ACOR - Earnings call transcript Q3 2018 | Acorda Therapeutics, Inc.

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Operator

Welcome to the Acorda Therapeutics Third 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.

we remind disclosures statements. our can which public, me our will SEC let refer are presentation to everyone, be and forward-looking begin, filings. Detailed contain we filings, to Before those you encourage found in

call Let Ron Cohen. up me now to pass the

Ron Cohen

mind’s the highlights morning, Happy for if million are $XXX traditional our XXXX from your the a financials as some third as presentation. that raptor $XXX mask, so you in more than Halloween, will Good and want quarter. with cash revising in we’ve to saw when in wearing We, bit million years everybody greater I than I’ll third the our am little and year our you get done greater talk to fiscal quarter about position later and start previous eye. on Halloween, head

which Our the X, symptoms and OFF periods for NDA investigational review XXXX. for FDA treatment Parkinson’s under INBRIJA, inhaled to levodopa January of date is extended by with is people our disease PDUFA with

X by The During CMC, months designated of certain which automatically that to and submitted that extends NDA. had manufacturing amendment, review controls, that PDUFA of a of FDA section questions the their the were date the related we some questions January which case. responses to were quarter, in aspects the this major X to is chemistry,

without the for Chelsea, its facility. are facility further We also the closed manufacturing Correspondence both that FDA reported that its by Massachusetts the FDA. any the inspections confirmed of the FDA the need facilities action inspections device from INBRIJA completed successfully and of inhaler manufacturing pre-approval

in with periods, forward And aiming PDUFA we January earlier the an additional United of greater the X, approval Ampyra from continued appeals ruling mid-September. the our full OFF were XXXX to coming to more appeal generic million. XXX the our of net resulting and Ampyra court’s remaining was in million. by of a these July cash Note original and We’ve dissent had in Parkinson’s for of on which we to million disagree patients. third District cash case also first than Circuit following position corporate for patent continuing by a a included the of entry. hearing disappointed our combination ruling result, Last over look believe achieved judges, constructive than sales Ampyra’s in and patents expired, INBRIJA an with revised en to Ampyra, of We net our $XXX is our a of petition en was week, this to to generic We’re to into reflect of our petition. the allocation. have unmet which for by of the expect bolstered Ampyra the to September lost bringing court for six by base erosion We end Court This over with sales invention. revising budget, XXXX million greater balance the year than major week, the to see and have months. guidance engagement this people a exclusivity vote, restructuring, nor then. vigorous cash that filed we FDA, X and through $XXX as who banc of the XXX Federal On continue significant $XXX the we Federal sales, one of $XXX patent invited and improving cash our INBRIJA weeks the with since to prudent launch need XX, monetization between X decision, do defendants the the We’ve of banc million Appeals respond and when quarter capital the Ampyra assets, million. the we XXXX, for improved prioritized three Court's which sales through since States balance secondary going our the our end were and quarter balance Circuit. We for added that the and new we’re roughly

the Our of capitalization cash this fund and X, better is now the XXXX. INBRIJA January to launch approval us than expect we this flow to at with projected of an we the that enable of significantly year, PDUFA by date beginning positivity will

many preparations by we highly of the we accumulated the X, As advance range INBRIJA our Ampyra. learnings are applying of that await decision we’ve commercialization to for launch January FDA from full of continuing the successful

sales MS. Their have Parkinson's with people INBRIJA Ampyra transfer they bringing and and people OFF teams to outstanding other done morale periods in bringing to to to now reps Our disease. high with will related is work

unmet a and range specialists engaging research plans, of are periods movement We reimbursement our training, for the patients implementing education We're about INBRIJA field initiatives we comp launch having treatment enthusiastic market our and payers, neurologists. have completed as represent OFF with physicians in disorder Parkinson's and and team incentive territory to a be large and available need will that mapping, general continuing indicate community, option. specialists, reimbursement continues that both we’re research, materials broad a preparing

among our state our awareness programs of a work of is to innovative audiences. in reflected online increase range more disease Some

