Moderna (MRNA) 3 Nov 222022 Q3 Earnings call transcript

Good morning. My name is Kevin. And welcome to Moderna's Third Quarter 2022 Earnings Call. [Operator instructions]

Please be advised that this call is being recorded. like of the Investor I'd Lavina over time, Head Talukdar, Relations this to call turn to At at Moderna. proceed. Please

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

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

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

will After prepared your remarks a.m. X:XX this we take questions through morning.

Before see to filings these conference to from differ call the Slide X begin, Act statements. Private will pursuant our risk our accompanying that provisions note factors and harbor Reform in cause materially results made the of of statements we that safe the implied actual Securities forward-looking please Please include presentation XXXX. this and Litigation or forward-looking for important performance expressed SEC those of could

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

you, Stephen Arpa you before good commercial review Welcome take come a XXXX dynamic before Jamey we close our QX financials. quick clinical or I afternoon Call. take your with of or Lavina. Today Good to Conference business will to present will I quarter everyone. will start Thank then questions. programs. back reviews morning a then and through will

billion $X reported fill-finish in resulting revenues. in delay totaling In revenue agreements deliveries our $X income contract the of advanced into $XX expect of XXXX. quarter billion now XXXX, deferrals deliveries We billion $X in range net We under billion the $XX to we in billion to manufacturers cash from $XX billion. billion $X.X of due and investments reported to purchase

lots dose and vials launching same QX with from more of complexity, terms moment. up In products, moving mRNA-XXXX.XXX delivery and the also average vials. deal dose in amount three to of XX% two X our the time, at mRNA-XXXX.XXX previous actually vial on had in of products about to QX, we share was the produced was greater thoughts will XXXX and Arpa quarters. XX

first in we program was over the first than repurchased XXXX have shares. completed. share more announced start of we in quarter, we shares. the end seven share The $X repurchased February, repurchase of XXXX, Since billion program In quarter, the through the repurchase million XX first our million

for in first Our XXXX an program is billion repurchase in share repurchased $X ongoing. announced August, additional

am which important and to made now the me same pipeline I progress review with pleased programs our the update. breadth program, the Moderna the both Let equating team world around COVID continue pipeline. have the mRNA-XXXX.XXX the BA.X at launches which last and received with pipeline very and highlights has addition product advances COVID and closer since advancing Omicron BA.X/BA.X. We've targets time to for XXXX.XXX progress on of a the booster for targets

We progress you have, speak Phase trials know, to we two that continue X vaccines in quickly. respiratory as as

Phase we in For immunogenicity flu announced was vaccine enrolled. fully the IND study first September, our X

quarter first the of in data XXXX. now expect We

for vaccine. As to a flu approval plan accelerated reminder, we pathway an pursue seasonal

also efficacy X that and flu We started is enrolling trial a study with Phase our quickly. vaccine

we RSV X Phase are track data winter vaccine this without on For for season.

share in forward. to for moving program fifty-fifty Merck announce mRNA-XXXX, vaccine, pleased We personalized Moderna with the commercialize paying were and develop costs cancer QX. that our profit We and exercised option million to Merck and $XXX this

year. from Phase We study in continue X PCV to QX expect data this our for

new GSDXa OTC. to we are and share at we candidate encouraging our that diseases pleased announce for PA clinical R&D saw development a above benefits Day rare early of and In sign

therapeutics. The programs Moderna our showing breadth XX in have pipeline the vaccines team to XXXX continues X,XXX and with On November, of in usual the company Slide and of members. grow than now X, see snapshot now you development we Moderna more across

employer the a week to as announce Science by pleased for very eighth we consecutive were Last top year.

