MRNA - Earnings call transcript Q1 2020

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Operator

Good morning, and welcome to Moderna’s First Quarter 2020 Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions] Please be advised that the call is being recorded.

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

Lavina Talukdar

operator. you, Thank everyone. Good morning, Moderna’s XXXX conference our to to call updates and quarter business first financial Welcome discuss results.

going we’ll You can well reviewing of that as this issued Investors by our be website. access the as press the release to section the morning slides

Hoge, call Stephen President; on our today’s CEO; Zaks, Kim, Stéphane are Speaking and our Lorence Bancel, Tal CMO; our CFO. our

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

that, With call to Stéphane. now the I will over turn

Stéphane Bancel

Lavina, the Thank or and good health. good Thank hope morning families in everyone. your I and call. afternoon, good are you, joining for you you

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out company, phase goal pivoted HXX was influenza technologies. vaccine In that days and enter The We our formulation company the the years December with investing when the clinic in and of early the we entered safely. manufacturing developing to delivery XXXX. mRNA science, growth clinic spent of our

important was modalities. next clinic, the In XX two generated surface of modalities our we disease identified data and comodalities, XXXX, these six different in the in We was In period. first cell technology our our therapeutics. in molecules explored and four-year tested vaccines across learn technology short a and secreted how or prophylactic our two systemic working not. infectious well different clinic to six We goal

a in development. Early phase company’s we the entered year, of new

while with ongoing early BLAs such modalities in aggressively our collaboration continue to four in in as phase next this and for history to continuing invent the to programs our goal exploratory Vertex. clinical our is new Our file research multiple modalities invest

to have the us in presented of taken first this we When three phase years. four February this the of company we year, early had plan next that imagined will growth

the FDA that virus, SARS-CoV-X start just FDA mRNA-XXXX, announce we trial are our with the light. from gave clearance very intend II. us a Phase proceed to possible. as company’s IND of It’s acceleration green soon development. XX, against We Today, to filing our happy we April Monday, from clinical the days the on to safely nine is vaccine Our major received a yesterday as

Moderna We’ve morning mRNA-XXXX Phase to is aim for a be the commercial two several BLA summer months we opportunity. should the be that years months sorry, Moderna III we is early in plan finalizing our a This acceleration ago. company ahead XXXX. III commercial-stage three That have years previous XXXX. had means is just That plans the this XXXX. to is sorry, approval are commercial protocol. a also plans, of announced a should company versus be of just Moderna our This we ago. we that in Phase dosing should And an – a a start – company for outlined potential unique in

So we are get company the working actively ready. to

us we’re the are deliver our where instrumental allow commercially. plan, company’s To acceleration on this ready three to leadership addition their be and several file of in Today, to be successfully roles expanding of BLAs to new leadership expertise will we Moderna. announcing team areas the

joins expansion. me. Merck. will in Merck leadership start President, biopharma where on Co. global he & a entire Europe, Patrick the at joins will Commercial most recently Patrick Commercial in Operations led but June for Patrick Moderna in Merck the and growth focus in the as vaccine Global the business has also global year health Patrick within Patrick Senior revenue & Head and from positions disease access Asia. industry, Bergstedt. Vice XX-plus Patrick Marketing was infectious Vaccines. First, veteran at held with report of initiatives U.S., The X. on Patrick various to

center the and team development in Epidemiology, and XXXX. XX and and Jacqueline the GSK GSK leadership built Dr. President, from the GSK variety Jacqueline Disease Clinical from joining Senior she President held U.S. first Miller. Vice she Infectious company roles May vaccine Vice the will a Jacqueline Development. Head, at and be joins clinical Jacqueline epidemiology Most was research on Moderna as where since recently, where Miller, Jacqueline led R&D of research the Second,

Charbel from served as he Prior And Charbel forward Sciences Moderna welcome Regulatory our the the group to this the Dr. third, was as Haber, I Writing embark for Medical and am Charbel XXXX. commercial Global as contribution and Charbel Global Regulatory look Jacqueline clinical and to at stage the Vice XX Strategy Department, he application joined President, Senior Regulatory at Serono. group. phase Biogen, EMD where on President April to and Vice on company. Neurology Head, and led very Global excited Biogen, their since of Moderna Haber. joined Safety trial In role, and Regulatory Affairs. Dr. built us we Affairs-Immunology Patrick,

announce private. company the Lorence Officer. when Lorence Dr. moment our a to today company company the was is joined the Kim, It from the XXXX departure bittersweet in of Financial Chief

you job to leave it decided with by stage As Lorence Sachs a remember, company some Hoge development was preclinical Goldman candidates. to zero super-chanced great on a join of I and and Stephen us.

XX we and capital for very transitions, manage is value. company preparing am I quarter of for on over entering about time very August with will call for now with the commercial. public its be us a and contribution do need invest with and company I company. transition. for The Moderna development a III. capitalized And company to He is phase second good Lorence leaving the the he billion with to years but never had before smooth candidates to thankful to will smooth around the well next There leadership for readiness create constructive discussion focus of a is transition. $X.X first Lorence’s the the Phase conference us in

have We search for Moderna’s retained Russell CFO. Reynolds next the for

and and Moderna has will We CFO global is commercial is focus company given on a this experience, operation public who heading. where

drivers I minutes modality. frame opportunity to hand We potential wanted a believe our mRNA vaccines, vaccine where I updates, in over each the the class take clinical a of Before of value be new for to few of apply. the Tal has to four to

potential excited our very vaccines to this We drive are value. of the about

discussed, can. as do as have that first-in-class on not very the we the market people First, to do large as to we vaccines today many products protect a opportunity, ability

of Second, a high success. relatively probability technical

Phase Lo Vaccine highest that our As in this medicines is all think clinical XX% of franchise. amongst we from We for probability trial. Phase start driver shown MIT the have of the Andrew the probability This to vaccines of this Dr. has post Day, value categories I, approval. discussed a II, is i.e., a at important from approval, very

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The second value CapEx chain. is the leverage across dimension

we when machine. any decided we example, did to to after buy new not go have For SARS-CoV-X,

to in CapEx of leverage able was team existing matter Our a days.

let me over turn to With Tal? now that overview, Tal.

