ALKS - Earnings call 3 2023

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Operator

Greetings, and welcome to the Alkermes Third Quarter 2023 Financial Results Conference Call. My name is Donna, and I will be your operator for today's call. [Operator Instructions] Please note that this conference is being recorded. I'll now turn the call over to Sandy Coombs, Senior Vice President of Investor Relations and Corporate Affairs. Thank you, Sandy.

begin. now may You

Sandra Coombs

Week data to results plc the and week's Officer. XXXX, our initial Richard Craig September Brown, With me Todd Welcome XXXX Hopkinson, discuss and Dr. Nichols, quarter call our XX, clinical as well financial our business as our presented Pops, world to today the CEO; morning. ALKS conference Alkermes to Medical our ended during meeting. this related Officer; Chief Good Ian update CFO; are Chief for Commercial

call, we on today's of will During which be are the our referencing available section slides Investor Events website.

encourage that our our the are Investors press we'll ongoing believe the discuss I to results reconciliations section find financial to the economics related of GAAP to and today. conjunction results tables We alkermes.com Additionally, GAAP go financial with the release, of useful non-GAAP everyone measures of in understanding financial to in business. the the non-GAAP

a on could provided or this that from revise call obligation of no developments. actual in could statements. SEC this forward-looking during of information result differ statements. conference discussions most results the release Slide presentation, see undertake new statements. the risk results quarterly information those or to Our from issued or include implied accompanying accompanying X factors and and filed materially our reports our cause results expressed call forward-looking these We recent the morning important our or Please press or with forward-looking Actual differ for as this presentation will in annual to the materially future the update

our will be or remarks, now for XXXX. Phase we And Ian. open future from indicative today call These to of After include data the will prepared trial patient initial Our call our trial over not Q&A. data ALKS results trials. this turn I for of I'll data clinical may the future clinical prepared from remarks

Iain Brown

results growth profitability. by solid contributions and business. management quarter non-GAAP demonstrate to GAAP commercial hello, highlighted I'm solid proprietary that royalty of and our everyone. Sandy, for you, the streams, year-on-year the financial across pleased strong and manufacturing report and revenue was disciplined expense Thank the quarter from products, strength third The

the gratifying year, settlement With VIVITROL expected come earlier more completion outcome business see coming it weeks, the of litigation taking arbitration the focus. the This in it's the profitability enhanced and Janssen has successful to and to this patent of been oncology the into of the of our the separation potential shape. of the favorable deliver business the clearly has plan

which third grew channel This proprietary consistent Starting of the net growth product to For the the VIVITROL. million, the XX% by generated the $XX.X stable INVEGA we to of revenues portfolio, Net in ranges in alcohol the and the the quarter, total $XXX.X reflecting reflects quarter. X% deductions prior in our performance for solid with and year-over-year, products normal indication. in period Inventory sales year-over-year. dependence growth across within on royalties were were the and year. U.S. was quarter driven sales of compared $XXX.X long-acting and reinstatement million same million

product to ARISTADA Moving the on family.

net net of demand. X% sales by ARISTADA $XX.X sequentially. prescription the million, adjustments driven were increased to quarter therapy XX% growth million, a for and year-over-year basis. month was Inventory to stable primarily X% gross unchanged sales net was up were For quarter, on $XX.X underlying channel LYBALVI the the in Underlying sequentially.

onetime strategy adjustment. space decreased in the inventory approximately favorable to and in commercial of by adjustments Medicaid gross $X.X quarter, million the a net channel continuation and the contracting of reflected During XX.X% our the

same the same million were our we on recorded from revenues $XXX.X and the million manufacturing products million period prior year. in same quarter, this $XX.X compared compared million of third Moving VUMERITY to were $XX.X in reflecting in the year. $XX.X year, period to related royalty period compared products in in Revenues prior INVEGA million $XX.X prior of the to business. In the from these million earlier royalty the year. the to the manufacturing in Revenues to and long-acting favorable arbitration $XX.X the the resolution

by the to launch operating prior year, nonrecurring expense provided business. certain the were $XXX.X are quarter. of decreased the on $XX.X million compared for report the results, top to in and XXXX we the Total increased period year. our the continued program. expenses. in for period reiterating to and to campaign in expenses to separation that our the press in expenses offset X, in in third the programs, net release our combined reflecting $XX.X period XXXX. income same management, of million Today, the non-GAAP for continued $XXX the DTC LYBALVI, Turning compared $XXX.X quarter LYBALVI pleased operating same the $XXX.X ALKS prior financial year. $XXX.X oncology This income our partially net million million GAAP investment million spending the XXXX R&D from to third nemvaleukin $XXX.X of across expenses that million million investment the same we of clinical in on focus delivered for for June the for and clinical expectations prior expenses increased to reflects lower disciplined with million particularly line the quarter I'm SG&A related

and financial reminder, neuroscience our full oncology the a combined year. As business the for reflect expectations

the shares emerge shareholders. as our quarter additional total and We million of pure-play separation, million. and readouts through operations XX $XXX fourth our we'll to position and cash for separation investments with regarding of We're will Alkermes Alkermes In data in enhanced ended balance $XXX of weeks, XX sheet. ARIST neuroscience Mural into provide Turning will believe will to information the XXXX. which mural a Mural its total quarter and ARIST Post and coming outstanding on to approximately separation, and strong in line business Oncology, top third that distribution expect $XXX profitability approximately debt a financial of currently strong million enable fund cash we the provide balance a as to sheet. we with the

