plan results the the for (ph) significant progress FDA of trial obtaining top line fourth quarter program, our in the announcement trial, and positive on this

based to ADVANCE-X, of of trial, of anticipate group on our completion regards versus half enrollment now we our the parallel this first guidance recent mid-XXXX. trial trends, XXXX in prior With

agitation Given saw registration we're FDA disease feedback all the the program, recently Alzheimer’s progress the on in and from front. received

a cessation for quarter smoking the additional trial. experience population with completion ongoing safety in this placebo-controlled Phase safety of NDA label submit ADVANCE-X and fourth safety ADVANCE-X to patient AXS-XX X/X AXS-XX AXS-XX parallel, of elderly expect of from consistent ongoing population, including in safety as trial company the as extension information EX we on the the well in guidelines. Based after to In in open trial, The FDA feedback, target with the of generation ICH intends long-term requested data this an XXXX. initiate

second product resubmission manufacturing With regards the of this to migraine, to for to and planned resubmission related treatment this of for we of NDA in expect the the are AXS-XX ongoing, activities year. acute candidate the the half occur

in candidate and enrollment in of progressing, results line product the first half pivotal is our XXXX. top trial of SYMPHONY are narcolepsy, Phase treatment X expected AXS-XX, the for For the

the has of reminder, AXS-XX to Orphan a As treatment the been Drug designation by granted narcolepsy. FDA for

candidate fibromyalgia of we product in related this also activities submission planned preparation the progressing the is submit NDA Our XXXX. AXS-XX expect candidate NDA manufacturing ongoing, with product for for to the and and to

initiate with SHARP trial in demonstrating treatment mechanistic the and X molecule. regard improving and solriamfetol we solriamfetol preparing positive or the These of function this cognitive With Solriamfetol for new to top the line in Phase results In differentiated the indication XXXX. we also Sunosi half of [indiscernible]. the potential to are first a quarter, shared highlighted of fourth clinical trial, pharmacology from the data for this results highlight further treatment ADHD,

clinical potentially we you is the milestones, be XX and readouts as busy As see, Axsome on pipeline can ongoing excited initiations, commercial next to team NDA in multiple success hit XX continues filings including deliver and months. to the trial prepare to months and

over turn Nick, to now will financial review will the who our call I results.

sales full period. discuss our financial some quarter in consisting comparable 'XX morning, and and quarter in everyone. Total provide Sunosi. two our of of prior fourth were was year I'll Auvelity products results the of Thank you, Herriot, of good no There sales and guidance. revenue commercialized million, and fourth Today, net $XX.X net the

net first U.S. on consisting November $XX.X Sunosi was the to fourth fourth quarter quarter. October and sales the net in million Sunosi quarter, closed $XX.X the quarter reflect of sales the acquisition in reported net the Because total of of 'XX, on sales net partial Axsome Auvelity generated sales net of international launched sales million. the ex-U.S. of million for XX, international $XXX,XXX. of generated $X.X and

and prior year Auvelity in million. for acquisition XXXX the year of were of occurred Sunosi launch was for 'XX. both the the reported of revenue full because there $XX Again, Total of the no sales

For were the XXXX, million. full $X.X Auvelity of year net sales

$XXX,XXX. of full net million XXXX, the international For consisting Axsome net and total sales generated sales $XX.X net of of sales year Sunosi to $XX.X U.S. million, of

the U.S. reminder, portion As a acquisition May of on Sunosi of was completed X. the

XXXX, increase was comparable in development were and $XX.X $XX.X million million respectively, quarter associated million $X.X prior Auvelity. and year related for fourth Cost and primarily full commitments including million million and costs and Sunosi higher for XXXX, quarter were $XX.X to respectively, million with post-marketing Research of the in for product ongoing and the to compared for trials fourth year $X.X The the $XX.X and quarter of full sales and the XXXX. none year. clinical period for expenses the fourth

the $XXX.X the period million quarter XXXX. for Selling, general expenses respectively, and fourth $XX.X for full million and million were of year million comparable and administrative XXXX, $XX.X $XX.X and in and and Sunosi onboarding, marketing for and as including force well stock compensation the full quarter for related higher sales were spend primarily The Auvelity, commercial to non-cash as expense. year activities fourth increases

fourth Net million share per per compensation loss $X.X to The $XX.X expense to for in the stock quarter was compared net expense $XXX.X the or quarter share million Net for full $XX.X period in for net stock per year loss in compensation the for or XXXX. of year year XXXX. of included included million period $XXX.X per full compared comparable million full XXXX for was $XX.X to The or million the net comparable million share of XXXX. share loss of period million $X.XX non-cash to $X.XX $XX.X a $X.XX comparable or in the of loss for of XXXX for a net XXXX fourth the loss compared the compared $XX loss million non-cash the XXXX. of $X.XX of

