Axsome Therapeutics (AXSM) 7 Aug 232023 Q2 Earnings call transcript

Hello, and welcome to the Axsome Therapeutics Second Quarter Results 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 Mark Jacobson, Chief Operating Officer at Axsome Therapeutics. Please go ahead, Mark.

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

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

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

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

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

Questions will for financial commercial our review then who be order received. in a will provide the questions. taken open are update, the they Nick results, then will Herriot, Lori line will Following

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

second Good everyone. financial thank business Therapeutics quarter call. conference Thank you for Axsome you, Mark. update And XXXX and joining morning, results

product business. our us to areas advanced flexibility the pipeline further and success operational to the financial We we and and in execute quarter, provided stage of second offering across commercialization continue the our of late that significant drove solidified In Sunosi, whole equity Auvelity continued strength. public our foundation

are In product net growing by performances million conjunction date, prescription Auvelity our and Digital trends and increasing strong are nearly reach. platform representatives. Commercialization on both number expansion we from were to prescribers quarter Based the driven Centric in the or feel force Auvelity $XX.X nearly Sunosi. should able Total Auvelity XXX clinicians, by from positive the double DCC the sales of the with to we feedback

will Later conjunction commercial on provide the advance. financials. development in comment pipeline details In performance will with and the call, Lori expand our first our in our class performance, further continues to commercial additional and on Nick

and focused shift reuptake and announce launch we the excessive initiated X With work inhibitor TAARX Today, Binge recently of our trial norepinephrine high respect sleepiness new Phase solriamfetol, potential disorder and solriamfetol. dopamine eating indications pleased in the value two for to ADHD. associated disorder. to with agonist we're

a eating of U.S. of this disorder the is for the eating recently FDA this product and currently binge pre-IND common Binge to disorder X.X% this with There positive approximately one adults. from program for feedback approved in FDA preparing eating received disorder meeting year. most end X We are before is affecting only trial patients initiate indication. Phase the

approved only two nearly estimated disorder. are of treatment FDA a work disorder, work, an one-third XX% work Americans the sleepiness disorder. There XX% for shift are shift perform of of shiftwork with currently to with to products excessive shift Turning diagnosed whom associated

are preparing a in first in for program meeting shiftwork and from feedback of Phase X FDA this XXXX. quarter disorder pre-IND We also recently received initiate the trial to positive the

increase dramatically and pipeline. Stay disorder, eating potential CNS rest updates pipeline. already successful to late binge patients class stage could and in in ADHD, clinical of these the tuned solriamfetol of indications more are Further of target CNS first testing. disorder, our leading the growing the for The number shiftwork help on have programs,

excited lie anticipate ahead that of We year. number of by trial us. the fourth value of the creating X AXS-XX of the for completion of are in opportunities We narcolepsy the Phase treatment SYMPHONY this of quarter

ADVANCE-X in to We of and continue disease ADVANCE-X enrollment track agitation Alzheimer's for to trial first of remain X of the half XXXX. see study complete the treatment on in Phase the we AXS-XX

fourth to We plan of are trial the of the of on which in quarter this progress the quarter year Phase X/X or making start scheduled towards AXS-XX first cessation, is initiating smoking XXXX.

finalization is resubmission half has AXS-XX the And for pace work a of slower result, now in nearing we moved resubmit a first the at migraine. the Additionally, the for This to the anticipated. work expect of XXXX. the team NDA than of NDA in as

content good the to finalize respect datasets are complete the we progress submission. submission making With will the to AXS-XX plan fibromyalgia, working NDA the are for management that and and of for

are We in the stakeholders the NDA fourth Each for our and continue to to we quarter next year potential of strategic this of value first an potential of to decisions the make for to year. growth. these maximize tracking submission future quarter milestones, builds

in by execute expanding public flexibility to may expanding the gross commercial also only multiple underwritten and foundation, aforementioned to indications stock maximize Lastly, but in by fortifying for field we on common adding recently that our financial million the Not solriamfetol fronts. of serve potential. proceeds, resulted new force, closed product's $XXX.X offering our activities additional providing an that strategically

half across up for next XX to financing amplifies expect and that discuss ability how a read productive the will sets us each Lori of multiple milestones all, Nick detail All in XXXX second we over further value months. in our portfolio. the our

