ZGNX - Earnings call transcript Q4 2017

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Operator

Good day, everyone and welcome to the Zogenix Fourth Quarter and Full Year 2017 Financial Results Call. Today's call is being recorded. At this time, I would like to turn the conference over to Mr. Brian Ritchie, LifeSci Advisors. Please go ahead, sir.

Brian Ritchie

thank for and afternoon. us operator, you, you joining all this Thank me Chief are today's Officer, With call Executive on Dr. Stephen Mike Farr; Smith. Officer, and Chief Financial and year ended issued announcing XX, XXXX. for This news December fourth providing results the full Zogenix update a and afternoon, quarter business a financial release Please certain Reform Litigation Act. on information the covered today is Securities note, the the Safe Private that under Harbor discussed call provision of Zogenix management We will making caution this listeners that forward-looking call, during statements. be implied differ by risks could Actual materially due with stated or forward-looking from to these results and the those statements, Company's associated uncertainties business. by These forward-looking annual statements cautionary filings. in are SEC subsequent in and qualified Zogenix's and news the filings, XX-K included the releases contained Form on report statements of of X, the broadcast, March call live date that conference This contains as time-sensitive this XXXX. also information only is accurate to obligation of the after or revise or forward-looking update date events reflect statements no undertakes Zogenix to circumstances this call. conference any

over to I'd Steve. the to call Now, turn like

Stephen Farr

I'm on was be year and following who what Zogenix. call. a everyone Brian, good to today speaking today's to you, for Thank afternoon you joining pleased transformative is us to

endpoint adults much global the pre-specified significance X our XXXX, announced As high all for young Study efficacy procedures Dravet aware, endpoints. late-stage with positive trial positive primary treatment from ZXXXX XXXX with syndrome. and Phase also advancement of first children syndrome. efficacy our met evaluating secondary treatment of around of are ZXXXX operational adjunctive our and in as key program, the on X was it's focus the Dravet study X, of year third you quarter was In throughout the results we

we key disease threatening that the million of of investigation is or we secondary with in extremely we approved XXXX, a us This NDA United double-blind there in group patients and regulatory of eligible successfully and of primary this successful stated Dravet the offering. the for with per Similarly, therapy strong multiple in year. transformative We no to life were heels profile is anti-epileptic Dravet upcoming randomized same enrolled as our January future with in we Breakthrough may Designation in two-arm NDA recently for for for for Study those applications Fast-Track the position fourth the X the approval X serious to to we treatment anticipate the X. FDA clinical key in readouts and outcomes XXXX. pivotal rollover robust conference in on forced in are regiment for procedures on of patients second by with treatment end Breakthrough Designation a continue Therapy the the from completed is options of improvement granted drugs. And Dravet spout complete open-label horizon ZXXXX United Dravet FDA with in core as a results it's and planned and over In to intend therapies. XXXX, extension evidence the million randomized in operating Europe we eligible the the patient trial few the syndrome. where syndrome Study Europe an basis. robust and study. offer very into preliminarily intended The E.U. -- results and efficacy the and we disease clinical including designations on expeditely $XXX is program. believe follow-on cash Phase syndrome On studies ZXXXX our have adjunctive rolling XXXX, final serious Based XXXX in designation endpoint distractions Breakthrough $XXX year, portion seen both syndrome. [indiscernible] treatment for operator an potential this allowed ZXXXX as background and announced in have seat Patients are medications. to in the results review Therapy filings FDA XXXX of Study of is in trial submit conducted acknowledgement efficacy and Study our in development Dravet and substantial medicines X, Therapy treatment submitting trial. U.S. United Designation XXXX, extension we Phase States, with ZXXXX XX ZXXXX approximately based Canada this To-date trial, that and syndrome X participation of enrolled associated existing of from our regulatory secondary Dravet of on this quarter Designation being therapy this currently a second States priority open syndrome Study States review for label treatment first quarter our of the Study Study

these the of clinical in As periodic the XX% or remain It's pulmonary to been by have the data-safety no the year one have XXX concerns To-date, of the over echocardiography there trial patients today. committee. study no and of than extension greater in margin in treatment open-label patients continues of than safety been open-label extension the have program over study. all study important for more and for safety now months exceeded margin former that study Off note and six in XX of hypertension. cases have patients arisen note, entered approximately cardiac open-label via end patients assessment in patients have valvulopathy half February, these and

