Xenon Pharmaceuticals (XENE) 9 Nov 222022 Q3 Earnings call transcript

Company Profile

Participants

Sherry Aulin	Chief Financial Officer
Ian Mortimer	President and Chief Executive Officer
Chris Kenney	Chief Medical Officer
Chris Von Seggern	Chief Commercial Officer
Paul Matteis	Stifel
Andrew Tsai	Jefferies
Tessa Romero	JP Morgan
Brian Abrahams	RBC Capital Markets
Madhumita Yennawar	SVB Securities
Laura Chico	Wedbush
Yatin Suneja	Guggenheim
David Hoang	SMBC Nikko Securities
Lachlan Hanbury-Brown	William Blair

Call transcript

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Operator

Good day, and thank you for standing by. Welcome to the Q3 2022 Xenon Pharmaceuticals, Inc. Earnings Conference Call. After the speakers presentation there will be a question and answer session. [Operator Instructions] Please be advised that today's conference is being recorded. to Aulin, conference Chief like speaker to now Sherry today, Financial would hand over the your I Officer. Please go ahead.

Sherry Aulin

Thank you for and afternoon, everyone. on operating financial good Xenon's call XXXX discuss webcast you, our to results. quarter and joining and us third Thank

be and of fund of Please to this of submissions future timing trial time are make number royalties regarding cash payments the advised during XXXX potential from our Kenney, Ian Kenney Von I release expectation are Chris additional sorry, Seggern, designs with collaborators; having around open Commercial strategies. results development progress Ian and events. candidates; Mortimer, potential of and our anticipated into during Xenon's proprietary Seggern sufficient our will related open the summarize with receipt our of will this clinical pipeline. questions and efficacy Officer; Ian our Officer; our our our and Chris today's and will commercialization a milestone -- profile, safety Medical X potential anticipated me and progress efficacy, Chris of Von market President commercial will partnered Q&A regulatory product results, the financial and Chief Chief Joining anticipated enrollment; Executive operations today's of and our potential data. call across and provide milestone that and the within including recently Phase will call launched statements plans, our interactions company Chief of will available XENXXXX address forward-looking, quarter's Xenon's our Dr. I Xenon's lines; call, a Dr. addressable Chris summary Officer. be collaborators' partnered statements around to and session we program, and that programs detail anticipated our

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

We financial undertake forward-looking press available accompanying results results from Our at www.xenon-pharma.com will XXXX differ XX-Q filed made to Investors any SEDAR. under materially release Form website may obligation on Today's third section the no on today's of on with summarizing quarter be Xenon's and the and publicly call. report quarterly SEC update those our the projected and statements.

turn I the Ian. call to would to like over Now

Ian Mortimer

continuing X-TOLEX research date, including all open-label Exact. with our play the belief patients Thanks, a launched in we endpoint extension could the XENXXXX build firm today's in good and profile in open significant with and called ASMs event data in seizure epilepsy. freedom. positive that is field tonic-clonic therapies joining leadership primary call. compelling active consistent These reduction are KOLs to The significant and findings role seizures seizure CNS. for called everyone. confirmation call statistically feedback with adverse greater X-TOLEX the generated of Phase in our upon truly from comprehensive The the of support our is with seizures Sherry, These afternoon, along other with on at data our periods plans in XENXXXX that plans for treating excited trials reduction XENXXXX have tested of X even seizure every greater reduction foundation focused Thanks our position XENXXXX, Phase in including trial the clinical a driving data, doses upon the that primary to Phase with build on focal to program, thereby ambitious epilepsy. KB XENXXXX onset our I'm Xenon X to clinical X X team development provide mission X Phase new executing and in for and generalized and

includes after providing number regimen profile and with in-class of differentiated titration such XENXXXX's a once statistically progress potassium while deliver a epilepsy therapeutic the and differentiated desirable day In Ultimately, needs only quarter broad for patients, dosing the no a an population unmet meaningful week of goal of our a attributes channel and within been over option addition, as significant mechanism one is of to has only significant. dosing. a reduction our seizure past

study study by In X-NOVA our collaborators clinical now ongoing parallel at our or Phase depressive Mount MDD. with Turning examining MDD XENXXXX to an Phase is disorder, being X conducted trial. major in investigator-led Sinai. This X

examine antodonia treatment MDD XXX a milligrams based was well patient part Ezogabinedose Ezogabineand important note most MDD to clinical with encouraging within to data population. that in with depression decision XENXXXX also as common XENXXXX. is Our epilepsy both and the as for results as It TID the in comorbidity on preclinical promising is

on date. We to receive study guidance made X-NOVA the the site patient line and have further the our with refined in that quarter we expectation progress from results will of enrollment XXXX initiation we've top as good third

