ALKS - Earnings call transcript Q3 2021

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Operator

Greetings, and welcome to the Alkermes Third Quarter 2021 Financial Results Conference Call. My name is Ralph, and I will be your operator for today's call. [Operator Instructions] Please note that this conference is being recorded. I will now turn the call over to Sandra Coombs, Senior Vice President of Investor Relations and Corporate Affairs. Sandy, you may begin.

Sandra Coombs

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

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

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

Richard Pops

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

the on over the how XXXX, three struck in just evolved the the much company of end So year focused has so years we approach I’m as we intentfully. past by

and the in R&D and the our the company. efficient business, governance management pipeline commercial investments of Our

providers. the the against healthcare positioning pandemic, of have competitive grow front and as year-over-year, VIVITROL and commercial resonated evolving of with attributes ARISTADA medicines continued to these the an On backdrop

source to been alcohol For for the dependence use VIVITROL, medication of a and of need acceptance growth. of treat a greater has growing

in market. continuing strong For moved acting it and needs the continue into inhibitors provide XXXX opportunity large portfolio, the XXXX in also And to has now switches. and CoREST-selective momentum orexin X leverage the with momentum. areas top SG&A profile while drives LYBALVI, of profitability advance nominated off. LYBALVI of developments commercial regimens established to a VUMERITY, moment. line. that distinctive continued all impact a in to differentiate these to ARISTADA, it well platform. Craig contributing doses has operating the is week its the and uptake we're is LYBALVI the ALKS multiple of commercial and harness business, Ireland mission concentrating Narcolepsy, VIVITROL, recently VUMERITY return disorders. the throughout. reflects And sclerosis to in teams positive to focus other into waning. initiating from And also hopefully as Biology see investments it's launched efficient will the flexibility, from the U.S. ARISTADA, validated Biogen IND treatment its has demonstrate growth we continued and LYBALVI last We've these But We to to their incredible for space. label over. potential cancer ovarian studies significant mucosal gains a launching on of inspiring enabling respect We're not pipeline. presents and studies. selective further and in unmet types. in market orexin want paying witness. of been our long been Nemvaleukin R&D track that's and melanoma, on products. an first see pipeline support first-in-human designation multiple this injectable revenue resiliency entered agonist tumor to fast management prosynaptic positioned COVID activities. detail an frequent in of has and to the as from compelling registration effective both patient our in effect We've and remarkable of has ALKS advanced designed We've It's the highest The pathway in launch inhibitor can into and driving HDAC populations, neuroscience as The with and platinum by a commercial candidate our XXXX, HDAC in opportunity known I granted thank characterized receptor we're the range been ALKS dedication the the that a portfolio. potential you growing to to apply capture resistant the

I'm So third results, the introduction, Iain? a commercial of Todd call with over review the turn that, brief followed and quarter as with and to pipeline. Craig for by Iain financial going a to

Iain Brown

quarter. will related our our Great. $XX financial and investment line of strategic months. the which expectation top Today the year-over-year our our the markets and the preparations and on reflects advancement million XXXX the included business ALKS on backdrop launch XX and delivered execution are of which normalize treatment report these pleased quarter operating Thank non-GAAP both We you LYBALVI. coming XXXX. focused of products results everyone. income COVID hello, our for Rich, we're in advanced commercial we for expenses, net pleased objectives. systems growth to as development the continued to We robust We're Based expectations in results, report financial focus on management for third we to evolving against expense pandemic. our for the And milestone reiterating and the

highlights. overview an let financial of our Now, with me start

revenues million non-GAAP approximately from proprietary same For key of of period the of income performance total recorded million year. was This $XXX.X the loss solid of the to $X.X increase income XX%. year-over-year commercial we Non-GAAP both royalty a million, $XX.X driven for in business. generated million, third a third well as and our compared GAAP XXXX. a by our loss representing the as of was of to the last million net manufacturing compared of $XX.X net GAAP $XX in quarter We of quarter net products, net quarter XXXX, products

million development the in year-over-year. Now net milestone, excluding the saw an income we improvement underlying non-GAAP $XX

VIVITROL, to alcohol execution at dependence. increased million by year-over-year, in $XX.X as VIVITROL seasonal treatment sales for third Inventory third Gross last compared in our increase awareness supported to sequentially XX% in XX.X% patterns. increasing of X.X% line levels trends option the of typical by of the were approximately were million, consistent net demand year. in with adjustments the adoption quarter and up in relatively units by quarter driven XX.X% For $X.X of strategy net quarter the drive a to and increase a

