VYGR - Earnings call transcript Q2 2018 | Voyager Therapeutics, Inc.

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good afternoon, and welcome to the Voyager Therapeutics Second Quarter 2018 Financial Results and Corporate Highlights Conference Call. [Operator Instructions]. Please be advised that this call is being recorded at the company's request. At this time, I'd like to turn it over to Mr. Matt Osborne, Voyager's Vice President of Investor Relations and Corporate Communications. proceed. Please

Matthew Osborne

second afternoon, a the the and press corporate for Good afternoon, call. results financial welcome and highlights issued XXXX The we release the guidance and for you. corporate release conference to This and provides XXXX. Thank our of and is goals quarter will Dorval, which voyagertherapeutics.com. corporate financials; and recent Today Andre we Voyager's available review our of then our at will Turenne, Voyager's up for highlights; Allison open review call, on President VP Finance, and the CEO, questions. your will program the call outlines

Joining and us and Paul, past for de of VP Mark Voyager's Operating is Member Voyager's Ottmer, Matt Dr. Sah, Voyager's Chief Somer, Voyager's on Steven today's Development. call CEO; Officer; Clinical Board Officer; Senior Scientific Advisor, Dinah Q&A Chief

update reflect or Please as that those I'll or could future that, pass to to materially statements obligation results circumstances. harbor begin, statements differ SEC view we about call release prospects company's these implied filings from Before remarks various as a purposes disclaims of the to With Securities that August Andre. XXXX. well expressed today's concerning XXXX. for of events during press forward-looking with of Voyager under constitute just the we statements Voyager's risk statements. factors plans company's X, any These refer the make safe as represent Litigation by Reform future provisions and forward-looking the the to Act information expectations, to call for today, over cause Private such the reminder the actual

Andre Turenne

joining good and afternoon, for us our on call. Matt, you, everyone. Thank Thank you

Paul to of our to I'd like on Board and take begin the a thank moment we Directors. of remarks, behalf formal Voyager Before Steve

this has the forward also candidates to its delighted attracted delivery. me highlighting an CEO as as get portfolio leading our than continue deal great seen With patients neurological expertise is the applying that diseases. programs, is at selection the company in CNS will faster aspect position then involved for the you firsthand as of of and company. made and like seen collaboration Steve severe with the and Genzyme, right. it of product Voyager by the I senior since founding programs AAV this new progress Steve team optimization that CEO the I I've and its with transformative the with expertise rigorous overall every as up of company fundamental therapy this contribute company at uniquely a development and Voyager early believe the to financials advisor therapies I'd enormous engine. biology to today. neuroscientist, such better current through member. is Voyager is company of the conditions, leader moving Voyager, a a opening elucidating joined what confidence I've vastly need and I'm with by interventions and is capabilities in creating for before. the and quality week degree me time been manufacturing it reviewing applied by to The in the my rigor focus refined one-time today and in days our disorders you the of a in you on platform. Voyager Sanofi rather that, impact of board I before scientific devastating fourth Having Voyager's rare will the This a start at the the to getting time As people's lives. on on to delivery when Voyager neuroscience its understood. ever Q&A. of a to When gives Voyager potential pursuit the approach has technology are been when progress because more update gene that have the to

established Voyager clinicians the as Thanks a to at in company's the founders patients, a a and compelling development. employees, inflection be So X-year I'm date work history. gene that and of all in our contributions has our leader short join well company point strategic collaborators, relatively CNS as of those thrilled therapy all to I done as of to joining and already the itself

critically patients. this pivotal deliver off a and clinic, a with we to therapies build pipeline program have the foundation kicking for approaching to rich on Now, needed potentially opportunity the

Now, turning updates. our recent to

announcements VY-AADC on As our show, disease, Parkinson's program. progress our recent for we've lead made tremendous

and On pleased designation Type FDA. meeting to C were the we the from regulatory RMAT feedback receive front,

As randomized, a life-threatening fast that designation, you X we alone, if written form all must needed, preliminary planned a such, Phase and Phase placebo-controlled from evidence VY-AADC clearly the The is on II meeting. or potential BLA or program the the know, our including a pivotal RMAT clinical Shortly for a responses trials, therapy the placebo-controlled or granted serious treat, approval to designation, benefits includes from C and now the receiving The of informed based trial. indicate FDA's track feedback advancement obtained therapy medicine products, It of to basis of be a program. gene as disease. designation for modify, plans randomized, programs. regenerative RMAT Type after To such the has reverse a the trial therapy. cure data our breakthrough from III agency submit from the

the with to the route of our and us program. preferred concentration of front, dose On select delivery pivotal experience the the for allowed date clinical and the have to regulatory feedback VY-AADC sum

focused We are the of trial. on that execution now

struck this where will clinical I to the XX represented. commitment referred by selected to collective in and -- this patients high-quality patients from recently all to have the successful where the We will have neurology be study. sites. which and sites, interest will administered, These neurosurgical or referred. sites, sites degree both opportunity We of was trial be an include investigator were had participate and the therapy execution of meeting the held be I and very pleased meeting,

