ZVRA - Earnings call 1 2023 | Zevra Therapeutics, Inc.

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Operator

Good afternoon, and welcome to the Zevra Therapeutics First Quarter 2023 Corporate and Financial Results Conference Call. [Operator Instructions] Please be advised that this -- today's call is being recorded. I would now like to turn the call over to Nichol Ochsner, Zevra Therapeutics' Vice President, Investor Relations and Corporate Communications. Please go ahead, ma'am.

Nichol Ochsner

Good afternoon. Thank you for joining us today to review updates related to Zevra's first quarter 2023 clinical, operational progress and financial results. before items housekeeping few we start. A of you press release, invite and be Investors to issued view the and can section the in slides webcast found website. both afternoon the this I our of were which

reimbursements statements uncertainties for that nor from the and During the which results cause next statements. clinical These EAP statements several milestones refreshment; enrollment, XXXX, important in arimoclomol, and are steps timing program; report limited AZSTARYS; SEC. results programs; neither of X XX, can March These be with regulatory other risks cause factors be found clinical, later our expected and for but be forward-looking to, corporate materially statements include, revenue to -- the today's from statements and completion months will pipeline call, not to from ended from Board today planned that forward-looking differ trials; reporting for and updates. we Risk Factors Form filed XX-Q are Important could on the involve factors the here. and the of making and other and initiation, could expected French actual forward-looking any actual our the to commercial leaderships members' quarterly and path is differ our discussed guarantees those section data transition in promises senior

Tamara today Tamara. Business Officer, by Chair President Mickle; Moving and call. Christal joined in Clifton; management Officer Chief Board participating Josh over I pleased turn Chair, will team Co-Founder; and today's to am now of Schafer. I to welcome and on to our call LaDuane the agenda and Executive Officer Chief Commercial our Favorito; Financial Zevra's Board for Vice the Development, call. Chief today's I'm our our members Development

Tamara Favorito

you, for Nichol, us joining all Thank you today. and thank

share eventful busy unmet a to address its like with and few to quarter and therapeutics as first headed. a continues we Zevra rare people are needs corporate progress, for today we're thoughts reviews team where of focused and the the where period XXXX designed novel on strategy diseases. commercializing been Before on developing about to execute I'd Zevra our has This

culminated Importantly, process, company's from needed Mickle, of new the advancing President entire Zevra's of remains of our Corey pipeline David Watton take provide to this Pascoe, priority. her been Tierney be renewed several down Posner built. Recently, for in and goals. To Zevra's Christopher Calder to the disease our Stockholders. the election has which Directors. the from Christal bringing company's of and changes and the Development experience shared our creation the CEO we change, Zevra's our from Douglas Richard It's achievement Co-Founder feedback shareholders With patients upon and about Bode, XXXX the Officer, cornerstone treatment look support the more CEO, top received effective many details X. leadership of Dr. and which executive Accordingly, during team, of stockholders in to Annual strategy John Interim that taking will and the to recent commitment we Board. completed And we to Meeting the in we value our Directors we rare June role Board. we our mission of elect a April, serve, to forward Board on desperately we changes. stepped voted welcome I'm Chief rare shareholders. This new has disease company's to We supporting our search strategy them while today announce conduct to pleased to intend that to value long-term a unified the for And our generate our continue also for led to team, leadership seeking and the

was Additionally, Wendy a the appointed to Board to Dixon vacancy. fill

his Rich's Rich from to In in indicated CEO as are the the response as his of Meeting, a Pascoe resign stand at our XXXX that have for outcome Joseph week, them. Last and will Annual not that, found addition for Saluri made effective choice was of June departure reelection soon and retire company's decision to Shareholders he the replacements as they role Annual to Board they Plooster advised Matthew that personal Meeting. intend to X.

effective the already a permanent that conducts as Christal a Mickle Board President search June I've and mentioned, pleased replacement. while we're serve CEO As Interim will for X,

David their their Rich the commitment years As and focused disease become thank of and vision Chair helped is to for Chris creating that Travis contributions I'd Posner, Tierney to it and like the shared Zevra numerous commercially our company. the rare a Pascoe, therapeutics leadership of newly appointed today Mickle Board, company the Zevra through

and As beyond. we of pipeline rare with strong look is positioned success to well XXXX in promising multiple the expected product future, for a with value-creating milestones Zevra disease candidates

to a the through and ensure over on to Christal provide our and goals. needed call and is of interest shareholder company period depth priority the that have patient execute and recent aligned. I'll to corporate highlights. the guide are with the leadership critical turn to team pipeline experience an We And Christal? to overview our this strategic now

