ALKS - Earnings call transcript Q3 2024

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Operator

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

Sandra Coombs

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

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

C. Nichols

quarter. product our generated We strong portfolio Sandy, of you, Thank everyone. morning, in third the good proprietary and growth

growth quarters of million, track net quarter in expectations aggregate by the net in million, During announced year-over-year With sales and sales the excess dependence our are on $XXX team we growth. indication. complete, XX%, underlying proprietary were the of growth of driven with billion third in quarter, reflecting financial VIVITROL. now year-over-year $X in previously demand our XX% of strong $XXX.X to achieve sales XXXX. Starting Net drove alcohol X representing

we the the $XXX of towards sales year, $XXX end full our For announced expect of net range million to million. previously VIVITROL high

Turning to $XX.X quarter the third in were million. sales family. the product ARISTADA Net

the we overall million the to year. full schizophrenia softness toward During the antipsychotic our With expect mind, to through some previously range which we see be of we expect sales $XXX persist continue net quarter, the the will in ARISTADA that of the market, long-acting end in $XXX for to end lower announced of million year.

we reflecting breadth prescriber LYBALVI and to generated million. during underlying net of sequentially and LYBALVI, XX,XXX the and depth. prescriptions sales strong the quarter, Total For of continued expansion demand year-over-year $XX.X during grew quarter, X% approximately XX% of

by million an range I profile are and disorder optimize the profitability. net long-term its and data. on we to of maximize sales differentiated focused $XXX growth To the For in expect executing its LYBALVI strategy efficacy to continue we important year, safety long-term full the and in our net access space, LYBALVI, and profile support option schizophrenia $XXX the of million. LYBALVI treatment is sales to and bipolar

progress with discussions We quarter, other ongoing. payer past key October are this are pleased our enhanced X access with important year. effective and another payers commercial This

we nets. expand we as well higher previously higher fulfillment volume have we unit to rates both and as As discussed, commercial as access, expect gross

net expect will adjustments course mid-XXs. into the of the next gross year, to move Over we

be enter on XXXX, we dynamics competitive the As we focused space. antipsychotic in will

a there voice. most and LYBALVI share plan the ARISTADA, we is work to competitive promotion our As both opportunities investment to increase for our via investment personal we of maximize field force, effective to preserve and our

our progress portfolio. focus we well our We the drive are to that, believe you. With will growth We and positioned strategy on to with are sharing our I Blair. across maintaining sharp executing call a look pass commercial to forward

Blair Jackson

you, Todd. Thank

quarter support important as structure several performance years worked the point have to of and we efficient to commercial last XXXX. by an the transition operating focus quarters needs has by profile strong over of products an and our to for and The the marks profitability. QX a our are us, of proprietary expectations performance that the been company of operating was for reiterating the financial With realigned inflection another driven we third the business quarter VIVITROL behind our productive business X results continued Alkermes, LYBALVI drive financial solid highlighted for on the and efficiency.

portfolio, with last million, product year. were For the to driven net third million which the year-over-year. Starting quarter, $XXX.X in we revenues our XX% in period sales compared quarter $XXX.X $XX.X by VIVITROL, of proprietary same grew million total generated the

remained the million for the month-on-hand ARISTADA same LYBALVI, a were And sales $XX.X stable QX sales million million year. to our Across products, family, $XX.X basis. million $XX.X commercial compared last net on $XX.X For net in product last compared inventory were for to proprietary year. period

were and royalty In third we $XXX.X recorded revenues year. to and the products manufacturing from our to business. compared million long-acting million on $XX.X Moving last the $XX.X QX Revenues INVEGA manufacturing of royalty quarter, million. for

year. and in royalties financial the our disclosed expectations, in reflected SUSTENNA on U.S. ended mid-August our INVEGA in of of previously net As sales this

represent of the revenues FAMPYRA. related activities, any expect during revenues the in we to $XX.X to of continue revenues timing HAFYERA million INVEGA VUMERITY manufacturing of on FAMPYRA the Due did royalties manufacturing will INVEGA record the we outside of TRINZA to year. compared from $XX.X QX of conclusion associated long-acting to This approximately our the and and $XX in INVEGA products manufacturing related the FAMPYRA and on U.S. Revenues last quarter, million million for were receive obligations to but We not U.S. sales QX. will net

year. to ALKS continuing primarily late clinical XXXX last million our R&D last last of to turn This support QX and QX to products. million and our our I'll program were Now $XX.X business million separation the goods compared operating $XX.X Cost compared commercial financial proprietary million consisted focused results from expenses our neuroscience activities programs, our $XX.X year. oncology for in of of operations expenses sold year. the related were for for investments $XX.X development following to

