Moderna (MRNA) 1 Aug 242024 Q2 Earnings call transcript

Good day, and thank you for standing by. Welcome to the Moderna Second Quarter 2024 Conference Call. [Operator Instructions] Please be advised today's conference being recorded.

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

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

as issued You Mock, going by our Officer; and Stephane Investors website. On Officer; morning press Bancel, access our the that Stephen release Chief of President. call can as be Financial the to well Hoge, Jamey today's the section reviewing our slides we'll Executive this our are Chief

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

will turn the call over Stephane. to I now

other to role on October of viruses. globally millions so continues impact the each major commercial framework. COVID. and to will lives. then data on remarkable progress 'XX, is our result to or today. thank progress. why hospitalization present Lavina. lives continues will our results then you I XXXX, combating financial NXX Moderna by in This our so profound why because to 'XX many you, second Jamey impact sharing patients, that on outlook COVID franchise review started provision than clinical close will positively is quarter impact the higher Thank Based the our just Good of has start execution morning of in focused vaccine, to play shown a that based business. poised for There good review and quarter will a I respiratory CDC our for afternoon, everyone. our Moderna year. that upcoming Thank we for critical of us respiratory you milestones. In progress ending and our financial joining and June for is with spike is team

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positive Our all results, demonstrated immunogenicity flu and candidates in XX has Phase adults, vaccine meeting XX and endpoints older. III

Our achievements respiratory has mRNA to underscoring Flu Phase plus public highlight positive These III, our also ability COVID results commitment strength illnesses RXX our effectively. of the multiple health. to candidate tackle and combo in and our vaccine shown innovate platform

now X positive are X out COVID, COVID, Phase RSV, and our III flu with topsoicombo. vaccines We next-gen of data, XX

has the We saved believe aspirations millions our technology impacting thus reduce are very of families. world about achievements for our and thankful potential and these significantly of teams. We around innate millions respiratory product to very excited are of these a globally and the

targeting and for highlights the of a GNX manufactured QX. 'XX/'XX virus. strength business both vaccine to COVID season Moving KPX the We

respiratory 'XX/'XX season. ready are the a to of meet We demand

ENRESA positive our U.S., the a Europe addition that CHMP. opinion to In are approval EMA pleased agency in we regulatory from with received

approvals We world. regulatory the additional are around countries in waiting for

address to awarded Moderna, X we accelerate agreement million BARDA Finelite, a pandemic the vaccines. recently through The future spreads. funding MR-based with in public of announced the For U.S. virus development partnership to health influenza $XXX and in

up expanding vaccines robust to strong $XXX nature continue Mitsubishi initiatives. business. billion. in with We with financial position. co-promote billion, is $X.X ended us Japan, the mainly foundation net Bozena which collaboration. of seasonal the This allows Tanabe revenues respiratory partnership our we continue and respiratory The $XX.X programs Japanese impact investing million, an this our reflect in QX, Lastly, in the important our and market. reach agreement, key quarter joint Japanese our Corporation With In will and was Pharma vaccine the highly our loss to investment cash were

continue operating by expenses more XXXX, commitment highlights financial our we Compared to QX our in expenses. Additionally, million reduction we have QX decreased make reducing to progress operational our efficiency than to in This considerable operating $XXX discipline. XXXX. and

Before we over an week. to to touch announcement last I hand Jamey, on want I made

decades most to international We the public are the Rubenstein, respected Co-Chairman Moderna and He week. very pleased Group industries. David David investing welcome matters affairs starting growing Carlyle globally on number to of businesses and voices is of to X related across of and has and the Co-Founder of next experience Board a proud also policy.

have excited build contributions joining the us from help is David tenure, academic. Board during Berendsen and would next to I the personally Stephen many to his board, level. to We are to With to thank down to like Moderna his us very him stepping join reach for including the

intention announced informed the the to also retire Bob has board. from the We that board of Langer

personally made to Bob our Moderna grateful will of Moderna, years was early coaching not today the As we so especially or the me. and vision during X has I mentoring, contributions co-founder, to Bob insights. experience incredible of am very be his to are company and valuable where without as and

With that, turn let me to Jamey.

performance remainder will for quarter XXXX. you our on the I Today, second also everyone. of hello, and you the through and financial walk for Stephane, update outlook financial Thanks, our

moment million, Brazil stronger-than-expected of a fulfilled with mentioned We quarter. Slide when largely a States. QX I other Let portion COVID-XX $XXX due lower ago. sales QX million, sales States $XXX down our the including prior commercial XX% outside to by sales of regions the me above contracts. year-over-year. volumes United sales driven the Net orders of guidance on $XXX X. recognized same were United driven product were sales for year-over-year, second from sales from Year-to-date, of in the vaccine number small trends XX% of primarily contract of last in announced performance our compared to our approximately a mainly year we countries, XXXX million, by start down we were just year-over-year QX the quarter

