Moderna (MRNA) 3 Aug 232023 Q2 Earnings call transcript

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

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

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

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

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

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

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

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

afternoon. start some Arpa plans. gives thoughts. Good present on Stephen our results will before morning programs Thank our will financial review commercial back I progress clinical come our will and then I the quarter. with Today, or an share you, second of Jamey business review Lavina. good to and will update final

$XXX we of approximately QX, In reported seasonal revenues million, nature the reflecting of endemic respiratory vaccines.

of quarter quarter of X, offseason and are per X, and of loss We a Phase this in our $X.XX. loss billion, resulted investments our billion. balance which GAAP GAAP also disease four diluted ended in in program programs, Given the investment cash $X.X in share net Phase $XX.X vaccine infectious oncology with a sales

our our investments capital on prioritizing allocation execute organic in growth to platform, of strategy, continue the with business. We

approximately progressing billion If were in investments and million. million. late invested costs QX, $X.X stage pipeline. Capital SG&A were clinical investments $XXX $XXX programs R&D, our approximately in we continuing

acquisition. was in OriCiro Enzymatics and of all Moderna our is collaborations, Year-to-date, was exception into which organization. being external with Moderna strategic Japan, development the integrated an OriCiro investments were process renamed manufacturing

capital repurchased $XXX a QX perspective, we for million total of X.X return in shares From million. a

Now the quarter. turning update to clinical stage late commercial in and

the COVID-XX sales. now vaccine globally, start updated approval are fall regulators we awaiting With XXXX to our of applications of submission XBB to

you wide, Arpa our to contracts rate. additional the for billion US vaccination a shortly, As commercial from countries. reflects hear sales range given and US will on uncertainty expectation updating between billion. COVID-XX other the the we're range market range is This XXXX This and $X $X in

launch RSV, commercial Our commercial around in team XXXX of have the respiratory product. our Regulatory next been is submitted the applications also for preparing markets world. major

started We've launch. in mRNA-XXXX the preparation also for to manufacture

healthcare products the with launch, prefilled As to a very strong syringe will well at professionals. position our reminder, presentation, in product efficacy these a which will profile be combined

for individualized INT, adjuvant commercial We're oncology, In scale in July. to continuing to in support has patients mRNA-XXXX, study very up we're or neoantigen manufacturing development to report and markets. therapy, Phase our enrolling X our begun melanoma pleased clinical

could we updated slide late means XXXX, X, in XXXX. company our of profile. breadth stage multiple see We'll our plan, The pipeline launches on XXXX,

am XXXX in Consulting proud innovative most by the for Moderna pioneering slide innovation the of to Boston to now one Turning world's that I named been companies X. AI-driven has share Group.

several of research years. Moderna's been many development foundation has and As know, of you the of part AI for programs

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we have that with Moderna everything key our the of recognize we as mindset we be possible central to One digitize that will AI. is this impact

and for AI required level training academy. team through Moderna is we all this members, training our corporate AI facilitate at XXXX, of As the

workflow. everyday at challenged Moderna of is into all I'm happy AI accelerating across throughout our everyone functions business our Moderna. corporate share have to We their to implementation AI

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I an update turn for on now to that, development With Stephen will programs.

Good afternoon Moderna. progress review I'll Thank morning everyone. our you, or with start Stéphane. I'll clinical key good programs our Today vaccines. of at the And respiratory

our on in COVID-XX, slide, left of moment. the stage the flu, a respiratory share viruses, three and side clinical updates pipeline late On RSV. hand important these have we programs commercial against program I'll and some

generation over first study, which in participants half generation a next X enrolling X. made mRNA-XXXX, vaccines Phase and of is Phase our year, programs next both Our the progress in which influenza have this substantial including are

We combination pediatric six populations. programs currently adult and vaccine have addressing

the to address infections, as Our costs. by designed such multiple providing and are combination reducing while compliance healthcare respiratory administration increasing largest burdens caused vaccines advantages

Turning to our COVID program.

