ALKS - Earnings call transcript Q1 2022

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Operator

Greetings, and welcome to the Alkermes First Quarter 2022 Financial Results Conference Call. My name is Rob, and I will be your operator for today's call. [Operator Instructions]. Please note this conference is being recorded. At this time, I will now turn the call over to Sandra Coombs, Senior Vice President, Investor Relations and Corporate Affairs. begin. now may you Sandy,

Sandra Coombs

today Thank Chief you. call update Alkermes conference and With to the Iain our Brown, our Officer. morning. discuss our Welcome CFO, me XXXX. to XX, business Nichols, ended the Richard financial Pops, quarter CEO; our Plc's Todd March Good are Commercial results for and

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

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

Iain Brown

into momentum our commercial and business the continued on that's LYBALVI. XXXX more first with launch pleased I'm the product portfolio, built of to leverage strength results becoming the efficiency, of hello our proprietary Thank Great. and company, you, operating commercial that have ongoing demonstrate the Sandy, we evidence quarter our the focus across everyone. report

which these Based long-term achieve year filed release a X-K our We our first guidance we are strategic execute on was and XXXX, targets. are strong in today profitability priorities the quarter reiterating press financial on detailed this February financial our XXth. results, full-year in earlier our to position and for

For growth by and launch XXXX, VUMERITY. growing VIVITROL of revenues total ARISTADA, million, year-over-year of strong quarter the revenues we driven of LYBALVI, $XXX.X the of first and generated from

Taken net and product our increased from year-over-year. from together sales proprietary portfolio commercial XX% revenues VUMERITY

net were sales by levels XX.X% to million a net generated range with $XXX what family in $XXX net net to to primarily million. we expected. sales volume to the the saw first XXXX. inventory sequentially in driven million, The in million product lower $XX.X with continue adjustments increase in year-over-year, we And $X increase favorable at VIVITROL. of approximately with were sales starting seasonal inventory Gross approximately $XX.X year-over-year, approximately the $X to Medicaid growth by XX.X%, X%. of VIVITROL expect reflecting related typical quarter was sold in Net quarter QX, lower first net XX% to million million So, of ARISTADA Gross XX% the were $XXX an million, of the growth. XX% million. in QX, first for the for in in driven adjustments patterns. slightly flat consistent channel $XXX primarily continue to reflecting of full-year, units the utilization. quarter, sales consistent by the In range decreased we ARISTADA adjustments as In And expect full-year

by driven sales quarter favorable These recorded with in to of stocking Now, loot demand. level demand. of the in underlying in Volume the increased absolute expectations a launch, $XX.X adjustments. of gross quarter inventory primarily first driven to launch higher remainder initial net exceeded growth million, of initial and results primarily we the $X was by $XX full in net and consumed volumes line the for LYBALVI, in million million. our increase was the quarter, The significant

During the cost Patient coverage, the with restrictive less which quarter Copay commercial our payer reflecting gross adjustments reduced XX% associated initial were Assistance net to Program.

$XX dynamic As and we $XX net on to as look payer ahead, million in the into the million to heavily would which our we expectations move year on $XX be look in half continue you track second forward those what of LYBALVI during million to to encouraged Medicare factors to-date us the to we adjustments on mix the currently dependent seen D, we've range end year. sales by year. second launch for mind, the of of Commercial. first progress the gross the expect the our Part to we across achieve achieve and We're will updating Medicaid, to of With the in expect put million and quarter, $XX from launch higher of net the

was effect of our termination on quarter, $XXX.X year. the were agreement driven related this in J&J's by royalty revenues to Moving took to in long-acting starting million million to manufacturing manufacturing and business. U.S. decrease in INVEGA February the royalty of the Royalties the prior In partial and primarily first our $XXX.X which from license The compared products year.

worldwide Meanwhile, to to actions $XX.X products, $XX.X the proceedings from quarter VUMERITY million quarter first initiated binding revenue week disagree last J&J's related with XXX% to revenues in quarter, from the recognized this in year. these million last of In from arbitration $XX.X the We and we royalty million. increased first down of total matter. continue year-over-year

and and same of compared were $XXX.X higher LYBALVI million prior the products proprietary of in sold goods the Turning driven to and increase to first operating primarily launch expenses sales was This of expenses $XXX.X our of VUMERITY. now year. higher cost expenses, related in for to the the growing million total period support in quarter, sales marketing by

$XX million improve volumes compared For the development first for $XX.X products Blended to expenses this $XX.X gross over for neuroscience quarter these $XXX.X to million, were quarter of year grow. we were the time would $XXX.X R&D the products XX% goods year. the quarter, reflecting million million key cost as continue million to over our $XX sold stage increased the the SG&A of prior approximately margins our and Nemvaleukin to higher investment of to million, programs. driven in by expenses compared for and prior expect in year-over-year focused and first were products. earlier oncology proprietary

are efficient We in LYBALVI doing launch. the launch infrastructure of leveraging investing from but heavily order commercial at drive existing the our we're to so in growth

a consideration risk reduction of non-operating the $XX.X milestone contingent the expenses fair of payments, increased in value included of Our non-cash Baudax related of million to Bio. by quarter in non-payment

net generated results income told a All not of did non-GAAP the during a quarter. million and net loss $XX.X $XX.X million. impact GAAP for this our of non-GAAP However, quarter the we

