ACOR - Earnings call transcript Q2 2018 | Acorda Therapeutics, Inc.

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Operator

Welcome to the Acorda Therapeutics Second Quarter 2018 Update. At this time, all participants are in a listen-only mode. There will be a question-and-answer-session to follow. Please be advised that this call is being taped at the Company's request. I will now introduce your host for today's call, Felicia Vonella, Executive Director of Investor Relations at Acorda. ahead. go Please

Felicia Vonella

Thank you.

remind statements. me this will let presentation everyone forward-looking begin, contain we Before

Our our to found are are more disclosures detailed in we you public, encourage SEC to filings. refer those and which filings,

pass now to Cohen. call Let me the CEO, over Ron Ron?

Ron Cohen

everyone. morning, Good And Felicia. Thanks

Moving taking investigational levodopa carbidopa/levodopa symptoms is regimen. treatment with Parkinson's our and OFF periods people INBRIJA disease right for in. inhaled of who are

looking remains Our October with forward we're to review and of our under MDA X, FDA, XXXX. date PDUFA the

European the we by Agency, validation end received we quarter, marketing next that the for EMA, application of the INBRIJA process. submitted Medicines the in await During or the that steps March. authorization We at

commercial and $XXX had we guidance the $XXX.X and year before also U.S. the AMPYRA June Court strong, of million, the of for AMPYRA reported decision. reiterating sales the we revenue oral Circuit, million are On net $XXX our for the were patents On we're of of for full sales our the the second side we business, X, Appeals in awaiting that quarter. July million. argument Federal

a risk for court's at July the generics generics of from launch Thus, injunction was the denied request Our by to risk court. potentially could XX, prior as preliminary to at prevent launching verdict.

we today, not of are such any As aware launches. of

which a and at includes check launched the and our out of among is with awareness Tell our many Well. off payers, recently that Moving to faces presences. livewelldotell.org. Facebook for social team managers, includes This campaign, NDA and disease for that community, Live that you The our state INBRIJA. disease discussions launch. audiences media is page reviewing Do pharmacy Parkinson's of can FDA and online And our and we preparing Acorda increasing range benefit expanding

force preparing sales launch and of materials territories, wide We programs. mapping our a range training are also

physicians there that we and be OFF experience levodopa. would levodopa work XXX,XXX market OFF study, Based very physicians research of to Approximately sales to OFF taking ask demand greater of receptivity reinforces the indicated our levodopa optimize their their on people our In drug periods. they a half experiencing with OFF who and The and periods. regimens, their in and agree extensive people OFF despite U.S. of of Parkinson's community. neurologists, disease the And their continues that also periods with We daily treatment million. market to in XX% greatest periods on with INBRIJA. periods, to the physicians both regimen study that survey inhaled that INBRIJA XXX in primary INBRIJA. a options, in of still than OFF need stated by conviction experience believe XXX In that Parkinson's are that are a frustrated stated the were bothersome." with periods. for to care we high conducted large Parkinson's receptivity XX% among OFF disease. disease same we be " would Parkinson's OFF showed XX% and patients Our their agree prescribe additional unmet market efforts market this patients doctors XX% the did people would physicians a of Parkinson's that Based simulation nearly strong Parkinson's lack patients for patients would best and survey, address needed specifically PQS research, are Parkinson's this research to the date, they and still case people and unmet specifically survey represent XXX believe quantitative periods are inhaled that surveyed that therapies need that XXX% agreed periods. $XXX for have include

that portfolio patent a have We into XXXXs. goes early the

will million well in INBRIJA body the process and potential large $XXX exclusivity we're assessing we value believe, a we know-how, to in on have key approval technology, financials I in that and ended a the and the S. which, the the long secrets and anticipated near the closing, highlight trade for gives in are of tail quarter quarter. capitalized the of a this In substantial U.S. second INBRIJA create for In with we are addition, outlines table to with market INBRIJA. particularly of of we position for This launch ex-U. cash of opportunity long-term

