ALKS - Earnings call transcript Q1 2021

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Operator

Greetings, and welcome to the Alkermes First Quarter 2021 Earnings Call. My name is Rob, and I'll be your operator for today's call. [Operator Instructions]. I'll now turn the call over to Sandra Coombs, Senior Vice President of Corporate Affairs and Investor Relations. 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 Iain our Todd Richard our me CFO; Nichols, Officer. our and CEO; Commercial Chief today are Brown, Pops,

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

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

Now over Richard. I'll call the turn to

Richard Pops

morning, everybody. Sandy. That's great. Good you, Thank

expected with plan. biopharmaceutical way and the over we our create on by the second be patients. track We've driven unmet disciplined management Coming marketed through cost on our important in anticipated results candidates. a solid Alkermes you is $X portfolio quarter's we new billion in treatment line companies the of antipsychotic the achieved longer But drugs. performance our we're highest medicines making is revenue and our developed which were for driven deliver capabilities, growth execution in medicines, identified of by being of by and an We've oncology to neuroscience that first detail. needs level, Biogen. consistent The we've specialized with top of and LYBALVI, focused by term, new point launch of on the value a exciting commercial Iain of The objectives a evolution. portfolio for enhancement will and will on VUMERITY, QX in focus value the and our MS address sold that year structure. next, developed, drug our the take but Todd we're at commercial growth financial opportunities development

develop relative Day, year. that recent have and for the molecule. neurodegenerative leveraging later and At studies on molecular a innovative to objective new anticipated do value our in this We developing design, advancing strength entities established small new this this with both first-in-human is diseases medicines clear CoREST-selective and and In neuroscience, through molecular proposition strong our biologic development reflect future based Investor potential neurodevelopmental truly of Our to our standards are current care. rationale broad in toward programs and large approach. announced we HDAC inhibitors utility

our new is pathways modulation approaches small challenging of chemistry oncology, In candidate. addition orexin clinical immune advanced capability this program have agonist cytokine a candidate and medicinal in engineering competencies and we that innovative most and most Our potential core two developed receptor yielding later year. planned nomination nemvaleukin, high in to our leverages for the oncology pharmacokinetic some expertise with to formulation molecule

unmet stop a create and our shareholders, with is investment. candidate enhancement plan capital throughout competitive the to we areas and have assumptions address a development protein value for a business incorporated rewarding excellence of of and it's explicit expected we've new a and introduced those It in a these way it These and focus the and into are we through criteria, Alkermes prioritizing also through We excellence last If equivalent clear major highlighted The value aspects to enhance drive return we R&D of in process. archived ability programs split cost are and business in highest efficiency the and future. If And on scientific make and can the the our clear intention meet way we investment. drives that that IL-XX prespecified and focus will an The to focus our unveiled in our on grow furthers test tumor-targeted makes neuroscience all also to the is our powerful fusion December is preclinical need We programs on provides that operates. value on doesn't profitability. on of oncology excellence medicines, IL-XX our of work efficiencies concept combination these profitability. advantages. structure, website. increase specific to program. a our investments presentations engineering Each designed framework year commercial what and allocating value designed

Iain So over first turn the to now to introduction, I'll quarter the results. that with review call as

Iain Brown

which Thank disciplined we on and press from financial of our year on back announced for the we these we reiterating driving growth are COVID-XX line filed principal the respect outlined you, management. quarter and fully expectations X the February release Rich, top and from derived our hello, results recovery XX. expense to focus: pandemic, in for X-K expectations with first areas results were and XXXX, solid everyone. financial our morning, full ongoing today, This Based our

decrease returns. our quarter, in XX.X% the pandemic-related a a lower And reflect favorable XX.X% to loss and in as results non-GAAP adjustments due continued QX, by These across levels operating continued first normalized acceleration driven VUMERITY. were level With VIVITROL QX expenses $XX.X unit and $XXX.X the to products diverse the $XX.X to were For including of $XX.X lower than treatment income the we the of is commercial portfolio quarter of of more million of by the to year-over-year our notably of and achieved million. higher system. $X.X for the Gross-to-nets with average some XXXX. in the solid net this, quarter items, a sales decreased XXXX was of first X% royalty in Despite in the quarter and of first net all expectations first to net inventory compared a GAAP performance quarter in an million. gross disruptions line in volume total consistent patterns. of ahead related net revenues, and net product approximately million manufacturing as XXXX, uptake sales driven generated we units revenues proprietary Medicaid typical seasonal of our million, by

by Turning underlying ARISTADA the in increased growth. to to X% primarily quarter sales the product family. million, $XX.X unit first Net year-over-year driven

As earnings in in This the ARISTADA approximately with the first represented we of $X fluctuation first XX.X% Gross-to-net quarter consistent levels with were call quarter. declined year-end our anticipated sales due sequentially and February, inventory levels. QX in in adjustments we inventory net inventory to normalized ended million, XXXX. decrease on a more