We of million in $XXX.X remain to $XXX.X for compared year. SG&A this last the range expect million R&D end the year. through to QX expenses expense were

decrease the we expenses expect the primarily of fourth quarter, activities. ahead, timing SG&A in to promotional reflecting Looking and mix commercial

of focus net to during continue million. the non-GAAP $XX.X of on profitability. from net quarter, and $XXX.X operations of GAAP And continuing delivered $XXX.X million We driving income continuing EBITDA million, we from operations from continuing income operations third

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

million we repurchase X.X approximately as shares $XXX program market year. During share million remaining authorized repurchase dependent million repurchase business. of the this $XXX part $XXX of opportunistically authorization, shares the deployed to may forward, on With conditions quarter, going the the of million and capital we earlier needs

business strong position we on for be against of financial across in profitability opportunities to while business the manage solid shareholder spend made next I'm a going we we XXXX. Switching the as will a key financial strategic, in have plan XXXX, investment our significant our In year. operational value. that drivers growth the and plans our and minute flow to believe increasing to progress the cash deliver and are We execute priorities for gears,

Biogen growth But proprietary we into mind. In XXXX we increase be top XXXX, the we transition driven the in within portfolio, provide our modestly will the support line will revenues our increase idiopathic revenues with ALKS highlight we in investment ongoing studies the early previously planned in reflecting the expect today, million success streams, advance and as expected and hypersomnia in in our by FAMPYRA commercial will X manufacturing INVEGA our sales LYBALVI few clinic as overall will and psychiatry to expect costs on ALKS February. our to Phase these in XXXX. Primarily keep operating expectations I we $XXX expect the royalties expand dynamics by primarily driven ARISTADA. in of of of royalty net manufacturing growth will detailed XXXX XXXX. to our factors announced We commercial revenue a manufacturing of impact and the namely U.S. XXXX, of and and conclusion manufacturing Collectively, royalty VUMERITY by footprint SUSTENNA approximately and considerations

to committed profitability in $XXX to and million next expect of than deliver maintaining cash-generating robust year. we're together, Taken business EBITDA more a

will as a profile serve significant years transformation foundation now our financial hand strong Rich. demonstrate XXXX the the Our of growth and several last and company to the future the that, for I'll over call performance. With financial

Richard F. Pops

We a from company. a INVEGA you, has year the That's company as pure-play strong royalties structure with year a our line cash SUSTENNA. and final to Blair. a year entered for great. for Thank planning of and streamlined the key been cost top transition flow related XXXX neuroscience

category. substantial in a outcome a of XXXX in in inherent Xb, XXXX XXXX advance business business, manage in X XXXX the and a focus amount type the the profile agonist type cash orexin the These Phase advanced we narcolepsy in patients on to sense potential. We generate has we've profitability narcolepsy into demonstrate for based Phase X positive the program clinical and idiopathic been successful of to quickly differentiated of to Xb Phase have get X hand program. data X, the And with now data while underscore receptor the ALKS of hypersomnia. its therapeutic the Our

important generate deploying risk the we prepare favorable us. for priority through benefit heard development XXXX, to We significant that from way we significant and with to medicines. an Blair, enter toward significant potential and the As manage as to capital new is That's cash value you shareholder plan create profile, candidates profitability. a to believe business

of orexin data other the potential categories. proof-of-concept clinical receptor ALKS preclinical disease in agonist potential have and supporting We data of applicability XXXX narcolepsy and the suggesting in X IH

that them materials portfolio website. our can moving recommend a we still portfolio. and a take is if meaningful other available update focus on be brief our are on value. Two aggressively from replay development I'll and I at the strategy orexin haven't, our R&D forward The candidates today. you look advancing ago, provided so review you program So XXXX in weeks that on shareholder comprehensive initiatives drive

actively studies NTX Our with XXXX Phase patients. and underway sites in enrolling X and NTX screening are

swiftly to patients. Phase success presented growing. data as have hypersomnolence that in the We're demonstrate different earlier in from supporting registrational transform we and that entrant to XXXX operational this NTX, to just neurocircuitry. our month, of As development biology The this pathway XXXX. requiring and With next Orexin-based as like this landscape. Phase in the optimization, advancing of X clinic. To we X provide to orexin molecular We has different the the both a and The of for potential companies the with in positioning hypersomnolence this IH with trial properties we second be in data potential investigational and the Phase have narcolepsy enrollment patients we strong moving transformative implications sites potential medicines will to for competitive beyond based treated. system only we're activation space catalyst on data foundation disorders. how therapies associated data others, design with believe class extend and half of pharmaceutical in company. The and multiple studies. The parameters X X to the of date, ours goal are Phase this X of in preparing and scientific ALKS molecules, neurotransmitters may year possible IH expect NTX, support further is is for expect downstream from studies disorders. into continuing studies. many is X the additional foundation activate clinical announced We're