Christal M. Mickle

as our our element The therapeutics. as a strategic key rare moves to the company culmination program X of everyone. KPXXXX, over during of of good our the of was strategic and Tamara, complemented past rebrand hypersomnia. a arimoclomol you, for afternoon, rare refocus disease company series as of this disorder quarter company the The growth treatment first development acquisition program, years of XXXX the the Zevra Thank the in-house was in known of idiopathic sleep toward

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for much Niemann-Pick We long-term C, believe to known successful therapy for in the the shareholders. type allow the we a this needed value as commercial also strategy create patients of will prepare execution the NPC. bring process with we our arimoclomol As of that also NDA, to resubmission are of building has to capabilities Zevra potential disease meaningful

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already strategy, Beyond a a reinforces with development-stage our financial have unique marketplace and as we the growing XXXX foundation rare financial programs diverse value our strong our of beyond. biotech that believe team, position. us a our shareholders name, in portfolio company stream combine established that we enable strong our in our to for and Zevra position deliver revenue Collectively, to to and clinical multiple

to company's our treatment patients Directors delivering Importantly, Board is or advance our we the enabling Zevra's new our have us hard-earned with retain of positioned on and of much-needed and commercial help to destiny a diseases. us of position, our our of no value that limited unique rare to options. the while therapies approvals capitalizes financial direction strength supportive addressing and unmet needs mission fully control engaged people with

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of our Vice Chief we In President Officer as grow team addition, Business Development. will added leadership team. as and commercial our to was and Commercial be Josh Schafer Executive our His expertise leadership invaluable

expected operating of Mickle Based the a scientific on cash arimoclomol position, as Zevra markets. of first compared into our he results. quarter to volatile in placing current be on available Travis strong consultant, with XX. our to companies resubmission. Shifting extend a continues ended cash XXXX, biotech million cash, engaged as our in position forecast, runway the and fully capital to to many in Finally, today's We is financial a equivalents our March is investments and $XX.X laser-focused other fortunate capital

organization and stated, are groups strategy, ensure life capable of ensuring concerns we and key quality of that the management and committed their disease commercial with relevant answering remains success. approaches rare therapeutic fully our Tamara our focused are to while advocacy to entire partner biggest are to opinion families As patients, on continuing that and products disease leaders, our

our first and months We'll of and approved, with the multiple as to in of Designation value III. U.S., we that for States quarter low were Zevra United been resubmission medical new its commercialize and of development Application access for product on With early as nimble to The believe It the for arimoclomol. Arimoclomol Union, Currently, Building strong its product commercial serve the eligible has extensively arimoclomol for administered Breakthrough in European both with pipeline the Priority Voucher. Zevra goal to towards also in FDA. programs arimoclomol has candidate EU well early our patient Therapy quarter from once Pediatric The to market Designation believe the Designation, arimoclomol help arimoclomol. we be our centers Review this recent from can the XXXX a small shareholders. a approved support Pediatric Phase Phase team, I plans the of Orphan significant for costs. commercial been If trials advance is as NPC Zevra studied the New clinical NPC the relationships and and retaining positive granted full Drug would arimoclomol have early we upon is the first Drug we focus specialists community, a ourselves, U.S. FDA NPC in the Disease for NPC. fully the within to Designation foundation Fast-Track programs. continues the third progress adoption and population as both treating year. Rare our to receive in long-term

geographies. arimoclomol a commercial also successful see Beyond EU potential we launch, our for focus U.S. outside potential and immediate on U.S., the other including the commercial

sites year-end. is early subjects expedited with line more expected as Interim safety and is to pathways. data top for potential small will the Phase Orphan KPXXXX also II clinical idiopathic early XX program our could study the products. The FDA as underserved future KPXXXX, and potentially from community for II IH benefits KPXXXX as with indication. than by and current KPXXXX approval at has and in Due Now help our an limited sleep our finish I'll for options idiopathic narcolepsy indication an begin designated its hypersomnia treatment rare lead treatment disorders. let's XX,XXX IH, to in turn hypersomnia, been is U.S., and differentiate that it for data our with efficacy as enrolling update as Phase on and and safety U.S. QX eligible as attention actively approximately Drug known the patients seeking XXXX, provide of potentially