to We have strong now XX commercial growth. billion of fund $XX balance Company our and globally subsidiaries a sheet

turn to With I Stephen? pipeline. now review Stephen to will the it this,

BAX Thank you, everyone. approvals for that and two clinical clinical We Union, morning I'll Japan, Stéphane. mRNA-XXXX.XXX authorizations authorized have BA.X afternoon United to countries. boosters induce in launched Good the in This or fall vaccine titers morning the and against XXXX significantly targets which Omicron market demands We've previously winter trial. BAX/X and season is vaccines. Switzerland, Australia, these mRNA-XXXX.XXX, other progress. received good worldwide shared our now review higher for different than European current sub-lineages Kingdom, or Canada, the meet

study For Switzerland, Australia, Canada, BA.X the data X/X is BA.X expect United authorized ongoing quarter. in mRNA-XXXX.XXX United variants, now the mRNA-XXXX.XXX, States later Omicron which and also Union, and Kingdom, countries. we targets this and the Phase in other the Japan, is the European

studies our X Phase detail the vaccines will slide. I review respiratory Now cover to X. next moving pipeline. I'll in in Slide the

Here influenza a mRNA-XXXX, for in now in I mRNA-XXXX, fully study. for is population, RSV, Phase stage in the is studies our in Phase X seasonal is respiratory mRNA-XXXX our study enrolled the X/X to want vaccines. enrolled. now earlier fully highlight the progress is pediatric with and

a very vaccine X/X, our mRNA-XXXX, have study. Phase enrolled. COVID and RSV to respiratory combination Phase has started progress we and fully to made enrolling COVID, that flu for or meaningful its is and in mRNA-XXXX in our now X/X combination our also flu pleased combination I'm mRNA-XXXX. vaccine vaccine is a fully pediatric announce Moving vaccine combination Phase started where pipeline new candidate, our And also is study study. RSV announced in development XB ongoing one Phase in lastly, we PIVX. that That have study. has and hMPV its a pipeline, targeting This and covering combination enrolled X/X of We and in influenza

our coronavirus in with vaccine. hMPV is RSV our vaccine endemic development pre-clinical human combination Finally, along pediatric

Phase Now Slide our XX. RSV X flu the review and on programs

XXXX. with in X,XXX fully with data participants flu, For is expected readout enrolled of study our first in X hemisphere the quarter Phase immunogenicity a southern the

northern have started X Phase our an pathway results for previously efficacy approval for the study support accelerated we've in flu have than XX,XXX efficacy our and noted, study. early indicated confirmatory seasonal candidate of by Phase the as case enrolling vaccine As this hemisphere this We've now the pending more could and flu readout come this winter. from accruals driven study as participants. be will in regulators also X enrolled Timing

XX,XXX Looking study our now efficacy enrolled Phase to more has RSV, X older pivotal participants. in adults than

in previously safety we As of vaccine will the endpoints X efficacy. in driven accruals our study. are be efficacy this primary study, case Phase and by that RSV Timing readout mentioned,

continue available this winter now a result the be to As of strong the very will that midst season, we're expect season. in RSV we

latent health to our Phase X our on vaccine Moving a ongoing CMV in and public portfolio, vaccine is study.

Phase X while Our infectious term EBV to in our sequela, is in mononucleosis to is prevent vaccine vaccine as cancer such sclerosis study, longer preclinical. a EBV and prevent multiple

are Phase trials VZV HSV our preclinical vaccines ongoing HIV X two and and ongoing have We studies.

Zika vaccine public a is in health vaccine Phase ongoing in our X Finally, is a and study. our for ongoing Nipah Phase X trial,

take a Slide on look let's pipeline our therapeutics at Now XX.

for They portfolio want evaluate I X the will First, the and to Phase to us they to a notified then program AstraZeneca IL-XX rights that study we for program concluding ourselves. us. the are review, note next steps the returning are that after

IND slides. end our detail R&D GSDXA finally, checkpoint of vaccine cystic by its study. to has recently that our submit programs in in Vertex program an cancer our started excited the the fibrosis talk this expects personalized for Phase vaccine we're our partner PA patients dosing first at shared in Second, mRNA latest And We I And year. more updates will on a upcoming our and those Day. to X

at programs. we Now R&D shared data recall Day from two rare that disease

first years September, of in and had is multi-dose trend encouraging. study, administered proponic experience severity is six for numerical observing decompensation over doses. We've well-tolerated, is also patient which patients. and frequency is propionic program, the events, acidemia The a also in biomarkers given is been of generally decrease these on really a seen our the encouraging the acidemia of metabolic in as accrued reduction events an well of XXX the and of which encouraging been It we which drug

