KMPH - Earnings call transcript Q3 2019 | Zevra Therapeutics, Inc.

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Operator

Ladies and gentlemen, thank you for standing by and welcome to KemPharm’s Third Quarter 2019 Corporate Update. 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] I would now like to hand the conference over to your host, Jason Rando. Sir, please go ahead.

Jason Rando

you quarter our Results. XXXX thank discuss today and third KemPharm's Financial evening for call joining to Good and Corporate

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 safe Forward-looking materially. and securities required statements to the made its provisions are as Actual KemPharm differ statements, law. revise forward-looking obligations laws the management's may harbor expectations. to any current update represent or by except of pursuant results disclaims

with More forward-looking encourage available can risks are carefully. found www.kempharm.com, the on complete KemPharm's uncertainties website files review the to and We SEC, statements, section. regarding Investor Relations at which in information documents be these under you KemPharm the reports

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

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

it is my Mickle. that, introduce to Travis pleasure With

Travis Mickle

will Thanks, know a for This high, while be is today. joining as fairly short we activity internally everyone call very

priorities where today sit much what and pretty our we are.

today. won't We general a be also providing overview

are website. you to please found disclosures previous you corporate story, deck our our ask KemPharm refer I If new the that in our be to that on can

topics we’ll move addressing, be that various like right of number X Slide to and a please. into jump be it will There to

is finalize the to we're the NDA September, that sections partnership of GPC with a speed, believe our right the NDA. So, Most various as today, up initially focused them KPXXX working fully announced we with expected focus on in to of back and We least now the partnership filing. is at GPC. on activity

timing. potential any far is delay the than in of here parties, are time critical for worse any both sort missteps minor While

on timing will the So together that NDA the with likely believe be with or of next mind, we year. around most of that in January filing GPC,

already could the actually little the And of or may decision know, in certainly as you with file certainly a agreement GPC. to sooner be lies entirely later. But when

NDA unexpectedly, supply. addition asked to validation, KPXXX has believe GPC In manage us commercial little we and commercial A us and expertise effort, to filing, working with all the with GPC experience ultimately prepare benefits our which given we are to of to-date. technical for this

appropriate It's that behind the commercial We be the and tuned able to certainly move fully KPXXX GPC launch also we’ll to it worthwhile more plan more discuss to something so. and to of do deemed it stay once expect has disclose into.

recently, progress As campaign we that Apadaz we and entered anticipated agreement we stocking made with awareness is has this good KVK and an quarter managed that, updated we underway has the when last care into launched access, year. as believe some officially with

that in Agreement. the we'd of to economics folks of mind, License phone remind some KVK With like of on the the

that a XX%. Specifically, be to share a there up in the in million potential to real could achieved potential profit up XXXX, which $X.X milestone reimbursements, and to million to the $X followed for be by is subsequently of

over commercial As like efforts, provide we At CFO. in the point can. LaDuane? with closely with KPXXX turn as call, updates the KVK we and to will this it our LaDuane work I'd Clifton, to

LaDuane Clifton

mentioned first Agreement, KPXXX And upfront quickly as consulting generated revenue million. $XX.X go License earlier. time, which for Travis, for services under QX reported we first and our reimbursements course we'll that the to the and plus you, Thank the additional the results. payments, the that was and KemPharm is of actually Travis revenue totaled

a with were was par fees, $X.X increase the that a expenses reduction professional same for million the prior-year income quarter, for Along licensing phase We per R&D in diluted and on in really costs, personnel course decrease QX. based KPXXX a $X.X license. roughly for you but in There quarter of this that G&A that with GPC earlier increase, modest which see per underway, reduction. that, expenses also was compared that the ended moment. process in was to based $X.X summer, of million related that through share. the net really successfully the with with the That million, so At of of quarter on on to end $X clinical cash I'll resulted million. did the we flow was $X.XX for the XXXX the -- completion Also touch a we saw $X.XX and ended or the basic drastic have QX of to of led and share,

for more then But one cash is runway, very we've operating runway of our that things really obligations. the spend. cash been update biggest the is year to our debt on along reduce this lines, working Looking in forecast our those hard near-term