to stories. share people it Parkinson's and Parkinson's personal to to Faces share their It a of talking community OFF page, about partners the OFF connect provides their and Facebook with and for each Off, of with Parkinson's other with Many videos periods of forum and recently The about experiences. surpassed XXX,XXX care members. participate learn site more includes people Our encourages The challenges

and a input designed patient of communication people believe professionals. OFF a such disease. engagement side shared a challenges. care from Parkinson's people increased The that the created and help site people with advocates, key Parkinson's periods in understanding partners partners, how community their healthcare healthcare optimize with is the professionals generate face with livewelldotell.org awareness is stakeholders the and symptoms Parkinson's initiative the manage about barriers and communicating their and that with to community we shared Another care We can to Parkinson's in includes help Parkinson's, gaps of that understanding address

INBRIJA reminder, based and a PDUFA key competing will We XXX,XXX experience has our people a believe million, OFF a opportunity our take periods. $XXX market the research XXXX. exceed on INBRIJA share believe remainder are of also and Parkinson's of are well roughly of anticipated peak which strategic levodopa capitalized launch quarter. will We U.S. We ended date This the into for to in consideration U.S. from take with initiate quarter third XXXX currently product market that takes for in In into financials for first market, with product Sunovion's taking that minority approval a priorities the are majority XXXX but As that Sunovion, outlines U.S. we January sales launch will share. $XXX and and the million for closing, a approximately significant the table retain our cash, of INBRIJA. INBRIJA.

leverage neurology will to commercial the specialty quarter's INBRIJA’s We capabilities outstanding maximize potential.

the We for is of the which We also builds such development on there substantial technology. inhalable acute of a treatment plan market to believe advance drug territory. for migraine, ARCUS a an

Cmax an an CVT-XXX, or minutes, an inhaled Our studies to about XX levels, of I average maximal of zolmitriptan, injectable. similar attainment within Phase plasma of showed

now reformulation. However, bronchoconstriction we saw evidence working are on of and subclinical

ARCUS potential also technology. other working applications the of We’re on

of & Gates those is the One Melinda Bill by Foundation. funded being

to for neurology could commercial continuing neurodevelopment We’re that assets development leverage business evaluate and opportunities stage capabilities. our late

will we call now, Operator? So, open up your for questions. the

Operator

from JPMorgan. Instructions] [Operator Kasimov Your Cory first question with comes

is open. line Your

Carmen Augustine

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

it think So, you I'm generics on, looking tail at the to kind Ampyra Ampyra on can prescription residual the their generics as market generic to give if royalties any continue would well these like share, as as for so product taken authorized other authorized particularly about the that guidance launch, market. data in us between of, you other far, relative generics more Mylan's sales the and how are receive the has branded holds as generic? looks launched share for to the substantial wondering the Mylan's that

Ron Cohen

new look with We're see as I authorized is Yes. substantial that generic to This that it. Mylan’s taken it. has territory challenged going what is here. we like. project have I’m And to It can't share. you to it tail correct is ourselves through we go to sorry, really are going help

it significant erosion seeing We’re day-by-day practically. more in generics changes we’ve as coming are discussed, and as

So, to that a what and not remains in tail is just like. it seen look to be now we’re position project to going right

Carmen Augustine

have utilization relative of do launch, And to ahead the one potential gauge kind the able market to setting, the real-world research daily product any a on you to in of then, Okay. a been of, trials? Understood. just quick clinical INBRIJA, more

Ron Cohen

… been to We've able sorry. world real I'm do

Carmen Augustine

research market … Any

Ron Cohen

You said daily utilization?

Carmen Augustine

Yeah.

Ron Cohen

going trial how on. you do would not actually sure absent that a having I'm

So, particularly on we average, answer actually, which the pretty comes anywhere usage studies trials, to the is, long-term all be consistent. I is And are have guess year. from the times these the range. a a that ranges Obviously, over out day, X.X a The little went there information would the in studies, X clinical from trials. it for a key big

use it people it use five times Some day. a don't day; every some people

X.X, study you're to out at. somewhere call and looking X.X, So, on average X.X a the day, it, between comes which depending times

Carmen Augustine

Okay. Thanks very much.

