KMPH - Earnings call transcript Q2 2018 | Zevra Therapeutics, Inc.

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Operator

Good day, ladies and gentlemen, and welcome to the KemPharm’s Second Quarter 2018 Corporate Update Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] As a reminder, this conference is being recorded. I’d now like to introduce your host for today’s conference Dan Cohen, Executive Vice President.

begin. may You

Dan Cohen

remind good XXXX and call Thank for like you afternoon. remarks listeners and call, including, uncertainties but Thank quarter afternoon, expectations to, about subject during not risks this financial those regarding our involve to would at KemPharm’s I results. second contain limited this may made to future phone of statements and changes forward-looking that joining our At that you, time, everyone. all and corporate this are time operating any results statements

to the www.kempharm.com risks and review KemPharm’s There of this is may Relations obligation to the expectations these documents the statements, These is information results forward-looking any the law. current on revisions regarding to or Laws. and differ statements at you Investor to or results actual announce more actually any management’s of at by forward-looking statements Information call Harbor the Securities of factors it to are on encourage based SEC. complete forward-looking uncertainties and Forward-looking website materially except reflect required events available under themselves. any update are KemPharm from is as made to Federal the KemPharm the statements with such publicly disclaims beliefs from Safe subject files pursuant in to any reports statements developments, section, forward-looking in the future we carefully. and provisions documents change

call. is via section website within introduce listeners also the remind and a the Relations presentation all that presentation on today’s KemPharm like accessible conference using I is speakers, slide to Investor KemPharm’s included Before is with webcast. the would I The

Chief is Travis on Executive Officer. Clifton, LaDuane today’s and me our Joining Chief Financial Officer; President Mickle, and call

the call turn by this presentation corporate achievements begin and our will the financial review by prodrug now followed of a recent Travis. portfolio clinical results. involving I call developments reviewing our over will to our and We

Travis Mickle

Thank and everyone joining thanks the for call. Dan, you,

build As quarterly currently of discussed medical prior prodrugs that are on treatment conference underserved. approved to or an needs address in on markets, KemPharm’s are drugs that and significantly indications unmet mission a portfolio is established large, in calls, improvement

near-term depth make expect of the and our is at both and alleviate and unwanted indications The effects. uncommon patient targeting a populations made that consists of and us progress and side for a unintended pipeline offer outcomes varying stages multiple large Our should diversity to of better products orphan company development, where prodrug can market value. treatment or our and we've longer-range build both enable pipeline to size, address

let prodrug portfolio, products the exemplifies ADHD and that this advantages Our potential strategy offer. can KPXXX, by

a our with second we treatment, for properties the current was advances believe duration X, trial shortly, of but and prodrug of quarter package points hours. be data was and detail of safety KPXXX. highlighted program, topline announced to KPXXX by ADHD clinical our two potential July will continues demonstrate results greater believe in we The discuss from the On pipeline. data which key efficacy XX I KPXXX onset compared ADHD. of methylphenidate-based with when represent treatments suggesting of effective the at of shown We an in summary, to to an important differentiation these minutes action overall effect XX the

products, potential of methylphenidate study IV outstanding, lower prodrug of d-methylphenidate placebo for of of Results the data second human as of HAP with potential. candidate to number abuse onset quarter, trial therapeutic In the DMPH, a both our currently of unmet d-methylphenidate from addition, is that found we're developing is the address of the effects both as KPXXX was their during prodrug intravenous in property announcement that produces from another SER dexmethylphenidate, were consistency duration, highly indicating the differentiating of when marketed highlighted effect, comparison possibility and prodrug these KPXXX active topline the to and similar product in or abuse KPXXX a KPXXX. action, including to injected. our well products, needs of pharmacodynamic that with were d-methylphenidate,

capsule Additionally, for and capsule KPXXX's design easier on if utilizes opened or a that to The sprinkled be a drink small can allows swallowing. food be. added need

physicians if that the All issues these since in it we best-in-class believe these represents significant KPXXX treatment, can and of the are needs, approved. of minds and address help potential patients, stimulant

trial is and trial to product the reported as designed only the a of EOX As KPXXX. to assess trial referred commonly pivotal efficacy from of was the difference efficacy change This are mean trial endpoint the is the style supportive data in safety KPXXX.EOX data approvable through but study. XXX in six KPXXX topline The study we of twelve primary Simply diagnosis efficacy classroom a KPXXX. not we standard post-dose KPXXX classroom The points parallel, a post- with believe years the all mentioned or analog SKAMP SKAMP-C clinical laboratory July. placebo-controlled, differentiated. for across be the experts baseline is that double-blind, of and score. efficacy of one medications. earlier, time stated, ADHD, The in randomized, ADHD FDA aged by measures considered of old widely children EOX also from to for ADHD was multi-center, a trial