I well as also concluded clinical as are cost of G&A expenses as so XX% R&D of reductions. reductions workforce phase taken other we've mentioned, that XXX, reduced. the Specifically, We've

NDA. cash cash payment course so KPXXX acceptance there's next And of an is and million another you know, milestone as important we payment at runway. also section here, License the of potential part Agreement the the And up $XX then from the of had KPXXX near-term front milestone a of that

of fee Travis are cash that, continuing reimbursements earning these a work consultation cost revenue flow to efforts. our as we GPC in recording an from again, into be In mentioned actually addition received will additional and KemPharm we to for see will continue as

together will due and principal that's into that of through really, $X.X I half first not the XXXX. into of All and QX, approximately in million the current cash due payments of us to forecast as interest where but goes then mentioned take here

And working is of around obligations, an trying course, shareholders. solution debt and So, to these a best on issues hard high the appropriate company. to of very priority we've been for bring

payments of our and in runway in to XXX. runway, past with goal of principal are And we approval June currently near-term February out the interest so due the push cash to extending respectively negotiations the address cash in a

would as quarter low will Agreement. because that be $X could our beginning the cash of that's of take per primarily runway License us cash actual successful, into that to coming believe So be of GPC the reimbursements under XXXX. we million a as essentially the burn all If and

recognized that, debt the to to options totality. we on addition our In now in start also obligations addressing need looking at for

so that the worked the transactions number And addressing one well, our in a years steps of has Cowen through we've to in who that assist we've actually of portion debt. a begun engaged company processes of is with us larger the first

to conclude process hope would that KPXXX potentially we so And have approval. prior to

updates process the in begins provide will we as that earnest. So on

turn to back I'll it Travis. that, With

Travis Mickle

LaDuane. Thanks

Well, mentioned soon know while are need in near-term fully of with that, As earlier, KPXXX for value. as XXX% maximize internal the our the file and NDA our stakeholders. tremendous is all certainty I value possible amount we with to hand a possible. two goals of the partners hand there are. of account activity, priorities nearly to working we we licenses To licenses will These as for our all substantially what

accomplish address balancing while In these still we debt and the and needs. creation near-term long-term both to order value must shareholder also goals,

and have nothing could is us a financial good already further guide made advisor goal believe we in While that well bringing to we process down and that that well respected certainly along be path. the respect certain, bringing a helps progress

have presentation. welcome it I concludes questions them. any we our point, if formal this At should

Operator

from question first please. the Our RBC Instructions] of Randall Markets, [Operator Capital line your of comes Stanicky question

Daniel Busby

guys, Randall. this for Dan is me. Hey on questions for Busby few A

matter you final file, items have any row? then First around planned detail there just before of meetings ducks can you And you more or KPXXX? your the the latest for KPXXX, a on in gating separately, give what's with getting FDA any plan it more further a is

Travis Mickle

a just the NDA NDA license and this agreement So recall, you XXX(b)(X) tremendous heft. this filing. isn't we The as certainly regards especially in an completed as here to NDA a case, the filing, September, is

speed getting been consultants time and and fully their consuming incorporate, up far for as fairly has allowing to advisors fully So speed us to review comments goes. them up to them to as for getting

FDA to need So what we’re meetings, is for I there additional additional would, no any there's is doing get work. finalization, no to what

filing taking then just your in getting making the label. potential the is a It's have, clear. merely well on best you it's feedback sure message And as commercial ducks row, the

done of possible as all we next early that year, that's to that's, as quickly more think and So needs be likely. than

Daniel Busby

Okay, and on KPXXX?

