ALKS - Earnings call transcript Q1 2024

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Operator

Greetings, and welcome to the Alkermes First Quarter 2024 Financial Results Conference Call. My name is Maria, and I'll be the operator for today's call. [Operator Instructions] Please note that this conference is being recorded. I'll now turn the call over to Sandra Coombs, Senior Vice President of Investor Relations and Corporate Affairs. Sandy, you may begin.

Sandra Coombs

Good morning. plc update to March for Alkermes results our XX, the business and the to conference discuss call financial XXXX. Welcome quarter ended Jackson, and today Chief Commercial me are Pops, CEO; With Richard Officer. Operating Nichols, Todd Blair Officer; our Chief our our

call, to slides. slides, We During are that discuss non-GAAP our financial we in along reconciliations and available be business. our financial financial results, the with understanding are of non-GAAP Investors the today alkermes.com. related the measures believe release, tables will section on of with ongoing economics referencing today's conjunction These press the of results, the GAAP we'll in GAAP useful

financial to in obligation We Blair results call a a in Please our most recent include this could Our prepared we'll statements. those with of cause accompanying as to for from our could forward-looking our or Actual revise see materially discussions press morning on expressed results Q&A. statements. results. call for of and quarterly quarterly for differ results that undertake and statements. now the materially risk Slide accompanying review from open the the release presentation no information SEC or or this the during important to or X And call issued or presentation, over information call developments. After the will future filed new result this of reports forward-looking turn the our implied differ the annual provided remarks, update our forward-looking conference actual these factors I'll

Blair Jackson

you, Thank Sandy.

driven growth and our business VIVITROL, a We ARISTADA LYBALVI. pure-play executing XXXX our and as company top proprietary we've and products, Over drive the X years, pipeline line plan a to with past streamline neuroscience a by entered profitability. our our of the been

we are assumed our Our beyond. reiterating and growth today, followed guidance. financial to expectation. This the be continues XXXX XXXX in expectations by seasonality, provided second And financial QX February in quarter our

investment Our We're and on our year-over-year of as financial to ALKS reflects a sales, the our efficient growth LYBALVI in in and focus first in net our position the program, of confident portfolio profitability. opportunities growth management performance advancement structure of cost ongoing as development of drive quarter strong continued well us. proprietary ahead product XXXX

For driven the first the which revenues alcohol compared same channel $XXX.X portfolio, million three products. Starting of $XX.X were This our product grew inventory combined top million million, by for drawdown quarter quarter, sales of line in X% our a we primarily year-over-year. driven reflected also generated dependence proprietary the last million, year. in in the total VIVITROL. result indication, impact proprietary period of $XX.X the the with Net $XX.X to by

$XX.X period quarter to For family, the were $XX.X million net the last ARISTADA product first million for compared the year. same for sales

For with to which expectations fairly were outlined flat February, Gross LYBALVI, adjustments sequentially. sequentially million, growth. the during in quarter $XX XX% consistent year-over-year we represented stable the net were at net sales

of last million for million related million $XX.X in first compared last In to our the INVEGA the $XX.X VUMERITY $XX.X royalties for to reflecting Revenues compared from for XXXX. Revenues compared million these second manufacturing of year, $XX.X $XX.X revenues $XXX.X million reinstatement the to to we recorded products were quarter QX royalty QX year. from and to on Moving and year. business. the were million of last manufacturing QX royalty products quarter, long-acting

to expenses. Turning

going on of Today, I'll the year, Following considered focus discontinued oncology the results last business results separation with operations, financial business of associated as oncology those forward. the continuing from relevant profile operations. the company to are our are more expenses

recognition driven slightly investments support in compensation labor-related certain clinical development, costs reflect Our elevated and expenses. quarter operating activities, the commercial certain of results by expenses, first phasing share-based of

$XX.X decrease will million remaining R&D year. Cost expenses operating flat QX were quarters for goods neuroscience of $XX.X XXXX million commercial program for expenses were of last million year. programs, compared $XX.X total to to sequentially the our compared development of products. $XX.X to investments for activities expect ALKS clinical the the throughout million related and primarily support year. sold focused the QX our This last reflects proprietary We in

for We were expect steady year, level year. SG&A QX and in by the reflecting $XXX.X continued investment primarily to $XXX.X R&D remain in decrease million, the launch million the of expense approximately compared relatively of . expenses then through that QX, end to $XX at million LYBALVI last

we noncash the million, promotional and SG&A, Looking decreases $X.X certain ahead, the during year, followed in and to the fairly nonrecurring the our initiatives we expect reflecting the million half remain consistent quarter of investments marketing second respectively, timing the by recorded mix and related criteria. in share-based performance quarter, selling second expenses of in across phased compensation to and R&D first $X.X award achievement expenses of activities. Within of