XX. Moving to Slide

million out-licensing includes QX As revenue I million, included sales This just licensing that with recognized $XX call. a nonexclusive line property which company a were upfront their Japan comes of we other COVID-XX payment and our in of $XX of an net deal revenue, QX, sales the leading is The explained, pharmaceutical revenue million. product double-digit earnings $XXX on in from in in intellectual Japan. announced agreement low product royalties in

inventory of quarter cost and cost manufacturing royalties, wind-down sales our XXXX, million This of in resulted sales was capacity which $XXX to included sales. of XX% For $XX and net representing product third-party of the unutilized second million costs related of $XX million, our of $XX write-offs. million

the voucher billion, from a last As of on QX expense of initiative priority a reported sales our additional of an established the full on million year and tax This of which valuation to in first are XXXX expected income a the resize detail $XXX strong continued will results. With or purchased cost we in slides. a of at discipline allowance tracking the benefit our second slight reduction in XXX%. the cost reflecting reflecting approximately when half our X year. application on tax X% million, $XX last upcoming QX provide for focus year-over-year. spending quarter, towards were assets, driving second continued I which $XXX a review strategic result the income was quarter of first sales XX% a the million due compared of cost is R&D manufacturing We during to shift quarter of of decrease QX, productivity were SG&A to our period year-over-year. $X.X tax increase down our of We billion. for XXXX. The result the is of R&D same XX% in deferred $X.X is we included expenses third expenses QX year primarily $X.X spend which in was Cost billion majority structure, investments

the Our loss QX share cash net an activities. research primarily billion, to $X.XX XXXX. and totaling billion of second down period of $X.X development We recorded ended due the of expenses last $X.XX in from operating $X.X loss billion of quarter a QX, investments billion $XX.X and net with at Loss end the for to and year. $XX.X from improvement compared per loss was was the ongoing

Moving to to want company. to are across driving XX additional we reductions QX, cost similar I and the the Slide provide detail on

You can due a spend see we had that efficiency to our QX in in reduction results XX% SG&A gains. year-over-year

affairs One drivers reduction for of commercial from SG&A year-over-year medical group. and is the main our in the

We've our and endemic the shifted our been the our into half market this reducing And strongest the by in of to purchase year, possible targeted seasonal, the invest built has external investment. and other more drive spend area how cost we we have also more us consultants on allowed we been as return internal capabilities, Over the past drive efficiencies of use focused on more to services. of year. commercial second have which has

seen company-wide for reducing clinical, on rates in Additionally, third-party XXXX. we has supplier team our and successfully been in travel reductions services. the progress primary first rates consulting has half components, Their cost contract strong focus procurement of and raw driven have materials,

to with our mindset. business the artificial an intelligence employees. will in in allow see by manner adoption continue scale us digital-first strong to We a efficient which

team are manufacturing. of thank with the handle and questions quarter, I'm are first Moderna example, our the processes and to previously and foundation savings solid asked launched savings results people, technology. of the the equity but HR in we cost in R&D half made benefits additional investments seeing operations and very to We a These in directed assistants teams. to highlighted significant we want and efficiently. Overall, purposeful year allow of savings XQ HR scale us efficiency drivers have AI-driven second the pleased and the For team our the in to GPs. some designed SG&A also frequently built

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

revising XXXX net of $X.X drivers primary billion billion. sales product We the expectations X range outlook. $X.X to are for updated are a to There our for

we member feedback and on country XXXX sales now expecting based states low health discussions in with First, are EU from recent very officials.

vaccines. we competitive in our Second, U.S., increased for respiratory are the seeing pressures

than While this slower RSD ramp continue potential. a anticipated, to previously we RESI's has in long-term to believe led

but our rest provided We remain from in committed potential our adjust XXXX. to risks, guidance it's of deferrals XXXX these mitigate appropriate the this of have to the Third, into world, revenue for time. risk at we attempt believe in the

assumes to framework revenue this similar a last COVID vaccination U.S. season. Finally, rate

timing across the QX Our to sales of to currently of in number the available XX% expect will be second approvals in XX% ship. balance mix regulatory the QX. in and remaining quarter days the third dependent split half sales with a on world of We

of as XX% of sales range our sales the of cost in be to for product expect updated XX% year a percentage upon full sales We to the based range.