XX, the to million We with cash $XXX year as compared of million ended XXXX. $XX.X December in equivalents and

periods our of quarter, while extend not the $XXX a accessing Hercules to our Capital rate to reduce amended $XX fourth the tranche. did we increase to and In the Difficulty] agreement utilize maturity facility the of loan and size [Technical XXXX, we to facility. with interest-only the During million million January interest

$XXX February capital anticipated balance, operating positivity Sunosi our now of our year-end is committed exceeds of on cash with out-licensing in $XX ex-U.S. into company million cash from with these based flow approximately cash from sufficient XXXX, along term current rights. our Hercules pro Additionally, fund believe to forma the million the facility Inclusive of plan. the that remaining Capital current $XXX events, operations balance We million. loan received

commercial now call who turn update. will Lori, to provide a I the will over

our certainly quarter potential and continued the QX Thank Sunosi. of commercial launch of patients. prevalent conditions with you, bring with innovation was Nick. highly the of for address to Auvelity an and millions relaunch Both serious, Axsome meaningful products exciting

still our are we with are on launch it And early encouraged We although progress pleased days, progress. commercial Auvelity by Sunosi. is

key metrics our by share from starting for will with commercial Sunosi followed brands, our efforts both I Auvelity.

hours. proven is sleepiness apnea narcolepsy X and first As for sleep the DNRI improve agent and and promoting wakefulness wake daytime a reminder, excessive only obstructive only and Sunosi through first and the to the

U.S. the Sunosi the total fourth in and quarter, quarter-over-quarter. prescriptions X% XX% year-over-year In grew for

with with remains and year XX% XX% versus XX% U.S. split for prescription narcolepsy. of of Sunosi prescriptions lives showed for of XX% EDS EDS For to the diagnosed due population patient covered. full the total increase OSA Sunosi for total by and for The Sunosi broad strong lives to coverage federal Payer XXXX, due growth XX% commercial XXXX. an is

therapy of share The OSA remains substantial. branded education and from narcolepsy U.S. drug-treated X% currently for in indication currently growth increased potential is share growth approved a available promotional only for we drive for market Sunosi in Sunosi who has drug-treated in patients. enhanced OSA efforts to the and disease the patients and suffer only share EDS the Sunosi product patients XXXX a the in and and X% expect

of licensing to well announced to recently to Pharmanovia, important are this the of treatment we rights With increase for ex-U.S. patients positioned worldwide. availability marketing Sunosi

new despite a tangible October for encouraging With grown to our XX,XXX to in HCP early in over and HCP Turning unique XX of patients. patients saw to unique quarter uptake X,XXX Auvelity. signs since X,XXX due promotion for QX, challenging a holidays. new adopters. and on have Those HCPs QX, multiple writers metrics launch. X,XXX traditionally over We only launched of lease prescriptions We Auvelity with initial launching

saw who with Importantly, trials promising clinical early with onset clinical is critical experience seeing action rapid and many in that that -- reporting are remission. that written consistent gaining have we’re with ability patient achievement response of we what are rapid of HCPs reporting and

or channel relates commercial have it payer of be we item. with of is as organizations, XXXX, accounts XX% been than active commercial January one as payers and for purchasing potential it productive. primary Interactions With regards coverage to largest more Effective to for to channel Auvelity expected the GPO’s, with coverage, antidepressant group Auvelity prescription contracted Auvelity. the the of for have

the benefit during health new standard drugs being and These this on PBMs payers proceeding coverage able blocked, As while when or terms. post-launch decisions as now will are to month commercial decisions six contracted nine formulary managers under are pharmacy based expected are with period GPO for be to made. the coverage interactions result, make a plans Auvelity

