Moderna (MRNA) 2 Nov 232023 Q3 Earnings call transcript

[Audio Gap] at least $1 billion in the U.S., our updated sales outlook for 2023 is at least $6 billion.

Now turning to the U.S. launch. The data shown here are from IQVIA.

As a reminder, IQVIA data only captures the retail channel in the U.S., which includes retail pharmacies and long-term care.

last share then weekly since discuss how compares to look share launch going it and like our to first what market our trends and I'm year. cumulative shares

launch On the what can XX%. Moderna's on see the that ending slide is share October you here for the market fifth XX, week post week is

had which Moderna in market this season for we over look share XX% the As the now XXXX. season is XX%, market share than to we date, majority higher is

Stephane endemic ability the As progress compete to our mentioned, demonstrates market. this effectively in commercial

Turning vaccinations This XXXX. now retail weeks to year, Slide the channel. in X, than which X shows pharmacy launched later in cumulative COVID were vaccines U.S.

graph the on do basis, that we To on launch uptake in launch, the result, this, helps we analyze versus a basis. look simply than compare As post based a of data weeks the calendar number on This XXXX. on at rather the slide. in a the data adjusted as XXXX shown us

the vaccination vaccination tracking a cumulative on and total represents basis, adjusted is the the line post last year. of cumulative red a the launch on in cumulative 'XX, basis, On line launch on basis. vaccinations a blue market And levels launch also this both ahead year's post represents weekly graph, but

season and shorter the trends a weeks As slightly largest the XXXX. are later reminder, the retail first X in launch given typically so these channel segment, is encouraging the in

segment pharmacies up health is government both the the and as total in season providers. In this mix to retail line the as nonretail line nonretail segment. The XXXX. we The Last and doses the million met in clinics Let's approximately IQVIA XXXX. vaccinations, non-retail expect capture mix segment blue the to now market reported between which CVC on The The the these turn XXXX, entities, of gray includes Slide systems, the season X. or represents at vaccination and nonretail in on other look networks, XX lines channel retail evolve nonretail graph year, U.S. difference independent progresses. XX% chart market. that reported in by channels X retail

data captures that majority graph, can of the see at data vaccinations the by between you the and in the blue spread channel IQVIA can season. represented be retail early the the lines, respectively. on in the Looking the narrow gray and CDC seen This

distributors seventh as of see channel, increasing. and year-end. this that in, week if current Now percentage the in slope week are increased shipments of XXXX, the channel We that we know we the is that to nonretail year a you expect can you such, 'XX, as nonretail grow at to the look between nonretail market launch have of recently in now and the

be share Importantly, we channels across consistent XXXX. XXXX and to market expect higher in in our than

patient providing pharmacies get and committed get partners In their urgency a are to advocacy help encourage focus vaccination vaccinated. and this and on efforts vaccine approach States, public multipronged patients health to to to medical all increase are COVID we increase We taking resources are the stakeholders education educate the United Across clinics community, we to fall. rates. the to groups, our their

branded we on direct-to-consumer well this channels. across also as as Earlier digital our week, launched campaign both TV

for holiday need such the during will families and at-risk particularly we year, the of as remainder be vaccination with education gathering prior the populations to amplifying For on season. the traveling

summer, with also COVID consumers who a importance this are vaccinated focused and November effort infected We are education in of the on getting for December. launching

vaccination based XX trends XXXX. Vaccine of at launch a billion Moderna's the adjusted retail early in be million both to on U.S. our at demand. expected To expect we sales least share, the doses. market outlook, ahead retail in summarize last year, COVID signal $X is on that least are tracking channel this nonretail, strong and administration across consumer signaling of a higher from than basis, consistent and year channels of

vaccinations with given given in the of an were end by million Last December. of vaccinations October, XX year, only additional November XX% about COVID and

our We expect the later percentage vaccination additional November This given to provide increase for consumers sites which market, the will channel a and of December. nonretail year, as launch allow strong for to of the a To nonretail the be our we will vaccination now the campaigns. in launch are and vaccines, of from and November continue their campaigns amplifying just marketing supplement beginning our customers' momentum December. channels efforts,

have patients Let but difference we a launch We our in also best-in-class me the that XXXX. turn RSV make profile customers. to upcoming product believe can a now to to both