the study. robust ongoing In activities than supporting These XENXXXX pediatric our years with trial patients who to are XENXXX encephalopathy, Phase EPIC continue evaluating X advance patients in developmental we X KCNQX-DEE. or addition month KCNQX to are to program, old in epileptic clinical our less clinical X development the XENXXX and

adjusted physicians, need. significant to physician study eligible rate XXXX. has indications, know about sometimes Taking what population, travel caregivers to clinical we makes interest medical challenge As patients. believe lives patients. these is on case and also young ultra-rare trials unmet further parents, sites the provide young examining we've supported and into this precision And with This Based to expectations of the other positively date the action KVX patient of impact mechanism completion our by ezogabine, to around while with the screen of account we difficult. around there is fragile these potential the taking a challenges which clinical enrollment studies identify, medicine FX XENXXX date, a important to to to and in a enroll orphan and or

reiterate the more I'll XXXX, the multiple Chris our points provide trials. turning X want in made across Chris? to Before comments to amount Phase and XENXXXX clinical progress on of detailed inflection pipeline ask I additional to forward I'm our some now looking call immense over program and in to Chris, clinical XXXX.

Chris Kenney

Thanks lot, Ian. a

patients me led an begin designed either placebo. X:X:X initiation XENXXXX run called support to X-TOLEX dosing be the Phase X-TOLE to Xenon the parallel hard for thanking Xb will XX or with Each milligrams X trial work, similarly X-TOLEX. randomized week, study results, will XXX for team will of approximately by once our enroll of in all daily XX clinical successful study or who identical the last which Phase of Let X-TOLEX trial the clinical

percent this Xb selection period informed X-TOLE XX-week with MPC The efficacy endpoint monthly the our with execute by of Based seizure Phase the data we're XENXXXX. endpoint as doses. our including epilepsy at differentiated was X-TOLE upon Ian, frequency an for studies change Our or indication. we greater compared the XX% median model frequency safety median of for an and profile X X which primary double-blind upon as Phase to the using dose underway, Phase is the placebo, to and plans baseline through efficacy the change both of X X focal-onset XENXXXX completed additional earlier endpoint well than the statistical within seizure trials by pursue seizure modeling, by primary in data as reviewed from our data year. PK/PD from hierarchy XENXXXX secondary the the efficacy percent With X-week support to continuing the week power in Phase on strong now we're program build to to also

by subjects efficacy primary of We and XENXXXX once daily our and X Seizure, will in and baseline the antiseizure of or Exact primary expect to generalized the PGTCS. models, generalized X:X the or be on XX-week with milligrams trials medications both enroll potentially known with epilepsy to efficacy XX tonic-clonic from focused an dosing placebo. monthly or either earlier placebo. compared preclinical randomized seizures MES, Of is valproic double-blind XXX our XENXXXX in shows pentylenetetrazole, focal primary We're Phase XENXXXX. seizures. period clinical endpoint which Maximum NPC patients opportunity generalized to These study seizures thereby efficacy approximately Furthermore, of The predict with tonic-clonic frequency predicting seizures. activity for acid in Electroshock photosensitivity subjects primary note, modulator XENXXXX suppressed through trial other in as the channel of with seizure potassium PGTCS an XENXXXX X-week generalized excited anti-seizure in did to lamotrigine parallel are patients onset like both for levetiracetam,

Additionally, in generalized focal seizure all demonstrated XENXXXX including to our that trial clinical broad seizures impact Xb progress subtypes, across seizures. focal X-TOLE Phase

of NDA X-TOLE of data data, of X Phase study, to study from submit NDA. application and tonic-clonic FDA clinical the OLE, release To X-TOLE X data the of an additional extension, requirements. for or additional following to an trial investigators key to or compelling to data support aligned seizures. also elements front, on drug XENXXXX from the trial first of extending continue safety during ongoing upon existing based our generate an to primary on We're other briefly of safety original meeting FDA order The to end onset with years. successful seizures. XENXXXX regulatory with the meet focal regulatory OLE X-TOLE our generalized from a significant of aligned from the and Phase years long-term the on clinical we summarize, XENXXXX Xb a X-TOLEX, indication trials with we single in the Phase Phase On new to X completion X pursue open-label Phase the to program key clinical continues package X provide to trial request At elements along benefit Phase important Xb patients, we're clinical potential X-TOLE our in our X plan

to to with we at there. and Society December, you present look data American additional We of forward Meeting expect all the Epilepsy in OLE connecting

significantly therapeutics our team significant there medical call our milestones. that partnered financial has to for like a these lives of is driven new patients. belief the I'd position, will Our who now to to the by is to summarize epilepsy, Sherry, treat Sherry? and potential programs and upcoming XENXXXX over the improve turn need

