ALKS - Earnings call transcript Q3 2018

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Operator

Operator Good morning, and welcome to the Alkermes Plc Third Quarter 2018 Financial Results. My name is Brandon, and I will be you operator for today. [Operator Instructions]. Please note, this conference is being recorded, and I will now turn it over to Sandy Coombs, Co-Head of Investor Relations. Sandy, you may begin.

Sandy Coombs

you. Thank Alkermes update to September for the results our XX, conference business and the PLC to discuss call financial XXXX. Welcome quarter ended Robinson, and today President me are Pops, CEO; With Richard and Frates, Jim Jim COO; our CFO. our our

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

update on Our on discussions expressed Robinson and presentation update We cause presentation or our for most risk materially financial recent these results Actual from forward-looking could statements. will during will statements. Jim reports or our the differ developments. new from his to factors those of annual share Please that in and the Today, on call provided undertake portfolio, forward-looking After or or call and no information Q&A. discuss this forward-looking information our a we'll result company. quarterly implied X this for accompanying accompanying call include see Jim open important actual could the materially statements. will as results to results, the the our differ Frates an in commercial Slide or remarks, obligation will perspective the revise Richard future results provide conference of our

our call Jim financial review the for to of over turn I'll Now results. Frates

Jim Frates

planned, quarter loss updates results in The has of financial additional AMPYRA, fully will XXXX, expectations This I elements delayed upside AMPYRA. to our full income expected with everyone. flow guidance. to we through and our generic for The performing in and our for net morning Today from share occurred. Good increased XXXX Sandy. reflect to a also you, as adjusting few now are entrance Thank review moment. business revenues I'll our for of line, increase are year non-GAAP with more fundamental a XXXX which will our GAAP net a morning, detail financial third provide bottom revenues due which improved

the XX% entering delivered to a by continued million. we total net higher-than-expected business, growth and of income growth million by highlighted non-GAAP year-over-year Turning approximately revenue the propriety our generics to quarter, XX% manufacturing These results strong driven results the and $XX.X strength base and of were of delay the in market. including from resulting our revenues products royalty year-over-year of AMPYRA $XXX.X

end approximately at were normal saw for in at QX. well weeks by quarter, to increase the XX% net During driven sales X.X increased stood million, XX% growth which approximately VIVITROL quarter, quarter, third inventory results The year-over-year XX% compared ranges. a the the channel down approximately unit in of net VIVITROL to Sequentially, X%, adjustments the the growth $XX.X second net with which sales by approximately of approximately grew our quarter, driven and in within from the XX%. favorable modest

VIVITROL expect of in $XXX be for like toward though million net to continue We range. to the million sales the $XXX range that of XXXX, to lower-end

for XXXX. retreating Today, for continued ARISTADA we for in are as to towards our net largest quarter, grew XX% sales second the expected, from were increased range in sales and the Turning to volume sequentially. XX% million $XXX the due Medicaid quarter, to to million X% the third ARISTADA ARISTADA. the approximately of the adjustments accounts. net in shift Net approximately up for quarter, year-over-year $XX.X to expectations of million the was XX% Gross during $XXX

$XX.X to we compared in same the to quarter growth of CONSTA the period the of our $XXX.X year-over-year manufacturing $XX.X last drivers of continued on This revenues our the revenues for important which for reflects of quarter demonstrate has and offset year. be continued manufacturing injectable streams. compared RISPERDAL diverse year. business, third million, royalty revenues of and during TRINZA growth. Moving third States continued market long-acting atypical we last SUSTENNA, to CONSTA quarter, in the INVEGA million saw solid was Overall, quarter. timing portfolio manufacturing $XXX.X million to of and recorded the during the And to revenue by RISPERDAL INVEGA in of the million royalty United

quarter, For for AMPYRA was $XX.X third entrants $XX.X same during as of to and FAMPYRA, stronger-than-expected last million the recorded revenues coming period generic This million were royalty the to and market. compared delayed manufacturing we year.

the AMPYRA from to revenues recent will in be lower In substantially the XXXX. We million. the Due approximately primarily our generic our quarter AMPYRA competition fourth collaboration expenses fumarate, we $XX BIIBXXX, FAMPYRA and Biogen. diroximel in to States, we R&D revenues during be expect revenues reimbursement million, development of of launch the quarter, expect with United the related recorded to our of for $XX.X from third

a level QX. activities to expect R&D continue of consistent We in around BIIBXXX

in year. expenses, In expenses driven ARISTADA. of by third VIVITROL This in for year-over-year XXXX terms the total the quarter $XXX.X of compared for and same million, were operating support commercial the of period investments was million to organization $XXX.X our last largely

decreased R&D organization for to for XXXX expenses our of the SG&A to provided on by quarter, full the guidance second fourth in previously the our ranges, slightly be Overall, quarter. the INITIO driven in investments ARISTADA investment our are expected and primarily in in launch year Our commercial based of QX. within timing compared increase activities