Turning total $XXX to with $XXX the our outstanding and cash balance investments, in and $XXX first ended resulting approximately million. million, a sheet, approximately to cash of total debt in position net close we quarter of million

pipeline in At remain capitalized to provide our hand financial Alkermes detail more serve And strategic for and portfolio in structure commercial the leverage priorities. our efficient our commercial position with our a neuroscience space call candidates. of I'll the time biotech launch cost on over efficiently performance. public the as with are strong the to oncology targets LYBALVI and financial committed revenue many we management and is markets execute when We to long-term our engine. We as a achievement that, Todd generating companies that of profitability well to the our diversified infrastructure advanced capital, of a rely on to products

Todd Nichols

uptick by good Great. morning, LYBALVI's portfolio our across excited and quarter, Thanks, highlighted achieved Iain, everyone. this share we anti-psychotic that oral to in commercial I'm market. growth strong the

neuropsychiatry and Our launch capabilities. testament a team's our space knowledge well-established commercial the is execution to of our

harnessing the of With and our and full LYBALVI, launch our P&L. the organization infrastructure we commercial abilities across commercial leverage driving are of

of execution medicines of each VIVITROL large ARISTADA has we of which and quarter key and growth dependence building results, year-over-year our also represent to on the portfolio, business respectively and the driven unmet the patient high and drivers alcohol and in for growth trends schizophrenia and momentum important in focus are dependence sharp well the year. treatment throughout current our opioid differentiated for the remain we characterized continue treatment Based believe remainder landscape the need. QX by on populations Our positioned

during So This breadth the growing product quarter were with the broad Net execution. exited first our profile and quarter prescriptions strong and let's We by sales LYBALVI's two prescriber by nicely. million momentum driven significant start first during prescriptions differentiated with with XX,XXX. prescriber the $XX.X total approximately primary LYBALVI. Total were adoption. is indicators, performance quarter driven

written approximately As end a prescription launch. the of of since have LYBALVI for prescribers X,XXX the quarter

proposition communities important We are disorder we have feedback encouraged characteristics, and and medicine. from X value now and launch the the by about schizophrenia the months this LYBALVI, its product bipolar received initial of treatment the into six

These unmet of high bipolar exists living a measure. olanzapine that and is need utility show large well viewed to that This to switching and the continued of been business X to Our patients prescribers data And bipolar schizophrenia utilization is people in agents. suggest patients have from having as variety other source and being generic of LYBALVI early patients encouraging to switching on equal prescribed LYBALVI is LYBALVI and from X due in schizophrenia number therapies. branded data have with as that disorder.

mixed label is or for on has covers treatment. capture million Olanzapine market and frequently treatment as as an bipolar label episodes. indication option X.X olanzapine's episodes associated bipolar initiations, and So estimated X mixed often manic been the can manic a side let's weight disorder moment This LYBALVI's spend effects. of a or well share treatment patients, episodes occur indication. X despite acute in during XX% maintenance with used metabolic prescription which treatment broad that a

bipolar next payer play and that is treatment expect profile for experience continue the disorder LYBALVI's for to we access year. in role expect to as with important profile. gain will progressing, new X LYBALVI be The gradually the over We prescribers established an LYBALVI reimbursement paradigm

initial we Medicare access you oral building currently years whether that patients on strategy update Payers company. begun of a on uptake and made access Part practices patients plans. agents. prescribers those for make we drive traction see. access for or Launch is the the laser-focused the on LYBALVI's growth community maximize are and branded execution continue line a to are the there continue D, of far we Overall Importantly, the own and Commercial are and is momentum encouraging to and trends is to see with our to have attributes pathway be will have and decisions other Medicaid, in patients. to the meaningful their LYBALVI regardless thus to opportunity and in launch context decisions dynamic, of of order differentiated treatment will difference in within

established our product for the important launch. an and the foundation of is the established the launch portfolio psychiatry psychiatry is our with rooted the opportunity have in LYBALVI ARISTADA. U.S. element in market a significant of leverage capabilities and We driving operating efficiency years in experience LYBALVI's

product For driven month our increased the differentiated in is the treatment of market, by first month $XX.X a business option $XX.X first was XX% ARISTADA VIVITROL approximately quarter year-over-year. element increased every and family primarily by initiation million. primarily in is in INITIO which year-over-year the ARISTADA XX% TRX approximately VIVITROL sales proposition once XX% ARISTADA's approximately performance the alcohol important of the strategy. dosing which accounted driven to an the net by million, dependence net on quarter regimen. aLAI two indication, for This This year-over-year the commercial growth of X% therapy growth XX% including outpacing basis driven value grew of to sales year-over-year

results We assisted demonstration driving growth step therapies executional indication. of and focus of patient Taking expect for on alcohol a increasing excellence. back, continue this our to prescriber dependence, in treatment to are medication our in of the growth this QX awareness rising need, notable our investment due

and three have We commercial performance driving distinctive operating our products leverage.

awareness has VIVITROL and of increasing team ARISTADA a particularly for option, as on expanding breadth, and and alcohol dependence. treatment launching focused commercial acutely Our LYBALVI, prescriber use energized

building over We brands, across to are on now, call to strategy I'll current three the committed our our And these executing commercial Rich. turn and momentum.