XX%. the XX% to the year-over-year ARISTADA turning $XX.X third by unit sales family, million Now in net growth product of quarter underlying to increased driven

gross During the ARISTADA were in adjustments to XX.X% of to third for XX.X%, compared the third quarter, net year. last quarter

resulted net Now channel year, ARISTADA inventory levels have over in quarterly lumpier fluctuations in sales. last the

importantly, to While have trends underlying prescription increase total quarter-over-quarter. continued

inventory their growing as second demand. sales QX related fluctuations. key just XXXX For that quarter, these In the third net in Recall ARISTADA levels by million million. quarter, a decreased the adjusted $X customers $X channel the inventory of third in over the levels support slightly increased inventory sequential was just inventory ARISTADA number or quarter, units, from to in primarily approximately decrease over to the net in sales by

continued despite to Now more a underlying demand, insight related market, basis, on recent transient ALAI sequentially TRX to overall believe softening which nature. into the a expect to of which is grow provide be Todd’s we COVID going the and in

year. million in year. million increased and quarter, increase VUMERITY of we for royalty This our driven $XX QX, approximately million manufacturing our in to end prior net the the which quarter Total million royalty primarily in in primarily market the business, by $X.X of quarter milestone. the and to $XXX revenues compared Based million the $XX manufacturing and million, from prior operating quarter million $XXX.X third on third development quarter compared increased the by manufacturing $XX.X $XXX.X in R&D Moving million the sales, revenues $XXX.X uptake $XX compared to third VUMERITY. the recorded the prior were by accelerated for same last to year the driven to royalty period million expenses in year. to in were on was compared expenses of

the in quarter million. $XX.X were R&D Excluding the milestone, expenses

Looking support $XXX.X including the ahead, allocation the efficient psychiatry in to $XXX.X increase with incremental year. driven advanced and return prioritize highest of we of launch continue the approximately million, to as third organization portfolio the on on the data and to for of LYBALVI programs investment our XX expenses representatives. sales quarter anticipated This we field were development compared for capital focus SG&A in by the reflected prior expansion our investment. quarter million

LYBALVI, SG&A last step that in expectations, to line our which in to due expenses financial activities became launch report, week. with expect quarter the we're ahead, available commercially we XXXX for happy up Looking fourth will

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

we commercial LYBALVI the candidates going launch drive driving continue of on pipeline to with hand term that, Todd. a to over for look to profitability. as long Now we leveraging ahead, efficiencies, development And focus creation we're seek infrastructure as operational call our our of to and successful value and advancing I'll

Todd Nichols

Iain. good And morning, everyone. Thanks Good.

parts particularly and to sequential growth a ARISTADA on of TRx NBRx antipsychotic resurgence VIVITROL Our fastest the the we and the alcohol of ARISTADA by commercial momentum This both quarter. the in these of the TRx months be basis, COVID-XX in to is due seen on and for for in encouraging markets medicines continued the light acting its country performance in VIVITROL of spaces. impacts third dependence indication. the during growing have long quarter atypical, reflects driven a therapy growth continued into and certain year-over-year

say commercially carried in last first U.S. also of our preparations made LYBALVI; final which the launch our the to week. pleased oral was I for We am antipsychotic available

to QX third disruptions pandemic access to psychiatry commercial XX% improve, We system. I'll Net addiction $XX.X activities sales in continued patients. by driven important approximately we starting bring to million. prescription despite a launch treatment in quarter medicine demand the related the organization moment. underlying are our but ongoing our first and of deploying Salesforce unit to this array with increased discuss patient VIVITROL new trends are year-over-year to existing support VIVITROL. leveraging to

quarter. that alcohol provider indication. and reached for to the providers breadth to majority reported dependence third Based capacity. VIVITROL continue to prescriptions market The return recovery the prescriptions date, than support yet opioid the dependence of market in treatments care on our adoption these seen faster addiction volume a September research, their in of the of highest alcohol-dependence prior by this indication has encouraged for pace treatments data increase month. dependence the The centers slower continue pandemic height patients alcohol on an the the to toner focus overall compared to of opioid its healthcare we prescriber of overall realignment following despite as a grow for surveyed market been including level to We settings targeting pre-pandemic of in our increase residential fully operational the to of since an be healthcare Certain have ongoing crisis. treatment at

VIVITROL an believe to are driving and dependence that patients. supporting continue and We opioid focused differentiated important care awareness for is providers on and health treatment option

now and oral to LYBALVI, newly typical a our psychiatry launched is which injectable, long comprised our Turning antipsychotic ARISTADA, of acting antipsychotic. franchise, both our

therapy injectable on growth has transient product new on of XX% in outpaced acting growth of pandemic. to fewer class grow. will We long data injectable a this the year-over-year fewer antipsychotic supporting or schizophrenia sales million, double The the proposition are believe $XX.X decrease the in the clear, of third long to this starts a quarter overall to have X%. increase for and For medicines TRx levels and believe switches important and growth we pre-pandemic. treatments the to acting of decreased treatment outcomes patient from note market This of prescription value primarily continue impact approximately that family the driven to use the It's XX% trends typical digit annual year-over-year. growth medicines is during month and related LAI mark of growth abroad net by basis ARISTADA

