Xenon Pharmaceuticals (XENE) 1 Mar 232022 Q4 Earnings call transcript

Company Profile

Participants

Sherry Aulin	CFO
Ian Mortimer	President and CEO
Chris Kenney	CMO
Chris Von Seggern	CCO
Brian Abrahams	RBC Capital Markets
Tessa Romero	JPMorgan
Paul Choi	Goldman Sachs
Joseph Thome	TD Cowen
Andrew Tsai	Jefferies
Rudy Li	SVB Securities
Laura Chico	Wedbush
Rohit Bhasin	Needham & Company

Call transcript

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Q4 2022 Xenon Pharmaceuticals, Inc. Earnings Conference Call.

I would now like to turn the call over to Sherry Aulin, CFO. Please go ahead.

Sherry Aulin

Good afternoon. us quarter call financial and results. joining discuss webcast and for fourth Xenon's full you on and our to operating Thank year XXXX

me Dr. Chris Chief Seggern, Xenon's President Kenney, Joining Officer. Chief Von Mortimer, Commercial Dr. Xenon's and Officer; Chris and Officer; Medical Chief Ian are Executive Xenon's

a call additional a epilepsy of in progress December, address to Chris provide during and our X-TOLE company and financial Phase X released progress available I will overview will session events. an within our questions our pipeline. our summarize about Ian of milestone of with Von results, be Q&A open programs, across Seggern as our brief will our well data we commercialization as program, today's partnered our supporting will summary summary Chris Kenny XENXXXX anticipated strategies.

XENXXXX will trials, programs; be a make market, our safety milestones statements expectation have our XENXXXX potential and in in our of operations develop timing we interactions potential potential successfully trials; our that achieve our number forward-looking, other of we and and enrollment and the our regulatory other commercial during product the designs; the the to anticipated clinical results regulators; product of ability results and sufficient into our timing obtain Please fund thereof; to approval this and including ability call, XXXX. that regulatory partners' development our clinical timing candidates, with our plans, of and addressable are efficacy and and cash successfully develop future development of our the of clinical trial regarding that to will candidates; success, advised from profile, and statements efficacy,

and to numerous described of and filings. uncertainties including statements from risks the which are are many in time-to-time beyond SEC our control, our Forward-looking uncertainties, subject risks

from forward-looking on We those may today's update any undertake Our statement. to obligation projected publicly materially call. results differ no

year of Investors XXXX and with accompanying financial Form quarter www.xenon-pharma.com be the filed and at report on release website on will Xenon's summarizing full XX-K section annual the our results SEC SEDAR. under press Today's fourth the and and available made

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

Ian Mortimer

our Thanks thanks Sherry. us on Good everyone today. for call joining and afternoon

on of reflect reaching milestone Xenon extremely and events progress I'm significant proud our I of in a As XENXXXX XXXX, key our building momentum in number program. for

of elements particular, for end regulatory Phase FDA another by as of milestone an followed in trial. X well with our was XENXXXX QX critical with key gained Phase In X alignment and had a first X required program NDA This we meeting the XENXXXX on epilepsy initiation as successful the submission. Phase our

including Furthermore, XENXXXX, clinical continued the the throughout only our potassium from for on presented the is confidence X-TOLE X-TOLE if a mechanism approved. a we extension, modulator would of action believe compelling channel market we novel data XENXXXX in what profile open-label in additional supporting available we from what believe and XXXX, be

supporting in early reduction endpoints Phase data efficacy Efficacy for Xb in our doses believe medicines onset currently to-date with tested. compares even to titration, Overall, statistically at at freedom. requiring and available dosing seizure efficacy trial, in QD demonstrated the patients. seizure seizure one we extension epilepsy week of periods XENXXXX greater favorably greater open-label focal all all onset, reduction our statistically significant data generated reduction no which and significant X-TOLE

with differentiated the that committed lives upon to strongly are seeking new improve existing research we options patients prescribing that epilepsy. therapeutic antiseizure of improving remain medications and market Our the suggests physicians

existing our to and enviable Phase clinical position an in resources in with field, the XXXX development required ambitious on supported clear plans. enter leadership cash and our program X XENXXXX broad in execute KV by We a

in major clinical trial, in depressive sharply in generating X-NOVA we X trials EXACT or evaluating data disorder. parallel, Phase clinical efficacy X-TOLEX Phase our the seizures well advancing our important generalized in tonic-clonic seizures, and PGTCS X-TOLEX X while primary our in are XENXXXX study Phase as XENXXXX X as of onset focused on year, in This focal from

Later the data of in to AES highly in will of today, Chris XXXX outline profile. Kenny the our that call belief some the support at product we promising highlights in presented XENXXXX's December continue

have in and other studies the faced about focal recently sponsors We enrollment onset including headwinds company of received epilepsy. patient ongoing trials, some slower-than-anticipated questions clinical other by

development clinical remain on Although we execute in acknowledge confident we ability XENXXXX environment the challenging, our current Phase to that our can program. be for still X

