ALKS - Earnings call 4 2023

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Operator

Greetings. Welcome to the Alkermes Fourth Quarter 2023 Financial Results Conference Call. My name is Rob, and I'll be your operator for today's call.

[Operator Instructions] Please note, this conference is being recorded. I'll now turn the conference over to Sandra Coombs, Senior Vice President of Investor Relations and Corporate Affairs. begin. may you Sandy,

Sandra Coombs

Good discuss to business our and XX, the Rob. conference update Alkermes call quarter XXXX. December ended to financial year morning. you, the Welcome plc for Thank results and

Pops, Richard and on Financial be Officer, our Officer; our reviewing are today financial Jackson, leave. me our Todd and Chief Blair who Nichols, Officer, Operating is Chief results Iain medical CEO; Chief our Brown, Commercial our will while With expectations;

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

conference our forward-looking materially quarterly Slide discussions statements. will annual presentation, expressed accompanying from Our cause for could SEC risk most issued forward-looking Actual to important differ X statements. recent these call the this Please see the with that reports this actual morning, press results the could in forward-looking materially and during implied filed include release of from factors or results differ those our our statements. and

or of information new We this undertake or update or accompanying result a no future obligation provided revise on information developments. the the as to call or presentation results in

for we'll call open Q&A. remarks, After the prepared our

And opening over now remarks. Richard turn I'll the call to some for

Richard F. Pops

great. everyone. Thank good you, morning, That's and Sandy,

an company productive major for strong and successfully year, which an one repositioned was growth. ambitious the in and last foundation and the eventful we Alkermes, a at agenda achieved XXXX So flows prevailed our We ourselves. We had us us, year arbitration established entered raise to to enabled reinstated we in strengthened financial cash significant XXXX and expectations. in goals matter balance our and decisively, set sheet which that J&J, with we for

agonist, for successful resolved also generating in which into generating type support multifaceted receptor the our in We to I ALKS on pending doing that, goal that X We orexin advancing entered VIVITROL's matter data Phase data year. this we were had NTX patent year relating another with X narcolepsy a decision-making favorable We Phase of XXXX program. protection, a II terms. in critical

the facility, multiyear our for by transaction business, our R&D completed company, We separation oncology announcing significant midyear. and is We is that which Ireland a initiative of to major of Athlone, operational neuroscience. drive delivered in and to resources manufacturing efficiency our of expected a the GMP on our focusing efforts element milestone freeing the sale close

And proprietary we also strong revenue our continuing from launch met LYBALVI. products, line including of goal top of drive to the continued our

as we attributes. X a Through emerge characterized Today, can pure-play Alkermes be distinctive by neuroscience these accomplishments, company.

products, revenues over business, core X commercial First, billion, with developed a driven by $X all Alkermes. by

Second, generation. proven for operating an efficient structure And that cash development significant business with capabilities an the profitability third, and advancing sustained pipeline. positions neuroscience

to with I'll commercial call the So as Todd performance. over to the an that turn intro, review

C. Nichols

strong achieved leverage morning, commercial products, proprietary Great. our our pleased XXXX our continue commercial in to to of XX% infrastructure. proprietary Thank demonstrate for and our everyone. strategy executed the to portfolio and are with X we we that growth year-over-year you, I'm good commercial Rich, of capture able operating each share across as we

disorder. million. bipolar the a atypical both LYBALVI with ago full We in antipsychotic LYBALVI schizophrenia and sales X Starting fourth year. net second launch, of with differentiated label its LYBALVI. oral X full for the year generated launched was $XXX.X and quarter that the of In fastest-growing broad, includes years LYBALVI

driven XX% the increased growth. XX,XXX Prescriptions fourth quarter, XX% quarter, TRxs sequentially fourth primarily to demand. million, reflecting the for approximately sequential $XX.X by grew For sales net to

at levels increased Medicaid utilization channel the from higher adjustments approximately patterns. lower QX and to end periods. Gross due the to to and in inventory quarter, onetime to adjustments seasonal the XX% net reflecting normalization widened of certain During purchasing typical slightly, related a prior

profile disease new need through place treatment We or their from demonstrate study bipolar health symptoms, establish disorder, up in a utility care or glycemic previous with X bipolar foundational and provider medicines forward of safety and In in patients was a had changes study in sharing and in disorder, disorder treated from to a Phase stability the X complex III X highlight to shared competitive years maintenance what for minimal the more we and X areas, The at data upcoming for which schizophrenia is medical parameters LYBALVI treatment their experience. option living people LYBALVI the in long-term potential with bipolar consistent that open-label recently to body look weight, seen extension lipid data paradigm a studies. we it's schizophrenia data schizophrenia meetings. their with with

in to range $XXX the million. Looking million expect we sales net ahead, of $XXX in XXXX, LYBALVI

of quarter we more expect growth first to the QX in flat patterns, to sales resuming For QX. be net growth seasonal with fairly due to robust XXXX, typical

