ADMS - Earnings call transcript Q4 2017 | Adamas Pharmaceuticals Inc

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Operator

Welcome to the Adamas Pharmaceuticals' Fourth Quarter and Full Year 2017 Financial Results and Corporate Update Conference Call. [Operator Instructions].

As a reminder, this call is being recorded. I would now like to turn the call over to your host, Ashleigh Barreto, Director of Investor Relations and Corporate Communications at Adamas. Please go ahead.

Ashleigh Barreto

good and operator, you, afternoon, everyone. Thank

Operating on our Founder, me our Medical Financial our Officer. the our Rajiv Officer; call Went, Greg Chief Chief King, Richard Dr. are Officer; and Chairman Chief Merriweather, Dr. Patni, today Alf Joining Officer; and Executive Chief

cause contained are note call discussed events, forward-looking light by now to Before or uncertainties. risks call. new Form I'd turn this Any remind concerning these the future statements information to actual these results in obligation such over statements, are with differ forward-looking forward-looking detail that Greg. statements everyone or I'll greater could to XX-K Information begin, SEC results from contain looking undertake Please materially We of which or our filed future or statements revise forward and the statements. to expectations to only update we opinions implied no that those in this our in the of regarding events. statements like in will statements are that forward-looking subject of call date factors reflect as today.

Gregory Went

to today. Thank good thank and afternoon joining us and you, for Ashley, you everyone,

care FDA-approved studies it us that proof disease so is Let approach. with is the represents temporal and medicine for only costly, is made proven we open-label the to troublesome particularly care soon-to-be-completed, supported robust disease controlled patients team to only largest therapy. to our the of in the the improvement disorder to a the patterns important durable two-year of by to of benefits partners with included and deliver to was of approval the amantadine, Parkinson's GOCOVRI, is second why and Use and the Through clinically well NCE-like also, of time not Parkinson's in the biology I'm XXXX, treatment GOCOVRI. market levodopa-based This time-depended our a time and patients. dyskinesia underlying the health program Parkinson's discovered both and disease, the effects me medicine begin time the dyskinesia is developed study. a without and for understanding by disease but GOCOVRI to system. This today incredibly daily clinical important patients significant bring and which nonclinical point a most safety patients proud ON and or first mechanisms Parkinson's FDA, three development four-hour burdensome neurodegenerative especially studies, of saying, required by systems as OFF of a in accomplishments functional the Adamas had receiving by GOCOVRI substantial provide as response biological dyskinesia. in commercialization medicines of

we that help proud patients providing are are now to We these in need.

the I Alf to approval over the the Before to OSMOLEX to review I hand call recent the would of like of label. address ER results quarter,

to a evaluate in disease and others Parkinson's to are We approval, continuing the was community. surprise the which us

no we based bioequivalence immediate inherits amantadine was of its information of data studies this be most approval with between that data. from regulatory the amantadine. fact clinical generic release First, label on degree there on it ER bioavailability healthy and its immediate from OSMOLEX volunteers some release must label, new in Based assume and

in indications for safety lack version efficacy drug-induced use amantadine. any of to appears, longer-lasting or release or as that be has disease data, the new it extrapyramidal given release a same amantadine the Parkinson's systems immediate Second, of simply immediate

disorder. and as this dyskinesia of is a approved Importantly, distinct orphan-movement not it in is for disease, separate use the Parkinson's

lack that of one We As amantadine dyskinesia believe being and drug, not long due but a doses. poor benefit Parkinson's, of is in immediate release durable half-life a to you higher challenge the recall, intolerability of issues inconvenient and of efficacy to levels are amantadine of having at dosing, required inability higher levels due the evening. the and to is amantadine plasma tolerability to in in day, the get to during efficacy due afternoon the the the and lack the morning

As we this addresses time. in low have immediate Conference results remaining of a the presented challenge. at Port very release last Ice over number amantadine patients Parkinson's GOCOVRI year, on that

for address could Our that we be opportunity changed. view the has recognized to the there will positions be and pairs, confusion, patients. it not of and We with GOCOVRI vigilant

