Moderna (MRNA) 4 May 232023 Q1 Earnings call transcript

Good day and thank you for standing by. Welcome to Moderna's First Quarter 2023 Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised today's conference is being recorded.

to Talukdar. conference like speaker to now Lavina today, would hand over the your I ahead. go Please

Thank you, Moderna's morning, on financial Kevin. Good and today's joining you results call us for to update. discuss business first XXXX everyone, quarter and thank

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

Jamey Stephen are Chief Hoge, Bancel, Executive our and our Commercial Arpa call our Stephane today's Officer. Officer; On Financial our President; Garay, Officer; Mock, Chief Chief

pursuant Before Act conference we the begin, call will please Reform the note XXXX. of that include this forward-looking safe statements to Litigation of provisions harbor Private Securities made

cause materially forward-looking statements. presentation or our the Please see these for of from implied Slide and in SEC and X results to actual those our performance that expressed differ important accompanying could filings risk factors

With turn that, I will call over Stephane. to the

good with clinical Stephen Today, Good progress Thank everyone. and I will afternoon, and Lavina. Arpa plans. before back programs then start will on will financial come close. an Jamie to gives morning our you, I results, our update commercial review business review or present a will our

recorded of So cash diluted quarter. quarter, $X.X first the of we net at investments end of income cash of the and in per GAAP share $XX the billion, GAAP and $X.XX, million revenues earnings of $XX.X billion

our business. in on strategy, We investments our executing QX, in allocation continued capital prioritizing

$XXX which capital entire in stage $XXX SG&A we in and approximately invested continued programs costs third quarter, in quarter, our investments. and AI continuing infrastructure digital in in In billion pipeline. the investment million approximately also clinical the million R&D, investment and progressing $X.X last were

Japan, acquisition This Bio. has our XXXX, OriCiro Life CytomX, and Edit in with been team In Generation includes collaboration active. the very of

further opportunities of technology. investment Moderna's these reach the mRNA expand of All

$X in were purchase growing are Moderna million the of shareholders shares X.X than returned operating less share Probably to quarter. mRNA million We system. with

in first the Commercial turn me quarter. to Let

We XXXX billion in advanced COVID vaccine in achieve on continue in With billion $X.X COVID billion to of are to deliveries signed well already $X agreements. way APS. from we expect $X purchase our

is to that negotiating billion. customers to $X chains, with contracts team The markets add pharmacy orders will other finalize negotiating U.S. The to networks sign actively the additional in hospital with customers. commercial team new and major is

the fall As XXXX any of a does include reminder, $X APAs U.S. not contracts. billion signed

and U.S. and in also important the is Japan, new these business the in in making commercial So as other contracts Europe are additional. America. The also progress Latin Middle East countries to Asia, team

contract new in for Australia a signed recently XXXX. We

the on organization commercial XXXX, launch health commercial is also the Our preparing for of the medical educating respiratory They're RSV. community of in our burden RSV products. next

medical Our of strong is disease vaccine. medical and shows sharing participating infectious RSV team congresses that profile data a in new the major

producing RSV manufacturing drive vaccine for supplied prepare The prefilled products. some RSV versus To begun our help already team doctors by as will substance, launch, has be will the for of drug syringe. mRNA molecule our believe that and vaccine. We pharmacists adoption a RSV

scaling are now mRNA-XXXX neoantigen markets. support individualized for therapy, we manufacturing INT, development up commercial and oncology, In called to or clinical

also is types adjuvant tumor addition and lung. melanoma in Our commercial working team X Phase to to studies select for to prioritize

our is believe the RSV Day, potentially We of pipeline. meetings. data at Turning to the were vaccine discuss we At best-in-class. detailed presented medical Vaccine from that research profile vaccine RSV

as as Phase flu next-generation the initiation for intend line we announcing or programs flu We programs. strategy that of X approval X Phase well the to accelerated the our for on shared data top use X, study

be We also refrigerator-stable. start vaccine, announced COVID mRNA-XXXX, next-gen should the for X of Phase which

in also HX. program programs. and for I'm program, has trial announce very our is greater XX% EBV for know, continued readiness also as HIV. you In progress two pandemic vaccine, Influenza than EBV, we're progress X enrolled. and early-stage Today, latent CMV our pleased new a to announcing Phase

The EBV mononucleosis also in adults mRNA-XXXX with X adolescents. and enrolled in fully are trials prevent to Phase

Our And for analysis Phase vaccine. we trial our interim long-term from EBV for HIV, the enrolling. at now infection started treatment X study shall EBV complication of for has

We also introduced new programs.

on will in platform first through from is the vaccine. X partnered We AACR with vaccines meeting on data Lyme we call, where are for we detailed therapeutics, Later presented In data working Lyme are we Merck. program R&D norovirus presented our take targeting pathogen you disease. in the bacterial Stephen mRNA there. Phase the with participated

pipeline PA in We're making trial program. to progress. now month this The data be at Gene academia presented for milestone dose Therapy also phase. in the PA And American Phase is will in and from Society Already this additional or May. later is Propionic new X/X this our for excited Cell announce expansion a study

continues The expand at pace. Company to a rapid

The program have new and of X,XXX underway continuing have this We develop. programs commercial now and appendix Pacific. XX in Americas, the now XX full removes the seen be pipeline disease our across which members obviously not of and also Asia inclusion can to than programs in more presentation team of on or quarter We that Europe are reflect website. the subsidiaries

also to by hiring In a to great our officially engineers who recognized I'm our expand Work digitize a Great the Modena help happy our data March hub, as we're addition opening and technology the was to work Place subsidiaries, Seattle where commercial a announced will scientists also we announce capabilities. place Institute. to in office AI business we're and has

at is to the Our G&A. $XX.X scale us cash of across enabling manufacturing, development, other our research, billion and quarter commercial

