Xenon Pharmaceuticals (XENE) 8 Nov 232023 Q3 Earnings call transcript

Company Profile

Participants

Sherry Aulin	executive
Ian Mortimer	executive
Christopher Kenney	executive
Christopher Von Seggern	executive
Paul Matteis	analyst
Brian Abrahams	analyst
Tessa Romero	analyst
Lin Tsai	analyst
Dina Ramadane	analyst
Kyuwon Choi	analyst
Joseph Thome	analyst
Danielle Brill	analyst
Madhumita Yennawar	analyst
Ingrid Ibarra	analyst
Tim Lugo	analyst

Call transcript

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Operator

Hello. Thank you for standing by, and welcome to Xenon Pharmaceuticals Inc.

Third Quarter 2023 Earnings Conference Call.I would now like to turn the call over to Sherry Aulin, our CFO.

You may now begin the conference.

Sherry Aulin

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

commercial around Joining call be Chief Xenon's Dr. me Chief Commercial Chris Mortimer, Chief will Xenon's -- will call, are potential during Officer; that our time major to open clinical uncertainties, which thereof, results, plans, that of our our to Seggern of questions.Please time control, fund advised timing collaborators' regulatory our statements sufficient profile, XENXXXX of of programs, to numerous clinical XXXX beyond Ian operations from research of development potential candidates; approval in anticipated regarding and statements risks risks programs, from subject opening enrollment our success Executive company that product and ability trials, we in addressable today's our Von with our a the partners' and into Chris trials President progress. I potential Seggern, make uncertainties SEC Chris our and in and timing our our ongoing our forward-looking, cash the market, number key have our programs the Kenny and will from efficacy, the obtain Officer; Chris and we clinical disorder XENXXXX to our many successfully major landscape. trial Medical in MDD described are future and Von our develop financial and our Xenon's will filings. will summary develop of and Officer. including and product candidates; milestone regulatory of and development partnered provide summarize summarize efficacy with safety Dr. statements including the findings and timing of are an our to the the and are will to other and of our overview in and expectation treatment this ability Kenney, a events regulators; anticipated the other the clinical or Ian market our results results call designs; potential and achieve your our XENXXXX milestones within interactions of progress depressive before successfully XXXX.Forward-looking

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

Ian Mortimer

months Xb a the patients to data submit program. today. includes excited we Thanks, trial pipeline. share successful begin, XXXX. good we randomized X initiated year XENXXXX our first thanks clinical clinical you and and to in we afternoon, experience with with in progress X-TOLE quarter along a data NDA generalized epilepsy ongoing of clinical clinical XXXX. our Sherry, site we focal X-TOLE, our existing of our our and our made expect our which study, QX or over call first in and Xb Phase relationships period have upon and leading program, for in or our seizures confident first I'm X-TOLEX, an in including plans to X-TOLEX, of that XENXXXX similar a with key the of onset of Phase first reminder, trial XXXX trials patients ability with on patients in X joining of ambitious strong screened clinical We space.As late design Phase this was PGTCS. our foundation trial investigators XX to and in our this aligned complete we our solid the meet Phase from and and the X-TOLE To neurology with our from X-TOLEX execute quarter of primary last regulatory tonic-clonic additional the with in remain elements completion FDA the we first year, to trial, past X clinical other half and with FOS, And our patient existing X-TOLEX patient this experience with enrollment the us trials requirements.In everyone, on to with safety clinical package through provides being X-TOLEX our of exact quarter believe second operational seizures Phase X-TOLEX across from

So this our in more X-TOLE reminder, patients than be line than as assumptions faster expectations. would X-TOLE. based or and on X-TOLEX current a recruit will And

pleased peer-reviewed recently to Phase improvements in were Kenney mid-December. program, disorder. around to that International epilepsy X-TOLE So demonstrated in epileptologists took the seizure Phase X during ongoing overall, presented patients of X seizure periods details the of our open-label in also experiencing patients' now to depressive will in showcase Journal.Turning into results our efficacy JAMA from this our report overall trial, Xb these some with ongoing provide at from freedom, Congress, in study IEC, from focal the and in program track and by late life. with to we also is and findings from study reduction addition data line study Dublin that major extension OLE more connect in are Neurology epilepsy, the to long-term Epilepsy our of to has Phase X-TOLE later pleased the Phase November far leading showing our X-NOVA our remain published made including neurologists XXth XENXXXX extended or top the We place early the year.In on call XENXXXX continued We adults quality prestigious the results in of with XENXXXX, team continue significance this we Xb of are execution Chris the September. and so in translating today.We progress see as

unmet need in and leading to call or Given Society AES to we data. clinicians, commentary scientific for their with channel at fact the rationale and these potassium turning comorbidity alongside in the in Dr. the is that mechanistic everyone booth our like depression In a for interested a most a next common who over we potential also planned September, are well-received James O'Mara; modulation, the and posters provided webinar presence month keenly exhibits. Dr. epilepsy, with MDD Matthew, Kenney, high hosted MDD Sanjay would as I MDD.Before we Meeting, American treatment and on supporting that have remind Epilepsy significant the Annual the Chris presentations multiple

of call Chris? now you, month.So we over to those connecting Chris. pass for attend, so, you forward who planning to to I'll look you the -- are And Orlando next in with