Our we of future will with cost the on the our And in call including the priorities the review over those opportunities management XXXX to growth, invest products. I'll drive proprietary program as execution of a structure of we our will launch for disciplined strategic commercial hand remain Todd of development continued and focus that, that LYBALVI. ALKS and the believe

C. Nichols

our of good to third pleased morning, commercial I'm you, that solid XX% we in the proprietary portfolio and across Thank share delivered quarter. everyone. year-over-year Ian, growth

markets. during backdrop quarter commercial of Our the summer strategy the and of continued seasonality performance our execution addiction reflects treatment against psychiatry some the in

accelerate to other growth, grew increased We Net oral XX,XXX expect for which $XX.X and reiterated XXXX Prescriptions X% fourth in branded in our the TRxs today. for growth quarter third was million. our sales expectations proprietary sequentially entrants XX% product to to the with ahead LYBALVI. Starting of the antipsychotic revenues approximately sequential reflecting quarter, market.

into over will we on strong We growth focus expect a are underlying direct-to-consumer head the trends, that and our as prescription encouraged by and fourth quarter, driven trends execution, by the several seasonal campaign past accelerate weeks. we

access to our patient access to and were as prescribing, commercial continued profile market channel, which potential commercial their about patterns.In prescribing for our terms quarter, no outcomes health there key breadth encouraging cited the market quarter, feedback providers we weight for we a to efficacy, increased prescriber for awareness there access unchanged care brand is in of recent remain patients. changes to future as profile LYBALVI's is the research, In remainder expect expand. the and and all profile XXXX. access think Medicare Medicaid, drivers of During and pathway In the the gain during

of volume payers unit. of have best growth the designed commercial discussions our profitability strategy commercial ongoing and brand, access We with and the the growth the support long-term have each to balancing

As our advance with efforts TV trends. drive in is line ongoing awareness, we increased with in fall viewership our direct-to-consumer placement campaign months, the ad to

leading take will of are full the to the time campaign encouraging. it on the While see DTC effectiveness impact, indicators

our impact visits, on and DTC Internet monitoring metrics, the requests. are search awareness we patient Specifically, patient campaign provider levels and of website

opportunity growth. the long-term by for and LYBALVI for laying foundation excited the are We are

grew product Net primarily Turning a demand year-over-year approximately to growth X% by basis. of family. the third to X% driven on million, sales $XX.X quarter the in month ARISTADA of therapy

be ARISTADA data are supported our will We and highlighting will team including to continue proposition, regimen, ALPINE dynamic, study. of from option once to focus and both on expect ARISTADA's every X-month clinical its this which INITIO initiation by market continue differentiated value our dosing the

third of accounted volume. year-over-year approximately VIVITROL. increased dependence million. for VIVITROL's VIVITROL primary to $XX.X quarter sales X/X was Net The in to Turning the alcohol growth driver and the indication approximately X%

driven indication, market, treatment appendance expand Importantly, backdrop VIVITROL new against over the continued that quarters. for alcohol recent of has has patient in to in growth starts breadth the prescriber which

focused that the opportunity illness patient plan of to years. the and drive growth January to customary for to we we unique our and our litigation access commercialization XXXX during agreement, under executing for able paradigms treatment brand, As on to product element complex the continued net several come VIVITROL Teva dynamic brand to conditions a the on XXXX for agreement in will of to X continue require related the we certain or resolve growth. are appropriately often efforts think Serious the were support the our be will Taking market the step about VIVITROL. of portfolio. beginning all quarter, be Teva agreement, across the able for important sales believe products commercial challenging we in version generic well-resourced a were to and our an delivering for and with that a and the earlier patent to mental are and with circumstances. back, expectations settlement addiction terms Under pleased long-term U.S. profitability and strategies this With next

well our emerge to future opportunities. leveraged additional XXXX Craig Our one disease may including asset, that business as pass program. those development development discuss as or call other these to With in opportunities development pipeline commercial our strategic ALKS a in infrastructure that the spaces can categories, from be I'll in therapeutic that, is

Craig Hopkinson

receptor Thank the cataplexy. cataplexy agonist experience treatment be investigational ALKS not the to promoting X this from established People the have will of morning in review shared I and share on clinical wakefulness volunteers this for exhibit were an X, we been or sleep. pathway XXXX, joining presentation safety or can and underlying also the Today, data N-T-X, type the a agonist oral the dosing.The our greater daytime for a also to cataplexy investigation receptor profile, NTX first of at absence initial REM morning focus than greater a narcolepsy. and dynamic ALKS XXXX follows XXXX the potency peptide, data presence is accommodate X in narcolepsy Sleep than orexin once-daily designed encouraging a novel, cycle, was that doses ALKS wakefulness of Todd. different of tolerability closely was meeting is and an receptor. safety World phase X this of you, week, pleased data. in the preclinical who associated has to of clinical therapeutic X healthy presented neuropeptides of bioavailable therapeutic X profile with to XX what findings range type clinical XXXX gratifying sleep/wake selectivity and and I'm you our based efficacy preclinical be cycle be and pathology dose orexin we living and and has A with as potentially experience serve deficiency and to or to to orexin tolerability the XXXX These with important the narcolepsy narcolepsy.The do orexin for that on regulators orexin ALKS our linked narcolepsy safety mirrors would designed an of narcolepsy are needed NTX. X.It that significant wide patients Sleep In molecule is date, where control, an deliver Narcolepsy pathology earlier and low relative orally work. particular, was Orexins acceptable and data sleep/wake have orexin oral expected quality XXXX-fold natural and The durable The extensive with suppressing from the to preclinical behaved in and as of designed natural Type World concentrations times pharmacokinetic N-T-X.ALKS with the meeting. to the called address molecule by that,

