ALKS - Earnings call transcript Q3 2017

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Operator

Good morning, and welcome to the Alkermes Plc’s Third Quarter Financial Results Conference. My name is Brendon and I’ll be your operator for today. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session [Operator Instructions] Please note this conference is being recorded. And I will now turn it over to Sandra Coombs, Co-Head of Investor Relations. begin. may you Sandra,

Sandra Coombs

Craig to results Plc December for today CFO. our With Welcome and Medical discuss Frates, Jim XX, call our me our CEO; Pops, Richard financial the are our the you. Chief conference Officer; Alkermes to XXXX. Hopkinson, Thank quarter ended

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

forward-looking will forward-looking differ revise also will results Slide conference that results discussions implied our ended a could undertake information update Richard cause result future from new to the Today, results on developments. on obligation presentation, prespective no statements. forward-looking financial X news statements. important or this of Our actual XXXX, the We these of to for factors two XX-Ks expressed statements. information December and call recent Please in as those or this discuss a include XX-Qs provide provided our or during Jim the or and materially XX, most recent for will results items. accompanying see could call year Actual the our our from differ our materially risk

Officer, an remarks, open with of today, our earnings Craig as call regular we We pipeline Chief Hopkinson, Dr. also of from our will for departure the After overview have soon call to to provide a Q&A. will development updates Medical you number our well. pipeline format. share our

over call Jim. the turn I’ll Now, to

Jim Frates

everyone. Thanks, Sandy. morning, Good

With expectations products third our management. and quarter as XXXX royalty for quarter. our business and to last commercial months reflect by top-line proprietary heading start highlights disciplined financial of two results and our I’ll today as expense one the remaining, driven results only quarter well the year-to-date revising expectations our financial Our manufacturing performance year. a into of we solid are the reflects the with

revenue expected total growth by revenues manufacturing proprietary during compared business. by quarter our management offset royalty million, $XXX.X growth, the and commercial third year-over-year our driven expense solid us bottom of These strength performance. lower quarter, products to solid allowed which driven development quarter, grew XX%, results our slightly third of than XXXX, by advance to and from the while VIVITROL® During generating line to the continued pipeline, were

$XX.X quarter compared growth $XX.X flowing These into GAAP our sequentially. expectations. larger in was quarter the reported growth. a inventory this expected the result sales Century lighter net with VIVITROL®, period to in three million, the our Starting growth year, which third same the the For loss overall with primarily of net non-GAAP in draw to X% net We federal last income million, in Cures, growth were lower XXst system. reflecting And of related than we were in believe the some the down effects $X.X funding, factors: delays channel, of disproportionally than and results treatment of states a million. XX% the

product in underscore market. third a Our quarter VIVITROL the as results unique an unusual

that monitor for growth indicator Looking in as a remains forward, interest to leading progress strong. we state continue new and VIVITROL

to XX% VIVITROL, expectations XXX number range growth, reflects million, XXX from revising year-to-date, quarter, results XXXX. programs more of which of During $XXX down our to approximately Based XXXX to programs. for expand we our the million a to saw the $XXX we third are than approximately compared on

million net represent to X% second and sequential growth, quarter. sales quarter where ARISTADA, to the within compared expectations Turning of third $XX.X our

the long-acting atypical in market the the was for continue we XX% we $XX compared quarter to fourth in third to share sales the million of quarter of year. new quarter, prescriptions ARISTADA in for net During market, the antipsychotics. for range of ARISTADA for million, to approximately traction approximately aripiprazole terms of approximately on line quarter to therapy growing sales expect ARISTADA’s our market long-acting be in Based net these gain to in the months last in results XXXX. of $XX expectations in double XX% with

ARISTADA last launch medicine. to we’re growing well-positioned and progress the dose the two-month the the being made keep quarter, this of new product important With on family,

a quarter third RISPERDAL our to and included the SUSTENNA million revenue on last the year. we $XXX.X manufacturing related increased third compared strong in CONSTA and for period Of which last products to $XXX.X the million INVEGA a TRINZA, partnered this royalty year. from overall of quarter, of $XX.X saw million to INVEGA same in Moving $XX.X revenues million of note,

the the pipeline was expenses R&D lower non-GAAP to expense our increase which to range year-over-year Therefore spend our terms $XX development also range top last the a be non-GAAP of operating and due same expense our third $XXX.X the in certain XXXX decrease lighter $XXX expense million organization. million to $XXX expectation XXXX. of million maintaining to to In to our loss This a of we're to by expected, timing. XXXX, million R&D compared a million, the continue total year, driven to we're in by as the for expenses, commercial primarily initiatives. line. net investment than our for and income range non-GAAP commercial decrease million the the lowering for disciplined year. expectations for company's a driven $XXX of SG&A $XX Overall, somewhat for the third timing offsets in of was for quarter management We're net to during expectations of were for able million, of $XXX period million for expectation $XXX.X our primarily quarter of

quarter of of with XXXX, $XXX total cash third balance Turning million to the investments. position in the strong we're in in sheet, our a approximately end and

to executing invest strategy, and business growth our on that We grow our we continue be product commercial will the our to drivers. expect in development programs late-stage future focus on

ARISTADA and over more VIVITROL high to that, and plans. remain We both a growth. hear for Rich you'll to expectations solid drive I'll to continue turn the forward we Richard. growth call our these as on Our With look quarter fourth from