billion to now XXXX. by range driven an of total range expectations second income now net $XXX arrange to our expectations We billion increase the reflecting to bottom $X.XX $XX improvement to and expectations of million for improved million. financial in revenues XXXX. resulting me $XX $X.XX expect in upside turn million of during a million our to half increase AMPYRA This $XX $XXX the net million to the of our non-GAAP of total improvement from Let primarily to through to flows GAAP million revenues line, a $XX in a corresponding to loss

complete outlined are quarter our in press morning. this Our third issued expectations results release financial

heading Turning well are the company's sheet, operating by quarter solid of in approximately $XXX total the results fluctuations and investments, primarily the quarter. of we fourth the capital. quarter with positioned September. third our $XXX outstanding Overall with driven quarter. position end $XXX in our our strong at change XXXX debt the million quarter our results million working ended compared and and cash balance at approximately the was total we're pleased third of The The during and to approximately million end was second in cash into financial to

ahead the VIVITROL that months. opportunities company's that, Our diverse positioned I'll well portfolio next of over updates evolution is With Robinson and turn approach for important we development ARISTADA. to the in support stage next to the Jim few our the call business over catalyst as the on lie in additional

Jim Robinson

Good Thank everyone. you, Jim. morning,

with medicine the that VIVITROL, grow market. in important an Let continues to start

XX% As in driven Jim unit stated, underlying of to net XX%. approximately of sales by growth the VIVITROL year-over-year third million, $XX.X quarter, increased

of care access and for provider long-term provide We and state a awareness of while across theme national, is of the is for are both continuity made. the in success support our political our improving Important level, community pieces gaining affected. the with growth continue to are and at central platform every being Vivtrol. country and fundamental legislation The the opioid patients. increase dialogue, These elements epidemic a progress bipartisan to

act that develop treatment treatment encouraged centers, treatment. in provides policymakers treatment comprehensive for engage availability approved by to to utilize the and of tremendous range are In qualified We recovery implementation policymakers the Cancer of establish and the Communities the will address centers throughout opportunity to provisions comprehensive have FDA of the with local of includes we to and opioid sign the patients for expand potential VIVITROL oncology. with to medications. continue comprehensive particular, systems, be to to piece provision This the an need state full The support This to which the to soon. federal, is legislation expected excellence federally funding impactful is numerous collaborate centers similar centers recovery President we and for process.

initiatives strong and collaborative both three states investments are long-term be in distributed infrastructure also in programs. as availability number see years between XXXX, $XXX to treatment XXXX building policy community state and At a well ensuring key a Importantly, level, and in extends for continue million growth we improvements grants to a the annually of in justice consistent of an to for as variety with legislation be additional made as the access VIVITROL. driven federal new of setting funding criminal will the by response funding state VIVITROL of

being XX% are approach implemented demonstrated the of care volume to our overall, VIVITROL a XX approximately of well While across the growth order the we Many five utilization country. to have and health particularly will and is California, Kentucky. serve country states continue and growth providers for VIVITROL. as are in top than over the Pennsylvania, VIVITROL year-over-year, as increase in today patients states by Internally, encouraged the Year-to-date, long-term. of XX% of across Florida, like and Michigan of states utilization foundation represent initiatives as growth widespread increased best refine the we VIVITROL organization more serve

managers. recovery addition accessibility to our fit options to that including account the their are We efforts need patients provided of treatment objectives. that patient the journey dynamics, and managers capabilities designed ensuring to reimbursement in of commitment provider respond to These initiatives Underlying all and are with are expanding VIVITROL. treatment our evolving improve is to our best of and market field-based key through

we year-over-year. So, was driven to by of quarter stated, million ARISTADA the now growth QX of Again unit launch Jim by of our as net new recorded product initiation XX% $XX.X INITIO. ARISTADA. sales highlighted turning The in

first atypical in the With can dosed market In long-acting The two on with real including have two-month across INITIO initiate providing one many months treatment in world dose in proposition patients that offering now will treatment. of settings, is INITIO ARISTADA be utility with offers patients resonating particular, and units and important the a where ARISTADA regimen, new the differentiated market crisis only hospitals is value day the coverage. combination physicians. stabilization fully the is ARISTADA and of the ARISTADA antipsychotic long-acting

the of dose, the growth have and ARISTADA's Following seen the accounted XX% XX% launch we of in third grew INITIO, for quarter. which the volume two-month in acceleration an sequential of ARISTADA

ARISTADA's terms gain which of in month therapy We in market also new in share continue market, approximately aripiprazole of XX% the long-acting for September. prescriptions to traction with was

of number customers' positive than XX both more response by hospitals and XX%. formularies the increases into by that health especially nearly We hospital ARISTADA To evidenced both hospitals of the formularies thus far, during addition encouraged context, at put this as ARISTADA the are and plans, by to including our products key INITIO quarter.

