KMPH - Earnings call transcript Q1 2020 | Zevra Therapeutics, Inc.

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Operator

Ladies and gentlemen, thank you for standing by and welcome to KemPharm's First Quarter 2020 Corporate Update Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. [Operator Instructions]

Now I would like to turn the call to Jason Rando.

Jason Rando

you quarter our results. XXXX thank discuss today and first KemPharm's corporate afternoon, for call joining to Good and financial

we any call KemPharm's operating like remarks would uncertainties statements and that begin, about our to and but Before that changes results. not subject listeners to at involve to risks future made including, contain expectations may remind this regarding are forward-looking time, statements during I limited

federal with More forward-looking safe Forward-looking encourage materially. available can risks are and carefully. securities required statements found to the www.kempharm.com, the made on complete KemPharm's its provisions are as Actual KemPharm uncertainties differ statements, law. website files review the to revise forward-looking and We obligations laws SEC, statements, section. regarding the management's Investor may harbor expectations. to any Relations at which current in update represent or information by except documents of be pursuant results these under you KemPharm the reports disclaims

on Travis LaDuane will President KemPharm's be Mickle, call CFO. and Clifton, CEO; and Speaking today's

will the Following we open remarks, call questions. to the your

that, my it introduce to With pleasure Travis. is

Travis Mickle

everyone Jason be us time the Thank and with for to you, today. thanks taking

to provide, those. are certainly a I'll number of jump right There into so updates

our milestone. payment least First, from importance of for the on million as as triggered the some relative our many FDA KPXXX of partner you recognition accepted agreement, by obligation of review believe acceptance part $X seen license I a the NDA this that was of May This GPC and X. at

eventually will KPXXX. company GPC and that KPXXX also Corium, announced We is commercializing portfolio which be

with third Corium report and Corium. that more I'm a actually GPC also revenue happy partners, quarter a our in the our team, I'll but get history development from into KemPharm has long minute. to consecutive services with

I the of table. that certainly is highlights underappreciated an that to value our brings think aspect but one partnership, KemPharm the this

as our remain fashion needs. goal company's we us. as expenses, The to until risks reserves well case ultimately aggressively is with address cash balanced as financing be skinny revenue to the it potential will most balancing available the will the is approval, As manage any in needs with

see can the and date additional brought out pushed PDUFA our our term we've led addressed revenue that to You this past in the the near that where in debt for position has has forecast KPXXX. potential

to As some story, a whole with a there of familiar spikes be just quickly bit as few may as a like not KemPharm of run you little is here that the through background. I'd

the today First, agreement of I with license listeners of GPC terms the in want remind to general our Corium.

are million as and depend of development of GPC a the label, very goals the is ultimately that believe approved We work this payment, the the short, In desired closely is the next label They milestone and an potential those acceptance common with Corium, maximum goals size After the on with best that itself. both product will do $X collaboration and the we KPXXX the agreement. opportunity. achievable. that market approval, possible label and with milestone

that the misconception of entirely Additionally, loaded. I backend economics general has been license there do this that a believe are

yourself, you case. the that As see for can is not

and each While of the first we of signed two license value that the details, provide in the totality for the originally years of exceeds this few cannot always agreement all Vyvanse, Shire comparable potential those is agreements. within

in believe and has I value services alignment XXX certainly and option short-term for KPXX, and but XXX, products our and Corium. long both represents also general with the this well support as as ghastly KemPharm underestimated. been KPXXX, strategic partnership This

by to the team right exact known responsibility commercial now abilities other's they on longer in KPXXX. only to be. team is now trust the to of and all that. for captained marking right Corium make Perry have Not the earlier, our partner for I experiences while do believe take Turning to experience Needless one stated would KPXXX also can believe to commercial leader. we we've far Corium, we right the there have success been as it than place, and they're aware both I each of say, and a no very else has

during that's departed color, you at acquisition Shire the us. here. been see Shire can presented most upset Perry ultimately, and hope I of some that that has of Perry Perry best one are time was that was all a the KPXXX we Takeda, by while been for while all whole were roofer And Shire. For aware believe had at on time - during we you that that story

