ZGNX - Earnings call transcript Q4 2019

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Operator

Greetings. And welcome to the Zogenix’s Fourth Quarter and Full Year 2019 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions]

conference recorded. this reminder, a is being As It Brian Ritchie. my pleasure our host, to introduce is now Please go ahead.

Brian Ritchie

call Officer, Operator, for Officer, Smith. afternoon. today’s joining you, Ashish us Chief Thank and Financial this With thank Sagrolikar; and me Officer, Chief Stephen Farr; Dr. you Chief all are Commercial Executive Michael on

Chief addition, the Gail session. Dr. Q&A also will In Farfel Officer, Development during be available

full update year Zogenix a December fourth news and business announcing issued a the financial afternoon, This quarter XXXX. providing and ended XX, for results release

Please certain covered will Reform management during that Private provision information note that call discussed Zogenix Litigation today under of be on making is Act. Securities Harbor listeners call, the We forward-looking caution the statements. Safe this the

these with to and and release the by Zogenix’s Actual filings, results could issued company’s differ the the XX-K materially in and filings. from report on statements statements by cautionary uncertainties risks forward-looking are associated those press Form today subsequent These implied including annual business. forward-looking stated contained qualified in the SEC statements due company’s or

accurate call is sensitive conference obligation X, date call. Zogenix revise to statements no also time any of this reflect this update as broadcast forward-looking information or contains after XXXX. undertakes date that or events March circumstances to conference live of the This of only the

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

Dr. Stephen Farr

XXXX on And Thank and everyone pivotal It’s a call. today’s us the very for afternoon company. a programs you, and our joining in good time is Brian. who’s late year busy exciting to development

priority to XXXX. extend NDA period FDA NDA filing the last by review in review. fourth six-month of our the Dravet for three year, FDA late syndrome, Starting a the the accepted XX, months decided Last week, in June the with FINTEPLA to with quarter

additional analysis the submitted new Zogenix in The from response target efficacy conduct from sensitivity the FDA two sets in our by syndrome. information to completed the additional on pivotal the allows recent FDA. was with time data information provided to studies request The to FDA review to PDUFA date outcomes Dravet

showing to III that is analyses. Our robust the own are very data sensitivity Phase analysis these

the FDA In there profile. was NDA the mention has advisory from during related FINTEPLA’s safety addition, to process. of the FDA’s a been committee review Moreover, request possible no not

reminder, treated was from pivotal study extension OLE, Dravet Phase based applications from XXXX, our time open-label a As ongoing for NDA Study data XX to syndrome trials two in interim the months. up our XXX which on patients III and included at the analysis or

with at primary when clinically the regimens. in of treatment met measures, all pivotal significance. statistical all antiepileptic secondary resulted trials Both in doses FINTEPLA stable to key patients’ convulsive high the rapid, added endpoints seizures, and reductions meaningful

published We During confident our the journals, supporting continuing work from fourth very this with full to the in Dravet timeline. submission NDA and prestigious studies remain in results Lancet these is as pivotal quarter, their JAMA along the review new Neurology. were they complete look data the and The two to agency, forward

syndrome, which trials the also Dravet I earlier, on open-label robust in as in the therapy convulsive for randomized observed Importantly, were study XX seizures patients sustained months. up the noted included in long-term to controlled in reductions

to with a Results range cut-off of a last total seven with XXX QX same year from of an duration in XXX of days with includes OLE analysis days. XXX interim date the patients, a median study of a days treatment

compared point at the and median there for that seizure in frequency, decrease to XX months XXX at XX% was a convulsive was convulsive baseline. two one years, XX effect median in comparing baseline monthly when for XX% XX versus year, the treated patients to In decrease treated patients to seizure frequency time treatment

Neurology be presented Annual along meaningful Meeting profound seizure Academy of and clinically data season in frequency the with reductions patients in Toronto with a impressive in April. will These American portion of at

Other program in real-world access and from the preliminary U.S. effectiveness presentations in expanded an our results meeting feature Sunflower this syndrome. ongoing of safety will of also fenfluramine’s efficacy and reports including open-label FINTEPLA, at pilot study

ahead potential we we year. are activities States and look date, quarter our to of the the PDUFA with the in planning for launch continuing pre-commercial third in target As United this a

Ashish is moment. tell our about excited you plans to more in a

also reviewers assessment is that final that opinion Before our also MAA this add continuing application of review we process toward syndrome. in let for to FINTEPLA the me Europe, though, The in are we their focusing Dravet in as a year. on assist

commercial be will over our provide our that, With opening pipeline full-year to Q&A. by call the quarter readiness an and will of let fourth who share the to He results I Mike and on cover development and update our before XXXX Ashish followed rest me highlight then the up activities. financial ahead go will

Ashish?