Stephen. me let now With that to introduction, turn

been first progress afternoon, highlight at clinical select Good the Stephane. are Moderna either RSV, flu or the has the good which core Today, The from quarter in Phase respiratory is vaccines X. everyone. you, past commercial against and few presented. data months our of in R&D and made in morning review COVID-XX, up I'll of Thank or portfolio

vaccines Phase study X. is which its enrolling that vaccine X franchise. second-generation mRNA-XXXX, We're combination second-generation refrigerator vaccines in influenza advancing in vaccines, believe future of the rapidly candidate, Phase includes our are next-generation We respiratory will two be this COVID-XX our stable and

candidates combination early programs represents viruses, including pediatric and clinical Phase now vaccine believe we in pleased X respiratory specifically broadest five respiratory this of and advanced covering we're in XX trials, vaccine have four for in And With different five trials, designed virus populations. the including portfolio that different clinical we most two candidates.

recently specifically turning FDA COVID. Now The to fronts. several updates provided on

formulation are of also doses Our now for of receive recommended with needed those with XX MBA targeting age United streamlined COVID-XX Omicron-targeting now years both strains adults. as XX States their original to vaccine authorized bivalent physicians. a Individuals, the additional simplified only our eligible and regimen and is and in children immunocompromise or certain kinds the by

XXXX fall is look come now June fall, we to to XX an meeting. VRBPAC expected the As at strain updated composition selection the for the boosters for

lower to adults Moving against large older with consistent RSV, RSV vaccine pleased in and we're by profile tract across of high study. our populations efficacy the in disease respiratory our X Phase

we've or profile At our them has two across with the recent high higher including grade AEs shared meetings, consistently X favorable grade efficacy mRNA-XXXX also tolerability all risk. shown put in preexisting in at groups, moderate. data was showing a comorbidities oldest age vaccine's participants mild and that to medical X, mostly with adult

Guillain-Barré trial. seen have today, Day, in other Vaccines we of during shared we cases any the not or syndrome severe As events demyelinating

flu. to Moving

that cases And did accruing efficacy Phase study. of in PXXX the that B A PXXX strains is through when the with that success study trial announced accrue is neutralizing compared update end the we early we The this the flu last titers showed declare interim sufficient That an data ongoing. study HAI the for that Northern strains Hemisphere, still to not summer. expected and DSMB recommended cases licensed immunogenicity with were at for consistent analysis month, immunogenicity study flu this from that non-inferior superiority X vaccine. the and season preliminary the Our to both the continue

X,XXX a initiated announce designed by Phase titers this immunogenicity expected is We initial filing launch to I'm B antigens. PXXX increase This that this HAI an potential approved is updated enroll the XXXX our will spring. to believe regulators. is study the approximately flu study adults the X Now and flu pleased with and an mRNA-XXXX. PXXX for support if formulation is to our study against an update we've of neutralizing testing that

to turning latent our vaccines. Now

CMV in vaccine childbearing age of participants. Phase ongoing XX% than women more study and X enrolled Our is and has

have an ongoing that vaccine dose-ranging Phase also X/X study We populations. with this eligible adolescent expand potential will

we against EBV, earlier, continue trials, latent VZV. make mentioned and Stefan of HIV As vaccines candidates all progress earlier-stage against in our including to clinical significant

of Stephane mentioned, prevention vaccine trials for two candidates, the our includes of EBV our clinical longer-term and are As two of EBV candidates, and for and program prevention vaccine in mRNA-XXXX respectively. includes infection sequela mRNA-XXXX mononucleosis EBV infectious vaccine

to which share pleased to vaccine, are continues our Not advance. results Vaccines we HIV Day, interim mRNA-XXXX, of

across autoimmune in needs disease pipeline I'll the rare Our diseases. unmet in areas highlight And ongoing. these therapeutic immuno-oncology, today, are recent disease, targets of cardiovascular a All few updates. trials therapeutics the and

shared XX, KEYTRUDA KEYTRUDA data here, for compared versus INT X rate XX% KEYTRUDA On curve melanoma with plus alone. solution are relapse there Slide at therapy overall, in of a and combination a a reduction in alone. Kaplan-Meier AACR was combination individualized of our Phase with the study from the adjuvant to relapse-free death KEYTRUDA our neoantigen or The of survival

remain picture XXX with to in even a there months. continued few are encouraged participants XX XX time, are data two beyond total. that the the the as will the than follow-up We get very that additional this of we week Thus, this mature, cutoff with right at slide, the by participants curves separation optimistic of follow-up Note at less cautiously continues better.

two relapse-free briefly shared confirmed The XX, Slide important the across I that on to Now KEYTRUDA. on Again, effect subgroup data survival. the treatment was of markers to some this responses predict strength highlight the that AACR. analysis additional looking the at want of known we're slide, at are to

case, and stratified KEYTRUDA side, tumor mutational blue. the in each the low in monotherapy the INT mutational control. left and for dash the tumor for On burden burden lines line In results combination is red by are are the solid high

expect. that controls line, you we what high know and of than TMB This expected as KEYTRUDA, a have by TMB start participants higher the the red you because for will control and we arms performing relapse-free low dash the about is the If that participants, dash the looking line. comparing are shows survival blue the KEYTRUDA, in note

and for moving the lines INT you INT high see relapse-free and to survival solid the can the same the the lines combination dotted higher led them against low combination TMB also exciting of as -- well to highlights population, that Now both color, well clearly robustness comparing arms, to improved rate INT. quite note which the TMB of blue KEYTRUDA. not seen in to response the that respond response low This the the does It's for patients. TMB historically