presence market believe therapy offer including to in overall relationships regimen class an And market an growing infrastructure platform the opportunity our growth our a month we have schizophrenia branded launch underlying LAI of provides dose. leverage in with be expect our the an injectable this a with other capabilities commercial a that commercial basis. healthcare ARISTADA, existing the is healthcare antipsychotic well ARISTADA as and attributes, into established we payers and expertise. long and While be with market, over of providers payer important will treatment continued and our access XX market acting now for providers. will In our from two and of an This the important amongst the the strong market and quarter fastest prescribing, that our three growth product be the and on LAI patients on is an these will several bipolar generating research and option against next starts this performance as focused one for within LYBALVI. the treated we and vary make position the Timing distinctive ARISTADA to carefully positioned its represents years. for establishing third agents, during factor for gradually treatment its psychiatry be ARISTADA's patient both we decisions Driving access last given schizophrenia, well over consistent expand launch monitoring three launch, ARISTADA coverage, product for performance to main payer offering months early profile feedback we oral opportunity oral in option new like Overall, disorder. month three phase we coverage months. our INITIO likely LYBALVI remains to are established us new breadth the priorities. With recent a most ARISTADA's to on XX LYBALVI can important channels. With Alkermes market as available The will priorities.

and be plans take made next XX will of Medicaid the and may Medicare over for commercial We decisions plans to available to decisions course for the the Part expect year, D months. up

we as support channels LYBALVI, care are are decisions, and to coverage as programs program. three LYBALVI help to there for prescribed pathways are such Importantly, access we each that access patients these in of support our await implementing

the with our for representative actively volume bipolar XX% week, one Turning account and schizophrenia began to last our branded providers, who sales for sales approximately of prescribers organization targeting engaging healthcare XX,XXX disorder. prescription

market which Our We support as the competitive a branded we with the and has Salesforce their product model for designed steadily is for FDA attributes of since promotional both in increased levels community advantageous educate believe approval. we Awareness LYBALVI on launched campaign, fully to voice LYBALVI LYBALVI the treatment share ARISTADA. LYBALVI. is

and drive educational programs rolling well of as healthcare consumer to LYBALVI. digital awareness also are advertising HCP as provider, We out additional

this We launch. are well prepared and ready for

We are healthcare are with execution living we providers people to and treatment with excited and new option focused be important bipolar to patient engaging access schizophrenia drive supporting on one as LYBALVI awareness disorder. of and for this

updates we to you ahead. quarters look opportunity the we While to LYBALVI the for sharing uptake phase, significant. expect market be I believe in launch with the forward is in gradual

progress Now third I'll to pipeline turn call the quarter. over Craig the review to our during

Craig Hopkinson

one year. us. a Starting oncology. new option patients. is standards to is durable Todd. this range to in our engineered our CPI and types, pleased innovative of and in by bipolar deepening commercially was we with novel, our and pembrolizumab of medicines relative be value care needs Nemvaleukin as and a responses saying designed monotherapy LYBALVI you, CPI variant treatment schizophrenia and with that investigational like to pipeline naïve progress disorder in offer both gratifying neuroscience current develop to are has significant tumor incredibly in And objective available with IL-X in impacted community Thank combination I'd Across in made a immunotherapy. source with patients and demonstrated now programs, experience in become our peer to are start patients. this future We've anticipated it and are caregivers their a to nemvaleukin, how of The able by inspiration to propositions development that mind. see to