Richard Pops

That’s you, great. Thank Jim. everyone. Good morning,

have We company. on a lot at the going

as we you New critical to and ALKS There presented every VIVITROL end ARISTADA, and and for XXXX be ALKS almost drug milestones updates number XXXX. year aware of ARISTADA, data are applications for and XXXX, want being generated head program new into the of and for we approaching today. a

legal expand more include joined to update. extensive from an know, R&D a having Dr. impact this call of Craig gives scheduling chance joins Officer, me we’ve our here. So recently us introduce already This we Hopkinson, you separate Chief webcast decided who to by Medical most the Craig organization R&D Elliot led in also Vertex. a Ehrich, to

what more perspective and So the to share at to ask I’ll first numbers, market long-term update we the on you potential through during Jim quarter VIVITROL this but of another of do, indicative the the our VIVITROL. Craig is a want on of growth will my to the ARISTADA, background sequential including unique the in of the take than with medicine. from programs, perspective, the nature of some some program. start particular immunooncology my on important I then and developments XXXX look

data, of in of policy crisis. beginning paradigm it. by status quo also is believe a opioid into in in shift is and we’re the is a funding dependence element of and increasingly integrated strongly believe will being necessity. We And There because are continue. the I going isn’t and to national epidemic. growing response in confluence VIVITROL this treatment the country. new national it’s adequate at the an this midst I of important the growth so a to change addressing The it

data. First, we'll about talk the

results performed study comparing from last JAMA which VIVITROL first and naloxone is to widely Psychiatry opioids. for heroin as most as a that important as illustrated published use and have used expected. VIVITROL and its of on Just we treatment reducing of demonstrated SUBOXONE, kind dependent. directly study would week, VIVITROL or buprenorphine retention other treatment The was the effective positive SUBOXONE opioid

high VIVITROL data data its the limitations, later up will these general. study, these this substantial VIVITROL the use called more build Each throughout MAT and year, and X-spot underutilized. MAT of demonstrated also supporting data we will Importantly, evidence, opioid supporting Medication-Assisted the aggregate, grossly is compare expect of has buprenorphine. value satisfaction VIVITROL in of also the And the in results in directly change. reported the existing of body nine patients be drive study. MAT comparative significant studies but to These craving of the Treatment, seeks more to which on XX-week reduction there treatment of

diverted patient treatment paradigm for This all to to the policy. generating actively policy is treatment and of all community research element population. The as makers, well to front. access the the Health requires and in commission as available other we the is approach participants options. next Department provided action is separate and President’s of Last of evolve MAT data that an system. to player month on underserved ensure Human to patients VIVITROL were and active on to is Alkermes features other federal informed a non-narcotic, state testimony goal utility encouraged the landscape We’re this to new about this in meetings comparing patient-centered that the opioid the part The have the Services option long-acting role a outlined addiction of is the not in treatment treatment or sold epidemic. illicitly. the and that on We drug its VIVITROL and as

in will of to of House steps weeks and the effective, ahead. implement testimony also the for and passed just addiction. and the Commerce widespread recommended help its the Energy FDA and year. in existing, Commission’s the the want Committee. importance that look Comprehensive for the is expected into medications He coming commission of to in combat quote, We forward days testified coming to last House approved the I We and White “FDA Recovery focus about equal also of approved to note Act front yesterday said and are recommendations promote dependents treatments. more they take final access all several There out to Addiction law commissioner was FDA to in safe Scott report opioid plans therapies President, implementation which needs to to FDA recommendations FDA-approved a the use of on that I

All of as allow offered to support. all work options opportunity seeks counseling providers a and these be and to in Everyone treatment combination deserves who patients to the three treatments psychosocial way our select the It’s into the has needs This each been treatment best policy. suited be for message to past to of to individual be several translating and heard beginning the with years. patient.”

country, That epidemic. deployed. matter to money has funds are being taking $X to new of in for will in Cures administration funding of the law front, government Last it Later to today, a allocating crisis. into state State their dialog. the take new the in XXst are regarding of houses underscoring and new the stage our will provide address to as Century billion opioid federal around as make appropriators actions year crisis and the necessity. opioid combat and funds slowed Setting funds an to report from been announcement the central the the but focus On move communities. the epidemic matter address the President Act will national community, commission's the at

have being and generated we patients. on with continue for the key this Alkermes and to health how policy a the on treatment VIVITROL of to summary, is frontlines discussion are this funding we be the the change as flowing presented to data addressing solutions community, and elements new opportunity in will new crisis. advocating public focus treatment, makers So country and

developments With the the have report. new on program ARISTADA. years development the ago. at program our working to of Patient-centered is core Next since important been beginning eight ARISTADA solutions

you the blossomed the made asked evolving. year-by-year think watch and product do we two I what to is announcements can clear. morning now revel we it’s You This how family see stand products more we’ve fast we becoming to and

ARISTADA. simple enable that lauroxil new the drug for we on aripiprazole revealed to for we under We competitive formulation, program new wraps design kept First, application development this initiation to submitted reasons. our

for initiation injection, to three this As employed forms. treatment providers. new Based dosage has system, which six-week currently faster delivery healthcare our studying is their And ARISTADA flexibility both well-suited in family This profile for of not and of NanoCrystal taking a dimension even a and the patients it’s formulation for enables release aripiprazole. the and monthly patients initiation on to enables oral oral product product single product supplementation. easier initiation make for our the than need initiation designed critical weeks new of without two-month