Christopher Kenney

Thanks a Ian. lot,

Let today. me the The publication we're acknowledgment clinical and compelling begin clinical by in efficacy that program Xb trial JAMA ambitious from of supported echoing in safety Phase pursuing of further this Neurology. Phase the the data development Ian's epilepsy and X XENXXXX X-TOLE data of

that we further amassed on XENXXXX's supporting from data look by long-term study and Dublin at presenting with extension forward Epilepsy from XENXXXX from the We extension in profile To-date, Society epilepsy. our of hundreds noted International Congress posters next have results the cohort for now compelling open-label to development in safety additional differentiating study. X-TOLE several patient presentations the We we X recently data open-label American from years. at the also of included patients other X-TOLE hosted of for open-label extension Epilepsy X-TOLE a month.As to efficacy ongoing Ian, and data molecules years than more continue gather and interim

of for tool the Inventory-XX, data on using in even all extension across saw social Quality of months a all at the group, effects focused as as least with quality-of-life at the consecutive time a analysis.Clinically in improvements and clinically medication XX overall group, in the subscales validated were subgroup data as interim the important called functioning seizure Epilepsy the Life patients, measures, improvements the compiled which by subscales was greater in seen Newly that improvements well QOLIE-XX open-label worry, assessed interim assessed quality-of-life of in important QOLIE-XX. seizure-free seizure-free

encouraging mid-December. potential is we results generated patients consistent novel evidence depressive XENXXXX, major and with our treatment differentiated to on a as remain the to-date contribute the X-NOVA clinical to promise to further are top data, which in Ian, compelling report work these growing epilepsy.Turning in clinician with by see a As November for as late quality-of-life to noted line of results track disorder, that to support the

include patient XX While arm plan our milligrams original trial per subjects patients. on line randomization results top data subjects XXX will or from the XXX XENXXXX, with placebo X-NOVA XX for of XX more than rates, milligrams XENXXXX design based

report of symptoms baseline the to placebo line milligrams and which using within a is the secondary assess of SHAPS report on of change primary to the which out using on to improvement also XENXXXX expect week symptoms to the reminder, top the on As score of XX XENXXXX depressive doses the from assess XX intend milligram improvement X. XX score on baseline objective, X.We endpoint, efficacy MADRS placebo to compared milligrams anhedonia to XX week efficacy to and the change of of from milligrams to we results, is compared

MDD.With seen that by Chris with research of program. safety XENXXXX our data of conducted summary will our the provide announcement, to will like near-term of primary some support we with Von who MDD in the and these I'd addition, In Seggern, in to overall diagnosed over call on turn Chris? Xenon share data patients market tolerability the

Christopher Von Seggern

key share that our research us Thanks, attributes need and have Chris. clinical understand MDD market drivers better in decision-making, medical desired future to treatments. unmet I'm the by the of helped pleased information in efforts clinicians from

would profile a Our treatment attributes, various and the with mechanism tested efforts to action high-volume involve key adverse physicians' the with efficacy, into in of prescribing event U.S. understand to attributes. goal tolerability, seen paradigm.We and psychiatrists leaders XENXXXX consistent perspectives product including potential how product the fit of profile ease-of-use X-TOLE pertaining opinion research understanding intended future

we are interested having other efficacy, with non-differentiated generally are unmet future new opportunity key that in Given in antidepressant products MDD for novel agents that and of physicians medications there needs as several foremost, action. an that mechanisms are space.First learned create the perceived

who acceptable safety therapies. SNRIs do used patients, to seen identified of respond efficacy, of the certain were of for novel common choice, offer many while seen events at X-TOLE, in not levels therapies pointed events, initially and we the could as products patients. as second be and gain concern out dysfunction reasonable and adverse adverse CNS MDD.In challenges X-TOLE. generic line Given when of feedback with heterogeneity And significant in were gathered treating such the Physicians SSRIs XENXXXX be as to depression, liabilities weight observed first testing, adverse mechanisms with patients with in profile action consistently a sexual dizziness event such would that

from for anhedonia, which current another a We of also response the Because relief potential dimension therapies deliver comorbidity interest not with depression. can interest. care. of rapid physicians address that products more delayed the This heard was do approved the symptoms of currently therapeutic about given represents common of standard

a in a if to the approved, that the Given no that coupled of the adverse support research, daily treatment the unique for once ease-of-use to MDD XENXXXX same if weight product we this sexual address is these our KvX anhedonia certain the us shows in is our a now third comorbidity compelling dysfunction turn to results potential associated Sherry? financial Sherry, therapeutics, antiseizure liabilities, before like update and call differentiated such in be MDD landscape. action novel role as will with in action, partner in epilepsy given results XENXXXX dosing identified patients.I significant ease-of-use other a of mechanism MDD, important efficacy common summary, in such the epilepsy, would addressing market our Its to lacks anhedonia, mood are titration significant with or could as of be a are a KvX also food epilepsy attributes there psychiatrist. as the eyes in to mechanism that milestones. prescribing gain, play differentiator summarizing with believe suppression preclinical symptoms brief who that unwanted the profile an striking and Neurocrine on program physicians.Finally, important could In role event and profile.Importantly, XENXXXX with could viewed as differentiator medications mechanism upcoming quarter and attributes play of a give within over

