Zogenix (ZGNX) 5 May 202020 Q1 Earnings call transcript

Company Profile

Participants

Brian Ritchie	Lifesci Advisors
Stephen Farr	Chief Executive Officer
Ashish Sagrolikar	Chief Commercial Officer
Michael Smith	Chief Financial Officer
Paul Matteis	Stifel
Marc Goodman	SVB Leerink
Danielle Brill	Piper Sandler
Neena Bitritto	Citi
Yatin Suneja	Guggenheim
Serge Belanger	Needham & Company
Jason Butler	JMP Securities
Difei Yang	Mizuho Securities
Lachlan Hanbury-Brown	William Blair
Michael Higgins	Ladenburg Thalmann

Call transcript

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Operator

Good day. And welcome to the Zogenix Inc.

First Quarter 2020 Financial Results Conference Call. Today's conference is being recorded.

At this time, I'd like to turn the conference over to Brian Ritchie, Lifesci Advisors. ahead. go Please

Brian Ritchie

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

Zogenix release providing issued announcing update a ended quarter news the for results first a March afternoon, business and This financial XX, XXXX.

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

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

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

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

Stephen Farr

today's good everyone afternoon you, Thank and Brian, joining call. us to on

the current Before power all to COVID-XX working the I medical the the novel in personnel would line the beginning my other put sincere quarter this team, themselves to remarks and pandemic. of entire coronavirus like our combat Zogenix on on behalf gratitude to workers of extend are front

all pandemic everyone this staying and you're else hope Our that’s thoughts been recent and are well. by with we you impacted

in business the position quarters. in we development made our several us our confident opportunities number unprecedented value-driving about financial these Despite the advances milestone events by for challenges times, next over a significant emerging strong given the programs, of key our and we presented are

U.S., advance continues of the this coming for First, NDAs lead our action with in in the program the quarter the for the syndrome for applications of authority Dravet FINTEPLA June the United date and to PDUFA later on review treatment XX. regulatory In target up States approval of the Europe.

Our about recent opinion risk to mitigation assisted have of Similarly program continue planned, FDA with for move and evaluation fronts exchange year. by strategy the NDA with end constructive of application target the interactions in forward an continued Europe, including review our or multiple regulators of and on work with REMS to turning this a our submitted FINTEPLA. a with we

now commercial rare quarter, commercial U.S. support past place the after U.S. and are team FDA. the commercial recruitment of to and deep completed launch experience. disease we well-positioned patient granted refractory and in programs team, epilepsy approval this for Second, In shortly our if by has our which occur

Ashish As at the medical patient we will launch health caregivers. and care facing designing adaptive patients ensure the seamless for shortly, to communities activities work, hard have to circumstances providers, address under the and been in outline possible order COVID-XX experience most are evolving

program access in pandemic. that the reinforce Dravet to extended extension the studies long-term In Currently, U.S., to community. have new Dravet posed open-label to strong in either are studies in clinical expanded Dravet FINTEPLA receiving circumstances the the the the access there through program. access expanded has expanded of for COVID-XX program patients interest to the or we continue availability the able been XXX from treatment want response challenging We by FINTEPLA centers approximately our of further in and syndrome spite

median in of results which of of Dr. The included treatment analysis study, The highlighted total open-label with Study XXX UCSF durability investor of ongoing the of recently updated the Sullivan XXXX. into a presented FINTEPLA days. a at KOL Dravet extension effectiveness latest syndrome duration from was Joe XXX event patients

FINTEPLA at to have reduction XX% of a XX% demonstrated in and over patients XX% reduction sustained of reduction XX% the period. XX% least least which at the patients seizure entire study

The from more interim previous occurrence The of AEs than or XXXX. common diarrhea. appetite, occurring Study and patients in consistent pyrexia, of a pharyngitis, most was analysis with XX% events were data gross of decreased nasal

Our and therapy continues investigational or valvular safe hypertension. well to tolerated importantly arterial be and generally disease pulmonary heart

environment upcoming treatment program pleased we ongoing report these With the that to we current date chain in not long-term are challenges. patient PDUFA COVID-XX and also foresee causing an supply do June,

requirements in meet FINTEPLA, With confidence additional and drug to product product drug have ability trials long-term all commercial the Europe in ongoing be anticipated substance current on current manufacture demand should we of to and the States under the will inventory, capacity United the clinical our concept lines. the future stability our program high of drug the approved access and time expanded any

be forward unique launch are cash As around In supported balance positioned million allowing the on and equity sheet. very potential us months. approximately launch of potential a syndrome the in towards successfully a our and secondary to quarter the in of first U.S. we completed execute offering by coming environment leaving well Dravet to us and March FINTEPLA securities move in to market $XXX midyear, we with in this in conclude $XXX by we operating the million strong fortunate FINTEPLA capitalized and

of our commercial activities. Ashish you highlights and ask ongoing on a background provide now readiness similar I

Ashish?