Medicaid Medicare channel, to coverage XX and states non-commercial plans and in on post-launch to In up the became X, have six to formulary. determine effective months add January coverage Auvelity

payer I more look next as additional formulary progresses. process months. six the over forward We expect to decisions discussing the

We fast and focus to adoption, committed empowering launch quality are progress extremely encouraged by HCP the driving and enabling assets. launch patients initial remain of our

a health result in of there health the a increase adults public depressive in all diagnosed or a significant aware major concern disorder, reported XX U.S. a crisis mental and that and U.S. We million the XXXX is are in as pandemic. major is MDD happening prevalence with

therapeutic our available living Auvelity and this Auvelity their efforts new is and important of devastating with option living and for patients an condition proud to physicians. we with are make product MDD to patients

I turn the Mark to the discussion. will now back lead to call Q&A

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

Yes. Thank you.

from is proceed Please questions. first with Charles Duncan Our Fitzgerald. Cantor with question your

commercial more could wondering, if congrats prescribers but the what And Lori great feedback down terms regard question, I'm couple Yes. our and real too of for comparison had just of addresses know their response but in patients think team in and who drill Good morning. getting it's long question, -- on from is on SSRI-based with seeing one persistence, market development. good she or Thanks. are one is she's Hey. said, a Lori overview wondering to questions early I I'm that to is Auvelity, any therapy? kind even and with patients I that a the I Thanks, on this regarding quarter. know Herriot, in just and of experienced too rates commercial, what the persistence,

question, Charles. morning. taking Hi, good Thanks Yeah. the for and

for from is field what of So is, again, purely very you're the most that, as back days and receiving it we're anecdotal. early right, us

So very I what are hearing we anecdotally responding for is take What that label. are you that worth. hope to patients it's consistent

achievement in Auvelity what not the into suspect just trials. we've saw it's a in months would remission few that will bit that than action seen the early what So but happening. different we're of rapid is label their of because are about very or onset little see Again, early clinical to They too seeing be launch, a anything talk we we

Yeah. And repeat are in have persistence. seeing they of think that one prescriptions, with been switched prescriptions, maybe [indiscernible] off I we to add are that, to things the so patients would those or

last its additional there, week's to of And you Exactly. give data, some from were just color reported growth about results. XX%

That's Okay. hear. great to

in wasn't Regarding efforts expansion agency, agitation, mentioned timing. clear on for terms Herriot, in of TAM XXX from completely Alzheimer's I you some that feedback

that? study. 'XX, in after you if trial I provide more mentioned you then think explicitly, the that possibly then And completing an after you could 'XX open-label would versus thought on color extension also prior NDA happen ADVANCE-X, but an

of on So could us sense could you give a when NDA filed? an timing be

Yeah. [indiscernible] trial, Thanks Disease Alzheimer’s correct. With regards from follow-up question, Agitation to new the for you're the Charles.

a that is fact ongoing, would also out clinical to than that regards in be now frankly, expect extension open-label would we six faster with our we based out the So enrollment in an has filing, NDA read within on NDA The expected. for space. read months of and expect we been we to that to first out position going after We had to XXXX. XXXX. half study to read And trial be, file

a taking Okay. Congrats questions. That’s helpful. for good quarter. Thanks my on

Thanks, Charles.

Our Marc comes next Please your questions. with of the question proceed Goodman from line SVB. with

waiting Herriot, discussions just question Can year? help off an is, efficacy how with and for you. us like safety if that? both on for agitation think FDA? you all about gross both to we're signed is you Thank on the for just products nets your they to standpoint And Can with can Have continue you data? study. confirm to second all from this studies this confirm now

Charles question, Thanks (ph). for the

Marc.