Todd Now to while growth, pandemic, ARISTADA particularly the on impact that demand overall starts, has shortly. patient an detail been resilient related on provide more will and seen we new throughout market have

were in orexin nemvaleukin royalty million prior stage long-term contributed expenses reflecting primarily $XX.X continued by business. disciplined volumes. were was VUMERITY, the royalty in In and period revenues to in our the shareholder compared the million prior organization. million uptake investment the SG&A INVEGA which $XXX.X revenues primarily million million partially value. for royalty believe, quarter for year. This to first R&D accelerated and the and of manufacturing compared year-over-year prior reflecting primarily for the driven on focus for same first first prior manufacturing million $XXX.X the million and down the by growth from in quarter the CONSTA reflecting quarter to commercial manufacturing and $XXX.X were investment SUSTENNA drive year, ongoing for the across year, the RISPERDAL $XXX.X Moving $XXX.X $XXX.X million our our quarter, and expenses offset expense year, expenses platforms. our and to will earlier we savings quarter, programs, operating lower $XX.X in from in revenues, the first of were compared on $XX.X TRINZA driven by lower Total management, HDAC million increase

balance was $XXX outstanding the $XXX first approximately ended in with well total Turning and We million to capitalized debt quarter investments million. sheet. cash our and total

continue We with highest consistent capital allocation our on long-term our return the to that opportunities focus on are strategy. growth investment

with noncore around stage to the the Todd a Our financially believe unveiled commercial the including Investor clear: the R&D strategy, are our look potential launch on that royalty long-term top growth, to and forward our seek at programs program nemvaleukin advance programs strategic to and neuroscience and And positioned other opportunities, on as Day develop our we and recent quarter well progress. in solid review and oncology invest call you I'll commercial for We foundation LYBALVI, over development our with creation explore hand I of value enter from early to platforms emerging execute updating streams. results. to our newest and the are drive priorities pipeline opportunities that, partnership second line we our portfolio support assets,

Todd Nichols

with VIVITROL first Thanks, the everyone. sales slightly team's QX with Iain, and and our good net both pleased commercial expectations. ARISTADA of I'm morning, in quarter, execution ahead

in Based ranges unit seasonal year QX underlying on solid for are fluctuations. and typical results guidance full trends ARISTADA and we our positioned reflect results VIVITROL. the within treatment quarter achieve sales landscape, first to Our demand we believe and both well current our inventory

impact and in illness disruptions mental patient addiction taking step of Now serious to we to a COVID-related QX treatment continued both as back. access anticipated.

believe half as and approach care. care roll we to second settings across of of restrictions will that and ease patient country out continue to the as vaccinations to XXXX We capacity continue improve access the

indicators We have for trends ARISTADA leading VIVITROL first in and the compared new-to-brand QX. seen quarter such encouraging as in both also prescriptions to

in us has in dynamic both and We promotional model it last hybrid model this implemented year, to highly response adapt the This market to virtual quickly on our continue engagements. to and was that pandemic allowed incorporates in-person COVID-XX environment. execute

increasing been continuity, While forward virtual engagements maintaining look to critical have engagements. to in-person we

from these through the percentage We pick expanding With March, January. the force early in-person up have their first our of up in XX% quarter. to seen XX% engagements costs in approximately sales

due working primarily often Net addiction VIVITROL. slightly as up VIVITROL access to patterns. disruptions higher due were requires particular, detoxification to the system sales with $XX.X adjustments, the COVID-XX broadly still generally. impacted to which back to and be of the and unit build of to million, demand declined care QX continued need Iain net first the pre-pandemic before substance towards sequentially, the medical treatment starting for impact Now are the well with And as VIVITROL the as consistent seasonal Pandemic-related treatment systems drawdown QX. abuse gross-to-net requirement ability in negatively health we outlined. for inventory to VIVITROL nature the quarter in of setting sales treatment in of care receiving impacted patient's levels. restrictions opioid-free utilization treatment, injections, settings in

pandemic restrictions locations. in we see increase dependence capacity, Now stabilization but settings the to patient correctional have of have and opioid to residential treatment yet their centers, since lows, fully seen treatment government most within that continue notably, facilities the other care

However, in XX% month. recent reported of the AUD we about health of prior compared to increase and research, a substantial In to providers in March seen growth the have in patient OUD we a market. slight volume resumption care in dependence, that our market alcohol survey

with for advisory medications alcohol SAMHSA consider QX, treatment patients. During new prescribing use patients disorder, treating to pharmacotherapies FDA-approved encouraging a when for providers issued

of patients. in and caregivers as focus on a of alcohol option driving awareness XXXX among dependence VIVITROL is our for Now providers, part treatment

the adverse experts and begins been and alcohol on pandemic, drive launching awareness the month, public to the concern to campaigns dependence including health increasing awareness in alcohol-related As we isolation health April about designed have organizations have is emerge the options, drinking and and rise increased education conditions. around of from country of VIVITROL. of heavy expressed disease alcohol focused the treatment

starts. and we reiterating continues Based million category XXXX. on today, our to the of trend, alcohol its are in by the VIVITROL our range for the of $XXX results new growth mix fourth in quarter, VIVITROL of for patient the upward expectation and dependence, net of $XXX driven sales prevalence the indication Now million

million, which X% Turning the therapy that first X%. outpaced product atypical of growth broader year-over-year by family. approximately at sales the XX% of driven to Net increased ARISTADA TRx now strong $XX.X market, in long-acting antipsychotic the months quarter year-over-year to grew

from As net the anticipated, sequentially seasonal down sales inventory fourth driven quarter were fluctuations. by

had the Iain end returned As outlined, levels to at inventory normal the first quarter. of

particularly space, impact the telehealth of providers environment, visits. changes the to have in long-acting of result the to particularly some context seen antipsychotic pandemic, prescribing fewer care a As psychiatry COVID patterns health the new in as within we made treatment prescriptions

new-to-brand result, in As second the a flattened XXXX. prescription half of growth

that encouraged was providers the patient sequential experienced the XX% highest ARISTADA antipsychotic our health care growth the the first research in shows are XXXX, We NBRx quarter. in quarter market. steady a volumes of market in that increasing or LAI Further, on basis,