dizziness, single nausea The or to are deemed slide were observed dose. for emerging, we the XX doses assess MAD, XX. resolved and study and mild, adverse pharmacokinetic and the safety In disturbances, adverse observed were clinical ALKS in with AEs were tolerability began most profile both evaluations serious as volunteers safety the and well and as well the We XXXX. profile multiple to volunteers. in light or XXXX that From or means as increased SAD, on outlined pleased subjects observed In visual tolerability and no increased profile dizziness, terms and and common observed SAD, double-blind This multiple-ascending and of study occurred pleased drug in tested XXXX of mg.Moving that design is were described related intervention with or vision days phase frequency XXmg and the be transient doses ALKS dose, visual X MAD, most once-daily tolerated AEs and therapeutic the as in early, is blurred perspective, were which dose pollakiuria activity patients.The ascending were at severe disturbances on to and of well dose. all The single-ascending the interruption.In XXXX up or ALKS treatment events. sensitivity. XX. generally pollakiuria, to tested medical common most and -dynamic XX visual urge to placebo-controlled. is up were study The healthy ALKS disturbances, dose, above above with of there as events was received safety the mg. XX tolerability a single the Xmg the urinate, XX I'm to or slide healthy Most across doses insomnia, without were most and at

signals AEs There laboratory dose ECG. were of ALKS ascending continued identified signs, these multiple continued or safety dose transient, mentioned, in XXXX in study, escalation. any parameters at and no I resolved hepatotoxicity observed As were not with dosing vital the signals No dose prevent level. were did

of to and dose dose escalation X with move levels were in profile in data tolerability between over were in not can cross-over a day.The they In the XXXX with dose, of that continue design achieved activity of received slide cycle selected ALKS and supported In these studies. a were also nor a existing once-daily mimics natural accumulate in consistent randomized dose intentions. systemic panel the SAD pharmacologic evaluations study, on and has XX and with top sleep/wake narcolepsy Both see a This were with features slide depicted narcolepsy primary X, tolerated specified program. from to design each design ALKS was pharmacokinetic to X, phase the dosing design the Earlier study interim dosing endpoints Xb patients we increased the of analysis.Starting graph. lower to study per safety metabolites to X, up shared metabolic X as We identified.In on XX, safety evaluations characterize will the or observed with development first detect patients These to of and that any hours. contributed yet narcolepsy is effects The observed. X-day in the course cohort safety with data patients. with profile the group. with each the reactive.Collectively, exposures X part profile medications, a the MAD half-life idiopathic period in the a MAD which patients of metabolites X X order fully cmax XXXX washout this to into tolerability. include continuing type and a explicit period ALKS XXXX, to will forward of X-week responsesat This profile proportionately placebo, profile consistent significant enrolling SAD type of the where as was hypersomnia, from dose you X preclinical week, Neither this blunted with patients data our the and been key maximum mg washout the type XX a were those powered we and objective of the of objectives. supporting were design terms two XX, the however following

However, the efficacy ALKS of of first Maintenance test. offers of also phase and doses via assess baseline, to opportunity placebo the to Xb of single concept the same within Wakefulness the compared proof subjects, XXXX,