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by X in study high of plus of the KEYTRUDA approximately primary is we that The everyone remind recurrence-free to alone our to wanted year. I resected personalized versus a therapeutic expect results The comparing Phase from close, patients melanoma endpoint recurrence. cancer the prevent XXX randomized our survival. KEYTRUDA PCV enrolled risk To end

Merck mentioned partner develop As and quarter. earlier, Stéphane exercised this commercialize forward look the that to sharing jointly we and option our mRNA-XXXX to data

hand With to Arpa. it that, over I will

world day mRNA-XXXX.XXX and I billion to booster were Slide review XX. deliveries were $X Omicron mRNA-XXXX.XXX mainly rest totaled of billion. of U.S. bivalent on you, targeting the the Thank to Stephen. Sales sales BA.X. start to And in billion $X.X also BA.X from the of third $X everyone. the Europe good Sales of will and quarter a our with were

Through about the the of we are the In U.S. for regarding the both Europe COVID regions. rest diversification market first key and geographical three and the you nine to walk $X.X the wanted $X.X thinking sales sales we year, XXXX to were booster billion sales across how these there were and month world accounted are to We through saw sales billion; of we periods, quarters and $X.X three long-term recognized questions billion. it. potential of

size in slides. market medical the opportunity seasonal As of expected for XXXX. our are COVID detail through overview transition the up endemic factors couple the thinking then These and the boosters market. will potential transition the to contracts important in the commercial XXXX. I you booster the will contracts COVID annual additional I considered frame wrap we an of outlook. of outlook I an and with include on We there ongoing commercial currently market the also market, of we the our section the next flu U.S. will signed factors our use that and our underlying the need into to in for some in in take

R&D from close potential in reminder a XXXX our in respiratory I'll what's a franchise, with that at we vaccine September. Day Finally, timings coming recently shared our launch

hospitalizations associated relevant a over with time for So starting compares with COVID and the on and medical period. the chart boosters, COVID Slide flu the need deaths XX seasonal

typical close the we season. seasons in and flu disrupted looked at which For We against vaccination be U.S. period flu, past variants through infection. of season. period October looked September back in and to COVID COVID, what COVID-related influenza XX a from before hospitalizations the immunity deaths XXXX at widespread And for population this to believe SARS-CoV-X immunity the could XXXX, endemic interventions is we covers proxy to an the its either or

see due period burden flu year season, which chart, to annual the seven severe three helps to during through can past the of boosters endemic rate phase. And included due analysis. season. shows on are medical XX-year times approximates the are medical need we you hospitalizations slide. highest to next the the higher times COVID higher the even the the believe take the higher I represents for months in which want in a a season deaths you COVID that than endemic the more and the here XXXX As of XX endemic frame potential with same higher a underscores This at flu than COVID burden closely on in COVID within market, also period in the comparison coming an It the XXXX,

doses endemic Volume pricing. as markets. size price doses size the hand The illustrative dependent the with global of on of on the start reflect of COVID differential side pricing well slide. price left and COVID market market annual in approximately million world. global number prices Ultimately, highly sales sensitivity market will flu the here around To are in million demonstrate is the on market The for the to as across the shown global range as is XXX volumes. the to booster a we flu mix shown of the boosters purely table outcomes XXX

that value world. to the on focused be the will pricing endemic brings Our healthcare around vaccine the systems

consumer recommendations motivation impact need, from we market health and in public year that key evolution, to As an move authorities to in endemic XXXX factors include our will viral volume ongoing the vaccinate. the medical

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and the pharmacies in specifically more and customer to XX, a chains, individual to transition base Turning addressing fragmented payers, we U.S., private Slide including physician pharmacy market the anticipate offices. commercial health the plans,

in assumed as and factors We shift to well such by predictability also vaccine dose reduced single a and costs deliveries, similar orders, to deliveries U.S. seasonality major continued anticipate a shifting distribution other as to in full as flu the Moderna, innovation of product differentiation. presentation