Nick details will I the who our now call to performance. turn financial of provide will

and morning. good Thank you, Herriot,

commercialized royalty of Revenue XXXX. Sunosi for of will and comparable Auvelity of second provide May revenue quarter from net I two products $XX.X out-licensed guidance. X $X.X discuss Sunosi of results and the period territories. our Sunosi comprised Today, was and the second of was financial our consisting sales million in Total U.S. some quarter sales and XXXX million beginning sales revenue

$XX.X were $XX.X Auvelity beginning U.S. in timing Sunosi's royalty There XXXX. million million, quarter net period XXXX $XX.X sales the million, sales U.S. were International $X.X the for to sales million, the no the Sunosi the Sunosi revenue in comparable territories. net million, sales was was $X.X X from approximately sales sequential out-licensed comparable launch. for XX% the were of growth. of were of revenue consisting Sunosi period sales representing May $XXX,XXX due Sunosi quarter including in in revenue net

compared was the increase current in both million the revenue of Sunosi to second prior the in period. higher The million year $X.X Cost in $X volumes reflects for product quarter and year. the Auvelity

$XX.X supporting quarter trials, second XXXX. marketing Research and $XX.X commitments were associated ongoing period Auvelity The expenses post stock for primarily compensation related was costs and in million in comparable the million Sunosi noncash clinical personnel for and development with to increase the versus higher expense.

million for to of $XX.X higher second to The and in commercial was general versus million comparable administrative Auvelity $XX.X expense the the noncash for the for and XXXX. period and commercial teams. both due build Selling, were compensation related out quarter activities Sunosi stock expenses increase primarily

cash ended loss $XX.X million year-end. as compared was quarter net share comparable $XX.X and quarter for the the in $X.XX cash per million a to or loss XXXX. the million share second million with period for $XXX.X $X.XX of the of $XXX.X Net equivalents We versus per or in previous

public Our the our received proceeds stock in balance from cash second quarter reflects June. net completed common offering

of an underwriters purchase exercised additional XX% pro June In XXXX, offering, of their million. option $XX.X the this this public forma to to additional million. of cash the balance $XXX with Axsome connection event, fully XX, offering XXXX, resulting Inclusive in in was proceeds July of the gross

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

Nick, you, and good Thank morning, everyone.

quarter, Sunosi results. Auvelity In strong delivered both second growth the and

by For is With early the on launch executing Auvelity, that early future we indicator our promising strategy. robust still of are said, adoption phase focused a and and in success. prescribers commercial

Sunosi, XXXX Sunosi of commercialized Axsome. of For full second the year by marked being one quarter

of begun the in see the results healthy have quarter-over-quarter. from which is to We growth resulting relaunch Sunosi,

for performance of in to brands second half both continue a expect the We strong XXXX.

with indicators success launch. The with patient new represents quarter quarter HCP for are the the only our and making full of progress our growth, launch key are the starts Auvelity, pleased the we adoption. script second Important of and second we

In increased XX,XXX QX, breadth of approximately to of second of patients, new prescriptions quarter, depth quarter-over-quarter. as early new In XX,XXX to an XX,XXX Auvelity as prescribing wrote growth for QX. were patients came of the HCPs reported prescriptions from total prescribers. at our XX% unique growth with number HCP a This well Auvelity, increased on over an the both of representing adopters bringing the prescription end

of number quarters. About response this to our prescribers universe Auvelity, we added force expanding approximately over we account In the has Auvelity, cumulative XXX the XXX to X,XXX specialty only second target In since increasing of success, XX% first-time total sales the full managers. are early two from new Auvelity after X,XXX. launch of initial written to quarter, subscribers

XX,XXX expected early more expansion XX% approximately XX,XXX increase from our build accelerate the uptake. significantly currently success help is will launch prescribers believe prescriptions. and than reach antidepressant who to expansion branded on write The prescribers, to of We that

to covered is XX% XX% to Auvelity, With decisions formulary additional channel regard we months. channel, coverage to in lives, In coming be currently payer look of primary the we covered the all coverage established for expected forward which coverage, have and at is lives. commercial the of for now

health In or currently a the is the health mental highly of and Medicaid Major are that concerns prevalent depressive covered. Medicare MDD, disorder, major public XXX% is approximately the lives and with facing. U.S. channels, crisis

Auvelity chronic patients and condition. proud important that this living providing differentiated We options are devastating with therapeutic is an for and clinically