the additional with We The execution expect launch approval our drug of potential value Europe, to and is INBRIJA plan the that technology. well year-to-date the INBRIJA invest of harness in power ARCUS to build pulmonary to the strong throughout fueling in ability launch. capitalized therapeutics develop the further delivery pipeline we to remain to INBRIJA and company's

capabilities and to priorities Our the remainder maximize XXXX into are: approval potential. the initiate We'll strategic commercial launch neurology leverage INBRIJA's to specialty for of U.S. XXXX Acorda's first, highly accomplished INBRIJA. obtain of

time to launch plasma of accelerate peak an that inhalable migraine. and of triptans. for approximated Phase be initial priority study, injectable first will development levels I Our post-INBRIJA the to an triptan CVT-XXX acute treatment inject In of

some as the subclinical this. bronchospasm, and However, discussed, address to participants next to reformulate experienced previously step we've is

And neurology assets your capabilities. call We open now and leverage would that, neurodevelopment development have to to will for continued evaluate that also opportunities business with we the our questions. up commercial late-stage

Operator

[Operator Yee line Instructions] from Jefferies. of Michael from question comes first

Your line now is open.

Kelechi Chikere

for good Hello, Micheal. morning Kelechi on

of couple my questions a Just from end.

or I have and I the preparing do how – at for? channel launching do be need do in what – would generics you what what to that. do now? What you – question after announced in And guess, need what know to another be we risk know you we about would know First

Ron Cohen

we what all only can really not And have launched if this And evidence generics we Okay, point, other are we we are We the launched. what at say see any on can’t do speculate companies doing, risk. – so to can that they have see companies that. about doing. at monitor that's they

contingencies plan expect. as business includes Our you would

risk, at at the launch Launch on case. all For the no risk, these verdict – well, contingencies.

business our for account, of and is of all all contingencies that So we taking plan into that. have

year working we bank. help million we've have the to as over in cash us, expect plus end $XXX been INBRIJA to into for year And the last that we the think, the hard over and with we in cash move said, ensure is key beyond. to launch I

Kelechi Chikere

helps. Got it, thanks that

and Another human question, approval? know full effort confident and to approval potential are on-time prepared know, launch facility including what you review factors, based requirements? what on an you be Would you in of have you device, fully CMC a on assuming INBRIJA, any fully and launch manufacturing

Ron Cohen

beyond. everything are and you so in Yes, we board across the on mentioned

prepared on date. prepared we launch looking October forward that to approval can't confident an we X, to on we are be FDA Operator and a – we're package, the PDUFA We will on with response to we date submitted but be October speculate launch, the the and will are X. Obviously, robust

Kelechi Chikere

it. Got

Operator

line question JPMorgan. next of Kasimov comes Cory from Your from

open. line is Your now

Carmen Augustine

Hi Cory. this Thanks question. is on Carmen for the for taking

INBRIJA Just you at one uncertainty rest question how for launch the about a around if and impacting the all? prospects preparations. bit Could those of AMPYRA's talk beyond year preparations, on are the

Ron Cohen

talking case, The were about patent you right? So AMPYRA?

Carmen Augustine

patent INBRIJA. Yeah, case for is preparations your so affecting the how

force. previously think, mentioned, standard issue I had the You sales in

Ron Cohen

to are still affecting doing bring see great highly not they're quarter – into there, any it are transitioning it, motivated. who to Parkinson's might what know you launch. AMPYRA a disease the patient process benefit they can from in transition as also is and need INBRIJA job to we training an them to They out of on at They're the working The with It also force to sales are from all. is AMPYRA. and going to

case. the of regardless changes that of none So

Carmen Augustine

a on I expense Okay, thanks. quarters? tax how should quick could. Could then provide over any you think financial if few next we about the guidance

Ron Cohen

think how about what. I we am sorry, should

Carmen Augustine

Tax expense.