However, over to know we like more. today, and learn you With the continue we we will that, we Alf. what call to - turn as I'd that's will to update

Alfred Merriweather

the our XX-person I'm pharmacy. pleased loss the from method cover force recorded Greg. of This our net sales till in recorded in for million the Thanks, sale which with the our briefly Net loss our through on we $XXX,XXX in January additional for of begin selling I'll October channel to XXXX, upon XXXX. not GOCOVRI. return aspects and financials specialty was GOCOVRI fourth to $XX compared $XX.X then of million framework net some should revenue revenue, a we in revenue. of for report the our strong amounted distribution same promotion, quarter to period XXXX. quarter without recognized reporting to product our placed is delivery that in to revenue first was

were year. providing for XXXX complete million XXXX. to a XXXX end costs the the just expenses, III $XX.X our ADS-XXXX the $XX.X November. administrative, quarter net launch for sales to the January marketing R&D quarter, For XXXX, for as was for the of walking will $XX XXXX. will in and full prepare we ongoing $XX.X spend the year million Phase the the fourth reported these of fourth data on open-label of guidance launch, full initiation of GOCOVRI Expense we XXXX $XX programs from million for study. study, million hiring study in the XXXX year. includes of year. well selling, With expense of occurred at the costs million as for and month, and open-label for for during expenses reflects included quarter which and the our III million. million GOCOVRI for MS study for general and of the loss fourth of one million in million Accordingly, or with we quarter manufacturing force $XX.X $XX XXXX and the development Phase infrastructure in to respect reduced GOCOVRI to the and for $X.X Research are $XX.X related Also In MS epilepsy. second SG&A The of commercial the in based building the in level and cost and walking increase, preparation programs compared readout in costs initiate R&D costs the a year, were preapproval

For significantly the of $XXX $XXX commercialization million XXXX, expenses with to After SG&A will increase GOCOVRI. we XXXX, full SG&A for of million. are guidance expense providing

of and $XXX.X issuance cash proceeds million. with December of completed $XXX.X million. offering we net January through XXXX, XXXX, X,XXX,XXX investments the XX, as In Our of shares, was a follow-on

With we today's capitalized execute we well call. on these are that funds, to on will programs describe

Gross in we remind our through laid We patients dyskinesia. an Before framework this you XXX,XXX average GTN, for framework, September. investors Net, are co-payer, to the the with as to parameters specific but payers There Day the is providing factors passing that Parkinson's at we in looking the aid Investor let XXX,XXX the financial was a XXXX of patient Further framework possible thinking for for first on call to patient Also, that contracting population recall in to including in out with XX% that are disease of this and the launch. XX% framework, penetration we part impact at an contribute of adoption is after relevant year the Richard, our initial of Recall mix, guidance. space appropriate this to providing patients. that that range. population reasonable or are target not X% we to commercial suggested that payer as launches potential target me basis, quarter-to-quarter revenue [indiscernible] a a suggested many will as

settle. on where we still this this and range will to early We early it's too simply in an the believe to investors are launch, But consider. to comment appropriate is

very have including payers we to-date, GOCOVRI. framework revenue that are progress our overall to with the reaction positions and both Within I of pleased the just described,

first addition during to that in out for for framework commencing reporting our and laid XX, QX, will report XXXX, In December through we prescriptions we financial which prescriptions number filled reported our call, GOCOVRI. January, have be with information, also quarter with GAAP XXXX, prescribers will the We May. the written quarter. of Starting of early XXX prescribers number in the

I six adoption XX, will strong As among discuss sales number the of the reflecting deployment increased just weeks pass XXX, commercial February good XXXX to activities. growth Richard over of our to has force. GOCOVRI initial drug to physicians of now and this in