that fourth including We to Part Medicare ARISTADA in D the quarter. SilverScript continue to INITIO coverage expect will expand, its the addition formulary

made and review Additional we foster to into as to we next physicians To more are support formulary year INITIO, the cycles. of INITIO. order payors' of ARISTADA annual ongoing experience part samples providing launch strategically in decisions hospitals using

With schedule this a effort, we the are half ARISTADA and compete complete overall the enrollment six-month available, evaluating looking completed SUSTENNA. INVEGA in leader to market. – recently to current the forward XXXX. ahead positioning are of we topline now study in of conducting family evaluing ARISTADA support first long-acting the study data atypical ARISTADA product we're and This against sharing To

the match We investments to continue ARISTADA make will opportunity ahead. to additional in

further will hospital-based During the opportunities force XX our based approximately and the seeing. by on we the encouraging are quarter, representatives field that are identifying we we fourth expand sales sales and trends

ALKS schizophrenia. necessary commercial in of future we the for major to XXXX in and I'll and And that, investments as ARISTADA, with Finally, Richard. in for VIVITROL opportunities support continue for depressive work data we regulatory pivotal call for to decision to prepare to disorder our the in addition over the turn psychiatry ALKS engage XXXX

Richard Pops

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

of each our this an trajectory of built in with late the and change and portfolio stage expected resilient to company. a billion potential driving important excess growth So, results quarter the with topline in-market we assets, products strong $X demonstrate business that of the the diverse

well As we data positioned success is regulatory and for business and growth. expected head quarter, in important for the readouts into future the fourth the

XXXX. let with updates that, I'll and ALKS with pipeline share So start me on the some

XXst, As process our you the we're of novel preparing efficacy system review medicine. next depressive of is for that for and The developing forward Safety milestone Drug meeting at know, January review the place we're PDUFA way. week under a treatment With Drugs major discussion this of We've on adjunctive next FDA. opioid and productive modulator will November for disorder. AdCom months X, is take a regulatory XXXX in date the of number the with and the important the the a of Advisory Psychopharmacologic to joint safety looking been Committees a well

You've program heard me through the that time, from will and study potential seeing, be to and designs believe support what a that data generated determinant to that we're differs benefit The presenting and including and we're in mechanism registration same with time application used this new AdCom provide At ready new we say of again action. FDA an patients of an of to has the approvability XXXX XXXX to analysis. go. the important they're large

next more of about have weeks' we'll couple time. to a lot So, in just XXXX the talk with

efficacy head-to-head of is weight completed replicate on while second study antipsychotic ENLIGHTEN-X, of topline against program. study The this of pivotal study, track to schizophrenia. So metabolic and the olanzapine In moving goal XXXX, We're to is from extend in of II gain six-month associated approaching its three-month for head-to-head fourth our the the the weight and receiving atypical olanzapine. liabilities. end evaluating development findings to similar we're olanzapine and III treatment our later oral the a for the weight successful Phase a mitigating of April we or in the provide quarter. designed XXXX novel enrollment results ALKS gain XXXX, study evaluated that manner in Phase patients antipsychotic

registration will in for is package, data these planned submission positive are the mid-XXXX. We complete which

here potential BIIBXXX, fumarate in of relapsing provide oral NDA to has a that we're our while sclerosis position focused forms differentiated stage and or so We're collaboration and the launch on on would This novel exciting profile. with Biogen. gastrointestinal Biogen XXXX late by to Next we news intended submit fumarate tolerability in is for in track to development diroximel it been year-end. great multiple attention early commercial for XXXX, make progress developing continue The much XXXX. to

In in elective clinical from Topline to study TECFIDERA is registration enrollment head-to-head are required the in mid-XXXX. ongoing. addition of expected elements package, the MS-X EVOLVE GI tolerability versus this

their designed of While registration, novel In which IL-X considering may a preferentially in distinct hindered we to conversion finish clinicians fusion administered not XXXX of and from data useful molecular It's the in patients not from metabolic treatment single MS-X not to IL-X the update being protein IL-X. a of its comprised XXXX, used is forms XXXX, for affinity I'll form its into receptor. our native being immuno-oncology to and while IL-X be for from with entity receptors metabolize require and novel other affinity bind alpha differs required MS. choices space. a ALKS receptor on case molecule active to EVOLVE does does binding the an relapsing candidate. approaches in permanently IL-X and intended high intermediate

the being clinic. has it pharmacology, own in which So now is its distinctive demonstrated