Our clinical efficacy. profile shows strong vaccine

a the has leverages have tolerability that COVID in well-established vaccines. mRNA been profile over that same X technology safety We billion delivered and

which clinicians. Additionally, by is not customers ready-to-use our we in seen of GBS we An cases important that Phase III are be pharmacists by have syringes, preferred trial. any differentiator for and the only with our company prefilled will

expect positioned in RSV preparing We launch we of expectations vaccine international also that RSV We're to robust demand. due by this launches several U.S. encouraged awareness are recent the in the believe beating year, for continue and launches and consumer to in we are market our markets. our And a XXXX. launch in XXXX well for the

given COVID profile competitive excited clinical our and I are differentiators. and about fall. demand syringes syringes robust particularly prefilled ready-to-use syringes, prefilled ready-to-use key for this strong My the are prefilled Our team our

vaccines errors. ongoing the in the of pharmacy and be reduce And our will will setting. U.S. RSV ready-to-use given given the time labor in shortages, presentation save pharmacy administration majority The also

with company multiple by steps require compared We clinicians. preparation will be which administration and pharmacists only to products, a one-step competitive the

strong respiratory launch positioned the will an And well RSV vaccine, over product profile. team Jamie of commercial to turn for our provide our is excited very financials. update the vaccine bring now are RSV vaccine given our I our market. We to to the to on it second

quarter the and and hello, provide financial for an will Arpa, I full review outlook. our third for performance Thanks, updated our everyone. framework year XXXX Today, financial

of we provide early investors, know couple on we're we our to approaching wanted for and next of given thoughts the XXXX mind how it's years. Additionally, top

XX% assets driven the and increase development expenses million, billion the year-over-year. the were tax down in This deferred now product booster our sales increased lower was as on The following shipments offset commercial increase spending with $X.X income the the The prior the sales tax were in provision growth Research was Product a were we market. were U.S. for will season, to was was the to market quarter price. by III and XX% updated the maturing $X.X sales development Phase against our $X.X which the by quarter XXXX fall in between of customers billion product of of expenses in I studies mid-September COVID-XX our and in prior by the Slide QX of launch of in sales an third detailed almost and Cost build-out the $X.X by products authorization $X.X partially commentary vaccine. billion, the by pending valuation X slides. selling year. $XXX in expanded pipeline billion, or administrative $X.X a reflecting primarily compared following of a of for and our provide approval. allowance XX% for on XX. distributed billion. U.S. We particular, evenly general higher and commercialities driven volume rest average driven Total versus Selling, Starting initiated year-over-year world. year. reported net billion,

periods. our not cumulative deferred loss share in of valuation year $X.XX was include to from billion nor last Under diluted which realized. ability for a assets income assets and our future deferred [indiscernible] for in products rules, when forecast, us it billion these In $X.XX to are cash was the regulators take income X to projections, assets tax indicate accounting current for tax share referred These restricts expected the per It's loss earnings assets. it to deferred tax not deferred utilize excluded we just to position. not allowance the be to the GAAP impact compared approved our a required from next Net was not of vaccine, years for valuation a may yet losses returns, allowance are to by COVID income in as tax future endemic fully combination also COVID This we note and with our $X updated to XXXX. launches. flows reserve, appropriate compared record important does valuation does year. future per is future allowance loss net income $X.X period Diluted determined projection

to versus the ended and driven the investments, and we with by loss operating QX. decline prior be quarter in cash third collected in Finally, billion our $XX.X was sales quarter

royalties $X of to inventory on me expect unit-driven Slide related also billion of expenses, to $X.X CMO now charges come and sales commitments, $X.X billion and cost back Now sales fees full billion XX. and driven of of which includes wind-down purchase let costs. of year cancellation We by cost write-downs

Stephane of As pursuit in pandemic. built strategic was third the quarter to manufacturing we optimize COVID-XX footprint, the in restructure structure for highlighted, to initiative our cost which our previously undertook a franchise, the our

and our this As before material initiative, levels commitments not to raw for cut and consumed inventory expiration. with back our several part vendors. We third-party materials on of commitments reduced purchase anticipated raw reevaluated we our be capacity

that related in billion efficiency The establish in immediate going the $X.X we in of are foundation consists QX confident for financial margins costs. improved will $X.X of expected $X.X wind-down inventory The QX strong Despite of an forward. this billion impact, are charge result, which QX our manufacturing is a reporting billion. $X.X are billion, to of As and strategic move of operations cancellation we charge million and charges and the costs improve $X.X wind-up a $X.X of CMO QX. write-downs billion fees and CMO

mentioned, have billion As CMO XXXX. restructuring billion cancellation and cash charges $X the charge $X.X less benefit in payback are and just than We cash net I years this in $X.X billion related costs. of a through of fees approximately the only X restructuring approximately a will total costs part project

charges for XXXX As before full of cost year now I $X.X sales in million. our is billion $X mentioned, forecast resizing of

be sales of year previous for billion is expected $X.X billion. to of of the at low cost to guidance our the Our end full $X

now So QX. back my coming to on commentary

our and and incurred unutilized of latest product of also to this $X.X unit-driven inventory material, manufacturing of addition initiative, spike demand-related cost and we costs the capacity approximately back excess manufacturing In write-downs charges for obsolete charges. million