We study, first The ambitious the leader the Phase flexibility initiation greatest of to new market of terms Xb based second an The employ ARISTADA. want products use to the INVEGA key two in the features announcement offer of expanded These evidence and durations. in on continue study in doses two current build of ARISTADA ARISTADA. builds SUSTENNA. to will relates to comparing and support upcoming the

meaningful Simple When new along builds therapeutic regimen described, This patients months care initiation to utility dose. two-month vulnerable ARISTADA with useful clinically together, world build two would just in ARISTADA alongside inadequate initiation data the have to X in may the of positioning Our particularly leader. these studies class SUSTENNA. Phase of positive continue I coverage ARISTADA’s schizophrenia are switching Taking symptoms. complex more we with just significant response patients with important, story from presented the statistically will patients study transition experience intolerance to INVEGA for upon outpatient improvement and treatment settings. This inpatient and demonstrated are and particularly real schizophrenia Two that the September. relapse. to

ARISTADA among long-acting the is injectable one, antipsychotics. bold for of gold the vision standard to a treatment become Our

So that’s all to cover. going I'm

introduce our we XXXX, Officer Medical our function other Now prepare where Medical Senior anticipated our also Vice and pipeline as be development educating to action Affairs the Craig. for and treatment for Chief the I advancement With and new Craig new clinical community over we want of for Development Craig President enhancing depression. mechanism implementation the of treatment hand of Craig ALKS Medical that, to is launch things, will Hopkinson, Affairs. of programs. I'll of the is Clinical this on call the Among responsible

Craig Hopkinson

be Track to development designated for updates with Alkermes the an portfolio. threshold. excited important I'm development I'll share pleased to ALKS be line XXXX, company's to with I'm top top line medicine important joining time such today in Richard. across Fast you, candidates. at you Thank start our able of the our for

this is one joined paradigm, disease launch engaging of and long-term typically physicians been an mechanism of a a important medicine key treatment to critical business I novel mechanism Alkermes. new success. established is First, is there not important a key and relief true of therapy. space patients of educating affected and healthcare treatments hasn’t of the into providers are This action action treatment reasons found introducing the When depression, I and for foundational in where to get an the know community, the We options the adequate success of eager anti-depression from understanding the XX for that ALKS years. new millions XXXX. safe will endogenous standard that to in be do of opioid in system

attributes profile safety context can that Within best key the be XXXX’s the this biology of of activity and appreciated. anti-depression

quarter, The submission this and Regarding rolling extraordinary pre-NDA excellent we meeting NDA into submission the and third of during the magnitude itself, we’re NDA. completed making of the that initiated goes is our progress. the work

and the FDA submitted in the next month to submission next and complete FDA in with we ongoing module dialogue an the will have the be January. We will

regulatory other team is as the works focused to While be launch. underway it’s preparing prepared well submission, our seem for on

for communities You and about scripts be of at can XXXX publication scientific the the continue review, committee data the and the ALKS to year. of clinical as prepare and more Congresses development medical in share an meeting coming expect course we advisory the manual and month, program, from to of key peer next interact prepare hearing multiple expected

activity include ALKS metabolic antipsychotic We addressing to to while spectrum expanding liabilities of broad-spectrum pharmacologic Next candidates modulation. the receptor of by schizophrenia. efficacy associated let’s weight the design XXXX antipsychotic turn novel, opioid olanzapine’s of and provide a to XXXX, the for oral, treatment olanzapine

Enlighten-X, focus development placebo agents XXXX. successfully of relative pivotal of with and a development This the of We’re olanzapine. and evidence to very to program, properties the hand the the ALKS a clear pleased antipsychotic remaining in milestone shifts positive first said active metabolic both the outcome. With study, efficacy complete XXXX and to the was as to now in compared an program efficacy critical weight safety provides which that

deepen We mechanism ALKS the to XXXX profile evaluating action recently dose compared study volunteers lipids. Phase day XX traditional of of assessments understanding medicine to impacts and continuing semi are insulin induced XX We medicine the from completed olanzapine X of this of the and way have our across changes. of glucose, new including to Olanzapine healthy and number metabolic metabolic a

consistent stage analysis have the and preclinical but findings. we data is the work received Our at our data already of an a are early suggest of number with important initial

causes induce the drug First, Olanzapine changes. use weight and metabolic acute of

the our gain second next to quarter. Phase These are a lipid number to believe still findings in abnormalities be observed ALKS We Enlighten-X metabolism to for sets recapitulate we've of over the data to metabolic analysis study of XXXX registration olanzapine studies. data our Enlighten-X findings very of weight Secondly, later to that of expect going from And outside trial mechanistic III we on preclinical is months. forward this pivotal ongoing important completed we six program, XXXX. look understanding house receive is related in and in XXXX in these parameters. additional [indiscernible] informative ALKS the study the compared ALKS these advance. work mechanistic One I this our of mitigates data of the foundation what Well, this set, to comprehensive of our that study set is assessing continues year. this presenting of

profile reveal metabolic stages will itself the the it the year and way XXX top continue program. expected complete track has of favorable on development clinical that final we to XXXX. believe patients in of as next to We line ALKS this that XXXX are enter outset we from data of enrollments the We to the designed study with fall early

