RGNX - Earnings call transcript Q3 2020

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Operator

Good afternoon and welcome to the REGENXBIO Third Quarter 2020 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will be given at that time.

As a reminder, this conference call is being recorded. I would now like to turn the call over to Mr. Officer Legal Chief Christmas, for REGENXBIO. Patrick

begin. may You

Patrick Christmas

and and this us Good are financial financial us and afternoon, Officer; www.regenxbio.com. Steve Medical on conference such outlook report to call available XX, are XX-K to file website undertake joining on with sections plans. and Management's results sections not Chief and webcast. information, or performance may and as account our any December third is and that and the date and for operating the X, Factors call, These press call The risks will should, of include afternoon we we on subject and thank Today's you report plan, released conference of XX, anticipate, provided Please at website. advised forward-looking Dr. Officer; differ for Chief call our believe, involve update and XXXX. words business today. statements Discussion Pakola, future and risks on Vasista, no September recorded is statements future is product such full Ken annual in only call November on may, information be Executive other statements available regarding SEC's ended XXXX. as risk make financial REGENXBIO this are Form our this cause These described release expect, results Financial guarantees of XX-Q, other Earlier year Any can today's Exchange With are Chief obligation that which may forward-looking the provide forecasted events are the Risk for Vit regulatory being addition Mills, the actual results to And and XXXX, we otherwise. on statements words the risks uncertainties factors from REGENXBIO's will, on of forward-looking President and this Officer. on Analysis quarter intend REGENXBIO's reporting in new similar our certain Commission those to forward-looking by meaning. of development of Any comparable uncertainties. and and ended be of and Form REGENXBIO's quarterly Securities the identified our

unaudited is I company. In over call not Mills. the Ken? to preliminary provided forma purport or addition, that project positions be any like differ may financial or information would and Ken the results turn may does pro results to materially. operating to now financial of Actual

Ken Mills

technology for a Good you, afternoon, hope on of Vit clinical and as provide conference financial our update platform Thank call and future from today’s is everyone, on results well healthy. recap milestones. we’ll an thanks update programs an NAV our provide Patrick. Steve everyone as advancing progress third provide and will expected expanding recent the joining staying will our us. quarter, XXXX. I On

in as parietal super to for wet underway during RGX-XXX. and study two our hit when the MPS We expanded retinopathy call in development pipeline II several RGX-XXX of delivered in space the additional and II AMD are the diabetic treatment include of we’ve patients X/X ongoing now program Phase the internal our quarter evaluating questions. open of proud milestones this important that up to say will then we’ve clinical I’m Phase studies for

therapy therapy treatment based technology for NAV pediatric milestone recently the over in the In REGENXBIO’s with therapy approved our one-time sales with the spinal gene a on of partners space cumulative billion in at achieved muscular Novartis of Zolgensma, platform. transformative significant gene addition, first patients have atrophy $X net and gene

contributed that’s their world. families children XXX over SMA with the have to impacted around a therapy of the grateful We’re and to lives

patients and health preclinical we’re the on focused employees, for have Steve and actively like partners COVID-XX pandemic, plans this monitor more our operations remainder during the focused remain call timeline we general will that turn continue always, on and regulatory impacts development safety over our clinical on pandemic challenging for As to we and to and clinical our for into and the update. detailed With XXXX. to the of that I’d XXXX of

Steve Pakola

When wet plans believe of of clinical management therapy has focused patients. gene potential and a all wet Thanks, impact the retinopathy a Ken. come. could broad We profoundly program option with the with range AMD for on and and the DR the for to that underway of program one-time treatment aspects RGX-XXX studies start pivotal diabetic AMD to in patients development be for several RGX-XXX and

the for patients of other selection for and first in sub dose number wet pivotal AMD of plans factors retinal the from treatment ½ patients from in including based the are delivery on inhuman learnings results study of Phase and Our X, study, X. the X including ongoing RGX-XXX, cohort

improve reduction well acuity meaningful retinopathiness visual the As as anti-VEGF have previously to stable injection. in patients and as these shared, demonstrated

