Earnings call transcript Q1 2023

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Greetings, and welcome to the Alkermes First Quarter 2023 Financial Results Conference Call. My name is Rob, and I'll be your operator for today's call. [Operator Instructions] Please note, that this conference is being recorded.

I'll now turn the call over to Sandra Coombs, Senior Vice President of Investor Relations and Corporate Affairs. Sandy, you may begin.

Sandra Coombs

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

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

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

Rich. I'll to now, call over And turn the

Richard Pops

everyone. Good Sandy. you, morning, Thank

I'm orexin the to to into made going so it with I'm related Ian number start announcement going a going and We have on with hand our right brief arbitration for yesterday I'll business through we're of updates back on of to XXX review progress of important it. quarter we program. the update update our Janssen. to an products. and a I'm go overview making then for positive the to then get to and today, results to separation the on of then come oncology close a an commercial our with and financial ALK Todd for the the

sell that to as X interim long-acting Hapur, X HIV In and well the under in recall license Tribunal, terminate Janssen Alkermes of which while to sales INVEGA to on Janssen, of TRINZA those central antipsychotic economic arbitration, with January, CABANUVA, arbitration second right is medications this the may are had award from and unanimswith week, in the agreed the the agreements, without an U.S. which which is SUSTENNA, issue as product. royalties regarding pertains the which which products, INVEGA a the an which paying experienced Vega we the Last INVEGA interim agreements franchise developed arbitrators issued favorable announced issues. is addressed So the award of panel the products received continue to royalties it panel, outstanding it not the that we Alkermes.

First, for million. $XXX of XXXX, we are approximately due back royalties

XXXX Second, INVEGA separate to provides and applies INVEGA beyond, SUSTENNA, that related TRINZA NAVEGAHAFIra. the each of royalty a and for term award

which August would our consistent with expectations. we INVEGA For owed SUSTENNA, previous through XX, be royalties is

beyond Hafiira, medicines. term years X an the Vega our royalty agreed in the royalty both position for of and for However, panel these revenues that represent additional XXXX of TRINZA quarter the extends would This INVEGA X with XXXX. second through

In addition, of end the for through award are XXXX. provides the the owed the CABANUVA in royalties U.S.

to of upside terms our provide potential result Cabenuva royalty This into economic forward in payment long-term summarize, royalties due, and from the back VigaHafira to P&L. significant So once would reinstatement the represents VEGA and additional and TRINZA, an going capital and for to balance strategic XXXXs. royalties final, sheet this contributors

prior remain the and to for to issuance whether that as parties the a the believes either next the advise within of panel issues award. terms panel party days steps, directed of XX any confer to resolution final In by

by and and award matter. position, of the we We look final forward this latest reward are to our gratified interim resolution of support in this

with and I'm So to to that, an ahead, for quarter then the going Ian. Go Todd. pass Ian overview of it to

Iain Brown

Rich, financial quarter, results business. have solid product commercial everyone. focus into Great. portfolio, hello, the I'm we and the efficiency happy commercial and by of to you, driven our proprietary operating Thank on report first leverage our built continued strength for our the

we confident we momentum this ahead to of as We XXXX. continue that the look build on are remainder through can

anticipated outcome XXXX. our financial represents final, the potential As for once Rich XXXX profitability arbitration expectations targets significant current upside Janssen our XXXX long-term of to mentioned, for and the and

we until detailed dispute wait business the in expectations. financial are priorities, today, press filed X-K financial which core performance will our meantime, and as our across of the on for and any XXXX, we February current to continued resolution further the revising strategic based our we were before of have execute we've However, expectations our reiterating In or XX. future release on

generated our quarter, first $XXX.X primarily dependence by sales XX% grew we were gross fairly million, Net product $XX.X indication. which the VIVITROL. primarily driven net were deductions for to year-over-year, in proprietary with portfolio, the the alcohol and growth driven year-over-year. by the quarter Starting XX% revenues stable normal of within quarter. million, the for was total in Inventory reflecting ranges Now channel

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

Moving family. the ARISTADA on product to

continue net a Revolving inventory market sales were pace year, Underlying to underlying increased quarter, was therapy growth basis. the by ARISTADA the growth million, rates. in these growth difference up quarter stable and XX% were channel of net to X on prescription gross net $XXX XX% $XX net Inventory prescription year-over-year ARISTADA million demand XX%. which sales relatively X% the between explains range And million. a at channel, End for sequentially. in faster expect $XXX the to the sales grew the in quarter. $XX.X million, the than month driven for of the adjustments full of For we primarily for

disciplined the commercial XX.X%, to a of adjustments QX space. Gross our strategy in were in net continuation contracting primarily reflecting

anticipate half and year We gross if net a commercial continue then high during determine in fairly channel. in may remain to to increase stable half the adjustments the will in the of we that the the as benefit second XX% range to contracting first

full of the $XXX year, $XXX million to we the by in For sales driven range underlying to LABAVInet continue primarily million, expect strong demand.