Sherry Aulin

Chris. Thanks,

and in equivalents June completion to cash release news million our epilepsy. XXXX underway. in as being onset of securities few the as the quarter preclinical us excited result the would touch expected Neurocrine. financial you with proud Currently, our by planned refer with details. our I'm Before there XENXXXX and XX, like marketable report financial X NBI-XXXXXX XXXX. our with to Phase expected was to trials to made progress and next from adult and some in and study study use operations as Phase about of to its turn XXXX, clinical look for forward cash we to The and XX-Q increase highlights pediatric I'll development partnered of $XXX.X and X well September public and is clinical data Neurocrine, XXXX. X discovery statements in is sufficient a with the on of We're XX, another patients allows offering of compared I into third evaluating position, comments make seizures year. program of on were the further program examining briefly SCNXA-related million our $XXX.X fully financials, focal Cash this quarter's support to which primarily prudent as data XXXX. fund patients with efforts our separate One are strong I'd management clinical, cash rest our December

XXXX ahead, from X-NOVA key including points year in and with data seizures. readouts adult expected within clinical Neurocrine partner another pipeline, program Looking our our focal inflection for represents

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

line expect top IST Our in while in of third quarter and results XXXX, the and MDD. is supporting Mount in parallel, X-NOVA the we MDD trial ongoing, are to Sinai we have

build business. patients in completion momentum We across XXXX. anticipated KCNQX-DEE the to with has continue Throughout to pediatric X this study in trial the knowns clinical EPIC with advance year, Phase our continued

is excited Xenon's part deliver to mission new of team highly therapeutics be Our patients in neurology engaged to to need. and

Nashville. in you AES the ask in quarters forward And of to of open the you colleagues my year, providing now on progress the questions. those we For this we to updates for on look line look attending the ahead. any call, to behalf forward I'll operator connecting with

Operator

comes from question [Operator first Instructions] call Stifel. Our Matteis at Paul

open. line Your is

Paul Matteis

of about I commercial sales There's rate who the have if commercially there are question that the when fallout wanted epilepsy what than in to could light of suggesting of of in that XENXXXX, drug terms Medicare a and sort proportion drugs confusing and data that we like guess, population. pricing we've the fall ask know demographic Medicare IRA you an it's on the you do was population? of enrolled And in sort curious epilepsy kind come legislation epilepsy specifically, a of out some across of higher general radar just enrolled, I I patients come IRE think drug where exposure. successful, of the in

Ian Mortimer

Seggern I he would address Chris call, Von And so Paul. the on early Thanks, say can it's this. days.

have done can proxy can But can some bit work little of provide provide use We the now, a a details. right as we them perspective and as Chris, our well. and you

Chris Von Seggern

mind since was and it's the And legislation a absolutely. Yes, great question that's passed. on been something our

question, coming product and to looks one-third that if population. or of not, below And is depending your slightly lot like, the profile years. that there's as in we is better will mentioned, know we it still a covered will Ian slightly elderly in is right XXXX's either And on the the population So But Medicare. be here, early days by hopefully, what answer the unfold that what your profile today epilepsy attributes. expect be directly approximately a it in depending could line, on enriched very number,

cycle, slightly could you real that, from time grow you the therefore, think things And we negotiation. the you price to considered. two at-risk standpoint. that that fall into at lifeline sales be But product life in product's for for in occurs, point product. overall then imagine has over as I sales some about a enriched becomes an we the what could proportion the So the of When of as consider would bucket could if be that that

comes product. product the well a late early going have life the product's over a and in that specifically. The the Medicare risk sales in that to -- of a be And believe done the we're really to exposure life from is going from cycle. we've first standpoint, is cycle. lifetime standpoint exceptionally billion don't certainly, the product In factor $X in We

products, late view likely competitive if that that quite product product range successful. our be of grow, is but the in life very to the early, we're as sales we're in cycle not So very,

Operator

question next Andrew from The comes Tsai Jefferies. with

is Your line open.

Andrew Tsai

of initiation X Phase the Congrats program. on the

views. time this get to about the maybe competitive I landscape love will So my be question would your latest

compound X you reasonable then Would for Another focal is well, think about hurdle X-TOLEX, X, you expect for in curious recently. describe XXXX, why be you as is you instance? what epilepsy. And to it impacts started to would enrollment in that differentiated see from enrollment? to competing any data in are Phase And whatsoever compound? other foresee words, KVX the do for that is, to Or some second you think how