Our has clinical are features. potential settings the mood suggests where CNS fatigue, to extend orexin-based disease to that multiple and cognition, pharmacology prominent preclinical data sleepiness,

candidates to demonstrated leveraging and with X these for promising lanes identify pursuing this selection shared models are symptomatic the program we our opportunity recently benefit continuing the understanding, drive a orexin to in potency clinical to required development distinct prioritize and development. efforts they agonist for additional selectivity, the advance planning properties. year. ALKS this X have portfolio. terms inform we're and and our company. In We'll parallel, believe early characterize next for orexin multifaceted see attention, benefit agonist data related designed that features for receptor pharmaceutical map XXXX will the but first-in-human of a highly certain We X of These domains to studies research in strategy greatest patients our the candidates share in disorders into mood, of where preclinical these translatable We're receptor We experience, we properties impulsivity. and in to most

We strategy sense for a will create value as to exit go carrying into clear XXXX and of shareholders, with great XXXX. momentum we we're

run to turn to Sandy So with that, I'll call the back the Q&A.

Sandra Coombs

call the Q&A, you, now will please. for Thank Rich. Maria open Great.

Operator

[Operator Instructions] Our first with Thome Cowen. TD from Joseph question is

Joseph Thome

bit a alcohol. these to Congrats impulse drugs little of VIVITROL, refraining VIVITROL on business? bit into seems sort might control after of going specific all other? the alcohol there's these like you the questioning populations Or GLP-Xs you impact the bleed Obviously, uptick progress. sort indications. Maybe each But foresee distinct the and it see patient on actually, in of competitive not on of as a around GLP-X threat any more aren't little been on companies sort do just talk from that from do

C. Nichols

dependence Yes. really with some quarter, monitoring VIVITROL don't publications as take an X%, impact saw that. the watching. that. indication. by that watching this the Yes, driven market I'll alcohol is and we really to closely We've point. demand, we're strong which been being been the There In see approximately have at We pretty that

expectation continue that in at of now, we be But this right grow. our point is will dependence. VIVITROL to and monitoring the don't see we general. uptake We'll so And alcohol that GLP-Xs impacting

Joseph Thome

a the just maybe follow-up on pipeline. And

approval? orexins, development program? are you studies as of the preclinically formal clinically or do For either abuse clinical FDA you before And or class anticipate that of guess, anticipating need will the potential sort part I this that

Richard F. Pops

Yes. Rich. This is

compounds, think studies. potential we'll of as a active abuse course, I matter and preclinical looking the CNS at for clinical be

Operator

with next Raffat Our comes from Evercore. question Umer

Umer Raffat

here, X I I if have may.

I First, I and only want lower when for your up? ones implications something know pharmaceutical of Blair, possible secondly, mentioned properties we'll which are from me coming thinking to a a you ready. look that's candidates, one patient aiming tolerability clarify you stay and to distinct development forward your about with next-gen is, Rich, new orexins, But thing that the you Cmax the for profile. And bit. confused guys I'm mentioned do

cut are you for this half you for about on year. tracking next into think EBITDA million Did at so $XXX next year? $XXX in I million guys say EBITDA EBITDA year,

Richard F. Pops

Yes.

is that So, right I'll PK the start. XXXX quite for now. Yes, we profile actually -- we think good

properties So explicit to no, to lower PK but is we've in focus design done as is objective it not an the past. Cmax, the on

Blair Jackson

models Umer, look, reasons 'XX this of mean, Yes, I into to next make for order that Thanks Blair. such is as such as a some want wanted a the move has then, And everybody into next one for question. we we it year year, we year. move transformational is as the we we sure provide the year guidance company for to into is their forward. And in move busy

on We couple prepared into have a the with of dynamics put going overall the business as we remarks.

revenue and The well side INVEGA revenue see the of manufacturing the first facility. is as where we away now revenue, of Athlone manufacturing out foremost and transition SUSTENNA revenue transition some associated with royalty on our from and we our the as a

being overall. to margin So this Biogen that moved side the relates moving and business into of VUMERITY then to the

that next XXXX, the year need really in things we So things some is on we the happening have move research exciting we see and growth our commercial of about that we revenue side. Separately, on the side. programs as a into $XXX as net million do of business our invest on of one impact of the to

ALKS idiopathic it's enrollment. the the program. of added NTX XXXX We're also be program. support to rapid And going continuing that side, On research to really and hypersomnia NTX now about the the ALKS and we've to XXXX growth

that million for is so. size our or program will that add -- So typical about $XX

cost that So increase the or R&D there. will revenue

we're something across about million side, to -- our $XXX next to EBITDA that line will more really investment commercial next the to strong cost of to north focusing the some finer year. of rest the the that's of put will we dynamics We're be then space. and On items, we going We'll year. we in guide it as But lead competitive have of discipline as as year. we the on of the and our a point sight get expanding force meet February sales to mentioned, have spend Todd where to

