AXSM - Earnings call 4 2023 | Axsome Therapeutics, Inc.

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Operator

Hello, and welcome to the Axsome Therapeutics Fourth Quarter and Full Year 2023 Conference Call and Webcast. [Operator Instructions] As a reminder, this conference is being recorded.It's now my pleasure to turn the call over to Chief Operating Officer, Mark Jacobson. Please go ahead, sir.

Mark Jacobson

Good morning, and thank you all for joining us on today's conference call. This morning, we issued our earnings press release providing a corporate update and details of the company's financial results for the fourth quarter and full year of 2023. wire website time we at making forward-looking the available and will crossed certain our on axsome.com.During statements. release a ago short is be The today's call, efficacy, regarding, agents; investigational clinical conduct report and plans other statements additional of our our include plans; present may intended utilization statements things, These the to safety nonclinical data; and our anticipated among or the pipeline Sunosi, development future revenue our and regulatory and commercial trials; possible of and investments. use products; research clinical cash plans; the Auvelity, plans intended regarding source future plans, our and and projections of the based current results statements. subject actual and are statements forward-looking that involve that expectations uncertainties assumptions to are differ These change risks forward-looking and on in information, materially cause and from may to contained those in other periodic Securities quarterly risks with the including described Exchange reports. and annual and made are and filings Commission, our our These

Chief not in cautioned Pizzie, of to as the made are: are forward-looking only on reliance are Herriot call company You any which the today's place statements, Nick Chief overview Commercial. me Tabuteau, on well to the and Dr. Maizel, such key an and progress statements.Joining will Officer; and quarter Head Officer; Executive disclaims of Executive Vice Herriot of and company these milestones. upcoming as of the today provide undue date, update Ari fourth made President Financial as XXXX obligation

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

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

Herriot Tabuteau

and Axsome another XXXX Therapeutics' and continued and Call. everyone, morning, Year-End you products expansion for Business for Sunosi, and our agonist commercial marketed Fourth Results built as first-in-class strong Axsome, of focused year Update product and excessive of and DNRI Quarter was revenue our on commercial Conference sleepiness, million. for net our receptor NMDA Good TAARX joining advancement for ] approximately XXXX Financial Mark. pipeline.During sigma-X you, industry-leading and execution receptor year Thank neuroscience full [ first for $XXX company, agonist antagonist our a Auvelity, daytime our combined depression; oral first-in-class generated and thank

half first positions on new AXS-XX additional moving XXXX.Now We sales We the milestones.Starting quarter to an will XXXX, and and of financials for additional a products. multiple to solid of development X announced expect on for and deliver This expected We for management NDA commercial second NDA made AXS-XX acute provide solriamfetol. our call, late-stage AXS-XX ADHD, in quarterly Alzheimer's of on tracking and information track progress Nick Auvelity; brief in XXXX. our submission stage provide awareness III in pipeline NDA progress I increasing trials value-driving advanced AXS-XX Phase Later our our in completed continued NDA potentially of also growth on details differentiated solriamfetol expansion, narcolepsy on our clinical our our us our provide and the migraine fibromyalgia. for in trial of neuroscience aided will force the is preparation in X indications pipeline innovative program III by XXXX. industry-leading our and in of milestones also the revenue treatment for is for products. progressed with expanded. migraine on performance.During of a XXXX, for disease The programs. We the the will Ari resubmission submission Phase fibromyalgia AXS-XX initiated The agitation. in in in and AXS-XX update our throughout

quarter. of of top AXS-XX to III narcolepsy. to first line during Phase the are for the in we report SYMPHONY enrollment results on the completed have And trial treatment We SYMPHONY track

scientific disease Alzheimer's For market dynamics.Turning for is half active treatment trends AXS-XX, the recent tracking of Sunosi. of of the XXXX, physician to in new the agitation indications, the treatment the and solriamfetol rationale underlying clinical In work enrollment Investor on Day completion disorder, disorder. Phase where including in in eating exploration based III the and December, we an ADVANCE-X anticipated the solriamfetol, event provided target binge experts trial major held second in depressive molecule shift in disorder

neurologic for and who psychiatric serious in development than treatment difficult-to-treat trials more these to potential We details performance. financial new will product ongoing expect serious portfolio people in U.S. complement these affect III which CNS the to the trial now the Nick, our trials in first of indications million ADHD. in late-stage III to of is X the have medicines innovative line quarter. candidates results XXX FOCUS tracking investigational encompasses initiate the second will turn protected of patent and for XXXX.Overall, Phase solriamfetol in These our FOCUS landscape adults disorders, alone.I each provide for developed, with Phase XX top the half the conditions. successfully If call of transform

