XENE - Earnings call transcript Q1 2019 | Xenon Pharmaceuticals Inc.

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Operator

Good day, ladies and gentlemen, and welcome to the Q1 2019 Xenon Pharmaceuticals Inc. Earnings Conference Call. [Operator Instructions].

As a reminder, this conference call is being recorded. I would now like to introduce your host for today's conference, Ms. Regts. Jodi Ms. begin. may you Regts,

Jodi Regts

you. Good our and joining on XXXX. you results afternoon. and webcast Thank of call quarter financial the for to from us first Thank discuss operating our

call me Ian and President are Joining Xenon's today's Dr. Pimstone, Executive Mortimer, Officer. Xenon's Financial Chief Simon and Officer; Chief on

to or and potential our a Phase timing addition into and potential the in clinical the commercial and related trials; your statements clinical will a advised and the and efficacy trial and clinical success give open and of results. our timing collaborative XENXXX proprietary potential efforts; candidates; of to with financial our plans, clinical product of After trial during we of will Following our our cash anticipated will XXXX; or and designs of certain of we a and later-stage trial. clinical our new an timing potential Phase programs this will programs; public introduction, efficacy, III regulatory research the market, development enrollment; - IND be timing ability programs development operations presentation that number achieve of clinical IND-equivalent future submissions review Xenon's into data; the questions. XENXXX call milestones this of call, pipeline activities; initiation about of the safety into of the the to to clinical up development activities; from overview the preclinical the results that are of Simon addressable II development and ongoing Please results the of potential and then Ian profile, make regulatory trials our status our publication including to forward-looking, sufficiency agencies; a future advance our that, the development fund future of statements and

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

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

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

Simon Pimstone

is our you, year-end good allow our of I programs afternoon, the Thank Jodi, and questions status during at provide on to each update call. of this each end today of so brief a everyone. therapeutic conference detailed recent on and candidates gave a call, aim for to update my stage Xenon's clinical

strong of continue development Supported make pipeline clinical sheet, a to significant this the candidates, anticipated with goal On of highlight plans and product half development progress balance second robust in I'll of having neurology-focused advancing by the our events or XENXXX milestone XENXXX. during products XENXXXX, XENXXX, We executing some year. this we're today's the multiple important Phase of year. later-stage II call, including our

treatment me XENXXX. epilepsy, with as begin developing we're rare a potassium that KvX pediatric disorder. and a for Let The neurodevelopmental seizure modulator channel severe KCNQX

be published epilepsy, previously treatment by ezogabine as could suggesting focal mostly on the ingredient adult tolerability. in this successful for also approved of was active pediatric treat population efficacious the with children FDA that use good epilepsy, difficult reported KCNQX to in XENXXX While ezogabine a reported series patient the case with

anecdotal physician as as well in series and feedback, development in While as reported additional non-controlled, clinical parental as burden improvements behavior. seizure these and well in

in was provided infants treatment patients approximately FDA we a tablet use currently briefing for our pivotal ODD, of the drug expect developed for considered of finalizing it package this complete in indicated quarter. with is or as children children, and In be in a XENXXX formulation Designation, to unsuitable to that may Drug by drug epilepsy. end pre-IND formulation FDA initially we show a single clinically and product that Orphan evidence XX a study submission, the up adequate, and trial response that as received meaningful Xenon hard-coated X testing KCNQX years the that XENXXX ezogabine effect. was the final are of preclinical old a Importantly, Recognizing from to pediatric-specific to acceptable

of test help that study quarter We will provide exposure healthy formulation is improved XENXXX study advancing in in a We be providing the novel patients adult of initiated pediatric III in the to adult which PK the anticipate expected this pediatric planned to have PK trial. formulation into product volunteers, pediatric before ensure XXXX. us plasma drug the third decided to our important the that in Phase information is adequate

order in now trial clinical we the this, this to Given in IND in III expect the an KCNQX of Phase to year application fourth initiate quarter file epilepsy.