Slide summarize been have far that signed we XX, for contracts Moving XXXX. the on to so

and $X.X the Canada, Switzerland, We have Kuwait Kingdom, for advanced Taiwan purchase United agreements totaling billion.

deferrals the and slide. $X total from billion to these XXXX. we are sales deferrals for to the purchase on billion countries $X.X from $X.X advanced deferrals These $X Additionally, agreements listed in Together, XXXX. of billion expect billion

a we expect importantly XXXX to where very and countries contracts Finally, of we signed. number additional be have

to are into next the XXXX America, year. have and seasons into COVAX. we secure EU, these as Japan, continuing Asia, working contracting U.S., We begins later in expect visibility quarter orders this Latin and orders And Australia, to

vaccine in COVID commercial the flu outlook relative is The COVID large market or with COVID of XX, higher the time. volumes continued market the including confirmed as XXXX, a needs. summarize to of EU, and we markets to well-positioned over from than larger we expect the of anticipate in flu, to Slide billion market burden believe a and medical orders billion evolving be we could So number ahead U.S. we transitioning to market on endemic are important key finally, base U.S., which to we X.X months of a have its to serve X.X And established adding Japan, contracts the others.

review franchise highlighted formation Now, that excited of in before our September. we the I'm our respiratory I R&D Day close, to during vaccine

they RSV. could deaths expanding we Alzheimer's, more with into stroke As RSV than in annually early year markets. flu lead as and as combined developed be look COVID, next flu we and And at diabetes or to

accruals vaccine this could and As efficacy, see Phase Steven case flu depending winter. our trials on RSV from we highlighted and X data

COVID currently We for a these and we'll the respiratory leverage are commercial commercial for vaccines are that additional preparing actively building. infrastructure launches we

With to like that it I'd Jamie. to turn over

you, everyone. and Thank Arpa, hello

our patients. in I'm are playing It's here you a to and excited more be company's to role months medicines future Moderna pleasure even with the of today. two generation After we about new bringing at in

Today of you providing the those key had meeting view by allocation the whom our look years forward performance. capital and priorities in I quarter finish you XXXX pleasure financial on of with the For I month remaining on haven't additional start third will yet, ahead. to and working on the results color our drivers with I and

the the driven COVID-XX manufacturing our related CMO product $X.X total year-over-year. Turning quarter due now partners. and volumes in market XX, the sales XX% to with vaccines, Slide our to decrease billion The was sales decreased updated for booster timing lower by authorizations of ramp-up

on will in the XXst, Union anticipate authorization for XXth. European reminder, Japan the a for received third as the for of We higher supply booster in marketing we XXXX September our August and be against vaccines. Xnd quarter than U.S. on the deliver the we September to fourth continue product that on contracts sales quarter As

This surplus sales of excess sales capacity. includes expense $XXX are in cost million, targeting to million and to shift our cancellation demand COVID-XX loss production of of firm and inventory obsolete associated by driven sales $XXX writedowns for million. with related a bivalent Omicron compared of for charges and related a charges capacity XX% year. to boosters of was unutilized product product commitments Cost These products last XX% and COVID-XX manufacturing on product charge of $XXX and purchase a

flu, Research COVID in increase $XXX overall by and and prior Phase XX% and our increase compared to increasing The was commercial continued RSV, in year-over-year. development XX% of the of services pipeline of The of year. by an by build-out. and expenses CMV support personnel general versus were accelerated company continues spend for be growth studies to $XXX and in increased The expenses tax including in rate last Selling, maturing and X% driven administration effective spending million, X driven boosters. XX% the million R&D outside investments year.

by As billion, operating end a the a a at XXXX the in carry diluted QX billion reminder, $X.X reported income of of net which to EPS After we XX% $X $X.XX. loss had tax resulted in net in benefit decreased rate to forward by XX% decreased XXXX, tax XXXX. to non-recurring

shares weighted to by end XXX XXXX, buyback of shares to result a year. million activities, as XXX of share count compared the reduced share million average million shares our prior the diluted the QX XX As of

