ZGNX - Earnings call transcript Q4 2020

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Operator

Greetings, and welcome to the Zogenix, Inc. Fourth Quarter and Full Year 2020 Financial Results Conference Call. [Operator Instructions]. I would now like to turn the conference over to your host, Brian Ritchie with LifeSci Advisors.

Brian Ritchie

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

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

Stephen Farr

Thank Despite what to you in on very much, COVID-XX on joining by here since to with transformative today the details challenges for pandemic, XXXX, year you all the us share to early brought be global a afternoon company. experienced who's everyone pleased we've I'm was Brian, the and good today.

physicians commercial provide patients. government are existing our by result discussions FINTEPLA, we a to of outcomes pleased team, of of well and option and as for many We're progress will And for to and families and along very seeing an optimal and detail, the with we many our launch the as as the is supported important us adoption of the FINTEPLA With and patients our U.S. successful and the encouraging syndrome, to living launch by providing are from patients, new work payers hard access date. which with way. our treatment clinical new prescribing with investigators dedication Ashish Dravet

report I'll European to the this Dravet associated in age to details We're for FINTEPLA announce turn in in month, call XXXX, beginning X the seizures approved launch. United of patients we pleased Ashish first that launch the in were Europe. for country approval Commission December with Germany, the MAA syndrome both excited older. European to of available on FINTEPLA of as our now for U.S. is earlier or years Following treatment that over is our the States how progressing in of and further commercially adjunctive

over to you. Ashish,

Ashish Sagrolikar

Steve. you, Thank

There we QX, commercial we reduction. to FINTEPLA. on seizure on by and therapy. we about seizure drop At a faced the and and have a starting we to positive The As our full are of achieved had been REMS FINTEPLA pandemic physician Europe. fourth new Steve in the face medical frequency has the of sales excited Dravet reflection the in disruptions and and and have significant in U.S., and syndrome in of unmet U.S. and the caregiver physician now that challenges We the patients In freedom FINTEPLA. net launch we quarter. pace. commercial enrollment and COVID-XX need very with reports steady program In end reimbursed community near transformational patients for XXX reached grow who FINTEPLA's first to since $X.X a quarter the momentum living product mentioned, seizure throughout potential provide the experienced seeing patients recorded and interest numerous consistent into practices, of families XXXX, caused million in at for the are this continues of durable starts patient dramatic believe the Dravet a awareness is

FINTEPLA. program December of the XX, reminder, registered and included FINTEPLA end enrolled physicians as number XXX patients, This had Of of up REMS at professionals were patients new XXX is registered nearly program number the patients to of REMS to FINTEPLA in Also, in prescribe who the had care into as XXX compared the XX% eligible December been which XX, referred XXXX. a making As quarter over to QX. third prescribed XXX of FINTEPLA. were program, FINTEPLA XXX these REMS and were in them to

into of at months seeing consistent XXXX. are the of during pace the We referral the new program a early patients REMS

early and enrolled the end patients the were addition, REMS in of program QX. all open-label extension our who of In U.S.-based were access part studies by program

on commercial As are product and approximately patients by commercial reimbursed track of end mid-February, XX% of receive the QX. are product on the reimbursed to rest these of

Dravet the the being notoriously therapies. added to is to approved syndrome level, and that multiple per current FINTEPLA refractory therapies, is patients' Given as

FINTEPLA. caregivers X onboarding REMS with reimbursed takes and ease process. a FINTEPLA X from the is patients enrollment see helping weeks work physicians time of us limited, team in have to done the data more our care most providers and dispensing including patients access the by prescribed of CVD provided enrollment proud the feedback and on the to program X FINTEPLA Currently, we on the being in already the that Both the and of the prescription. Although to are REMS concurrent drugs, seamlessness of extremely branded therapy. I very and the am of or it patient positive health average, antiepileptic on reimbursed

had approximately XX% As XX, their of echocardiograms. patients baseline of enrolled in the December completed required REMS program

with access, by this to We our positive. reflects With the which have team. efficiency, pleased U.S. successful respect onboarding extremely discussions execution with payers been our very are