We of interim expect this III from study advancement the Phase KPXXXX data into IH. pivotal will the support trial in a

interim the phase, New Investigational of Drug Phase will or include open-label in III we an titration for last narcolepsy. submitted the quarter, which data believe will the Zevra designing from information to an help the end FDA application, IND, Importantly, study. At us

informed data indicating FDA conducted clinical opened we will the KPXXXX the and disorders. our can under our initiate be the we of in IND, newly Zevra studies Thereafter, sleep may support I program in the narcolepsy for spectrum potential to proceed further IH. our across both of narcolepsy, program KPXXXX package extending Phase clinical

trial to initiate in whether KPXXXX could determination narcolepsy a II in in the IH the study phase addition, support In III future. of Phase the

results. will provide details LaDuane XXXX financial our about Now first quarter more

R. Clifton

good Thanks, and afternoon. Christal,

under trend license During week the and the of as encouraging that gives continue AZSTARYS saw our believe will us we remains of to X,XXX May an expected, first QX for AZSTARYS reported prescriptions and sales year. XXXX, second reiterate agreement this milestone net X, trends estimated achieve The during the prescription XXXX. as possibly guidance we we confidence with the

of partner, and substantial patients As milestones in sales approved a in net know, insurance by put was sales our available. With of It who is revenue believe you commercialized continue business. X treatment the the ADHD our the the Inc., product together be Corium, a coverage to force, a may XXXX we AZSTARYS to will throughout make the of team U.S. base this sizable part U.S. field being for has foundational great royalty growing and aged March in and older.

capability future Of what course, generate, development leverage on future. with opportunities remains to our commercial and especially possibility own can it focus the pipeline the our our in

financial for our let's Now XXXX. QX turn attention to results the

are from XX% revenue quarter. Ongoing the the QX primary access solid reimbursements reporting AZSTARYS approximately $X.X have We begun the XXXX as representing with QX XXXX. $XXX,XXX, year the compared increase revenue million over were a million quarter, a supplemented during of nearly early net earned driver French program by to $X.X during royalties. Royalties of prior

which be While the driver of steady arimoclomol of loss reported $XX.X foreseeable bigger royalties the increased the associated and programs. and net the diluted million activities was stream, are growing R&D underway income future. We basic QX provide to or driven license with milestones and from investments the by expected a share, AZSTARYS KPXXXX and $X.XX for per the for G&A, our value a all

program million $XX repurchase XXXX. at of As under repurchase of of cash, with average December company's was XXX,XXX There $X.X shares a our as change by investments of $XX.X was $X.X March and March our price XX, company's million of were XX, the the an $X.XX stock activities, The combined share. share equivalents per approximately which XXXX. for of our XXXX, XX, cash is to driven remaining million approximately common operating decrease compared million,

Looking from the guidance financial remains last XXXX, results of our towards our rest unchanged call.

capital balance extend available is expected existing on to our the sheet runway XXXX. Our into cash

Our operating PDUFA what resubmission, arimoclomol as EAP, through possible for development well IH KPXXXX approved. need from arimoclomol the NDA NDA's of complete and program forecast preparations includes for as submission we the the our the launch potential U.S. French for reimbursements in if the

to quarter confidence from program X prescription license Net at at $X trends of give and steady that AZSTARYS expected under EAP during of XXXX is during us milestones the net possibly for sales will reach a per throughout approximately agreement remain addition, French potentially In the least revenue million rate QX XXXX. the AZSTARYS the year. we X

building the We execution I'll Christal. believe commercial and is resources plans focus on have in to for needed our development these that, KPXXXX we with return accomplish our Our of goals. And product the important well arimoclomol the capabilities. to call as as

Christal M. Mickle

about continue excited what Zevra lies transform I'm to work to we shareholders. enhance as creation LaDuane. our Thanks, value ahead and for

and our resubmit as are early with discussions NDA of the agencies year. the regulatory ongoing this continue as We preparing third quarter arimoclomol to

to in disorders, a license For growth, net our third early program the and access the milestone idiopathic our potential quarter, ongoing $X data the have anticipate in recently KPXXXX II have support potential as III narcolepsy opened rare continue million anticipate but this in growing possibly expanded in interim trial royalty may approximately one as both study trial to addition we at revenue sleep to advancement data year. in IND. To the the sales we program under preliminary per from IH, fuel we support quarter. the to of AZSTARYS arimoclomol and in Phase the into a agreement, France III Phase streams the These realize also from second hypersomnia a KPXXXX Phase under

open into with a ask Our runway XXXX. With questions. capital that strong for will that, extends operator remains the to cash I call the

Chief and of Financial our Chief Schafer. and Chair our Favorito; Development, Officer Board reminder, EVP our Tamara management today LaDuane Business Zevra's team Officer, and Josh Board on Commercial a participating include As this Chair, call members Clifton;

Operator

question Louise [Operator comes Fitzgerald. from first Instructions] Cantor Chen, Our

Louise Chen

progress the this on Congratulations quarter.

