KMPH - Earnings call transcript Q4 2018 | Zevra Therapeutics, Inc.

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Operator

Good day, ladies and gentlemen, and welcome to the KemPharm Fourth Quarter and Year End 2018 Results Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will be given at that time. [Operator Instructions] As a reminder, this call is being recorded. I would now like to introduce your host for today's conference Mr. Rando. Jason ahead. go Please

Jason Rando

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

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

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

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

to the Travis will remarks, call pleasure the your Mickle. With Following that my is open questions. it to we introduce

Travis Mickle

joined everyone call. Thanks, I'm Jason and pleased today’s

develop believe will the organizations recognized. ourselves need other products For which marked with a to take accomplishments to a then that cases in creation. and select project KemPharm key and in with we existing them future. year that be see candidates commercializing a those a company. in either lot those could commercial the approved XXXX KemPharm consider those of value year quite [indiscernible] start or those technology We our XXXX key We products of was value refresher, out-license little simply is or drugs, improve

APADAZ never right efficacy agrees differentiated work as completed heard a trials we we human the that really vital the and that clinical for as label back, NDA is manufacturing was KPXXX with that many in believe well all KVK for our necessary partner the and vision and finally Finding file non-clinical step you to was abuse the process. commercial ultimately about. potential us. shares approved other with in Looking APADAZ

process with plan to We advanced valuable debt. in capital to entering principle created of debt as shares. introduced realize approval, June NDA order twoXAR to an offering the potentially by to value goals reduced of we and an as some our be of convertible highly on in with October reduce collaboration in to the believe in with we KPXXX more debt the to senior technology our advance KPXXX. the Deerfield also We strategic KPXXX our forged and back complete note completed create a well through as could order a In exchange asset and this outstanding start partnership in last KPXXX with well some what as another our and to ahead year conversion bring with preferred

on duration for needs of lead or which are unique the for are items be longer unlike take through methylphenidate onset stage hours the I is is of KPXXX effect patients space. the candidates using XX products. already much appeal d-methylphenidate similar minutes our SDX, that these like KPXXX clinical But in trials. of Shire/Takeda's within adults, for Most to next to is which in has growth. a which and broad lived a on Both other Serdexmethylphenidate, potential to of have with IP ADHD. of lower-abuse of key ADHD to of and products more a both recap. prodrug duration. many prepare to our just focused will intended KPXXX proven known products KPXXX the product a intended prodrug in the treatment demonstrated both quickly XX methylphenidate All XXXX full KPXXX has as our product and product unique subset day KPXXX, the MYDAYIS version formulations long were is with in Vyvanse address lasting in of and those actions of continued order familiar call

potential. I've of clinical this that unmet slides, KPXXX onset we and mentioned already our the of As have with in action, completed the needs meets demonstrated have previous product work duration and lower-abuse

plan to, would NDA that now we has of most that government be you The probably shortly that quarter shutdown that nothing of file meeting unexpected. the and there's I the Turning second why call. KPXXX are meeting the for our until on reason believe assuming comes to delayed which the pre-NDA thereafter out

about in As update have than I partnering and we process. are we also process, gave fully talk a forward we believe believe when we look interested today right parties, place sit December. better very engaged here we as the a the we our And that in in competitive

Now get interested well-informed that at update, added were in hand. parties several since partners potential very were that some in several remain that me parties late -- get there Those active discussions stage more don't time. proposals we've wrong and and

value is at the bet that best Now can a away will we process. and What we no mind, this as that quite and place that you guarantee the effort heard suggest sure as as been time be very how added you appears indicating as I of is seen I'm than to we really soon with you well timing partner has paying competitive advanced in This update a good understand don't we're with question a I strategic thing everyone's anyone the advantage. everything our as giving anything sure off other on else and have there a thing, part be become given possible. and would highest can is such control and but process soon possible

Turning now to APADAZ.

we part should've have been. of half doses comparable much preparation that receiving than strengths two commonly those this hydrocodone/acetaminophen One it with work We Interestingly, treatment. approval continue launch. used so ahead to a APADAZ KVK was a to for with longer to advance was in can that process second additional

our sNDA As that's approval process. questions and the raised at regulatory by the with all believe to during after environment issues we the shortly difficult no FDA that were highlight or concerns I this any there point involved filed continues opioids.