PD-LX by stratified the as status. On see you'll right, the result

the with analysis, as to to immunotherapy. response is known Now rates TMB PD-LX predict

you the look dashed blue see As monotherapy patients red groups, lines by the acts access. unfortunate dash for worse and survival these better for KEYTRUDA positive have PD-LX control curves by negative monotherapy are This KEYTRUDA tumors, PD-LX as enough for can surprising lines, relapse-free the lines. isn't the the PD-X, dashed blocking tumors, PD-LX

As positive negative. and blue left, combination combination the lines solid there the the note improved combination in the the analysis Indeed, in the increase with the for red cases, this the on for is of subgroup response is significantly are patients. denotes on curves rate PD-LX of both ratio the PD-LX show TMB with that INT, In is encouraging the negative an treatment. again survival RFS relapse-free PD-LX hazard X.XXX. It rates to denotes

in in with looks an patients burden tumor indication Now to of the in alone. survival our highlights KEYTRUDA compared even data monotherapy progression, broad-based initial PD-LX Phase pulling of or who benefit status whether improvement have mutational the relapse-free back, a analysis study, across observed to higher that of risk X these important subgroups potentially seen due

be this are primary biomarker the be that for and data sharing data study. endpoint data ongoing analysis just X We'll We'll distant just shared. additional these cuts in conducted was which metastasis-free survival additional Phase sharing positive important from Now just the ASCO, the I also the data. including study at same secondary beginning a

across at is which will population, States Europe, will await patients. regulators designation we events, In the for protocol be full updating addition, subsequent we curves Kaplan-Meier analysis for time also survival we the recurrence-free XX follow-up and with this INT as calls eagerly PRIME when frequent updates. this with United facilitate therapy quickly received advance treatment those to the work in in breakthrough which dialogue for longer has and

explore closely initiate Phase additional beyond Merck, earlier, opportunities adjuvant additional Stephane with lung As study in and X types, indications partner, to our rapidly in label. We're including approved mentioned working we melanoma plan our cancer. and expand XXXX within non-small to cell tumor that to KEYTRUDA

our acidemia program. And finally, propionic on a update quick

X.X and per study Phase patients currently cohort. enrolling is kilogram ongoing milligrams X/X in Our the

and in dose a identified have have We study. for arm that expansion moved the expansion into

yesterday through update I'm Meeting including the and on update a time the pleased including presented year, higher lower Gene safety from clinical an this dose longer-term dose -- be rate that compensations announce at cohorts from Society and the earlier of cohorts metabolic and just XX. to Cell the American point Therapy now of earlier the May will follow-up on major

the abstract for link a of about now ahead. that other in forward our presentation months look to this available on The medicine found We sharing and be lot the this can rare is slide. the and programs more in disease progress

turn I'll over that, the to With Arpa. call

the the start Slide summarized of our first will I in Thank and quarter. sales you, of with in quarter. a Stephen, On everyone. day we review sales to composition XX, good the first

on chart, first of sales of majority were world half $X.X first rest billion. As billion in $X our were representing of delivered of announced in quarter the to expected the sales vast Europe billion and billion of from to the the the see previously APAs were XXXX, XXXX. you'll Approximately the $X.X the $X.X sales

expected reminder, strain updated of the half vaccines a with manage. sales U.S. are As for COVID begin to in XXXX, second

continue Slide And at billion COVID the deliveries as we current to looking COVID reiterating we of agreements. turn a approximately deliveries, purchase XX, vaccine minimum today, Now from are in $X we advanced from deliveries APAs, billion, announced $X $X to are XXXX. Of of mentioned the expect expected in the XXXX delivered key markets. in be as to I first previously additional earlier, half billion orders from XXXX

substantial that the and Union. We billion to delivered with $X.X have already billion $X quarter Japan of fulfillment European the in first

We in remaining year. previously APAs the expect this $X second to deliver in half the of announced approximately billion

the happy in announce Government sales Union, the new Japan, that and to team a with Latin Australian expect Asia I'm has for we signed XXXX. U.S., commercial Additionally, European the America. contract

commercial U.S. the positive, in U.S., discussions a customers that with COVID are are aware our Throughout is will I discussion that elaborate is on substantial with Our buyers and still customers as health COVID hospitalizations. leading of our in urban. shortly. that In it the commercial Data to continued only chart September the as the in shown leading in a heart COVID first cancer, on cost XXXX, third through and be cause the left. death the list U.S. available of after XXXX, disease clear

available side right-hand shows COVID, the the most U.S. flu on the for chart data hospitalizations and for The slide recent of RSV.