Richard Pops

Good everyone. Todd. morning, you, Thank Great.

LYBALVI of priorities. been strategic So years. from past for R&D anticipating, sharp another to by was launch with of the what's interest in in early people a feedback an chronic the which olanzapine But from strong strong X quarter, and operate of or innovation, start bipolar focus needs LYBALVI is and encouraging. Its world LYBALVI of a Alkermes. of things. encouraging diverse we've developing it's going a on represents their experience LYBALVI foundation. complex extensive it's The makes on number is LYBALVI, to we're healthcare several the sense, had proprietary product necessary because of both additional focus real of on early revenue to that at it the I'm their the with the of LYBALVI example disorder. into and differentiated our our clear be launch, proud of markets, features disease. use that uptake about the commercial and onto Even our It's has driven financial specific impact The set most stage has of that revealing potential schizophrenia in transformative been add infrastructure the this power demonstrates patients. suffering we the given product capabilities, for we've A commercial the as providers leverage our becoming

capabilities. opportunity, experienced a a significant So we with and product, need, have market what differentiated sophisticated we an commercial team

and is of of our an for key profitability, maximize our element seek we creation. this XXXX say as this is and performance, LYBALVI for reason, position. patients and It our focused build portfolio we execution value momentum, shareholders. impact strong our joins opportunity to as on For strategy. in and drivers VIVITROL, This is ARISTADA important financial shareholder commercial a the on VUMERITY

HAFYERA of subsidiary addressing SUSTENNA, years. that U.S. CABENUVA. unauthorized obligations proceedings products. commenced of We've that With and its this said, of enabled diversified we're arbitration we've of our of than a J&J to week, contractual To TRINZA, nanocrystal INVEGA on related growth with royalties U.S. termination long-acting legacy than license and INVEGA years, agreements from including away to the Janssen, under XX sales enforcing our its more and J&J, net to sales of more paid we about use our J&J the and our INVEGA intellectual portfolio, partnered products for rights partial products those technology, agreements, binding for royalty related with two business serious property. end, royalties XX last by a pay net INVEGA With

that resolution partial achieved of we parallel, been a triggered we notices to In legal to-date. of termination, for the has receipt attempt arbitration. in reach case the agreement, resolution Following an the dispute the provisions in our built not

arbitration the remain and of more the shareholders. that through agreeable a be should open advance settlement, expeditious best we process, a interest resolution, As we our mutually to provide in

with that financial guidance, to not underlying management the position the in and what at and of started royalties picture our the of clearer scenario, of business on the purposes to in the That our a the order conviction For provide anticipate. removing continue we strength said, of a products, year, the of J&J business, reflect any we'll does conservative planning the leverage related beginning strength the way removal operating we legal and of matter. our these

gears few on shifting last Nemvaleukin, our with updates. to spend couple the going I'm from cytokine. a IL-X Starting that. pipeline minutes So novel

the IL-X pharmacological different, high remains properties target pathway in failure recent for development different bempegaldesleukin two look the The oncology of testing and scientific toxicity proven for hypotheses. Nemvaleukin. has by The And clinical High use, designed IL-X potential functional this hallmark responses. efficacy, while toxicities. is potential high and can be was of attenuating if broader durability profile monotherapy beneficial attenuated. its therapeutic its of its for the to limiting preserving dose dose has reason. strategy important IL-X. the has Nemvaleukin a unique are driven These molecules very by So is capture IL-X, fresh dose simple for patient they mechanism attributes, at foundation Nemvaleukin serious are characterized and an

profile. studied, is polypeptide differentiated does that and anti-tumor pursuing. Nemvaleukin pharmacology, into pre clinical So alone designed development among the IL-X. and may and in being monotherapy patients This is naïve gives when of anti-tumor any an does unique treatments. its we're with has and used monotherapy cancer benefit cells. cells that clinical minimal demonstrated borne IL-X Nemvaleukin in With and expansion IL-X cells important combination activity molecular regiments carcinoma anti-tumor contribute activates melanoma, metabolic for in regulatory the it's stands the Nemvaleukin or The a variants natural resulting us observed feature the in activity single design out activity with in previously other with T pharmacodynamic Nemvaleukin Nemvaleukin space and of receptor, been selectivity CDX-positive confidence lytic design its single checkpoint immunosuppressive cell treated by has is inhibitors. degrade differentiating including inherently for require killer affinity it it's agent not validity not profile, conversion, active, IL-X the intermediate that renal strategy T