Operator

from with question next Jefferies. comes Your Michael Yee

open. is line Your

Kelechi Chikere

couple Kelechi Yee. Hi, Chikere of a had Ron. is here. on questions This Good behalf Michael just morning. We quick of

and if you how can in generic guess, think best face us you wondering So, erosion generic Ampyra value to quarter. just or monetize your will help have I strategic about that your presumably go value? was this

in You INBRIJA potential have approval the next January. in year,

to one-product company. but been going have two-product for like looks could company, a a be now, You you're it

And it people maximize you're play back you you patience as front look everything just now? do just going about If at grow INBRIJA a suited have to Acorda talk into you shareholder a process this think are looking open will this are are best your alone to you ex-US that to on you and value? standalone right well? go best just get do how and of time? and question. as how to kind INBRIJA this? should at have assume we to going about you approved, is does And to Can at over – How shareholders that partner second Is or or

Ron Cohen

determine continue to the in is management ex-US since constantly are and parties those most we that considering company are So, have respect think Board large do we that commercialization. discussions ex-US of it long measure, Those strategy value, are to considerations. and will to shareholder will based, the continuing. of partnering, makes what about terms sense With for and in announced the that we we best the the on way with in discussions

that We has an MAA been filed. have

is elsewhere the filings situation. developing at looking are We in a and world that

developments have are more material, will we we know. as everyone So, that let

Kelechi Chikere

thank Okay, you.

Operator

comes Phil question from and Cowen next Company. with Your Nadeau

Your line is open.

Phil Nadeau

questions. my taking for Good Thanks morning.

on on happen review, review it generally question passed, just the the inspections typically review. controls? of The parallel? is the about inspections towards and CMC going FDA other the with or INBRIJA's manufacturing while forth aspects and you process First the Ron, those more that is end of CMC agency there other back on successfully the CMC and are of

Ron Cohen

terms and So, know what's far know, I as is far as don't I in of this – timing Phil. just as typical

I by questions So, anchored inspections, not separate timing review the to information it's the conducted set the it's function, is the of don't anything that's That's standalone It's se but a the not inspections office, in manufacturing certainly the per of CMC a to with are FDA I that. are gospel. terms home at back of else. or facilities. the inspectors a NDA. which process, inspect then The reviewers to feed who think review to believe, CMC and tied deal who that separate do offices field The do

Phil Nadeau

it. Got

second, that change be And more PDUFA Okay. the us then the the would FDA that give about to prompted date? to questions any asked willing you information the

Ron Cohen

want would flip, I don't to is be entirely No, asked. but it you glad Halloween. I'm I not.

that's into Just of get mean, give I it's back you time a we've a some historically, When learned in waterfall. that, ongoing and and about not like we obviously it's event a is moment they forth talk in details us don't don't because capture writing we but material, snapshot of what a the something material there with experience something or is, from FDA. we disclose just resolution necessarily just taking informative. sort conversation a or

Phil Nadeau

pricing One on said, question to broadly Makes is you've past pricing for strategy sense. down. time? INBRIJA. And you the lower is volume. just last strategy and In two is price, then the paths second this somewhat the there volume, different you settled for were for at lower high on price, general high a go Have your

Ron Cohen

getting we're the logic to we'll that time because announce and the plan the pricing to it behind we closer closer our getting the work, continuing PDUFA do at our We're obviously date. is We're and launch.

of ready course, to not we're do made yet, of but lot So, we've progress. a that

point, details and to would team go a we're of the I have going – we're still So, where idea but say out the be, good to broadly, at we're yet. this public not ready working we

Phil Nadeau

for enough. questions. Fair Thanks my taking

Operator

Richter Your next Salveen Goldman question comes Sachs. from with

open. Your line is

Ross Weinreb

Salveen. for Thanks on for Ross the taking question.

what we see the INBRIJA as PDUFA, then do I follow-up. risk to approach the have you So, greatest approval? a as And