combination evaluation in effect implementing data monotherapy next we'll dose four we're now process the initial dose in the of the In our from at that expansion or Phase we dose and initiated expect we meeting, the for dose enrollment Society study, cell escalation pembrolizumab inhibitor XXXX, Once melanoma. complete of we natural escalation I of fifth circulating quarter on T protocol the cohort reopen in of cohorts. discussed Cancer cells optimal evidence first with variety quarter, will tumor dose demonstrated with of the is and next advance into with escalation Immunotherapy last cells provided the cohorts renal the with enrollment cells regulatory month and checkpoint types patients and pharmacodynamic immunosuppressive and and effects these we month. amendment monotherapy Separately identified the During under of of to ongoing of in carcinoma meantime, activity. part T minimal positive XXXX's from present killer way. the a XXXX biologic on CDX the dose-dependent pharmacologic non-dose-dependent Data in

presenting of administration administration an of subcu comparing to In two decision data dosing. be from as our addition IV evaluate XXXX SITC, underlie pre-clinical studies to IV administration. data alternative we'll subcutaneous to at These XXXX

we During a for study the year. protocol and the third we that to study XXXX Phase early next the I clinical new quarter, submitted dosing expect to IND subcutaneous initiate

progress the finish I've efforts for will our challenging to Drug We the over because the line to So, readout Phase and see our efficacy clinic the the for with we expanded of significant in we to and Both activity catalysts range our on XXXX year. clinical nominating lives the ALKS year progress here and of expanding the ALKS important potential late-stage internal research you XXXX sharing just important Committee the and discovery and families. carry generate scientific our Advisory data outlined, meantime work, in company as development candidates insights be XXXX we the with we're we our an tumor capabilities initial In are is patients from coming anti-tumor for continue use the the forward in and types. for a III positively invest biologics. development success. in to program making particularly progress into XXXX psychiatry. approach planning to look separate programs of the new We're and and opportunity data impact good

and we'll to be With resilient and a it opportunities progress on diverse and have updating to turn forward I'll We turning growth. the for that, over The lie you over business that Sandy. opportunities ahead. many soon and cards look will our back

Sandy Coombs

now for call questions. the Thanks, open Richard. We'll

Operator

Bank Gerberry. ahead. America, from Please go have Jason And Instructions] we [Operator of

Jason Gerberry

good taking Thanks for morning. Hi, questions. my

when ZYPREXA and guess discontinue gain, discontinuation to in we as sense those just therapy? of outliers then in trying to basis drop the a you who commented out. getting rates last the potentially could then Have maybe assumptions? I on these And on weight you've my track Just that. patients question about with Just patients two past do with how your study a on sense think Rich, that think I secondly, just about one. when on in tend maybe the And about largest patients line are a rough to first know have a XXXX. question just blinded get BIIBXXX.

switch you filing the patients hear drug As curious tolerability become get that of first be to approach on tend or to think physicians NDA some actually ask the are just Biogen you that on proportion and does, your from thoughts guys the we I'd TECFIDERA manageable months more reason patients' of the subside treatment. GI couple issues I is and after candidates of

So, to get market the much of I'd just for you how be sense Thanks. up think is grabs. a curious of

Richard Pops

Sure. Good morning, Jason.

can on XXXX olanzapine, setting ENLIGHTEN-X So, on I'll like you've gain That's discontinuation in study, in differentiation heard this time. in XXXX is if rate. to inverse they'll turn. accentuate our which talk in the retention I'm interested before us has thesis people been the take keep with weight. a Actually can rate, if in always the we continue those what of the keep about we conversely will their the over the study patients weight And because

So, study. of critical retention a part is

that TECFIDERA discontinue. types is into model in with about that's your answer consideration modeled. this, experts is studies to on second the the that we BIIBXXX, about tell on would have this ZYPREXA medicines, general the all BIIBXXX of these through the profile of who switch. patients from profile the to of stable anecdotes initiate centers that see X%, the hear a GI and be understand On to who built power on view on with Biogen. to we tend most challenges the have ability see I come patients study seem the have data the looks efficacy. people XX% the I can favorable wouldn't But is blinded we of discontinuation really couple place, we calculation. NDA so of the basis patients yes, rates that is because and We schizophrenia, tolerability what years, keep approach about get to are order are starting and for in but for refer to safety And and together but even our a open-label be program we will pick GI now the what in something completely and below efficacy that my obviously Biogen equivalent the from own sites said, on would the as to whole logical say loss might as I'll This in beginning these people follow a the study, with we GI the to patients tolerability clinic. didn't in all you up me excellent and from offering saw new but I that question for on submission patients AE your seems in have we our questions a benefit we likely to you

I stronger this into move program aura phase. around is think as whole getting the and NDA the stronger we

Jason Gerberry

Right. you. Thank

Richard Pops

Welcome.