been by the viewed going commercialized many Vyvanse brought the version be methylphenidate has as now very as to by Vyvanse KPXXX who forward. person of

that more I for think that I Stay the you some him. At coming has and both months, Vyvanse even it than Perry we potential believe tuned directly to better on features from hear some are version. in point a for provide forum to that. that hope

of this with not and the just market abuse. number And action, few for just now, onset large opportunity quick methylphenidate now we indicated ADHD some of Turning whole. have slides a unmet that KPXXX very and based those had time focused mainly ADHD are to as on research in our possibility for that us the stated market, of on a products, needs but there's duration a action

the all next look addressed to those. slide you of with If KPXXX specifically, we we now believe

an action and I look a a viewed this XX to been a abuse. for Vyvanse, Now doesn't think as kids, Vyvanse comparison but what's and and for and at potential if hours on lower do duration versus you has of nice a goes half up had to hour come

predominantly brings be patients. Now but slightly may now The forward of a the is based product onset with this that slide in a action, that recall products. predominantly improved KPXXX you that, may that introduced actually in paediatric highlighted methylphenidate previous

above some beyond that So where have improve to initially with focus our with but benefits that's and again, products, methylphenidate Vyvanse. those also been has upon

hand forward at actually hand to a of this that potential the he as look overall the left is very well well We But while right different have case, profile, KPXXX in hand Shire. product abuse. the as part is Shire the was MYDAYIS much was a which to Vyvanse’s KPXXX we to Perry for left KPXXX launch less was

component product. a the Now being with of predominant that prodrug

going to back with here when debt on, debt long-term I'm collaboration holder, announced turn KPXXX a we was partnership Deerfield now potential away things from discovery to partner to with up collaboration We new in forward we've the the working prodrugs. focused financial our of were the again, discover on Deerfield the that some two to look been and largest that primarily, and restructured.

the to multiple at milestones covering these opportunities. on they including get along their out costs, with have to collaborations build potential to provide other timeline. the updates look early moving forward future as and R&D and value add collaborations. development And Deerfield We working These royalties in business stages, with licenses, more

also over good Looking can very in we difficult now opioid KVK, environment. APADAZ, a our at made with some now attention very turn partner another progress they've commercial

it As everyone manufacturers have - litigation well opioids have whether or to or you're aware, economic intense And all pressure, otherwise. been under heavily through from come be scrutinized. patients

that happy located drug on lists, APADAZ In Medicaid now states authorized informed form the APADAZ but that FSS. pass are has to of generic spite that along and we have XX I'm preferred us the that to is added stock to of available nationally KVK their

even of commercial seen a to as So acetaminophen, comparable set certainly availability generally X for hydrocodone we much generic have access, as and Tier remarkable progress.

very continue With to remain we commercialize the on about positive will updates we the working in APADAZ. to prospects pass We with to both all are KVK as spite of And looking happen. that forward they of next steps the environment.

that, discussion the LaDuane. I going return to With to I'm believe the

LaDuane Clifton

Thank you, afternoon Travis good and everyone.

reported million to reported this QX, $X.X in services quarter, we've of revenue million. we XXXX, of XXXX $X.X compared revenue me QX For of XXXX excuse as

this mentioned, As Travis KemPharm’s with development continue revenue. trend work is reporting And of sequential other to partners as to our quarter our the third we of KPXXX product candidates. expect continue this and on we

per $X.X $XX.X XXXX significant net for quarter. of diluted the net a or reported and compared diluted share. a to QX, million loss or basic share million and per $X.XX the loss improvement This basic $X.XX is We of

a in measures reduction shifting Over the reductions, G&A partners a costs well adding services other as number our including our cost position, development undertaken year, as to financial we past workforce, and XX% revenue. have improve our of to

expense Considering of expense that as the net principal expense loss interest $X.X includes the accruing compensation of of million, quarter. such non-recurring severance a number non-cash of stock items and $XXX,XXX $XXX,XXX during

have You in can improving financial see substantial position. that we our made progress

sheet, to balance glad about XXXX. of XXXX on to our had of $X.X to the extend KPXXX as to the we million maturity March Returning decrease the existing date with of current date resources, which was total cash I'm our PDUFA our XXXX. based runway December XX, a debt compared XX, million, March expected revenues that $X.X report to cash expected and operating and is along XX for potential up the of forecast, past

