ALKS - Earnings call transcript Q1 2018

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Operator

Good morning and welcome to the Alkermes First Quarter 2018 Financial Results. My name is Brandon 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. Please note this conference is being recorded. turn to now of Coombs, will Relations. Investor I it Sandy over Co-Head And begin. may you Sandy,

Sandra Coombs

Good the ended Welcome our and financial With morning. Jim to today CEO; results discuss call me CFO. President for our Jim to Frates, Robinson, the and Richard our quarter are March our XXXX. Alkermes XX, Pops, Plc COO; conference

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

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

Now, I'll Richard. the turn over call to

Richard F. Pops

like we everybody. doing morning, been frequently calls Good Sandy. have. lately, these we've it's you, it more If seems because Thank

by about the program in do surrounding I'll start the last the we commercial all some a ALKS think progress discussion broader results XXXX additional over for the I weeks. portfolio, the to made I'll being developments the providing the context quarter and across what get few So, before

all week know, filing developing January XXXX. regulatory for review we're January the PDUFA on accepted the of and of date XXXX announced last adjunctive FDA we based you had XX, underway treatment a disorder, date with original and NDA As that our in major depressive is our

Our will The be has rigorous appropriate complete support without review raised would with of of direction. application, has designs, bias been data been FDA the our and There study is and forward outset This and analyses those and belief review look we new profile expected during on interactions. comprehensive process and benefit-risk either agency. profile including XXXX the the to XXXX the review a believe supporting scientific rigor on efficacy, We our and important in things. proceed will that application of that for provide set questions patients. and the medication an other from safety, the within approval the

years. Internally, no depression arrived in our is confidence clinical in package is to deserve care and program the disorder and patients more than professionals a depressive an unanticipated with and Patients than address serious new couldn't challenge. people outcome team. trials the development Our approaches generated health to foundation coalesced the be have Major there and treatment of than at the more MDD. more options. the and proud and of desired been condition of FDA-approved I clinical on more new XX pharmacologic data unwavering of it's based the XX from X,XXX data We activated XXXX

operations for as new Chief He who to contributions President March President industry leading Jim important where and we in experience Americas he valuable from the before rest us we already build our like and as joined in successful establishing Operating introduce extensive get the to leadership for Astellas, will I'd and North organizations. comes financials South and our the So, his made and organization commercial the served pipeline in Robinson, knowledge, global to brings of quarter, as proven insights Jim of America. Alkermes the He's particular job on managing portfolio. to his the with be strategic our and operations, continue first assets pharmaceutical experience to two months commercial Officer.

perspectives Jim it introduce to have I'm and over to to turn to share delighted happy commercial we're and Go him portfolio. ahead. I'll to you his So, on on him the now board

James Robinson

drawn company's Thank very you, be very this I'm joining at time I reasons. role Good was to for happy to two Richard. evolution. the morning, Alkermes specific exciting of everyone. this

people the these is the disease is first us, the address to patients opportunity The in needs areas in second is major that the realize of of important at leadership front of unmet the and team our value and Alkermes, to the of the and long-term and magnitude medicines.

expanding One on for as well as nimble commercial adapt of pipeline. opportunities to be our of and market real-time effectiveness. a and a VIVITROL top continued efficiency my priorities focus we commercial With is and deep drive pool both to based environments. on the organization positioned the talent, within Alkermes changing to organization building ARISTADA late-stage are is uniquely

Net sequentially role epidemic. driven play $XX.X nation's first the decline let's the So, has we of VIVITROL. (sic) unique did It's opioid growth million, QX over in [underlying] during product as important underlining guided February. in with start the a sales XX% sales that year-over-year. (X:XX) VIVITROL were of to by quarter an addressing

However, expectations. they with our are in line

that challenging into career, my innovation. opportunity about months track we're a four is markets year, for with on market believe only our we challenging provide XXXX. in an for but we're growth encountered expectations just While market I've the as VIVITROL's

and and to been the where and of amount the Congress activity funding promote increasing drive opioid the VIVITROL and additional months, access areas in growth. treatment data continue as to into And increase in there opportunities significant remove community obstacles to new also utilization and in expanding been to to focus VIVITROL new Specific developments, seamless legislation with primary epidemic. additional patients policy we've funding Our clinical we address broad provide expand for a areas has both to and the of with is recent policy, in we're successful. engage and