Travis Mickle

guidance that There's Yes, to are on yet. commercial any have the says other activities that don't going side. we KPXXX, several on in

we they we'll licensed were license able interest. value could will there work, to other may for be supersede have potential with That more I in how some activities provide So could the this product timing be on to see, But first the once that little KemPharm. and that the XXX. know a why that clarity place. certainly more there there, and That's to is a

the of the be again, guidance going here where believe what's on product way So and provide will, will we pulled products through. we'll ultimately the along the

Daniel Busby

Okay. questions then couple just And a Apadaz. on of

as market, First, percent of And long-term KVK’s a product formulary and get if then you trying of potentially color to the have around overall today, could give APAP intermediate quickly how stands could status. you hydrocodone coverage your to this sense what it with just preferred access and targets ramp? any there,

Travis Mickle

database through generic complete them we XX% this before have with with and that, versus relative of we Well, KVK. know our process, clarity authorized about we We the have APAP. work don't hydrocodone whole have reported but certainly on that benzhydrocodone coverage MMIT seen to the

we Aetna, preferred list in So, products. drug are with Utah. And that's on large know confirmed like in those Alabama we in Medicaid we've and where many we generic tier cases, plans Cigna, a we are, particular and preferred a are

good with we pull-through, as that's determined. So, as yet sit mean here. we're be progress to guidance making do Where far I KVK’s certainly

Daniel Busby

Thank helpful. Okay, you. that's

Operator

Thank you.

Oren from Our Livnat question H.C. next of Wainwright. comes

is line Your open.

Oren Livnat

milestones follow-ups. runway cash debt targets hitting second Hey you some and the a have longer, the upside? And us or milestones if your you could come what that are on help with quarter your of you renegotiate based expecting me Or Is if you're next I remind near-term. just can couple assumptions certain flow Is just milestones year? of certain I in assuming was do can wondering in? into

LaDuane Clifton

million that of cash license expect in then includes anticipate that agreement as Travis's which Apadaz during the QX acceptance the we $X runway will the Yes, the XXXX. and under milestone receive potentially NDA milestone half first also to it contemplates we mentioned,

Operator

Henry comes Capital. question from Scott Next [Operator of Instructions] ROTH

open. line Your is

Scott Henry

the Good on did guess towards afternoon. Thank expected to I get to correctly, quarter? kind questions. prior $X wanted you a you I down hear you. a the follow-up couple of of burn I million quarterly first, just

Travis Mickle

to Scott, reimbursements license under So, out agreement were successful principal operating in interest payments, able the being costs or bring by then would being the we're other our revenue push offset able generate if and to that

to burn cash that down level.

Scott Henry

also they're but would that a the that imply a covering statement? not are so only R&D, fair reimbursements that Okay, is lot those of covering G&A,

Travis Mickle

Right.

the to that we example, a managing the that's agreement for plus commercial provides that the we’re commercial, cost that, And for on build license consultation margin, able is fee. So that, when help essentially. KPXXX GPC manufacturing

that And is the so of portion therefore company large G&A. revenue and covers our to a

Scott Henry

probably for end filing reimbursement continue and with is level? expense obviously if that XXX and Okay, on the would work does it the XXX start same and done, to then after the at

Travis Mickle

right development they end. naturally about So an will you're XXX come cost, to

is However, that continue part And are and are consultation commercial NDA ability the potentially. services of then even ongoing past again going the support as managing also prep. review and process activities the we through to commercial launch to up to build our

a once KPXXX, GPC consultation the managing And to through all in would approval phase the inception development billing costs. case, like XXX. with whole in similar the to its With from that clinical the fees. that up then be program for would be way, that's and begins, then really into program paying just on we regard licensee And

does So, a level. it similar at continue

Scott Henry

for I any on I missed acceptance? of have recall but that, don't it. milestone and magnitude Okay, seeing you the disclosure may the have given NDA the

Travis Mickle

at been No, unfortunately, disclose. so we've was items request able one not the the of that of that it's something was to and redacted GPC,

Scott Henry

debt the when process the press release, I its a guess entirety. talked I initiating to Yes, explore Okay. it in addressing read about

be exchange debt. there just as for to course, normal issue debt that would I options options? in way considering any Or options to the the you're there equity curious natural maybe? read issue any the if Now, or more outside Are non-dilutive of