coverage, through decisions post-launch have of health plan While resulting to in the enrolled received, the FINTEPLA This our the encouraged full pandemic of has of The our trend coverage REMS program coverage were months the others received it already enrollment. ways we positive are favor ongoing policies XX% receiving in similar industry. continued the and XXXX, of established of on in decision by we launch approval process. than remaining COVID their very patients in necessity of coverage positive impacted typically By to in takes FINTEPLA more positive patients up based year XXXX. the the medical a the end had in process to has coverage timing in establish early

had some Specifically, size customers ability to manager regional mitigate it COVID-related has territories we key the meet this, these large restrictions. of our travel are and and reducing To face-to-face. impact one and an team's on managers address adding account X to travel

launch their XXXX or levels. pre-pandemic antiepileptic approximately Symphony second the down have assessment XX% we in data specific pandemic class by benchmark how prescriptions on from numeric While cannot our Health the were impacting indicates is in the a that new-to-brand the overall, efforts, from half of a

in member was FINTEPLA seizures Europe Kingdom, approval in our United the as Now as the progress On Dravet and Europe. all EU for associated let's the XX, December Iceland, Liechtenstein covers well countries The discuss with syndrome. approved of treatment Norway.

FINTEPLA countries, the first Following the beginning we where with major reimbursement for the year automatic EU approval, reimbursement Germany, can process. we securing in process of began utilize

We the in the To fully of access medical of have also Products received the of Safety. in Germany and patients before submitted pricing our the are French leadership, year, for FINTEPLA Agency we authorization our the this provides negotiation X on in support FINTEPLA pricing first staffed initiated in France, dossiers and team. product Munich to January Germany, In and Health the and to Germany. process authorization with Dravet country launch launch with Medicines temporary U.K., week Italy is area France promotional We first reimbursement National during This February. designation a for shipments to the commercial sales February occurring for from in patients begin negotiations use office finalized.

in France In We and quarter. expect that conclusion, FINTEPLA for during with entire patients this treatment the team. very is exciting Zogenix a will this begin time current busy

and to significant date. pleased the in U.S. extremely progress Europe We achieved are with the

this with advance forward we U.S. updating soon. and momentum Europe. through acquisition XXXX, and in for demand continued patient building FINTEPLA strong to and solid foundation you As look we FINTEPLA and We expect both on

Now I'll Steve? call Steve. back turn the to

Stephen Farr

advance the launch us the States Thank and product success you, for I'm build Europe. Ashish. well efforts further as our year to our with pleased in United this FINTEPLA in expect during on as initial very commercial

turn efforts now syndrome FINTEPLA for Japan. for me Let Dravet to our in

announced FINTEPLA Upon which JNDA submission, III occur marketing global supply positive will our we authorization year. a As Zogenix FINTEPLA The partner, from will positive in Japan, which expect patients our included commercialization you obtaining Shinyaku. study for top third Japan. will recall, results line of syndrome, this Phase in in product September, Dravet this by support Nippon we may study quarter for third in in results of distribution manufactured of the a

Now syndrome opportunity, indication our year [indiscernible] progress for XXXX LGS. to potentially significant second largest was to or switch a this key program. or of Lennox-Gastaut

These a closeout we as data for highly LGS, actively FINTEPLA seizures sudden for [indiscernible] all for severe a positive was data All are announced unexpected in on a in both important February nearly integration EMA will in reducing GTCs. trial FDA of is factor are We're in last treatment in patients long-term complete, or to from study effect Epilepsy effective from of This SUDEP. XXXX therapies safety potential working LGS similar tonic where a relative submission in in were United More the turned to Including and of data. lifelong which activities, named syndrome, that III attention trials. label magnitude death FINTEPLA of AES and our observed LGS have last required at we recall, seizures. pivotal important States [indiscernible] patients. the in Phase of or will the data, combined differentiated that other have Study approved supplemental FINTEPLA Study seek this option as meeting You and and American with an seizures submissions submission finalizing treatment NDA December recognized to extensive the to analysis Society or expansion epilepsy III that experience the efficacy results to presented for support on because Phase mechanism for novel GTCs showed action treatment-resistant the generalized chronic studies results conducting XXXX, LGS. GTC year. primary year, This was epilepsy [indiscernible] risk position

