ALKS - Earnings call transcript Q1 2020

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Operator

Greetings and welcome to the Alkermes First Quarter2020 Financial Results Conference Call. My name is Melissa and I will be your conference operator today. At this time, all participants are in a listen-only mode. [Operator Instructions] Please note that this conference is being recorded.

I'll now turn the conference over to Sandra Coombs, Vice President of Investor Relations. begin. may you Sandy,

Sandra Coombs

Pops, to our results plc the and XXXX. Marketing; are March Welcome SVP Nichols, discuss Sales of quarter call our XX, and Richard today me financial business Jim With CEO; the you. Todd conference our Frates, Alkermes and to ended our CFO. Thank update for

the session, we Iain of SVP our Q&A will by During Finance. Brown, also be joined

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

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

to update to the provide response on company's the turn over call an I'll to Now, COVID-XX pandemic. the Rich

Richard Pops

everybody good well. morning staying Thank you, is and I everybody. hope Sandy,

and and on I communities ranging health first is impact we this acute an and significant. has to the caused virus economic that the by the getting our wellbeing into note quarter on results So circumstances challenging had before wide business, COVID-XX, have our update of

and April in on weeks the with outline on and the and today difficult compassion will of that Jim to particularly expectations detailed for to Todd will first navigate discuss XXXX. potential impact quickly a of conditions for efforts. VIVITROL review financial of few implications the the provide observed commercial our results activated and the We provide impact have balance our our mitigation ability the we

In has our conditions stigmatized for to the practices continue caregivers health our that healthcare can marginalized facing meet that with and responsibilities mental ongoing challenges of face are which our illness often need in living this many their medicines, public and accessing pandemic, even become adapted yet Alkermes business have are system. in pronounced. addiction, we have People serious their more an society, the so and

with other patients function continues are communities. their and stakeholders these many active their treatment We families an for participant to the to in system that ensure along efforts for

As navigate healthcare medicines. and access we protect to rapidly the environment, the together and uninterrupted health employees that work main evolving are to our help to ensure the to have priorities our our patients of providers two

and This to engagement. first do stage implement wellbeing for provider has organized mobilized change three employees, distinct do healthcare work field-based and policies those adopting virtual business for physical to who jobs home included transitioning maintain from their distancing, could personnel remotely continuity. we our we our way quickly evolved In the Our team protect over our the response business and the stages. of the

patients important on complex rely are and sterile only of injectables forms. oral dose manufacturer medicines We the including the several solid

our instituted including manufacturing work For our laboratories, critical and practices. employees to physical distancing equipment, precautions in safety continue facilities increased on protective additional in we sanitization tasks to our and

manufacture; third and for supply anticipate our patients the to we to one that interruptions. on two, and our supply investigational trials. response not expanded preserving for products ability second focus VIVITROL the time three, any rely this that commercial products do ARISTADA; the In our our future ongoing stage At we clinical foreseeable of to product party

supply clinical regularly situations our are and we chain assessing as partners However, the appropriate. and adapting

Our important than opioid support with and Todd we that providers resources It dependence, that more support this focus and access and alcohol now the them of people some of they the in living manufacturer information is ever to our healthcare outline extends to help medicines. efforts dependence to have will and help patients the ensure schizophrenia, beyond treatment. environment. our

new in on how a third meeting gain the ways expenditures response our being eliminate more our of advantage of needs In find agile the streamlined working, stakeholders. of we stage focused and competitive we're can unnecessary by

to a have we business. best have develop be opportunity an and new lasting impact and on positive conduct our can creative We way practices that the

is this dynamic that recognize We a situation.

are and on the latest to of access our research. in informed information to make designed monitoring the the of our medicines continue We decisions health COVID order support timely employees, closely to our advancement protect uninterrupted

and for performance with commercial on to call a commercial first of the So quarter review I'll the our Todd that, over response front. COVID-XX to turn

Todd Nichols

success Rich, for We these we quarter healthcare and everyone. achieved to sense with in made our both and heightened highs year commercial steady of adoption past to to ARISTADA strategy patient provider VIVITROL. progress the our adapt good and efforts needs. our QX Coming Thanks against into a results organization starting initial to focused urgency was and the all-time QX of reflect strong continue this as on morning revenue commercial drive

shipments we our VIVITROL's entered our COVID-XX impact pronounced commercial approximately ARISTADA. more began see pre-COVID of In quarter, a have the second of on pandemic expectations. VIVITROL than few the been As lighter the impact on than first to the with April, portfolio, factory XX% we weeks

extrapolate given trend is early a forward reliably the to it dynamic However, too situation.

prescription discussion few much, environment our magnitude portfolio. our time, data as certainty we have But the seen with shipments across a of efforts the impacted and commercial results. will to of impact following this in predict I been COVID will duration flattening or adapt be not the our outline QX but to current can't has we what At ARISTADA last the factory over weeks.

with healthcare the prescribing VIVITROL, driven work quarter VIVITROL important VIVITROL's net The VIVITROL in XX% state the expand the sales to increased XX% network. first level, driven. approximately year-over-year accounts we by number at growth. to funding the growth of provider overlay to increased unit year-over-year $XX.X provider policy continued be the as XX% Starting and million Due of to geographically

Florida, first long-term year-over-year. in five Geographic of an strategy. net growth states with represented growth strength VIVITROL In our New for the growth diversification and lower growing continued XX growth than quarter, remains York Year-over-year share broad-based top XX% QX more driven states in and sales. our states XX% by was part with California, and important of

trends California the diversify particularly alcohol from strong across contributions and Michigan showed saw encouraging greater as we dependence VIVITROL growth VIVITROL like in dependence where to continue the experienced alcohol we recent and demand states has business dependence, opioid indication.