Sherry Aulin

the patients examining with on focal to has its month. Chris. much, seizures adult Neurocrine Neurocrine adult are very SCNXA-related data NBI-XXXXXX. Beginning this partnered separate with our study clinical X is is focused released be programs, of and that our trials X in collaborators Notably, One are study Thanks the onset at other focal use study later anticipated epilepsy. conducting evaluating NBI-XXXXXX patients for with guided Phase

of plans, have this we of sodium a million, $XXX.X the details. report reminder, channel securities as called at and marketable we for XXXX.So is compared a December steps expect channel studies, We Based some Xenon As cash tested. Neurocrine, from and some NBI-XXXXXX for current discovered of which look Xenon, milestone data to clinical highly upcoming highlights and important to Cash forward this X excited touch anticipate now XXXX. to operating sufficient million, completion news near our licensed NavX.X, to important and ahead and a selective XXth, next Neurocrine hypothesis were and you be program.I'll statements the as of inhibitor term. the epilepsy inhibition in X cash the of operations XXst, selective we're Phase further looking working having with and refer on $XXX.X would to to to we the XX-Q in data on release readouts equivalents financial including September the into release fund events sodium XXXX, XENXXXX on

results MDD late X-NOVA line November top mid-December. our to anticipated First, are in

We complete upcoming our second progress in epilepsy to half onset at reduction partner, X-TOLEX X-TOLEX importantly, November. extension onset make our focal in seizures focal Phase trials and and X-TOLE seizure also December.And study -- programs, meeting seizure on by trial adult the expect patient X expected clinical conducted enrollment We Neurocrine, rates in of forward our including advancing and of longer-term XENXXXX to data, presenting look the in to exact data freedom XXXX. AES open-label in our with continue including we long-term PGTCS clinical the from in X-TOLEX

executing patients progress a in ask plans open in make operator forward development any focused the to Our We look milestones for and team can reporting lives our believes questions. disorders. our with remain Operator? and difference and the on months line we neurological epilepsy the of on living now the other near-term to ahead.I'll our clinical

Operator

the question from line being Stifel. Instructions] our [Operator said, Paul first That comes of Matteis from

Paul Matteis

on a just to some I would progress. on on questions, execution. the on the enrollment, top the some and once really Can then second, what for the X if clarity you One on broader don't Congrats had get color for to full question Ian, you you be line or X-TOLEX, thanks mind. Chris on give X-NOVA. timing data?And the had I timing team due And you be problematic thought congrats still a competitive population. the to profile to these might Chris, of how versus that draw side pretty clinicians the commentary, Ahead especially profile, interesting, of acceptable discontinuations you event to was profile CNS more as rate for relates in dizziness adverse mentioned data, you where line, effects. AEs, a related or it would it on remains actually this where commercially think I

Ian Mortimer

I'll Yes, first. Paul. tackle the Thanks,

you think we're of Seggern half just patient terms the -- but [ think and start be prepared just Chris in one, it terms the enrollment today of about maybe of aligned then, the Von on year. we remarks, kind provide a there, in profile.So Chris AE On that think we've completed the can AU did acceptable all profile, we about ], I Paul, differentiated guided second in and X-TOLEX, Kenney we we of as know, what's on ensuring just in will second perspective next that what yes,

period, a count the last number their the a patients randomized, into number before need the to need period. -- of patients for and and or are seizures their there's baseline we of to count to count the when it's patient a baseline so need patients patients sorry, gets program, number So screened X-month double-blind those X-month number then

top that's some line we So provide be before then total.And results. data to X position follow-up and there's unblind in a can in

X-month top to X- that that again, but analysis, database data, of in enrolled range. from of timing patient lock depending follow-up on last the in just and kind it's data So line range to and

on Chris, Chris then to and helpful.And that's -- AE hopefully, profile. over So you the

Christopher Von Seggern

Happy to AE profile. the Yes. address

what indicated testing profile prepared AE epilepsy what coming as we've them remarks, in with consistent AEs and present with both an across from profile prescribers from with profile So done the profile is we've from the common X-TOLE that were of we the the XX-milligram seen U.S. study. a that's the with XX-milligram dimension

seen what's terms the of specifically with offering consistent XENXXXX gets appreciation for has with with we've an assuming products profile treatment of product the that epilepsy sexual that risk a So we've view, physicians MDD efficacy in concerning ] ease-of-use what as to weight of paradigm of AEs dysfunction XENXXXX and the specific future of potential specifically for and of other there's in profile seen from was what overarching different once-daily every looks very are the that then that in viewed for context in role a that SNRIs, in [ that's space, a is the clearly tested. dosing, the well.So is and the that lack and driver that's utilization. benefit SSRIs profile as mentioned compelling there's that a product approved. we like the And from a point very clinician's been heard be attributes gain And product

Christopher Kenney

Yes. add I'll just bit. a little

really the really what's of question not I'd DRESS But [ perspective. like rate be understand to safety upside. any serious the of like used that So that's that relevant, will phrase data ends kind Chris sexual and event up an serious issues effects, of totality in safety if serious whatever that safety of a serious you're I an having whatever the your anything risk ] you're is a being, the or not any because rash like or the context side Also, adverse underscore from just think I benefit that. acceptable your -- sort causing dizziness if right?

willing safety I but needs on the overall the context back drug think puts focused into safety, also I in signal think the is sense. get -- you're which benefit the substantially separation to context.And just separation it, be mean, of up because in the goes then, to ezogabine risk in active points between you couple really, that controlled question sort course, placebo, that the events to taken what of -- with you're the compared of separation it terms if and placebo. I where point you're and sort X.X of trial makes adverse it's of seeing something, of a and of of accept a to between active there's