Ashish Sagrolikar

patients, is everyone. challenges physicians is good time with of and healthcare Steve availability the the therapy truly community. new this caregivers, It for community. It the in Thanks an At has and time about COVID-XX extraordinary afternoon an families same exciting time, patient providers. increased Dravet and to for brought

has FINTEPLA FDA healthcare and highly our and their seamless on commitment been approval assumption on ensure delivering to our families FINTEPLA. timely team the to a patients to June on and Zogenix received focused providers access XXth, On experience that

with syndrome evolving understand needs. we the unique versus the As telemedicine of to to and engaged physicians online situation and of the activities and substantially online and have world medical Dravet the grow move response many their solutions communications in tools from in need COVID-XX community

Based and tools These have we education a deliver discussions can traditional well access to and who be approaches to developed used processes provide tools. variety include of that needed. digital ensure on as inform and FINTEPLA support insertion as these patients virtual

of examples include initiatives remote capabilities for engagement. these Some

are We allow developing online promotional tools and and sharing material information remote augmenting as physicians the as to product staff well information for important our their visits. with and customary

number we providers conferences. have HCP care breadth education education, medical the digital of capability health Digital expanded compensate of our the to reduced of for

the we as online we In these tools awareness to to Fair conduct reliably developed interest education continued multiple programs medical has high and of education been has these which have facilitate and uninterrupted have level conferences. engagement. there online initial quarter, for very been a interactions launched rate first able and

disease collaboration awareness Dravet On community. caregiver-facing and education community have with developed educational the via patient signed website was informational to we launched in recently the engagement, This continue in forward tool and invest with.

our families part Central, and U.S. Patient of And Support patients in enrolled early Pharmacy distribution is hub to finally, Zogenix access specialty up it's currently and Services program. U.S. and our supporting running and

Dravet treatment significant As physician we data we option approach from QX, about support the FINTEPLA a segments potential a our well prospective as as strong more U.S. launch the for in community. all from learning of interest as see continue community in study to

now place. team commercial in U.S. is Our

condition are to potentially approved are distance launch for well by post patient community. support Dravet a Thus assist in transformational as positioned programs Our option COVID-XX. to this then FINTEPLA adaptable now we evolving the and treatment social

our now And turn will programs. on to back for Steve Steve? I it updates other pipeline

Stephen Farr

Thank you Ashish. very much

Phase to quarter. pleased February, positive announce syndrome LGS. me now efficacy this we clinical X line FINTEPLA were from or very Study global past for Let pivotal move in In developments data trial from to our additional top Lennox-Gastaut XXXX

novel as patients. potentially become treatment The of these refractory majority events for most therapies LGS time. action option With results its differentiated positioned pharmacology and FINTEPLA to existing important mechanism over a positive should

the the full We're XXXX forward or LGS of on and an required to NDA testing sNDA the FDA analysis meet and this support NDA intend to half finalize submission. results finalize a eventual syndrome. of these of to our supplemental for to with an for approval studies second data on for plan now Dravet the in sNDA Study presumption We discuss year complete and

the FINTEPLA -- LGS, to initiated X recall study X FINTEPLA the amongst conduct [indiscernible] regards several complex CBLK and other Phase dose a for indications syndrome disorders, to basket we in explore that quarter potential to potential for activities in In beyond including rare tuberculosis epilepsy past started will you difficult-to-treat others.

as COVID-XX Phase and X patients health studies activities to trial. With clinical patient along for possible, temporarily and care significantly as study important impacting we frontline This safe new with pandemic decided also communities. desire is initiating this the provider their an us for for shared pause our families keep to

a to are reinitiating activities to So to we we environment. are when favorable looking ease begin and return conditions COVID-XX operating forward more

of deficiency. MTXXXX to the strategy Turning investigational TKX for our treatment disorder now, mitochondria

previously COVID-XX trial or open-label enrollment was are is January. assessments retro study a for XXX, subsides. until study Study patients patients of XXX into treatment, the enrolled this situation are the XXX ongoing noted, continuing Study completed end As Study and MTXXXX on but at on-site prospective from involving limited the

In the MAA prior CMC meeting discuss meeting this and FDA June to an third minutes X to program. for late submission is in the agency update and is will for and similar an scientific clinical eventual requirements activities the meeting for A NDA NDA once Study an data official discuss end scheduled for we the to meeting is States of an we non-clinical United regulatory Overall, advance the program, the plans in FDA parallel, meeting in requirements receive we on and the support a constructive An and the CHMP Phase advice the quarter with understand requisite we to interactions in are of provide with lines additional ongoing scheduled from FDA. We an Europe regarding continue Europe. to time XXX studies with held with recently and hold the manufacturing MTXXXX. year. future product very path and

a recognize Vice new our a functions and Shawnte member I'd Mitchell. board management Before will and over her Secretary, very evolve company. to and Mike key President, on have Counsel stage General seasoned into be Executive a we pleased to as compliance team, commercial of the our global are corporate leading handing and as review legal welcome strategic we adviser financials, Shawnte to to like our