Tal Zaks

to in ability the with the adjuvanted demonstrated we’ve good immune quick of that’s our an over time of Thank antibodies. Stéphane, observed data and datasets Phase positive I’ll date to and consistent you, X,XXX we’ve vaccines. volunteers And morning, the date, the In a safety vaccines. with safety X healthy reminder X everyone. response and to neutralizing on again form the with generated profile elicit start

vaccines mRNA-XXXX, more high-level with and progress on start CoV-X, our SARS detail I’ll against a shortly. give will

from the and to to dose NIH-run shortly. plan the run in of study, As Stéphane Phase start which first completed This has study, heard we into enrollment I earlier, the clearance with FDA parallel three have will our cohorts. study Phase you II we move it

II Our having to CMV despite we in some year, expect and readout come COVID-XX-related third study quarter is of fully Phase enrolled, data disruptions. dose had this still the confirmation

At our achieved and XX% At respectively. microgram, now we microgram of our XX for vaccine. Phase and announced microgram enrolled. dose XX XXX%, seroconversion XXX XX, of of April XXX The analysis study rates fully the microgram I Vaccines are positive lower we and cohorts interim on two of doses higher Zika our two Day

As hMPV/PIVX to study as caregivers Phase a COVID-XX enrollment reminder, to and a their paused disruptions. due we Ib our measure protect children cautionary

with continues. RSV Merck Our program

was first production by February selection X, a by by to XX was had of of at March X, the February been NIAID on January associated had and NIAID clinical XX scientists with a covered our days filed. IND the that sequence been of an quarter and place, that this quickly but vaccine, has pace demonstrates speed subject work of in we everybody mRNA-XXXX, and provide, kind SARS-CoV-X just which believe this So first the the the on same platform can much year, detail, of discussion from released our to later. That a collaborators in batch our on XX, open

Friday, FDA Last collaboration of billion The BARDA, course, awarded from – IND Lonza XX, scale, X led collaboration doses days, the strong this goal manufacture U.S. between we a U.S. Phase government study. the for we today, contract up start trial the agency, about on we’ve the producing an we was II and the announced opening to clearance announced to II before. with to the And to On the XX April a this within at and submitted part. Phase April we mRNA-XXXX announced with of to FDA were to year. us NIAID And development. spoken the accelerate XX, a

The Phase participant I receiving two cohorts, in aim and XXX started XX-subject design as to study In an Slide and we apart. that XX. on vaccinations the III with dose microgram, with summer Phase a a start the of the XXX protocol, finalizing XXXX. three on have is each trial The of working study we XX, parallel, with study been the are month

III vaccination trial include cohorts, and XXX the a now is XX-and-above age XX-year-old the and been shared them NIH age at two XX, to a Phase and dose these the when microgram be cohorts and same dose data available. immunogenicity schedule. additional XX-to cohort. cohort of at XXX Each three age will cohorts levels also include fully safety will from The enrolled, have expanding

to ages study adults, mRNA-XXXX development at will study for and before, two The participants seen vaccinations. mRNA-XXXX, apart. expect our This year XX as safety healthy or reactogenicity given confirm to XXX expected above. enroll meant is of we will XX and In and both to the in is I. XX to XXX one-month immunogenicity the as the well placebo, in will evaluate two of late terms as immunogenicity shortly. This safety, Volunteers Phase old cohorts of II phase study the of increase the see and Phase receive that the study XX vaccinations both database phase mentioned micrograms either start

and to to week, and assuming protocol, as Lonza this micrograms. and this doses Technology said, the are year, strategic a manufacturing a Last XX goal dose announced is collaboration transfer expected of III Phase summer. this remiss begin quickly mention June, U.S. anticipate a the billion internally be this. year. scale-up, study X to and with of enable first manufactured I We for is finalizing, Moderna the with to expected to allowing up is of and is to both of at we this award begin in be to move Lonza. batches Lonza’s BARDA July not The sites are BARDA’s in would with mRNA-XXXX role I as the as we us

reviews our development plans CMV. for CMV. late-stage on Moving XX to Slide

in enrolled, quarter remain readout the and previously the II track announced, data dose As third fully study is XXXX. for on of we Phase confirmation

participants XX% participants now as expand frame for received than have well. time amendment their dose. was dose second receive their to vaccine the remaining greater of submitted protocol the Importantly, second A to

a a dose is the to As first plan the which after we for data vaccination. reminder, post Phase second analysis, the select the interim III

in Phase for in the which intended start and XXXX Europe. We is U.S. III, the continue to prepare to

first C with During feedback had we quarter FDA. constructive of meeting we’ve Type XXXX, that the also received the from the CMC

our mRNA-XXXX, program. to on Zika Moving vaccine

at and Phase preparing seroconversion to the and encouraging, boost, seen data benign for this a dose a with Slide vaccination the the This XX a Let an Day, trial. forward on me other trial. Phase we’ve regimen, before consistent doses and after program prime we that II what XX% And the has our two move ongoing I vaccines. lower of interim micrograms analysis XXX%, recently respectively. two were and presented XX study at profile, where into recap reported data fairly XX we demonstrated safety with rates are are we These Vaccines of

significant The as we exploratory to see core catalysts if continue readouts make modalities ones. our exploratory the are – what a you as of a critical from and And the well we of programs, modalities clinic. you XX, the both up in you’ll many Slide each do part scan from a our on page, strategy, of and part see the

With that, turn me call now let Lorence. to the over

Lorence Kim

you, Thank Tal.