Ian Mortimer

and well. can I then perspective Kenney Von I'll on their Seggern of some start as and know both jump Chris and Chris in

the different that we focus at competitive to development. late-stage late-stage program It's And we in I and clinical in the mid our think the programs, on mid- about the So are are we kind think molecules on through I stage are going things. Neurocrine program. certain focus landscape, need extremely a development. to I that kind then advanced moving of to initially on know talking One, that think market, of that a clinical obviously, couple two well. of

is we're specifically where just is and others increase. subgroup emerge the desirable that only not haven't that specifically attributes the product being as in we for I the not we seen other really no some that's that drug of around clinic I comfortable just asked you done XENXXXX analysis development the data, to another attributes But overall of and clinical with KV, there's efficacy data development and surprised molecule. the X XXXX that the think the seen compelling well, right the I efficacy, but field, we've derisked going in efficacy titration, and really we've on starting that matched XENXXXX in about the know the are which the week in think of some has of to now profile of has competition also think You terms program we're

think about often branded the commercially. And space fit maybe in the we we thinking and this thinking market that's was should be XXXX comment space, can we're would set. about competitive as actually commercial So on think where where because I Chris how really the about

Chris Von Seggern

Ian. Thanks, Absolutely.

generic with a clinical of market requirement a while being for broadly emerge, have compete believe by once likely meaningfully very, the what the used potentially a we and from often our be into used attributes perspective, efficacy, with choice marketplace. introduced is, the XXXX branded about all today. interesting disease, in from armamentarium the really available market. XXXX associated has in that in from result strongly think see one So advance still therapies this are attributes being of XXXX mechanistic the branded a but of it opportunity fit The And that and into this rapid really X Vimpat is to our as as the standpoint. for X of the think therapies when of past, QD marketplace. creating about future now product lacosamide profile unique are may very used likely adds that or new in as into separate product product We've the compelling for supported to XXXX we've these both Obviously, said before, XXXX that talked environment. exclusivity, dosing, quite a and we opportunity are very an that research, compelling will they'll transitioning all components this about we to or mechanism other lost lack KVX we our KVX of unique overlook to can't but titration, onset that's a things of to

Ian Mortimer

Andrew, X-TOLE X Thanks, just you And Chris. X. had then, question X-TOLE on a and

given guidance as on we we know, So formal you when haven't, expect data. may

continue the we're proxy. years Phase we COVID comfortable through pandemic are a an summer those but think mentioned, And really definitely we about within about days or XXXX. the that patients study best study -- was -- on then the and larger, -- today. X-TOLE profile about just as impact the used a spring the X-TOLE is in complete. program information has and ballpark are started recruitment. Chris little X differences, obviously of and of of the we And kind bit The the XXXX have best also, I talking initiated to Obviously, took study. X.X same before the we And of the the X-TOLE pandemic. X-TOLE saw early in new just the screening just impact an talked we've had everything and of studies

them think their have compelling to to I really patients have investigators conversation a we in on for the Phase X a and participating pitch program. with

Chris Kenney

just can is Ian, I other This Chris? build the on that?

Ian Mortimer

Yes.

Chris Kenney

I Just a thinking that things you few mean about to need. an there's NDA, getting

exposures XXX months least X You need for exposures and exposures at unique hundred need for you X,XXX and several a year.

You to at need studies efficacy. a couple of least confirm

we're We're safety X, in data you one are right we where NDA. have pivotal. so finding, think away really of end that to is positioning Phase addition and complementary Phase dose past I, able And one past to past being study about from study when now,

pretty we're I close. think So

Operator

open. comes Tessa Tessa, [Operator Instructions] Our JP from is with your Romero line question next Morgan.

Tessa Romero

questions us a as about think from few So x Nova at here. we just

And mg mg monotherapy also So this mg we mg the a say, versus, of know study. selected is are XX doses XX QD XX QD? or how XX X and

on any equal the any greater So for HAMD-XX? have for or severity antidepressant net is chosen shafts clarity XX can prior taking? of than the you may the what washout why period was other to score that clarify been And the patient the in

Ian Mortimer

period. important with on dose think Yes, little I'll should got don't just if not, is tests don't you've population can your we to and can selection how background I patient, on follow little we enrolling. severe I bit to If know patient the -- the why we there. the -- a always washout Chris, back then the the because bit talk I fingertips, just up at of start the And a on that answer moderate got kind of of we're history then about some

active XX So of This in right. as chosen. XX terms per placebo, you're study, is milligrams arm, and XX doses that MDD X-arm our a subjects and X were study,

of times, have started multiple we've about the even ago, thinking that prepared remarks We X-TOLE readout a data year the in MDD lot before the background including a today. given stated

we and it that drug have initial was then at were designed to what dose. so to magnetic also placebo draft like that of very look data transcranial reduction data, in that when dose. XX-milligram supply that seizure And us active XX And to and in had the saw the we terms that then protocol. we stimulation, ready the profile. mid dose was we statistically knew the the XX-milligram unblinded We for looks protocol is we We interesting at dose unblinded when was was much of And go. its AE significant milligrams. And