Operator

from comes Paul question Stifel. with next Our Matteis

Paul Matteis

I data the you explain revenues, on that if Street something could I as you think when think And give follow what On side is bit then to optimistic guidance, there Phase about at think color, us the does of you a you NTX the manufacturing you what Blair, been just look wanted with have more up increases or mean, just take biggest for there. Alkermes LYBALVI XXXX royalty a models guess, early market? And that the product overly maybe run in to And consensus. folks gets what the also like as do it EBITDA back, little translatability mentioned the mismatch? some as those I studies? IH that view Is comfortable biggest doesn't but really succeeding here from rate the of step XXXX, the delta and the risk we for know you ARISTADA, in versus you could X feel where and I maybe on risk? competition if

Richard F. Pops

take ahead second go and you then I'll one. Blair, the

Blair Jackson

the look for on question. it thanks and Paul, you really revenue. the Hello, manufacturing is I the actually, No, royalty mismatch, actually, if Sure. think biggest at

was I the folks handling how think the transition understand the, and the that a the we're of inâ€¦ going next b, just revenue just manufacturing looking a, how of INVEGA lot then activity dynamic we're to year, through at transition; didn't

Sandra Coombs

Affluent.

Blair Jackson

â€¦in affluent.

think clearly business it it, I were time long been wanted moving forward, for and we've transition. and trying just been we explain this think this a as little to more do we I lay the we look out a how today. at going to we've for really planning And to

XXXX increasing are our The program. year think, in deeper development into R&D that some models spend their are I progresses it that missing folks other with associated we as the is piece, next for

those Street areas really the mismatch of models. so X were in And

Sandra Coombs

Rich?

Richard F. Pops

Yes.

you of think the orexin out. NTX, sort take of of and variable of NTX, makes a I certainty. lot I'll as contrast IH tone NTX, being from of so in further orexin, replacement outward perspective, course, even Paul, a and concentric circles deficiency our IH, moving in -- you're patients biological NTX, sense. So

from you in the so populations as variability move one And increases other. those patient the to

in So in of the meaningfully backdrop change those in variability we I be MWT. Interestingly, test. biggest test. the it's one of against approvable Xb, is we can the IH, scores. maintenance And endpoint not hypersomnia just studies wakefulness Phase the the we've probably have of tested variability in maintenance But going is think is more wakefulness population. primary endpoint NTX way The the of risk lot the shown what to don't the a in is a that patient already dose-dependent of the primary yet. that We idiopathic experience with though, of endpoint the IH in

we the actually design So that disease we're IH, program capture new as introducing for accurately. that more endpoints Phase X

of I the answer biggest the is So populations. to think the question, patient the variability the probably simple risk

Operator

Duncan Our comes next Fitzgerald. question with from Charles Cantor

Charles Duncan

one prevalent of highly could to or secondarily, the with us commercial, there, not to picking you're and When pursue? Congratulations rare a had but mapping you're the may you -- that indications looking scripts be muscarinics? And the more the be this, a Would pipeline. on could LYBALVI and market competition on to it next-gen in more last I follow-up how compounds, type where little as perhaps impacted still think I by to think a dynamics you With you the in commercial know quarter. give neuro, you of would the the on regard the regard progress you're to diseases? us one. about question increased more sense may on to dynamic very or highly and it a then color pipeline, orphan give up be quickly, then terms due

C. Nichols

I'll dynamics. first LYBALVI This take is on one Todd. market the

bipolar disorder indication. really So are seeing part the our is start been and sign. bipolar, bipolar through across but X LYBALVI which healthy addressable is patient That's maximize since patient of XX% full for coming our growth really to is starts markets. market now both, strongest day schizophrenia, which coming Approximately X XX% new really the strategy large is disorder. X growth new a of through we're And is X to encouraging the

changing the So was market, dynamic really we the recently see don't coming that with to approved. one especially that muscarinics the

market was well. to And know, HCPs probably approved It's the is they that of schizophrenia the all stable from a patients. That's continue As to one just a recently in you very us will research, we market. tell that space. our play switch know that not going switch dynamic

well So LYBALVI is established really there.

any marketplace to with continue upon The pay second consistently the coming competition aspect and real-world based years, generate off. our tolerability. and the for attributes. really use product evidence. that efficacy, they last the is into profile X The hear LYBALVI in We we some product well-established type been profile market. attributes look HCPs at very us of that able the product tell And over that meaningful the we've to the

And key evidence entrants determinant for so competitive a competition future be we real-world the the to and marketplace in when new think come going into is market. for in the also the LYBALVI