Our indicators, research resonate health of basis. a range for we $XXX X-month QX indicated to on results as leading XX% of ARISTADA XXXX. plus also month proposition to are X-month $XXX the our for with recent sales value growth million expectation dose by market of net the continues reiterating TRx care within million therapy on our and Based these the in year-over-year INITIO ARISTADA the evidenced that ARISTADA providers, dose

Moving to LYBALVI.

under olanzapine while its with FDA of the June associated is antipsychotic with of the investigational gain to X. mitigating Our designed oral weight PDUFA offer date the review efficacy candidate

antipsychotic As highly team as concerns the for compared the the on potential new to is and a fit XXXX right of like profile was occurring physicians atypical in believe due and NBRxs in a LYBALVI. join treatment ARISTADA adults value efficacious, for with commercial XX,XXX differentiated oral strategy, schizophrenia prolonged our bipolar oral to being antipsychotic needs. LYBALVI for olanzapine December as disease suggesting providers look with entrant our of approved, to for treatment will our fastest-growing XXXX, launch seeking we often payer LYBALVI, a product this X proposition approved, has the over infrastructure. the unmet franchise, profile. the with market each community. if patients half potential treatment leveraging We their that the important different believe increase atypical awareness a represent in while widely persistent serve adding market LYBALVI, avoid a and will The XXXX, patients. highly treatment in gain. scientific new with is XXXX, dynamic, need December focused disorder, for medicine as Olanzapine with weight in increasingly its state for are X adults and propensity but utilization driving psychiatry patient markets: engaging to second XX% recognized a if is in exchange. Interestingly, efficacy potential an for the olanzapine's about a prepare switches existing We approved, in a finalizing our suited medication If of reflects opportunity month with patients psychiatry and

LYBALVI's we payer Our about force XX of field universe. representatives add to throughout year provider ARISTADA already sales of fashion in based a access. first staged And the plan XX% launch on in calls approximately targeted additional

these awareness VIVITROL achieve prepare Looking and of we LYBALVI, ahead, we are proposition for launch to important medicines. focused for the as to work on potential of our expectations and execution ARISTADA the drive value continue of

the I'll to Now turn Rich. back call over

Richard Pops

Good. Thank Todd. you,

But pipeline and R&D value company. priorities the financial for of the and emerge. is beginning our to investment top commercial So remain execution the

is dosing Nemvaleukin that now. well its in are beyond potential and few Nemvaleukin rapidly value activity, to to both The the and benefit of results as It's design, nemvaleukin. minutes So of field because late-stage biology. support in monotherapy and I'm later proposition. IL-X a has course, are, more a data start another as emerging on at of for prominent recently Day, program antitumor accumulating immuno-oncology have Investor and failed. stage conceptual the stage have promise differentiated and to we combination patients as the ASCO. variant phase strategy is and that's our is clinical that. presentation the at differentiated of garnering its spend We development most clinical NDA and therapies select whom at flexibility, potential agent, with focused moved elements inadequate I'm upcoming our presented in or more terms therapeutic our data advancing LYBALVI attention a going nemvaleukin current going on

on recently. I'm So operational today, important to developments focus going

antitumor designed Tumor signals unapproved wide carcinoma. tumor late range has melanoma pembrolizumab single We've PD-X we I/II Phase checked pembro. is A and parts. the pharmacokinetic activity supporting This both types evaluate Phase successful. the from is stage intended to for of perspective, and signal partial enrollment Part and broad time to primary nemvaleukin. renal melanoma as C agent dose First, has milestone utility II last potential was dosing, efficacy. therapeutic and establish and study to the activity with the the program study identify B activity preliminary started box where pharmacodynamic designed Part human in of activity the dose of combination potential C dose. X and both efficacy with began with for in monotherapy C We that for and the study identified achieved recommended been types an cell in year. to important IL-X was with to was the proven this designed was new molecule. IV combination responses the seeking Data first continued the of mature. ARTISTRY-X. that Phase completion B data Part we a nemvaleukin, and of to of in ARTISTRY-X recommended tolerability antitumor from escalation we've our recombinant of also seek and confirm monotherapy tumor reveal validating after of nemvaleukin profile types. a It and From in on Part nemvaleukin, essential has intravenous parts observed RCC, PD-X of tolerability II the safety across revealed the approved anti-PD-X in

set and we've to continue a in talk Subcu a the of dosing is where moment. the more the in at plans with of platinum-resistant could maturing, a ASCO nemvaleukin a subcu year. was accepted Phase knowledge, responses evaluating a on administration nemvaleukin. still set's our in at poster durable ASCO ovarian clinical open that for will clinical Also of IL-X data ARTISTRY-X will The stream clear about cancer, subcutaneous throughout I/II opportunities. provide the I'll next study to broad is was just currently a update While only in option of ARTISTRY-X accepted our our data development. area ARTISTRY-X, C up of And the data which poster presentation. remainder observed part deepening a and range occur data dosing signal variant