Operator

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

Brian Abrahams

the progress. on continued Congrats

just MADRS in safety On that to then could is could X-TOLEX future to timeline much during since on now -- you and limiter Or for update of closer the scenarios or how filing? explore indication?And more submitted, the how prompt on both focus focus data wise? of is that that -- update mood X-TOLEX, the that rate SHAPS anhedonia gave guess, a a just we're review? safety the little timeline getting could the the secondarily, clarify, research epilepsy on you talk behind registrational program as out a be market that on more signal the -- far I to study for MDD, a building those just you more can side And and for efficacy data, you focused to about might bit done we've MDD

Ian Mortimer

the paths see but differentiate call risk we're compelling not And I a jump that's medical program, there's we all in to everybody compelling X but talked education, I'll in a don't seeing see good Yes. mechanism, Yes, are side, remind an and paths on think in. QD, opportunity think do things that then and believe the these, a if remarks the terms multiple space.And ] early of of a if add epilepsy efficacy anyone in titration, even and kind And then seeing our on we've Brian. activity, that's think is in that week the that really no separation we epilepsy. knows, add but registration potentially didn't seeing in we and effect, Obviously, on I outcomes has [ still everyone mood have focus we we for I that clear. then X product we and there's to XENXXXX could we of we are of separation efficacy to only activity, MDD think terms very forward, us antidepressive profile on right? in believe to with if if think -- a that continue onset in our different think anything On epilepsy, please about and Thanks, if then be to it very we novel I today, stronger. I can terms that communication at tackle I'll

we then about we're is put So if indication in are risk I and going that's is previous spoke we work of ahead with overall that to although the moving not benefit think obviously think benefit And comfortable I option.And the depression, question, registration we just in an it. specific important, risk major disorder. primary compelling depressive in that think around numbers the

we the on X-TOLEX data in us to then can your there bar question that really is larger has the terms to Phase X-TOLEX, clear replicate there an studies second a in critical So X-TOLEX believe X.In that path filing and on we be so of NDA.

to the path X-TOLEX X-ACKT can Obviously, into critical because So patient that X-TOLEX use data in extension, X-TOLEX any on combined future, discussed filings. of we with and But in requirements some we data registration give filing obviously X-ACKT. part those X-TOLEX, in the meeting, the critical to previously your really and path answer studies, and with or focused point shared filing the on we've at End as of Phase it's safety question, FDA X terms other not open-label not the with of the the data guidance overall But can as our at on terms X-TOLEX that on X-TOLE database. through goes or the as of we're published, specific we'll from we'll FDA safety X-ACKT. we've on be X-TOLEX well.So go or

Brian Abrahams

That's helpful really clarity.

Operator

Instructions] next from of comes Romero from question The Tessa [Operator JPMorgan. line the

Tessa Romero

alluded next on versus enrollment to the being later second half So of sooner to in little in X-ACKT. thinking but are Should enrollment latest year is X-TOLEX? thinking the X-TOLEX, about a levers the how data X-TOLEX, guidance? that? complete to what bit and the the question, And was in should cadence prior pivotal the expected what key X-TOLEX for end with Or really the set of the on we that expect X-ACKT before of it we

Ian Mortimer

my Thanks, specific versus in provide be don't earlier Tess, to Tess. as pull half well. completed your for later in the of to I'll there's start. from the second half second Chris I -- to perspective any, patient think XXXX lever of Kenney perspective, enrollment XXXX.

well executing patient randomization. screenings patient are and initiations against and site We the of plan

a or We are. assumptions do as best to feel we're have guidance there is error best put going year we some and expectations. And predict. bars based out our on we where we so, our that confident So to

be we of trying get closer, lever go any in think we'll make that I faster. those.But to As don't to terms able specific narrow there's

the have I'm while I want there, and as beginning, the of to if add study. don't jump I specifically as run to the of think go we the in on the you anything happy to second data events. study, can question we from a know and then, cadence have on the integrity quickly and very we'll we conduct maintaining good Chris,

Christopher Kenney

variables patient at so country. anything don't variables in and I add. that's clinical to I and No, just different many each different -- so enrolled there many for any have each are variables every site at trial,

it's -- just to put timeline things drive or my the of extent it's complicated to the it's another. on and say sort going X is to one this what's or hard so, way And that X finger

Ian Mortimer

question in of terms your cadence. And then second

that those So that to obviously, experience X-TOLEX many X-TOLEX, and relationships often in been past. with X-TOLE, that from with have tried have the focus, as investigators And leverage extension drug in talked with sites of we've treated being we we've clinical worked still so had open-label the has XENXXXX our with study. we've patients investigators frankly, X-TOLE the that in are that that in and investors quite

have read separate of So is we out When that trials. in premature Tess, to X-TOLEX first that X X-ACKT, of Phase we're clinical to to which one doing It's guidance guidance X can come we X-TOLEX. on then on today. those all the going do back and

Operator

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

Lin Tsai

Just MDD AE out. We understand reading from and different the be XXXX MDD one could on between -- epilepsy. of profile

you've blinded monitoring think monitoring -- safety. how are previously mentioned you I

rates AEs speaking, you -- compared in seeing study? to AEs So of compared how out and maybe study are expectations? anything the directionally the discontinuation the on epilepsy going blinded assumed are to there guys your due lower to what AE MDD the Is in to way, your the rates internal looking to you ordinary relative Or study? another said