to presented We to monthly trial we follow year, generalized Europe AES or the the in of investigator-sponsored showed Late were NDA monthly by reduction that of year-end. in we a announced in quarter XX% submit were XXXX, last program, next highly drug antiepileptic added tonic XX% supplemental also frequency in Phase III disorder a The and from FINTEPLA Dr. results an excited year. to quarter third encouraging expect see second a CDD, meeting will existing in to by upon CDKLX FINTEPLA to meeting. with crown believe in Based ahead initial enrollment with at very submission January, Vinski tonic seizure moving promising CDD. regimen. we MAA and FDA EMA advice the allow experienced that the we in Anda of their these seizure frequency, was patients on to study FINTEPLA begin reduction the anticipate in median results obtain when the deficiency median trial of that We and results, with the half which

study late X MTXXXX deficiency or study TKXd XXX, Now DNA of also that progress. of outside I'd data MTXXXX, treated continues patients discuss with ongoing. mitochondrial to the Study advancing called prospective to investigational on efficacy nucleosides our and chart deficient studies TKXd. for The treatment is a kinase age XXX, disorder, program several has like the Study pyrimidine review studies therapy patients. thymidine enrolled the with our safety XX captures

begun a renal enrollment chronic to in XXX, support dosing. has study impairment Our Study

well to countries. continue after an work, soon approval half development to we first the through screening more patients have TKXd the the various to U.S. and of sites We in other for submit in Italy plan United diagnostics as States, submission. submission intend with parallel clinical NDA In European the projects identify to initiated XXXX, as

busy commitment Dravet underlying novel of Finally, lives in pioneering of Tevard the of epilepsies. partnership December rare for epilepsy needs Biosciences, solutions hand we over a other seizure continue an beyond to stage Mike continued a the control. with to treating we financial incredibly patients for to with call who Mike? me tRNA-based discover as productive let This and an disease and syndrome With to collaboration important rare help their company. transform recognize disease long-term early-stage causes face year and our to In commercial for Zogenix, the families, seeking gene that, summary, the as therapies company additional reflects grow last genetic unmet was and year review. we treatments announced develop goal a

Michael Smith

due fourth of for the for expenses as XXXX. Shinyaku XXXX, fourth totaled ended of the sheet in ongoing. in for fourth driven prior our which announcing per We and strong $XX.X the now now review. equivalents press and the XX-K fourth $XX.X commercial Net for million million to net I'll $X.X period third quarter recognized $XX.X Thank and investment the note, we is million, you, and product began XX, which $X.XX Q&A million of quarter, And quarter Operator, XX, operator the with financial the Europe, XX, to million. loss $X.X our Steve, Nippon Today, launch the year, related for U.S., XXXX, fourth XXXX, call distribution $XX.X essentially FINTEPLA the quarter the the in FINTEPLA or SG&A XXXX, continued the can turn in afternoon, fourth results in our line revenue R&D share, to expenses for period please Monday, with million to on share with cash release to session. during and December million Japan. corresponding balance over full our of marketable XXXX. good the business ended preparations issued $X.X December a U.S. launch was in related to quarter loss you our March compared compared We to revenue collaboration to the million this X, was in approximately year. or now million was corresponding $XX.X everyone. the last quarter million, and We XX, per intend a start up which FINTEPLA primarily compares I'll flat to of and of to of $X.XX year. for this premarket of a $XX for result a questions. quarter file exclusive of open in $XXX.X the XXXX. December in the related that, and The in increase and this $X.X we million quarter ended December year Please the ended with $XX.X sales million with recorded fourth year-end securities cash recognized the the for