XX. made to our and target sales. longer-term cost Moving resize In our we XX% of to XX% accelerated our summary, of towards substantial progress structure COVID to path Slide

and CMO sales also just our charges addressed year-to-date future. our not cost cost XX% for In impacted today quarters, but be calls, only predictable commitments to and recent highly expect we a at write-offs of as We more level, sales. previous lower charges and of inventory are supplier-related by be and of sales were in to the write-offs in

Starting on in be expect than we to of less XX% those XXXX, sales basis. annualized an

billion XX%, with capacity better sales footprint, of In resized scale cost expect we XX% other is of higher moving and significant positioned we forward. approximately million to words, now Our even reducing XX% now levels. expect At to and sales volume leverage of at to volume. $X $X to XX% sales level, sales manufacturing approximately with our achieve

Let's now to move Slide XX.

results, the focus wanted While with resizing of give you financial without QX GAAP and on and we intend valuation tax to our a allowance view continue charges. results to in to we

GAAP our billion. $X.X would total been was billion, excluding loss $X.X third these in have While net quarter the charges our loss

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

QX least sales product the and comprised $X additional mentioned U.S. at third sales in which Arthur QX expect billion As through international now of for billion least of the at sales for sales $X.X year, $X XXXX is $X.X the an quarter, we billion of of from of full billion earlier,

As which explained of year for $X expect earlier, includes we resizing of now approximately $X.X the billion. full charges sales cost of billion.

be SG&A, now in approximately approximately year and full we with billion, R&D $X.X and research expect development. billion to expenses For $X.X

Our by in mainly higher forecasted, clinical than spend slightly as is investments R&D $X.X our is trials. business well which million late-stage additional previously development driven the as activities

approximately billion increase approximately $X.X deferred remain now And billion $X a guidance down consistent in year expenses to tax we from $X.X approximately by billion, our $X expense previous capital billion. expect the SG&A for of allowance $X.X now finally, the driven I billion forecast of full We billion. tax at referenced expenditures $X.X of Our earlier. expect

the XXXX on I our are the next principles our Before today I wanted over share and into on with operating to years. XXXX, company you how the on we specifics X plans get

ensure efforts and will profitable We are we on back our our resizing believe focused franchise COVID time, COVID pipeline, laser significant product is excluding late-stage sales organic us development also costs for recent beyond. increasing recognized and our for same and unique XXXX research and ahead in look growth that making spike of future cash franchise profitability, We and our our At at we a of source opportunity a income generation. our and continuous pipeline. with the

approach We still upon our mostly in disciplined lines, product also SG&A it our we based in and will be adjust and of which investment the XXXX RSV. but performance COVID, R&D include expect is sales to

late-stage next to years, in more break loss the our raise X sheet pipeline in to without fund investment our will We believe need help in over our balance this a us the expect plans even We to is but starting XXXX. current than sufficient result equity.

shareholder at an intermediate back, unparalleled not shares to in also term. of this while value is lives creating planning opportunity to repurchase the same the the believe are We time. impact Stepping we patients

XX. Slide to Moving

view our with start the over of sales next couple years. on Let's

sales The We COVID-related from change year-over-year to our XXXX. mostly low at expecting XXXX delivery our APAs related of are sales in hit for first deferrals point $X of have to $X that XXXX biggest signed contracts. $X.X APAs. our a existing were half in billion XXXX in We is billion. billion approximately currently Recall

in expect we half So sales XXXX. the first of minimal

U.S., it we to XXXX expect be least grow time. believe $X over and at the For billion will

expect other to XXXX, finally, we And and $X we international sales. approximately from COVID in expect RSV return growth. to Lastly, billion

more our XXXX Let me fulsome XXXX. thinking view giving finish on you by on a and

Starting with XXXX.

XXXX a XXXX down [indiscernible], moment. expenses sales, will of approximately in of R&D for $X registration just are $X.X to sales of be expenses In to would we be the on approximately expenses our R&D $X.X committed. speak would XXXX, R&D in SG&A of million I billion. mostly now sales XXXX be expenses which approximately are explained, billion XX% our in of I be As down majority X%. expected to are expect XX%. Cost view approximately

be billion. to taxes expect to similar XXXX at and in XXXX We negligible be $X.X expenditures capital to