from also matures. last advancing Investor ovarian toward year, that the those ARTISTRY-X as and II it's our antitumor progressing in X development we're activity and we platinum-resistant study strategic At recommended dose in program response focusing X positive we it opportunities in of with At activity end broader next on further our ARTISTRY-X, cancer. studies the cohorts. and the Day, program, monotherapy pembro that present advance and milestone antitumor mg once-weekly melanoma platinum-resistant identified Showing an the in forward of recent data expansion on for well. data we'll subcutaneous the combination cancer seen partial of for as the We're therapy set signals triggered collaboration. additional to focused stage. we've we is look important efficacy next The PK the mucosal developing phase. ASCO, data Phase and sharing the a from from first at escalation safety, tolerability, in We dose to As dose study our patient that with presented PD ovarian and initiated

So month, those leverage with cohort subcu results, designed particularly will monotherapy activity ARTISTRY-X receive antitumor and Mucosal for severe And and FDA monotherapy trial nemvaleukin the clinical on patients turn. observed an initial This let's ARTISTRY-X, as orphan we nemvaleukin The profile. is ARTISTRY-X. its study melanoma in treatment align recently checkpoint for also signal limited infrastructure activity who enroll melanoma, a proof-of-concept II with experienced a with Last monotherapy. of with evaluate put single-arm and administered designation the weeks. what seen nemvaleukin we've magnitude in this also on ARTISTRY-X, cohort To cutaneous granted in form with disease. This support melanoma the was with to mucosal of design including initiated Phase to study nemvaleukin. is met of In call study indication. safety options. establish we of the in responses of inhibitor this nemvaleukin patients will first a in melanoma. durability drug study this Obviously, in patient patients antitumor dosing IV take rare place advanced is potential being coming will We registration. in anticipate to subcu and depending intended the aggressive

to with observed. recently still and to study. is platinum-resistant We with the entered pembro signal PROC. in ARTISTRY-X analysis area cancer, ovarian of of by with the nemvaleukin a To activity that focus a III second study to known study, that half the the finalizing is year but with observed last second of chemotherapy. only and with we've has And where Merck Merck. participation investigator We're pleased important The the plan clear that and in be is collaboration partnering approved an is their and not limited we in be combination PROC will initiate believe nemvaleukin pembro design Merck a primary signal agreed into combination year. of supply acronym, compared we've antitumor this validation that support we trial pembro of in And we an clinical on This shown activity. a very choice FDA, indication We're patients. Phase study

in prelaunch reason we and we The of look sharing This strategic review, various why to because the LYBALVI. Importantly, incremental clinical thought of the and nemvaleukin. acknowledgment various activities leaders the types. IL-X logic range to momentum the value. through of the we're a proven collaboration relating is are data the business, a Alkermes' clinical and accelerating. of process second Across the And duration are we're with variant tumor-killing confirmed complement intention approach and the impede focused advancing. pathway We've an complementary And is half. to to FDA various -- validations X accumulating efficiency human and to focus important new throughout compelling updates priorities for need our response to for establish nemvaleukin great year. programs forward clear, on commercial the we're finish for drug path commercial -- important company. human PDUFA laying toward of the and duration is the on There ARTISTRY a of to in on a in In and the to number with pursue foundation strong development care half the as our parallel types underlying are the investigators date. driving clinical our strategic the hypotheses a programs developing in the intensely which reenvision not the program Currently, priority update program, in June collaboration will does is ability be to followed the IL-X approaches. of development. tumor or program tumor are program, broader launch I'll The these data This and relating working with trial the brief taken response to execution. remains

we value efforts While in believe real we some will out bear opportunity to over significant have of these drive time, XXXX.

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

Sandra Coombs

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

Operator

[Operator Instructions].

today first with Cantor comes Brandon Fitzgerald. Folkes line from of Our question the

Brandon Folkes

Congratulations on updates all the year-to-date.

and VIVITROL. ARISTADA just focus I on So to actually want

these a COVID on headwinds for those going sort been the and time. long have and restrictions of the -- about talked You --

this the there's of change injectable to color Is sort market? expect this lot of a long-acting work of Just sort we ramp kind commercial to a think from up, much you pre-COVID as well we great pre-COVID back space of as take in How any we open levels? permanent the a bit back how been addiction paradigms levels? side? should think in of atypical be of should treatment about terms the in the do going would that's So ramp to something there as

Richard Pops

And Yes, thank you. absolutely.

the for to going also providers. access assume really in of which patient with driven volumes half both to moderate be treatment products normalization improved pleased market the patient includes the performance QX. very are which do is growth, of We in We commercial second by a year,

All that. of our qualitative research supports

One the in that telemedicine. we percentage you both saw to continue interesting up. fact metrics from a see therapeutic shift to think the areas we're key HCPs surveyed is watch I right And to pandemic engagements utilization. telemedicine providers in-person switched a when huge starting of And our treatment physicians and back access the to of that showed opening gradual happened, to

treatment expecting to believe that So When an these ejection also half in year. that drives products, we of we'll normalizes, in that the as normalize LAIs, second we too. are that the drives of switching see start really to increase both for the That drives landscape the VIVITROL but market. well

second So year. the that's how we're half the thinking in about it. It's normalization more of of a