Turning for capacity billion, an XXXX customer now to increase Total XX. Slide to the were XX% year-over-year. sales the first fulfill was manufacturing the mix of year-to-date attributable to The financial demand. product customer of results growth favorable months higher $XX.X and nine on mainly a

of to compared of For was demand by of last to half increase sales substantial The sales of was XXXX year. product sales the the first half XXXX, of compared driven from XX% reduction cost product first COVAX. XX%

due of decreased prior mentioned EPS bivalent rate. associated cost decrease X% sales, to a The targeting $XX.XX. demand call, tax capacity. As higher versus decrease expenses shift in and billion, other and After our X% a Diluted to QX net Omicron $X.X income year. tax in with income in higher higher primarily by surplus of probate a was net was cost to COVID-XX production operating boosters earnings our

$X.X second the quarter. reflects XXXX Slide deposits compared and ended at end for we product at of the $XX.X with billion $XX federal $X.X and XX, cash quarter The the cash in of The billion. was buyback cash investments to QX end and billion future ending of $X tax on the supply a QX to of balance Turning the of of payment cash billion share billion. deposits decrease

allocation unchanged. Now priorities turning to capital Slide XX, our remain

will to multiple increase. investment and $X.X business be areas. billion priorities in been base XX% reinvesting a Our continue the has September top year-over-year across to-date period, year R&D spending in the was

year-to-date be as to increased ongoing our have now continue X. footprint. by multiple manufacturing platform XX% excited $XXX about We programs on our to expenditures now with million mRNA studies our expand in We Phase and we development year-over-year XX capital

company We also commercial capabilities as continue the to overall as invest our digital in and out. build well

is investment opportunities to Our priority and reach and second attractive the Moderna's technologies capabilities. of further collaboration expand investment to seek external

considering are enable and take in that our evaluating opportunities We disciplined approach attractive complement investments. and platform potential a outside

in uses shares active discussions collaboration regarding utilize are billion. $X We opportunities, for repurchased February and assess August In and internal external began October we repurchased opportunities. X September additional the XXXX of completed to the investment third million we additional multiple XX billion. authorization shares Year-to-date billion external cash. million In after we approved additional of Then for quarter evaluating $X.X XXth $X the in we through $X authorization. billion XXXX then

updated contract supply Now X.X% $XX includes we to short-term again agreements XXXX signing, chain on XX. which exchange $X expected compared of the to for of the negative be We in expect chain foreign financial to advanced XXXX. reflecting total due sales approximately year billion value signed estimate supply full impacts to XXXX This at now purchase Slide constraints. billion, $XX it billion billion to XXXX to into framework turn of delivery our $X deferrals

remain exchange through rates year Assuming end. the current

as manufactured, Our total well as and warehousing royalties logistics third-party the includes of costs. goods cost cost of sales

now further year cost on volume cost mentioned year-to-date, of full updates. potentially due driven by range to XXXX sales the product our incurred in to a charges previously range, to percentage We XX XX the be and expect QX reported our

be deduction. low-to-mid tangible $X global company. our maturing expect full continue and SG&A business R&D result approximately compensation on XXXX from we continue derived income by teens the to effective Based expect we and laws by mix be to to billion the the development of international tax our a scale-up and of driven tax year our rates in stock to benefits foreign and driven portfolio based as expenses our For current

$X.X regarding $X.X range capital $X.X of expenditures, now project billion expenditures we approximately the billion, driven Finally, previous slightly of expect timing the to below capital by be to completion.

concludes the performance, and the This over will turn back Stéphane. my call remarks to I financial concerning

you Thank Steven this Jamey, update. and Arpa for

into to of opening close out and XXXX. just to Q&A, we some the Before this review key as want I priorities year look

delivering remainder on we'll For year focus updated drive boosters sales. of Omicron the XXXX to continue and a our