the Revenues Moving was million Janssen's in on first This quarter primarily reduction partial for year. royalties driven products VoMERIty million sales decrease our million products business; quarter, long-acting a which royalty subject of to States, in the And related same revenues recorded arbitration Royalties the $XX.X of agreement is ongoing a net termination prior the to compared these million million royalty market were and $XX.X sales by with to the and to reflects United first the end period this Vega Janssen. the year. on to product. compared in manufacturing compared of $XX.X our prior from same in million decrease in manufacturing in were from sales $XX.X $XXX.X of the $XX.X Biogen's period XXXX. of the the in of we of

nemvaleukin expenses the $XXX.X the year, Orexin for reflecting focused compared $XXX.X and period of first $XXX.X launch in expenses million the clinical agonist the including year. for million the quarter SG&A start same studies million expenses; the million million reflecting program, R&D life Labadi, the investments total period year, X campaign, addition $XXX.X the to to in business. oncology certain receptor $XX.X compared quarter management same separation related the the continued operating our to in Labode to from expenses investment in in cycle same of digital to first the for decreased million program. the expenses increased $XX period Turning to prior the were the for prior of prior in direct-to-consumer to in

line GAAP $XX.X expense resulted top on with of continued our million and Our the income focus net approximately disciplined approximately combined quarter. net $X.X non-GAAP for a loss results in million management operating of

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

noted resolution earlier, would the balance Janssen sheet. strengthen of Rich As arbitration our a favorable further

reiterating on of we're efficiencies. operational performance focus Now for our based solid continued products commercial the expectations today, on our financial our and XXXX

year. As expect to is expected currently as the a the and XXXX half resolution of neuroscience as business for the year full financial we combined planned in not the potential expectations And of the reminder, arbitration favorable for which upside we reflect I earlier, financial provide. the work expectations complete mentioned oncology our Jansen to reflect separation, yet that our do second towards the

of our XXXX that as to a to record adjusted net royalties million, net way would sum, measure $XXX anticipated income which long-acting to non-GAAP both estimate related through current Vega out million payment. GAAP be and $XXX of nature royalties By XXXX and of above would to in incremental products, be Separately, of inclusive framework, revenue course. the as back of financial this and related to royalty earned would expectations for for onetime worldwide over we We interest revenues sales of flow expect a that approximately lump line. these the the normal of the record bottom due non-GAAP and in of the the ballpark would to expect could we XXXX royalty our

cost work has to several appropriately to efficiency drive So support opportunities. over company's priorities structure the calibrate years, done taking operational strategic past a and and step our back, growth company significant the the

our our positioned Looking is well we well core XXXX as this achieve believe year targets accelerated current profitability ahead, year. to guidance earlier we business as announced that the full

for our business, of portfolio its the Neuroscience enhanced and potential profile, business, profitability plan is strength oncology its financial growth. by characterized the As the the on of maintain we long-term and of commercial the its we and which quality separation for will potential focus

that, over I'll call Todd. hand And with to the

Todd Nichols

to delivered growth generated Ian, commercial the we in first we good off building XXXX. proprietary pleased momentum portfolio the share everyone. Great. I'm Thank our that quarter, across in you, and morning, strong

each VIVITROL, double-digit X ARISTADA and LYBALVI. Net sales from increased of XX% brands: growth by the and year-over-year our for were driven portfolio

We oral with of are continued LEVOLVI particularly market. uptake pleased into the strong antipsychotic

start let's there. So

grew Leave first $XX for quarter, million. Total quarter. prescriptions sales XX,XXX sequentially XX% to the the TRxs During net approximately were

prescriber prescribers care the end launch, the of launch. launch. of this focus X,XXX XX,XXX to written expanding to a which As LYBALVI nearly on have be grew treated X,XXX since quarter, by of with providers patients since At stage have prescription health our approximately who the continues breadth, first been

prescriber year, for X XXXX in LEVALVI. we growing LYBALVI building our key initiatives: on for is access outlined As focused this earlier awareness strategy breadth, and further leveraging our profile

from brand be areas, and brand provider, campaigns psychiatry, where in growth high health research a when a that have in brand a key their campaign patterns particularly market been prescribed factor likelihood these in requested. therapeutic in to effective shown patients they be will suggest request direct-to-consumer accomplishing specific Our highly goals. is will care driving there DTC the be many prescribing

media strategy X DTC and is provider schizophrenia including well opportunity grounded significant Our and care the patient in consumption as as habits of health bipolar unmet deep need in disorder. insights,

people differentiated evidenced and consumption bipolar highly been by broad, Our including media returns goal portion disorder is and our as execution through have The brand of to quantitative campaign patterns encouraging year consumer targeted the LEBAVI based and is a in awareness. engagement awareness increases on initiated from schizophrenia. website across Early the uptake traffic, TV. this digital media campaign X digital multiple and with drive earlier of campaign of for was and digital channels,

a bipolar week designed and on The high and campaign health Medicare in TV component next for In all space. patients, to levels be will DTC Medicaid, LaBaVIlike awareness play pathway caregivers brands of to among launch patients. we and continues an access drive disorder. of is all for role focused care our Market will to providers. have X this program Access currently important The

commercial solid established foundation. we the side, have On a

the ahead, and look trajectory of with to is may look in commercial We and to you. volume on balancing the Looking unit. each profitability sharing a strong forward contract believe we LEVOVI strategically progress space, our