Operator

Vamil Divan comes line with question Mizuho next of Securities. from The the

Vamil Divan

Great.

if could. I two, So

date came to discussions It and LYBALVI. at your all manufacturing labeling already sounds my date. from you X track the the question sounds end. sort before to in on like guess June question things investors, that up towards be like -- one we've finished been So this getting of it you're PDUFA November, sound the then on I prior

second of I FDA? that's point? of sort curious potentially trends those the sort the or the And right things? way product should is And interpret there to well with to VUMERITY. Any just at really we've anything being given So prescription of is known the then in question sort you still if those to mitigation be strategies? of of the around I'm any there. seen have on discussed already of that is get sort Or things? just kind which change risk And this restrictions dramatic patients Would

of curious like that. think talked streams enhancement cycle, That's long-term the of you royalty how in could figure need for sort what early questions kind the product? your out about still patent things while is that one about as outstanding plan. can part exactly a Is as well. of you've product really I'm at you think life term? you you you Because just being some a wait look Or sort something TECFIDERA to to a the pretty potentially given near that is. of for the monetize value little what see value I before value the the tough of around of do maybe you little

comments any be helpful. would there So

Richard Pops

Yes, start for -- then I'll can X/X on be he and Iain in. seem the Rich. date. has it's we will he track to if color, some Vamil, chime LYBALVI,

continued which But discussions on are label have label that came why we In But anything our right. is negotiations in and with manufacturing those there's so up cycle, been FDA not some never stuff until discussions think this previous unexpected over. You're the in been iteration, at we're far, to now they're we minute. over had has last discussions. label We've had track. the

that I we're but FDA, this we get So indication we caution of optimistic these finished days it But think off. so have is warranted, far. no can with always

on I VUMERITY think phase. is really question you yourself certain answered VUMERITY. a part the its beginning of growth nonlinear

further we'll at that we're pay difficult curve will attention the shape So something With be moment. be, the interested in, that to it's the basis that? and it's of of this would Iain, monetization what any that other project color very on actual to. a said,

Iain Brown

we've Obviously, I there. then that into add to trends quarter. and fourth the with seen very we're the encouraged think first revenue just in much Not the quarter

do new Rich trajectory. as like it think says, it's products. We the on looks manufacture I a

VUMERITY. need I said, what's into the order more future us a in from few And quarters early. an those get consecutive But insight as establish it's And happening we encouraging very more manufacturing to are patterns into bit Rich think strong a as well. the order to in we trends. for So see value, of little

Operator

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

Thor Nagel

and In VIVITROL, One nemvaleukin. dependence Thor is on ARTISTRY-X This one then for path much on on is in question on registration? VIVITROL alcohol the look for in then Paul. like that does assumed how guidance? what to leads growth your nemvaleukin, And

Todd Nichols

Yes. off I'll the on with start alcohol. question

be saw so strategy alcohol. in to market we within We significant good our continue linear. a marketplace. in And year, a to year-over-year. maximize for that to continue, we really the to need make to We're category. the It's expecting gain expect progress Last unmet share about growth to X% somewhat opportunity continue the

Overall, a on at. to that therapy X% be to we're range is growth overall we expecting somewhere within we're that to of is that close probably think X% that, months So looking basis. going the

Richard Pops

Mucosal the Rich. a with at is unmet are And ARTISTRY-X. disease inhibitors. answer about progressed who've that this needs. the melanoma question beyond checkpoint And serious patients is I'll we're looking people

very options. treatment limited have they So

number the clinical two tolerability. rate; exciting of nemvaleukin One like things. think variant responses. And three combination X is response of is I IL-X durability an is is a number is that about overall profile those so

will that we'll at be evolves. ARTISTRY-X So the looking as be profile

Operator

from the Cory next line of Our JPMorgan. coming question is Kasimov with

Cory Kasimov

Two for me, on both nemvaleukin.

subcu both First you've about IV of the one talked know ARTISTRY-X. future evaluating ultimately subcu on factor and Can I formulations about is for rationale following the you I up talk contingent more for being there? mean partnerships. a

for follow-up going expecting So terms we in ARTISTRY-X? if should should you about expecting the can for strategy. be placeholders essentially what then bit are relative be that abstracts be And upcoming to the those themselves, Or you've talk how we of there? already? meaningful for at to more updates a disclosed posters ASCO, And much little

Richard Pops

the with followed Cory, I'll efficacy activity the first good think the voice. we're of more essentially ARTISTRY-X. And expectation as wedge hope recapitulate we that that in hear the subcu then IV. and Throughout the and that's exactly IV second with what of doing by could see we the nemvaleukin, the for leading to part. is subcu the and the take the expert on Sandy edge your program part,

melanoma While very them. little leader we really investigator interest at in patients great mucosal stage. There's thought for that with for have treatment

patients. clinical as we ahead that moving an us the well life-changing life-sparing, setting option the the into well subcu for context of would introducing protocol. within subcu IV if dose of of see lifesaving, same But give be as the these type the So could therapy with advancing efficacy that

in putting mucosal asset the a we're countries and to see feather as piece clinical those this great So when various to well, network and around do we'll various subcu how in evolve. data to subcu sites, melanoma leverage it's

Sandra Coombs

ASCO we on did the Day. the posters. your question our just an Cory, at Recall And give nemvaleukin on that Investor update program

that of we'll possible. data that that a But So updated in be as we'll as keep set as but try probably month follow-up additional poster. data, data refresh to evolves, there'll investors worth

Operator

the from is question line next with Mukherjee Our Jeet of Jefferies.