Ashish Sagrolikar

Thank you, afternoon, Steve. Good everyone.

launch are able I be been we shortly granted. approval have the ensure to We am that and place in to to intend to commercial that after programs report is ready pleased

entire recently team our place and called hired U.S. have comprehensive support Zogenix Central. that hub, and accounts and commercial team deliver in will services is the which patient have managers account key our customer We onboarded team in national through

experienced are rare Dravet specifically who in considerable syndrome. These epilepsy professionals the have diseases, experience and

them and reception Dravet very educating been we continue have to the positive will with engage we of first payers have exists In and We the beyond. discussing to-date, year that community. payers the with through half significant on in need conversations the a received and unmet

number at partners and to to These the of FINTEPLA positioned in Product to launch manufacturing, approved. partners ready distribution if most patients the efficient launch. access supply July ensure are uniquely are for greatest

to to healthcare process. personalized able location and providers is single offer FINTEPLA for to committed physicians. fulfillment Zogenix Central it robust will a families system and patients treatment a service Central FINTEPLA service Zogenix patients, throughout and are if need approved. caregivers We and providing support access are the ensuring who

healthcare reimbursement the and healthcare caregivers, and a Specifically, health with coordinators include REMS specialty including who start through led ECHO the caregivers pharmacy. administration, of with help will hub professionals therapy, that it the will is to process and care team by professionals continuation work and support

community continue of the better We especially their with communities, to understand Dravet epilepsy engage needs. to members rare

for grateful their educate and potential raise we to XXXX, we encouragement In efforts await of and for are also FINTEPLA. education programs, our patients. our approval launched as to portal the We draveturgency.com of awareness the and rare support disease continued the needs

Let for where to the FINTEPLA. country similar at level launch Europe, European of me the to are turn now and under way activities prepare Pan potential

team with experience and We as rare diseases in and areas have access in a built market such epilepsy considerable marketing.

health develop We have with specific country economic initiated healthcare to authorities models. discussions

major from continue these will we in and all regulators had So we positive XXXX. European very have markets and far engagement conversations feedback in

We in Europe already have and offices in recently Kingdom, and medical set place local leadership and have teams Ireland. experienced country Italy Germany, and United regulatory all up across we

desperately are to In potentially and so patients this who to transformational bring we summary, launch ready FINTEPLA prepared can therapy approved, we when that needed. so

that, to With the over let hand Mike me financial the for call review. Mike?

Michael Smith

for our corresponding LGS is fourth Thanks, Shinyaku recognized issued quarter during a Ashish, and our revenue FINTEPLA for revenue full the results XXXX. we financial quarter syndrome good this release $X.X and for afternoon, and the XX, and fourth with for period press everyone. million year recognized collaboration and no Nippon of a Today, Dravet March result the business of XXXX. of We XXXX Zogenix in in Japan. XXXX December summarizing ended

quarter -- the of $XX.X XXXX, expanded increase attributable for fourth Total corresponding in Phase period were million activities from to clinical development $XX.X largely to and the the LGS. R&D million, FINTEPLA the ongoing trial of an of expenses related III

of totaled of the countries $XX.X increase quarter million fourth ended expenses continued in with U.S. launch in million in the driven preparation Europe year. SG&A treatment prior to prospectively the for syndrome This and $XX.X the this fourth compares the Dravet the coming was for in years. quarter by the various in and FINTEPLA investment for

or Net Net million per was December loss net $XX.X $X.XX per net fourth a year This $X.XX quarter share, XXXX quarter $X.XX per loss million the in $XXX.X with was in of the of a $XXX.X compares million net ended December XX, or loss or loss loss or share. year. of share net the $X.XX prior per million of loss compared XXXX. for ended fourth the share to of $XX.X XX,

quarter and months. approval we totaling execute in are for syndrome Dravet million, believe sufficient us support assuming at of operations resources securities the in marketable which We to fourth planned $XXX.X next of equivalents ended cash XX for cash, FINTEPLA the on with our launch least

that, With to will back Steve. over I turn the call

Dr. Stephen Farr

Thanks, Mike.

