Acorda Therapeutics (ACORQ) 15 Feb 182017 Q4 Earnings call transcript

Welcome to the Acorda Therapeutics' Fourth Quarter 2017 Updates. 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 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

everyone. Good morning

we begin, over will let be that we now public remind in those refer filings. I Ron. me forward-looking statements. presentation will and are contain which can the SEC this you More to our to call Before pass filings you encourage to detailed found disclosures

its of was XXXX. in number of thousands of a the needs XX% you, Good We approaches the AMPYRA XXXX. it our reflects Thank reported achieved This And strength to Felicia. MS people sclerosis. in of to which to morning, also AMPYRA the community reimbursement. we walking for with everyone. neurospecialty of $XXX net over and increase commercial with help sales milestones a has risk is creative Diving in multiple million, tens highlights which right sharing success the associated key serving also organization, providing and impairment recognized been that

We pursue our step AMPYRA next November argument, filed in of continue likely be to briefs which scheduled XXXX. next oral the months. will is the vigorously believe with in most The few replied we appeal

otherwise also early other would three they the in two approximately XXXX NDA file December. took FDA for letter positive periods at and refiled we the to levodopa to was achievement and review within process. during of efficacy the with safety Parkinson's data ask people in had important most for questions to to symptoms months Our received we INBRIJA, the refusal standard the of inhaled investigational the OFF We the our the treatment of disease. August RTF have issues After that end indicated, time respond

response strong position We to the balance in day. $XXX year refilling a ended sheet. with million financial the the expect any on We FDA the

uses positive inhaled symptoms levodopa technology addresses development X our with OFF study multiple Xb periods is safety it this represents a commercial goes Parkinson’s XXXXs. need than delivery, the it and patent clinical address significant settings and into more large opportunity, subjects long-term to for in and that earlier of it across for have medical X,XXX included is inhale studied a Moving unmet self-administered to people proprietary Phase INBRIJA, an were a disease program, data. a which and a safety INBRIJA positive quite efficacy we study, encouraging portfolio the ARCUS Phase

addition the million, on tale I gives does of technology. based and continued projections. who to have In have to people research opportunity and portfolio that will Dave, to the the long review body is U.S. that secrets large for addition now will greater INBRIJA approximately a U.S. and we exclusivity a trade particularly on market the the our in in ex-U.S. XXXX believe XXX,XXX in than you. OFF both and market we $XXX Parkinson’s financials the with which include very importantly, believe the not we pass patent periods knowhow, believe We on the call

want note to to a items I financial key take few in morning, comment Ron Thanks, of a everyone. and good results. minute our on

These tozadenant charge royalty as monetization As the quarter. for net $XX.X of fourth was operation a we GAAP in This and quarter other for income for fourth in of when revenue. asset $XXX.X our SYNXXX fourth XXXX charges recorded net programs statement million impairment royalty reporting of a non-GAAP determination approximately $XX transaction XXXX, the with In adjusted ended quarter these included of recorded as we million. for million are of we million that impairment the charges charges in result of Selincro are $XX.X proposes revenue of XXXX however received two the of as loss, the the program, program. well

We receive financial of quarter on Fampyra. right revenue XXXX, receive exchange and This from on healthcare for statements. to $XX the liability fourth as also royalty our a the in transaction partners million was recorded

continue actual will We biogen on offset to based the and royalty healthcare interest to the as revenue royalty recorded payments however the be record to liability received, revenues partners an expense. will

sheet XXXX balance of the On position in we million. the and cash strong cash $XXX equivalents ended with

guidance to revenues AMPYRA to for million. Moving net to our $XXX $XXX XXXX, million project be we

is based exclusivity R&D expenses SG&A AMPYRA the maintain These $XXX through expenses appellate to of XXXX year on associated the million. court’s expected be XXXX. the costs XXXX subject healthy $XXX be to I to Year-end to least expected call will guidance be $XXX to turn million for projected full for Ron. full INBRIJA. manufacturing cash over expect change with XX, at are expenses July million XXXX $XXX $XXX We million. include now are This decision. to is year for to at million. to back the

Dave. Thanks,

they NDA any number I XXXX, the a INBRIJA this will ones see are day read I for the milestones and expectance and won’t but clinically expect include all, corporate key month that we them expecting of So, we here in now. highlight you really

PDUFA discipline the by capitalized. the continued looking strategic our approval patent MAA in are also the advance in that and includes for appeal remain toward the and vigorous to year. first AMPYRA date quarter to prosecution INBRIJA also looking looking of of approval and priorities well to end file AMPYRA, maximize the In ensure Europe our commercialization, are the this we which a the of year. and value quarter, also also potential we closing, by decision And INBRIJA financial in would quarter. of of we this are fourth Obviously this commercialization expect the We end to a year appeal,

Operator? your take questions. now will We

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

line Your is open.