cutaneous to Earlier mucosal responses and and clinical in with treat strategy ARTISTRY-X once designed randomized early with into with cancer. nemvaleukin to and and with will dosing form patients the Network IV FDA with collaborative has with we expected for that approximately melanoma, pembrolizumab granted clinical trial IV combination of build tube the in of inhibitor entered year, address activity; We're is potential of unmet endpoint will less peritoneal free orphan plan the may patients demonstrated of five The and pembrolizumab primary settings. to European epithelial objective trial with year. patient of as designed to study combination for observed, expect infusion Phase-X This RV this this tumor tumor less of route may ARTISTRY-X, study information two continue resistant including clinical Foundation regimens. designation in we've three evaluate patients in key compared of ovarian an the studies, every approximately on of announced also investigators once weekly clinicians we the evaluating a consistent the enroll primary for that PKPD dosing field consider checkpoint registration. The platinum treatment mucosal preeminent and we a in support in plan frequent Based is chemotherapy some centric and initiating groups XX-day have ARTISTRY-X melanoma, add that monotherapy in seen with seen that three our inhibitor X the is combination granted safety potential gynecological three and on of will explore additional and encouraging support additional patients enroll of checkpoint inhibitor, IV we've in on choice experience this and XX ovarian, on populations, clinical regimen, months, treat the is date, this nemvaleukin to designed subcutaneous sites monotherapy based combination fast progression believe patients, needs is durable a disease who collected RV investigated to administration. XX scoring ongoing see XX in X.X. nemvaleukin, weeks who with current we've rare study acceptable A of types be the the evaluation expected significant on the which we've free of cancer. Nemvaleukin tumor receive treated four activity aggressive is offer melanoma half conduct off This tumor nemvaleukin seen signal IV that combination XXX be pembrolizumab patients we Our which initiation potential patients drug studies days, the we to to next in post trial progression ARTISTRY-X survival to also process to pembrolizumab. need, our studies to RV patient platinum pembrolizumab to resistant to types track clinical treatment dosing Based regimen. patients on followed expected with and the gynecological study. mucosal patients, designation and who in fallopian activity every the GOG IN melanoma, first durability we've nemvaleukin begin including to unmet program a survival We've is potential and the with registration types extensive development the ARTISTRY-X dosing multiple ovarian dosing trial in focus, for agreement to setting important experience to the post with monotherapy the and label our phase been We're I development useful nemvaleukin the progressed or outpatient weeks regimen where in melanoma in the platinum frequent patients we approximately responses dosing and agreements program, platinum The to in intravenous ARTISTRY-X and subcutaneous modeling twice In enroll combination ARTISTRY-X of Based limited is clinical utility is FDA in nemvaleukin. types, groups our supply difficult patients difficult and options. antitumor in regimen observed reported believe nemvaleukin also oncological clinical clinical oncology, our nemvaleukin in disease the oncology with in also in we and the also starting to RECIST one being receive approximately monotherapy therapy, associated In as is pembrolizumab designed a entering disease. tumor be to with fast for with focused such a patient track outlined and nemvaleukin investigators arms under pembrolizumab in type, both Merck control and dosing safety XXXX. monotherapy, space. a this conducted checkpoint or treatment chemotherapy. flexibility antitumor the of two a randomized checkpoint to an choice study to Earlier as earlier. encouraged intervals is ongoing benefit. study an for clear on to inhibitors, ARTISTRY-X standard-of-care weekly efficacy and consecutive setting This evaluate resistant in options. antitumor with who cancer, has period. Currently, minute by and in continuing receive of in open in quarter first potential study to particularly at the initiated collaboration week, global ARTISTRY-X unapproved differentiator

For to appropriate ARTISTRY-X and medical data present we'll meetings cohort is which those year. dose next expansion the ongoing identify at

a combinations nemvaleukin As we tumor clinical variety utility. there are believe look and of have for type therapy ahead, lines of potential may which we

forward towards in work clinical the cancer. types platinum going tumor partnerships. in consider potential additional melanoma and resistant advance of we'll to potential mucosal And positioned ovarian nemvaleukin We context are now well registration and

aberrant neurological loss, dendritic XXXX, ALKS synaptic to Many plasticity. now HDAC abnormal selective with candidate. synapse and density Turning are synaptic characterized inhibitor and pathology spines, our signaling disorders of by

slow functional may and progression and synapse, preserve abilities. the targeting cognitive disorders these For

volunteers. ascending recently in and in-human study We our brain the to determine and and doses expect studies penetration confirm ALKS studies the of healthy to molecule. a are to intended conduct for are first and studies, designs. this novel of multiple parallel profiles these may in-human single proof ascending zero from phase first indication market studies XXXX These have In of we program inform safety selection complete to and in to XXXX. biomarker pleased Bio initiated clinical provide target also engagement to plan PKPD study

are psychiatric ALKS and considering XXXXs of which of We biology in a we'll as potential neurologic and indications utility may selection for and indication and considering of a highest different to continue neurodegenerative ALKS offer XXXX we number clinical the regulatory commercial the refine may our indications clinic. to carefully success. approach in number we have advanced likelihood are areas,

apply dose challenges with biologic favorable Moving XXXX recently half-life our molecule design nomination our and pharmacodynamic and relationship XXXX also ALKS XXXX. preclinical triggered to for has narcolepsy programs strong and mirrors dynamic pharmacodynamic studies. is to innovative humans pharmacokinetic for IND our dose in ALKS dependent risks first advance to with for X associated decreases the in which enabling which human XXXX a profile orexin preclinical that selected certain potential a the to Republican dose suggested rationale, activities The wake to goals we that important receptor development cataplexy for safety was demonstrate novel This and the model cycle, towards stimulant in-human model with observed strategy molecular of work candidate a nominated and dependent with from design agonist, to the low in drug Data presents for receptor existing that avoid but initiation a has safety predictor and aims medications. technical orexin of wakefulness a Consistent burden, ALKS support kinetic may X clinic. natural [ph] with necessary serves disease the tolerability. a design increases sleep be in to as

pressure, rate relevant key pharmacologically model safety elevate XXXX exposures at related rat blood pathway. to adversely or preclinical orexin did two heart in parameters a ALKS the not Importantly, hemodynamic plasma

have late completion gates questions. molecules the believe about enable this allocate the With key sharing our interrogating continuously And to XXXX stage the we I'll Taking early activities. in and currently advance through as turn forward expect step continue advanced a following call designed to well We development, enter I are we defined program addressing you. XXXX to IND-enabling to efficiently excited and our of we of look or are critical Rich. and that to stages various progress driven back, capital. to our making, data back are with positioned the decision pipeline, over clinic

Richard Pops

we've great. across substantial. you, made the Craig. is The That's progress Thank business

clearly We potential options believe defined meaningful have and creation shareholders. a we drive neuroscience oncology, treatment strategy important for new in our that therapeutic has the to value advance and

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

Sandra Coombs

Thanks, Rich. for Rob will now open the call Q&A.