COVID, season see, than well infections to As triple hospitalization to almost customers severe COVID clear continues protect against There you'll COVID flu that with need. as more a of current that recognize hospitalizations RSV. of over rate need as that per be our of the XXX,XXX is and for triple

U.S. XXX market be of approximately full For we XXXX, the volume expect million to doses.

earlier highlighted driven of a COVID we the critical. year, transition government As in from business successful to the commercial-driven our is model a U.S.

plan to on on great action our have rapidly commercial executing market. We develop progress front, made this this

the team Importantly, with active discussions throughout commercial is customers U.S. in the

government and national contracting pharmacies, integrated Defense, VA, the the delivery regional and providers, providers. networks, the for of health other with purchasing, Department and are including CDC organizations We

our established and national operational. In is distribution e-commerce Moderna addition, Direct infrastructure site our fully

activities I'm launch for campaigns. We vaccine Our chain time including activities launch. will single-dose all place in global COVID-XX consumers the files get for the the of and some to preparation supply vaccinated. syringes fall share is of needs to these drive U.S. handle excited vaccination to updated customer prefilled believe at

will disseminating healthcare physicians, approach demand need physician the are be decision-makers, providers. approach year, broad us First, to tailored production. to for content Later drive well to continue taking an this and multifaceted institutional messaging via drive will customized to across we omnichannel COVID as ongoing immunizing we as emphasize digital awareness allow This influencers.

assist skip also flu believe opportunity well harmonize simplify vaccine. base is patients. as and immunization provide with across in to opportunity as to continue are their believe programs. our different there are to partnering their customer vaccination staff the we there's the an We segments to going patients for both education, who fall an to commercial And process with We to to

be COVID efforts. to Consumer focused significant promotion in will through vaccine patients driving DTC the of year, Moderna's seek fall this primarily

for I influenza to in who together experience simplify As the this are are mentioned looking vaccine our going fall. earlier, seasonal we already consumers

for season. We this are energized fall

will our Moving on on to second which Slide XX, you near-term RSV. is update I commercial opportunity,

are We what will develop ensure that excited our of is the XXXX number activities large share of hope undertaking we commercial as a be for launch as vaccine the a to expected RSV quickly that possible. and market we of team

detailed X RSV of generating raising already health meetings. presenting data major of and by economic Phase medical at are from awareness We and the our study burden

in team figures across with age all has shared medical these The data is we showing as tested key vaccine our our opinion groups by right-hand well encouraged additional that efficacy the efficacy prevent comorbidities. platform side leader we the detail on of participants Our mRNA the data these on and and data of medical application consistently data share important subgroups, are preexisting in as to high as slide, feedback congresses, RSV. at

payers engaging active XXXX. access commercial markets We're is and launch for with the a in to team launch. ITAC ensure in And local preparing commercial upon

we the are begun manufacturing so able will invest is prelaunch we to as building we we educate as syringes. in efficiently our customers prefilled and soon Specifically, activities, approved. components that the have be vaccine capabilities vaccine And digital of as already

large products be respiratory excited these of are We launching markets. will the we about the into profile

roughly $X can market. billion this take three for flu respiratory addressable respiratory the With $X and We billion billion, and we of share sizable $XX to substantial. to potential of billion $X offering vaccines at a billion Vaccines markets believe billion, Day, estimated COVID, we markets are RSV respectively. As discussed total key $X addressable our $XX

with preparing vaccines launches next-gen underway We our will us combination believe with importantly, well in drive future market expand in is over the continue to opportunity team time. and RSV commercial and for share XXXX in The to respiratory flu beyond XXXX. positioning vaccines, our

Slide you patient identify eligible to types. Merck, various tumor Along we and commercial have Europe partner, indications. how with populations start our of will for cancer. on settings cell population XX, annual in helping with we Now share I in Adjuvant new trials the that the want these and adjuvant is team the melanoma two to adjuvant announced in lung in already non-small X There an U.S. is patients XXX,XXX and over neoadjuvant Phase

for adjuvant types side. neoadjuvant potential right-hand additional on populations tumor Patient listed and are the

Our are unmet commercial largest our addressable tumor closely with working teams identify need the for teams for clinical individualized neoantigen to types therapy.

to excited are medicine a be launching one have areas in for we into in great one patient of space where cancer. We

Given commercial end-to-end. model, with journey, we individualized along patient care approach, partner, reimagining are our our with the along

With to it turn that, will Jamie. I over

framework Thanks, and for Arpa, and review performance, our XXXX will provide Day This hello, QX our morning, the recap a everyone. from our recent financial I quick cover financial Vaccines outlook presentation.

first Moving and is billion, our in $X.X decreased year. quarter starting year-over-year sales to with sales consistent by expectations XXXX on product mainly lower to the results, the prior driven XX% Slide Total our compared XX. decrease to volume

surplus costs on associated with charges, and primarily of These from were first Cost than million, cancellation inventory an following and $XXX capacity $XXX $XX overall of the $XX driven purchase was fees by XXXX of unutilized production demand to write-downs excess manufacturing to addition This capacity countries. million related and our royalties products, $XXX firm COVID-XX million; million. includes for other and losses for related unit-driven obsolete charges: manufacturing lower costs. of commitments and sales the of quarter lower-income in forecast million royalties,

fixed product a manufacturing as charges XX% year driven well sales higher to to sales compared was lower switch lower dose as product The to by sales aforementioned prior and compared product costs. XXXX. percent XX% in sales QX we of the costs over the absorb Cost as to of as smaller was increase vials manufacturing

in the expenses particularly to increased prior XXX% spend billion, trial-related Phase expenses Research X were year. and by continues attributable clinical The agreements development studies and with with for R&D increase due our The R&D RSV, recently $X.X in Generation was also collaboration which to increased driven versus be headcount our by Bio. in and seasonal personnel-related flu announced Life and increases costs increase CMV. to Edit

related XX% company an activities of reflecting was SG&A and marketed our outside $XXX expenses were investments growth well driven of personnel increase our services in commercialization primarily continued as support The products year-over-year. by as in expansion. in million, spending and

million of provisions, Income a earnings net provision was benefit income per nonrecurring compared billion last a was net and outlook, our earnings the $XXX $X.XX $X.XX income R&D share for driven by of share of first Diluted credits year in QX items. $X.X million a per XXXX. year. Net full was international tax $XX diluted quarter, to includes to compared which