of month performance were including sales which driven supported $XX.X product quarter both and our once differentiated XX% proposition, by study. basis. on was every TRx ALPINE ARISTADA approximately Turning Net of million, growth family. data to the option value in by first clinical are therapy ARISTADA year-over-year ARISTADA's of driven from X-month INITIO initiation by dosing its This a the regimen,

market LAIs of seeing to a brand. positioned growth well we recovery the and are signs believe drive to are for continue We for continued encouraging that

offers the a together treatment address care proven represent ARISTADA supported face and among providers, payers designed important We patients clinical and growth. LYBALVI treatment health and efficacy. to platform commercial future systems and options believe with differentiated specialized capabilities this real-world psychiatric for challenges our Alkermes distinguishes by portfolio, potential

and indication net important million. the The approximately in dependence driver increased year-over-year continues be Turning VIVITROL to $XX.X for sales to of alcohol VIVITROL; growth volume. first quarter to the of an XX% XX% accounts

the has of the recent Importantly, of starts we took quarters. within to which in prescriber this the the the patient unlikely. market place litigation, the the in the it innovation year. The expected expand the embodied outcome erosion generic over new second decision in in indication, We make our continued confident with for half Teva remain and in of typical driven February, iligation nature trial VIVITROL which in Regardless of product complexities breadth and dynamics alcohol has the VIVITROL dependence of is believe is commercialized and and VIVITROL.

to the first on the positioned and achieve goals are year ahead. very the throughout the progress we our look we for forward outlined pleased well to commercial performance updating We the in Overall, of we portfolio you year. are quarter believe our product with

hand And to I'll with the Rich. that, over call

Richard Pops

great. Todd. That's you, Thank

on So of planned year, priorities: significant we months and shareholders. and hypersaline in we're at oncology advancing in our outlined all narcolepsy X the executing that believe of conditions separation for the X can other the in, strategic driving program we ongoing Four business. value drive our of advancing beginning LIBALVI, and Orexin launch the

we're capabilities. Levolvi a the our strategy for clearly for and Alkermes and As heard to we've of science the growth. Todd, power you established opportunity our executing strong demonstrates commercial from leverage just LEVALVi, platform

same our the a aligned for investments neuroscience opportunity the the stand value into of oncology oncology We're simplifying made. business, decision-making pursue new focus, to would the value realize going growth reveal and and shareholders business, toward Plc. is and company that focus from the clearly their flexibility and the and in and to business with of named what more allocation an provide separation on of launch which capital each including we've now separation with quarter the sharp has where goals. come the more more independent XXXX We we believe become with directly We've business ALK time, strategies to benefits a oncology investment respective independent Mira-Oncology each the yield with progress business' a program. at Orexin driving separation the focus The significant expected investors to number of public of made launching LEVALvI strategic will direct increasing

registration Last week, a statement the we draft we submitted confidential announced with Form SEC. XX that

to In support U.S. ruling time we and private and the lead represent in XX the purposes. a request PLR recently addition, of as Form of separation. submitted a tax for tax-free federal separation support long the letter to shareholders for the X distribution request streams labor-intensive to income a work Alkermes Submission IRS

the this to conditions, be review to approval believe of X we'll these subject complete separation from With customary submissions initial including in our later phase, Board the now as well expected, final we Directors. positioned year

and in identify neuro opportunity, other We're the you the high develop. oncology. key sharing the senior caliber positions interested pleased forward with as they we process of in management our to advanced with look about role updates to CEO candidates and also recruit leadership lead and We're to

by advanced stand-alone immunotherapy. As expect the IL-X single most investigational mural we and of as variant investment the cancer anchored monotherapy in checkpoint development an Nemvaleukin novel will showing distinguished potential inhibitors. with a combination in a attractive be data is by nemvaleukin, in anti-tumor is Oncology first-in-class that agent our is clinic, the and engineered company, IL-X potential activity variant generated

and IL-XX we a oncology MuraOncology for addition, -- targets. which the our and and preclinical business programs, to the immunotherapy both opportunity with first-in-class and milestones developmental represents preclinical would IL-XX been pipeline attractive oncology potential of development have of tumor-targeted be the engineered the medicine, represent assets advancing pipeline candidates, have preclinical In a late-stage clear of asset oncology-focused ahead, believe separation investors. attractive an engineered

capabilities complex expect we The to with a and the following markets compelling investment neuroscience business to valves demonstrates advance shifting the clear line, to profitable our focus planned back psychiatry stand-alone a our with addiction the become products, ability proven So company Alkermes; commercial success to in potential launch specialized drug capture the leverage separation, and by our pure-play strong thesis. infrastructure a drive neuroscience operating and growth would a represent for leverage, commercial new top growth capabilities, of medicines profitability opportunity significant proprietary and driven development neurological disorders. and Alkermes

of We're some program. the aware investor So on that time point, final in spend intense interest certainly Orexin let's this on area. the

usually So than you a detail a bit I'm program. for going more might to I Phase we give

orexin-X ALKXXXX. receptor treatment arcolepsy. for It's a is small designed oral a once-daily called of lead agonist, tablet molecule the molecule Our as

the a our way, by During volunteers pharmacokinetics is Ib of ascending safety single type, and in dose multiple in several gates clinical I expeditiously informative, made we in is ongoing data compounds we've progress Phase proof-of-concept multiple structured stage quarter, patients. trial. program. and has followed I which ascending and why pharmacodynamics this the with can to and the important With dose highly clinical study a Structured Phase Phase I a study multiple team study, dose healthy early single Phase tolerability, this program in early cross components, the related

cohort ascending our did dose therapeutically dose were work, be which to In dose successfully toxicities. our and we've dose-limiting dose the to any the we single doses To in dose all cleared we range. not patients. exceed sufficient study, that single-ascending absorb study trigger ascending narcolepsy doses will advanced of in initiation Ib the expected date, proof-of-concept we've now relevant Phase our tolerated, well believe therapeutic levels, multiple In

therapeutic has desired wakefulness during promoting the important and our night. of of tolerability, the with of the given modeling, goal with which effect pharmacokinetic and time profile been at indicators early ALKS these day encouraging consistent sleep consolidation the to XXXX addition is course In of