One our funding closely distribution the to primarily with to QX priorities of from the the growth strong. court our in to growth leading expand state we drug remains criminal treatment by XXX reported authorities highest of state timely in justice driven VIVITROL Since programs re-entry and local seen the to is Expansion systems. of indicator various we've encourage federal of work in number results programs, XXX roughly is programs a and programs. February, that

the lives of for ahead impact I value. the and drive optimistic about opportunity So, to am VIVITROL, look patients I

a a significant line now market years differentiated So, driver turning has to expectations. was product, In a million, to growing come. ARISTADA, which to QX, potential many $XX.X recorded in for the growth with net with we of in ARISTADA sales be

among our XX, dose, increase to our ARISTADA's without in we is treatment. further new launch on ARISTADA of This in in hospital upcoming of Operationally, the gain approximately in This initiation simple launch three is exciting strategy of to growth patients last that in compared is this the the and enable of ARISTADA's family. address where of a part traction market into executing approval to ARISTADA in antipsychotic XX% those further to ARISTADA to continue With long-acting first prescriber product expand ARISTADA's third new depth for needs the aripiprazole of We in weeks the which XX.X% and driven market supplementation. oral prescriptions months XX% product of unmet was This is of share year. designed allow and prescribers. need in was market. the of growing opportunity long-acting March are increase formulation June breadth new quarter. will initiation setting, on base date the utilization potential us an therapy PDUFA to volume and track two-month it terms for start a the of of patient estimated the March product grow by

effectively approval against XX that representatives of planned, deployed we hire opportunity. expected this As will the ensure sales we hospital-based to are ahead

a have to lot do this we So, year.

to the to I'll We With on focused commercial growth look execution over the you. our Jim our Frates. turn with that, strategy forward sharing I are now call and of progress

James M. Frates

Good Thank everyone. Jim. you, morning,

During business, as manufacturing reflected products solid proprietary the the our growth royalty results expense as -our base our and the of disciplined and year-over-year our well management. first continued quarter, strength of

than primarily impacts two which compensation. into force, is XXXX. ALKS of expenses expectations late shift XXXX financial XXXX. the With PDUFA of share-based rather cash certain this updating ALKS timing the in two anticipated items, and NDA These now move the XXXX today to date reflect the Financially, noncash accepted, a sales expense, action now hiring XXXX January by regulatory we're our the will the

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

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

a million non-GAAP approximately revenues In During X%. million sales the generated we net $XX.X growth of million quarter, $XX.X net last demonstrating recorded $XX.X for of VIVITROL compared loss. the the of had first million quarter, period same to year, total $XXX.X and

the QX underlying growth percentage XX% in quarter adjustments in was the approximately of XX% XXXX, growth approximately unit As increase masked during to higher from volume. Jim unit This net mentioned, a driven at stronger was by primarily by our XX%. to Medicaid gross

the of Medicaid expect XXXX quarter net may the to growth there for adjustments business. XX% variability from to While some to gross we approximately quarter, to be be due continued

the The quarter first range growth As the of the of from deductible throughout levels net $XXX inventory for the are the commercial the commercial million we've happened reiterating accelerate resets reset in net of and build insurance us, inventory beginning current the sales XXXX. the during VIVITROL the of behind million fourth quarter. we're $X we to year at during deductible our quarter. sequentially, by past, our of first impacted expectations and plan down was VIVITROL for $XXX fourth million expect that sales seen quarter at plans be approximately With in in worked down XXXX in to preceding the and largely build inventory year to channel

million to of range first in growth and we approximately year approximately ARISTADA and ARISTADA year. we're $XXX XX% the to million Today, expectations reiterating the were we $XX.X the modest XXXX. net an for prior the $XXX saw in this same in XX% sales the adjustments Gross million in period Turning for to quarter, number of slightly go our throughout to net of sequentially. for to increase up quarter ARISTADA, expect of sales net compared the will XX%

million CONSTA, to compared to products, INVEGA to royalty compared of included SUSTENNA year. $XX to $XXX.X quarter, This revenues the in revenues our manufacturing and saw the year. first overall last million relating of million million quarter TRINZA, partner same period RISPERDAL for we INVEGA first $XX.X last on Moving of key and in $XXX.X the

for $XX.X quarter of during in quarter, compared the million reimbursement revenues of AMPYRA and for last period same generic the in orders $XX manufacturing lower. of we royalty million Biogen expectations expenses development FAMPYRA, recorded Today, Due For revenues million $XX.X for our BIIBXXX. we FAMPYRA R&D expect AMPYRA XXXX. of XXXX, for our we're to also manufacturing quarter, our In second AMPYRA and to year. and of to reiterating to million competition $XX we collaboration substantially revenues related the recognized be range $XX.X revenue first timing to from first the July expected with the be million and the to