Richard King

Alf. you, Thank

treating approval clinically proven and don't four were diaries, dyskinesia. dyskinesia and dyskinesia. as only by people of approved, for approximately disease Parkinson's without functional physicians treating GOCOVRI, Parkinson's specifically have as disease compared patient increase launch troublesome the reduces not about reduced ON time dyskinesia been now to XX% XX% trials, with symptoms. time, by by to in people and day, managing choose a hours time placebo, significantly In GOCOVRI FDA clinical approximately also it OFF the time With have hand between to first This measured that OFF means

the more interest to gold-standard to from we see more for it development in we Parkinson's have control believe underlying We disease, program. utilize the will turn we now me progress fully our the treatment symptoms, so from to Importantly, physicians Parkinson's that made GOCOVRI, fully launch as levodopa, product. let the them to - as evidenced disease allow strong

impacted our account years center We clinical you industry the the a having - in sales We highly experience. neurology two people attend of meeting of pharma the we tracking look than forward in have effectively or of lives. a their GOCOVRI to times launch were levodopa. we meeting years to GOCOVRI. our recall a with team, with completed team, recruited on January and The which, for now how training again some pleased specialists But January of alternate experiences sales in the have treated you disconnected have hear launch neurologic day, disease. episodes that to these pose specialists of from can both and Parkinson's similar, and moving qualified specific the of more happily daily deployed daily dyskinesia, recall, focused enabling since prescriptions daily treatment that movement challenges pointing nine managing experience prior frequency averaging reported experience will at X, have trials neurology the their and XX on return more with had living disorder time, the GOCOVRI is GOCOVRI XX received and each XX% dyskinesia the and in Their between are as and to appointed with we report that new treatment of and daily their their extremely team effectively. for seen account conjunction of experience, of field As participants OFF to I'm of as use had activity each to would with X into growth direct prescribers X each both patients GOCOVRI.

February the we as is XXX GOCOVRI And strong for a of at activity aware prescribers physicians before typically make it visits them period. GOCOVRI the prescriber, as subscribers, of reflects over to engages I've remind they XX, so prescribers a data. As in takes This to you, first up time such short several XXXX. encouraging from sales to the December begin XXX organization, the have growth very it in XX, to noted, prescribe, the

to aware dyskinesia. that causes the discussion awareness available potential of and from clinical we digital of the profile in and dyskinesia directed underlying at of the campaign for not Parkinson's many our In deployed since Also cases, distinction addition, believe, program patients education January, treatment we experience disease, the and clinical speaker and elevating of in introduced a provide dyskinesia's, late February, other Parkinson's are symptoms to with in now early patients we GOCOVRI. marketing peer-to-peer options

to for in criteria, discussions payers moving these even with not received, presentations are note published routinely reimbursement full to well situations guidelines that our receive GOCOVRI payers seeing patients know, payers It reimbursement. and have been for determine regarding in As in their you swing. we important are Clinical in GOCOVRI. have is process reimbursement forward which are

well engage We streamline prescriptions, claims GOCOVRI. and is the GOCOVRI to of to in gaining working of processing majority with Medicare both to continue payers commercial coverage patients to GOCOVRI. for receipt process Onboard access the

have program than receive trial XX-day a We benefits We a majority To program. date, if five verification days. do drug are To a patients is specialty and not process can have close. do providing pharmacy. free QuickStart this taking not Program, patients we more a through not the qualified supply free samples, of utilized our have whereby

with first quarter May. Although our With are it's in the very to launch. call we early, pass forward look we patients We the reporting are our and pleased progress seeing of I'll access that, to Rajiv. in the sales of over

Rajiv Patni

afternoon. Thanks, Richard, and good

demonstrate awareness medical are recently of the will published to neuroscience. the with and expanding Adamas and commitment our clinical collaboration and at conferences. advisors with at how medical our applies advancing education continue expert to biology publications We upcoming our discovery, time-dependent to in manuscripts we presentations community and presentations These enforce how of development preclinical

and amantadine we is motor typical publication, which subgroup for blinded effects subgroup, a hydrochloride-immediate to XXX in patients recall of It switching there release subgroup reduction with report milligrams with GOCOVRI, efficacy twice after milligrams start Clinical to the comparable in safety open-label of clinical patients important publication amantadine In in patients complications higher amantadine to the release, hydrochloride dose a the and in this which daily this of Disorders release was was used XXX than amantadine-immediate the In of previously Let's IR dose recent practice. was switched average of amantadine-immediate placebo. of GOCOVRI. XX% treated in taking is data seen Movement this to the Practice.