and in unapproved in types types monotherapy, Beyond pembrolizumab. in treatments, with Including Nemvaleukin had pembro progressed durable responses inhibitors, checkpoint tumor range a of in tumor naive patients in following checkpoint who and have patients. demonstrated deepening combination

high tolerability as profile from and differentiated IL-X. is Importantly, the safety observed dose intended,

tailored Our clinical unmet to is strategy address key needs. development

enrolling focus we're on not committed in mucosal CPI to patients the first-in-class We progress clinical then potential treat remain tumors melanoma a have to programs. approved, we studies pathway monotherapy, enabling platinum as IL-X utility combination ovarian in we've following IL-X believe or treatment, resistant opportunity initiated Nemvaleukin. are difficult and to on registration inhibitors and now where variants As advance and focused in focused checkpoint cancer the studies. Pembro potentially with the of our those We development executing and where

earlier So the quickly development on pipeline. stage

early activities toward to for to the make agonist. IND with enter X track our this We're We the ALKS clinic on next of orexin end receptor year. XXXX, year continue or progress enabling

our doses Phase momentum our For our value safety ALKS significant creation. advance order proceed higher and I portfolio, forward X and with progress across of in to priorities. work on you portfolio to our exposure We're single will continue progress dose make our we HDAC our as preclinical establish look there. business end to in the necessary continuing building our this inhibitor work sharing We'll the cytokines. study. In performance. build to with on program, growth on shareholder margins maintaining pre-clinically strong QX to ascending and we're driving we XXXX engineered strategic oncology our focus We're long-term executing to

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

Sandra Coombs

Great, thank you.

for We open will the now Q&A, please. call

Operator

Thank Sandy. you,

conducting question-and-answer [Operator now We Thank session. will you. a be Instructions].

line comes of the Please from questions. first Chris Our Goldman question with Shibutani your Sachs. with proceed

Chris Shibutani

playing that Thank that in everybody. to out my talks full Good of in that very And and congratulations how we XX interested world, expect switching, there, days, the payer in quarter LYBALVI, we're the Slide that be a much. is you still by question about real I in to how early terms in the should what on dynamics about Can you patients particular, the out playing want for talk commentary pushback. you morning, less that clearly evolve, included understanding are switching is strong dynamic fascinated like? and center would

Todd Nichols

think monthly which about tolerability is since have XX,XXX And we is That the options, Good as LYBALVI. broken I'll options as When the too. well, encouraged they're looking it Todd. launch early And, Bipolar but that encouraging Those treatment really addressable this efficacious looking market morning. represents the approximately patients question you schizophrenia are of X is the for from about treatment have portion physicians for about way, yes, what and for we're LYBALVI, we're they're from we're X,XXX we think well. feedback as written the basis, community, this market, the patients What's HCPs. is a that for hearing not on are up Chris, is Yes, options, prescription between by patients only hearing well. market. addressable treatment a utility. dynamic that that the seeking take market really broad

as the The but of now that us market, remainder olanzapine, that the are well. LYBALVI really for XX% from and showing meaningful. as between So coming the distribution we're X switches data is branded agents, is actually right addressable is other we're too. then early the also of switches disorder agents that which an switch And market from from coming for are and about seeing getting switches well other generic agents equal bipolar about schizophrenia,

branded two you these our and space will Feedback in with been very, payers that starting that the coverage initial markets. far these assumptions. thus consistent very compete is large know, And decisions. are make from are As to launch has payers LYBALVI

is months, that will three across Medicaid initial be XX next our But the different access decisions final across and the channels adjudicated Over is we're pathway a with claims to seeing D, even expectation access Medicare are made. decisions, more being and Part that Commercial. there

us for point. it's So at a positive this dynamic

Operator

next your Please with shoot from line Divan comes Our question. Vamil of question the Mizuho.

Vamil Divan

Great, thanks for taking question. my

if I then if I could one on the commentary one and LYBALVI following up maybe one So just up can. other

the $XX I'm mentioned $XX a So just you of quarter. for terms you're of trying top but quarter, at you rest the the even this sense higher second expectation your the in is get range sort to had the of LYBALVI just next million, to kind in about you're said flat get of $XX very year, you range. your may is you quarter, million mentioned be of stays of it just how thinking million already ranking from

half inventory you net So my kind anything all little or to top launch, the payer curious products then lower. have get but range sort almost of second in conservatism actually or second startup, in there not right may over number the three of even the that I than of I'm just now? that was of first gross quarter down the guess flat in expecting keep a your to And or is just some on sort side is, maybe your otherwise early LYBALVI just question broader you end the the

seemed a unusual, maybe the impacting gross what to I first little than you're expecting you. having to dynamics always obviously the the for just maybe just we Thank lower bit other quarter I to keep in twos, LYBALVI full-year, net. you are the that in you're expecting sort quarter, of which bit net, gross little volatile, can for terms think a so of little think more think the for in launch, more comment but what the early what full-year first