Operator

Instructions]. [Operator

Matteis Stifel. Our from is first Paul question with

Paul Matteis

a one on couple of -- some quarter commentary. on couple a So just on your the and then XXXX

on to to passed I the the price And confounding then alluded of you of in so quarter-to-quarter questions the quarter, was you may inventory? your to saying was in been in data comments? revenue what One, number any EAP the average you kind patient On then changes patient XQ. far XXXX. you that with separately, just and there observed trying of this in similar kind titration. things And We're pretty modeling already wondering patients to of basically the one [indiscernible] or pace that X extension XXXX, be sounded is get on material kind Ashish, could if has adds like provided. expand based of of so separately, clarify on any It the

your FINTEPLA following of for of kind what to in saw wondering kind average through and this launch? quarters cadence now the that what's the more of that, of you're dosing relative expectation early the I'm quarter So we

Stephen Farr

Thank with to you, drug. I'll that reflects how Paul. and who are revenue patients just back start on

Just recall, for we FINTEPLA. specialty a pharmacy have distribution

do is And ahead well. a you that other which anything to our really think asked sales questions dispensed And reality, go I the to to I you inventory what There's do said, I Ashish think good being please an to great build to in patients. reflect add up. not just as that. if want that's So Ashish, had, it's drug -- address, and you

Ashish Sagrolikar

inventory. see everything yes, have pharmacy, no as the patients. There -- Sounds to is the Steve straight is in terms specialty will what one is you correct of just and inventory that we good. the said Paul, sales in

I modeling in was on trial pace the as dose transitioned, terms their the one in would it's is And In patient terms all of quarters. patients a almost kilogram. again, XX% XX.X adds average of early. them. average dose, early is And weight average correct. an access We similar, the them, of But have see weight of on that the patient-add clinical X say similar commentary are of past all with very X.XX and now we of thing seen

first consistent that seeing And coming months. are between think we is But being with of will in, the new say in I it's X the will similar ones months, the stay same a So that trend escalation is X forward. continue. what X modeling are months, schedule, small I somewhere going and that will consistent dosing if again, the perspective, really to And seen. so trajectory X to think, difficult we be X that if from data use

Paul Matteis

Can already are because Okay. that be Ashish, to able that, comment you're of fourth are I I'm titration patients in know able I at this? you past you quarter, but -- helpful. of, the of just to would the clarify if most guess, all, are who don't kind therapy the on

Ashish Sagrolikar

Yes.

thing to one come month. by say take, who tell pipeline that X have sometime months, their if the would is in you would I'll say in dose, October anybody the say, So this be you optimal at so X

that you way. So the model cadence if to that's want it

Stephen Farr

an I Physicians they're Just use to does a adding titrating think, because or true thing weekly to slowly we've to drug. by other But on more drug is basis. add. the what titrate to existing seen one for early regimen treat inform the drugs on tend label unexpanded access The epilepsy. program, that that

tend we to to months is out cautiously, they So X modeled that described. Ashish X which go there why more

Operator

question Our from SVB Goodman is with Leerink. Marc next

Marc Goodman

gating are give at in was the a all in you talks. this kind of to point? was of are your remarks. was the the going other talked pretty where I just so have I'm patients mean, or FINTEPLA on about I then issues been the All And dropouts long, talks short I patients any heard can know XXXX, just things how For there maybe had so study, feedback nonclinical past, in far? you've period noticed that time, reproductive you been so I just much you some curious, there dog a it well? know on not from mentioned sense but that mean, the you a of staying And prepared just but hasn't review drug us it's far? such just of -- we with file? could retention

Stephen Farr

the Marc very small. Yes. rate is discontinuation

in So want early in still with -- but we're encouraged certainly with seeing launch, I robust also that reflects it early both and relatively studies what efficacy very very in we're we caveat sort rate. our a discontinuation program that of and also to saw we've but it's seen low long-term I today. a think And the access open-label what our where response

we'll hopefully, that So same on continue trajectory.

our his remarks, recall doing FINTEPLA. seizures, are seeing in in our are to even dramatic feedback a we clinical trials but saw that during the FINTEPLA, in seizures phase have of titration saw a provided not remarkably well, and reduction Ashish patients in were curing of as a controlled response clinical part terms some prepared of same patients we of reduction that our trials in new seeing in our been trials, dramatic the randomized

