ZGNX - Earnings call transcript Q3 2021

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Operator

Welcome to the Zogenix, Inc.

Third Quarter 2021 Financial Results Conference Call.

As a reminder, all participants are in listen-only mode, and the conference is being recorded. After the presentation, there will be an opportunity to ask questions. [Operator Instructions] I would now like to turn the conference over to Brian Ritchie of LifeSci Advisors. Mr. ahead, go Please Ritchie.

Brian Ritchie

contains statements. after will Sagrolikar; company’s XX, and accurate Chief nine XXXX. Zogenix’ announcing and note qualified news stated or these of cautionary filings. the this in release Harbor XX-K all are Act. or events call. any implied information months results Form afternoon. press of report no Stephen by listeners to those November undertakes afternoon, call during Reform the be SEC could Dr. uncertainties obligation a reflect statements live annual discussed only forward-looking ended Officer, three business date the to filings, circumstances Provision today Officer, operator, We is revise X, by making Litigation September Farfel; release issued with today update Dr. Zogenix company’s on This broadcast, from under due that information this providing Medical certain conference Zogenix that this as Officer, also financial this Chief and of and call Chief statements joining and Michael forward-looking is in differ management date statements subsequent including time-sensitive the the Dr. Officer, conference and Please materially XXXX. Zogenix for that contained are Ashish or Commercial These update Chief risks of forward-looking the team On associated statements the Galer; Actual Farr; forward-looking Zogenix the results Development the call, issued to business. thank you, the Officer, Securities caution a on for Private covered Safe Gail and you Brad the Executive Chief Financial Thank today’s This call Smith. management

over to Farr. the Dr. Dr. turn Now, Stephen I’ll call Farr?

Stephen Farr

to color Positive be for prepared of thank continue as launch launch of U.S. to FINTEPLA today in FINTEPLA programs the growth. we here potential a number stage XXXX. for strong Europe advanced Brian, market Syndrome, MT leading solid provide over delighted to moment, again, form us. on in dynamics quarter late and launches to additional or and with another everyone, syndrome, FINTEPLA or both Zogenix, updates growth provide the we regions. commercial both momentum joining once good of perspectives on and I'm success afternoon Thank for patients in In and FINTEPLA net Ashish and Dravet for prescribed on you in quarter that execute and you development sales the you, are a quarter for in results, consecutive continue, Lennox-Gastaut continued FINTEPLA of achieved and will the to

as excited opportunities syndromes. remain also epilepsy We FINTEPLA expand to treatment with potentially option severe a in other upcoming childhood-onset refractory

our remind have patients notably trial approved Several development on we Galer, Towards Chief anti-seizure detail this the the kinase Officer we in later pleased made TKXd. sites we for for or walk call. submitted an XX,XXX studies were Brad MT taking progress Also, our deficiency we the CDD. therapy Chief of during Officer to on And X the will Ashish? will November patients. the substrate suffering anticipate in or Gail a begin NDA events overview I’ll goal in of MT we're that seizures Farfel, of Phase enhancement with now and more option also and enrolling call on the thymidine provide States, or with Lennox-Gastaut in patient study of that, the the progress from to indication ongoing investigational in X, next through disorder starting quarter, global recently With few CDKLX our I on the as more September, experience of by their label patients the to this FDA upcoming with disease now our the would getting program, or both Development X presentations will first States in Medical close TKXd XXXX opinion interactions call. virtual Last, programs detail deficiency weeks. you screening through hand LGs. FINTEPLA these of regulatory you associated over feature treatment despite in seeking natural within on patients to to United and Ashish, XX,XXX patients. like seizures, TKXd investor estimated to United this the the that Syndrome the majority are have XXXX leaders treatment medications. expand history key There the FINTEPLA LGS for existing uncontrolled a and to with supplemental