David Lawrence

David. is This Yeah,

the towards allowance of things corporate we've place. got rates calculations on quarterly got some basis, XX%, a So with the related our working tax and the valuation we're in we've on that that go tax but strange to

So I on least going look at give specifics you can't really forward, term. to it's near like what going any

Carmen Augustine

thanks Okay, guys.

Operator

Sachs. the from comes question Salveen next Your Richter line from Goldman

Your line is now open.

Marine Abiad

couple of questions. Abiad I My morning. on Salveen. for name is have Good Marine a

precedence is after oral Court kind all, U.S. the of that of what have arguments for at First the of legal been heard the situation Appeals?

Ron Cohen

for the I what? am legal sorry, precedent

Marine Abiad

how of ruled know? do that litigation historically Appeals in kind situations, like patent – you Court have the For the U.S. of what's

Ron Cohen

I'm sorry. in How question ruled about talking Are what what? need to respect here. they've some timing? I with kind specific of situation

Marine Abiad

what patent expiration how to with well, with the respect were they mean, Like mean, are When – I was. with is also positive I negative? timing, or respect – they more general but

Ron Cohen

we really verdict I about? talking you had sort X, not of I'm your oral on June for of court. precedent difficult. are What arguments question. being waiting trying to Okay, am are We the the and understand

of sort you precedent is sure case case is about? Every every not its So, I'm what individual. case. talking own are

Marine Abiad

kind U.S. is Okay, I it, was cases. if – how figure I in to Appeals out trying the that of of should basically say Court benevolent

Let's move to question. Quick INBRIJA.

that how process Given an injectable? from does it's inhalation the regulatory device, oral or differs approval

Ron Cohen

combination Well, dealing manufacture the dealing which device is and additional the includes you're at the of that in to me, Safety the you advice on a simple with, the that it's Because comment efficacy case, it's Fundamentally, drug that excuse pulmonary drug the the show involves I all in review of our includes with in obviously, it hurdles But CMC deliberation. differs can major which in also can’t the as layer division. division because same. their of that aspect a groups terms device both the injectable, aspect. product in reliably, FDA as it that. FDA pill, but it and oral well as not there well. different pulmonary way the and are oral from in delivery, of is In terms a and device you you're have and the versus device

groups, from other So not precepts are although they're fundamental philosophically which – approve it different involve not drug. does additional they on the any

Marine Abiad

population, for you large Got also question on the very that And quick a it's Are And the out patients? expanding centers thinking who centers? How preference? what versus guys you preparation are the treating a how launch. you're force? given – you're you patient nonacademic is about sales it. like thinking the that? academic physicians Do geographical about have Parkinson's reaching Do have

Ron Cohen

on preference – the of size force, the personal. The of verdict case. but in on the force geographical sales New sales terms depends it my Well, is York, the that's

on even exclusivity would we and this the neurology AMPYRA nice though event to to force keep So overlap two we different year, they're that sales for need detailing – the expand there's account a beyond the all there. in drugs,

expand existing from INBRIJA. into right So sales then a that force. case, shift would straight be it or we give have will we we XX%, the lose take. move the and just estimate If we by generic We'll about entry,

right they there. out as now, rightsized, INBRIJA So are selling be of to

be would It we exact force. So contract. the but expand, would would we also same not sales not

In terms certain the respect robust issues, of who even the dictated the both geographic preference, is country in terms those patients of and way physicians and into disease where are have movement have mapped the where out we primary and treating through general neurologists by with practices. it really the care Parkinson's all are, specialists disorder the to

So have gone in through it that's by data. to that's dictated everyone why is but And the is is, find I process, And We space. which force. same think, sales we the with really preferences overlap, don't AMPYRA our MS not have goes the the through. what by double we there exactly certainly

or other. in So if may it's practice country That's lack not overlap it's so to or are have to street a why and that. across out there in spread the have same there same across account specialist where is much an the movement say general both, for sales MS the overlap of the about each of practice, or disorder might they country. be the specialist Then you other to XX% in building same who neurologist from they areas the increase are account the we where treats for more the force

Marine Abiad

Thank Got much. very it. you

Operator

the line question Your James. Chico Laura next of comes from from Raymond

Your now line open. is

Laura Chico

given just the could should question. got potential quick characterize for you And the assume guessing the how impact setup And remainder this to duration during taking the I've any the Good morning, wondering over – I'm follow-up. if one the and quarter? I'm inventory of will of the XXXX, unwind we of then thanks second?