of significantly on portfolio, quarter disciplined separation product XXXX continued from our during the year-over-year, income the of net expense the efficiencies operations proprietary $XX.X the $XX.X we net quarter, of driven and EBITDA enhanced operations and from and profitability, management. primarily operations driving of profitability oncology operational continuing of delivered on business from during million, reflecting focus million. Non-GAAP to first focus fourth continue by our the continuing growth continuing completed income million commercial and $XX.X of We GAAP

total We with ended our total debt $XXX.X position sheet. of million the million. and cash to outstanding $XXX.X first Turning quarter in a investments financial and in balance strong

our year. infrastructure the we for cost operational receive with a our our back, our closing, were the multiyear of and expectations, of payment significant results program represents efficiency largely with to the with a further provide facility of element Athlone, Alkermes we growth quarter X. In million. sale and rest align drive a to manufacturing needs first and our to anticipated solid will Additionally, framework of Novo the believe step Ireland business. Taking consistent through $XX of foundation This next cash transaction the approximately close Nordisk onetime within connection our or a expect the day

line management and expenses quarter top our the into the the focused expect thus the quarters as second enhanced now pleased with that, profitability to trajectory through our growth on expect hand far. to call of remaining are accelerate we of year. With Todd. remain move We and We I'll disciplined

C. Nichols

everyone. Great, Good and morning, thank you, Blair.

first sales proprietary In for channel grew in product year-over-year, from in the our quarter, X% three portfolio meaningful net products. the with even inventory reductions all

and the our LYBALVI. second we of are financial enter with LYBALVI, XXXX VIVITROL. Starting expectations each As quarter, proprietary reiterating our we three ARISTADA products, for

and the we quarter reflect During prescriptions Total prescription with $XX during net million, of flat the our quarter, approximately channel continued XX,XXX was underlying as the demand prescriber in fourth of This expectations. to sequentially $X.X X% million. XX% relatively year-over-year by in of the sales was breadth. offset consistent well as decrease quarter, approximately which inventory equal to growth partially sequentially compared a generated first expansion in growth of

market quarter, to brand. basis. is in oil strategy fastest-growing Medicaid our for long-term Medicare a element the on LYBALVI continued most LYBALVI's first the Optimizing with Payer is access coverage profile across access. the a pathway growth brand to having and be the During prescription an important of patients established,

for expected selective to strategy formulary to is gross access. a to access anticipated through net as sales expanding channel, payer positioning. year. This For impact the we We disciplined LYBALVI patient commercial contracting contracting profile seek of pharmacy improve while with not large significantly LYBALVI maximize is contracting adjustments out net enhanced benefit to our playing recently our this the manager

opportunities We strategy. have we access believe well continue payer patients to further additional our to positioned commercial for and enhance to are execute

range in to year, we LYBALVI continue the the million. $XXX sales expect For of net million to full $XXX

were quarter $X.X ARISTADA the channel, to seasonality million, Turning substantial pronounced product and inventory approximately to the a family. sales first prescriptions of $XX.X in the Net in decrease million. reflecting in equal

to second more quarter. the in normal inventory approach levels expect We levels

to continue focus in on supporting data. differentiated clinical features We highlighting ARISTADA's

million. of the ARISTADA For to continue year, in million range the we to sales full $XXX net $XXX expect

volume. awareness underserved approximately area. the an dependence and were team to uptake normal XX% the VIVITROL. $X.X of million, first about reflecting Net that be and alcohol inventory flow the VIVITROL and of sales opportunity, opportunity currently Moving which disease to VIVITROL growth in largely accounts equal our quarter channel dependence in million. continues approximately patient energized performance trends a is is to indication, by driving for in in Alcohol in the driven decrease seasonal important $XX.X

year, $XXX million. continue to Looking $XXX to ahead VIVITROL the expect full to net range million of we sales the in

With the quarter a second first us, now we the and the solid year. have behind of into growth quarter foundation the half second for

recent For started rebound weeks and expectations. QX inventory levels all to with in has in our prescription growth line been our three of products, have

focused to portfolio, across commercial execution to I Richard. Our will forward on our that, is sharing look we and team pass call the progress. With our