Ashish Sagrolikar

patients progress us prior environment, patients paid and epilepsy. REMS the therapy syndrome XXX in in of Steve. patients we refractory the FINTEPLA short, third is and year a COVID FINTEPLA to new the We U.S. the steady of for is eligible you, about prescribed new therapy treat with Thank refer reimburse continued overall, Adherence in in in lower referred FINTEPLA’s confidence rate growth estimate The growth commercial medium to of support rates with outlook consistent seeing as been quarter, experience and and other reflects believe from commonly providers, XX% patients trial Dravet our during this with patients, of that program. Since XX%. to clinical the third long-term. expanded cadence and reflective FINTEPLA This is used the program. over FINTEPLA. rare single payers. XXX our strong and with to caregivers, a new potential the quarter, remarkably in started year. with geographies the and XXX typically were within U.S. multiple in patient strong We and remained the penetration syndrome solid the U.S., program with indication restrictive new the REMS Starting from provides By quarter, commercialization, XX% similar the all than XX% market end support That are completing first also healthcare and currently substantially the have to launch, long-term Dravet around these access medications, among are the quarters discontinuation the third within in over patients. to observed anti-seizure our indications

market increase with Our able we fold internal the be three research indicates least by at should that time. to penetration

completed teams brand epileptologist field of awareness momentum, our expansion this almost example, neurologist of To take based U.S. understanding experienced for team epilepsy XXXX, higher syndrome. XX%. support the recently since than the of late Dravet The among has For providers now deep FINTEPLA adding doubled in with and medical to expanded by list is advantage market. configured professionals and and is about an healthcare FINTEPLA sales now educate and we of based field

some still already seen trends to physician it's have early, respect we fourth While increased quarter. to in leading positive engagement, with prescribers the new

receiving coverage be We FINTEPLA to determinations. two very FINTEPLA And Typically, insurance with government private the receive payer and both a to strong, referred REMS in weeks patient they payer continue be law program. to continues patients for to positive new for once takes to are effectively pleased sector. all the with four coverage it

a third More participated event. through photo than social events, the various unique that quarter, diary FINTEPLA we in media. supported the Dravet through XXX caregivers community local During contest including and virtual

Europe, continuing all In In is patients our more Dravet very probably XX participating As virtually in-person FINTEPLA the month, Dravet educate community And syndrome this progress epilepsy team Germany patient to and you to prescriber well. November grow in is caregivers. and both and steadily. base our of continues in know, awareness support and than in is events, month. to launch

temporary of eight new France additional Zogenix use program through continue therapy through access the patients program. We countries authorization in and reimburse add to our in to currently

markets, We the have reimbursement next in and objective reaching progress in determinations launches significant final European executing and pricing commercial with of negotiations year. our made major

of the ramping new preparations our potentially this sNDA significant we indication Following now for for FINTEPLA. submission launch for and our LGS, are

are momentum to our all position LGS. and with will of updating understand in positive approval law potential In our caregivers with potential the We XXXX. and for on with FINTEPLA to best the us already Europe, research the in you strategies team our and are continued launch forward We discussions upon helping immediately in refine to go need we strong expanded look into are commercial summary, the along to pleased and the coming LGS These market continued boards conducting to of one FINTEPLA providers, and sales in growth advisory geographies, key preparations healthcare States, preparations commercial payers growth market us United months. one in expansion community. anticipate

new to over Gail, Now, FINTEPLA. I will turn Gail? to data exciting on the share card

Gail Farfel

submitted chronic reveal any LGS, which granted, six LGS who submissions endpoints. assessment new request expressed contain enthusiasm submission and the in primary the concerns a trial, cardiac our The would with changes review observed. on submission of The toxicology September level. echo Thank a XX secondary and not A to prospective participated Phase establish a of around and dose if safety and studies sNDA key for patients, in timeline. non-clinical efficacy set you, Ashish. data months. microscopic XX-month goal at valves was no of carcinogenicity safety from positive X reviews, did sNDA also priority which I'll standard these on were in Steve XXX the Ashish take FDA action by a submission review which would our and for studies, consisted Furthermore, met any

J-NDA and patients were X in p in patients reduction XX Next, patients And Annual for of results at XX improvement we positive and in improvement. the the from profile safety the in compared Child improvement reached value profile the results of effect in XX, and is a presented at of FINTEPLA threshold, frequency both of unique of less produced the meeting of extension. Japan's XX.X% nature refractory we LGS with LGS months this XXX devices Japan considered three points FINTEPLA FINTEPLA baseline. the evaluated a analysis results the extension FINTEPLA their a the patients. ongoing threshold, of mechanism label seen Each on that trials months of that medical the is the to of interim in FINTEPLA significant the time treatment The in and recently I’d Society. at improvement the the in highlight The of with Neurology of XX-months durable in experience agency condition. the was This reached study long-term LGS remain conjunction to marketing drop interim frequency months, to become patients options Phase study seizures the XXXX by over XX.X% XXX to Today, reductions the XX% XX% drop patients Dravet profound statistically add syndrome the highly highly XX.X% considering enrolled post assessed X.XXX XX. demonstrated the for treatment families, LGS on track at analysis seizure action, median and our potential to setting. submit to than comparable and pharmaceutical highlight our and Of XX.X% who the in at level XXXX. end Meeting which particularly results the also open