Phase FOS on studies, X-TOLE with Xb This experience high study, and our along confidence is familiarity have to our similar based XENXXXX. our of with whom key was with size many continued are with investigators, experience which our in already level of X Phase relationships

are enrollment our not that we timing the initial still have given stages guidance on or X Phase Given topline specific we in of yet data. trials, of

expected as development However, with in site our and terms screening, and we patient of plan. are consistent tracking initiation

investigator-led ongoing recall X-NOVA Phase Mount trial, to that you at study our in an depressive Turning this in will MDD X parallel Sinai. conducted X being XENXXXX collaborators examining Phase our is with study briefly disorder, clinical major by

as Our MDD XENXXXX and antodonia, as evaluated a well in promising with treatment XENXXXX. clinical examine be was to data ezogabine at XXX-milligram based published a decision TID as for encouraging on results preclinical dose MDD

population. is It a important the depression common within that patient epilepsy co-morbidity is note to also

We quarter topline XENXXXX this results for guide X-NOVA future MDD. our study of help third our will the this are in plans and anticipating from year in

XENXXXX generated look forward of in the proud team in in made clinical build XXXX. am I our our While XXXX, by to additional inflection determined points we to great progress and are upon we to program the momentum continue

comments Chris and XENXXXX more additional generated. ask epilepsy provide data we X now you. over program on have Phase to our I'll detailed some supportive to that Chris,

Chris Kenney

or I'll in in data Phase briefly Society XENXXXX some trials and AES Epilepsy at our review clinical Thanks presented the American Okay. lot, that highlight for of Ian. plans a X Today, epilepsy December. our the was

randomized study we expect will will X-TOLEX parallel or dosing an which X:X:X now to XXX or Our milligrams once daily identical be either X-TOLEX, the approximately which in initiate with will studies of these underway, Each is XX placebo. of study, XX patients with near-term. XENXXXX called run in of who enroll

Our studies X endpoint the as X-TOLE as the eight-week PK/PD baseline period we double-blind the Phase median with and in was change XENXXXX is The the selection MPC data well from placebo. by completed informed by for through to efficacy frequency modeling XX-week safety compared efficacy or seizure dose year. primary an percent and monthly last

indication, model, our Phase primary either milligrams support another enroll To data clinical our tonic-clonic also X-TOLE the primary we Using have of of to our we've both be initiated than endpoint doses. to power EXACT pursue epilepsy randomized for support XX% or greater will XXX placebo. a with dosing approximately XX will PGTCS. which X Subjects subjects once-daily with generalized trial seizures of XENXXXX or X:X plans

MPC tonic-clonic eight-week endpoint seizure an frequency and XX-week efficacy to the compared monthly from primary XENXXXX is primary double-blind the baseline of placebo. period generalized The to

We're to XENXXXX study activity types, parallel focused bilateral seizures. excited trials all focal generalized by PGTCS our that to seizure including progress on focal focal broad Xb trial, onset across with in opportunity the seizures XENXXXX In patients with X-TOLE Phase demonstrated in seizures. clinical our

approach generalized broader use stage lead be at to path unique tonic-clonic that XENXXXX XENXXXX approved. development is focal and may clinical this of should and of to both seizures believe to this We onset parallel seizures primary potentially

efficacy open-label ongoing as physicians in data, therapeutic an onset American X-TOLE many of the Society data body extension interim supportive at additional with XENXXXX connected with team presented that the where meeting in the Epilepsy effective evidence seizures. to-date key onset we of and opinion associated as dose. additional for the the from well starting XENXXXX clinic, X-TOLE of leaders gathered and suggest for including growing well-tolerated was These advancing data the rapid at Our sub-analysis focal

a compared dose-dependent one for in seizure significant focal median focal statistically from reduction was frequency. onset median in frequency a onset -- seizure with median There baseline focal doses placebo reduction all weekly week within with

and Analysis of yielding with XX-milligram of efficacy periods experiencing be the at daily freedom. open-label the long-term open-label extension shows to reduction once extended XENXXXX interim the seizure well-tolerated data seizure generally continued dose during patients extension continues

open-label double-blind using and by a extension, monthly XX% frequency to to baseline at in of XX sustained a the the XXXX. data cutoff During MPC XX% XX seizure measured as September there from period was reduction months

than XX.X% of and greater to for months equal freedom XX XX.X% six respectively. than to equal months and greater or and Seizure patients, was achieved durations consecutive

Importantly, prior with to open-label in be the results and well-tolerated consistent XENXXXX medications. continues adverse generally extension events antiseizure other with

study of occurred two the drug, and urinary possibly To-date, adverse any without the continued to requiring related patients study both in events open-label intervention. extension, in retention

we seen for to-date, to tissue with long-term continue the that associated Although of discoloration the emergence monitor exposure to ezogabine. was not

the has medications, antiseizure driven of about with the that patients significant are hear XENXXXX improve potential belief the for to by continue to We living epilepsy. and lives our we significantly need

to program over us Sherry, call Sherry? results will a partnered brief before and our XXXX with the Neurocrine financial turn summarizing who update milestones. upcoming give XXXX now on I'll our

Sherry Aulin

onset with evaluating is adult are Within NBI-XXXXXX X with from forward Great. in pediatric partnered Thanks in Chris. the study use readout We're of another year. there second the currently and the epilepsy. trials data excited two is adult One study about its separate clinical Neurocrine, study seizures underway. progress and Neurocrine's our half Phase focal patients examining in with anticipated this to look program focal patients SCNXA related

The result XX-K would report refer public financial of $XXX.X you as I'll further December details. XX, for cash touch million primarily and Cash as of on and offering June December to last our some in our of equivalents XXXX. were compared the the marketable highlights release and XXXX year. and news XX, $XXX.X was million from securities to increase statements