In me agreement people fibrosis a Let months. medicines collaboration development or Vertex enabling And on extended XXXX, of in an see strategic treatment we research Vertex was us to potentially produce in In entered that functional into the cover were of the Vertex the CFTR preclinical July further six collaboration and agreement. months. license CF and mRNA first elected we for XX extend update July cystic cells of by with XXXX, XXXX, lungs discovery of for potential that based promising pleased proteins. in the generated, to this March by term upon initial data a that

approximately reported results with We our million raised $XXX Now proceeds let that me unaudited. press In $X.XX Note XXXX $X.XX cash of from financial equity results. investments which equivalents turn the compares these to release, to we net at offering, billion. ending today’s first are This financial us XXXX results. quarter in QX of and end resulted cash, public the XXXX. in February billion

which Net in-licensing operating for $XX will million, And was the $XXX a quarter an of cash payment XXXX. in number activities recur. latter million used that XXXX million first includes reminder, in of compared just $XXX as to not

million $XX adjustments XXXX. purchases $X XXXX for $X compared compared used the equipment This quarter XXXX in first XXXX. Revenue of million Cash first property decrease of the million million was to of for in and for coupled to $X quarter estimated the was our with changes future of to satisfaction was in of our timing the our amortization mainly obligations. due of costs deferred revenue to obligations, cumulative $X from revenue due performance of resulting performance for catch-up million in

materials compared expenses and in personnel-related supplies offset in XXXX costs. to trial costs, and in and partially was first quarter million of million of a XXXX. lab the $XX driven R&D by million decrease clinical The for were decrease $XXX mainly R&D $XXX manufacturing by

primarily $X million spend. of for was XXXX. the decrease legal to to million million was for consulting services And XXXX $XXX and quarter XXXX outside This decreases expenses were QX to in $XXX compared QX in G&A compared of XXXX. attributable net loss first million and million $XX other $XX in QX

for remainder I’ll what turn XXXX. to now we the of expect

you cash XXXX, million $XXX see we If line two you on expectations. with look out these our at our quarter items, our of activities can in cash flow property of line used in QX and operating here. cash equipment purchases In laid of which is by items, used and are

remember that on XXXX, two to you we And again, $XXX cash used these million payment. included QX that back If items. go number licensing of

Overall, items uptick with a our in quarter-over-quarter through decline slight QX QX in XXXX. the these see for you cash can used XXXX

November, And so expect and initial and $XXX in which be consistent guidance, our XXXX million. back equipment to with in net property activities used XXXX we issued our cash we approximately of operating purchases

While seen result of we the our expenses in we down impact development flow for results and investing a supplies, back certain its BLA clinical for such of as to of in parts spend That our cash vaccine. levels. as original the COVID slow late-stage also our trial potential and laboratory COVID-XX, bringing preparedness guidance are filing have

vaccine rather that award, in a the year expenses is general expect We by reimbursements. We BARDA Note to reimbursement we much BARDA are is spend incurred. upfront, of our the recognize this to of significant award. matching but that but expenses covered in as not expect relation award incur do COVID expenses that and cash

our BARDA We ended candidate of we composition against balance cash on invest investments agreement sheet and of funding have which into for coronavirus an QX and equivalents the entered been with of cash, funding up mRNA committed. we strength to of XXXX the accelerate the of million development and On with vaccine billion. novel value. million, of $XXX billion Let’s XX, to available cash and $X.X go down next $X.XX to create $XXX has XXXX, April our

established this fortunate available Foundation, Additionally, have Gates alliances DARPA cash aspects we business. award $XXX strategic Together, Melinda today, BARDA runway, run for ability comprising a and the with of the strong additional shared creates cash and the are private-and funding long and in organizations, to to million. we Bill including many government-sponsored another multiple of invest of guidance that the considering years

of it programs phases point me the a our I August. I The an this my and let to seamlessly But to Stéphane, brief back make But development which I’ll expect various turn just the next now. reiterate that slide before shows is here. snapshot with pipeline departure remark a announced responsibilities from through through my important transition morning,

I’m of mRNA of company, opportunity ago, talent. I’m joined all, at on We’ve come. in a horizon nascent to team believe as with what foundations is be First leaving Moderna’s of new contribute company many the and to this this I was into BLAs medicines, time this unknowns. story potential of heavily years part when been new to so was have important XX multiple to medicines grateful the of of with a a of invested the invited the more pipeline mission and scientific the the and establish medicines. class platform to new future to has growing turning new I now class the unbelievable company six the an full in

to It’s business. of invest the financial energizing built the its to Moderna the most company partner proud been executive employee we’ve the motivating the and passionate and with appropriately personally Stéphane, in foundation enable Board, base. team I’m to

look with not next plans going time more these but which step executive. stay to to on be of For close this about in innovation me, down at the take a road my will to appropriate forward you the I’m many as company call. an sharing I to biotech, in career,

to with closing And remarks. over that, it Stéphane I’ll turn for

Stéphane Bancel

On are and Lorence, with today, stands XX, for our partner been candidates our see thanks a for by years It’s Phase close Slide starting quick your we two again where pipeline. to remarks. has giving me which today, III, my incredible as six the let having But our update SARS-CoV-X preparing we quite vaccine have those a you ride. you for vaccine. CMV that exciting company for

have preparing either in that We an since acceleration II. II or I I positive Phase Phase What in now for six XX our Phase IPO programs December XX Phase result. and are XXXX. candidates

programs Our are very exciting.

there multibillion are these where approved of vaccines, market sales have dollar first-in-class no viruses. those Most against vaccine on seven have vaccines the We opportunity. annual candidates peak

innovative large Vaccine we at at very EBIT opportunities margin. to As going with shared life long-term Day our a be our vaccines high for believe presentation, we Moderna business a annuity are

programs. five immuno-oncology programs exciting with program also disease that autoimmune the all in We rare checkpoint, combined are that have two disease and four commercial clinic, already a are

The company at has never formations. been stronger an and look

than in about mission We studies. and volunteers employees energized than every our We the meaning have getting and have more by progress care now team month. and is more our now The patients dosed strong of XXX deeply X,XXX who stronger healthy and our our and work. proud are

a strategic other annually we doses only up have who as Last know week, partnership We enable to. changed agreement, for also with to added in X of SARS-CoV-X, but can us Massachusetts, not have with but you league. against capabilities our GMP site billion integrated pipeline in that our visited, need vaccine manufacturing products to fully the many Lonza a we’ve has and Lonza

am over great Hoge of Vertex the partners Vertex that Vertex. relationship the to last of we AstraZeneca, scientific work the done years. the pleased are very Moore I Stephen the very have Melisa expand and in and with proud progress that with with team And few We Merck Moderna. decided have

to leading company very are to are we for mRNA right course, for a in first the vaccine. clinical $XXX go, the world. had SARS-CoV-X safety we invest for with well and partnership very of build BARDA, focusing do study with of us $X.X enable latest to business the But course, and billion with thankful to over the capitalized the we’re in as And on continue fast million, to DARPA, as the up partnership years of course, BARDA, we’ve Foundation. also CP Gates And the thankful we the