Operator

Kasimov. Cory we Please have go ahead. JPMorgan, From

Matthew Holt

Hey, is on for questions. thanks taking guys. for Matthew my and Corey This

Just a of questions. couple

XXXX, this on First XXXX the dosing and we get should quickly your to if curious this just about escalate program. you expect in thoughts see can from data to subcu on how

Richard Pops

positive experimenting comparative to as with five, as be. may actual we we controls regimen times here dosing lymphocytes data what see that of to IV. CDX IV expansion to well we cells expect from daily what Yes, the compares the have in killer We're the may natural be, can see the we the see still But XXXX. see because infrequent how how

expect I enroll driven study, should fast but by everything fairly can quickly. information we the So in folks you – get I think how is

Matthew Holt

for force sales potential sales And force? here XXXX on overlap ARISTADA, great. with expansion just a announced XXXX Okay, or either any then the

Jim Robinson

both accounts. on Yes,

be launch to not also and but of the expansion XXXX. used support today, the XXXX So ARISTADA only can supports

Matthew Holt

you. it questions. Thank Okay, my That's great. for

Operator

Credit From have here. Suisse, we Louise ahead. go Please

Unidentified Analyst

Vamil. is Hi, for this Louise

with info have you us FDA briefing you able FDA or of the expecting to seen exchange such AdCom the ask? just if you is with XXXX, ALKS questions type the any have any to had are documents you would the might on share be of and that soon, as So sort wondering the

Richard Pops

Richard. is This Hi.

comfortable that the questions with made we to number efficacy? to we've of efficacy Is are it. ones or throughout obvious very the been self-evident evidence using data strongly the think program methods the the going AdCom of which is submission, there the beginning that from when I one is the have substantial shown the feel designs new that new obviously confirm incorporates committee efficacy? analysis study which quite about and We

You've it seen you'll to those and data presented continue see published.

So, we looking it. compelling obviously we're a story that's believe to and forward that telling

it of are the system point looking as this one piece purposes the opioid information, well it with making also oncology the a see needs So, education AdCom second for molecules, modulator, to you're what small in that be convened an AdCom, CNS is I more labeling, has Q Okay. that the the you new in opioid the the therapeutic sure categories candidates for with the into whether major it share fact an and almost at or addictive by issues the be clinics. it's And think get general even The setting you more safety the I as are will it's designed XXXX looking - two of launching biologics, or for psychopharmacologic think further the to the both you're is others? compound, said an what's because you Unidentified to about into which can us right Would of Analyst whether directly and patient's potential right to? those is drug AdCom. and drug FDA What's issues address presentation what's molecules, able modulating opioid gets right the crisis. move of midst buprenorphine or of the to kind the

Richard Pops

been discovery which Yes. and chemistry was other drug historic disclosures I triggered I this interest highlight I program in It's strength it our what increasing by biologics. and at today have won't earlier, and the than and our said in getting and is molecule beginning small that's stronger. we make think in small stronger any augmented new by the XXXX expertise molecule

programs as now So, small large well molecules. that advancing actually both we're are base the labs as in molecule

interested And combinations number XXXX have a foundational in an psychiatry. and of and particularly expertise types obviously so, we may of we're oncology for deep in area, CNS be as

So, we'll natural lanes those are that along. progress

Unidentified Analyst

from all That's me. Okay. Thanks.

Richard Pops

welcome. You're

Operator

From ahead. Cowen, have Please Shibutani. we Chris go

Chris Shibutani

very Can and XXXX, or you that efficacy you and been discussed much. far the part there's the clinical just reviewed overall for that substantially anticipate documents have confirm that data anything as presented has been us for disclosed? already? entirely the perhaps profile will that Yes. we Should the been in briefing whatnot Thank hasn't of that was NDA as additional filing

Richard Pops

Chris. morning, Yes. Good

the it's another You've publication, potential yet. don't as seen I study it's the XXX data is data. think which in yet presented efficacy I from as II been you the abuse the pivotal the is studies efficacy human know well study, Phase study. What probably seen haven't

Sandy Coombs

There was APA. a at poster

Richard Pops

well. poster might not supported that is you APA, have data, one we'll abuse human seen. think was as which very liability we but at There some data potential that There the or be long-term human of is may abuse have more strong

seen seen say consistent think be with can't I you it, all everything what I that haven't before. seen but So of will you've you would that have

Chris Shibutani

Great. And scenario a might is asking binary frequently an not to Phase was XXX a an while a I I believe additional this III study. that in call and a which the of type then potential alternative we about event it's difficult IIIb AdCom And back there FDA study, I'm sometimes think but is particularly an of question which believe framed thumbs-up thumbs-down, study context you Phase theoretically like see? commenced as study event the what could be approaching as

to does committed be to XXXX instance the recommend I think for a view scenario of that looking approval, on outcome a the your it? realistic where implications these of XXX based and team looking development? other of been paths. is for be to path kind task point and on that we'd there be it and thumbs-up obviously beyond forward could do a in you'll prepare, work optimistic three to if believe Sort different study we but that not Advisory upon about that And is you've there doing the continue we continue there nonetheless and Committee Is So are so that scenarios realize of the beyond need thumbs-down, X? to have is November could