so we amended and to include arm. the protocol XX-milligram that modified And

add activity lower milligrams profile we're X So I I that mid of the see depression it's also have and AE the work to interesting their XX dose seeing be obviously, as a generated and was really doses going a drug both and in would depression Ezogabine in well. given those in they higher that, at dose dose, done the at to epilepsy the data and XX XXX data both milligrams. epilepsy milligrams study. think to X-TOLE data the In

that doses talked I'll of we terms do in own can major the for some the I've in activity modeling exposure XXXX of see at dry our we so and that may about And the the the anything washout coming it dosing the and you at scores, and want the you baseline period Chris, then disorder. the to if say to on in pass depressive patients. else scores

Chris Kenney

or weeks for couple elimination , with longer or of a the they at the X half-life. pharmacodynamic which to be least is weeks for question the pharmacokinetic It's for washed lives. is So fluoxetine out about that X drugs easy half a have

I the As of this patients case the better far this population make population the prone is one as in because more is not the I an you adverse could in this can dose patients maybe tolerated goes, or concomitant events they're to should medications say, of epilepsy, things be epilepsy. drug mean, taking in that in well, as argument

So And you could kind in need data complete of just of the terms tolerability. ways unblind argue ultimately, and we both see. study to the

that So played a the little bit into I think of that, dose selection as well.

Ian Mortimer

And question then, was on the [Indiscernible]. on and Chris, just last HAMD than the XX baseline greater

Chris Kenney

Right.

to was enriching that conversations of will let severe So leaders define that that with -- to anhedonia you through population are opinion I moderate patients addition depression. know key basically had The in a for depression. we to

of already MDD an of quite by fact as there's that it population, is. bit create However, virtue you a anhedonia the

based anhedonia And much. there's of because sure enriched the there's the change a patients. additional anhedonia upon population that so that largely already of cut-off It's impression making amount that in a of actually sufficient substantially those amount fair doesn't

Operator

So the next of question comes from Jason with Bank America. Gerberry

Your open. line is

Unidentified Analyst

is Dina quarter. progress Jason. for the this This on Congrats on

view just pipeline of we cell activators. view sort index on your get on Biohaven's differentiation profile potential emerging the potassium if such competitive the product Our and tolerability benefits, dynamics maybe get regarding data and receptor KvX activity question the We could activator and is channel your GABA potency? on as from of

Ian Mortimer

just unique one had very features some would our differentiating we specific some -- the had I some Yes, say is questions -- of very a previously, and attributes on I'm XXXX, of happy answers about of those but And potency. answer on about you questions. talked to

first-generation potent times XX XX So to about EzogabineXXXX XXXX, target. back if we on is the go more molecule times to

CNS more versus it's the molecule. than So KVX potent and too Biohaven and on Ezogabine

Biohaven is So XXXX target and of view Ezogabine. on a molecule potency point from somewhere between

I advantage, the So molecule addressed in development most that the of potency, the XXXX. is be and KV but mechanism potent potency by clinical can dosing, in terms think again,

GABA either a or the of terms believe that's data effect these any so -- their mechanism, more trials. don't GABA on XX our XXXX to we have drugs human being XX safety. shown through efficacy And has activity some In on data. is some than micromolar, that that any a which concentration believe XX of of in you, And of we generated, have don't micromolar -- just GABA, some plasma at others clinical the XXXX time remind

assay So is it's that not relevant -- not at a done even concentration.

comfortable these that that we're are also the we're side think of I target and effects, KV that's seeing seeing drugs, effects these we're efficacy. mechanism the very on So And the side are drugs Capra things had questions at successful around in We Lamictal. somnolence like anti-seizure other dizziness. with if you Actually, consistent very very X-TOLE, the look sometimes rates they're somnolence. medicines, like or

profile So both efficacy we AE the the also drug believe and very of that we in have active drug. driving the a again, CNS that's the

Operator

The Brian next question comes Capital from Abrahams with RBC Markets.

Your line is open.

Brian Abrahams

durability effects completely led in and more or think, not potent target of better which has I KVX So to better better modulation on understood. But depression, complete the MDD, mechanism Ezogabine is epilepsy. safety, in I know regulate to channels which as is terms XXXX relative by comparable

we there activity for impact binding either should are to are have in could any be there that biodistribution preclinical depression XXXX? you've how Ezogabine. for about receptor might relative that shown So I guess even I'm that with curious, just properties subtype any behaves better comparable or looked or or to thinking at depression selectivity models, And XXXX instance, differences regards that