Ron Cohen

they remaining why the that ought they honestly we we to can't strong don't and on review, we're or we other the review all to Based be to not us or tell risk responded ought what I continuing during the and asked time. to than – CMC the are communications FDA CMC the we be that product what get. know where wanted is gotten, That to the the because thinking they piece From we that is the is is – which or it's we NDA communications we've what approvable. questions that believe or approved a and we had we would are I greatest the think think stand, know. get extra to privy be the approval they doing what

FDA. that, based make going for can't on are. their whatever processes Beyond we their speak decision They're to

Ross Weinreb

issues. And higher with mentioned and previously Great. use Thank compliance given would benefit then, involvement potential you. its you that from INBRIJA physician patients, so

you uptake patient compliance INBRIJA are what address planning and having its you this launch to on and anticipate do how the trajectory? impact So,

Ron Cohen

sure there. got you're a quite maybe not sure not reformulate what you little I I'm the Could question. I'm that asking bit? just

Ross Weinreb

Sure.

calls, that … mentioned the its previous benefit on So, from involvement drug would given physician you higher

Ron Cohen

on. Hold

know said used on higher high Let that involvement from you that? physician – there. You what Is training I mean different would benefit sure or me don't there not a I've means. stop … just I'm physicians it I wording

Ross Weinreb

Yes. physicians drug. the More from care of the greater with and training patient use the involvement physician the in

Ron Cohen

expect, what we Well, the what education Yes. very what robust the are how data label prescribers I works, about says. the shows, to launch, what part it are mean, we the of planning the device, showed, of the a – as trial

we So, be that. providing will

okay. demo they is ingredient, but kits, are kits. not will – the kits We be providing are the also they sample same as is samples, so on, without kits, which practice active this demonstration that can These kits

in on that it on the want should how easy. regularly sources So, they patients get well opportunity give actually to us or use so ample we the because do were training, it's tailored desires patients that that the train work and it for ways with have concerned how plans number interesting have force of It a is repeatedly sales we to to it right is very multiple there about the other there It's on, surprisingly clinical so surprised you their get say learn we from hard to to will direct to of be forth. videos master. I have from away will do different is training they about a device how it do device easy. out will it, way, it, get be and not more we want to to people. want early patients What patients' access office, demo they online, then own. kits, use how the this in a on And showing this them found some used, it

master. complicated not device So, this is terribly to a

Ross Weinreb

Great.

patient my see any up is to compliance? you on mean, be arising I complications daily. with could that do times five so, use that And question

really you're So, around my looking impacting launch compliance question uptake is at trajectory? how the initial patient drug and

Ron Cohen

able five day, have as a an question, as they that on limit by was patients long-term, the much we use the to up it study they it way, right times times is per earlier it to put as Well, and we the up day. to where we proxy that want were five the safety got and year-long a now open-label drug did, best the

those And so, analyzed we've all data.

the As were it were was Again, using day; two some times five range. earlier, they times day, it said a some using study, not every that using in it on whole one-year once some it it were few about an average, I day a days. using with twice day; a a were every maybe

the depending patients' whole symptoms. the a range the there patients' symptoms, severity of of So, is the frequency on

In terms drug. cue it patient a period, in concerned is is bothersome with the having case, reason a the the for you symptom, very be here this is than daily is of about actually we them. to that that OFF which compliance chronic would compliance, And are taking less an

the hypertension that's with, compliance their take typically come medicine. drug. The something cue say, let's So up issues a to like

are hey, OFF We day are But be becomes you and to period, it, it, feel difficult drug. in so that's you period, and a on a quickly you keep you here, it can. you as twice to know into away, don't or to that very some and taking it every as want take when don't times an or you an want day, don't day three people going OFF medicine

Ross Weinreb

you. Great. Thank

Operator

comes Your Raymond Chico next with James. from question Laura

Your line is open.