compendia which to So half the big both on second going? KemPharm. KVK is KVK the pricing next question the We're focused -- always way way on APADAZ now and we how APADAZ brand well is with belong authorized all of for get that we're this Well, generic on and with launch. our

a us like supply, ahead. the additional items and behind continue are compendia We steam as full few gating well as for to pricing outreach provide with the support payer we now strengths,

beyond -- XXX Let's briefly at take what's ahead KPXXX for KPXXX KPXXX. and a look and what's

late this efforts at APADAZ if oxycodone/acetaminophen this just this and immediate-release our reward for prodrug of this political We the As stimulant regulatory developing no that one continued product to hydrocodone/acetaminophen at have as these and still we essentially Use advancement products candidates other a refer more is as longer given may a don't to addiction. the in forward market similar of can is time. very candidates there outweighs treat We path our other But Disorder are seen deemphasize space. Stimulant intended large, show the do KPXXX, very opioid marketplace. here, our our year exception oxycodone we to see to as commercial the and start oxycodone There believe could ahead see for announced opioids one with actively that will you opportunity than We risk backdrop momentum. the last be are XXX better candidates have to advance and see time. we that you the companies which market likely of societal legal

there's And treatment Groupon nice for Now there’s to meaningful as no and a the addiction very see where methadone. none. cheap for presents orphan use generic size opportunity opioid there a you is you stimulant great can KPXXX treatment have currently approved market chance add products a here. But disorder.

pharmalogical data Since some period will alone provide Adding clinical pure these NDA ample opioid candidate there's fact could Somewhere filing. over into abuse more release support AGNES move with long proof-of-concept need. I we individuals this expect the to methylphenidate the a a time the with definitive the associated therapies timing provide to of addiction potential be development. rapidly the the really have for prodrug appears low slowly and an prodrug studies to KPXXX, ideal we on after that

that rely on Given that development this could our faster help programs program there we like and be so the are we treatment to forth -- able process. FDA rapid already Fast also options could Track move than no believe even there

others for diversify at fully with greatest our will this to the year first look creating create continue core to of leverage resource. part We our this been us we turn over to commercialize. use LaDuane? therapeutic to focus provide with like At LaDuane and outside like twoXAR long-term value the to call point, to least to for our prodrugs and last Another us technology develop and the who'll partnership update. accomplished of has financial I'd similar for opportunities

LaDuane Clifton

afternoon will quarter year for of both our full results you, and Thank Travis fourth operating a everyone. and XXXX. I good provide overview brief

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

loss $XX.X compared spending basic million increase same loss last loss expenses quarter that income or was The XXXX increase of $X.X interest in $X.XX of to me respectively. million noncash of in of net diluted For is million $X.X by $X.XX $XXX,XXX which million basic XXXX diluted per and million million. QX net quarter to QX $XXX,XXX for an million and primarily operating loss and per in and the primarily XXXX year's net compared of was The of the partially we operating of offset net per R&D adjustment $X.X share $X.X or XXXX. $X.XX was a result an million fourth of fair QX items driven reported $X.X of other share share in for excuse in value the by $X.X operating loss and of loss $X.X G&A expense a

non-cash million as as loss per for year $XX.X of of primarily for $X.XX primarily loss to $XX.X adjustment compared was loss increase value operating income of The was for $X XXXX million operating $XX.X This fair an million of million. loss increase XXXX. an This G&A $XX.X in decrease $XX.X was compared by our expense or to of net and to per million $X.X expense net million million diluted year that ahead XXXX operating due items million million, $XX.X a for for by severance to of and recognized partially We $XXXXXX. a partially other of driven of reported was and was loss R&D $X.XX or modest in and diluted Moving basic by million an and an share expense full XXXX interest in share offset XXXX. of expense Net of XXXX. results. offset net basic loss $X.X $XX.X the

third a this our step moment, to of an million capital have December expenditure of -- XXXX, flexibility the to it's forecast, investments stability. easy address fund been back been on actually have just million through was and we If the steps cash operating for XX, to expected financial total into, year. not which $XX.X working financial taking increase quarter strategy current end that of compared we are we $X.X expenses long-term the details towards QX of XXXX. from As a adds but actively that actively purpose our resources and requirements to while existing see Based was

million the of debt shares net X.X million during provided debt earlier, exchange of senior which another preferred $X.X underwritten shares completed we by liquidity. October year past mentioned proceeds million and an added via equity. $X.X reduced into into converted offering $XX.X Travis our of and this We million an As secured we