approximately be billion, $X.X billion to R&D, we down expenses $X.X continue expect For to full year in XXXX. from

For first the be down year-over-year XXXX. Note half on expenses commercial continue to to SG&A second year expect SG&A, be still $X.X higher be we that second half, a to billion but versus we in the approximately in full the half $X.X to billion, due activity, down expect basis. primarily to increased from expect

continue be to expenditures We be XXXX capital $X.X and to approximately in expect negligible billion. to taxes

will XXXX we that Finally, we cash. $X to with end continue approximately expect billion in

progress improving strong to management, call which made will working Stephen. now outlook. With that, sales in have product the is in capital hand change our offsetting the I our We over

oncology Starting I'll of the second vaccines, in in important had review portfolio. quarter, programs we X X Today, In our in diseases. development vaccines. updates our and updates Jamey. respiratory you, clinical respiratory with from areas rare Thank the

vaccine, by adults In XX same risk to U.S. other XX We increased pleased are adult our RSV an for and and unvaccinated and the XX from for older RSV RSV. approved was ACIP MRSA. very for years the approval in recommendation for vaccines. This all recommendation the the X age previously unvaccinated as of years

recently MRSA. European countries. also towards we positive And as earlier, mentioned for approvals from a the Stephane CHMP We in additional received are Agency working opinion Medicines

to flu. Turning

multiple regulatory in We in intend and are authorities XXXX. discussions with to file

full participants and efficacy adults we COVID-XX vaccine, III results years SPIEFEX than non-inferior of We all older. to and -- next-generation COVID mRNA-XXXX, positive in efficacy Phase SPIFEX announced for against years in demonstrating higher compared FSC older. was XX age trial our

for shared We data news the III development. results approval flu COVID XXXX. In vaccine. file to out Rounding are the Phase and the trial quarter, with results excited respiratory combination sharing beginning we are vaccines and the regulators positive from our and in by our with and intend

of the participants the enhanced co-vaccine, in older with with next flu immune in age The vaccine responses subset trial higher the met we than eliciting results and an in its vaccine and sharing endpoints the of XX group years for and have immunogenicity combination immune Sars-CoV-X higher primary XX age the In is trial. combination given in countries, flu United many regulators licensed older our also and the older, adults and begun vaccine years separately XX that age against and of licensed are States. than including These and the recommended steps. flu exciting, elicit planning responses of them

to Phase now antitumor program, quarter, the III known cell multiple In patient's on mutations melanoma T a elicits partner, an other studies adjuvant also responses our bladder large II/III expect Phase Turning other additional oncology. X adjuvant our X which II shared new cancer X the adjuvant in Merck, trials, types. cutaneous randomized INT, MRNA-XXXX kidney trials, X we is and by in or cell adjuvant the neoantigens. and IMT update including X in randomized tumor trial as unique studies, in tumor Phase We in start in cancer. squamous and non-small and carcinoma cell to lung cancer targeting

for development past highlights launched melanoma. back The study the June. next that shared endpoint X-year on trial We recurrence-free the that -- from presentation. of recently I the or few back has slides, this survival the was the primary program launched ASCO melanoma summarize randomized quickly RFS. on at adjuvant The will is data in Phase results from adjuvant II the on II trial And follow-up Phase impressive clinical

monotherapy of years receiving INT ASCO, the with plus KEYTRUDA As follow-up. KEYTRUDA XX.X% years alive years. without the of a treatment presented sustained follow-up in impressive X there group. This through in was improvement world X data survival an combination versus RFS live which in years, X showing INT is at were KEYTRUDA share of years plus of or also XX.X% showed patients resulted of points combination IT and in metastases KEYTRUDA INT of and and in spread of tumor X treatment X.XX. lastly remarkable alone of the at plus an KEYTRUDA at plus were ratio follow-up. is We of versus KEYTRUDA. and KEYTRUDA survival their impressive to equally hazard XX.X% improvement tumor-free overall patients percentage trend distance metastasis-free favorable higher plus ratio combination of group of XX at X hazard The pleased that distant of patients at than sustained an X.XX. in combination early

IMT our remarkable ARM adverse impressive arm. side, for than This profile Immune-related monotherapy novel events the safety continues cancer highlights the risk on tire a emerging were finally, in therapy. in IMTs Now program. our the to benefits not demonstrate I&T profile the benefit combination KEYTRUDA KEYTRUDA for despite the

the from to STAR break I'm selected proteins our is patients properly now that was diseases. M&A a cannot happy candidate rare to and MMA rare in down disease Moving for FDA the share digest. food mRNA-XXXX which program.