to is ahead, to efforts Looking COVID-XX particularly current the important needs disrupting addiction treatment contain responding care patients continue to and which seeking for our by in environment its strategy guided patient to access some services. be will as are spread

a with centers, could over providers. healthcare more the patients' last three desire decreased in by and weeks new pronounced closure starts and of to addiction detox treatment seek of ability example, a pressure. certain been variety the new For VIVITROL care patient factors, decrease access to including services, The on have to driven patient engage impact be starts under

the and New hardest over note, pandemic in Of We the hit last and California three geographies. York, States impact are VIVITROL alignment also the by the earliest areas weeks. believe seen United is like that VIVITROL we Massachusetts this have augmenting certain top on

these in carefully trends geographies and monitoring be will We the in months ahead. weeks

of to needs the while In virtual protect advancing and and COVID-XX and to focused strategy the employees. digital our healthcare providers to transitioned and the to response challenges, customer pivoted model on support our our and of of We engagement wellbeing medicines our quickly patients. access health support to we rapidly broad capabilities continuing our a customers needs

support providing to of helping for materials site expanding injection our highlighting we patient educational services locators To network telehealth them services. and where To care resources, provider receive we our our reflect can patients are these sits navigate additional are reimbursement virtually patients updating support injections. providers, while

XXX Coast we Midwest As measures in providers injection an will Albertsons treatment engaged expand adopt we injections access. offer and access which with further predominately recently continue its to additional potential engage West to pharmacies the to access We're monitoring to situation at of to patient other example, and and regions, with support now appropriate. on-site the as

and family, in year-over-year impact data sales Turning of XXXX. ARISTADA million. demand months of fluctuations in to growth Underlying net solid growth year-over-year $XX to the prescription This XX% inventory quarter the in of ARISTADA underlying total of reflects for demonstrated XX% of terms increased first the therapy. product quarter first

an February all-time market the month for for atypical ARISTADA. of share brand data, useful we market in ARISTADA's XXXX of for believe terms months in indicator the of of achieved trajectory Market prescriptions XXXX, the for for In available new March hit a therapy of growth which prescriptions leading XX% is share long-acting XX.X% in antipsychotics. new latest overall high

focus reflects are benefits in strategy is sharpened proposition utilization of X differentiated a ARISTADA Positive of Phase last doses INITIO. execution an an to of communicate which on among middle rollout year and ARISTADA ALPINE driving healthcare focus and we and to our in INITIO and intense our two-month making of into awareness the element the progress we and we of we Heading dose on the providers. in at drive data study XXXX value our positioning [ph] The as the its announced from continue the market. two-month XX important

offering we access ARISTADA differentiated clear and a growth of reduced ARISTADA strong proposition, of in dose resonated family, the and to the have compelling within a future. profile, With context interactions, Particularly with physicians. we the payer INITIO a along value product opportunity believe two-month has personal the a drive with

that I in data has than flattening on with pronounced a of As of prescription VIVITROL, weekly the wholesale we of impact April. to-date seen shipments been seen have mentioned, and COVID-XX less ARISTADA but

predict As social an distancing practices pandemic will medicine going early relies on healthcare a the access impact to patient injectable ARISTADA too ARISTADA is to whether on administration provider and forward. measurable have and utilization

Similar to support network are we our healthcare injection expanding provider VIVITROL, updating patients providers, and strategies and for implementing to locators ARISTADA. including

We for awareness digital our deploying support virtual and are HCP's and and access resources highlighting campaigns. services patient

new can and not these practices believe efficient also We disruptions, efforts translated more long-term. best to but over advantages that the opportunity develop help into be present only competitive mitigate an will potential

intensified the remainder our the launch will for preparations which to throughout Turning year. XXXX be of

in planning spectrum scenarios launch event challenges navigate environment. and evolving will to are the We continue that for COVID-XX disruptions of the present work to

the planning access. will remain force keys to expect We and successful sales meaningful market awareness, a launch

congresses have This our data will and some campaigns and of value commercial education efficiencies launch state through we As exchange. capture formats. at opportunity we represents scientific prepare and XXXX of an a operating virtual scientific number maximize XXXX in disease presentations infrastructure. drive which an awareness place of the of for to important planned take to includes opportunity

in terms as capabilities field concentrated in expanding marketing, organization. sales of With universe access our we will utilization medical driving the our already to investment right-sized team place launch of prepare Currently, to psychiatry physicians for primary long-acting affairs address injectables. our be reimbursement, and is of field

potential To across for we to antipsychotics sales accommodate organization expand the the broader one plan disorder, bipolar schizophrenia the footprint meet appropriately of to opportunity. both and prescribers field oral for indications

of sales over months. finalizing We be that coming and strategies will are a and the number evaluating planning force configurations

important Establishing an success be meaningful early factor driving the market of in will launch. access

and research, contracting are key research, are completed pricing We developing our engagement for payers. health updating have plans our

vulnerable dynamic remain we look with that focused addiction. we forward new committed execution environment are forward, Across illness commercial suffer progress from and the serious and to our this to on sharing building mental we populations portfolio, and capabilities in serving Moving deeply you. the

over with our for and to guidance. I'll an quarter that, to financial update hand And this the Jim on results provide

James Frates

of am and revenue GAAP solid Todd, a I in $X.X results. to base. $XX.X million loss and report net you, of by non-GAAP Thank in recorded net our our year-over-year first growth quarter $XXX.X million. everyone. We pleased We diverse good revenues income generated driven in total million morning products proprietary

key of to on comparable business to in year-over-year by COVID-XX adjustments highlights net VIVITROL discuss quarter first sales quarter start driven financial Gross increased impact million the XX% and XX% of financial then XXXX. $XX.X in unit the were to I'll growth. primarily the for first our XX% net XXXX. the of quarter with and the outlook our quarter for

under primarily two adjustments. within Consistent at were to net with the seasonal just inventory back with VIVITROL due as patterns, as QX of bill sequentially levels on well declined specialty pharmacies. and wholesaler of weeks the range sales slightly At gross end the inventory higher drawdown to and a the the quarter, first our inventory net half

sales net same nearly of ARISTADA product inventory strong period to the quarter ARISTADA to also first the Turning demand million. $XX drawdown underlying XX% in increase significant year-over-year ARISTADA in quarter was reduced by the This first last increased and driven XXXX, in the net year. which that the experienced sales family,