the with We III our approach of trial a Phase filing about and advancing additional endpoints in will and as pediatric to with final trial opportunity in forward look antiepileptic details can generic to first closer mutations plans Our trial epileptic precision believe we take treat final XENXXX in that the us epilepsy. clinical this as We medicine genetic IND. and precision epilepsy, of an approach design a provides medicines these drug address medicine get leadership XENXXX underlying novel encephalopathies. we're excited the these potentially providing KCNQX form to an use to role potentially to be progress

last transcranial announced I tinnitus potassium the best-in-class of potential application study. for epilepsy adult such with and XENXXXX, is developed focal in results including Annual At clinical treatment Meeting disorders, to Society, a Phase other illness. the neurological TMS the from American depressive as ALS, channel stimulation, up major differentiated Next our we trial, final or the KvX of highly magnetic the XENXXXX next-generation being Epilepsy modulator pipeline promising

were Phase projected of efficacious were summary, and consistent tolerability antiepileptic or AEs or AEs the as exhibited data All as the XX-milligram with of significant clinically majority class. or profile dosing with effect where XENXXXX by by results respectively. this moderate, evidence findings. suppression the TMS were of spontaneously measured a Ib dose doses. brief mild, a There CNS PK and drugs and I provides of the study supports mild a ECG and good EEG include excitability indicated being once-a-day single Phase XENXXXX serious of lab EMG, As The and corticospinal cortical no that

Phase advancement of the our of assessment complete development. package data Our I of IIb into Phase supported XENXXXX

focal An in epilepsy. XX of compared administered been XX-milligram trial placebo The helped selection to percent for the results active a of this from evaluate application trial our adjuvant Top the active using XX line our the with FDA. dependent now mid-dose designed focal for United has of Europe. adult treatment endpoint to authorities, anticipated versus of of we will Canada which results placebo clinical period of study X placebo. or regulatory groups tolerability a fashion dose the This treatment X:X:X:X XENXXXX patient XXX with XXXX. safety double-blind, adult the selection as the enrollment are we epilepsy. X monthly is, trial three plus dose by upon patients arm. results. a clinical for multicenter milligrams, [ph]. set the in focal the XENXXXX IND of as in median And is have be to of milligrams, second line enrollment, by We milligrams IIb from a primary are and active idea Phase treatment TMS as this half seizure and with is recently States, XX time XENXXXX patients numerous clinical Additionally, including study placebo-controlled, the the of patients rate randomized XENXXXX doses in underway of in Approximately efficacy, the The of the a better site doses to IND-equivalent in and blinded time manner of baseline expect in trial IIb the trial accepted randomized, change Phase release IIb Phase QX XENXXXX clinical and we trial with course, initiated frequency now in

channel highly sodium for our epilepsy. the the of Turning to developed NavX.X the third treatment XENXXX, potent, pipeline, product in being inhibitor selective

I we to changes mild, dosing safety, of XENXXX the well. X To Within pilot healthy we suggests suggest study in be Phase cohorts AEs I predicted reach TMS like serious demonstrated a EMG with have We humans with Phase now planning laboratory are of the deemed moderate clinical data clinically twice - at to that on trial XENXXX's resolved ability in and I meeting. evaluate dose ECG, development. parameters in majority trial a and were results, clinical subjects, to placebo-controlled for a transient We the PK mild X XX CNS and clinical II hours activity XENXXX compatible Phase pilot TMS preclinical hours, regimen. an demonstrated vital daily signs could were being PK along The or dose both of the been related ascending the EEG XENXXXX, trial to were PK no with included All efficacy to randomized, the in There tolerability XENXXX. or of double-blind, XENXXX trial, demonstrate spontaneously. TMS or December in or arm with have once a XX in profile models, with observed in Based adult summarize data these a completed as from I and AES Phase the multiple majority unrelated and tissue. TMS proportionality half-life study, which and TMS XENXXX and we significant where ascending safety single by AEs Phase findings. our XENXXX target exposure sorry, pilot reported promising