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

Michael Smith

Thanks, Steve XXXX summarize quarter now release, ended everyone. XX, for business issued and good first a and announcing and Today financial our them. the results March afternoon, press I'll we

and of corresponding recognized revenue period We in XXXX the result XXXX Japan. of FINTEPLA of this collaboration and revenue a no in for the March Shinyaku syndrome Dravet for is our with XXXX. for Nippon Zogenix during LGS million $X.X quarter first recognized

XXXX syndrome. of and to Total R&D is expenses and just III from open-label increase Study million, for LGS the largely concluded the this quarter million attributed this in $XX.X study period activity past XXXX in an we the Dravet were increased extension quarter in which $XX.X the Phase ongoing study corresponding

SG&A preparations coming continued investment for $XX.X years. the perspective Dravet quarter for quarter XXXX March expenses million the in us of the $XX.X for XXXX the treatment syndrome first to various million initial first for the compared ended European U.S. of countries totaled the XX on in in with in

also on This enterprises R&D years other I R&D one U.K. $XX.X the In development from item FINTEPLA fourth quarter, million from the to XXXX million we and that government call $XX.X offset million the financials. additional for the tax under was to $XX.X qualify small wanted recorded medium-size XXXX as in helped credit sorry income and the of received loss quarter in U.K. out notification first related operations. granting -- tax our activity the tool. and relief the the

ended the first quarter of again, in public quarter XX, $XXX.X and securities, March. $XXX or million quarter $XX.X equivalents with was as net in ended million we marketable March first in first successfully $XX.X we compares the million $X.XX and for the cash offering includes million ended this And net indicated. loss cash, We the that per closed share the this loss $X.XX received year. totaling or XXXX a per Net to share prior proceeds

amount cash R&D $XX.X quarter U.K not this tax we for payment credit of funds are the Now forthcoming as expertise million those in is team. inclusive the recognized

our for have and U.S. With FINTEPLA confident advancement program development syndrome for Dravet of continued Europe key enabling of resources MTXXXX and in and deficiency. LGS a strong FINTEPLA are for balance TKX sheet we and sufficient

Q&A the that, you now over I'll with turn session. start for the the call up the questions? to And line to please can Operator, operator open

Operator

Thank And comes you. [Operator first with today Instructions] Matteis from our Stifel. question Paul

Paul Matteis

mind. you Great. have taking Thanks questions. very much don't for I three the if

what on interactions FDA your regarding REM, you on just from First, FDA proposed receptivity? and so gotten comment and you you've feedback can any the if far

commercial in and your meeting this or of how XXX priority this on And many I Second, the syndrome Dravet left FDA filing if FDA of to guess, And what's so to at the convert Thanks U.S. LGS then year now, right maybe Europe? much. launch gating are or there in of -- assuming either the early these for drug? on patients the kind goes patients year anything the filing that would second half next? be this study, and well kind late is a third,

Michael Smith

Thanks, Appreciate questions. your Paul.

original REMS, Regarding FDA a and we submission. then REMS. our the first NDA on received interactions draft The REMS, interaction propose did include comments proposed with had telephonic the we COVID-XX in our a REMS a

have aspect echocardiographic is with we really clarity agreement have what will you REMS we back with what yes whether most have and forward us moving pleased a not good guess respect on to do be and that important So that. to happen. on which the most And or essential to I to is concordance understand say the I the commentary transplant. think I'm needs between the FDA

a if are echo they baseline naïve And will be patients so FINTEPLA. required

have they six every echo treatment a then during need months. will And to follow-up

is So what is Study safety pretty what in as ongoing that which our study. consistent doing open-label now same right you is know the actually XXXX we're

least that down at gotten now. So we I think right have

we But in Some up good how as were the more think clarity other the to FDA. of comments agreement with -- FDA sets I and and with administer said, the respect have an and from manage I operational REMS. and we nature

maybe I States FINTEPLA On I address to at in your do or left. LGS, Dravet what's Europe. stand that's what question And Ashish just just on patients, either United the open respect are And and and I'll a plan I'll the what and about was a timing the patients commercial patients. Dravet combination XXX of in but part say ask excess onto split XX-XX roughly program. as we around are that just in still moment comment patients product. in with not a to patients who would extension which FINTEPLA plan to we of are quickly third expanded LGS said the do which

in Well go on is in year, the the moving -- as forward the half a will of this I the remarks, for second to with be just we what said required with NDA. really doesn't meeting FDA supplemental exactly

most and the now a is elements doing clinical there right included is nonclinical the submission that being right portions inlight report. assumption the path now two-year N towards or of on which that concluded we working then the important Our are being study most at -- critical is study a least which histology are the has moving