Ron Cohen

quarter, always call, levels. So mean, that in two they depending. weeks. weeks, at two talked or they've inventories first and about contraction were to which weeks said were see some two of did normalize, we normal I We we've within been to predicted and did one we have inventories the they they that also around normalize. going Typically, on

– the in we status see we is assumption again, the inventory in generics now terms depending not levels. the unremarkable see the dictate now, extent generics the completely over don't substantive do levels of on forward, year. we will of change if we of what in it's And So expect right to inventory going the any rest marketplace, our that that's

Laura Chico

Okay, one follow-up, on were discussing INBRIJA. that’s the earlier helpful. And wanted just of I to then kind complexity Ron, you clarify. just your associated comments, with

Just wondering capacity remaining Thanks. complete the you at to been again, inspections capacity could terms stand still then in stand you of to remind you do facility and And in if at launch in where What's where treat and also your of FDA? peak? of commercial terms done? us by what's supply, terms more

Ron Cohen

Okay.

we on to So unless report. ongoing need we comment don't process material something have that FDA we

is PDUFA and expect the we to the process, we're this With say that from to stand. fully months for NDA we guess accordingly, launch I the continuing launch build comment So August, status a with we're have in an be approval the see up to then and What on – to two building can PAIs stock, we'll it's up in to so where away date, a to and forward stocked of inventories, fully at look related the – planned else point are PDUFA we ongoing respect October. process. date, we we anything can't continuing we or

Laura Chico

much. very Thanks

Operator

Cowen. Your Kenneth Atkins next the question comes line of from from

Your line is now open.

Kenneth Atkins

taking for my thanks question. Hi,

to updates partner to for those ex-U. you previously partnership S.? Do plan discussions mentioned S. INBRIJA. program that You'd still Any with in that you're conversations? ex-U. regard on

Ron Cohen

We're continuing discussions. to have those

approval in We focused the mainly, on the launch you near in term as would U.S. are the U.S. and expect, the

point active we might have a to However, this discussions. – ongoing. as are we have we discussions ongoing do we wouldn't I have ex-U. when S., at deal speculate but

Kenneth Atkins

Thanks. it. Got

Operator

Ram next the of Selvaraju line Wainwright. question Your H.C. from from comes

now is line open. Your

Ram Selvaraju

much very taking for thanks Hi, my questions.

the to what qualitatively helpful. be percentage spending of would you anticipate AMPYRA? to of terms that some or time the the how percentage be us what that, respect sales detailing you appeal? spending information win and with on spending appeal time Just detailing lose give time you force its could INBRIJA be be of if would If they'd they In

looking you for with Secondly, that And pharmacy would I for a previously development asked the Parkinson's or about had involve that disposition, way a not? and to resembles you what channel which to respect using potentially specifically with specific is specialty pipeline, I opportunities the strategic in said any be would just further of this context neurology network previously to for distribution favor AMPYRA broaden about at whether INBRIJA lastly, in wanted get disease. your sense the of

opinion in if L-dopa If delivery drugs? anti-Parkinson's INBRIJA? to regarding you. time L-dopa consider an you would you would if gene the of other focused potentially other use mechanism? disease you modalities at as complement Or especially, an this And adding Thank have therapy at look Parkinson's