ARISTADA is the a demand volume consortiums. declined gross as for ARISTADA to remains reflecting during due as As slightly typical channel of year-over-year Gross Sequentially of trends of believe Todd four Inventory well terms to level net sales certain Medicaid we compared seasonal as higher wholesale in to underlying plans inventory of XX% roughly ARISTADA. total XX.X% net of quarter into typical broader prescription adjustments QX mentioned, months at adjustments. which were represents to net in the weeks, XXXX therapy patterns the better ARISTADA. in first for XXXX growth consolidation XX%

to royalty $XXX.X manufacturing in of in $XX.X INVEGA SUSTENNA same increased Revenues for our and first the and timing million X% injectable $XXX.X by year-over-year by to INVEGA TRINZA in market long-acting driven psychotics. batches of INVEGA CONSTA, revenues CONSTA. RISPERDAL royalty manufacturing our period increased million, prior the and quarter in on INVEGA end year, and from RISPERDAL primarily million compared sales driven were business, our Moving SUSTENNA TRINZA to the manufacturing the

for our XXXX. the commercial Biogen the ended sales first $XX.X to recorded as with as approval VUMERITY our The of QX manufacturing largely the revenues, product. than expenses of growth last reimbursement decline year fourth the offset from quarter and in royalty of more and In quarter revenues $XXX,XXX revenues net development the of of the XXXX proprietary products in of we in that R&D million compared in R&D

same for in $XXX.X to the prior from total the million operating period quarter, down $XXX.X expenses, the were million year. our Turning expenses first in

year R&D of Our million ALKS activity $XXX.X clinical for first the increased completion prior in by expenses compared in enrollment to were program somewhat was development the VUMERITY the XXXX which the quarter patient for $XX.X XXXX in million the program. reflecting offset

ARISTADA million the the million investment VIVITROL for first reflecting the $XXX.X were quarter prior and growth related start year. to $XXX.X compares expenses initiatives strong SG&A for and in to

investments Turning seasonal decrease is normal in company's the sheet, at compared related we with total XXXX. to approximately and of changes approximately million first $XXX million our and The loan ended to to end was our $XXX quarter approximately cash the the XXXX. of million outstanding balance capital. cash patterns in of flows in The $XXX debt in total working due end at March quarter the first term reflective

surrounding Today of now XXXX provided for our the to to we shift I'll are due healthcare impact COVID-XX expectations previously system. to and our financial XXXX. expectations uncertainty disruptions financial the the COVID-XX withdrawing

it our patient began and with to for country We disruption our in contain services Todd to intensified has While addiction financial treatment results mid-March access ahead efforts the of our pandemic schizophrenia. slightly first a the and as were see expectations, line mentioned. quarter plan extent in in the to operating treatment services to realities lesser of as the and around

expect business the of primarily the be Alkermes on We by will severity that pandemic. and COVID-XX duration impact of the the driven

monitoring We're this the it the our are reasonably as on as unable strategies daily basis pressed across the pandemic mitigation a outlined. results demand country. predict At impact implementing to future and of time, extent Todd we on

discipline. we're confront we pandemic, focused As exercising on this very financial

base, of see highest on the We our capital and impact where allocate our potential adjustments will areas the to better pandemic analyze continue our as on we return the make investment. to we cost appropriately topline, understand

the environment employees, to our access protect uninterrupted our part of safety healthcare products facilitate in do we our of support patients, and this and to providers business evolving As continuity.

when we We continue responses and a liquidity believe to health the position rebound this objectives With positioned in business, weather a well With financial impact operating to the strength. advance public of to be of our are allow. diverse well-capitalized pandemic. sufficient

With over that, to back Richard. I'll call the turn

Richard Pops

That's Todd. you, great. thank and you, Jim Thank

environment. you've none major live we from this while us emerge a business behind clear us, heard, we're to when to adapting be first sense our more and plan And focused. of COVID-XX have has resilient disruptions everyone as of quarter had believe else will even strong So we the a we and a

activities to development and research Our continue advance.

is Our and treatment trials. to safety ensure continuity first support our patient priority clinical ongoing in

as We the extend in investigator are on as burden environment collection to trials a in have like frequent conducted clinical to the how are current Efforts biopharmaceutical long-lasting the visits potential on enhance beyond and this patients streamline sites. the identifying well communication are and other like with investigators, impact have positive study the data country. companies, on and we reduce to ways

Another most programs, key The protocols say clinical XXXX clinical XXXX oncology our those. to advancing intravenous is dosing accumulates ALKS priority and in continues be and studies. And including that investigational is of initiating to monotherapy supported the for our combination sites potential important keep subcutaneous for our studies both trial I'd data medicines. across as ALKS new in and one

Across was enrolling development ARTISTRY our highest program the call March what we month.

continue ARTISTRY-X patients We to enroll in ARTISTRY-X. and both

We paused our in slowing patients to sites enrollment have in will due as minor and result of investigators COVID-XX, April expect which enrollment to in of those seen we have temporarily network trials. new some delays a

trial of resume activation quarter this Looking ex-U.S. the network expand and soon as possible. ahead, sites further we select plans to Asia-Pacific clinical in will we region expect as our primarily Europe and our

its its to value its therapeutic XXXX will the for lives we to as on to to that the broad-based creation ultimately and shareholders. collaborating driving at of XXXX we collaboration. capabilities advance potential see are resources maximally a focused If promise explore patients building for up continue key lead set to the and data With this development, stage

antipsychotic, and oral disorder currently is our atypical review novel at under ALKS NDA For for the bipolar XXXX, FDA. schizophrenia I

target November the this PDUFA dated of So action year.

in timeline. of they regarding format We The shared details yet not FDA in have their to recently communicated hold have Advisory or an us made delays aware focus current intention potential although review not Panel, the the been any environment. to the