We at IRB patient now the site are of submission, screening. activation and stage

During year, to enrollment. updates will our we with as provide of patient the the progress remainder

conference Friedreich's May made pipeline. Turning was showcase clinicians programs, in ASGCT Chicago including progress to for our in our present and on a The scientists ALS, and Huntington's to ataxia.

candidates. our also We manufacturing in of AAV our shared some the advances of

was Last As Voyager I touched to the distribution the and for of ALS been improve in programs. upon rigorous the into opening its vector extremely comments, program. optimize cortex further all spinal the candidates. to on the potentially that cord company for ALS delivery optimizing throughout HD science I HD my believe chose of aim our our in has aspects year, of systematic and our and and in our The program

consistent this on that While to We're preclinical year believe it scientific right caused make, clinic, later efforts slight we at the these a delay advancing optimization our to conferences. into was provide therapies. develop choice before data best-in-class goal from this with the updates to excited

CMO a Steve, key our this in a He's Like Bernard, Finally, entering transition A a to With future. and moving the Bernard to in search to Bernard and for as our played take pipeline's to medical programs lead role already to the I turn is continuing to the advisor. I efforts. steering Allison, us new to to call well-designed you now natural our review is look a point. point Bernard opportunity management of to forward translational leader near therefore, clinical original is the updates, that, a will execute new update with I the introducing the program. on at financials strong transitioning in to inflection will one highly who program contribute Voyager company quarter. pivotal way, in at continue asset while private medical Voyagers. the I'm over leaves on team on under a a confident to place want Ravina. this moment

Allison Dorval

Thanks, increase million same into the for an million million Andre. second to into back of announced XXXX, million, GAAP rights everyone. in second Genzyme or million. XX, continues share, that October related $X.XX share, The and expenses loss and operating $XX.X for quarter cash collaboration, net total cash in reported accounting cash ended for a the the General same fees. and with securities for to per related compared advancement debt development AbbVie. $XXX cash, the the per costs, to for GAAP good to personnel, quarter under period from was call increase trial. The $XX.X and projects same to second to II expenditures plan, to company's for support in Andre, compensation a in Sanofi expenses securities XXXX period XXXX period XXXX. revenues capital under new net in to the and the Collaboration XXXX, or XXXX. in the the quarter facility stock-based I'll This expenses requirements exercise with development noncash, for will loss XX, January for of XX, external of June expect operating of for in were AbbVie XXXX its $X.X and afternoon, increase be million Voyager end $XX.X that, Sanofi With and personnel offset research which by second of reduction $X.XX Phase Parkinson's and of XXXX $X.X was Cash, to February. reflects debt same XXXX, of existing approximately the revenue securities $XX.X increase Voyager the Voyager the Genzyme as to for compared revenue current June R&D X increase quarter in and associated turn and Sanofi's Research of $XX.X the in costs G&A million, sufficient of million $X.X for adoption with cash, its to equivalents agreements due the collaboration, option debt as revenues recognized of primarily early its by program. on the and in fund administrative expenses Based ex-U.S. $XXX.X marketable The second professional the primarily expenses of XXXX. including quarter primarily XXXX collaboration period of in to to various increased rules recognition, related the compared programs quarter XXXX. second amounts compared marketable equivalents XXXX. provided to and in was the to as reflect to services the compared higher of expenditure expenses partially a Collaboration million million not Voyager's June ended revenue marketable well VY-AADC $XXX equivalents resulting decision XXXX million

Andre Turenne

with And now operator, we Allison. can you, Thank that, questions. take

Operator

[Operator Instructions].

line question comes the of Morgan of first Stanley. from Harrison Our Matthew

Unidentified Analyst

Thank you taking Matthew. for Hey, this on for our is Ismael [ph], questions.

me. from two So

first The and plasmids, commenting on a is: of on field the you fragments their source also manufacturing, material regarding I Can that. issues in their with current given your ramping progress recent us have follow-up after and and some update then And the chain? supply DNA while

Andre Turenne

your for thanks question. Yes,

manufacturing our with to full to PD rather at past significant the our Maranga, and the and strategy, So across on able -- program multiple us introduced deliver joined in moment. which the on we at overall, suppliers our helped months. through, this manufacturing and to have internalize not other process made And has we our programs progress, work recently progress, our moment us Luis be think to who but is

every be everything on been well, So to of continues high our one a named level, at on advancing has track, programs. certainly very and

Matthew Ottmer

on add own message the process as to as -- I'd need well, facility. one don't that and us material. things we've manufacturers chain, based unforeseen particular redundancy is can Andre's this allows the source the And and Matt baculovirus We so -- into the we have here well contract that have actually multiple gone well, there's But transitioned especially supply along far, if very that any we event. as own

the but X that that, at we cleared As secured comparable ahead had you it the is it, and what already beginning we provided IND the systems. know, of the data confidence -- had certainly believe that year, we of between for us

Unidentified Analyst

can in pivotal Just, first the speak still you to work need you are enroll enrollment you. take what the thanks. doing steps Thank to start patient? And about before Great, next, you're the the program? you key

Andre Turenne

Andre and for your thanks Yes, question. here.