patients, Loulou seizure Dubinsky, move a support year to CDD and Zogenix of and experience childhood to deficiency disturbances Langone open to label severe our our small pre-IND trial supplemental milligrams either treatment with Medical controlled symptoms controlled which this FINTEPLA day epilepsy developmental positive patients In XX% a sleep seizures, compelling a indication. refractory XX reduction to gastrointestinal, six characterize study the study annual in as FDA University will in anticipate launch meeting dose could results kilogram two-arm to The These Center, treatment CDD. joined this the collaborators in rare, in randomized is a in initial seizures. disorder a disorder. this the newest or series confirmed With in X.X presented of basis and by we FINTEPLA NYU first trial addition will trajectories enroll let's industry with over median patient tonic a resistant seizures placebo. Now, study the patients Pennsylvania features MT with months. Oren and form clinical the to CDKLX shortly. fenfluramine CDD per overview other generalized case reductions clinically duration a our an at on-set XX% has to in in visual and meaningful of with a CDD single decision NDA earlier I'll patients conducted on Dr. fixed XXXX. a X.X of reduction tonic-clonic it Treatment in in epilepsy, CDD of such three Brad, or for at non-interventional per XXXX of a produced in multiple that, of of American society Foundation, enroll patients highly basis year has meeting placebo program turn of and randomized and formed program. a frequency, FINTEPLA

Brad Galer

time XXX previously shows difference Thank MT in was survival reported between be plan a The enhancing the treated X.XXXX. NDA. significant previously in Study quarter, and study reported for and included consistent trial additional our survival XXXX on final NDA p an untreated patients the probability you, our data Cox control that highly Study Gail. be expanding patients of regression efficacy primary the CSR data efficacy termed study made for to continued updated of with that progress throughout and and our consistent formally will was results, We meaningful Among using in included submission in retro at endpoint equals XXXX. results. The history XXX these dependent analysis, model the statistically natural dataset updated with highly that will primary analysis be our program compelling

and lost compelling this some of In demonstrated motor clinically motor, meaningful addition in MT to treated our milestones. XXXX also patients the respiratory survival benefit, previously improvements reacquiring with abilities, feeding majority patients

in the has non-clinical timing study vital of the are studies, in As by in that this review U.S. and in Europe, The untreated of status and make pandemic, been not We're for treated motor data any collect impacted disease and the continuing has our patients, NDA XXX, TKXd patients the the involved good is to and rarely and improvements into our submission. sponsored the onset, year. XXXX. in patient XXXX Study for quarter We're age milestones progressive second end the progress in of and meeting of all NDA of of seen and is this the second-half clinical population. literature studies is clinical spontaneous a described of from an quarter in first which completing to moved the regardless pre-NDA confirming, next retrospective year, not on for chart a submission planning a

that, first me to Mike. for in addition Mike? with the U.S., XXXX. of In scientific we it regulatory preparing hand meeting quarter our are EMA to a With progress advice let over

Michael Smith

Today revenue an communities. of Dravet across which Of $XX.X representing in product form significant million includes quarter sustained million Hey, our the quarter in a $X.X million of and was compared In financial interest Europe. XXXX. million continue and we of of again thanks, recorded sales of second the of FINTEPLA sales over $XX.X announcing third with increase results ended We the ’XX, we million Shinyaku business the sales observe of LGS Nippon Brad, press growth Japan. in ‘XX, and reflects initiate net and for total related recognize during good million the of release to as and afternoon, $XX.X revenue second million $XX.X of the quarter to everyone. and XX Dravet in FINTEPLA, FINTEPLA in in total the the globally, quarter $XX.X The third issued the our September XXXX. FINTEPLA collaboration XX% in we for quarter the achieved $X was net to product FINTEPLA sales $XX.X syndrome therapy which XXXX. U.S. to This million third growth XX%

