MRNA - Earnings call transcript Q2 2019

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Operator

Good morning, and welcome to Moderna Second Quarter 2019 Conference Call. At this time, all participants are in listen-only mode.

Following the formal remarks, we will open the call up for your questions. Please be advised that the call is being recorded.

At this time, I’d like to turn the call over to Lavina Talukdar, Head, Investor Relations at Moderna. proceed. Please

Lavina Talukdar

Good to to financial discuss operator. XXXX second results. and call conference business morning, you, Moderna's welcome quarter Thank updates and

well the Investors You this of our we’ll press the at section reviewing as www.modernatx.com. site as be to can that the going release by Web slides access morning issued

Officer. we Lorence Bancel, President; this our our Zaks, Today, Kim, Tal Officer; Chief Medical Executive call, Chief on and Chief have Stéphane Officer; our Financial our Stephen Hoge,

undertake remind provided everyone X to revise from and Before this differ I no future this implied presentation on we cause like those to performance to materially statements. in developments. or important Slide begin, will our call update see and for or as new the information forward-looking could or of of that or a statements. results include factors result filings would conference accompanying that information results expressed risk obligation actual our Please call SEC We these forward-looking the

I turn to over will Stéphane. the now call

Stéphane Bancel

medical diseases and Thank addressable small the to medicines. and recombinant everyone. potential mRNA the class has new large a molecules. treat not proteins be believe morning, you, address unmet to mRNA to medicines We good potential that We have are believe Lavina, or needs by of

relative technical market platform and the faster mRNA, to medicines clinical traditional we of and of higher nature to probability success Due provide timelines the believe medicines. our a mRNA trials to to

similar to proteins We scale be at that molecule costs also is injectable. the commercial of mRNA materially lower believe the and than recombinant intensity that manufacturing capital will small manufacturing

that we We same we portfolio, technology the derisk read-throughs. sentinel programs be believe potential, they risk similar meaning large and program, a once the to continue this managing our risk. important focus especially of risk, in risk are that will technology biology modality across of on Because

it candidate. uses example MMA most be important as technology the chikungunya our as our key rare clinical antibody same future, program, near in disease an a program will readout formulation As the our we believe advanced

on Our focus priorities. is corporate three

pipeline; development new move three, into new execute to new in in candidates the on modalities the development the First, existing two, lab development clinic; modalities. and to from to invest candidates

now melanoma May. review update ASCO, ASCO and meeting with cancer our vaccine. PCV, most since the presented June a last to Phase Phase adjuvant at that the will X quarterly important setting. since are in I X head-to-head progress we started report today trial Starting our We happy positive interim early data in we personalized in

of plus versus to forward important look can to monotherapy. increase if program readout this assess immuno-oncology PCV survival the We Merck’s KEYTRUDA KEYTRUDA recurrence-free

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this, on me to pipeline. turn With give color development you more let Tal some to the

Tal Zaks

Thank you, Stéphane.

have in advancing few made of As medicines of these. highlight each slides In progress next you this know, modalities. pipeline the our the I different quarter in will six we’re we

in we’ve Slide starting have from prophylactic have will healthy to last you So eight vaccines. in and a participated this emerging significant we pleased profile over quarter. safety our see progress Phase the In tolerability with on total we X data the XXX have volunteers our and with made and XX, vaccines date, study in modality remain who we programs of safety

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we of to after months in mRNA-XXXX, and the last neutralization PIVX continue look or baseline emerging hMPV terms In seven second the vaccination. at titers data, interim see above

fall. We we in data. from at January full plan the context, immunogenicity data For this to in study two-month present Phase X the reported IDWeek the

development from FDA the against both pleased fast a protection where discussed evaluate study. also to plans in hMPV for and single Phase PIVX We’re X feedback regarding forward potential mRNA-XXXX we the the with

to plan seropositive enroll we our in plans, these with trial. Consistent next toddlers

published X Phase HX Vaccine. in vaccines the Finally, were influenza the data for journal against and HXX our

a Let on few spend me CMV. now minutes

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aren’t manufacture given to is one a required using Currently That’s on the proven the structure antigens, market. technologies of there a vaccines any has to which elicit to think CMV challenging of response. immune pentamer, protective against we traditional CMV vaccine the virus because the be the

overcome of mRNA can believe challenges as base by We with our components. vaccine encoding itself five pentameric be antigen our the translation viral these technology producing further lends simultaneous to its