Ian Mortimer

can be to unblinding can some We're and now have close as Thanks, first guided details is you I'm very data, sure the Andrew. of study. others late in to November may mid-December. appreciate we'll coming the the is in of questions study of I'm complete. MDD well as the this the on other data we've sure the just weeks, and

sharing be need forward safety to any study, So not and do any term. data.We we're going review we're previous full in set on to committees about study. we're run the said going safety make we're have are there as But to adjustments data, it going to in near hasn't the the review monitor comments specific those obviously, committees, to required. that around the way, based data talk previously and to the along clinical looking that, in we're specifics going seeing any we're not And on we blinded the what

Operator

line The the Gerberry from question Jason America. Bank next of comes of from

Dina Ramadane

] and Jason. thank you quarter the on taking for Dina Congrats [ our this question. progress for is This on

being I just, sexual safety see guess, is research MDD a lack profile in on is follow to kind of SSRIs be major given driving that antidepressant don't serious of space the or and to the that a AEs for in of if wanted force of in on safety the this trial, we'll the kind that view come any besides the with shortly. And then, we SNRIs line generate -- positive patients? about patients. So your that that very dysfunction, epilepsy does XXXX's ] guess, seeing that MDD MDD the to part be uncertainty market had out sort able point a XXXX add positive I sort just any KOLs additional AE did you differentiator question could we a gain, in [ X-NOVA top of up mentioned XXXX in data risk effect earlier, on profile weight

Ian Mortimer

Dina. Thanks, there. lot A

I miss So one, all here. -- them we've in. I'll But just down we jump back got think if

make the about one X-NOVA disorder. then, of kind pass epilepsy to Kenney depressive I'll And comorbid obviously, depression, I'll the just different comment patient that primary, it patient an Chris to has study. that the talk global maybe So has than around major which is population is the that

we're X-NOVA, with in we read-through -- work don't I question any we in in about data I'm there's not you Seggern, XENXXXX the if maybe we are program. XXXX comment that. And Chris Phase but the if your looking, see obviously, he can MDD.I think X. you then, looking at that the confident separation, talk so some epilepsy And in stratifying, don't profile a those think into just think started Von can Chris, about AE doesn't of very And saying

very ability clear studies we and in and consistency So X-TOLEX have that. and be to epilepsy the across in profile I reproducibility We're absolutely compelling and the the from X-TOLE confident execute just want to X-TOLEX. with

think I deeper, is near why read-through term of an But go in the patient? depression program.But don't interesting has this Kenney, comorbid a outcome X-NOVA. patient So that's a the I at we just in comorbid in that really and epilepsy important our looking readout or has any patient into that don't think the Chris epilepsy little that

Christopher Kenney

is what looking neurodegenerative epilepsy. different mean, issue has symptoms or a of or be underlying depending psychiatric I on issue who the the can a I say depressive Yes. at different a you're that would whether pathophysiology patient,

mean focused it's going program, of that's certain focus. exactly X we using be in one concrete mood are patients, at So obviously, antiseizure an looking to just more developing way epilepsy But scales the Phase those that just a and the drug, in in the we're doesn't our to behave little on drug population. the same a is because the in other.And population behaving

body So we're standpoint studies about their done, going X once of enriching enormous downside from those is, this those drug are have symptoms.Now not the the purposely how to we're Phase us patients respond the of to for depressive same studies in symptoms, for and are data the just to X-NOVA isn't we're as depression so are some let way the epilepsy. limitations. and that But both guide there fact information the depressive acknowledge we going the

Ian Mortimer

or profile Thanks, on more Von XXXX MDD of Seggern in Chris. a the on little AE bit Chris MDD.

Christopher Von Seggern

Absolutely.

about comparable, So the remind these if from were profile majority dose the take the milligrams the XX-milligram mild. of a it just step think was difference think profile. profile, back XX from that we that AE highly as to reported about placebo, And to emerged when and between pertains indistinguishable the not XX-milligram and and you milligrams, XX folks, are the if X-TOLE with the XX-milligram

XX-milligram highly end then at So still AEs dose emerge antiseizure with patient the that with appropriate but paradigm, consistent dose-limiting the of -- profile, the other high population. active for -- that and really are medication CNS

MDD at be of -- AE the profile other the to question there AEs So of in looks as are clinicians. ] AEs seen context cleaner there other think a trying the market emerges positive the better XENXXXX the the are around, research.So I differentiator? eyes [ was specific that look can Well, the in the

the and care. ultimately product in the and totality in in But profile armamentarium. viewed be in within risk the So also of to within clear, that profile which from being mild it X-TOLE. be positive is current would spent be time the sees dizziness, an perspective -- the common something in our into emerged benefit little context if AE diving market XX-milligram was transient profile differentiator a But of to AE on very of could their a certainly less that as the reason result reason -- an well that standard in similar is one we the AE potential such a being research, to clinicians deep potentially that the used

Ian Mortimer

now. we we maybe And comment. add huge point would I on XENXXXX -- body have If one to Chris' just other a data of

comments out Just our dosing. X as we earlier, Chris have reminder, first years patients Kenney's than and more a of

that our consistency of we potency from seeing up -- step and this a as CNS milligrams, milligrams depression, and hundreds this available. now, we on dosages drugs tolerate you as have move hundreds in We think think up and not exposure about we're drug. of about would be from know XX step that patient to in some to And we you experience, same.So or going XX years And the we adverse activity epilepsy know the in XX efficacy in based we multiple events to milligrams a when -- profile. X-TOLE patients there we epilepsy all get in of the get and are of these

dose, for a tolerability. if the so, you address opportunity some there's dose, of And don't you which certain tolerate lower to a an to can move

have we I we that So about from patient amount XENXXXX, differently and tolerate patients it, about will think know because patient. drug have we to we the we -- tremendous a when flexibility think know

Operator

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

Kyuwon Choi

I have X.