in of June forward program have of XXth advancing the for FINTEPLA and target look action NDA this to are all Dravet date year. our heard, As syndrome you we actively aspects the

with LGS. a our Last XXX were for positive third III trial clinical delighted patients in data III clinical announce FINTEPLA, topline pivotal month, from trial XXXX, to global Phase we Study Phase

uncontrolled, The the or endpoint of years statistically seizures medium from a study in whose baseline while of included one significant primary The highly patients and its AEDs. more compared to drugs between the seizure or placebo. change monthly drop reduction anti-epileptic two on showing study frequency ages percent in XX met remain

existing LGS before, resistant multiple notoriously causes, severe is epilepsy and rare making to a to mentioned different seizures have of highly we which therapies. treat often from difficult As forms it arising in

currently size has at efficacy significant make in patients multiple some many Based from there approved comparable treatments. to on FINTEPLA a the of tried continues LGS. AEDs. they XXXX, and results Therefore, LGS LGS well the point need all Importantly, to have an unmet failed be effect Study shown

Therefore, for meaningful refractory pharmacology treat we LGS. the therapeutic believe to that if its patients become differentiated has potential approved and unique physicians who a action of with FINTEPLA mechanism with option

FINTEPLA expanded for syndrome, and in we will under and be from for anticipate studies standpoint supplemental label or regulatory NDA a pivotal a assumption From Dravet further of approved required do indication for sNDA efficacy LGS. an NDA not the safety any

to the the supplemental later content under studies conducting support studies. toxicology of way which determine sNDA, to year confirm with the the submission, I in this or timing completed Phase To this We of have well meet several submission. and intend will clinical currently our non-clinical we FDA

Phase separate placebo the to is characteristics initiated in safe rare to addition FINTEPLA LGS II and these patient understand populations. cohorts evaluate and in exploratory epilepsy of effective we additional In whether syndrome, study have versus and Dravet an disorders

United has year. quarter to proceeding sites cohort enrolling in roll first by study data seeking we expect currently in end IRB and study now The been II the second in patient and topline targeting are and the the We fastest Phase from the the finalized States. opening with this on of protocol the basket approvals study

which we deficiency open of epilepsy clinicaltrials.gov In in of treatment investigator-initiated CDLKX Sunflower on several syndromes, sponsoring and disorder. are addition, two are now Syndrome up studies the for

Next, treatment or deficiency X and TKXd. our investigational the mitochondrial like to would I fatal of thymidine to for a frequently kinase disorder, devastating DNA therapy switch MTXXXX, depletion

DNA to fixed-dose serves MTXXXX deficits this as at that the study end and enhancement XXX, combination Study prospective to RETRO caused an trial mitochondrial by deoxythymidine overcome the deoxycytidine January. in was is a from oral treatment restore Enrollment of completed substrate patients therapy disease. open-label the involving of

completing Good also non-clinical States progress designation enabling PRIME and being product finalizing in toward the Breakthrough is in for the the has studies NDA. designation United MTXXXX made requirements manufacturing Therapy NDA and Europe.

the once appropriate we have look a meeting have QX. plans We discussions. regarding update to regulatory these an future with obtained FDA forward the I from in timeline, on providing feedback the early scheduled submission

later We continue meeting with EMA a to this to similar year. expect hold the

So, now you line the can with up session. questions. can for Q&A Operator, open the we that, begin please

Operator

Certainly. is question from coming Matteis Paul from Stifel. [Operator Our first today Instructions]

now live. is line Your

Paul Matteis

then in much data just for and of Thanks taking the wanted Great. ask one questions. PDUFA on the extension you very I to shared. one the some

PDUFA sort what little and types little you a effect maybe you wants in bit seeing the conclusion are bit you differentiated think, clarify year of just so extension, if your on you additional long-term to just was big sensitivity maybe presented, on approvability at study analyses extension are give the in can could why you safety confident can color as any the deal context you why and up? arrive are isn’t wondering agency appear then, as comfortable II the Phase think And different of you a how just to Thanks I retention give on at to can just us agency, as and really you relates secondarily relates size perform data the for much. Dravet? trials that of this the that the years that’s On and color you it second, to extension I and any two rates holding one it a to have of