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

to both its emphasize ARISTADA sales supported to initiation data expect by continue regimen, of $XXX of in are X-month value clinical ARISTADA as INITIO differentiated every range and our once option ALPINE million from ARISTADA's study. million dosing we proposition, For XXXX, which $XXX net the we including

at growth. primarily to $XXX.X quarter to VIVITROL driven X% were by flat In XXXX, Moving $XXX.X the VIVITROL. grew sales net million. year-over-year fourth sales unit in VIVITROL net year-over-year million,

by alcohol approximately partially year, accounts dependence opioid-dependent XX% driven in indication, the of in volume. was growth erosion the VIVITROL During the by Growth offset which indication. indication for alcohol primarily was dependence

dependence and and remains uptake for about that an expect As we sales $XXX team dynamics Alcohol is area. of driving these and growth to we VIVITROL underserved awareness persist XXXX. net opportunity, range in in to market million energized expect look disease ahead, important the $XXX million our

XXXX, net important our an are sales. proprietary important opportunities executing focused milestone $X optimistic about In contributions are products on and of the of to across billion provides to expect we in growth the the by the portfolio the company Each generating we ahead. than achieve for and company, more proprietary

that, will pass Blair. With I the call to

Blair Jackson

Thank strategy business you, Todd. In XXXX, and we profitability executed to the growth. position successfully our sustained for

business, and for results with the notably, expenses consequences. long-acting financial onetime payments settlement a the tax of factors, the VIVITROL onetime and of associated matter, oncology the had most operational, financial of separation Janssen royalties, such arbitration back Our patent legal the XXXX number of and reflect as INVEGA reinstatement which and the

results the the As of operations in of year of separation as Expenses our expenses outlined completion discontinued oncology-related a the fully are November, in bottom discontinued morning. result press line incurred and qualify our release this these inclusive during issued operations.

to those focus the of Across more That streamline continuing we and work growth. financial in relevant the operations as company on results the company going for forward. future position to are I'll said, today, profile the business XXXX,

believe With financial I pieces we well have the clarified as a neuroscience profile company. execute the positioned now pure-play to strategy business, moving mentioned and on and our behind the are we of we us, strengthened

to XXXX through you take turn I'll the then expectations. details XXXX financial minutes, few next the our of results, our Over

of strong product XX% by billion, portfolio, our total XXXX results nearly core driven $X.X financial year-over-year. proprietary neuroscience reflect of business. which grew our Our performance primarily revenues We generated

XXXX. perspective, GAAP $XXX.X in $XXX.X of line to income prior to million a $XXX.X a compared $XX.X and of From recorded GAAP million of non-GAAP a the bottom we net net million compared net million in loss year, income

Turning proprietary to our products.

sales For XXX% net the year, net year-over-year million, we family to increased million. the $XXX.X year-over-year. X% by product million And LYBALVI sales growth. $XXX.X Net in unit VIVITROL of $XXX.X recorded increased of growth X% XXXX, to sales driven ARISTADA reflecting

our Moving on manufacturing and to business. royalty

in the compared reflecting these were prior million in year, prior Revenues prior long-acting from to payment million and $XXX.X royalties million reinstatement recorded compared royalty revenues we in the products INVEGA the VUMERITY million $XXX.X to million the of to year. $XXX.X For $XXX.X $XXX.X year. were the XXXX. to and Revenues manufacturing in products related million of back $XXX.X year, the compared from

Turning year sales by the proprietary increase of net Cost $XX million, million, approximately a sold to operations of were of to $XXX.X XXXX. expenses increase in goods driven continuing for products. full reflecting related year-over-year

R&D program and clinical $XXX.X investments million focused were our reflecting flat ALKS products. operations our activities the continuing in related year-over-year, for XXXX and including support proprietary to neuroscience expenses development programs,

SG&A the and launch expenses to of related primarily to increase XXXX. million expenses. continuing nonrecurring the operations related in was prior were $XXX.X LYBALVI to The million in investment of compared as legal year $XX

the of we and related the to partial fourth a business onetime a operating More issued valuation our of During loss be the net million, detail press sustained is of our going of carryforwards Irish net in our to oncology adjustment forward. primarily profitability $XX.X recorded tax can in allowance a the morning. this year, benefit release quarter. by driven due expectation the found separation release This

year, and the operations significant work business the of to undertook During growth and profitability our enhance forward. streamline going we the

on flows, operations While non-GAAP GAAP and generated and we profitability from million, million. EBITDA million, focus of income continued of this net and with of continuing $XXX.X our from $XXX.X operational continuing efficiency underway, work continuing income was cash strong net operations from operations $XXX.X

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

flow. cash we to business ahead, Looking the continue to generate significant expect

the customary cash and be purchase year, In sale will the addition, in $XX.X manufacturing expected of subject to facility Alkermes facility adjustments to this closing accordance the a Ireland payment entitled to of upon with Nordisk Athlone, our the for million of agreement. assets, later related Novo onetime

outlined I'll for were shift morning. XXXX. release expectations issued our press to expectations and the this now X-K These financial in

to sales reflecting range to growth $X.X led expect products, expect exceed total our $X billion, by LYBALVI. the be continued and of billion to from our for top billion, line, revenues the proprietary with net Starting XXXX in of proprietary $X.X we products

the revenue XXXX. August the previously also of total sales year reflect expectations in the SUSTENNA expiration INVEGA royalty month for of disclosed to related the of X U.S. Our