We this are unique our very partnership thankful we trust as company. investors for build for their and

energized are new of We build to a by ahead the of medicines. class us opportunity

We appreciate, and be, its which a moment mRNA-XXXX, will are for company. development to company historic BLA potentially our you first as currently accelerating the readying pipeline file for can the

us the in for to to potentially and right future, the get get the vaccine the processes foundations many mRNA-XXXX. the BLAs We’re SARS-CoV-X there, additional Zika with vaccines in investing CMV behind starting

We need those be and to are already the up have never the very address scaling future I enabling as potentially to doses Moderna investment supply come. years. about last of for therapeutics to billion in for up X organization vaccines the will the All and excited optimistic first vaccine efforts, to additional been mRNA-XXXX. nine and processes

We we and patients. by to started North That medicines the our opportunity the for been new excited company. forward has a bring class of since Star are humbled

a recognize people to like who to since great week would to partners help I X clinical this our have and participate to day, vision the team now days the achieve share physicians literally, including fight I many would patients. to worked employees I’d our to nurses. SARS-CoV-X studies, of like in and patients, like with that thank of us helping volunteers, the many us healthy vision and all to January working hard Moderna them thank virus. every very our

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

Operator

[Operator Your Matthew from first Harrison of comes Please Morgan question. Instructions] ask question Stanley. your

Matthew Harrison

in you about low talk of being interview XX-microgram doses just SARS-CoV-X confidence in talked I And to move on the opposed highlighted immune the to the right elicit the Fauci responses good forward dose also testing? your Great. other in that Dr. doses the able low response vaccine. you’re about kind first, and dose in with guess, his as you’ve animals. think Can I

And be is by can out field think initial then what titers time Phase the if you I where you neutralizing on the Thanks. the report are available and secondly, just from data us update study? they’ll antibody you and figuring

Tal Zaks

This is Tal.

that that looking me Let question. Two spot-on we’re at. take things

best platform I short it’s expect you’ve this That of, Fauci’s factor could really all, first is is selection as current will we a guess. three XX what of – dose the said, our We and deliver. microgram elements. remark, data So on think, seen final being of the be based, Tony

The enough much need up get is doses dose overall having sense dose. you a available. as in to in how do you the go case of more balance a the first this obviously response of pandemic, of Because with we

don’t so unnecessarily overshoot. to And you want

an compare is understanding to element serum. dose you that could of as what second The mean convalescent

so that the think And ability on element of being level that and enable data of and what to models species back ultimately, But get lot care there’s more protect higher seeing, we in expected last connect the animal commensurate understanding able a mean. assay the is given the is understand done additional obviously, And to human of about that dots work the to of what to performance the in those titers disease. And reliable any the with being minute, is. the antibodies I’ll then SARS-CoV-X a will to animals, levels of what us validation, do connect dots the get. for we I vaccine

it’s short, will guess best now we as and more So comes for a based story on the and to it’s long data, data emerging it refine in. – estimate a continue

consistent make give antigen cell and otherwise mimics within scientific-first virus would the the from the have presents technology principles get right we’re of of with that Your experience if the I And clinical trials, question other about in the of the response. kind principles think to ThX, characterize preclinically et seeing the right that about you measure the we the the an mRNA seen of across kind ThX the mRNA-XXXX cetera. with models, emerging we’ve the across preclinical both versus The instruction I we across that. immune date, to we Look, a clinical of antigen, as all all data of immunological antibody board, think an neutralizing mentioned, in kind as we’ve an response, how trials, that scientific-first is of antibodies cell the however success. neutralizing want set reported routinely it, in immune data to

are Your transferred of with at speak. question, antibodies They’re from to antibodies, when we And stood the of to the types as They’re is see yes, that the parallel up assays on we report, simpler in both being those being commercial data validated. actively looking to kinds vendors. neutralizing data expect I. able be Phase binding final being NIAID we

Operator

question next Kasimov from Cory of JPMorgan. comes Your

Cory Kasimov

you got I’ve as them for two of well.

guess, program. nothing obviously, design Phase might more this there’s, III first, traditional I the talk COVID like? about can about So you look what vaccine And

regarding how some There reports of the very and So interim I’d out have for second interested question to you been full virus. amount should the then either emerging be approval? follow-up or views and is And need your be also of like endpoints what we for effectiveness you use on for mutations it conflicting thinking my on mean – you potentially about could COVID vaccine. analysis the think regarding emergency kind with this COVID-XX. hear of there your authorization

Tal Zaks

is Thanks, This Cory. those Tal. I’ll take questions.

people by of demonstrate right? cases, people be that well Phase in you order look, let that So and large trial efficacy to among – to a so couple as the design, pivotal safety placebo-controlled Any vaccinate, chance make the occur there me will the as III points. will has enough

demonstrate. expect And case-driven many expect cases statistics design what and in your you you and vaccine you so do see placebo based you see the and cases fewer how to on to the how set it’s a then many to expect

is in people. for such vaccine the can come good months the then how predicting you how three depends exposed to But risk the trial vaccinated, at if they whether you be vaccinate things: case-driven won’t to are because effective a up when the start, to being we any rate we then design, it big Now you it’s population that work. if attack end infection, not of an of know lot the on whole

And the clear the third efficacy, the and find sooner estimate is point is, because good our the vaccine element how vaccine the can are you for results them. the the higher

what of and have ongoing bar we function the a our set data, I a the FDA. how see and for well NIH, parameters, all those between It’s expected follow-up to is here going the you of elements sort ultimately, are Somewhere benefit at conversation. those to we at and length cases can The collaborators as as us, design soon between think, is. where NIAID, of have

asked what one of does and question into expect. you interim interesting could where on Now does data where this, approval, come kind an EUA

that So it’s day, as looking know get to I – we for is next that, a day, sense if sense you everybody. my and suddenly the one available at it, closer think binary event the we’re in nothing, not

animal models, we an more I potentially understanding first what levels and about convalesce potential as think will from this data the on Phase learn confidence I gain vaccine. potential the mean II and of in based we interim, as could those benefit and surrogate benefit more to

about approval. talking be not an still will We

appropriate larger the when pivotal healthy In safety a that’s have an COVID-XX in will then both database. are endpoints And We is a given older important. get benefit. of you ranging of to anticipation people, group are and about a I that with an be next safe individuals, and think with not a to to trial endpoint generate I potential the going I data mentioned. people sense have disease. piece to two to the the full context comorbidities. thinking that build benefit, vaccine relevant database final – clinical go that But think step requires is of need actually are that’s placebo-controlled the who to we meaningful. of is safety start And for And pandemic, demonstrate that The to then utility a

however confirmation. course, you you if basis, a are a endpoint prevent asymptomatic, from So having and will, because they if of is the And being infected se symptomatology, microbiological also that can on severity even appropriate actually we themselves infection, know fixed. infection then relevant population others you asymptomatic people, a define disease, getting and per a prevent

a individual to preventing there’s less benefit here So even so if vaccinee. to infection of the society