and The investments September development million million investment was MT XX% or to as expenses million and September $XX.X launches the quarter operating Nippon XX decrease related R&D is regards XXXX on equivalents third U.S. share. $XX ended quarter period this in revenue XXXX per total per original million a loss ended call quarter in to with our the FINTEPLA have and third with and the ended September the net associated the start the the Dravet late XX third cash $X.X quarter the by past for future in sheet, compared that, for decrease cash with strong was totaled XXXX operator share corresponding LGS Q&A session. $XX.X related for of ended securities with million $X.XX of result $XX.X by our period as with million. were Shinyaku, stage Japan XXXX. This approximately the and continued turn The million, or offset loss in for agreement with FINTEPLA as a $XX.X in compares decrease the million. totaling programs and of amend the was can please $XX.X third to the increased $X to for for compares activities year. up prior overall to sharing the development. to increase This a the the as marketable million Operator, was over well license costs you to year to driven balance We the corresponding of quarter and costs million XX concluded. $X.XX one-time $XXX expenses a questions? recorded decreasing third Our collaboration R&D third quarter agreement revenue $XX line our Europe. of open an the a charge XXXX. SG&A collaboration Net of and some And prior to million, FINTEPLA, to I'll primarily $XX operating

Operator

you. Thank

question go with ahead. the [Operator Please question-and-answer Our Matteis session. Instructions] We now is begin first Stifel. will from Paul

Paul Matteis

question one maybe on lower. program comment demand you then were And second, just, saw the what U.S. to so for just to new there looks anything had just sequentially on question. were taking little world. as I in a patient I patient bit Is feel And that? if a comfortable? the October adds behind you're quarter it. the monthly Thanks how that guess see of rest stable. like if curious Hey, you of Good and much so basis? could out it I REMS mind you Appreciate And thanks for breaking throughout relatively the wouldn't be kind again. you far would is

Stephen Farr

going your to it over to for address Paul. I'm question, that you you. Ashish for Thank hand to

you on Ashish, are mute?

Ashish Sagrolikar

sorry. I’m

when So quarter. the Paul, you by of month seen COVID, with the the at growth. for have patients despite the consistent add resurgence And look were the consistent QX, new month, we prior

see we that July I think seen towards is when But when especially is And August which are. over say we a broken resurgence out. a where what lot overall when variant, you But had haven't of have Delta little dip closures quarter you we the We the of of we did the contributed and been look because has at growth numbers that starts, steady. there. to XXX last of

haven't we of because patient terms because very rest in In world, patients you of Europe number finding regulations. and down the know, broken the difficult U.S. of numbers the it's as of actually

number Hope is question? reporting every are from answers that patient U.S. your that purely the we So perspective.

Paul Matteis

out so break you and Can revenues? Europe Ashish. much, thank U.S. Yeah, of you in terms FINTEPLA

Michael Smith

Yeah, was in was quarter in $XX.X Europe. and the million U.S. the $X in

Paul Matteis

Great. it. much. Thanks Appreciate so

Stephen Farr

to and it'll quarter, physician beginning very start we field obviously, just to physicians. which a so expanded became to sales team, the with much this did conversation that a engagement. what But get to far I question an team expanded the have with you want quarter, think quarter the our I we’re effective seeing at in we've we weeks as move Paul, take been during acclimated you had them increase pleased about to this remind can with of few forward say. as

led us. And So positive prescriptions. know we very that's that new has a for to sign

still, say doing with early but it's days our is we expanded team sure obviously So, Ashish now. right that, encouraged what feel would I’m

Paul Matteis

Thanks, Okay. Steve. Appreciate it.

Operator

from question The is go Securities. Please with Jason JMP next Butler ahead.

Jason Butler

Hi, questions. thanks for taking the

give get you've for the planning you do as with work then with can one, to or context any dialogue KLOs on you're -- insights looking some of just get like scientific Europe Just payers or you're MT done the what regulatory XXXX, you've path speak prior the advice how any to of had on ready LGS look meeting? And payers first them launch, can what that label consultants could the you to to in give that to us preparing out approval expansion? for with there? the And

Stephen Farr

will one. going respond ready Brad to ask to second I'm to Ashish and your to Thanks, question take first Jason. get the

Ashish?