Turning to Sunosi.

commercialized the campaign. and our by XXXX and of HCP updated significantly mentioned are efforts. a one in Sunosi, with an campaign we media launched promotional seeing second and All-Dayer Pull complete DTC full campaign results year of the redesigned marked the promotional In As for Sunosi quarter previously, directed Axsome. which from these immediate updated second quarter, invested was We being

represents in adding base depth patients the drive, and cumulative past of breadth and net prescriber within over Sunosi current by have than increase field working XX,XXX Since added new in the which quarter-over-quarter, XX% Total an that greater grew to year, approximately the X% patients, prescriptions we both U.S. revenues prescribers. of for unique unique XX% new The expectations. exceeded with year-over-year QX team is last year.

new The covered. year, currently Sunosi XX% broad, growth such potential shift and Since potential for as we of well disorder. of last lives and of for indications Sunosi QX total as work disorder approved lives in by growth XX% indications in eating increased target ADHD, as binge unique its Sunosi the remain commercial substantial, new coverage have XX%. Payer of remains with writers

first the and the and reminder, and disease available wake-promoting enhanced is branded nine growth to sleepiness, a the increase through only obstructive who Sunosi agent daytime and is patients for OSA proven sleep promotional only, excessive wakefulness Sunosi drive expect only therapy And efforts As education hours. product for and apnea, for improve first in XXXX. DNRI and the in from continued and we to our EDS narcolepsy. suffer

launch of and execution the the clinically half Sunosi. and success and efforts unmet both execution saw the continuation of of XXXX a of QX on continued for second in expect differentiated continued need. strong focused products relaunch products are the year. commercial address of high patient We of remain commercial Auvelity Both the with populations

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

Operator, you, questions. our we Lori. may please have Thank

Instructions] is Our first Fitzgerald. Cantor [Operator Charles coming Duncan question you. Thank from from

live. now is line Your

taking Good performance all, the morning with hi. questions. a of congratulations, and as Herriot broadening revenue a Wanted as Thanks strong for of well progress. Yes, pipeline off team. to, and start our first

A questions. nice quick couple So quarter. of

sense most approval depression, competitive disorder. and they're regard depression major Auvelity's And Auvelity? with for but can its wondering interest in why that to prescribers an clinical all, your really I'm not of if I what if us postpartum on give a of the the candidate changes you a in prescribing First views profile guess, profile, environment product clinical of drug?

for Charles the question. Thanks,

we're business our for what doing, all. does In at terms it changes our terms not of in of change it plans what

There prevalent. of far there. XX Auvelity really seen As launch a thus million great. What clinical need patients is highly out that with the are the major depressive reminder, disorder is is we've

as disorder, And and also while And of in want to drugs a are multiple sure we've past, developed that the that have we anticipated patients different served there depressive good be said these we clinicians get for lot that being players. we would that because make space for think it's the - options.

I passion. our and that's take And why - asking side, that each other. you're know likes sell the accompany I against So question, know to the

is commend we [indiscernible] hear folks that assess safe work the to so talented the and - that treatment and lot especially and dedication we know passion, getting to of companies really with a say drug individuals. the work new depression. a experience that patients takes We just they'll approved cyclical, that other postpartum and provide team in Like development colleagues, hard It CNS. their for from new of

to what in new just And going are to work that day other every we with work. depression, us patients, That's CNS to also but to not brings end, to treatments continue that provide ensure limitations. our we with

expansion So if you far the of million patients it in XXX announced brings that look U.S. at whole help, that number pipeline today, patients the our the we thus we can of

remind enable could in will migraine. just any for NDA Axsome-XXX that you And provide follow-up more an on helpful. unmet one I if target work that required profile And if the to could filing? you I'm or AXS-XXX regarding us also on serve product That's wondering ask color candidate envisioned in the the just need the migraine. just streams

Charles, work NDA answer about for this is resubmission. the first Mark. streams question I'll the the

be to taking this that's behind just than going seat. and expected, some last So as clear, though were the it's on there is since call us setbacks not longer the just

finishing what time requested taking to get were us to get we or that the this that by it we're right. need FDA. is additional And of batches So right our in

it and reminder, the an the technology. external innovation is drug drug is system. substance are buffering This mosaic the ring manufacturing stabilized a new. The active a As with [indiscernible] product it with is that

the asks data for package. to So support additional FDAs as that's

that done. work its on So it expected, It's way, be remain right. to longer get just confident than and taking we we'll is able that

And then profile. I'll product pass on for the

Yes. Right.