In primary study XX to additional data, as of and daily collect to dose The receiving and the study volunteers planned. of the of tolerability for multiple ascending pharmacodynamic objective XXXX are the well dosing is and elaborate as as XXXX study, once safety is healthy pharmacokinetic days. of ALK profile further this proceeding

data design data in signals program, the informative and and PK driving the critical dose provided study the patients of based together, multiple ascending EEG and including provide proof-of-concept into initial of X wakefulness getting cohorts from type are to drug next and response narcolepsy. established development with ALK's which EEG-based central activity other dose encouraging Taken the evaluate on narcolepsy clinical phase signs. is the XXXX of confirmation efficacy maintenance These single in highly that patients is have potency us will of allow and X idiopathic hyperomnia. and type streamline endpoints, with The clinical narcolepsy test profile,

placebo act design, biological in done treatment orexin agonist all of well as validation these own cohort, believe approach recent the both efficiently number per crossover market dose as will the future dose assess target and as community a In the continue level with among ethics washout a well surrounding committee between. as multiple in and in control the the small clearance Ib levels for subjects potential work a weeks, pathway, a cohort this year. strong With ranges doses single allow the the subjects clinical relevance of their as of received the we data poised of of in Phase this will expect from enrollment opportunity, this following studies. to dose subject later commence across to excitement inform response this class, early high from We're space, and period us the underpin coming investors. to

on We significant this focused track over at on sharing progress value confident shareholders. We'll we'll advancing strategy, our is year. in create right and of you the I'm going the careful company. continue program. the exciting is executing the our that to This end priorities. for on on with while We're strategic to remain look forward believe course sharply I continued expeditiously the to business to focus an time there. execution

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

Sandra Coombs

open Thank Q&A you. please. call for now, We'll the

Operator

first be of Tewari now we'll time, Akash [Operator question this conducting session. At Sandy. question-and-answer line is Instructions] you, the And a from Jefferies. with our Thank

Akash Tiwari

just Orexin, from think the your exposure cohorts have you this Can any this started into doable sales perspective. TRx, seem point you on you evidence in crossed accumulation you've on of at study XX% -- seen into So at -- in gross narcolepsy you MAs get on are metabolite grew point? that XX% therapeutically Feb. X% an levels worsen XXXX? nets does tested but we as heading Labadi, that is to many consensus likely and you've and quarter-over-quarter over dosing efficacious sales are QX, in And given And grew go deeper if baking IH, growth how

Richard Pops

I'll metabolites, I'm to the that earlier subjects it's you really are comfortable MAD think been and doses can to now dose PK that. I'll remarks, and information really between to above principal start would we the with that's with and it for specific anticipated, then is proportionality, we're from those program, relevant that other to XX respect The Rich. Akash, why we And the say to hand that's dose not encouraging. And on narcolepsy. Orexin able are With my things. feel rolling have we going various says profile, SAD I all it. program and the the characterize metabolite where over than levels tell as tolerability, we give as encompasses the and now. pleased we've are see think therapeutically we

Todd Nichols

LEVAVI pick on up well. just as I'll And Yes.

uptake is say what The quarter with the guide LIVAVI. first we is But for on thing not that really would of to are going QX. we're the I pleased

new starts, TRxs. New patient prescriptions,

demand growth market quarter-over-quarter, research we growing As hear prescriber on TRxs supportive of well. we is as a on universe, grew We quarter-over-quarter. that ACPs based believe the which it's and said really expanding call, very the from our strong result XX% that's of

to that expect we So continue.

Operator

Thank you.

Brandon is line of Folkes question Fitzgerald. the next Our with from Cantor

Brandon Folkes

of year the interplay launch TV contracting should of campaign of broad And ahead think campaign Maybe campaign. firstly about for we the contracting? unfolds? the the broader me, the the initial a we and of how think as DTC TV DTC the Bob just effectiveness between about How like perhaps it broad interplay should on and TV DTC and