PK There were subjects studies paused are couple of Phase in a X that also which of temporarily really because COVID-XX.

to need complete we'll well. So those as studies

a running half back sometime address dependent obviously running. line the very trials and that up Ashish you So supplemental they're commercial first of enroll NDA else tie I'll is those do and get studies probably and briefly X quickly maybe question. that once that will all quickly if if right up time We now. to quickly on on conclude how ask are they and the anything together, just and you in I XXXX comment upon And Phase small think

Ashish Sagrolikar

the the to targeting commercial because the we COVID and the product From do these patients Steve. contingencies yes have plans Thanks, situation. also Paul, of

where place, individual we and now individual is doing patients are clinics right they understanding plans know know, situation. treatment what is of putting getting what their the you And we treated. what As in are do are stage these are

their whatever be start unable a is we that reach person that family get of we including we on particular preference to done, a and asset through working out that can so to situation, product. education individual transitioned they So them to are about learn preparing if of it. the virtual tools and the commercial also reach particular as We're that approved, once can

Paul Matteis

Thanks Great. it. the Appreciate color. for

Michael Smith

Paul. Thanks,

Operator

you. Thank

from SVB Goodman Our comes next with question Leerink. Marc

Marc Goodman

I'm you curious for physician the epilepsy are could for had the you're need days? environment Thanks. gotten just thing I second, in we And what guys. to just talking Are new want community do there flavor data? CMC which maybe other Yes. prepare a they're the this you Are give the just One that? give Or is of do still clinical to acting? flavor you've left us they them. things. any XXXX new trying What Two saying hearing realize seeing these Hey, us just Can out meeting then your only and on how drugs? you to they patients? another for you meetings. kind trial they

Stephen Farr

to be you And Thanks, able do XXX. FDA. But we talking and the first. will the patients our to taking very important do say, a that you I your just have provide have who final communication our second up Obviously, question, disclose consistent in know about address be to what appears, with its is minutes we once MTXXXX remind I importantly, XXXX with to the will a Study we'll that question FDA. supply And asked earlier collecting the that, want and question. I'll we clinical running, that, NDA on much Marc. data Ashish study more core for said are very take ask is study the everything remarks further efficacy, because from the that for I'll the people the he's safety just commercial that and information supplier. from I prior

ongoing. study that is So

time. continuing I limited And but of are being visits studies some -- to this patients their take as drug they mentioned, during then severely are

timeline information generate CMC to clinical occurring the both back from has more meeting the the get study. how meeting, again we'll just as talk about minutes have more June. to XXXX, can clarity when on we as much is that occurred, in general in we But some for need we'll So -- well which about

Marc Goodman

Stephen -- you

Stephen Farr

study trial so generate -- ongoing that continue until prior information really to to the and will need product do how much run But an the to It's it's -- will is basically continue approved. NDA. we submitting

the with that's we able minutes. the So talk official once piece be have Thanks, on we'll Marc. more clarity to that,

Ashish?

Ashish Sagrolikar

Steve. Thanks, Yes.

that So, of and and entire these have patients. situation what also the other profile. we or one of of respect and be during and really And are there by increased. last respect would now are only seen with connecting And there but And that has for things, right in the mile, we changes eight need if their through nurses treatment, lot also in that and depending many this has physicians care really telemedicine, was is are to have We're depending on What tremendous. physicians our done redeployed to doing seen It teams conducting my provided not any say been health consultation heard use weeks, research. attitude to continuing providers, market also, that the patients dosing, them first a our thankful. with and process the institutes is, I continuing grown see either is really of in they we places for. on is also or is a is have any be to what reduced the to

and prepare experience not placed, be And is and we a by have of way no education seeing program have this, time to will where to to to the there be early some procedures geography able the will either timely virtual terms as is learn method, we seen And where are seen the the we of to manner. are is get continue certain whichever restrictions physicians be launch. this site we preparing that, the able on should are, patients. accepting the continue And And reason are we that visits, haven't you at of address visits. in our believe intakes that. the In site we and we continuing able patients areas depending the access

Stephen Farr

Marc. you, Thank

Operator

for moment today with Brill one will next question. Danielle question Just next Piper our Sandler. And from the come

Danielle Brill

for Thanks few. afternoon. I question good the have a guys, Hi

at how a environment, and just just relative about bit little then Specifically First, how for you're color your on how the current your to ahead go for in REMS strategy you I'm wondering echo baseline? curious requirement provide be more if difficult will could patients monitoring FINTEPLA is Epidiolex? launch? to that positioning thinking And get

for sorry in -- your finally LGS me terms Thanks. filing I required preclinical wasn't but Dravet? recall and you then don't of can remind why Tox data PK five LBS this, And needed the for that that are