Ashish Sagrolikar

the Jason one Yeah, from in payers prepared remarks, we unpredictable data well as hearing with we a and the on launch, LGS as the challenging is and they disorder, advisory are as LGS also too And well are consistently meaningful. that as LGS every are said a What I’ve stakeholder. one other think refractory is aware boards as that condition. is payers are is And and appreciate they that excited. pretty doing

these that are going started and quarter. as quarter conversations, last we doing at be we this AMCB in week continuing doing We will next them to be as well

with soon As the the that them is reengage label is as plan to approved, product and covered. gets our indication the ensure

Stephen Farr

you? to over Brad,

Brad Galer

to MT excited, multiple regulatory ones that regards to In Europe, with with are The and Hi, we are KOLs us experts MT our help consultant KOLs XXXX. have very there. path definitely engaging the utilized especially Jason, with XXXX

different in indication. different with a looking well indication as more for requesting bit patients, Monday, been Europe, a a with the difficult be maybe medication, benefit, EMA a discussing well. has also all of are and And on treating the a will this we're outlined on fact, as little experience matter for mentioned excited little but We're the seeing which more an she'll be non-survival adult as with onset of U.S., her in The in As especially data, bit as patients. call very on survival, regulatory path Whereas other they I Monday. one tremendous about benefit.

with information of may be it I'll Monday. more onset patients. indication younger So age a providing different be But on a

Stephen Farr

the onset. the Just patients around are early of majority the to [indiscernible] fact in

that's onset onset. on is for we I of we EMA have the use think, later just to the fact opposed data [indiscernible], So really, young issue early And addressing that Jason now. later children, more that right on the as onset reflects

Jason Butler

helpful. forward on call Monday. Okay. That's And look I to the Thanks.

Operator

Next is Guggenheim question go Please ahead. from with Yatin Securities. Suneja

Unidentified Analyst

this is on for Hi, Eddie Yatin. Yes.

can a around talk could there that to why potential Is Like, is couple there work then, in can potential do you use talk the about acceptance? approval adds will the XQ? off on Thanks. affected LGS risks year? that the by non-clinical you create next risk? seeing? what seeing And patient level in me, a cadence you LGS a label the even Can Just in you're remind us from what about think of use the And you are filing? be of assuming debate FINTEPLA label per you're anything the a off

Stephen Farr

would Gail, first you. question? like take you Thank to

Gail Farfel

Thanks unaware are Certainly we Happy Sure. are the that would data pose in complete. to. the Well, risk. questions. and straightforward non-clinical the such filings anything a studies for those of are

as terms and as to In come the with meetings. included sNDA X And and well about the for the meeting, happened diligence of be Phase has to datasets same course, good clinical the the we’re of in filing. submission. in data, And pre- the fruitful agreement done we in agency should we've our had able comprehensive discussions check what

that accepted time. the all So submission be will we believe a

Stephen Farr

second address the Ashish, question? And could you

Ashish Sagrolikar

patients. of Sure. the in LGS, cadence Hey, you of terms of adds terms Eddie, in perspective after number of give patient a I'll

of than syndrome. you have Dravet five we As going patients coming in in you for than to times least the at times LGS, number what larger be will or higher see six is Dravet, know, it's consequently so

remind is Dravet that I will any how only only indication One impact have for question, is in and second and now? terms that we to thing your used for right have being you we promote like Dravet. As syndrome would just it in of everyone

us it's around Dravet. prescribed And previously, cohort tells are majority being is of LGS QX. for that the However, the indications for that we as this stay are data and who than other and of that particular said XX% true patients our and FINTEPLA

for they are reasons forward number Given that of LGS and because is sense to their the novel them, treatments a feedback are the the control. the inadequate data the are have also somewhat we excipients excited are seizure FINTEPLA significant meaningful and And looking current to hearing these toolbox, treatment that in from in have options. of patients they to have the

We a expect will factor. be huge that that not

Unidentified Analyst

so much. you Thank

Operator

Company. from The Needham Rohit Bhasin ahead. next question Please and with go is

Rohit Bhasin

Hi, this far? FINTEPLA then should for particular any Thanks is XXXX? question. payer prescriber coverage, my terms for changes And we Rohit for of Serge. expect taking in Are on for trends any you noticing thus

Stephen Farr

hand I’ll again. you Ashish, out to

Ashish Sagrolikar

Sounds good.