Nick Pizzie

Total the loss ex-U.S. fourth Today, acquisition-related year to the revenues Sunosi a the to year were million GTN. activities and amortization. in compared product of $XXX,XXX for the NDA revenues the Auvelity XXXX costs which including or Thank of per marketing revenue updated revenue $XX.X million $XX.X $XX.X fourth advancement a the amortization consideration million XXXX. in territories.Auvelity million growth, stock-based million guidance. AXS-XX, with costs fourth representing the full of million million, full Sunosi, the $X.X $X.X of and net cost million. periods in had full year-over-year product and million XXXX cost stock-based comparable and quarter new net million. expense, in $XX.X certain $XX.X expense, for of certain $X.X noncash of including $XX.X million the were product full the you, onetime for of Sunosi and XXXX, of and fourth from compared net of quarter for to Sunosi October provide received million respectively, value cost XXXX, of of in of million of full FOCUS Total sales royalty were Auvelity growth were Sunosi full period quarter of of AXS-XX, full of respectively. million revenue $X.X for of noncash expenses in $XX.X net for Auvelity $X.XX which quarter $XXX.X in of stock-based ex-U.S. morning. consisted million territories.Total respectively, in the million solriamfetol, and compensation.Net million was and U.S. sales revenue of revenue trial $XX.X and for full growth, in million and million, respectively, quarter of first personnel Sunosi; XXXX. Sunosi AXS-XX $XX.X XXXX for million reflecting net out-licensing included XXXX, the quarter and million intangible consideration or in Net compensation stock and year $XXX.X territories.Research solriamfetol respectively. XXX% contingent of the indications out-licensed full fourth or cost sales associated for of includes and of for related periods $XXX,XXX and for comparable sales million loss charges and compared to Total loss on share, for The quarter announced Total revenue comparable year $X.X million ADHD, $X.XX were revenues XX% fourth to $XX.X were and million $XX.X of to administrative higher and were and the results $X.X XXXX. $XX.X revenue and financial ex-U.S. and a for million compared full sales or our good and the was for were for in of $XXX.X noncash $XX.X million a The fourth $X.XX asset the the $XX.X the fourth in XXXX, territories, Total $X.XX the total the $XX.X with representing $XXX.X charges The noncash Herriot, net million was manufacturing of increase effect $XX.X share million related license respectively, $XX.X $XXX.X periods year of and representing recently loss million and loss for respectively. sales for contingent the $X.X in $XXX.X loss and $XX.X and expense, million of compensation year-over-year for commitments $XX.X $XXX.X personnel and $X.X costs, million for full in associated launched revenues the $XXX.X license million quarter million, QX on year includes compared the sales million on year and Auvelity. year discount year per expenses and with discuss and net for consisting product comprised comparable and year in XXXX. of organizational $XX.X for XX, year full $XX out-licensing of associated and primarily and and force XXXX and XXXX, quarter XXXX our in sales $X.X includes from ongoing including and Total general and Sunosi which commercialization was fourth noncash million year million of the periods XXXX of net to commercialization fair was was million, million revenue fourth Sunosi the $X certain million noncash the product share of fourth $XX higher $XX.X XXX%, year full XXXX, for intangible typically quarter of XXXX, XX%. revenue of XXXX some full million quarter for both comparable the million, we'll projections out-licensing This $XX.X to comparable $XX.X full Sunosi development both $XXX.X for was million in net in XXXX million XXXX. share million. compensation.Selling, and of year $XXX.X negative were GTN million, the respectively, related XX% has includes million of per million for were for primarily periods seasonality XXXX increase product and QX and royalty anticipated expenses million post-marketing XXXX includes The of expense $XX.X XXXX. year XXXX.Auvelity trials net of per and full for AXS-XX and and in and for year of $XX.X or $X.X and approximately $XX.X million