Lori god, I'm Oh No, to sorry, my not. course of are starting won. with analysts sell-side who these all Marc.

you All are distinct. very of

saw with (ph) the patient safety is regards is the also on data, elderly from long-term Marc, the that trials. just agency feedback we data. The we to So with interactions of referral FDA, that population, theme feedback important, but not really got the safety the safety in

trial, randomized study. ACCORD the So withdrawal was it a

provide is which patient in it population. data, [indiscernible] safety So really this important does not randomized the

this study fact And with truncated did the not of other show-stopper, study. the that aspect necessarily the highlight, was is FDA the

So guidelines. -- the must database the and exact meet regards importantly it numbers with patient to safety EX is that feedback though, for ICH

a good data ongoing, already to the which NDA. position points is is good of provide which have do in actually those what's we're to trial, So the all is enrolling. We ADVANCE-X

And so sorry, already I'm which -- the enrolling. is ADVANCE-X trial,

for And so position be would filing. the we're required safety in the to a good which provide data all NDA

then standpoint an ADVANCE-X fails from Herriot, if efficacy what?

would are this that speculation. positive be But Well, encouraged two currently in we we that indication. trials have

positive the question, did agree two that trials? you FDA Right. That's my have

you never file that it's agrees they we do trials. until positive NDA it. review FDA to clear But have an two very anything The and

And to are NDA needed information very We we’re be provide on filing. encouraged the by an will that. that for track safety

Okay. year, And think both we products this gross then for to the nets for how do about that?

Marc. Nick. Hey, Sure. It's Yeah.

I'll net XXs. to for the for gross quarter For quarter sales start the gross the in net was for with, Auvelity,

of now, to As give currently in around position not guidance specific GTN. we're a right

planned no need However, to typical then PAs that this you would actually there's be be quarter potentially obviously, could we seasonality remind a you inclusive year, expect going that from in to co-insurance, -- QX deductibles, typical the improve need recreated resetting being of to to of expect coverages worsen in some headwinds again. would and based plans reason that's on

mix co-pay utilization, the potential And impacts and then distribution So channel of GTN. obviously, always card. higher utilization

and worsen. where QX expect we that than we So at would anything were wouldn't we today could potentially QX expect in better and it

GTN The the Sunosi, them in low adjustment that received Sunosi, for the pretty claims, much adjustment XXs. XXs. we $X.X quarters typical Otherwise, Again, quarter. favorable is we for it's in stable a have low been this in Specifically as the we which from were this million. updated did received around quarter, of Sunosi. prior we

you. Thank

You’re welcome.

Our line Purohit from next Vikram question with questions. Please Morgan with your is of Stanley. the proceed

for Thanks our morning. Good taking Hey. questions.

So we on Auvelity. had two

provide kind wondering the lines have on and the currently being history treatment of been the that typical profile receiving prior in that Auvelity Auvelity? patients color just first, prior therapy are some of could terms of you So if to prescribed of on

wanted what I discussions looking those update then a you could And been partner provide if on commercialization see And secondly, have and for in AXS-XX so, just potential ex-U.S.? ex-U.S. Thanks. be partnership if to you'd an happening. for if

that. Hey, Vikram. take I'll

as mentioned block, patients in [indiscernible] have NDC demand requires we've which we're commercial effort we're as driving the an an Auvelity excited that most which to quite the the in times currently, about plans So multiple of why coming is online, standard, get challenges. despite these really

to However, therapy use third with now due in I the Charles, answered in question, with right response been line the line-plus. later extremely second is about to that, line patients been, in and been consistent label. to XX% again, sitting And The line has sitting encouraging. see later with response very very, that the why relatively XX% has has

add, Just with we in be to regards ex-U.S. question, to Auvelity would the your of for a to with regards looking what partner for as potential second it to part relates

that geographies I the would look with of navigating certain has it regards reimbursement experienced capabilities, the we such that a as landscape think for Europe. in one pretty but things partner complex with also is partner proven to

Thank it. Got Okay. you.

line Gerberry with next of The your from is America. Bank of question proceed Please with Jason questions. the

just guys math the XXX the into to on, by enrollment months? the Good doing ADVANCE-X planning I went and from I what plan XXX withdrawal, the Are current get my for question. patients to of taking think, you randomized XX other enrollment ADVANCE-X. for ACCORD under patients Hey. increase to Thanks was morning. six

to how you the just curious XXX? So get

number that last any fourth just is on Thanks. be there? any comments going question, ramp place how number. sort should basis, or SG&A you of growth here about on if XQ an any step-up think to then quarter and on of And we launch OpEx off be XXXX good is to some from thinking stocking there then a comment about And inventory the annualized on can

The the is ADVANCE-X Lori, database. answer I'll enrollment to will take having we safety anticipate Nick meet required the in first patient do to not question, others. and no, increased take

went from trial most a patients were patients, As ADVANCE-X, one a but of trial. experience, terms in we a the ACCORD those enrolled reminder, of general of patients XXX we and then of lot and also extension safety have into label reminder, those who patients in do safety as have period

[indiscernible]as good So from that rolling over well take from the shape. an in if patients you the expected pretty patients should as from put ADVANCE-X Nick? over

Sure. Hey, Jason.