gene this of treatment of months. delivery In wet to therapy. important announced company for our of evaluate look study We we was Cohort also as SCS clinical patient in for parietal in the of for X AMD any of us trial expect two long-term the which milestone the and wet confidence an parietal well for super first as XXXX sub the feel of of have RGX-XXX years, in The the as the space. AMD. in to now durability more the forward initiation the quarter using dosing providing treatment delivery Phase for to the super of X the AVA trial gives We delivery therapy gene to September, the our initiate out in micro the from the the details injector first data this the retinal RGX-XXX first the pivotal for trial program evaluating coming

sub retinal about which delivery. beyond the patients targeted may in office provide parietal options We’re of the delivery RGX-XXX super for excited additional potential approach

or To-date end RGX-XXX first the data tolerated therapy We inflammation. cohort RGX-XXX. to the track of report of in well XXXX. after XXXX been no an from safety trial first and active receive of evidence early has patients in cohort not propel Importantly, this including by complete suppressive of on initial administration enrollment would immune remain corticosteroid before

Phase patients trial the is Americans. and XXXX. of RGX-XXX is adults leading with diabetic to delivery evaluate X blindness the expect X approximately of Our end by super and in million begin retinopathy parietal patients of working we active in affects altitude age to enrolling DR cause

non-proliferative from of surgery. patients threatened. There As Most waiting complications. often progresses until in watchful disease current for developing including of stages becomes treatment severe at risk patients retino with options anti-VEGF to at as threatening increased DR more vision the are disease untreated are asymptomatic disease, the vision patients non-proliferative which DR repeated care laser go standard and chronic is treatment injections, are often with patients

desirable waiting receiving vision large safety However, that endpoint DR treatment, is for patients. observational enroll is complication. sustainable diabetic RGX-XXX and used ratio. one-time at based expected with that the development DR neo-vascularization many dose a versus to eventually be Other of treatment scale of less threatening can The of indication. control diabetic injections proportion A DRFS with well-known of Eylea in a primary long-term actually watchful the ETDRF, DR to macular across on complication weeks. and and frequent regulators DR potential vision XX The retinopathy changed a X:X to Lucentis asymptomatic believe preventing Unfortunately reducing include of blindness. two XX cohorts. lead will at We severity threatening Patients the these endpoints ALTITUDE anti-VEGF randomized treatment provide delivery of to scale patients and option study makes trial edema treatment versus and with anti-VEGF has develop retinopathy including severity approval the for intraocular without complications. will patients diabetic related for to the receive RGX-XXX

retina XX centers to begin and in dosing of from the XXXX. interim expect by XXXX across report We plan patients trial end to this U.S. data leading

patients Turning expanded for to II to treatment an ongoing of our of an two. disease allow the for additional September expansion study including in we rare MPS X/X program in cohort RGX-XXX Phase amendment to our portfolio, announced

to of the already announce in two we more updates anticipate cohort further dosed excited We’re end children from and by trial that XXXX. we’ve this this

to X/X intraocular in older label planned patients patients MPS administer and to pediatric with II. directly RGX-XXX through to cerebrospinal severe injection. open we RGX-XXX multicenter evaluate In We’ve plan the trial intracist to Phase addition, second rebrow fluid a six or to initiate enroll up intracisternal

our filing for is look sharing initiating of to age and We look with manifestations I’ll activity gene by biomarkers key neuro-cognitive number for for of We call CLNX Ken. disease, designed XX This for being a the adoptive II headed intended key IND in detailed to of address also provide address with be parameters met, towards these Ken? patients RGX-XXX perceptively behavioral critical the advancement cognitive programs year the additional document with impairments and of disease, rare believe observational pipeline. With early but XX development with to forward MPS severe and CMS patients and these our is the delays community. our may child clinical biomarker apparent turn of the the RGX-XXX clinic XXXX to by of over cognitive and manifestations trials development a the which new II months apparent We severe we to We milestones designed data becoming candidates which back changes announced that in of observational a to our the overtime study disease function from years. trial young to of this to neurologic will forms data plans designed both and within particularly addition I the coming serum. study program. to MPS have become look in in of the the In ophthalmic on-track CSF characterization six the course forward months. forward pediatric neurocognitive deficits neuro-developmental therapy II. to programs MPS is a developmental in in months trial initiate provide patient to Notably development,

Ken Mills

Thanks, Steve.