XX, combination which actually that shown gB As for mRNA-XXXX a infection. to encodes of six We and mRNA five protect the that X the We one and the reminder results sequences, as potential Slide mRNA-XXXX against look pentamer to encode this encoded and believe potent for on contains soon. the of by durable Phase against CMV antigens forward these will produce two antibody have titers protein.

to turn now Let vaccines. me cancer

the vaccine, see the modality in will on mRNA-XXXX. on You XX cancer I’ll Slide focus KRAS and mRNA-XXXX, our programs the and on vaccine, personalized

running in our that high against risk Recall The combination trial mRNA-XXXX randomized melanoma announced Phase the the patients pembrolizumab a the the the trial. and this have that arm first report X happy patients the is combination control in X up partner and Phase with of is design we consented to earlier today Merck in X monotherapy I’m pembrolizumab that adjuvant Phase and year. trial setting. testing to

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complete to the response. a to the and prior personalized at cancer responder pembrolizumab of these dosed of with five and partial monotherapy had pembrolizumab other mRNA-XXXX was vaccine receiving combination One the

previously of with five were who inhibitors. these Two were treated PRs patients checkpoint

us that benefit to and right the the in trending X are signals ascertain early trial help direction, our of believe Phase these will definitively incremental we mRNA-XXXX. While Merck

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Europe continues a in Our open AstraZeneca Germany. also clinical trial in application open additional now with sites partner to

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in of subjects we’ve eight enrolled six today, dose of the As the cohort. third

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the Lorence. to call turn that, over let me with And

Lorence Kim

compares In billion Tal. at results of investments QX release, XXXX. equivalents XXXX with This we end these Please press reported second our note are the XXXX cash unaudited. financial quarter We to today’s Thanks, ended results. of cash, $X.XX $X.XX and billion.

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activity XX of payments in-licensing million These XX million in respectively, operating of compared and in stated months XXX numbers XXXX the in for XXXX, used of in million cash footnote. was quarters the first as and XXXX. Net XXX million six XXXX the to include first

affiliate. of million payment and equipment XXXX used XX obligations After further to for the first of months of quarter six XXXX, Cellscript and no its compared first purchases we have the property XXXX. million in-licensing to XX in Cash was in

months we XXX, retrospective And recall ASC then the on revenue, that standard which on January recognition to mandated the the XXXX. January modified as first revenue total this to of of not completed transition applied XXXX, the adopted compared XXXX The XXXX contracts was standard. were QX revenue X, attributable using X, of method revenue mainly adoption for those decrease in six new and to as

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hand back that, call I'll over Stéphane. with the to And

Stéphane Bancel

our Thank six The in advancing is during priorities; remarks, in development quarter. our at executing team candidates I existing modalities in board reiterate the three on pipeline, focused like the you, to our on team modalities. Lorence. and close Moderna across the executed investing new would To that the development investing new

the we patient the quickly trial. first with summarize trial the X To consenting Phase highlights participate quarter, initiated of in the PCV to

Our CMV vaccine started study and two new infectious diseases. two in is four fully enrolled. in clinical We trials; immuno-oncology

cystic research Vertex’s collaboration. fibrosis

collaboration of treatment XXXX, exclusive July at agreement in therapeutics recall, an might aimed research the for Vertex licensing announced the of CF. you and As and discovery development and mRNA Moderna

the extended delivery Based based potential first future work XXXX quarter has extend this administration route progress. to for with date, a on further on will Vertex mRNA collaboration the clinical for to Preliminary new of Moderna. options present

forward CMV clinical progress X as and the term. Phase look will I XXXX XXXX am data antibody data and the chikungunya X rest the in particularly of I Phase near with pleased data made today we the the approach for and look to we results.

a the antibody human. encoded dosed soon. and trial X. complete And first As a should are technology by RSV transition in if we antibody Because chikungunya to Zika be to healthy dosing reminder, Phase subjects, is intend monoclonal the positive, to mRNA this

and are first now on clinical proved in patients dosing AstraZeneca of Merck’s for five in of combination clinic, a All are the milestone MMA. IMFINZI of which with checkpoint the on immuno-oncology We Triplet. KEYTRUDA trial with already teams have focused two inhibitor, for programs sites PCV working dosing

class opportunity that a to ahead to to and energized the bring potential us product has that medicines these see of believe new we important of patients. We the are be a potential large mRNA medicine. We

approved vaccines large opportunity commercial no a are as such today. there where needs medical unmet products. and millions large have towards That for unique we vaccines is Four