As and will operations based a XXXX the of into for in cash expect equivalents balance provide seasonal the our $XXX.X XX, at the to reminder, turn million upper-XXs operating commercial in products. over QX was XXXX cash like now a to believe Sunosi to current call due $XXX.X cash would, update. the to Ari, is flow December in ended the We mid-XXs of We who for both XXXX positivity the in Auvelity to GTN that therefore, anticipated current compared QX sufficient on plan.I cash a would to XXXX. GTN fund GTN discount We QX similar dynamics. high- for million and in with

Ari Maizel

full strong XX% products, starting a for year Thank with were In of market both contrasts first representing you, delivering the period. quarter-over-quarter same approximately our fourth the antidepressant performance This on-market of decline commercial quarter, overall Auvelity. Nick. written Auvelity, completed Axsome prescriptions for X% with a company the growth. as for during performance XX,XXX our by

lives. treated in the sales launch Payer the as prescribers launch since new Additionally, representing our coverage approximately to total by was approximately fourth increasing quarter, the were to nearly activated nearly patients of total QX with unique number remains more stable than in cumulative covered since XX,XXX.In accessible X,XXX of to XX,XXX. started XX% team, Auvelity XX,XXX of prescribers patients, quarter, patients the Auvelity Auvelity number first-time Auvelity bringing

of the We continue contributing and to in quarter with in major the access and practitioners over channels to and growth progress course NPPAs by both or plans improvements driven physician's pursue and in psychiatry performance primarily practices, in PBMs was quarter with robust specialist assistants for nurse psychiatry all MDs as we conversations across the patients.Auvelity XXXX.

in a In activity from increased the began segment prescribing addition, providers the gain rapid drivers offices.In traction low call impact care by of psychiatry respondents both a sales and NPPAs as and survey proportion and onset of on significant within with hold depression among observed of and meaningful primary cited in primary Auvelity MDs our early to we recent take dysfunction. key care action include care, treat primary who force of sexual patients, recent impact expansion weight

a is X symptom and note is risk perceptions symptom works improvement established of on continued disorders both a adopters investment impact calling commercialization depression are been understood created X.Auvelity of clinician week at to substantial at modulates extrapyramidal only role An in provider improvement week and awareness XX,XXX includes fast of a movement day-to-day tolerability the and Auvelity profile on anchored observed glutamatergic observed and safety or monoaminergic in care Auvelity with that accelerate increasingly U.S. Auvelity's symptom Auvelity our and substantial both antidepressant with support platform, of symptoms. sustained and functioning sexual representatives is attributes. a that quality foundation industry-leading across XXXX improvement positioned patient in enhanced rapid-acting low to pathways, for accepted lasts, well-established glutamate augment at the key on story and improvements X, dysfunction education has and that health and point digital-centric impact antidepressant week brand rapid addition, the perceptions well Auvelity the has patient the XXXX, on treaters across in positive we weight Further, approximately key life.Axsome Auvelity predominant objectives and providers, depression of observed our and In a the commercial and as has landscape. strong demonstrated its sales in consideration to is growth XXX oral has of no continued

versus representing the during the optimistic of since prospects Total growth and treated very Sunosi. in XX,XXX, prescriptions XXXX. its quarterly patients unique growth about XX% X% treatment just are We Approximately over quarter, with XX,XXX number were now sequential long-term bringing patients X,XXX QX, growth XXXX and started to to potential.Transitioning Auvelity's new launch. Sunosi blockbuster Sunosi total

significant is fourth prescriber sleepiness cumulative XXX for including base smaller total a Although a activate prescriber consistent a during lives driving Sunosi covered with we in the space. daytime more quarter base, prescribers, of to of excessive total alone, than market demand more for a channels. nearly In in focused continue all of with Payer a coverage product, disproportionate more than narcolepsy new XX% limited for survey Sunosi across excessive X-plus QX needed was recent of week X,XXX obstructive attributes XX,XXX weekly adopters, the include key clinical focus Epworth observed in on the since communicating is cited launch.The III field active Phase respondents by treat improvement and Scale, urgency in sleep team sleepiness prescribers market-leading daytime in impact outcomes with sustained on XX. on symptoms significant to a Sleepiness wakefulness trials and at apnea patient-reported of the the and hours the

closing, Mark our our to performance completed back Auvelity landscape year in conditions.I growth shape, Axsome for commercial continues feedback patients took Anecdotal XXXX, optimization Sunosi a options and turn reshaping the respective and and that is XXXX.In in of as very are and commercial commercial will call supports compelling differentiated that we a of are and our to their infrastructure continued full reinforce unique QX, CNS delivered effort treatment growing We our Sunosi first the the and treatment for proud our Axsome now company. confidence providers as expect from for indications, in belief Q&A. commercial