our expenses of $XXX the sold to of the reduced our the million. be focus and expected across Cost XXXX efficiency In XXXX due range terms expectations of oncology million of to items reflect for in $XXX line on profitability. spend are continued and nonrecurring expenses, other goods to business, all separation

of ALKS preclinical orexin of of as $XXX approximately as reflecting products. to and business. are million decrease R&D spend support million, for portfolio XXXX other disease accommodates R&D be in areas This result $XXX activities oncology compared the million of narcolepsy our as separation program additional XXXX the $XXX of expected Phase the of level well work advance a a in to expenses the to II initiation range to in of proprietary compounds

of levels $XXX in million, to for ARISTADA. are LYBALVI appropriate be expected $XXX range VIVITROL investments of and SG&A in the expenses launch reflecting of support million the and to

With rate our in expect of enhanced approximately tax effective profile, XX% XXXX. we an profitability

expect We of range in $XXX non-GAAP $XXX and GAAP in million. net million million to $XXX range to EBITDA of $XXX million $XXX range be million, the of $XXX income income the net to in million, the to

this line billion we and have business we've the With going to strategic operating $X forward, expected a positioned the needs profitability. calibrated year, the exceed proprietary top and company growth a carefully sharpened for believe of is that product to structure focus support significant an we

I'll Rich for of allocation broader now hand discussion strategy. call to the our a capital

Richard F. Pops

That's Blair. great. Thank you,

a and and approval medicines, successfully group have developed generated novel small companies of significant So joins them cash Alkermes for that biopharmaceutical profitability commercialize regulatory flow. and effectively secured now

allocation capital our importance. distinction, that takes strategy on new With

are near expertise. with focus. commercial decisions and now growth, designed scientific by it company, pure-play allocation a starts and capital neuroscience leverageable is and a Our demonstrable long-term Alkermes drive guided to and with framework

current are intense most is commercial near first and products to the to with deployed of designed Our term. of to growth support investment the over maximize These medium investments growth drive our the priority LYBALVI. currently the potential

early advance our and and that each and gates in translational criteria neuroscience discipline significant new with with candidates emphasis programs. pipeline an data. Second, for and stage are R&D Investments in drive ALKS can we'll clinical value, invest predefined rigor additional to program, on including earlier-stage XXXX and success with develop made

leverage internal align efforts, neuroscience the focus. fit opportunities to a our expand our beyond portfolio assets fit. capabilities strategic that infrastructure with explore these and efforts, are expertise we we and assets development strong as core to to candidates In plan well Third, with within our prioritize will external as our that commercial

organic And and capital allocation prudently excess needs our to is our capital to strategy the of growth fourth shareholders. beyond element return inorganic our

plan up looking program As years. we which the to for flow. significant Directors ahead, Blair deploy continue to next This business to repurchase share the expect mentioned, our week, approved opportunistically a Board several million, cash to we $XXX of generate over

expertise, pipeline on programs the for year. accomplishments now set a toward building concept, and future. for sights with We standard a potential there's With strong biological payer our the the design, for key that of advance significant importantly, early this care work be the rationale, patients. challenging we gravitate Augmenting a to us, the align this strategic the intense significantly our proof company priority behind clinical and of XXXX business environment, of pathway clear where will and molecular the with in development

track ALKS XXXX our data next II. program acceleration initiate opportunity. and on are The one to supported Study compelling, quarter. in Phase underway narcolepsy start-up were now, the type activities represents of from Ib with such study into patients we're the X and Phase

dose cohorts. process these The Phase Phase inform and the narcolepsy study enrollment initiate world, type for ALKS and possible. a Data study. XXXX them idiopathic working Phase of of II for completing from multiple be For X the will conducted will we as as sites at Ib we're selection potential the quickly program around cohorts II are in hypersomnia, to

to the you company. our continued we and the by enabled is work past the years we look progress, updating set for reposition shareholders. the significant be company, and the And an important several forward to appreciate of XXXX support year over to on our exciting

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

Sandra Coombs

Rob, for will the Great. please. Q&A, we open Thanks, everyone. now call

Operator

with of will Sandler. And from today our coming David question Instructions] Amsellem the [Operator first be line Piper

David Amsellem

Just a couple.

they cutting do -- you My in out, some I'm to that the with NTX. Richard, concerns tox. not Takeda forward moving sorry, make is TAK-XXX what dose the liver capped first, about due understanding So

make your you what thinking? do XXXX IH. us here that And for what the relative like that? you Any for that changes I remind And NTX? XXXX? guess, regarding and question NTX Can is, secondly, does picking in in what dosing just brain, your then to just of looks mean there

Richard F. Pops

David, for you the thank question.

be study a drug like into orexin dosing XXXX, to that going premise higher in is X than significantly in the the So agonist receptor of have narcolepsy NTX NTX. will

On between is to but with the XXXX. we -- to would Xx what reckon our Xx Xx to order, see you Xx assumption Xx,

dose in us Takeda, early they necessary range that the move that enough for So have to NTX it's higher not flexibility surprising January, that gave dosing NTX. might with to update they beyond not into

in emerging. that cohort, encouraged pharmacology particularly seeking NTX therapeutic had the wasn't we're sort they we of it were and So surprising, reaffirming all that actually in to to see results strong the this exploit class that's

remain With testing in we IH, and as blinded those complete are XXXX, we enrollment. in we the NTX and