against the XXXX. ended We activity. end of billion with buyback from was declined compared the by fourth by our QX XXXX to of line in driven Cash investments of product at and with expectations. deposits products to cash prepayments share The end of reduction billion billion end as supply $X.X of $XX.X $XX.X quarter XXXX, a decrease and we QX the deposits at the our cash delivered for $X.X of future billion

have turning Slide to XX. an want on priorities. update Now on we give made the capital to our allocation progress I

across be in investment the multiple base will areas. priority top reinvesting been business continue and Our has to

billion the the increased As first year full to project quarter year-over-year, of investments of mentioned approximately in R&D spending XXX% $X.X earlier, we XXXX. R&D and continue for

the generate As the significant term. Day which discussed returns franchise, to this vaccine near of expect is respiratory Vaccine investment majority relatively we at our presentation, our for in

manufacturing to We the build-out are expanding plan commercial international accelerate manufacturing as XXXX We capital footprint. as expand in expenditures well our as our and digital our organization significantly we both U.S. also investing in the capabilities, our footprint. of

to investment enable platform. opportunities our collaboration that complement investments will attractive external priority and second and Our seek is

the integration quarter our OriCiro underway. operations announced, of the of are first and well As previously the acquisition we successfully in closed

Bio. collaboration agreements entered we the Edit into and two quarter Additionally, during with Generation Life

additional repurchase After then million. our billion XXXX, opportunities, to of as evaluating external of had be quarter investment cash. additional XXXX. XX, opportunities, share authorization active we'll multiple discussions in remaining continue and for million uses approach. the March internal of assess We of we first regarding X.X we in disciplined are shares repurchased $XXX collaboration In We and external X.X

let's XX. Now financial XXXX updated turn our Slide framework to on

have for for active And we COVID market in XXXX. of government negotiations purchase for for in to contracts continue sales other advanced the agreements markets. are Japan, U.S. additional We key commercial $X in approximately and EU vaccine billion contracts the and delivery and

We $X continue to first half be expect billion. to sales approximately

nature Due of respiratory sales business, we billion. our to $X.X the to expect seasonal in QX of billion $X.X

expect We X% of to continue to XX% fiscal to reported which year sales XX% sales be cost XXXX of royalties. includes

of expect then the to seasonal above of For the billion reduce through nature we range of to our the we year QX, our and of expect cost sales our cost be $X.X the first of $X.X half sales business, to XX% Due between in and year. of half average billion. XX% the the second

billion approximately $X finally, $X.X For to a billion. be and we expenses continue We billion full to expect to with capital expenditures SG&A, benefit billion, full anticipate research credits, And items. and of billion, approximately expect tax approximately $X.X nonrecurring to we driven $X.X R&D year continue R&D provisions by in $X now international year of and development.

Day presentation, from quickly Before or recap who the financial takeaways. Vaccines for able to Stephan, wanted our haven't weren't the back turn seen to webcast to I I call the those attend

the return envision the for potential franchise. out current the year we to franchise, significant wanted by lay Given our this investment in XXXX respiratory we

size Arpa over COVID, ended billion billion will by believe market remarks, earlier billion $XX capture where of $XX the we for RSV we marketplace. and be to this to and $X XXXX, her expect up Picking flu

to of we our remain this goods sold will term endemic from the XXXX. to as normalize we believe environment, XX% XX% transition by a should to pandemic short percentage in a While elevated cost an range

maintenance the We vaccines $X routine which billion also investment cumulative by will normalize R&D to years, laid over billion amount of required then revenue next respiratory to three out XXXX. XX% a $X a

cost of capital the the $X durable future flow which free billion the intensity, return, growth. vaccine and to flexible to high highly Finally, for further of with could franchise, we cash like revenue respiratory lead low potential annually room given base, billion $X characteristics

to back remarks, and This the concludes call turn my over Stephane. now I will

Jamie, Arpa you, Thank and Stephen.

me the close In we'll to has projects the U.S., around thoughts in Let we before And in share significant for Japan outlook finalizing COVID, Q&A. some into promising world additional that with fruition. and customers. commercial development 'XX. discussions Moderna's several we see I come are contracts believe

COVID are is is getting market ready development I'm we governments And campaign to great as the and prelaunch manufacturing away vaccination oncology, team not we in launch have begun for RSV, pleased expect in the going risk 'XX. in fall. which that for and making progress.

We to months expect eight of deliver pipeline remaining in on the key development our milestones XXXX.

'XX. VRBPAC to to We on COVID June we give fall expect and regulatory strain updated the authorities direction of with meeting, us expect launch an COVID-XX for vaccine

to by we X/X QX. approval be We data RSV enrolled study this summer, should and vaccine and Phase fully plan expect to for for of in file

therapy, and data for And our portfolio. May present our make in update, in expand INT on We make into adjuvant we launch of continue XX. to types. to expect progress For Phase revenues melanoma X cancer Phase study cancer X additional PA additional we'll

a teams at our for for is like their exciting all us and and Moderna, very This time to our I their thank hard would mission. commitment work to

Our and closely platform now followed portfolio where and MMA look is GSDXa. on data In bacterial respiratory, a INT And by with and cylinders. excited at rare the PA Very latent Infectious disease of going. entering by is Disease vaccine, and all the is firing vaccine.

year. annual we updates some September this give We'll R&D On XX, have there. our key

possible all second the greatest positions present our ESG We made for have of every annual mission incredible our new entire believe will of motivated to development company hosting We the pipeline day. across data company the our day to be and X, December we'll that progress we mRNA our on modality, come medicine. is success. deliver team was to impact long-term for to work people But financial for our

We we a disease technology to on of work years viruses, in to of latent paused cancer, market respiratory caused technologies to eliminate have and number viruses, a mission. reduced next diseases. human or suffering our believe and growing bacteria, greatly more We the a several our regulating to continue bring have fulfill promising by list to

take questions. Operator? we'll this, With

from Our Barclays. with Gena Instructions] comes question [Operator first Wang

line Your is open.