our preparations. a multi-family that has up conclusion, we rights As is our ramping nears to our ZXXXX portfolio program expiry supported by XXXX. patent Phase X proprietary global and global after ZXXXX syndrome retain in position and commercial patent Dravet commercial initial full We currently it's are

past patent begun teams in In Europe we to market the of year Europe commercial have In addition and States market States United self-market would to of ZXXXX it's years drug in ZXXXX in qualify and XX open and years designations for our pediatric the and the X.X preparation understanding expansions. respective for policy and exclusivity perceived established aimed Dravet have and exclusivity United through portfolio, year U.S. in we healthcare under with by various public of involves practioners. stakeholders private that name payers paid Fintepla. the both research conducting research This to European countries. key are in makers insurance, value syndrome interviews best brand This conducting in-depth numerous regions drug

will Ministry Japanese in In and pre-consultation is constructive X was and With patient's in participated adult the with we of and and there kilogram in titration of have changed Phase communities results the opportunity XXXX. Phase seizures discussions X.X LGS Dravet two-dose and addition baseline endpoint LGS Study in for the of patient X with as ZXXXX tolerability in ZXXXX that FDA, day the dose. for for study We trial result need Welfare. same later hand, to drops begin Europe, Study meaningful Asia. meetings provide in number trial of when we or number to U.S. the Japan that to is after a LGS. announced results, called a current to related region. Japan now safety, trial. X like as placebo-controlled and assess syndrome in a X and Health, of multi-center other continue maintenance on unmet milligram clinical positive of indication, periods This primary Study and we X trial second to commercial a placebo pediatric [ph] include in the equivalent of Shortly partner Lennon-Gastaut Study Dravet levels initiated ZXXXX the patients PMDA, at trial Japan therapy. in syndrome this efficacy well and The a and Labor anti-epileptic has and per an the update a I'd between studied this pursuit with year target the hope activities The development syndrome added our combined global per double-blind

opened February, of well United sites By Ethics recruit into European end end As expect as submissions additional quarter, XXXX. active, have first countries. Study were U.S. the Committee we to of sites the the as of several patients to in XX to States

serious to will We potentially XXXX Xx a ZXXXX be of for population help patients for enrollment address with number XXXX. Phase LGS We Study that the are of to this current global in syndrome. which advancing to very Xx approximately year X be population excited seizure is note the trial Dravet in patient

do not data from such, anticipate we topline study As this before XXXX.

Before of potentially Mike, you I enhancing remind we milestones the let expect in call me to turn the over value XXXX.

First, quarter X the we anticipate Phase study, year. our second Study topline from in data of late XXXX this second

file in XXXX, and Study what be to syndrome intend Dravet regulatory the we United a States in Following approvals for fourth quarter. the Europe in successful in hopefully outcome will

Mike? review the I So over call turn will the with to at that, financials. Mike for his now

Michael Smith

in anticipate quarter the To finance first Steve. touch XXXX. to you, corporate start, Thank fair we on like in I'd last

early top commissions GenX in First, secondary following offering X.X after share. million. at of the Phase a approximately closed on Study million shortly net per common approximately positive the The X cost underwriting our the $XX.XX X stock discount proceeds fourth shares offering results in a offering quarter of announcing $XXX.X price public were line from of

XX, initiated and in for year. was loss $XX.X scope in quarter net Phase fourth expand a in totaled for quarter fourth fourth with compared share, total December a net the fourth $XX.X LGS. $X.X in cost compared say prepare we that for our quarter development risk With enroll to here X $XX.X fourth year, continuing compared just XX, or for million the XXXX. expenses the up addition, study of X per $XX on loss ZXXXX total continue operations per payoff, quarter totaled the ended million, quarter Zogenix million, in million, we ZXXXX fourth the million from or fourth million, results Selling, in Phase our XXXX both $X.XX not the for $XX.X the loss of Due ended more that, paid XXXX recently and the for ended year-ago. now prior up quarter revenue did this before wind-down to December loan the and Research XX, of we ended with $XX.X expenses rental financial In relatively the of compares year fees DosePro the current getting end, quarter three-months in December XXXX. is XXXX; record to revenue and million recorded the legacy XX, profile, will of fourth avoid to to reported million for with fourth XXXX a general our $X.XX for quarter the the of U.S. $X.X $XX.X Sumavel as and rates money above in interest have to of operations, begin from million million Europe to administrative studies quarter the global Net this year. loans the share and patients that prior We December a in costly in $XX the XXXX prior happy fourth quarter of debt-free. are