Richard F. Pops

XXXX This pipeline. and commercial covered financial ALKS profitable everybody. expanding elements. the going recent Alkermes morning, for Good. clinic a to neuroscience Thank an objectives you, development receptor is an developments NTX. within levels. for deficiency narcolepsy. Starting is orexin absence program once-daily core on ALKS X of ALKS NTX, in is development Type XXXX, Based in X Narcolepsy in R&D agonist in in Todd drives minutes Todd. company execution, our commercial the pure-play our with advancing Blair our orexin the with pipeline, oral a I'm and development pipeline. the novel now on with spend our particularly of XXXX, our progress few associated advancing XXXX and the significant Good profile which biology, or

this in quickly moving are We indication.

compelling initial the data proof-of-concept NTX. II data data with made Toward cohort our patients, first in the important year-end, the generated conviction we our reinforced decision. had planning. we from accelerate XX full in year, NTX decision of on patients patients that the Based Last the Phase to four from

this or doses work culminated week. Vibrance-X investigators. X, Phase placebo-controlled X cataplexy sites of underway milligrams utilizing of of XX a II II Scale randomized of or the wakefulness treatment efficacy recent ALKS profile or dose the weekly interact further clinical Vibrance-X, So characterize X to XXXX with we safety Phase single study, will and test, These enroll well the with and we either planned protocol, including and to approximately efficacy placebo the study supplies from Phase period. subjects, randomized daily clinical of FDA initiation entered the last maintenance multinational a endpoints, announced over is manufacture and XXXX activities strength, Epworth Data MWT, X-week in which Sleepiness double-blind well-established to XXXX, study ALKS finalize II of rates.

X approximately take We will to expect year study fully the enroll.

clinical lines. gain more to put site we'll point a and on the look enrollment patient finer initiations with we experience trends, As time

crossover cohorts Scale, Sleepiness the treatment. X-way idiopathic received we or data launched patients, of community each full participants as and tested. We'll safety, Type looking XX in potential these additional were to forward NTX April cohort improvements sleepiness cohort in in press in more presentation Phase tolerated we're and efficacy Ib XX significant of design as measured by cohorts, placebo first Phase and all for XX related positive hypersomnia. In Phase II ALKS clinical X study. study oral the the latency X washout data These resulted in generally a ALKS as NTX safety, the month, release the in also doses to each this well was in the randomized meeting doses on and the at X, which NTX clinically or MWT you XXXX of KSS. Narcolepsy we As tolerability levels Sleep XXXX and another sharing meaningful between milligrams include tolerability for observed from measured from our the announced the line ALKS June. with scores to in full XXXX cohorts these well will and refer subjective single statistically for study, the significant and opportunity with improvements in XXXX. as of top Karolinska Ib periods represents Last improvements MWT we participant wakefullness details by data of Ib at from sleep issued

moving the showed data in dose be Narcolepsy only supports to XX-milligram planned NTX effects in that known of recently patients, our plan for dose-dependent in pharmacodynamic study Type XXXX. ALKS XX, selection with receptor which a XXXX XX advancement Phase agonist profile later-stage as into the is that Importantly, We X. will finalized a II Phase clinical evaluation into orexin-X move and currently ALKS and study II forward doses Vibrance-X.

our properties, and possible, as second are to potential populations. to quickly for the and cohort clinical in agonist be validate from patient of hypothesis data NTX Ib we pharmaceutical XXXX. The the appropriate the with We working orexin Vibrance-X expect to benefits both provide has initiate as half which NTX

orexin disorders opportunity receptor Importantly, where into nominated data this excessive agonist in our to the This orexin-X we may plans that additional in treating preclinical expansion in receptor a space opportunities, next now in these broader advance and studies. without forward evaluate also IND-enabling year. known which a explore is have significant continue look this agonist is such our details ALKS as to demonstrate represents feature. To of We sharing other utility candidate, daytime orexin our XXXX recently deficiency. X about to patients disorders portfolio sleepiness later

back this with So with growth execute evaluate to consistent Q&A. look to on priorities. to the The development opportunities X program external you. we and year, year, return capital our now against represents to months that, capital performance. to delivering Sandy earlier into our for to and track business continuing team shareholders. We And with XXXX commercial is the business, allocation development it business. Across the potentially run framework we opportunity transformative continue I'll we're unveiled sharing progress the to forward on turn is our our financial and well focused the strong a And for strategic

Sandra Coombs

could Thanks, Maria, for please audience questions? you the Rich. poll

Operator

call from [Operator Instructions] Charles Duncan Cantor Our first question comes Fitzgerald. with

Charles Duncan

team, good is and XXXX. of primarily progress. I around and a Rich questions, a of on pipeline that quarter congrats couple had

despite the clinic, by think is $XX the million. And trying to you're I in coming mentioned was progress all I'm that that reconcile it making of R&D down that.