Charles, part of So first the to asked, just you in product the start with question you regards your Lori? second profile question. that

Yes.

So on interest on and to back piece on Charles, XX. also I'm the most answer question competitive answer - but going the then I'll to Auvelity the positions, switch

three most the very is, trials. clinical HCPs, action to world obviously, we I about interesting saw would what impressive Sorry seeing things. out results are we're that. seeing what of rapid the we onset What in to really say, - real the in One, and is similar

therapy, starting is, second on point through have enough are where patients we getting where a we effect really the durability come product. now The the piece to the of to sustained is

really that's out there so And encouraging to physicians.

we symptoms and we're physicians remission. remission very to on large are able able of is two to on number achieve what trials not everything clinical that that does trials quite as clinical Again, as is the commenting fast achieve or improve, to saw are something similar a patients very bit what remission, how seeing but in with We have early in are a the weeks. only we

side is thing last the then the But profile. effect

both physicians obviously So favorable out is some are the versus the side and them. of there profile competitors and patients commenting effect on

lot the That of are that mentioning, reduce allow multiple terms patients is entrants and in with is technology In efficacious. as for the cycle still onset more of despite now therapies. promotional through action of was the dollars, to of patients their than for know are now AXS-XX, pain. XX% right We activity really and that for fact dissatisfied does a of current Mark they very a - the looking Mosaic category that's something lot there therapy early even

as And them. so to market us we bring to option hope an for up

point from you differentiations out three [indiscernible]. Auvelity, Regarding key

the on quarter. congrats and color added the for you thank So

Thanks Charles.

Thank you.

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

live. line Your is now

for you be my size the that quarter. force for what and any who hires for the time expect wanted the sales or foreseeable be pool from Auvelity concluded cards? further be little able ask much on new perhaps frame antidepressant experience. you. expanded steady to that sales CNS as on composition the expansion what the taking sales future? force also, prior Or a the about you you're you so with sales again of state facility candidates comment those Thanks expect the on new might bit to the to if execute effectively you congrats kinetics within could a which questions be for just Thank to I see of if the and And going to have if expansion force

Ram thanks.

of don't try write get you down if I that all them. just asked. to Sorry, question every

miss something, I please me. if So remind

So, QX. and and to in we out rolled to expansion completed ready are intending the perform have

We have that much right are and very been now building expansion underway a in little bit. for

Part the early success. so of reason right expansion strongly we seeing are now is why think believe and is such that we the needed

on obviously, so what we're this And and of therapy now. new We patients HCPs is, We're than XX,XXX and encouraged between X,XXX month. seeing or every launch, typically struggle at about patients have breadth. field why or XX,XXX we're HCPs writers, more stage right depth X,XXX adding forces HCP

are a target force. We XX% right And now, remember, target of sales very written. has greater trying very both. our to list And is our a list already than achieve substantial target with small list

XX% of write. already also XX% those writers than to already But have found those patients more two have that of written,

so really a expanding uptake. And accelerate breadth both a launch we force and the from the and further standpoint, think encouraged depth that that's will sales

of In composition that greater we psych experience. our experience, recruit, CNS pull of with candidates, terms than first I XX% more and think with had than

is our are piece We as going this to well. goal - expansion for obviously that

Thank you.

Thank you.

Lee coming from Truist is Joon from Securities. today question Next

line now live. Your is

reason And you. Alzheimer's completion if stuff. expect first why year? strong half the follow-up. trial the year, also to and for in to on first the trial next quick of agitation in next have half or of a also also the to fourth of taking narcolepsy I we in Thank quarter? can you're readout data just our pushed Any And completion similar completion data completion, a if trial quarter. Congrats Hi. thanks SYMPHONY And questions. by And particular out got trial referring by

questions. the for Thanks

and update. not complete study is orphan regards quarter. track change the indications on they be. trial of results the around our with could timing report fourth out orphan that the last to this for - and granularity is And to medication And reason an - not a for in we're the this SYMPHONY, the is from AXS-XX the So

So try let as me and get granularity we provide closer.

track And this of is completion think I the to so, completion the we're nuance study. guidance that prior yes, - With there. of the enrollment, regards is it's of the - on

of with first That's it. this is or similarly, check? top line [ph] And to really also helpful. agitation, can half year Got we expect Alzheimer's that just data