Hey, good morning, Ron.

you. ones quick Two Mike. Hey, for

Hey.

so some communications get is had filing us you FDA NDA in You should really the can a guess anything that us the of notification I a give confidence suggested initial that that about that general previously that should you acceptance presumably and know black had communicate the isn't all I you or problem. filing. will no any deficiencies. there you this with be of box to could in

programs first the question. the X efficacy. data, high feedback reported you are second pretty there stacked out to was are think because question that's Maybe with talk another think is or how we've could much. data you so differences that. program and to And So meaningful it? your clinically that recently Phase then various Thanks just And efficacy up whether gotten you some the around

Mike. Okay, great. Thanks,

accepted then So back we with any FDA after day the submission. hear hearing high statutory have hear we'll to back, get to XX and Literally the should filing usually now. timelines, around If confidence respect should we we this and back. it's the that days keeps

I would technically believe that So this Saturday. be

give if We heard advance, that. them say So be somewhere it we the already. expect at except not point reasons. from have we them for to before anymore that, in or best we on had would particulars from would Usually not this that usually that after can't would heard be

So believe data With to, we anything that's we of you've high the and to have respect really the the film than quality I technology. in referred have the you're sublingual confidence referring bottom-line. to the confidence more high NDA. And

the that we in all, those our So We that's that we've of Other about time OFF think say don't can we in peoples' changes nothing say fair. to broad thesis expect in in we of think for terms, we take these that what comes U.S. first is from them, take $XXX other but market, top, would a products We've of data believe leave or And the than comment the a will greater if we to majority let's some sales any that takes the I it million that share just data. account. into the on for said articulated periods INBRIJA significant other product market, consistently share. the INBRIJA market. for that minority take we will that than projection to

does share INBRIJA that the into market we account is player that share. another take minority it million significant $XXX that's taking the project, is in a there but So

in major studies. anything and Parkinson's Parkinson's You patients than And products studies variability especially across in notorious across the and comparing and have placebo careful very effect. major the to more variability for in data in disease. is be

you by used a we studies you if placebo the which own was NDA a study, robust look even our our Xb studies So the of main which that adequate for as program, showed one is being if way study, randomized at look the for -- controlled NDA. at Phase two

you we difference look X. that change showed placebo If one, at an X adjusted Part over in UPDRS point the

but two difference, our point If adjusted showed almost the studies on all between about effect. you based the placebo then X, differences locate Phase placebo we X were

looked the were If in the about they in studies. UPDRS, same at changes you both absolute

that acquire why rather fact you were We it in Civitas, that. statistical present fact that and studies as comparisons immediately studies, it, the is that back products. was that in the that to of we market L-dopa formulated would that try to ourselves at L-dopa, INBRIJA, they using be look populations everyone secondary caution because periods, L-dopa overall, saying the this are whenever we with choose outcome company really have toward than you back deeply, for comparisons OFF But choice like are not for see will if ARCUS strongly especially it originally Parkinson’s because valid we It's data is important. understand these different the a significance not products, make hit When INBRIJA, we're been I therapy and to to with Apomorphine say had get they and those very prescribers What technology make comfortable why on gold and to careful the number in are same for to so regard. measures that now research the their decade. dealing are caution forward time. I we space across have valid. we is on L-dopa an the they high looking different they which important the you So -- primary both was the outcomes, gravitate detailed standard came cannot they Obviously need they in you're which and

market original will into So that that drove then continues today I you our validate assumptions. decision since the to ever and and research that tell

Thank questions. appreciate confidence comments the those in you, and appreciate from both

