KMPH - Earnings call transcript Q3 2017 | Zevra Therapeutics, Inc.

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Operator

Good day ladies and gentlemen and welcome to the KemPharm Third Quarter 2017 Corporate Update and Financial Results Conference Call. At this time, all participants are in a listen-only mode. And later we would conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] I would now like to introduce your host for today's presentation Mr. Dan Cohen, Executive Vice President. begin. please Sir,

Dan Cohen

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

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

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

the to I the the question-and-answer At the of will CEO, KemPharm's we our now corporate proceed on then development KemPharm's a and will and an Travis. will be results. and presentation conclusion remarks Joining over session. Clifton, to Travis me will update call on Mickle, provide who LaDuane will XXXX President achievements review clinical and turn fiscal third CFO, the quarter who call today

Travis Mickle

you, Thank everyone. welcome and Dan,

accompany As have Dan we mentioned, provided to brief slide today's remarks. presentation a

quarter was advances has the we therapy progress an third our XXXX continued by several development the believe KemPharm of LAT platform. demonstrate or active activated ligand prodrug and proprietary The which been potential what for of highlighted

the we FDA for ADHD. IND super-extended KPXXX, submitted On front, of development for treatment release clinical the received newly for clearance and our the application prodrug discovered

new a FDA we the which the of quarter, the FDRR the and During Apadaz of completion amended process also PDUFA drug XXXX. XX, for assigned announced submission of February for date application an

agreement to when a Syndrome Genco ADHD. develop pleased Sciences licensing are of treatment leverage LAT by our accompanied to announced for have with technology a Tourette's potentially we pediatric to Lastly, prodrug the platform

hopeful serve are beginning expand agreements also active and involving product our XXXX us the are be in to XXXX. LAT what ADHD the platform. this only expect agreement We model discovery future our still that not to will close these of a the for as an enable stage we we developments Genco to set will but pipeline, for with phase, Collectively, licensing

KemPharm's on In calls, cohort in or established risk a projects an indications to drugs offer that safe. the to are extensive and because conference that currently are drug treatment is the be shorter parent This necessary. mission time portfolio improve offer vastly prior chemical entity. As significantly that than known a can profile typically of that improvement large attractive estimation markets discussed active unmet is usually studies and not Therefore traditional trials horizon safety and projects development is clinical is address quarterly on in needs ingredient new and are their underserved. performance an prodrugs build medical improved of our

it treatment offer. highest KemPharm our ADHD patients effect. large believe the market. as With our and therapy, potentially for exemplified priority that of could have enabling earlier of designed currently and total is ADHD KemPharm announces the prescriber that prodrug strategy capture prodrug and and therapeutic methylphenidate treatments of portion of portfolio value consistency and prodrug of products ADHD two we the to the of therapy meet product candidate patient the to growing our this unmet of pipeline potential ADHD one greatest KPXXX, The methylphenidate to driver. differentiated release marketed needs needs a key managers onset ADHD address potential candidates KPXXX, Our KPXXX we longer extended is duration near-term including the

opportunity, to a study are human of the In with the lower our meet plan human prior significant in data abuse that duration prior Recognizing of addition demonstrates important that quarter to of and advancing first hours, announced into half we the a a efficacy trials several the XXXX. we and a potential. the update. KPXXX very with pro-drug than align potential patients require KPXXX we of onset believe quarter initiate a expect expected profile trial duration The XXXX. total required data intent for methylphenidate including up favorable single studies, rapidly available for the is which KPXXX results milestones to the advance in the with from phase trial suited better second Data in of we Namely, well development yearend. a typically is with to the ADHD XX to the the early And number are efficacy should efficacy to produce X fourth product. possibility offers expect early conjunction

the In abuse via liability studies, efficacy close We potential later the continue intravenous, the and year. Initial the assess initiated to prior should new to oral of XXXX end to abuse. have abuse a drug filing human XXXX. early abuse intranasal with project we methylphenidate HAL in the relative anticipate data of oral of available be the routes and program the in a data intravenous intranasal to for KPXXX KPXXX parallel application for of to