SCNXA In and expect our and for We expect development epilepsy, as to And B will plans, pediatric the or forward directly treatment feedback the SCNXA FDA, focal pediatric a submitted epilepsy depend pathway the adult underway. epilepsy A formulation forms document well evaluate from been we work are order already seizures. support quarter. to rare outlining within pediatric meeting. XENXXX has toxicology receive pediatric the advance future to patients, XENXXX for studies type upon feedback juvenile including requirements for into to this of briefing

a dopamine, in active treating reported United the in product clinical States, histamine include calcium CNS-acting childhood fourth has have channel other flunarizine. neurological modulator also treatment treatment the countries of benefits ingredient and vertigo, for the as of Xenon reported inhibition. migraine, a adjunctive as childhood disorders, in in migraine. Other hemiplegia a mechanisms label, and has of serotonin certain certain has of alternating been and outside FDA with XENXXX, disease absence AHC epilepsy. AHC epilepsies, an migraine that and designation ODD hemiplegic including number flunarizine hemiplegic both Available granted and The off of to pediatric Our including and is contains treatment for T-type rare granted a XENXXX XENXXX

Given widespread my anticipate physicians one XENXXX status flunarizine, supporting at development number studies. programs. strategies under for investigated orphan are trial who neurological stage Phase interest updates of we In consideration. XXXX, each II use with or We've good have an in sponsored our expressed discussions various later had indication. of in concludes of the least clinical on a initiating clinical That

the you development we're Looking assets on In our to to the experiments make work, of months. over to parallel, products. progress on stage-ready outside potential keeping forward other on our continues conducting I on development R&D preclinical look new from candidates. go/no-go a allow exciting team decision-making at our coming number company advancements up-to-date

in position half a additional of to year. the in updates second be provide to expect We this

promising to clinical poised candidates, strategies today's our on continue So II drug to support diligently or to potentially development comments, very to four this development be year. Phase in all execute summarize we later-stage

of therapies are pipeline, medicine adults our or look novel as focal epilepsies such alternating such forms advancements as pediatric KCNQX very to as population, we epilepsy anticipated targeting We common hemiplegia disorders, broader to our address and with the patient designed epilepsy. or well SCNXA rare of near-term childhood children about of more childhood or excited with neurology-focused forward precision as

to like our briefly first to recap the Now position of XXXX. after financial who'll the turn quarter Ian? call I'd Ian, over completing

Ian Mortimer

compares cash as Thanks, guidance. I'll well The release details cash position, our press our our on financial cash And then so specific Cash, securities I'll were within milestones. statements of million of equivalents XXXX. as XX-Q upcoming XXXX, filing, the covered Simon. of This with as are an XX, million. marketable and as overview conclude December XX, provide March review $XXX.X runway in a today's $XXX.X to of

outstanding. - XENXXX, and sufficient fully this Based assumptions, a approximately at fund X approximately the preferred we supporting one-for-one operations option on XENXXX, anticipate holder, our shares potential outstanding revenue March the These planned shares to As of XX.X current subject and from new on shares X XENXXX XXXX, XX, are fully certain convertible million having XXXX, of partnerships limitations. which million development or and which we XENXXXX, existing of common the basis Series clinical common had into generated excludes to any include our cash partnering arrangements. either into

backdrop So Phase this Phase trial and a of IIb clinical we sheet, receive hemiplegia strong III adult in with events migraine an treatment trial epilepsy. epilepsy; ongoing trial the advancing number a important childhood, as look for of XENXXX depends absence FDA for clinical or a II or to pediatric KCNQX which later of this in XENXXX anticipated for Phase in focal initiation initiating expect XENXXXX balance focal quarter; orphan including condition, this to our milestone the on feedback, epilepsy, such epilepsy forward alternating childhood initiating the trial hemiplegic either Phase XENXXX upcoming, or II neurological as clinical clinical epilepsy; and with we SCNXA of a adult

are when can So keeping development our questions. I speak into updated now that year. entire up forward Xenon propel and to our driven you for we pipeline open the And to progress. deliver clinical I results look call we we late-stage neurology Operator, this for the say on and mid- team

Operator

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

with proceed your You may question.