QX a can in essentially So proxy related relates thinking expenses launch this OpEx year, full we of year-over-year. view release quarterly SG&A that's like think of we'll quarter I expect Sunosi from -- Obviously, that I stated growth a of expenses press in being year to increase quarter, a the as as that think guidance, think a a expect SG&A second on proxy, with to and estimate, have -- to full using almost and QX potentially about the a acquired I we fair you the think it piece the Auvelity and you being as modest on basis. I a mentioned XXXX

And I question your to a but your broke where is, you the think bit, year. little end was think inventory at and of up were question we other the channel I related then,

in we of demand Auvelity, weeks have roughly X.X the For future channel.

not we expect and our we fluctuate at in do brand, additional growth just we It's levels we it, patterns we've builds patient the and demand the momentum seen. the that launched distributors to are obviously, market. interim we think reflect really in believe I Auvelity strong unexpected, as

buying somewhat increased The to wholesale at inventory have elevated. of -- did QX. during we Sunosi, the seasonality due the were end For levels

-- distributor, we relates However, for title as traditional model. the in trick a for was reduction to every from weeks. coming now -- launch X.X our QX and channel Title that is we in see to so model these which we will man see inventory model actually as we we and weeks. are operationally, are inventory that two note XPL -- licenses Sunosi the we sales model down impact changed to X middle reduce -- We a by roughly in in to changed do model get approximately the QX that traditional we it And an essentially one will ensuring the distribution, levels that XPL state. the QX, to

Thank Okay. you.

Our Please line next with Piper with of Sandler. questions. David the proceed from question Amsellem is your

Thanks.

So had a just couple.

can First, predecessor that differently is narcolepsy? the just to an focus the a sense Sunosi, you of what be the is on what broadly, at going from OSA think number how company do in control inflection prioritizing on just different believe And landscape to asset do the you're that's volumes? all? be you and terms commercial And more driving one. of you it versus give over us the for prove extent Sunosi might to So time in

about number two, think on time how sales gets commercial to that's organization going you. just extent about to and eventual of And we you more over how Thank need Auvelity, the evolve talk as expansion the the then product to should its into life?

I'll Yeah. of both those. David, Hi, take

talked of how with do of inflection think we'll strong Jazz first with this that about the start an have initial we've Sunosi, point and for launch foundation really we Sunosi? all, the for relaunch launch. I'll So a had

initial The remember shutdowns. about three months launch to to that one important launched COVID they the was the about prior thing Jazz,

really hyper focused doing was believe highest What impacted for will for of of And prescribers. the on we the have the gotten help now point heavily that we that are we so inflection an XX the potential majority that product. provide the months launch initial first right is launch

approach. s that five to really our and with quickly Doing prescribers the that get out profile clinical we five help of share make prescribers as on us will And penetrate those start our we market that differentiated then that gain sure sophisticated targets. very is to expand terms those in plan

has of about prevalence In million XXX,XXX. OSA narcolepsy patients XX terms of is and OSA versus a Auvelity.

difference in So right a start that that opportunity OSA. there much is you tells larger

will, but our now, right foot OSA, gas the on to not continue we're off narcolepsy. focus on We letting

still of room a growth for well. lot So there as as there's

XX,XXX In XXX terms on we right the sales about reps expanded in coming Auvelity now, have organization, HCPs. of

because that our to to And -- confident calls our the very We able approach doing DCC it. using make that reps are about very be sure to effective need tools in very, before on our penetration sure and those efficient have are make they is the of highest which are on any the space we high plans. original MDD in in that, the prescribers we additional comment making very target focused any potential further really list, are

Helpful. Thank Okay. you.