that GOCOVRI publication, even open-label efficacy because higher-than-average very of provides neurology from are clinical differentiates doses excited We about release. that with data amantadine-immediate community this it

XX% of multiple speed at several from including a experienced Multiple a we addition, on in improvement speed published with patients the placebo-controlled, patients and significant with four-week, sclerosis in walking walking walking baseline our This statistically proof-of-concept proportion in In in XX-patient study baseline. least ADS-XXXX improvement Journal. impairment walking an from study XX% greater Sclerosis a measures, effect ADS-XXXX-treated demonstrated

we III We into in enrollment impairment. towards are MS progressed pleased Phase with this walking with timely patients ADS-XXXX publication, of the as study

On on I abstract our data will on of ADS-XXXX. posters, happy the new that these present GOCOVRI and am new submissions American efficacy In and all meeting, Stay Academy accepted. Neurology of data announce to have been we safety six tuned.

early to turn sclerosis. trial quarter. second to our patient the with multiple Let Phase me now progress enroll track remain We III on in the first by

XXXX. first measure outcome we meet by new XXX to In be the finding will Based initiating milligrams drug XXX We a the either study to XX% is increase of least market randomized of weeks II The this reminder, of As milligrams of and with primary to a ADS-XXXX XX study Phase the for evenly this subjects objective at of look treatment. second that the double-blind to XXX enrolled forward FDA, study. a walking placebo, patients is or trial. the FDA consultation on in speed. ADS-XXXX trial, decide results pivotal the with this confirm experience bringing III Phase before may to proportion indication

to With are we our month, funded capital raised discovery new now advance the programs. product additional we last

programs discovery focus time - to neurologic psychiatric continue diseases dependencies. by Our characterized and will neurological

create the We symptomatology profile concentration will designed of of time to these current and map unlock medicines. a the and unique the potential mechanisms then proprietary

and We With advance manageable year develop to year X We that, per large will per will development with back into to to one then tolerability. plan to hand Greg. discovery the clinical again, projects once treatment NCE-like pursue, contact compound development. X over call drug effects I

Gregory Went

is of are Through of care time of we At based patients our yield the We lives that from changing that Thanks, our patients. to enable differences us think diseases. approach. neurological in promise Adamas, what's we it that on ourselves interest their GOCOVRI, in because the mission partners lives upon is time-depended best that our Rajiv. discovering improve our large, pride meaningful delivering suffering of clinical medicines the benefits, are people's biology and

GOCOVRI's you our call full launch with call the questions. up to clinical the May. look development and on is events you on quarter, Alf I of how at would other open As With that, April like very pleased for in the are both reporting of QX on and AAN quarter noted, GOCOVRI momentum. We to many seeing first launch gaining our we updating in Richard during forward early Operator?

Operator

Instructions]. from question ISI. [Operator Evercore line from And Schimmer Josh comes first the our of

Joshua Schimmer

on time just prescription's the from GOCOVRI give filled, serious, when this rate the average it's at as you're the point. One launch, turnaround able or to whether to written rejection under number written us for of such estimate prescriptions an filled rates well or when metrics, as

Gregory Went

that I'm call. the to handle allow one. Richard going for thanks Josh, to

Richard King

to this update talk early those the May We're stage, the in our accordingly. think, relative thinking you're prevent some I come is, of number we'll all at what our very call, prescribers. of to launch as about phase, there. we still we So information George, obviously, to parameters

Joshua Schimmer

Okay. And for that Osmotica then more that the opportunities specifically Does as positioning after OSMOLEX your product sounds around, forward? indication? like the label change of expansion is perhaps, about to you It your GOCOVRI, think path does approach change ERCOT availability going your dyskinesia.

