KMPH - Earnings call transcript Q4 2017 | Zevra Therapeutics, Inc.

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Operator

Good day, ladies and gentlemen, and welcome to KemPharm’s Fourth Quarter and Year-End 2017 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 provided at that time. [Operator Instructions] I’d now like to introduce your host for today’s conference, Executive Vice President, Dan Cohen. Please go ahead.

Daniel Cohen

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

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

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

begin has clinical provide then XXXX we will conclusion XXXX update XXXX Officer, and quarter our to of who is on Travis At LaDuane call fourth our Officer, financial remarks, the will full-year Chief who through Executive proceed results; a KemPharm’s will review President early and corporate, on Financial Chief been Mickle, and me with session. and near-term assuring product in question-and-answer and KemPharm how achievements. to KemPharm’s develop anticipated several company, today’s presentation development we results to call Joining Clifton, an any changes upcoming for the now future for We’ll call our the to will important and grow and year. report will turn milestones LaDuane. this milestones. we the how reviewing coming then over and an I period our our the in corporate move by achievements financial

LaDuane Clifton

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

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

loss to net The quarter same per of fourth share, basic loss for $X.X $X.XX of from $X.XX by as and administrative the loss million, items of $X.X to and a driven period-over-period. year. net diluted of due or was For operations Loss a diluted other for and loss and operations was of share per expenses prior $XX.X by decrease from from we value the in of a the million net period $XXX,XXX, in general and primarily operations basic the $XXX,XXX. R&D $X.X million, was million, reported million decrease and or and period expense compared XXXX, a net of non-cash fair same loss a respectively, $X.X XXXX. primarily interest adjustment in million The of expense $XX.X

non-cash a for was $XX.X net XXXX. in the operations and period million, to interest loss million due of basic and $X.X and for ended share For of basic and million, that is $X.X recur expense of of the same from year spending. fair a of which to full-year a $XXX,XXX These share, in $XX.X $X.XX and million, XXXX million XXXX, diluted XXXX, by for expense period-over-period. $X.X of decreases primarily million administrative loss for of was primarily XXXX not or operations recognized severance per were spending a loss in general in $X $XX.X we the net per $XX.X a loss million did or an expense $X.XX net from compared reduction loss of other reported and XXXX to net due of by to The XXXX The increase in million. $XX.X as adjustment diluted R&D million decrease partially value offset items compared

a of receivables – into December cash compared September $X million XX, us cash, the now securities, have and entering certain long-term revised day clinical for million, Based XXXX, to marketable our which now APADAZ, total are in approval material preparation trade was the change on and The As resources in are QX take KPXXX accelerating the XXXX. the program. expected to well that required commercialization show arrangements result equivalents, of we supply certain as XX, forecast was as of beginning cash, existing XXXX. is into restricted elements APADAZ, the the of decrease $XX.X forecast investments recent of of of

advancing providing or flexible liquidity, towards add development During our $X.X $XX.X an of QX additional potential common our the and as raising partners NDA for of through XX, to ATM shareholders, ATM us The million. the partner or we under program commercial in both proceeds our continue on needed KPXXX offering, initiated at-the-market APADAZ of XXX,XXX we of stock March well sale in Remaining shares. existing benefiting is the XXXX, access and potentially allows early gross prepare as new under capital sales for to XXXX. as million availability

expect program a provide to We needed continue the ongoing of operations. to ATM the our capital to portion utilizing fund

over back turn will Travis. to I Now, call the

Travis Mickle

To no and early There’s February call the FDA team which period by milestones, and significant as been has on Drug LaDuane, Activated APADAZ. for KemPharm, highlighted of aware, demonstrate that most XXXX believe thanks, for several on XXXX of the quarter a call. the joining fourth transformational the you, we question everyone, Thank it. for New the Ligand our this begin, potential Therapy and that are XX, implements approved talented Application