the updated have our mRNA-XXXX.XXX, recommendation applications June the We meeting, recommendations FDA CDC authorization for was the our approval the and fall. by of updated use preference approval submitted COVID-XX authorization committee XBB.X.X the ACIP a and guidances. the vaccines vaccine the monovalent XBB an guidelines adopted In this for WHO expected following is is This the COVID-XX EMA recommended in monovalent with of targeted VRBPAC concordance variant. with and US, and XBB.X.X for strain. targeting Recall that and vaccine, to publish

this clinical uptake Moderna an the We're important the may in June XBB other VRBPAC potent Data a which and that Phase of are demonstrated candidate with our of data clinical was XBB.X.X the during XBB.X.X subset against lineage. with presented variants that XX meeting. presented of only data team study advance help the slide season, from company vaccine. X/X believe the proud mRNA-XXXX.XXX of we our neutralization On

RSV. to Moving

use on accelerate Stéphane this regulatory we month, to track XXXX. for announced to rolling priority in mentioned plan we FDA, a Earlier voucher are submission review. approvals to earlier, As to pleased that be we and a the

forward year. to filed We're the look next additional and Europe, incredibly expected Switzerland, Australia, encouraged the commercial of We applications in profile launch the and mRNA-XXXX also by regulatory UK.

a that titers Next, X to our an will on neutralizing to forward enrolled, and study the I'm mRNA-XXXX accelerated study increase fully is the updated safety testing look candidate. pleased to designed support PXXX believe quarter. There's Phase the this antigens. an we update against B HAI approval seasonal we PXXX influenza sharing that update of announce immunogenicity program. is is the and mRNA-XXXX to

turning to Now slide our latent on vaccines XX.

forward Our XX% Phase age than CMV women is in of participants. share and enrollment to soon. to study pleased enrolled We childbearing full X has vaccine that of trial I'm that more the study of look ongoing,

HIV HSV early our EBV, our and In VZV is programs, in trials program preclinical. ongoing, and clinical are vaccine

slide, therapeutics a few our at look the and let's programs. highlight Now mRNA portfolio I'll next on

announce excited the Phase And melanoma our Phase X with study in is now are that design to enrolling. moment. We X a INT I'll share

needs are acidemia, in ongoing methylmalonic disease programs acidemia mature. the and Xa will forward look when are rare unmet GSD addressing and Our updates medical data to we propionic major sharing

we Indeed, at ongoing. our is part update some on propionic program during of acidemia The presented quarter, ASGCT. study confirmation dose the PA an currently data of the

collaborators continuing And dose in portion to and fibrosis Vertex lastly, study. enroll Phase patients cystic dose the of X are our at that single ascending

at Phase take Keytruda of study patients in slide Phase individualized moment therapy, share want high INT. for a plus X combination melanoma controlled risk Now recurrence. This with study trial of the resected placebo placebo X to I to double-blind, of today, neoantigen is randomized, design the on INT plus exciting or my Keytruda last a against

or six X,XXX a enroll arm, every patients, receive in patient doses Xb active will one-to-one every weeks the INT resected of every Each arm. comparator weeks melanoma study up weeks Keytruda Keytruda three approximately X every randomization. through weeks placebo The six X three the will stage and X to with of in and doses

is between I'm impressed and the The primary survival clinical Moderna recurrence the collaboration to stand this X and Phase and free distant secondary free endpoints begin and endpoint Merck metastasis overall and teams with rapidly survival enrolling survival. up incredibly include scientific study.

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

start Thank of expectations you, we a everyone. review And COVID the XXXX. vaccine and to of good businesses. Stephen. line of approximately In vaccine quarter the I'll second given the reported million of XXXX, quarter $XXX nature in was respiratory first our of which day in the seasonal sales, with half endemic sales with

