KMPH - Earnings call transcript Q3 2018 | Zevra Therapeutics, Inc.

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Operator

Good day, ladies and gentlemen, and welcome to the KemPharm's Third 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 be given at that time. [Operator Instructions] As a reminder, this call is being recorded. I'd now like to turn the conference over to Josh Drumm of Investor Relations.

begin. may You

Joshua Drumm

Good call Sonia. recent thank for you and Thank to afternoon discuss our today development and KemPharm's joining product you, highlights. and QX corporate results

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

based are pursuant statements to to files under contained are current to and to circumstances, obligation More to is call KemPharm's www.kempharm.com information the regarding statements beliefs Harbor this publicly you actually of Federal forward-looking factors Information by is such Safe website section, we to change carefully. update on on Laws. provisions available in Investor results KemPharm any reports may not in differ statements Forward-looking under encourage as subject forward-looking available law. made actual these expectations announce risks or on and based review These and is revisions materially at documents any required the and statements. Securities from forward-looking the management's the are SEC. documents the complete future statements, at any Relations except with uncertainties KemPharm forward-looking

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

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

Travis Mickle

thanks joining today. welcome and and Thanks for everyone, Josh, us

is of together. company working KemPharm on team especially as on prodrugs. here been and many at pharmaceutical the intro prodrugs The you focused to of know, quick upwards years a KemPharm core already XX As R&D has related a

product of which Shire's most leading is billion VYVANSE, the and was of ADHD accomplishments plus product. discovery market One $X the development our notable

our technology at our I've we to perhaps discuss things potential focus, us as In four our technology. we Pharmaceuticals. months therapeutic the and do Host been our and LAT and in as expand River outside at areas bigger what are with occurred of for The very twoXAR to of time, explore company product were our at team partnership technology the position area together partnership the of this seen a have commercial have APADAZ, well and experts progress of truly ADH any last four we stage. of when can strategic financing and announced shown All span foremost all of best to the abuse a New our that better closed a prodrug on for future. the months

to advance up rapidly study continue efficacy that lasting lead the action for positive was at XX from of XX We hours. and assets minutes results KPXXX, to our onset by showing highlighted our

program abuse also seen We have collective the I with data the data our human in experience. completed surpassing prodrug even potential best my

KemPharm KVK. agree as last completed, key annually. distribution these will partner, And market With and of commercial We has ultimately the economics license tablets KVK to we and large also Abbott the supply APADAZ week, are the NDA of not a studies product. that of quarter the year. and pleased next to that This what as billion the to soon the a file APADAZ real announced a part market. This as billion believe APADAZ to think the potential now with X would first we KVK meaningful secures X acetaminophen disrupt is only dispensed it hydrocodone secures commercialize agreement

to commercial Turning the strategy.

will well-intended to before, is secure with I very to those generic we've push be to product PBMs and a a the mentioned supplying by force. to for will sales not cost. cooperation As plans exchange establish KVK of This and which with KVK an MCOs directly large require at outlined active to and as hydrocodone times, KemPharm's current market tablet a current large collaboration plans replace number products APADAZ contracts their and

in could sooner possibly with the future. next second as as launch this be We that the expect half can of with potential soon that various conjunction we in KVK year, levers pull

fees well term as and and intend therapeutic In licensing the as without have AI-base Turning produce novel fully prodrug indications collaboration identified that with two KemPharm opportunities commercial this candidates or we here with hefty as been potential twoXAR, based revenue technology royalties is a potentially now areas to We the concluded R&D will deal weeks, alternately our value receive announced a in receive of products research candidates in in. both on development technology requiring technology. value our we prodrug their expands development sales. for These don't on adds budget that utilizes we on long team, focusing we KemPharm's near second two as this agreement, milestones we having believe uses. XAR's The partnership. this

the to also as as KOL a event needs, well ADHD provided great as on encourage opinions their of experts these abuse. expert the in overview as to Over ADHD market, to we last learn with a the data, clinical well month, listen topics. more. The unmet hosted recorded I you webcast stimulant key