So, on in increase we terms as educate after FINTEPLA, the as And see consistent previously, as syndrome. prescriber connecting of Dravet physicians efficacy seeing trend said Rohit, we we are them, with that we we are month. what the is and month transformational in them

that. they As product. REMS, the process they the as central, of from entire they the the with comfortable Zogenix get using start And snowballed product, once as start well using the it of kind

getting also neurologist only at response the So the them. but prescriptions large. from the from we And community not epileptologist, we and are from good are neurologist getting

has that's been very So reassuring. something very promising and

but determination. not conversations In to the we been we we able the patient payer is based what only having, coverage, there payers, who from almost on are every prepared to on LGS also said I Dravet, see concerns as not remarks, feedback in And doing the and there. have for positive any that any we are and have do get roadblocks terms get it is they of able my FINTEPLA prescribed

Rohit Bhasin

Great. Thank you.

Operator

ahead. with question The is next go from UBS. Please Esther Rajavelu

Esther Rajavelu

for on Hi, TKXd. my guess and for couple thanks me, two Zogenix one a questions. taking I

patients through take of off us Or whether the community if drop you if therapy are helpful. to you to talk readily available treatment approved? process to about expect going you're And you at of steps dropping patients? referred point the average year so part you the can therapy, may then new be for majority the a on increasing centers? doc, if epileptologist that therapy prescriptions regulatory can these TKXd, rate, one, for identify sense patients share would duration first what these next what or have And for lastly, is the you then on in you of are to be The give as do the off, larger can and treatment comprehensive

Stephen Farr

take going for for you. Thanks ask to questions. Ashish I'm to your two again the first

Ashish Sagrolikar

Yep.

add think and from majority imagine. are new program. are prescribing as already of we you docs, at clinical So, and are trials up the in who product of physicians, were community I The more epileptologist, the REMS for Esther can all terms the large the part our centers prescriptions signed neurologist, of as them

quite many So not there are time neurologist period prescriptions coming we long new community centers they're COVID. of because did every every for group, where or in, we new bringing a physician have to this that of from frankly, centers, and from because that access physicians are also

I think we opening them, prescriptions make slowly and inroads up with we are that. seen they have from as

on as second off, at far months average. between range an the your it four around The five and is drop six. usually As takes question

out, will off, not for therapy. they months range the think have the great know reach least that is five they the they they're still majority because then working at who take pretty of patients FINTEPLA that the if the So on offs you and stay dropped start product it that tolerate escalate that drop who for that between drop six. four the quickly. that for did it you. seen. try about But impact. usually maximum And when has the we And they and doesn't, try they the the patients will And as started therapy, work them. the to One and And that on I see thing you long and And been the then you have this therapy product can dose dose have decide off. for

product, we label they also part of patients launched patients are when last who who and are of August, our started the program, the expanded on therapy. the still have And we we access have the on majority So therapy. extension open still

the So is in this point longer average much, duration at much time.

TKXd, to For over hand it I'll Brad.

Stephen Farr

that for I'll take Brad.

to the becomes get approved. in of doing conjunction when product developments identified in are number the you're terms [indiscernible] this in patients. the you the question trying Obviously, In very work critical this increase about space, of activity

we for our relating to to surprises is Investor activities to right coming be lot earlier. ongoing Monday, want TKXd So Day is able talk testing. of this. now. increase in identify give to we're more have to up a advertisement also a that’s And about right But, a physicians next areas genetic that key increasing number working where clearly I we'll another disease a helping awareness, no now diagnosis, component of

We activities number of the a genetic have TKXd. with testing associated availability for of improving

be tell we'll you that to thrilled on Monday. all about So

Esther Rajavelu

Okay.

Operator

next Lugo go is Blair. Our with ahead. Tim from Please question William

Unidentified Analyst

for the Tim. Hey, is on this for Thanks questions. Lachlan taking

I year, I place? launches the to already have European you do the sounds then, to there? in get need powering potentially the sharing you markets what wondering, was for assumptions was and next you infrastructure And of secondly, wondering around in details with any study, comfortable of the be there? you those that, So reimbursement several of sort some closer like the commercial Are decisions CDKLX are as markets you'll across you building maybe going use

Stephen Farr

And per the and similar reason we that ever to power power, that about where to lead syndrome. monogenetic to as of respect that group LGS. would that. for Dravet duration I sort The you the opposed had those is powering we is for for and Dravet use within equals we comfortable But CDKLX type you. With haven't talked XX really epilepsy, take that very probably for can of needed significance. we that feel we've I is

Just remind first again. me of your question

Unidentified Analyst

built and Are with between you out infrastructure already in was I think you I building you wondering, those commercial Do have have that expect? to reinvestment said when that. into countries? be you now you out markets eight going the

Stephen Farr

playing approach. much stage very a we for Yeah, are

in are our the have we we as countries are and building and UK. then presence based in and And certain when there. product for Maidenhead, various functions in commercialized So Europe, centralized important which becomes

So presence of for as example, employees that's country Germany. today, where will in have we know, you year, about we the the beginning we have we've launched XX in Germany, a probably have at and largest that office in this Germany,

of up country we presences once build sort these will have approved. So we reimbursement

Unidentified Analyst

Good. Thanks.