Dr. Stephen Farr

Thanks, questions. Paul. appreciate I your

the On part the well. of am are FDA sensitivity analysis sensitivity conducted. have we as conduct which there analysis, several want to that as I work the sure

the that not in in conducted we very small, have are any sensitivity point very seeing is endpoint and p-values small are What the robust we I will data say very, shift analysis incredibly to where any estimates. to differences

is have So we going to very able have robust. there we that think not to are here. is been anything our seen don’t that already the establish uncover FDA really and data But we set

think, So, addresses that I probably first your question.

retention question, is On the very, the very open-label in III our second good. still Phase

the seeing label. in open of still are remain We majority patients

know, you over to moving Study there’s which there, another As it’s extension is we XXXX, around XX% retention. are where patients study less label study

we So feel about good that.

a the from that’s the indeed or have nothing reported any seen we really what the perspective, extension safety trials Now seen we have difference randomized in in open-label in safety. controlled

patients in no the at has the AES, heart to and which of think disease integrated forms also pulmonary safety summary or valvular that our we I last includes of NDA hypertension. cut basis presented that year

Paul Matteis

much, Appreciate Thanks so Great. it. Steve.

Dr. Stephen Farr

Paul. Thank you,

Operator

Thank you.

Goodman Our Leerink. from SVB next question is Marc from coming

is now line live. Your

Marc Goodman

we just done fourth second for yet? this spending and expect than where come just to we Yeah. a mentioned is us, exactly, then, sense time just how second, commercial the a can don’t Thanks. are And will you a little bit play what happening define just the the XXXX tell I you that, and carefully should had on in us back to more Europe Can from you give have you approval out, year? what quarter what given was

Michael Smith

Yeah.

Dr. Stephen Farr

ahead, Mike. Go

Michael Smith

Marc. Yeah. Hi, Yeah.

payers, a continued that lot six-month activities we kind of were So the lot with to in that quarter, the obviously, payers, there the hold the are we executing ramping research launch, communities, of conducted with midyear of launch physicians, of discussions past and are lot were terms in of because initially dialog we a activities do that our were anticipating so on. a we inside window those this

activities of fair the specialty that which Europe, things preparing States context been there. be lot amount how the for distribute a we a are to runs able have downstream in through the of fortunate and product test in to participation of We activities also getting to EAP, resulting dial-up so hub in United SG&A to respect with and other will pharmacy

spend. the lot a there’s additional So of

of finalizing We are kind patient-facing as this we have, mentioned, onboarded infrastructure Ashish year, set that there. -- and group expanding in our and have for physicians XXXX this of core subsequently our in coming plans

market, a to -- people States it’s rare have think, I So, we across the inside of a net one external one these of It’s XX% disease outside it’s things this plus talked launch. facing sales where about it’s XX% force. United XX in and the

it’s that would that of So anticipating for be costs kind the fundamentally we would year. structure similar that for be

activities a Europe, a we to for prep Epidiolex’s to similar off the go case there base timeline our of lot now then to. so of is that And that right countries we do where and organized big in timeline want

those -- early we start since until earnest this in not year product in decision will But XXXX. year, from the a product commercial in up perspective be providing to mostly are that are the and expecting later going a activities

Marc Goodman

give of fourth how Of the many people, sense were the quarter quarter, be going can first to many us been in many are you hired have already, XX in how a fourth the -- quarter? how

Dr. Gail Farfel

So, and me let U.S., team place. has the entire in that. the hired Marc, is In been commercial address

the of team be QX get will already we preparing team the were of early place the toward is and in we the QX. for and we launch the approval end part that as in So that deploying

Marc Goodman

Thanks.

Operator

line now is Your live.

Danielle Brill

questions, guys. Thanks Great. for the Thanks.

can field sorry, talk of market that then, those your think this the indicated the fully people? later for quarter. you If the a you expected number you not could decision. Can guess, and it’s how confidence first, XX you to had the And EMA based a about are what can point follow-up decision U.S. in me at I year, one X,XXX Thanks. you targeting reps, So you remember I come that what address and now why approach also docs, gives this with remind the with until couple, I who correctly, your that did Marc’s CHMP go? identify

Dr. Stephen Farr

will sort the that to you, you Thank I but take EMA. of second Danielle. through take part before can I the ask Ashish

no with clock As review equivalent MAA Europe PDUFA an you along respect under various stops know, there the way. to in of is the

is we Where are coming -- right MAA we that the to at the this are with want they questions of key quarter. that now with anticipating up toward make end

and a finalization, from we time. feedback then reviewers will So would be next that will around at where be a the we have the that the if of time will better the what any estimate timing see

think in approved a And historically. one on that syndrome. the Europe than you We think Lennox-Gastaut frame that no really We recently, time of bit Ashish, have they been take are reviews do drugs the one? States have in including other that’s a and little our different number United take. The is to next longer could we in Dravet