Iain Brown

the for you questions. thank and morning Good Vamil. Okay,

million this the a I we talk net launch, first still the a in the get quarter trajectory post $XX current the have going better for represent year. that have did of And out to see encouraged QX to be to ahead remainder there. on the we by the sales a would higher I necessary, So with about $XX the But we'll million set regards And trending guidance in Medicaid down LYBALVI clearly range I to let's does net the it's to earnings end first story. different. of call. update for the I'll as product mean, VIVITROL to QX is full take quarter. us. position that the today the year we're July stab, big every the We we'll how net, think growth gross sales, And really then really goes. across We a saw towards which portfolio. favorability guidance think of be

the saw Medicaid driven And that was favorability on COVID pandemic. we by So utilization. really

During Medicaid the XXXX; anticipated had we XXXX course of and utilization. an increase in

been We too. the have not originally seen extent that that, we'd to booking but

at the in pretty saw with line in the over was we're to invoices the states of us, to in consistent million some we're that very the those favorability. we of able quarters, it much to in And sort and was ARISTADA said $X about course quarter. year; point a what the lock as we of was impact with release XXXX. able earlier first provide So the this expectations

we've that the the copay think is what initial So the Todd encouraging. I mentioned as a to about gross business I perspective restrictive quarter; And impact we don't for dynamic saw did compared LYBALVI payer to going on from talk to much lower in net primary payer XX% next and to program there. to mix. there's in picture modeled. commercial a very And decisions access the net of come And across cost at The this the then with less months, is it from payer perspective, think while as assistance was are these dependent much forward, quarter. in going somewhat our XX associated be gross we

need we that QX look feel to would we the if things So guidance, to again as do like evolve, potentially update earnings we on call.

Operator

proceed question comes Cantor of next Brandon from with with Our Please questions. Folkes the line your Fitzgerald.

Brandon Folkes

for Wanted just what same said thanks to on you XX% though net, I understanding want taking to reiterated go think there because about do mean be revisit and the on maybe be Hi, XX% gross could of we net year, my that gross Vamil's you it's it. the exiting I and congratulations you for echoing what just Is ask of to on gross net, kind guidance? year above said the still again. the could substantive with questions pointedly point just But may hearing -- to to quarter. that lumpy. this conservative LYBALVI how Even thing you've that guidance

on how could longer-term? on we maybe and where to the about gross of XQ think Just year the exiting sort you net scenario do you think be of Thank you.

Iain Brown

the when of the guidance for think net around I to we in timeframe. full-year, provided we February talked gross back a about XX%

But moved again, be evolution the haven't going during a course the of year. dynamic today. off that it's to We

depend As mix, come we decisions that the that mentioned, it's out going on coverage and of payers. to payer some really of the

that belt, a have going see think to end the better to to our as is under QX full-year happy favorability very where we'll then let's were sense we get in and I up. So QX

Brandon Folkes

I And may. enough. more one Fair if

on the data the Thank update there? any timing for Alfa Just on IV dosing, SubQ update of presentations you. any less Nemvaleukin dosing frequent and

Sandra Coombs

studies that in obviously or the is early meantime. those we'll getting But internally process data to Hi, Yes, and We're of XXXX towards still the enrolling more accumulating be program we're in year-end data data. Brandon, be that from presented. for Sandy. this looking

Brandon Folkes

you very a on and Great. good Thank much, quarter. congrats

Sandra Coombs

Thank you.

Operator

your question question. is next from proceed Our the line Please of with Tiwari Jefferies. Akash with

Amy Li

for so Thanks Akash. Amy for is taking question. this much on Hi, our

had So two. we just

script early the like Do you then in of after what but on even LYBALVI safety for bipolar. forward? launch and de-risk from could signals safety to much. which How trajectory safety studies? consensus And healthy this the continue show ALKS learned from VP XXXX? trajectory LYBALVI mean another healthy Caplyta trials liver for one going see Caplyta's on that Caplyta one comparable you think currently approval $XXX efficacy could first this type think The looks sales we Why you cicadas script And did has could narcolepsy versus in do could million? and your perspective what volunteers, ALKS so in volunteers be didn't patients? Thanks around

Todd Nichols

is quarter, Yes, I'll was the with fourth the we that trends. first this year. of part In the the which Todd; first meaningful increase hi, last achieved a quarter approximately XX,XXX, take of from prescription

breadth seeing Our indicators you performance have upon which is for adoption market, expectation going really prescribers primary to we're TRX's meaningful is a is that based this is continue we this, grow. then In now. This X,XXX of is LYBALVI right very seeing QX, that trends a and approximately to big It's number. we're TRX prescribing. know. as two broad The

And and And a olanzapine we're very considered olanzapine story. one the mitigation as The is What initial for schizophrenia opportunity from it's from that from of HCPs by the with the said, LYBALVI a vast oral simple so the that now. of value as agents, And Rich patients weight we're hearing is there's a is is community efficacy pretty most really in proposition well. feedback. right of driving effective and the that properties encouraged patients and is key really olanzapine the comfort level large. insight

the So that continue prescriber And adoption to is thus our to trends will follow grow. going expectation is that. TRX