convincing We of baseline conduct measure, efficacy this X.XXX. of study, endpoint state pharmacokinetic to concerns threshold speaking, value or treatment trial, of Day less we due medication with should to related one the KPXXX Statistically efficacy steady XX ADHD. the KPXXX, to of might negatively important of we based met meets the and the this than an a as designing of carryover KPXXX data. on X, effect which a is approvable this primary that on for a the potential As and not a the result, view achievement indicated slide, In be Visit overlooked. impact very profile thought pre-dose assessment on the the P this elected

the for correct in so scores. could analysis, would XX, versus X patient methylphenidate pre-dose the pre-dose pre-dose treatment subsequently also data is from was have Visit by we effect of a analysis classroom-style shifted To ADHD the a Visit this measure scores to study. Visit period X, placebo a baseline Visit that to post following X far patient no washout hoc that any No two-day baseline had table on, differences. we carryover group on X, baseline more from occurrence, which was baseline our Day treatment efficacy group this actually hoc rationale conducted X post The of but Visit or meaningfully way a Our randomization measure the observed, contains efficacy right column board. prior typical

data use statistically efficacy all measurement in the significant intervals KPXXX believe assessing see, efficacy demonstrates of XX can placebo. X results you to We to Visit at XX comparison from to correct the in are As the results minutes the hours.

reviewing We from also most believe this the scale, for accustomed is occurring. FDA to are that these or performance, the is which results measurement take test analytical that reflective patients of efficacy map of an of SKAMP ratings are the Supporting this while approach the the permanent design. studies product PERMP ADHD more results that were analysis objective

PERMP-A, details or table questions measure. first the data attempted The from

post-dose, time data a statistically as placebo or X X. intervals indicate whether hours Visit baseline indicated, significant to using all PERMP-A XX As from at Visit between XX minutes the difference

all PERMP-C answers to statistically at a whether PERMP-C intervals data On or also significant correct baseline the measure. the indicates The Visit next from X data post or using hours slide, versus shows from XX this dose, Visit XX placebo time difference table minutes X. as

of on as FDA, set, examination Dr. of KPXXX.EOX that at data. hours. duration are the highlighted as that shows a of question. the available XX we whether one overwhelmingly analyses post-hoc decision an efficacious regulatory the would generated the that and FDA a X a standard prior demonstrates believe evidence that or baseline division, products, well at that analysis, the by and on the KPXXX Dr. in duration, approvable KPXXX likely KPXXX the are simple this X typical duration Based from KPXXX, utilized meaningfully XX remarked call study a and previous FDA ADHD trial, appropriate KPXXX.EOX a viewpoint, analysis director can believe nearly compiled based as Capital methylphenidate, bring and a that The KPXXX hosted effect use will KOL and a that for of Tom the onset hours, based secondary about the should is reasonable retired reasonable differentiation safe data the to in problematic Visit with on our and reviews our to Visit faulty would we onset, when Visit the [ph], differentiated that study product. and have statistically Laughlin XX currently such there KPXXX.EOX ultimate minutes noted rely onset in and marketing overall fundamentally Center XX methylphenidate a opinion duration evidence down it is data has is and products, of as which baseline, the been confident the Evaluation for as interactions Visit overwhelming market. practice action supportive to of FDA order minutes than Classroom of endpoints but especially consultant clearly our of we Research that years an enables X, division an on Although and that and and determination. RBC that, it efficacy, KPXXX history in arbiter more often PERMP their for the the the data be of FDA, would the historical precedent, make believe of at conclude this are a make is X of It his XX very also slides, Supporting psychiatry onset analysis, Markets clinical Drug recently on by corroborate division it Laughlin with hypothesis is boils in to

prodrug were efficacy during effects comparison following pharmacodynamic recreational the quarter, study the from SER the of d-methylphenidate as addition potential to produces known second the study SER assessed placebo the and abuse to In of injection stimulant in active in The trial, and KPXXX. dexmethylphenidate that HAP the we intravenous from to that to KPXXX.AOX, data comparison abuse. our study active control of in users or The KPXXX when d-methylphenidate, an who injected. intravenous intravenous results prodrug molar KPXXX little dexmethylphenidate the similar abuse doses results, administered placebo. XX of In products, were suggest human study the dexmethylphenidate, is potential KBXXX has the IV favorable reported suggesting SER in very one with pivotal only dexmethylphenidate less SER key Overall, potential compelling to crossover needs unmet design abuse and IV double-blind, no methylphenidate of Lower results or that methylphenidate received data injection. abuse this the via potential potential ADHD provided study IV of placebo. included potential product is when subjects for an evidence IV the equivalent randomized for less dexmethylphenidate, and we HAP