IH. exactly we testing We in we see see volunteers, because when up you if data are saw the doses patients to just work to doses how Xx necessary, the those Xx NTX to but that NTX. translates higher, -- comfortable in that with And into did healthy feel of to and from wait and going the we'll at that the

David Amsellem

your competitor? regarding your And view then

Richard F. Pops

to With them respect NTX? in NTX or

David Amsellem

-- seeing one I this where NTX. that in to it's mean, markedly you're another? question behaving Is the these of from another. class I to sort guess one just it? a is, about are that you molecule differently the just think And way is make should hard we from In drugs Yes. comparisons vein,

Richard F. Pops

think look exactly we at I it. that's way the

clinical demonstrates seen program, fundamentally, properties, program, Takeda already ] that [ we think out the -- that with bearing the believe with and are different because molecules our it that Jazz significantly these program. I we've with

the are liver their Takeda efficacy outcome. toxicity, as fear and point, fact, in unchanged limitation to earlier, And see I given of dosing And underlying result. said surprised by weren't or at of assumptions potential that to so the our we respect the the with this NTX in

what that in same Now it with tolerability -- the do NTX. now and that show we have remains IH NTX to is have we we in way efficacy and cohort, the

at first the were the showed we So by Sleep data cohort. World confirmed full

cohorts NTX the from weeks. first we'll a the IH similar in unblind Now data we get and few when

Sandra Coombs

ready question. Rob, the we're for next I think

Operator

Jefferies. The coming of line the Akash question will be Tewari next from with

Akash Tewari

will So hours? given in of NTX to is the [indiscernible] team your insomnia, aren't XXXX levels XX X and as Rich, that imperative that XXXX half-life patients patients how these concerned NTX NTX, induce doses efficacious is have about

And trials, you Are will when medication make taking sense to maybe in Phase protocol there any on patients can concern? your the II be any with that adjustments right? help

justify And then DTC on LYBALVI, what's its XXXX LYBALVI program internal guidance? what is the hurdle cost investment? of to in the ROI your And your continued

Richard F. Pops

take I'll Akash, one. first the So

about like the we things the of we've along half-life. is dose one seen the proportionality with XXXX So that

the increased -- X duration in and X, that from saw you as to as saw to and thereof. escalate you X So you NTX increased where cohort, you wakefulness actually

we data, our my on the the as in to threshold changes original hypothesis which It unchanged. and are, of -- the in face I we're So said of PK only is respect in NTX with dosimetry the obtaining.

indicator as to clear, just AE, insomnia, be actually So it's of an efficacy. an

And if at had so would And whatever so had the about you that. mitigate insomnia in lower the be a to solution you if persistent dose, you have you -- dose. I think would concerns doing, obviously,

But that background patient right. a where of that in different are IH the patients, patient there an thereof there NTX orexin is the you're and have normal. just agonist for we'll is much see because the of NTX in detectable whereas They none, levels superimposition an than entirely signaling orexin, not

C. Nichols

terms the program, in LYBALVI of for question. And DTC for our thanks Yes.

launch of went last is then our ] linear As you our campaign TV TV, actually remember, year, digital and launched we campaign, campaign, in on we might at DTC at [ beginning QX. assets 'XX, on our our full which pushback midpoint the

HCPs, the as just of important part program our of within I access. patients. just response also with far awareness. from from It's it's mix, marketing with to building a also driving And important part demand we're mean, physicians and an really market overall pleased but really so the

just I think starts. the patient best effectiveness to looking at at way overall now is new the look right

We towards continue in growth bipolar than And then we're mix patients to nice more to see schizophrenia. starting going that with new of grow. NBRxs saw shift the NBRxs. a So in QX are

So in for bipolar fourth the about quarter, XX%. represented NBRxs patients

So nice campaign driving and it's a gradual shift lot shift. we that we're -- that a our that that's DTC think a seeing, of is

website of indicators, All patients, requesting granting the we walk what point with it's leading product, patients watching, in keep rates, Grant digital our of assets, a direction. is which utilization all the awareness are HCPs are that when the heading into levels right key and HCPs -- the visits the product. office,

our right now in So right everything in hitting the view is direction.

So our plan to is XXXX. that continue in

Now, every reasons, I'm the We going patients single is you plan adjustments this competitive that maximize of quarter, make and single into I details our all we not 'XX. but to every that, watch will of to and let get for know in activate fully quarter.

Operator

the of with from Our Matteis Paul line next comes question Stifel.