NDA two application of this plan entity we been [ph] an November Because involves Adcom year. we contains molecular for since submitted and divisions, the last new have in different review preparing and a

new differentiated an schizophrenia efficacy the treatment builds that a that potential to we've one in and presence of has olanzapine built profile, XXXX important option, with ARISTADA. With ALKS the tolerability on the be

of The maintain has That is order interest to track. platform. efforts, our remains other has scientific HDAC-inhibitor intense of largely and shifting team on area work those the conducted our by and COVID-XX experiments work In has in continuity options. geographically most sourcing prioritize innovative continuously been and critical internal momentum spread and and optimal Integration contract external across research as organizations as assess stage we peaked. development research early been high-value

and forward Across we people's dedication the organization and and all being challenging this I'm as brought navigate together. grateful resilience that proud these the our our to is I of for remarkable. to times continues accomplished environment be ability nimble innovation and employees adaptive am be see in to

changing opportunity underscore We and company. are focused In on the objectives the crisis, society. biopharmaceutical order this are to priorities to delivering business on industry the value has value the immense pandemic. advance these the to Diagnostics, of demonstrate key the first vaccines, for therapeutics, and to our the the build responding operational

economic some of fear. can the implications health by social are that hardship, we on exacerbated important focused isolation, and Alkermes most At be

and the serious of the of in level pandemic on take will importance. of illness addictions care new a and and wake During treatment mental

play these to the very disorders. are we help proud of We with struggling people role

the the to and there run to call Sandy Q&A. finish I'll back So turn the

Sandra Coombs

open you, the we for Melissa, call thank Great, please. Q&A now Rich. will

Operator

Please question. from of Instructions] [Operator comes question you. your Cowen. with Our line Chris Thank proceed Shibutani with first

Chris Shibutani

very Great, thank it. much. I you appreciate

that mixed think about that You has injection you shift something the alcohol a and adaptations Can of just see in the put on treatment more alcohol or working very part efforts, option, go which that? at described the as maybe as in You quantify being you shape addiction could marketing been particularly that little to talked between terms sales pharmacy on a for relevant which extent the you sites places side, opioid some putting maybe had forward the I you're be help more, a terms of of including side. a you. efforts? bit such Thank versus emphasis Can your Albertsons.

Todd Nichols

Todd. Yes me is spend, this Chris, let

Let VIVITROL, minutes so the More spent as that few and how also To we've me that. and of to couple the on spend point, those opportunity only for ARISTADA. areas, just spectrum weeks. do across we're injections, over of last expand access of pharmacists, a time a too. lot so a or great thinking not we there's month put healthcare thought but probably your deal In of an for the seeing one about with clearly, last well,

of lot the now, of of top practice at pharmacists to a at There's right of lot a state acceptance the energy allowing level license. their

regarding And that very and level injections. a working point at access the level, the discussions right retailers we're well, about Albertsons you do situation It's have state excited this will how closely with so the expand I the having very right of to tell early. as we're policy also we we now now. lot at major at with

level have, this. we're that nice are the that open early seeing that encouraging from state really signs at customers is discussions other like It some to

a we are of to think that that injectables delivering term. the big the be vaccines this in so, delivered And part similar to way going is long

now, with COVID long-term situation, the is clearly both be right will well. So for for us as an this products although a opportunity this opportunity

it's So VIVITROL it's VIVITROL ARISTADA. and not just

Richard Pops

from derives And idea is pandemic. particularly Hey patients America. a retail because telemedicine It's way the of injection. can this to I country, fundamental have, that for the of add think the one it's of we use conversation changes the psychiatric services Chris, bigger rural this across as a and in pharmacies pharmacies to maybe deploying Richard, it's but I not just on want that of

of different of compliment we could as country the the a that the dispensed I to acting care. availability And the important, an in think be long think across telemedicine sites would be important of telemedicine injectables component an

we're driving in psychiatry those So this addiction. is in that both one changes of in fundamental interested and

Chris Shibutani

question for or payers, we cetera. those you where shift of we along or et to Got Are done and had Jim, consolidation mix then one in terms of payers Medicaid anniversary about about talked that, type, it the and with quick continue the there can or Thank all course the that half in get the transitions at midpoint we to be any if that are of this you. case lessens of is as that particularly year? towards chance second

James Frates

Yes, to specifically our last it thanks year compared ARISTADA. And Chris. affected with gross year net to this

think a I providers probably through Medicare bigger and the major think seen. a another for might see major gross we I the come impacts side. to from Medicaid see really point it what's to have those net And I and the - gotten DMS are consolidation hard but two happen don't going change. predict year or but we've I think has the future, the from in of ARISTADA, course in is The mean to commercial we a Services through of

we've So impact side. the think I ARISTADA of major on the consolidations those seen

Chris Shibutani

the back get I’ll you thank Right, queue. in

Richard Pops

welcome. You’re

Sandra Coombs

Thanks Chris.

Operator

you. Thank

line next question comes your proceed question. America. from Bank with Our of Jason of with Gerberry Please

Jason Gerberry

Hey, my taking for questions. you good Thank morning.

VIVITROL up on Just first. a follow

You I'm clinics. just being mentioned mentioned is more impacted starts new patient of and you negatively closure curious,

follow a term managing patients also longer the your from back. know, term, I but how that negatively in able opportunity to are clinics curious adherence their being perspective you you up come impacted? being treatments, patients know preexisting looking I'm how talked about being with is and that is So near-to-medium the just

Todd Nichols

there as on adherence. early couple range impact Jason, in is that that. Yes. Yes, in adherence VIVITROL this watching time. glad you if asked to little different well, X to questions the over It's something Hi, X.X closely. a we're that historically an around A too somewhere Todd. determine is is very of

on have sense based this we actually has now. a don't right that point So, changed at that good situation, this

would you areas. prepared of disruptions the of the are some that think Florida, best spot point hot and now regionally lot I assessment hearing to New right based was in York, that I I my really are those Michigan, states seeing and really California, as A we mentioned remarks, the

those our customers country in as close we're We parts of hearing in than other are very some the to areas, U.S. Then more of well. the disruption across

depends of really and upon site care in, the is it profile. the state, also the that so practicing And the patient physician

still VIVITROL We patient patient to that's do the encouraged the by know made so is a very that's very product because well. patient a a committed that, we're that and as commitment

And see so to we we're state start monitoring flow coming to the at we're going and and hopefully to to going in and the more the be level, monitoring weeks state level when the up, months. loosen at adherence, also start closures then patient policies start be increase specifically to and

Jason Gerberry

I'm Can closure we just just offices if any dental like you around addiction you up should about reopening metrics And with expect would Great. reopened? temporary? more a once I economies - these this clinics, you'd the this? comment the curious, of follow could of is something that expect put be offices to

spend more because about of during do just And step physical you have that to this the discretionary down up with actually thinking that's to then up you spend potentially my How marketing spending. sales discretionary or is follow second you the and don't period, physician? flex in marketing have can that nature touch your point