from expect ahead, to in the year. studies the new file dexmethylphenidate and expect quarter to between and position Looking studies, Upon oral for these completion we first intranasal report of of drug the of XXXX. KPXXX we SER data end the to application the in of now be a HAP

pivotal In with studies which allow ahead an addition expedited to progress to late KPXXX, to should year-end, prior potential to and NDA XXXX. the timeline us KPXXX development towards expected initiate a program along moving is in efficacy

ADHD advance the sizeable business market development we're given KPXXX also continuing to for each product, we're explore continuing various KPXXX opportunity. in pathways to the clinic, While and

a profile, a $XX efficacy abuse As status. life for further, as even with billion market, potentially their products, or stimulant NCE leader, well best-in-class where both long attributes differentiated off patent We their approximately best-in-class in represent KPXXX’s as large, the Vyvanse, in that these potential XXXX. product all and comes the the as along well branded ADHD patent product potential methylphenidate, reduced believe

an active financial complete presentation and As quarter's let by partnering me over to expect results. now to partnership that, turn have underway who will presented discuss year-end. earlier this process today, a the we With LaDuane,

LaDuane Clifton

everyone. of results afternoon, second a provide quarter brief XXXX. Thank you, I good for overview and Travis, will our

just our press call. in prior was available release, Additional which details are to published the

period XXXX. net XXXX, of loss QX XXXX. of loss For $X.X for million compared net net general of The KemPharm increase per and for in loss million, was increase share driven a $XXX,XXX about non-cash Loss to share interest development quarter same million and by of partially by offset per diluted in a $X.XX income operations research XX, of million partially $X.XX $XX to and by reported QX operations $X.X expenses, $X.XX expense a the basic million increased $X.X administrative QX due and value XXXX for or diluted $X.X or XXXX offset fair June basic and per other for share, million loss from Net an primarily $X.X adjustment to was to items and ended $XX.X the from million of in of $XX.X million. compared expense. primarily

but operating to as quarter thought I existing you through with partner one progress forecast, amounts, As expected restricted the equivalents, decrease fund of and requirements and cash $XX.X June QX to current day receivables compared capital first which Apadaz. we and leave additional not marketable Company’s the of as approximately our resources trade a was cash, on XX, to of million, toward is $X.X securities, a for into comprised are forecast Based expenses cash security-related want XXXX. cash, XXXX, commercial operating related cash total This of the XXXX. expenditure to million. end was of

previous million certain costs as the there a Apadaz or material is extend the to QX As in other cash API this expenses batches. of forecast, in us commercial preparing scale discussed related $XX allow cash partner. the could a purchases, related approximately currently we all are included in have our in and validation commercial to these $X million are portion We a to costs avoid year, shifted would there into to launch, believe our This that potentially raw included forecast earlier and that costs forecast call for of such purchases, XXXX. be potential to

Apadaz posted partnering as progresses. process We for the you keep will

will call the Now to back over Travis. turn I

Travis Mickle

Overall, the a KPXXX KemPharm, progress and program. was in of great particular, for quarter XXXX of second the period

can extremely you for hope we KPXXX optimistic. outlook As now our appreciate, is

next of KPXXX before an a KPXXX partnership of study, and year, submission of then and Apadaz both early the our With KemPharm for Looking XXXX. the an of before near an efforts several call half well HAP announcement a program I our to KPXXX NDA as ahead, efficacy we that either abundance as companies foresee of with including and several your questions. ability LAT quarters, KPXXX potential the oral the growth for other a of intranasal open term. events, and partnership data this announcement the KPXXX value-enhancing over second to that, development in the additional opportunities develop combined harness These to will or now offer products milestones year-end, pivotal in of long initiation an year-end,

Operator

first [Operator RBC. Instructions] from question from is Randall Stanicky Our

is now line open. Your

Randall Stanicky

that hoc had Great. Thanks, you’re they’re FDA on just question then front second any how is up then color the a and thinking just got I or more. guys. changed And have provide there the a the and partners, Travis, couple out about on data? spoken Any in discussions couple or anything since tone with front, But that terms that of the ad has you opportunity Apadaz. KPXXX, from can having then I’ve communication with one or want on putting to you any data? ask