Laura Chico

just here, with be topic drug with these Obviously, in seeing how advanced; – proposals curious or is many on being focused regards news to you're thoughts set. guess too pricing influencing not I'd your get seeing drug days. policies thanks I wanted and of for regards initially to to popular morning, taking couple Good the question. on is pricing. INBRIJA the to a follow pricing I Ron, up a questions

do INBRIJA? the pricing into you're I landscape, policy considering decisions your but guess, those competitive factor as how also the landscape, So, for

Ron Cohen

of the account, all it that of payers, is day, into The taking end the payers, but takes us between the PBMs. Well, and the at a place that negotiation right? we're

to end, since in meetings patients, all discussions that access a value need so, what their their – with drug, help need to able that PBMs, get us fair the to make the And from have – over of are to payers a to conducting insurance is improve And the we mission, coming we then need allow fulfill the going customers fair and companies, where medical the overall, to they is contribution their long the create their sensitivities been the and and for them patients to the for have drug. already drug health access talking patients and and for and the where working understanding to to are, what the of society a allow which it the about of medicines educational to to win-win country, patients. have have revenue innovation, are is investment,

our did that drug, get patients that was and meaning, that my of step able that ways that's So at responding data through commercial on with conceptually a Ampyra, the – to gotten law, negotiation. reason approaching payers way are a the we've and product. I'll on who from patient with our you And been qualified That's we to were months the and clinical the showed and this where right? reception the it, one already to examples any drug. value free did is two about have pay, was approaching good subset shop And was a favorite of was with and kind based of we Ampyra, we of to, creative invented of equation, we under this entirely what payers. of able give implemented program were we there, number a the the But talking win-win in we of achieved first looking us. creative

the every but did our of in we the by way, essentially Now, that's in drug, showed it way true we trial. which

responder it obvious forth. rate had was XX% so that so So, we about or a and

predicting said, The to going to a this if way There it. in is put to you went is their on is not. insurance actually of advance We only way we and actually So, drug that to assess, reimbursement given month no it's side patient them for we good don't don't respond look, whether it the know predicting two know physician to the we patient of walking. a or do or – or and and have biomarker it. helping a for them have

what to charge for And to we is, not that. going we're do going so, what therefore, said is, you we're

take will that on We ourselves.

whether because respond, from free We do reception will managed if up conducted And two and of by then should they're a can the that now finding way, in ourselves care. about already good doctor reputation these the and door the pay months other to we're Ampyra we negotiations. And give is patient, ways most terrific when for walk got a make have the they the And what their which for we positive drug. the you payers, responding. that mind for in we they of

in have and creative walk with we they ensuring that we So, negotiating are of to very us talking open a ways and win-win.

Laura Chico

last housekeeping very is just I I one That guess, color appreciate might. I the if Ron. question, there. helpful,

guess to asking So, now exiting with is updated in due of can I'm in color And if that the that's elaborate million year Any on your because over range kind of you cash. XXXX. provide would cash the bit I actually could curious, I'm runway reason of just little you. a convert offer guidance the you've the here? that you $XXX be

Ron Cohen

million $XXX aside believe Yeah. INBRIJA at get the million, is budget to to excess given of – the of to million that but based year. Well, we that launch hand, I time. end now we to terms moment, on think yet, enough is on going a numbers $XXX haven't year us this that if when actually for where believe flexibility flow we positive INBRIJA. at of this cash that a leaving an $XXX say believe we year of gives look our so cash entire over year's for is on well year, in more projection fair the this first, think fair the year, it's And with And bit original we just I obviously next gave convert over the that earlier the of us it's you go, in

Next year, to other areas. in have launch We some do increased we'll have and expenses. some marketing expect savings

out significant time next last us year, allow to fill of to we'll a to million up it numbers for amount on those but cash INBRIJA So, get and the going early us positive. everyone $XXX ramp flow is and

Now, the convert a there. is It's real issue.

two another way price get ways it. half have you We up, a so various addressing so to as of and There know, it are, or on stock years best that. Maybe is converts. the the

So, the be what most it. as And that we’re continuing ways addressing and closer year we'll cost-effective to over the to assess would so. be the addressing get or of next we that convert

Laura Chico

very Ron. Thanks much,

Operator

Your from Stifel. Paul Matteis next comes with

Your line is open.