Todd Nichols

I'm again, Jason well too. glad that asked Yes, as you

is for the see important future I element as this do opportunities we in we VIVITROL opioid to thing that continue think of a well. in how about be VIVITROL crisis. the keep mind very nation's will think growth to response And our the first to

So hard It's that by to driven pandemic that's right well. really we do assumption going now tell. the at our being right this this is now point believe is issue an acute as

on us little a do point. we question will bit your is well. Hopefully on this an able acute future, provide more So be quantification that as believe at that well. this for data in to issue quantify very But to is of the difficult more as we that

quickly resources And well, And them. around Rich as your very, you've also patient that with Number area first to our our in areas. saw prepared programs the that March heard in customers to point on really discretionary very to remarks, make in is commercial our relevant engagement, my were we're the needs. marketing part shifting we're maximizing spend to sure and the we we that as we're and and that from we from sure virtual of latter making resources that three investment support offering one, dollars, shifted being

Secondly, then digital about we're capabilities enthusiastic as expanding work now such And a as that lot is that well. thirdly we're presence right our we're injections access to doing work. new area in and is that and of building

resources we And both healthcare brands make to proposition the the to patients have communicating we're and ARISTADA of that well. increased also in of but VIVITROL value so to domain some providers, as sure digital

Jason Gerberry

thank it, much. so Got you

Richard Pops

want Hey, I on not it's it's to QX. on something to Rich. Todd that focus well, in build something Jason, said, just

concern. and We social the providers And is dealing aftermath people living of right now, a in now. opioid as had COVID-XX. country are There's around homes as the with payers, and that lives and conversations right have serious is consequences deal with happening the people growing the alcohol what major of health in with public officials isolation and about way use their

of these Todd's to in VIVITROL mainstay point, medicine the is conditions. And treatment a

to is as use when So to tail be manifestations. of predict over, rates going disorders and going period and a while this there other going to is as the alcohol well this in be we to sequestration be psychiatric opioid can't quantified it's

Jason Gerberry

thank you. it, Got

Richard Pops

welcome. You are

Operator

you. Thank

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

Cory Kasimov

Thank for taking my questions. you guys. morning, good Hey,

commercial as with you ARISTADA were to And you we've for for talked tailwinds I COVID-XX the or there see first other or other this earnings the through follow all, either I the ask related season? any is, companies far of want early so that do quarter seen VIVITROL business some helped a about any of pull quarter have up. First then

James Frates

it’s Yes, hey, Cory, Jim.

We have have not with came QX. to let's seen we actually the in dramatic COVID levels the as down beginning. expected Inventory QX tailwinds, from changes say would

off surprise and focused So last commercial We're in we many we the year we start growth people to can growth, across that a and to the really compared was like effort good it the XX% the before XX% saw think year and think think. that the pandemic. of the many growth I in I saw companies, say underlying we unit really got teams country COVID and ARISTADA, from nice I that that this VIVITROL Todd

Cory Kasimov

Okay.

Todd Nichols

We to as just was focus our add for on started focus start to execution. well strong If Jim's I the Cory. year too. comment - Yes, could and really commercial

And XXXX offering so feedback encouraging from it's dose well, encouraging major been, some as and well. two-month proposition as we are around seeing of in our some it's the underpinning commercial customers our value our a for also strategy signs,

[ph]. initial plus XXXX So

VIVITROL quantify we encouraging, in little for alcohol well a the we too, signs are with is are trends but as And some earlier the optimistic directionally comment are Rich's early XXXX. it, distribution of moving about seeing doses that right so too, as seeing It's with well and as to direction to some that. we

Cory Kasimov

in well, resonating if of that Okay, not is but something that even two-month actually is second in was be feasibility would the a actual beyond an receptive was to you question to to uptick was seeing and it, be at the think going terms seeing if do all implementing curious products that, I what payers around going administer the at surprisingly you're dosing, you're maybe but like my home what going that? of step commentary if your the adoption, nursing into and

Sandra Coombs

do to you take…? want Todd

Todd Nichols

looking so absolutely. injection for the number of we're expand a feasibility at opportunities patients. to Cory, of Yes,

access is our have to make to centric Our as be number well patient sure one focused, too. to patients medicines focus patient obviously that

So can't anything strategically options. we'll we're well as go, of number you point of give this site I on are injections a alternate but different we firm where looking looking at at all kinds at too.

Cory Kasimov

Okay.

Richard Pops

beginning Rich. to was on It’s was that answer I Cory, but mute. before, I Hey,

of So can the the see being There for at best that data as having are in are Sign of implemented being pilot really the isn't around jumping we in And thanks islands this practices certain times, Todd things others around in. care in country like moment you the home interesting are it? We conversation with look where these pilot payers and large addiction country. some programs. for are programs. developed

system. And model payers care a or could payment we're into programs these comprehensive major within about now, a of consolidating pilot even talking represent small anecdotal what to two major

conditions here time answer the So to over the treated question, an but of there's these across simple way to country. a long yes, are opportunity absolutely, a change some that

Cory Kasimov

I guys. thanks, answers. appreciate Okay, the

Operator

you. Thank

of question Please with next proceed Umer question. ISI. Our Raffat from comes line Evercore with your

Umer Raffat

my first has sure right? just AdCom, that make want you guys heard much for I Maybe is right. two follow thanks ups. an it I told so I question. FDA there's taking Hi, had on XXXX and that you to FDA, Richard, mentioned

Richard Pops

or format haven't any told should about AdCom, Yes, but for they that somewhere us about specifics the content the the us yet. plan we given

as like So not one on count of it? having you're placeholder it's count now, on a almost it

Umer Raffat

Right, the to some issue I'm approvals happening. was be, considering might generally AdCom was But thinking have they issue things reviewed just the preclinical Intra-Cellular ended was they so samidorphan told part an AdComs. It has understand that already could up up guess, were never about trend given an review, of looking what need And has the I recent of come and XXXX just some speaking, the ITCI Richard, not at. of the review? been during as to the I trying