Stephen Farr

Danielle. then appear question take first have and to two. your your time Thanks to address Ashish -- I'll last will

submit but required become to LGS, the for for to studies without they indicated non-clinical we we're us. the respect and with by be gaining FDA other first these approval studies So that could a us words, In the conducting that NDA commitment post-market Dravet. would were information, the --

part sort Lennox-Gastaut for information we've it With be supplemental that have they was submission. interactions respect clear made to of of LGS, to that had approved the with original treatment appropriate the and already the of they would because NDA the that FDA drugs us it

we once approval towards and rather went we from information that a had knew for be waiting NDA. they because Dravet obviously we supplemental those So would gated a FDA, started to than studies got

the I more and that that for trials clearly patient for are are studies well addresses things think LGS the Phase population the sort Phase as well. both non-clinical as of and trial. an population adult as which I renal recognizes the I adult impairment appropriate So patient question like has

behind appropriately address are think this supplemental if I background I types your for not that's these the studies Ashish. NDA or required question LGS then NDA. hand required of an is So over why I'll to for information for And

Danielle Brill

Thank Yes, you did. you.

Stephen Farr

Thank you.

Operator

ahead… go next I our -- sorry And question am

Ashish Sagrolikar

question. the Answer first

think supported the And we the transformational be by of is physician of as because it what the we of data what approved. the things FINTEPLA about will effect. have which know terms that's that community durability the the is of as heard positioning that from is in is in plus its talking one is So I when that efficacy well something

need this well to option the is what the that clinicians, there the significant as know this it in to -- available the there what is Tri we believe heard we unmet we a as that that like And kind community - wait product is would to from market. and when of approved. and And have patient

In far this what in be we have so the current patients in And last able we seen said terms the have believe of access with situation X as is launch launch. and the program onboard go requirements this that, will that into weeks our we to in early I earlier. REMS been case as we

Now has of for educating it the on terms of happened sites. depends it are our restrictions team. we in is medical the cardiologists everywhere? and commercial No because different And this preparing is team educating actually

have open-label So will echo are closer to centers facilitate help that identify patients which home. the we extension,

will them of go getting the the through repetitive process, baseline, easier to vehicles. So not in that terms question? for become but hope it also that the only I answers

Danielle Brill

about positioning I you're think just about try the I'm I asked about, you to When the patients clarifying when that you'll one that Epidiolex? to to addressable about how wondering population target guess at question. patients you and just FINTEPLA thinking Are naive guess I I thinking failures? you the launch? going Epidiolex capture are have are

Ashish Sagrolikar

Yes.

for higher needing who on to Dravet seizure therapy reduction of if clinical for that will life. future based a the patients, change or do needing either in believe FINTEPLA therapy are quality or -- are they more data, the the be looking we achieve are currently they think I impacted this all

data see educating the this will about them be them. to therapy the So and let patient, the physicians, make therapy is patient. the right And all along the on offering with choice, based we the who if for it the

people syndrome therapies. Dravet place do we therapeutic do a move a have epilepsy you as in will that, And launch it. we pharmacy argument multiple believe FINTEPLA And and is use and poly when that

Danielle Brill

Got thanks it clarifying. for and

Stephen Farr

like add just Danielle I'd what said. to to Ashish just one thing

think was Dr. presented Farr in few I the by a reflected it we weeks ago. data

seeing are of a durability to very We FINTEPLA. impressive fact and

of the saw seizure analysis presented what control extension to seizure Dr. same really in open-label it we depend reduction, presented, up randomized data that in years long a study to trial. the and The we our compared time level period control that showed of over two Sullivan

data appears long-term. not from just that trials people the randomized-controlled So, happen of which to our durability are It's and the with. sort of it's impressed effect physicians over which the

Danielle Brill

Okay makes Thanks, sense. perfect That thanks. Stephen.

Stephen Farr

Danielle. you, Thank

Operator

Our Citi. next with question comes from Neena Bitritto

Neena Bitritto

first X in get the Thanks through of about, data taking Hi. kind currently expect syndrome. can my Study that question. of you've that who the of kind terms in included to are also going second for data set? My in patients that is patients who question cut drugs? of Dravet initial patients When And number data cited the from on number of XXX-patient in are are those we

then, get have drug? go through a drug, that launching And the post-approval in to on I order have you're the question to of kind about, some what just broader going to are of once is other stuffs a patient

And have office So to get in face-to-face setting? kind baseline kind of before versus will what a other take done can what steps will what echo, to they will else they through remotely but they have of they that have be to Thanks. go drug? can the understanding -- on

Stephen Farr

you to on -- back to using second we're I'll is that study you, your in then support well. to question a NDA for an your as application can come address an can Study study currently and Neena. I first Japan. remind X that of address blinded Ashish everyone Thank X, With question respect just

the control that portion right of We there's for other into least at in the robust are study currently trial Japan, opening no patients now, that sites trial. enrolling

So line occurring we X data top year. this Study in expect from the second of half

the two not study number. maybe the XXX, Does and the included States that XX or XX. excluding think Japanese and subjects Neena? with are actually but -- address so included part are the in just that are in XXX, the who patients question, which are party than patients from Europe, I Those of XX are were more United They

Neena Bitritto

Yes. That's great. Thank you.