XXXX. operations, epilepsy position us Phase Our fiscal the allows studies fund XENXXXX our management completion by prudent supported including strong of cash into X to

in summarize Before EXACT concluding events our trials X With our and we clinical I'll expect prepared to near-term. remarks, initiate important the ahead. X-TOLEX X-TOLEX briefly Phase milestone underway, some

parallel, in ongoing, in this expect to trial the of we're topline X-NOVA at Mount third Our year, have study MDD in quarter an results Sinai. and while investigator-led is supporting we

our study half their onset have seizures. data second readout focal In a from in patients adult X the year, Neurocrine collaborators expect with at to this of Phase

We Phase in trial continue EPIC with in XXXX. our pediatric KCNQX-DEE clinical patients completion X study anticipated to with advance

forward XXXX. grateful we're I'm need. to neurology closing, to about through are success look reporting In deliver who and to-date our mission new employees progress in to committed therapeutics patients to excited all our to our Xenon's

for ask open line I'll the the We operator questions. Operator? now any to

Operator

your floor [Operator The for open Instructions] is questions. now

Matteis proceed. Our first line the Please comes Stifel. of from question Paul from

Unidentified Analyst

is Paul. our James for taking for Thanks this Hi, question. on

possible? to will it? initiation previously the facing for focal mentioned, Thanks. how relates you're speak still you two a others guided Xb, it as you that Just guess as which half based recruitment years about possibility from are data trial epilepsy on if the challenges, to and coming space, put the some in of around completion thinking data is you mid-XXXX. I Phase sooner, around Can the

Ian Mortimer

James. Thanks

as we we So, prepared the on for haven't the we expect formal and X data -- I Phase remarks, topline when haven't specifically mentioned clinical for trial. X-TOLEX guidance given in

The two was a and study, approximately data Xb to often little bit you're we we smaller, X-TOLEX talk XXX that When a topline subjects. half and initiation referring to the is the study, to study contrast the data. about Phase the from compare took that study X-TOLE that point years X-TOLE

As his XX-week similar. Other eight-week XXX Phase remarks, that, Phase an are protocols a in in studies double-blind and the Phase mentioned Chris X. are double-blind very X in period the it's than versus X period

have same talked prioritizing about and the X-TOLEX investigators, many of the the those with of in to the program. investigators experience to we're drug And X a that we're you we've As same from sites trial. sites going Phase clinical lot

we'd a Phase on I executing program we together, earlier, we mentioned when data. But X a can I position we confident put we where all timeline the need so quarters the feel in in of belt to under think specific before our on Phase get couple to program. of X more and guidance enrollment topline And provide that as really be

Unidentified Analyst

sense. Makes Thanks.

Operator

next Our Capital of line Please question comes Markets. proceed. RBC Brian Abrahams from from the

Brian Abrahams

or you're thoughts there's And MDD? under for to timing a the label our taking XX latest like I'm latest the on curious, to thoughts you're other Thanks. the there? might looking in your so I if if expansion pursuing program. generalized Hi pediatric look your areas in guess, How -- for that addition further important particular, is? pursue And there. what much on of any potential and drug, that question. XXXX Thanks

Ian Mortimer

then plans. and maybe Chris, pediatric Brian. high-level specifically some of give Thanks on I'll a comments few jump the in

X going seizures study Brian, we've major disorder. focal in and X broad Phase you So, mentioned, as depressive got obviously, a Phase primary on program a in and generalized epilepsy tonic-clonic

to but literature why epilepsy is broadly best validated would there applicable still broadly, more the areas, and we depression mechanism and may that think suggest I we the when think there. I are say other channel be to potassium started therapeutic that's

future, as therapeutic where would areas. priority go focused really right now. other the generate additional epilepsy and the may In into and data, on I we on we depression we're is But say

Phase can a we both in through to extrapolation rule kind obligations do we're younger you X Chris program, do into get As generalized the we and epilepsy and in pediatric of both in have and focal seizures indications. walk how tonic-clonic primary of patients those work,

Chris Kenney

Sure. Thanks Sure. Ian.

done I fairly onset not So, on level sort ambitious right? program, series, seizures seizures and doing mean high just that. of of I already think parallel. our I -- typically, kind generalized primary is in I we're usually focal doing we're tonic-clonic embarking in before do already mean

we on the plus have then MDD. And also concept that. doing in of we're going proof So,

I activity amount there's, say, an would than already. more of So, average

you specific the the and US require pediatric the attention regulators will point, in Ian's population. to in Europe To

And it in ongoing. gets that -- approved fairly population work the population. XENXXXX adult so regulated those wouldn't the because of to pediatric in we reason strong conversations There's have and think no It's interest. are a

plans to adhering and So, guidance. regulatory of well sort are all those underway

Ian Mortimer

a Brian, generalized focal seizure, to commercial little lastly, Von And and give relates Seggern epilepsy Chris maybe primary as least of at tonic-clonic just perspective can it opportunity. bit the

development. be with the populations mentioned, there are and then As diagnosed epilepsy with generalized moving Chris and focal younger. that agreed be into regulators, we'll patients we are younger upon adolescents much move as ahead with the we'll as into seizures, moving But

can Chris of comment So, dynamics. commercial about the some

Chris Von Seggern

absolutely. Yes,

or XXX,XXX when think categories There same epilepsy have both the with patients US. start about epilepsy pediatric you to durable the So always you total into to that in seizures seizures. with going that's adults about million opportunity, the focal X XXX,XXX are generalized fall