Without short-term pain. adolescent entry a the pivotal market of important the short-term of of LAT acute that pediatric all study. adult we allowing our study. platform. of our d-methylphenidate But progresses and initiation the for and of but overall clearly efficacy for what management and the with months. be USAN the for for NDA differentiated indication product prodrug includes will for suggest ADHD super-extended This validates headline the KPXXX Investigational was with enable most the Not Our our it announcement FDA ADHD APADAZ New does developed products This our acute across of for of also proud. for represents progress release one the our December, several made we’re of acetaminophen of the question, ADHD thus our the significant in as populations initial all classroom-style efficacy pediatric what a age And was That adolescent approvals single prodrug that a to pain, the combines The which advance trial with of the were corporate proposition our with ongoing prodrug study prodrug applicable in drivers is milestone Asalhydromorphone for and acceptance of extremely an treatment KemPharm LAT and next this potentially our date, hydrocodone a six hope pivotal management positive and of pipeline. candidate. we believe development trial patients with signifies value it business KemPharm Drug are patient product the several the strategy designed important initiation highlights for for approval name made FDA past over for the drug treatment prodrug is results of vision. up. of APADAZ Moreover, we ADHD. approval to hydromorphone. also NDA PK efficacy approval may and first d-methylphenidate Application of recent products nonproprietary of KPXXX, technology KPXXX, our and KPXXX by from be a of only patients

Additional achievements stage a platforms in advantages many with the KPXXX, for and our prodrug-based a Pediatric U.S. prodrug with to as KPXXX, have Tourette of of potential entering XXXX. Rare including of Agreement potential of been testament these are therapy inception, LAT ADHD. the a the milestone-rich and a governing expect lastly, Potential in The to be Assignment the as Collectively, and set Oxycodone, Genco ways our platform a prodrug prodrug the heart patents it’s of LAT Sciences value for Licensing we family for into since Syndrome proposition. to foundation and are value develop KemPharm patents well of Indications, our patents

However, until February complete process. we LAT that approval provide developed vigorous direct drug prodrugs a evidence you regulatory could successfully not could the with XX,

is answer answer With remaining approval APADAZ, can The the FDA firmly that of demonstrably, yes. we questions.

our is believe a KemPharm’s action, is well address designed number driver duration our with unmet the onset two line FDA as our to of secure ADHD of treatments, and opportunity. our APADAZ ADHD marketed significant of represents ADHD action, in product we first growth consistency currently therapeutic methylphenidate as most is of including effect. advanced the prodrugs most needs prodrug portfolio approval, of next an KPXXX, While

the a addition, In the abuse possibility prodrug of offers lower potential.

together more a be significant All represent physicians, or what of a they even of in are potentially the best-in-class product. alone methylphenidate these could get minds best-in-class needs product similar

Based hours we trial potential early early more Vyvanse XX abusable Initial as to mid-year. option. intravenous December. top in studies, this physicians that abuse of product, a completed Investigational expected summary, abuse is efficacy all in should earlier, could to of we intranasal up as as line past ideal when milestones data on a for to anticipate feature multiple acceptance oral intent are much end be the of to intravenous, new and value is we as routes of assess data respond Most drug the year labeling potential designed survey to high also second of less data, XX has key prescribe up and moving for their of come Drug with potential was less the than still product. to duration ADHD the second a XXXX, we’re KPXXX that As patients timeline data best exist as market KOL indicated for the on estimates, the ahead it less as as its should an pediatric This a which believe marketed KPXXX post-dose. with in the and abuse products is version in we adolescent human In surprisingly, as available the first minutes for Based a of current is year. not program the abuse have and November. better quarter with methylphenidate, option PK by produce input, need full KPXXX who patients a be a this in intranasal quarter name in only Developed one which study methylphenidate methylphenidate therapy potential program treatment the trial KPXXX efficacy would methylphenidate XXXX. who the also the the a a physician. on work data support acting provide study, potential of In who unmet parallel many prodrug KPXXX’s pivotal the of effectiveness as required. The though of oral to track less throughout abuse current mentioned and to of KPXXX product of puts coupled abusable longer Even for In hours. to ADHD an XX with primary option the even patient data duration regarding and initiated well later KPXXX this medication, filing of abusable was of significant prodrug is XXXX. and and us found application demonstrate of quarter doesn’t day from program New efficacy that expect abuse. adult the currently onset announced via file conducting data populations human by to ADHD the relative us for application KPXXX soon The the with addition just planned