So where endpoint, trials in going between disease pivotal endpoint infection the think the emerge. and see that’s the you’re I space to

question the on your answers design. I hope that

get NIH it to FDA, it be we in lock with we it, describing closer will, the course, we the of and public. As down

emerging regarding question Your the mutations.

that for one, following to interfere make – of protein. to antibodies we’ve make expected closely. generated been two the far so you with full-length significantly the neutralizing here, would or binding here. mutations encodes spike that that described from of I’d the all full-length I And the seen, have none spike activities are protein. actually will mRNA-XXXX remind We’re points what I Number our

mutation saw domains kind binding last we think had I the week them. everybody of doesn’t understand that increased as critical submissibility alter the but to potentially with do that necessarily neutralizing mutation

this the like assess everybody potential watching area impact. else So closely we’re to clearly

exposed going the fast sort to that, relevant actually, Should and vaccine, any just a generate trials, a longer-term one mutation the in a appropriate say, against of is, we’ve can much be should the path and of platform you one kind uniquely I’d point, the the vision. look more arise contend world based it. one of population two benefit and randomized-controlled next a with move is our Number chase second understanding been future, But very as of a if mutation the address new that’s or such approval effectiveness mutation vaccine demonstrated, envision reasons. a we’ve you on I sequence would benefit the be and alter virus as virus, of immunity demonstrated for the be to importantly, that this the and for you to you for to immediately against quicker. vaccine efficacy suited there’s to if could slight the where expected The

vaccines a of mutations, generated. that doses there’s think of can production is flu deal of sequence, new you actually soon whereby to world are the and has And evolved way as put the with as millions sequence into

the to platform. development II, mutation need don’t every Phase III a established the I, path once replicate time entire there’s minor you’ve You

to So future, fundamentals I platform look from in of think very place we’re rising the envision good any of our as a I to mutations. the to that response sort

Cory Kasimov

the responses are great CD and making. Okay, progress thanks you guys full impressive for

Operator

Piper. [Operator comes Instructions] Please Ted question. next your question Tenthoff, ask from Your

Lavina Talukdar

mute. next please? the you question you Can go to back come Ted, to be Ted. we’ll might Operator, on

Operator

from comes question next Your Salveen Richter of Goldman Sachs.

Your line is open.

Salveen Richter

challenging models that – really expand And demand supply? handle partnership guess just levels that second animal at looking supply you a of where is around you’re question in and of examining beyond are the kind and and regard is demand you the to Lonza then constraints, I humans? with going kind to antibody to Where – then

Tal Zaks

This is Tal.

your take first question. and try me Let

is, think able we And and I we the I who deployed, understood correctly, ongoing. with the collaboration VRC off, what is That expect be in but at NIH. animal you ongoing cut I those connect And if being close challenge vaccinated. to you dots been think models see between to the we the dots that you work and in got work between the we whether asked eventually human the It’s convalescent done development running Graham’s Barney whether vaccinees. channel yes. answer we’re will is and that are connect team challenge is assay see able to models, have the so serum of the serum been from that people

answers that hope that I So question, Salveen.

turn Let or Juan to talk it about me talk to question. Stephane about over Lonza the to

Juan Andres

Moderna. and Operations Clinical Chief in Andres, Officer Quality Juan is This

in products we track producing question a for capacity, in that the and and our quantities. you that let Moderna the me also and will an in second So capability, scaling capacity Lonza’s record brings help manufacturing have be great worldwide. with the supporting together the site Massachusetts take incredible Lonza have. up

with will in with once partnership needed, We existing finished CMOs more bulk, Lonza Thank manufacture are going with to distribution, formulated new ones. and I the have if together you. expect and we that we’re

Salveen Richter

Thank you.

Operator

question. Tenthoff, Your your Piper. next Ted question from Please ask comes

Ted Tenthoff

Great. Can hear me okay? you

Stéphane Bancel

Yes.

Ted Tenthoff

Great.

wishing for all best Sorry been you, with about too. during It’s the you working the the nice really risen to last been thank of work. couple you and all has company the hard run Lorence, challenges. just of weeks this And before. an that incredible so it’s and I’m

guys CMV. do know with of the actually and the question has I and challenges my about those you sort have sets final the data with So all talked process just final things. And to getting

to for much. I third really if not this the see progress doing whether the there’s on vaccine general will expectation And quarter. Thanks an CMV. platform you’re also, any in help there’s wanted in how investment and to changes so and or So in update that the what data

Tal Zaks

is This Tal. the kind words. for Ted, Thanks,

both dose post I the that believe III. Let of me maybe second critical and should do we analysis, Phase here. and people XX% simple try math dose Stephane it’s with interim can for remain and questions, can we’ve of you If dose, second take vaccinated and on. our already – On those track, the CMV, over on that add confirm it’s

understanding response we smaller subjects, data the of of recall numbers with dose much and Phase you a tight good had the pretty bars pretty the error If from curve. I,

larger to also than the even ran going to safety powered by of COVID-XX, sort size to study, see the here. understand be immunogenicity. the understand immunogenicity, that it into profile with some the need not we’re because much the Now just if but was really more validate difficulty to And driven we of

will move for we that So XX%, our protocol, Phase to dose, amendment as mentioned on remain plans fully the and able that remaining and get of continue less to have on managed the numbers on. the into second CMV. stay III as data track, we’ve we And I’m discussed the that confident than before, for track for be people to the the of with

a preparing experience as maybe placebo-controlled the relates ability the understanding manner of for data, will the be will. how a of run much a informative to to and for I’ll doing accelerating this you and The of becoming to sort platform. the that us. of us Phase expand approach Your wider it’s then development, medical I you much at and give of commercial trial three phase. question And safety more I’ll performance if a it large for platform, Stephane of COVID It safety than leading so we level database from of its really things the immunogenicity sort moving in edge and of let talk the the company sort answer I to life on the is rapid expect brief is far as at all had platform. our