Richard Pops

from or or scales. Committee that from the tune need those admonition data. believe ability one disorder, outset, if I more as in study Advisory always and XXXX quantitatively know for as a than placebo as think placebo under we in study, another thoughtful separate have indications XXXX event data, question to exploring HAM-D of the being the With features to with caveat and the agents that major often says and well. of disorder were and value you back might way, we in other some the due the the comes know indeed But active that's you're potentially we patients XXX classic order be studies need course the mechanism MADRS provide in captured interested depressive to the we in major response. we other we high the different of depressive of and it's the medicine correct is what clinical in the of deeply don't

decisions clinical to make as make trials we of designed So we whether the out of XXX initiate or depending definitive how XXX on run what out we or other modification coming not it whether learn or further whether meeting, we any Advisory is, about itself. Committee we'll the

November the review our call a well couple of that really in you the and weeks' if a space of bit January actually is because where FDA drug. where So, other the out time between there we'll and review for of side X or the time on the any completed of completion on other XX gets deficiencies happens are the AdCom then the a quite of and as launch side figure prepare what with of the make you

Operator

Umer Raffat. go we Please From have Evercore ISI, ahead.

Umer Raffat

up types curious making it in injectable been the into plans looking on forward how IL-X, same taking first, in that my into is as have of very and we with for buprenorphine long-acting they then FAP letter given saw agent potentially think as could much the ties developing to as Hi. expertise Roche we in an all Thanks Alkermes' was doable. as Rich, we've FDA what injectables, responses trials? Secondly, presumably make questions. tumors the terms been so why that's concept AdCom, of saw seen put And the of as RTF I multiple the were going monotherapy head the for the your XXXX, finally, at? like strategically something you're you request well single much the you my shouldn't on so date seems mind

was So guys thought you. of I'm is process of to curious as thought you injectable internally not whether the or something still what buprenorphine consideration? Thank sort offering, have an about that and

Richard Pops

Umer. morning, questions Good always. Good as

and of affinity T-Regs efficacy should Roche in if IL-X. intermediate the the preserving that the normal because to done out a and one, just what misunderstanding expansion the last And since things The design RTF an with to that for track. be first to multiple specific the basis The request time, was were the it agent to were long RTF in able it we reversed for getting minimizing on trials. binding while the cellular we FDA XXXX recapitulate asking we've got you do, was what deficiencies the we facial once expansion, the before, the data In cleared been single refuse receptors didn't up I actually reason course. be we've to positive review application, just appropriate file was of intention about actually the we've interested back was because see that we for clear. FDA March, set talked that has

why And our monotherapy carry we with escalation. dose that's on so,

is injectables monotherapy in you foundational checkbox and So, space, us it's addiction that and that. important make I think the the space see continue do. say I hopeful policymakers will efficacy I the combinations space the well in us the established think you launching said, in medical to space check what's to to can I'm a in in just and With in an addiction world and you It's to that of has the addiction Alkermes and new treatment and system don't you'll think sorry, sense. the do media that fact more anybody particularly as the the the system. injection impediment major development outside I'm hear – long-acting I continue that's drug explore all, then experience obviously that think is can to injection as we piece And this it that to we than

They speed all because used approaches use any systems are they’ve the ossified. forever. New not the with agents are treatment at adopted

to incredibly as doing So, we’re and world. fight with our into success to been by step antagonist injectable role a in the step continue we VIVITROL about be long-acting optimistic going way of this we’ve

We’re even launch. choose products, slow I – you a times of slow if plenty interested it’s And play to – we long-acting of there can think see time do growth. plenty in the have It’s but we’ll from so. a injectable to buprenorphine

Umer Raffat

to dose on be noticed you will sort confirm I expansion IL-X, the in just monotherapy Rich, And melanoma. guys of mentioned and renal

Richard Pops

Correct.

Umer Raffat

responses And the dose curious consideration the I cell if tumor expansion. the types. that’s about was response, cell squamous you as well expansion, in two think Roche as were of

Richard Pops

Yes. too, about was answer Umer, we I those course talk formal noted have as too. and will I data was that a but interesting don’t that talking the be of thought that well. about team we’ll interesting on that

Umer Raffat

Thank you.

Operator

Paul have we Stifel, From go Please ahead. Matteis.

Paul Matteis

the one Appreciate if a more relevant have One, outliers? might of Great. think meaningful opine clinically I gain analysis mean if relevance on gain in And then endpoint. or just the then separately so on just And wondering weight regulatory that follow-up a couple I commercially weight have be could Thanks it’s the if study on question. benefit what was you Thanks. does much. meaningful questions. commercial or XXXX. you A

Richard Pops

of Those because bell statistics say of after clinical important. saw just what the a determination heard are characterize statistically Morning, And slope so two time patients thing correlate I we co-primary think few few as at see compared in and relevance good shifting And out and primary the is change times more essentially who of of they the that times Phase categorical think I analysis, clinicians endpoints. Yes, and olanzapine left but a I well, cares. you’ve is many center hear They're who us before people difference, that is of If there pounds of important, ascending gain most a analysis, to no really a and matter the of as Paul. you've often inappropriately mean the XXXX submission the important necessary weeks' shape it’s a zeroing which say curve hear the weight we which II, think well like all. both it’s which – is from question NDA – for than it XX% confirmation curve. there’s the a co-primary that's heard an slope, for flattening time, body is their we slope weight. we to us say over that the many regulatory

the short of have that two mean of data time. think than the will the change weight greater categorical after the period flatness gain be that change So, statistical measurements of the we I arrested will at essentially a meaningfulness and But be XX%.