Stephen Farr

for your you Thank questions.

Operator

question go is Raymond Danielle Please next from Brill The ahead. James. with

Unidentified Analyst

for question. on Danielle. taking Alex our is for this Hey, Thanks

if now that So first-half And by the notes like if you're delay? guiding then I'm REMS to enrolled you for Could be we'd second-half today ’XX. share the XXXX NDA was be how getting that me year-end looking and submitted this this, my meeting? correct And for in to then the Type MT data ’XX. wrong, now reason quickly, by forgive in many B informed the And that additionally me are was I FDA came anything up that missed doctors said program?

Stephen Farr

the step you Study to XXX question right on take submission. NDA being can the Brad, into the

Brad Galer

in no B – studies. our there our type there were no meetings are So new meeting, in

agreements. delay the and to both across which sponsored of and mentioned XXX, the in industry as sites patients IRB the due clinical is quarter. the I delay outside and that's As problem that untreated And signing meetings, you having we delays is is one know, because earlier, patients. studies, trial why the identifying pushed treated And, they're out the genic that’s pandemic, Study a

Unidentified Analyst

registration, Okay. on Great. on then, number REMS those? have do just an updated And you the

Stephen Farr

XXX quarter, and writing there were that the half REMS of Yeah, those prescriptions prescribers for in at were last the over end of program, were FINTEPLA. approximately enrolled

Unidentified Analyst

Okay, great.

Stephen Farr

Thank you for your questions.

Operator

Instructions] Bank Arvind was go [ph] question Patel next Our America. Please ahead. with [Operator of from

Unidentified Analyst

Hi, Patel good on questions. taking Gregory. Thanks is This my Buvan for evening. for [ph] Jason

certified, hear physicians with XX-day the review? ahead FINTEPLA a review, of what deadline want new with on XQ. certified I priority want quantify confidence get first, degree you you'll for of And the weeks left ask do you So REMS I thoughts to could Doc to number few also to that getting the granted the just be end filing of priority at regards then, your of the on LGS to have if

as can we you us call even event your ’XX are just on of and wanted looks the And meet to And expect XXX in goal can you any that it asset? how market your to mentioned, by next the data at or on like to of prescribers that given so MT XXXX, well? so the year-end, get pass-through you tell just identifying mentioned about you've had list what you like thoughts the you. exceed XXXX XQ, for end finally likely then Monday? And more Thank at adding

Stephen Farr

question? your LGS you'd thanks questions. like the Hey, if to take for Gail,

Gail Farfel

Sure.

granting decision. a that approved products is number are other review of And know, are FDA you LGS. for an of As priority there

options. among there However, better patient treatment the let's action the brand still to community, is mechanism say the And alternative. great to need of was community FINTEPLA medical unique unmet with have provide new a

a for pediatric the LGS in meets response written Importantly, time the to of from six review months. study request FDA. a is pivotal this standard pediatric request requirements submissions And the written study

be we to priority granted chance the of So would good we have that of because or a believe having review characterization. response timing granted his

Stephen Farr

end Maybe program Okay. the in subscribers -- certified in doctors September, program. doing And so of I’ll what XXX end of number we're the just the QX. you about case number misspoke, the can talk at was of REMS over to the the of I enter REMS Ashish, increase at