XX,XXX is a filing the IND. super with methylphenidate, of of best designed longer acceptance patients. therapy version more opportunity but key a Despite by plan only to initiating near-term and ADHD current data develop to received in effect. of KPXXX FDA, KPXXX our in in clinicians program products not ADHD as as the launched when because study, MYDAYIS, August. release desire the HAL and along moving KPXXX should advancing into financial the and consider the a each late treatment amphetamine our based revenue a project KPXXX, required, early which of because Shire's and evidence could timeline in Developed us extended XXXX. toward prescriptions accounted As mentioned to product therapeutic According XX.X that recent clinic the the results, KPXXX of exemplified new leverage million voids the success s earlier for Shire's release in Having of extended adult of MYDAYIS as an therapies improved we speaks clear progress has XXXX. that expedited is consistent importance, offer is candidates recent NDAs, PK development patients patients KPXXX from that call, fully towards is also as space, allow movement ahead the address in KPXXX We to patients rapidly This KPXXX much for including the is an generic planned similar NDA in IND clinicians to among our in duration benefit. need pathway and landscape. differentiated and which typical market. and the and development clearance potential in of respond along offer the quite This for with there's the ongoing patients from studies believe innovative therapies prescriber which a potential on and duration research start that months strong ADHD two to is important approximately product to ADHD efficacy Of the is expected KPXXXX fill provide interest in as medications well and meaningful ADHD and

with KPXXX million accounted of for sales. which XX.X KPXXX strategy to demand ADHD market, X.X billion in the methylphenidate approximately and Our is prescriptions XXXX within portion address this and in

a we adult patient in to adult to has treatment, offers the market therapy, last large It patient ADHD adult approximately of the early to in ADHD of Further, approved have of been has in one if first ADHD pediatric market. be have ADHD which be potential space potential forms. MYDAYIS, in same products weighing KPXXX and the market key adult population meet indicated years. prescribers. addresses the of million past ADHD, methylphenidate abuse the XX.X launched developing the that to that underserved. For the KPXXX patients launched typically KPXXX for factors, duration for and several seven KPXXX new based estimated making namely to the Prior several adults lower the the as ADHD potential the deliver advantages product ADHD the we the onset on which The we're the increasing largest largely fully - product the potential believe has as segment this truly compliant has demand by and potential action. include growing KPXXX of of these is primarily all which differentiated KPXXX first true These developed been methylphenidate patients. is with design is prodrug of market market. believe dosage potential there is dynamics. alignment ADHD focused

based therapies address to provide have several effective. potential could stimulant indications beyond KPXXX shown Additionally, where opportunity ADHD an

KPXXX to our ADHD a advanced and the most two our add of product opportunity While we're products, exploring KPXXX represent to new now portfolio.

prodrug the with Tourette's treatment early technology As accompanied by the Sciences a when with October, Genco of into entered announced new for creating ADHD. licensing product we pediatric goal of in syndrome a agreement

the new our an are discovery ADHD potentially for Although very of platform we harness still phase, LAT the develop area market. opportunity to prodrug to a discovery by orphan-drug excited product in

Public pharmaceutical I would of drug. first LAT Cohen enhance Additionally, and to Affairs the our strategy like review marketability hope portfolio. a of will FDRR our parent our Dan developments an we call now of to Government be of for as this back the performance of leverage is hand increase model Relations, who the and agreement pain the replicated Apadaz and the ingredient to active EVP will the what the to

Dan Cohen

an the XX, The Travis. or requests key of you, formal process and portfolio Apadaz, of assignment NDA Thank the pain filing date. the for quarter a completion our Apadaz resolution was XXXX during the dispute the February FDDR of PDUFA development for amended in third

we process in to the to public forum policy, year a labeling November began of FDDR science and of questions expectation open the discuss an language for Apadaz appropriate with Apadaz. last reminder, for provide As involving

that and agency, public interpretation the FDA believe informs policy outlined possible very product of offer objectives discussion a physician a thorough we for pathway has science, in of viable related labeling the the issues a potential commercial demonstrate legal related a of issues label, we information the professional the to to Following and to the that may expect the believe product including we commercially product potential environment. approval of

a important in was are this we significantly believe we better accomplishment Apadaz. for KemPharm, While position very with a

As to of a reach a failure to there for course adcom second several in products to These review review. environment agreement of a our label consideration on the NDA opiate risk data. existing and a language, of even result, changing approval remains over the product approvals possibility include Apadaz the the the

including deterrent KPXXX/IR. is this, products, Given strategic the process, decision-making our Apadaz continued investment abuse advancement The NDA of that other the that and be resubmission opioids and is process. of of iterative KPXXX/IR, should decision our is it as a pain noted prodrug KPXXX/ER part in

Regarding council pharmaceutical nonproprietary name, descriptor that the KPXXX Asalhydromorphone, as of we a use announced the the program, on approved for active use for ingredient. USAN the has the Monday

the enough as conjugate severe potential an a lead for structure. and two itself. of our chemical may hydromorphone developed It Asalhydromorphone that abuse being of long-term hydromorphone is officially marks by potentially product LAT Chemically, compound hydromorphone the to pain a aspirin The treatment new prodrug assignment opiate developed to USAN lower than product believed be recognized opioid Asalhydromorphone is resulting is to a abusable treatment. of the granted with second of platform a moieties. less require prodrug Asalhydromorphone daily, of hydromorphone

non-proprietary KPXXX, or prodrug benzhydrocodone will I The assignment now with Apadaz in first occurred IR. of in Travis. name, the the XXXX return the call and the KPXXX to