long-term a discretion up that purchase purchase we is of KemPharm ways them and possible filing outcome NDA as partnering additional do opportunities of Fund of today, of purchase provides Just for an possible. million the sole in and continue best always shares and to Overall entered process flexibility progress Lincoln into seeking we creation from these to working announced continue we Park which we common as the of preferably provides worth multiple have seek we XXX. $XX bring company for terms agreement agreement. purchases with our KemPharm a common wherever that the the commitment the for Capital for the to KPXXX on stock the on so non-dilutive value based KPXXX timing to The towards

that to I'll the with Travis. turn So call back

Travis Mickle

year have really how well planned LaDuane. And execute this and to of to address wrap that value and we really call value up outside and in do Thanks products to today's KemPharm. try There highest is the represent last the those highlight that tangible those actions interest walls as the creation of year accomplishments XXX value. as assets. and ultimate realization in real of well our as as KPXXX,

with deals the have conclude may Our approval in be partner, job also that KPXXX is This there. or to potential to our these of capture not Many the of that NDA potential forget in value work but send other include in best scheduling. squarely and except types could also that camp milestones and submission doesn't labeling accomplish.

partner Some items for process From launch other need even and these doesn't of could importantly but stop. be to critical would the these cash that milestones, potential there -- product. more the

a build that studies, to marketing product groups there doesn't it's As and like Vyvanse, age changes From product preschool and isn't a multibillion-dollar story the with process potential be will lead better There stop. indication added label and better launched a new built.

launched, As to studies, build story referring will larger new share. product groups potential label on There age product I'm added marketing just to And built. only be really with lead like VYVANSE, changes a and market indication a isn't a consider preschool, it's better-and-better profile and and multi-billion-dollar KPXXX. that

be answer outcome. and certainly are there me, could all the course, -- that, of or diligently try assurances any working of no But I'll towards best Beyond said. of we're what and we excuse what

future, and twoXAR that, our the of to question next. Beyond own ability We to try the collaborations answer R&D like pipeline we and opportunities with and the Genco. Nicely towards of what's Apadaz have working have these commercial license KPXXX, be near of point KPXXX. and and we I'll build assets opportunities with what potentially Or with the KPXXX similar these to KemPharm. some to of may in look

to call, working today, our see I'd the are question. executing plan today's can towards support. continued future. be and time well on on your for any your you take appreciate happy As I as as we preparing

Operator

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

is open. line Your

Dan Busby

on for This afternoon. Good Busby is Hi. Dan Randall.

as it So go First And detail there's what question, partnering you've a were but from the initially? any can tell on? you helpful. that received with could happened war thus a outside whether bidding Or if process? more structured be was little there you don't I on going would this, you KPXXX, to the on comment a little into KPXXX, the low-balled offers color then would know could a given exactly characterize be far It hard fair? whether you process

Travis Mickle

Yeah.

think interest. as this all we've -- process I tangible said, in press that I competitive can't details we've process. we a already basically real has again are call how the really said on any about they It's release have evolved. or give

different that ADHD. could you there you in not that think may interested probably able others But maybe I ascertain are to identify. certainly be organizations

year. last parties interested were there So

more So than if you parties interested assume there's added one. we've there's And more parties.

here. that folks think can involved I multiple that So give there's sense a

Dan Busby

point? at you fair Okay, is process? And on new enough. what this a see Or that there can timeline

Travis Mickle

away as given can. of process pushed on. our every advantage we internal party any along We've we timing. execute as we've sort our own indicating have rapidly think I And to here by

west now. So pretty that we're keep going close to the one right to

Dan Busby

Okay, got it.

your then, you other some KPXXX, earlier. terms touched pipeline Moving any upon assessing us you on milestones focused of with point outside other on be of year updates in of it progress to that this Can just we KPXXX or should specific pipeline?