new life-threatening high designed development rare diseases, metabolic promising of and need. up in there a a and accelerate a episodes of is unmet FDA in STAR program is As program where build result, toxins recurrent decompensation. the to cause bloodstream The therapies

mRNA-XXXX forward in Phase evaluated with shared. accelerate encouraging that Our study patients a working being to with MMA And previously is to the this we promising medicine. we've of the in results development potential I/II early look FDA candidate,

With that, turn back I'll Stephane. now to it

Thank you, Stephen Jamey. and

start with COVID. Let's

U.S., contracting of the of competitive start last we we weeks most and we season the Comite the during speak. increased almost for pressure In few is completed have away, the contracting to With as not season a the year, contracts. seen only finalized the have compared

pharmacies to health officials, with are vaccination We working rates. care drag public closely providers,

these spread with are adoption. what stakeholders critical efforts collaborative taxation Our driving in

the advanced access. In the EU, provide on to tender framework market in discussions we're

now governments, to recent sales [indiscernible] are and we on variable expecting based several large XXXX. in EU feedback However, from

back countries significant not Some updated which to expect deferred rest for additional large In sales with an of are multiple contracts in season. discussions 'XX, the on not this will the signed XX framework. we a have we do buy could but of XXXX. Contracting some world, have into some ongoing countries, impact be place,

for to the preparation the now 'XX/'XX Moving launch season.

the prepared Capital selected global is of develop ensure we strength thanks the year by to season, teams start effort strengths. In for to quickly North made supply back America, ability are to our the as to organization demonstrating a substantial by manufacture ready COVID Moderna Our fully of and targeting buybacks vaccine. availability the upcoming for

the are of strength rest we world, in the In the vaccine supplying hepatitis GenX targeting requested by those as regions.

to of to me U.S. doses take the all be supply We'll on millions ready now market. COVID Let you segments through upon the market regulatory approval. of details U.S.

network, pharmacies, hospital at season. time was goal to water all facilitating key Our Privax vaccination. to entities Securing us and to the this health the a pharmacies, Idan system is is that spread professionals, independent is for priority available early larger vaccinate ready public ensure care health customers, same to be

which and implemented on order a temperature size package every all real We status. of provide and available have tracking information to is real-time customers system our order, timing, detailed including

Our the within supply to buybacks preparations broad are our meeting of market locations the market. the of using ensuring optimal highlight distribution order tools U.S. help and to to demand. estimate chain AI These availability commitment

me marketing rates. to Let turn education now We and important will to drivers campaigns vaccination our be increase awareness efforts. believe

We have these efforts started early.

is the of how initiative critical launched back is raise basics a works awareness season, to get to designed to the we about campaign. and For end This SascovyXvirus new have why a we various utilization mutations roster the deaths. reduce The year over reduce new need time, have each to infection, system, to immune flu. tool new and reduce a and tests like for vital to it

adults. middle-aged on authorities public vaccine are the young educate risk help the how highlighting to working impact Covid, long can of and care public Additionally, we for with reduce

approach are benefits By major who products venerable for major we to and the focused, market the vaccination start aim effectively most our during targeted are Harris for vaccination in-season will reach that with mitigate groups. audience our collaborating those retail groups. emphasize pharmacies, and critical season. outage the maximizing aim efforts This leveraging we a to By ensures to need our we those of outcomes. channels, Soon, the broader to severe

relaunch. Let me now IRS turn our to

about very are launch second excited the mix. our We product of

on Following the approval, the ACP competitor with par vaccine recommendation vaccines.

and adults this season RD and risk. Based to recommended revaccination anticipated commodity as to market age an adults, which in are on 'XX-'XX will for all RV are dose beyond pharmacies. we retail pharmacy large the the our XX at RSV, includes in initial approximately of on vaccination. U.S. which vast for the unvaccinated people XX focus the chains in In are of dose ACPs are age the single unpainted depend for we ECP XX the meetings. board. eligible recommendation, future have The a segments the discussed a between be by as size XX, recommendation, our the into single Specifically, our targeting increased the vaccine direct majority of both In well segment, we U.S., occur. efforts independent million

last We highly competitive Jamey pharmacy are And Together, shipping XX% for seeing began total vaccine as Pharmacy segment in we accounted in environment. earlier, products a administrator. of year around our mentioned July.