In summary, expenditures, in capital our combine of be nearly we at for approximately $X to balance of investments that projected estimated the billion XXXX. When XXXX, $X income. end and Spikevax with our million will cash generate R&D is

preliminary Now thoughts on for XXXX. our

our registration of sales levels growth. committed only growth. greater given of R&D will spending and sales sales approximately mentioned half return As will to with to be XXXX. will have earlier, flexibility much down, we Cost that improve R&D the for flat reduction, increased are of current for for trials

cash our will SG&A and to Canada continue negligible, summary, will flat in be of will of to billion to lower remain XXXX. capital investments grow income estimated the after or be the XXXX. flat ending will down, leading and will expenditures taxes Australia materially and In to us first be billion our our facilities COVID balance $X the completion in half U.K., of $X an lower in approximately operating

help us Finally, during this new launch in XXXX. period, products we to X break expect to even

with So to I'll turn call over now the Stephen. that,

clinical at do a R&D and I for trial for afternoon. good Phase details COVID the our Today, the INT trial mRNA-XXXX shared quick also programs. and the I will programs III review from of cancer. review these III will designs combination Phase Good our lung were flu morning Many cell vaccine, non-small or in design our Day. of our

our up years combination Day, COVID in launches vaccine, in During subject review to a made and anticipate regulatory the flu through for vaccine shared have next opportunity launches next-generation late-stage year vaccine. RSV vaccine, COVID the to we've our pipeline, and through we the and the creating flu approvals, our advancing progress R&D to our product significant and we X XX XXXX

metabolic across of XXXX, vaccines, cancer the diverse areas. potential disease other have We're by and medicines. range therapies medicines rare excited diverse pipeline of these benefits, beyond a very offer a Looking we therapeutic

Slide XX respiratory of is our pipeline. an vaccines overview

from vaccine, Phase rapidly on older. for enrolling against leading III data top of success, shared as COVID, this we've started XX pipeline flu line COVID heels I/II commercial earlier-stage and well programs and and mRNA-XXXX. We includes Our combination positive and and our multiple programs adults in next-generation COVID in And recently III Phase mRNA-XXXX are flu a and and Phase the flu study RSV as illuminations.

is Slide XX immunogenicity older Phase active of XXXX double-blind The overall, The stratified of design randomized, XX for participants study control co-administered to and X COVID of X,XXX and and years safety to mRNA-XXXX. age. will a III vaccines. by XX the cohorts the XX study, study shows Phase flu evaluating years III compared enroll participants X,XXX and with age stratified

Both cohorts or vaccine an months. will mRNA-XXXX X for COVID receive approved Study vaccine. our be age recommended plus will flu quadrivalent followed participants [indiscernible], licensed

other an is and Now Slide XX next of overview latent pipeline. on our vaccines

announced, vaccine is CMV data and becomes efficacy look is to against VZV, in accruing age women safety in The and cohort. forward cases, study and enrolled, our now available. fully to including III of HIV, norovirus previously Lyme continue Phase adolescent vaccine against and HSV child-bearing efficacy it As clinical we Earlier-stage progress. EBV, our disease the of programs vaccine when

therapeutics We're across other Slide our of is at presentation recent and were and of the highlighted cancer, XX on you an of data website. of the pipeline. study, Phase Many INT of the interest seen investigators diseases enrollment refer tails to of III overview year. of R&D that melanoma our patients continued this from our Day these the which ASCO I earlier progress rare the areas. since proud Day, and adjuvant Phase a R&D since is rapid at has great Notable II deal presentation programs

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I'll over Stephane. that, With to turn it

number Moderna's X that, and Our sales to we focus execution. profitability. To priorities, is achieve return growth one, commercial have

the we can in U.S. share demonstrates compete. market Our

steps are use X safety market We for of high-efficacy, workload, four [indiscernible] on be to in leadership we given very one the believe we're [indiscernible] profile the easiest especially the are One On in [indiscernible] complicated has of from the as the about important and before launching to [indiscernible] steps. said, you And that believe and better today know, on that. are will excited in four focused The injection. pharmacy pharmacies food challenges have vaccine, as that I this differentiation. very an range, class discussion vaccines pharmacies, we is that with seasons. is nine the [indiscernible] and prepare profile Arpa

[indiscernible] launches in know, in believe number of in We should a new XX', in to In COVID as the to XXXX. product combo the commitment higher the in again growth in [indiscernible] the Xx volume did Our sales XX' COVID [indiscernible], doses COVID. Moderna we market vaccine And U.S., example, be you for compared will sales work market. XXXX.

number based disciplined in We'll Priority sales investments [indiscernible] our two, on disciplined performance. our be investments.

projects saw, As The we you with reduction continuous the to in footprint in done, a quarter. manufacturing team of drive there [indiscernible] bold have is and cost are taken third actions manufacturing. not many improvement

our our some look if costs. costs allow partnering us programs, also and We responsible at needed, with be about R&D to and to disciplined

For SG&A through [indiscernible] currently are SG&A, XXXX XXXX XXXX. spending had as our flat than mentioned, in XXXX. and budget XXXX in we lower versus Jamie we [indiscernible] X going our SG&A

We them. are and XXXX respiratory teams launching products same the XXXX sell we anticipate in and we

operations. also productivity we our as We improve expect commercial gains

pipeline As drive Jamie three. our Executing in mentioned, we growth. Priority expect to XXXX. to break even sales number late-stage on