you the the this HAP to that which totality potential and first which of high market have highly this could the see in that we value classroom potential efficacy that the start the In Together a inherent upon Focusing all that still of candidate all was at this related product we focusing a it this can filing make planning study, plus and evidence in should the a differentiated of now a announced in for data and a patent could at based onset be XX product. onset the actually, would which, our of see NDA of has minutes a also life also amphetamine shows XX be has one July them KBXXX potential. to hours. From data on product blockbuster at here quarter product most could we through standard half clinical XXXX. We're hour of and efficacy any $X look see out we why listed study, this of hours. until are an the has product approved. is product methylphenidate an clinical exists. benefits ADHD in on If the up KPXXX and to billion XX to data back efficacy action believe suggestive lasts the intended to case believe VYVANSE, prodrug

the of shown to intranasal a start in someone human diminished X KPXXX? like drug intravenous this the study. research last what more through it we've and benefit has So trials clinical for benefits already administered efficacy At project drugs study. takes abuse am, compared to abuse. like at X:XX product efficacy with until Clifton, and Market physicians, have LaDuane meaningful Data has oral, or our great combined demonstrated turn at presentation abuse potential that announced mean show if over remarkable KPXXX behind to from versus The greatly should Fundamentally, potential value now pm. with X that active out CFO. point, when especially when I'd this even it would KPXXX will were than our

LaDuane Clifton

good Thank you, and Travis, afternoon.

KPXXX our of an timed DPXXX. those proceeds and was per stock shares of the share completed XX.X Pro $XX.X the for X.X million with in we with at received strengthen of net mentioned, of partners now balance shares initially common was $X.XX offering We million. and million. approximately our underwritten public to and early Travis The common APADAZ sheet in strategically As various interested approximately goal improving our potentially shares issued October. negotiating potential after forma outstanding position for offering offering

results. Now to third turn our to quarter

was $XX.X increase The by $X quarter recognized or million share XXXX. report of a in primarily million $X.XX compared severance net loss value by loss of $X.X period partially per of quarter loss fair million, operating million. net net or during quarter expenses operations driven of of a The $X.XX income of of other $XX increase expense XXXX compared same and primarily by per third a million adjustment million. the was third of $XX $X.X decrease offset increased For and the loss to in basic an $X.X $X.X diluted $X.X partially by year's for The million a operating interest million, in from offset and $XXX,XXX. KemPharm million $XX basic to million expense last R&D net non-cash expenses XXXX, loss loss spending of QX result of and share general and the in administrative and of diluted

from cash burn and cash million the June a total not comprised XX, was which restricted was timing primarily decrease to due September $XX.X equivalents, investments is accounts and $XX.X securities payable of The cash cash XX, it XXXX. increased cash, of expected of compared is net million. represented operating existing continue This to $XX.X marketable of to operating rate As approximately capital our but expenses Based at proceeds on resources through million, of pro current the requirements XXXX. million. and was quarter the expenditure a forma expected cash into level. are $XX.X not investments fund forecast, the offering that Combined to with of third

KVK. $XX rate our been million the of burn the of are recent responsibilities, have some forecast impact cash to but the license including now agreement $XX continuing of to to Our runway, evaluate a on partner our million a projects current APADAZ quarter, between cash shifted of benefit we the

the expect may that burn actual rate We lower. be

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

Travis Mickle

LaDuane. Thanks

well for value KPXXX studies forward, potential as including a milestones partnership filing as Looking KPXXX, KPXXX several see strategic we for results KPXXX. and upcoming for clinical NDA high and

or as pipeline. move or R&D call do candidates KVK I our more these wait for Please weeks discussed the prodrug team on over the to from coming last announcements we plan Additionally, our week, one months. into

same fact don't have allows securing to year-end. development project a partnership So at as working be so KVK, as working plans the able at the us defined question. timelines, to begun. with demand. accomplishing just diligently much with terms a launch to secure this time same well something to we structured it product to process those the are this makes months over the have with We by We're four the that potential We as also the is accomplished ongoing possible, last of is also work expect still But completion a of Due but next? goal sooner. as has we What that but date. soon the APADAZ drive time, to

you see, big there As company front believe number the catalyst a of for we that in of us. can are

you questions. this demonstrate that we KemPharm. that at I ask starting point, believe also At We here if see, there's any to concludes can we're can do can now really presentation, our what