BIIBXXX activity We R&D consistent throughout of level around expect XXXX. a

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

our Let me now financial turn updated expectations. to

a be million. $XXX reflecting of range SG&A the of expect million, to $XX million decrease to in We spend $XXX

of hiring earlier, expected outcome will we XXXX fourth mentioned of quarter shift the the of XXXX a Advisory force I in Committee As sales await into potential ALKS the as meeting XXXX.

$XXX make continue the million. in and loss infrastructure in GAAP million support manufacturing necessary potential improvement to ALKS in range commercial result $XX $XXX a net launches and the in a initiation the We ARISTADA to both XXXX. of investments to changes expectations of our million product SG&A will to These

FDA our in expense compensation XXXX, upon share-based company-wide share-based certain approximately Our $XXX million ALKS stock be We a to related approval compensation updated expect expectations of reduction also vest expected XXXX. million in of awards reflect performance XXXX. to $XX that the now for timing would

a these together QX, with an we of adjustments non-GAAP a to changes $XX non-GAAP non-GAAP million expectations Taken to in million. improvement non-GAAP to net million in result the a income loss of our recorded of of that $XX $XX range net

investments approximately by end with The of our during the of working changes in the our operating and we're to results, compared and at was in Turning quarter the total capital sheet, cash XXXX balance to driven expenditures. and approximately ended primarily in $XXX million cash first change XXXX. well-positioned capital million quarter $XXX

completed our of a the debt our refinancing, During XX the in extending outstanding term also maturity and March was by XXXX lowering company's debt total million from points $XXX The loan quarter we interest basis to rate XX. XXXX.

building are investing to executing value in forward a pipeline. and over position, diverse in the ARISTADA shareholders. turn the growth focused strong grow. base to revenues potential commercial for preparing solid plan deep to these ALKS ARISTADA, royalty our by call a of medicines This With We're driven I'll business our initiation We the and pipeline of VIVITROL we're year, and financial development Richard. bringing our and well-positioned important manufacturing XXXX. With late-stage pipeline, we're on that, for look launches our focused on and back to and product in a on patients and and business

Richard F. Pops

you, Thank great. That's Jim.

XXXX's chronic. for revealing our parallel and the receive for designed effects to antipsychotic in olanzapine metabolic that finish on ENLIGHTEN-X, efficacy ALKS powerful head-to-head and a acute and to other a to morning, top prepared So, share we some III adverse evaluating overview metabolic schizophrenia. did in submission XXXX. addressing for profile. activity its announced treatment and antipsychotic mitigating gain financial the plan completion differentiated the and to new the six-month atypical of and a keeps weight submission associated to of our ALKS This enrollment include of weight from you particularly provide ready Phase in an the in study this line action antipsychotic giving peer-reviewed program, our on We us timing second development in webcast. clinical our spectrum be presentation may study, olanzapine's been the for we'll are research of positive, of findings distinct clinical patients track This gain receiving or XXXX of This educational the pipeline study and I'll journals quarter and by weight preparing research the the These role conducting next to provide important brief package, would fourth liabilities of modulation. the XXXX and insights is benefits in and plays with of patients planned of to metabolic XXXX. have exciting being teams preclinical oral advance announce and of I'll our we extending efficacy with that XXXX, first the both That complete of mechanism community by if these XXXX data the is registration data the and ALKS We're via olanzapine, opioid the unique which with that webcast to data pharmacology in few weeks. is while shared. manuscripts half novel, of In start receptor olanzapine, samidorphan of candidates.