[indiscernible] have you [indiscernible] cancer. exciting pipeline is fully in RSV, As [indiscernible] III X Oncology program the [indiscernible] Phase all with melanoma lung cases. we [indiscernible] which its One mentioned, assets. Phase know, program, flu, CMV, about. [indiscernible] an in late-stage III spoke enrolled and

sharing X data year. of data to We before forward be end basis and regulatory the for will believe it having discussions a we are for from study potential melanoma the strong, year of approval. this activated the look If INT

INT. platform. in XX With pipeline the in next in this, commercial Thanks we launch up factory X mRNA enable We investing the with Marlborough to for have the years. been an launches building exciting to Marlborough, a to have

impact are operator, in for to The and to are of company we the patients. this never world, pipeline largest excited on about With to vision. we now. happy be to the take to that taking have execute We us been to people questions help actions more we'll the potential possible deliver for the [indiscernible] last-stage I've mRNA deliver we'll greatest focus medicine. continue

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

X have the questions commercial questions. regarding I

billion be give additional Could breakeven. a in a billion you us the when XXXX outlook, point? mention base have if XXXX XXXX?. based will XXXX and to quick take regarding what did very on as quickly And we're range. we resizing, cost your the looking internal what could XXXX capacity the you and is what in total sales sense second look $X And First, be doses? you're And be it to seems that in manufacturing After full regarding a the guidance $X XXXX, the a using resizing. manufacturing could the

I'll Maybe for first question. the take one a further

of the thanks for question. XXXX, terms in So

how Let's it. about about thinking tell we're talk

So we And $X to million our $X is mentioned approximately in XXXX, this coming fruition. pipeline late-stage billion. about all

So we'll a in RSV, then sales, kind second full we'll half so it's in XXXX, launch of mostly of the XXXX, and year have growth. year that will provide

also exact exactly you here. unless certain not COVID come numbers come on it but that. get market costs, going XXXX. where to $X with million we line are, sure and to the assuming in go lay a have $X But flu will We with market a to tried to We'll we say sales out by let mentioned back you to there XXXX. of depends sales what the to But portfolio. combination in you're full me Again, timing. We're also not what in XXXX, flu should on

If for a should should XX% that we cost. should overall we've this you or million our said billion $X need of of historically costs we sales, which sales, investment, at we have make of R&D assume, Day of year. $XX have $X to billion XX% And instance, then average $X billion

come [indiscernible] our to you without numbers we in pieces are we're what's telling you officially we adjust here's sales, kind don't investment. our of expenditures also any But in hopefully, XXXX. will enough important is guiding giving that those So

adjust our question. we then that -- confident part of not they are the hope I we investment. it we missed to happen, -- but that's should second pipeline, our the prepared So we were in will, are

after question, is of capacity I percentage manufacturing will Can what you part I the then doses? the full apologize, second regarding what And repeat missed maybe . resizing, internal? it. Basically your be

is to So leverage. and -- you are showing as volume here capacity out this built for we lay try

we that and at will $XX least sales page, capacity. it billion So of require additional no put on

for Australia of built INT for the getting should X.X framework, respiratory answer $XX is we're and the the leverage need will for ready We no different, volume building least course, beyond that facility, forward. million. Canada at project over facility but but and that the that, we years, But more, question. are bit won't I we U.K. that that purposes, and complete little facility. commercial moving next

Our next comes Sachs. question from Goldman Richter Salveen with

Two here. billion guidance RSV. $X you is One me for COVID provided about between and of

and Could flu On you're you the each contribution is and your just from about for the to second the framework how thinking XXXX. speak for development? ability the And are R&D this and there and to the programs would flex you flexibility on [indiscernible] monotherapy share how you prioritize R&D parameters can here question includes XXXX of range SG&A. any . in that financial

can I in the attributed that the mentioned date about countries super RSV on we is $X COVID. across out $X will I as and remarks to prepared say we million, we're also in confident the not that break we've we profile. All going So billion we that amount product to her the talked filed and our PDUFA see say, of globe. certain a are and

an and beyond. by we Difficulty] how encouraged market the from are [Technical We and compete think will we uptake started it's well perspective, and very already

to R&D, in XX% pertains for and so spending on it billion XXXX, obviously, $X.X billion $X.X investments are I our of As or our don't know, for for flexing R&D SG&A. the expenses

So that, not levels XX% the current as is spending of I mentioned, committed.