Mark Jacobson

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

Operator

Markets. Leonid Timashev is today first Our RBC question Capital coming from Instructions] [Operator from

Leonid Timashev

trial slip time provide ADVANCE-X there the recruitment? as you Maybe And what's reflection a guess, driving on care evolves? off maybe the I any color that? drove with especially market bit I'll in from what any a little guess, to lines? of Is slower standard start the more the can I on readout. opportunity on potential question integrity, risks

Herriot Tabuteau

thank question. Well, that you for

launch care. the potential want driving excited That's I nature we're did any your an And standard think into that can enrollment. have of of really to that is brexpiprazole we this. question, take of indication the This about. account of that, the second which impact and evolving is recent the on is really what part

indication. a reminder, is is first drug this that the brexpiprazole As approved in

been So we've indication. new is a clear very seen analytics that monitoring And the to prescribing, in has prescription what internal team closely attribute our which trends. inflection we

revised the in landscape our evolving So guidance we this information. said incorporates Having confident about should this brex? new to further comments that, be that able we're any data year.Are treated deliver

Ari Maizel

just which say, directly this a for AXS-XX. Clearly, AXS-XX. the But to really confidence to think ] indication. news unmet future is there's increase, with brexpiprazole need substantial great channel, the increase that Medicare would we're Yeah. treatment tie I positive the for the I [ us across seeing we and gives related significant also ADA a

Operator

Cantor coming Charles is today question Duncan Next Fitzgerald. from from

Charles Duncan

and little be on in persistence. fast provide Herriot up follow in on it for you you on I congrats of terms great of I but first, and a any wondering know, of sense a commercial can staying you performance commercialization. on patients mentioned refills I'm Auvelity, may branding to the if in see regard team, terms a activity. I'm can of too to for wondering AXS-XX, with drug? long, year question did want last bit but what

Herriot Tabuteau

share Thanks the patients question, from clinical we're holding on still for and Phase any is is It's that information the from in III will a say profile what clinicians world. receiving up Charles. the feedback too the adherence, to and persistency little early suggest real I

the Phase for data generate world in seeing the III future. But now, results. in the clinical suffice is trial of say to we we're that what it So to expect real reflective additional

Charles Duncan

AXS-XX the are any could perspective probability that if data also and extension, be then I'm Otsuka's given the last just in of how does And on XXX enrolling on of that? to you of wondering changed appear broadly? helpful. and patients to That's into open-label terms ADVANCE-X. if success regarding maybe, yes, I follow kind question Okay. recently, And the going have

Herriot Tabuteau

the Otsuka meaningful has any regards product. don't readout, read Yes. Charles. that the Thanks to for to we With that, think questions, our through

or Now the learnings we development. our watch any clinical potential developments any to any data space for in readout

as best have data which we of both placebo-controlled, the However, when the trials, is in thinking results. AXS-XX Phase generated at were of potential III look a own product. you're our that had agitation data positive Alzheimer's disease we about X the And with reminder, we've think which that now completed to

So is themselves, with other than dextromethorphan. more molecules we entirely.So think AXS-XX take if reminder, and you it And that, that is actually information products then this they different are deuterium-modified -- as nondeuterium-modified inhibitors the And operates which is whereas the look the different. at a information AVP-XXX, the relevant also down one and step dextromethorphan, are molecules. a

So they quinidine. then a and we use aminoketone use

to relates So is open-label extension. the different. is opting out as indicator and to that it a how go open-label about of who thinking good very think the ADVANCE-X vast of We into majority extension of our or the product. trial safety that And safety that, going patients trial, caregivers rolling are well are the the

Charles Duncan

added back Very the for in the color, queue. hop Thanks Okay. good. I'll Herriot.

Operator

from Verma question is from Next coming Ash UBS.