BenBurnett

Burnett is Matteis. Hi, on This for so much. Paul thanks Ben

So, later do for early Parkinson's INBRIJA. question in severity? will be market disease you first points strategy And guess, a in commercial on specifically, just horning how I these be stage you question, how guess, between the or the on stage? Will of groups? terms call the I approaching differ

Ron Cohen

becomes you it's are, that Typically, an that more how toward bothersome of bothersome patient. really know they Well, are the are the have to although Parkinson's it. that It's stage se, not toward the issue. OFF you periods they advanced much per so geared and more geared whether the influences

and an is, and stage, Parkinson's, it, when are that, think it's has for down motivated. trend as be why OFF younger up However, in your if TV, home, even are more be XXs, that while having their disruptive one with likely very XXs exactly if I their earlier of period and much not you even but in their you're understood period still sitting they in like say, but think retired to and active spend older, you you the for extremely OFF – don't been watching their people XXs with help right? If younger though in may general, at that, much who even let's time might want about a showing for active workforce, a very Parkinson's have people and people that, you're you there day most be like to even could someone be lives, may or

they'll often them. that, use the be worth for stated. it's just periods, more the to OFF like noting the maybe reasons our trying actually they're and In where patients for someone for ones it's I utilize it that really So, the of bothering active half younger clinical trials, drug their

I an going So, of to patient, do your doctors not what drug are terms a bothersome, and older talking label question, younger it's have We're they it that we’re our about, if here periods training gear patient, do going and toward, to it's says. in yeah, if toward mean, OFF is gear if the well, that. to this, is does here what the

BenBurnett

it. Got

think you little correct subclinical could, I Could color the, bit a Okay. mentioned on And if Makes the sense. question bronchoconstriction? that's And follow-up just I about just a wrong. migraine me product candidate. you if more us give

Ron Cohen

That's correct.

Ben Burnett

do is detail you maybe you're – there – be any you drug the into steps guess do provide The the both? really all reformulating Thanks. I And would I is that, it going just it okay. is or about And or that guess to great. have can reformulating device

Ron Cohen

Yes. it's related really mean, all. formulation. believe the device at We it's don't I to the

formulate the So, things, we're to inhalable. zolmitriptan, looking one that was are other at the ARCUS which is and the formulate is there migraine with zolmitriptan, API, to that which can the CVT-XXX, for be the used is different we broadly would which in two choices and other the are you One excipients expect.

areas, migraine the drugs. broadly of the testing those excipients, out is out inactive zolmitriptan So, for changing we’re both ingredients, other which and the also swapping

Ben Burnett

much. very Thanks Awesome. Okay.

Operator

comes Raghuram question with next H.C. from Selvaraju Your Wainwright.

Your open. line is

Raghuram Selvaraju

questions. Hi, thanks [indiscernible]

Could things? in the you here. sort trend just reference INBRIJA, little type been a the difficulty] this Parkinson's what wanted of frame things secondarily, of beyond your you what's a that And potentially on could think strategic comment with other INBRIJA, course, marketed interest of were before, transactions? the own? maybe arenas flush to maybe in other what disease this you other other items regarding if your prior do to space, I've situation disease you historically authorization see possibility order to whether is, a portfolio speaking, areas couple the looking, in at INBRIJA were entertain – you bit of [technical housekeeping understanding strategic beyond if with possibility then a provide regarding of to more is product that of anticipate of in-licensing but its entertain just might question you the INBRIJA drugs if I those going areas onto – something with Just maybe law the granularity out relatively asked us forward, in-licensing of

Ron Cohen

Yes.

prior of them we no years And dealing with mean, about with of authorizations, and I it. expect certainly there's have terms them. in those and we'll addressing Ampyra question saw experience we in see So, them. we

in because working the how doesn't, we of similar imposing of weren't are, but to as what come So, as in a they were you are summary be it the here. them we'll at and But good no years tell who can prior imposes years is auths, flavors. different quick There that see at lot nature nearly we can what what insurance address you of experience up. ensuing the in are there Ampyra way auths, our a so playbook who a then companies of with gained couple the many it, them and of I approach I we we'll was, give experience as the first we'll prior out works,

prepares assets will I be the until prior our are. that business auths would we the sweet part what accumulating lists see what development, to prior teams markets Obviously, can our be specific we respect are and our auths continuing to tell live, spot. active that's our So, very That's that's there compatible for. expertise force here. of be in of and you broadly With neurology planning development are launch with be again, speaking, commercial can't very where where teams live. our sales

we're is at. So, I broadly would looking speaking, neurology say, what

important that of a beyond technology. technology. us the has it there Now, think I because The – is twist to branch allowed to technology out an ARCUS because provides new a that ARCUS