a question I addition, first answer. had I'll In that hold the but Vibrance on too, for

Blair Jackson

that to quarter the this this payroll recur. of and comp. the of is year. dynamics a have number group to for With R&D won't this things expenses Thanks we a is couple that taxes question. associated nonrecurring like R&D, imply the apply Charles, One regards share-based first Blair. in that Those with spend there's

the you so of would the phasing of expect that programs. the declines course And from with there's also, payments then through a year. And associated the

then and dictated a lot XXXX, that program had know, course with some Phase of closing lot of IH, we NTX we leads to associated expenses that. Ib we there's NTX in and kick of year. and phasing and in had you the Phase contractual ALKS off as And As out II a with activity the the over our program, spend,

Richard F. Pops

I'll the as one thing at leaning throttling aggressively only that needs. a gets not all it the perspective, what that contrary. from add can. as Charles, We're back XXXX is, into capital allocation We're on we

Charles Duncan

case. the that's like Sounds

Wondering thoughts Regarding NTX, is I misheard you target but Vibrance candidate? if suited IH? of is you're And have if Or I'm too, not that it, second provide NTX or in any better -- profile candidate perhaps in an moving further yes, indication you're sure that into on specifically. product for can that for differentiating you a on color second terms from XXXX? moving

Richard F. Pops

really great it's NTX, question. those with the IH. in NTX, whole it IH Yes, with taking a We're pleased data and

almost to we're You the go consistent that in underlying most as just Vibrance-X and can. Vibrance-X, clearly, see irrespective ALKS disease. But in of we is for very approval driving path as NTX, wakefulness tone aggressive NTX, orexin XXXX profile first this why That's fast the the indication. narcolepsy, prioritizing

itself. But tone about with daytime a working may that the be other aspects might that interested to I additional or with an indication brain. It you'll we're are do excessive in something necessarily profiles backup the be disease expect year. indications indeed would be compound. next-generation to are characterized also you may hear not compounds we sleepiness more reads as on the give to I'm something specifics on. that competitive with We as this orexin or subsequent XXXX by in population very because on some there the But IH it the going later

Operator

Sandler. with Our next comes from question Piper David Amsellem

David Amsellem

and one question on LYBALVI. one orexin on So the

orexin. are stage, others. receptor certainly in-license, are There's the preclinical recently, agonist number think, orexin around, there that a X of First the and kicking on Harmony agents these I

you're help in can hypersomnia the hallmark IH understand about Richard, where orexins extent multiple and how about So to but thinking thinking coexist, maybe which not maybe symptoms. you're just is us narcolepsy, disorders a as other

availability as relates move So wanted that noise, through also high-level of perceive I marketplace to on impact as you there. And get any high-level starts thoughts think the secondly, we LYBALVI, new if how to and it LYBALVI just then XXXX? noise your in question and KarXT on the the you could a

Richard F. Pops

that. David, perspective is yes, front space, learned learned too to when from orexin it. But clinic. on thing about anything, lines then the I'll a give give start anticipated that Todd into on one each if and the the we thought you and his we've I'll And ask molecules orexin on LYBALVI different get this they these we've the quite of you is

the small we've recall agonist which that developing an optimation multiple times, If shows parameters you one into brain. presented that the GPCR oral that needs slide consider the molecule gets to various when

the competitive programs pretty humans from when is saw the get they programs distinctively. we that into that separate what And molecules,

your case. are going the similar question, it to the orexin there's I in co-existing profile. just presupposes multiple commercial be that's So that agonists to believe don't that

course. in Now a focused yield for orexin once we're But NTX, that that the will daily, I that NTX. data, approved think of our agonist case, very is narcolepsy on well-tolerated developing

on think respect And And the we're will approval the is I is about what's indications and oral patients a need said, populations. With right your LYBALVI, so the competing LYBALVI. Todd, in market, differentiating of across in really for setup is KarXT in first this expect both schizophrenia, bipolar. drive and the And focus good LYBALVI big And efficacy think patient thoughts? that. With we space that's a I schizophrenia in LYBALVI. track sales feature to are multiple in that most if that efficacy, multiple our broader schizophrenia. that in to remember far, talking of schizophrenia brands be which for physicians for

C. Nichols

Yes, with that. would agree I

speaking category the for market large schizophrenia. The think overall, remember, Bipolar LYBALVI a switch. at in we to important are look it's category of and I'm general, X very about, is I dynamics the

is a this switch So market.

coming market, know as to the in switch market. compete is first to market be well. the a KarXT to So be is going the This able we within obviously out said, Rich you have very that indication, schizophrenia.