MDD? team. First and for tracking competition patients the comment in hasn't question on developing appreciate faster recent the whether But of any has trial is recruiting comment or second of potassium in for for others out on sites pace any with zuranolone can you X-TOLE. a I channel under on seeing your scenario, the potential drugs how to it's clinical you affected where you're overlap if than could enrollment FDA of rejection comment just X-NOVA my future regard X-TOLEX, your that epilepsy?And your positively, maybe thinking development With maybe reads

Ian Mortimer

Thanks, Paul. Yes.

running X-TOLEX, lot X-NOVA the a please communicating epilepsy I'll -- then about in perspective the have Kenney, the we to close today on So think and you're we Chris in as mean, of comments I'll I of a think can I as your question.So that get very experience site, maybe and add one studies. we're obviously, well, couple X-TOLEX of global to so we is investigators make messages first the

any if we we other run have studies the look we number think the to largest when few last epilepsy I years, over of sponsor. back compare significant ourselves

the of at at experience amount look that companies studies, so the we're we number our recruitment years they when perspective So huge focus others. we look there.And a rates find that but to I our let provide don't these will think run then in clinical there's epilepsy site rate gathering. over other X-TOLEX, just X ability that believe of one, a Often, will have when recruitment I'll complete have last I we on his Chris outperformed studies, on that studies competing and take

we're comments the at has But obviously, work done. And you're that sites on individual Chris, so very seeing of team other the competition? that proud any specific

Christopher Kenney

medications issue challenges competition I my is challenge Yes. come the more knowledge, that with the sure support hasn't other able has at And to sites the single up, antiseizure mean, that the #X probably down site even be resources site. have appropriate making of to about to the each a the slowed study.

believe start to of Biohaven year. X a public believe when drugs, think the ago. I we about Phase going this KvX -- sites the you're information you out the timing if quite going while went to say -- you that I to of were end in is alluding So We by terms out

already on. sites we we've so, most those And that locked focused in were

-- terms other in down has us to-date. KvXs of So any competition not that had slowing with role really

Ian Mortimer

Chris. X-NOVA maybe your on the other And regulatory Paul, environment. Thanks, and question then,

division. We X-NOVA and haven't meeting. with interaction the we X development, had had if move an psychiatry into -- late-stage positive -- Phase clinical with do of End is haven't regulatory we Obviously, we

to we interaction.When looked have zuranolone we're as through program. still So think summary information disorder in of have we don't regulatory mentioned see I work caveat, any approval that's think the the I the interactions, at doing maybe basis we with late-stage as available, we've read about need we'll major depressive look regulatory publicly we just the detailed at pause more to and the on would that that question earlier, XENXXXX until we with that

Operator

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

Joseph Thome

the time How potentially are with some it the Neurocrine one when us, Is Is data. moving an considerations on And decision? Maybe you FDA? of End immediately you forward about you it option? thinking initiate just Or safety you Or start remind sufficient? data? is data that upcoming you to What to have first is for could after kind additional readout then X remind are a NDA time can after make XX-week that? that that having of with the filing? need co-fund have? us, Phase line the through after XXXX there on what that?And period double patients Is the you can the you database will some required filing, before

Ian Mortimer

to I safety Great. one Thanks, co-fund, and do first database? perspective tackle provide Sherry, want on then, Joe. the you and can on Chris

Sherry Aulin

Absolutely. Yes.

So a with we as royalty reminder, Neurocrine, a for structure. collaboration our tiered have

for we that are on the be based if would sales. progresses, So royalties ultimately, eligible drug

the [Technical So the to which up for to have Phase royalties. the the XX% in fund get an allows amount at before step or the of [Technical incremental around information we for hand we'll data evaluate study, We're tier X decision in the us X information X opt royalty, have more we're would option highest which lot we have the in development pay this trigger make able the program. of all the Difficulty] co-fund in would to going be co-fund.So to around benefit in going to development upcoming return, to importantly, costs. to And a from to to addition of having Phase Difficulty] Phase

make that on Neurocrine all of of and and want protocol are what a Phase in I that the of X say [set XXX very be able very up and well decision are. able we'll review space, make will we their positioned And what information.I driving to we'll informed to to is also, have ] stage, the next X, this steps be at ultimately, to see development the program. And decision. our look experience educated based upon with totality out, development a around the agreed that to that, FDA full the a Phase budget given an I point program like, do think will So

than it case, into even finding may around possible X, Xb directly are study decide X from larger proceed is Phase which they Phase in study, that So the signal into this a rather longer. that to Phase timelines

to decision going are we into at that term. they regulatory a months, that least near information straight need X, say, say all like Phase expect that of I'd make maybe have I fastest, if discussed. XX in probably, So the don't months XX at until it's and they I'd the interaction more