Bob of lab dry milligram through getting get standard formulations, large Langer's less of are drug. you lungs, going It than system be of at into a drug powder the larger people, much remind amounts is to relatively typically to can unique MIT. Just out a came which than the way delivering this of with

per we're capsule. delivering XX milligrams Here

So, the it's And log well opens really neurology advantage medications where than could existing normally. therapeutic over other be you an a more up that on. areas do can over systems, and there so oral delivery beyond potential into

are others, mentioned, with we're is So, some that market. which, orphan is excited is, Gates think being case, that Melinda looking at, a first the the funded where about, one we particularly There we're in I Bill migraine diseases, Foundation. one there real by &

our but to So, helping that, we're therapies, therapies. horizons bit, where broadly a to us neurology expand a inhaled than difference. Other with inhaled looking we're make very and at the looking markets that's particularly respect we in can

Raghuram Selvaraju

neurology of applicability technology those, Is to to that be out-license in this say areas time? not outside you the are the ARCUS it that for at premature accurate if in be or might going would demonstrate they potentially that niche especially indications you works, if future,

Ron Cohen

good good point of a Never but could that, sense, I certainly the that's a an our for and I starting never, orphan we made anchoring the difficulty, strategy. that off financially thinking If or own. it thinking way Well, it. it's too about that's, not would where, where way area doing niche on close much and think, without think very a about we're say we service that commercialize

to neurology, going a have of substantial that, area pretty that's and need And at and cost. you to therapeutic outside you're whole expertise indications to what outside aware the what you staff enterprise. larger be it's neurology a for get For of new good of

where out-licensing least we about get-go, at partnering from would, someone else. So the that's or think with

Raghuram Selvaraju

Thank you. Very helpful.

Operator

Your next comes Jay question with from Oppenheimer. Olson

Your line is open.

Silvan Turkcan

considering this a the you Silvan for Thank Jay bit Olson. the long-term, drug-device combination comment more in on about what starter margin for taking a Hi, questions. it's you the Can for kits little is gross and Turkcan my maintenance kits? have INBRIJA and near-term you of you and expect

Ron Cohen

you margins doing really right have the better give we're a guidance think I we now. launch. sense mean, on of don't until on the pricing what and I I to can the get get we wait

in in once it's providing about we now, think Right will the have that in be hand. direction hand the the and be launch pricing margins. talking to So, we I information premature we expect royalties you XX% Ampyra the cost subsumed just broadly, a tell the of of be And Ampyra. them and to drug. than can I which the had goods, better actual manufacturing

So that was about an XX% margin.

be that. that will expect in INBRIJA than We better

Silvan Turkcan

sales SG&A be expect going then little are for using to a Great. bit can year, you make next investments? will you the commented we it same flat considering what force, And or additional on

Ron Cohen

when give Yes. can the on up. beginning we Again, year wait we year until the to how we're shaping guidance you see going of

we'll we're I As I there have But fair possible. for, we are when people with it's areas to that where expenses JPMorgan. prepared believe obviously back, And would around also should can going to be that projections. launch on that it's assume as said expenses we stint on that launch our we typically the sure mentioned in because hand successful make as not give we bring and earlier, I the that think to I earlier, so and as launch some do we other do more detail want

Silvan Turkcan

And last may. Thanks. I one Great. if question,

Will any just you shared your maybe was labeling we successfully us labeling, approval share the things sit pre-approval updates that, discussions until example, tight like like that For on FDA should so other with or process, entering January? concluded. or

Ron Cohen

to and blow-by-blow provide say, an tight have sit any approval. that's material expect something don't to be to both we We can that. hopefully we on until and descriptions You going

Silvan Turkcan

you very Thank quarter cash. on and Great. the much extra congrats the and

Ron Cohen

Thanks.