XENXXXX from our is being value populations attributes as believe the pediatric population. compelling are to the market same those as with apply favorably. research that in attributes they And we the very are associated viewed adults we've heard What just actually pediatric in

about we're opportunity when with So, tonic-clonic seizures onset as into to very patients move the appropriate. as both those that excited well the primary product focal generalized opportunity in

Brian Abrahams

again. Thanks helpful. Very

Operator

from comes JPMorgan. question line next Our from the proceed. Romero of Please Tessa

Tessa Romero

Yes, afternoon thanks good team, for much taking our questions. and so

in So, one third from we're the Phase X-NOVA expecting the X quarter. on us here data that

Are Or really about more thinking you so decision? no-go that end are the So, the no-go just about the endpoints there your -- how hitting is stat think Thanks sig should decision with go on specific important is you to respect primary totality this to we a or And point or of important of be here? the how data MADRS? that gather much. here?

Ian Mortimer

Thanks Tessa.

a disorder the just because an moving similar now. but it's language believe used that doing we major the data important think totality question I think we're I of not the right multifactorial, analysis and that we've of work lot depressive into of is

data more primary we're endpoint in part MADRS to generate running both on doing the the as But commercial about study as So, think important the we the also input as to opportunity of and registration clinical epilepsy decision-making. do work, depression. even to we're obviously, work X-NOVA the

We think about XX% co-morbidity have We population. depression. XX% a co-morbid know epilepsy of to the the lot lifetime that of patients

generating to And important an through epilepsy XXXX continue drug. really about also as data we X-NOVA as think be so could

about different we data part And inputs. to of year. the that when in being of unblind lots I as number been QX next and steps like think that there's about So, clear ways of we entire think there's a this this just of we've analysis think we'd data the

Tessa Romero

kind and those just lay out I of be you are a picture the bigger Xenon? And mean, what what following would scenarios of as quick Thanks depression for us kind key X-NOVA follow-up. for Ian. for might

Ian Mortimer

Yes. Sure.

the we I MDD. support development the think may of big primary in that I of in it. the a the couple mean additional one do scenarios where is data indication I there's of think take we work terms and

And development steps of primary additional this depression. clinical be so in then indication the would the next after

in is be talked properties Another show differentiating that prepared are clearly think important option, number from in that spoke there's as to a epilepsy remarks, This of an I ability had one if another about I the about, XXXX on ASMs. information could the we space. differentiation of mood. generating we're other we

prescriber the So, as in we population, important. think about epilepsy, that in the could be

do and those right and and And one investors then last we organization through ion the moving some a CNS, to about molecules have deep drug that obviously, preclinical the different other have that different in have studies and chemistries we properties drug is than that spoken experience XXXX are now. target have KV as discovery and channels

we to distinct bit to and moving differentiate about is the chemistries Brian earlier maybe opportunity number we a how as of we're also I forward. think we going the a so have have to from want therapeutically And think little to question may differentiate

Tessa Romero

Great. our Thanks taking so much for question.

Operator

from comes question of the Please Goldman Sachs. from Paul next Our proceed. Choi line

Your line sir. open, is

Paul Choi

My for Good our maybe the data the X-TOLE us with afternoon market the given of feedback the to first potential is, And sort question regard market team thoughts updated clinician can potential update you. for and thanks any any question. follow-up extension XXXX? longer Thank taking on you -- there? on

your bar, this XXXX versus the program into your much. to And in look second of opt I Thank is to you Neurocrine's partner would is then year, second that additional my potentially half development? question the readout very guess, perspective, you allocating from in for pending that resources what

Ian Mortimer

had open-label at We question I'll Maybe of clinician Kenny, if know just lot about to over meetings XX I we want And you and had Paul. data. Von Chris on importance just take hearing obviously, AES. then, feedback. talk some continuing second Thanks a view, long-term talk point interaction. your one-on-one Great. Neurocrine market the from the of to the of and community from then of us just over about feedback Seggern extension, five a Chris on years. data generate you're can you the

specifically on Neurocrine. Paul, But

running understands will Neurocrine is that So, Paul year. is to read is everyone What and we a focal that make to, just it's agreement. study referring Phase that epilepsy have milestone royalty licensing out later X this -- a sure

we successful. and a licensed as of in invented a selective after we program that then we and This that and Neurocrine to X. is XXXX receive is NAVX.X inhibitor milestones So, royalties Phase drug,

the in Phase opt the points program can an have tier to percentage Phase for five royalties the in increase at we where each We ability X program, co-fund for X to royalty. the of

Paul, think I going your so data And the so they're that to running to to smaller question, answer they're like, we'd directly generating. that other plan It's see what the or go X Phase any there's do. if they're we've like Phase they'd like to that see obviously, a looks development if and future X study got work a to

have full the to we including for But visibility the Phase and clinical of on X Phase all X. data have that opportunity generated, plans they've budget the the

that so whether on do And and calculus have into a not. information all the in take that decision a we'd or we as opt inputs to making of would

Chris Kenny, over to data? you on the OLE [ph]