Richard Pops

there's no been come in the up issue review. No,

of mentioned obviously in level I ran weight of a it's metabolism looking well of a As because – an and so also claim, the Because interesting clinical XXX(b)(X) the we well. safety as seemed difference as information – different, sorry, it's differentiated bX because review as leveraging olanzapine off trials label, I'm for right? yet we're efficacy ourselves, profiles earlier

the when both reviewed of put by with it together we of integrated those knowledge of be safety, summary So divisions. efficacy, summary will it's the integrated

if guys a if review. or what it's you more more know know yet, issue we give yet, we'll may of information don't but issue the we more is through there as So discussion, just but labeling get the be or don't we an information

Umer Raffat

Richard, for And Jim you. and is of you it. maybe Got both this

the is, what revenues of you more the track revenues carefully, scenario, just OpEx I'm or I the cash if tracked crunch cost are and at $XXX end managed at than burn million out, the could that about trying previously the was $X plus lower and slightly I burn As isn't the cash and say look be guess around the lower lower million. let's cash I numbers gave and guys If arriving to and the billion total revenues $XXX guidance quite will easily. approach in

year? $XXX So you cash now willing the now. question really can getting I I have that's debt net is, number mind your something you your is net to how minus cash, spend I'm what much balance million guess a Do of is are have right expectation, OpEx of in you And this your at right cash because control?

Richard Pops

as I’ll Yes that. of and that to But circumstances amount then year, well. to our sure let is those to careful Jim projecting just modulate right have bit the spend Jim economy based on that end Jim more access of We for medicines. to we have I'll we as I'll need going a now little there's resurgence in can said, let to going the the of attention medicines you a answer color be think this we you burn pay make back year. his answer give so and to you With of remarks, give on up of real that be open significant said to and the cash don't COVID-XX. the But, first topline

James Frates

Umer, regions. three in with and of impact in, weeks a shelter-in-place COVID know particularly the dramatic New as four you that exactly and thanks is I think point Sure or seen right. activities, We've the in and is distancing social in out, may a mental be and as the illness, York come fact of treatment have surrounding significant term we serious to going back we and don't rebound. effective long addiction But think

see are changes, obviously, There's do, going lot of we XXXX managing forward active in and we've suspended be in we absolutely will dramatically There's costs like guidance. side. terms revenue is launch on the that things we short-term of the course So as on through impact and we currently meetings changing the in we cost can why changes around And the invest what year. forward SG&A move line. our those the person and a travel as the if expectations

modulated mentioned. we trials, be that's those then clinical of months in hope of And in on we longer going or our be weeks as an are expect, impact delay as we there's if terms COVID than if – this again costs pandemic well. terms XX And to obviously studies. But the to counted clinical goes the of going

we're this year, short the around and COVID been of watch was can what net know carefully, by that on and income of the we non-GAAP positive So impacted active you We've lot a take have going $XX as a things our for steps we target happens. control in depending guidance. to very our and term, million, ranges very,

Umer Raffat

and say there $XXX balance Right, to you're more. assume for than a million fair just more burn Like beyond but let's of assume it I threshold a is burn of mind may, you to that is there to for which on in to it going not to this you're in not both reasonable year? Jim willing follow cash cash is mind, Rich if million the up us is in of that, $XXX net number

Richard Pops

a moment, on is answer that but the put of this it wouldn't yes. I number Yes at

Umer Raffat

Got it. Thank you very much.

Operator

you. Thank

question. proceed Stifel. your comes Paul of line question next Matteis Our from with Please with

Paul Matteis

and medications? how or keep And alone when at new I XXXX get to you historical revenues was world On these Great, thanks only pandemic stable let VIVITROL growth. historically the of in annual starts we rate so think trying non lived that guess what ARISTADA, the I'm even persistence my these on few patient for much is, about a were for months what kind medicines questions. in just ago, reliant much XXXX, to

you there? parts given a in I are while wave much. worry one threat And I alternatives guess in to certain oral so year, then you these durably later this contexts do given the medications more forward ideal, impacted looming when the at And that new an Thanks starts they of could are kind that up. that have of second of be the all look patient follow

Todd Nichols

the take I'll of Todd. first is this part as Paul, Yes that well.

we So curves the with brands. persistency closely both pretty watched

see… start ARISTADA As consistent X, VIVITROL better for you a it's X.X, than which to is bit that pretty earlier, I've said that little approximately around for

Paul Matteis

average duration months in that saw treatment is right? You

Todd Nichols

thank you for duration which average clarification, acting what consistent longer right. a treatment see that's injectables. would the with you pretty right, is It’s Yes and month, with

to we in XXXX, with start with move get little which And as more strategically. a line what fact, to well, the utilization as two-month bit expectations option that's well. In are we with a see of as a start our ARISTADA is dosing

big need know, way the the vulnerable need we you think I a we in They patient with question anticipation are short treatment, illness serious need there mental with about they right organization for period, the as you're flows. that think is well, term about patients very across options variable is they is addiction. that now. too. And patient disruptive services, us, just flows? the and are What and talking These

soon So social we that is back the access too. fully as as soon believe as will as available treatment practices as lifted, well distancing these to them patients to come are

to patient So vulnerable flow VIVITROL XX%. approximately to your to for is flows. little bit earlier more comment, VIVITROL a XX% new patient The new is

that We MBRXs For to ARISTADA, it's XX%. as also X% and around too. well with NRXs watch within

we watch here. in so situation a short think we term it And but closely, we're very

across best we're into to and general the see healthcare apply then sciences the will into practices life that We in sector going winter a the lot that believe fall also well. as the of

in the how Rich to We better well. commercial So right flows, as XXXX actually we'll move of best to fully apply the forth that much time of practices of get period And organization. companies actually earlier through we're so that appointments and the developing too. as manage capabilities And as comments launch those we get, even and their that manage patients one will as how offices, patient made and to the on a now manage was plan leveraging how well patient healthcare now. providers will and to this we right believe that

Paul Matteis

but at were historically of around mean half XXXX, new which around the base? other treatment one Got VIVITROL the you to If does over percentages, month patient okay. what wasn't clarify percent on it, need returning the I patients I don't you I by guess, gave the just but know from maybe this, duration context months, think in it, keep adds? that your second so say case four numbers patient of of I in you four, to could is sure comments because average about if kind And VIVITROL, revenues continue maybe way of other can just

Todd Nichols

for I don't would off first a I at patient say greatest to longer see after they have way of months, is, of that that don't detail the therapy. least right duration think the a Once about of stays therapy month. this, persistency to on drop level I well have we two But tend now. second as and to the three

So it's the greatest typically off. drop the first month that we see

you've reasons of why predominant around continuity on as about talk heard and calls, the One previous us well of this is care.