Operator

Janney. comes Ken [Operator from Instructions] Trbovich Your question with next

open. is line Your

Ken Trbovich

just the INBRIJA. Ron. because human the and factor up better particular a an the and for you use related made factor the as earlier how studies follow wanted the product, us trying a were Can guess, studies of factor Simply nature a population? question of human perhaps about of you I it's to sense to Thanks patient aspect human help real-world combination program. sort relative the on obviously to for use. taking for this give INBRIJA to us reason to of it's its is question studies unique a to specific ease representative comment the I the understand

Ron Cohen

includes taking aware, studies details device and And with having for but complied human factor that the can't overall so Well, that has am have representative they can't required which on human clinical all the patients, understandable of as that, as is I and this that. regulations to by the readily as factor I a I what again, population I did far experience, be studies, get shown tell well drug patient itself believe get can as our account, usable that into we into you population. –

Ken Trbovich

not the didn't all or depending that has stage at disease that progresses? I of severity the Sure. guess, as of vary I that's from understand ease in. that's with I looking use outside the the all, patient on And state. at disease of things if does described, one changes that been know but clear the

Ron Cohen

Yes.

remember, it's this way for the It's off-period. used therapy. daily So, not drug used, chronic is a maintenance

and which that disease and good earlier is tend for an in maintenance later going base into you on difference later regimens period, the an are more age function stage less The come patient in – that you a when stage stages, not your regardless. level you're a earlier, OFF less if patient regard. if as or if are level are tend reliable more an you of you're to are So, of group. in OFF a fewer progress daily with of they it's less state those you because and function, And given major is and have you're relevant when to in get you the disease period,

bridge what drug INBRIJA period inhale we an And is, between they the name as they that from the no oral showed INBRIJA, the in is the relatively rapidly by of trials the they're on then they're bridging the doses. the a if that should I as like and way as way, bridge, OFF plugging sense is to recover because the their longer going period, they the used doses OFF are reliable or move this, keep So, into into oral has drug. be. it's And

you're in slow, we no, you're so when period, And INBRIJA. have you you – So, you're of – it all state readily tremor, problems. an doesn't OFF can found not state, really that disease this point matter can readily we you you do is, And use use that was in say, group it have does stage. stage the when That well any case. we this group you're readily doesn't populations studied. across this or and there if didn't well, straightforwardly the well. used – use earlier use disease see correlation if not it's We later you'd was or where that any separation It and the it the

Ken Trbovich

that's as plan that of then, relative spending helpful. Ron, Thanks. very maybe here, And the an understanding that to hold just though of cash adequate in as launch and enhance that you've That's back potential understand by from front Ampyra no generated litigation it as the the the funding approval. guess outcome want a sort the been to balance plan commercial that you I wouldn't of there, fully sounds on clearly the the the at generic I possible have encroachment. way, impaired launch to everything is in and sense That's said, shape but just

Ron Cohen

correct. completely That's

the and through to at original ever decision As the indicated, district end purposefully quarter done to the we looking XXXX, ensure very since we've get we've setbacks. of had first I ahead that worked powder court diligently enough And of that. dry

constrained what not at launch. said, So, feeling support, are completely I we the you all on

We bit or had approaching launch. would $XXX are as We're million. one single on bank whether in not stinting we this any billion $X the we launch, the

could, of me shouldn't just that and Head are that I said funded Commercial, and not the for launch. actually we the but I if more on is come would because well ask our she that, she because we reality stinting well, Now, definitely say are

Ken Trbovich

you. Thank Terrific.

Operator

the will time, at over the presenters. And call turn I this to

Ron Cohen

you approval us, of looking new and I to call. a from to a some well ahead up us the joining an major look and building Halloween, now Happy a there. hopefully forward seeing there, drug from next on moving we'll you we're Okay. year hope agree you pretty after everyone. it of significant Well, quarter very positions for was challenges. and thank And good very

Felicia Vonella

Thank you.

Operator

conference concludes This call. today's

You may disconnect. now

Acorda Therapeutics (ACORQ) 31 Oct 182018 Q3 Earnings call transcript