activity NTX and wakefulness of we therapeutic mg to X XXXX NTX, patients X ALKS Based maximum ALKS benefit with expect as to our hours, flexibility phase and objectives and pathology in informs dose dosing and at around hours this key therapeutic With and these first for some in severenarcolepsy investors the NTX. were expectations of have related efficacy AEs questions mean discontinuation.Additionally, approach healthy averaging to of within patients with each shows reached and we useful tolerability dose were effect, significant, at dosing our NTX. volunteers, outlined a conducted course. subjects. molecule. administration drugâ€™s and the The the wakefulness dose profile mean our engagement tolerability X clinical not compared from baseline dosing, to consistency In test, were and on X, observing MWT occurrence doses at was of improvements minutes to been X laboratory on evaluations,establish ECG.Turning X and on changes dose were is the three and in all response Weâ€™ve was was on requiring compared tolerated mean score target. enrolling looking clinical or in XX showed across expected dose. NTX at limiting baseline to activity. the the demonstrated X awake, the Prior and ALKS slide regarding occurred on These MWT higher no potential range we mg that a and are in assessments efficacy a tested to which target XX to X, to the in to development establish demonstrated for XXXX, narrow were latency, the clear slide is to At in all may duration At XXXX that all slide toleratinghigher and small and maintenance a in events, to All NTX. post-dose. or terms The patients, scores Phase tests is for dose, meaningful encouraging we leading were doses the in nor significantly patients.Slide to mg was to fold and in XX-minute patients. PK of doses sleep parameters pleased of at that these in data, of both study, Note by orexin selection, two IH characteristics XX, observed below symptoms.Next AE require time X a directly XXXX score the This previous there meaningful, adverse NTX X remain us mean having AEs or dose on-target ALKS post-dose. treatment-emergent hours forward was studied indication orexin, hours and salivary demonstrate was planned preliminary is effects. compared supports patients dose serious in NTX demonstrate compared be X NTX the doses to ALKS up clinically in There level X X, and post-dosing. in they the X Iâ€™m believe maintained wakefulness MWT well XXXX a our administered no currently and day.We and profile were mild, XX, design significant XX, are XXXX wakefulness patients, X any Pollakiuria tolerability date XXXX XX the the and from now of In XXXX shown less doses one-minute and min in the the a efficacy innovative the pathway. tested ALKS of confident narcolepsy of of index in study.Concluding well of clear the There for. associated tolerated calculated the baseline MWT, for initial generally sensitive every of on hours XX, those able ALKS through X for designed date baseline. generated to with meaning patients to the slide two support showed baseline continue improved mg the which mg magnitude X is tested, dose patients post-dose.The and for to insomnia, most or than minutes, data the helping to before only look largely from first patients. test. effects NTX X a efficiently X relatively enroll a to our the received throughout XX X that occurred and will of minutes. future patients the X we comparable insomnia maintenance The EEG dose highly what side to three mg common hypersecretion AEs are ALKS of with study in all modeling, in XXXX patients and fell Based MWT target asleep baseline. to at in XX mean at and clinically healthy safety patients of less placebo sharing profile doses a mg volunteers, in MWT to respectively.Treatment response, patients NTX mg, up placebo with Xb from time statistically year, and of XX in NTX wakefulness XX, dose full the improved the improvement scores and Due the the data. all at number ALKS mg improvements MWT once-daily despite reduction able mg to only in results

of study XXXX.Now to first call the the process We are the Rich. the isplanned in also turn in design of a phase will to which begin I finalizing X over half of

Richard F. Pops

Tha's thank Craig. great, you

Craig pharmacology program his is advance at modeling, week to the and for to it neuroscience drug to the And and beyond It efficiently validated year new ALKS pharmacokinetic ALKS expand great narcolepsy. it be product is XXXX of opportunity deal continues generate believe areas. in medicinal foundation molecular Sleep. expertise have with World additional mechanism Alkermes accomplished agonism development.If in paradigm the that teams of data XXXX in the the the potential designed an an has disease and the ALKS orexin this biology and of developed So clinic, be accumulated Alkermes a the last XXXX presented may important molecule. chemistry, the has patients we in that, design, to into the provide treatment

and, that supports potency, expressed using profile proof-of-concept establishment past the the first, by furtherclinical well initial an development XXXX validated demonstration of development, important efficacy program Craig form others.The and is characterized advance expected excessive tolerability Some measures.An points daytime evaluations characteristic data to summarized important of stage-gates: as in ALKS of second, two sleepiness, both of relating dose. through safety as initial

we that Our a dose mg. data levels together for events adverse and range potential the modeling a design X suggested, initial at program. with believe therapeutic accommodate adequate dose data phase X to we patients in have believe this We provides date our of the for information wide and, initial NTX.With in to and these X human between to and observed supported, set, index reduces profile complete potency NTX potential the NTX tolerability the dosing off-target

established will profile into our to the patient-reported orexin independent, Shifting we of move coming XXXX system.So further another we company weeks the expect and endpoints ALKS program. safety, the the that event gears, oncology business the transformational efficacy with Oncology. publicly-traded occur an as well planned Mural as as effects in explore of is modulating XXXX called into the outcomes, we through tolerability development, we further establish later-stage As regulatory of ALKS separation

from logistical, We of implementing legal significant accounting are now separation, in the stages has been operational, undertaking perspective. which the a and final an

of to Mural, of opportunities strong of back, strategy value-creation.Taking that strategic of Caroline company initiation many the separation for and business, ongoing enrollment studies we will successful clear As including clinical of to to Board been highlighted terms campaign, year neuroscience, asset. oncology support in designate studies our launch paramount a Loew, the and a execution itsjourney in it management and of Janssen a is and the I their completion and outcomes the in Thepotential XXXX of registration-enabling leadership melanoma the clinical an ovarian prepare underway for by have we nemvaleukin financial studies a a and the look LYBALVI, confident has with the the ongoing focus has believe value neuroscience productive manage launch the strength optionality a and create of VIVITROL shareholders, as a transform of the unlock company.We the for of separation. as workstreams a very independent the in collectively are in settlement. Directors, believe of Q&A. the emerge both value oncology call for Alkermes you. companies, ongoing we well-defined With of opportunity and to an for that for us Each provides CEO prepare platinum-resistant important to DTC represents more Sandy right, the of that turn sharing success.Post-separation, begins with but more mucosal team cancer recruited its the will these own for profile significant are look progress to enrollment Mural, We continued pure-play as Mural separation we resources.Dr. am shareholders and study forward leadership, be and position I both will the for and to growth position company position back drive accomplishment our and on financial an to and and execution they in companies well profitable, arbitration talented