Operator

Thank you Sandy. [Operator Instructions] Thank you.

your line Mizuho Securities. with of Please questions. Our first Vamil with proceed the is coming from Divan question

Vamil Divan

taking on call. and the info the thanks questions my Great, for

follow stuff So on maybe couple questions discussed. just a you up

XXXX? think for given you sort ARISTADA bit LYBALVI. that patients a in they're sort just again bounced I or a then quarter little for one of payer to just the to the Can about appreciate on need the to regarding of the question some past talk your one, about about fourth have is you little access the year. just comments relative you appreciate So net how that related. a of and slowing to expectations Maybe maybe dynamics up gross COVID talk quarter last this market can feedback. before take And unlike get to comments olanzapine expectations we the frequently generic regarding for potentially again, around mean, initial LYBALVI, bit

clarify Thank there on the in products terms just of latest wondering your market? you expectations that if access So the I'm can now you.

Richard Pops

Yes thanks, Vamil.

with generic Let me gross ARISTADA. just question kick off around

we've this actually They QX over and XX.X% ARISTADA as at nets the have year. gross of QX been consistent. think looked course relatively XXXX, the both in were I

of So that's level that on a It we going appropriate to the into sort future. that's depends continue believe obviously mix.

forward. We relatively that have increase. XX% year-over-year we Medicaid caused XXXX XXXX, the compared higher going has utilization had which as we're consistent But slightly to think a in around

Todd Nichols

morning. we're the is LYBALVI last really by Todd. This good the first pair take this. question know access. excited week you launch and Yes, about on We're week, encouraged the it’s I'll very

seeing we make over over of our access Claims last medical is decisions. initial we across pathway prior adjudicated a years. in this means are And a in with plans are do coverage is with the it is didn't. are we different the consistent seeing We variety this we've the to is expected. right research three our being This what authorizations learned what But beginning line payers channels. there exceptions, stuff to that are And what and couple now. expectations

this So they we stepped us, works, and two but specifics be payers olanzapine be in generics, through will will on be medical it at knowing will place, branded in have place. how authorizations it category in or told exemptions could be have there how the place, edits time, step if have one prior don't there

I XX access in next developed my reveal months months. really the said profile as XX will the and remarks over to prepared well, As the itself as in past and be will

Vamil Divan

Okay, you. thank

Operator

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

Akash Tiwari

Hey, much. thanks so

every target heart think your or think the that it couple. the metabolites? be increases program? a One, Wouldn't then And So allocation and show the the to for Also, ARTISTRY-X in and IL-X? would study didn't an can be IL-X ending you could Thanks X do we spend program back unexpected recent Or perspective? XXXX of be so and for for to pressure by the you you could with stepping that suitable go on what's approximate effect secondly, isn't IL-X Do AE be that commit target a where capital much. you related rate. program your blood considered do partner [Ph] their found? an on from over the metabolism Would preclinically your stand discontinuation take TAK-XXX mentioned you program on effects? you cost

Richard Pops

the detail Yes, target events effect. as seems I'll doesn't terms you're in It address it thanks. question. may give saw they of question. program. And they that right. the Thanks event be Takeda the for safety orexin off an or if in that their much

we hemodynamic occur And are going [Ph] had in be predicted effects But also that sure to model XXXX. that with we important model that examined that dose and any be of these In on effect. terms target seeing low. stimulant of heart to blood EEG to pressure with and events medications. red would rec extensively with rate the viewed our that be wanted human our believe a weren't we We've was make performed I those compound an

so, profile enabling how generated and we've the for R&D that program. pretty into the safety activities confident our And to next on we're date, preclinical steps move in to

Sandra Coombs

please? your Akash, ARTISTRY-X Could I you on X. and repeat missed question that

Akash Tiwari

Yes, absolutely.

if of those So of what back to partner XXXX the Thanks. costs approximate perspective, be And suitable then both you your are stepping isn't capital program a studies? by able for spend for a to kind allocation from would the IL-X ending commit found?