the the We’re focus by work pipeline on the congrats Steve obviously in very new poppy. the and and again the progress on internal the entire the and encouraged team by acquisition

Steve Pakola

you. Thank

Ken Mills

space only extensive highlight this we are therapy worked the couple and a in as in know in basis to we’ve development. clinical the now of including one internal are internally, program several of candidates addition Novartis’s late to an vectors marketed also Zolgensma as and others partnered quarter So, things many gene REGENXBIO product but has footprint not as the working product in that stage well

their Kurma collaboration neurological to agreement with license conditions. with form And Partners, collaborated and the Corlieve use received receive a venture Corlieve, on NAV for milestone to are the and leading lobe equity a focused temporal in Therapeutics, new recently AAVX formed European for team vector company eligible of capital refractory as of newly epilepsy. we’ve as Our severe firm, return treatment payments royalties under the well

this and progress sales on Danos, as Olivier cumulative great release a And also of week announced program, year last net is joined of and closely Officer development team payment REGENXBIO by Zolgensma work addition, far development Directors highlight quarter our our billion of as of earlier, achievement throughout encouraged Zolgensma. one are will million has pipeline. based Board press Corlieve’s and on on milestone of In I Chief the mentioned from so in Novartis the has our new POE with that, this $XX the received Science the one over to so in

potential therapy, the by with and help encouraged many families. strongly more global strong momentum and patients We’re to

and the I’ll financials. can with the So Vit over he turn to call that review

Vit Vasista

as ended $XX.X $X Research you, primarily million operating candidates of $XXX.X and associated ended for personal over $XX.X regulatory $X.XX and headcount, and The excluded of used result of which quarter third XX, October increase net XXXX, million revenue and XXXX. XXXX. Net of increased QX, a other million increase $XX for the of with to XXXX loss to recently $XX.X services. totaling and XXXX. million basic for to end of attributable for The milestone or to for the compared XXXX by $XX the achievement XXXX securities million product the personal Zolgensma $XX quarter $X.X increase XXXX milestone was related at million launch. a one-time December the September XXXX, count some since million compared reported attributable was for as recognized XXXX. for Zolgensma XX, of property expenses deluded three was net primarily as Cash September ended of for were loss expenses sourced of Sales attributable as of as were professional The of net G&A quarter. September costs $XX used a related compared reported increased cumulative compared payment royalty months REGENXBIO to quarter quarter primarily and ended of manufacturing-related received basic announced to costs of $XX.X from and to increased XX, September quarter purchase activities and The the ended XXXX. per $XX.X third development equivalents in the was quarter diluted to $XX.X and $X.XX decrease to $X.XX net third share of quarter as per September million third equipment was increase the and $XX.X as in and primarily to million of million clinical million on quarter third receivable XXXX in XX, the XX, conducting were share QX, million. September advisory Novartis cash, activities. was the ended XX, preclinical, XXth lead the basic quarter cash fee net million the of loss Thank externally with XXXX. attributable months for $X.X and sales cash net services in third million or three XXXX, compared Revenues million income for fees our compared for the XXXX head September in Zolgensma billion revenue marketable Ken. the for XX% $XXX XXXX, diluted and expenses result cash XX, to trials accounts

the With plan, balance in XXth as expects XXth cash September approximately September of to As in the operations XX.X turn XXXX, Based REGENXBIO in of shares results. yesterday's XXXX, million from will back received we and until operating its October outstanding. to Novartis private call million the multiple had provide cash, including addition manufacturing internal fund common its current that, of capabilities equivalents its its final on candidates completion on clinical mid-XXXX. of $XX securities XXXX and to its advancement to Ken I thoughts

Ken Mills

Vit. Thanks,

wanted of Steve's as it on culture be here also really manufacture a in updates construction well-understood XXXX for time the a company value by work also of and of is facility suspension REGENX the fully the Facility optimized utilized that the that Our is This us of that continues. financial with GMP and stakeholders. good and to partners. as condition our continues the regulatory highlight Again allows Rockville new the cell top about to is for the it encouraging advancing good well be to our system. agencies. summary platform I developments using program leader to scale widely HEKXXX patients And

both team a And across of substantial led make to multiyear in programs. and efforts to in of large consistency continue all, we great effort has and across that high by supply multiple our been So, clinical as commercial to improvements our products biologics ensure therapy emphasizes this volumes the have gene global commercial well-characterized emerging chain that people REGENXBIO. of experience match well scalability level and a quality, demands in and expertise

we So, with to and the remain therapies will improve the myself challenging online. to epidemic. With we're questions. team making the look our the single about the call and time to that, the driving dedicated strides to our site operator want forward talented we this to that curative gene despite have excited mission turn definitely forward over in towards leadership business COVID-XX and were general, express look employees take sincere for to and appreciation backdrop I administration forward And that to coming potential to mission. progress lives more we dedicated