Todd Nichols

absolutely. Yes,

be So week. space. portion. as will Medicare and which really It's seeing broad understand what excited the for the patients position digital are did the this to campaign, We've the -- got them. of planning TV and I a with launch meant launch pathway Medicaid, earlier We've Market actually to to of HCP trends There about a there our off looking kick this of is our for, and the amount for We access component. in commercial consumer we've is pathway of tested segments. we a actual point. access. very across this of portion insights. supportive well Access TV X all responded campaign, in said, It's with majority at years. an patients encouraging a enormous been of we're they patient patients the a for is to number deep really insights, next good We're a

to market segments. services and is seeing X we it's today's U.S. It's a just pulling is through broader contracting. pushing have all providing So access, pathway good and across also through utilization providing environment And it's care support -- utilization. than we're access access, access health

are our a We're high services know, a you seeing products a very we've the to know this seeing have of these available. the access. of in of program. of our utilization complexities of to as space similarly. PA and all lot HCPs navigating are high get And how we -- utilization products of As very program. somewhat physicians talked, We're used market treated our prior support co-pay They and

with product. to patients access So get is, market we a think we're access spot in the where can good

a be Our our earlier, they awareness. to said patient we've will for is seen the number also the that research campaign, a and very as there's planning HCPs as strategy, our request will like a to they campaign, about been we've if campaign, drive but ask their years, build likelihood sees granted. I that high demand of for, And through

that. about excited we're So

Brandon Folkes

for public a just on us on can And expect just Great. the given that of you alternative Do the the spin, spin? latest Nimble Alfa? data just news follow-up, on the make you and dosing on to the update ahead

Richard Pops

That's a once those IV X, and in frequent Rich. in it's we're including right every happening regimens, X-week Brandon, is cycle dosing now. cycle. in which And called a less X-week twice primarily study accumulating cohorts living Artistry in data

mature. now course We as right get like specific I to the on year, what that of sense back And have of a will present you they don't over but the those looks that. data can we

Brandon Folkes

dosing, And the subcu Rich?

Richard Pops

Subcu is still underway.

is subcu, but say I think preferred belief a that probably the we definitively. versus team's right the will frequent less IV that be route can't the now

because presentation. we when IL-X I think these be original hallmarks for nice subcu seen get and pharmacodynamics these of response the that has durable see one we've of question The -- some the subcu cytokines, We the data, we seen been with through pathway response subcu previous of and responses. respond people from with you've data presentation. presentation would durability of

story, For subcu, Proleukin as was originally in it durable. but the active it same wasn't

in what as the well. that's clinic we're testing So

Brandon Folkes

progress. the Thank you very much. Congratulations on all

Richard Pops

Thank you.

Operator

question Next Evercore Umer comes ISI. with from Raffat

Umer Raffat

I here, I have may. if X

readout the study, guys moving your forward are extent you you Phase ovarian or study the melanoma will in with those can as what's absolutely trial -- clinical would the to the one. point key nemvaleukin whether readouts Richard, Phase for what remind on visibility well not determine And get us number the for II First, III you trials? as spend

mean the is, types Takeda? of one think Orexin molecule would and that versus compares e-flux relevant are your doses for that second speak clinically on what doses. can to how And guys The ratio you the you to efficacious

Richard Pops

are Artis to the clinical both trial question is spin while so your XX punch Recognize blinded. on the going that that to and underway the still line -- and we're XX

ovarian we help the get variable enrollment So in will the study those inform the spin registration-enabling measure in where us we to the will QX we we would rate we RTS amount is over study us think capitalize key for stand spin. all XX be we the a time spin in study. RSX before as enrollment time will overall in frame, you of turn that should the that the happen determined controls that has multi-arm will expect But need prior is to a cards appropriate ArtSXX, how enrollment the underway.

a very will it it's ratio numerical to respect with comment registration-enabling why the Canada. the So e-flux well-designed, as study orexin I appropriately a described controlled that's on lead that we won't study. --

respect receptor it just its of of a over over them raises day. really not important body all are engagement I agonist. course the effective it's and the going why Retit about effective be different about half-life It's human think with -- of though, Obviously, because the time them potency molecules and to these target it's point, an in each as to

So the as but concentrations or the mechanisms. and the it orally, a you blood other pumps brain take how bloodstream, gets substrate it crosses it's stays it how what for brain, at then how gets target into how other tab, long it the that's reaches it neurons the or into whether there eFlex happens any barrier, the of types how target

we interest, of taken has I as is All humans. species until always matters it you which that into none into consideration stuff design But XXXX. been of as of say, get

all we're Phase the excited And which be I that. get is go into NTX the with along would to into it work as are step. now, patients, And actually next as now well systems leading

Umer Raffat

the a looks spin we Richard, on if oncology not was there I potential the you understand discussed side. just and to saying in had will I properly. sure forward I back, maybe be may I'm right recollecting spin. of make the with because want ahead the clarify, I'm thinking recall interim I Are I the that plans? thought trigger go to there's change

Richard Pops

study those to that to looking We the pass looks safety and respect board an monitoring Sandy sure data have melanoma and benefit, that's at hurdles. we to make continue I'm an risk accurate with futility statement. ongoing

Operator

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

Chris Shibutani

a across perhaps On XXX, in about the of for that think potentially have be be interpreting that you or I you're dosing differences modest we to plan in or contact next your of Ib in about dosing such ultimately is different how as the expectation required. And you be subtype. segments help us speaking, potential positioning be TX. potency would thinking and I denominator your different with you'll steps whether think specific level and It the NTX pursue should over how IH and development X that the relatively or data so emphasizing IH. patients of of patients understand seems Can because may subtypes each NDI the proof may Phase X