Ashish Sagrolikar

Yeah. taking terms the you multiple activity, want Dravet number look is focused as rare last of a back, as the yeah, work Danielle, we -- as of profiling to XX talked have the research, the the over about, U.S. in step done that which it targets condition, I think, in you months well syndrome and at

from as particular treated how major well these centers that came this in majority the list on diagnosed the these for X,XXX is of that’s who community, we are as being the the centers and physician mentioned. epilepsy patients we of what Dravet And who community have learned are and to and are you

half a years. this same at that also looking one is the happened based approvals newer time have on the of have some and the at we What last done in

in patients any confidence to these we as months, will all at who found We been gives of treated that least XX our product the and able are at treated first places that connect with year an be looked us offer. in launch being identified have to at been and have patients the have and making how the

time we to of believe our effort be we your process. move that as expanding see who question. or And will and goes large will the a be misdiagnosed who those, Hope a diagnosed those we focusing into have this on the by, lot answers patients lot in U.S. because and that there we are of are are as

Danielle Brill

Thanks very It does. much.

Dr. Stephen Farr

Thank you, Danielle.

Operator

Thank you.

Company. Our is from Belanger Needham coming next question Serge from and

live. Your line now is

Serge Belanger

on couple talked there But was me, been Dravet is question you of an component the A you filing if an review trials required for that afternoon. that review, the be inspection non-clinical will can point? Thanks. in delayed, request supplemental some syndrome then, on of upcoming of about at this additional FDA NDA CMC for elaborate related additional questions And Good the for Hi. second of the us that I provide can manufacturing update on Phase data. has to the my LGS, for for and the side you filing? these update

Dr. Stephen Farr

respect review, not had peer very questions. I review ask have and second CMC occurred soon. the process Serge. addressed scheduled certainly is to same we your has The elements the Thanks, Gail at take of will CMC moment -- Yeah. first. the be to but With to this

Dr. Gail Farfel

are is typical second I this of the part. for LGS filing, we We Gail. -- the completing hello, And the profiling. take some will

have dysfunction Dravet carcinogenicity and reproductive and been clearance LGS filing, studies the of So the for so included ongoing profiling, in toxicity and where of deferred and specifically hepatic be specifically preclinical long-term will as studies drug, those the well and developmental as filing. the some the the renal

Operator

Thank you.

is Butler coming JMP next Jason question from Securities. Our from

now live. is line Your

Jason Butler

back then, have with give less a you taking open-label study. getting wanted you -- for many patients now for what terms how echo can just study, Hi. of you XXXX, the proportion XXXX questions. that talk come of experience frequent in the IRB about Thanks to extension to us the of just sense to the move Thanks. over transitioned Can and from approvals monitoring? I

Dr. Stephen Farr

we address and Study ask how I they frequent have But the will over extension, talk the Jason. in patients are about IRBs once that. to the XXXX. to Thanks, completed less the terms monitoring open-label of moving Gail

-- numbers studies at look XXXX around those XXXX. approximately you between XXX Dravet it’s currently And of if both and total in over in in XXX patients the those XXXX, and

So are Study end sort over we moving them XXXX. of as they

Dr. Gail Farfel

have I process. XXXX had countries the It’s have am that we am any had aware like questions, a sites any There I’d in have from follow-up, have not were from may prevented XXXX. we not patients I we many aware concerns which transition large are to to addressed, many that -- that involved.

step. by So it’s proceeding step

Jason Butler

And U.S. then the from could me, from scenarios in on regulatory just from you and Great. Europe? one plan layout meetings us both for more the -- XXXX, just

Dr. Stephen Farr

assumption generated efficacy. respect Yeah. for side now, other to right that sufficient It’s with But scenarios of the the tough data meeting meetings I to is Jason. would FDA. our to the me like we layout really the the into clinical get have going with

We mentioned are data XXX, to as Study collect in earlier. continuing I safety

the then, level also And we submission. non-clinical data, as of NDA need was required understand to data CMC the for well as

we the lot about the So, I of we better feel a that when side giving guidance meeting. think, other some FDA get on

Jason Butler

Okay. Thanks taking the for Great. questions.