larger to would Additionally, approval have share than competitor contracts XXXX were resulting negotiated we launch, prior lower and our liked. in

presentation offering be approval, frame. Argi, covert near world of high-risk III milestones upcoming continue some Phase individuals, ready errors. with potential medical expect in term, to the look use in In to We forward back years our August, to believe to more ability ship to reduce release them above. the the of and to efficiently Long with respiratory time, expect we fall and we'll busy rest in for we nation time during the well will the much and we U.S. vaccine, September term. the season XX and customers, data In major resonate PFS age the a

our program We regulators file and in are in on discussion with intent to XXX. X

in We adults to also for closer. versus expect other present vaccine flu immunogenicity data

arXe Stephen about incentive accruing and enrolled For XXXX. our And next-gen in potentially cases, Locoid a able cobimetinib regulators look about, be update fully and decree vaccine readout file we CMV And regulators also to combination III we to we engaging XXXX. let as engaging vaccine we're IT soon. are just excited and efficacy talked with give an are of program. very Phase forward with in

are Phase of the the We adjuvant of a is, major in which looking III forward melanoma, milestone. of a element course, completion to

the are of keen possibility approval discuss the study Phase regulators We on accelerated data. based II to

things access As presented, approval pursuing RP. you of we data, Thus, that, with as we for shared there. as before, which necessary could we Stephen consider before there are of durability believe are X we

substantially enrolled adverse readiness a our MANA study; third, Second, III at site. Marlboro manufacturing Phase and

portfolio, possible people achieve progress pivotal PNM. reads to our and for we continue our for impact to these to Lastly, greatest eager deliver milestones towards medicine. We're study look mission to MRM to to initiating the forward

our and some to with expect events, these in in be your R&D platform favor of York years advancement potential Day our important morning held patients for for will to September new further power pipeline City. go. An We XX combined serve date New with calendar, its our confirmed of annual the

now also And Operator? webcast course, will would Of questions. we to the with the you available. to like your listening be take Thank for team call.

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

the more demand help And clinical for with on of or might me couple into noted -- specific you year-end to the and half can on for profile, balance A guidance here. second competitive what guidance revenue have to contracting contracts then vaccine date? contracting here, the pressures logistics cash do be? how regard to it's COVID the be competitive on the maintenance third, second Can factors us the following lowered factors contributing dynamics product regarding or that based you RSV whether understand for you visibility range much half,

Yes.

So Salveen, year-end I'll the question the take first balance. cash regarding

is on I Number collect but of in that the one, have balance of which some push of the collections are capital. cash the team mentioned collected accounts we receivables sheet already there. I and balance remaining ultimately, will focused revenue, two, that my and factors it, from We've inventory XXXX, a teams as can into Number have So small a on been the great prepared our say this there's doing few the would working in we some got might and balances, progress, deferrals a at point. a already our we balance payable, relatively prepayment. on receivables you see job whole on working remarks, is

third, is a coming So doing we which year, offset cushion little the into $X great just then a bit had helps And the job, team to it. the of billion.

overall, billion in remain pleased of the heading that into we ending $X So and confident with are XXXX. kind balance

the I'll Stephane. Salveen, questions other at And take X

the pressure, from products, more On things, chain, Cobian which also of both average I bundling on competitive if those very think want supply products and B, marketing an we much be it's are on ability, all core is activities. wherever with pricing, you seeing portfolio competitors similar activity to aggressive funding larger were

it's seen level. customer intensive a really mix of just the COVID We've versus more to last a of year. customer much pressure So

of And trying we're course, on share. X player, entering is We, you with it. as defend where large know, IV, the very to there's large market market establish X

market X share they has last not want other year. market pleased The who are gain indicated because share they to with

And have really been so we actively that. on working

for In RSV. of visibility, terms

and contracts and already the are actively the have are to PFS of product with season. into to signed be we customer able been that We contracts that demonstrate to the customers move being to There ability some have a supplying value in season some are under ship. that finalized that

but don't the it very important patients. for we very company. goes, we're things. important think the through So provide is season working all is We'll as for updates those

on on all COVID are and we back RSV. add So

Stanley. next from Our question Flynn Morgan comes Terence with

words flu, here, Great. you the the seasonal well. on me Maybe was the noticed just versus can release flu are plus to much RSV? on regulators And cut, steps. that the be I wondering on with flu XXXX, X then in as seasonal that next file the guidance I COVID intend was quantify press combo seasonal for if on parsing and from might but combos how engaging COVID

could So difference help think there. the in kind gating each maybe in language through the of you factors of those for just us

X take to the between first related Yes. what's Thanks, COVID I'll guidance. And and Darren. split the RSV.