Richard Pops

question Yes. the anything, other of emphasizing because our it's If don't misinterpret please narcolepsy. of IRA. in a comments that IH the direction, wake important were Chris, really they over particularly that's the any

indication, indication, narcolepsy TX. this it's that orphan think indication large I in attractive really single is but it's an a spanning as because a indication, orphan orphan TX and

will given central narcolepsy we're So indications, better a first rather more focused I if more stretch we which other sleepiness really embodiment focus elaborated, if is But our there's of sleep I here wake on circuitry biology mean, the than anything, that done see in IH come is likely developed the axis that think eMagination with more down the indications pursue could potency elaborated this as drugs by narcolepsy here. excessive And into as and not to profile. be we any certain PK/PD in XXXX to clearly that and this additional data is the lab. gets compounds. the

study and But bull's in Ib for going of on that's we'll XXXX purposes NTX of the IH patients. first eye, the core the the the enroll the NTX, patients then to Phase proof-of-concept is focus

NTX But NTX. potency is on why You're by dosing differential such right, concordant and we important expect previous between that's an variable. done based others

think higher could want NTX, versus with to as NTX you you fold start you as you this can high get. that in low as high into as potency drug If several go NTX

seen data on far, the the and work we've modeling consistent the in based hypothesis our the far, in. so clinic sense? make are Does so that And with going

Chris Shibutani

in No, the as footprint all Great. Ireland. has And commercial then sense. always strategic that company, in then entirely question, makes making revenue the follow-up, broader domiciled been that if U.S. the the And a progress you're in a is separating given the significantly, with -- not And yes. Alkermes

much do more business be with and how XXXX team the which opportunity, global to the are neuroscience and through how portfolio Board about so, think potential thinking aspiring potential commercial the pros expand you management and you you vast and and ultimately can cons that? about you the if on As to has And the particularly talk market with presence? the certainly

Richard Pops

another Yes. Chris. It's good question,

markets. operations in have leave PLC U.S. and outside but as extent, an to significant different a XXXX that's will and and portfolio, global mean, a some pricing psychiatry expansion for company U.S. we in So Alkermes completely it with product, we ally is opportunities ARISTADA, story. absolutely those Ireland, the remain strong have foundation about topco Irish the in the a such. given didn't Interestingly, think really I really ex VIVITROL U.S. reference our we great

are And teams so strategy for and a through presence. our now global the strategy our working registration

market on go million of the with a for after order with an Given infrastructure of couple OUS the and tractable the XXXX. a the worldwide, U.S. very about presence hundred patients size in thousand X company to our respect of to it's

information on that So as we'll more give you it evolves.

Operator

Piper is David with line next from Our of Sandler. the question Amsellem

David Amsellem

just couple. So, a

had you gross that to of a the roasted commercial year contracting. LYBALVI, in certain extent this the will about a commercial net second on So that potentially be wider more of or sounded you there's due half the talked widening new contracting. past, impact the to there In to

strategic generally, pipeline? of to build number sort the purposes. revised as about payers then will. which use to Janssen commercial of by could be you So in that thinking seed oncology in extent that's with commentary, Can business? you is the there out anything just mentioned coming you secondly, you your capital And somewhat driven has the How are you of changed win. revised talk cash the that's That's the broadly about also, one. to neuroscience about used the And if that discussions think commentary

Todd Nichols

start I'll Yes, first with Access. LYBALVI Market

have X across channels. commercial. all And to think be across important to pathway about I that access now a nothing's your built to would is and thing the continue question. of access this, will I we to most to profile The say patients thinking solid and what changed it this about the continues established, a be established. is make those right sure to the X market channels, foundation Medicare, way Medicaid think been we've

our time net growth change plan are to to if to line top continue support our growth. our to access we managing need is commercial. strategically to within We position determine over And

discussing informed all if time. in has we'll do And profile, to discussions But LYBALVI. things we're keep And our the So make so future need change decision plan of with over a to of do we progress. we actively that as your nothing the you commercial changed. that is to payers regarding question,

Iain Brown

income would amount with or tied to provide point has award strategic helpful the the business, next funding potentially is cash, obviously to the would information in into And the the which it that the certainly that seeding Then to appropriate at could on reflects say commercial reach With we the further awards. respect look then but materialize be things asset, leverage infrastructure we level oncology with to and more direction. that, not final we business being business. beyond items its believe the the That's oncology the and needs we'll we of to pipeline cash change assuming to provide. oncology some the interim as future, a the inflection always augment respect that data point, in in order products

Operator

Thank you.

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

Paul Matteis

the Appreciate it. I year full wanted to ask your a question in guidance. baby on

even net, stable handful low sequential little quarters, your X% script say, end the of get a gross the declines that to the assume at closer to of guidance. you X%, you If to next growth even over

sequentially wonder was the way is quarter just to we think or the demand DTC seasonality XQ what for I to that's a or reasons. this actually that So whether if maybe is lighter a of to various about going here growth relative of assumption whether boost kind part realistic just saw

Todd Nichols

Yes, well. I'll as that take question

guidance and Our we scenarios net to has as from discussed of -- earlier, demand, range forth. gross from a so

encouraged We've We launch what QX months. up with story this was -- XX%. for now seeing. approximately a we're are at XX the story, demand for very We QX, been

uptake broad such usually awareness campaign Typically, this it campaigns We XX and support a through as months. best type that continue to time. of expansion see this point. see strong about also some watching utilization. we're aspirations We what and psychiatry, categories direct-to-consumer of the metric breadth fully to to will probably That's in you will be takes actually think X inflection. demand of is see overall. it building other also with gradual We that and believe our at over