Travis Mickle

Sure, mean, be a in early depth for meeting. don’t an request a later I a traditionally a have turning have that with quickly your in C a say, we questions is year. what pre-NDA, question about have more to would key planned but for at very they discussion type next several the year, turnaround the that Type opportunity FDA. a, There No,

if it decision what we any we So of do receptive are. really filing, but a everybody meetings course, still be hear data maybe we’ll I now for let receptivity. review, they we our if think expect expectations consider the would But and I indication two and at NDA between only even call, to final know on of say even that’s I it, think us, they’d best, as said have could

data that their is very strong belief would Our represent interpretation. this

but as discussions, that we’ve our speaking anticipate by the say with to. As will on only agreement not I partner been think definitively we the confidence probably indicates details and specific those a far anything. I said have that KPXXX can’t of confidence partnership give or I year-end, reaching that we will that a

Randall Stanicky

the it learnings XXX that like would things. unchanged, for Maybe sounds of that us KPXXX are forward. how – would the two XXX presumably, be us to And that. One, about timeline helping inform be but talk part remind just is path

Travis Mickle

XXX, as the It together. prodrug in would both they’re same and two go parties. yes, IP. to to license individual different those so far the It’s for As related have KPXXX essentially to same be difficult products, to them would

we’ll an study was don’t program You’re and here, general the right, the adult-focused market, have lot endpoints efficacy we’ve been KPXXX. able and design of to same study. as well you of case, of as and issues. particular But track that’s there classroom learnings that such In don’t designs you have a be about the this secondary so the using alongside

why that’s waited we the So with really KPXXX. in to started earnest get for data

Randall Stanicky

a question We’ve on some And deal time. last been my for possible Apadaz. anticipating

We’re remind deal can, guess, you that getting to closer I type that thinking about. to year-end. you’re the us what of extent

You’ve partner talked PBM, of should same the be Thanks. type the changed, evolved possible manufacturer it a we deal Has and or structure about of partner. about possible or way? thinking

Travis Mickle

our still that's plan. No,

questions I I generic manufacturer we has happen been expect partner, right marketplace. think a the the to the we that as having plans now kind help can more is of proceed first, that a in expectation will down pathways, supply that one here kind evolution really our we can place of think And other. before give overcome both supply confidence

substitute Apadaz to manufacturer that's it's with still various generics completely is by I our same plans, in of Apadaz. generic priority pathway partner kind and this the or have PBMs, a So that order set, followed that plan them for now first, where our think expectations is prefer for to we

Randall Stanicky

Travis. Thanks, great. Okay,

Operator

you. Thank

and from Bill next is from Our Company. Cowen question Maughan

Your line open. is now

Bill Maughan

afternoon. Good guys. Hi,

if FDA this doctors themselves? one? XXX even partnership mentioned of approvable baseline, their adheres and still generally, we and this to then specific design find a kind then, very you X of to, differentiation hands analysis has expecting a precedent like the on it earlier. And shifted a can in precedent And Thanks. patients be us the issue what the then, deal? would be the should you point would then structure the What in for where FDA just say, just So Visit be to study based

Travis Mickle

Vyvanse. a would discussion, of Yes, structure can a exact I with you we point focused partnership be the on that don't so this I Again, agreement. have share with could starting today. an lot upfront licensing with what was $XXX to afterwards, milestones a Again, million split various did in with a back deal you XX/XX we to post-approval. $XX million profit that post-commercialization, with culminating about a up

So I in think are economics a products best the $X feel ultimately, like thoughts ADHD. see, would for we because opportunity those we for what along our these to is billion-plus

real-world and done As precedent silent the on with a you onset we is could various to what you endpoints which there you as this an is can to the up as-is, used Ultimately, the And the do using performs, the of can believe Aptensio, look how actually left data you change approvable Cotempla, a that comparison, label would course, has endpoint. secondary in been X, division and can kind the way some to to generate at is they FDA analogous that duration. to in addressed duration. used initial it duration, thoughts study, onset the do, believe is which but statistical analysis, this don't around at SAP, at products, this either that can all look met the have and comparable to can way look primary to direct a alternative of you product. show we And the for effective. We far met yes, the label second have We three practice look sponsor's its very this Vyvanse to physicians an again, ADHD KPXXX, use see or directly we the what of guide, if you at be and always correct analysis examples question, as last if where ultimately, and issues has Quillivant Visit used said. along the the or

Bill Maughan

All right. Thank for you the response.