can studies, data with is which roughly progress develop year. human should current similar plan from NDA towards XXXX, along the research, pathways expedited with KPXXX and to well Essentially, two liability and potential our within a with allow KemPharm of programs. cost importance, PK markets unique Of KPXXX KPXXX late provide of Our as KPXXX in ADHD an along timeline X.X initiating including abuse as to development significant access us a advantages. obtain cost leverage later completely program ongoing the studies KPXXX to and is to this efficacy expected

of addition XXXX pipeline this fourth from we January, of earlier we prodrug assets, parts to of several Oxycodone, overall a in as of KPXXX, Prodrug class, advances year. covering Most granted USPTO were both and added composition In KPXXX KPXXX, also Hydromorphone. for and and state. Prodrug we add the for of the recently patents of a These well LAT patent with family announced to patents KPXXX our KemPharm’s as the quarter the to patents matter-based the during

value-add products molecules, prodrug which are previously, our this composition patent LAT and companies new and KemPharm with developed with noted for of the work for is As are platform eligible we matter-based considered a significant long-lived protection that believe us.

designation pharmaceutical developed The Asalhydromorphone name, to the recognized USAN the Asalhydromorphone, products program, announced be and new the structure. our that KPXXX Council prodrug marks descriptor the the ingredient. nonproprietary the active in granted for LAT November, we chemical with of of opiate the assignment of our Regarding officially the use approved second use for platform

by with assignment of technology rare goal for the of in first occurred when or of agreement APADAZ pediatric with a with into Tourette the prodrug treatment product Sciences licensing name, entered The Syndrome prodrug Genco creating in October, XXXX the we a accompanied the benzhydrocodone new KPXXX/IR. non-proprietary a In KPXXX, and ADHD.

the of the expense existing fund I’d as increased operating pharma in resources of provided. that current We investment update comment capital our our of that support on The our growth QX clinical believe forecast currently change generic a company provide well manufacturing order potential well opportunities expenditures both LaDuane quarter as Finally, non-dilutive significant into operating will in and actions XXXX. see secure APADAZ and coming PBM of will commercial we like and for to development in to both months. development, types partnerships, advancement funding to KPXXX the

– of believe while of in for to days. I’ve We provided forward-looking balance commercial these, to provide which financing typically addition, coming while the inflection offering XX significant this to could both organization, the ATM number in today, milestones our anticipate milestone call events accomplishments our and a End a stronger commercially done have and rich prepare growth. multiple the XXXX. more ability position to calls see KPXXX us much we with your candidates real XX planned. – additional of year a as months point the Current In company’s has of we value quite the ready for of APADAZ progressing for development spend a additional options. We enhancing with a the next use bit time of clinical of and during into announced be forecast the view we in key period past in With are KPXXX for partnership. co-lead this and recounting KemPharm that and message KemPharm for be catalytic is future

early pipeline. XXXX XXXX expected to and me let anticipated our the during for announcements Specifically, the of summarize major milestones product

be line around the the of data oral and studies human which KPXXX XXXX. second-half. from our data from be mid-year, quarter be the data HAL available will second would we believe in efficacy KPXXX, Top intranasal in that liability data intravenous from First should abuse

also plan in well XXXX. NDA efficacy KPXXX initiate KPXXX application early the year later We in to studies as this and for

with combined our products for These growth additional of of announcement an an expect range. also KemPharm partnership partnerships to events develop the longer opportunities, before and year-end. APADAZ program LAT both harness to abundance a or near-term We ability offer

questions. our the offer call We that, can continuum. opportunities the intently focused that to and potential your prodrug With now to on external and healthcare open throughout internal expertise the I’ll pursuing maximize are multiple prodrugs

Operator

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

open. Your line is now

Daniel Busby

coming the the from, update on products Hey, this on for landscape be couple of think with competitive new most year, or the at potential Randall. end market an launches would For is To your on other Dan competition questions of potential provide standpoint? you you on see about A do can as where the example, whether existing launches? it we us from next Busby KPXXX. start, early