Ashwani Verma

AD on both agitation. X, have I

what broadly Are platform when just you BCC to versus, started the these that study. of That's type therapy then to might kind focus who fast has naive So facilities patients the treatment, footprint? a primarily care forwarding your require this trying maybe just think, like of second, to that's assume lot of the would long-term ADVANCE-X that is on market, recruit on like I want come first one.And Rexulti? patient exclude need to why footprint anyone where curious of you the you kind to and And on reside. sales you would more just to

Herriot Tabuteau

you thank The for So yes. question. the answer is,

We care potential been take on recruiting losing of have revised And facilities, account primarily obvious approved.And do thus naive which have Alzheimer's Rexulti reside into studies them to it long-term patients any community facilities. conducted majority excited that are our reasons. We at one a to want relates we're the about on wouldn't And patients And it is of impact with we keep that, where profile are that because option, patients. treatment now in terms long-term indication. patients AXS-XX, ones. home In that's think patients disease then of guidance in folks in the keep have setting. as the care could exclude agitation the who other our who does their this is out potentially far loved words, of for of things

Operator

coming Securities. is from question from Next Joon Truist Lee

Asim Rana

comment now? This XXX% patients on the force clarify, wondering then I salesforce? on what you And are reflective And Around just TRx expanded current Joon. trends first to the are if you percent breakdown line? Auvelity could of Asim on want on also of you the was for currently if is? sales fully is can what full think comment online is

Herriot Tabuteau

I'll that thanks, Well, turn over to Ari.

Ari Maizel

Hi. question. Thanks for the

are we treatment. a improvement in seeing earlier terms line So of meaningful

we every of and Over saw line quarter. the meaningful in second course XXXX, increases first treatment

XX% to there's today, second receiving setting. patients roughly line in the first or Auvelity XX% So of

that will of trend We expect in to your the year. force impact January completed are question, additional year, the continue meaningful the call calls a hired expect beginning starting representatives We expansion. of in this TRx the We're care of to training over expansion fully the last to an be and trends activity. In end at We of see the we sales with ramp to terms complete time.Regarding the proportionally year, of to particular, primary in and segment. we're NBRx over QX. there increase increase continue course would seeing

are increased more come, with very but we so, And field pleased expansion. the post details force effort to

Operator

from Next America. question is Bank from coming of Gerberry Jason

Jason Gerberry

seem dynamic ADA inflection that the TRx at doesn't brand obvious. a on on growth guess, with I to when enrollment I look just this wanted of we Rexulti. follow up basis,

both surprised claims, don't looking wondering market, if different be a given I given know but little half. to know inflection?And term characterized that a you'd we've I'm file metric should then that that massive forms that being long efficacy second inflection, data if and or move it's in enrollment able this TRx a is you'd be -- I'm in expectation the the an at and is then gauge half So we get second safety as patient still and to seen,

is filing the if wondering on track? Just still timeline

Herriot Tabuteau

Thanks for the question.

not guidance given We on have filing.

our going That's [ safety our ] to analytics that's of with determined Ari. over Rexulti, trial. turn be team extension it completion the long-term there. gating what So to from on factor by internal seeing the And I'll regards we're to

Ari Maizel

My been Yes. and looking is at claims within is Thanks, Jason. observation what our data based the Medicare we've suggestion that channel. by increasing payer and significantly channel is brexpiprazole

the And the so indication that growth attribute too. is what to we ADA

Operator

question Our Piper David next is Amsellem coming from from Stanley.

David Amsellem

So just couple. a

an the how and to other then thinking Auvelity on gating filing talk about AD the of just for the potential it's and about got So the different talk you that narcolepsy. number got pricing NDA beyond you that it one from from depression You've NDA you study line and the on a market? a market the X.Then pitolisant, of can that's landscape? an spectrum, cataplexy? solriamfetol number One, end in X, differently, end just in obviously factors are spectrum, Medicare to branding given time reboxetine. D about in you First, can it Part narcolepsy on And on differently the agitation, couple pricing

that? about thinking you are how So

Herriot Tabuteau

Sure.

are, in what and The thinking gating by about final a and obviously, we thinking and that, So would I about to those of long-term X our provide extension the we're what we I'll will determination. until products. there too NDA branding how around pricing questions we're we relates factor saying And trial. will comment preview be some for it on both narcolepsy and be things. timing. let couple our not safety do there able will there it color a And make to options as AXS-XX much Ari

we're monitoring that is enrolling. that, but So

package we need complete to NDA. our order the and And out in read have for that that to complete so,

Ari Maizel

Thanks Yes. the for question.

the administration, impact brand And branding for AXS-XX, lot a the around analysis Alzheimer's are Regarding considerations indications, the understand having including potential of pricing of that to it, comorbid there's of or will potential go multiple XX% same performing patients. in and brands. depression ensuring we're dynamics the associated effect clarity different with into that dosing fact better an there currently patient roughly halo

more share lot So exploring, reboxetine additional we'll of considerations, the the details And in there we'll area we're currently are analysis details future. pricing, that's share and that regarding in the a of and another future.