Suranjit Mukherjee

Two for me. perhaps. Back to ARTISTRY-X,

be Investor many you that implemented a continue in perhaps on elaborate melanoma highlighted management. reflected enroll? expense efficacy the perhaps cutaneous steps patients meet the melanoma? are to was, and throughout bars the hopefully several sense perhaps you to bottom what wanted you on how for of And plan year had to be And believe Just will steps what to do cutaneous at to get you and facilitate respective Day, Could line? mucosal your perhaps second the question

Sandra Coombs

is the the Sandy. Sure. question number. enrollment Jeet, this patient I'll on take

enroll cutaneous be on that, the approximately will you and the So in be response? mucosal ARTISTRY-X, arm the will the arm. comment melanoma XX approximately Of overall, expect to XXX we subcu want Rich, in in using patients. to XX do

Richard Pops

Yes.

level. approach biostatistical see durability. I of mentioned that think additional feature is to XX-plus before response with the want the we I But rates to that our percent in this it's also that

really striking think of response you that I response, this year now. partial first a really talked I therapy expense aspect want we the for, in on durability we has that's nemvaleukin over previously been And encouraging about setting. believe, is important. to the Iain, side? had, It's the comment patient with on

Iain Brown

at consulting expense really also at organization the on internally we year. external beginning then the of both And yes, everything, mean, side, I in brought we're management the across business looking and the

continue. is have just side we into leave We're And the out came we that headcount people a XXXX guidance. our the as on initiatives sure that number of going factored So to making of go of the some we're actively managing that, of organization. as But the focus things which forward, we right resources we're within as commercial On example, estate going that like as well. right the at both footprint our real on a R&D, return that within and looking basis, really well, focusing that program maximize to investment. opportunities focused opportunities we're the on with ensuring And other are investment on programs. we're

process, So to the to it longer-term we're and out very enhancement the targets it's profitability be that a in in we've plan. focused on value able pretty laid order thorough achieve

Operator

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

Marc Goodman

Yes.

a Just continuation there.

on talked data assets. just just -- are I'm back noncore kind were enhancement the partnering, the talking we're thoughts additionally, monetizing you area, you've your On curious but maturing of about plan, there. about in curious, this what thinking oncology about throughout you value there. And just discussions just could start the on quarter. obviously, out, just secondly, you just types light just process spending, topic year or certainly signing separate your completely anything. about before And curious I'm of maybe lay of kind thought very the in those still

in year us give sense line. of the Just how a just throughout SG&A goes the spending the

Iain Brown

earlier the regard We've off stage covered kick value. R&D monetization, -- that earlier necessarily to to programs. a we R&D we on of to that with bit not sort a little to that make And with want think, really assets. noncore monetization noncore on, We focus proposition. talked royalty I areas of If sure regard with sufficient of it's internally. get the value identified of number about the we're the I that, some We've programs, continuing a

this think in And than came products. that remainder year of of increase perspective, our want there. think maturity for the royalty I in last point look just us with out in. that is value of and anticipate perspective, with new be time. pleased last proprietary would think Expenses from a QX stream of to across the we year, very establish I at year. increasing see And we'd QX were to us goods trajectory a as the of to volumes, VUMERITY this I cost where we spending able board specifically were valuable most order for we From of through our both QX lower

tick will will the little though. well around time as program. program the continues, $XX the then SG&A, we of then the there PROC HDAC bit investment Todd to incremental It we force, line kickoff the well. nemvaleukin regard into and be And a million launch as And saw ARTISTRY-X XXXX a will of a the to On and related That we some on and half PDUFA will as also sales then mentioned, the will June. as of I be up gain R&D milestone in have closer as staged be side, program. And access I with the spend. LYBALVI think to little specifically the second incremental augment expenses maybe basis, year the bit for think,

the we're we I very think in out we're the that that's But really reiterated February we frame, guidance comfortable guidance hence, at. So the with profile today. that and time looking all, in went with all

Richard Pops

elaborate. II the Investor on in right that question will in at the recommend nemvaleukin, that how particular, I the slightly up I expansion first PROC. We really of that the to threshold the year. the and in of We end our differentiating We entrant in emerging highly the to into monotherapy We of pharmacodynamic of just that programs want think our think were the is on you'll partnering interchangeable. that right in Rich. than first continue your response subcu by. it's see last because dose the cohort. expect do interesting Marc, so I that to now. their ARTISTRY-X ASCO the And X we're achieved Phase It's is subcu space take features field. we of want some presentation the with subcu efficacy beginning dose fortunate And just saw encouraged a as are segregating existence what's lanes. And it. would actual But we clearly of are emerge patient, that, efficacy. at profile different really subcu of elaborate being important are The are durability to They various IV Day IL-X opened this the now own not features about this

most about on nemvaleukin. for the When what create value program. partnering into move this we and after. adjudicate spend not should do do to do really we it's our how own. any subcu go we not we to we whether -- the expand all or discussion time dose the drug that is a the partnering How can trying before, We said whether want efficacious. medical or economic don't I've discussions, indications So in works, How

that continue the to now. will we I year, -- but this in hear drumbeat the So data distance think think I set it's can mature