Ian Mortimer

you double-blind database Sherry. Thanks, assuming period, exposure. more NDA think referring and when your that on safety question I around long-term you're [ I'm specifically -- And Joe, of the to kind ] then, after said

that answer is follow-up, one. this have know.So us opportunity. a let a And large market you I'll if then, So

that we about of that have long-term in that's ICH I'm going months guidelines things So XXX any safety be experience or not is an to much of exposure to terms guidance of [ months XXX we this think competitive exposures as XX long-term the a required think is subjects NDA we by differentiate one have sure, amount subjects XXX of can exposure. significant us to versus space data. of continuing the exposures, now with this that subjects filing is means. of I those X gating long-term And so that appreciate, the Actually, or are and in is ] the even you of molecule of

Operator

from next line Raymond Brill James. question of Danielle comes from the The

Danielle Brill

you We patients with comorbid could was response other rates enrollment or I to and more decision in anxiety about just disorders? response to PTSD you antidepressants, curious without with wondering this the plan rates, treatment with out enrollment PTSD or if PTSD permit can X-NOVA. treatment of you stratified talk lower if in associated ask if specifically since break be patients traditional

Ian Mortimer

there? can perspective you Kenney, provide Chris

Christopher Kenney

the line safety, line on MADRS top et analysis and cetera. top focus SHAPS of the Well, is to the going X-NOVA

So it's the top not of line. part

numbers. isn't And sorts looking -- of but patients round things, the differentially second the we're head, we I don't at not a major I of know those relatively that small don't in Danielle, at PTSD, my stratified The it's think study. -- look talking of looking numbers of I off top responding know are about at plan. but those the data, whether can isn't the part

a of that think so, size, doing this in utility. may even have And that I I the think limited study context

Operator

next of comes Goodman from line Leerink the Our Marc Partners. question from

Madhumita Yennawar

on This development. your in the XENXXXX for and candidates data is the also formulation near expect any term? pediatric an Could preclinical just line on of from update us give are molecules to in these Madhu Could second-gen your you we that Marc. see

Ian Mortimer

Thanks for the question. Yes.

We what calls, got the we've -- think, are -- from alignment for on stated, we regulators I plan have previous in as we pediatric XENXXXX. is

we extrapolation younger some cohorts in there's U.S. open-label do the rule, PK seizures, -- terms called where to an of layers onset to of So this the ability have can focal the take what's in advantage work patients. in we of

our We moved of XX tonic-clonic from lower will feedback to age based seizure study, have, above start the with X-ACKT adolescence we and or bound and then children.With on generalized regulators, the study study. primary for our move that into

patients to So group. going an then formulation. -- terms into younger can age so to get a certain in the capsule we'll pediatric pediatric need much of when those we're oral work formulation, program. in be groups, on go to obviously, And some specifically a on X Phase we age the And enrolling then, down

in clinical the of the that a times lot that don't next X, development, transition question. of time move or the would next molecules probably the and will year those, that preclinical over to with expect data but an appropriate well.Operator, we sharing we have we start of publicly stage can some would that's to we into where development, as different we're and about So of and yes, chemistries a molecules drug, preclinically internally.In that communicated target CNS. channels terms Kv work talk And of that we've ongoing potassium kind we is we of number have I think -- next-generation the we've publicly different are a number interested

Operator

I apologize.

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

Ingrid Ibarra

be this XXXX approach? to ] [ any any speak ] that with type explored I Ingrid optimize, Wondering you challenging [ ASM. at to This to could realize efforts Chico. this Laura epilepsy for if another Would there be but to something space. may focal all of dose be would in be co-formulate is could on this advantages

Ian Mortimer

time Chris Yes. you've of over done interesting about obviously, and Thanks, have Von medicines developed Really thinking some types Seggern, the Ingrid. antiseizure this, time. know question. I that been

can add well. to Kenney, Chris you So as then, start. maybe And you anything have if

Christopher Von Seggern

that what commercial And a Yes. in thinking frequently for increasingly Levetiracetam, can combination be of commonly there something lamotrigine handful used is the with medications. are in we been that's I antiseizure lines What co-formulation for most certainly definitely expect which from our other about candidates products, say standpoint, use market those early opportunities. used potentially of products consideration. are seizure is a and It's ideal are would therapy, and lacosamide radar on onset focal use quite

the there full doses with XENXXXX range therapeutic to of requirement other us in Although, well exist, initial titrated technical require to to the that to advantages that gets products think we complexities about when the dose efficacy.One as for selected. of are the is of a don't the titration treatment be as consider that you and dose FOS key of

medications a that used obvious So desire antiseizure co-formulation question there's bit needs other commonly with to little the be to explored. more to that think and something still than about technical complexity

Ian Mortimer

Chris Kenney, add? anything to

Christopher Kenney

Ian. to Nothing add,

Ian Mortimer

Yes.