expect We working million rate cash but as $X reduce approximately our we're will per can. to that quarter, as be much we burn that

to debt XX, the directly compared under which exchange December part XXXX was was of which which December exchanging million, XX that $XX.X due agreement, total to million. of decrease was March $XX.X Deerfield, point their This million at transactions. of As a XXXX, $X.X was was

by $X.X to million added They principal of offset of was that and interest exchanged $XXX,XXX. principal, worth about

the remaining QX, of exchange XX.X under of shares Lincoln quarter agreement. we Deerfield into credit Capital, end approximately line proceeds equity entered of the during to as that As of has in March XX, back still the facility. that received had of Park of their for shares the also of XXXX million resources under available contributed XXXX, X we $X.X million has quarter and end February the million

And we that out as unexpected timing remaining still flexibility occur. put this delays shares under or providing was that million pointed X are They're some back capital other in of in items as there we the when first event place, this facility. sort the see could approximately

outstanding. As have XX.X currently XX, we of million shares May

our And regained not with quickly an update with XX and now on have turn provide we today, our NASDAQ the and compliance Today listing. is of two outstanding yet May compliance XX as which commonly of minimum $X. million, or that market of the requirements minimum listing listed are as cap, being a market both a of is bid securities value the price, known I'll

NASDAQ that an providing issuers April, had to the actually to back they were crisis response announced companies. or in extension COVID-XX non-compliant in

requirement. cap price and still listed of anything the million securities. bid a related to market therefore Unfortunately, However, to requirement to only market we NASDAQ by under the reach float it public value - $XX the extend specific And requirement of not did the are was tomorrow.

So would an we today, extension we to that give and believe I determination. receive a it's are in expect where delist fact, NASDAQ unlikely given

do to occurs, venture possible way on we any when OTCQB, the be as soon securities this that at that our if if minimizes intend a we'll OTC occurs However, in and this disruption all, of the there's list or as able securities. we our or to market expect in trading that

the hope execution and this discussing by be directly core and affected see solid our that Travis is there Obviously, to been business I've change trading continues not we to securities. as in

to that, with Travis. so I'll And turn back

Travis Mickle

Thanks LaDuane.

as, what acceptance later the NDA date get and us, this the expect you the letter, received we the is potential until in forward which ahead FDA day confirms in March know now we let of certainly look a in of it we lot to that There's work that once is don't behind XX week. of actually exact PDUFA We'll So a look and front us. XXXX. to

among as way work support of continue well supply as will and commercial to launch. along We Corium the the closely with approval KPXXX

They sales their point. and needs organization ready are at prepared marketing support and to up any are full we ramping and

it As with provide within, kind of that This later update KPXXX not speed, best previously, the time, currently suspect on Corium everything and mentioned and something an this COVID directly at in is up to be both hope this I opportunity until we this the are we view ADHD imminent, year, that but feet guess. get do my will to market. may jumping current be I just not experiencing. environment we from to

closely. upfront, by balance risk, mentioned to believe and I We managing those need cash factors the dilution.

related control, to we thought, what virus related delayed filing to like and was well factors COVID risk outside conditions. mitigated potential currently we're from timing that that then factors as have potential acceptance We the experiencing, our NDA as all risks, any market had

we multiple acceptance hope There time to PDUFA. to us are resource NDA us. be look to we're potential open two can and options behind as up revenue As we address We in restructure. to this debt front the blind direction. with in to to the look and and to look of us place our in take we to now that close have With factors milestones the positive our available and plan ahead, and prior issues phase towards start not that to able of our something

market what We that play a the and should be our all that ultimate role. certainly what and be. - consider will timing partners structure big will factors will And ultimately