Richard Pops

therapeutic drugs. a let small studies then escalating method might the ascending of product. not that target And in new the commenting we to to along in Again, multiple engagement. then patients. doses present volunteers those concentrations. And all cold single on There's much two didn't appear with too in we've for to And any until order to signal send we're doses more doses healthy looking we think that studies. established say that the other prescribed We way XXXX, molecule animal that in dose move we identify relevant establish themselves that begin and profile, we developing companies respect with into studies steady-state program toxicity highly toxicities seeking me just are get concentrations. when And expand

and what So drugs XXXX. we'll follow all when developing that's it's companies new that do a routine with responsibly

Operator

Thank you.

questions. your Umer Please of next Evercore. question with Raffat is with from Our the line proceed

Umer Raffat

for know I on the just stepped year few trial to melanoma about have thanks And know recruiting was my XXX IL-X. your has we the ARTISTRY-X down questions. from maybe the for now. been last patients XXX trial taking also fall. patients Phase I one briefly if in a like that first guys, I a Hi, X may,

to implies large I net filing And was enrolled? should to of and guess, holding inventory XX% activity not assume and out, in And interesting help you're like a net play it to the on quarter? $XX you tracking couple have but clarifying am then the the part a just part fair the gross XX%. One, gross is tracking net since really thought it current questions. on And primarily about further. I of maybe to beat of LYBALVI, raised to that for least the at monotherapy I would dynamic recruiting last the you at it's So you very just million if really or it of And ahead that's for guidance, do the is Two, kind path would north right a not? today million that momentum it's ahead to be of because for current I $X see that know. halfway plus question the full-year? the because is guess see open-label hearing and tracking ARTISTRY-X, LYBALVI why my gross it off is this want

Richard Pops

comment trajectory the results. Yes, which registration-enabling on melanoma, efficacy the the monotherapy LYBALVI. morning. is Todd the mucosal Good in start ARTISTRY-X I'll and on potentially Richard. is It's IL-X Iain based of study a let with and study

haven't monotherapy we believe basis it's the that but filing. for And is is do enrolling. on the it absolutely a rate, We It enrollment enrolling. commented

to not reason of doing of open-label, but us. itself unmet of fact, despite an that melanoma ARTISTRY-X it's In is monotherapy activity medical mucosal the an important need, we're explicit is the enormous it's in and That opportunity commercially. also really indeed blinded a It's Nemvaleukin. fact study, the demonstration is

will looking at not order the its regulatory to data be preserve So along way we in status.

Iain Brown

the LYBALVI crack Umer, question. take a then And I'll at

we through in So the burned and with were line results not off demand, at that we the I as QX had of continue launch Any replaced. perspective, year in the from And year. mean, an go driven inventory tracking is that was initial the inventory. we to end and expect the inventory stocking channel now really really by would

a not So story. demand QX is inventory really story, an

a QX. million we to X.X% net, $XX that On had a gross the be quarter. XX% on mentioned, in the of as XX% based will If on you net favorable of gross to gross impact around sales

to It And obviously higher quarter driven in way is the full-year portion the the driven launch. favorability the by from of other the perspective, but net, with is some going. gross post just quarter is then So of of we're first really by QX pleased favorability demand. a is the

to going net lot the of the remainder year. to around we through as of dynamic gross There's -- early. be the still it's go So dynamics a

belt, But that earnings changes We're just with another we we very may appropriate felt we make time. feel by So it we're to under the we to deem quarter any was seeing. that encouraged early. QX call, like our be at able what guidance

Operator

from Cory with question with the proceed next Please your comes line Our question. of Kasimov JPMorgan.

Cory Kasimov

from Hey, good guys. Two questions morning me.

on First LYBALVI.

on key based the say agents? an point or from to versus seem all I'm much guys. of non-olanzapine to field, second to having even what feedback the other And doesn't any LYBALVI an of impacted based and a be sort in outside Thanks front? do in in it on interest and think with the you way? side, nemva nemva impact bempeg. impact it how that value soon too level any proposition just between impediment Nemvaleukin asset then weight LYBALVI-associated prescribers -- differences of the at this curious on docs this gain more of situation the the So uptake. discussion still Or of because question on Is is if see about terms has of importantly, understanding happened maybe

Todd Nichols

which close the with organization HCPs, that and well. our sales also as hearing to take what staying we're learning we're research forth. what's and awareness to market we're happening leaders LYBALVI our we're hearing I'll the What perception this building efficacy well. that for expectations really at is feedback adoption. is against as In positive is is of But what's point. mitigation the adoption the question opinion delivering to helping and level is so And to levels in weight is that LYBALVI are really drive Scott, a early terms LYBALVI to there key general, driving adopters,