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VEGF, [indiscernible] Stephen hard candidates The is could MI. transform which of it his who into development have wave are innovative only products. the move the the labs from innovative the cardiology Hoge care and And program, to new team working patients of first and clinic.

clinic a our in XX significant. clinical our and of and three platform first a we’ve is we productivity in had trial mRNA just years, started We half rate. December In the XXXX. dosed The high success programs

did have authorities. a by of delivering and IND and to opportunity new we special team are promise local to We bringing get the patients. CTAs The a our forward of medicines know on opened XX science, we committed of class

many also would the participate thank to a like every clinical hard great would like end make our Moderna the employees of by healthy our working in physicians. including and patients, team thanking I people I day our remarks who volunteers studies, reality. vision to to

take to With questions. we now happy that, any are

Operator

[Operator Instructions].

of Our first from comes question Goldman Salveen Richter Sachs.

line Your is open.

Andrea Tan

is, for follow in then growing is Thanks I on the KRAS you our up. And have taking context vaccine your in This questions. a competition thinking are Great. My Salveen. about Andrea for of disease? for how positioning first one

Tal Zaks

Hi. This is Tal. question. Thanks for the

First are finally of mutations. as all, we that effective therapies against I’m emerging happy that really have KRAS

progress that tremendous. the field is for think I

make think let early I days, still it’s two me so points.

our activity and the HLA which exact First, still against needs mutations and in to of defined. case which be which the nature mutations and

– necessarily patient So as you distribution them the at if I competing. even on see look don’t

is more to trying think to and importantly I are of in emerging what inhibitors our do very patient the and what things terms fundamentals, are think on trying the vaccine do benefit. Second different I

therapy into it’s sense targeted into benefit we But struggle patients. been of curative-intent treatments. that I turn think molecule to history them terrific real these the the translated in for has small

a approaches more the immuno-oncology translated were other into I successful, think hand, durable the effect. on much have

the them that approaches expectation see is And if really to story so plays for complementary road to both these I’m expect the have in successful, you how benefits patients. are out. coming my And of down years excited would the

Stéphane Bancel

GXXC. the add his GXXD, Stéphane, GXXd, to remarks maybe, for we and thing, that it’s mRNA just actually GXXV, coding And is described because Tal one designed in mutation;

Andrea Tan

are enrolling rolled have that just from been in your the program, your then study? And Natural study patients on many MMA clinical how right Great. History now over

Tal Zaks

we So in study have the clinical yet not enrolled.

We’re XX study to-date. History enrolled actively have the been recruiting. patients there Natural In

Andrea Tan

Sorry.

that anticipate guess patients do study rolling So I no? you over History any or Natural from

Tal Zaks

possibility. a is It

We’re it. looking at

Andrea Tan

Got you it. Thank much. so

Operator

Matthew Our from next of comes question Harrison Stanley. Morgan

line Your is open.

Matthew Harrison

Two taking for Good the morning. for me. Thanks question.

I cohort? just are And far think we stop I first should broadly comment so if think given safety molecule? know the forward on OXXX gos Ligand. just this take question how about to Can in can the what on the do and what you’re about I’m chikungunya the second regulatory a from can you comment asking about able probably in you is need that then to is, FDA? with almost that be through So one to study should you talk what third how Thanks. you that space standpoint. potential don’t to safety a we guess tests

Tal Zaks

Sure.

picture Let ongoing This comment totality we’ll studies. there the so can’t start volunteer describe study rules see expect data stopping what then these you the me you. in I are a of for we until and on is it It’s so healthy would typical study, really with the the chikungunya.

after Phase terms ovarian of if at the cohort, look going cancer. into where the OXXX expanding In we’re regulatory you X we’re path, Ligand,

be not we straightforward. benefit I monotherapy. demonstrate really to are clear because have relatively marginal I approval the inhibitors will to has If a think combination that checkpoint setting path activity approved patients, they yet the in that and could as it’s think

looking that’s Matthew? answer So how your we’re Did that it. at question,

Matthew Harrison

It did. Thanks, Tal.