Todd Nichols

the expanding we're a I at look the we in to believe with We event and that found registration that allocation ultimately potentially perspective, going IL-X that think can capital be with suitable continuing probably to and would from in program, we only a partner. we proceed mucosal program melanoma the land. we studies can

Richard Pops

Yes, Akash, Rich. it’s

there's X, but And medical of line anyways, planning it in needs, primarily So the we these in These just the And seeing plan on clear, of case places think these of are be from mucosal we would we've clinical the program in additional for we're we PROC, the this will type durable are of treatment go these don't we limited nemvaleukin. signal because responses the indications. certain if evidence the combination ARTISTRY-X in we're patient which interest in with where melanoma, because seeing a to needs. the investigators support are signal we tumor scenario, inhibitor, in unapproved with are had actually the is cases, the -- on scenario, checkpoint in real that in in of to and real nemvaleukin unmet no IV These these types. the that quality finish of seen is unmet case program, there where, options.

to need medical for think the a to commercial us I there's, get So both finish and there's compelling line.

on hope we expand the program context partnerships, for able Our based the outset. to criteria of the that design be meeting the in is design nemvaleukin to the at

Operator

Thank you.

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

Cory Kasimov

for for guys. well. taking morning, Two me questions. my good as Thanks Hey,

between to schizophrenia if cancer? the have sense, LYBALVI, ovarian second the two? you. to on So launched a prior any if then expect just in interest there's just wondering interactions ARTISTRY- way physician early an And in this from between if delineate last wondering week. recognizing there's you it Platinum first days I'm initial and these Thank your you if education and similar bipolar built or pretty be question, just interim resistant look into

Todd Nichols

the its profile over Yes. received. The profile Hi, the first here, Todd. clinical being week well is Cory the Appreciate comment.

It's are And very encouraged value So for interested very done the are we're the the years. the utility starting different patient them. ATPs is of with consistent indications that us research telling couple over and types with we've last the really broad resonate. proposition to to that. the

that market. don't from tolerability, but safety, specific patients schizophrenia on bipolar. we for interest we're thinking the ATPs data Patients or about the are have point, So efficacy, at type branded is specific data the to this switch agents hearing of is switching and around

So anything actually point. this we time. have categories we're all at at this don't hearing specific But three

think several data provide that the we'll at claims time. the I some see over it patient more next of specificity can will start quarters, and to

Richard Pops

the regards aggregate interim at and design with haven't question Obviously, Cory. Hi, the team in study the the is any to we your discussed inclusion in the our in a throughout study. ARTISTRY-X an blinded point look analysis teams open we this to conduct of won't this keeping though at take data label data And study, to time. of be allowing we'll be even the the

Cory Kasimov

you. Okay thank

Operator

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

Brandon Folkes

Hi, taking question. thanks for my

and here. VIVITROL opioid about the talk of [Ph] sort opportunity And

few where I focusing quarters been that think on it's opportunity. messaged a you've about now,

little all some headwinds, and opportunity, should you. three, of any just here years, to towards color how Given this paradigm treatment given five treatment treatment? you the VIVITROL? but of that you're here, moving for the instead size alcohol large around you're given the changing are maybe getting capturing bit medication the And we paradigm making towards assisted about then, opportunity Thank of the questions, think prescribing tailwind these a timeline

Todd Nichols

Hey, let by dependence. the encouraged We're adoption, well. Todd; and and me yes, me alcohol is let VIVITROL really as that this Brandon. utility take for

right market growth distinct If you or here markets, look really performance overall an see opioid driven at stabilization as now, overall some during the we opioid market two pandemic this for alcohol-dependence The the right within we're and market. and see post dependence. to And dependence. total starting now alcohol-dependence pandemic is being by

consistently, for patients and about in we market us this to alcohol-dependence, seeing actually research, really our more flow opportunity, telling that's think the physicians good point. outpatient, seeing are with believe patient We originating place are an at mainly offices, when in that that they're for alcohol-dependence, are play physicians increased they a their VIVITROL that

the new we from opioid right TRx different -- growing is at digit market trends, starts So way one for showing the at is versus patient and now. year-over-year, for growth, X%. multiple XX% look then And about about looking double similar is dependence we're metrics, at eight is this alcohol-dependence actually VIVITROL to growth,

VIVITROL now. growing For market, now, is right with at the right the about XX% north growing is of and alcohol-dependence about overall market XX%

treatment. is So within The population. We about very trends. encouraging XX Again, that opportunity are have adoption term. be really actually big There's penetrating some that there's alcohol-dependence only actually XXX,XXX, addressable Americans to in opportunity patient long alcohol-dependence. a that see significant we million on see the have

awareness right VIVITROL So our is focus an those then now building patients. and option for making strategically,

as see long do growth the brand. we opportunity a, a for this term So as

Brandon Folkes

very you much. thank Great,

Operator

Thank you.