Stephen Farr

you, to Over Great. Ashish.

Ashish Sagrolikar

Thanks, Steve.

them gene So, diagnosed identified now Neena, situation eligible choice, is have with in the they therapy have is Dravet are to, remote. are epileptologist. they that, the visits we terms therapy, starting induced for many consultation if patients of the those believe can seen what And All that of and on will it and who do all been COVID think by right say, being the to patients the right the and be if the let' either happen remotely. that

the echo, only standard And to a support they we place to our Once hub somewhere if all know can that a remotely. REMS our families do product, the where product, will REMS as all the we of part putting the like. shipment think that the caveat, through prescribe done, have need as I well and the is something that report don't to looks office go to program. and of what handled patient physically to the the physician is the is of provide that which goes be echo the

that steps the needed. steps even if question? to able -- the areas, able to not we that, we if Does that patient situation taking handle or able has there to in to is the be we So the feel confident of the go get the drug. patient are the your support are Because really other echo, that and stays if some will the other before answer

Neena Bitritto

you. Thank great. That’s Yes.

Stephen Farr

you, Thank Neena

Ashish Sagrolikar

you. Thank

Operator

Thank you.

Suneja Guggenheim. Our Yatin next with question comes from

Yatin Suneja

Thank taking my guys. you Hi, for question.

couple. a Just

some you Following the might doing for that been patients onboard that Danielle's you earlier while? be have on Have has market. your in order I given to a up drug? follow-ups. discontinued questions those to identify provide patients might market the make dialog the launch that you when Can on conversations on on drug been the have that do And sure you have some you color able

Stephen Farr

don't that? you why Ashish, answer Yes,

Ashish Sagrolikar

Yes, I it. will take

Sorry.

there as me know in debated speak, are cases products. knowing of tried So the do for not looking we clinical it are try who Epidiolex patients on may that and it physicians some trial, in is terms and patients, have have to let another worked they in them

do epileptologists will we So like that that. patients know the all have

on your and it's them product. they the sure we FINTEPLA. the towards So -- if we choose towards to getting they and know And them support will that Does about making available question? them for it, calling answer that use be them

Yatin Suneja

your available? long-term that setting XX% in in relative the to level the for the about drug recently stores? would of commercially any What we Dravet there compliance, I think And Or patient. data Dravet? think helpful. the in we should Yes. compliance you the terms That's presented real-world drug is an what expectation once be be the then showed how about saw of And difference compliance should in

Ashish Sagrolikar

I'll the will early answer access at and if the the And results, on the patients the is launch on launch. the know that based side. it beyond what are given if we program, therapy of worked translate and it stayed we product. is the the the but with hopeful has time Dravet And

at To looks that's point the I have So think long-term one to that the data in point this have I like. won't this data to that we I you, would we need do be on time. say, see in what which, be surrogate comment that time. best would at we And tell able

Yatin Suneja

received about you. from Any Thank that that Got talked feedback that? range it. past? Like, you receiving they on how And the the pricing have question are pricing is payers on just the in you have front. final the

Ashish Sagrolikar

access, talking FINTEPLA, earlier, be -- have And the rare the includes with continue rapid will speak, are payers has for about we these launch. of been said And as which far been the we have will the the launch. profound feedback outcomes, but also very pricing at received discussions patient time clinical profile so do the about also positive. of to as durable the conversations preparation population. our then launch, we we beyond of are the but continuing we the in we the also but So, the And

Yatin Suneja

Thank Great. you.

Stephen Farr

you, Yatin. Thank

Operator

And Belanger Company. & question from Serge our comes Needham with next

Serge Belanger

afternoon. good Hi,

ongoing of a regarding resumed interactions the an Previously provide label and in their questions that me. could you for FDA to approval REMS if discussions. Can late update you discussed review? FDA couple CMC step the and the And a inspections, whether June? has that the approval Just on be component

Stephen Farr

during Thanks the the Serge. We to don't XXth. PDUFA think going decision impact that the timing CMC is of

least a the is that in not know the news has is restrict to decided -- from the now. FDA But lieu the our of international virtual non-site perspective conduct inspection. traveling FDA from pre-approval inspections. you right They As inspection did at good

is PDUFA be supporting That certainly has the a Kingdom drug submitted and going to currently manufacturing documentation with to -- was in their XXth. And United for that review. the date So the inspected on it FDA consistent of is the June ongoing. timing

Serge Belanger

Great.