So durable very the response onset fast, seen of speed we've thereafter. a and is very

studies who commercial patients track. thing are seen we've product all the onto to to are FINTEPLA. are same respect who coming far, on tox the MTXXXX, With new So

there's nothing need we in submission we there. about. worthy this year really the as We're everything XXXX, for get to a of end talked do order just by ready in continuing news So what to

Marc Goodman

COVID down? with anything issues no So slowing

Stephen Farr

Not on the alternate side.

efficacy that by Study study prospective some But to been really local XXX, in work to, ban around But periods hospitals could of them Study we've for assessments. had to been get that travel, clinical XXX. and where couldn't program some have offices is that's the on to the sites. last We get of around on continue those really able most around biggest part, COVID -- or trial. particularly they patients the [indiscernible] our factor to because it's which year the going international We studies, get

Operator

is Yatin Partners. question with from Suneja next Our Guggenheim

Yatin Suneja

as GTN talk of gross-to-net Maybe you physicians think the have Just is how you do a a end me before go type patients should And through flavor mean, early terms are? bit on you to us FINTEPLA? for are couple seeing, are And I about us -- of they Epidiolex about the what in can Can the at population? the then the Can launch. in still we year? understand generic well. remind I of start on give currently little patient you this you where maybe

Stephen Farr

can Thanks, question coming you Yatin. you second question. of patient about the And Yatin's to Ashish, Mike, maybe therapy. type address can gross-to-net address the then on

Michael Smith

United teens. gross-to-net now, under -- States Sure. Yes. sales little in now a XX% launch so Yatin, of the Most of our is in are obviously, we're roughly beginning the the bit in

So inch United will of year. this the a speak, contribution the up number be it and will mostly throughout to some Europe. It in States year towards that XX% for

Stephen Farr

Ashish?

Ashish Sagrolikar

the regarding -- and all question have for think, already, is we more. remarks, the X is Yatin, anything of in And them of say different FINTEPLA majority majority actually, more really in patients, that terms them which we or of or What patients receiving prepared [indiscernible] And product per and policies try to prescribed which the not you one type have your already still Most the my per to products, dose more branded thing Yes, exceeding on is positive and products as are well of we I is the said primarily seen FINTEPLA the haven't the is both just patients. other seen neurologist, with the parity the who product. will patients. patients drugs, -- dose that not least getting try the are Medicare therapies. is received on REMS really if FINTEPLA X the not the of label, X in which that label. as by enroll gets typical patients least are as the are the are in on ECHO have at on we is XX-milligram second that that, the anticonvulsant FINTEPLA. your have or if of policies XX antiepileptic been that, side, One exist us on And is added, for do and on commercial has mention at hey, or added the or [indiscernible]. and X day seen you other I one we to Yes, the the program,

Yatin Suneja

Got regarding the it. follow-up. is do clobazam? do you receive little was percent you dose. bit patients Because to think half dose I just what the is a more lower plus have price. Can -- the one remind This of think regarding be I maybe those stiripentol weight. patients I us This expect on Dravet

Ashish Sagrolikar

Yes.

is is early early stiripentol that in clinical them. is very So have the low, And seen low. product of seen. terms lot the of we an in a days, have -- is it's time. percentage trial, of extremely what usage In our Again, you

So robust maybe give or data. pretty is for to once quarters now, I have little more think, able low. perspective, X we'll be right X But the number in another set modeling of we a a better number

Operator

Butler Jason with is from question JMP next Securities. Our

Douglas Buchanan

for It's Roy on Jason.

couple ones. a Just quick of

COVID. mentioned essentially basket a trial before You guys on II contingent Phase

Italy identify to thoughts updated you mentioned patients. have couple Steve, additional I U.S. any Just and on of think XXXX, on a And -- wondering sites in that? thought you the if

they that. what have Are look like if patients? sounds open. they could -- are for to doing more color It the sites provide wondering you And Just found they any are patients? on any