of I last all would of X RSV. you I are what And break competitiveness look say similar the respiratory is RSV deferrals down, and related to them COVID them category COVID. So And between all then first at a to is vaccines is if size. in in are all COVID. related if that then the vaccine The or split EU drivers,

understanding some . give general and So of that the should between split RSV. COVID you

Great. the good on question And the language, for pickup.

program sharing the be XXX recent fresh. what discussing flu regulators, have of results coving the data with is meaning Phase submission. So would just expectations process them begun their most the with And and III really that quite we engaging on

you For at those submissions had the discussions, preparing obviously prepared and other programs remarks. said that our for we referenced, obviously, more time, some we we're of as in

Yee comes next with Our Jefferies. Michael from question

Two questions from us.

obviously forward year. on Looking guidance, you have revenue this guidance

years, flow you And You out to project following given cash have guidance. have OpEx guidance, SG&A. as which already and we see is around the R&D $X billion you of

given same who along could So Can there? Jamey, guidance would perhaps, would if staying lower. cash I trajectory, you think things you are And things of and today generally stand and to speak talk that for guidance priority aggressively think about the importance heightened guidance and the to more that I said math flex been investors. in the change OpEx, where cash concern a be that is you as heightened has

The to or is RSV. it lower And was price RSV breaking due the share are lower I just going that Is helpful to projections the in and have that comments that be half? to in say question perhaps super is going you that that. down. appreciate speak back said you second to to

Yes. Thanks, Mike.

$X next we'd billion are and end currently and for in outlook billion year change XXXX still me have we let -- in said break So we down. different as that don't the I that billion mentioned, expecting still $X any in our to we're $X with cash

to billion $X $XX went in loss year, no this included prepayments longer repeat. start many So That the cash. so into a billion first, year, will the $X from of we billion, that the year coming

So cash drag the won't that from be a getting operations, and we're not year-over-year. actually

balance earlier, market, some change. bring expecting mentioned the growth be of OpEx we plan mean, XXXX. But products we year this look and return always moved so we But on have our operating hope the more what understand deferrals we to into to in and by continue we're fact still XXXX. I RSV, Second, return laser-focused some billion to that to heading are do don't have to want will and time, think $X as at I yes, growth. we on there, we will also experience so, to entire cash new and to we'll billion $X that we to And at an to

Okay. breaking on market little And that? to of more the contracting down be a then on think how and to about just it and share price impact specifics

of RSV. this Yes, to a really split terms on questions I kind out in understanding have is between expected. of both. turning can as we And guidance third get Terence bit nor would year. we much is answered again, not I COVID say given we and But this down so market RSV, were you year an of Breaking But there. it how

get retail But we chains. us across get We were already the are the only We product. us comfortable second hope half. the with negotiated. participating I think a access our in of Some to contracts second many that started to of with is

a more So we head can we into get market share on when that XXXX, RSV. fair

Elena comes Our next UBS. from question Merle with

UBS is Bosco from for on This Merle. Ellie Eli

in earliest how future you the purely on event you potentially interim? months deferral XX potential we from safety based on likelihood from protocol study necessary see do are on rates follow-up, based And the a what Phase years. of the on again timing III revenues just second, the tracking? us. international in CMV could Can COVID Two then get XXXX? of median What is perspective, the is latest for the you And expect elaborate

question. first. the for Thanks Great. I'll the take

So guidance, first, We median for safety timing update have we case account And any a could our of may have perspective. not efficacy But we at a would we also from year. that follow-up on don't this an I'm for numbers think sure. interim Day, which CMV. to do change is have the analysis that R&D happen enough prior

that believe continue year. new no the for . interim we happen analysis And to update, to CMV so but FCM at point, the this stand could program this

XXXX? they some this Ellie, the push happen. into year. is said, happen That next could deferrals, will in on Yes. The always yes, can answer they of

we're if point. those and those would So X at offset not push that -- that of the year, into some expecting following

other the The our is I'd contracts Canada. and as additional additional will in as with us well provides those come areas say well. we in resilience as an market to thing participating public growth tenders in potentially Australia U.K., That

as additional contracts. of with this . we the risk, a there's as mitigate it bit So I but deferrals resilience well can little from year think

question next Wang with Our from Barclays. comes Gena

we already similar this just And year. X you the year, way since question X last the and have expect regarding is mostly the revenue contracting regarding particularly for I also the guidance mainly the players. is know down in there versus And U.S. COVID vaccination only

what to year $X lead prior guidance. from COVID So billion . could the this lower revenue