Paul Matteis

the Congrats guidance expense on and discipline. the

Rich, the like potentially to That about you're it When was here. what meeting looks margins, your wanted I exceeding you [indiscernible]. of of light look ask in or goals kind on at your comments,

what's the context cards, debt, X margins of sort money Like see if how in here where X of that side, the over doing over to company your issuing years? you structure thinking the do going more next any kind the could going Where the targets is there that spending be P&L whole play you think of could time? of? development goal? R&D And Are on business peer you're into

Richard F. Pops

I'll and for then has Blair start the it. Paul, provide any color, question. please if thanks

we clean years now the now guidance a transformed I XXXX, complexity by it X But how do the it. few enter and ways. reflects now think Our is XXXX, of to taken it's and we've One, the is. 'XX that cleanup, XXXX, in the company, it view

Board levels, to a on Our view the sustained, out. be management profitable we're here at level, company from going

with we'll its to expansion clinic. drive the on guide we and how aggressively manage to But So pipeline XXXX derivatives and think respect an profitability, we the in expect we annual basis prosecuting business. can

monitor the line we'll Obviously, year. top each

flow line As sustained we we is line the expansion profitability, pipeline generation cash all and forward. that revenue light how in growing. expense going of to grows, see the accommodate But

add? to anything Blair,

Blair Jackson

we The thing provides clean you need us forward sheet, be as move I'd also, opportunistic can that mentioned, is we very as add, only we have a and Paul, and that balance optionality we be. as

Operator

next line Our is the with of Jessica JPMorgan. Fye question from

Unknown Analyst

control run not, on [indiscernible] for reflects we Jess Two roughly This company we The to sort should expenses. the if nice maintain XXXX how is should of operating Is on over expect next from years? us. about Fye. questions this really few think rate the that? cost guidance Or

have NTX confirm in And can on you patients disturbances then dosed so secondly, far? or whether IH of any visual observed been the XXXX, any

Blair Jackson

is this Well, with take expenses. first Blair. the operational Great. I'll question the to regard

years across a structure disciplined carefully And on long managing the So very move time couple we last really organization. of over you're cost at spent as the being right, we've looking forward. we that plan our and

growing in business But being with line products. lines future. moving foreseeable in a in we're in That to healthy envision, the we Rich those going investing grow, the that research profitability said, our said, maintain be forward key I as continues think will as to margin can development, and you business, investing that

Richard F. Pops

And XXXX, blinded. we've remain released on the with NTX respect as any we IH data not to

Operator

next is The Goldman Shibutani line Sachs. Chris of from with question the

Unknown Analyst

hearing question in ended seemed back up to for had came to middle LYBALVI, fiscal for the was This LYBALVI LYBALVI 'XX guidance. year, of fiscal Chris. earlier over And just that a on Maybe last towards end I we're recall, trending where is that the that in now 'XX? year regarding I towards Charlie of more shifting year the commentary we range. year upper seeing

guidance? 'XX may there we at wondering year of we implications are and Just the changed have year need mind course what the that in look whether over fiscal to when keep the

I commentary KarXT the later as could a year? hear the team if of wondering we around quick approval potentially changing potential Karuna some sees the from how And market this with then was just follow-up, schizophrenia

C. Nichols

Yes, absolutely.

as questions take those I'll So well.

overall. So for $XXX.X the sales year full XXXX, million LYBALVI were net

also down, to some patient some visits. a of QX, overall in we draw due softness and seasonality saw remember, inventory might bit You with little

year which XXXX a that see QX, TRx the XX% recovery of demand-related a nice story. led to full Overall, really of growth. into was do We

our year-over-year, supportive bipolar So research, right only of utility And HCPs, demand we seeing encouraged now, not schizophrenia. all of to with. which over really LYBALVI but we're a also they're market for of grew XXX% talk disorder, that's when very within lot within

competitors the entrants is we be into sometime we watch something closely this KarXT There product that later could indications, that about potential schizophrenia. -- on marketplace, new year. of be which that think this of that's way very is would our is, overall. approved the a terms In The that approved in one is

contribution I that it's remember TRxs to equal important -- LYBALVI bipolar from basically and think schizophrenia. an has from from disorder

So product. utility there's the broad overall within

the also important talking of well, -- to marketplace. HCPs the the that in as is efficacy one in We really attributes believe most

So LYBALVI. a the if thing to want that's marketplace in good product, schizophrenia we think were thing, discuss into that and a and come for strengthen really would the they and good any overall we be perception and actually think to KarXT, that's efficacy,

sophisticated to But regardless overall, commercial into ready couple built marketplace, ready, we're of And the we're infrastructure. last of the coming really and compete. years, we've a entrants new any

Operator

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

Jason Gerberry

you if the a probably little than can on like inherently provide update This the level be Coming given patient at about any the think all if might perspective just I'm update to noisier the variability. versus can just we update, when seems that? NTX get comment Rich, on just back wondering NTX data how to you wondering update, MWT the NTX but XXXX, the data

Xx? you guess, Is like hypothesis exposure a there's at wanting seems sort then there go prior a on level hypothesis. NTX is get Takeda's wanted liver to your trigger it least I not beyond? don't want a dose toxicity just to Just Is that and it It based from Xx? commentary, around sense. of with And to dosage

in a So setting? if that want just don't there's IH curious exceed sort to the NTX you threshold of

Richard F. Pops

Jason, I a think thoughtful Yes, question. that's

first set hypothesis, think NTX, so X in remain That's we'll blinded latencies, the inherent is up from data under I minutes. all These test. that, people described. the latencies end, to that minutes range sleep and where that there the you pretest minute to around IH we What we the presented contrast sleep or with NTX, as or as somewhere see XX expect exactly to in -- XX a low NTX variability. that were in