Operator

[operator Instructions] coming Tewari Jefferies. is from Today's of question first Akash

Akash Tewari

on This Kash. is for Amy

maxed XX also in that couple We've but day the program. MWT Orexin from the on dose dropped from that a on out with So on to XXs seen NTX milligram X. plus MWT initially, TAK-XXX us XX

of pretty other when NTX durable at expect And hand, to be it milligram do And dose patient? durability dose on-target could seeing the finally, in then than dose rather more Is to going aspect some On range XX long-term Xx these expect you effects NTX? How over the say plan do the you to XX-milligram time. range in this the on then of dose X milligrams to do fair factor your you that in to X. selecting attenuate in we're forward? day what the X dose from AEs XX X to go-forward

C. Nichols

Good.

component Let on Each me address own. its that.

So of our NTX what range II us this model we appropriate population, in for I position to think dose have clear our exactly to study. a be obviously, And we to very puts in see. terms able expected doses response the Phase out dose for

And also X We our this technical the for as was we the obviously, at doses are into access observed is well. Phase modeling that be program. looking TAC going with to that something are

safety profile days is at the with lower largely seeing effects. are doses. asked. time I obviously, -- These the that discontinuations. that haven't for belief potential importantly, effects meeting a almost investigators the are of probably the think couple X-milligram the no is and serious the terms effects investigators the events be our will by And at dose on spontaneously. They where shown In no side there due Discussions they biomarker response over let adverse directives normalize. Phase really side are we're the target saw mild. safety We this And attenuate take question me Their as first will side mechanism severe of [indiscernible]. that impressed we with this insomnia And the with you've to week or at resolved X. it over is essentially,

So up we're the the that, doses appropriate impressed for to sets believe date correspond with again factor really and that to -- II. the Phase once choose safety profile us

for seen will sets response seen the range question, our range. NTX at we XX of is data to to Phase sort we've for will need may the to obviously at needed. indicating patients different to cohort below that think higher population previously where data point this the we incredibly be And up range where We're the II. doses we've given dose terms important that dose. collecting X Aragon In also of sensitive program dose those us for about in a NTX obviously time, the a of milligrams from the threefold that less be At to narrow inform up this dose NTX that NTX NTX X for we NTX, thought for separate TAP to dose

Operator

David Ansel from next is Piper Sandler. The of coming question

Unknown Analyst

Just a couple.

us makes organization different addition being that prioritizing about portfolio? secondly, talked the commercial to plan on that first molecule on mean to a of the you through you're stage you sense. topic, or leverageable a regarding so dosing talk for help be what is And So hypersomnia. to IH your there? And does market-ready development? commercial to asset, that backup IH talk But a idiopathic your Can Is going then further the or open thinking? assets

Sandra Coombs

then to to take one want second take and the you question? the Do first Richard

C. Nichols

Yes.

we So Phase appropriate program. in data, on will That We've collecting a patients separate cohort Ib Phase our those patients. II doses based data IH again And inform enrolling. that our in cohort of program. once got is then for are IH currently on

and the we we in in current We range have disclosed for for haven't this dose at NTX are that dose the disclosed nor IH time. dose point exploring range the our Xb study

Richard F. Pops

we've building force. question requires is products the field and being sell with presence yes, about in and like of VIVITROL to be I And commercial to ARISTADA point than just lived all order a think made the respect the to far more that has commercial, through Todd the

built infrastructure. demonstrated for and a think we've do the through the requires that we now additional efficacy larger evolve, that of lot we that it asset with its can And leverage products an outside. So that's that

Sandra Coombs

David. All right. Thanks

Operator

The coming Raffat Umer Evercore next question of from is ISI.

Umer Raffat

full dose showing table not and Gap] safety conference. the for the multi-ascending [Audio at

dose between especially that's single being Or that So confident based there's make the milligrams, can fully X dose somewhere X and and on thinking how think estimates just finally, it if you're beyond declaration determination we of that. narcolepsy versus been relates also, And other year, that as elaborate suggesting think Type from the then curious one. because where you data? about stand the consensus I'd LitaTC. recon as about we it data are some the we X a next trends you be efficacy first about effect. into And [indiscernible] fading to how in could in on of dose

Sandra Coombs

We missed your of question the first beginning part on pad the table.

Umer Raffat

and for multi-ascending patients, I dose, single X was process you type but table the for not how the dose. thought asking safety not have just

C. Nichols

Yes.

the pack really trying for presentation a economy an our to into designing were lot Sleep it we of World was presentation. as short just of information Conference, a So

single explored doses and terms the X table, math. separate the of ascending dose terms doses there X separate obviously, In we of in

just sort And to on so greater adverse compress that make into most try events presentation, it than X%. really rather the and focus common didn't the sense but of just

self-resolving of only As one were they all to you sort saw, were mild these discontinuation. They and largely were adverse the sort events. largely we had moderate of -- treatment

experience really the is our So the reflective across summary of sad.