Chris Kenney

of a seeing would related the after Yes, been in sure. are for year and who keeping in mean on that XX% in the the I Ian. still pretty really we're in was greater MPC In response prepared remarks. Thanks, data. nice data the seizure that the open-label freedom I than order the has substantial subjects reduction open-label, say with

fair with fairly doing et we investigator seeing individual enthusiasm we're that, getting the that we're is as perspective. and So, at MPC a population compelling an with amount committees, patients an seizure physicians overall boards, how there's the meetings and steering is either are ad of consistent for then freedom medical which the feedback conferences, a both cetera, from or that interact on level numbers about are those that

going So, it's yes, there's no -- well. there's --

Chris Von Seggern

difficult it difficult just patient enrolled What that X-TOLE. I the extend have standpoint to population a to to still treat control. this research very commercial was And market very different from very into can to in they're add reminder, and treat that perspective you is a and those the the was difficult as patients open-label, as consider

research as time light population. rates we point data the quite at that from the are What patient seizure either actually is freedom hear compelling point time our the in six-month XX-month measured or of the of

well that this efficacy, exist titration, of the as reinforces And attributes rapidity potent the the with lack other onset. XENXXXX, the only value both of as

what data that a from reinforced the we're standpoint, had market from So, hearing as value Chris research just proposition, mentioned. open-label just

Paul Choi

taking Great. Thanks our for questions.

Operator

Joseph Our Please Thome next question Cowen. proceed. from comes from the of TD line

Joseph Thome

and to bit. some the know Good the increased question. seeing potentially changes thank use taking mentioned continuing landscape that And I you as in Maybe increased for X-TOLEX. Hi we're of the penetration a we're historically, [Indiscernible] there. first afternoon obviously, you one, our little field of generic see

maybe this on making So, adjustments how can any a Phase of saw you population program and comment change might pivotal in what you're you the little the based bit X versus baseline the that? if on

KOL, And on were and bit urinary just a randomized in effects to I'm open-label, seems tricky portion this the then retention be sometimes. talking to side little characterize the second, AEs these to retention urinary and the really

any be Thank you. So, helpful. around that thoughts would

Ian Mortimer

Great. extension, get I then in seeing the don't we're data drug can and is a more on details what because the least why add few Thank Phase you. a at then I patient on urinary been into on they've and with little population the open-label specifically, lot and those X we longer. bit in maybe relevant start just patients two a which retention think Maybe

that were actually, the they Phase published And of look list. we we we've it population, it's a see long Ascent published medicines study. the if tables data, patient on we about X a Phase had Neurotherapeutic that conference ago really the on published anti-seizure these and where So, you'll either failed at X this year patients at or initially

of study. types don't coming I are our of patients kind of So, these standard-of-care into any think that there's

variety Phase of to into they prior be variety And similar will in on study. would drugs X study, so have a we that coming failed there'll the a I coming see that patients wide think wide and will into be

know and if BRIVIACT don't to any around I you if you XCOPRI urinary have comments? specific Chris, the then or want to comments move retention But

Chris Kenney

referencing Seggern I or Von Chris XCOPRI are You assume? for BRIVIACT the

Ian Mortimer

-- was it no, No, to Chris, I Kenny. was you, no, I passing

Chris Kenney

Okay.

Sorry, I Yes. misunderstood.

So, X, as change Phase the cause it's I a to the of predicting mean, whether as X. like far early in that's with I mean, sort going Phase days

think say. it our we would XCOPRI too it's or but be So if early X wouldn't just way in be I to -- the one another. say of we uptick X haven't able there's to Phase time have surprised I don't to program in somewhat -- be Phase program, an relative put in enough to

As seems two were that of I pointing retention, far as mentioned fact there were a a to you the it open-label. kind urinary the misnomer. of the patients the you bit in like think that And

were catheterization. have obviously, then right, required to procedure. issue if And extent it have to catheterization would complete none any or that some fixed, retention, kind So, the someone of these urinary permanent be that patients with to had of

that's complete So, it But not it's Phase retention. X. urinary was obviously how in coded

X So, this we -- that for is approaching that instead, or X, Phase to urinary get to it X site brought going bottom did Phase is sponsor in not? Phase up. have that urinary actively cetera? -- et the this very something we're really more in well closely you way if very into we systematic feedback between this like than reason forward going the there's of hesitancy of Is we yes, to retention -- there's an event have we're very adverse so reported, immediate kind Now, a a systematic be following

Ian Mortimer

about And that Obviously, comment, two those and just to mean, retention to ago, in talked with double we done were urinary those coding blind the of and patients we we some patients the two in to cuts haven't open-label, then Chris' different we've data. that I seen additional retention, coded patients add quite saw two urinary time any open-label. patients in to the had when additional

point, Chris' of none reemphasize needed whatsoever. these any to just patients And have intervention

in sense definitely able -- it's we all. at have avoid that think symptoms, retention not it's So, of some the if being definitely even not urinary they to not

Joseph Thome

Perfect. very you much. Thank

Ian Mortimer

Yes.

Operator

America. Our from next Please question the comes [Indiscernible] of of from line Bank proceed.