say able have going to and spend So in Difficulty] amount make to to registrational be are we amount of of market time what R&D decisions XXXX. to what [Technical trials we

how sense to the still much hopefully, for flex. ability a that gives So is you

flexibility that have amount can other bring we down team of probably have SG&A, the the magnitude, not disciplined pull, cetera. about it, in Difficulty] from is. some that business in expense to there's some the past, but our to a also we still et that line sales We flexibility, variable be also levers we do where perspective. [Technical investments but base will the knows to how the same

comes next Eliana UBS. with Our question from Merle

This Eliana. on is for Sarah

then it I into how and First, that you billion in guess, 'XX. contribution talk any Are And talk R&D be sales you in where them tracking Day, and about $X tracked, about from I can international you were cases you can RSV in maybe about how you're versus flu said great. number. again, they're 'XX on thinking where XXXX, expecting on X/X that would CMV, of you think are currently

Sarah. on thanks, it over hand Stephen part take then and So I'll to CMV. first the

flu in outlook billion. no of $X is there approximately contribution sales our XXXX So

do, and at So is in RSV solely billion international We products We mentioned that sometime COVID in that and that we'll answering Salveen's time. do launch expect I XXXX, other in see to $X combination or question. flu projected our we've in sales. what as

the CMV thanks question, And for on that.

we're we So the R&D a did in back accrual update about Day. yes, through away that case quarter

the to think the case think next vaccine recruit next steady we continue is do update spring. our provide in the will day I a pace. likely I at --

question with comes Terence Flynn from next Morgan Stanley. Our

has estimate as of know I well. Pfizer market provided RSV the about pounds terms in X metrics of billion size an and has some GSK given

assessment seeing companies in we're on total these market the what with as now, can out And us ultimately your of doing now competing with comments you early you market where you're larger in your space. see launches, of your shaking Given with RSV given provide COVID some here? do size then share

question. the for Thank you

similar excited consumer by the are overall. awareness the Pfizer and both and terms the And already mentioned of market RSV as In I earlier, what guided. projections of the total our we're uptake market, to GSK have

But are are And efficacy, about profile projections yet any terms of our provided we as both in share RSV, market very share. of terms we on safety. provide or ready-to-use are to product have our with prefilled syringes. ready In forward-looking mentioned, strong not I excited

them this So the from RSV we launch be year. success leveraging and COVID year applying our next will earnings to and commercial

of the Stephane. Arpa what important. is market very share about and is I COVID that I think [indiscernible] Yes, point made The

commercial, are believe think to know moving I that some we because you and market continue we far will we're share that season. to only the in of to culture, in new company improve so already we're able the year because as our a to I think XX% compete, that start not improving but the cumulative XX% from doing things that are show people Arpa compete the shared we able is and not data share last

download pharmacy mentioned, speaking it's what let's finished team have, of the issue, U.S. is you defection they I know, I was basically, the already what all over. when see BFG very achieve. a the workload. label from able season, speak. that But flu RSV very at COVID XX% those tracking the of type a steps think they think is and so of season the some about and we then workload the of how you [indiscernible] I leadership, And business to just and as [indiscernible] preparations in this to been I products, many therefore, the deal chains X going look know demonstration we then pharmacies our [indiscernible] as have. products then as think website, as And of are you those the complicated how don't with It's you they the big have a then mentioned, to they're we and and pharmaceutical if [indiscernible]

good safety very [indiscernible] if the have differentiator profile. I a really is tremendous good And we think, very We believe with into [indiscernible] have so and good you product a we means don't efficacy very the that fit. and market with in best-in-class that coming syringe a

comes question next with JPMorgan. Our from [indiscernible]

second, the Just then differently. to others maybe number trying contemplating we in coming you XXXX, season where just market has are bigger channel to this sales I the XXXX Do in that are at couple Does . one retail And reflect What we of year-over-year? grow think jobs similar picture you running shots embedded from were so I progresses little on about you as of been to the the far the shifted some INT that at, in know COVID back you assumption? XXXX? believe vaccines? through your all Or that remaining considering could in what a it proportion season. relative should a would respiratory proportion it of then? get nonretail but percentage breakeven said think think be that around has as Or

RSV, all confident profiles back much XXXX be in too of product it. we there way next-gen we've talking keep in late-stage and the well, terms flu, in for all the mean our year our product very about compete. and getting detail pipeline are will been without those that will XXXX we how as to to COVID much I about to how think on combination, Again, going you that we best

said cost of of that. at be of our will on to That envelope us And That [indiscernible] XX% our give X%, our would portfolio. we mentioned, cost of And will portfolio at we'll all by the products, $X be be cost which our XXXX. portfolio. sales sales at that launched disease continue that will course, sorry, our we invest. we INT I to As billion, will the will of sales In much $X our billion, be rare for improve be future how XX%. can try

I a that's have say to of disciplined we very growth think to standpoint committed much just a can and breaking flexibility, everybody are as I a want even both now. a we we in that and know right So as lot investment from standpoint. year,

on take the percentage can of And the I question second nonretail.

the market XX% So the during weeks. majority than few with has the as been more expected, of first the in XXXX, rate the of volume