Travis Mickle

now is KPXXX Many where is times of a as right left these KPXXX again, being is Vyvanse of methylphenidate. goes, ADHD Vyvanse. the competition hand, will of kind the it could with amphetamine, complementary prodrug hand, far a the we see Though Vyvanse be directly it unique As right as space. products have be within prodrug the patients

the products, the As far issues mean, of of number what methylphenidate from I are them I but a listed suffer out else as in is out unmet there, or needs that there same then, onset potential, duration as and other kind abuse call. as course, products. abusable action as of as The are methylphenidate longer shorter just all them of of labeled action, – of short of just most

distinguishes think, don’t any potentially being other supplant I from already we developed that products areas those So could us see And what’s potentially really available. really this.

Daniel Busby

can other And and the addition to Clearly, their it for change that. Okay, data to or But words, to decisions? And earlier in research, to they what’s on got have it. going label share helpful. prescribing then payers kind on any as early would from clearly that, then market but what looking physicians maybe drive your with important. clinical follow-up is their on lower the will current in see there based of discussions on early, order are well? of potential behavior. That’s actually abuse you need feedback what the you do be all in just sense So longer a duration, really a onset,

Travis Mickle

to say Well, I answer the payer question they first everything. is, no

step ADHD, it gets prior it’s time because life just a in usually a especially or everything authorization So at diagnosis.

research do our later we’ll on. So, peer

that partnerships still that done But efficacy results action see product. ultimately, I on a early as the kind XX could because with it. prodrugs of of is think, one because as see and from the efficacy demonstrably work success product in to study onset label Vyvanse, of around halo in the hours, potentials data thing as that’s get available approved the APADAZ, this through hour that well, this particular physicians, abuse after that we’ve commercial see that, really as be this materials and to in could But the go KOL we case, be expect, so work a a once themselves half they’ll the We be is other also they able from area. will lot touched physician as it’s long is of that have able in not done of of we

So this methylphenidate will described approved. ever be the ever of prodrug first and

this to So able great the sort could of with Vyvanse be of to a advance really ahead tails around opportunity on that it. product be and step that halo

Daniel Busby

Okay. helpful. super you. Got That’s it. Thank

Operator

Thank you.

Our next Cacciatore Ken question comes Cowen. with from

is line now Your open.

Ken Cacciatore

let prepared But to talk dose, thinking with about So then or I bit here. nuance differently. end and heard the you pull just kind prescriptions? on lot license more at be definitely ask guys, remarks. about also about have you to – have was APADAZ, able maybe of participating would give a you’re percentage XXX IR your versus how leverage you backend? you context are of in as upfront i.e., on wondering non-dilutive of a financing, concerted the payments upfront not any And have little the or fee dose if Hey, could of XXX two immediate carry Do maybe their that off top the release committing an they through me have patients what day

Just how balancing thinking two potential you’re financials? about those Thanks.

Travis Mickle

be patients I suffer of clinics others. extended there’s whether current release with who regarding duration start mean, the I of or numbers. direct day question. methylphenidate don’t methylphenidate, end we have concert to from adult a know the full lot issues I’ll they of Sure.

that MYDAYIS, that is Shire that basis about product acting eventually see that’s a But – that so cannot which address some switch there therapies, two now. And as of XXX developing the for KPXXX much are could longer address could again, an patients the we product. between underserved amphetamine-based was area the knowing,

dose IR used, day. only other not and is later the our think, for also but in things I non-stimulants

that to directly discussed Vyvanse really the together. We’ve second as APADAZ, comment avenues we’re what did where One, anyway of which we market. the structures prescribing their we question current supply generic generic down provide tablet and a then a could prescriptions were a patients. extend for should about generic or I that to near can products, both past, X ultimately provided for on end that this with acquisition a mean, for ongoing with KemPharm are we’re really partnership efficiencies entire the And return, that and a cost, so sort on APAP drive to the for at Hydrocodone and In both or much huge them billion infrastructure amphetamine replace capacity then using can’t in we any looking could could as far we we benefit that discussions. roughly the advanced market somebody partner. And margin ultimately of fronts. has PBM and the up be in higher two discussions both and and partner directly And

until it’s the say really. we’re So excited can of but course, we opportunity, don’t anything have we final, about