Paul Matteis

XXX, it. models it preclinical for and was describe Thanks study, NDA? pharmacokinetics regulators, did was you have patients? I chronic ultimately asked this that whether one additional on Thanks. you're for in this on Couple questions that volunteer leverageable if Appreciate or an just was to second, done toxicology update. much and do the wondering fully to you about of On the could the clarify XXX. then work old do comfortable going of you you can that XXX, toxicology better healthy when you so is animals something the any decide work then juvenile into ahead or And of for to not talk in was file all by

Simon Pimstone

important questions. very two Simon, Paul. Thanks,

study. So the first FDA-mandated this question, is not an

the internal And weren't it felt, just have We clinical told at was information use all delay. more to slowly the an the in maybe have rather FDA done lose be beneficial the think a expected drug - study decision the engaged new study not on to than was do and be PK being even to the able the adult for would solely. to submission with need the This I that time, without we our there we going FDA, team to product. submission risk greater much given to where

had might is It's this or very little. significant doing more lost time the a month actually So delay versus probably so what very, a we been have waited.

we practice. FDA think It mandated, but this we way So good wasn't it's think to a forward. move is prudent certainly clinical

the III recently which in work for from data any the was other start. an start. from question, nonclinical tox, obviously In do were We to I - was, was we'll had Phase has in coming in we Zogenix support back asking FDA the sufficient experience say, necessary we older that's second deliberate can III them is, a were do assuming the reference current of nonclinical words, need the GSK to they very was it had think from the molecule. a in preclinical data Phase no terms of Paul, whether for all sufficient. writing, deemed with answer which that On is very right additional writing The yes,

toxicology at work ezogabine whether we written tox retigabine deemed obviously for and fenfluramine the engage ICH from that new and really based the thing such question which on necessary was would ezogabine, them But that guidelines. One there's on fairly We feedback is on required, decades the apart, believe recent to the should be time is registration. anything GLP remember under fallen asked there the on FDA. the have might FDA the haven't we was versus have through course, and think that Of study don't done you anything studies that.

I with and least whether can But more fenfluramine, done certainly And that issue to that was so I done respect say under is recently don't we ezogabine tox the at underlying much think new guidelines. acceptable know.

Paul Matteis

you Thank on Great. for one And that. on then all color context and SCNXA. Appreciate the it. just

have genetically tested population, go number patient of a Phase and you sense patients get centers go that Assuming straight have a before to those that whether not you good kind of Thanks. of begin can do high ultimately these certain and whether there ahead the II? the or or that are diagnosed efforts not you clinical into initiating

Simon Pimstone

Yes.

So that's another important point.

it's probably think of that have I aren't these patients. numbers high centers there that to fair say

So any double-digit specialist trial where, like about assume, of in example, to numbers one We multiple an one doing at there's patients. - increasing building and we'll we this a these center for screening and patient Invitae so, is know, would example, I rate. across just expect be That that clinical for GeneDx don't do others for in study, we year. centers, center where looking Europe KCNQX, budget look per per are after

ordered now Invitae, U.S. institutions up XXX for have - have signed on over tests think I through example.

getting be registries. monthly building We are We're Behind reports the Seizures getting - Invitae. with and our part we as are monthly will collaboration of

registry of We academic over collaborating with also population, for patients these a who an for has of we're example, know, XXX the SCNXA children.

diagnosed are norm. now at become the U.S. to good tests going rate think number have being finding the to where cases, a will an Paul, kids sequencing at centers, a we incident all offered then And as being at get have that not-for-cost - a least increasing we idea, are will of exist. as these So offered, I be they studies these we

there'll So single the there around comment. U.S. we're just wanted with quite be that good while Ian centers large numbers, numbers aren't comfortable a very add to

Ian Mortimer

just add couple things. a I'll Yes. of

I patients you're think QX versus are one that XA physicians seeing comment the seeing patients. not is

- is like with So to of we're get work we're XA all we'd all what if XXX XXX. these epileptologists into available doing to the with with pediatric work XXX are do population the is doing the leverage we're

pediatric So these XXX investigators. can study we an encephalopathies, QX the a can it's into same incident go from the cases it's the would they if the feedback if And same into they diagnosis, that XXX centers, get rare if have trial. go XA new to And diagnosis, then a go with if we agency. they

I think there's we that a of lot do. can there leverage

actually than other been The thought think maybe higher interesting, paper just a previously. the we incident is that population of thing actually there's recent that's XA the was

the to happy XA that population. rate are the diagnosis you in direction a that's So recently point of But come publication in out. the higher we seeing of

Paul Matteis

Appreciate Okay, great, for Thanks awesome. it. the color.