Operator

question Research. is Wolfe Akash from Tewari line the next The with of

Amy Li

couple just on Amy is program. your have orexin on a This Akash. for I

it's about any the do at your polyuria the you're Just design for? but related effect about one would to you another pressure design OXXR of proximities more we'll and terms specific mice. It looking on-target add related Takeda. or blood-brain are candidate color here and competitive space, how effect. this at be orexin an DTA optimizing wakefulness acknowledge like benefit penetration it looks lower in And just wanted So as indicated And or you blood and off-target half-life, you think although data molecule? on to selectivity? the early you're in leading in think barrier doses of then potent data, looking increases cataplexy an can drops of Is super helpful. early kind you your of trial, what think lead your to OXXR at the is And compared

Richard Pops

address is you sounds perspective -- of is from like clinical a this. condition. time research focused like part between you're on brain. relationship accentuating the thee presentation side technical the into based the trough, -- but partition peripheral versus is exposure molecules to but those the the they life way design, and are which translate various it of which aspects wave on Things we're the patient form all of -- the PK pharmacodynamic profile, folks see to also effects I'll conversation companies looking a that lot well-tolerated, on CNS agent -- white leverages once mitigating years, other doing and our daily, coefficient, or view spent half blood-brain profile pharmacokinetics, low PK for our it of team, many the some this of effect to give what a actually are we or with the what on over perspective, ready we Well, something And we've exposure for something penetration, pharmacodynamics, compared space periphery is the

here. I and recommend won't happy because of of all of I follow-up you everybody you bore There's specifics a with about we're there's a and the that talk it. asked, conversation that to the with will So lot questions data, a have lot science we

Operator

line Our next Douglas with H.C. from the is Tsao coming of question Wainwright.

Richard Pops

You might Doug. muted, be

Operator

open Mr. line Tsao questions. is for your

Sandra Coombs

move on if we back go can and can we Doug don't line. reestablish his certainly Why

Operator

Our Bank of Jason next from coming question Gerberry of will America. be

Chi Meng Fong

This is on for Chi Two Jason. from us.

nemvaleukin. a at I we of TECFIDERA off you guess, comment market. on Partner showed is Are Day? as First curious to the Investor the But you rulings, can patent ASCO? the from this that generic something declined TECFIDERA possibly VUMERITY. one unconfirmed impact follow-up confirm responses I'm how market. from that on able on VUMERITY of came backdrop comment of can to Biogen the removing generics couple look you if a a to an if update big Or forward positive at

Richard Pops

more Look, fumarate second Biogen, experts the our interaction maybe can tolerant. first on of next-generation are the in you Sandy take dosage perspective, tell you, we're one. should a real in and the From that's VUMERITY was VUMERITY focus. that's designed form with benefits efficacy really proven can seeing I take preserving GI of one the a form in for molecule and in I'll between a TEC fumarate and the what namely as And monomethyl patients, the world. the

patients. should its of And -- So generational clinic. my a benefit utilization increased drive VUMERITY for advance our represents view the what in is if the that's

side, nemvaleukin answer one? to you Sandy, On that the want

Sandra Coombs

repeat your the Chi? sorry, question, nemvaleukin side, On

Chi Meng Fong

Yes, couple responses. Are you unconfirmed able of to them? the confirm

Sandra Coombs

won't We this comment on call. that Yes. on

ASCO confirmation. to additional on look any can update for forward an You

Operator

Sachs. question from of Flynn Terence Goldman the is line next Our with

Terence Flynn

Was if an XX%. know you into your your would LYBALVI be latest universe? provide us of with And here. reps might What expectations sales you give can data Great. additional for coverage adding are know you that for incorporated said then the you targeted provider potential the I much outcomes wondering the How just weight I there? how XX additional label? mentioned

Maybe expansion just So think XX%, would much those from help additions? how go XX%? you that us get extra to about

Todd Nichols

take I'll both absolutely. Yes, of those.

That the benefit trial, a You're referring first olanzapine. trial, LYBALVI to is III showed pivotal the which ENLIGHTEN-X. weight versus which Phase efficacy was of

earlier in the with point, still So still, Rich's to we're communications we FDA.

what So have our But on really label been actually and approval. we're to the we going with until have is not discussions very comment consistent expectations. are and encouraged we

a something coverage, excited the professionals. to covers that's terms the once and key the a going as us In actually Currently, fashion, new sales category significantly point audience. That's this we about up targeted about, our in we're it's XX% we of sales for additional oral really with staged product. into force of leverage ramp an footprint add launch

Our the strong is the as substantial oral of get going that cover of to to marketplace, we share going expectation a launch, to imagine, very approximately which, of coverage, is amount we're when branded you which to voice XX% in a have marketplace. can us allow is

Operator

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

Umer Raffat

I a of set, tolerability. Maybe lot had and into things. And ASCO? just safety we one lot a few, realize there's I should may. emphasized Can I the know companies comment. if follow-up I Richard, prior just level going to a a of you how we expect reporting setup guys

expect So we is, set should on That's subcu, meaningful maybe on my hasn't should not know responses if so you question or one. been I efficacy? us we updates guess any if On monotherapy could far. there further level

not know then the And some regimen out. I buzz the perhaps it's try why almost But the assuming the from the no anything quite is with a we on of how for a profile rest works, of truly PK for lot new funding that the And days see Suboxone. been for last IV. there's needle in if already we'll opportunity cycle. Could trial? create administration which further an hasn't one, the wonder subcu could wonder from a the so given shakes I where row there's new move monotherapy there sort subcu, -- in activity. And of X that unusual on meanwhile, and And also different out on

Richard Pops

you morning. wonder I were where the Umer, in queue this

you got... If

Umer Raffat

the I Israeli in was call.