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

Marc Goodman

commentary see you system the release, us if revenues sensitive a to least give you Yes, we're, you how you been little of not good in on you that? are morning. until that's talked could color comment Can I an quarter, your improvement guess just is? the can maybe what months, kind well more the press of at about In And How don't on the a in going. meet one expectations.

follow referring I the the around should after? just thinking the a commentary we of Thanks. reason a of And just as gross-to-net, be in all, we're past just Are obviously you of XX%. it to over it's yet, a got I down it capping the how been rest next of year? so Second ask to to few the just year and we you know feel you year is up like going XXXX Were us indication the you've an a if place And referring fast but [Indiscernible] ARISTADA because about can up narrowed lastly, years, finally picked the sense to? couple then warning, where give out. you a indications such haven't you

Richard Pops

So if that Marc kick off I'll I can.

our regard to happy I the we've on year, the with were we call financial we expectations progress reiterate the for expectations course today. to pleased So July We those we're of the the with think able the made during were, year. to call, be improved and on

that that the we a we went range. with that for we the have ALAI with range in with that seen respect the in middle that pleased the out QX with said, being as market. think Todd things even have softening we in But business. appropriate And on with very VIVITROL. anticipate we We're ARISTADA mentioned, that still to well of to guidance of coming July anticipate with guidance I side still respect range the

question think we gross-to-net of I ARISTADA have last out quarters think the increase at kind in the over gross-to-net equal have has a things On all that been seen gross-to-net, I XX.X%. for being the we seen have We're few last year. specifically, two evened steady XX.X% quarters so the

way from the potentially gross-to-net model through we Obviously forward. that. being currently perspective, would as things that So anticipate there a good a pharmaceutical equal, would is going go ARISTADA. gross-to-net XX% we going things see is, market But I which a forward pricing I a impact to -- XX% for are with constituted could think as all few

Sandra Coombs

jump XXXX the to indication want you in selection. on Craig,

Craig Hopkinson

Yes.

and at terms screening of are in program. our taking in approach And a studies are in indications we're believe selection. that number to indication So us. to of the which interest XXXX, in-human We Australia in a of there potential patients stepwise first we're we're that mindful moment, initiating

which we of more things. people synaptopathy, time, and others, a selection neurology point proof-of-concept inform have running as inform believe this would refine us going move neurodegenerative sort zero proof-of-concept pure in will forward in neurocognitive help studies phase we zero and side that and as indication psychiatric, which studies forward. we those include function, of of we to them At be well biomarkers and of those other will phase of studies as Some move we're our studies, biomarkers

Operator

Thank you.

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

Umer Raffat

lead would the dropped. prior on on think Thank of topics LYBALVI, met if especially bipolar XXX, as different what so I've to for I responses? that has one well for as differentiation had guys, is perhaps happened in very what a XXXX? lack if preclinical said a in and XXX? substance the schizophrenia sort just ask my thanks trying abuse more may I And was and three then on update I I because the data, we XXX the preclinical holistic the just I problem? of about you. as had I percentage this the Hi, of the was haven't And responses you had abuse I'm talks heard considerations at what's first, today, how background question. population target on about of think remind rates don't taking how never on Perhaps you broker been conferences, any I antagonist one? because number do as molecule, now. could they but curious a perceive Rodon I problem, us you is data in IL-X, are updating XXXX, asked, finally, And we the to including that Are company substance of something? versus private what clinicians data Secondly, patients was a profile and they coming some reacting months response in Should actually LYBALVI program or helpful several as on be because recall, there clarity, the theme accumulating all asked have who in much on were and were

Richard Pops

this know we of different that LYBALVI multiple you all, looked at First ways.

patients this are at [Ph] data, that also, of [Indiscernible] opioids on X% reports about as If well, you to the category, also X% look in as well. FDA bipolar schizophrenia,

there's make patients. on able And LYBALVI they're tell physicians identify sure So types, those how us we be in this positioned? lot about this, identify at then that talked and to would that where research, physicians to a to our patient clarity consistently

So or see we to barrier as access a to as don't a well. that a acceptance as barrier

a LYBALVI We combination of on Sammy since product, approval also the hear well, right metabolism, with very with of as encouraging feedback well-established recently potential effects now too. and the weight such the most even a Dorf using a as such as agents olanzapine

to as the interest medical We were high a in specific you is know. community -- the community used is actually Sammy for approval the nine and there So Dorf, have studies interest at point. in it that this

Todd Nichols

we're the an ASCO. on Post, trials ESMO, increase enrollment look population and ARTISTRY-X So melanoma ARTISTRY-X the in ARTISTRY-X regard then, on waiting at did at to conferences and on to XX. and for point progress. present time, to We with With this we'll appropriate we regard did to question the in IL-X, at in updates we data next extensive updated the question melanoma year. at mature And cohort. on

on these safety, data XXXX clinic we regard design that move to as it really XX to which is in to it design move now. relates preclinical hematological superior inhibitor approach to engagement that complexes, lead preclinical believe compounds XX candidate. did and profile confirmed, and but provide our that has confirmed devoid of to decided that's With toxicity been program forward that. to and into interesting properties Our Rodin's although compound profile our are HDAC target why the the to the our as with has has HDAC studies And program, and that we've the selective of pharmacokinetic, the tolerability,