Stephen Farr

Thanks, Roy. II trial. Phase basket

diagnostic demonstrate of well COVID study recall, up just respect anybody and we a of and disease We overall a understand CDKLX either number you an and diagnostic of last advisory year patients prioritize not is that critically decided better United being and And of also on countries. way this year disorder. intent continued make that understand -- team a partnering year year and And Europe, inability the on studies harm's or myopathy various trial. studies we to that basis to important on to time that now are diagnostic the test, we work wanting the initiatives II of whether advance what awareness, But basket critically we particularly Phase in we to where they The deducted our could to a projects, of development the we important. some back trial we States was all days a was partners. start back so prevalence. powerful. the submit program. All a to to studies we data best Phase look order XX the not may not also that would with out efforts potentially with And neuromuscular for haven't end got to patient put to a said right understanding mitochondrial deprioritizing market CDD we're can But that's us do have the but off III get at paused program. Phase investigator-initiated We'll III or advocacy to the time really last certainly groups and put screening into in panels. really formal to that We point patients interesting of in deficiency some in to for results sort diagnostic plenty inform disease we're really wanted ISS with working order ensure going study As expect it's exact whole it's sites to investigator participating see to pandemic and as get product think And program different continue more the that forward that the we that [indiscernible]. in move starting as II in study. patient Phase support for overall the to respect the prevalence running identify again we're have looking to of before really doing boards, this the the support this with in because groups we to MTXXXX. by well, working we're of our look in NDA I'd as XXXX, really and signal. patients that do and trial, research, around at to we -- moment running going

Operator

Our with next question is with Difei Mizuho Yang securities.

Difei Yang

beyond about of unique similar I script Just how Would written? be FINTEPLA, the if typical FINTEPLA. the that mean are on it prescribed And time certified? certification the a be able comment REMS you second REMS on we U.S.? who Would trajectory Germany? which to there's somewhat around, have among those how the couple is lag a then should doctors prescribers many between to to The think first question uptake in that,

Stephen Farr

to going ask address to I Difei. your Ashish questions. Thanks,

Ashish Sagrolikar

Difei, in what around broken prescriptions as that treat out are core unique is physicians But XXX the from [indiscernible] XX% that the number. the that about we prescribers, tell receiving talk centers we we you the terms of that group, of patients. can is haven't key I which

COVID they what the is related due through a this be that in really the rolling where with reluctance And earlier, the get hospitalization. situation we all of or to to the And to through time. we commented So that -- have and which setting group, a the like of patient is to we to X, majority past, it which situation, and families state-by-state places on from have then with led take Dravet that lot of from COVID as the received fears to be And But them other many potential And -- physician shutdowns. are process. received have the what in places some their things contributes able of January, the had patient diarrhea in of is we patients get of have concern. closed, physician think, and to there's in chance. And with and able this medication of especially don't have experienced does a will and that the physicians process. reduces switch get terms patient said dependent also want situation, entire X put part And the kind happen access. they products, in mostly the ability and I It the prescriptions maybe we community of too. lag prescriptions is a may X are prescribing. who And when were also which they this in that

Germany, are that program the trial the who to divide the the got in. early things. is and just X Again, been to in trajectory the access it then clinical On weeks. patients it's new and coming patients we on One X are

difficult the quickly. reimbursed once have these is that about the very Europe, trajectory. guidance in transition talk you is pretty it's I would product by approved in is to But to one law, and say countries, So

commercial they early FINTEPLA. So for to trial when patients be of the other be should access it in the will lot the and and But again, anywhere between have are I have the on will same of we we their to visits. And that believe X.X transitioned the reason the of timeline to product with months, study able end the clinical depending expect have timing program to the months X X patients a early products. access That's do span months. not X, no a seen

Operator

Ahmad of from America. with Our question Bank next is Tazeen

Tazeen Ahmad

and on one on Dravet upcoming one for LGS. Maybe question

LGS to or be a kind next being how case average the something to of awareness? So to from how for color important underweight sales launch? about curious might Dravet, to would to year early it dose part you Can to might be might order able as that about the Is it just doctor it into And for the kind launch? of relates tend early Is to it pace meaningfully Steve, months patients? it the as the been thinking now talk it great. in think of the most weight for the the this REMS? to patient, little team that and Is on in for of accelerate was Is be indication. more any to the of an So else factor environment? ECHO? that Is bit do as potential any COVID Dravet gating translate is you've be you LGS LGS that it right underweight -- then that observe they often? of relates it is launch, relative patients And what if I what an there differences be your clear happens