Richard F. Pops

it's voice. hear Rich. your Charles, to Good

or what switch on Patients a is the And average any on Unfortunately, position the olanzapine little antipsychotic market. realize an is And Todd a now that Todd months switching think probably it's efficacy for on the strong track color a lot oral is which both really said, marketplace. said that length its LYBALVI constantly. has as of record I in LYBALVI be the based folks X and are what and of a in the in entrant true what well, market Just will don't therapy category. so. of

of churn can drives that's the these large, and become products. why number large the So of what a is brands the market, patients

a commercially of the would we and development-wise, like into we certain the onto On even where and on both say, it's through lot were we pharmacology going some mapping deliberately experience, as coy neurology psychiatry, bit have well. categories where ultra-rare the conditions. disease in pipeline, general from rare and about insights We it have But extends interesting. the competitive feel because a we're

characterize X, different mentioned the price ascending of in piece agents a dose little different take more and diseases. different those going I these to probably clinic And next-generation about we're to the bit into step then points so where is clear ascending earlier with remarks, on orexin the with features. be the in as to single molecules particular multiple map And studies it and

Operator

with Our Amsellem Sandler. Piper next question comes from David

David Amsellem

to LYBALVI? remind your us How that your business LYBALVI olanzapine you could portion acquisitions can sneak impact comes do what And in-licensing of your olanzapine beyond schizophrenia ability How just do you all? And business I'll from form the from a LAI landscape, availability question bolster about legacy are orexin? you looking LAI to think specifically impact the the drive ways then thinking days? in So pipeline an to of think quick at at development. switches product and these of could competitive an if and oral business, on you olanzapine

C. Nichols

is Todd. Yes, absolutely. This

new disorder stronger encouraging you of when terms to with starting the at quarters, space, patients. market much is starts, several X still see approximately the to again, and patient is mix, a as TRx about and look propensity which, In the really we know, we're mix trend schizophrenia The larger the switch XX-XX for bipolar last within growth though, bipolar much between a bipolar. is

that trend. we're So encouraged with

that of for something an HCPs. rate-limiting really olanzapine still LAI, of consistently watch therapy years step regardless is we gain, olanzapine-based of It's a delivery We metabolic the weight the from that terms The hear In any type disturbance. do out. few closely. that's

solve continues of is be standard olanzapine-based have issue. care the belief delivery, regardless the becoming you to LYBALVI our of therapy. that within to So an

see type LAI don't that into impact the would market we of So coming LYBALVI. any that

Richard F. Pops

as same robust fairly that last credentialed company pipeline, we pretty to or biology is the so, orexin on -- David, love over And with is the where pure-play the heard molecular licensing, you've something the hear to neuroscience add stand-alone and non-covariant I on development think and design in year response well business places this is consistently which would complicated. to the you'll love is play we pipeline. Where a

places. in BD those looking are often our so efforts of types And

to a that stay I'd it's quite So immediate I think we over a add in expect don't for if the not time. while. to space be in but the portfolio, something we future, surprised And

Operator

Akash from comes Jefferies. question next Our Tewari with

Katherine Wang

This is for Akash. on Kathy

efficacy minute orexin-X, X a week at showing NTX, week MWT week response waned at then placebo-adjusted between TAK-XXX's X-minute dropping for to X So X X, and X. in

So are in or XXXX's follow-up led And this efficacy a to you longer patients what about NTX time? do waning with at IH the you think concerned X-milligram dose? efficacy

Richard F. Pops

Kathy, it's Rich.

to describing effect. I So their the right the I simple don't to program dose, for don't answer have And want question interrogate efficacy that longer really you're the because they you overinvest right in the think the able NTX. not is have until to dose

across be. We within NTX, And so I shown curve doses don't to response bandwidth. a not they really be IH, where a attention in that contrast dose they're NTX, on efficacy pay of shape of because all with lot and effective XXXX, their range of well-tolerated a to need curve the the where we've we can

of us. to response flexibility going for down competitive advantage ability curve that is be to think and major pursue a I the dose up So dosing, the

Operator

with next Baird. Our question comes Beatty Joel from

Joel Beatty

is there? LYBALVI For to quarters. go some know contracting, much recent How of added further I there the you've

C. Nichols

It Todd. a in continue pleased think I'll now. really, we're the We year. good and going with that negotiations. profile net upon opportunity commercial sales. payers, We're to continuing all really We're is well. to this really progress access those is This the comparing growth as to and position and depends Yes. that right volume discussions talk take to the

is focus primary profitability really sales. net and Our

would that, brand. to access, decisions additional to and make expand to year. next really going profitable But impact into some clear be So that volume back the it has we'll we has be to

Joel Beatty

this that ramping on us was like spending seems for tell again LYBALVI, Do follow-up about a front-loaded the program. as more more also up that this It It in anticipate year? And quarter ramping you QX. next year. DTC is down

C. Nichols

Yes, absolutely.

part the a as productive very important is mix, this investment DTC marketing of it year. seen we've a So really and

a will fluctuations little You upon our see quarter-to-quarter based strategy.