be And us but of and attribute as all LYBALVI of our you the proposition the very have well. HCP continue is research, good for to value core But efficacy. safety tolerability have has efficacy, is that tell core to a balance positioned. Through well LYBALVI to

well So the with and coming new future, we marketplace. in now the extremely is products into believe positioned LYBALVI even

Operator

from next Joel with comes question Baird. Our Beatty

Joel Beatty

First XXXX. on one is

it's data, with or recent the And if original other NTX target, on agents it as on with hasn't off such IH With you disturbance Takeda's? why target? been do think seen is

Richard F. Pops

that And I said the in Well, molecule a is is, as each selective the of I agents think is clinic. these earlier, XXXX quite potent, different. this very very

to very occurrences. And clear, single with were patients patients easily is in we it observed as be with in infrequent. Just We and patients the at visual doses parlance when talk in understand with what and we've respect mild their disturbances, transient noticeable by activities. And tested. event one self-limiting saw in something no we mild, one event about and and visual characterization, adverse very it's patient, NTX tolerated impact to far IH, the so disturbances what NTX very to but saw the just that mild, both when doesn't is transient, characterized it's with means is patients

be across we'll the to So configured, on extent sure. dose with. a that profile range But need that is currently the we're more it know to for wide very comfortable data may target,

Joel Beatty

outlook impact to the for? were it And be the seem LYBALVI, Does campaign? for then having you what's the for DTC Great. hoping

C. Nichols

trends visits, we're the indicators, right in our would as say such I I'll with searches. as discussed of over really lead that The the the planned. website DTC we've branded program take couple quarters the as executing positive, pleased are We've past, Yes, been last program. now, one.

shows is our program, significantly early which In overall our TV indicators, digital, growth. And TRx they're early the analysis contributing fact, and to up that is year-over-year.

actually data contribution. that meaningful is shows our a So there

throughout So our program continue to to plan the is that execute year.

Operator

question comes from with next Akash Tewari Our Jefferies.

Katherine Wang

just This of is questions. Akash. have Kathy I couple for on a

architecture? think for data restrictions? your to be you what at points are the do when will And full need sodium sleep you oxybate? And June, are regarding sleep driving So any oxy give in won't measurements you then then important finally, most that combined NTX for looking presents what you tech will that confidence with study, require data also,

Richard F. Pops

that II Yes. Houston both dosed we I data mean twice a we look Sleep Takeda's randomized study well should of June in forward as there, in of drug, at to safety Phase the results see the day in as doses because efficacy. presentation multiple seeing for

And theory the So to think be look begin sleep what fully be II that driving for orexin that that's need to normal in study. for full we'll see But forward seeing the will And architecture. point in we polysomnography presenting. to be wakefulness, is sleep of II effect the Phase obviously, day at resume this proven that they're in our consolidated that characterized. don't no data with of that a they looking agonist Perhaps study think doing any to should study June some on needs what and architecture, to the that we'll restrictions I I both at know Phase that. Vibrance-X. respect yet describe in our there's be in But more our no, and lab. We'll Vibrance-X present. With

Operator

comes question from Matteis next with Stifel. Paul Our

James Condulis

and around you profile think Paul. you investing as royalties in kind or specifically as I as ahead just EBITDA is question context, going R&D how kind EBITDA. on some about do you kind in looking BD see in of of goal that forward your sustainable I I I is look -- and kind kind opportunities? kind thinking James kind like of then one forward? at of off, to guess And guess, what guess, of repeatable? margin these of looking peel are the midterm of had you of current This do kind of I the just margins the guess on for start

Blair Jackson

context on with our This and then give BD is strategy on I'll things. future Maybe some and Rich to Blair I'll the margins. start ask

have I as said, we a think margins, with you regards healthy margin to forward. going

portfolio want sort at in allows the forward. -- still this on And for to a range investment, for plan but that's you business. to to operate profitable our We comment both in overall business. Rich, We significant that for significant of the all? our expect generate the business cash plan and did moving to business, in commercial and level continue the

Richard F. Pops

Just a you see Blair growing line. indicated, you you profitability long-range what top is our at plan, growing if look see see, you as with

And to to accommodates maintaining as return shareholders, capital significant well potential as so that while profitability. R&D spending both in expansion

So we think the that can it's this we do all and by top driven advancing at all same line. time,

Operator

Evercore Our next Umer Raffat, question comes from ISI.