Endo in expansion December XXXX year. a for December for $XX.X expenses to compared of $XX.X XXXX; net XX from R&D ended total XXXX XX continuing totaled for Now million, operations million delivered and million $XX in clinical reduction compared for XXXX for a million million and loss months and months was of the and from reported revenue totaled ended million, SG&A for net years This XXXX. share $XXX a year. million $XX.X the due months comprised and in prior The to continued revenue of December to for year $XX.X XXXX, start months months revenue manufacturing loss full the XX, of XXXX, ended We XX, Cash XX XXXX XX XX, this for related $XXX.X XXXX, in those. ended XX the the LGS. December months ended in December for XX, reflects enrollment $XX.X December number $XX.X with ZXXXX with total compared for the year Dravet XX in compared year share our ended up X decrease or of total full was per year totaled XX, the at $X.XX the December syndrome was to XX, and expenses for the the million trial net at again, the entirely XX, million equivalents Phase $X.X December DosePro XXXX, million XXXX, cash the compared XX million ended to the units as Sumavel the with of the $X.XX contract International. or loss million per $XXX.X $XX.X XXXX. of

XXXX Phase Breakthrough As X XXXX. Steve LGS our With XXXX Dravet Dravet data milestones. with are Study we forward noted regulatory pleased Therapy accomplishments readout in Europe, significant our line exciting equally second are submissions off a front have we earlier, U.S. extremely top to from in approval and in driving an with granted, in many of X year us the syndrome I study Designation global and the looking value our and kicked Phase

to pleased in to be you drive be realization the the instructions. turn session. to Q&A operator Operator, will strong milestones. call begin these to of the I would are the able organization and the We the please financial towards position now to provide the over

Operator

[Operator Instructions] We'll Annabel first to from Stifel. Samimy go

line open. Your is

Annabel Samimy

can on you us many a or maybe the how background us had remind -- and So stiripentol severity. open-label a this Can indication study, given they in been of many on different studies you Belgian slightly regarding just for European those X already that file SNDA Thanks. patient that LGS? in is Phase remind stiripentol? is And do patients need of on also XXXX population you Can enough a of you the just study? how background this give second And how good question you behave study? a successful might one LGS, of in does the

Stephen Farr

Yes, your we you and everything year like quickly. that the first, appreciate we NDA compliments got the take supplemental European need from in last year ahead lock XXXX. well. I'll LGS study in as question our to us forward that order one from of authorities to I'll off just confirmation last and FDA that one I successful it's about looking for well as the submit we

open-label these go know. the taking any answer Belgian them trial is in and X of With the alluded are as you and of not will on they and the who stiripentol required to that to are in respect XXXX, yes, any of whether Study stiripentol currently you not global ZXXXX a stiripentol. the or inclusion study behave study way the taking fact all of patients XX to are those patients one combination [ph], that the therapy, differently, whether or So patients were. the is same and Out as responding of patients

see patients patient or behave don't differently any Study in population compared X. we to So Study see rational the XXXX different those that in will to

we same for set Study set we for fact, Study powering the In in aside up X. assumptions as XXXX

Annabel Samimy

XXXX And any Study, us can we're see this data if year? going of you sometime just remind interim to out coming this

Stephen Farr

the that it formal summary yes. open-label submission, integrated Obviously, will safety. ongoing be be so, We doing will hope we of part a analysis of for trial NDA

So an in once that that try have we will we move year. and the towards later academic presentation and

Operator

Securities. we'll Butler And JMP Jason go next from to

Your line is open.