Stephen Farr

don't Dravet. could had actually include LGS, away, to that I Why more questions adults, straight did take a take launch Tazeen. our question Ashish, Thanks, Tazeen the about in trials maybe With the LGS and you then respect adults. clinical included

So where fairly had that, was higher high placebo. of are saw on the versus in age proportion dose dose average in who XX milligrams highly consequence the significant studies per weight on and maximum that a difference of was Dravet. And We it we of large basis, patients group, a those also the the average than a as in day.

then, as product. expect that because as But dose you is is the a are commercial question. disease that you'd other weight the older. we recognized of so because be also is adults this -- that's higher dose it to patients the So because question. Hopefully, can higher expect your part maybe weight well be because the Ashish, average higher the addresses does average the children, ultimate case the in will Tazeen's for the If average take

Ashish Sagrolikar

Steve. the I'm patients and the of our there done. said Tazeen, gating ability think my a proud terms the in the to the as and have I what we help is remarks, Thanks, once investments I process. team reimbursement ECHOs, prescription, really factor, has of in the achieved through through prepared execute Yes.

the time. up half. XX% in second that saw remarks, products, the I prepared limited And where shared on can we it's we impacts this by customer antiepileptic XX%. how And do impacted accessing for almost families data team's the down the -- does facilities to medical only also NBRx's the the believe saw right And time. in face-to-face face-to-face full that are the where reluctance that say we that's during we ability point fronts. that all for think lot with vaccination, this access, I facilities opening seeing at we is a getting their now customers and and opening of our is and now lot already what is the the that we thing things all getting did I up, are the And increased confidence COVID because environment. we face-to-face we -- -- we access. X by in take have the environment. COVID a of think and card the the starts wild how And that corroborated When the in seeing remotely, not you a you places have one patients biggest and at travel and are look see biggest One as

So the I see just quarters. in can this up going future

Tazeen Ahmad

Okay.

predictions what levels to normal the going XH said? should half year, acceleration we meaningful So if of based about the true expect about in semi on script trends in second you back of are to the see

Ashish Sagrolikar

don't I reference point we be. it but COVID what should, will We time. to say have the Because launched a during

this will So certain been a in more again, reach or physicians year able be because for more, in there least to we are launch we haven't at face-to-face.

on Zoom. We have done that the

So will that's continue something I think see. to we

no it's least, this a in at point is case. for benchmark exactly that what at to there because give difficult time, guidance So will be our

Operator

Tim Lugo from Our William next question is Blair. with

Timothy Lugo

to for prepare yes, of physicians to GTCs from label You data out filing? is which in of the effects with the kind going study And on. the one kicking in XXXX? are draw that to the we effect able of should be second XXXX, you FINTEPLA of the that half you a year, in as in off see signals honed CDKLX mentioned be on as Are the being of able

Stephen Farr

the prespecified a on you Tim, it it a was with respect impact hoc GTCs, endpoint, post wasn't, like, Yes. analysis. if to

So information specifically unlikely that label. the that you'll in see

now physicians and However, in Dravet, dramatic in different CDKLX. we've syndromes, animal observed we to epileptic we've than we effect models differentiated obviously, publications, the have patients. And this LGS very we'll that -- important what will that. is in aware and And we're reflected continue what in actually all X good that as the seen do interesting on And we're -- it's and seeing making effect, starting impact in to animal on well. data really also that GTCs to some actually correlation experimental GTC,

So that's gratifying.