Operator

Ted comes question from next Jaffray. Piper Our Tenthoff of

line open. is Your

Edward Tenthoff

Great. much good lots you very updates; for of you progress. and Thank the thank

analysis not certainly and additional special potency special the any the So but Thanks. therapy? I safety especially if Triple of or doing question potential is the of are concern this to respect you here immune Triple just safety apologize my because asked, durvalumab, activity analysis with but was my is with any

Tal Zaks

think safety wider looking the is. Thanks. over reality understanding That’s you. way clinical inhibitors in the trials people a better good that of a in by answer that the profile is the maybe for really I checkpoint I colored a question wish the do at we’re safety what of years traditional I The had and alone

autoimmune phenomena, safety assessing carefully Triplet, cetera, signal events to inhibitor see that If very we attributable And to there’s of then the we’re I and two et checkpoint adverse looking at finding that one think would expect monotherapy exceeded. the whether is all other and it. so other from got ways we’ve any whatever

recall First, it’s dosing in And so the us and will not carefully a we’re think Triplet. unfortunately all adverse just I that very second, the view they’re safety monotherapy the on to as field profile one And the at characteristics. give of predict the clear in combination very arm we’re frequent. reactions looking sees hard clinical that the

point do that can got we careful what unexpected. to expect anything not a for answers the question. sure a visual not maintain you’re all I’m don’t one. I missing and So sure better make if at know this is I’ve

Edward Tenthoff

With just a systemic question. That that. any Then treating That’s appreciate Thank collaboration, incorporated sense. you. lot quick a that disease novel there to really really but the really of modalities high-level that lung for disease? or being right. I all this just is respect are not delivery are makes CF

Stephen Hoge

Stephen it’s Ted, Hoge.

Edward Tenthoff

Steve. Hi,

Stephen Hoge

we’re progress a So to first preclinical to excited all, collaboration with research based on it Vertex continue of it’s the and date.

range of look of broadly we part delivery activities, do at our a As a different modalities. research general

obviously the Vertex we’d to for CF provide direction about been that. diseases probably could obviously as haven’t delivery which approach those valid we specifics progress on for We intensively with our address applications specifically are well. route at patients has administration have without unmet Generally, for the and But of [indiscernible] that need here in is a yet other who but and a development point CFTR made commenting in disease. be particularly example, the CF, in systemic pulmonary other one pulmonary defined candidate or focusing CF

Edward Tenthoff

I’m Thanks ahead. – a looking the sorry. yes, to lot. forward Go

Stephen Hoge

That’s it. No.

Edward Tenthoff

Great. to you and guys Awesome. September. looking the see in I’m forward data Thanks. CMV

Tal Zaks

Thank you.

Operator

comes Our next question JPMorgan. Kasimov of Cory from

line Your is open.

Cory Kasimov

well. guys. as I morning, Good for questions. have my two Thanks Hi. taking

expect of else CMV you one next us guess would just a or validating we I see new is walk of through XX up. then And can in is period and cadence I So recurring the time Beyond we the change the months clinical chikungunya what should the you first so? updates your R&D what that see have data key September? and has at Day updates, in follow clinical in

Stéphane Bancel

Cory. morning. Hi, It’s Stéphane. Good

Day. but updates not hope the we Day, I make good R&D sure we’ll you So to on come I R&D we will give everything know the comment that on then.

On the on as XX important. on next as you CMV months, comments, see presentation, Slide the discussed my XX really in is I can

you of product. As of very XXX% We own is it it’s out opportunity. a very large believe really know, need economic this there. medical the We a large

into good the dose primates to already that good data. you the speak, I in have CMV we from a our the they’re move Phase going are have plan quickly. to remind we because so translation the pretty the for clinic. as data shared, positive should assuming to past And And shown X RSV data is Zika, company. very important in in we I and and in Phase as that read X humans, be believe healthy subjects vaccines have they into we into are dosing

look take we a study. will need PCV, bit to data recruit little big the board. tumor a going need basically patients then We so across all because for X. survival That’s of this in in medical of very believe types. Phase forward human. is course, KRAS looking there’s And four [indiscernible] interesting. we important of We be all that to a in And months. Phase to started at time a XXX it’s X, course