Yes. Gena. Thanks,

we So define both and price. in in competitiveness, share of terms

in think bit competitive But After -- nearly pressure price where share. U.S., a There's XX% that we market U.S. share. had of our we're a or the will market some competitive pleased relatively well potentially generally last we pretty this So market a XX% in speaking, more compared are year. the approximately year seeing we But to year. a perform there. with

seeing the we're pressure, business. confident So of still U.S. performance . the in overall but the

with from Capital. comes Luca Issi question next RBC Our

question Stephen, quick the ACIP meeting. recent on Maybe, Great.

you whether be estimated debate ASIC annual meeting every If was to year other before the RSV was or that either going vaccine.

is of said, and meter them chose a this X ACIP However, simply done. clearly and

think flu me Were RSV in long versus annual by So Any flu. And for maybe color X light appreciated. vaccines. and surprised and that thinking about much us decision? COVID how opportunity X our we fact market is potential there what the on can of the then questions. quick term bird and the the this maybe should two, you done walk for vaccine obviously through latest And

both for you Thank Great. questions.

I our So higher think RP XX the those those who who of of we they in of cover not pleased obviously, age recommendation. with And the risk all folks a the do pleased number vaccinated million-plus are first with people for year most that's and thing the can foremost, the large increase market, really with at over back the noon. we're get recommendation and that quite from cover to hope focus we're a meeting -- should XX clear now parity large ACIP the only old we a recommended is are soon. as and important it's number to who quite was as

Now on the question to your specific question of revaccination.

vaccines, of think X does data. all show of is are And say just it the season but really the X including significant although real-world we that ACIP ImrisVia, I to it's looking second decrease. also important protection year -- at

too. a is there still X perspective, year, trial season so in clinical there into from there's protection a that And but from X season decline

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year look and But fast would you a much X year, I year, for vaccines if for there's of to people decline a X you year think your other rates by forward year. won't the fast there and clearly you the X, protection that of this that vaccines really if X and X have those the if perception. a at pace from be decline be X ours, who to suggests waning in received the first from and forward my

unprotected a start to continue think leave need them to or question probably do that's people when asking those you of boost I we again.

asked you perspective, life. infected view, doesn't your scientific XX with in you a my will times from Now be almost RSV

get will You repeatedly ill.

why times XX it waning risk that reason in see you by before, because other at will over is medical if the It's the multiple the of get are age a booster a And who seen infected from need ultimately severe before. from future. that you even they over benefit probably you the vaccine. infection life, their virus protection you've of that people comorbidity, lines many or fact, RSV complications In with

there to efficacy, benefit. public who to in waning those CDC provide the are that continue highest the believe and risk additional revaccination ACIP people And of bodies public the boost at and for be as will again we look hopefully will so potential recommendations eventually, And that for health story evolves, at that RSV. recommending

to, not encase is groups they like to to recommend principally are that then if our CDC and data obviously, the will choice Now, it revaccination But to regulator determine States. the we ever, United but that providing in moment, the right

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Hamman with from BofA. Our next Alexandra question comes

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from comes Piper Sandler. question next Our Edward of Tenthoff

my the answered. detail. wanted bit questions programs. been to about the ask I of have disease little a I Most appreciate all orphan

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Thanks, Ed.

of somewhat conversations. So and different they are those are stages they early regulatory

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question Our from Fye with Jessica next comes JPMorgan.

for I address And for the you what's there latest maternal want what's to updates your your expect you near-term latest can curious population. customers that an and Are when trial? product? saw on on melanoma that RSV vaccine progress I'm on then And that Phase RSV, going? For can that's carry clarify, to both complete how enrollment share milestone projection on Pfizer's the older but adjuvant I&T to the the the manufacturing take III any comment slide, of share to on adult

is We that even overwhelmingly to to in that are comment to try adults. smaller overall focus and say XX-year-old protecting retail in Phase terms we the potential do we pleased study population, obviously conducted maternal call, recognize So need except previously our updated, of XX- and older and Pfizer's RSV competitive the III who we we've their overwhelmingly, vaccine as the the What's a to population broadest quarterly continues provide and population, high-risk younger goal an label and on for many offices, may of that this this is with in for channel, benefit label they are that market the intend from happening physician at the of be the with population an Americans. in those recommended opportunity. if high younger. year risk positioning file the expanding are to -- medical wouldn't obviously, I majority on the country in on older

moving And valuable, label so I by would say old to as people XX- we're our think possible, we filing. with that's many agree is as that cover to forward I a broad XX-year where and excited it's but important