BIIBXXX's to efficacy presenting multiple our oral as prodrug of report in developments known fumarate XXXX, novel, we formerly at submitting AAN, to NDA. data on have BIIBXXX, relapsing treatment and week now sclerosis, new important its forms we're favorable sets This and in efficacy, two regarding ALKS III its profile the important monomethyl towards safety. progress Phase our of progress Turning

and efficacy. study, and First, the patients relapse and two-year with efficacy, data the clearly from participating MS. for These data, with ongoing to collected we've demonstrated patients were were remitting first relapsing in respect compelling presented which safety BIIBXXX's MRI BIIBXXX in

an looking safety cut at from tolerability. including now On we over safety present front, patients, long-term data the and XXX study, the updated tolerability will

dose Biogen BIIBXXX's reinforced now very important population. this on on least, rates the to to data, The these and In year, so results for expand and bring expanding response the accelerate pleased certainly to discontinuation made build And as later to partnering. safety in the XXXX, of profile novel the but tolerability showing partners supporting at is last optimizing not program. is decision immuno-oncology our candidate. the continue this data ECTRIMS to to with we last, which track we're ALKS the continues, first and which are going into clinical working The quarter, year dose we with patients with forward which option our We GI desired look driving are new sets, lymphocyte exciting at MS. together evidence our below based and trial data to the NDA do submission three planned presented dimensions; evaluate immunological levels evaluating X%. expansion significant adverse-event and first GI escalation well the stage dosing We're in

expanding the data First, sets.

We complete now to study I of escalation a measures the assess the and the of year, begin of efficacy and objective of program. stage broaden tumor opportunities move patients. dose phase in to in expect this this accelerate into we'll various where phase number to see We Phase expansion our types larger

study is our therapy in and to Our to first with ongoing both anti-PD-Xs monotherapy include move expand expansion stage. the combination

dosing. is Next

As began chose known dosing agent an schedule regimen human efficacy. initial us on based Proleukin, dosing Testing schedule the we for to being it's a expansion the opportunities This monotherapy limited make the not is that, IL-X, to to this enables we setting. same dosing we're program, known important, Proleukin. different seen have cell with but as in a XXXX development as dosing to different with for optimize relevant developed we comparisons the agent also because recombinant

this We front. initiatives have on two

I dosing First, we have IND-enabling activities underway subcutaneous for study. a Phase

In to an cases, IV goal provide administration flexibility to dosing be regimens. setting. plan other increased we the evaluate would Second, outpatient both in with

we very understand better number with data have of suggesting value. a is we an agent active potential This partnering. believe initiated to companies as strategic its immuno-oncology progresses. our is emerging a options area We've our program discussions that dimension and third with The in

agents. two have areas combination We One interest. of accessing in is IO

The combination strategic but and other the patients. groundwork types now the laying would large high expanding of the in is numbers we're simultaneously tumor by of any I address expect encouraged until we're deal multiple program major interest. to we're along, further in not level

So, there's our data clinical look here later We'll forward plans year. ALKS this our a advancing for XXXX to at and significant program amount of the surrounding activity sharing Alkermes.

and the across pivotal ARISTADA, XXXX, important continued look initiation expect XXXX, ALKS for launch we BIIBXXX for and important ahead portfolios, approval the remainder VIVITROL growth to of catalysts product, weight we XXXX. and data and ALKS the potential (XX:XX) As adcom of the our of commercial ARISTADA NDA the year, pipeline data for ALKS

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

Sandra Coombs

Brandon, Great. Richard. the we'll now please. questions, open call for Thanks,

Operator

you. Thank

We And we question-and-answer begin will from Please now Chris ahead. Shibutani. Cowen, the session. go have

Chris Shibutani

question. morning. Yes, Thanks for on for taking update pipeline. the good Thanks the the

but trying think the For for agent? about things. any in about because other i.e., that be, would work how When And that doing find and/or the partnering, So, further you that to formulation, secondly XXXX combination I would you ask combination? IO not particular, two subcu schedule to you differentiated would thinking that also in that the you either taking as about phase, you when a Thanks. efficacy? just having expansion partner, clarify would the can say or PD-X we wanted be dosing monotherapy we're along be should timing talked

Richard F. Pops

Perfect. Good morning, Yes. Chris.