Your next Cory Morgan. J.P. question from from comes Kasimov

Your line open. is

[ph] question. the Carmen thanks Cory, on for for taking is this Hi,

quarter, you to in for timing For there? getting given first INBRIJA, to partnership partner launch you MAA going? is an that guided just what ex-U.S. filing the optimal timeline see onboard the speak could a do for You’ve discussions how are

partner I partner Well, for optimal that is that deal timing excellent. say a get a is think the you you when overall the getting would with

would that various that's continuing not time in strategies letting most you develop it parts ready dog. have do exploring to that important before to you to year We're to We think were we The going the a launch. like in of obviously so rest it those I to and we is continuing conversations loan announced and versus ex-U.S. So, wag approval last that of partnerships the MAA the I'll to leave thing timely that have it. tail we're the get world. on way

you on are an erosion pace then, leave AMPYRA And I it expectations one at Thank. July what Thanks. for could, assuming does the if exclusivity that other question post point? of

the the is Yes so, we to that loss so that erosion conditional expect have and filers, there approval to generic you dramatic deal that. imperative with main appeal or don't us of what for a already. got we exclusivity we've deal expect our we obviously do have have If to whom with win pretty that's XX gotten we end of by several XX July, curve,

So, entrances and market curve. we rapid the erosion expect pretty multiple a would into

we We mitigate significant anything worth and because meaningful whatever taking it is the can revenue are to curve a company. to that to mitigate steps do we

projections on numbers exclusivity those you base steps that year taking curve extrapolate our will as rapidly decline. look how we based do just take at a to the of So that can July. this like, the are loss for end and year we AMPYRA case And what

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

open. is Your line

Good morning, my for thanks taking questions.

where for how couple were inspection? First else what you an you you be to manufacturing, elements Are one with were able rectify importantly that you those on about this ready commercialized INBRIJA, can bit a do year? referenced letter more manufacturing? more there a be them talk to you File guess Refuse are of INBRIJA I and INBRIJA to in the today need What later to elements

Phil. Thanks,

than inspection, really it them just related we would -- There the was we're their ready weeks. reason three one we because let put which was three other right submit for we And I'm were else that that took we something we’d manufacturing. review of the we sort presented do way It been couple out resubmit rectify to able and trivial. time wasn't to and there right much and that preferred to of probably it issue, more ordinary me it or so really which not a in only rapidly. that on have gave reason in FDA all had to ready of took were was other So, to the to was that issue only going stuff one The questions. if the manufacturing was going there. very inspection issue frankly whether the of questions, an certain about took only it have a The matter in add NDA were the months the which actually only was data yes, months

we those So the out ahead way NDA. of the resubmitting got of

and possible plant all be believe we as prepared manufacturing the about at as are we aspects it’s manufacturing. So to

inspections, We with own have mark PAI ex-FDA many external people. our experts, inspections them mark done of

as as can FDA. absent the So having we about the that had PAI confident feeling we’re from actually

So that the expect we’re chain. even entire would that manufacturing you doing reasonably think everything or would I integrity the of to unreasonably ensure do we

approval? stockpile And product in advance of Great. today able you to are manufacture to

We weeds into get this. are too on I much want to the don’t

we -- for stockpiling be year this an launch. will adequately are We expected

this we the And okay. Is or us the then signals were should safety for again be data XX one in any that for there Xb simply the Got events quarter, be it, there your second look data? later it pipeline on efficacy? what Phase could thoughts give you a looking can of is

given an endpoint if primary in is who you fact acute the they really antibody. in are we’re you an will state relapses, people introducing are safety will the charged experiencing that So immune if and

ways at sure But there ratio wanted one of relapse with myelination most magnetization CNS. no at untutored looking said the that indicators or myelination state. the various we is there one are the in in probably the to that, having markers the we be make So MRI, of an study is is better interesting to to which transfer on felt interaction acute look

in variable So we’re have of it safety here Phase as crunching relatively difficulty X number a all participants those the small a the because designed data study, study, highly is conditions. and you was very

power come is that’d very what get kind home great, conclusion. you we relative take a but be would a have really of to to number patients this some small situation. So with need you can If in of it kind a signal a of you the

is me, Got would one thoughts are authorized it. And your on last question what consider? generic for just the something you AMPYRA potential an generics, that on

preserving what we We’re with have lost tail with say we very of and have exclusivity I every authorized we guess way mitigating familiar example with Zanaflex after for is so loss experienced explored there, generics I’d the potential stream that. Phil we of revenue did on exclusivity. it the

should have be explored it want to you But we I ways We choosing. have those that right certainly comfortable authorized to thoroughly. don’t generic, commit different now of are which explored we