Richard Pops

Okay.

orexin Okay. by And X all you incredibly guys are questions was well. as asking about I the impressed the

drive it's respect data not I biology be to that it's on that, all at really showing quite of think going respect tolerability a PK/PD going down, infinite relates at now we're induction plus some are. But focus there first different of maintenance? subcu think to combinations but where we mg as the regimen of it for there the spend in of monotherapy And approval the coring it program what's is IV important, the to we actually bit just of the the of program. on are its are ASCO. subcu, which With we There weekly is rather is believe But tolerable presented with And there's there it I relationship side. a there and IV about interesting monotherapy other what We ARTISTRY-X, expert Sandy daily question had believe for Are presentation one times efficacy. X? We're on are broader more the to question, not subcu actually than actually So worried -- opens a clinically that. your regimens really X IV is up permutations. we've as because think are. the example, so q. good focusing is down pathways, We the well. to ASCO, the

we X-weekly start. think think response, to that that q. felt the subcu were thing, that though, recall is And that first the On quite improve actually q. with pleased we also appropriate weekly seeing would also that pharmacodynamic has we q. side, our other but like but have regimens the we place weekly. of the regimen we're there if would we a probability change,

Liberalization Suboxone, with XX% the know, on prescribing is Suboxone. a you couple the market. it's There's as Suboxone Suboxone, interesting. On of is of going of things anticipated.

the in who patient happen to different and things detoxification VIVITROL receive So VIVITROL the don't is VIVITROL patient is really much a therapy. affect that undergo patient. market because market Suboxone wants antagonist that monthly

change Todd, settlements moving opioid which the So vis-à-vis suggesting of and dynamic free to on think world, tectonic others settlement free feel part comment don't states, you the that. are But is VIVITROL to -- the of in can the Teva Suboxone course, consideration of the we that is all. at other plate going provision to where and big Suboxone is

Todd Nichols

agree, is of they're the totally in Suboxone we this way different is use journey The for think different. products I these Rich. The different. Yes. is is terms The different. patient that clinical completely about and indication

very believe the the to and the well watch we are aware of elimination are waivers. We that talk changes of very used these we differently. closely. very journey, really We -- our know products we with the customers, talk and that in we administration, follow But we patient

label the XX those of proposition Americans the growing about And way the with we months. year-over-year. opportunity million the has think upon talked to with to suffer evidence-based are standards really for I based the think growth only clinical to TRxs an opportunity of for and seeing the nice XX opportunity AUD, on is an alcohol -- last we've enormous up and an opportunity, use around the XXX,XXX couple VIVITROL offer about a It's X% as a basis patients. that for from therapy, nice think TRxs. Actually, broad we're available VIVITROL value are

are we now. on that something right that's focused So extremely

Sandra Coombs

types the from side, the update that broader will that update time IV Recall study, to data recent an please. loop subcu on Then we Rob, that data Day, refresh also the update that plan provide in in melanoma the close mucosal more stage. for ovarian -- ARTISTRY-X provide focus we're plan opportunity and program. and have signals a be a and and to other provide related early really we to just seeing a of expansion enrollment of any We'll analysis the we update presentation just broader use provide on the more the a for at our platinum-resistant one I'll to efficacy cancer nemvaleukin provide narrowly to Investor on did study. We're PK/PD across question, the comprehensive And tumor on ASCO. we'll of that going program. the the safety

Operator

line Douglas Tsao The of from next question with be Wainwright. will H.C. coming the

Douglas Tsao

that about Sorry earlier.

to terms characterization sales how sort a in of Just know you of as question able you'll gave the the I LYBALVI to expansion. the in terms universe of be of follow-up a force cover. much more

that currently could you you'll targeting ARISTADA be Just by types the now that curious targeted force? characterize aren't if physicians of sales the

Todd Nichols

that. Absolutely, Todd Yes. is well. This I'll as Doug. take

about include the total approximately So XX% encompasses we're our LAIs marketplace, cover all well, prescribers, which Currently approximately really X% focus branded of XX,XXX will to as north within is prescribers. going which on of overall, physicians marketplace. of the LAI ARISTADA there

XX,XXX. a there of approximately So universe you're looking at about

that It institutions branded going a and well. as be to in the of we're will as be coverage. broad voice It confident very you said, practitioners. this of pleased will the when commercial be year the nurse we're a organization space. expanding We're share going in with focused into oral, It's very Iain made we increase forward adjustments system to very psychiatrist. that footprint and HCP voice. with looking voice. share some to into have market health share will the much be strong larger. very So the And we're universe of Obviously, U.S. year to that late compete IDNs go is across We're our to to last going and our to have

Sandra Coombs

for don't the everyone, any there morning. appreciate a the great to follow-ups, day. us Thanks, reach are Okay. questions. Have company. out on hesitate us this please We call If joining at to the

Operator

This concludes today's conference.

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

Alkermes (ALKS) 28 Apr 212021 Q1 Earnings call transcript