Tim, what question, exactly... second might remind your would you of again, terms just In me

Timothy Lugo

of similar that see Sure. kind are to -- you're out Is will of to trials? XXXX? and you going broad And -- going general the XXX study Yes, coming is data be like? use it X.X what it we going to look doses? X.X to maybe in CDKLX, be that historically Is patients? If to just run should able strokes be

Stephen Farr

my to FDA obviously with in EMA, still finalizing Yes. that I prepared we share We're need and remarks. as the mentioned protocol, and

But will to it's Dravet same would arm. it it's be the we that of too in I what effect did high early see so So you to tell probably like. in what trial, syndrome. because similar you trial as XX around the the did assume be safe the in to very think And exactly Dravet design be sample open-label that do per size expect we size will the

the next as about sort protocol go several can we'll we as obviously, for through of information so think more as I But say weeks. that the covers And have much now. I

In to terms me of will for predict too year. data early that. be available It's really next

rate the study the going started enrollment is haven't don't what to know We We be. yet.

trend, to that when and hard for when data. investors appropriately year, see get me this But we and more project data. see we when running get expect the we study should inform So after up would it's to it's they we obviously, can

Operator

[Operator Instructions].

with Raymond Our Danielle James. next Brill is from question

Danielle Brill

follow-up have quick I prior a a question. to

Ashish, France remind Can should And you wondering to will of in expect XQ? mentioned quickly. Germany terms in in use reimbursed then many I'm also what EAP drug EAP that the patients program have in the we in convert pretty how patients in you us you Germany?

Ashish Sagrolikar

XXX. little is than approximately number Danielle, think, EAP So, I a from less Germany patients in

is will and expect reimbursement give start I the So difficult France, to process. the usage pretty primarily use and then convert we for physicians it's that's very quickly. the to to In the to the authorization primarily get think number temporary because apply

it this that, And So and they can we to cannot about they the if reach the got do through We have is cannot we to are access not something medical But talk we to need reach going central And have available. a physicians product. program patient can the our team we do promote. just make on, that. team. or put that will they to to a they which

and project the to will why asked for that's and be this based the difficult who do utilization what very it's facility. what expect this ahead do we there patients be. but authorization, know accessing product But -- be went So will that we on through we interest, will

Operator

is Our Stifel. Matteis Paul with next question with

Paul Matteis

it's to supposed is just was But might looks you And a quarter there quarter, and that clarify? or I to be now. our is like right I wrong. could looking was I thought notes, else this push? and help anything submission that, back I first kind third have half of that LGS it the at second that, Am

Stephen Farr

the And Yes. a are Paul, studies basically complete. out. it's has been [indiscernible] all [indiscernible] pushed it

to mode. So we're now to in study upon we as the before well us. as data do And and visits the analysis site do for of closeout as sNDA a have part rely for parties vendors outside analysis lot the of preparation

that timelines receiving On the from basis of that, of we're sort under the we've CROs.

if we'll quarter, as that's moves we third the will it best sNDA which third that that Clearly, then submit think for estimate to highest are it's think that I into to the we can. ensuring I best course into take. the submission. predict the quality can quarter going be we focusing on we And

Paul Matteis

review for Okay. the the of All appreciate right. Do for any I sNDA? it. expectations duration you have the

Stephen Farr

Well, it's a XXX(b)(X) supplement.

or either will is standard review, it will a X-month be priority we which be XX months. clock, review, review a is which So

be FDA it's opposed Paul. the it's can. -- But as decide priority doing to why or than to But day, of X best the at determine our so We they review need should which this. XX will a justify end be awarding months, upon the something we to either and for

Operator

the over would gentlemen, for back reached question-and-answer call the Ladies closing like CEO, Steve the Farr, end to of I and and to turn session, our have remarks. we

Stephen Farr

call. We've for pleased very obviously us Well, commercial thank to joining stage today's company. very much, progress thank We're and on you the now disease share over of our operator, year. transitioned to you a past rare all to you

us in your providing forward on the further on XXXX. for and for joining enjoy looking growth activities Bye-bye year our Thanks are and the to clinical commercial of rest day. ahead throughout again call our and updates further now. We today,

Operator

tonight's concludes conference. This

you this participation. your at Thank You time. may disconnect your lines for

Zogenix (ZGNX) 26 Feb 212020 Q4 Earnings call transcript