It's come well have continuity that centers that really treatment solid a are through inpatient that care set residential important these that services of patients they the patients, addiction in system as too, is well these too. plan to treat as up

lot lot do how thinking care. So of continuity put do of emphasis around a support we of and strong a we

Paul Matteis

which might largely COVID units context a it that detox is just which where one about in of VIVITROL, be actually also or occurs, the competing Okay, in a guess, on from you - just the the detoxing patient pre-treatment this go in addiction talked specific is kind before context of sort you general centers, space ever last is hospital occurring search? thanks. to that largely for new I Maybe question the they for

Todd Nichols

let a on - minutes that. just me that's few Yes, spend

that's the right Predominantly, happen it to where unit. in an Typically, initiation a about see you detoxification that. with way. VIVITROL thinking prior inpatient would You're

we very with well. in the patients the landscape consistent that the for and surgeon ramifications around healthcare sector hospital are social And that broader do distancing, are as see so, COVID-XX

do will But placed you we that I for environment we know right that and as emerging emphasis trend well. of the some also how is let the an detox outpatient is establish

settings patient proper the there regarding our in environment that a from have majority about approach of care, criminal we in of inpatient point, reimbursement market too. the talked as different setting hospital, inpatient the also sure But making is well but in strategic And we've for us. a as as to only justice strategic that happened for various pillar your a well. so, detox, about setting the detox and includes group, not is access has past, within And

Paul Matteis

Got it.

Okay, it. the appreciate I so much for color. thanks

Richard Pops

Yes.

Sandra Coombs

Thanks, Paul.

ask as the many Before that we remaining folks to next we can get themselves our limit question, the question, the remaining possible queue as in so time. in take one I to people

Operator

you. Thank

question. question with your next Fitzgerald. Cantor comes Folkes from proceed with Brandon Our of line Please

Brandon Folkes

funding bolus these funding the when are get Hi, the post thanks redirected taking quickly Maybe you funding pandemic, effects? you've COVID-XX towards just had potential being given addiction, pandemic you with with question. COVID COVID-XX for state on on any for do VIVITROL addiction knock XXXX that level for seeing at think of my about that you and talked versus we'll and

Richard Pops

the I'll hey, is and color start ask no, federal Todd Brandon. that's funding for flowing any address the seeing. But been to So opioid he might I'll be crisis allocated from States, treatment the have the of opioid Federal within those ability appropriations then statute, Government states and of for and the into the the other the the to deploy addictions. monies context

allocated we which and coming funding Federal that So interruption Government. see the any don't is from in substantial

on the any that? seen state manifest haven't frontlines it comment the yet, level, do On itself but have you at Todd, we

Todd Nichols

you've think I No, it covered Rich.

Richard Pops

Yes.

Brandon Folkes

thank you. Great,

Sandra Coombs

Brandon. Thanks

Operator

Thank you.

question. your Our comes next proceed Please question with Amin line of Biren from Jefferies. with

Biren Amin

were terms On and prescriptions. other from XX% Yes. stated questions. came patients monthly in for of on psychotic? patient what year-over-year or starts just you've Hi, versus all new these provide that guys. on my ARISTADA, growth from you Thanks LAIs Can taking growth, switches, switches

Todd Nichols

I'll Yes, that as and with too. Todd. well this is start

specifically, very really think prescriptions, of way XX%. inter-axis of time. new are or period hitting new been brand So the more in that we the an closely metrics But new two share. to product pleased that very domains, starts, These patients certain for high one on with we haven't patient the about patient then, all-time of is starts new follow we're is which

and highs we've launch that. high it's XX.X% very period we're encouraged as said the hit an in now, at right of with I all-time And my prepared of brand all-time remarks, this and as well, for

and through received this now majority we is really that at of says that through the is is good we so feedback that. what even right data now, right now, sense coming our strategy that a our qualitative feel right point XXXX, substantial research line in which about Our with our

Biren Amin

you. thank Great,

Operator

Thank you.

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

Marc Goodman

clarify I if the in for Yes, into hearing someone good any pull morning. We're quarter from and any, about quarter first previous quarter? the first question multiple guess reasons one Can booking huge think that amount through you there is, multiple there was I they VIVITROL was that of sales a the just comments? pharma sales there - ARISTADA companies and your obviously. of that the is asked they're

as And how believe that revenues, to that I going because And obviously any if did VIVITROL ARISTADA as just so the royalty has implications you wondering be of have like could sounds in revenues you on and comment forward. was not manufacturing it well that the you're going for booking quarter.

Thanks. telling us you of on comment give be all J&J is of that expectations it and understand help what sense was just that your and for about on going maybe what could they April get pulled just through? you sense a could VIVITROL XX you can expectations the number? INVEGA also us give those worse we or you just And below XX% just you of I mean, clarify so were with what's trend? to a us did below So expecting there it products, down

James Frates

happening, what haven't to Yes. I And all reports we're the very Good April. Jim. into morning. understand It's so, had three three we Mark. think Sure, right, it's what's because hard exactly weeks, weeks and

all we look that seen at. the haven't we So reports would

be orders the in in of at is things like and our Some But May wholesalers, of of do to sales last to going out our as that. it year. to we those we look again, best compare are demand early coming terms QX can

through where we for pretty quarter consistent that inventory at trends sat the And VIVITROL December ARISTADA. to ‘XX. again consistent. strong and of we and the drawdown, was were saw both And compared the