Ian Mortimer

a actually talking talk conference question. it's I that at presented just -- conference, was a a think Chris neuropsyche just a then opportunity And really, mechanism the Maybe I'll about Chris for bit depression. and really the profile. about Kenney at little interesting in XXXX

now just think the I as what of both and if in the upregulation link epilepsy recent some with potential the have we seen way. haven't on in reward just -- think nice on the given question asking the can and and you're to you KV populations, and talk mechanism fascinating around as is well. right -- a in because Chris, ketamine really these seen But read we've of both So preclinically. We've which relates I there And data. people then depression, you've XXXX epilepsy great terms it the to data think, Ezogabine probably publication, it most the Brian, circuitry I

box depression data XXXX. checking for missing that the is So we're the

much or different. are these so how And similar

feeling Our the form binding is sub about terms in is selectivity we're channel. And of there. site concerned these the the certain Ezogabine well. to isoforms same -- brain XXXX that they're do way as not that in just part channels similar. bind and the in We of in

shot really that So good given we a have think Ezogabine. comfortable we with we're I everything know

of social Ezogabine some KV modulation data, defeat ideas run in mechanism a stress really brain. In around was model, the potential in the terms think drove which preclinical and the I of chronic

We haven't other and but very little I'll mechanism we XXXX more specific pass Chris at to the well stuff about. some just in looked bit preclinically a and model reward performed give models. with to and it run that have on of we're that excited of depression XXXX, those models the

Chris Kenney

only proteins to I'll think difficult contributing a X.X these are remember, to about add together The thing question X.X combining I Yes. right? the the because very current. mechanism, that's tetramers, the form you're asking And and

is along our was mechanistic that you than to will or for answer know it's the to think Ezogabine I I out. hard And as just seizures argue I when efficacy be ever tease I sure data. compare onset focal based that's then of it you something What's difficult two me I'm able asked we the to you Ezogabine doses upon to And a so clinician level. the it's I reassuring I drug have saw think highest data, that Ezogabine. that And said that on to not a all anyone question beyond it's in very mean, so one worked the another, those we that, data. better. lines study stronger the definitely expected what the do time. that but we one do would that

that was don't that's your is And effect that it last around So KVX story to as just really more at of into specifically, translate its we got story appears as to in this being know the very was targeting mechanism. KVX kind of been is ketamine some what if what's though the going through thing, depression through which just obviously, Ian scientific exerts It's least question study The published antidepressant was interesting conducted. reassuring. indirect alluding this to year MDD. that

fact fact a pretty potent into same the we've so is associated compelling. we we're you studies the antidepressant. from without at mechanism tapping looked having that as know, ketamine into, The the tapping far could is at effects, least And so the that pretty side of that be any

seems as it's story by. still unfolding, time to getting interesting goes mechanistic is be but more the So

Operator

Marc The comes SVB Goodman next question with Securities. from

open. Your line is

Madhumita Yennawar

One Mac. could exclusivity. just a for onset is, thoughts overall that on Madhu today the new of following latest helpful? insights you bit loss about be you're would there Vimpat talk focal seeing question is given and your Any or the you're little on trends This the patterns market

Ian Mortimer

Thanks. Chris, over to you.

Chris Von Seggern

this tackle one. to happy Yes,

to plenty product research, to other fact in growth. sales although What that's days. So KOLs very product in of the stayed substantial we unfold by safety expect lot replenish both future, Vimpat expect seen understanding of the see coming [perbiact], And to sales obviously, support the strong at based is of to from to continue good use will so increased rises And have efficacy But to from the as that indicative marketplace. shifted track. that is agents over the the is the product Correspondingly, powerhouse proposition been novel still for we've in that lacosamide that biggest with marketplace event to continue exclusivity environment. given potential we on potential offers. a lacosamide hearing our the value branded commercial which generic unfolding of most profile. the not utilized to it's our X in third steady, overall the least resources product we we've space. within in individual sales that's a months we reasonably still arena certainly mechanisms to we've is of and unexpected and would new of from market is its environment Their year. use a that dynamics moving likely last this of reasonably predominantly in that UCB that we're our are early the think the and what launch, and its far, the the increased category what products Vimpat, the and X-TOLE lost continuing that, what seen our use opportunity is replenish early a commercial for in from and There branded the has loss given speak are trajectory made that seen generic the OLE to as

all It's high could competitive that there in into do, on XXXX we space, everyone's our added coming else we mechanistic the in much happening major likely next late-stage really and mover late. that space. that of both -- is well the as mentarium And radar from the hear the years. only therapeutic the in be the that research we're differentiation So in the as the the terms offering isn't

Operator

Chico Laura question next with The comes from Wedbush.

is open. line Your

Laura Chico

bit thing as for has other few players seen been constraint clinical One staffing from tighter. of various a gotten recruiting has a we've CNS studies CRO stage on

were to You through COVID. quite X-TOLE able a with turbulent time move

So you taking on on you're could for you're steps be any as and might started? wondering kicking headwinds obviously, avoid things horizon X getting any to X you but just I'm to potential off, you're see and that might you comment facilitate the recruitment, trying X-TOLE if