So ability looking with to profile. that fashion latency change what actually we're for acceptable in is the an dose-dependent tolerability a

saw to well do So NTX, be be way we the affect to and doses quite responses we each in uniform able we that are so in but at patient as and in don't acceptable expect expect tolerated. to a wakefulness clinically do

that's we unblind data. when we'll So what see the

in we're thing doing threefold same in did a patient only all the regimen we our priority. and a we higher or NTX and We're Remember, the placebo sequential We X or X of X, established a doses, testing thing. fashion. and IH, those randomized milligrams that doses two picked NTX. same range of three received advance for -- fixed we in X The with or NTX test, chose to each

the we data. could We have need be too could have we could the range to for we we low, high, too So the unacceptable NTXs. be could we for beautiful see just tolerability, dead dose dead tolerability, find that be pretty happen on NTXs. much could We to on

cardiovascular to answer to dose, in seeing we're than without tolerated see only But to the any your higher going need without But worried we We'll make priority. whether we volunteers, and signals. need and question, other not adjustment. maximum milligrams the just XX we data a healthy the to that declaring the about or decide selected doses escalated our remember,

The molecule, generalizable that's phenomenon see for to the dose orexin for We a toxicity a receptor dose-dependent final point liver the be that's won't dependent class. believe that phenomenon and believe general. in is that, you that that is not don't -- agonist we that is particular

Jason Gerberry

know Phase if protocol? requirement there your could question [indiscernible] I planning? and from visual it. follow-up, that gotten a we've it's a Got in if one a in Rich, And there'll just investors, squeeze driving II driving that requirement be I and is regarding you're disturbance

Richard F. Pops

we is effects to a be something What required will assessments in make Phase to will drive. to we are precaution visual dose, if You That's want there matter be on-target sure we just we investigate visual joke. II. any a as understand, that's doing No. be not will of doing at

Operator

is question with next from Our the Charles line of Cantor Duncan Fitzgerald.

Charles Duncan

strong on transformative a 'XX. Congrats execution,

pipeline then question I quick LYBALVI. had on and on one the

pipeline, the or of of just narcolepsy? on I'm provide treatment timing NTX? versus terms wondering can And -- guess, NTX On II any you XXXX. the and/or transforming of in if more your the design NTX Phase on view regarding granularity a in the the for perspective of being I important

Richard F. Pops

the for question. is This you Thank Yes. Rich.

II Phase is parallel ] in very arm [ for design NTX study. a the actually straightforward design So

period. randomize washout we'll placebo, their we'll arms. a patients X of on evaluate dose to a be assessed. X-week subsequent a X, X of will and primary will or That at or A safety maintenance assessment XXXX milligrams that efficacy or will be then them medications of be to. will that's where extension X wakeful over X So test the -- X-week move And all existing patients after there

So also the with Sleepiness Scale, test, patient rates and cataplexy capturing wakefulness in be NTX of maintenance along the will Epworth be primary population. the endpoint we'll the

look study, said, patients, placebo, there's NTX get similar we're NTX, parallel not for data. to study we if us at NTX. I data, to successful the the cataplexy very look as at NTX aside, X-week but with basic X and an the we'll the when expect the But architecture, design, in As -- sense we in doses makes looking

the that I NTX a starting of bullseye, of deficiency is think orexin. the at core

shown orexin and blank that an profile, into others clinically reintroducing have we that we meaningful agonist can dosage So drive intolerable form. now wakefulness and

before, tolerability I and that the tolerate X fairly as curve we But human dose that can -- empirical doses, the data. that shifting But diagnosis shifted NTX. meaning agonist can more as require that to see fluid. mentioned expectations, IH. the also the as as in they orexin as curve not the is will -- has the And response we'll sensitive they're and NTX differential between doses higher think well, I with patients is because higher is

major NTX. medical hope drugs and itself, could by if others that commercial and to the have, they a Commercially, innovation. I meet the treatment these of we transform is That, think profile

extends If NTX and it implications to there's of that. IH, X

patients narcolepsy. other therapeutic number much that can two, outside their for indicates in wakefulness, bigger opens set, products it of But potential agonist First which up a an opportunities affect background, market orexin other existing is it's indications orexin obviously. with even that we

we're So seeing interested data for in those reasons. those quite

Charles Duncan

a that the persistence sense. drug? Makes being on LYBALVI, Is How do growth color. your terms or and Quick persistence you the growth. more bit question the expectation? a perhaps [indiscernible] brand exceeds view or Appreciate refills driven in this year by of into on little

C. Nichols

I the question. overall, Yes. a all really are really, across Absolutely. those important healthy dynamics right really would X now. say, It's

at look just just we which TRx XX%, QX, quarter, we if encouraging. First, was finished this was really overall demand

both over at category full the is which If look for branded again, metrics X, it year And at XXX%. great. the year, you led those of

having on a and And very market the product a it's they they're are to of so -- that are experience, utilization. HCPs utility the expand finding patients we consistent hear us lot our that planning good have what their in brand they for and with tell research.