I have two quick questions.

first regarding half in The U.S. this one is second opportunity the year. commercial the

question commercial still my for discussion the for XXX How PCV are your contracts groups? clarity orders? ASCO on a the see is update out to XXX start second will benchmark? with two then actual play in pricing government between and quick you You expectation is or And When peers, program? is good regarding to these both, your

Great.

two So, with hand to ASCO. on the Stephen over to first I discuss questions and then will start it commercial

the terms U.S. XXX In XXX. anticipate the across vaccine pricing we do to when market, to in have of list range we our price updated be our of

you're in differentiated to will commercial commercial providing different types, agencies government well. we players aware, payer across be discounts the from As market, through as

orders, actively In the terms negotiations U.S. customers. with are of we in of the timing

are We two on very encouraged fronts.

that and get partner do want make protect and and of they that potential the our fascinated to appreciate their First understand patients burden customers foremost, success sure significant hospitalizations COVID to can as to from health severe us diseases. many with do with and continued themselves

and effectiveness customers, our appreciating full evidence to very the continue vaccine. different of and we behind if The real-world other encouraged recognizing are profile thing by the conversations be buyback in with our and they

and contracting, the of through end continue clarity over anticipate into begin weeks, see around to to early six we will some will we QX QX. more So, which the next four

Gena on ASCO? had Okay. a question

Gena ASCO. Sorry. open was at date what

Stephen. it's So

sets So, data two there's be will of that two said, presentations, I as shared.

X The for usually, survival on focused is a greater distant is that's first metastasis-free you metastasis and and unfortunately, DMFS, as in looking concern. obviously time The survival, secondary be a both we'll will data the for another visceral, survival, of first know, metastasis-free protocol surrogate DMFS overall DMFS. and endpoint, study at the Phase the first distant distant primary at analysis, analysis, was RFS ASCO. and presenting be included the that

it, across of the in risk will we'll stratification is basic we're look and The further the the is benefit That will more seeing data believe bodes for additional in second as that Phase that well in poster will the form as be well product populations. INT but potential on data who provides performance we the of on those get data really and INT biomarkers some science terms study for into are interested even more action into of shared signal for data that of be future. X the confidence resilient in of mechanism that the

Thank moment you for question. our next one

question next Our Goldman Sachs. comes Richter with from Salveen

Your line is open.

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question. maybe the And take Salveen, COGS I'll

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Thank you question. one moment next for our

comes Tyler Our next from Buren question TD Van Cowen. with

open. is line Your

on for Tara is Tyler. This

about recent I once then than does and winter you commercial season the announcement take timing. previously So month, and perhaps anticipated? we're to the is, approximately Pfizer bit the you Europe in ongoing of you it larger wondering And next a finalize COVID with But outside strain an Europe specifically, separately the U.S. regarding little negotiation drive and know U.S., long a mentioned contracts what in create is the the for to the abroad? do opportunity for will think how fall selected actually guys contract

Thank you question. the for

first question be we in the contracting to middle final around U.S. on the June, already conversations timing variant Your strain contracting have initiated waiting while variant. we of of selected in FDA-selected based are for an the

quarter. do I these third weeks, seeing as the several over signed anticipate contracts So mentioned previously, we of the next being into some leading

on the evolving based sort customer. So time an of be it will line

with news From an in that Pfizer. EU by is perspective, the encouraged renegotiations the we're EU

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question. Thank you our next for moment one

comes Yee with Next Michael question Jefferies. from

line open. Your is

talk you INT discussion areas talked there FDA Two you shall do or a accelerated that bit potential I how to think that to a to as on wanted Talk recent you've feel bring the breakthrough say, slides have I this the around around years with data. scenarios just you do mentioned your the little to Stephen, have patients I this time to therapy. run the as And designation. a and we ask you X? PCV in or year. around cancer well argument you mentioned really that sooner approval, have wait Can about about to Phase

see Obviously, a second the I then important you to of is to coming be How revenues. do we'd love question, your year. RSV. see This diversification also And could with think, regard next revenue Is opportunity that of And with market yourself revenues battle out do next year? where your competitors and couple in or is advantage? see share you there, how a XXXX? a payer

take the the for one. question. Mike, I'll INT you, Thank

in will probably to forward still it's us to this even patients. take bring it's So think Look, for I that data the the proceeding X couple this year say accelerated next think over there point of consider. what really regulators while it obviously this to it's -- in exciting, is study, lead to an Phase appropriate for early approval. at -- discussion notion the being But we to premature that And about for that to sufficient or thing years conditions could directly and are

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from path under is I there I we we might had stratification sharing at yet, are study with consider which regulators point Phase well discussion as the towards would of enrolled when and some potential some were they a data and even think the conditions out being in being really show today. enrolled patient of and a accelerated but really to where continued path matured in other the higher at the a data on perspective pace not lot in pursuing in that populations perhaps future the described X the benefit read the here, be for compelling partnership had on approval risk well obviously

the it's And the in medicine factors time an to complement waiting bring that confirmatory read that way patients those an say accelerated for while opportunity to to this trigger out. would --

So premature.

those still things of happen. All have to

randomized our why continue story follow started, study. get So focus this enrolled that Phase and is right the to get X X that's Phase really in now intriguing it

take And question. the can RSV I

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Thank question. one next moment you our for

Our from Morgan Stanley. Terence with comes Flynn next question

line open. is Your

I you Phase about on was any you lung design just on that this the comment there. of then move just Great. at at front? all the X you that driving can point this point? to INT, us Can of just remind wondering what's confidence if in at And forward data have

Yes.