Paul Matteis

given if Phase make one If start back. a get more think more interrogators antidepressants beat three that of I it's know think the then to horse, end this in out next hypothetical is got you taking maybe consider half second starting relevant on just Phase scenario the around, I the time first step that a I case the Thanks, III try, work, just you really of then more and III my question fail just dead CRL to that approvable? can it out through Okay, if you and to I it. XXXX study is would studies two guess another so doesn't sense follow-up would one in that for you if it guess clearly a do you getting we a up III. but go were it., not Phase have in appreciate in one functionally And

Richard Pops

after when see we'll believe and the want to a the call whites say me to as Xst. out make of But FDA think we we'll we let's heard more finish you've then I errand helping the it’s determination presentation, you other where side figure lot the have is But and as to hurdles But on. – decisions land it, you before, you’ll from this fool's can a the way see think the case AdCom Yes, see we patients. really do regulatory – and but are we’re for if insurmountable, see off make November and then the – of your while drug and preparing then strong so think we watch if it. it eyes information to the the don't it's and it. a make that we far on and a you own get of We AdCom that patients we’ll at let's

Paul Matteis

Okay. Thanks, Fair enough. Rich.

Richard Pops

welcome. You’re

Operator

go David Buck. From FBR, B. we Please have ahead. Riley

David Buck

thanks. Yes,

questions. Just a couple of

money be you’ve other should your And for of from can in about, little questions talk anything if that we of on that the the and questioning VIVITROL, and little terms of product? from for bit you any effect surprising the treatment you about filtering down aware Richard, into in to see potentially, types talk or AdCom that you can you’d as seen that new a just haven’t mentioned? what were you opioid growth First – bit see – XXXX a that the you bill, of Thanks. of how

Jim Frates

Jim I’ll start with VIVITROL. It’s Frates.

I the for continued think right. growth very much opportunity we see VIVITROL, for

the using toward level improvement state levels As amfAR moving of this treatment year, Rich addiction. the both as to well I seeing system said roughly mentioned, X% initiatives when And in treatment where are all system. legislative and the federal the federal the opioid at comes has as back and are the they change medications come quality three go more that that came slow of centers data country out the the been to you’re dollars to in earlier treatment basically it

for many we medication for the and patients as excellent as exactly seen It’s Tanum a different, slope are VIVITROL. states treat increases for option the prevention attractive very various and centered breadth are to think sees as with of way patient more a the option and So, to that move we to see approaches this in patients predict is injection relapse data continue that I growth understanding the we’ve and disorder, that that X:BOT quarter-to-quarter. data; to monthly hard a growth with

in annual And do we our certainly VIVITROL. optimism for lost predictions of February, XXXX give we’ll so for guidance our when not growth but you have long-term we our the

Jim Robinson

have AdCom, so anticipated. review far vis-à-vis proceeding would we as the And I the think is

meeting the as materials for final see But have we’ll would you we So, them. it guys when the all prepared briefing we’re see for along. prepared

forward it. to So, looking we’re

Operator

have Amin. Please ahead. Jefferies, From we go Biren

Biren Amin

on Richard, the hope get more SUSTENNA Thanks, year. next Yeah. What out my you reports ARISTADA achieve and versus to just to wanted study taking color will enabling? label study be that questions. head-to-head the do Hey, guys, for in this

Richard Pops

it SUSTENNA and agents formulations aggressive are adequate been interesting We’ve to get not that antipsychotics a common congress really ARISTADA an is who less on year ARISTADA to the or at Yes, that ago really showed as be in was for which this to data some a the patients, ARISTADA, sense and be one responses floated we powerful time idea relief more rather of sometimes morning, risperidone. belief that surprising than presented when being which Good that study, it as out considered we failing compared to is at were suggesting true people, other. thought may nice patient to was switching never clinical a better – powerful first switching data the the it different pretty those ago, Biren. paliperidone aripiprazole because a about because has that had few bored was remember months or

with study payers, to powerful a can providers a to us that’s say to two-month very and world that’s really in approval meaningful dose, offering led INITIO INITIO the and that coming, we in initiate setting run which patients a in let’s discharge the and is real the So if to community. with hospital on

Let’s compare versus head-to-head that SUSTENNA.

relative not their will in results primary the a the but efficacy that, way something then months compared two certain at parallel time It’s just an give to two the look of is inter-group. a baseline or month medicines. also of group opportunity in a at each or the the patients at comparison to So, point, looking the like us

in don’t know folks give that label I it interested community certainly information the in will will seeing. us leaders it are a give lot the indications, us and the opinion So, but of if

Operator

Sachs, Goldman Terence we From have Please ahead. go Flynn.