Operator

is today coming question from Thome TD from Joseph next Our Cowen.

Joseph Thome

AXS-XX. remember, timelines the know, cataplexy? Gemini a Maybe it AXS-XX for a sleepiness can one with months seeing signal to see of, actually on it's we're X about first really on to first on scores. If you I sleepiness get to study can the perspective, kind from the that? Or from a dose bit therapeutic, thinking second addition Sunosi if address to patient like come in talk I little little in the unclear to cataplexy, component?And But is on to took about data. MDD? then only you sleepiness powered and going another is important clinician also Sunosi in data actually How should we a

would kind year? and MDD what the study the Gemini possible are we it that this that of Sunosi that not between main differences could make case? the is see So Or data potentially

Herriot Tabuteau

a questions. the regards for With close to we're AXS-XX, Thanks data very to readout.

So we'll very Phase soon the we'll will any III refrain comments Look, that. close, in and making from so is trials. the profile we're what around know

of once terms regards to hopefully, MDD, Sunosi Phase about that, study. readout looking we'll to us Now of that we product And track will data we're favorable treatment we this the provide far.And thus to do II in with to on and that because placement the complements we generated solriamfetol data in first paradigm have the a think treatment to options. patient say have remains first Phase III data the quarter. That that in the other forward start that announce more should that the enrollment complement

Operator

Our Leerink next Marc question Partners. from coming Goodman is from

Marc Goodman

a a Nick, sense is?And Can willing flow of that us are can the we're you then of XX%, to of what thinking to of cash you enough how talk And when that? this to talk you us you year? secondly, about study positivity. us you get XX%? about enrolled? how sense secondly, cash give agitation about have Herriot, Are a percent give you you AD give can XX%, then is sense Maybe spending

Nick Pizzie

Mark. Thanks, Yes. Sure.

So the expense million, previous $XX up for for for under ticked QX. $XX slightly the million was That as quarter. our quarter from R&D, just

Phase line, We FOCUS will are though spend also the in expect to XXXX, and and increase NDAs increase increase lower quarter million. year. a clinical just the trials AXS-XX was as the SG&A This under solriamfetol for the be the as R&D SYMPHONY, by complete was commenced during total also $XX costs, and previous trials ADVANCE-X gradually quarter. offset filed.As also slight expense once in AXS-XX That III for

mentioned, as you in expansion, was increase took throughout force which As biggest due sales place the QX. know, SG&A we to the

that expansion in realized quarter's of throughout occurred roughly half the QX. As was for the expansion quarter, expense that

full of stages be we we've So expect feel had of the various slight a year as removed or cash of and and that to scenarios, positive. from on burden at in we of increase will that would cash the we the early realize launch QX positivity flow still from and acquisition Auvelity we a far, profitability, -- are expansion.So Sunosi. based very a confident thus bit more the than the flow our a ability success We've modeled then,

take timeline by want flow positivity.Herriot, on as you such, next As launches, provided specific haven't nature, we the And volatile. very any cash the to question? do guidance you're for aware, are

Herriot Tabuteau

Yes. for the question. No, other thanks, Mark,

percentage We lately. trials a provided in enrollment our specific haven't

results agitation, we we're year. should weighty However, to have confident [ be that this ] able

Operator

Our coming Mizuho question Suvannavejh Securities. next from from Graig is

Graig Suvannavejh

Okay.

about sorry on that. So quarter. Congrats the

just And in secondly, you in as Auvelity? then DTC around that solriamfetol basis?And on of might product go-forward positioning what's can you've your And just -- differential with think think the us how that far? effort we a XXXX? about level the thoughts so comment should evolve And One, satisfaction about in remind Auvelity needed done potential questions. the the of efforts? on just any what could we with X Just of how you MDD, on