Umer Raffat

Maybe question less and boring question. a boring then a

D an So reform, the this into could realize top is do boring be question impact how much And Part and line of I year? you expect on EPS your relevant. next

curious. I'd So be

second orexin, to wanted the potency previously. On some good shown know I a look little on just one, data I very into the you've more.

world it orexin. XXXX native sleep I think more And assuming I'm to XXx a But IPX data other orexin also was was it where IPX than seems about in potent assay it [indiscernible]. was underperforms was assays. native the the in where suggest

native a assay? potency is, your question flipper in orexin does versus look my So how

Richard F. Pops

boring both say. I must are those Umer, questions,

companies the one that in So to that the D, begins Part D to folks, phase-in. we on for certain phase gradual are phase just interesting qualifies more is companies, for qualify as that, so in in, orient because of catastrophic liability companies that the phase-in. them take Part very the for

So X%. the exposure in XXXX is

the a of participation so. program a it's ramp So full in at or the it's but decade end a the toward small,

in the potency. we're demonstrating X, I efficacy. else I in X, high of because have that XXXX matters everybody where the that and in we're won't XX the X, of the the mean, doses potency form NTX and in of it XX, meaningful way XX ahead human actually think driving ALKS about is of on NTX So XXXX. I potency much And impact potency an smiled

day selectivity and as but it both all to medicine. necessary, as but relates determine talk a can we the absolutely systems in-vitro various they're So say potency actual about potency, would I about insufficient

So we're actually point. this far know are that values I that what flipper so our at our beyond program, could now in it's essentially the -- irrelevant development answer don't because

Umer Raffat

much the of max made, it a Whatever that Is X/XX clarify, XXXX, just you that in or obviously. Richard, that? Part by is max is to you impact point on the there's XXXX? X/X how D said sorry, And the by of phase-in of

Richard F. Pops

It's X%. the that X. in from participation XXXX no. that's But phase. value is Literally. catastrophe absolute No, a is X%

now. We have X right

scales specific we as then smaller of specifically over oriented Part like from X weren't next companies a by add devastated the full hits on carve So in in make policymakers going that with and it to was significant And it are that D a dependence it ultimately catastrophe. XX% out population companies years X% for level. But the source the several until it's XX% income. exposure by that ours catastrophe to or a sure exposure companies

Umer Raffat

Correct.

So it's correct? max X% of XX%, It's the not...

Richard F. Pops

X% it's of XX%, absolute. X% not It's

Umer Raffat

X% absolute.

Got Okay. it.

Richard F. Pops

because which smart. take in did whole If know through it, you you have phase we is to call that want. if us, Umer, on you I can yesterday you just a briefing

can take any particular, in give questions. and you if phase-in you a us have through ring the specific we -- make So

Operator

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

Jason Gerberry

have I questions of well. got boring as a couple

Just...

Richard F. Pops

judge the be of I'll Jason. that,

Jason Gerberry

nets? that a Is follow-up to mix on might bipolar. the shifted you the I your XX-XX? was that bipolar? about looks? And and I'm might towards know how bipolar that with And you impacting Yes. more thought commercial more then towards the more contract LYBALVI-PBM does activate we XXXX-plus. to contracted impact. CAR schizophrenia more XXXX. curious a On the patients these DTC, that XX% your about how T think grow just directionally shift as not even Or actually about comments move sort just -- gross bipolar Like of high directionally, still basis, has mix

C. Nichols

is that. Jason, take Yes. this I'll Todd.

on continue strategy, actually For gross to to that execute net, contracting were we our our able were really strategy. to pleased commercial we

did had a enter the patient we're get with range a PBM plus said with that to for the for remarks, that, we to sales. improve to really more LYBALVI. Even gross formulary prepared So we agreement in pleased as scenarios large I positioning to a into of with, net XXXX, really access new net

So in range perfectly outlined. that that we've fits the

full that be to XXs. still For expect high gross to we net in year, the

But that beyond. for we're bit on may access as 'XX get continue our into formulary for guiding we to not and and commercial. patients widen and strategy more 'XX Going a little beyond, execute to

of still and mix approximately schizophrenia the terms In for bipolar. for and the mix schizophrenia XX% for overall TRx bipolar, is

see to Bipolar was continue of new part again, We patients our more start skew X, towards strategy. which,

XX% little overall, we're the approaching volume is most new the volume growth X. from the a patient now within seeing for it's brand Bipolar starts, growth and coming So of of right north

now. So have we also we of, activation obviously, with think of and prescribing breadth right of combination a that's patients growing the

Operator

Our next Ear question comes Uy Securities. with Mizuho

Uy Ear

Just high level.

by is orexin the rare? strained. given an And I molecule agonist, color have Or a kind the of easily, of access went company the deal curious, on to X from It in-licensing of see one Is the these the what it provide just was be little orexin Harmony next. to molecules. generated? to recent to landscape an Just like. curious is one this Maybe can ability guess, just