clinic. because clinic. will and also we’ll in IL-XX at the be with into getting thing dosing, first and Phase sharing same [indiscernible] The the planned So very see in antibody combination checkpoint. clinical be meetings for Phase In forward, discussed, X, as straight the the then we will dosing is observation we’ve body patients the what different chik observation the we [Indiscernible] important medical in a Triplet clinical with combination meetings and patients. soon the is update PDX. oncology we will go in OXXX are in going it’s to and so two we X the of us in [indiscernible]. then intratumoral be are And except

have MMA dose we starting as that showing commented some before, in a we having are As animal benefit. has models been

few rich, and think be I data quarters so going few And to next months quite the wise. the next are

We drugs That’s potential a have of in data. the [ph] lot [indiscernible] clinic. potential for

Cory Kasimov

then high patient melanoma up do personalized see less potential have for PDX considerably indications And at resected program. XXXX is of you is and that risk program or your refractory? near-term regarding may plans indications that cancer this neoepitopes? great. What Okay, are the vaccine, exploring of Any follow beyond the relapse,

Tal Zaks

Cory. It’s beginning since this Tal. ourselves program. question a the that, for that of It’s we’ve Thanks asked

want are first to strategically success highest the of is and think with for look we to program this go before I the we likelihood more where that philosophically, areas what do is challenging.

so And that that’s an study histologies within in Phase adjuvant X and into Phase the definitive focused went X. we that’s for into the in a why have even we why we’ve setting melanoma

I that. indications. clear will explore some clearly to not of there’s But concept, any additional plans of proof we think have to a once do begin we those current

Stéphane Bancel

remark. Cory, And to Tal’s to Stéphane, it’s add

in going it, our about very think comments, capital are back we disciplined you allocation. to If Lorence’s

personalized have we could a be too aren’t all with of course, there many today. so because we have cannot cannot opportunities trying the increasing that about be of you will as could cancer things the we portfolio, of could treated that [indiscernible] think products we one But be across we lot patients derisking, unreasonable. not of different much vaccine before – of So, our unfortunately think an important know expand

those help that disciplined. allocation just training very to team capital clinic so And oncologist the the Tal love it of we trying we is spend to and trust to to very and we on be spend in be it, when know patients. the a spend disciplined clinical just There’s as me, be But – things, we based where we how have That’s who one risking. in much you lot and example. want by

Cory Kasimov

a makes for the Thanks Okay, of lot questions. taking sense.

Stéphane Bancel

Thank you.

Operator

Carr Needham. Our comes Alan of next from question

open. Your line is

Jennifer Shen

I Hi. is a for This speaking Jennifer of Alan. couple have questions.

assets. commercial the us team give that to specific the if you. and the be wondering some was target patient strategy planning possibly on CMV for I groups is, question you Thank can may color First

Stéphane Bancel

for So the thank you, Jennifer, question.

think quite R&D would Day on time because opportunity. CMV you great I join can be the will spend we if at some it us commercial

populations There of past, many There’s to discussion women women about a age an age who also put might As women. humans in bearing because to the try in adolescent eradicate CMV, want down to the do discussion protect. CMV. are you very [indiscernible] those of pregnant we are discussed child, partners there also from was

we simply It’s you on on back that a Day. going But about go the this timeframe this. we the different to we CMV, the mind same look and and think a there’s believe the for opportunity can in R&D very But largest I world maximize with quite we’ll So do length why U.S. can investments. the of population you time. be can vaccines, very not take we we Again, at are lot those [indiscernible] HPV that in so and at of allocation it them is important products much discuss all if only segments vaccines, if capital our label XX-year the of how cannot vaccine, vaccine very given do can to be CMV, like those very how lifecycle indications we largest important on at have and very the and get we we the all much to old the this do the around the management eyes XX,

Jennifer Shen

you Thank so much.

possibly could hMPV/PIVX vaccine, effort? for of this some The any level comments to other progress us needed you. the titer understanding new color, Thank is give or the question you

Tal Zaks

is Tal. This

from on is on our of to from respiratory have a influenza. what I one we the the market, there with we’ve protective. modeling sense it like and date Unfortunately, seen virus, is vaccine a draws based so no so the preclinical going science titers understanding protection our viruses similar are the experience to what mostly on that that a there the titers of flu we and is the have get don’t be totality understanding respiratory really correlative is the you parallels think like. in the But from

our infants, in the seronegative here think we’ve Recall to X is population of ability that target I supportive in is right. though seen immunize. Phase what the

in and to to the we’re going boost the population ultimately significant to to reach respond down So immune the road. define our to that titers have ability maximum capability response

a multiple will to it come think from I Does reasoning, think of clinical think be help white from may and answer, that it I lines that. So studies you? inference I vaccines black not very because from take and science from to and other

Jennifer Shen

for so questions. you Thank taking much my Yes.