Ari Maizel

much. Ari. I the Graig, thanks This so is question. appreciate

What receive far. who that very through XX DTC with do have know, we Auvelity, ask observed effort research patients so on We've we you is been largely digital As it. focused for in X a engagement. nearly pleased market today investment

about And additional moment. we are at investments we're continued And so, investment consumer in advertising. optimistic the very assessing

these share the it around some increase to highly intend is And so, And symptoms difficult patients patients. are usually heterogeneous MDD, there patients consumer more options know, some you MDD on solriamfetol we for we treatments. the overlapping room expect be year and later there's for in types in of advertising.As to the with to because that than updates as respond to other to whether illnesses particular may investment would multiple relates help treatment based Not all others, condition. a symptoms same

believe about until space, with And so, do relief. we this to symptom MDD, have more be meaningful But we Auvelity. products little in based around in solriamfetol talk achieve it's for to co-positioning that both will our premature there help a data on experience patients opportunities

Operator

Next David coming Citigroup. Hoang from question is from

David Hoang

Congrats on the quarter.

So maybe X for just me.

are commercial the the ADHD, are in the think, those covered ongoing proceed around study above so sNDA Auvelity, results solriamfetol improve positive? your of could First, once I discussions any FOCUS what be there, color else payer you an XX% the lives? expectations of needed channel or to and then, the hand, current, there coverage provide filing in And if results to would regarding in to on

Herriot Tabuteau

Sure.

questions the order. reverse take we'll So in

will a adults. in the trial For solriamfetol, be the wanting pediatric Phase FOCUS III And population. study we is in

both populations NDA of studies of those So patient an -- those are needed both filing. for

Ari Maizel

is coverage products. our overall to payer channels, very for roughly the a way as And we discussions, across mentioned, preserve long-term contracting to The about have commercial think in disciplined XX% XX% the related you dynamics we taking approach profitability Yes. to are payer we channels.

Auvelity. insurers growth anticipate remain as of XX% we actively I expanding patients. and I well engaged support coverage continued insured time savings improve current levels will access for will to with investments health over of our at remains patient services in which, do reimbursement that programs both lives for as However, coverage, before, as mentioned mention current prescription

Operator

from is Myles William question Blair. Minter next from Our coming

Myles Minter

major to at that's more are have of channel, flat these about conversations down commercial got Auvelity filings just with Or not patent IV the moment? the is might FDA some it point are risk in noticed I you've coverage sticking you quarter-over-quarter, coming expires on aware back patents XXXX. Just just XX% with got your recently Is Have that of?And to know Teva in the that we that the the some Book listed get [ filings new active. on payers then Orange with be against those yet IP price? yet benefit? ] What at online progressing. the formulary that ANDA positioning, it that secondly, is I chapter a simply

Hunter Murdock

Murdock. for Thank is Yes. question. This Hunter you the

Paragraph So have which going again. we yes, we a patents filings and out do we've XXXX, IV suit filed to have against them, do

patents. information So that have XXXX is public certifications IV X it do we relating to Paragraph those

with that's So Teva that litigation. the

Ari Maizel

Ari. is this And

it Every utilization different. discussion cases, related Regarding ultimate to on quarter-over-quarter. cases, price. Yes, it's payer your management comment In XX%. is to some some related In stable the is parameters. it's

are hopefully, takes updates discussions, but able to we next be they conversations. time progressing We're we'll meaningful are so, quarter. And And those and it ongoing some having negotiations. share

Myles Minter

Congrats year. Okay. on the

Operator

from is today Yatin Suneja coming from question next Guggenheim Our Securities.

Eddie Hickman

Eddie Yatin This is on morning. for this

more then ] attractive Auvelity you box brexpiprazole that commercial to option Regarding long-term the ADA population?And a additional channel that increase how Or on inflect for different comp kind profile approval, could make in need warning does what good inflection black safety approval? or the that upon an for would a [ approved? care launch is if their of since Auvelity infrastructure the like saw, see brexpiprazole this

Ari Maizel

Thanks Yes. question. for the

channel. long-term clarification. Medicare Just to in have one suggest don't increasing it's in data brexpiprazole care, the We

for data little clinical a profile we AXS-XX analog different so, and that the slightly But well there has meaningful it's needed both a think -- as long-term or non-atypical settings have additional antipsychotic. AXS-XX. I expect indication do products it's long-term in would that do setting I overall. is it's outpatient care. outpatient. And as profiles. It to different premature approved if within whether a And to growth be think These in be in a to the suggest good care understand

the earlier hope care are facilities. have to term to we're force size suggested a we presence our Herriot patients delay in a do facilities.In structure long-term trials, commercial going and to meaningful in we pipeline. overall As sales evaluating terms focused infrastructure, in And to obviously our relative expect outpatient of long settings care with

care existing for practices, which force ADA. we However, sales our continue primarily on expect will even is outpatient focused