Joon line is Lee Truist with questions. question next Please your with Our proceed Securities. from of the

the press to Hey. taking release, to XX our four the for and XX if And I'm up questions months that In mentioned Phase sufficient NDAs the narcolepsy. the so, potential next have follow-up. Thanks also and And for X updates. you SYMPHONY is assuming over includes it to months. file? I a

you the is and SYMPHONY for believe SYMPHONY file Phase to that be site. will question. that we do Thank sufficient (ph) the Yes, positive assuming trial X

possibly more what at the at a very Great. And valuation, you European looks than regarding to the Sunosi monetize to had worldwide what value? change think extract you deal, that at a high level, attractive such rights, for you it like do able the you were allowed rights

value about the for product. This value think the potential Sunosi felt I overall we've licensing reflects of that the ex-U.S. transaction, of strongly Well, the the the product. it and

So we always has the potential it's our What strategy been of the with product. communicated consistent our and what perspective. to with regards

Our next Cowen the from question Company. with Thome of proceed is question. line Joseph & with Please your

then Auvelity new Good for patients the Friday just And what for ANDA you was date the Hi, the that and XX,XXX was that or questions. one, -- cutoff gave as the a you did that? taking the last our on of Auvelity. was clarification there. first see on Maybe we that second number earlier, morning, thank for TEVA

overall in they're are know a only next the then quick strength Thanks. XXXX does of have on that? thoughts about just steps I'll great follow-up. challenges And I how think can your XXXX you here? but company more us If the give patents And what and XXXX,

would Thanks for February that cutoff the last reporting Hi, the which be week, as date of the Yes. Joseph. on question is XX.

And you cut-off, the question. from part of the second

challenging Yeah. patents. just in we from submission saw TEVA -- terms of ANDA XXXX those So the [Multiple Speakers]

or litigation could strength of So the what the XXXX terms next confidence maybe comment sort XXXX and you in of in settlement are Auvelity? the of and your on in terms the for of just if potential patents steps

Okay.

GC that. So will our Hunter, take

company’s Hi. you. I’m see I’m Hunter – to General the Counsel. Murdock, Nice

So previously we're our did no IP notice we've normal, letter expected an to with receipt relating Hatch note part the the question, to as was announced from quality proud month, of Auvelity. earlier of Teva of which X this paragraph your the portfolio, of And receive get Waxman it's we -- indicative The way to of. process. the extremely

of X if wall we commentary days we're proceedings. provide the carefully substantial steps. carefully have and we evaluating notice XX-month next now. to notes for right not street Teva’s legal invoke regarding Hatch XX analyzing or additional wish you I’ll the Under may delighted Act, even the We're steps future stay, against our much Paragraph the final Waxman regulatory Teva,

Thank then Great. you And quickly, And that narcolepsy, need X mentioned safety have on an the open-label you. an this sufficient and Would necessary that out? you be you. standpoint. the Phase just trial Thank exposure experience? Phase really for know once will would X additional I efficacy reads you

have on. in the do We trial label safety extension

of -- experience filing. the be So that that part be will will safety

molecule, Pfizer a did is the our As with -- in also part which with safety both should licensing data, which is safety with will get get extensive reminder, the experience, success. conjunction deal the that be

you Great. much. very Thank

you. Thank

Hoang your questions. Please next is SBMC. with the with of line from proceed Our David question

fitting into me you Hey. the Q&A. update for Good the morning. and Thank

mentioned for improve on any the we Can in improvement quarters. just would should rate to sense quick which over us of I you give And that six months quickly I you net generally month coverage know for question with months how GTN plans? coming health at that to to to take expect the insurance Auvelity place. time? major at So you a had also assume GTN over correlate months window to gross favorable or establish six should to that nine nine can time? fair Is improve

Nick. Yes, David. Thanks. It's

the a any GTN that. guidance and be that's broad really we rely. we'll sense coverage to and payer quantitative hard what we think seeing then of guidance where give start and gave the able to that GTN It's we're until staying previously I GTN the good give further on to

So of you I give will several give better be. to better a think able we'll be a quarters GTNs now, -- where sense from

Thanks. Great.

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morning Good Yatin. thanks Eddie questions. is on for This taking and for Hey. our

with the provide AXS-XX, from bit in detail of moving then that confidence due you much what especially quick few How the Thanks. you And of revenue just a for channel more give comparison On was Auvelity you to X.X forward, to need quarter this on follow-up a timing those the a can see to reported to inventory. just Just on data little us. year? And would stocking? Sunosi?

want last to take You the question?

was Yeah. amount I X.X the as it on earlier haven't quantified mentioned weeks question, But I the to roughly related inventory. future the actual specifically of demand.