- trial completion - disease And - incorporates with of also agitation read the Yes. similarly, the guidance Alzheimer's then data out.

on even strategy with commercial is migraine, And based may you Perfect. also narcolepsy the or road digital-centric or your Alzheimer's? Thank you. experience something Veeva, ADHD this partnership in for with consider that down

behind entire it is, pipeline. our think, leverage together putting rationale The I the for platform could we

So, we're and made a it candidate. for we very really glad leveraging we looking investment, that we're haven't forward to that vast raised - that pipeline product

piece one I commentary Joon just add Yes. of there. can

now both We it across are are so leveraging we products as leveraging. for Sunosi that it is well,

Thank you.

Thank you.

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

line is now live. Your

Thanks my question. guys. taking for morning, Good

to announcement. come sales Just back wanted the to the force

will or physicians of and of breadth So, the covering thought, the providers prescriber, called I that was strategy being - digital maybe that of and that's each a in on to there's on just be not calling provider. were rep get meant I like but also past, productivity these improve to trying guess sense just reps new I'm a think prior? I sort

component the new terms of in kind and reps specifically changed of be the where like So will wondering just adding kind you'll value? how digital of what's leverage

Jason. Thanks, Yes.

So kind reverse. of I'll the answer question that

field at our and/or HCPs omni-channel so as we So our was is maintain with intentionally round DCC was as share voice same part measures sales as as our It structured a platform size well well reps reach face-to-face forces DCC engagement structured. by rate, of the times as how remote and of through that could of our size. platform X

how So we we DCC that's so in - HCP. why the platform instrumental is reach

I XX% they are of cover XX,XXX expansion HCP of reason antidepressant, on that taking were the - important magnitude And we cover prescribers, XX,XXX branded terms XX% therapies. that make XX% want is originally and the not prescribing therapies. branded the of now targets, they XX,XXX But we almost up to of In calling they up about only do prescribers. is of new to so to going cover of

therapies the So, new they are that is put HCPs on a of that writing. are this XX,XXX These the large the - finding are HCPs, the target are the very patients ones and writing expansion are list. to branded

be and will it current going to XX,XXX. up So then targets to addition in

just can ask I If a follow-up.

approach providers, guess, just utilize get those or with of try physicians So just to XX,XXX to means those suite under the not just order, digital would sort those reps caught added you I providers? on have to fewer

were or That's touched or mean through just doesn't being right. It with. non-personal touched or or engaged media been with engaged promotion that They we're digital efforts efforts.

calling to individually them the reps having are we detail product. Now,

you. Got it. Got it. Thank

Thank you.

Amsellem Next is Piper David from question today Sandler. coming from

Your now live. line is

Thanks. Hi.

So just couple. a

of patents know what there. but on guess you the are first, question you I the how I that all have book, of So a think guess, runway filing, But opportunities product? PX so lot for been internally the on you're kind surprise a pursuing, what you exclusivity Sunosi, have the have thinking no molecule. you'll you for runway underlying exclusivity there's in expansion the assuming, label I about is, with here orange

how then going force in the guess you're extent in to and to do And adolescent to you're thinking leveraging you in as Thanks. particular, setting And sales just So which you're headcount have to one. psychiatry ADHD place going ped in respect what's say, further back headcount, think setting? to the is, solriamfetol broader number that's solriamfetol? I the the need the the and question about about pediatrician going with

cover think the in runway, even all to go also then the allowed current we questions recently So which label we have claims, indications. we XXXX. and and those that on - issued - recently new least addition with of have so - running at out a about to XXXX, issue to And patents, December exclusivity exclusivity the lot to out regards of expansion the how With there.