However, shift beginning mentioned. channels, a now I to see as towards nonretail more had we're

that was seeing the of are mix about XXXX, of in be think to XX% only the to at I as to about X/X retail IDNs, whereas vaccinations weeks. about XXXX We recent year I than mix. channel will we retail could the clinics, XX% as believe pediatricians stronger full XXXX, increased and the in land of to shipments And saw total

Luca from Our RBC with comes next Capital. question Iss

how continue year top appreciate about numbers P&L. Maybe to materially as manufacturing effort $XXX and this on this Pfizer [indiscernible] all buy-intech and seen billion focus plus their plus We've CapEx OpEx by circling OpEx lowered and back CapEx on COVID year think line. believe should by Pfizer to we I margin. billion I gross $X the million and year. on the realigning come next But down. the resizing $X.X

this going the flat generally anticipate next has to However, is changed not down. that your you be OpEx CapEx to plus year materially year and

thinking year you So impressive thoughts but can year than with you a next obviously, market every you And scenario there of just not aggressively year? face RSV, maybe then with year comment Pfizer this the that Is frequently much on is and your penetrated Pfizer what's why other less product, an as and year initial there, Any you need uphill pretty [indiscernible] down every appreciated. think vaccine that. whether battle or turns on that's and a the it and then GSK every vaccine second differentiation right maybe strategic launch the latest organization? the needed decision question on maybe for the

the second that and first -- of I'll for over first. take question the part Jamey to it hand Maybe then

So on yet X- don't for RSV of less obviously, data in rate point, every to I regime. we this public of At or this epidemic year. health whether vaccination it annual need terms situation and will X-year something or not continuing the ultimately we're have it, the follow recurrence annual, or the on than say, be think an

every is of convenience vaccine. looking well a the seasonal think everybody offered that year, we'll making the manufacturers' sure to which our other of vaccination vaccine, an flu that are guide just reminded season, data vaccines as epidemiologic are approach, I like of to for there of health, to plenty an public as benefit example, else, where every the decision. the both people but because also get data, the be that by data because as there's the There approach

to on to recommended data number [indiscernible] we'll well is provide have the public decision. ultimate that factors, going of we'll the to So decision the other is not of manufacture, health factors on make work ours will but as be sure need data to they whether which and they all a make officials this include based

the Luca, take the part. for I'll first question. Thanks, And

we the and I are ahead think the short of answer us, is set opportunity acting.

just down. I that So you break referenced some to of our want competitors,

impact the will We have our by thing XXXX by additional encouraged and XX right we this growth or do. that's to we patients. to launch that ability we by for super think And And XXXX. products the are think opportunity

We company are to investments have to I for to I are we to be opportunity have and grow to out the grow the believe acting. think acting. unparalleled this. be able And this to able -- capture we of our afford we

of I mentioned cost that everything think perspective. sales doing I from we're a

comes is R&D, and that think line XXXX, down sized in level, SG&A to when it volume and much in to saying X% because we down will down we And good so XX% R&D can on adjust I have And appropriately a both leverage very come. it are SG&A.

trials to for committed our largely registrational XXXX. are We

XXXX, as we I much more as mentioned, the we flexibility. have in So don't even have flexibility by But year.

afford growth be the we're about take investment. this to and optimistic to prepared very to, still but this we we're is coming. much through pipeline should coming hopefully, that's we'll And of So action able need

Stephane, said And super who Jamey, Yes. well. to just maybe it adding

know, company. And we platform you of very good those the feel As [indiscernible] we success have a programs, about.

Phase you II COVID If with just look at and[indiscernible] flu.

X of positive average. Phase out have X III We [indiscernible] industry

can we think we for through search pipeline. late on high-quality are capital in return that shareholders by capital value, So create increase investing projects that

very [indiscernible] largest create to drive way of right is which with we for sales believe profitability. to [indiscernible] the pipeline is best results growth I now. as very, And soon and our soon, X As the as the company programs shareholders ship in any said, have XX'. We

comes Jefferies. question with Michael next Our from Yee

your for just is a a get to seeing jabs channel I Dina QX of in COVID And fill? you just and are jabs wanted what This is sense on versus right follow-up for that How much assumptions actually now? on QX Mike. actual and of injections that.

what year. half and will same you've vaccinated season fall COVID Are continue that out, COVID. get of vaccine people XXXX assumptions got this who essentially seen your the Now assuming sort to you year every XXXX for XXXX for that of play are the

And planning last capture year. is that our quarter about weeks saw November X launched are a total December. the well retail is year, fourth we're our efforts later larger COVID the hearing similar XXXX expecting what to into there terms portion, the in than likely we did the we In as jobs, This XX what given as season campaigns customers we vaccination vaccination from in really they're happening and significant XX% partners, and of XXXX split, December of pharmacy marketing month. we on in November and non-retail a different