Operator

Thank Raycroft you. from And Maury of comes our Jefferies. next question

may You with your proceed question.

Unidentified Analyst

for is this Maury. Hi, Swapnil [ph] on

I couple had XXX. So on of one a questions,

reported not work preclinical do are And Phase planning I, do better. previously any understand more in limiting to that see to you dose you toxicities. you then therapeutic So the index

I you in not do case? Like on what proceed safety wondering, how like that that. happens was more do if just any see any So update you valuable is there if like, And signals?

Simon Pimstone

month may we'll Yes. tox in XXX, the in It's indices studies well question. therapeutic the as see underway juvenile the We term, X as well tox X have look like or an so as important for long as long-term studies. do what juvenile

And that current tox in up we tolerability we'll concerns, don't Even exposure we will ultimately, humans. exposures be the hit have go study, an clinical is in based know the don't I can limiting will we would with the if we see tox. which the Phase we limitation. have Assuming on to limitation a animal MTD, situation

be the comfortable above. in we're go get that quite we high would So to animal a can studies get enough cap to exposures that tox hard

of room the pediatric design study course, what still both adult. this play does So be into we've for the clinic. and the some And is got to going the in

exposure of as overlapped have some what rat think TMS the we data where exposures a like, rodent the with predicted based data TMS with effective on looks well XXX, a dose achieved I quite the MES know and were exposures predicted fair significant as signal, those adult a amount we idea assays. what our of gave we plasma that well actually us from volunteer

setting, both predicted in can from studies that And from then the effective so cap will vivo TMS human study, select the help well long-term II we've as that, us will underway got the that as in the by said, really as tox a tox in I information, driven I the help be range. guide And clinic cap. think, and got we've and, juvenile Phase preclinical

Unidentified Analyst

just one Yes. That's XXX. question more And Okay. on Great. helpful.

time you move further any that you study mentioned last So bioequivalency need won't forward. to

case? has And anything like been IVIVC is formulation? on So seen updates with any like, that the or, you that the there any still or have if more new

Simon Pimstone

earlier, that's not old the a And as earlier that this been on after But again, was to mentioned drug the bioequivalence it's to thought study lot formulation. drug discussing we've was have just XXX, it have study of with what ezogabine decided and PK in I Yes. equivalent the internally, with FDA product don't But the versus adult an it we today because with test. prudent the with based felt question guidance, is formulation do not formulation. new to tablet which ezogabine. we update, completely new available new study we PK do strictly the discussion, prior we the a It's but a

felt after in the it we delay even longer clinical IND informed So go have support do the the to in told if dosing can were Had for we and submission. by children with done PK. FDA that these an the it at we had we with into that study not would it we so left this been sufficiently risk, we armed, FDA resulted proposal the and

somewhat It's X would X from and bit we months or Phase probably So done had it makes been it I The think a think it have a X, a we to sense. QX QX changed not start. month to in III we've parallel. little guidance,

And typically a ezogabine. So because other it this the head be head is you're not to to to. to bioequivalence that historical a bioequivalence referring compared testing not so-called drug. study of it's reference It we're will the

Unidentified Analyst

Very thank right. helpful, you. All

Operator

next David Martin Our Instructions] Burton. [Operator from of question Bloom comes

You with may proceed your question.

David Martin

for the unusual So in did PK the is you do in XXX, it anything - this? see animal work back study that PK you that to making

Simon Pimstone

No.

right In We type has far. yet fact, that though, the run, run We've prototypes. of quarter, stability. stability have multiple a of but and underway we the feel finalize animal prototype testing. prototypes not also but where we been through stability, hasn't Dave. only got none we'll comfortable dissolution the PK includes are to sure dissolution so been as has being number that on well select Those are, accelerated profile, still expect the but PK we with We obviously term tests animal this stability have have as done right do run stability make