Sales of met half $X.X our billion expectations. XXXX the first of for

our were is the As first mRNA-XXXX.XXX, from a targeting reminder, BA.X-X half variant. the sales which in predominantly vaccine COVID the

heard and XBB.X.X the you world around have for selected of authorities from earlier variant the the health Stephen, As season. regulators fall XXXX

updated of We our have for awaiting to are authorizations. Subject vaccines, regulators from we the expect and and second mRNA-XXXX.XXX. submitted approvals, regulatory additional sales we globally XXXX, primarily approvals now applications to in half

sales outlook. COVID the now Turning to XXXX

XXXX our updating with States. billion, expectation $X the United COVID the from of rates being the range are key for to be variable vaccination billion sales $X to We in

the around the previously from half second-half of several slide. first sales Our signed recorded in year, customers delivery for be $X original mix those to another the agreements deferred billion $X of resulted with Approximately billion $X discussions purchase column including for world updated $X originally billion. of the second XXXX middle $X from in now XXXX. sales year, of delivery in billion in listed half Recent the this are the billion billion this expected sales on already consists to of confirmed this have in advanced from countries, the expected contracts $X.X in

anticipated from other total billion sales in $X billion to XXXX $X billion such markets as US additional Also COVID $X well is expected as contracts now sales the expected the of included and billion in $X an range to in EU. as the and commercial Japan signed

market new the so on provide US that of The sizable portion commercial of in some this expected are second in let sales particular. me half contracts a year, color additional

in endemic you other made many employers, the delivery shifted market retail to wholesalers, aware, vaccines has group pharmacies, In the market commercial purchasing customer a integrated US, the transition organizations, vaccine from market entities, networks, systems, the the and government the to As pandemic the of health commercial up different are US providers. is COVID including phase. segments, with

Today, I on we each of and work these have that report in segments additional customer am signed contracts to contracts. to continue happy

We are ready ample be to with upon shipped approval. regulatory supply

the in give XXXX the new orders. half expected weeks us US confidence expect the additional from coming in launch of and Our into the we signed sales in second contracts visibility

turn slide Let to XX US the me COVID help market. XXXX to frame fall now

earlier, market arms during uptake As the the September in December will vaccine or frame. time key a the I mentioned shots determinant be size US for to upcoming in

for billion in which $X XX our informed in Earlier vaccination US roughly in the the to for rates $X year XXXX, of with are the vaccines we years, administered the will I've volume sales or reasonable a of in and US of US XXXX; an of with XX; of parameters high-risk proxy the be age the is especially XX XXX our expected fall we Americans doses given seasonal burden forecast nine comorbidity US those the mentioned before, of billion last who category, in market. for vaccine, believe provided the a over the over in so every given the COVID. by As flu average year, million fall included driven doses XX those primarily higher respiratory range a that million disease XXXX which million

forecast fall for XXX shots. a of for of the many volumes is, market, will market million this the their But year These volume a accurately predict Americans fall in and supported this it doses to come fact transition market XXXX. how US first endemic parameters is in difficult predict for the to commercial matter

As such, season uptake Hemisphere their as US to in the the fall/winter Southern during countries months vaccination inform COVID well. potential where we to look occurs

vaccination their completing vaccine rate Specifically, the Australia, just in are XXXX was the XX% recommended. where COVID booster in they was season, populations where

sales with Australian to this the volumes be to second for market million data, expectations prior-year year. XXXX million supports XX doses, comparisons, indicate of XXX for in and fall combined half US US range of the the our The

I'm increasing to First, for focused disease the vaccine campaigns with launch. the size and are fall are Moderna's excited branded slide vaccine Moving two-pronged solidifying market updated XX. through market to Moderna's campaigns vaccination awareness share programs; and COVID fall share the on secondly, on: promotion.

goal to disease recommendations educate get and seasonal With from flu COVID-XX our with latest we on aiming to drive clarify ACIP, consumers are connect the to burden, campaigns, this fall. the vaccinated vaccines awareness disease with

team focus from preference energized running commercial brand of updated promotions media Branded driving highly COVID across campaigns launch with is conducting on vaccine the will The vaccine. the direct-to-consumer healthcare major channels for campaigns and promotion Moderna's providers.