XXXX December be [ph]. That'd

indications. runway, then and December even XXXX, exclusivity of we provide covers that things the to little a that And the one the neuropsychiatry is one like force sales psychiatrist overlap. ADHD do we to primarily bit to of fits it the so our And sales more But is additional to nicely that's operational so additional turn of the with color. over current treated and force. leverage maybe regards longer things force the Lori I'll regards all and so by current that headcount, in with our sorry, very with sales in I'm like, expansion. that

how Yes, perfect, I like add more about into and looks don't we come than thinking other the like talk bit like to about play Auvelity, and can that current what that overlap obviously force when lot know whatnot. if other early factors And size is looks I what efficiency at that with you're a with that much it's time. - sales are what looks of entrenched

the So, We sales it's of we definitely we be from like thought the to effective. a seek standpoint efficient in structure force. terms how always overlap. Obviously, our strategic and very

it a that be consideration to fit sales comes will time it So of when force. size the

Thank you. Okay.

you. Thank

Morgan Your next Vikram question Stanley. from from is today Purohit coming

is live. Your line now

morning. our Thanks Good taking for Hi. questions.

us just on So two for Auvelity.

you evaluate of for. months? partnership your is provide might over have could couple receiving mentioned commercialization? U.S. prior something treatment therapy of the color drug on then the us the could remind And past, a this of ex you I latest you could patients in of been past thinking First, this the and in on terms evolving plans and profile prior additional you secondly, has line how status believe some for

if so, I So, to still how discussions that's wanted your just And current are those if thinking? see going? internal Thanks.

questions. the for Thanks

question second to the then the - question, it the to I'll over profile. patient Lori answer the turn So I'll and answer last on

U.S. So plans. ex

we've the always - look we've always U.S. that to out-license we would So, said ex product

and And has - Lori? not so changed, direction that strategic that those plans

early move have up on of of Yes, with very seeing we mostly -- later-line in But that based patient patient starting gained especially experience market, earlier action. success line. they mechanism getting new the therapy course, into that need days a coming the launch, subscribers to and due were, of use and just novel to with unmet to thanks. population, In the product as are early the

Right XX% that because now, success encouraging is is about warrants feel now means physicians there the always product that profile patients typically that have failed in first seen the therapy, either using that first-line that two XX% XX% really it's But in that to they which we're line. of seeing is is one benefits patients patients getting therapies. roughly right around majority we're have usage prior or

And more experience and As clinicians But be expect we that experience prescribed launch. people algorithm. again, in quarters get with access the clinicians more treatment with we to full only are it two to our into as Auvelity get to Auvelity. [ph], do earlier

Got it. Thank you.

you. Thank

Yatin from from Next is coming question today Partners. Guggenheim Suneja

Your line is now live.

for you thank Herriot, taking my question.

the Like show? just maybe cataplexy showing of what even in? talk Just the With to real in benefit if to the to need just channel do Is net I the would Thanks. the you can let important, the on and then expectation what what And trying you it, gross be. quick endpoint maybe the there? maybe you about is Auvelity? inventory it if hitting missed gross quickly, exact what to you know what net. cognition was said understand ones. for regard to can the us Just narcolepsy, that

Thanks is the With questions. trial. primary endpoint of regards to AXS-XX for the the cataplexy

other endpoints endpoints looking specifically also in that at the study. CONCERT looked Phase we and X at So, the are we

was those of cognition, you as mentioned. One

to do demonstrate we trial. Auvelity reduction concentrate in a that in improvement an or So,

symptoms we're something with some it's experienced obviously, of it difficulty, at. narcolepsy. exploratory, the definitely one Because one or patients that's by that but cognitive is the of that's cognition, So majority looking symptoms that the the of key

Nick. it's Yatin, Hi

the gross had which inventory. of low proportion to improvement question And a the scripts, it to QX, mid-XXs. if to your you the was more upper from related relates of due was refills quarter, mostly to versus I the Auvelity in think it can the scripts. As second net higher high for favorable This in XXs [ph] an for new

inventory the for not clear want that level. the I performance be impacted Auvelity in was changes to by

weeks. stated previously, will and remain we two be As inventory normal around levels

So, no levels. impact inventory to as it relates specifically

Okay.

quick net. sort expect gross have mean do, Thanks. how reimbursement, one I expect understand out? that just one you trying to you I'm full once over to to Just it time. of to curious sort you change Do And it where shake - on should just of

Yatin. you. Thank Thanks,

volatile the the to reimbursement. range for foreseeable and for obviously when GTN in expect future. access comes then the that on We mid-XX% that offsets remain Auvelity co-pay in payer It's depending

GTN. in So expect that for future, we the mid-XX% range for foreseeable

Thanks.

you. Thank

is coming question Goodman Next from Marc Leerink from Partners.