Ashish Sagrolikar

thing get funnel. a the physicians quarters other one on a said so of patient our getting that at number patients they certified and of Yeah, of is prescribed they back, terms And certified, few value the of top getting and say these realized have more is physicians focus I'll we FINTEPLA FINTEPLA. the once once as in

more and that day to these patience, getting goal have a basis in get the between focus have last And educate is And and have more who we than that And them, have certified physicians we they we number you are Dravet prescribing. list all But with pretty XXXX few been So months. answers and QX is educated started on physicians, and and one almost on easy is But is the physicians from the the we XX XXXX. QX, new expanded to on along product patients REMS. for more question. in getting I QX, on it's the day physicians physicians terms XX do that's focus get them certified. number on thing prescribing now tell physicians people your to to we to Dravet our just can it the what something process, to decide the than syndrome. are transformational can the efficacy is they already prescribe that's getting of who on that of the time of increased write top then came they Hope once and funnel. more in focused Certification And on cellphone. in to

Unidentified Analyst

XXXX. you. wanted the then, Thank on I finally just And MT

Just we at you. what data the about can any expect event you can that next us tell Thank Monday?

Brad Galer

quite one one patient and pre videos from I viewing advertise. me will which allowing But all the it Europe, our impressive. thanks to give both won't own their Yeah, will away. be KOLs you U.S. investigators and from be post-treatment, see showing

in presenting we'll XXX. year. also addition, as I'll the But addition, some till is Study Study be next mentioned, prospective XXX analyzing In data. non-survival And I running delayed be

more it data Next a non-survival year, will as be lot well.

be a the presenting great Monday, KOLs that So an come pool lot more to I'll next out. data in coming ongoing be

Unidentified Analyst

Thank you.

Operator

from is with Neena ahead. Citi. question Bitritto-Garg next The Please go

Neena Bitritto-Garg

thank you for guys, my Hey taking question.

number great? of end how drug you. of you be provide at total And September could Thank you September. actually the could if of the I just also, the patients as that was were on cumulative wondering actively clarify of would since then if end many launch So starts

Stephen Farr

handover I’ll to Ashish, you.

Ashish Sagrolikar

Yes, I'll take that.

almost to the future. The continue And foreseeable mention on monthly will add but didn't on patients, in basis we call we to able of And the ship top And in FINTEPLA get a we prescribed on do number determination. the gets is So, to of that us that for product the of them, we continue focus to are not we every four all them are weeks. patients. funnel. them know if of they the once one to two positive

patient second the starts, think new your question. that of terms I was In

is XXX. QX. well started in And terms of that XXX We over cumulative in start, are number the

Neena Bitritto-Garg

Thank Perfect. you.

Operator

Securities. question Suneja from follow-up go Please a have We ahead. with Guggenheim Yatin

Unidentified Analyst

my Yeah, thanks follow-up here. for taking

about sort of Just still a XQ was consistently of I more quarter, wondering last quickly, this thinking to guided numbers? per of that missed month. you're add slightly or month consistent about sort XX you per XX if XQ given patient for quarter And Thanks. for patients you

Ashish Sagrolikar

that, take Steve. I'll

that COVID QX August. our as consistent It's been have because will say the quarters. reduce in -- was we increasing. have well geographies and expansion we also So, of have that our know, them. in for we normalize early, the I on you I'll the for [ph] we to we we seeing are because face our prescribers and large with number And QX, that what we adds face thing you experienced July, in make really Dravet is are we significantly help is team. caring the reason FCB them in ability the call what call call the think call that to This more when patients in prior them. And on the expanded of as for happy but of allow And one interaction. resurgence with face expanded of because that as which have will wanted new we those for patients, expansion to COVID, that are of this prescribers, very couldn't list face with list more to and to want impact geographies because we finding And

coming made, beyond. the of the and visits. through have start We by made impact in we team but a see progress QX, encouraged expansion are and FINTEPLA, And And are since educating meaningful speaker in the see them one of months quarter. our very to programs, we on by expect especially the we on one this also progress this we do do very

Operator

remarks. the to closing for This session. concludes Dr. I'd to like conference turn question-and-answer Farr the back over Stephen

Stephen Farr

rest and the able especially indication to this virtually. all I'm have us report today, well. Very on you to and the hope as appreciate sNDA focused the on with second Phase And FINTEPLA enjoy quarter meeting call happy to your asked questions a joining of thank X for strong you third initiating that day. very Monday. sales, cover you Goodbye. you're attend us close MT XXXX again, event growing a submission a investor first FINTEPLA. mitochondrial and disease our particularly I to for Thank our and of all also today's pleased and for excited to next trial indication,

Operator

concludes This conference today's call.

lines. day. may pleasant Thank You disconnect a for and your participating, have you

Zogenix (ZGNX) 5 Nov 212021 Q3 Earnings call transcript