Operator

you. Thank

Trbovich from Ken from is question Janney. next Our

line now Your open. is

Ken Trbovich

Travis, any with Is after study about Thanks regard couple question. for I until you taking specifically XXX. more the with have get program? on guess pre-NDA start the the the of meeting general questions additional that feedback agency thought delaying to and the in there overall perhaps

Travis Mickle

so along separate would a No, any program I'm like that meeting efficacy did sure study, would we request because before we that's KPXXX. for initiate altogether, we direction, a just

doesn't But meetings, It of So, specifically again, front designs same this of to want in own of would with is we or be that sort KPXXX. an to have its set adult product. the consideration.

Ken Trbovich

on I confidence you just do when hand XXX getting done? Sure, guess for specifically then, data and timing have with would be in you

Travis Mickle

clinical by I on said I as study Again, on the focused of we’re think call, year-end. still initiation the

think about that’s exact I I but imitated We think announced last year kind reasonable data year KPXXX it’s timed very and all. have details and the at a here, late behind. I in of don’t again July, the to assume

Ken Trbovich

this to Shire, trust help in the Sure. you’re and know that with with a I’m sort us alluded as earlier you that late just My can discussions, signed us give process like And summer, partnership, with timeline an an regard to to and then of facilitate River helped partnership fall agreement and process investment bank comparative with relative it transaction went New Vyvanse? what you to that was in River? regarding to was if to recollection at it that sense the through you new where was that that just start-to-finish early was at as curious to you relates I

Travis Mickle

earlier a They study no, I much to of little to that sheet was One by Shire. they add would the great study readouts signed with agreement led but any is and a was Ken, question. did efficacy underway a kind New had single thing an definitive pharmacokinetic Yes, have like stage. terms a bit, at and to River time not that that that’s a a completed data

was at year-end, led started know binding the of head for August XXXX. group might New terms when XXXX, sheet the that partnering works Johnson. we here, company There We process. by He very rapid the that and was group gentleman, inked was the one River, of of it actually I banking worked the Rusty in the with in February he that process. agreement was you a So early,

much that of and that already River had additional a are have along data process. New multitude further We never during

So should that’s why we healthy it. and feel of this opportunity we a is advantage take such

Ken Trbovich

Makes sense. Appreciate the clarity.

Operator

you. Our is [Operator Instructions] Thank Capital Markets. Roth question Solomon next from David from

open. now is line Your

David Solomon

thanks Hey guys, taken progress on congrats the for and my questions.

Just getting started related on color to for discussions? the the HAL partnership thanks discussion we it, all to critical nasal learn is for how just that to and going the heard, information the you're studies and these near-term related oral

Travis Mickle

extreme there. the shown effect route, we've and is Intravenous really zero most

I additional active this which we don't they're get think have I process those those have already think underway, before are critical to points. you underway.

a we clearly, everybody along that's haven't lot we'll that seen resistance, update in of but So, process path. the

David Solomon

to waiting But it that or Is that negotiations could you may the to maybe potentially that looking have data? significant be those you're upside along where have? to lines, is Thanks. guys something something it the have coming value

Travis Mickle

Vyvanse, the months, and Yes. value abuse be abuse informed data as everybody here this out a of I kind we much lower best than huge lower what couple would us, next keep provides the data potential, is But agree of potential to over mean more driver potential great. is. opportunities the that’s abuse having reads the like

as have to as get to available and we sure we and anything want value data that through, possible before the the make we partner. course, much think maximize Of

David Solomon

the study we get Great, they two significant if post analysis, endpoints compared. why it points, X, how we was thanks. color and regarding those Day on about for at thinking final be And were how efficacy hoc time just some and two should on Just, maybe those more but the the so other? those are

Travis Mickle

because shift there underwent from was to Visit different X Well, themselves scores X the Visit conditions. the patients a in fundamental

Visit the everybody to Visit KPXXX number all was for and baseline two in dose. prior then taken weeks of So on days, out for washed optimized to Then a they X, on their were X. run had

of their X, and into either Visit two optimized placebo. different was everyone KPXXX During on on randomized dose groups or placed

one differently, could now be change And that, a after that treated expected and so, so two-day be that about happened washout. think essentially, not you group what pre-dose of placebo for there was to if is scores completely really the was different the than kind

and Visit to Visit that's why there So fundamentally different X what the X. were so scores happened from