Dr. Stephen Farr

you, Jason. Thank

Operator

you. Thank

is Our Partners. Yatin coming Suneja question from Guggenheim next from

is line live. Your now

Yatin Suneja

you my question. guys. Hey, for Thank taking

Just to submitted the regard you LGS, the have for what have preclinical with prior could submission talk would perspective status about preclinical they to What a the couple, Dravet? from studies those studies, be the and for then, is, factor do you especially I have whether more carcinogenicity those preclinical been follow-up. maybe the to and side, the do -- one complete gating studies on

Dr. Stephen Farr

you. Thank Yeah.

started NDA that for deferred to we these these original studies we to for approval for be be in cost FDA, required were LGS. in the The prepared so studies an Dravet. that for relation assuming supplemental may are And and

for So you NDA we are not Dravet as required the know.

completed. just one’s Well, studies. CARC two conducted have We

ongoing. mouse the is other transgenic in CARC two-year One a is is rodent. in and other a six-month still The

rather not whether FDA CARC would determine this submit studies or what of not discussed trying the submitted needs part accept. as really CARC around with to exactly two information whether be could are or we you just studies one When we the with supplemental, than the to just FDA, not

report opposed as example, n final report draft to plus audited data. the For a

to of for what for questions, timing of the questions help down will type the those us So response narrow is LGS. those sort an sNDA

Yatin Suneja

on with balance Okay. there QX. you your the an level sheet talk $XX sheet have if confirm, ATM comfort was both Can thinking the that then need maintain maybe the there pricing now, about about And about mean, you hand? raised think, looks That’s then range that like, I be we to now it true, million is what you also and balance is in can I that data helpful. you you side, -- And launch? in do should about the talk into going Dravet and LGS maybe

Dr. Stephen Farr

over hand will I to Mike.

Michael Smith

Hi, We of that QX shelf had our we the raised most we that assurances had and Yatin. ATM through acceptance million an $XX Yeah. after activity around -- all active that NDA. to that or $XX got of of million we of in

are needed financials on resources being $X.XX confident efficient, that the of have size year. somewhat infrastructure inter-bank that about that coming other the the got this operations we we We team billion need we say and put our launch account point given the to the for and for have at very and to

in it We seen a in got that with classified that that’s response to of syndrome. Dravet lot have robust we the different that with some patients respect the getting confirmed data on disease a number a have LGS and things of

lot to responses have your disease didn’t that in doesn’t a the we we context saw very, level the really We of a in that significant of did options very refractory same Germany. difficult some treat responder market. broad epilepsy of have and necessarily isn’t rate see But

discussions strategy the community. ongoing of in pricing and that looking is kind remained to-date price are we our consistent on the and basis value being our So product informed to is payers off an of with with the

Yatin Suneja

Thank you. Okay.

Operator

Thank you.

next is question Mizuho from Securities. Our from Yang Difei coming

now is live. line Your

Difei Yang

Hi. Good afternoon questions. my and thanks for taking

financial the you you the to Just about would of a why Dravet XXXX? efficacy patients? the quick -- regards should in should with R&D couple, what durability could with we the durability of syndrome, how follow LGS comment for rate we then a on now And efficacy that know question that in run assume think

Dr. Stephen Farr

we have of rate take will your long-term we LGS. any not But hand reported data for Difei. question. yet, -- question the run Thanks, I Mike part the to and have over first in don’t data

that over those will be it we talk time. So, when will data about something we see

think we are we how are we the I is that’s emphasized that today. for actually and long-term showing about So very excited latest the efficacy data the talked cut durable Dravet by response and about in

obviously So what But go that as will time. in report have certainly don’t forward. moving on this know is we ahead? at it Mike, LGS data we the in moment we

Michael Smith

Yeah.

We operating haven’t item today. coming the line costs specific the guidance to any respect year with given for

We will not won’t material our up be year. swings this any to context with have the down changes those, in or those, large offering there respect

Difei Yang

Okay.

Michael Smith

I can say that.

Difei Yang

you. Yeah. Thank Thanks. Yeah.

Michael Smith

Yeah.