Operator

with Our Thank of from you. [Operator line comes Instructions] Gena question the first Wang Barclays.

Your open, line is please go ahead.

Gena Wang

for my questions. you taking Thank

question a and So, I suprachoroidal of two and trial questions have microinjector regarding in steps that program, though first AAVIATE is do. these

mentioned on already dosed you So, that the patient. you

is related patient first seen quarter the next that been the And data then this far, dosed. haven’t safely the Just regarding you've have question in or you was patient. any got inflammation year. already in wondering many patient not so how right And

give Beyond color including per and second just also we that if What more rescue regarding bit and data maturity And will and II, MPS also question the regarding visual type in wondering and down you year-end little will safety, of a numbers Clinic 'XX terms initial patient update. I and Will that can of see. OTC? three injection the XX. from show of data data the market the data type be assume you is patient efficacy

Ken Mills

an questions. and ask what provide for question AAVX Hey were on XXXX. thinking to far or about Gena, seen early the thanks we just we've Steve, update and maybe for you I'll what so

Steve Pakola

How and of not seen true trial Gena, early any we as AAVX thanks as that of inflammation today you've treated. It number for in evidence the still patients so questions. disclosed is Yes, far. the It of we've terms mentioned. so is in

that also dosing We early September. patient of the You in just the have announce first did only question.

of any we've do that In cohort. for of with proceed that in is initial overall for of long that and dosed suprachoroidal And study delivery initially no to-date. the space. course study then ago safety follow not say seen general patients to a with This subject we even the not That weeks. actually and the RGX-XXX. for and sentinel is for first that we've where in first we able the dosing as human at So, as and to follow we're view a announced rest couple of dosed if in typical was a albeit of to for inflammation

And in now where XX fulsome in are early initial X, key But in have that's a not example as But all of This before two of first seeing that's XX were in at RGX-XXX. ramping topical test one sites achieve of looking we're no safety total with of of a And a ever the mentioned to and by want certainly give really be you've will whether But the and specifically immune and position and deliver game update. for spite with suppression, dose will study a up significant cohort ability example at activating milestone next being AAVX in after as really that the safety suppression able can tolerability. delivery which to being to assessing importantly recruitment. of immune steroid not the And gene we're we patients. space. still what pre-clinically. not RGX-XXX far receive subretinal terms fact multiple we To-date, all in to is space. giving suprachoroidal This reasons We inflammation as therapy we've we RGX-XXX. that achieve year. the early we're without no therapy without having and more why terms we're for encouraged update inflammation. this patients or The

that at able been for to provided certainly early patients provide cohort we'll caution. guess effect more able expectations, biomarker really I always. that measures at as along program. question months of of still update, cohort. XXXX. that fairly part consistent as pharmacodynamic terms plan that of want number we have terms first our for XX also have Though the the to pretty of few second we treated assessment, on And of first safety durability of years tolerability complete to of first treatment in in all the we've I now be recruitment patients measures in you since So, in and patients and subretinal look several and the the to part in how where guiding we'll continue still of of pharmacodynamic we're overall we'd about again we've initial to in some we to in a and safety what importance activity at. looking be we of manage a your provide update look traditionally can expect to be the It's full talked think been months early But that typical

data. For six example, months of

a So, there. before have you sense really

typical in perspective. safety assessments. that Even including still just update safety a some So, initial would from be nevertheless of we're those

Ken Mills

just the answer that for year bit Well, the update for to the expanded two on do protocol. at additional is quickly. MPS an what have before have We half a have end level of And enrolled the to plans timelines we it's of this And Yes. for you new and patients this quick, patient enrolled second in Gena plans data dose announced have very thanks a set complete EXX there. pulling pleased updating today, then previously II, forward more. just under

that to in the So, couple we'll looking of next be do months.