companies tested believe as be the into agent Since interested to phase, XXXX IO always a some own agent. combination are the who agent generalizable accelerate follows. better in people XXXX. number would Even with will with with combination partnering think sequencing your the phenomena, new it's in in like to a the working their go have decided expansion combination So, we though work particular these I of XXXX, there's

partnership and notwithstanding evaluating strategic patient is actually we simply early having with be the those partnership can could of consistent combination and I an now, that's we're are we're study but think probably response, discussions a not our now. the XXXX responses to have We to and actually those exciting types data, immunological And something objective somebody's So, something tumor and the generate seeing underway which accessing we business where without with right agent work running we're a IO partnership see Once phase but such discussions hypothesis, together. a will, now. interest. next we that because responses initiate right

builds reluctant more the the fully be of I momentum. when program partnership value we're studies, molecule we its think much regimen. really type this subcu, that's into dosing the enables what to frequent to less the business With respect And review strategic In of subcu going until to the a may enter be. animal absolutely. any

a day. testing formulation, would be certainly than we'll but the be of the and so, a release waveform tolerability more subcu expectation, extended of it And once significantly

Chris Shibutani

try other safety up follow-up. than if could here is and to the Unquestionably, one better with And goal I ask come Proleukin. a profile

standpoint particular outpatient word your development. when queue. Thank of you're next generally get talk in you a I'll you. the were XXXX? used in about Can you describing from the of stages with seeing You some safety what Then

Richard F. Pops

head-to-head of the Well, started, a long point, fact pharmacodynamic the been point XXXX for not days on obsessing been that in But, there's Chris, well we made the in not terms IV that the optimized more where five we that's once regimen. that have both in is It's there's want to we well could the as tolerability investors, compare dose make is to Proleukin, to our I and competitive response optimization. so the daily regimen way interest because it's a program, regimen. more immunologically. is saying, And number and reason of go a as as

will that clinical is study, an So, as end is is because that fate, being an XXXX's ultimately our will And be also a an that's medicine. outpatient inpatient I that trial misperception there's medicine. our it up there's think inpatient it first belief run being

Chris Shibutani

you. Okay. Thank

Operator

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

Unknown Speaker

the It's from more my Thanks the question. programs can Cory. taking so wondering I you in Thanks if rest regarding XXXX. a guys. been state for for guys. This update, (XX:XX) XX for little the online coming XXXX? is has since Hi, programs into the Matthew to on state flowed this is good far have states that of And added system. seen the that you've thinking my then, Hi, was last way be additional treatment about quantify a what for for the question. changing taking funding

Richard F. Pops

(XX:XX). Hey, Matthew

So, take this I'll Rich. is it.

XXst explicit state heard various state single wheels programs of Cures So, the amount government fact funding that it the omnibus that been that the into and dispersed about two the there's that has tells crisis. moves in states bureaucracy these and million bolus authority apply move the Interestingly, came federal they into Century made you The first government the our into of of states packages grants, have XXXX grants, via subsequent methodology the million federal around billion dollars fairly an first the allocated get us its chunk, then $X big that way which money in fraction gets and $XXX systems it slowly that $XXX have treatment in information to the states via is chunks XXXX. still despite the and quite a the a small of country. the and from the national we for was

$XXX believe. distributed million second week, just was The I last

And will. bolus moves so although a that money faster into system indication first, the bolus the it we than moving hope the there's necessarily and next it's bit that the no second of

looked difficult now very be the quarterly the it's should of treatment view, system an statute, to think of a programs indicator rate in model. states activating that our but new we've of annual So, with few hard the And in up those programs on at growth ways their the projected I crisis they're not XXX. by to but from treat they it in VIVITROL opioid basis. point the to approaching sales, We zero I to it learned interest is basis, correlate almost as the pacing and end started a just on will of inevitable But as time. over of in them ago a years leading we're the of and view were very state.

Unknown Speaker

you. Thank Great.

Operator

Vamil Please go Suisse we ahead. the LLC have Thanks Credit - Suisse, Divan. Credit (USA) K. From for question. Hi, Vamil taking Securities great. Divan

just if any in pricing the question but sorry you've or the shift I sort VIVITROL, quarter, asked of one have last do seen the the you just what second net then because gross quarters. remarks, (XX:XX) on one this this So, just missed in few I before, dynamics around to over and And terms I've do bit Richard, prepared curious if in or pretty capacity from sheet updated pretty now. you whatever little reason, it's leveraging the general, everything of you thoughts good for on you have have more, any have a just other I'm balance, with or a to whether have good balance feel and cash assets Thanks. purchase right in going