XX. slide to on Moving

best-in-class XXXX the for vaccine front We profile. about excited of believe our are the vaccine continuing strong vulnerable high older in potential prepare have across and of a includes to We and consistent are opportunity efficacy us. our clinical shared. in RSV populations, shown data as we This that has the launch

billion X well as X our vaccine Phase has same COVID We is mild more X mRNA to cutoff administered our profile any have events vaccine. April RSV Additionally, the adverse safety study, our mRNA-XXXX of Phase now reported date. established. doses as than RSV using technology In in GBS our XX had solicited trial cases of moderate, and events were most the not

important market. one for conveniently differentiator We the launch which presentation us save syringes. reconstituted a at with to products ready-to-use comparison errors in ready-to-use and exclusively allows dose be reduce be will will in formulation. the finally, packaging will and of for consumers time And professionals believe drug our the on the customers prefilled healthcare this product, to This

invest and prepared are year's for to prelaunch potential activities continue launch. We in next

to vaccine. and organization is Our commercial deliver manufacturing globally, team well-prepared is our active the

With to that, I over will turn Jamey. it

financial our morning, This our will cover performance I everyone. hello, full-year provide for second-quarter financial And Arpa. and framework a outlook. Thanks,

sales million, were year-over-year, mainly lower down slide by XX. XX% $XXX on sales driven Total volume. Starting product

to a pandemic sales line move with were communicated transitional an commercial second in XXXX high seasonality. in at expect the we range. with a to as from endemic low, the significant continue end We while came our our be of quarter to market we year In expectations, relatively

the for XXXX quarter was sales of second million. of $XXX Cost

– of purchase unit-driven size product this These to vaccine includes on unutilized year. commitments obsolete than addition million. monovalent at million, the shift related lower firm expectations a losses charges, write-downs $XX to $XXX latest and driven costs, capacity were million to compared of by COVID to the and for inventory other $XXX beginning following our excess and charges manufacturing the an In COVID-XX at manufacturing royalties, overall primarily our in market candidate XBB.X.X demand product,

manufactured the in a chosen to at we that additional selection, able meant we have P&L. that XXXX ample the was to of use supply strain The fall prepared monovalent the cost to order goods. In not of semi-finished beginning fact previously various were resulting the season, for also outcomes

by which were R&D particularly costs due flu, our X R&D seasonal to continues expenses to R&D with personnel attributable RSV, to expenses, billion, driven $X.X to increase in late-stage in The XX% increase in Phase research development versus CMV. increases efforts. support increased prior our be also for by increased year. The and trial-related clinical and headcount studies is

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

the was Income a second a benefit loss due of million quarter, mainly from to for tax $XXX operations.

income was for earnings compared Net loss $X.X diluted year. XXXX. in loss was the $X.XX diluted share period share $X.X $X.XX billion compared billion to per net of of to And last per

with the decrease to end and was net the QX the by of billion investments billion driven compared approximately ended The and $XX.X in of We loss at of buybacks. $XX.X period first quarter. $XXX our share million cash

with million quarter, in to expectations. line our product future the the was approximately Cash by of $XXX end the deposits second for supply declined $X.X by which quarter during billion

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

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

the XXXX increased and we first billion, in invest remain billion to for on in to year-over-year spending the full R&D half track R&D year. XX% of $X.X $X.X

both We've We investing the our are XXXX as as our commercial build-out footprint. US we manufacturing our also capabilities, expand expenditures and in digital expanding capital organization, our in well the footprint. as accelerated manufacturing of international

discussions. to platform. multiple seek external and remain attractive will in our in opportunities Our enable and second are investment disciplined is priority approach collaboration complement and We investments that our active

In we internal evaluating $X.X had repurchased uses $X.X then of of assess XXXX, repurchase billion June share XXXX. the for XX, as and half million authorization remaining and we approximately external we cash. first billion, shares of opportunities, additional X After investment of

the updated Now let's turn like our framework purchase to We XX. to XXXX would beyond share financial on slide agreements. thinking our advanced

existing $X and $X earlier, the billion mentioned US, to approximately EU, to now to of from $X of for in billion, other Japan, Arpa XXXX countries. and additional sales sales billion billion As approximately product we from expect the range comprised $X $X billion APAs

world, of we XXXX. $X of deferred approximately As with billion original in be a $X billion APAs the to expect now around customers recent to result total the discussions

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

costs We outcome. helpful of point by you largely for range this portion sales year is it the of cost more your driven to now dollar absolute $X production billion. to an year, $X.X would sales the and expect our in billion the purposes. Therefore, be a only At for full the fixed, we range are provide thought modeling of smaller