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Operator

moment Thank you one for our question. next

with Jessica Our from JPMorgan. next question comes Fye

Your line is open.

have of been some on the asked already. follow-ups couple of A that questions

endemic COVID, First, or early participate for lastly, updates for example, Europe? in improved third time the the see any on opportunity are like needs XXXX? we in how combined price on finalized real for in do you status of U.S., shift an COVID in for more XQ to believe for a Second, approved as for And to quarter? the example, the expect contracts to report, soon with results do on you for outside those phase the with be RSV sort fall, co-vaccines contracting RSV, should U.S. for you

you. Thank

minimum, updates quarterly are we not providing updates real-time committing are In in our contracts. question But at updates commercial on will we with per we terms first currently at of terms for U.S. a commercial to calls where contracts, of contract. U.S. your be providing

pricing, countries comment you procurement is the primarily I are tell pricing, government our majority we of centralized not outside The can the question ex-U.S. around a for still do on in the model. second we what but U.S.,

more endemic pricing or we not for markets the U.S. So, of of yet traditional most have the commercial outside set

the contracting. question, I And RSV last believe, is on

XXXX per But are in particular. market. our the believe the XXXX details do we launch to for for for the will of in through -- U.S. current time We we contracting targeting assuming continue in work be contracting a market for the we U.S. a launch XXXX launch a in assumptions, to

moment question. Thank our next for you one

UBS. comes question Ellie next Our from Merle with

Your line is open.

guess, just second, the reactogenicity then just in these also you broader this additional add plan just housekeeping. your file Maybe confidence with on this little in just updated elaborate can strains comment if formulation on And balance B of if the maybe targeting here And level this on could and RSV, flu the of do studying quarter? the still bit compound, additional platform just is dose. to just influenza. of you higher in broadly, if as you your I dose absolute but antigens, a you then a compounds? terms And thoughts bit a just the in

Yes. both. Thank you for

So first question. on the flu

the of the B strains. for Hemisphere, study non-inferiority already Northern that the So, ongoing. been have in that shows have we or study that with obviously would nonfert met the we've immunogenicity came considered PXXX out data that's Even

clear current that in high study. the and even the we our supported And improvements bar Phase before able strain B is so made being I in of update the confidence think X for that data by to the

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now We antigens have a others. and vaccines lot our of experience and updating with COVID with

that in specifically data perhaps superiority. PXXX. goal to hope and see than just look even we in we But that so -- And something for did study not forward study. I we'll trending we'll non-inferiority, with towards do the think the to PXXX achieving will we better be believe we but to that's the

in is doses dose, in reactogenicity In so general, we respiratory our a think higher have as than a it's across terms XX not pipeline, say substantially still large candidates that the are we about and dose change number dose to And for of changing reactogenicity micrograms. where micrograms, XX we level. this XXXXPXXX gone of and I'll study just we've vaccines not

shared on to And that RSV data Even in pleased whom that where micrograms did works we And we believe that vaccines study, profile the XX very tolerated. for in our are we well. flu is extremely by there micrograms there We're to XXX up well are before. like populations date. vaccine fact, that

And vaccine so we actually a be think it's going to vaccine by case.

optimizing going at those the reactogenicity, and look can't we and terms And vaccine the to benefits You immune the dose the in studies. responses will against high of measured we we of efficacy often that tolerability as into deliver combination profile hope that decide. by in start be combinations,

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that hope we you in that with commercialize are next filing includes those Now which in -- globally. And on updates. as working And markets to and RSV, launch our that yes, of closely normal process on into all of we quarterly we regulators course, product appraised keep regulatory year. we'll move the regulatory it

question. next for moment One our

next RBC. comes Luca question with Our from Issi

Your line open. is

been the IMT, highlighting adjuvant on settings. I you've Maybe think neoadjuvant opportunity and

related you head we And that much there XXXX? seen have if However, planning color and to for in update is I neck it, settings, the Any wonder set on metastatic metastatic could there maybe to are settings? metastatic data a the the IT place you what's comment cancer at plan appreciated. to

question. this for you Thank Great.

terms we later the one and INT about term. use. in can So question in that think prioritize we I And challenging a its short think do go do which both of earlier it's

huge activities. is current where believe, hear perceive, our a there's all think of in I opportunity you adjuvant. we That we

have into our you That's we're to we X very, pivotal adjuvant, experience. trying That's adjuvant studies, move But if Phase look studies. where focus. very to do quickly

pointed neck data. You head the and to

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size the of situations that the of active to barrier tumor any think therapy. I potential little the a activity bit And of a tumor, is immune of the where think we burden

immune technology, of generally, later-stage tolerability its in and fact, the real In disease potential have benefit power where the therapies upstream. profile, safety is probably struggled

right while go decide a closely partner, now did for metastatic metastatic signs we and short little see some with we study are following space want the in course. to we the not we So neck the in head of Merck, to whether more waiting settings intriguing those data are that and referenced, metastatic or our you into term

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substantial at very could we present pivot an We areas, have two those effort don't into quickly. going the but as

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down and if those just explore for sure I'm can. potential find matter a a working of areas all opportunities for there's now of INT as we the will to benefit fast as we ways then it's

maybe is plus in combo the the potential up. When COVID I And follow flu can earliest you market? can if have that the Fantastic.

the quickly, get the so I'll need comment but flu want point to approved. -- to vaccine we the very first combination is

Day, COVID-flu talked combo expectations, I to the approved launched hope are about and XXXX. think we our Vaccines in have in our the

for our question. moment next One

comes Geoff from question next Meacham BoA. with Our

Your line is open.