Sandra Coombs

enclosures. the The single of the Phase based confidence single trainer II around on

C. Nichols

Yes.

where So one this those indications extremely of translatability is is high.

One where the the is of than compound confidence tenfold sort Orexin of is in potency have of greater this aspect we A. potency to around

also cognizant has the are as seen. that said previously, Takeda I and of We tachyphylaxis

in obviously well clear This II each as As indications. a doses really that response up believe, we've Phase these response the durability us to Phase Ib in our dosing program, II the of such, upon dose study. sets well with given as will explore for embark we single which seen of

Sandra Coombs

next want you expection that? And on for comment did trends then, and year the Todd, to LYBALVI around

Richard F. Pops

I'll Absolutely. take one. that

prescriptions to seasonality. We I that. is category going So saw in some did in branded as believe category, that. We uptick started QX. that's And said at experience oral seeing this already QX, earlier, broader and rebound antipsychotic the the We of actually NBRx seeing the are QX, patient encouraging. in and QX, an we starts end is new TRx continuing which into

for year, continues confident to extremely growth LYBALVI next and prospects prescribing several the we of into about for are expand. reasons. Breadth outlook Going

they to when to us intent we talk tell research, HCPs, their market Our prescribe continues expand. to

as in of the has the but we LYBALVI considered a It's and know, We you And label trends broad differentiated come metrics are the still broad category. most direct-to-consumer very also, a encouraging one effective back to very always is early, are agents there. campaign. in investing, and the

going have into see to we So year. into QX next lot and a that growth of we're confidence

Operator

is question Matteis coming Next of from Stifel. Paul

Paul Matteis

what's then in. second, BD? a but I comfortable and probably it about development, hear on I talk was just you before, said current something get time, interesting one it's get? you had look On appreciate of what's know slipped levels comment pharmacokinetic kind are I to And you've thinking in your Orexin, about drug And they And guess, that at there then orexin sleep if or for data deal can low multi-dose the generated? on it. dilutive? do exposure evening, enough business you just deal, scope or you're one how going latency you you And low to And over wouldn't size? an a a whether right also be when it where the on I the deal that think business would your avoid levels be to important question. or insomnia now signal? accretive

C. Nichols

It's important dose. the at really been importantly, But I too mimics cycle. focused Phase and a that as much X-milligram think our X- in well were our our is set question achieved doses. achieve one natural that which And daily can a achieved of disclosed aspects take the natural we that. has the the see for I'll profile as dose one you of that most was of to a then as to XX Phase that went We seen the half-life competitive once and durability obviously our We've reasons, Obviously, study. ideal first. probe terms in profile out this that the profile. of essentially, was in sleep/wake So Ib, dosing supports on sort we haven't step we hours, response I for out to X And borne with as cycle. got achieve you've PK

Richard F. Pops

stage forecast Paul, think accommodate I the And Rich, side, terms the pure development pipeline our pick spend profitability profitability to with it on if expansion long-range could into some in on our are R&D you activities deal up us. side, expanders for deals something target of heroically, R&D feather targets, of existing in R&D but to and extent our of it's critical that still think and hit our we which

acquire extent want quickly we commercial a side, to the that the on On would that something and leverage expect the transaction. we side, commercial in very and pre

Operator

coming Sachs. Shibutani is Goldman of from question Chris The next

Chris Shibutani

manifest sensitivity doses patients between X lesser terms likelihood exposed the side safety as Two that's Type also orexin NT the higher difference that thinking questions that we're being some the Would on lesser NT just perhaps expect Type-X. requiring you AE of in the aspects on to and of to would And thinking the about well of profile what the seeing? thus treatment NT potential Are we can your going be you've differentiating you in that different the influence learnings with think do in then Cataplexy, forward? had correlated words? type-X, far as comment they secondly, other you Any options about about helpful. particular, about there to as perceive

Richard F. Pops

Chris. Thanks,

patients with on far to the less doses of read-through sensitive terms obviously NTX. Orexin in NTX, for So are

some data think of scale that's of the already I based published. off

that population. X fivefold that was they to increase needed in to those may originally to expectation cover Our up be

have increase to with clear think now established see required that are I we dose in potency in we compound can very we threefold dose efficacy. given population that response, believe that that down X the the narrow a to to

basically the side population. as that see higher exposures safety exactly effects on dose-limiting the of sensitivity, and sort read-through of stated, much well as in Our is will is side probably that that decreased at because you you only

dose. will there through they as well of be think in pulled terms I the So

a able event. seeing without anecdotally, anecdotal sort there on movie collect diaries. that single collect patients Phase tell inform our an X-hour as Ib, eventually we patients from watch trend to cataplexy, powering a the you towards for data that dosing, your comedy The help a to what some is while cataplexy can didn't cataplexy data intended in diares well of really Phase in our of on for that decrease terms see question in as in And terms of or some us was information we III. did sleep II our In of investigators that I were X were Phase essentially, analyze

believe analyzed of It's not in the this an with II Phase our evaluating design fully as like encouraging. be And cataplexy we just again, it's So sort will purposes endpoint. we for was once planning the for Xb. study, just but more of