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

range a billion. R&D benefit operating by finally, provisions, full-year to capital driven anticipate continue non-recurring $X.X expenditures $X now loss, in We to And of billion of tax the and credits, expect billion, $X we items. approximately an international assumed

concludes back I'll over my and to prepared the That remarks, turn call Stéphane.

you, has starting outlook, Moderna with Arpa, Stephen. Thank a Jamie, commercial promising COVID. and

uncertainty XXXX $X as commercial a APAs billion. the US to underpin is vaccination revenue billion we range of market, rates our in in $X to transition and there While from endemic expected COVID our contracts pandemic

combine selling we are this I will revenue for endemic visibility very COVID believe provide vaccines recurring to year time, We will working long vaccine. a first into believe and flu stream. a be COVID we to and single

prefilled anticipated a syringe profile strong differentiated in should to has vaccine the XXXX presentation work launch. and product RSV that RSV. to a advantage Moving our

indication. in cell now our beyond lung we prioritize be oncology, The which strong, are Merck, data cancer. INT X melanoma commercialization. manufacturing and ready Phase working our announced, non-small and already partner, melanoma to are we very Phase scaling indications are those X for are to With capacity In with we are

at [ph] back I'm disease in Stepping disease and broad very excited vaccine, oncology, high-play are that of clinical positive in data with scenario the rare of looking the infectious we portfolio, genetic in with Moderna liver. playing and

For product growth. portfolio that will the from our launches we next position company therapeutics XXXX, multiple to XXXX for three across anticipate vaccine and XXXX, sales the years, strong

stream time. This is the a robust a The diversified unprecedented be in an Moderna and with time of incredibly a number will very is enter as we short a mRNA era revenue platform result pipeline. exciting working, new an launches at and

at be New We look further of we'll hosting City also in December event our Day. XX. ESG live R&D X, will will online. York be and, on updating course, That event you September forward to Day This annual be online. upcoming our available second On

The to deliver the mRNA through is approach lives suffering. patient and human alleviate people multiple to mission launch impact especially medicines. of our medicines is now greatest should This that mission of relevant the we extend company possible as new

is All to of us deliver all benefit our privilege stakeholders a are to Moderna as on for part its It of this company. continues potential. of to be poised

We'll now take Operator? questions.

[Operator Instructions].

Richter Our question Goldman with first comes from Salveen Sachs.

out? to regard reaching impact you XXXX vaccination deliveries, the fall discuss as to additional rates spectrum that US sales be speak can higher plays might the in With of wouldn't of confidence the second-half that to the you addition to pushed And that contracts range? factors the expected for can season additional end

around $X fall many $X In billion terms mentioned, billion billion of to sales their in billion, the Americans key $X shot. this factor as to that how come get of really you $X within landing the to is additional of

factor the is that biggest rate within swing range. vaccination So

We in the that commercial US. thus progress with in far market making we've our confident and contracts share been are the

being was this purchase we deliveries the advanced the additional all to where second year, confirmed of and into question US, the with have already deferred, $X countries of have outside which agreements met of on than billion, XXXX. have pushed different for other Additionally, the half potentially contracts your we

in we're $X staying confident at billion So that range.

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

was expected implies the Is tail? $X real years? expected be we in APAs the vaccine about If to APAs the $X $X think how we locked from $X for demand? billion COVID-XX sales With COVID-XX should half? what the would from of billion about true at you Thoughts billion as since the the $X billion what billion booster year, franchise demand there it billion start prior of annual second helpful. would $X vaccine billion not, of think the proportion already the it eventual the that to in consider $X year Perhaps, of for is

thinking how given we of of that would I countries half terms fall about the volume reported not outer are look we're In XXXX, volume portion have sale annual most towards anticipate is XXXX, the in recently at of recurring billion shots. vaccination going a first with where as $X.X a campaigns do of we years, sales, that

$X about of increase vaccination remainder volumes billion, believe will the we the start COVID vaccine that will believe demand to. flu billion and, the eventually over to rates For we the $X do trending remain that we think time, as

States, range about I over million burden XXX we we mentioned high a every think also XXX for are as in trending will we And as to there to combinations, modeled example, earlier, fall. So XXXX United future about the is XXX disease start million. time, for the closer vaccines we've of What about think XX million. given given and million flu