Unknown Analyst

Good taking is and this for our for question. this afternoon. progress on Jason. the Dina [ph] you quarter on Hi, guys Congrats thank

question So, is our first on XENXXXXIP.

investors to later Can patented food polymorph of may which claims skepticism extent Some explain over need labeling. food have And with effect covering you you XXXX expressed expiring XX intertwine secondarily, the generics effect. patent will patents method desired think to in XXXX polymorph? to product enhancing why the copy

second then ability to -- out Biohaven's seeing the Biohaven's changed you. any of at X data doubt on all thoughts Does on after presented? our And safety AEs? have question is competitiveness the your Biohaven KVX data on cast the Phase dialing GABA-related differentiate Thank

Ian Mortimer

Thanks Dina. around last question, KV. competitiveness Sherry to happy the IP your commentary will and some then in tackle provide I'm the on question

Sherry Aulin

Dina. Thanks Sure.

way background, by just maybe So everybody to call. just of let know on the

So, XXXX. yes, we had two important patents that late were issued in granted to us or

is you first referenced our polymorph The patent. one that

polymorphs that XXXX. of and were successfully patent expires XENXXXX, novel in So, discovered patented, several which we

entrant essentially doesn't a trace successful. novel to be to have So, any our of generic new polymorphs discover patented importantly, have that a there would polymorph

to multifold the when which important in patent point drug there, second AUC that effect, -- food that the has the is with taken addition, food. referenced. the XXXX there's increase and a late granted In us or was XXXX you And issued is is Cmax in

So, a there's food positive effect.

And important that FDA. will of pending be be the been dosing that's to will that, with that and studies on that within an safe XXXX be dosing for label part clinical food, is both that, is label expect has with do the food, taken drug have our do Obviously, expect we the been or we label. with drug and negotiations within given the But and we included taken that the effective.

think expires in of both maybe for would strategy. XXXX. work around to mention a feel reason, important food the that's And I'll point. And just in So, And a patent need generic entrant confident those patents. IP our very I we effect that lastly, really

Ian Mortimer

Thanks competitive Sherry. question And space. the just on then your

a So, number mean study. clear we're competitive our increasing our space of we Phase not in of the I position. have it's times, up Xb surprised just think and given leadership that a I mentioned as in strength the X-TOLE we've is data heating

molecule pharmacology, we this properties we known think have also are but that that clinically a drug from Obviously, is any I seen yet. well that haven't other and has extremely performing

been hasn't the there any So, efficacy any generated with competitive of molecules.

very from we I a think position and time leadership perspective, So, just comfortable. feel a

very comment dose-dependent adverse of have questions And that these we and in and for X fatigue, we being events the adverse some CNS, drugs CNS events, developed somnolence, types just adverse data see medicine another dizziness, do with think all Phase Maybe that's that these get is that headache. molecules. antiseizure events and around like in active about we that active has things every has of activity drugs are the CNS-related the as

fully that's expected. So,

we drugs And then CNS, you see at higher flupirtine, and and mechanism the see as specifically dependence that. dizziness. when you look drugs when KV ezogabine in see these dose push the in we And adverse like XXXX, the associated events with we significant look at activity

are data have obviously, data about of best-in-category be evaluating we as efficacy efficacy patient when and believe for things the think those some else competitive And obviously, we would So, nobody this that that molecule. that molecules we're has to-date. we we generated treated, efficacy population then the looking for we've the potentially

Chris Kenney

This is Chris.

penetrating We for I to add experiments, doubt CNS. it's the about quickly we're with have know Preclinical system. no nervous that the definitely mean penetration we that. there's XENXXXX confident clinical sure, is right? to one central thing of Just that, data. There's

Ian Mortimer

Thanks Chris.

Unidentified Analyst

you. Thank Great.

Operator

of line the Tsai from proceed. Jefferies. comes question Andrew next Please from Our

Andrew Tsai

progress. afternoon. Thanks. on the Good Congrats Thanks.

primary have data because wanted the good see have on I endpoint. we to you on program more in understanding QX. MDD ask what generally want We of a to the So,

in earlier. You the shared I you're did about But time. terms about of some ask curve kinetics it efficacy thinking to want over how about details

my epilepsy. or two, could a you've effect the epilepsy, you within rapid-acting mean do it in believe instance, show don't depression has one shown seen to drug question think what weeks is, has in epilepsy. I XXXX ezogabine for similar I or shown but in

So, Thanks. thought for I'd ask I compression.

Ian Mortimer

Chris to Thanks then Kenny Andrew. happy please and Yes, I'm start in. add

efficacy and -- stat seizure at XXXX mean, think -- kind summarizing week onset I in early Andrew, job, a what We nice of terms know that actually of So, did yes, one. sig in to you we reduction epilepsy has I what really we know. you

CNS depression. getting impact seizures don't are early yet we Obviously, do in in with epilepsy we target to in treatment titration have that no and that an So, very we into an have enough to information drug know population. the on

we and When generated clinical at with the from they early the - Sinai start data publication did cost Group the is the data ezogabine to-date and clinical placebo-controlled look see on. Mount separation to is this [Indiscernible]

between as and So, separated there's placebo obviously, separation look MADRS time. the those active in definite curves over more at we and

We looking be at will that.

look will we we but have of endpoint, six have throughout all of week data to a do we -- at all six. week it's weeks -- will weekly MADRS So, up the

when unblind be data we'll those are and directly Andrew, data any able answer able be see So, question more curves, comments? least available. when Chris, the we at your to to additional

Chris Kenney

I on. think with it early was a bit pronounced but you MDD later it. ezogabine covered the certainly separation There on, little of was more

into that translate will seeing information what weeks whether we're So, epilepsy at one to be it in at certainly two. depression. looking We're and remains seen