Second from could trial? see still Is that before Lennox-Gastaut it meeting? Epilepsy expected data additional about question then? X was when you Phase we a the December at in Or could see

Stephen Farr

We earlier, currently. doing full -- analysis as a we're mentioned we

the that year. Epilepsy American data So Society be we anticipate by of the would it's the that at end that likely

now nothing is use. best to assumption I think and So between the then

Serge Belanger

Okay. Thank you.

Stephen Farr

you. Thank

Operator

will be JMP And Jason next with Securities. Butler

Jason Butler

two. questions. Thanks Hi. for have I taking

your First, FDA have of you think you the the about think you dialogue U.S.? any comments can European of regulators, make how ECO versus with requirements in alignment you in where there terms with about frequency

secondly consider can patient here, patients? Thanks. positive to into give given basket for on any that target there reopening you sites the trial, or then you're population? the what terms of enrolling be they would further And of us any considering would And insights are need study changes the that in realignment before trial

Stephen Farr

Hi, the first and Jason, risk Yes, plan, just responding we're around discussions around the to in currently Europe. management EMA RMP that. the questions on

United I Europe. alignment what need provide is of can't in more have we to our in on between do that. need hope we clarity any with ensure to to good that we the States But, what do So course,

not have that we would enrolled and not it indeed or if that, patients On And felt sites, which were were activated the basket have and there study, pause and getting difficult. getting we got been we currently approval. decided even an up the other into run because did IRB to were we sites running on we trial, sites then

companies trying current get So many it just and back that this and wait like for up studies, situation running. is we appropriate clinical to this sites step just most initiate decided ease to go and in back at we juncture before to

something do the to words about, basket about the modifying some that with think and other prioritize thought of That have think internally. considering others. about to In question is design? we internally Your in study about we the syndromes

we right any We now, haven't have consider. that will certainly on decisions it's considered made and but something

Jason Butler

you. Thank Okay.

Stephen Farr

Thank you, Jason.

Operator

you. Thank

comes with next from Mizuho Our Yang Securities. question Difei

Difei Yang

Hi, good afternoon.

the how on reviewed? say, you maybe every long clarifying I recall that six one months. doing talked have can REMS. the further cardiograms normal cardiograms six earlier talked question you for every see -- many if once how then once I about about be Just normal, patient is is quick monitoring months

Stephen Farr

Yes.

think try I that a will at question to address with the approval. that's post FDA point certainly some we

relaxation -- program there and more echo having every be there's REMS the on collect in to information an before, will any a I months. think desire on the six

think So, a discuss rather than that at I to that's something we'll vary. later point

Going be launch, the where a it the into one and a requiring every thereafter. by months followed we said, REMS will baseline have I six -- echo as we

Difei Yang

you. Thank Okay.

Stephen Farr

Thank you.

Operator

Our [Operator Blair. next you. with Instructions] Lugo from Thank William Tim comes question

Lachlan Hanbury-Brown

Lachlan This is Tim. few I for for if question. had a Hi. on Thanks I may. taking

questions. Just first of of all the one failed for are building another? that? on how you have have many patients prior after moving a they or therapies what Do to Epidiolex discontinued sense reason And

does at the that dose in at that on day X.X it I XXXX of that per all differently? indications And the And And to suggest think seems range. finally, presentation development? current then another in meter recent Study after a of X.X sell the data, patients you? think and any another the to found one in percentage to you indications or about make -- development the to during lot current the surprising results Is

Stephen Farr

Yes. Thanks for your questions.

that a we patients All out really something, look very is the do just to a the which terms to clearly around extension that as difficult is we've In dose in have of other XXXX rate you there, milligrams per can it seen about experience on Epidiolex the ascertain. from I'm there sorry sort clinical at X.XX of finish kilogram. two and Actually is well. assess perhaps or failed I median and comment about finally is your make questions our addressing dose there.

This XX% XX% other titrated dose It working for above So, of our to optimum doesn't that. safety. other be words, that and in really dosing below appropriate epilepsies. assumptions will that around effect a any and change is

And think, is efficacy think is -- a it lower dosing very think does So compelling. good that other about the syndromes. at dose we very are fact the seeing I the in than not we which but we that way change dose, maximum

then good is syndrome, right in And investigator-initiated to actually that Thiele by Dr. study. respect more into very results now. generated study with subjects She enrolling Sunflower

that determination in make more we're on anxiously whether we point. we'll looking So, for do that then something a at and syndrome formal Sunflower

Lachlan Hanbury-Brown

Thanks.