And sort profile on speak Medical safety Officer Chief as here, eye a a I of of platform. our with the keen

the database across application. will thousands of unexpected with consistent seen all X,XXX sort it’s and we nothing of go benefit been But subjects when into course, of COVID. far, greatly So we’ve a

competencies with do file, on the BLA a can and to pharmacovigilance our a has expanding front, regulatory our development team cetera. element building that front, up second up The capabilities, et the integrate building build

a think, All CMV, of progress I us. all – I’ll sort elements of on the where to accelerating tremendous Phase effort the that III large is of ahead other I’ll speak benefit of our And company. Stephane is for a this let

Stéphane Bancel

allude today, platform, started Tal. add support create which you new something where I take a effects, is think shared manufacturing. to few an example of some quarter had And Tal C things. I the which if very meeting a it, we we positive really CMNC to power Thanks, would network our for – powerful is just of CMV which Type around last

week, that engaged, you going appreciate, dialogue the making shape safety, The obviously. on responsiveness, had around to a mRNA-XXXX. agency every process on without Because shortcut is we’ve an to very with any in agency very FDA. has, willing helping days amazing be dialogue III the to a with As can deal very CoV-X III seven way the find Phase CMV urgency SARS us of instrumental the for this the Phase

because of to So to on months, go BLA to really in team, but digital should all This that us on through question, side. able quickly on and access we terms infrastructure build process, the the in next also within help is the this both agency, critical, be this clarification the capability the ask to get will clinical really the as powerful. data side the with ability to an able really that which here, for also mRNA effect, manufacturing both gathering, do to ability on companies, being take I CMC. clinical whereas you’re CMV. to network to that and very there’s it robust that’s be to to next And I think molecule, be you level. The are quickly platforms, have Zika, sometime know, most going because Moderna make information on Then going underappreciated use not very and on very think

other much BLA-wise and we on and faster all CMV on SARS much that’s replicated can Zika, stronger the do CoV-X programs. what So be

I think around things same it’ll commercial. be the

very Moderna you that’s to to appreciate, going are we Patrick, will months. other of that transformed totally because, arrival you been build We’ll as the that on on appreciate, has has brand competitive quickly going But of months last in standpoint us few accomplish. as the all the you can the very as on team give products. But updates happen infrastructure. a the results rapidly to the the help With in COVID work that coming been branding in because commercial our able

level. clinical at the product all, advancement the center of First at of

So the think extremely enabled I momentum Moderna of going SARS process. is strong to by CoV-X the be verifying extremely and

Ted Tenthoff

helpful, much. you super That’s thank very

Operator

ask [Operator question. Roth Instructions] Your next Please Partners. question Rahimi comes Capital your at from Yasmeen

Yasmeen Rahimi

Thank team. making quick questions for Two Hi, you’re for day the you progress amazing that over continued day. you.

question you range about there the highest patient are as to manufacturing. Phase to highest you’re cardiovascular at obesity that about XX to and first who thinking thinking risk And that at given second incorporate question the is maybe Phase above. this that healthy then going there after? which Phase The patients or a maybe a disease? are mentioned cohort enrollment? there be we going How are a going Phase are III regards risk have is but be And to they of population and that how not the is II then III in into II, will In the Phase Is cut-off? the related cohort to among above II be and are you age defining you’re are

understand, what If scaling the unknown up mRNA us is single largest you it comes when help therapeutics? to could

Tal Zaks

Tal. is This

the Juan II, question. limits. The upper answering let the there – take then Phase start our I’ll no is me and manufacturing clinical by in ones, Let

XX. think I above

You’ve seen little a out the more NIH it bit Phase parse finely. I of sort

think, we’re I us, take for no XX all age with limit. upper to comers going above

with disease for on comorbidities. people at terms to infected, should this the distinct In question cohorts relates your of higher risk they elderly both get and

the we there but to obviously, need there, get we database, As get build responsibly. safety

to that expansion careful. it open in that will into how Phase have the that that’s between sure II, should not the up, I discussion, then think they and the that FDA who a do high-risk expand a in the get do way best sort infected. and initial goal. people clearly disease and is a In of takes numbers it And looks most will that’s we Phase of larger appropriate manner needs NIAID the III, population into obviously, interim achieve we us, to that’s ongoing responsible that make an we

me take your let Let Juan question. manufacturing

Juan Andres

raw hard bringing is where associated people question. together discussed we’re the as in And unknowns very the it scale assumptions in up. obviously, before very materials, is single Okay. think we one don’t the a Thanks equipment, we the then industrialization the with the the terms product, dose. for is of working bringing Thanks. Obviously, of capabilities of dose. the bringing unknown I in which

not these very essence. at probably at going. we that gives obviously, what partnership Having are it’s three are doing. Lonza confidence we me a of the we We this have done rapidly. that’s about, things before, scale with what is this tremendous are the And doing going to together all which be speed and is the Bringing

Stéphane Bancel

Yasmeen, Yes. And maybe to just add something.

this We team. leadership and have are to extremely fortunate Juan

system have that know As be of have organization. large every experience. will get of very complex lot They organization. a the extra you of managed a have from a They million know, large he can people. come helping dose all lot manufacturing our team we They out and

every a output days maximize we for thankful system, seven the pulling the So week, for really working so we mostly of day the and thankful literally can I’m very to are They can that I’m shave them. tremendously team. all-nighters

Yasmeen Rahimi

Stephane. you, Thank

everyone so that behave you the grateful doing and very has work for And were all on humanity.

Operator

Geoff America. with from comes Meacham Bank ask Please of question next Your your question.