Terence Flynn

build about commercial taking is the just on how for into the that guys stage you Thanks. or next us input stand outcome you’re Maybe with is remind of and really Thanks of the Hi. just also us, Maybe the you prep XXXX, question. key can the where AdCom thinking Rich, size a remind footprint. of FDA the decision? the

Richard Pops

ask and Sure. the Jim, part, first Jim I’ll do second I’ll to take part. the

think XXXX, I the really FDA’s decision-making the to So AdCom central this. is on

is approval, And so step important doesn’t we’re and X view. really certainly necessary our – in that it January doesn’t mean XX. It in between but space some November guarantee there’s not an

the enormous the if a approval Remember done the the go we’ve we we’re approved. DEA sales another drug this, receive be scheduled of it is time to amount it have – of three process, will as until preparation expansion are for force but but we hiring of FDA then going next expected so be drug a fortunate, is scheduling months level trigger sense such So into pull is won’t which typically. to like with which will we that on really XXXX, launch

us time. we summer is clarify? actually months as in you to launch, begin three that expect Jim, want to for So we the to the operationalize which very happen to useful

Jim Robinson

high lot work of fact Yes, that major of about of regarding going mechanism action work and creating depressive medical will that’s just preparation disorder a it adjunctive benefit Obviously the the will how and the role lot a in awareness into there’s therapy still also the discussion on treating for the need how patients. of launch. unmet a few things XXXX and

like as the sales sales key there’s meeting sizing right to at amount upon field with work a value done as a of as leaders, in size as So got lot quality a force meeting payers the make sure you’ll we’ve there’s from time the right of the with as well in from with tremendous of been expect, providers, XXXX. product And of work awareness well perspective going meeting in force and perspective ensuring that approval. a opinion

So, we’re that of prepared for work the XXXX. going a lot and well of launch into

Richard Pops

up finish It’s an simultaneous to we’ll just bit Terence, have because as before the the a XXXX well. of data equation also, important the a end thought. year It’s of in readout

XXXX. VIVITROL So ARISTADA VIVITROL and and in psychiatry, thinks or is in And commercial that ARISTADA sizing as it configurations those it footprint VIVITROL is ARISTADA all are our or are Jim and XXXX play. about different XXXX is

Sandy Coombs

we question, for please. time one Brandon, more have

Operator

David Here go from ahead. Please Morgan have Stanley, we Risinger.

David Risinger

little in much. weeks. Yes. could I hoping bit acceleration recent a very you in the about VIVITROL Thanks was that talk

but up So, and wanted what attribute working to. we’ve better is take that efforts, on their seen to wanted to I if to mean you you. has the planning what would of VIVITROL. then also picked you’re on to you’ve in ICER been that the improving understand data your just obviously And is of the the effectiveness how that. Thank understand IMS report understand value just to wanted respond commercial your and negative performance

Richard Pops

Jim Robinson take I’ll chime and and can So, Dave. if then Jim to it they in do, Frates want maybe

week. than asked product. the just acceleration it wavelength you VIVITROL week I moves because about to don’t different It me, typical a look when pharmaceutical on smiled for in I – VIVITROL So even your really at

try see is two done of money flowing injectable or the long-acting three and hydraulics single guide we’ll But in treatment for as any best system. that interpret guys past antagonist we and policy shifting over VIVITROL as more or more with is we you wouldn’t VIVITROL. in trend I can we’ve to – the basic as So, therapy, favor to week

positive against those that’s it. away run change, system so broken it to slow institutionalized but and a forces in chipping forces we’re up is treatment of changing at And for the inertia

objectives very to ICER to be actually And remain preliminary approach thing, negative. cost I with the it’s sometimes a we really different replacement is review policymakers think and interchangeable to the So, substitutable wrong-headed The report the viewed that optimistic I idea patients of long-acting about antagonist the expect or The the and should is disservice that treatment care. ICER as different alternatives on be VIVITROL. an who is therapy have negative based treatment. for take example medication their injectable

whole so, actually don’t report matter that the to lot. a And ICER I helluva think going is

Sandy Coombs

Alright.

concludes the you. to Everybody, questions call. out today. So, the don’t later I thanks Please into think reach have if today. company for our you that for hesitate Q&A dialing Thank to

Operator

you. Thank this and today’s gentlemen, Thank conference. for concludes Ladies joining. you

You may disconnect. now

Alkermes (ALKS) 23 Oct 182018 Q3 Earnings call transcript