Ian Mortimer

couple not say comments, I as in to and appreciate protocol as try X-TOLE we've want about a you and I'll add Chris it trying I'd X-TOLE it his X-TOLE. to things Laura. We of we're that Thanks, talked a remarks we Chris to couple do, make the terms stay Kenney, a to of -- being X just Yes, well. today. it. X, lot if of and in can. as consistent want then true to about talked of

with X-TOLE investigators. we have sites a success that. of lot We and to want replicate extends also That to clinical

doing success their loaded think of with that to know back have some we of the we contracting, one well. of product already a institutions. know that And the with relationship front-end about even you that things the is had we've sites going when we're So stuff in terms

making the we into can space newer there's I front some companies but on So that advantage we can can't, kind of are do the the that of anything sure to something add be we'll as monitoring we we else quickly of be this move as we will can. go it in full Chris, that take that can epilepsy along. as end terms think stuff

Chris Kenney

said and over just you with still now finish to people line more want I study internally, the that what on And here X-TOLE. build about brought who resources. were are to folks more financial the successful who trying replicate

the So the here. we've the beyond the built folks already with building then were existence with and going is in already is the well and answer them beefed sites CRO we've say -- up internally, relationships, relationships on that, are really further. but who And with relationship just then would I those not that expanding

Operator

The Raymond with Brill next from comes Danielle James. question

Your line is open.

Unidentified Analyst

is This the Alex Danielle. on continue depression. for on I'll theme

on Just kind you of ahead or efficacy threshold about what whether regardless hit stat? of of in want looking terms Is signal. go/no-go you've to you're curious, been an a thinking there that not

Ian Mortimer

Alex. Yes. Thanks,

with a study. talked the mean, I X-NOVA many in is as proof-of-concept of designed the past, good question. about as Another we've you study

only talked everything we study. stats really Ezogabine today think design study, I data. the based terms informed but the the us have Ezogabine designed also we've good in have for we not data the And on of about about rationale the

don't published is proof-of-concept comment, separation year that it saw significance. So to is first data this a statistical is again study, I But same powering my terms think in in is to is the important, the need really our expectations of inform that show us. that last from we

-- study, data at think we look we're steps. the of would finish and in the next of totality I the just the going unblind So to data terms

Operator

comes question Yatin The from next Suneja with Guggenheim.

open. is Your line

Yatin Suneja

for one quick me. A

could the for incorporated If you that that on of we program have comment might regulatory that the the can on the U.S. how finally, And then you that how comment you financial mix, on in broad [indiscernible] has you are it's undertaking? anticipating been you feedback you that studies? front, also on the ramp just contribution a studies. the site and received comment are In given can should terms planned if EMEA expenses

Ian Mortimer

European and kind you I forward. then on provide then on add can site -- Sherry can of the Chris, going and can perspective that I feedback to start can spend and

So just recruitment as coming with it from recruitment coming about between split Europe a the reminder, was a U.S. XX-XX and from X-TOLE,

X. we're to think exactly, predict I And but probably that it's be in range X-TOLE be comfortable today, somewhere going would so that I difficult to say we'd for

with we've to really past, about in interaction the as FDA. -- talked our have we We wanted prioritize

after we that, to end that our up X had meeting and get X And we then And the had able running, Phase of X-TOLE first the June, minutes the so initiation and we through our of U.S. we in and X. and sites was Phase protocol. got submitted were

into European sites regulators have go and on feedback well, we We consideration as have get now because engaged with will European we're that we as and forward. taking board

Chris, major So to add moving and had that? feedback can we that any we're in we've all want and the sites you really U.S. Europe we've for within that kind to forward. jurisdictions have of incorporated, more regulators comfortable that details

Chris Kenney

already an to there's then efficiently wanted to take as which makeup in is move the worked that you've forward what And I X-TOLE parallel. on that are up last which running said. to placed sites done possible, an X-TOLE, and Well, standpoint getting number on actually being that There say of the just operational the emphasis need targeting those question for triggered order as X quickly question, a in that headwinds. the activities be about on to to from and trying

over we're bring Sherry? as of direction or You to where shift doing a as in are about talked order program, can you to but in that's favor other resources quickly activities one And whole the line X-TOLE of the another. finish X FDA there possible. what number

Sherry Aulin

Thanks, Chris.

the see initiated. ramp up yes, I'll spend high-level on program R&D X make got that expect Phase our to we So some comments OpEx. Absolutely, we've yet the now

So XXXX. we'll program in XXXX over spend see X increase and an Phase the around

for earlier, which best program start years. now we saw from is mentioned took with X-TOLE, right Ian As proxy X the to what X.X our finish Phase

in years mind X the studies of open-label an 'XX will in duration. that and into Keep X those is extension, which Phase will So fiscal bolus costs feed those occur 'XX. in

thinking costs when also through in will -- then about sheet and ending we we take reminder, 'XX. a the us and for $XXX the that. a open a And strong costs cash and expect million those pre-commercial into 'XX at balance So we very extension that XXXX XXXX. we continue and bit label in as that, will beyond into But are have quarter, potentially commercial get

Operator

next comes from David The SMBC with Securities. Nikko question Hoang

is line Your open.