Alec Stranahan

sorry This is moving you’re to Lorence, go, I for but you assume And on Jeff. we’re better on and Alec things. bigger see to

So in capital allocation term. on the near my question is

guidance. your on partnering manufacturing take bit step commercialization scale? give And that readiness question you the think within But that second the Any reiterated take to, that you color Or do more much as takes in Do here. Or on how could could you potentially forward a to that? You CapEx. activities would point at you will expense U.S. would And within can And and COVID-XX build-out great. you hoping vis-a-vis are be versus for to well? the commercial intend there’s the OpEx give color I XXXX if front. deliver was gives my historical reflected it government yourselves? and some is vaccine context

Lorence Kim

Alec, Lorence. it’s

handle me trials, mentioned a expenses, business, respect to as we’re the Let With I’d around components, I mentioned you noted. will, some the to the we’ve of that sort the as guidance the so slowdown work seeing and lab OpEx clinical a pre-COVID question. of bit financial and if related of in

And potentially those we coming when ready that what there’s out timelines, be expenses relative we – to thought down XXXX. the and road. of the offset the a that this vaccine do lot acceleration We’ve commercial in COVID to to rapid at mentioned need we the company be being for originally are coming ready set be is to for we down will that’s The making investments guidance. so all

the up. change. BARDA BARDA, platform for will continue of being continue CapEx, will forward. board. of component to would as like work – not because those huge vaccine development a at to on is is the funded that all And And by we With by got mainly anticipated OpEx you just expected we as COVID on update as offset, clinical thing in scope those I last rapid But now Lonza that update we’ll then of a the we respect anything move the reimbursed that there so partner we’ve is respect the reiterate time. cycle we right it a great substantial the leverage to the to investments guidance And again, benefit very as well scale should with be having budget, here paid as

there And offset. would why the course that’s matching of and I through that so year reimbursement substantially that this be mentioned of expense the would

Stéphane Bancel

Alec, countries. having And as Lorence. of commercialization, before, the and CMV, capability appreciate, with said investing we’ve anticipate complete sell we our products as to the in on do the can Thanks, case you not Yes.

different For a virus there’s think we product important And is CoV-X, we it’s not then phase, pandemic believe product company, obviously, in do in to this phase about some pandemic which two this because a horizon. I time believe, think opportunity is going are. away. all the There in we as for the SARS

with So it’s partnership be governments. for pandemic going phase, the to mostly a

as as you we’re we’re case, that at the on vaccine. is buyers, times, necessarily sets because are constrained complex we’ve for with industry, we to working global for everybody working discussed, said of across some be So manage going be, which in we to many the publicly going have time, the why, to don’t potential – level supply

We have going be of vaccines those about are there are task the are think vaccine. in have required because ahead two with just they In hoping couple and to already clinic, is a you manufacturing both have are can that companies finished. that are that very our many midterm for scale it, things. And few that actually the to short my if impact there opinion, the companies meaning a

it’s partnering very think you XXXX, going to if in it a be governments. world about supply-constrained mostly so And with in

gets the will for will appropriate. be in they in different allocation We So U.S. do vaccine. That that example, not geographies. not intend, the decide to the the who do

with already So to sense the Tony team we to U.S. that Dr. to doses, be for the country. supply recently, assume continue to few to years, more partnership I able done our as And the know. eventually, in that clinic intend BARDA, NIAID. the the with And decide for we’ve you the a them for with government government, makes the U.S. and CDC, allocation Fauci’s

Alec Stranahan

you, progress. on Thank rapid the and congrats Great.

Operator

Needham comes Carr & of Please your Company. question next ask from Your Alan question.

Alan Carr

around putting a I these are increased success on question vaccine focus vaccines, is your emphasis congratulations planned give to stage internal? you couple extra COVID-XX feasible on timelines, are extent know and can. update XXXX, and on progress. you with Thanks got for but and you us accelerate? of along? your I III are in trial sort and don’t Can in and the high them, have of How analysis give early an EBV other those what that XXXX Phase are the res questions, able the programs an to even RSV What my your interim extent you info moving XXXX? taking Then programs? is of your it you To to program.

Stéphane Bancel

with on So let first EBV and me maybe start pediatric. RSV your question,

do we timelines. not know, you programs' As on guide

on give is team working have those as will we timelines, vaccines timelines. not the advancing as So But important no and fast given we possible.

III we quarters, closer the we But do say communicate think timelines, the and SARS plans. especially give when get kind to given I late stage important the it’s And our can suffering of given to for programs, interim the appreciated aim that. we Fifty we summer, you we that hope start as everybody is retail, best the around the Tal, can over pandemic with appreciate you to derail when On to world, development this want and the to data plan. early early things CoV-X, best are Phase physical the possible take not a COVID question? communicating. the

Tal Zaks

once immunizing a people share being with design we’ll to the able and the the sense question. of we start, to how how a agency. the good design can at and a the down have it It’s for are a that mentioned, is it. it big case-driven as because, look end analyze at the cases is with partners trial who be able a how But vet believe soon we end we expectations then are should details by risk Yes. I we the our And on cases occurring, good early Yes. up I the Yes. function and of again, be will of year. lock to potential

Alan Carr

trial another, mean guess with global? larger about vaccine. Are be talk a U.S. I I do to Moderna So guess, for versus to is, you follow-up what a just just the that, extent would you planning or who the expect candidate Or a of to – it Moderna too? multiple a this this And go contemplating versus you’re trial, you placebo? – I Phase II trial possibility is that a

Tal Zaks

be questions NIAID So is trial in with let first me the pivotal NIH. both with This turn. take partnership to a going

be, will U.S. a trial. solo either it at or predominantly stage, So this

be. parallel, wiser globally, the will looking at have I in here, we Europe ultimately, opportunities and parallel We’re launch to trials we in think, pivotal the because data more

me your – can please question? you second think I remind

Alan Carr

Yes, a trial I or think you a answered the it. I was trial. contemplating wondering if were you government – contemplating

Tal Zaks

yes. trial, Yes, Right, multi-arm right. the All yes, yes.