Operator

question Our Markets. RBC first Thank from you. [Operator comes Capital Stanicky of Instructions] Randall

open. now is line Your

Daniel Busby

This is Randall. guys. Busby for Daniel Hi, on questions. few A

I going? was are those provide First on you year-end a color And confidence process. in your remained on any unchanged structured how discussions you does can based said level before broad know it KPXXX, on done more those getting discussions? deal a

Travis Mickle

provide additional and in have goal, But the or really we process can't we're and negative we within that to positive diligently an attainable as we still don't color indicate because again this achieve remain anything I that working want we any it. potential partners. is past, believe to to we're certainly

Daniel Busby

for to Okay. date pre-NDA And anything? that follow-up want to committing a getting a getting And commercial a and is KPXXX? FDA put with done? differently, partners on deal FDA's anyway before have a I meeting the to guess feedback you faster that. Do hear do your

Travis Mickle

line, we made have requirement. have Not that security, I've date anybody heard so that nothing has aware time We that a to general don't nature. a

Daniel Busby

year-end that shortly Okay. expected is thereafter? before to or be And still

Travis Mickle

best I quarter. first probably is quarter, first early can now we do right believe so

Daniel Busby

early, your Okay. now on still from to partner proven have it's realizing for switching can Have And feedback a the deal but gears show on you and in then distribution? supply conversations initial noticed board channel any with you difference KVK. they APADAZ,

Travis Mickle

lead undergo to discussion collaborating happened. there's of area detail and forward. certainly We'll before get be several KVK's now what with sort steps them off ground. we to really that's the have that helping Well, on them the to But in product that comment

a So see there's interest. that I of lot still

deal the KVK's it I of catalyze really I can't give discussions. any is But think announcement because more specifics those will the product.

Daniel Busby

partnering And deal fair. less let's moment off year, pipeline, That's Okay. and or just both that that responsibility those one your assume for for reach KPXXX a passes KPXXX last products. you later then more on for question the do this

share kind terms potentially something and I clinic year. about products there know to you of bringing your you can in more next more forward? alluded is you're into what So thinking of But any bringing how the priorities color on are that

Travis Mickle

as that do of don't development. our see Yeah, well get if partner, KPXXX, the we KPXXX end

commercial a but really lead to with knowledge our diligently us, would entirely will product given we becomes resources development that base for So the company working certainly now product focused it effort still be another on effort. and approved they here get that and

we with ago an where that, opened we two was were IND. Beyond years the KPXXX just

can we to hope products have So able also advanced very, than us bring to with front rapidly would again opportunities and development advance more you very we'll be process we're forward we're through likely functionally, see value going high several the those as in and similar timelines. and that of

Daniel Busby

Great. That's Okay. me. That's it for helpful.

Operator

you. comes Instructions] [Operator question from [ph] Rajavelu Thank of Our Oppenheimer. next Zal Henry Esther

open. now is line Your

Esther Rajavelu

This just with to discussions payers? PBMs and KVK managing wanted APADAZ, clarify there. Esther are I is you Rajavelu. Hi, on or

Travis Mickle

be KVK funneled party, do is that through we the them. commercializing so would anything

the that lot agreement done, a through today lead discussions but efforts. is they now been of So our all have KemPharm

Esther Rajavelu

Got it.

when that's rather gets expecting that determined is by team? of your than deal you're kind timeline that a the payment milestone really with that them payers, done really So

Travis Mickle

described the we're I KVK this time, is but As at the bus case. driver backseat call last in on driving least

I to well do So their timing. and have to their leadership defer

so the line. goal We actively relationships with have we'll in the working them them be get to across place,

Esther Rajavelu

you Thank it. very Got much.

Operator

to Thank conclude remarks. now would this over you. I our session. Travis gentlemen, like to call the closing ladies question-and-answer and any turn Mickle does for And back

Travis Mickle

like Thank afternoon. upon and thank time better evening for and bigger a great we closing, successes interest intend I'd of build to rest to you. to Have things. these In your your and initial Thanks. or you

Operator

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

a great have all day. disconnect. Everyone, may You

Zevra Therapeutics (ZVRA) 8 Nov 182018 Q3 Earnings call transcript