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months is three important majority additional to first TECFIDERA. clinically of will data, alternative. the provide The GI quite insights tomorrow will discontinuations are These treatment provide due patients the potential as be with MS XXXX morning, suffering important an this when treatment from into ALKS the tolerability with of which occur community with available to

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for half to at inform studies package XXX to safety competed submit number registration. one in and registration we for year. of requirements competing We're the on standard NDA second the next the patients of needed quarter, the During of we third remain year exposure the track a

you with affinity provide IL-X. XXXX compared activate on selectively and intermediate immunooncology is ALKS potentially update designed tumor high of to the killing to well our This candidate interesting increase number program. on also tolerability an immune novel our as IL-X cells, developments improve as receptors Lastly, I'll the dose

patients We've of escalation CDX expansion initial stage clinical are pharmacodynamic have trial dependent optimal first-in-human Data encouraging cells and demonstrated effect from the on To tumors XXXX, dose are of XXXX’s assisting evidence data looking the have and and date, four enrolled. and circulating pharmacological non-dose advanced dose to regulatory with now dose to solid dose-dependent underway patients of XX are of Our in provide effects markers is cohorts confirming biological achieve T completed with we in sum doses into ALKS for effect sometime. programs. on dissipated activity. T identify escalating minimal biologically has pharmacodynamic been of of doses. safety and The cells to clearly the the four advance ALKS those cells. been the immunosuppressive cohorts natural and killer range active This in first we

for the at preclinical from present escalation dose time results present to XXXX model complete Cancer the will in preclinical the a the xenograft early on of ALKS Brian Gastman meeting at Clinic, interesting, of month expect In Meeting, a We Immunotherapy XXXX. the Society next new Cleveland melanoma. data medical in mean Dr. collaborator

will this be will Importantly presentation first to disclose the be the tumor – made in effects microenvironment. ALKS XXXX

clinic We’re evidence profile build the months. in program the supporting XXXX advancing of coming look of the forward in to continuing the and unique to we this body

today’s that So is update.

development have robust medicines summarize at here reflects very clinically commitment a potential in a To and each their the solutions. developing underway these patient-centered advance to Alkermes disease provide medical meaningful have We areas to of Alkermes. program

part this that candidates I’m turn progress Richard. and time. portfolio be We’re of exciting call our back the of to With making organization delighted to across I top-line important will this at

Richard Pops

will That’s saying programs the the We’ll careful will regulatory XXXX, program a company launch pivotal half. the report during enter XXXX can great. the from study simply data quickly complete significant and second Thank six-month with of advancing you a milestones. the week to transformative review expect Craig. perhaps XXXX And phase year finish be that are I’ll development and our by for you, clinical that with see

for create ahead. we program. and for to the data to report submit Each to expect development and year And these advance proof-of-concept and gearing intensive, of parent the exciting up XXXX, an we're plan NDA. potential we For XXXX, value significant active has and

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

Sandra Coombs

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

Operator

go question-and-answer Instructions] Please the From Cory We'll ahead. we session. have now Kasimov, JPMorgan, begin [Operator

Cory Kasimov

guys. morning for on good Hey, ARISTADA. on one the and VIVITROL have taking questions. Thanks I one

of on in guess expect what JAMA and on the be the I study versus buprenorphine product you a head follow-up head impact then recent to So first one the of published on your ARISTADA. curious VIVITROL, to

Richard Pops

showed Good ask to any of to at head was that compared on last place VIVITROL first study of Craig saying SUBOXONE. in you’ve morning, study the quite notes Cory. some end will past craving treatment head the importantly, and Richard. was point what things It's But particularly really other to we’ve that mentioned But observers view efficacy of day And related disease. as approaches have us week gold I'll then were very Psychiatry that the the they’re for noticed be is it satisfaction we treatment SUBOXONE. to it. diametrically I the a said, it JAMA these take head that to opposite to this of heard published this to because in – considered high. what’s medicine was head to that the VIVITROL standard other comparisons treating commentators on in patient because positive With equivalent the

think – a regular in it’s from VIVITROL medicine. have substantial third-parties piece I showing that any wall, was thoughts? brick Craig, study another So another do you in another evidence the mainstay of

Craig Hopkinson

think that the that that profile seen importantly would I add Yes, is I this efficacy well with I what established to mean we’ve VIVITROL. adds to Rich already

conducted company. of was that the independently So a is study this

that and that’s note to an one think the medication is important get And use because also going demonstrates an me And from therapies medications bodes fundamentally the every that patients But And I is there the opioid that it’s treatment disorder. evidence important be patients approved for tycoons approach think is access and most I the to single that of the all for FDA point. all on these think they of individualized for to it of that’s underutilized. in are suffering space, roughly I foundation being no patients assisted important a is importance so, patients really important.

addresses of I later study see And so, this those further questions we'll data and many this think year. emerge

Cory Kasimov

on Is show Okay, ARISTADA the study to I to to XXX this everyone would trial. approve with And it really this designed with to SUSTENNA you IIIb treatment. a patients hoping you what the follow-up be it’s given regards great. long an demonstrate that believe active then you non-inferiority with to INVEGA will ARISTADA going and announced how are expect and on Phase