It this, and not concerns. if only the driven driven any started delay be the the was of to be were if was that current this test incurred going require no, test the sooner. to we off off solely was so And might of FDA concern longer than that

study in now. for of a in in now one And of need this to CTA up and to for geared we do this quarter data course, a U.S., we that Canada IND with And an IND U.S. we've need long-term that's on because you month. versus, more don't rapidly, of in the minimum PK at the third - We the have can initiate so on want will going why it the the stability outside QX. the and actually that's submission submission get why phase

David Martin

Okay.

a XXX on might you table? address wondering, think that formulation for possibility that skin I case? the is there you new had be Second the mentioned thinking I'm Or was question, a are not that issue. coloration the still might

Simon Pimstone

believe with presentations on Yes. drug at data expect intellectual Obviously, feel, not that of we can pigmentation do the based do production do date to at we've we product we limit we property we're we quite improvements disclosures that on of making we'll that this new liability that We But made. have developed. for this significant the least, the and some purposes, point. have

have we believe well. and IP still been guidance PK. a to novel we'll also very there affect on out our because firmly III us give formulation little how So I protection should commercially point formulation, this the number we This that. readout. the get we've of extensive questions just did around as And IND line pushed we'll of have And want as the the which not noted, you've that filing. the should a on course, top make Phase to have

will but guided, that is in formally which haven't year. impact hoping aiming We believe readouts, to top the out we end month and or going certainly don't two any way moving be we're towards a line next of

David Martin

Great.

you're So from it. away this reduction of not direction, right the skin color, you're the moving moving in

Simon Pimstone

young of consistent in I - we all just was completely is pigmentation, perhaps the and as lower what's children, discussed very young improved we've but in of at expect patients, children, focal the ezogabine, a for where of pigmentation said, risk to adult it and David, before, commercial we all. not these ability and that being a infants risk no. think is different certainly I've are liability. product That epilepsy. liability a these entity completely discussed have terms profile think risk should also the discussed It's a I old these that with has today in been we administer No, past terms to properties over Not drug in publicly, whole

the on was launched concern label when and also drug has know it resulted today, in the visual pigmentation We the this was retinal it. pigmentation, of - the not was soon major visual toxicity, course, which, was after placed

parent We every which we didn't know KOL for the is that was discussed this a is pigmentation concern. So secondly, we've result toxicity. and nonetheless, every in indication, two And still risk with, important, we've now with but it liability discussed this things. know cosmetic, not pigmentation this the

over works, to I even dial be not form, can that turn a in have commercial drug we it reported pigmentation out, achieve commercial of very will the if I impact doesn't subjects. significant a we in not still So important, kids. cause reasons think it we children, in be do to these old of important can fact ezogabine, think two pigmentation the its we that. it's everything addition, the current And up any going Remember, to in there's single case that years blue. think dosing while drug was for to in it some may in

will - to most but But is likely minimize that's risk, benefit say, to what risk to in in I certainly different than because was the adults. with the out wasn't But risk even Now are very so observed I risk. we indication think all time profile expecting tell, the it the think or this long-enough of just the dosed. dial this

David Martin

in focal I'm some this wondering might see if use Yes. you of adult seizures.

Simon Pimstone

Yes. we'd something not certainly certainly something we would not Look, promote. test. I don't know. It's It's

that of of the retention Of patients I course, not think PK renal negligible with risk XXXX affected XXXX ezogabine. know we urinary for excreted, properties about course, another so are or market, issue. And better of renally XXXX. a if developing ways. we with has is is few It's in And X% the

XXX. for into or of that if on adult physicians get hopeful XXXX referred epilepsy, opposed they'd clinical get to So I'm to to on opener patients as trial channel patients a certainly potassium wanted focal be wanted our

David Martin

Got it.

thanks. Okay,

Operator

to I now the any to turn not I'm this further for like at would Jodi further remarks. Thank call any questions you. back Regts And showing over time.

Jodi Regts

we us everyone, you. now for the Operator, call. joining Thank will today. Thanks, end

Operator

may have gentlemen, you and Ladies participating conclude you. This and does today's in thank you a Everyone, all program, day. conference. today's for disconnect. wonderful Thank

Xenon Pharmaceuticals (XENE) 12 May 192019 Q1 Earnings call transcript