Our next with comes Wang Gena Barclays. question from

the that any approval slow initial label COVID stocking learning launch, your second order? time, regarding have US and the and you launch for the vaccine, definitive contract any language given And Pfizer RSV were this could Regarding initial the GSK the commercial there prep? a and

volume go progress, around volume contracts take time. could we contracting many commercial first. I'll And vaccination of have most over do at our first uptake up closely depending question we're looking minimum the but on contracts, across In contracts, commitments. that our with will our customers, our commitments of monitoring be we that US minimum

meeting, vaccines the will more mean In decision-making gradual approved. been two ACIP shared first think recommendation ACIP the RSV recent have the a for uptake terms a for we that of clinical

there GSK uptake that time, to as over of is potentially we is the there as broader recommendation, both Though data which opportunity clinical update would, as more RSV and from lead programs, program vaccine. believe to Pfizer's do clinical well our

of Yee question Michael next comes Our from Jefferies.

on Dina Mike. is This for

Just a question quick update. the on flu

are I are So second for then your doing that or that infection timelines to going to with that? Have about Are share QX you data QX What on – study in yeah, efficacy study that have that the update how a and that. But for that saw infection from shifted? guys previous you second immunogenicity the study? that? going

also updates are be to additional you regulatory you forward? on Or on on other path et cetera? sharing And PCV, sharing lung, any going updates any are the moving

update. as on study. be And talked continue end-of-season in I this First, on quarter, providing the our immunogenicity where sharing XXXX in flu to we progress And also program, as an the as efficacy that study, said, Day, influenza. you continuing X you the and PXXX referenced, Phase pivotal Vaccines we be have ongoing two we'll And we're on are excited to ongoing accrue be – studies, data. we we that have about actually know, study on are referenced. update three we'll PXXX updates two the but doing you the We'll to

program. everyone reprising happening INT, that. INT, month to not opportunity be, the and program, relates great a also R&D ASCO course, other INT at you PCV, we're Day it that just provide our an of As of going to And all now some And in talking to a we progress to ago. at to the update had

we'll we're Phase and a We melanoma now, and with are start really excited obviously by we're study lung of non-small up studies, get running hard but be X cell providing in the really in first pivotal our the York. New month cancer, working further in updates to – but

comes question Ellie with UBS. next Our from Merle

line Your open. is

on [ph] for Sarah is Ellie. This

give second color how on next thinking Just follow-up any going a volumes Tyler's earlier forward, first question. you on half Particularly, about versus of expectation half your first color about on you're can Thinking more for half? COVID year?

on And when enrollment? the seeing you'll data CMV, should then how rate? maybe we complete on could about we And blinded a think and event on any anything get expectation basis on when you're

on first I'm Stephen it and happy then CMV. will over to to take the hand question

come the winter we're half of how in about and first it thinking half terms the Hemisphere, expect In we versus sales from Southern second first of fall forward, the their where that the will going is year, half season.

in continue patients. populations, be elderly highest-risk some there spring and to boosters, particularly for the countries, and higher-risk in immunocompromised, Additionally, campaigns

boost So in well of this high-risk late anticipate sales for into carryover any do from January. coming spring the as for year Hemisphere we the some as Southern winter

to year, will The will the and of half expected fall sales campaign. from as the though, of the be the be second majority of vaccine continue in our the anticipated our majority sales Hemisphere Northern

that, year. enrollment We've And enrollment, set on CMV hope of on of by good toward recent a half to We this sure excited XX%. the the question past do hope this and in first enroll We're year, enrollment acceleration we're so really haven't completion there. yes, complete of target we shortly. made but progress we would the specifically to it for

to gets in and we will that cases so participants very talked started accruing not analysis analysis, have full CMV more we the who the to We've predict cases we accrue get will tracking Phase and we cases, to in an I think it X can timing of. Then as of which the where efficacy, And our we enrollment, first contribute event-driven Vaccines interesting that's interim be will Day. something can already about program. be

Our next with question Capital. comes from Luca Issi RBC

Maybe one, I back circle on margins. can Jamey, if

XX% to new bit implies Can prior on I what's your margin guidance that more change guidance the XX% just today? little a today maybe at your think you expand gross margin driving versus gross implied midpoint. XX%

B argued class actually could for Sanofi lower the a immunogenicity the think I be flu, on Stephen, that effect. strain Maybe,

So for your there. are strain. players Wondering it'd mRNA any difficult B thoughts Thanks what for the so to be of much. actually have immunogenicity strong

I'll take the first question.