Richard Pops

on So – that just as background. again I'll Cory, I'll one start

INVEGA those flexibility of who the the U.S. it’s initiation. long-acting So features call, always and about the you use in billion don’t in terms its SUSTENNA It in had injectable and product of to growing the has is and of follow $X.X most the – rapidly. preeminent drug It’s doses durations ease

clinic. and So of that we of the in the made terms that use announcements leveled initiation with with plain in the I think the the our field dose six features today, we’ve four week, ease week, two month

can the earlier INVEGA in has have TRINZA for medicines. most satisfaction remarks mentioned oral in viewed always extremely disease setting been particularly establish This healthcare a in community this risk the directly strong. is from that’s which treatment is we coverage with in fight a initiation that study we the around my SUSTENNA on our presented the product I easy story really will as a ARISTADA that initiation clinical and the from dose relevant our not efficacy in to demonstrates us a ARISTADA we of patients with has a patients community, community. offering. the are in efficacious system discharge had who strong provide And always this two data the that with What September think is I showed adequate a the then excellent control months the getting i.e., that of period for in and of manifestly hospital

these of for head is head to to exclusive both real versus world efficacy community real in So our life SUSTENNA the directly setting in patients. it’s a applicable demonstration an that of

Craig? So

Craig Hopkinson

Yes, Richard I absolutely just concur said. what

important incredibly study. is this think I

a be of regimen the in schizophrenia think really big both care We with studying. dosage cover the in questions time data of INVEGA is that is provide two-month patient SUSTENNA. six hospital months initiation transitioning basically to the two extended provides also to a community answer will but into important for of is I the relapse the one lot easy of from ill our period treatment a regime group the study an and on will new initiation challenges aspect and This administration us particular that this and acutely combination adherence comparison same so both ARISTADA. to actually population in believe up a in and and the

and important it’s believe an study us I overall important study incredibly So to. commit for to

Richard Pops

ready do, we timing, say give I’m weeks curve guidance momentum then and fast of will builds, once the can how the let’s see from Cory we study you will it like we we’ll launch project get not how the in the underway. couple to we and always the And on next enroll,

Cory Kasimov

for Okay, back the understood. queue. in questions. I’ll hop Thanks taking

Richard Pops

Cory. Thanks

Operator

From Credit ahead. have we Please go Vamil Suisse Divan.

Vamil Divan

for Hi, great. Thanks taking question. my

of So charge made one a lowered X% you the million in that terms of comments but just $X you there’s XQ. on VIVITROL, of think I one-time product I progress just the the current appreciate sort growth mentioned if sequential

yourselves for you state. a So this I key some what take get Maybe of wanted inventory of growth for your impact. just mentioned lower quantify you quarter could sense to dynamics that, in if the channel larger

changing forward. then Thanks. changed of it the there after are on anything impact the few And you impact is but outlook doesn’t that. your sort one maybe next sound have there quarters I what could like Just long-term to follow-up trajectory, that going just

Richard Pops

thanks to expect the fluctuations good it’s those. the as morning. see quarter-to-quarter past. important Yes, to in There seen to some time we've VIVITROL as well think are we Vamil, and I Sure, continue over look think I

balance saw we year. So this lead really for XX% of projections the quarter our the year-over-year you this that’s would what growth

And county year. But the we the XX% among can is an down growth so states. talked the in we’ve And a stage started looking product. differences by a we’re really, there there a slightly be is by little beginning from at just and year-over-year different, about stage of where lot literally basis on ecosystems every the stage unusual is VIVITROL county

states. systematic. in there when anything issues our is of at see a looked But affecting growth quarter, didn’t variability that this a some we So largest were few we

instance delay change payments in vendors, the the for in cause and a was throughout Colorado state. reimbursement, to related them of in there Medicaid Some payment disruption the which a

that So year. funding Ohio, were There XXX% than growth growth. we affected more saw some In delays. last

a transition delayed, so start programs was growth XXX% core versus delayed VIVITROL last slowed XX% this year until in a for if drug when a to that practice Some to XXXX. quickly, moves write were GL Ohio are of ones key in always the built September, state you it until very provider there but wide program to using it the new different prescriptions some the is it that retires And time overall And leads, then be year. up. over prescriber individual takes causes drop a

quarter-by-quarter, predict about VIVITROL to very fluctuate growth for very then the earlier in are long-term short-term, and the going reasons sales the in so confident continue we're we've well to today concentrated. target in VIVITROL. So you Its but the know outlined

Vamil Divan

understand filing. – just All I give a I this one-time like startup on want NanoCrystal follow means to dose looks just it dispersion had also in because treatment. the the you that Okay. right, up that on and ARISTADA

resource opposite you patients position to to of this – get then be in it's time. and samples stock commercially, a prescription start something when how instructed get you understand is trying just that work So supplying at what if for product that then needed that to just or and that

Richard Pops

the for continue a three quickly new be absolutely the offering. doing But up hospital an is in that’s orally to we’ve injection And offering. they a get want problem, been this initiate product fear taking is what this new might medication without will who important weeks any Yes, people It’s not a – in point. certain or adherence patients to embodiment. there months the commercial be until aripiprazole who where three all is oral this the

Vamil Divan

Okay All right. Thanks.

Richard Pops

You’re welcome.