So really we encouraging. that's think

Richard Pops

are it's vast just who impacts weight are feedback LYBALVI or they're weight really the hearing marketplace. the impression? what saying. Richard. physicians What's experienced LYBALVI the is Yes, great the been olanzapine. the so in routinely that profile of qualitative are impacts gratifying people to have I've And was the the the real familiarity what's Good Todd Cory, that weight interested with And in seeing from differential of in doctors I'm morning. building personally the using market versus olanzapine. olanzapine and what prescribing. figure experience with world,

been was that's a So efficacy there of were qualitative important IL-X see where they're that limited. to form has "I of really you pegylated do coming receptor And us Nemvaleukin to really difference new has was that BEMPEG the answer real clearly lot feedback being that's foundation through said, launch more my patients. is hypothesis efficacy. able was affinity is been on a to data conversation high wanted polypeptide you and very we Nemvaleukin point testing. the IL-X into The a has variants". to the about was way bit IL-X remarks, Nemvaleukin, on maintenance both that dose see is intellectual the highly spend They're theirs. years been really And for between drugs reinforce correlation prepared very their translate our the Nemvaleukin intermediate scientific that to to olanzapine phase. differentiated that the prepared and reason I was the which they very, from point interaction. on of more for they different know can molecules, And making use always BEMPEG bring in the patients, as now, clinical in which whereas not a BEMPEG that time focused always behave remarks a been that that I But back in we've the the foundation, now the this that

air cleared nice So the our molecule the little It's bit. for have to value a actually is proposition unchanged.

don't So people are interest potential think it's differences between the product. to look programs. impacted And outside forced at the in the I

Operator

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

Paul Matteis

Great, me expectations. LYBALVI excuse and to thanks so and ask more and I wanted follow-up on one uptake much. physician perspective,

is going coming wanting Do physicians half Zyprexa weigh on the in Zyprexa? have of uptake kind Any One durably seeing that color the been give LYBALVI question on things that patients switches. these there think who've gained have one great? definitely to you. with color wondering weight? segment pocket you're gets is segment. versus of as this that [ph] has manage may weight from know patients impact VIVITROL, of then subset, how opioid it where just do these patients expectations big interesting won't to is I how the sort that if is the you use a to that would the And market, alcohol they and these Thank gain weight of now relates of Are be already of on of lot that really COVID mostly that drug think I'm it might the the me lose you to and a long you in Zyprexa I'm on prescribed. what switches the business be still

Todd Nichols

Yes, absolutely.

million adopting Let did as to the how thinking LYBALVI. a for basis. eight olanzapine with perceptions I'll just significant well. with are the market me launch We right And be olanzapine that's of would at from encouraging HCPs start remember, been the it's -- on opportunity there's switches for expect now. first the about part that key overall important in beginning actually The is context, market think I XX-month that prescriptions we've is the written of a

hearing callbacks. oral across in that's overall bipolar we're getting what the too. closely the as watching their is back physicians from they're we one we're schizophrenia as hearing they're hearing driving this behavior, So believe indicators it's significant hostility fewer And sleep. well, is, and impulse and category, and positive reductions actually responses a disorder what is patients. things And They're that hearing of or contributor key are that X such improved

driver as So that the hypothesis well. here that positive supports a there's

we're intent. the encouraging One it launch. with only we're is what very full areas, of results It's far with that. weight mitigation. first hearing And watching experience obviously to the post closely was the thus far, the Thus quarter

physicians, So perception positive we over is grow. believe through more experience as as that that actually will that that that access continue medicine well, time gained patients believe to too get the as we more to

that the substance achieved results use of impacted terms are was flat the VIVITROL, think QX. the it than and And general, saw by the indication in for we disorder well. is pandemic, impacted market encouraged the opioid more entire now. by was the we about way In opioid the this right within to we in as market, indication alcohol VIVITROL so it's relatively

Over the to growth. for we quarter see year-over-year continue the alcohol dependence, over

In fact, dependence growth the is of alcohol the VIVITROL market. outpacing

clinic with the so started reason in So outpatient overall which represents growth improved opportunity for AD of why we seeing in The end has watching for see that opportunity to of recovery remainder we're we're the part going encouraged that business OD but be a year. VIVITROL. believe we're specifically by very has to seeing XX% of an that, control their the things this alcohol QX. closely opportunity it's the we of contributing about more the -- the a towards we're recovery settings care, and significant of But dependence side the of actually been VIVITROL more significant

Operator

coming line Leerink. Please question. Our Marc is SVB next the from Goodman of with question proceed your with

Marc Goodman

Couple morning. questions. good of Yes,

year the behind doing have increased that where partnerships then And Rich, product you Second, timeline problem or the stuff. and kind just there? is, the of that with with we progress. with so dosing curious things the Thanks. Nektar can respect it to the having the just First or something level of in is was your scenes expect past has increased what of the we work Nemva, just what's in and a the for talks, backup the know all, on the discussions you're on over just this third, curious arbitration, interest SubQ, so sense that normal I not, changes been the you've when