Richard F. Pops

I think relatively actually it's rare.

and with profile drive wake to brain bind consistent choice. with neurons cycle. coming are with make G-protein-coupled that think and I have agonist concentration that's chemical And these all profile, complicated they've they me diversity normal And signaling done brain such of a yet need to the to the up difficulty space. to people orally ad that's molecules cross have this pharmacokinetic the barrier. so why bioavailable are target receptor had heard blood you've once they an do as as say because time in -- be that, These sleep nauseam, a the a over in

wake So at go can in sleep night. the up morning people

number kinase why of I Even commercial it really other contrast bear. right even a to diversity to molecules quite to do. to small available or other and of But medical in constricted can ranging systemically difficult chemical products molecules molecules. the with that where see So think of now. there's here, -- And really area. I this much brought types be it's promise, of a a drugs really, inhibitors lot you that's from clinic very small a from large it's small

molecules So question molecules. think they I to are license. that find good can The one is,

Uy Ear

And that? you have it speak if of bit Just about an a I is Could your share that you also that. what maybe platform you advantage, follow-up guess? the you perhaps on gives molecules a that about in-house, number can

Richard F. Pops

when from what potency. features a needed than the rather to talking I important, it's lot integrated think medical insufficient. the be we platform is that of -- a sensibility you'll about absolutely Potency but chemistry absolutely people from so began derives our outset about hear the

missile others. we structures based confer chemical optimizing began our patent it suite, yielded in on different of separate all these there's from can And attributes. of ] limited [ our But screening think even we a So number structures all these and chemistry that domains. efforts that across

critical compounds. are Within suite, of foundation a patents our multitude the this. can of we generate patent to that So

if this the neurotransmitter we're in in a so job we're And stratify is that molecule why This is circuitry best such beyond And disease that chemistry a analog. indeed NTX a whole But this map place it's about start idea preclinically brain with our to of thinking biology. replacing into pursuing. The small the has narcolepsy. and narcolepsy. is particular indications wakefulness, to implications that eye core of those that of the embodiment most on to that's interrogating simple deficient the the with drives try ones whole great bull's to the

Operator

Our Jessica JPMorgan. next with Fye from question comes

Jessica Fye

Change some occurred more only meant that of the rates you volumes that. on these one listing versus see for example, NTX cyberattack And from the quarter? I And just than happened description about the the that Curious, impact in IH the orexin, wondering certain any those think update, first more you'll you was have two if I just think the than in on AEs of did in recent separately patients participant. Health saw, for and investors that

curious if you any can there? provide there's So color

Richard F. Pops

want you do to? Todd,

C. Nichols

cards reports of Yes, there overall claims. brands Yes, had were for in issues Healthcare, three for a impact. really terms with operational Change biggest the cards, co-pay was marketplace about HCP in no lot about of of with and co-pay three The overall processing -- absolutely. market pharmacies impact claims. our co-pay the Jessica. We our our co-pay, offices, hospitals processing

see impact Healthcare So we didn't cyberattack. the all any from at Change

Richard F. Pops

were me, were were discontinuations. study to AEs transient it the treatment-emergent to profile events pleased the The mild there but the I all or And was related adverse treatment, drug very that IH to serious AE observed across doses, Jess, are tolerated. remember, as in well no don't assessed severe front without reported generally resolved with And have table cohort. the that of remember be study AE AEs NTX led drug and no we in

when So full tables data we'll as the provide data profile this year, I but just we present later the the is described. overall

Operator

comes with SVB Marc Goodman question Securities. next from Our

Guofang Li

Marc. This is Rudy the on for line

for increased mentioned you LYBALVI breadth prescribers. So

reached? strategy you depth XX,XXX increase prescribers percentage these in to moving breadth and have your forward? is what the of prescribers what And So

C. Nichols

I'll absolutely. take Yes, that.

about There's of this prescribing. Overall, a impact X,XXX we're So for prescribers. in with meaningful timing. a -- we see about approximately We've our meaningful in of with. of our of breadth really XX,XXX target encouraged which quarter, is prescribers XX%, sales year-over-year the we a -- That's -- really QX. growth really And overall, had lot a depth we terms just and force there

single week bring of And utility We to X. by is month. with just provides and Bipolar differentiator, consistently and efficacy single is across the it that this the the prescribers brand. continue broad of being on and that new every HCPs lot schizophrenia every We driven utility a hear

to some that our XX% year. they about continue research, in market of report calendar HCPs next of to Additionally, over prescribing and recent plan increase prescribe the most

encouraging we So breadth very to trend also prescribing. but a continue to think drive depth of that's