question? Next

Operator

of our Bank And Geoff of next you. question comes the Thank America. with from line Meacham

go line ahead. Your open, please is

Unidentified Analyst

Alec Hey guys, questions. thanks on is taking This our Geoff. for for

make started just my taken the injection to your be would you for you provide interaction for considering Do to pivotal dosing also physician injections reimbursement but question and looking is XXX on four months how able for be premature three account, clinical an study evolving would or of for and acceptable So, to of first thoughts six what from may be your reimbursement rate in a are will VEGF Thanks. with adoption, rescue therapies frequency Lucentis be on could it decisions? X/XX. whether those have know and rescue discussions gene also early payers particularly next teams at a month Beovu PDS? sense year And I bit three the

Ken Mills

intervals and Steve, we're Alec, treatment. pivotal phase let lot we I for a intervals interaction of you terms discussion the care just compliance receptivity The in about treatment physician wet eliminating standard AMD, of of the question. have terms extending moving the to some entire swing changes value development Sure. system we started but that convenience. exist of engage. back the need I'll in and to of not maybe in and around thanks have of mean, to into of for around and is in

this value time amount moment that of and at influencing. adds and this pandemic to gene continue has the we tremendous that So, overhang of really really where affecting unique in I a profile view was think emphasize therapy

hearing we're right people reimbursement and much how outcomes provider think I on and effect and well happening and more in cost ultimately their people productivity side, if regular going to able have the on is and they're that on as other come side both and is the from get now to on care treatments things. to as not what

That So, a lot attention the the now. at of we've engagements, while that has eliminated. to for profile least think right I been half injections people that paying had get a we've worldwide of talked much about injection through rates. And today VEGF respect this in as for at hasn't taking all to what our a target It profile, look moved product with market is the that labeling. changes

the what's the that and when to coming clinical hasn't a all look maybe where on that to unmet you need. you things Lucentis and how We be sort and moved of focused and think I come much. more Beovu, at look needle like data, doing when we're that's Eylea of or clinicity at forward, need

clinically that the you what there. to talk a the and stakeholder or conversations that or value that think that ultimately, more where seen the I view a that in of XX% dramatic of treatment or at been are maybe therapy terms we've existing been has the huge and with for In pleased so like. one incremental, engage the to engagement's there one-time able can emerging lands been are therapies very it's have we use opportunity reduction far responsiveness level Steve,

Steve Pakola

interesting and have a in ultimately that light and risking one-time an been caregivers patients But by reinjection you able dynamic that's the that really raised we impact vision durability And where for only physicians on evaluate Ken, a who've have visits. the comes these a not COVID potentially as overall fortunately your treatment raised And patients benefit you good risk, back in to treatment. been seen a you dynamic our of that really is on threatening not to for clinical you how space know, real-time you areas you're we've it patients the it's the which admit Yes. very too, comfort and to visitor shined Beovu risk. benefit the and we're and need need a from study, their It's foundational And the ability trial eliminated standpoint. point, like possibility importance have able been complications how to from extending anti-VEGF anecdotally ongoing PDS. their space. the and hearing and the retina a been And a and surge the who have of don't

And So, we've in terms can known about and looking that burden profile a of of even or these target patients reduction, programs reviewed product terms Ken and XX% completely while have need their our done advisors investigators in changed least that looking at minds retina hasn't our either because view their treatment the hasn't for minds for who reinjections of the terms away That are of with. and these what's in months changed it in three think specialists, experimental five and in of are one-time needed for durable, much welcomed of do of patients. the months intervals really these months a clear be get durability ultimate need six as we validation of even or competition. to anything, treatments. able approved injection. advance or that it's would of And other advances these sustainable to any interesting there more agents to that four is way to of If how don't to

continue that So, Ken and a this see to for one-time elaborated product further for treatment target see as validation profile support we on. continue to the

Ken Mills

have that subretinal target we product a of dose the at assessment Yes. we and very that profile outperformed with we've levels, challenged the multiple of in work done And in remember, already patients. and feel severe population

set also of the phase development, profile and progress good it there about suprachoroidal. very funneling and pivotal as the feeling we're to So, data we're into differentiate the looking with

the question. for Alec, thanks, So,

Operator

our And comes Chardan. line you. Amusa Thank the question Gbola of with next from

ahead. is go Please line Your open.