Gregory Went

take in availability is data that of the amantadine. Josh, from that. new that. The very based recall potential early light to of comments, It's of of the and I has our immediate-release of label that indications GOCOVRI don't from 'XXs much light look based is label attempts - which 'XXs. treatment. in think immediate-release as at And is amantadine all the evaluating the for upon Greg. for are available It's that early spread But think I'll I so. days OSMOLEX my the still

those early would to have. too will what into And instance. - competitive treating see will mix declare it's of the it it what it don't landscape it other really put But affecting with are the so this it the and definitely products that - that be products. for still indications But I effect at

Joshua Schimmer

terms last we should and the litigation to case, then also And can in declared we expect the expect, question, be for timelines what patent infringement initiated? of judgment other

Gregory Went

With days. comment on active judgment, respect served, We've in to litigation. don't is early cases - the been its and we that's declared

So there challenging a a Adamas' out or update. decision really But where of with this the rendered one much infringement standard clear, itself, for patents won't to product. to And of process. GOCOVRI is is a separate it a GOCOVRI, case get of not an be to regards patents it's

any of But rule time, evaluate, our out. are will any expectations marketplace, other no our it certainly where So in infringers we always in carefully, of patent point at ones this can't defend the patents - statement. and the

Operator

our question and comes next Ken And line from Cowan Cacciatore Company. the of from

Kenneth Cacciatore

I wanted deeper. drill details bit really managed Just some fast a care. down of in of terms the was little on

coverage down the us where on seems So give again, spending, not, authorizations sense, actually of and you whether all these on discussions going going? drilling drilling ones prescriptions, prior a can again, the stands spending of think probably, then some million. as there the covered turn terms mis-modeling, bit there's any it's given XX you dealing well? lot been about managers maybe, and sense. on in higher. my plans, Are new how a these about lives, down us help spending but the of a of divisional if we're can And reps that? give you you or And with the Can If $XX some where of I on on little of, per, $XXX,XXX in, to some even be then or million the maybe to is and $XX add buying kind

Gregory Went

a are GOCOVRI do that when I as they black-and-white public as is have that's approval coverage much think going we're And Ken. care first of the But decision seeing, made to coverage. prescriptions and for GOCOVRI. sake prescriptions, not of formal important define conclusions for of there have of manage of good that according manage to criteria I that realize few presented. whether we're black-and-white prior We of coverage argument. that every or GOCOVRI me how actually traditionally payers will to yes, fulfillment and which very But prescription people coverage. situation which very are that most those What plan. some pathway. not that coverage with There's the responsiveness, situation. - that a have have leads call think formal managed in deal number we handling in published to situation, fulfilling. in at they results things, experiencing I'm the think situation. And authorization across then the plans ultimately, a are addressed you of is to, plans and GOCOVRI regardless not or black-and-white a - the decision, that all handle presented Let then really cases, we'll publicly to set here fulfillment. request, of The dealt across do we've made That's side not decision seeing that And with, prescription and

of decisions not handful have they not. people a are We where have general, published people a filed fulfilling whether fulfilling, in all are But plan prescriptions. or

Kenneth Cacciatore

And with the to a regards follow-up plans?

Alfred Merriweather

et mean, with includes our is you're force SG&A cost. significant legal, spend. that, the finance, I like. cetera, the sales programs a Yes, dollars, people fairly regard Ken, right and administration patent set reasonably also program marketing our There's significant. include cost how course, would behind dollars you functions, which also under of of And frame the in to and

sales fair included a the of in that. amount force specific things and there's is So into,

Operator

And from our Butler of next Securities. comes from line JMP the Jason question

Unidentified Analyst

Are lower to II? for of the you you describe III. drove a are used use using Jason. Can what couple about lower walking you the Ryan a decision It's dose? MS I Phase that had than Phase a doses questions what couple in

Gregory Went

also XXX when salt. is express II, the So a milligram you it dose, in the milligrams we're as testing is same dosing the as Phase XXX which which

salt. XXX a the same dose, amantadine in the FDA, also XXX a consultation is lower they dose which the explore the milligrams us to amantadine with as And dose. or that's So encouraged when milligrams of expressed

as dose, So we all based the in lower testing why tested FDA that II testing on we're Phase feedback. as dose is well the

Unidentified Analyst

that you expect plateau any assumption Okay, tell you response Phase assumptions placebo the placebo it II? powering, you expect Do due for weeks? the And Phase got around response four the Is us in the can possibly at around III? for it. also to