Travis Mickle

Dan. you, Thank

Apadaz both market development, stages of the of program, our inclusion indication. targeting varying consists orphan addition of multiple With at the Genco pipeline products mass of the and and

biotech hand With Officer, range. who that ability and size and offer believe financial overused company both unusual. I diversity LaDuane review results. to and abundance in platform the growth potential Chief our would LAT Value Financial programs KemPharm now an like longer KemPharm, the our the is a call over opportunities, of that, our industry is our current such and to near an For will pharma harness Clifton, of depth I term to combined term and with do

LaDuane Clifton

a the our Thanks, Travis and provide will third afternoon, overview of XXXX. good quarter everyone. brief I results for

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

for For a and basic per in XXXX. The third of $XX of net value a net adjustment the quarter These primarily compared share, for from X.X interest by income of same in loss Loss and million. to which recognized QX, net not and was operations or was diluted respectively, was non-cash compared items prior the period were offset last year loss to same of share This of year expense diluted The from of reoccur spending during as by by $X.XX to same and XXXX. period. million of and we offset $X.XX reported in XX.X loss XXXX partially per XXXX, million, million administrative or severance current quarter partially period X.X development operations million, loss and fair of for a X.X $X driven and other period over was due net $X from recognized research million, loss million did and was expense that in X.X general quarter. million primarily increase the $XXX,XXX, in decrease an the operations in decrease QX. basic

This compared of was leaves total existing which June September the Travis. XX.X marketable decrease XX, development quarter a million equivalents, fund date million, and to KemPharm operating resources to of our activities now cash, long-term return I and XXXX. second capital solid receivables with securities, XXXX. call restricted As position expected back trade to XXXX, through about a XX, cash in cash, of will the reflects investments, $XX.X

Travis Mickle

several momentum would like milestones increase of question. from this only third to later as continued thank key and for I you see With which should wave over time XXXX approach there early strong XXXX. any if of year The and it turn quarter a your KemPharm, we that, to is

Operator

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

Dan Busby

Dan Randall. Busby is This for on

approval you a provide Can regard your positioning commercial you could you that when XX, and related thinking formulary couple potentially for elaborate to you've any then now and on color and specifically date have PDUFA you talked on February Apadaz assuming So on around strategies. current to of with about could status? a pricing launch, upon potential that, different that touch

Dan Cohen

roughly Business the molecule Yeah. launch your we XX-day it are not hopeful a the seek that, once we a the next the in after Substance actually accomplished have Controlled launch, molecule this that with is I'll that on actually on product first and case, the item placed In But Rusty And go the take DA that of get it's with to second we which our that current to stage over potential turn because answer quickly. new quota. process to approved, that Chief Act. straightforward have and is actually the and new particular can then process, part Johnson, to we Officer question. a based be has window, I'll

there may dosage to Additionally, want we additional include. strengths be

We haven't from days a time, potential later about you it provided guidance but can date. specific after approval launch or anywhere the expect XX

Rusty Johnson

to we've for both your people in And pursuing slightly for involved question, thanks two them strategy, us paths, really okay. Dan. a some commercialization talking I to different think With partners been regard direction. And time of

product in potential a take as to PDUFA fairly and at The a that partners might pharma look close one then know, has could Apadaz. all it drug they first you the a discussions on that imagine, range, going when obviously, how the rate might portfolio and in around determine do within time begin their as as background are the and to you fit try

sponsor, speak, take about generic The and looking this second general PBMs well would PBM combo here novel equivalent at that alternative a idea and we selected so we've of its people hydrocodone/APAP and the to helping work being plan posture patients replicate sole partner, are it be talked to Then product, of to and as is in model with Apadaz as a in across plans pricing the PBM United to PBM. States. that combo aggressive the for would members the make very that hydrocodone the selected its the various serving across that various with and PBMs the selected a obviously

Operator

any Instructions] [Operator I'd time, at over closing the questions. like Mr. conference this And I'm Cohen no showing for to further Dan turn back to remarks.

Dan Cohen

our coming call afternoon months. look afternoon. Thank for a good over thank their and discussion you we We on participation forward everyone and the the and want to weeks this continued have to

Operator

does your program. for This Ladies thank you and in participation conference. the gentlemen, today's conclude

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

Zevra Therapeutics (ZVRA) 9 Nov 172017 Q3 Earnings call transcript