GTN with weeks, that you of ballpark is X.X we that kind deductions So do can that. take on

though it's distributor, channel. even it So been to sold, sold sold haven’t hasn't been our to

on So we that. accruing on expect what would January's GTN based we the or are proceeds follow we

we expect that in AXS-XX, to regards the year. timing the trial of for half to results with have And first this from

So see placebo-controlled guidance. would we so figure to lead the a And that of you terms we think to study. trial. positive June. is, end what that's want first can the out is of see, a half what want this And Then through I would the in

a the we that obviously, that product. want efficacy So us trial of the studies give demonstrate to see would positive two

the to regards the And to with indications comparison are different. Sunosi,

cataplexy that’s of So in narcolepsy patients patients AXS-XX studying if Sunosi big treat with approved in to time – or few narcolepsy. a significant and with a

could I just context mind, you add, provide don't if to if Eddie, just there. And Herriot, help

XXX% in patient it's of excessive give you cataplexy, data only terms difference patients, estimated – all from difference sleepiness in XX% suffer going context just were narcolepsy from and to that patients the For the about narcolepsy patients. that of

it. Got Thank you so much.

question next from your comes questions. Graig Our with Securities. proceed Suvannavejh of the Please with line Mizuho

could remind products of maybe you you and the think agitation what AXS-XX see so perspective, in guidance in for you've Auvelity and financial Thanks provide for Congrats your picture a points each us Auvelity in Maybe around sales company you bigger the Great. might perspective my at question gotten total from do you to for and question. of to a just Sunosi, even position and you've my as those you and and it picture know relates EDS, also a year. be but sense on AD I Thanks Sunosi what marketed in taking or in think narcolepsy? your a how Auvelity quarter is depression bigger on launched OSA just either you as so and for what products Sunosi, -- much about opportunity you revenue have and the both in bit a about hands much. as

question, time sorry, of I'm part your repeat can the more me? for you Greg, first one

timing Yeah. It as when around more really company. questions was a the of a

You you're particular or in line guidance how might what situation where forward-looking buy comfortable three Just financial Is about comfortable? on thinking years? to down a maybe you're perhaps that this year feel might enough two years for the sales be this? any

say, would is, as prefaced the originally I obviously, very Sunosi. for Auvelity in as question Yeah. stages your way you early well we're

relates guidance So product both mature we when fluctuate would Auvelity, looking a to as somewhat discussed first. here more that with we and we potentially Sunosi would some drastically. haven't give on at to [indiscernible], product sales would it models one able guidance give various would being that we're be products,

timing when give So you along. further any be we we're guidance. it can't give I -- sales would specific

current of here, we Sunosi, leading or into And also indications. sales at you HCP that take new that potential, What that have we we -- the talked said a the if we the indication, believe us as of potentials for $XXX sales we've did product with part your potential $XXX has the as sales account Sunosi. to least the with just $X -- billion, million Starting question Auvelity the potential believe potential peak product the well million. second brought the we expect about both product

well the are the to that think in MDD which treat those has MDD just market Alzheimer's that about fact in of And size to currently treated MDD upon Auvelity based billion both and agitation [indiscernible] not individually. patients number discussed, make based the who we that on And as we we agitation $X in nothing of is potential there's the of patients. also regards patients Alzheimer's who the with as trial upon launch individually pivotal to prevalence the have Auvelity, Disease as disease [indiscernible]. have disease XX%, the about terms percentage of of Alzheimer's in agitation,

me. And one more for then maybe follow-up

on and in Sunosi, current split in where I the the believe, in plans, in as look I'm future OSA Just your narcolepsy, its currently if XX% current it wondering will a use And it will there. or out with that you might XX% that there of split? number from does it evolve, any stay evolve evolve terms whether is Thanks. is, which if if on that sense direction in

size I don't evolve I Yes. but as don't indication, Thanks, especially I think or this in to OSA, heavily before, on that's is focus our foresee Graig. much current gone -- just mentioned given off a of but of also narcolepsy. position, that narcolepsy efficacious the on it is foot prevalence the sheer product our we're very, not -- the very gas from taking a in