LaDuane Clifton

shareholders. that one so a of non-dilutive. monetization, top we think royalty be reasons kind another then, we're a that is of and bring would some Cowen potentially with the of option, would license for else way right to best alternative, Yes, or what financing that's do could a the another is be to we creativity bear And in see mind working

Scott Henry

Thank great. that color. for you Okay, additional

I think questions. you that’s it for for taking me. the Thank

LaDuane Clifton

thanks. Yes,

Operator

you. Thank

Wainwright. Oren have H.C. We a question follow-up of from Livnat

open. Your line is

Oren Livnat

little faster off Yes, got last time. cut I than expected thanks. a

areas, level? help or KVK piloting just you're I written Apadaz, Does to target the don't could what's or call an -- show I substitution obviously, model do us commercialization is as they be approach mechanism to uptake? Thanks. goes how Are So in big Apadaz, and these and regions at us but these coverage. understand mean, docs, to if the you're someone drive calling idea and that be back? targeting here, just prescribed sales this prescription here? a just the have exactly I written it not know pharmacy market I piloting Just as on in basic Just the the down? going think to doctor follow-up. getting on explain you've a some there's on give you force right? can running got of

LaDuane Clifton

first to you can looking I'll relationships. for can line you're so to reaching as there extent The Basically, I authorized generic, is create access out that. well. really with work is on of sales and those related think them a he pass to additional the and I to we're at is and know then manage so payers outreach force And some PBMs preference the take markets, here. Rusty to right, that no a or Sure, you're assist the for Apadaz gain Oren,

that and of Apadaz I'd making The is prescribers second that both part available. is say aware pharmacies

consider. simply not promotional. being there something trying We're should that available again, let to know folks just very they is we're there so that And

Given sensitivity to that. appreciate this I'm sure environment, you can the

have of in what that. we as some and initial I those case, from when so know this And they we and efforts and Utah awareness you access Alabama Alabama our talk access look formulary PDL is current the most they're then, part understand where about Utah, Medicaid KVK that of through the in focusing are

would we So force a maybe example. is efforts, pharmacists possibility to there phone for provide non-sales outreach to that use other education

is without So there's as looking at KVK fielding a variety of that mentioned. you force things that the sales doing

you Rusty, any if So know to I to add thoughts have don't that?

Rusty Johnson

covered following. and to would Where preferred I folks, you managed access But the think LaDuane. have think well it I markets is I you of a essentially from there's of I some talk add believe we all utilization. position, pretty in conclude the when And that, diversion, Yes, it formulary that entities people elements misuse have of these excess they of that Apadaz could think utilization improper help hydrocodone that APAP variety a reasons. reduce maybe of help lower

financial a on to to there's that. So large plans incentive perhaps work

trying as so pursue large that sort on of process. angle scale helped. the Hope a we're help well, to KVK that's basis So that

Oren Livnat

nope, in hydrocodone let's I just some I area, time. is could call guess an writing is that for that you Utah, awareness back them tell will Alabama we're or pharmacy happen is because going something time, to say follow-up. and mean, pharmacist, and or it a Apadaz, they write If insurance here takes If write I else? doctor what need and the doc example, say, that scripts not thinking Apadaz, plan for in APAP gets to to their to

Rusty Johnson

It's I result. than it. to a of don't this that that, more be complex right And can get there's that good to Oren. the a done things But venue know lot is try

Oren Livnat

you. All thank right,

Operator

turn management over to the like I'd to time, this At closing for remarks. you. Thank call back

Travis Mickle

months everyone discussed are the today. of the We on can't to here various over to And able much. topics Thank some time we you updates be today. thanks wait provide all very excited for and very certainly your coming

a again nice thanks have So, evening. and

Operator

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

disconnect. now may You

Zevra Therapeutics (ZVRA) 14 Nov 192019 Q3 Earnings call transcript