Gbola Amusa

questions. Hi, my thanks. call. two have Thanks for I taking

that recognize heard processes manufacturing, not facility have certain people or analytics. online, you But advantages. that a on is it's coming we've which also first the The given internal footprint, have it's just having

may pains you therapy best of doing could the some rights with to of doing the what growing be you're those the So, on based about in have talk sort we've seen anything space a or AAV manufacturing? that gene practice avoid you to to dimensions

Ken Mills

And think I manufacturers I'm existing the Yes our with has others. subtle lot. well, thanks bulk I and you a, supply and subtle Gbola, and these say Fuji strong on because previously finish chain but would with it's and point it final investors a went even collaborations like with less for have areas. we glad maybe groups there been less fill a that,

here quality not release capabilities assessment, procedures, installed about have side with only the with not subretinal working and here. AAV we're working assurance, intracisternal intravenous procedure. of working but control, and procedures, route in side and criteria procedures We device the suprachoroidal quality that already we're of Rockville administration for let's We're forget with analytics, relate in the labs equation to

has comes like are important things when of sent to well. range well potency that's internally yes have commercially and a things assessing as of that's capabilities, of already really that we expertise types across of a and as AAV been with all vectors it have the of sort So, clinically different And been major wide that here. to quality these compatibility focus analytical devices being to of sites strong

to view bringing our terms other need in that pointed lot a of in foundation is that areas actually we the with to next especially as So, we those strong But ways into supply of commercial ourselves that further of have we we're scale out. really risk. chain in respect some a in think the that commodity things you more insulating what Rockville, take steps

manufacturing blocks stumbling emerging certainly I can new science. in a think, be have been area science and of and especially and

Next question?

Operator

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

Please line Your go is ahead. open.

Unidentified Analyst

Matthew. status a quick and programs for file to for the This CLNX you in on question is before what IND you on programs. XXXX? have Can please of everyone. done about talk be the Kostas I you. needs your the Thank Hello,

Ken Mills

Sure, Kostas.

milestones We're two at let's those else soon here respect to see level, to with very has if Just a are anything high programs. that Steve to guiding add.

translating our in in are particular existing XXX really that instance. keeping study completed things and So, evaluation We're in the the case of ongoing borrowing is like both, and that phase modules phase. readout study levels IND similarly And having from non-human from for route word the like familiar we're the reported we're packages that demonstrating XXX of for we really mind injection. preclinical things that like certain from also right vitreous, in of written administration following And the now with. TPPX things using primates enzyme already program we've into of IND subretinal We've the sustained filing. data RGX-XXX, and highlighted a

phases of we're here the the similarly, now and the an year. to documents of in right at writing reports submitted. filing in a the beginning the IND to be So, of preparing November end literally We're the final be phase by

helps. that hope So,

Unidentified Analyst

thank you. Okay,

Operator

Our Mani next from comes question the line with Leerink. Foroohar of SVB

Your go open, please line ahead. is

Unidentified Analyst

our for This thanks Mani, Rick Hey, good and dialing afternoon in taking for everyone. is questions.

like, look first So, arm control the received are of trial Have aspect quarter of endpoints, or is get any on you set the would now to the other trial start any trial XXXX, design? that from we color some what the of in pivotal the feedback FDA XXX duration hoping to endpoints pivotal design. the regarding

Ken Mills

update at Hey next when updating initiation the year No, the Rick, not beginning the and to thanks. of will of we talk that today we plan study. we're about that

phase into the and to like up fact development for course products, So, brought things and different bred modalities, that continue retina some this familiarity agency Beovu types and on different so PDS pivotal already types of the we that of has of recently guide of have course, in moving call, think we forth. of with to

departure be some here to retina. to things comes surprised people respect and at expecting when massive it in FDA AMD not considered how to with wet we're with ways are So, certain

as forward with next is come there study that add and to clearly design we will more RGX-XXX at details And definitely gene early anything year. it well. on event to stage? event Steve, a However, therapy in obviously this else And

Steve Pakola

excited it this We're you there. nicely. move No, and about we're stage, covered into to

Operator

with our you. question Thank next the of Walter line [Operator Capital comes from And Instructions] RBC Lisa Markets.