you. Thank

question comes proceed Please of Hazlett questions. BTIG. with Next the Bert line from with your

you X/X as regard Could Phase you. is fashion to And it's a comments dose endpoints, there and the timing, is trial, of expect to it titration agitation? all would on things like question size cessation of then frame the here. there, dosed to Thank MDD similar the taking that? of the top it parameters Yeah. AD question, in AXS-XX, the dosing you administration in with for clarifying be and My again, surrounding smoking timing Thank program. you some just

expect Thanks, do the that fourth Bert, year. in Phase initiate quarter to the this timing, we very regards is X/X done. the for working The trial question. get of the team to to hard With

trial, of And the design standard parallel a design. this the be sort will of trial

we'll of that provide in trial at. will say endpoints terms we the We have as the launch looking once details we're to more well always do,

assured be have FDA dose that study. once what launch terms we'll we rest registration will information from we gotten the we trial. the we endpoints provide those will that exactly the of will feedback endpoints. in and look also provide like, the that recommended And the launch once But on details And

Great.

to forward that. you. Thank Looking

additional with questions. your this Myles we question Minter time have William two to At The for -- next from more questions. with take proceed Please time, Blair. comes

the taking for Hi. Thanks question.

wondering that will percentage many of Just when what plans used or anticipate lives those online covered at are brought month those and making actually through last decisions? how the (ph) you plans JPR represented

Mike, I'll take Yeah. one. that

nine that covered one remarks, now. Once have have operating contractor those updated through to and them, the they fairly PBMs and currently the as the months three the underneath expect So right rates. to their of NDC it work blocks. of Each GPOs of prepared amount lives access was in standard are six plans and a ability are now series that the substantial

expect six other reviews as active -- So are GPOs with made clinical payers, and that the over discussions both to discussions be We on from other as next formulary well months. the decisions. do

Last Okay. met you to you And year, a then just as and run FDA ADVANCE-X. when follow-up. with the decided

safety you data changed wanted had? guide additional agitation that well at they they Thanks. the placebo-controlled just they efficacy as additional see at because study think wanted commentary to time current as AD that an did I or and meeting to placebo-controlled for see that that time

business the a made was Thanks, decision the from When made initiate we that Sure. Myles question. that just a perspective. the ADVANCE-X decision for to trial, we

feedback requirement And or upon so not based is that FDA. the from

data, ICH once for filing. that particular, didn't will provided a meet placebo-controlled in NDA well to safety safety the information with that as guidelines requirement as on less was database data be safety However, we based that

Okay. Thank you.

question is Ladenburg Please questions. Matt Our Thalmann. final of the proceed with Kaplan line your from with

in on. This Hi. Matt taking on the quarter our is Raymond (ph) Congrats questions. for for thanks and

of I Auvelity to platform. the quick one. DCC about ask a Just wanted

of experience initial in wondering initial Auvelity how learnings to DCC. incorporate had large driven as early And you'd any with Thanks. success You've hope that Sunosi DCC kind sales? with your progresses? was and I the

one. It’s Hi. good for a the questions. Thanks Yeah.

Sunosi, a mentioned, operating I that. rehash have you done we've So that of. What still Sunosi very seeing we Auvelity, so on on early. as the about what platform, won't talked is established same we've And is, platform off we're we're

We the HCPs are drive will of size given very sales as tools believe confident number force rapid growth. we've as that the to up well we that in our reach them

are drive to pleased really on team way. early the helping they that. and bit how the that comment growth a But platform. with it's too using And how so is very we are

Thanks. Appreciate that color.

I now to turn any for call concluding Axsome's Thank the remarks. will CEO you. back

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

We is lives. are things in differences patients' work resulting in This for of fine the is year of a team development is of great Axsome. hard which only was XXXX proud the more pivotal the come. meaningful Axsome now to

were strategic year ago, We next wanting are company all we year a same growth the not we for the anticipate. and the with the same we’re

market most We treat and multiple are the plan: Axsome XXXX, candidates at Have XX aligned CNS work to NDA is by in has and track great multiple of report those disorders you. in value-driving a in the products the rest XX months months. commercial clinical meet late stage next the to hard of five trials to your Follow with we're goals. challenging Thank updates to some state day.

This will participation. your conclude today's conference. you for Thank

disconnect lines now your may You time. this at