now is line live. Your

Mark. duration on you of launch, [Rudy] And one for the of Thanks. gross early helpful. and more color inventory in on changes line effect also Sunosi I color This stage provide and you're still but any quarter? painful Can Auvelity? know persistency line the be the in is will for for like the

Yes, question, for the second Thanks question. the had the you part repeat we Could problem good. of hearing?

wondering line The Sunosi just inventory changes for quarter? gross I'm the in our the second part,

Thanks. Okay.

the trials And at duration effect CONCERT six as So the Auvelity, with endpoint weeks. was know, of for primary saw our you regards we weeks. clinical trials, six to what were in the

treated large six year. and onset of looked studies. the time action wait We one of including at for So and duration as out at at subsequently every we week, at And one were to then patients showed in weeks. effect, very early at two point follow-on least weeks

use year. And the field seeing - what least or increased the we either now, patients the one maintained out to at what of many have we're as got improvement that what we was we that. actual how product saw And in from on the was

XX,XXX.

to are seeing who've rate we patients It's XX,XXX have treated that experience expected. the therapy on the at but prescription the and been Yes, trying that we're support would the patients early, still with this, being the product.

Yes. inventory the seasonality it And the QX, in stated to typically from Sunosi that for did on inventory, believe for relates I as asked to XXs level previous we the slightly remains GTN, were due improve low in question, around two-week GTN. as Sunosi it you impact QX, And I also on for general.

helpful. Thank Got it. very That's you.

you. Thank

is from TD question Cowen. coming Next from Thome Joseph

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for my the one. Maybe Hi, you there. taking morning. Good questions. Thank first

is essentially And Thank maybe the AM the that Or over are not of written - Maybe lack kind that profile? the for kind you. to there just prescription that new ease getting the target written points? second, where should why were next drug, that do see you the had it I maybe everyone progress, with remaining else think the waiting? something can is XX% a little what of wants emphasize they quarters? the authorizations and prior over maybe touch Is Auvelity. this already couple product drug in-person writers then really of mentioned of say great have force the sales of we

Thanks question. Joseph. for Hi the Yes.

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cards, physicians' we savings samples, support NPA of a terms offices. do that very support robust services the In pages what including for product, patient have program,

So, the patients product want we product. that get feel the who very confident can

X maybe and patients of on you the open-label therapy? seeing response present in then rate patients, focus? did TRD one is the TRD of in prior in line we Phase data patient Obviously, what follow-up. that meet have there are but you. patients? didn't you in terms saw ideal based that Or place I And responsive on population. Thank the quick mark Are you an strong guess, Perfect. responses seeing to TRD

Yes.

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you. Great. Thank

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

is line Your now live.

that just on and give terms binge into Hi. quarter. the you you in eating Good Can detail additional expansion disorder. I feedback the of us bit shiftwork more strong on FDA positive the congrats And guys. a little from morning, wanted received more respect to with to focus indications. solriamfetol Sunosi the some disorder and

file to many complete you how these indications, need NDAs? to Specifically, will studies for

lot a for Thank Matt. questions, the

plan. the feedback So with received, the words, studies FDA on development products to the received entire to get clinical regards our approved. we In other that feedback plan we

binge stays one disorder, we'll only two shiftwork for and need with for So stay.

that be and these give us And of can for you will in detail - more terms endpoints what you on studies,

Yes.

trial started details So we and the design the typically, the trial endpoint the we once on provide the of trial.

so details those So more do some be of launch on tuned we'll we order. and both in intend studies short to because to - very stay intend providing we

continue quarter fourth the order and quarter. the in disorder in So shiftwork first this

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Yes.

rivaling you So it's or a [MDU]. or very maybe population, large to know, patient close even as

have you categories. available, who therapies right are two the fall ADHD. the into patients if And So only just they roughly think about extending that now,

with with scheduling. tolerability You stimulus the which have have had work, then the and very issues sizes, which effect large but

have you the sizes. lower then which nonstimulants have effect And

But approved see be regards solriamfetol. remains seen, currently what trial. see why it to with we from the obviously, to indication. we're with indications That's the we'll conducting what the So

provide is right any in - [indiscernible] still translates not patients. except addressed which So now, the that need fact ADHD, think we'll large a that is size spins does times then to we and that treatments. and to at there's it a very growth And could effect by the current

Herriot. Thanks Thanks.

this time Thank more At you. for we questions. have time two

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

live. now is line Your

Okay. my Thanks the quarter. Congrats for on questions. taking

seen first growth basis. a we've NRx force flattening a on my expansion, on curious, of one sales I was rolling Just four-week the

perhaps expansion, sales if of And force I'm the or is force related somewhat sales does expansion was to that? that down there adds? wondering a - additional just contemplation line So the sales force seeing

laid number And new confidence were time then in just uncertainties delays? or my Or second could updates. current I'm and question, a trigger just your pipeline the lines sense of trying that potential there of in timing, are to the what factors the shifts get exist still a just additional out? were that swing There on that Thanks.