Ian prescriber and and building guidance is aspirations reinforce, that just growth the reiterating the have we But those we expanding the we this going are we're continue awareness to demand our confident right long-term brand. do range, are. this breadth And ranges so is and that support now as we we're seeing think I'll believe encouraged said in today, about And again, to grow earlier, what quarter-over-quarter. our for

Paul Matteis

Can have happen? you your say of or what guidance anything about what would to end would the top assume

Todd Nichols

direct-to-consumer. I mean at demand -- we've access market also the a from provided with range possibilities we No, of this looked It's outlook. at point,

So comfortable now. we're where with that range is right

Operator

with of Fye Our the Jessica next line J.P. Morgan. question is from

Jessica Fye

the the pathway coverage could market? between commercial? stand? commercial have on how mean what erection. you you And the Where contracting? to couple can in I and mix guess, follow-up payer a access elaborate I a bipolar by remind me can be does government And of of Wally, And Just improved on via you commercial then access one specifically, in quality the on

Todd Nichols

Yes, absolutely.

broken So all across see across about what commercial, It's is channels you category Medicaid, overall, it's the X/X into typically, X/X X/X. X/X the Medicaid.

more and a a more also space. little bipolar within a and commercial see bit little less bit little a bit Medicaid bit You of a little the change Medicare. There's

keep in health think U.S. it's access care about market. by categorized gross typically in and that to is Medicare. mind generic market I'll and dynamic as We commercial bipolar doing is just a And to contracting the the than very And really it's a the broader pathway So that's system. net large well.

branded generics. products, through have the these step of of all to All products

U.S. So that's facing. providers comfortable are not what through. managing in and steps for HCPs exceptions, different authorizations medical the very LibaVIis and prior And with

with look the that that really HCPs And and Medicare, hear watch that what's lives. patients a in formulary and large. of goal commercial, the that that we be we and we marketplace product our and branded do to right lot So LaVavi's access. would on access managing within we'll commercial that's we're block terms with the the with We consistently HCPs closely, happening in along Over be is very programs happening see would NDC at And now Medicaid that providers. able of need across space. And patients watch balancing perceived par -- our to get also we sure access the to continue research watch access with to we competitors. also time, is profile make

number lives a have that We also access. have open of

tell too. we it's of so market. focus can It a takes a that. to stagnant not I put lot as And this well, of and you lot a attention, and attention

going And big have for the we're long-term to be making our a strategy It's overall, managing sure that support net. we the access so to to growth gross aspirations. the company, profile right

good with right that place now. a And so in we're

We have foundation. a solid

Jessica Fye

year? should Ib prepared Phase for thanks Orexin, prior And expect learning then SAD results color update for the to results later additional in the a the and MAD on we the detailed remarks, more this

Richard Pops

Rich. it's Jessica,

what as the occur I major status is the as do mindful being of in to fall, would what move trying quickly scientific some and of the that we're that meetings be. can we late-breaking think

data MAD finish much with right cohort for But present as just release. is off Ib SAD now the to fast I primary we data, than respect think goal press possible. comprehensively to try scientific the Phase as rather get to as particularly the NTX via can and we'll So the as

drug, and So a present the and we'll sense we clinical profile of comprehensively as data get as rapidly can. the we those real of then as

Operator

of [ph] question Eric Mizuho. Yuri the next is Our with line from

Unidentified Analyst

that's of what in sort else of Hapur? and you follow-up of walk additional from know my you anything much a like guess needs but the interim is, royalties just much, expect procedure sort we tell there Is I at get come say least the through sort should finalized? -- interim can't question. of probably Transa could first to you awards? awards how us question So the for the can or order us to I arbitrations

Richard Pops

are because we process. panel way The conducting and the careful both opportunity on arbitration respect voices It's throughout And make sure the procedure breathe Rich. for has the they're sides proceeded the a deliberate really to heard lot essentially, have that parties is and the giving the a of way. itself in

the term that's terms. award. the fact of That's different what with the product days alert the the panel, first us we of panel there's adjudicated to and to in off being which That and on. issue, in So now our various just XXXX independently parties a that award second without continue central the paying XX let's learned as January, mentioned, ability in sell check, seeing royalty. And any ticked the want treated royalties. XXXX back and interim The start the then what interim, -- products other is the numerical for favor. whether to opine I The X looks Janssen the the to have are they of how quantification said like want that then, we was each panel, second next the question to the check, the applies directly was okay, and the those in panel things that's terms products came

end nearing we're the runway So here. of the

I outstanding any I if issues, has think we that J&J other the this think -- outstanding don't award. approaching is Alkermes issues. we're see see final going any issues, perspective, we'll down to remaining now the From wait any to but

Iain Brown

a to the TrinzandHafierra. related XX% this Trinseo is of to in volume U.S. therapy to based XX% on on that with and data basis IQVIA month then would Halper, We is regard somewhere of estimate And between