Andrew Tsai

Very good.

a you're second the you an of to question so follow-up terms extent in ongoing would to open-ended the -- willing study. and it's can be -- the only of execution share more of operational And is

can you the can instance, of quality share, goes you to what of kind and forth. the extent so into Again, of for ensuring the quality discuss sites, the patients

instance, high safer distribution seeing sites? [ph]? or you failure you of across patients balanced rates are Are intervs even your a Thanks. screen maybe using For

Ian Mortimer

safer through do all study? of that the and were to things -- and Chris, the want added sites go kind and to we've you CRO

Chris Kenney

the I sure. just want MDD, I just to want to to to be epilepsy, correct? pertaining not question be clear,

Andrew Tsai

MDD, for yes. Correct,

Chris Kenney

Yes.

best that is So, in the to to trial quality several to I fold. try that the extent can key mean we the maintain steps

there's You evaluation, using we're an group we're enrolling so the mentioned external that patients. one, safer that appropriate ensuring

anything We limited number sites keeping and data general, then that the in Trying are on the to based to be keep huge there at that in sites that eye the more of have we're and in the that to a number real-time US an of those sites. data reliable. contributes isn't variability so unexpected to the the that quality there ensure it tends and solely the ongoing isn't sites data of

excelling. Do would I sort there point Ian? lagging It's expect. with one distribution typical kind clinical sites are studies, mean, are think about think that add and are that of I I you that, all others that want performance, anything recruitment some To in a as to to your of

Ian Mortimer

just only epilepsy than The We the you in we studies rate. other studies. that's rate ask higher, screen is failure thing, screen failure about Andrew, see a see depression in obviously, the

Andrew Tsai

Very helpful. Thank you, guys.

Chris Kenney

we with rate want we wouldn't have too we expected keeping for, to right, that And very a and low. that's in don't -- screen failure Yes. hoped what much

Ian Mortimer

Chris. thanks Yes,

Operator

SVB proceed. Our Please Goodman of next question Securities. from line from the comes Marc

Rudy Li

Thanks Rudy Marc. on the It's for for taking question. my line

question focal about have I So, seizures. market would dynamics onset a the for

your specifically, color provide regarding uptake of So, what been drug both on recently you've and the hearing or Thanks. XXXX? XCOPRI the can versus feedback profile more thoughts you

Ian Mortimer

Seggern. Thanks Rudy. Over you, Chris to Von

Chris Von Seggern

absolutely. Yes,

done profile they're So, I this uptake from into in growth in most efficacy continued marketplace. market a of quite And with marketplace and recent would from seeing expected is that observation a is dynamic, to the level say that obviously the space. XCOPRI standpoint, well. launch is offering they've some an the

this What we place the to clinical XCOPRI. that there tends period. for practice. is a is line fact research And have in titration our based hear and a agent current difficult be for profile, a does it from that on And lengthy the latter it quite is

the that positioning for being in result, we've a pulled as primary particularly adoption for. And heard first-branded and mix some for that's does earlier agent where that XENXXXX limit the

paradigm. data on treatment But for product area that the the marketplace. drawback where some primary and the in hang They we product. seizure do leader see freedom their again, offer That's have well-received been meaningful of in level placing they the the hat efficacy,

titration, XXXX for both earlier efficacy six-month before, onset, use from and we product be of research the lengthy the that requires which simply What as rapidity attributes with hear our of a is seen other can't well as use and the the treatment paradigm. the mentioned freedom seizure data reinforce data. XX-month a in That XXXX with compelling open-label as seeing we're experience and pushes with associated

to And hearing from medicine. as of one for was what And generic as first to often, positioning you primary the two the really you that prior product exclusivity, hearing the well its that's impact have for compared we're XENXXXX. profile of what failures which or between it's for pull we're after loss XCOPRI in distinction really

Rudy Li

it. Got Very helpful.

Operator

line comes Laura question Wedbush. from Please the of Chico proceed. next Our from

Laura Chico

and much good very thanks afternoon. Hey

quick two ones Just for me.

XENXXXX? know First, into X-TOLEX and a on submission X-TOLEX, can you this does remind be on us is how I the regulatory and for rationale submission X-TOLEX. actually the to package But fit going data X-TOLE focused for study here

Sherry And trial on XXXX, clinical quite then for into question expense just year. operating trajectory one a load this heavy

So, cadence spend much should guys. Thanks the of how we think Any XXXX? expansion? versus very about further headcount

Ian Mortimer

or a just X-TOLEXX, X-TOLEX to us want point of on? Laura, you clarification, comment do

Laura Chico

X-TOLEX?