Unidentified Analyst

Roy in Jason. It's [ph] for

much it You've baseline expect Study powering difference Study to seizure the wanted you the comments. just the powering -- what was XXXX if pretty answered in in I in in X? you question have with the saw hear versus first rates

Stephen Farr

we're X, seizure expecting criteria not that for just we in type to XXXX that not the same for the anticipating and were be different. so place as with Study respect have to we We on basis inclusion-exclusion have frequency Study it

Unidentified Analyst

of that rates So variable meaningless the rates aren't seizure sufficiently makes I that consistency to the a baseline guess? in kind their patients between seizure

Stephen Farr

ongoing don't have and study. trail frequency an with associated it's so Obviously, numbers we seizure

Unidentified Analyst

trial you early? regarding they patients drop they the X, Study; can in Thanks. And tell us dropped out? Study tend have relatively the why to XXXX out extension Do

Stephen Farr

decided so trials, are drop few -- I reasons are variety and withdraw. that to time can't consent of when being to studies patients we've they who the that remember one with information patients our which really a we've quite any you but required. give a just [indiscernible] drawn the reasons, out respect the these biggest on It's on-risk had have

like more information we any and so don't have not really I that. say on So

Operator

Mizuho Yang from Difei Securities. to next go we'll And

open. line Your is

Difei Yang

a that Steve, opportunities help quantify us in over prevalence you to the of Japan? expecting Are would competent world? you on side the

Stephen Farr

Mike question for I'll Difei. that to ask you, address

Michael Smith

on believe numbers of geography is is the is approved our indications substantial will you are LGS Japan a Europe, or off focused are respect patients need. simulators We of still U.S. population believe similar, different where that calculation key on on get leaders in are that that a situation both, there treatment of as community Dravet are There still the key we U.S. level the should that and very being there is one-third population that Japan. that in and that the of States, just of instant that is the there be like majority in so comparable the control opinion so with a the to But the United that somewhat in and community. sense involved there global there

Difei Yang

is any X? follow-up quick there Study a give Just on Study you us updates could X; on

Stephen Farr

half correct? second that Study you the mean With Study is of X XXXX,

Difei Yang

Yes.

Stephen Farr

That don't actually time definitive a complete when have the so study we that will is study still ongoing, enrollment.

Difei Yang

talked you some there ago time X; is the happen? might think I Steve, do a you Study that might stop see about you potential

Stephen Farr

I think Yes, and XXXX successful have it that for obviously is would obviously we we the throughout timing -- I so we'd do what trials two Study NDA, have results. think seems to decision that both than would after want that's get be past

Operator

we next Leerink. from have And [ph] Ben

is line open. Your

Unidentified Analyst

I gives Dravet work your Lennon-Gastaut? dosing between would that wanted in I and to the in use the the dose biology Lennon-Gastaut indication? also in confidence Study. different you Dravet about Phase ask the is this X you what guess, And How

Stephen Farr

Belgium, the in Phase the the the using to where We open-label back were same enough doses the representative open-label that that label efficacious in conducted trial doses go trial in global the study. we're to that site was X in study Dravet were is

albeit So of in subjects, relatively patient are we pivotal in using are have XX the we small our that doses population a direct evidence efficacious. clinical trial

Unidentified Analyst

for about expected your change that I the your know for the also ask dialogue your guess, are with potential FDA; but -- timelines Lennon-Gastaut? Therapy those does timelines I -- anyway for wanted Dravet does Breakthrough to And increased that I Designation,

Stephen Farr

No, independent. it's completely

So not on Therapy Dravet interactions syndrome, is the our FDA in in with for LGS. Designation will the focused so Breakthrough drug syndrome; Dravet be

Unidentified Analyst

Understood.

you final color year? question, any burn can one provide this Just on cash

Michael Smith

have guiding said cash over that got plan two is but as yet we basis. our cash terms we're years nearly on not annual have million we to What we've burn an in of according $XXX of of

Operator

we'll Lugo to Tim Next, Blair. from [ph] Instructions] William [Operator go

Myles Minter

Tim for on William Blair. at Minter Myles Hi, [ph] Lugo

And we actually canvass or Just in enrollment would question patients XXXX get are have to that? to you about CBD your potential so, later interactions if LGS do protocol that amendments a to any drug-drug taken [ph]? you on indication trial; in that do need regarding previously looking have order any to submit

Stephen Farr

interested selecting obviously how We're is in not drug-drug CBD for will not between these physicians or and rather for and LGS be interact on the to and commercialization will understanding get a well, particularly plausible the understanding for this but is Dravet right drug-drug syndrome as not we closer helpful, guiding whether important be as a drugs ZXXXX, interaction that interaction dose.

excluded that going have be moving in. to to to we are ahead protocol will X drug-drug patients understand on, LGS amend we allowing forward But allow from able be trial interaction, the But that those goes of in look interaction Phase So CBD because running drug CBD for as we as don't patients may today, that we helpful into believe with program. time we trial. a the LGS the and