Yes. Okay.

not same the real everyone titrated, there's said, a drugs dose. think, have is challenge these Chris you are as of and gets a I there lot that to

co-formulation. provides And inherent some challenges that on so technical

Operator

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

Unknown Analyst

[ is Mohit. on for This Serena ]

two. have I So

is help or synergistic of to a if any is there's second monotherapy treatments there MDD a the there study see doesn't are no it if it my possibility then in benefit [ some studying first if an if is, question The adjunctive as looks even effects?And MDD that antidepressants in does, on anhedonia, XXXX, work have why for understand when us shown scores? ] can like approved anhedonia you specifically

Ian Mortimer

turning you Sure. Kenney, your development and start as a start future can to do you adjunctive I And part to in provide ahead positive, this. global setting first want can separately maybe think running and we and signal would on very of your -- think move perspective Thanks a an weigh maybe questions. would you we the study on we perspective to study just Chris if in with then that comment, have, potentially think with and your see if X-NOVA you -- -- be that's adjunctive this Chris any and studies? for monotherapy the I'll both isn't question that unlikely on I the well? adjunctive on.I if don't

X-NOVA, scenario, the perspective we why also is it ahead, thought provide don't think in you there definitely question. positive move about, it's then I think where your we're and moving to anhedonia I and a jurisdictionally question interaction based somewhat will that then can we regulators.But the with XENXXXX be on and Chris, dependent

Christopher Kenney

I Ian. that. add think have don't it, covered you to to I anything

Ian Mortimer

Okay.

up we the maybe monotherapy is ahead And anhedonia I ] showing your look X-NOVA, in think a in now, Chris endpoint so Chris, or an we're development. mean, primary and both if studies, we're I development.On seen on registration or haven't in that as adjunctive haven't I but perspective as just used know, definitely then way, endpoint potentially studies and future different either yes, more moving [ we into why we positive would a side, anhedonia in a -- seen maybe lot studies at

Christopher Kenney

then, and hand I'll off start I'll mean, I off Chris. it to

then at find it's look is moderate for case you If difficult depression, lack severe to the who take X-NOVA anhedonia. meet a to complete criteria very of the patients, a having study, in the which the

that's MDD. a feature key fact, of the diagnosis In the -- getting of

closely. together anhedonia. Ian said, pretty interest as yes, in lock increasing there's I this to tend they mean, So just been And

something Chris? not your it's focusing the think by just people and I in on think, observation I of not is past, clear it's that more treatment. now driven, become it worthy --

Christopher Von Seggern

Yes. we these associated years. that to go a point, profile research, can and the anhedonia, that there's endpoints is efficacy a gets The see FDA I do this a and very MADRS primary there we're only market to what [ in on order approval. the ] products only interest space. consistency assume in that it's increased around this seen for ultimate from clear with regulatory with Ian add unfolds avoid as And But eager component out depression. deviating how one of perspective when And thing fact Chris' we given can in efficacy to coming comorbidity the have in

Operator

And question will William come Blair. Tim our from from last Lugo

Tim Lugo

squeezing in. for Thanks me

X-TOLE. very For X-TOLEX designed and X, to I similarly know they're

and profiles those features ] a I now However, of was unknown patients one the think is very and many X-TOLE therapies asset company within defining of have eventually community. of the [ how from maybe and and X-TOLEX XXXX study. maybe are the failed well-known isn't baseline swing an be how Xenon you will just -- talk Can the results how that up X-TOLE lining could coming the what versus X

Ian Mortimer

Yes. Thanks, Tim.

that be think question a I on really interesting we're it say but today, tracking. we a think absolutely monitoring. that's lot have something that we'll don't I to

I'll So and yours provide Kenney well.Yes. perspective, as my give Chris then

is the just very comments naming and some and deliberate. point, was opportunity take that So obviously, X-TOLE, which are made, this of the there maybe is back designed to you after X-TOLEX which step good a on X-TOLEX a convention confirm are

an are severe on anything studies, were completing as population. look X X-TOLE is difficult a trialed X-TOLE.But in have molecule we to of a same an study, the patients that we look to X-TOLE, part that to and X-TOLE, at they at that to was the we was failed as at there study, and we where during run you're will to measures. patient look the be severe we'll exclusion the those number severe patient look burden.And We're that and But got baseline be was add always a think as as a And as it enrolling into so be a as well now relevant point you're quite a therapies Tim. able because right know literature, inclusion, prior something characteristics comment maybe for pandemic. closer that, X-TOLE changing that X-TOLEX the to can't background is at population, we we run, as it running different on less when that. seizure another study, number we And And Yes, as drugs an at criteria patients. not when find to to would that? the every We suggest, compared X-TOLEX X these study I population. get us So of during a day, would on.Chris, comment also, get It's unknown at least baseline hypothesis time. X-TOLEX, of at you was more for XXXX that coming

Christopher Kenney

importance eye these of of as the I emphasize Well, want baseline keeping just an on we go to sort the of studies, characteristics forward.

make with that's to of study do and to the So something able not we realize that then population we is because till want wait end somewhat not, And we if be what to the keeping expecting. that want pivot sure that. the always we're in to

a that where something very that's impaired. scenario, we hard to who follow are imagine end patients, we're closely.I So think going up more it's to with

patients up patients, respond data think from impaired. the actually And it that tease who with end And it's better. so, suggests less out we point as I those more likely we are X-TOLE, to Ian's that

have I how to remains Phase compare. all we So of the course. populations It But confirm so in say. exactly seen I'll X, that's that think to -- be

Operator

you. joining. that, this With today's you conference concludes Thank call. Thank for

disconnect. now may You

Ian Mortimer

Okay. Thanks.

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