So you ask things. I to a few wanted

of on a Firstly, give potentially and for milestones, then milestone narcolepsy? And your this lastly, you're you can 'XX -- these might that would as talk IH, outcome that readout? KPXXXX amount how market as you in you addressing for on successful data third early the quarter you the are? And interim us consider just much secondly, the you they that in can about for a in need then XXXX, what narcolepsy, what might here unmet hit timing when on sense year different

R. Clifton

LaDuane, to other that. the and question, start appreciate then and the I'll go with This I two. we'll milestone is Louise. Thanks,

under AZSTARYS. this to at been have we license agreement milestone disclose not publicly able amounts the point, the So for

end it That's be that we're And after will by the paid so have the likely going the year, the about so one, my I I it's mean between QX in QX frame in to likely you that It's of one. expectation. And the really tell earn I I first year, still cash that can't or payment we'll and do would year I the expect I -- But of today. we earnings time we talk they're the reported sort think this of is when and the they're way the second then able earned quarter beginning end 'XX. of reported, if a coming in earn to the with arrears. expect

question. to first you with IH So question. And that's the it the to turn I XXXX Christal, guess, would regard I

Christal M. Mickle

I question interim first And on the your on narcolepsy? it was data Sure. -- on believe or was the

Louise Chen

Yes.

second interim there. and then, on first what the one need addressing unmet And that for the narcolepsy, was was The yes, IH. one on data you're

Christal M. Mickle

unmet and wakefulness, the they also IH. is very excessive the the narcolepsy having sleepiness and daytime that issues have fact same with hypersomnia regarding need, fog idiopathic similar So as to brain that

so And that market consolidate have few can are some effective limitations do -- aren't but feel that but they're to do they are as ours and are the a profile. market, products look we that necessarily of as doses products the on with -- based we like helping are there could be -- off that they sleep, really our the there to unique are don't give on

we well. as there on So unmet there narcolepsy some feel like is need do

Joshua Schafer

I is add. this if also Louise, Josh And can just Schafer,

at lack an XXXX safer would of of as basket we potential improved the the be time efficacy same clinical having One is of profile, the to some from stimulants with much abuse. a its alternative as XXXX the And think current well.

Christal M. Mickle

analyses for things that's safety the study also And interim about our what point looking based and couple to that. your there's the And the at whole powered other so we're here, we for Phase the we're that continuing looking really, so then for see there, primary of is to data then if going a is question -- looking we're off -- enough endpoint at. the to of are look obviously, II

which things interim, looking the as what one we that the use. regimens like may far for as into the things and amount are of the would -- insomnia are any looking be for or least potential with with stimulant we and come effects far there's as As be those for effective X different that, more may side if that those well dosing as as

designing would to the the So those the of are as all help we stages into and study be those that go things we begin first planning for that. looking those would for, Phase III us

Operator

question Jonathan ROTH from comes next MKM. Our Aschoff,

Jonathan Aschoff

of kind efficacy II to in What to see see need and maybe in to trial IH? it's to you with efficacy not, Phase of And proceed would have you a pivotal Phase narcolepsy? in would in in IH but kind what both to in a XXXX maybe the if same, pivotal proceed II

Christal M. Mickle

this, as -- far with similar. we as So are are we efficacy products at that haven't looking

difference at we that And are point a maybe those again, while products is we other to a have doing the so looking have products. specific the II at point I that's maybe believe we but a why that Epworth Scale, Sleepiness yet. But that a Phase as don't looking are at, don't think We on differentiation are there well. -- other we I X-point are that. different Again, particular something see there the was differential, or like trial out looking that point that

Jonathan Aschoff

nitpick, wasn't was or that just the fee? was What the way, to revenue consulting AZSTARYS Okay. the By what arimoclomol?