Operator

from comes with HC Douglas Wainwright. question next Our Tsao

Douglas Tsao

last the mean, question. improving prescribers? is curious, universe the Just I Or of opportunity first, bigger a in the individual with as see on to of that depth just LYBALVI, you follow-up writers? just it do expanding I'm prescribing

C. Nichols

the launch. would overall, still early of But both. I say, our it's in Actually, stages, Yes. we're

improving. breadth Prescriber prescriber is obviously actually been job every And so single #X. depth, primary has quarter

a done research they to to rapidly. schizophrenia tend we once the bipolar that. a has LYBALVI, an pretty HCP with that. And So utilization positive lot it's insight continue expand see of is We've key whether really, experience with or

So pleased we're that. with really

with lot over But primarily drive for time, the that. we of we're population think a profile early to a product #X really of still will So depth. prescriber And overall ultimately, job breadth. the schizophrenia bipolar drive broad with right now is continuing

Douglas Tsao

of terms of writing take And does for a more? that, accruing -- confident experience just start -- of that docs quick long accrue to feel to just sort in individual follow-up as terms in how on to that

C. Nichols

about think a that Yes. Well, we got the this earlier, market. context bipolar I the that think in as this market of compete. said you is switch Again, is I to for schizophrenia and patients,

So Patients it's switch in market. Xx. a therapies this to category will dynamic about X switch

It's rather than it's dynamic. and bipolar dynamic schizophrenia. So more

they're the experience would take having, patient, it it the of origination but couple a of So upon the depends typically that really months.

patients, positive So what a is with utilization. they LYBALVI, HCP a on, to has from or early whether we've schizophrenia once seen quickly expanding very think about and they're have an it's outcome good experience bipolar

months efficacy it's the usually patient at upon couple So on with really they're of medication. large, the based the would say tolerability, upon current a issue receiving I based the their

Sandra Coombs

we for Maria, I more time question. think have one

Operator

Okay.

Our last question from Goldman Chris Sachs. is Shibutani then with

Karishma Raghuram

This on is Karishma Chris. for

well. penetration in at is with of So point markets, in continuing have to increase schizophrenia a here, this bipolar to are there, progress and this and injectables I then ARISTADA, with the assets of follow-up in U.S.? your in plateauing terms LYBALVI and And regard the particular as time? Or long-acting kind the namely

C. Nichols

Yes, absolutely.

they're I LYBALVI obviously, all. encouraging not with product on QX And So starts. the fastest-growing the And patient really we is indicator both also for think now. our important plateauing and leading right still products, that's the in view support phase, in be to at launching. is continue to trends overall see for LYBALVI initial to category, not only in TRx's branded but continues a new year-over-year for the that

we've growth in trends a starts. And in ARISTADA, opportunity new we it already we're see QX. already, of LAI lot encouraging in seeing ARISTADA quite us terms of So category seen going into fact, in in the QX encouraging has confidence a gives term. And in long of the bit seasonality QX, patient but

slowing lifeblood new ARISTADA of that see the starts well. we and as brand the So patient don't is for down

Karishma Raghuram

And Great. see mechanisms implications What they Okay. developed? one potential then Should such when agonists the products are new follow-up, introduced? be you do successfully could. I legacy as to muscarinic potential if

C. Nichols

Yes, absolutely.

category landscape watch clearly. the we So really competitive

the the that addressable key us is right think for we're I now on. focused market

on for for market clearly both also very The we're focused We brands resonates differentiated that LYBALVI and proposition well. very have value a ARISTADA. for

it's LYBALVI, LYBALVI branded products one in category. For is about considered the most efficacy. the of efficacious

in And so to in really position a really, at this strong launch. that's point be

us the initiate report to It's category. see to In lot up X that, a market you X of They the a don't were day within differentiates LAI months, HCPs able to differentiated molecule HCP's the us ARISTADA to coming into has only terms that on you the tell that profile. and typically growth brand. ARISTADA, themselves. of typically trade with that LAIs continue for

really and feel entrants market new confident products we now can on into how the So these regardless future. of compete

Operator

I We have reached to turn like the our floor session. over closing now end of Q&A to comments. for Sandy would Coombs back the

Sandra Coombs

thank to out if questions. the company you, and any us day. Please don't you call Maria, Thanks, have everyone, to hesitate reach on good the Have follow-up this for a joining morning.

Operator

teleconference. concludes This today's

Thank time. lines You your your may you this at disconnect for participation.

Alkermes (ALKS) 1 May 242024 Q1 Earnings call transcript