We are on in sales afar working already Europe, and Europe Japan from XXXX world. contract; the around

setting also in are that XXXX. in and team can up market team it partner U.S. we the the private go so U.S. Our scaling

flu, We the we pipeline. forward we have data be execute to and great it advancement Phase a doing is to RSV rare the year. our it and end expected our on to look to programs. PCV able see I'm to the Phase We present team X cause study our of The job before excited disease of to TMV when enroll X continue for the for

market year and bring manufacturing, programs vaccine Looking for team next the COVID including to three. well to and in as organization to the potential quickly commercial move in therapeutic phase very is including Arpa for as launches entire year the multiple

of webcast. we XXth. from hope November that join week for available The finally, first you will Day can ESG be on event our next us virtual And many

happy to your Operator? With question. we'll take this be

Sachs. from question comes first Instructions] Our Salveen Richter Goldman with [Operator

open. Your is line

when thanks COVID you to the of morning, in XXX to in Pfizer's pricing do the market. next for taking discussions what think vaccine, Good thus for year? far the Is my guiding private suggested, price will questions. private with emerge market and line here this your XXX On

give some a second we distribution look as the us situation OpEx talking color the – look about year and of on costs you infrastructure out and cost directional trials. to commercial RSV the for building Could around then And next were flu, burden you with just question forward? some here;

take pricing can I the So question.

health endemic position setting, a evolve but comment us real pricing we we as value that for healthcare pricing, to to effectiveness they the on around cost our that an on are about think and in the our focus that not I'm the authorities vaccines as is reflect set competitor first from setting by on a system So provide priced pandemic world. the are public guidelines to the based ensuring

that would ACIP. here for be in the So U.S.

think we channels. to at really the do some some note has discounting the that been I anticipate it's a important level growth in guidance past released different is that pricing of across and

the it's the as for in important a remember commercial evolve here we is States pocket setting, all for also vaccines into cost United Additionally there to out that recommended zero consumers. of ACIP

from we will expect a perspective, So consumer a that the pricing be to barrier do not access uptake.

And Salveen, maybe I'll take the cost part of that.

So Number will that think endemic moving change yes, are syringe presentation prefilled cost dose our single in to mode. more will one, year-over-year. preferences I different there and files be

will We to well moving as costs as the United pick-up distribution invest the have in bivalent continue forward, States. now to vaccines in particularly Moderna

so in out come that terms our profile update at change a we'll and later what date. yes, cost will and of means And

Thank you.

One question. for next moment our

comes Our Stanley. next from question Matthew Harrison Morgan with

Your line is open.

p-value given Great. X that Phase X.XX the than proof that's Good could ask this on considered success to for concept a question. PCV; a a is just study. in I this morning. taking study hoping was grayer of Thanks be

data in So about about available study, you're internally? us maybe that could study and open given think label is Thanks. how thinking you just it's just you how success to an help then the much

Matthew the question. for Great. Thanks

sizeable XX. one. quite efficacy. KEYTRUDA, us but which Its of a actually care, this XXX therapy So so look The the received a as is Phase patients you a quite actually that's in they sample two-to-one, at were and said standard study, combination it's case randomized sizable to XXX patients and does for allow X in it's have

p-value we it get hazard ratios significant specific over Now we against so, a demonstrate at won't premature that or on a standard is standard of at but of and to threshold are X hit, across and ratio hazard and are study do I will that care. a to pre-specify benefit that didn't It's so we Phase we'd a care time. statistical p-values. obviously looking a comment we this but looking want

participants. that the note at for wasn't powered important just It's XXX to study that

result it program. X.XX our be move and looking in depending we the we as will ratio said Obviously, ratio with that strong hazard then make the p-value, a benefit to less terms will there's very indicative. we'll result, as want so that p-value the the of very strength is fact, how hazard than proceed And more And quickly stronger to that decisions upon development. towards the p-value you in to if and of lower a the then subsequent the forward advancing about and

Thank moment question. you. One for our next

comes next Tenthoff Piper with Our question Sandler. from Edward

line is Your open.