Operator

From Jefferies have Amin. we go Biren ahead. Please

Biren Amin

Yes, you ARISTADA, market your just think aripiprazole on compared thanks my year XX% Maybe guys share XX% to for a said taking ago. question. I is

would is you you achieve aripiprazole So this the And a when to expected would trajectory this achieve majority market. I guess, you an hope that in share point. thought at

Richard Pops

of the doubling. as of reiterated say idea that the on. the at very year the this sales I’ll we’ve guided track beginning year we’re And that’s to Jim

that product of this all is would knowing year that the have beginning built it’s didn’t to we we know out as what family? expected. also we So how proceeding the at you But And expected knew this we year-by-year is transition study a foundation building sustaining was support with dose what coming we’re we stronger more and from the what to doing, were forward. we we’re doing initiation stronger go knowing a and growth as

So ambition XX%, going we're and that��s it. cross to our I do know hard we’re when but at

Biren Amin

you the know ARISTADA, the original the we traction early, formulation seeing but for more that to what formulation? guys out pretty traction And compared are are good extended then for I there. seeing on it’s with formulation just

Richard Pops

Yes.

on head I grow to talk particularly we're going probably transition the But used. in or about I across nicely. of months, started never if where was – people at to really dose again, dramatic. into broadest to the the care move based say two-month its care that [indiscernible] be, people the when are think study in as expectations. most going losses is we really, our hospital be on launched taking important. the never the we It's can the a a schizophrenics community we're and outpatient seeing when all would get two of in are programs And LAIs transition frankly daily basis

the hospital of that two on going months So factor it’s is therapy that’s still is be month the the use this potentially good not going across very earlier because to initiating six with an think medicine. of which LAI’s be under we’re with we long-term improve to what class important to studying in

the and that So we months this the will and be two initial focused both on year. coming

exciting at for growth we them, prospect they’re people about franchise going unveiled this us, forward. pretty that’s and Now as look both a know

Biren Amin

you mentioned on because And And prescribe driver does the VIVITROL would those think JAMA. head-to-head SUBOXONE. of be published I trails, how that bigger then compare of trial as European the percentage couple design of and prescribers for the versus X:BOT what just expect that by lack things a to VIVITROL don’t apparently of study the Richard, you a do

Richard Pops

XEPLION, So study the sense study that the I design, detoxification go in it’s before to detoxification. remember settled the through patients randomized it’s European SUBOXONE. critical, recall The head-to-head different distinction, of study the but NIDA-funded versus study sounds were mean, who people rather on than like that that because study And in VIVITROL the the quite only after detoxification. go a than wanted that XEPLION to Vivitrol need the was

So drop lot if you buprenorphine. get randomized with have detox people study get arm, actually of were before and could the out in that happens, on to a you

you the and disagreement just with JAMA paper study Psychiatry, design out registered with tandem we’ve see it’s there. That in well-known So think our that’s – said, like I Vivitrol. the Vivitrol

So study And what the month to and what happen to that the which in want with get patient prevented injection be expect in the we levels opiod earlier fine. this will TAM just high we every in thing Vivitrol dependents. your last of underscored reduction craving of was from saw who is Vivitrol perform XEPLION Patients still patients. is is for and world satisfaction their there real important treatment will

add treatment, evidence to Craig, think one data about right want limitations do detox, studies all look had? building will medicines, an bigger you’re its requires particular for one of design but it really do the base we're in has own but patient as the is – important more one forward doesn’t, just comparing reflective an general. use we you any one I said different is So first antagonist, fundamentally in I a the MAT the it’s their these form the is because and you agonist, totally – wants data, to two seeing color of is of each to

Craig Hopkinson

I with I said. completely No. mean what agree has Richard

are I are challenges think that fundamentally faced different. we these the medicines really

meets – one that design all. the so of And requirements trial

regimen the think VIVITROL. for was well his controlled of studying had way very a the I effects where approached ideal that tandem we study standardized detoxification

– allows for detoxification X:BOT designed the in in this patients study standard been study use the – each late. be I way study practice would some to and that really think of slides has the enrolled early the

add And going And the both both that I value here think so important studies of medication to assisted reason. aspect think important of is for therapies. are to that the understanding I

Operator

Chris Shibutani. From ahead. Cowen go Please we have

Chris Shibutani

Yes. very much. Thank you

providers follow-up number providers, include have Some those you’ve kind of care used. another any of treatment of past drivers of questions any key underlying seeing the trends taking the on on such things Can is the to number as of question. patients comment you duration then fundamental of VIVITROL. drivers In and upon of you’re treatment described the each the I

Richard Pops

line with historically. Hi seen that Chris, say we've morning. are trends what good I would those in much very

users market because our in in and on well. the fits number say number of group providers For The expectations touch Biren’s that long-term, of so about of growth Right, XX% prescribers to the to expanding would instance is have we ways another just I quite compared if low. triangulate – is expanding. we prescribers of number that's VIVITROL the X%. of a back as share for one question still that the below buprenorphine providers in the is at

is part and data our standard So – as discussed. out, because looking treatment grow to we've across of care as we areas, more of base VIVITROL comes the should more provider the expect be part

and as growing those when So still continue very on are that we'll key you VIVITROL and the if to nicely on update metrics changes.

Chris Shibutani

contributed what component going not a third variability there is the know taking expected far private be seeing trends the continues as treatment broadly as results portion, actually than and any Medicaid you. to that addiction VIVITROL but weaker past of terms you revenues of are there in the fourth are population sub-groups for in perhaps And the you of insurance quarter. us of are have in then there the you VIVITROL who contributing non-Medicaid it’s and you a on lowering the alcohol group. on Thank populations looking quarter lastly to that of the then significant in of growth characterized some your terms to And patient was units that obviously the Can speaking what update compared guidance. I

Craig Hopkinson

and utility it alcohol safety that we us. would people That’s say the and has that the Yes. on is high. of VIVITROL We for of total is usage in consistent recognize potential I the again order, VIVITROL. reverse growth an maybe been in think that quite I patient satisfaction actually think area understand as VIVITROL of where growth see range XX% again

for So us. that’s a potential area future growth

as question, this. of – part I first your again the on me we think sorry, look at remind

Chris Shibutani

versus medicate patient The non-medicate.