David Solomon

how Great. between starting themselves. between time two the was endpoints were understand PERMP they to endpoints, significant trying the two P were And those highly guess then you it just slightly at significant? come points. I for the see still but I'm just score to greater values,

Travis Mickle

understand the that Sure, so same it. they and your Visit difference was the for. where way had drug a The had was and at difference I everybody group. been guess identical then in I everybody X, basically question didn't and time, placebo was not glad first I'm accounted treated you all was same the When restated were because was a shift difference, Visit X accounted for, and there

because that's early when late for you out. placebo, splits X you'd statistically Once data placebo. the the when significant the you for and the study in Visit didn't true use so, account baseline And see differences you accounting weren't the

or study was Now, wasn't because really same any the the change there shift conditions for change the PERMP, individual the in additional exactly subjects. for the those

So I while between difference. X, a the it the SKAMP X the crossover there, this difference, consistent saw and PERMP Visits for itself saw was difference but think that's you

David Solomon

you That's is do helpful. think? label, how that for Great. And hour, really critical it the just XXth regarding then,

Travis Mickle

at back labels and ADHD might the look different some of Again, go products. for to want you

are at looking Some some it there both you duration, been can actually and silent of goes, examples. on and have label said off so them on there. as far the as We've

materials FDA. that marketing that the this take think Visit strongly going not I we data to as believe X really we far the as are that data is include This will by used have, be ultimately would data. the and they lightly something

David Solomon

kind understand. then, they waiting discussed is on partnership that the What partnership? may that doing, just near be doing could the lastly just mainly to term, And planning you're be you I do could things. it of or a there but are Apadaz, be for coming you so things that things

Travis Mickle

that under several be approval. that [indiscernible] have yet and have gone we manufacturing since activities No, to outline doing planned we done, as and were things both

So a lot planning, lot onto be once partner happen our referring cost believe that We forth. will possible. rapidly of pushed it's of happens. and LaDuane that regulatory a so as to to manufacturing, as that's commercial But was that going and

David Solomon

Great. questions. Thanks taking my for

Travis Mickle

welcome. You

Operator

you. Thank

Our next from Canaccord. from question Steadman is Dewey

open. Your line is now

Dewey Steadman

so question. of just ADHD outside us guess programs. ADHD Hi progressing guys, some status are you've of scenes program, those, fruition? behind the pain Can and I some programs the to comes earlier on of remind and the as thanks for those and the taking got sort of other you

Travis Mickle

Yes, we haven't things we have disclosed.

other for. We the pipeline Of the go, recent in have course opioids as as they'll opioid path we follow clinical there's did that highlight other our that Apadaz. far the programs of data the

program successful becomes that we'll to a as So kind decide partners, with those. of prioritize commercial how

a year rare again that a for have disease in-licensed we of pediatric Tourette's. we product we area that announced that that, Genco last project the Beyond with in we're preparing

are these interesting know, very components. You

this single time, amount we're sitting culmination to at of here KPXXX. data a a had of for pharmacokinetics Just study. we remind you with everybody, Last know, year a huge

very with work so about progress time, year's do with XX clinical a that study, exception be of amount to made in roughly XX able wrap nonclinical we've approach. rapidly can our of our studies, up So all to the one been tremendous

Dewey Steadman

over superiority a doesn't with XX or label agree ADHD potential maybe of against study for you and consider you would to head-to-head shows then get duration, of products? if product hours so Thanks, duration, potentially of generation doing you a an the and duration that older on last show FDA the

Travis Mickle

of are always with studies. of and one know, our belief of do that clinical to those probability really if But it's very, the X Visit really the guess regulatory we of risks type analysis you very Those all think accepting haven't sorts is I types low. hour I study. you of considered XX them that fraught

post-approval, had that time a rather similar what in if duration another would to It to I a Vyvanse--get spend So that be of with in did effort a who and do did the add effort, XX study we two that's think very approach and study what Vyvanse. that, in, hour additional and that approved. they product label. partner A would doing hours, put is with could on we used then I the exactly do and

Dewey Steadman

Thanks a guys. Great lot.

Operator

now for showing questions, turn I'm call time, over Travis like the I no this to At Mickle, CEO would further you. back to remarks. Thank closing

Travis Mickle

In as your we updates continue appreciate multiple and everyone. milestones. forward value Thanks closing, future look I our attention to and anticipate time today pipeline advance to building and

Operator

you This Ladies participation for concludes and the today's program. thank gentlemen, your in conference.

You may now disconnect.

Zevra Therapeutics (ZVRA) 10 Aug 182018 Q2 Earnings call transcript