David Hoang

all on Congrats quarter. progress the this

around any question indication. path regulatory thinking that help of I product versus you focal the to focal talk at have sNDA approved as bit you PGTCS labels epilepsy? and relative the the both had the this expectations about So Would PGTCS launch little just to a data and you has does for with Are label a timing submission? just Can have launch? of with the you intend helped available -- that epilepsy an you

Ian Mortimer

question. Good Yes. David. Thanks,

launch and think that timing and this a can us Chris around Chris one. on start in and probably I I jump label and of then and bunch can questions stuff.

bit and in the delay, potentially that bit molecules. David, of focal with the as post-approval they it to study to would then companies study onset these We smaller an common primary exact dose is they could in and a is of drugs the if the do other believe and we've readout file to I in dose get run given and a a a little be most a generalized anchored generalized companies which we're I study that if these have very milligrams, all look timing. in the in we've again there's profile is then a same seizures down be the other seizures. So and -- as look it just the we'll then reminder, and can say it trying the study part can at XX you we X they molecule, a process do ready, study, run If we're in primary of epilepsy chosen will run molecules, come other single little do part an that approach the sNDA. sNDA. generalized parallel think FDA high you we parallel. What at of Often, we're approved trying primary is if colonic path that package,

early think I to to trying too we're run the but a in essentially, exactly timing to it's going So is little parallel. be, tell what

have time primary you So generalized and Von done and and approximately just to in focal label I in Chris you to, epilepsy Chris can that, and in Seggern, same don't have add know, what companies add maybe if to anything market other want both the the frame. these Kenney, you we then data as different local indications.

Chris Kenney

this. is Kenney. on just This Yes. brief be Chris Can real I

as challenging I go predict these conducting think You said, done focus Ian usually, and We're because right? on FOS it's just primary you to it's in to generalized. parallel. in series,

there rates recruitment for to just it many that that, there the were it's are We need those primary I with slower? And compensate difficult difficult general, Phase be so think should order In variables And generalize, more find I that patients. targeting to you it's in predict. really so fewer think are but be fast seen so relevant, were I sites, more to in or patients. should it

Chris? Just nicely. to the theme more unpredictable to a that add little Ian summarized content

Chris Von Seggern

Yes.

a excited the of the one to opportunity, standpoint, shortly offering to of broad overall at or a well And as else under the near decided the And is competitive any commercial run mentioned, if approval the prospects we've have standpoint, do a other to can because real as time post-approval. in a or one they're has about segment either being market X spectrum spectrum that X unique that's From these patients a with us care. sell as done, their everyone's study to thereafter, really an gives about for second largest parallel. the which we're that the of near in opportunity launch. so commercial the side, before a day already full spectrum environment, agent excited is mechanism is XXXX product, things typically to commercial this XXXX the broad which one conversation offering as We're from which no clinicians what the offers begins epilepsy the be going well On unique FOS PGTCS the efficacy are that's the both that day of of in on staggered differentiation population.

Operator

from question from comes Blair. William last The Tim Lugo

open. is Your line

Lachlan Hanbury-Brown

of on CMC. XXX? wanted us This current kind for both for And to of NDA where and resources? just XXXX I of touch need what sort maybe terms Lachlan you're remind secured for your what with you on supply Can you'll you have in Tim. at an

Ian Mortimer

on we're not to Yes, with we're sure is high-level or critical that. approval that the comments on making CMC a Lachlan. Thanks, mean, is filing and comfortable I CMC path the

all time have required are all And So CMC batches we work the approval. part to of an of done we're and the continuing NDA, ready for registration we'll that's the and NDA the and work the CDMOs. validation with by as of

sure critical I'm lot a to file the detail there's So not is path, the we've seizures. X-TOLE to now. talked more focal onset in NDA But share as completed right about previously getting X

Operator

At back for it Officer, Chief Sherry Financial would this turn to time, Aulin, I closing like to remarks.

Sherry Aulin

now Great. Thanks, everyone, us Operator, we'll end joining for the today. call.

Operator

conclude for you the in your does conference. participation This program. today's Thank

disconnect. now may You

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