With will So most then Lori value. regards will do that update, is what the the I'll make take second generate the first. trying pipeline and take we're decisions to long-term to question

we're different and late many stage. potential clinical to programs, have So so fortunate are which value are which high

prioritization So trials, a lot occur of has seeing. so we're with this enrolling with do two, that to the one natural what uncertainties that's and

value. execute are, create So we're well resourced to to very right the that's do. we're thing the that very happy expansion. with where and We also what we pipeline think And

kind might be the with that's the grand you there regards to scene that business we BXB? I decision standard involves running expect where So think within Lori? any are. will shift things of And in of that

Graig. Thanks, Yes.

they what that seeing believe the seen weeks of physicians. launches seeing great we'll by the the the to a nothing we're purely What force, basically sales trend with - about So the fact that just that flatness go in do we're terms trend update pretty through we've in no what to we're adoption we're where the then seeing is that's short seeing four sales has we expand is driven very and and is pop. and answer need terms of the force by

bit effect summer feeling go can seasonality effect. QX XX% drop think particularly what in a I they Antidepressants, And little a seasonality as as through much the QX, typically right the in QX. versus is we're now, sometimes

the we're likely But running should And sale to in we're very that in QX. that seeing So and confident be is the add what again, force up now. will force that. right fact sales

Thanks Lori.

Thank you.

today final Blair. from from is question coming Myles Our Minter William

live. line Your now is

to just I'll it keep one. Thanks.

you are covered pre-IND mentioned that I will commercial of meetings added occur commercial second next as one you the Do here, have lives think months. you sight the to what X% or but of ongoing in in quarter channel few covered in are of of be proportion And plans that similar plugs that the represents? in channel that those peers? commercial goal ultimate still your would couple XX% is to meetings that from lives your the

repeat question, part out had little maybe that bit. of you a the you last we - break Myles, could

lives similar just XX% that ? be - to commercial in aim is would was goal still channel It to covered achieve of Yes. your the the to about that

Yes.

chime benefit well that discussions the has standpoint. to a thinking around payers with it make about I'll our clinical some want of to from net ensure are from might market So the color value bring novelness, But we Nick in ability to sure of been our we that and growth as add we're start. the in that capturing as how always the goal to we standpoint, innovation the

want are X typically any with patients prior kind to of There another of X who all those patients. access and a patients we X.X taking also, therapy, see But to weeks sure million to therapy. make that we are fell for ensure path response to

believe remission bring onset we delayed into therapies, So can low and both value rates, of payers the action really profile to patients. current clinical Auvelity's

that careful So we want very Nick, capture you that? anything make to sure value. that to to add want on we're

Yes.

mean and I much truly want abilities value. - I really think pretty secure it, you Lori maintaining said meaningful to we long-term product, a just access differentiated - it's while

said much pretty time. every So you

Yes. and access have, it that we with have The the the coverage favorable. contracted that list is very only we add thing I'll

to very make of and value want product. of value So products, we payers are the cognizant long-term sure being the that of protecting we're seeing the

that it's is to Yes. lives which right covered just the what then reflect can last place we we're great does of also thing - is reporting is, a report And time XX%, the percentage while not lives, covered real ongoing products. But percentage would of a I great that add, be which the now.

tuned. stay So

Thanks.

Thank you.

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

schedule busy joining of update. for out again taking you thank your the us for today's time for Well,

excited industry-leading next new new franchise clinical CNS submissions. a trial to the anticipate half back months building billed few and with our XXXX. potential readouts, initiations We continue of are We trial milestone in

the goal for XXXX. potentially ensuring We of our and achieving way continued by of having fast products Auvelity Sunosi growth launch least for our to five are commercial committed to marketed and our at success on

look We of forward progress our milestones rest to the year. you the throughout updating and on

Have a your great rest day. of

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

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