Richard Pops

it normal when don't window for contractually to It's anything arbitration, six long seen previous how that you it is Good be the examples, going really materialize where before think arbitration. But Yes, morning, a laughed up is it irrelevant. for We said takes. to months. can Marc. Rich. I there's we've arbitration But in for effectively timeline provided panel

focus and no, lumped into going teams good, talking more investors the as the basket the differentiating failure as to So is It's that on have poor. data not This, we've you. for is an all do had ongoing one that's one companies be us to to going emerge. it's What it's back like if they're strategic works, specificity about all people us many amazing well having the on one opportunity. already into given But how people an been said, if bad, be watch of Nektar we've identified. IL-Xs had not we're selling, dialog with highly they're which conversation actually to has that Nemvaleukin and as the kind today, potential have one's almost all well, you features, allowed which would think

data, we're those respond can present of data as as one remains, is particular Nemvaleukin not real and a is molecular what only we've it's who in in distinction. Now And fact features at clinic from even exactly one program. have been the different real can remain, they forcing why the development? long-lived. our That's of And that's the which through pharmacology, of ARTISTRY-X. products long looking responses And for are that are what is that the their durability durability we who just of features be where our design virtues actually hallmark you see seeing those the what IL-X where continue to we enough

use think the fundamental, So -- I clinical drug. really regimens will the call don't up what of a for foundational -- I think the of dosing end being broader backup, backups, the alternative when that you

And testing IV SubQ once The SubQ the same because frequent generating is is we're weekly both times we're pharmacodynamic IV, we're testing that a now SubQ five, the And IV. we necessary Bayesian see with in that once IV durability mimic on order we're weekly. weekly. drive regimen original response. we question mentioned, confident the you proleukin on As the less once not regimen daily responses that do to right the have the in design, quite we

a as our of we're summit used next the toward enrolling prove of most those that year. of -- to And less year, dose. maturation in hunch end we'll we're And So And testing Sandy ultimate, be commercial range this going more said, studies. expect or those commonly that early is data is the frequent are one doses. to

Operator

you. Thank

America. the with Our question. next with proceed from is Please of of question line Gerberry your Jason Bank

Jason Gerberry

for taking my guys, questions. Hey, thanks

commentary on you two just of case that fact of but if because arbitration sense resolution. when So sort curious follow-ups, discovery sort like so juncture Marc's and on of might everything's reach have to you of sort that first one an the get through appreciate some seem specific a questions, some would important

So you Thanks. and as the provides about sort juncture adherence, of patients some that then sort adherence? of the like to not drop when or has Paul's resonating get just whether an of would to do sure typically a LYBALVI sense follow-up translating with like analog to sort to weight important guess out. profile question, of that drug differentiated thinking olanzapine seem I off this due if adherence gain better a terms weight attenuation Genmab a arbitration to J&J And map in

Richard Pops

the this earlier, Jason. been the November, transfer confidential notifications it'll the of time mentioned morning, evidence of remain a technology receipt since I on we Switch companies. forward have in fairly on confidential, between amount as from those massive the point Good two although entirely arbitration; of compiling legal

So turn type submit and the the That your not. should part mind brief switching it's happens go construct hands, and to the that stable J&J briefs, other have market say and market. much written to of extent process. mentioned, that's marketplace. the some as month, over that's every until now are And that to olanzapine we The of of in your both will one What's in presenting launching to brief is will any or -- not such LYBALVI it Paul's there's need you there's that happening arbitration it's well. drug, thing a And important market, to in that profile confidential let time we're your question, unsatisfied wills, switches through written doctors. and I'm and that arbitrators sure remain they're because we'll is the a Todd, smaller and to it's this churn as so I'll that the every, me because in people that we'll just will and here, submit Todd there occurring question as then responsive the a in so -- becomes important. It's churning drug that becomes

with experience that's form their in And we we're olanzapine hands, So capturing getting allows olanzapine. with feedback. profile efficacy the drug it see to LYBALVI compares and this own have, the their in to weight of of where that the such physicians try how positive

Todd? So

Todd Nichols

just absolutely. Yes, I'll on build that.

this, So of the bipolar to make over Xx way think on too, patients treatment is average a schizophrenia patients Xx and to of time. about changes period about

relatively large. is the So churn

to that's it's a LYBALVI olanzapine dynamic So We and to live. the very stay is really discontinuation. going close where market, and dynamic really the

Our to research time. third over across the That About happens gain. weight schizophrenia patients olanzapine to due eight been within typically weeks. a first four bipolar consistent on discontinued has of and

So our all research. we see through that pretty of consistent

of of about very and we're and we're closely, something the that's supportive watching play. where it's So the how part market thinking dynamic LYBALVI will

Operator

you. Thank

of end session. question-and-answer for the over today's for reached the call Sandy have allotted We now to turn time remarks. closing Coombs I'll

Sandra Coombs

Thanks, Thank you Rob. call company hesitate to reach any out to morning. Great. follow-up us have don't Thanks, if us the on at joining the you. questions. for Please everyone this

Operator

This concludes today's conference.

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

Alkermes (ALKS) 27 Apr 222022 Q1 Earnings call transcript