thanks taking it, questions. Got my for

from Piper Duncan Jaffray. from comes question Charles next Your

is line open. Your

for And that review. you been to any whether ultimately have that Ron of flow question other in taking of provide forward label on subsequent speak Hi, at process specifics, you’ll creating of near-term. wondering think to in able the to news could this looking actually if INBRIJA. Refuse to the be approved the or that about or questions an you time kind Thanks you team. and to addressed. regulatory Thought on additional clarity subjects could our and terms Wanted were about color File least and a the interactions regulatory but ask of some not some value

question, the for Charles. Thanks

to not people and that, and Refused we File, say do complicated to just never see the usual often great. something we we to were said review drug it during more So, that things as We do drug recovered look, point and well. overall less an internally me repeat FDA But to have combination your that contemplated it’s pointed that. got we’ve process. have have and device pulmonary therefore have and as happy that’s from let And I hope having

are to give the did FDA a it or which you anything review to up already So, [ph] it straight a with that good you review, questions. from and And is ahead make or it us point the -- couple of in first the NDA. of out months' to their is worth do can opportunity their that, forward they for did our doing new And lining, couple we’ve respond first give point silver easier months that that NDA, more thing. review mitigate question in is came because responded multiple of us they months two hope during of the a to original starting of the with further

So, on come means that would we us hopefully it be what this now to going timeline. is beyond the that, question gives which get up leg new

to out. in no way how that there’s think lining that Now, silver But say will respect. a for we it’s I project works sure

forward to could like that’s are chance the and is panel contemplating conducting add Okay, seem any we’ll a nice And there wondered that comm up this you look but bring PR near-term, may helpful. and question, idea they panel, the that? a of

is usability here sure and of of a letter trying that, only should it is and would own would they’ve comes with letter From a L-dopa they’re far. delivery not heard our not panel, raised The mode the into well-known our that indicate expect safety of is that. the no so down frankly they it drug. the when because to that, than be FDA. -- won’t we’ve more It happen a we difference just that we mean perspective, that We’ve Well, our indicate panel, accomplish about and anything the possibility doesn’t conversations contemplating in anything. if to any the consultants it’s with never get it inside what we’re

look long-term from Our data our safety on this. terrific perspective

what to would trying comm. accomplish, if an they were want clear not So, add it’s be to they us, to

having in want the presumably letter. If Now they that, said comm, see. an and have add they decide out we wait we’ll find to

would I’m that’s regulatory delivery of the XX review, it assuming And of use question application in foresee further merge that in and segue to the XX that to not months, eventually with Could a challenging. key of mode ARCUS the technology about last contemplate guess, here you approvability great the it’s that technology? my approvability, being to expanding terms really said overly of question. I Talking call the assuming you

Yes.

reformulation, on. plan couple which but on the Foundation. felt high we is in really focus is year, tweak We’ve of further triptan for accounted in the so the & that priorities the it already orphan MAA we’ve so interesting we Conference histories refilling, a for, year lung this issues and as once Bill by migraine patent ahead into year with of one program Gates, that triptan that not ARCUS a that the that and there It being our We was need bit that the we able in a reported of formulation and funded organization We Morgan bronchoconstriction, have programs looked seen RTF at appeal So, that Gates the of is So, a been that accelerate like accelerate one because rapid that to with programs asthma disease at our this for of and ran hopefully to JP migraine of involved on Melinda well the that Bill we the bump required last bronchoconstriction diseases some particularly a INBRIJA, people technology. plan, we as other the little inhale some was get relief to that’s a the CVT-XXX. elsewhere on. priority year’s reported of last

that. So we on are looking to continue to build

Thanks for taking questions. my

next comes Chico question James. from Your Laura from Raymond

Your open. line is

think that band. how would influencing taking mentioned expense, wondering kind could for be if my you Thank that what manufacturing about that you one, revisit R&D the the could in color more if just of you are I the follow-up. we I in just little forward? where I extent question. was you Quick thinking have of I is And a give for going should guidance be underlying a terms and us then also bit R&D

the you're or I costs Yes, the specific those right exact to numbers, loaded includes for so of Laura, the the next it's around for breakout launch, for XXXX the guidance manufacturing, launch all but can’t year for preparing fully R&D cost get into product.

FDA And we complex I I yes then emphasized come like kind follow-up RTF, a think last around drug been of question, greater senior three definitely the more issued FDA products combo guess Okay. and guidance recently seen clarity device just device of out out RTSs drug the putting is to have for leadership combination. of the four related poor

can if or communication perhaps with experience I'm kind the compared and guess how might has INBRIJA given see you between changing I INBRIJA your So if just and wondering AMPYRA? that you backdrop own agency direction just of AMPYRA opine all with at changed

and device question, the have with answer to giving FDA hard guidance has I drug better I sponsors can with that to FDA they realizes deal and to combination will combinations. yes, clarity which the they -- the that drug acknowledged they are respect doing It's device -- with that be who say, the they think

thing good them we accelerate to that we encourage and as a that hope and certainly So see process.