So going into we're the program, really QX, healthy returns. to optimize seeing and we continue

see more you'll obviously, and provide next the invest. more a to are to streamlined continue be get going but will good view year, the we into good got it more that on Going a quarter-to-quarter. We've We'll productive. when February, really handle consistent little bit most color, channels we're to

that's And to making investments. be those going we're where so

Operator

Our from Uy comes next question Ear Mizuho with Securities.

Uy Ear

So correctly. understand the make sure to we I guidance wanted just on EBITDA that it XXXX, for

indicated up operating expenses modestly. to I think you you're expecting go that

So sort forward potentially consensus before royalty case? And just that XXXX essentially are maybe away? million going also question SUSTENNA is is cut manufacturing to it the the going Do going of expand beyond you that kind of you primarily the due you -- the commercialized? EBITDA is, Is orexin INVEGA us second expect help the trend and the could the the from saying $XXX for product understand level? the to comes mismodeling

C. Nichols

for Yes. you're question. right. the Thanks exactly No,

at that's you as transitioning for think business have the revenue. on the the EBITDA we And focused missed moving towards folks I proprietary forward. are lot what think XXXX, I really look a of

it's the primarily of driven So by revenue. manufacturing the and royalty transition

to continuous moving on growth expect see products We our proprietary forward.

side missed manufacturing VUMERITY I pieces, shift key revenue and of the that the think one have folks royalty pieces the is the -- the of revenue. on

done manufacture things the a it for And to Biogen in basis. we've number on One -- put for a just of of years. that context, cost-plus we

of out converted the royalty. and revenue product the that X% a transition line hands, manufacturing gets Biogen's out actually into in and royalty Athlone we As and into increase

you're next exactly we see right you'll the will activities it end on side. the but transition through margin expense neutral in -- the So a be And year. and revenue decrease as of

at a trends profitable the second have XXXX. With in depend related investment plan force and run the on to franchise future. and business the do the And rate We sales research make. investments associated expenses, see and commercial continue EBITDA, regards this we R&D psych as the LYBALVI investments foreseeable moving our how to ALKS to on we is to increase with mostly as business that on profitable the ARISTADA for forward. your well will question, But to as increases that we for growth of a modest need

Operator

JPMorgan. Our comes next question with from Fye Jessica

Jessica Fye

we when you I talk the over Does specifically January couple for you arithmetic on X% had the just sequential enhanced? on it like you commercial starting seems of implies the gross if of that category year, starting access the the what is? But it heading towards Like expect the X how is improved that on elaborate continue. just should guide, next softness say, kind the about And any you nets you products. right. to ARISTADA mid-XXs growth, was said end think negotiated range then as Can that low LYBALVI the October step-up, my linear? have a X? And of in to a

'XX EBITDA context? how reconcile negative the do to you about stock then in that. repo of the trying a extent to there's reaction share commentary, the Just And that the think on back lastly,

C. Nichols

absolutely. start access the Yes, with I'll questions LYBALVI. market for on

So yes, impacted in payer remarks, commercial my enhanced as that lives. I QX that XX access major prepared there said another was in approximately million

commercial this year. significant which X the very we've will that's -- encouraging, year, strategy. Part Medicare which X had is D so of space changes our lead in And in next disciplined part the and That is space, contracting

year full be of reaction to gross that will net impact. the see You'll

that gross throughout and the And expectations is will the into mid-XXs, move the over to will time so that net year. be our

from quarter-to-quarter, should for it full year, mid-XXs. expecting but big step-ups we're the be in So not the

growth. now, but ARISTADA, came In schizophrenia is really look ARISTADA believe terms QX, schizophrenia part we to watch with at key seeing of we're in visits. through Right related market. factor as seasonality is marginal very market to also patient and the LAI lower that growth of we're market We seeing the really

there think So is impact with we that. an

in see of for terms we to breadth. prescriber growth the QX, brand In continue

part sign, believe encouraging of which we business, also the that an XX% our and we the encouraging that's about non-retail business. So persist. see represents within And of growth will

and us meet So will forth. through set we've of which to play the breadth guidance prescribing, is that allows that also non-retail our that, to continue belief

Blair Jackson

is And That regards you Blair. then of as this of executed We've $XXX million about Jessica, With authorized. we year. to repurchase, that now. repurchase about half earlier share have this was share know,

we've assess be To we about need way. we the the be business on may development that So repurchase. clear, for think our to $XXX by being how stock level, that done undervalued come moving cash we've at said, share -- opportunities going we our the the also business may and done that That share needs repurchase date. also for to of million forward. We're of this deploy is evidenced be which to opportunistic that is

Operator

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

Jason Gerberry

cautionary challenging language, redesign a D space but overall. volume the we an I your general see it's we the launch When Part companies just of Most and pull like to next them the have year. guess health it LAI see hear been like around sense Indivior off get already, trends of just overall LAI wanted market seems of the of tailwinds asked market. kind cautioning the

volumes general again outlook can business. that grow your on ever this So

beyond on Just that general to year. sense front wanted a get this

C. Nichols

This take Yes, that, I'll Todd. Jason. is absolutely.