Richard F. Pops

Jim, why first don't one? take Okay, the you

James M. Frates

the nets Good Vamil. last Thanks, they morning. for XX% on quarter, specifics, to a XXXX Sure. year Yeah, our VIVITROL. for gross just were as whole in they XX% were

increase. slight a been there's So,

explained I you that look think that as be quarterly. can

one that reset general often of quarters, of commercial of higher Medicaid percentage because is plans slightly first again, of quarter. highest first the our the typically The the is in the quarter business

XX% again, see price a particular. by mix little from being you in with but of not vast by opioid businesses, state a for we're gross general, expansion the covered rather Medicaid Medicaid and competition down crisis patients and grow. driven fluctuate Obviously, of Medicaid the a with right in will expecting track opioid a majority programs various that we are suffering up quarter-to-quarter, on and the are that's who would the being And begin VIVITROL. roughly guiding to year So, and were or and bit net really price, but really of disorder to business in states

with last year. we that's what pretty and about saw we expected So, consistent where

Richard F. Pops

remarks, the respect with XX years debt rate in to by the a the heard the of the but points. out nice of couple lowering really quarter, if pushing a prepared this I last you interest And and cash, know we maturity don't executed basis refinancing

now excessive. position cash So, very it's not is I right but strong, think our

we So, we launches here and have anticipating identified we're these is sit uses for really One three today. of XXXX executing cash XXXX. that that as

but the you, efforts and of a look more large LLC research in-house some at I our will is and Credit a - of (XX:XX) licensing visible as I see don't been that Divan present (USA) productive second progresses. side year time Suisse the on Thanks BDA targeted Securities which more time. cash to to particular the then transaction. some as Vamil within think strategic not. so of K. we in But much. of themselves We've active you pipeline, The opportunities company is it And very is that size that Okay. see use from about

Operator

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

Umer Raffat

for my question. much so taking Thanks I Hi. to... wanted

Richard F. Pops

have to We speak hear up. can't you you. Umer,

Umer Raffat

Sorry. Can me hear you now?

Richard F. Pops

There you go.

Umer Raffat

excellent. Okay,

Sorry. to XXXX and on if XXXX, but order, I I in that may. focus wanted

IV, on subcu include either I XXXX, I'm track the in more will to be you I you subcu get now? your PD-X stepwise year? will with that? combos wanted just or dose in well in XXXX trying fast right, combos can subcu I with it are or something that as that soon combos, will how with And of this PD-X is towards And and be IV? expansion phase sense to for a So, Richard, with also PD-X heard basically your confirm Phase you

Richard F. Pops

Yeah.

you Umer. heard So, correctly,

towards this we right subcu, of... to IND subcu So, year first expect on XXXX, the the phase end be all the in of in

Sandra Coombs

the Towards year, yeah. the of end

Richard F. Pops

submitting IND-enabling as based we'll move around subcu. end the dosing that we'll studies believe But the the in through modifying expand on limiting the yes, it we the phase study move yes, be combos what monotherapy of submit for include PD-X study, ongoing and the timing finishing We're the now cohort year regimen. an won't now submit well. to FDA we just fast that with that. for are the as IV expansion arm the work. and We'll will And the But IV doing will to as be I to that. now. on can with getting IND on And the be we protocols

Umer Raffat

certain earnings it. last then the launch. I in well. we when Got on noticed, – the expense when in, to there modeled on XXXX preparation XXXX spoke guided And this call, for initially about early as was if SG&A may I you

Richard F. Pops

Correct.

Umer Raffat

went obviously RTF episode the restored. And PDUFA the we and through was

And push out the does for of you're and the PDUFA should even you for about it odds anything launch approval? about same, when So, the my we though year how expenses, I cycle thinking that? first think guidance imply it the is, guess not is does question or how the change the

Richard F. Pops

we actually made No, it's September/October the it guide nothing has which to guidance, conservatively review, should into or a priority a would do you towards odds. with launch in more to year, the toward do I'm put with of timeframe it a simply we a decision assumption original the more we because should approval asked the was and question. standard glad review. It which guide good have the conservatively has in

not numbers So, at was or which in order the on it as standard review, review. priority as guided we'd conservative to as time, the although clear you'll recall up make possible, the we based priority with, end

the we excursion, RTF into review, ended the January. with back With original but up on filing standard the which it date, puts

the you in really that SG&A it's just timing the shift of quarter. the a is shift So, by see that that, just