In XX their get least in we and who that our XXXX, gotten to XXXX, believe getting XXXX million also this booster strong will in we in So booster year. month doses everyone for at anticipate be has do November beyond. at a their do is And assumption least total, will us. December and

the understanding the become consumers see more as normalized, both flu of believe some COVID disease we the over more start annual COVID, higher to given Now with of getting as do convenience becomes market. recommendations, burden increase the in COVID we'll and overall of time, and

with Singh Our comes from Hartaj question Oppenheimer. next

question bit be a for from vaccines example, of XX%, flu. little XX%, other for got on just minority to areas, treatments, monotherapy the COVID-XX vaccines I just to infectious And diseases, a monotherapy treatments oncology, tend generally question, aside the a frame the of in combination Currently, therapeutic dominate market in programs. give XX%.

goods then combination you do products. the might will secondly, get singular you combination vaccines be tend to combination would vaccines for again, going, you the monotherapy your the any research probably approach, a cost approach that versus when And suggest of monotherapy imagine going So forward? the different dominate market versus a that sold

Thank you question. for the

are share So the substantial that available. vaccine take of vaccines our monotherapy anticipate will combination that we a do

help and vaccination can research, market compliance perspective, upon X helps one availability payer hearing in market mono rates. we And need authorities of broader of And get multiple from very in care to lot workload combinations, our combinations frac time an issues, conversion From consistently boost a that shot government we combinations, market. more expect shots. had with consumers similar from Stephane seen and pediatric from see and adult prefer a shot strong uptake the [indiscernible] a vaccinations. customer and to they you in our increased we believe have them have and greater health trend in health get uptake care just that We as saves system are protected. From perspective, over heard actually that a the adult to the also help mentioned, patients

are our and an we about excited think future So could point vaccines. for be very inflection really products in this respiratory the combination

to just to [indiscernible], add comments. Yes, past

of come lot. especially and we have lot [indiscernible] basically. death birth health system has a people the outside combination the topic U.S., have ministers [indiscernible] of lot care government with to you vaccination care discussing a from And you think, the of COVID, a been taking where During where you have as

that production country We because several very hospitalization. the got are viruses, prevent know combinations the of the has very, participants vaccine, interested we in got which

shortages were a negotiations, As the you through of see They getting done [indiscernible] they population like combination was some partnership the older. know, edition critical Australia countries with we've when actually time a hospitalizations a go number of the and and the to you prevent healthcare. of future sources with that [indiscernible] those and U.K., will because concept the Canada, see making in in ability decision. And determination is over just up of as the the key you project

but So even I to U.S. think will we drive in the go like markets combo market. the to need commercial [indiscernible] actually system, move faster, healthcare integrated

sales question. And of as, cost the I'll you take for Thank it. maybe Yes.

So this expansion provides a substantial opportunity. margin

of is substance. So portion if drug our the smallest about our cost sales, you think

or cost vial our cost actual whatever, cut a the now of finish a terms and portion PFS overall and whether mRNA or gets in half. it's Everything in So sales. presentation of from small of very it's the drug that that's type, product the to our product

So when cost of it's a amount we a sell to, very increase versus single limited presentation.

opportunity. provide does expansion it a margin significant So

next question comes with from Wang Our Boran Guggenheim Securities.

beyond. XX you on Appreciate [indiscernible] guys and

there you COVID in get and ground flu, and regulators wondering of some thinking COVID like recent with the if any the as how from terms plan had about of about It 'XX the the with running terms RSV competitor potential in are RSV. For specifically, longer-term you talk approval? of in you International, can contribution expire to sounds you split. there [indiscernible] on the comments conversations from with premiums contribution

Thank the you sales? question. international About for

where multiple the across billion international second anticipate we of secure to In put on Japanese continuing COVID-XX a work competing a agreements expectation year of international RSV. is In market And the on do XXXX, the will to to we across terms countries. commercial launch In expectations vaccine. are we have half we number in for pursue countries 'XX. be our of our the We in for options strong about business. continue our in a fully and COVID, the side Japan, we be with EU, $X will COVID

As year. this publicly has renegotiated their with disclosed, EU earlier contract Pfizer the

also in XXXX. a And individual for right So but are at agreement the country they procurement been see EU many commission looking to from joint now, we a has a level in substantially are can be markets, that but those we states in both supplier level, if satisfied a European are discussions established at for member demand hearing second vaccines.

And question. flu thank you for the

We're Phase we So data study that out for about flu of that. our R&D III really strong as you Day. referenced, at PXXX we had excited released

about with engaging pathway the licensure about speak. have we or conversations I happening multiple across are have right update We to all because clarity regulators an But provide we as now those the we they're licensure. pathway will, an all markets, once don't on update.

of the Thank Ending conference. you. this call today's Ladies and gentlemen, does itself. conclude the Q&A portion

now have may wonderful disconnect, day. and You a