So qualitatively, a good that's sign.

also We terms consistent olanzapine. this we're rates that level of at We it's look data. of better in now, terms than with there. persistency in levels as are encouraging seeing and category at And claims persistency refills. been well the look branded very Right

just And of then again. I'll kind reinforce

that showing released, are efficacy. of at durability well, discussing really as also of be long and meetings showing that prepared too. heard [ X profile that patients metabolic the just the on to AXXX for important durability remarks some been we're weight You in have term was They're my some They're low That's year. going gain, the approximately this product years. medical the information. ] Those data

term. the long to expecting that levels going that's we're reinforce persistency So

Operator

Umer is the with Our of line next Raffat Evercore. from question

Umer Raffat

for to X So narcolepsy data And with Takeda dose upcoming some observations go knowing previously? And type don't X. not of and levels disturbance IH, seems move for you those visual in obviously dose. above we realize about you wonder, XX want the forward the know they is XX of decided to milligrams I XX like single XXX. I narcolepsy type thinking of how to that at might are doses been because have milligrams it

Richard F. Pops

give on our earlier know current to but you my responses if don't this, heard you I view. questions I'll

of versus driven to by in clinic. compounds with the our NTX as respect predecessor is well own as experience experience Our hypothesis the NTX

well meaning terms to expect to we as are So response expect as and Xx shift the higher. both Xx that doses efficacy, we tolerability of curve, dose we're in dose to testing

shift We tolerability to profile expect the also along with that.

So we'll the we unblinded, learn data get as how plays that out.

in expectation more the sleep in But in variability patients as our MWT test. that NTX terms lot baseline their of is be latency before, mentioned a the there'll I

for doses what we manner tolerated. in dose-dependent And a we're so shift can are well that looking at that is

designed that see right the dose So hours -- that study. across doses, during that's every a to MWT, X well a XX-hour that of as us and now, we the across single response allows multiple run period test exposure it over what which durability response in as is both

the So being it's the a saw NTXs. replicated in data-rich format NTX in that you

that profile dose. like tolerated didn't milligrams in flexibility maximum the XX we feel we at So a we to where lot [indiscernible], the declare tolerability established of us dose a gives

priority NTX to IH. So they're low, have those, too we've at whether correct, or see of these study doses unblind whether tolerable we not they're we those picked in But whether When we'll to to should our too hypothesis high a be be drive pretest any dose at acceptably data in wakefulness. replaced soon. But that we very dose theory tolerable. is wakefulness that's drive by that able will meaningful and

Umer Raffat

going Alkermes -- discrepancy visual that how reasonable and versus Got opinion in been to disturbances factor there's view. are it. milligram? in it visual your it XX doses like opinion some know is at gating Rich, those Is I looked a your assume the And [indiscernible] at disturbances not to

Richard F. Pops

first the establish principles. let's So

XX that all are disturbances above so self-resolving. principles doses visual moderate. They milligrams. we healthy evidence saw volunteers First They self-limiting. in or They some mild of were were were at

things -- visual what or photosensitivity that. We which healthy We've and volunteers. in of disturbances reported these So differently, photophobia, have that. might reported the patient disturbances or a reported was people other categorized blurriness like we by hallucinations specifically meant vision not and visual

We also reported, X we did and not see them in the full NTX milligrams. cohort that X, we X tested at

the they So in to dose-dependent, they the we they're to visual present than to extent wakefulness threshold [indiscernible], not present, one them there that drug. extent interesting transient, i.e., And small which they visual is earlier that saw that yet, for if that much self-limiting, disturbance. correlate the the a haven't our be dose anywhere transient dependent, the it'd limiting them is view see we saw are a presented, where mild, be i.e., would seen to is extent you might disturbances

done more just out. it AEs. daily here lot the instructive be study, Phase figure needs And So to we'll that up in to and more. all on be will target? in that's a be I picking weeks, science we'll here, be really there's II dosing we'll Could I these think for But think Absolutely. know be that consecutively X this because of --

And thought because about is the from passage on be based these we've the with will AE and single doses what of AEs final make heard reported drugs point leaders change the patients is I'll time careful determining accommodate time. your that, profile over their

data the we full complete see Phase II. when so And a set we'll

Operator

Leering come Partners. from the Marc line questions Our Goodman next of with

Marc Goodman

Two questions.

this changing to just years, you next for whether strategy and expecting we year can review and over that First, continue about be to talk how of you're the the couple the thinking net? about it should there. Just gross LYBALVI

VIVITROL, And they this growing happening color and on little is dependents, the expectations just completely? quarter the more growing, that. Just is is little a maybe dependents versus then just from opioid year? Or help just what declining one also, both -- us a is with with are faster? mean, alcohol it on I opioid secondly, the your

C. Nichols

Yes, absolutely.

both take I'll So of those.

gross First, net LYBALVI. to with

to was higher The XX%. driven utilization approximately gross was some QX, events. for So increase Medicaid by net and onetime

point. at stable is that it going year Our into the expectation should be this relatively

well for full the and in widen. will some it sign we're XXXX would I as that year. additional So for be upper constant that's is XXs. we expecting payers, say expectation discussions would we're net in extent gross that agreements that with the do that the what to to the But

opioid the In dependence QX for Americans. And terms dependence, did growth that's largest of strong really VIVITROL market, than seeing with some see phenomenon. We of in the more you that's, right a know, as really XX is strategy. million part subnational but now, headwinds our we're alcohol

care So dependent. dependent. it's It's state setting of

a more decline the was alcohol little that. dependence actually for a there overall bit So indication, that is offsetting of but

continue from after really VIVITROL strategy and to brand So the coming large is, all is go And the really last the dependents. volume we've the through drive over our transforming of alcohol of market And again, alcohol units that to several through strategy addressable are XX% dependence. been years. our very is