Tal Zaks

Thanks, Jennifer.

Operator

Oppenheimer of from comes & Company. question Singh next Hartaj Our

open. is line Your

Hartaj Singh

Can other efficacy if just then the Great. that little about a two. Thank is just an too to XXX manufacturing over antibodies, you that see mRNA I be on see sales of you the in being antibody see that I that areas One mentioned regards, the maybe then your chik in that a Are What you know are concept other could antibody important. that vaccine side, I proof the quick of very Would you types billion using into the year. and would antibodies up. or go have types looking bit just talk follow per And into? is; questions. got you far vaccines? for of other you there in amenable the yourself future? diseases is approach

Stéphane Bancel

Stéphane. It’s morning. Good

modern first and future very all I candidates a we know we a have in development technology in you research. comment important a as it’s human. as and is It’s milestone. we Obviously, my on produced in So disclosed said don’t being time using remarks, plans the antibody XX think

technology the to the risk, capital products you thoughtful driver has assets our so shareholders’ applications. an lot of a with What risk try always And that to portfolio about always of commented is do important for big that we and a develop innovative important technology create that’s patients. managing we to That’s as be us. biology as different for

is If you on big on the portfolio the most the you no need look at today, enough the in the closing slides, back of medical product solution and there’s for pipeline, to with no market my look of there products one if market.

And But it would course important so we in are always thoughtful about very of become tool all Moderna things. a toolbox. our those

partnering an know, our you part is important of strategy. As certainly

we’ve few with back done If with partnerships Merck, a you look AZ. over time, four

We’re the happy expand to collaboration. the of Vertex with decision course, very, by

can technology why that’s made available be to a so partner. And

So toolbox. this Moderna of is piece an the important

Hartaj Singh

just of a Great. more about the visited might getting a research have just had your to other of how to That might the material. clinical and you helps material? bit grade diseases cool one little a really, rare from your It on you’re sort thinking talk your or where sort be sort strategy. a you about kind commercial-grade material to which then get a Thank where lot. you question just Norwood see then others? of two stuff the I regulators manufacturing rapidly And facility; bit commercial really Can a to talk point of strategy. You’re you is of Can I now about modality And going manufacturing there. clinical little fairly intensity able perspective clinic commercial the you. than want to that? actually and on requires

Stéphane Bancel

questions. Those great are

ready to past, as front, in do able it’s the commercial, commercial the shared today. Norwood we’ve is but on not So,

the it’s risk, be the before able Moderna’s part be have of the We registration not first out commercial strategy of Norwood. has do around to facility that been plant be have and itself brought the will to to again That’s can company. do What so site shared much derisk also commercial we so studies and on. we to to readiness back validation But quality important the product approved. our focus the infrastructure studies, to going built we pivotal our and a systems on of and have the managing very commercial work

products So Norwood. We we Phase out of out launch can do Norwood. can of X

that. on so that the will ready time site We get we can do

manufacturer for a be way to would That company. strategy. too the be risky. have always single want never We also contract We sourced

actually data as virus. have we path vaccines, to their have the killing on different and are you we capabilities from the very mostly So already. don’t virus. supply doors think you a Because also of per the our on very, Because the human. is you published, question, speak quality which the the if the end, drug second products And vaccines manufacturers substance it, system site to X,XXX on thinking so which mRNA a go you need back for about that efficacy if is portfolio, contract at have lot micrograms the we millions mRNA about of commercial show tiny, think is back

that can So you in kilo enough. a a do do half kilo or can doses of lot

the gigantic and into Don’t patients [indiscernible] end – quantities. go so And low. of because is

to oncology very we is manage that a Of But there. ballgame. course, program be would happy get different when again, a