KPXXX, how Looking we product option we beyond a this. And KPXXX potential opportunities. and full who the as to greater a with Corium products. potential KPXXX as Corium has what the is those well think to about of KPXXX like currently when - and far use could could optimize it add evaluating

for As APADAZ. looking in the discovery also highlighted potential the we're through and our to next previously, collaborations stage of forward the launch

partners business, the to could and All have well are and bring to can in very present we compelling stories can value we proposition. develop, a acknowledge all, from remaining developing the the develop, certainly risks can All term products KemPharm. these in that I of value near long-term the brought value and the have

helps It you valuable assets some to have it that market upside, partner, well a to as $X.X the add team plus degree with with absolute even can add of other when right all that is as you say have deal more. of that all potential huge APADAZ you a can the billion confidence in

So part concludes would questions. this. actually for to like of open that I up my

Operator

first is Oren ahead. H.C. Instructions] question Wainwright. And Please our Livnat [Operator with from go

Oren Livnat

and awaited that given relevance few of ADHD have you've and missing, on Congrats that just, and the Corium their out fact back first coming current about questions guess now I'm will highlighted you NDA are space, long to them kind that PDUFA, I And of history the more before probably pointed but makeup. the filing. advice is a have several they of I you anything this and as some talking asset? party, times there people about holding all,

asset wondering, in that space? I'm I and yet or about innovation are hasn't not aren't they to And of There been couple more it a we're a see talking this label, competitive this have that ton for just is follow-ups? reasons waiting we publicly this

Travis Mickle

our we all not to studies. like going duration No, label be do we believe the wait have to that along, certainly is I they yes clinical in that label with going onset we're to fully and seen and the what as to it's going features think, the see be said we've abuse

was until by of NDA factors managed kind been mothership, GPC, the were which to here, it's Really, multiple it I the is think, this as was accepted, really Corium.

official is Corium to them announce very so and They until partner, would couldn't the ADHD. commercial They're recently, we opportunities. official even to the the intended take time with going And all be now different - it are partner. But some it's the familiar they the handoff. has commercial that now evaluate

possible. to do like as soon we'd as So it

Corium And like think to do that see I discussion. both fully think they form for timing it's to KemPharm and best value not I the the the that get this is. possible. We'd what proposition at point, that like in ultimate it would

Oren Livnat

curious, what process obviously, give extra that maximize case us GPC huge you months you I'm of issue. Did that's other Okay. have And pursued been the onset Have claim? getting with your of haven't chances color for just to working And guys there? sort been best we there several submit that since, a mentioned can you conducting Is that this on you anything data NDA, seen? guys FDA you any duration to you label, analysis?

Travis Mickle

extra. additional No, publicly. has haven't It's what analysis. we seen didn't do anything submitted We really everybody any

did be a product. for to I for makes subsequent of their Of get GPC approved potential it and consultants rest to bit And their up get context and sense how the to again, take course, that product little speed longer think all all all reviews. in put the it the has through of then

to work there really already with the together work and Ultimately, was it any provided NDA really them the formulate that was made the baked done. NDA but data better, we It additional packages on. all wasn't into

Oren Livnat

And regards the with and ever that on to Okay. you us that clearly, be may best given it's around the labeling. on approval, milestone case? lastly, going I worst if Have bookends for dependent just

Travis Mickle

I KPXXX be little mean for you it'd approval, don't facetious can the most the a as because million $XX and if best both be but could right you we XXX That's right. and do get bit is really can't, zero it now. the

organizations upfront, that As has things didn't materialize allow $X million and had typically the for fees get the million $XX pass GPC closer, willing intended and us out or We would go of need that is those been well, money to that very as through. there to about in in to folks organization was upfronts, another was that to kind more more. that realize did they anything well receive actually that that paid disclose additional thought reimbursements

show particular of think million we've to milestones, case, They to today this that's there full that really in roughly it So not more restriction. story. the I didn't and reimbursements subject - come is had in $XX

is better appreciate So economics we really that face certainly us people there here for can think then value. the

Operator

now Travis Thank call to Mickle his for would back And turn the to you. final I remarks. like

Travis Mickle

just and today your I you all time for and want appreciate thank your to continued again patience support. of greatly

forward optimize as judiciously these address press possible. issues Thanks will value and our continue again. We the as agreements of to to

Operator

Ladies you. today's gentlemen, and concludes Thank conference. this you participating. Thank for

disconnect. now may You

Zevra Therapeutics (ZVRA) 12 May 202020 Q1 Earnings call transcript