Richard Pops

sorry. Well, patient medicate, sure,

Chris Shibutani

on Add sorry. that,

Richard Pops

medicate stable the remained have as of are growth our in roughly and the for gross-to-net the coming medicate patients to the so has commercial side. side Right, XX%

so, months But we for seen state two we by this would really down of slowdown nature the really trajectories a quarter the VIVITROL. I brining for Again, growth one say difference basis there’s because are a long-term is don’t in the real have prospects only state a in year. either. VIVITROL because of guidance those left, And idiosyncratic a on where the we haven’t and our changes market this bit

Operator

we Paul Partners, have Leerink Matteis, From please ahead. go

Paul Matteis

how much. so Thanks wondering questions. clarify should was belabor of Jim the long-term help VIVITROL, to couple if I A point growth could considering be curve. you we us but Great. Not the on kind

it a it So its, growth it’s like was And new year I like in XX%. year-over-year XX%, XX%, think the five-year is about year-over-year. CAGR with year about was last XXXX XX% looks guidance this something

of just are the years. a have or wondering growth trends couple is three four you of I then and follow-ups. a what next And quick thinking if So for of reflects kind decelerating sort that

Richard Pops

you, hit Paul. Thank think you know I growth numbers right. the Yes. I

Our guidance XX% does at look growth.

is very it’s expectations I on short-term. expectations is, difficult VIVITROL we've things you what done based we’ve we've think about most recent given one seen. consistently that of growth the predict And the in always guidance to said

in had say that which excitement our is deceleration what would current all. in and are for adjusted more X:BOT a we it. product I isn't what So unequivocally out, ALKS changed broader the why own our coming study, solving appreciation slight seen that not crisis prospects coming backdrop Tanum at this this growth a field growth coming now do our that the and importance We XXXX about program, of out of with the against study our long-term VIVITROL can the – data opioid and its again but we're this doing guidance, data

growth, the as bar I quarter, been for but VIVITROL slight But in the right as growth has a the I the that this in opportunities quarter-by-quarter a through past. be We in and to of year. just take today slow rest at cautious we the view too see year say, into either, the would think next bullishly deceleration look quarter long-term make the slides provided that a we have not you're we also things progress and let's of the growth with quarterly to charts. how much have

Paul Matteis

if look just just enough. the Fair cover. was okay. at I Jim. X:BOT know all. was to I And addiction documents the you then there. any you at recently attorney know in follow-ups, quick Thanks, Thank a will you there know and can couple study you that is quick study if And subpoena there I any wondering can Okay, talk the maybe about then is was you I murphy published, perspective tandem think the provide so cost it in had update if provide. VIVITROL U.S. related on for effectiveness. update the any you from I regarding much. regarding VIVITROL that XX-Q XQ disclose

Richard Pops

my it effectiveness an paper actually might overall view, what I actually the cost paper it read summary have doesn’t the the – says. doesn’t paper of in get to you The study. I that whole reflect Yes. take think which understanding to

standard generally The than practice. on other patients that patients is broader account you on seen have into thing sticker and I think VIVITROL to that now we've seen others keep have their are much

think that on on overall at – patients of patients just other point So one often are than But sense. patients next in coming and of that the VIVITROL have the that’s more you’ll standard data pool many again see make looked out co-occurring if – disorders year. that a I

to system, very think state jails, these to medicate also criminal addicted I count frankly programs economic growth success the – state you the and value wouldn’t these someone in that state having programs seeing those of aren’t the also, Paul, and we And see no providers have if hard success. So courts expanding longer we if opioids. justice drug it’s

way get member, at would look long-term. opioid But your more that’s rather in benefits think it utilization than ask value somebody someone we’re but jobs. work just the continuing dependence. lot employment, free a now their care just that at aren't lot you addiction, terms some a the family in and is good have what like cost and a of this added it's We really of of say, of also right can there having of don’t opioid I You very look free something health for model than that into on that historically their to of just in to quantifying I to terms have models

Operator

have we Douglas Tsao, please ahead. go From Barclays,

Douglas Tsao

questions. Hi, good for taking morning. Thanks the

applied of expectation. the base a bit [indiscernible]. little your context in we some Can terms the guidance, as concentrated how then topline for of doc terms in follow-up Just prescribers position is. a of for reduction in you And had obviously just

the basically cost was guidance So maintained.

how curious thinking margins of be just gross sort leverage operating about of terms forward. we Thank you. moving So and in should

Richard Pops

Yes.

think of In we’ve terms about for and I obviously buprenorphine of that the prescriber for I mean concentration, the talked between the VIVITROL. difference number prescribers

think some gave XX% growing our on I as last at prescriber base detail I is year Analyst that mentioned We our around year-over-year. Day.

are and data So driven knowledge specialty X,XXX prescribers. that’s we being terribly think medication prescriptions from out of other you different that’s continue to and of there XX% the don’t roughly on say as by I broaden VIVITROL. the roughly

I that think grow. we expect provider to base

sense, year. revenue we're because down. as made that think million roughly of well doing adjustment the that the of of And the just brought terms margins range, range In quite I this $XX we

on You change simply the didn’t of have cost goods to percentage sold.