does it available that On something fillings, but millions no, to not end, is to the capability that’s do of the manufacturing. back readily contract vials have of

to current So we’re with to capacity the that increase we we that ability have an We time the capacity, partner, is we manage Norwood that capacity. why more needed one of the to can we we with of infrastructure for we partner thing we that. that if very have get pivotal, current end, confident tremendously remember capacity. existing and And we feel If that have vial versus new to about a – have, contract need back more do out Norwood is the commercial. do the

night could shift don’t We with We a put are a two-day shift. working on shifts. course weekends. We only of have

the you lot. GMP So that be the can you capacity moved We in have have can away available. a warehouse utilities. right be can moved lot access move The and the there parking right be of site warehouse more QC on doesn’t the site, have of of the It can you to your out off lab plant. facilities the also

GMP building. the go a preclinical Same suite a The doesn’t You have material. thing, because more to capacity. new all preclinical. in preclinical just here, but And again, it’s currently – robotics GMP build it’s are you with be,

parking can move lot the building. or a new So there to it you again, in

the at Norwood. We cannot mission a need so come manufacturing strategic big do central in CapEx investment. the we a Norwood Norwood think Moderna, so that think high us a it invest of But it’s was this of the that strategy the to about we pipeline on the node a years you for deliver company So level. there if that without long not investment. or really for to have the becomes term very We

plant the way risky. products in approved. We will That would be until be are not commercial our too

Hartaj Singh

Great. great. Thank you, Stéphane. That’s

Operator

Merrill from Lynch. comes of question from next Bank Our Alec America Stranahan

open. is line Your

Alec Stranahan

taking Hi, congrats on guys. the for couple. my questions I and had just Thanks a progress.

a FDA Phase Xb combination you October? So of more. with of I have your study toddler hMPV/PIVX comparisons? necessary first of the we’ll the sense the as begin X? before sort then likely have in see per Phase antibody titer data one vaccine, And data And see outside you on the do conversations is we maybe will a And

Tal Zaks

Thanks, Alex. It’s Tal.

typically safety, totality so totality of in we believe it, titers, antibody accepted the as you’ll what IDWeek. the see I October, the that’s you’ll present see see see you the the the describe to you’ll have when been data we’ll of study. And So we

the In development terms consistent path the yes, of the that and that toddlers, expect with step of is one seropositive here. terms would I agency think in that development the in concurs next the

structured rigorous down infants, is which So ultimately a work remember and pretty way so population that by the population. here target there’s into that your way you

Alec Stranahan

great. Okay,

Tal Zaks

clarity to of that pediatric designing in sure and given from put wanted agency terms we press discussed to make we’ve that’s in and the the why release that it study the the interaction. we that we got population, sensitivity Now

Alec Stranahan

vaccine, pretty encouraging subgroup KRAS combination Right, seems although from your to XXXX, others population. I And it that requires understand gears that’s maybe there’s are therapies. additional a sensitive that a Amgen on and seen patient data then GXXC, we’ve shifting

it So terms are KRAS I vaccine monotherapy what combination Thanks. checkpoint and for was just inhibitors? in thoughts also curious on the as with your of

Tal Zaks

one Yes, as versions two developer. science so I’ll answer, the one of a drug the you give on and

because combined one addition. and think get science, as would previously, they’d orthogonal I these described unquestionably, combine On as in we benefit, as with expect possible early one checkpoint there’s to the inhibitors would want

own on combination. that its As developer, into drug to get a merit go the confidence individual you you want before first has each

combination that us for is responses. critical think I to PDX such in it’s actually mediate the cancer demonstrate vaccine with can inhibitor the

in in have I they inhibitors stage, time. we on the that point combinations will where the are Alec, get with interest that question? pursuing your a we answer did think obviously at to depending once keen right that

Alec Stranahan

Yes, that’s Thank you. great.

Operator

to no for Bancel remarks. further Stéphane There the questions. back call are closing to like any over I’d turn

Stéphane Bancel

will us joining Thank meeting look wonderful Thank seeing you September our the held annual Day R&D This morning day. New of you your We for during upcoming third today a be during forward questions. City. for XX. to York Have you. and in

Operator

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

Moderna (MRNA) 8 Aug 192019 Q2 Earnings call transcript