So as have I selected mentioned. sites, carefully we XX

sites, where that be have and sites of them We are of neurosurgical them patient managed. are nine referral patients will that XX

approvals that's to that active that process. We on been at have, a we IRB other patients finalize there's be site activated screening is that screening, have sites as exactly currently be one start and to stage we of at found site. clinicaltrials.gov, screening can one And able number are so fully of have to

screen to other use in -- that's have sites soon So a some of progressing of them so expect starting we nicely. to very number and will IRBs, common patients,

Operator

from Our Wells Securities. is of next question of line Fargo Jim Birchenough the

James Birchenough

could you on do up you're if they in, XX the the patient population proportion speak a landscape? following what experience Just initially first bit looking you with you cover how that sites and And to look the patient encompass? then Thanks. follow-up. to target target centers question, I of fully really maybe get And need that if a enroll about population have to at really your many

Andre Turenne

question. Yes, thanks, Jim. for Thanks the

experience from decision adding the want of to start, to that we participated train a great the to clinical sites new medical have account continue that number fortunate very with execute from on trials who new in it. this made have the to program the and here, We've management goes help trials. and care take this have early was to investigators delivery and we've that So and taken the transition have to into participate to been

support the able So referral that it's ideal to the time of sites a a the want where also close quality that very -- we in catchment, but that for we management, have, be to sites, as II, have we very high to just selected terms to have can of enroll this sites again, we be terms Phase number number for of being frame. the and sites within of for in the trial medical reasonable sites

of light that are are to So scenario the as as as serve, in to first basis an going that is filing, potentially, able do to, prepare study. BLA feedback, a regulatory this this where for now could this trial project what you we filing ourselves organization a for with we do

move transition pivotal throughout this the mentioned this; to we shared Phase the in a enthusiasm, to ago have about, help setting number work, there just clinical place how be of to in the what per continuous from and of off of up it lot I And highlight represented, commercial and from So happened a then, every trial. investigator we from do there to a is to the weeks just shared again, is to our kicking to to Ib to thinking had present, everyone the trial again, scale able setting? site couple meeting throughout lot learnings procedures program, with features incorporated have there's design, has this a trial, this also in we learnings experience.

Matthew Ottmer

mentioned, the neurological eligible wide the also that sites, we are sites and right, that are that in are also, the trial. capture for this feeding are Andre actually add, well, are neurosurgical to thing of who But And we Jim, delivering are nice too, DBS. these have as range especially feeder that, into with performing in surgery, geographically dispersed around surgeons as types country a of the so treatments, of skilled specific the these these patients can range

James Birchenough

Phase the what And protocol ahead, it. manage to avoid so maybe you potentially, Just could Phase you're of And dyskinesia reduction we need the to saw haven't X? may Cohort with overshooting you Cohort certain overshoot we results little levodopa adjust. level, a yet, as get in but that a presumably looking just the one the and in terms of talk follow-up: to doing II X you about the at got III, Okay, dyskinesia seen

done versus have in what the the differently we from protocol the Phase II X the Thanks. in what in So experience saw Ib? Cohort Phase

Andre Turenne

for Yes, the question. thanks

there's the So about selection learning study. again, for patient here, a the

is dyskinesia important. So the baseline

is fashion. reduction is levodopa was in I meeting limit in this rate able highlighted managed provide at therapy protocol we the a that this to that in this to which therapy guidance a rapid we important stepwise after clinicians think also the do so and another levodopa learning the at to investigator be more

So Phase is in -- in from reduce from that we that, think some experience again, a the would that is us variability to Phase this II which variability learning help clear which Phase going reduce II the of trial. Ib, help

Operator

Christianson comes from the question of next Our of line Laura Cowen.