Ian Mortimer

Okay. Yes.

aligned make take nomenclature. So, all quick a on sure just maybe we're I'll and the back step

So, our seizures our completed, we've we we've primary onset X-TOLEX, got And trials X is call of which clinical are seizure. very the study generalized in Phase focal to and similar Phase X-TOLE, study. our identical study, that EXACT those or X-TOLEX X-TOLE design tonic-clonic two the X the then and

the is X-TOLEX X-TOLEX. program. about Phase for asking extension open-label you're X Laura, So

starting X-TOLEX. can double-blind milligrams, the period open-label call complete that or go patients So, we XX all into at that's extension X-TOLEX, what and EXACT X-TOLEX, for

important we've So, path X-TOLE X-TOLEX. as is that what believe we the the database And data, part US will in critical the filing already generate the all and filing. mentioned, we then to of of and open-label data that for regulatory generated that from is including in X-TOLEX a data as data safety be the you the X-TOLEX,

Chris Kenney

-- I sorry. Can

Ian Mortimer

ahead, pass go we'll Sherry. Chris, yes, then to and Yes,

Chris Kenney

I purely comfortable drug. study the in Well, that's from upon them doing really well. regulatory I -- patients important. obviously perspective, wanted these they're X-TOLE And based which didn't we to from But extension the open-label mean, is just removing feel

the The X regulatory was The extremely Xb right? development Phase other Go study, thing this XENXXXX for I'll efficient, quick. Phase add program very is to more question. from back to kind of

And making so of there's of ICH adhere unique terms as have order to a bit a work that, little enough done we to exposures result that to guidelines. in be of sure in

of the very think thing thought think, up, was be regulatory is I the there I a but would the So, on recruitment we it major be-- And recruitment, to issue do. then touch first right that, rates. brought would top to question there, was point, of That in about a just

Laura Chico

I-- Chris can

Chris Kenney

Go ahead.

Laura Chico

guess also was to be -- I an complete file ask, I to does extension? does open-label not going to basically X-TOLEX need

Chris Kenney

Absolutely not.

Laura Chico

Okay. That's--

Chris Kenney

gating for time. that X-TOLEX point is in

Laura Chico

Got Thank you. it.

Sherry Aulin

question touch OpEx about XXXX. Laura, for to And on just your

going in overall but So, relative I XXXX an OpEx increase see as color specific happy to you in guidance, spend. know, to some give we I'm don't we're directionally obviously, provide mean, to XXXX

by the continues period the extension studies open-label to extension underway the also And that's in start on and X as well XXXX is Phase well with going that the see from the then R&D now X. parallel have we're particular, we're Phase going well remember we in three an driven that increase, running largely as open-label And five-year side, for fact ongoing that as program, our finish. for a X-TOLE to because and epilepsy are to

to what what that's to the respect costs, that we can in will can you spend roughly forward think roll G&A you plan QX With flat I and costs to we'll of so costs, relative relatively stay that saw XXXX. G&A expect for XXXX, QX

R&D see is we our of to personnel side, maybe funds in add do -- expand probably the continue and support rest we'll to to another an And resources that increase development as our on our to continue continue internally pipeline. we the to our costs piece ambitious

Laura Chico

Thanks very much guys.

Operator

proceed. Our of Bansal comes line Please next from Wells from question the Mohit Fargo.

Unknown Analyst

confidence developing Mohit. MDD? you. that potentially Hi, other in have in Since this you is Serena modulators what Phase would our back compounds? And could in just early XXXX question. was for the give guys you for preclinical Thank XXXX like have worth on tandem entering the going taking on and MDD X multiple to much the versus guys is wondering wanted programs preclinical development, having you for development MDD. then I about opacity and go for to Thanks talked path

Ian Mortimer

think, CV I with scenarios Yes, then MDD, some in may were the additional to molecule a walked in clinical development obviously, in working of now. bunch we develop another of XXXX we clinic. on through kind of decision if into going going were molecule, the earlier call, MDD, factors to on we're backup the made But or we through based if right that I and a we move whole bring XXXX that the we still think ahead

asset MDD. it a running be that's just think is to not I to important. KV very into less and would two developed having I necessarily major continue development out and drugs valuable taking think our But in another build I we -- molecule in being disorder about KV, depressive have think,

a depression will made that of one differentiation into areas. be want a we if molecules preclinically then that where to have chemistry, some think other we into therapeutic based wanted that or I the may on situation we take decision therapeutic we

Unknown Analyst

it. Thank you. Got

Operator

Our & next of Needham line from the Company. comes from Bhasin Rohit question

Rohit Bhasin

also Can expectations Thanks. talk from to trial about going payments the And from the you later to that's your us can about out collaboration? remaining you just with talk Neurocrine any this read year? milestone

Ian Mortimer

Sure. take you upcoming can milestones. and I Sherry, if part can answer some then, first the of the on

us. that's So, I for Neurocrine think for a than question better

seizures a X-TOLE than onset mentioned ran study that running our Phase in is I X the think earlier, we significantly I smaller. quite smaller study focal Xb study they're Phase in

important But not study sure more I'm dose they're we sit I'm range. going data specific proof-of-concept a success. criteria think how where kind it's over a generating I of there's think not today, to a where go-no -- we of So, or be about

we're describe to unblind Neurocrine going that then data, the are next what it good think and drug. Again, share think obviously for them it's to steps they the publicly, have I let to

Sherry Aulin

for And we Yes. upon development milestones the reads on $XX and then eligible payments certain additional of specific million be out clinical if milestone regulatory-based payment then remainder milestone milestones it and sales-based through eligible the would obviously, royalties. and study, a for positive, the are

Rohit Bhasin

you. Thank

Operator

call remarks. like turn Sherry for to now would over Aulin closing to I the

Sherry Aulin

end on now the us call joining call. may you the Operator, for everyone, you, Thank today.

Operator

Thank today's conclude call. Thank you, and ladies does for This participation. your gentlemen. you

disconnect. You may now

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