in algorithm So not later line third line. a the we're typically change seeing for use, with and reserved overall, of kind LAIs. They're fourth treatment

that brands that's year when watching dynamic are said neither something seeing the of of react some obviously key a in that just expect brand new showing space, been is watch growth that phase, that closely biggest typical did we the we're you're see launched the earlier. growth. very Again, lower of And are growth. really of to couple are you So brands. schizophrenia we in is some The launch we dynamic your how the in as you a and we're The And there have the last launch HCPs those early is market. That's that. growing I brands overall will and that part in patients seasonality. There changing. hasn't change think

the seeing durations. molecule just longer You're transition a to from base

moving risk we're constant into be impacting that part we with payers contact a we some gross will So the constant as our is see And for in don't in something ARISTADA the see guidance, there net. overall. redesign, especially pressure, next we're year. with our That them to market payers, really overall. And with big in about that obviously, discussions that contact D and But Part of well. with we're that's and as don't

Operator

comes Our Partners. Marc Leerink with next from Goodman question

Marc Goodman

coming Because we how market. think settlements? about post-LOE we should model And Can us just a VIVITROL to that? is to the going the once in, you help competition have LOE, be how I can't normal this imagine

Richard F. Pops

adapt. the a thing even into is single It's parlance form important a you really particularly that late Richard. at we this really LOE, it is rates their be alcohol But its it's punch what the the unknown of this market I life think as And have of a And of growing we'll in to most the different And the drug in capacity realize to the and is It extent enter entering at is, saw. is coming that market number so it the was point. VIVITROL a we question. to unusual Teva. indication, the additional Marc, is one to in which untapped. is for they foresee entrant are growing, models. good which

So to we with see continuing field, in activity our the promotional grow. market that

a you'd And typical really don't the single if see real I see a there's But it. compelling for LOE marketplace, in so don't for the entrant yet. reason erosion. There's additional know logic we why no

indicate a have all of -- range the we models of but So a date. different past of them XXXX shoulder

Marc Goodman

Yes.

going maybe change. you're So the the Teva generally in, and mean comes continue a to like only little typical brand? support price to I the same a player where you're because lower other will of much be the you're they the spending not expecting situation a bit,

Richard F. Pops

articulated flex this if think case. that's would order That's you the spend be I key for base consider for will happened, our anything brand obviously But could the sure. our case drive to the I maintaining case would because base other benchmark in profitability. be we that than profitability what And just be to robust

Marc Goodman

I like, okay, after we happens Yes. next you're set questioning we growth And down well, profitable. the given to little there the we a that year after? about, it the think like, around, in bit going of of again I in will just the on numbers that guess, question to remain comment was that for really But And was was expect a should reset think I need think Or indications orexin? question the guess how about one all year what a spend for coming we working I level next the was commentary the the year. EBITDA? you're year, should the support the have

Richard F. Pops

can top drive the call make we'll basis, to we The an have on worked several cost years line and guess profitability. last substantial drive structure profitability. annual I we've but on we the

So 'XX be starts we're inherently profitability. 'XX as in the be dynamic we manage as XXXX see just talked see things But as be will 'XX coming as to going the pipeline evolve, than different competitive market, the change, than we we able to will to business 'XX, different to about market.

the tell to capital It's see in we've the building business level pipeline able the investing be and a to not on run question. it Board excess it's the to profitable managing you, been highly we avoid in plan. just when the and So while from down, capital returning to business.

it So year-by-year on basis. to that's the way continue we'll approach a

Marc Goodman

Yes. you find to And in buyback the want spend share development telling can't is basically business you us anything on?

Richard F. Pops

of you I question smiling when an plan. part overall all know asked you're it's because that

of have cash. We billion $X

but lot have of we burdened side on the with that we're away -- deals licensing plenty just team, a from, IP sophisticated they're their need at do looking here, pretty or of regulatory fine often or times. and But results diligence it's We reimbursement to the mesh space. to out walk we we're issues whether for. in there you firepower we're So BD that a experience And looking whatever. or in a the have all this

Operator

from Goldman Our question comes Chris with Shibutani Sachs. next

Karishma Raghuram

This on is for Chris. Karishma

Regarding be how to move decided decision? you will order the forward? in in a push-pull what talk an implementation since not the previously this compelling factors opportunity pursuing be does implemented going And assume needs commercially IH, support was of IRA, which for about to you can and factor you've to what IH this how say forward, to IRA

Richard F. Pops

And Karishma, it's It's Rich. you're right. excellent an question.