the programs, you very COVID? with vaccines you concept of desire I much. Appreciate market with and you much very a to assume COVID move Thank first sort Great. similar [ph] Thank this detail the proof from for expanding all forward. to on there and outlook be both concept of the the the to we congrats progress. pipeline is orphan what of back on the my the all topic, diseases as Questions did with favorite upon proof

Ed Thanks the question. for

we're disease to see two encouraging I in the or that we short even for is a importance. importantly or we absolutely. our think patients, what is modalities Where concept. our vaccines so orphan in. infectious now whether disease version the technology And to we've a or diseases where of they're believe achieved of expand cancer any wanted rapidly that we vaccines of In forward we implications in number and look the we in we achieved proof bring to And our technological that we've dynamic profile, terms are results of biomarkers really the more safety from for rare efficacy But primary orphan data which extremely potential diseases across tolerability of patients. suggest have acceptable encouraged different readout, starting by diseases using of benefit as we and different obviously two case the now of shared, medicines can

we've of moved strength the to given pipeline. those expand quickly our so two actually prior results, And pre

programs We are publicly number that disclosed moving of trials. have a forward in already clinical other and

clinical R&D that already programs. day we're our mentioned studies. to looking pipeline are MMA I substantially at expand including Some in as And of

And that. so substantially of that just we be you ago that announced expect the OTC month we'll can a program but as adding one to instance

years the on to Our goal data. as than de-risk in back be diseases that in ahead our will investments that of clinical pipeline more we the rare expand double

you, Thank Excellent. Great. Stéphane.

our for moment next question. One

with Our comes Yee Michael next question from Jefferies.

Your line is open.

Hi, RSV read results; XXX%, we've good for the or question two out Maybe a depending for had players on I plus Stéphane. the minus, Thanks morning. minus or one questions. is In XX% endpoints. plus think

opportunity to view So soon. the competitive could read how bar out there being differentiation vaccine you in where and RSV is I ask that terms you wanted of some for

So talk bit a that? little about

can timing just then Merck just the of [ph] the talk idea the in; clarify had data? bit a that follow-up you. before of implications PCV, just as just little to the or to they in And you before whether opted the about a data just had comment opt information again I guess sufficient on, Thank

Good. you question, the Michael. Thank for

RSV, So encouraged the other incredibly by vaccines. that first we're been seen by are on results obviously

our established think platform for XX% demonstrated in There's us disease potential in terms that specifically bodes range. we in the you terms vaccines, in its of has a study. been previously respiratory bar severe in referenced COVID Given it that's well as of

know. for we're would going will hope are the same same But absolutely "severe efficacy between by hope we what's seen They're not to exactly they and conducted even and par time hard as definition don't exact be others. type severe have disease I It's against you that disease". than compare to would three-symptom We and studies. or on looking the the with, at expect the of always see better been

looked X neutralizing to also platform with sorts able anti from achieving and those I'll benefits. that note as RSV others been of see we and par. we and titers we Phase titers terms in certainly that were been our was the their of compared previously It's our technology of RSV-A boosting shared potential to at results we've well case COVID the as have on – companies other both Phase we titers that and against RSV-B believe clinical early X that

seen. – you perhaps or others on could better You – had with you argue but worse could should always what par

So coming RSV encouraged we're looking the efficacy that. results forward I to by quite think winter. this And over we're

this Our good or than others been. bar be for have is better to

as – well. I in has PCV, asked of Matthew PCV in of said, question and our terms as terms know opted you the In Merck

study, is through have have the vaccine we an And open label for last now be patient that the passed follow-up that and randomized not now to have important that two-plus one-year receive that have [indiscernible] combination follow-up at it's KEYTRUDA. of of cohorts. study. to of was not. study so to those primary known That a year different it following least and versus combo years disclosed analysis. in previously the that we've Those KEYTRUDA note then and we So follow-up received across in many standard been un-cleaned we an events two of that's as us Merck, care Those cancer those as receive data mark cases, ongoing but those and and