Operator

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

Jason Gerberry

generic of of been revenue it addiction becoming commercially and alcohol, opioid but product component an about in VIVITROL, talked my harder the couple. when the or of product more to conventional about business the -- you've prisons shift just whatever this starts making I'm versus is a channel challenges the it more was reach. generic and wondering, was have VIVITROL a occurring to in takes, were a questions there shape Rich, of past, Most of thinking of to the clinics, maybe ask asked, threat given I'll to selling lot and a a whole commercial

any follow-up, So Orphan comment And Drug that's NCEs lose about different then X change got as one the your just adjudicating obviously, you just one there's indications a noteworthy in IH? wondering thinking, there? and for space, if Shield for me have IRA and X narcolepsy the the thought orexins you about orexin

Richard Pops

I the saying I this that's I awake earlier, fundamental to Jason, whole is Todd than side. sleep-wake became with classic thinking what of and engaging first These second different think I'll but question, so more your yes. already our cycle comment. important setting. Yes, remains, was wish alcohol ways care of mean, conventional other about pathway VIVITROL let I embodiment pathway. the the and we're It and that I is medical to XXXX settings of advent definitely think are think absolutely, I the

with overlay in So it a... the patients bespoke remains a that incredibly in treated government incredibly way idiosyncratic of still and large and public get intervention policy the

Todd Nichols

Yes.

that. VIVITROL dependence. for -- We about And a cycle, hitting alcohol dependence. stage of alcohol prescriber now, just product. actually well. add of it's contribution in as typical receptivity highs me there's dependents. -- the breadth not a retail life right highs with for Let of account alcohol XX% the with this and coming story At the very I'll to high all-time the we're VIVITROL is utilization to we think from all-time When hitting We're volume

is of a well, well, complex small would you there's as it that to of really There's there the regardless commercialize. And believe And don't too, of market is the able And overall. also of said at lot that dynamics. models, market way Rich It's which settings molecule down your to marketplace, fulfillment not And about analogs so than to our payer just if typical setting different one channels there's be various retail well, various care. of resemble And too. the care is to complexity the think coming have various product. erosion. as that It's it was a kind injectable we we've a naltrexone generic too. into done looked expectation a low-cost, as comes what

think commercialization attributes. product So attributes, complex, it's the actually, really we the actual but

erosion. a So see generic this as typical don't we

Operator

next of Our is question of from Marc SVB Goodman line the Securities.

Marc Goodman

like the right you're of BD obviously, pretty about some and mean some there new year that pretty Can for these Which do know I talk you out last must probably outside? looking capitulating on feel actively from closer the important Are on this year are be now? I valuations? landscape smaller you in molecules. assets just bringing you new to companies you, than

Richard Pops

it's Mark, Yes. Ray.

getting about I haven't the more for ago, so. expanding small helping. the very on I'm not think think along. that of there's over focused moving LeBaViand the the the spend pipeline getting and program launch Orexin couple and other we so things R&D in last rabid derivatives the being labs that of been -- and the years area of as disclosed the of its you And would have characterized going capital is cost and this say, companies development for being not business a I fertile years to we've couple it's

position don't nice us something. we there's in urgency a do feel an in got we've going, where pipeline like we to prime to but get So enough feel to the the pump

company tuned. way. our But -- want its pipeline, from sophisticated to through So We to and do business cost-efficient scientific they're late-stage development neuroscience spins, is obviously, ideation looking the in that will it capabilities. mean really the commercial that things and as we're the letting a with but things at we things augment want I we broad. I -- feel mean play consistent have like stay we way out. things so team to all at

Marc Goodman

multiple And potentially thing. the ex without about the different having and cataplexy, of derivatives, that kind is that with for of referring to the cataplex, IH previous orexins question channels

Richard Pops

done it thinking how think small first molecule probably receptor Yes. the figure I as full the be that lot agonist that to And a is there's be to orexin embodiment drug would create these we out in naive.

curve of make want the we that. to So ahead on sure we're

Sandra Coombs

Okay. Marc. Thanks,

have one I more question. think time for we

Operator

question from Wainwrights. Tsao line of comes Douglas with H.C. That the

Douglas Tsao

to bipolar asked demand just you greater the on campaign, more Most on answered. you think of of indication? have have terms isoprene the in been expect indication? and the DTC do my it I'm Or impact just impact But questions a do would for curious, have

Todd Nichols

which think over is works totally Yes. what a a learned -- how is efficacy-driven it Doug, differentiated. The the the the is that months we thing not about is first Libavi typical market. that and launch a XX we is category. This have indication, is an this really together. that's we've about product very broad powerful way in LEVALVI for is and

of patterns So schizophrenia campaign the we believe of We consumption habits program know that is are. bipolar. know we what launch bipolar. really our a The specifically patients digital and on schizophrenia that have We focused their differentiated. media and was with initial

With the TV component up There's over anywhere a of large this, opportunity. the is market switch to a of very span. Xx lot between therapies within bipolar marketplace switching their to patients X the

So we switch opportunity. large know this is a

program this overall So works actually together.

that the we'll get both bipolar digital the to activate You have then through hits but component patient TV. indications, really

Sandra Coombs

the us follow-up any Please have call reach All joining you thanks, right. for on today. out if hesitate Well, don't everyone, to questions.

Operator

conference. concludes This today's

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

Alkermes (ALKS) 26 Apr 232023 Q1 Earnings call transcript