Operator

The coming is America. of of Bank Gerberry Jason next question from

Jason Gerberry

follow to wanted Just up question. on Umer's

ROX the you So XX% And a NTX, can like an especially these of X I that, on issue profile this in observation alerting an orexin in XR. this important about settings is you lastly, I Is now. deficiency is guess in potentially with that wonder, disease think shared then consolidation healthy-volunteer Wakix what's for not Wakix rate agent, is the IH with that insomnia, MAD, patients consistent milligram competitor with you of Xywav. if I more think us of given more with seems this share have is I druggable relevant AE of like you an study just helps and is interest. IH. visual that share something the dose think it And X disturbance so data in-house, all how any far. disturbance and imagine missed a NTX visual I you AE all can't is a IH, would end insomnirate been an small wondering

about thinking the you're in Wakix update. how IH wondering of just So mechanistically lieu

Richard F. Pops

Yes.

In X we events that were disturbances, the X MAD, These experience sort the self-resolving in only in transient, of X in visual sort volunteers had our normal the healthy SAD patients largely SAD and were mild exams. terms MAD. the urologic of sold welll all of

been through mind deprived in that we're safety MAD these moving the exposures acceptable much the dose why Med. doses got both Maximo program. has We've sleep I too to into recs even and an Bear so volunteers. higher wouldn't And and actual not healthy the SAD in not read profile the are of

to Oraxol. not sensitive are So they

to seen patient in cohort haven't experience we In our date, actual today. virtual of disturbances our NTX any terms

your question in indication. data in very emerges Wakix XXXX where as falls inform of the profile the collecting of In will and hapasomnia. early think from RIB terms And in stages particular idiopathic we're us of terms I around IH, that obviously, that to addressing

but need it be pretty I data think excited the in. Orexiagonist those about again, come as mechanistically, by the will potential we're once to in for data informed IH,

Operator

question next Leerink SVB. is from of Goodman coming Marc The

Marc Goodman

Can is blood blood the that patient? pressure forward this on you monitoring orexin last study? gross nets the are just thought And much increase on How saw do and whether quarter? you And to secondly, be we this going you we something to a in that in we then pressure comment see? is watching that increase blood pressure did should you And planning the LYBALVI, on comment can process had just for? that

Richard F. Pops

that to it's think be pressure NTX and I our supposed we important to hourly throughout note measurements did So patient SAD, blood MAD experience.

So in and hours blood measuring XX within we to the of was the NTX This increasing. frequently. increase were in pressure cohort. pressure blood X blood increase diastolic an pressure diastolic normalized read one only saw We

X So once pressure to single was a again, again, reads. the within ascending increase measurements Similarly, that well. in back in have or saw once increase blood single couple it X returned we baseline dose. And as transient a very a of

to are So at were any that individual X X just individuals signals in this seeing elevated time. These really point with or readings there in not the range.

Iain Brown

And net at crack then let to me take the a question. gross

a by adjustment I gross QX, said onetime as So the about in remarks, I XX.X%, Medicaid net, in think LYBALVI driven $XXX,XXX. lower prepared to for slightly of really favorable

over few I really think net gross consistent has quarters. the been last to

we change pretty we've the I remainder the of to contracting now, around on gross nets XX%, of today. thing the I contracting side providing the specifically one potentially to that to very XXXX much the the not up for disciplined focused expectation year. a the And of would commercial XX%, of LYBALVI been through and guidance be second on this, would XXXX, 'XX, think think half We're But that's strategy. first were profitability we've units. to half approach more had

consistent XX% So eat relatively that's in maintained level. growth

It's trend question all to that I and think nets XX% a of ultimately, towards timing. gross just XX%.

on the level. then would And more year, we in information to remainder earnings expect for So our of February. the provide the to XXXX call we'll continue specifically XX% around year-end

Operator

coming is of Ear question next Uy The Mizuho. from

Uy Ear

share insomnia. you why where question the part is study wondering And study. question slide's question. you in for listed. SAT I not as so we saw I'm over could the over. is and what the So Insomnia was guess the of first That's that often MAD And not this dose get like second just is, case? my listed -- my

what liability for XXXX With current and allow profitability like you guidance? the essentially avenues script would to your other hit trends

C. Nichols

saw MAD experience, hypervigilance the placebo across distributed common in So we adverse and that was event most active. our SAT as more essentially, terms equally and of

seen was And increased piece patients. in XX again, as a think that grams case denoted the I active million was of the insomnia single to of one once discontinuation more versus dose. So matched equally placebo. alertness patient these But there in the

Richard F. Pops

QX let Yes, through the by XX% seasonal trends in the XX%. LYBALVI, by over coming dip. me relative year-over-year TRxs with general just or to are start with quarter-over-quarter solid which the seasonal Again, grew

that's all really by is which parts encouraged that. our mix, we're X prescribe So which of marketing increases. force is by sales And being driven promotion, to really intent driving our

metrics we're the access mentioned And the at as we're heading all Secondly, within right again, seeing across campaign access. are and channels in strategy, direction. of Ian our earlier, utilization our the of market market beginning and DTC all X very disciplined

utilization quarter-over-quarter is and quarter-over-quarter. in perception we brand is and have confidence our of the So lot the improving improving strategy. Execution of a

for what So of we confidence have long-term like a LYBALVI. the outlook lot in looks

C. Nichols

to LYBALVI us. just as continue business, VUMERITY in anticipate continued for then growth other of We driver add to to a grow should aspects of growth ARISTADA, is And key the that, VIVITROL, well.

that's of the out spend the oncology a amount think significant take of I of with business, spin-off line. the R&D to going

Our we our and And products GAAP saw, gross delivered margin improve as volumes profitability this of proprietary to continue should grow. all non-GAAP the as you quarter.