Thanks very much.

Jay question next Oppenheimer. from from Olson Your comes

Your open. line is

of going how with fourth talk INBRIJA? questions. the over for the in Thanks loss number for are and about taking the potential up they in guess you and doctors they calling of on. sales the to transition line then terms representatives INBRIJA to in organization launch I your just how of prepare are And quarter, of AMPYRA PDUFA July for can my for in the you exclusivity the coming

sales the for be transition a the obviously loss pitch overlap, July, the launching of new -- force it’s But for our out, sales it’s Sure, same wasn't account the where at one, important them Parkinson's so some brand sales in Parkinson's not drug, of end space. it overlap force, take be about realignment into we that of would sales the size have amount there's same sales there a force is very prospect already of the there the will drug same just to one and all I also the of will essentially exclusivity say excited I’ll seamless commercial if same force force, will will that space. by over territories the a medicines with transitions territories areas just mapped done fair it well what We've outstanding but to organization, be communities. just got are pride and they they've real there. very these important ownership and see force AMPYRA it’s you say out an in the prescribers respected delivering to neurospecialty take They complete. real it

and very for for excited have we're So happen. that us to them

if so fourth period, there transition exclusivity at approval the end an to let’s a quarter they’re still be working AMPYRA. have don't the we the loss going let's on mitigate until expect of say and to July tail the of say During we out

with on to we'll the on delivering the being they being as are best we continuing are to complete get be messages Obviously fully job with delivering it walking and They're importance about they already trained people patients, And the employed label of the do to it trained. disabilities. Parkinson's possible once will fully the now training. AMPYRA, INBRIJA. they MS disease So the

the potential. AMPYRA ready we're immediately they And as transition will be to will until maximizing that making they be as they soon launch, be they ready make will transition. So that

AMPYRA on win would people around sales high the that we the and that. very about in then and -- so have. counting. we them it if people the would would comes quality we our every appeal, XX XX%, we case, realign territories have that is of We heading which that, you're keep we intention, both under we have, increase would We expand call It or that and so in like depends problem Now by INBRIJA. something another force, it XX% promoting AMPYRA expect the But currently XXX would field. bit the add to who to

any on payers update then latest discussions. how And you've to you. feedback And about from Thank your any great. please you plan thoughts with then us those had price Okay, if you INBRIJA? can discussions

with research. we part our pricing yes, payers had of so Yes, market as have and conversations ongoing

having over months and be conversations will many We the into next launch. more the approval several

developed now. I of here drug. we think prepared And to have trends make market will of is about price We're a we we're expect my the will don't about we remarks original where today. market talk price we when -- launch, I'll pretty space, in disorder robust to I by we've proposition determination. overall the in talk an the sense as right of encouraged market, on not in into final alluded the is We entrance say until overall to as new What not period research see in a value INBRIJA we movement of receptiveness research particular the payer terms been OFF around very the the

that make now together, to million. increase point all picture about reflection research. can getting reimbursement of we're our best we're projection from market in on in the statement I entire is think potential it I it and which it INBRIJA, is a So is saying for $XXX the the our market U.S. to that putting And over the

for you my thank questions. taking Okay,

Instructions]. [Operator

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

line Your open. is

Rag. taking questions, for my you on this thank Julian is Hi, [indiscernible] for

You expected a year. decision takes at this half in previously place place is to receive from soon the the indicated this appellate after patent How oral take court? the you argument would of to for the expect AMPYRA first appeal

is it entirely the prevent timing again existing not that we July the docket if patent, had how months it's and No, a dependent that all and Typically their an It's prior but have judges repeating many factors the from to months, generics their for measured that. us months, on don't would in the launching. -- the on really it's go you and don't the that’s would we know. to on know exclusivity end. to And possible be the worth injunction that such request we XXth, verdict in

I see.

the we have verdict. Until

Okay, thanks.

Instructions] any will have to this at questions call time. the I the not over phone [Operator over do turn presenters. We

you thank everyone to updating and Thank Look for you, joining next you forward quarter. operator Alright. us.

you. Thank

concludes This conference call. today's

You may disconnect. now