Travis Mickle

there. a we Luckily clinical for already XXX, lot work have of done

molecule KPXXX. all there higher prodrug more with the again, this It's regulatory by found specifically. in can that importance. now is at itself. just studies of real kind the IND, filing ahead So same in isn't officially doses that's KPXXX, and something move But you of a step of It's really that

the So, provide think have case this submitted. we more we'll guidance to get once in NDA I

of have -- studies We looking have we as timing yet. on are some that we're don't to. But that forward those

Dan Busby

Okay. trends it, for operating one. provide last might've expense then any missed LaDuane. XXXX? one Thanks. can Perhaps I And on just but for color broad you

LaDuane Clifton

Yeah.

about briefly spoke I So, current forecast. our

-- where we million. is of rate $XX between sort million think $XX our currently, I burn for to are

to into Although, is I reduced part the the we expect our somewhat. rate going that as year, go of be burn in deeper

So that, the which the of that rate course, QX. suggested run I forecast call takes into cash supports during

Dan Busby

guys. Thanks, Great. Okay.

Operator

you. Thank

Our with Partners. Roth next Capital question is Henry Scott from

open. is line Your

Scott Henry

sense good should I'm you, to the real-time? a where just me how get you cap many tell can how kind ended anything shares with Thank outstanding with? is shares of table other we Perhaps staying in some think model, and afternoon. of you excluding but levers. the the fourth the And just Park, Lincoln on quarter in about trying of just XX,

LaDuane Clifton

Thank Yeah. you.

approximately we million see, approximately. -- largely ended offering. that's where of XX.X the shares year as the out it's we let's So And we were came at

continued there, that's that's of is the where at end So it the year.

expect changes forward, be mean, I that But able Lincoln dilution how facility look much we As obviously to the Park. price changes with in to we utilize represent.

to manage that sure executing potentially we But continue a our like we do make extend to. to. to take on to some cash it the to flexibility want we that down Our to referred runway Travis intention what fact provides is more closely. that of need have lot that don't than things We need we and

Scott Henry

And this color. to Thank then that read may we when have data Okay. should said already, out? Great. if I you expect you that KPXXX. for But did. And apologize you

Travis Mickle

KPXXX clinical studies. is now work in really Right done planning the that's and around some being with formulation those

we start we more But kind as can not second half on to have some of have until that move I'll So may of again data studies. early we those XXXX. of year XXXX. expect this into But timing definitive

Scott Henry

to milestones any coming Okay. back. should APADAZ model through we just the with again -- we on in -- relative -- collaboration? expect Should the And shift to

Travis Mickle

come that available a milestone initial be with year. tell early that made an But there milestone is this you of when that million could possible we or around goes. I at can't announcement certainty There on outlined depending the how $X milestone that that would payment is original that had in just the in. an deal is lunch

very a moment, So pressing the reach at the to that. but unknown timing we're again is bit hard

Scott Henry

you for taking my Okay Thank great. question.

Operator

Thank question Rajavelu Oppenheimer. Instructions] you. with [Operator next Our from Esther is

open. is line Your

Unidentified Analyst

Hi everyone. Henry question. for taking Esther. for our Thanks This is

funding confirm all, continue you Park trend quarter you just Capital. R&D And I guys want -- over would over each all, mean first the of capital lasting? Thanks. XXXX? think So, get assuming of Lincoln I about spending to be second long How of that you from do with would

LaDuane Clifton

Yeah.

we as the R&D you the it So to And had a in specific trend into was efficacy at of going this tell on that XXXX. ongoing this look safety spending compared we'll that's QX. work year. up likely XXXX, for to But certainly with could we trial an trial up KPXXX wrap lot continuing

So it to prepare all doing year. work NDA begin and Travis around the terms later we've until as call actually just less lot the and and formulation work we're done as for some won't in a studies this expensive those I'll for of work capital of the in mentioned, now, XXX

to just spending the naturally ebb and R&D flow because activity. of the You're see going decline in a that of

So that I helps there. hope

Unidentified Analyst

Thanks.

Operator

And Thank no closing time this for remarks. you. I at turn would back to to Mr. Travis the questions over Mickle call I'm further showing like any

Travis Mickle

your for today. again Thanks time

updates KemPharm. important Thanks very at developments We here on to exciting certainly time will continue everyone. a as soon as we can. It these is provide

Operator

Everyone participating in great program today's conclude does may day. all you today's have thank Ladies you This and disconnect. a for conference. gentlemen, and

Jason Rando	Investor Relations, Tiberend Strategic Advisors, Inc.
Travis Mickle	President & Chief Executive Officer
LaDuane Clifton	Chief Financial Officer
Rusty Johnson	Chief Business Officer
Dan Busby	RBC Capital Markets
Scott Henry	Roth Capital Partners

Zevra Therapeutics (ZVRA) 28 Feb 192018 Q4 Earnings call transcript