R. Clifton

around It The was during were very small. QX $XX,XXX. fees consulting

modest very a payment. it's final So

Jonathan Aschoff

Okay.

quarter? this quarter, do we look popped quarter? like that of first to going at the significantly look how which What's fourth R&D, in third quarter, So kind

R. Clifton

during the to as II the active is have III in I on we as of also QX but is into the then going the that preparing Phase KPXXXX. year the think similar R&D complete we're trend be through and then we kind trial, tracking begin go And going for So here up Phase XXXX. trial

Jonathan Aschoff

Okay.

that popped up So new new another low SG&A? -- run or at from same rate kind least, slightly Has year? your Is the very QX. in for the of

R. Clifton

into flat should launch some around we that once we Currently, get arimoclomol. the we'll we completed, to for of there that's uptick be as could commercial then in resubmission I say, or G&A in XXXX, deliberately I But and the expect think be into beginning process area. that forward about look prepare as more

to So very be stay going we're flat. and thoughtful

quarters. repeat, a might So right now kind few how the And just resubmission. change to after assess the G&A it we'll is in then similar for going of be it place is to where a more

Jonathan Aschoff

thing to one this, happen I kind change managements of know, it's And when would Okay. mind there's There a be much with is a than you're change. to Zevra much, in to in if answering forward the other change seem you way how stepping going typically what's don't be any name doesn't done. going with change this to of and really how like and back going

you're So Why forward the doesn't me. going with you've way changed seem It what's different? management the just to been? same kind really of if square

R. Clifton

maybe still you're that? address Tamara, on like if to Yes, the call you'd

Tamara Favorito

proxy have very, have what as Christal is in for And Yes, and think the rare we I take changing was chose Jonathan, of said strategy as go reelected. in contested our for Board, CEO were now because new where as was important as fight annual afterwards. he been a for That's we mentioned of that you very Zevra. Nothing our where the that's X and years, through working not And meeting Pascoe, Rich and going that. terms CEO, X of for for asking resign Directors just had the drugs on you, to this before comments, put disease strategy. market. X Directors to we're well. is we her developing He going, the be was reelected that. And he we to to I'd reelection. aware, X Board elected a we like and you up not And our were to may went Thank

change for We very So he Rich. what strategy looking in and a did, sorry will see be new no CEO, we whatsoever. the we're understand we lose to but company's

Jonathan Aschoff

see the in interim is? was quarter, Louise II how third data, just on early data powered Lastly, primarily trial as so as look interim Phase coming that your an referring to, to that's the the data the

Christal M. Mickle

So exactly yes, right. that's

data the interim coming of if need we in the there's increase adjustments make, study to the just the to we fit to to of any to if that numbers need that middle powering that, the So the primarily the see in see is effects the trial be our that that to molecule. like out have we look are see we again, open things and to of And things it. or -- able other effects then portion at titration also dosing but -- of the because do regimen can

Jonathan Aschoff

Okay.

So And your are initial if intended what that if jump -- was that again see in are enrollment? you what to underpowered? could you you

Christal M. Mickle

Sure.

looking enrollment, if exactly, the number remember We initial go And it to was. our but we have above go a that. So does planned and percentage that, I do we're don't don't at back look XX. and to have I do when enroll can I need remember that exact up.

Operator

to [Operator for the I'd over or Christal additional the like any Mickle call turn today's to Instructions]. closing back This Q&A remarks. now concludes call. portion of

Christal M. Mickle

Thank you very much.

like As today's we to a few you leave with I would conclude thoughts. call, additional

As today, goal of discovery career unmet for in addition opportunities one on to these products of I and founders as is has to build the a take to development. President regulatory company, this supporting part drive CEO I'm to from of Interim are scratch team June that forward X, company to with and commercial one have more previously a our Zevra's of providing we to success legacy journey part the build significant through not And role needs. products the objective our development, natural approval but a continues upon toward now fully move The in in culminating multiple capabilities of available the where with proud our we been patients, my many of our the execute able successes helping drug of into team devoted evolution, more step of and as future. of to from as

day, We of of committed to company most. of guiding which I the as to with with forefront therapies to with I need began at One promise of excellence. every committed integrity those clear our stakeholders. of is we communication our novel and know our are the our sincere of bring one serve our our scientists and business remain and all hallmarks patient The principles providing the was as and of shareholders how completing we who fully do communities the dialogue needs professionals am what and rare through them work of disease team

the our the tools and lie journey get with it and which to results I'm the built team and on be Thank to on have needed We with capitalize resources have we this fully to the you much. ahead proud shareholders. opportunities the done. you, very

Operator

This concludes today's Call Zevra Earnings Therapeutics First Webcast. and Quarter XXXX

You have your and a great line, wonderful may disconnect day.

Zevra Therapeutics (ZVRA) 15 May 232023 Q1 Earnings call transcript