Stephen Farr

you. Thank

Operator

you. Thank

Michael comes Ladenburg. Our next with from question Higgins

Michael Higgins

Hi taking One for guys. Ashish. Thanks for the questions.

the either proxy any business what you're outlook how less and development there? with watching last concerning in a launches changed your more here And as for any or aggressive changes months, witnessed you adjust accordingly? the field Ashish can COVID Steve aggressive given we that's few out -- how to

Stephen Farr

question the take maybe after could first Ashish And Mike you the you question. that. take development business

Ashish Sagrolikar

this situation, let Thanks When as proxy, clarify. that, Michael. get me in question. Thanks for I the it did you launch mean just And COVID right? you say a

Michael Higgins

launches similar to can you yours? that looking Any gauge you're Yes. at how adjust

Ashish Sagrolikar

quite is so Well, this are and basically unprecedented as our we situation Yes. globally even country. in

point we companies in doing credits. We the haven't for launch terms other preparing because stopped this are of at the in at what the if upgrading are looking time

of happening. in as is coming are So, we more in we watching approvals are what seeing terms closely

consulting the physicians that situation this to talking been eight the that they think we not are to and only is have based dry because run thing have is physician patients. forced understand for What education, go tools, the how very with are doing from doing for virtual And remote weeks, talking the caregivers tools patients they we a because I say where one and from including the. on of are and would we there adjusting the coming tools, and well-prepared can what kind telemedicine to during evolving using that and has of also we route, these also think education, are last to feel I tools and using is this the all of if caregiver I we but believe also

I on think when piggyback prepare and and can launch. And we receive for use that we we that approval

that the for question. Mike? are and Thanks So, we process said preparation looking that's that's the at. the we

Michael Smith

Ashish. Yes. Thanks Sure.

question. good a Mike So

upon horizon, industry near-term changes opportunities the the that them. of affect number landscape kind COVID-XX of mostly the in the think I in the put

a really is or take filling development We or licensed for to see business key the maybe the to partnering perspective most pipeline business independently it competition the for ability may from get asset the store because that opportunities opportunities has the developed not. forward opportunities side more other acquisition

kind the portfolio the ask they question group development number probably business typically on has. a exceeding that one That's that first focused the of competitor that's themselves and

very happy is good say in pretty And we that going any keeping active our are principally not way do would that materially ideas with the our then space. on. And in going disciplined U.S. got ability are to on we're to focused that I we launching to be programs anything about of we've portfolio focus

execute most look to be for So, our and of are are complementary doesn't always are your opportunities at up perspective we're product which -- on something again different because them looking day getting it that the base two stage keeping onsite situations. for right line. would if things on eye And that those there the assets at materially our are fill and and are at it that we're provided finish programs the company over look for we but really We to opportunities now all the the that operational are always current hit that capacity important good affect to on. really resources the

Michael Higgins

guys. Thanks it. Appreciate

Michael Smith

Michael. you, Thank

Operator

next with question Stifel. from comes our And Matteis Paul

Paul Matteis

Great. the follow-up. Real taking for Hey, quick. thank you

on in no restrictions any no patients anticipating Ashish's Dravet. comments for

Just reminding me of a question I had.

your patients think I the you at? to like an study I be an a finding expect thought regurgitation one on indicated was of that And in that IIIs. from trade would XX% that contour of excluded patients Would Phase exclusion something that echocardiogram. something criteria

Stephen Farr

We do not.

Paul Matteis

you. Great. Thank

Stephen Farr

an physiologic forth there's were And start a wanted indicated we we've as because or But for about as absence. Thank talked our study grades various absent. finding. of and and we trade as to clinical obviously regurgitation, with between the back we've of trace between a in lot before, where is essentially it oscillation just -- Paul And trial was looking deputation at you. we

absence. into trial echo enrollment In of had trace role that being before consideration through our formally upon in regurgitation initial or subjects was actually where subsequent trial several our the involved fact a we had

the do condition we from security patients therapy. should a FINTEPLA exclude not that know patient be So a to

Paul Matteis

so Thanks understood. much. Yes,

Stephen Farr

Thank you.

Operator

Farr conclude question-and-answer or And back additional I'll turn Dr. any for session. closing you. that to Stephen over Thank now conference remarks. does the the

Stephen Farr

we've to thank and this focused development and we share So you in on on us providing you past for also expanding made and to approval excited joining syndrome during thank you all therapeutic We're indications multiple the footprint in the in a our of for diseases. look quarter operator months. progress today's call. obviously to extremely taper coming provide pleased from as potential updates company in commercial to ahead as tenapanor to solutions rare I'm continue launch advancing

So, your thank you day. Goodbye. all again of enjoy rest And the for joining on call. today's us

Operator

for today's you. wonderful you conference. day. Thank your does Have conclude We a thank participation. do That

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