Ron Cohen

a That's passel questions, thanks. of Ram, hefty

that expect drugs, generic and position presupposing are is extent time, first the we respect INBRIJA, of bag. not that of be to detailing then they approval to that an the – entry, that again, presupposes INBRIJA that in them second to the would force position for there's going take and in would sales So AMPYRA with as the both

allocated time would still but would So obviously, their on when that majority flips. specifically INBRIJA, and of in case, be only exception MS they would offices, time be would The call on to have the bulk time that the be it obviously, the to – their specialist of they or MS.

we time we've AMPYRA, that done launch. have directive to touch similar the and because lion's which successful will a a This forth. on high we to and spoken is benefit a compliance launch think specialty hub will With we what that pharmacy network. say with to would to be of respect anticipate overall, that the it be distribution their that's would with is terms share of in drug more so So patients channel, prime the expect from

So On correct. we and be it absolutely good number through reasons, other BD, channel. – would and will anticipate of you're for that that a

We neurology are broadly in assets. interested

between the matter broad much pretty complementarity episodic clear specific novel did is people have periods other together a chronic beneficial that what, daily or because remain and last regimens end assets. in we interest type that address with interest OFF or regimen random year. been there a new would within is intended in to had and chronic INBRIJA, product drugs no complement they which unfortunately, regimen was Parkinson's are matter not – out no quite work on. Phase Obviously, We a with what we which that that PD get and of indicated the at X great a tozadenant But interested, have

So like we do other L-dopa modalities.

action. view in think mechanisms other view. in gene earlier our profile interesting. interested in are We our therapy very stage a higher-risk It's and We of is

So level data risk going for – time we for the in at more at be our involved. existing on thrust later-stage term, is near it least squeezed would of to assets really them a our and that depend on intermediate get overall the of because confidence based out with

Ram Selvaraju

very thank comment the question may. coming you Great, you much. quarters? trend stock-based you I comp on one Thank Could David, And quick over if you. how expect to for

David Lawrence

changes historically I on seeing what in anticipate would comp. stock-based not you're any

Ram Selvaraju

Thank you.

Operator

comes question from final Oppenheimer. from your And Olson Jay

line Your is open. now

Silvan Türkcan

for congratulations sales. on on Thank questions. you, this Olson. for taking my this is AMPYRA Thank quarter’s Jay Silvan Türkcan you And

Ron Cohen

Thank you.

Silvan Türkcan

and surveys? Can anything if a size And your your bit expected learned tell you've recent packet little utilization? us about the more launch kit you AMPYRA and from new

Ron Cohen

I the AMPYRA. I think kit? launch INBRIJA You mean heard

Silvan Türkcan

I’m INBRIJA. course sorry, of

Ron Cohen

asking And preparations? kit about the launch you're

Silvan Türkcan

up usage one-month because day. and expected five believe you doses the trial I for the in XX per used patients doses kit Yes, to have to

terms your usage post of survey? So just in what you expect

Ron Cohen

Yes.

from, talk to information look kits we what point the not look will about or but not announce time like. prepared are we'll this that I'm also kit sure at about At kits what. know where we You what a came the like. that talk pricing,

Silvan Türkcan

Okay, is great. the that going Thank Is there of to quick any Or anything judges? to the follow-up. case? your you. injection separate And read across then from be separate just denial or a a court, appeals

Ron Cohen

Yes.

way a it's same are It from what case. – or not it the very We about one-page quick have speculate was doing the not no and judges But a detailed who the means. denial. from denial that to was accurately

the respect with on there information case no have we to reading through So itself.

Silvan Türkcan

thank Okay, you.

Operator

There this Cohen. back Mr. turn I'll are to time. further no the call over at questions

Ron Cohen

you. you, here you as quarter forward for thank looking I and And move questions. and thank quarter being Well, a great your to weekend, everyone. all, a year. this think, updating vital and into We're exciting, we Have third fourth

Operator

This today's call. conference concludes

now may You disconnect.

Acorda Therapeutics (ACORQ) 2 Aug 182018 Q2 Earnings call transcript