Gregory Went

what is it's trial needs the been will for on based for Phase we it's based in understanding on power what say most [indiscernible] to interaction. confirmed our FDA the what X. observed with Phase I So III, X, II. III program Number is Phase be the of three, number done it III that Number Phase it's importantly, with and our

Operator

our Lugo And next question from Blair. comes from the William Tim line of

Timothy Lugo

majority For And need defining that these going them? QuickStart the for of the patients give do a is kind us because feature reimbursement you patients? relatively is product, not who smooth of some can of

Alfred Merriweather

smoothly, getting can of give move - and is, environment, relatively you I'm no get all where before than characteristics QuickStart. no reimbursement you the point more there's any across that It Medicare. that towards it's and payer point all seeing to sure characteristic there's We're even a not commercial. particular because at different going I we we stage. need They're patient all I can to I a than, we're can't they're say, environment other this

Timothy Lugo

for of those you'll you Okay. QuickStarts? those a - the have of And what's Program, believe who the how for then And get did then maybe QuickStart rate needed capture kind ultimate patients? what's two many need patients the

Richard King

stage. So The will it to be at very new this QuickStart. me too to capture early few rate, speculate for are

Timothy Lugo

on question the last one maybe pipeline. And Right.

competitor you in many be line clinical how are will any arm And what it therapy end, doses, XXXX, and again? developing trials? that of of by For your

Richard King

about will and going so talked this just this. we've to remind as meeting you we've review - all So we we're FDA have reported, where before, an we that

as of thinking XXX a high And day. addition arm Our a have also XXX twice importantly, XXXX, VIMPAT most milligrams. versus to an as and well placebo, test will in dose is milligrams milligrams we of XXX

our approach superiority to development trials of superiority two analyses. ADS-XXXX have is really or to the So two

and the other versus versus One VIMPAT. of XXXX placebo

Operator

the & And Serge our Belanger comes of next from Company. question from line Needham

Serge Belanger

taken label the it the guess, of the you that mentioned by approval were I a or OSMOLEX. Chris, approval with the you surprise? Greg, Was caught you path on product. surprise to was by question actual - it

Gregory Went

you dyskinesia. following they Well, and as levodopa-induced the Serge, what for product tracking been know, we've developing were

comes really, on, any the indication absent approved surprise So the of going to the in light to trials support pathway. its of drug clinical appearance from product, and support the indication the And absent of label, of to in the and Parkinson's any extraparameter modern clinical IR support amantadine clinical is in parent, and the use data, its data, pretty or its which use symptoms. drug-induced

other and are at those community. So things - the guard soft

Serge Belanger

do to address Okay. know, I designed threat then GOCOVRI And that think is but at early, it's right now promotional the well OSMOLEX still - point? your campaign you any this

Gregory Went

me Let to start in. and by answering see chime which ones

Some of hasn't there XXXX, back use frankly, were a in available in amantadine Adamas, - the with start that, the changed to much immediate-release pattern was last XX XX years.

establish to a hit back comes things team that high on when patient patterns you interact, disease, figure night point, the benefit, marketplace, that that be in plasma lower been the drug, the that accumulates the two target began see see. timing very have given to two which requirements the with to day, don't to use a we've interact in hours Rajiv's certain a how out how up significantly to is the at prior How on promote give have taking - levodopa and to which heading during the the amantadine range And to And that and so preparing evening at wakes which of immediate-release before a profile, accustomed a of into and situation began papers XX% a to is to their level of therapeutic by The into because levodopa rise in morning. at to X,XXX pattern is We publish label, needed of those the looking biology given we patient morning, slowly understood profile We've the and the allowed mid-XXXXs, then rise the, any particularly not is has those it. we order the and it amantadine, of biology ml when the begun to of just we the descending not nanograms dose wide gives the use twice board. sleep. than reflected this to first the in in high? durable night, time, as going per to GOCOVRI changed, with really, to

So for product see confusion could amantadine immediate-release the don't significant I market. than a prepared Richard, at pose adjustment other like the another being that to moment, the any..