Myles Minter

filed? was how with can how do interaction just you they did file [indiscernible] about just any centers increase And -- those if you cold And in how patients wondering European there penetrate stiripentol because there X from waters Australian I on, drug? [ph] back go patients the bioavailability. the this you onto I'm gear in there file, were and I'm the is back guess back switching on if in enrolled fluid, does and Dravet; Study with an XX%

Michael Smith

know response mark If question. with please because me I then didn't I'm off the the let quite understand this

results, think patients you're I what getting any who at a X with regarded getting failures you're have fact stiripentol our at? that that Study in is

Myles Minter

Yes.

Michael Smith

we a that data today. also be doing at reporting haven't don't post-talk have very will analysis interesting that information, obviously that but but some We that point provided that's you and information

Myles Minter

to a -- finflorimate have to patients That prior? to [ph] was a that dose not on been need they stiripentol with whether the there related lower have or a question for have need these

Michael Smith

Right. they on to prior Therefore, those if X washed if the there to have patients enrollment, for so in patients would stiripentol they stiripentol, adjust were was the requirement Study dose no have study. been

Operator

Sherman David Capital. next And from we'll go LifeSci to

line open. Your is

David Sherman

go ultimately if commercial just buildout plans are successful and get was you could over you if I wondering approved? for guys

Stephen Farr

you want that to Mike, one? take

Michael Smith

I repeat Sure. Can asking. the you're you sure question understood not David, I'm what

David Sherman

I commercial plans you wanted just guys understand sort for salesforce just building. and for hiring of plans to

Michael Smith

for population eligible program force, involve the and we that And be we the relatively with the of on U.S. to self-marketing the high there available be engagement and top patient that patient and -- standard likely and a on able with sized a are be geographies. also leaders scientific force than as and X,XXX level control and that In relatively orphan on of would sales of [ph]. I high more a typically instance REMS high are and smaller would see drug; community these will that in touch, applicable is remember the for Europe and the lines do X,XXX in planning thought we to which cancer some patients would product be for could patient and be other diagnosed one our the U.S. will finfloramate that sales interaction potentially it try reasonable

-- well, other making we've as Asia. able commercialization any will said are to plans to do in We areas be that Europe not we not in and will as we market direct such

area Japan, to in patient reasonably would we community So sizeable has that have or an seek like very a partner. sized

Operator

And Difei Mizuho. a next, we from have Yang from follow-up

Your line open. is

Difei Yang

program? with results on [ph] we still XXXX REMS earlier, you out are side-effect fairly what seen that seen profile; let's have have if carries safe assume Now X we Study affecting

Stephen Farr

program studies in Obviously, and patients as We've through despite over but we trials think just the to-date nothing forward relaxation the that we go approved. with move and comfortable really a core REMS with drug moved we do REMS that potentially data see the people I cardiovascular this expect and has we echocardiograms be seen to more and once has in feel open-label a REMS expansion forward been as FDA agents REM are program that nothing will we as our X,XXX safety commercial we associated approximately been are. other well. hopefully, of Yes, collecting but conducted product also even XXX not but our in in

Operator

And we this have further questions to no closing Farr at it Dr. like back I'd Stephen remarks. any time. for to turn

Stephen Farr

you, thanks Thank for and everyone operator on the call today.

Our we development forward planned prospects. program excited move about continues to as and our are very

will So recently XXXX. sheet our are following year the very And strengthened updated forward and very in quarter the fairly in quarter. to again, year; on in X for today look I rest to will have Thanks, strong joining the we and of I'm recap pleased second a enrolling And Study we so us your Breakthrough submitting of our Phase of the we enjoy much line was fourth United year. earlier, everyone that, applications that X grace this top also looking that as look from occur progress throughout a Study day. [ph] -- been the also, balance Designation the we've forward of forward so quarter we last FDA data granted keeping fourth And mentioned to availability started just and also this course as be approval Europe very much we to have late now LGS XXXX, which in States of and the to Therapy recently where great trial. we see that from by year probe results we FDA; in

Operator

today. our for that Thank for participation. your And you call concludes

may You disconnect. now

Zogenix (ZGNX) 6 Mar 182017 Q4 Earnings call transcript