Your go ahead. line is please open,

Lisa Walter

on Thanks Issi Luca at This my wanted Walter and Thanks. between an dispute ask taking line RBC. just is there. as if for you going Passage on Sarepta. Hi, the the we as question. for have could Lisa well on Bio IP update to We

Ken Mills

today. a any thanks provide specific lot. We Lisa, updates Hi to have don't

that under working Platform information our guess are are respect I have property people previously interest feedback Technology to with and provided with provided or sure on in license. We that making overlaps NAV our with that intellectual science

general with be looking but we shareholders if free So radar interest that our and up groups science they're of also getting action of the interest of with our respect to we're and commercialization it but so, fairly overall. come doing And that on tends also, what we their that they're of to when space stakeholders sort the that that that will interest not you do in are screen to overall. sort to closer and representing view IP respect higher to out biotechnology for only in have our we think

So, be but view it's our that have an and nothing industry XXXX and that's are than shareholders. our not actions update for to question. think coming the important also updates IP for only on as specific throughout reflecting into as an one the as a field today we philosophy. and on to therapy -- more in We other more to gene specifically And year. those hope important Thanks

Operator

Thank question line the from we of a have Chardan. Amusa you. follow-up with And Gbola

is go line open, ahead. Your please

Gbola Amusa

again. Hi, one And just thanks --.

million get long $XX the on royalties lot payment should I a on congrats all, asked the of how Novartis. I First about model from Zolgensma.

say, duration on those Would the additional XXX the in that have think payments protection relevant? analysts What can approvals. what's the and process relevant are given as say So, royalty multiple we I've do noticed you you the should of less a term jurisdictions them? of supplementary they patent as ongoing extension certificates you to or

Ken Mills

term I like I particular. biologics that XXX, side patent side, think AVXS-XXX, in thanks. the around of sell extension, the in I that; processes Gbola, doing The the was the I on Hey understand clever. all you on mean, about that we're think, as much work I

now Europe now We and in are it's started into U.S. it over have that and carried in jurisdictions Japan. the occurring, other approvals

that term that Platform forth the And for process Technology right. fall discussed use the they mind issued patents NAV for claims and in are so but the in of filing extension jurisdictions. and have the licenses under patent keeping so, to And the that compositions always methods our reemphasize, our underpin worldwide, and the of just we've all as

term and it to three be up jurisdictions or extension extended to that the in of follow We've value approved in products, is Zolgensma at of consider relating is years that license of individual feedback actually major products or includes amended in appropriate I extension we So, it With one it approved. patents an to the it's of those process extend bit the to process, now, to U.S., on in norm for years. closer based normal I how and AVXS-XXX. in therapies like how five type on in occurs and in we to our and expanded get the to each years. with similarly, to expecting it, them with license and license and or Novartis our But protect more the to AveXis, this a course is appropriate in somewhere to had lot being patents be jurisdictions Novartis and through that of to curved potential U.S. to that. likelihood years gene guess, as sort that's of and Europe have case-by-case the IP case guided Zolgensma going patent possibility pursuit got Zolgensma structured, provided we basis as And in portfolio between of are The in biological think five how is Japan therapies. and manage and file and the us years up gene respect existing the quickly following for extending the to a to protect they're four think jurisdictions three entirely biotechnology nature similar

Operator

further further Thank I'm you. would Mr. any for questions And conference back Ken over to I time. turn at showing the like And no to Mills this remarks.

Ken Mills

that great appreciate look And operator. Okay, the the with up. really again, questions, to, and touch for well safe, with are we've in and build new end everyone's from questions. It's some XXXX, coming outlook coming we XXXX; listening. of to lot guided everyone that. Hope into more Most evening. healthy and excited And maybe on as positive the as thank that a we're year as to I well. now interesting an the everyone, and with Thanks importantly, general everyone in the conferences appreciate is but a XXXX transition We've as you the continue accomplished nonetheless. in be been definitely milestones to well, we will in updates hope have year I all

Operator

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

REGENXBIO (RGNX) 5 Nov 202020 Q3 Earnings call transcript