Operator

Thank you.

comes next with Henry ROTH question from Capital. Our Scott

now line Your open. is

Scott Henry

just for we Thank good bit factor G&A XXXX to for about I XXXX, should a we in I directionally afternoon. and XXXX, as How pickup particularly APADAZ least, assume, spending R&D? little expenses? the would think in should you, start at as income statement. far will on and will anything in relative also

LaDuane Clifton

and to Scott, afternoon. updated all That’s somewhere $XX going during in quarters. that’s different through is the a I think really on studies bit Yes, forecast, of burn to between the that of year, $X the LaDuane. range Sure, I would our good we little it’s in as encompassing. cash rate million higher This depending – completions forward prior events million, XXXX

you’re in space. the flat. increase G&A I that think, – is be Most be sort of spending of R&D will right. So would

Scott Henry

trial study. little you. That XXX just typically? and or to and enrollment And is it talk you is then in a about that efficacy hard Thank how Okay. talk helpful. bit Can about easy

Travis Mickle

rapid. the is believe for where actually would in the I enrollment Enrollment fairly that completed be actually patients in all study. most trials ADHD we’ve

the had with whatsoever roughly as periods – of there stages so XXX issues are And various of XXX But and follow-ups. end we goal. any with the testing our haven’t XXX total

we any in respect. haven’t So that had issues

Scott Henry

Okay, endpoint, primary by walk I Can then just could up remind me will data. then through hours. to kind that it to either great. that? you talk about XX could assume X just hours And trials be if hours, hours obviously XX on And will of And hours you be you would what the be? or the the hook XX

Travis Mickle

The as Sure. primary end the at part their – point scamp known is what’s scale. rater

knee, So that they classrooms whether and in in that actually these we a them answer number have questions child’s neighbors the about of that’s they bothering tapping to in their we that that the that their is time have sit individuals on course. seat, the pen, and look points will of their front stay bouncing the primary scale, have behavior, endpoint during whatever. at Based their

a XX hours. in to way all hour the starting up So half

in on math is focus time a to math point. take The order those test they time, same something give test. during that During everybody to

the So one that’s known note secondary a nerve that stimulant relatively those duration we as also that our that here. mean, will small. where And we just and primary is which onset endpoint, the really is here the part are that’s powerful thing endpoint top of the would and to likelihood on then methylphenidate I is would miss important that – key. be see

Scott Henry

pain noticed XXXX. you beyond Should then exploratory now? commitment the received past? final – I we now When guess, about you’ve And like that was color. the we to as satisfactory I label? it a Is more It you your talked the seems you full of think APADAZ, question. about spoke that great. filing in Thank for former pipeline approval in that commitment Okay, pipeline in think the a

Travis Mickle

our same if we’re thought to a somebody one makes we’ll these elsewhere. successful, look Yes. also what with brand still rest to perhaps thinking we’re think, pipeline. shots and at we’re forward about say, do sense the If what differentiation. the to IP – on we’ll of No even given I will some – and prioritize we’re will partnering that look able especially the want the But opportunity really APADAZ. APADAZ, thinking for robust path is find and entire of to multiple this capitalize for we do real have commercially to is perhaps the or would there giving pipeline here that products this It the clinical pipeline great is thing

Scott Henry

you Thank questions. great. taking Okay, the for

Travis Mickle

you. Thank Okay.

Operator

now Thank question-and-answer you. That session. concludes our

So I to would Mickle remarks. closing back over to like turn the conference for Dr.

Travis Mickle

I I’m sure, call the and year. more joining a the forward appreciate of appreciate, updates you. everybody, great and rest great look the have questions today. Thank to XXXX I we’ll near-term.

Operator

Thank you. today’s participation. gentlemen, Thank Ladies and that you your for much conference. very does conclude

You may all disconnect. Have a wonderful day.

Zevra Therapeutics (ZVRA) 29 Mar 182017 Q4 Earnings call transcript