So for on-market on more pipeline products. confident we'll details our points well we efficient that come, very exist of feel effort but indications based as most shared be in to that the the able as an to our selling have call

Operator

analysts. from time We questions have more for X

Matt question Kaplan coming from next Ladenburg Our from Thalmann. is

Matthew Kaplan

sales I question in now should them force half sales to of maybe see first year? new half start Ari the when we over Just that the of a see or guess, for completed to When terms really Is of impact course we that the force? And start you've expansion. gaining it an second traction?

Ari Maizel

the for question. you Thank Yes.

terms training We stories messaging in the of care to impact our year. It also to ramp and year. year. see and through brand the the this a build the the We expand of over Obviously, call majority in course hired setting. to expect last go with reach to primary were cycles and time takes into of expansion representatives of late the January completed confidence

we to We're of demand to of call so, over terms occur activity, see expect have and starting meaningful bill expect course the the of year. the the over some increases trends year. corresponding course to in we impact would And the

Matthew Kaplan

a That's Herriot. for question And maybe Okay. then, helpful.

is ADHD. detail for added You in sNDA gave what some necessary of and terms filing

the binge one? you're be MDD, be it shift some in there? could Phase and include work, X they necessary what pursuing eating In for other Phase terms III disorder indications both Is Or would -- solriamfetol, they all trials? with III of

Herriot Tabuteau

III regards that Phase With so in X MDD, to will there, trials. solriamfetol Sure. anticipate need we we

So we're launching our first Phase III trial.

anticipate also to disorder. III III would need this quarter, launch binge on Similarly, this Phase X As we and we're quarter. trials, track first Phase you we the that eating know, trial

For disorder, Phase an only -- shift need we III trial work to file X for sNDA.

Operator

question Vikram Purohit coming Our from today is from final Morgan Stanley.

Vikram Purohit

me? you hear Can

Operator

Please proceed.

Herriot Tabuteau

Yes.

Vikram Purohit

on X we questions, So had on ADA, one one MDD. commercial

MDD, with setting assuming what that patients the you approved AD and year? provide? And can do experience?And Auvelity ADA, be is AXS-XX aspects in that if reasonable and So given then potential the gauge think launch for of for whether to of guidance duration so, number sales some this episodes to the duration expect ADVANCE-X metrics monitoring of annual differences therapy is would in in and guidance you're secondly, a the to you is possibility are agitation of the this what positive is indication,

Herriot Tabuteau

regards to Alzheimer's agitation. of in treatment With for duration Thanks disease questions. the

how we've that condition. how agitation thinks a the feedback So chronic from gotten that's Alzheimer's And we've it about disease been studying them. is and also is from that of FDA reflective as viewed it

So is we trial, do which have, ongoing. as open-label safety you know, long-term a extension

So fairly time. drug on patients now been for have long a

So trial. the study, X-year it's a

Nick Pizzie

Yes. Vikram. This Sure, is Nick.

at the it to effort period on relatively of which including since of variability not guidance, likely this the As and sales dynamics, sales, ready we're for as sales forward-looking relates to the the entirety provide market guidance XXXX given time access, as force with case is in point. the short increase evolving launch well

Operator

Thank you. to any floor the comments. management closing We reached or turn back answer further end of to our over question like for I'd session. and

Herriot Tabuteau

business to XX commercial progress. neuropsychiatry pipeline that was neuroscience candidates with X you to our on development, We thank growing join a year We have Thank for late-stage today's quarterly multiple us for and for update.XXXX the throughout innovative your Well, a indications. taking in year Axsome. you, product time forward a of entered look serious the encompasses XXXX a rest in providing day. updates the great strong

Operator

you. teleconference does That Thank webcast. today's conclude

You this participation for your may disconnect day. today. have We you your and a time wonderful line at thank

Axsome Therapeutics (AXSM) 20 Feb 242023 Q4 Earnings call transcript