XX% in addition to We those pushing you're cost to volume-driven, largely of $X.X APAs an XXXX as were to billion for planning into $X for our well. still margins, it's right. billion on billion So markets We yes, I'd the have example. XX%. other as $X out fixed say

So I that think due volume here. we to this quarter coming some some our little anticipate volume higher, push-out, through due to expectation just prior overall to was a

class effect. a of see I'm it And same made the way. the about I'm argument not aware sure I that Sanofi

I think I'll question X forward next that look we quarter, it we'll answer the to are leave at We'll in conjecture. the to sharing study and than to rather the PXXX Phase where data look that. in

Our next Edward with question comes from Sandler. Piper Tenthoff

is line open. Your

My a of one. strategic of kind a bit question is little longer-term

continues COVID next the from today a vaccines So, as of three is then from are you approval combo-approved also one plan then get As standpoint XXXX seek evolve what for maybe combo-approved approved and ultimately and how two, these where or regulatory year RSV, do to even commercial we a vaccines? combining multiple approved, standpoint? we with to and one

got As a we forward know, six you new flu, we'll COVID we in well of combo of be greatest as if to where vaccines. second-generation that And said, different the rest forward, expect looking We've health at moving clinical options approved I multiple RSV, a look those, combinations bring and COVID continue trying that and the be at flexibility. there, as have can we we to assured data out public situation provide lots in we're as have to you combinations.

safety need the season, approved, demonstrating Those studies. bridging immune we they They studies the know. can the quite monovalent run And combination those studies, in that once non-inferior we don't have can vaccines, studies, do be be the you just immunogenicity and and also achieve products quick. are in as those to really

year, filing, at and the said quickly goal and throughout towards our the vaccines Phase complete to is move work approval, combos. into to pivotal this three hopefully, going eventually, least so, of monovalent progressing multiple approval the one and be, as And for to is Xs we've

administration decrease and reasons, again, is and healthcare. value, be cost beyond XXXX goal, improve of the will deliver to actually more obvious those they the compliance, launching Our in for

very the the are we of where to from here, is RSV allow provides pretty strength to flu COVID, the in we'll XXXX on path an we be the and actually data guided. hope particularly also clear providing monovalent very that quickly thereafter. clear think So very given that combo Xs in I shortly and we're update And a Phase the path the clarify starting launches launches shortly for we've then

studies. pivotal if would Just one those you to Phase When Xs, the clarify may. point, immuno-bridging I be said

studies. safety and immunogenicity They're Correct.

quick we perspective do not monovalent – efficacy once of So to vaccine. the norm studies, you you've subsequent that it just efficacy nor established a very believe regulatory studies the do from the have demonstrating is

comes Bank. Our with next from Deutsche question Papadakis Manos

Basically, if of revenue the that regardless that I what terms range range? could you to provide? ask not, does wanted just COGS And is guidance, in apply sensitivity the the of

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way. So not to that $X.X billion sales $X either happen will billion dependent on the much really that is outcome too

talk to is year I market. unpredictable maybe And this longer so an term, just to what with just think suffering we're

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

on Can vaccine? the how the Alex on for you need? Will other indications pursue is This you which or indications you this decide may unmet first? about potential all to be pursue talk Geoff. And an [indiscernible] based INT for will

for what Secondly, respectively? and hurdles entrenched RSV, competition commercial the expect flu do given entrants and new you

know. forward moving you we're lung obviously, in in as melanoma, And so cell non-small forward INT, on moving cancer. First we're