Operator

proceed Matteis with question Paul of next the is Please from The line with Stifel. question. your

Paul Matteis

follow quick one Hey, on on much. thanks pandemic impact commercial. just just I on have one related And LYBALVI. so question up actually,

many it's from there's because So I LYBALVI so guess, year. a every modeling on perspective, scripts olanzapine challenging

reasonable recent doctors few any in what I of of a months seems, kind curious say was gauge the do are person as you Thanks the it launches people comps, launch separately, percent interactions use past much. this success some against? the And of six versus of in months, then And atypical just view with actually comp so your to ago?

Todd Nichols

Good question. is the the part -- morning. take first I'll Todd. This that of last

in we're in is our XX% engagements. of all seeing the now, approximately of year. our person from that's of beginning it's Paul First, XX% engagements the is in-person for up improvements Right Salesforce at

fact, area. really of research prefer see in they engagement launch. in that some And, XX% they engagements. prefer the to especially greater us you have we tell than product when improvements in-person a And continue we in-person So of conduct, in physicians that

is really think point that's established strategic the the commercial a just us as well for half around of marketplace, LYBALVI. well, million efficacy too. TRx opportunity for look to the To launch it of also Olanzapine your you're we provides. mainly our at So looking When TRx’s infrastructure in leverage you a schizophrenia, basis. disorder and about and an because to at bipolar that one X four on overall annual

time. it's that's could opportunity that business us Physicians that a So market growing. it's over tell a be really source of large a

think share physician attributes that of approximately as is well, we So XX its be olanzapine marketplace, LYBALVI a received within holds the efficacy and based very growing it overall with population. know, upon olanzapine, in as well you that would large penetration

Paul Matteis

comps? on thoughts Any

Todd Nichols

one upon but the and challenging within we a in is do the as are the to enormous. the $X well market, we the billion launch time, believe that market look compete dynamics And that the the right to just and over opportunity a LYBALVI opportunities, at. the will at one Also, that comp said, to launch we prepared absolutely. the very space. It's I good now as we in is launches we brand think Product remarks good general recent market yes, over in as comps, pandemic conditions. based overall. be recent over a be [Indiscernible] that gradual market branded the my going would well. market market But Oh, But probably said, with most most look believe

Paul Matteis

very much. you Thank

Sandra Coombs

Rob. Thanks,

please. We have question, time for one more

Operator

of Bank Jason will America. coming of question The line the with from Gerberry Yes. be

Jason Gerberry

for guys, questions. my Thanks Hey, taking morning. good

IL-X comment thresholds does you guys profitability one has Elliot hit product just first more agreement And thinking be any So how not learn And here just about incrementally to data clinical for talked sub-q for then you've about a format asking consensus, it entail about to margin directionally I the you do does just year how require of is what should to see you we the Thanks. from for question curious it's pretty past with maybe IV? discussions? in OpEx sort at asked replicate can on with we new would because in what need I'm guidance, maybe curious, but partnership guys just XXXX? or to threshold And to Rich, we growing that that looking facilitate guys to you which that? mirror get if negligibly. accruing launch that derisking

Todd Nichols

question, I'll maybe part So say the first that of Jason.

no are XXXX with agreed So for Elliott the there profitability targets timeframe.

managing And the XXXX. and to in are order committed XXXX we'll to be in hit those We to obviously targets. profitability be business targets the able

Richard Pops

with And Jason wide distinctive into is dosing heard dosing seeing But frequent decided based IV moving think the because of question, enabling partners. original to of we're well, space. you we've always produce approved in in IV today, in which this With dosing on that schedule, that XX combination that's data year we're first final schedule Sub-q Pembro importantly for which say also more with as registrational better. feature. potential the IV, already opening needs. that tumor year I respect you is emerging remember But impact days, remind quality based with think in I differentiating on interesting nemvaleukin a discussions to That's Pembro really is by having these perfectly unmet schedule. last to to followed as monotherapy days of well rest. is on a IV studies And on daily new both on Proleukin compared as acceptable we're signal Craig introduce types, in that less five the

in much so as Were than gotten has be capability there IV back regimens could there, modeling whole more confident more that economical sophisticated those dosing and well. modeling days. quite Our

support stool efficacy frequent So of the IV, IV, we're and three sub-q, mainstay seeing. to that legs the less

Jason Gerberry

you. Thank

Sandra Coombs

speaking forward to thanks so on Please in morning. any up hesitate much February. call there Alright, us to the everyone if reach joining are out again to to questions. And don't look follow for you this us we'll

Operator

Thank you. This concludes today's conference.

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

Alkermes (ALKS) 27 Oct 212021 Q3 Earnings call transcript