Operator

of line The next Ash UBS. the question with from Verma is

Ashwani Verma

Great.

on X have I So LYBALVI.

plans? where at us year, half First second like during contracting? update process? you are where you you of were we presence in commercial LYBALVI one, the the expanding commercial previously, on that looking can last more said think you are in Just I this

second, then LYBALVI, still better still bit a of little a And issue, but than for olanzapine. so there's weight gain much

versus not? products as bit would consider is, on more obesity willing LYBALVI be a patients affordable my these weight-loss to commonplace, little question So become more in drugs these

C. Nichols

Ash. Absolutely, Yes. take I'll that.

So in formulator upon payers. X Medicare you as access of channels: is And terms of commercial. access, really know, the we and those market access, each market the design there's way about dependent Medicaid, think really that of

for a strong very and has access patients. access to there LYBALVI pathway is

a that we to patients think balance terms reason net, help very healthy providing about to The once on start we plus back. therapy. get of know you difficult So that gross we contracting in why increasing do it's is services this of that pull to

primary focus unit. profitability So our sales is for net really each

net we we And have the individual an And the individual versus and constantly expectation net discussion -- the that at at where that have on But really for Our volume payers. net opportunity by gross to to expectation And basis is to each focus look sales. discussion what stable look is is our balance we expectation. commercial payers. constant we each to would we're we year a ended. with relatively gross be it's

similar point from think available of patients. perception the right majority the is that we be agents. other branded to this We hear the At access HCPs, to now, that their that to is continues LYBALVI

So not as this a step right seeing point rate-limiting at we're that now.

with step a big rate-limiting gain, terms also developing metabolic LYBALVI. always olanzapine, weight That's there addressed behind terms profile in was it's and -- that In with the of gain, was LYBALVI. hypothesis we weight that and -- the

actually that upon benefit just supports The utilization. treatment. continue see is a our olanzapine, so the based foundational it gain going we're for And expectation to to efficacy now weight of right therapy be to to broad maintenance

happen strong demand be going the So is weight LYBALVI for to will in will some products of with see 'XX. the that to into come that we our determined loss continue But expectation be yet what's to now. it right marketplace

Operator

Mizuho with Our from is question Ear of the Uy Securities. line final

Uy Ear

guess, for I VIVITROL the are LYBALVI ARISTADA -- a little not the and you, speak what's for Could XXXX? net LYBALVI, expectations gross and for bit -- about your

able little, XXXX you can about out of in XXXX? versus SG&A speak also, be came If to of that'd were the sort quantify you what great. And that a

wondering Just planning XXXX? DTC going how into on much spend you're to

question. quick and third data the for NTX IH? for a timing readout And What's the

Blair Jackson

Blair. Why I the is just don't with SG&A. This start

where year a I number it recognize year it's to becomes So compare to a 'XX, important such were that of activities complicated that because had think that for as you 'XX was ongoing. us, 'XX difficult a we

running we're We have driving an efficiency ensure item. line efficiency on every program through the we're that organization to that

G&A expenses SG&A, with in business. the of onetime of Mural separation in that, associated Oncology particularly along the the element had a also We number of

really So the those 'XX 'XX. and between difference things predominant drive

I'll specific Todd And questions it turn over to to answer DTC. on

C. Nichols

Yes, absolutely.

really starts. -- feel [ see assets. we market again, good tested in benefits to campaign patient the ] of research, starting about that It TV and to well overall DTC, of that new broad we have. It's plus includes we're digital very the program terms In a

the Our going watch we're it very it quarterly watch XXXX. DTC. level, invest in reasons, into a the basis, and competitive to we obviously, year. but plan is not specifics going to the to to continue on for get spend throughout We closely that on Yes, continue in I'm

with In recent for the terms ARISTADA, and gross to those to VIVITROL consistent products trends. we be of of both for fairly net expect

VIVITROL ARISTADA for XX% for approximately approximately and XX% for XXXX. So

Uy Ear

expect I And Phase NTX when for IH do you the the and study? readout

Richard F. Pops

We're Rich. speak. It's we as completing that enrollment

do or clean I'm what we'll early fall. until but Sandy, summer think data, data I is to medical top immediate those there's because the not So we probably when looking an up line those meeting

full So wait disclosure. the results it'll probably then give us for medical a sense on of meeting for a the line and top the

Operator

we've of I'll the end call reached now the remarks. time, over Coombs session. closing this for Sandy to At turn question-and-answer the

Sandra Coombs

Rob. reach right. you. at don't the joining All company to to out everyone, Thanks, us call us for the today. Thank follow-up hesitate Please any for Thanks, questions. on

Operator

concludes conference. This today's

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

Alkermes (ALKS) 15 Feb 242023 Q4 Earnings call transcript