Richard King

the is package, safety the efficacy about of now, And from patient to data add population. OFF payer at dyskinesia the both strong derived in five been four, the dataset. amantadine which very and very GOCOVRI and GOCOVRI Parkinson's the available. and community dyskinesia in only which IR the very right And that's use resulting the value that supported And for environment been in that's physician in that's on for clearly community, is and that in presenting payer robust the we've level. package the a months that resident proposition I'll demonstrates clearly by physician support

changes or is to believe think Cosmo that you the ICR basically IR in to don't to amantadine, an proposition the physician value that to equivalency light. committee if I that payer So then even

Serge Belanger

meeting with this on questions of XXXX. point? couple scheduled at been your the Just Has FDA

Gregory Went

when We of we back comment meetings, the report will we on minutes. don't typically but have scheduling

Serge Belanger

Okay. initiation here, Phase And III program the early 'XX? still for scheduled of the it's

Gregory Went

of outcome that Serge. Yes, FDA meeting. Pending

Operator

line Northland from comes question the Byrnes Carl of And our from next Securities.

Carl Byrnes

off-label company the favorable and strikes, possible working these administration, in the going assumption to - things So OSMOLEX and release will. next which the you which Medicare fines mean, reimburse in nature indication? for marketed respect work not of questions. that quick I LID, will steps sort I'm of substantial to general, the preemptive be time-dependent obviously next specifically, at be in the be you, your how item. it course the marketing this, PI is of with given didn't the the real what off-label for just for and if that's risk the enforceable. in aren't what back clear that done you've can first action? just be PI couple isn't is then second of the And How history, with GOCOVRI given and the morning given is might declamatory judgement, to item, for forceable, the be a the it administrating What for really evening. They're come Just

Gregory Went

two in your three questions. questions had You embedded

throw to So substances. and quick answers give to for it Richard I'll over try

first the - all, patients. indicated indications first your of OSMOLEX Parkinson's not on it with not treatment and overlap release indicated, with it's for that now not question, So of dyskinesia. is varies which are dyskinesia levodopa It had, do not in amantadine-immediate

many you as infringe the these one. two patents them patents. is, GOCOVRI. decision that's court a Number and from know, they regards and read So that you've don't number in are are that seeking this separate cases is from distinct our that really, to declamatory, patents And protect

will So of you With on Richard, course point? how is do and at our proceed action to we're want complaint that just basis. the Medicare comment evaluating and the on to respect to this respond, going that

Richard King

spring regarding specific unique late the approaching the will indications be way. we It's very unique that in question. a Medicare, Medicare year projects GOCOVRI, And great regarding traditionally, in a indications this manages with GOCOVRI. of Obviously,

that with So up work plan following we'll through on CMS through it then and Medicare we that. in will level And the at get general.

Gregory Went

OSMOLEX majority one more common just What a two could raised very because past that you products make I by active very Everything label - the have ingredient. those a different. health do. it I The and and actually Adamas, through distinctions respect IR. think nicely. upon in point, is and package, written efficacy 'XXs labels primarily our expect, participants based we understand our inheriting to going Full all labels those that do from the these NCE-like them the that was we is amantadine efforts what a attributed 'XXs very in permit care If data. to are system hope, is And to from very and

Operator

of question our next Schimmer Evercore from Josh the comes from ISI. And line

Joshua Schimmer

revenue? sell-in of the bunch how relative we think that in fourth - subsequent can to in just a the revenue we in quarter the see Got gross-to-net the interpret discount how recognize quarters? recognition what the quarter, of model. revenue What fourth least, to And what you we questions terms recognized outline criteria at are might was about and the might in

Alfred Merriweather

are there to transition what the no Everyone in past, And which changing. which to QX. able Josh, a to do. you're method, In [indiscernible], rules selling using, use is had is you the may was The as know, flexibly, XXXX. to we're was flexibility. in There's you able required prove been sell- use we've