it's strength quickly are that's process and whether we do statistical And is now That's thing and all positivity And that the two of is we're evaluate and on review make forward hazard scans, get whatever the significance that's the sure diligence which at undergoing point clinical – nothing process the a next conduct closing sets correct with or right was and we before data to data finalize now. work this the database of that actually all begin between those then decision process, all so per question ratio the now. that Matthew's of to into that open move the it the positive associated important negative while hazard on missed how the the make major right we the the right is conduct label is ratio that that the outcomes, the ongoing analysis cleaning and primary development arms. that for to study, in of data

this really So to quarter. will we're having will contract expect what on of while the important base yet based really do conduct open driven that the next access calendar the one was now in decisions which Merck label not and information, is and analysis we trying one obviously that opt-in which on to others to primary decision, more regulators right their but we is that result the made – and our as do completed, analysis,

it. Appreciate helpful. Very Thanks.

our for question. next moment One

Our Gena Barclays. from with next Wang question comes

open. is line Your

the PCV question in low-XXs Thank wanted across in XX, like price since label survival change model And PDX how what regarding comment is that free you in also to follow arm, in the for that's also for that major opportunity. range? what you're control data Another data? you. U.S. And rate? the then that data market rate? the Steve, the $XX Slide does is price Merck, your would $XX data the Since the confirm maybe to just the price the with COVID Merck that market would see to significant ex-U.S. share Phase expectation be historical recurring line will X giving want the be confirm just you global increase for the open we on expect in

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question. then And I the can take pricing

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Thank you.

One moment question. for our next

Tara Our from Cowen. next Bancroft question with comes

is open. line Your

questions. Hi taking guys, thanks for the

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for the question. Thank you

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comes Our from J.P. Morgan. next Jessica Fye question

open. line is Your

say to reason point? this potential your Hey you. that does is optimism of Thank for relates question. to China's guys, so supply bivalent Are delivery the or resolved a it How next your orders morning. Western year could this my for some vaccines, short-term the of delays reasonable fruition timeline, come so? good that constraints compare booster Thanks mentioned to taking time within level at as mRNA uptake far And expectations? what's fall

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question. One next moment for our

question Geoff America. of next comes Bank Meacham with Our from

Your line is open.

the question. morning guys. for thanks Yes, Good

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follow- comment. on your Just last up one to

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Great. Thank you guys.

our question. for moment next One

Our Merle next question comes from Eliana with UBS.

line Your as open.

Hey guys, taking for thanks so question. the much

one on Just RSV. another

relative you as are relative more in modalities beyond a thinking thinking the mRNA the traditional context other vaccine from how vaccines vaccines, about mRNA advantages some and we modalities in also the the And more guess I COVID potential upcoming about guess about it vaccine both, I RSV, we terms of of in and guess to tell broadly? RSV? readouts, learn could what to move mRNA RSV of opportunity Thanks. I for us potential other the context of modality potential could as In what but for

question. the for you thank Well, Great.

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moment for next question. our One

with comes Our from Joseph question next open. is Stringer line Needham, your

Hi, our good Thanks taking for morning. questions.

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questions. taking Thanks Great. our for

One moment for our question. next

with comes from question Securities. SVB Foroohar next Our Mani

Your open. line is

Hi, related be Foroohar. to and [indiscernible] have good morning, expected. a Mani this I just to volume for question is

much COVID know based but I the how or I you would production, anticipate there, continue the say wondering exclude by probably also to of I [indiscernible] be volume was volumes our to locally driven move on the So you of in would had vaccine, endemic you. that to future? you anticipate mentioned XXXX, you for because APAs? variability your And do XXXX that you APAs do Thank northern model as for

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Thank you.

time. further like at And showing Bancel to over I'm not back any I to turn this questions remarks. for call any Stéphane closing the

great come, the days for first everybody We your forward thoughtful look questions. and today thank next day. to week to speaking you Well, call And or Bye. come. hours a you to for joining also many we’re to our welcoming Day. ESG Have

that Ladies and today's presentation. gentlemen, concludes

a You may wonderful and day. have disconnect now