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Wang question from Securities. Guggenheim next with comes Our Evan

few me. for A

thinking on the historically, RSV pricing some just in for you comments there. longer you and just the made term are COVID of outlook earlier given the year dynamics the given and market how of environment, first, higher the all share some versus and about Just competitive the assets

in flu and there? a you in PRV, in add recommendation -- with use lastly, the and for a or having competitiveness the June or combo a changes confidence between the level meaningful contributor that on having And COVID EU what then? is ahead Does to I saw the what's your you next Second, stand-alone getting year? -- potential being are combo a of of the purchased EU and guys tender, that now in comfortable combo potentially

Jean. is This Thanks.

the So on on higher kind on products train the will lot. the help as experience to ISV will be have customers COVID-XX. that are to through have to What full competitive and get is and really believe ability to going to the able the environment a we product, PFS of channel season that

than 'XX So the in to better share in a 'XX we anticipate U.S. for

course, for So growth. not in going to have we're going to of but in that's markets be launching all sales 'XX, will the 'XX outside be important U.S.

and the COVID, In market of we important portfolio bison forward dynamics. believe plus the moving in driver of to and kind COVID, expectation flu is terms reset NexGen COVID the

EU and the and current of Pfizer between terms XXXX. contract EU, in In the

So we XXXX think to be and low. still going XXXX are

used vaccines. actually air countries of lot Some a have

as its could And so and to 'XX given some COVID in vaccine countries wanting their and our diversify supply then base. 'XX well needing see vaccine more performance. We we

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the combo something And that really customers are valuing. is so the

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Van Our from comes next Securities. Beurden TD with Tyler question

behalf on of from Greg Securities. is This Tyler

agree? latest the in in just being they magnitude of last relative you're built understand . size on the on earnings, so year versus expectations the what And elderly during market thoughts I small prior thinking So of the patients you market, to overall RSV we the the RF your is your

So you question. broke up during bit a little your

is we end caught of to the thought what -- the of the the relative previously. think is market question, your RSV what I we which tail . size

Yes.

believe market to just GSK reiterate smaller last to that relative call. being I business So quickly, earnings discussed

the Now add billion latest what atonation? was side if billion $X you your thinking $X overall the prior on versus to

Yes.

So it. let stab try me at a take to

most time. believe long evolve the what public this organization said, the will said, Stephen we term, it all at believe probably we evidence that leaders boosting be As But is. data as Stephen -- need they as real a is by current that over gathered for will is in potentially

last reaction as you thing paper, that's clear number For not consumer guidelines this interesting with arms interesting I on going is is and in out the size and seems terms that than from what And it vaccinations, it a guidelines clear how pharmacies and plays be a be larger are of to versus much the a could know, year. as think year, with smaller see of doses in is get market. market more sometimes population The it in better guidelines doctors you potential.

the out. So because be factors, those going it's to plays X season of how see interesting to

on the well. comment size year just would market I current as

of those of to be still that will may year similar is, I last think in believe was And year, that -- sizable And and year I there overall or believe that market at play that the are more. population the bit There still lot think customers what sitting inventory. sizable. be we've other that little is inventory of talked sales on prior comments. lot was happened about we the factors a this which with some we a patient a

revenue we So year. this that bit be rate different. perspective, perspective, But from vaccination believe not will a it little a might similar, still if be bigger from that a .

question comes . from Cory Kasimov with next Evercore. Our

Adi This on Cory. is for

vaccination XX% for vaccination year. population -- COVID is similar XX.X% revenue vaccinated on the which is was I X overall caused infected summer to And is as any concern population coveted the our as tracking not months. think get at the recent usually question CDC above. has infection? Another last XX for case and for U.S. base fall the for recommended post

Yes, I'll take it.

this So the row the in seen the first, We've years question multiple a now. summer on epidemiology. wave in

bit folks wave. so for we is and the move need for in virus highlights a many in in and the we whatever protect ways, why years protection towards people incredibly because at It summer is to creating see just little this time. vaccination spreading, even after a the the at effective summer, higher And winter in February effective the some season a of see other fact geographies you there rate disease that November through incredibly dramatically certain

really to business, wave And the impact, summer protect it doesn't we're impact terms that's where perspective. so really wave, that trying But wave of the people year-over-year the change summer for. that's fall year small And similar as of in the see to do minimally we're be to why And coverage hope We but said, we confident them last the the will United there. rate still see vaccination as Jamey we them States. in view same. better,

Thank today's the to you. turn this Q&A like remarks. of Stephane I'd call. to portion conclude any closing Ladies and gentlemen, for back it Bancel does

coming seeing many look forward thank Well, R&D days to September X. Have of in day. and and everybody, the for great we if us, in weeks you, a joining you speaking for day not to and you

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

a wonderful have day. now may and disconnect, You