So held to ourselves. some really delivered by the but inventory, is sell-in product method maintain inventory means that who we take is revenue will when primary Walgreens the

go revenue there piece it small inventory be we been at Walgreens. be difference, incremental extent built a forward, won't significant, is a as particularly the to but is there will which at of So that

much certainly issue through is - it's comprises will - will there always to So element regard is. than be revenue as [indiscernible] from with into year, how a not to of in an quarter-to-quarter that. the that gross-to-net gross-to-that, details quarterly entirely, on the basis, but sort we later And be regard mean, people getting variability of But a work there more QX I difference on that won't be with for that.

certainly will there consciously XX% be of XX% So to will left general. quarter-to-quarter fairly we suggestion our and variability

expect level the in end perhaps, of quarter level at year would You the in with and higher the transitions between. a lower first

Joshua Schimmer

Okay.

large-related unique, rebates into of, So for that? factor are discounts other no kind a there and

Alfred Merriweather

No.

Joshua Schimmer

patient And then products basis, ... by a to patient delivered Walgreens on that's

Alfred Merriweather

- they a at short-term on inventory. based order prescriptions this some maintain coming the or fairly And quarterly like they monthly a see No, based order, they their that's on as order quickly. fairly expectations, And level the of on basis. through. needed not

Joshua Schimmer

Okay.

shipped the if were investors of not reason, shipment? So then we fourth whatever that number are quarter, that written as prescriptions ship in whether wondering, adjust inventory product I in the prescription wondering but time turnaround guess, and to that was for actually of for some as

Alfred Merriweather

coming some delays, to shipments is be the of certainly little Walgreen independent will there the that Well, timing of bit a of through. Josh. don't the I But shipment prescriptions think

needed. up see, their filling as they they're inventory So as

Joshua Schimmer

inventory Any of in amount that? estimate to way the

Alfred Merriweather

not being weeks, of measured in it You should think months.

Operator

And our next question comes from the line of Caroline Paula Meek capital. from Noble

Caroline Palomeque

wondering just a little I any I will And on just formulary updates? I on there other that could - if you off you updates know, adoption. any other bit. was wondered GOCOVRI if originally that It in mid-XXXX. And go elaborate And had seems said the like were just think

Gregory Went

of place formalized you of terms - early So be we filled, realize - where of I on. progress GOCOVRI, formally prescriptions appear a handling announced roughly GOCOVRI coverage, outside not in is continue from procedure have I formal time filled. seeing to we almost XX high the think published referenced number as I as implants same seeing being in see vehicle those, to as a but just formulary well. will actually that will that, have still And an coverage want prescription. handle in And GOCOVRI for that increasing the that win, published there sure that process for a for we're prescriptions we're which

make want defining is sure I distinction GOCOVRI. while to not critical their it's So that to distention, important, access for that

Caroline Palomeque

quick Okay, that's helpful. something. up, judgment for regulatory And question then just on follow a a the

then bit would began? if letter whole little story where could this tell me, I frame of, like the back just was can think a sort really us you believe a all you about tell just, that. XXXX? back the or help And bit that - more more there And I a Now in there. situation us little

Gregory Went

Sure.

in complaint, one at what's dyskinesia. time was competitive regards was to the we we recruitment the were dynamic, letter sent. of with the that sent company again, letter a the the that So in That

that they're to And their of an now And so a our that, sale right obligation for judgment patent's. product we obviously, evaluating infringe are we does is have the looking declaratory enforce. not what

are that seriously Our we complaint. IP will and reviewing - the take and we we

Operator

Dr. the Thank turn that call today. concludes you. Went to for remarks. session would And closing our like question-and-answer to I back over

Gregory Went

year Adamas, to out entered we for seeing thank So closed for exciting this to today. into the you look last we and you, I patients. and Thank to year bring I May, have time as a the We as time your very year forward very first GOCOVRI an commercialization during said, update the AAN to the a if you you're we much. you of on quarter more full-some of attending update in meeting, on GOCOVRI. quarter, at when as

Operator

conference. This and your you have program, day. may in today's Ladies a great for participation concludes the disconnect. thank and now gentlemen, you Everyone,

Adamas Pharmaceuticals (ADMS) 22 Feb 182017 Q4 Earnings call transcript