XXXX XXXX units were roughly down we and ARISTADA. with in from we with where were So, from VIVITROL units roughly where inventory we're

to had And we the strong those a through orders So we out again, think wholesalers quarter. were that they were months. first the very consistent

a shift think Todd the months I part ARISTADA, thinking. from field I was of As we're injection anecdote two-month the two that that's for hearing an is interesting to is that, mean, the the discussing injection move towards perhaps the

patients patient injection actually again, of the And for physicians is the see benefit if a and actually monthly you be or a the in shift one either to monthly period to this scenario. you're to not a it some know a going two for for months for able month LAI real of time,

want just make questions. So to I sure your get

we So we what I growth again and ARISTADA, think saw VIVITROL compared to consistent last saw in quarter.

really their J&J, rates saw a there's From been in haven't the we consistent what that with in with growth had growth quarter. again information they SUSTENNA. We saw change

difference J&J part that the either. seen haven't business from So we injectable with acting any long of

COVID into So we as I headed had just first think strong impact. a quarter we the

when the comes April. at that our was decline the of with And expectations beginning the year it VIVITROL, comments to for XX% on our based on

the quarter, strongest we So the typically saw first one on the quarter we quarters of the growth have. second is

And and change in XX% orders. expected there. roughly of seen three to terms So in April, see growth the first VIVITROL we weeks we've continued that trends the in in again,

in as the Very go Northeast around we'll Massachusetts. New duration it's York, hard think long it's we to know be trends New how Again, the of through what Jersey, very the to that's And focused. watching we very We the last focused will those rest year. be. predict going

that's hopefully clarity. So more little bit a

Marc Goodman

Thanks.

James Frates

are You welcome.

Operator

you. Thank

of Our question. next question Vamil Divan Mizuho. with comes your Please proceed from with line

Vamil Divan

color the Great, for question. Thanks on all thanks. my the Thanks call. taking for

XXXX. to of a couple clarify maybe just So

now You Europe. expanding a they was that I of in just mentioned sort because new in curious, Asia-Pac are U.S. the the change of activation [indiscernible] and sort of right the of dynamics is out?

And of it's point but timeframe is that, place are sort mentioned for should through then data just things still just give if from I'm more that in second looking and around taking of something other set later the next data this wondering sort the time year. you're little Obviously, be can you - any there. the expectation Thanks. that we that already fluid, sort Right that highlighting a product? planned, the out should that, was or we release you expect quarter? of

Richard Pops

Vamil. comes sites. Rich. Europe that lot the for morning It’s as ex intravenous we of expectation enrollment at plan, melanoma, in Pacific part U.S. in for a from has monotherapy the the The look site renal always Good been and Asia ARTISTRY-X looking expansion of to particularly protocol

still is are pretty Europe quiet now, Western So to parts of right but Pacific much Asia and starting other back Europe come up.

data. ambitious but data site with we around and plan the QX expect So last and have timeframe very been shifted for a activations. they're And Those [indiscernible] a bit, September we'll QX the much the of and certainly see, part have plans up we we year. we'll little still came present

be pretty right how in to now are fluid all to conducted and trying going We're be now. these flexible up. meetings understand medical firmed They're to right when going deadlines fairly abstract are

I be significant a to program fall we'll provide in certainly and across think the we're So the by position a data accumulating update.

Operator

Thank you.

proceed Wolfe next of Akash comes line question the from with question. your Please Our Tewari with Research.

Akash Tewari

thanks on opioids withdrawal on on reset are for the in background VUMERITY on year. do in Hey, TECFIDERA VUMERITY need next observed? were consensuses much. serious to be And there you more like many How events drug and by you outcome? baking feel a any And that estimates color just million potential you $XXX to royalty samidorphan so looks TECFIDERA, it is forward? XXXX the there like patients a given like guys, Can XXXX going related patent win, the give adverse opioid trials any caused

you. more maybe launch Thank a be you the So need think expectations bit temporary? to do

Richard Pops

there's don't new anything properties background Umer's beginning the it's people the on the issue in in No, any not to I take answered think no signal. specific I'll on Akash The antagonists that receptor to issue that's says that. Hey more no, is samidorphan's about the question opioid safety opioids, contributing I I NDA what of drug when numbers XXXX was responding application. think, appearing I data but the no have I that

I'll for but what nice quarter first on drug has street in is – of they did be for of Biogen This let expected and and minimis. comment don't product because that. of in Jim de VUMERITY Biogen to and were And an and obviously grow marketing the looking plays for looking with as commercial are the then to performance it of year MS. we're expectations, very more Sandy we growth actually we the charge going sales features We Biogen I are know models this. it's the think through. more VUMERITY, prowess But this important deal we're their year. and so, from

Akash Tewari

it. Got

Sandra Coombs

Yes the models of are Biogen’s I models analysts. VUMERITY – for most think the from incorporate that

I new want right the next on looking in come we'll that looks now. days. over speculate to be like see what But few don't models range to So their

have for more We time one Melissa. please question,

Operator

Thank you.

Our next with Douglas line Please of comes H.C. Tsao from question Wainwright. question. proceed your with

Douglas Tsao

Hi, questions. good taking for the morning. Thanks

of the of by on regions COVID. most geographic impact terms I about Just, affected VIVITROL spoke in you know some

it you regional about ARISTADA ease might so on as we impact restrictions? think Just far? to can for forward Just any play you. certain curious how trends states the Thank seeing start are so

Todd Nichols

social similar they that some of seeing Yes patients customers we're accept Doug, of the watching to The clinics with Todd. practices, nuance but ARISTADA injection. is is difference feedback ability from a is still really regarding originate this more there difference. for distancing so when We're

that's is adopted specialties broader psychiatry rapidly more one psychiatry, within watching So, the therapeutic telemedicine trends other than of areas. the

of By will estimates, some telemedicine around practice rate psychiatrists report that at XX%. they a

Our a the feedback though receive available. the telemedicine physician open are is offices practice at the still injections originate qualitative there and a of accept patients we feedback sites of to will consistently that that even still is lot

for ARISTADA don't of VIVITROL. with geographic disruption do as we dramatic now, like And so a we right see

Douglas Tsao

Okay, great. Thank you very much.

Sandra Coombs

morning. for on Okay, the us joining great. everyone Thanks, this call

company. hesitate any reach very If you us have you to followup questions, the at please don't to Thank out much.

Operator

today's Thank you. conference. concludes This

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

Alkermes (ALKS) 29 Apr 202020 Q1 Earnings call transcript