Umer Raffat

you. Got it. it. Thank Got

Operator

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

Douglas D. Tsao

Hi. Good morning. the for Thanks questions. taking

VIVITROL, of five? Also of for versus top for much in point, the from seeing five are you states states the now small the of hiring outside mentioned top ARISTADA, hospitals. you growth the right terms a how force Just sales starting

anticipate like other do have you XXXX? sales down road, potentially curious, you that terms products, the for targeting using the then types in in Just a just deploying you in do particular dose maybe force of sense will be of expansion the XXXX, think that tumor you a or when something stage? And

James M. Frates

question. the pretty XX% typically we they our were Last of approximately top Interestingly, our start saw I'll last year, VIVITROL, region. same. see across with remain to with this It's Jim. the so the region of Thanks, states balanced were sales, they Doug. but changes, quarter, five year-to-date, they states, that We VIVITROL sales. total the some growth XX%

So, what good see. we like exactly is to which are to starting broader the we base grow, see and

maybe you On to... sales the hospital want force, Jim,

James Robinson

Thanks, first, sales size for believe Jim. to right hospital Specific for the force. the ARISTADA is the we force sales XX

sales can leveraged for than forces hospital that be more We one also believe product.

leverage XXXX, the So, to the as as an be if can we for be further we look to and leveraged. we to in force at asset looking hospital sales also prepare future will we'll it see continue

Richard F. Pops

IL-X I these with clinically work Obviously, proven on full efficacy we've tumor various the with Proleukin, types. on on XXXX, of settled range agents. tumor there's there's efficacy think also types IL-X, And durable IL-XX in amount and going fair of don't type but a

So, who consultants interest and approaches. in various of sites, our with we're kinds dealing our clinical all have

we'll So, figure next that out several weeks. in the

Douglas D. Tsao

just to details results? able a us with XQ quick to as those with And follow-up, of I do be mean, share you maybe sort expect

Richard F. Pops

you hope trying posted. we're so. to as guys I keep mean, know. I don't I

we soon we'd things are know that know. let meaningful, you As as

we'll to So, the be earnings it ready on call. if about, it's talk QX talked about

Douglas D. Tsao

Thank great. you. Okay,

Richard F. Pops

welcome. You're

Operator

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

Biren Amin

for Yeah. Thanks, taking guys, questions. my

any launch Just have guys the VIVITROL, SUBLOCADE? seen you from on from impact Indivior and new

Richard F. Pops

morning. Not Biren. Good yet,

Biren Amin

And on we is ENLIGHTEN-X Richard, can week data in weight expect of year, what XXXX, XX change, the right. Phase XX-week II I was given this then this and at terms All the guess data? later

Richard F. Pops

the replicate II XXX-patient randomized larger study. think the the we study profile saw in the profile I Well, to that is Phase we in expect

of the the weight which second months study three second of the So, first that that on saw the the XX patients Biren, first study, the over for you olanzapine of study olanzapine XXXX the defining In gain, were by weeks the was characteristics of they the switched then the those you study. of samidorphan the for was that recall, three and of arrested in progressive group, then if inclusion curves, on to were the first in in months three months study.

slope saw zero change it of numerically not three plateaued. The weight Its the weeks, XXXX was other from first gain the six-month study. receiving through or weeks, and group for four did group and you in in that actually the of just study course balance then that three

study profile replicate basic we the as that's think well. expect we as in to So, this

Biren Amin

Great. Thank you.

Richard F. Pops

sorry. I just study three patients to of six-month they're we're on want that period. that to just going now clear. You're because switching that the referenced, instead welcome. I'm stay the olanzapine thought I you the finish not sure first full months, after as running want Yeah, it's if on make In to olanzapine for the

that space would the of curves we to time. with that passage expect between So, two delta, the widen

Sandra Coombs

ahead, Go Brandon.