Meacham. This for Geoff is Alec on

your are deployment what is indications? about pipeline terms and how or vaccines, your disease, just assets data for proof capital And how of of strategy go Moderna for bacterial breadth indications opportunities prioritize line you the INT its the clinical let's clinical after? finally, given program? does of additional thinking in say, the for concept new Once then has, the to targeting So potential

Kevin. colleagues the take my I all I take to I'll think, three, I'll first question. but invite

where so we into we or have. places pivotal how technology we version challenge -- look a patient as on high a our And transition So validated. first very studies modalities we It's across pipeline. our obviously it opportunities. is populations of is its the well through we great We're think for short success about rate think seeing

differentiated and have probably next that so where there a indication is And a that we need highly in large indication. success in unmet

financially and of care If ultimately there value to of unmet systems, is usually in we a there's that's want terms health large the unmet kind medically, deliver large into a need need it.

space. we it. about So that's be franchise. That's about our That's how we're diseases. expanding And in what latent thinking expansion POC proof-of-concept of be diseases, we we've to can do the approach you're established infectious there. is we rare to going start respiratory as rare same expanding we in as see are how seeing That already metabolic franchises. that how us how sort our think disease That's doing,

terms larger I'll just in do of we of how of course, There about very allocation which third And then, you INT. asked capital jump is question, to about part in maybe a question your think and the INT few a in And are treatment and potential things burden cost costs has morbidity than believe mortality that that social financial do space. transformational have obviously of that be we a INT disease, to the cancer. of of

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as in advantage co-investing a who are degree in well exercise, this we that of has conviction talked about, one have we partner as and a Now is we with Merck, around have them. high we significant which

INT. in And there are unmet indications is where what allocation with at opportunity, perspective, so we a an looking capital oncology together start the need from

stage adjuvant, line at as well. before, be we'll about said how I earlier of POC question, I'll does the it looking middle unlock As right focus is address we what big think do metastatic now is I one, course, of and terms think Last in but disease which is in bacteria. and

-- the particularly associated need address think unmet we're the of Lyme Europe northern disease, because States. in the to very in Lyme and United keen with I

bring provide approach will a look a rare or to a research. demonstrate one us in is bacteria won't like have you substantial bacteria forward bacterial concept as -- latent updates very other antibacterial on preclinical is quickly. we we approach rest our proof those looking interesting I we specific in in our targets will already we that line see that demonstrate is as assured, But INT discovery for that vaccination, very or it respiratory still can or pipeline But at diseases, of which proof-of-concept. if

with probability We will down double programs success. have other that think we quickly high of

moment for one Thank next you our question.

Simon next Our from Baker question Redburn. comes with

open. line Simon, your line is Your open. is

you to some Do queue? question. me You from want can your remove ask the

can last Yes, go Thank will you. our you be It to question. the question. next

Thank question. next for our you. One moment

comes Hartaj Singh last from Our with question Oppenheimer.

Your line open. is

today. for on Erica Hartaj is This

provided immensely caused combination combo you vaccines? of of time have range so then understand this by question degree a the and the questions. the context about pediatric for your just for this range, I'm So share what lines the Thank estimated the talk pediatric high. burden development? in is if revenue program, Can the affect progress high you with cannibalization almost the or program vaccines being the and market versus sales in like in slides, you respiratory children respiratory by competition trying the has disease RSV standalone to curious below. end product we're can potential XXXX does of double extent you of and to the talk secondly, for on RSV And the RSV about

start I'll Thank first around the respiratory Sure. the opportunity. you. with question

two, are vaccines We enthusiasm potentially burden the three one. our to We these adherence of as putting believe both enhance vaccines. consumers by customer it from as into address respiratory broad significant will well and hearing that disease compliance base combination

commercial the the combinations about opportunity that, the monotherapy. do of think we anticipate forward do the in we cannibalization with look will opportunity, as of think as And So, be we majority we XXXX.

future. strain and we our With advantage fluid to the particularly continue that time, us improve better efficacy, in I will efficacy, too, I COVID, think over the also so products better in the as the think, matches

pediatric question. And RSVV

in So, we've as RSV. been long as been we've working in RSV actually pediatric

have different population. across couple a that we area. combination and and is We of vaccines completely diseases agree. a trials monotherapy that so, ongoing unmet clinical need It including And impact respiratory huge

be data We'll the data guiding from timing look on will of We've see conducting get actually more the will terms we of In both some like there already provide benefit our what who we're boosting There of Those so updates it. reinfected RSV, look research. shared clinical like, and forward set as the have is early programs. some there. seropositive children pediatric will that previously kids do been a studies.

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does our closing Q&A gentlemen, to conclude Stephane to turn session. for this back any I'd like and Ladies remarks. over Bance the call

going you, next at to everybody, questions. new and for your data XX and early today PA data month us INT May is be ASCO in joining June. The Well, for thank exciting,

day. Bye. great a Have

this and gentlemen, conclude Ladies presentation. does today's

wonderful now a may day. have disconnect, and You