have indication as the orphan of we about well, that negotiation say, ran And became you'd numbers, why I outset, time, and a more think it single to the X in orphan additional a years' negotiation. for thought open from said at potential clear. couple up add you or things with would one exclusivity and would the exclusion

rare patients diseases And with probably First to is you'd change probability hurting of think also provision, love is which the X looking the from all, this the years of IRA in low. same various exactly extremely particular now. IRA. of things what's I It's

treated the going narcolepsy that are patients. With I putting that particular by U.S., could said, at forward Congress be are diagnosed patients because there the IH. is hurts it with aside, XX,XXX with provision if think this XXX,XXX in that and least one changed there

it well be and the we distinction that clinicians and because the X in the for and as needed us so because clear to the the IH data was is talk price this NTX as between adjacency market to same to blurring, will patients drug from in became clear, Xb, Phase so significantly expands years. X point and IH to develop them them, so the we which is the compelling And so show

to So say we're went to into going that IH. bore decision into all our go full

Operator

Our next question with comes from Ash Verma UBS.

Ashwani Verma

not with the really were I about line -- on some not -- the you're mentioning of inventory wanted side. you that kind were to quarter-over-quarter? asking reporting seeing you sales carrying that that inventory go I'm script back are on are seeing level what we to movement impact just you the growth any that. about you're in But seeing

inventory ARISTADA either carrying? VIVITROL, So that or are comment or there on you is if LYBALVI any for can you

C. Nichols

This dynamics quarter were Todd. with our Inventory is absolutely, expectations. Yes, consistent for Ash. the

We that's growth inventory some LYBALVI, demand. but for with consistent with continue see to

we're and LYBALVI, So grow And would our seeing, modestly stable. point, expectation is for the demand TRx that ARISTADA it is this inventory at is continue to consistent. support which to

Sandra Coombs

We'll please. question, take the next

Operator

with question from H.C. Douglas Tsao is Wainwright. next Our

Douglas Tsao

or -- or 'XX to you've I human pinch initially go healthy second orexin running good first, need you'll how to have be pretty data? to Rich, about want of Or know year? you where indications the I'm at you analyst the idea you terms on of X Phase you what data generation we go, volunteer potential do X -- yet curious meeting. molecules, different want what that to in Phase get Just obviously, a the in just the next talked much go studies program and several just the of uses the

Richard F. Pops

more it's latter. Doug, the of

the we one, we preclinical have running we MAD. that SAD think I we've of that to have assays, to still commit just to think in and sense, we're good number have prerequisites pretty until pick the although a don't the don't obviously. completed and a I But necessary formally

Douglas Tsao

sort don't asked And you introduction about I the of indicated the sort did see not because X injectable in pressure? impact. sort should gain think then immune somebody the LYBALVI, think being Or profile long-acting competitive that as LYBALVI's market weight of in which is the oral just that any you potential of see you injectable, olanzapine that of long-acting and you of Is just it is an market? same that to it make sort

C. Nichols

Yes, that's right. absolutely

market, So entire stay you the about the LAI just -- the class. molecules think within when typically the base

long-acting to see a from you'll patient version. oral transition a So

Our research orals. patients tell continues to us that prefer

X first gain. to more LYBALVI. about the tell X weight think first will That's the step of why XX% X% the of we weeks. oral. step So is you olanzapine, whole is within body And developed When the gain patients that an weight rate-limiting reason HCPs than consistently us the

the olanzapine-based so an for therapy. has become And of now care standard LYBALVI

So LAI we've this don't see olanzapine-based At now, that point solving solved we right that issue. an issue.

weight to issue, the going mitigation. be again, So core is

Operator

question today Our from last Raffat Evercore. with comes Umer

Umer Raffat

these couple I had make of numbers. sure a to on a just full I handle wanted

to I on it sure of of I'm is line? from of just what but that So $XXX the down million not that say $XXX is to sort EBITDA of million, to the royalty OpEx make sort move fair is on and mistaken. I'm XX% seeing, XX% want That's

Blair Jackson

Yes.

the OpEx on it's think the side. on I than royalty line more

royalty give with more obviously, as see the impact. royalty we'll But business, revenue. impact manufacturing it's is but our associated expense in and the impact think some from expanded not do We in have associated major guidance, investments the that I February. with as much we So

Umer Raffat

going $XXX like that's more not So be reasonable? Blair, that to to $X R&D just plus this billion. to SG&A clear, million Is It's million million. going year, $XXX $XXX

Blair Jackson

yet Yes, I'm to not until put there February. out any going numbers

be that going definitely not force line. on up line. the SG&A small going on associated with our see increase we're to We're sales very to disciplined a expense blowing expansion. We're So

Operator

Okay.

And would over have back question-and-answer the I the closing end the for session. turn floor comments. our of We reached to now company like to

Sandra Coombs

on the us joining for everyone, you, Thank morning. this right. All call

be questions. for available any We will follow-up

Thank reach to hesitate don't you. please So out.

Operator

concludes This teleconference. today's

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

Alkermes (ALKS) 24 Oct 242024 Q3 Earnings call transcript