Douglas Tsao

Okay.

Operator

question for have ISI, one go Evercore ahead. more time We we Please Raffat. from Umer have

Umer Raffat

much Thank ALKS my on question. on couple so VIVITROL ALKS taking wanted ask on a one and may. guys. I XXXX, XXXX, to Hi, you for one I if

on VIVITROL just know just thing states, new growth new X.X% flushing I’m the ALKS but on year. a curious about you’re data how curious, run well read A, anti-tumor mind that But I on XX% activity Sorry in you ongoing curious relapse VIVITROL first if I of commented maybe this also of monthly particular the preliminary event XXXX what other because rollout data lot in Alkermes, worth for the finally to looks activity rate guess activation well? kind label the questions. are or on noticed you know the anti-tumor ALKS And in what’s thinking just about GI you. is GI new the your you’ve comparable, on as going the but either in XX%, I’m order, then the how we as XXXX show think funding, just of at is the So in. growth discontinuations, so And Richard, rate next – past first too. on rate. couple month this consensus has open it think XXXX, potentially T-cell ECTRIMS the just about over comp has on presentations the a that efficacy any trial? do as I over – you your then stable buprenorphine about the on the no tracking we ask it AEs think near-term, I How the TECFIDERA, to Thank What’s next ALKS number serious And On is GI, but next year-to-year, years? one. coming you choppiness you and growth about do of understand

Richard Pops

good I’ll all questions. that’s No, – are all. them and excellent answer those remember to them try

XX,XXX about is to going introducing you first understand would deal combination is product product physician community, so huge to of tectonic going going Later dependent unusual things statement to to think how or put new just to in pharmaceutical a an do an that classic the the week the is and die. on Because defensive one announce growth going but November also of today, the what about market. of the a that, are these really the policy. then public of because epidemic such for, next commission present, to I with response VIVITROL don’t to and President report things to is it’s do their upon ask, the change of it plates week the administration about this a where I is okay, So Christie we’re fact to unusual this people this, – how going in

X% cone face in growth of is of share VIVITROL of – the So because almost market broad. incredibly with it’s possibilities express in really a national way, I hate over And in terms to it it under what being unknown the the epidemic. a that for went responding a And peripheral the a data and medicine this the in underscoring TanDEM that’s addressing in this country. medicine effect tragedy X:BOT data are the increasingly main to complete from becoming of It to happening just stage epidemic VIVITROL.

capacity beyond. production XXXX more building we're So for and

need strongly gets it. really sure patients, are the this We committed medicine really who making to to

numeric So we it it's really hard to wine put growth just divine swing in so said. Jim, on often

more share of to slowly because there's supported this go say positive patients. a a we and to we're with potential we there's and quarters, information, that value of where data. it's and new we recognizing here, the quite and in get from for going quite being we're here The and the optimistic we incredibly retired it’s by guide next that data medicine ahead. the about more you are committed to lot it, is next guys are we're As But about so medicine critics who of super whole period the outcomes increasingly transparent important,

seen one expanded has period, see let And systemic flushing you decide, the data of and – what because that That's this type branded use On VIVITROL. going you’ll access I’ll the flushing, – doctors pharmacies it itself more that’s And you believe same injectable to is in specialty market is flushing think that’s the will the bup, of the from we we that in it on We're systemic three-month ALKS the systemic on XXXX, doing. positive. monitor more yourself. effect the – salutary active for the put predicted important of we important, patients MMS and doing paradigm medicalization a outside treatment GI. of which the think we’ve quite for show acting those the and a monthly give see piece the color, is be and the TECFIDERA basis. so side trained to medicines. AE on because the are I is I can of Craig comps and it’s any on necessary The MMS, equivalent the medicines was that think long you exactly injections we'll this are but speaks side thing

to is So on the the product designed for we various a the side, think in into that question. side, but I And got answer efficacy data reasons study. open-label action the the terms don’t where on data, we that, of we’re not luminal going provide to we the know I’ll GI let don’t Craig the actually molecule. to obviously efficacy tomorrow – an differentiated any safety physicochemically from

Craig Hopkinson

Yes.

see said, and to GI below are add to Richard perspective. they data would expect tomorrow well you from already think We will incredibly just differentiated what think what presented we to So with do I that has a think impressive TECFIDERA. I are the see

data, sinusoidal long-term data those be able speak comment will those it's be to – And collecting we know MRI well that. you presenting the relapse will of able to as to be on data as terms In us mature, we're on and and premature as still the for today.

Richard Pops

models On work XXXX of the microenvironment. at in the – on infiltrated looking XXXX, preclinical tumor presentation on effective

So story confuse vivo. the XXXX what – the data complete its will make in as – just sure, to history come that didn’t I that we won’t human want human about later medicine you another cohort. that just in of piece be the data escalation

Umer Raffat

you. Thank

Richard Pops

You��re welcome.

Operator

turn closing. Sandy for back it I’ll to

Sandra Coombs

hesitate for today. or Great. questions. company us you call us joining further to don't the the Please have to Thanks if out on everyone reach

Operator

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

You now disconnect. may

Alkermes (ALKS) 26 Oct 172017 Q3 Earnings call transcript