– very we significant. so immune therapies for to it's obvious know, generally, an the the go that's next. opportunity And the obviously is need I as one us place opportunity for is there and of unmet think largest there

before, upon Keytruda what's said be. But path still guided with As the achieved still we not the we've are going Merck, the of have with we have headroom, on successful, we been where think said have yet but places PD-X we significantly improve where publicly all what PD-X to that follow will opportunity antibodies. there indications been to the other partner, our is

the and can there through short as moving And us stage where of order. in expect well those so, to settings are you as settings, there the be follow some adjuvant X perhaps benefits

be studies. appropriate obviously, in and said said two. quite as of studies as first the in process that is lung time, order, very you rest program they Merck And the and will and short Ourselves those assured, a on here before, large cancer non-small cell we'll finalizing just there up of we've ramping melanoma some at and the are plans. But really of are those of start guide the

and be are RSV next RSV take can flu, we excited question year. on very to the launching I And

the groups, lastly, only best-in-class will is about we being we high-risk third bringing consistently confident we're well-established RSV, the safety prefilled effectiveness market, high product to I ready-to-use in syringe. for a platform mRNA the only our be a very mentioned as across earlier, while believe with product with profile and in our profile what So thinking

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from Our Guggenheim Securities. Evan Wang question with next comes

given enrolled, ex-US, strain, market you any confidence see some and markets Japan? thoughts on some And terms want details PXXX like XXXX? terms in size just the in of of of And competitor orders updates. change in your of updated just COVID. of in want fully on Just study I flu, some we're thinking positioning up follow share as what And can the to could to the hitting in on B great some

we I'll execute as get as take this and Japan the minimum August, country product From the commitment Japan been that to ex-US so just have signed soon is a an minimum with announced. commitment has with signed into question. first that fall. to The we perspective, we're ready

coming vaccine expands, anticipate do orders Japan. their additional in If uptake we from

world, we including those of as the as rest I the international in – advanced already have on Union. column, For agreements that other purchase well markets, with European have ongoing conversations first outlined in that several the

more XXXX In outside transitioning more from expect actually what US we the to central the procured expect and through changes, more transition is of we government going terms as of be today. that such markets an market, the to US is endemic commercial

do the those and as where well pricing So happening changes changes. around in going of reimbursement as be changes forward. procurement shifting will we anticipate is Most

question. flu The

So, and yes, ahead provide enrolled of that, will this PXXX study in we're the fully PXXX, said. quarter, data on schedule we we on shortly as

remember. B goes, this we the earlier strains actually study, the year updated As achieved in B we you'll the missed non-inferiority that. had we PXXX, the PXXX already far that strain, as in In

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comes from question Simon Redburn. with Baker last Our

was, in profile? achieve the and In two-year the second a competitor can you about think X Just if enrollment data recommendation? and just of more bit you'll by view you full how two the me. be was from Phase think questions enrollment what CMV your able that you of the has light little to best-in-class get do One RSV regard changed question quarter. this opportunity And ASIC

well recommendation that start. decision-making a revaccination, we the In around year this of at light do some of with anticipate question. I'll the data shared vaccine RSV as start was uptake the ACIP slower the as shared

that In our enable vaccine we that a outer market, a our be additional confident in very And potential program, do the brought could will profile. from to continue best-in-class hopeful in of data terms and get faster will uptick we be that be recommendation in as have ACIP we years. – own are we

where we be is development And at and only the will combination system will one looking the of different thing The vaccines, continue it around terms the increased I convenience that. recommendation that and add I'd there – think evolve, be it side obviously that that's of if create to healthcare of will are can we in value, versions have to compliance. people multiple obviously advantages RSV

trajectory we we would past CMV, quarter, we but on will complete. out to haven't this relates the enrollment actually expect year. that when confident, But year. saying the that we're not it As complete already enrollment given this we're XX%, guidance to set I'm so this a

the first here is not I of cases events or as what and enrollment. forward. we're XX% XX% said, at really or the And matters probably from whether will It's XXX% interim analysis accrual drive

more of events increase obviously, enrolled Now, – and the patients – over pace those will time. number more participants of

very do we to hope and operationally, that focused on are so, year. this completed that have And we much

to back to And the any turn Stéphane call like I'd for closing remarks.

days you. on forward Well, in very to the see of person. especially R&D the many look you September you at next a thank seeing Thank but you weeks, to of day. your and many great Have We questions. for much in Day seeing you XX

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

day. now You have wonderful and a may disconnect