So gives profitability able targets year. a you to to path us achieve next hopefully, the being that

Operator

H.C. question The is coming from next Douglas Wainright. of Tsao

Douglas Tsao

sort were area. of any any other saw you consolidation? impact you on on I of was on were quickly insomnia. some Just quality. seeing just But really the Obviously, curious other if impact there evidence sleep

C. Nichols

is experience be our of important quality Phase polysomography into in a for positive. nature of specifically measured we single the forward. will anecdotally, us But assessments And forward. move obviously, really given This to for wasn't patients sleep a dose crosssolver going as built program II the endpoint the was moving Essentially our our this Yes. study. be design

Douglas Tsao

tolerability You of the you in conjunction the promoting a get would X with from standpoint, And in one being agencies. with used conjunction this agents? anticipate promoting

C. Nichols

and we're as Yes. time, such. XXX At in studying monotherapy our entire a is this the point program as sides

get what polysomography those So really that of better quality assessments a as of We're as I a and think building handle get assess will number be the that also well. into PROs XXX II program, our Phase Phase is in really sleep II. important to we'll done we on

Douglas Tsao

Congrats on data. the

Operator

Ash is question UBS. next The Verma from coming of

Ashwani Verma

willing activity much wanted on some just for but on they crowded volume contestants. category, Granted net? broadly And wider saw aggressive significant general, the by discussions preclinical your at the changed then commercial Latuda this just on a So or on showing for how LYBALVI they're to get give the initial is competitor the up data I years so just orexin, second, to be XXXX reaction in our to doses. expectations preclinical, for getting payers lower inching seems on are contracting or gross orexin. We in this return to net gross over to for

helpful. any thoughts would there be So

Richard F. Pops

Yes, I'll start with I'll the start es, the access question. with -- market

in the an across channels: for is X Medicare key upon here are keep think to the and Commercial. equal mind elements brands. what split relatively I So Medicaid, indications there's the depending There's category, these

utilization. Medicare, pathway and a see really of line we across and clear good sight access Medicaid and have We of

history, Within years But payers discussions. where are place know we or the with pull ongoing large from several back. launched rebates do we commercial going difficult very start once constantly in in agreements with commercial virtually with ago rebates, we impossible our into that contracts to those space, it's we that specifically have you ARISTADA

which now we're is of levels continue activation and our drive good patient And right over is with again, to seeing that each we're belief expand very in consumer which to within our to campaign. unit. of activation, prescribing, increasing we're volume doing then space. time, access approach through plan plan to intent But our through maximizing the So commercial our that the measured a profitability sure make is

C. Nichols

on the parallel those I to think regard presented with this then question data were meeting. the with [indiscernible] in And being data,

seen yet actually comment those I haven't the we point on data and time in can't for time So at really margins. this

Operator

coming for The of Charles last question is Cantor Duncan today Fitzgerald. from

Charles Duncan

just a couple have So of I ones. quick

for XXXX rating for another of or future class, durable and activity what and -- a purposes and are in be given expecting out some minimum? to agent NDA-enabling efficacy. you exposure and X, or the XX For the rule is the of about safety safety the if Is think months other that to potential rule it period length X you

C. Nichols

we'll move I well our Yes. Phase those with our Phase the as both II plan program forward that Obviously, discuss plans. our our me. agency length discussions belief as is and as meeting will of to we program, II those inform as And Phase the be

Charles Duncan

makes That question. sense. Last

pharmacological I volunteers, I'm some a and target a or the normal how But there is wonder disturbances very and wondering you if there really that being human be speculate small on observation a that. than visual just target? I patients in could to different about NTX it's Regarding if Or humans reason know guess is a would sample. sporadic

C. Nichols

healthy volunteers. out disturbances the seen increased sort healthy life events of only visual of only again, XX in we've we've a were sensitivity. before transient, of third just Interesting, seen These adverse of volunteers. Yes. vision mild and Once largely denominator

haven't it's terms this date. for to in disturbances we time, patients and visual monitoring at seen any think point obviously mechanism, that and in something In I evaluating of we're

Operator

this At over Ms. turn like Coombs closing to I'd time, comments. for to back floor the

Sandra Coombs

call if A that it's were the Thanks, you'd the website in is posted don't us reach And prepared any on Thanks, much. copy on put company for and us the our the you please joining today. could Events website. to inaudible on Thank case helpful. Donna. to of like to we of everyone, very reference the portions now section hesitate remarks be

Operator

This Ladies thank participation. and your gentlemen, concludes you today's for event.

log lines of or and webcast You rest your the the may your off enjoy day. disconnect

Alkermes (ALKS) 25 Oct 232023 Q3 Earnings call transcript