Operator

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

Terence Flynn

some XXXX the seen prepared little in your agent resist unclear markers. immunological to if Hi. resistor responses? responses us on so, you bit that? have you actually you it terms yet. I Thanks just single me But And remarks, was you give any any of for seen question. if can Thanks. any talked know taking a guys wondering more was have about color Rich,

Richard F. Pops

sure the doses. Terence, them the the at way works that because that enroll number that sub-therapeutic expect and duration we No. not lymphocyte been in just I'm We study And in responses most small we've action patients is now cohort would we yet, We're resist types therapy escalate. of had any a mix have and for seeing don't each we responses, the time this this. and not of of a the doses, real in of we've in study, but we're tumor whole where much where, then

is that And so, phase are it's really why We see these six so be immunocompetent, expansion. patients. often, want But line can this so we expansion them lymphocyte is or to seventh really important. the

interest. figure of You to the out denominator the get the types we begin then to and dose, in we the build tumor dose

Terence Flynn

Okay.

you're doing know but Are already the you're so, now PD-X, doses also the pushing in going you're as to doses. in up expansion? yet? I or then doses combo higher you those not higher with to well higher And

Richard F. Pops

make take right was Just accelerating the find dose we're would news And to expansion But well. in inclusion at that to try that a of the sense? the the we to arm the do the be PD-X that, best as clear, phase as imagine is that into then expansion today now phase past, in Does we're stair-stepping monotherapy. dose. now to model up that

Terence Flynn

at you're guess... guess yet, to dose top a be going it's But I Okay. your higher dose. not I

Richard F. Pops

Correct.

Terence Flynn

trying out. ...is what figure to I'm

Richard F. Pops

Correct.

Terence Flynn

Okay.

Richard F. Pops

You're but... We we're getting there, think correct.

Terence Flynn

Right.

Richard F. Pops

okay, haven't yet hope get there formally And the we to into move fairly our here's expansion soon. to ...we said dose phase.

Terence Flynn

Thank Okay. you.

Sandra Coombs

We have one more for time question.

Operator

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

David R. Risinger

Thanks.

Operator

is your David, open. line

David R. Risinger

Yeah.

about Sorry I that. was on mute.

a all, to role. on first of couple I congrats, questions. your wanted ask new So, of Jim,

you could third, your top see you bit the just subcutaneous the expect Second, little could a of provide And daily timing regarding Richard, more originally dosing that maybe metabolic could was clarify shift Phase trial? we results of First, XXXX, color, then III the XX-patient study for for that to versus Thanks the we how studied? should to line much. you so to expect IL-X bookmark of when infusion disclosure? sort the your should infrequently

Richard F. Pops

morning, Good Dave.

a webcast, going all. the metabolic So, you we XXXX, for for study a are webinar, to have

preparing weeks, And we'll earlier and we've work been and about based a on publication I webcast in we're presentations, out think. finishing in next now, that pre-clinically clinically as said remarks, manuscripts I As we're put up, few would the metabolic for the ultimately well. meanwhile, that those the doing notice

we're a very quite now area So, share for with rich of that's to that you right excited science us and all.

clear on from two-year MRI, enrolled presented the important results be to was III real looking week XXX(b)(X) safety why the That's no are because efficacy filing data we're using the large employing. progression is this the that and efficacy study patients open-label Phase actually at XXXX, Just actually relapse the there because we so strategy rates these in of disease study.

but out. that bona Phase study report a it true need per and data, it's efficacy III we'll fide we So, don't there's not se

NDA clinical which study this this and comprised goal we've IL-X, the complete then the study, PK the are of in-life the perspective, days, over the bridging they the looked requirements submission our at that The multiple weeks. submission NDA. subcu of safety on not sufficiently TECFIDERA phase bridging from for to for completed a be for dosing exposures back enough was two-year of if the So, and to

human the yet, want to subjects the I response guess tolerability in because dose well. as we'll at look and don't the just at we So, look to need see.

but animal work, we the it's do encouraging. why that's experiment, quite the So, in

David R. Risinger

Great. Thank you much. very

Richard F. Pops

You're welcome.

Sandra Coombs

if to any company morning. questions. free Well, reach feel have thanks, on out call Please everyone, us at the you us the for to you. this follow-up joining Thank

Operator

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

may now disconnect. You

Sandra Coombs	Alkermes Plc
Richard F. Pops	Alkermes Plc
James Robinson	Alkermes Plc
James M. Frates	Alkermes Plc
Chris Shibutani	Cowen & Co. LLC
Vamil K. Divan	Credit Suisse Securities (NYSE:USA) LLC
Umer Raffat	Evercore ISI
Douglas D. Tsao	Barclays Capital, Inc.
Biren Amin	Jefferies LLC
Terence Flynn	Goldman Sachs & Co. LLC
David R. Risinger	Morgan Stanley & Co. LLC

Alkermes (ALKS) 26 Apr 182018 Q1 Earnings call transcript