Difei Yang

Where are going where question looking breakdown the, Phase when results? the final you then And on for analysis for to plan present? or study, the detailed LGS should additional III to do or we be you for data additional

Dr. Stephen Farr

consider, to would the the Difei. year this And most that’s realistic we that think year something AES is at probably end of do like the to I and conferences

Difei Yang

questions. Okay. Thank you for taking my

Michael Smith

Thanks.

Dr. Stephen Farr

Thank you.

Operator

you. Thank

Lugo Our question coming from from Blair. is William next Tom

line live. now Your is

Lachlan Hanbury-Brown

U.K. look that all only at events, Tim. are been one on What supplier like FDA there program to for questions. taking fenfluramine Lachlan have in And has current I expecting the Thanks was is the the wondering like? just you you the interactions and I then, made had This solidified the does believe in progress program REMS the far you you light thus the Hey. or for in at of have if what all REMS moment? look of

risks of you can just moving thinking forward? So sort talk supply about how you chain are about

Dr. Stephen Farr

to that so REMS guess. month based or With been respect our and in I NDA picking questions. we your propose think next to for would the the extended Thanks we actually be discussions June the has the PDUFA those over REMS, did Yeah. anticipate date up XXth, REMS fact upon

with the chain, producing we the pure of of terms of patented a site supplier In by supplier a manufacturer our capacity, are highly United also drug actually that mitigating the as around we supplier yeah, we form of our using mitigation a around product have method have risk risk ensuring is well. supply some fenfluramine, fenfluramine in Kingdom single another we have going and

would doing do mitigate not is in adequate to we the looking capacity you it future has what indications, So for today. all only things supply the Company expect risk but to ensure those are chain,

Lachlan Hanbury-Brown

Great. Thank you.

Dr. Stephen Farr

Thank you.

Operator

Our Thalmann. question Instructions] Ladenburg next coming [Operator from you. from is Higgins Michael Thank

line is now live. Your

Michael Higgins

for Thanks Thank you questions. for -- hi, guys. the taking

say Just sNDA earlier directly? be to the in the up included CARC CARC the discussed was studies, one they that would to or not about the talk studies. with follow When FDA did two-year the on about you results need

Dr. Gail Farfel

was not LGS the timing, was able deferred and the the and based to -- It will directly. two-year it. be discussed NDA Dravet six for we well, the include months we assume for It least for we at on for

Michael Higgins

Okay. just Thanks. that review, European regarding on on follow-up FDA, not questions some And has an a the earlier efficacy of quite analysis the by said? sure the what from the then you had impact

Dr. Stephen Farr

do No. not review. believe it impact on We has an the European

do analysis with European U.S. We to have the do conducted intermediate data own well conduct as FDA to analyses and for likes we some both their regulators, as that. for actually sensitivity have assessments

Michael Higgins

Dravet see on and last feedback FINTEPLA’s Epidiolex how then one, role fared has those And patients? how Thanks. payers the in Okay. they from any

Dr. Stephen Farr

over will I to Ashish. hand

Ashish Sagrolikar

our discussions FINTEPLA Yeah. think, syndrome. on profile feedback has the in that we Mike, the Dravet and have positive very for clinical shown based efficacy received I the the is

how the therapy a syndrome that focusing needs like FINTEPLA really also fulfill need. approved, unmet can and the Dravet our are discussion on We in

payers, -- other In the appropriate won’t of comment to from community do not but those I a is from be there condition us feedbacks. for used different think, only products, it we will we understand that and expect But what on that also the given of launch that when refractory and for approved. we burden, seizure terms it need therapies get is and nature the given the this

Michael Higgins

Great. it. Appreciate guys. Thanks

Dr. Stephen Farr

Thank you.

Ashish Sagrolikar

Thanks.

Operator

you. Thank

We for have the our comments. of to reached session. over back I’d Dr. turn floor end any like closing question-and-answer further to Farr

Dr. Stephen Farr

Operator. joining you, you And thank today’s us Thank on for call.

MTXXXX allow XX. diversified to more milestones we achieved -- with have and into transform to acquisition Zogenix pleased of further a disease very are start We rare through company that XXXX in us the FINTEPLA

toward families. a to and work company becoming year commercial exciting an their focused patients to stage providing forward we as on Looking therapeutic ahead solutions

the on thank all joining again of us rest you today. So our your call day. for Enjoy

Operator

does today’s you. That conclude Thank teleconference.

at We You you for lines today. your your day. this and may have wonderful time a thank disconnect participation

Zogenix (ZGNX) 2 Mar 202019 Q4 Earnings call transcript