Laura Christianson

on of to the to trial. there's scientific that that achieved X conferences? I been seen any those off to that with the the the improvements data time bit number I'm when little trajectory at conferences improvements and consistent when talking same curious you're about say point, Phase color from you patients just Is are Cohort a you us more all X including the or you the still get and/or medical try now referring holding in giving X of that are future on until posterior

Andre Turenne

your question. thanks for Yes,

that the size, out full upon, with sample looked once as of best sample to at X report the So look months. so at at we scientific report, at half look will hand, that it the the report we're the And months, the size, to appropriate to time have data we will of at to and patients. going data XX data marry we cohort, endpoint get -- we the way we've we've we is that's reported X of X we to conferences. type obviously, And at that, before, so that think

So full patients. in an as coming into for of we'll opportunity we present look move detail months, X the cohort the to

Matthew Ottmer

the we greater to do And And were across in patients. learned see way the get that already that posterior coverage surgically report. and then a in total at mind, lot all surgical sites? did we patients so approach multiple with than that X Laura, right to baseline, keep XX% And consistent X wanted we could coverage that with the in did we reduce infuse fact a could times? from had we this we able using We

we we is convert the Month last we indeed into right saw X keep motor really, baseline, were levodopa X. we the clinical points mind, that X. than Cohort Month And cohorts, And does Cohort and and with And at from at dopamine, different same that, to X. and hope X do consistent to X, from that was ADDC see in this part function the those again, see? time improvements saw what in So for posterior, the X, would was, enzyme there, the all once

Laura Christianson

anticipate Cohort your approach have to presented or for Cohort anticipate in patients you same? those been And Namely, it. that full the remains and the some -- cohorts the that some between is what combination X data you previously posterior Got expectation the deliver? X X

Matthew Ottmer

Yes, the continue on and We'll as beyond we're and Durability Cohort follow these response updates time. program, these now and provide any as seeing follow, in X X even X consistent and I to of we'll the serial gene Cohort is X think to key coming trials. years. therapy something again, we'll of Certainly Andre that's mentioned. provide we'll with with X years data X that is treatment, we'll in patients. that important -- Cohorts and and X X the over us, trajectory results, over certainly that posterior to monitor versus But Cohorts continue

Operator

Our Instinet. Nomura line of comes of next Christopher the Marai from question

Allen Cha

Hi, Allen this Chris. on for is Cha,

have therapy gene you registration on to of new programs? pipeline Phase with any meet guidelines. us how your got Like, some programs FDA for FDA those on there Can changed you are I've tell to So I? one your approach I design follow-up. regarding the question have that And one trial updates upcoming plan

Andre Turenne

for thanks that. Yes,

that prove the the going really, which we on which to that other the designation for gives that early program, for we'll also that is be the think that overall the access regulatory to we regulators obtained, So in recently beneficial to and in I'll I the pipeline. program, us consider highlight privileged pipeline, have programs RMAT

so evolving. the benefit that this and now it's that to into designation, we're important So having think already program, is we're tap we seeing field going RMAT in of received the this

to multiple Now to now therapy, from together companies some dialog advances. there of learn space gene similar think field indications, that frequent clinic for as the the programs in all the similar some in have in I that benefit are be with we for the agency so serotypes, vector able with the

Allen Cha

faster no Got to it. that approval? get path But think a you program can specific pipeline

Steven Paul

this Paul. Steve Yes, is

the SODX, a to are Huntington's pipeline other the but Just progressive ALS that outlined Andre particularly of ALS disease. fatal ALS, -- and case Huntington's as it's comment rapidly know, programs briefly, you those diseases. Friedreich's, -- and In

on with being So and don't and to what something at they're we ask might really we progression very we to to discussions the receptive to look we FDA, want think as that there ventilation well, in something be disease-modifying, works death. comment going delaying but quite delaying

see Andre progress But scientifically to progress, as going said, on continue we're some will updating we've delivery the We think and we we with to of time that great again, I as discuss them. their made programs. there in tell program X the -- made receptivity interesting So we'll be further part. those

Allen Cha

was Got it, That got it. helpful.

asset, any are us Just kind there going to on you in improvements? off used in point that, that biomarkers or Anything with for functional place the can of SODX can sense? combination be that a to get

Steven Paul

Paul Steve again. Yes,

can for the So chain, something be plasma biomarker is CSF, encouraging looks in that marker really good to disease progression. ALS and seems one of emerging looks to which in called and measured light neurofilament be very a that both and be Huntington's

develop actually disease. very do ALS. fact So as that that a we're excited mutation interesting And about in humans, in develop data which that. same chains neurofilament progress light in elevations published the they with the has model quite dog some -- SODX We've in

for encouraging right and So the both biomarker Huntington very is very, now. positive, very front looking ALS

Operator

Andre And closing any no conference further to I'm showing over the questions. for turn like back would to remarks. I

Andre Turenne

you, we'll call. thank And conclude Okay, with that, Amanda. our

coming near for for We much, afternoon, Thank the also thank on you in I progress weeks. questions. to personally, and updating So look our in look everyone, you to meeting the you. forward forward your future, very you attending this

Operator

thank conference. for and conclude gentlemen, program. participation This in today's the does your you Ladies

disconnect. may Everyone day. now great You have a

Voyager Therapeutics (VYGR) 7 Aug 182018 Q2 Earnings call transcript