So as both on there’s been a of well about lot talk side that, the WHO as the NIH.

can it’s clearly for front center brain two and my reasons. intuit, you not As in

is, so pivotal But the is there expect just a get and and have to one vaccine’s on potential. trial for be trial, our we – First fundamental. the first demonstrate one second out to we more our

the where sense more less we’re for use or trial. be a like it immunized many for volunteers think to a up it would the lacking not the to vaccines makes important understand field is of to line benefit I and in vaccine. actually It’s case who single run

And frankly, in to scientific rate time that value. of and consistency the would no up, degree there is over of where epidemic expectation make it that shows add any so a attack down, what it that is unpredictable comes how and

of So public question from opinion personal a a for – a perspective. merits this is the scientific need design health I here. and that my

the we’re candidate, there’s need few vaccine I them. whether for matters as one alluded it percent than is those works it think scale point that and make you’re matters able to and estimate less a on the know to of it here you available it But of Stephane what most. more what’s who the is to, it efficacy, to going up every apparent critical need difference

Alan Carr

Okay, thanks very much.

Operator

from comes next of Please Singh your Your ask question. question Gobind BMO.

Gobind Singh

is This for XXXX. Two on George. on Gobind

understand comments us doing results be this maybe lot. you around a probably guys. with evolving help agreements help the And be there’s how other I development? maybe The the NIH, saw. That their any kind you of really separate data many presented. first place? can landscape would guys preclinical profit if you vaccine? then be, they from just can And including commercial would other NIAID’s parties, you results when But see in that with so any helpful. in share and about to preclinical there studies one understand the might what the vaccine Were do us they’re just Thanks you’ve understand seen candidates follow-up their

Stéphane Bancel

Yes.

it’s and So start of then to going I’m issues drop. think team I Stephane. the might

NIAID, that both Tal is of So being to and it there’s Fauci’s Dr. as data as at work. and makes with they complete – done, team, body sense, just we as – and in pretty labs that Tony publish holistic, preclinical soon is said, work intend both the

be of have as term share, not public, In arrangement. previously the soon aware. So as any we it’s you’ll profit disclosed

other not this was what comment I will So question? your And on one.

Gobind Singh

The and are vaccines development? commercial how coronavirus in landscape other

Stéphane Bancel

Yes. Thank you.

commercial landscape, last on know, are scale the a where of the checked on as I mean think important the world. research I are Wikipedia, worked candidates I around minutes vaccine there few thing clinic. ago, The I projects briefly mentioned those as and you is being in are on So XXX-plus time that manufacturing

said doses I hundreds that As of this few with ability month. not doesn’t a to He’s able big minutes do have come be I research the on to in that millions tens going ago, believe up of group at millions to this project stage the a ramping a have pandemic. of dent off per to

end. to line. and of I commercially no going And could a early get think if investing not we the the have that drug impact we you is talent of a screen, which XXXX that late finish like few number we chance as with just commercial capital deploying on in stage a stop do, that two might anticipate timeframe to might players, this. project have an are very is development, a I or end again approved, a something always, are to for vaccines those in also what every Obviously, And have a use because so once lot up few in candidate

is year think the my sense at that One very, helpful I people So very doses with the not lane, them is a a of stop going few to line, two scale manufacturing million finish get while there very lot or of the be matters. is scale. global to on

Gobind Singh

you for help. your Thank

Operator

Your Please next Kim comes Justin with ask your question. from question Oppenheimer.

Hartaj Singh

for – is This Justin. it’s Hartaj actually on

real And doing. again seeing just you thank to Moderna It a for in I very sometime So that all to secondly, then much. work look you. future. you so thing was the the with pleasure first, you’re working forward Lorence, one

compression I you of that thing really, of think understand of are don’t on wood. a the – people people just really knock a beauty, really timelines government engaging. lot the It’s and the

So regulatory questions. One second manufacturing strategy and worldwide. is a two on

if just gone to bit Lonza. talked, batches. it’s with So now millions, to billion about about can little on talk you commercial millions from I manufacturing, from clinical of a going know tens you’ve going

to manufacturing you When you batches against that Can can talk Lonza from And that on And I secondly, first how clinical? is EU going be mentioned approval then just guess broadly will timing? July. in know for remdesivir. process, that remdesivir. maps about the BLA approval start file? that a starting just you’ll an approved the strategy. you’ve regulatory through I process Japan the go fast

of you the the BLA year? how file I where of are So you’ll the towards end worldwide United from approval the States thinking aside strategy the assume

Stéphane Bancel

quickly manufacturing. start maybe on me let Hartaj, So

shared have have the We per ramping up output Lonza both XX-microgram year XXX What not and given do is that we’ve site. which at per doses dose, then said we and million to done up the Norwood, month. could said precise we’re

output this basically you going is month can month the year, next As appreciate year, to every per month increase. every

XXX,XXX do more out they hard that is as vial team working the get every so as And we extra the of system, understand, can trust they people. me, we will because protect

We this will spread slow of down virus. the

you now not. per at not of So process course where XXX start month, million dose a linear it’s

be decide will going you we’ll allocate which want And and the a as to why QC’ed be the and of mouth for basis. go hand process, we’re on kind just take in is where to the some it’s regular time maybe? So just then this they’ll an government and regulatory government, product made be acceleration as allocation, they how soon going dialogue we term it. is to quite to with to question of Tal,

Tal Zaks

active now for Yes. the Thanks, the Stephane, U.S. regulators question. and we’re the in Look, beyond thanks, Hartaj, dialogue with

up coming ability supply global with That partnership those on need shape the over for more a I territories. applicable demonstrate should we’ll trial to to and the who think ultimately take do huge both the will scale envision months. than Lonza the and that That to is and enabler expectation in a certain will having be for being large, potential at it filing the the eventually point, we said, a to weeks benefit. one have most. vaccine that footprint By obviously is benefit. data data, and have I other The benefit

absolutely we’re so be able eventually And actively and need available to mapping intent to it this it who make is vaccine to our out, most. the those

Hartaj Singh

thanks for question. Great, the all

Operator

no further questions you are may Presenters, There continue. this time. at

Stéphane Bancel

and his participating, and at forward you Science much. you to everybody, Have will June and Thank for Moderna latest safe. a on Bye-bye. much, to Day. the for you, the good so X So host. look thank team very hosting we day you stay Stephen talking

Operator

concludes this you Ladies gentlemen, and participating. Thank today’s for conference call.

disconnect. now may You

Moderna (MRNA) 7 May 202020 Q1 Earnings call transcript