Moderna (MRNA) 7 Nov 242024 Q3 Earnings call transcript

Good day, and thank you for standing by. Welcome to the Moderna Third Quarter 2024 Conference Call. [Operator Instructions] Please be advised today's conference is being recorded. I would now like to hand the conference over to the speaker today, Lavina Talukdar. Please go ahead.

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

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

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

Thank I before then everyone. you, delivered business third Lavina. Good present will $X.X for quarter. review the of and Stephen and our Jamey I revenue start our our in share will a will of joining programs. clinical our the outlook. will back afternoon, priorities review you in Thank results with financial come morning key or good billion us. Q&A. We third quarter.

with was Our we investments and cash quarter $X.X million of net the $XX income ended billion. --

by efficiencies. This first been XX excludes earlier cost health of achieve would like we XXXX, and the As of segments cost This to and care figure cost system. than charge to $X.X know, that operating first third to compared of you was backlog savings across XXXX was of SG&A. regulatory benefited have in productivity these continue to the resizing been all reduced teams working of the I hard in we million available days RD improve our over have U.S. now, year the the billion company. This our expenses from quarter to U.S. quarter a year, improve sales, coffee the approval In across money for we'll $XXX XXXX. working market who our thank [indiscernible]. of quarter

do teams customers delivered buses logistics compared week were to first and of season. able year's of core to manufacturing the the number For to vaccine last

seen U.S. Now graphs the retail turning Acuvia, we pharmacies on in this channels to back measured X retail shops in retail what of far for have market. is which The Baskin in includes Long-term Care. Slide the as and harmed so

graph helped approval the this left, the year in of total were point year weeks earlier this last right doses, above market see what as vaccine weekly shows see the you the can on can the season. which, The they few you at graph at on the a saves. has As past to in push maindoors

we'll not a share is Moderna are preshape we this season. encouraged until be that and market. know to market in of of curve season, covered arms has shops to While prove of the long-term starting retail XX% the the durable sizable end

the delivery dividend of are other. part respiratory pay Their major who networks X the There trends and these year our from programs group, are for pharmacies basically doctors inform to at where of and delivery to We U.S. retail Slide Turning market. third serve channels in integrated are and understanding to look opportunities ID, X. to COVID the vaccines hospitals additional government accusation grow there or which last networks

XX% U.S. compromised see, can Coriander you year XXXX. the total of market channel in last for retail As

provides we see the help execute opportunity improve combination Since channel. market, discuss that other COVID on the COVID migrate closer a at different convinced COVID now course, time, in to and underpositioned and distribution a greater If rate distribution core decreasing will Fruin the on flew IDN strategy, vaccination creative with remain burden vaccines and with in as to drive which significant have the public expertise We COVID smaller overall rate true look especially time F opportunity axination been to of flu the in the charts. We especially much United the is colistin, we Therefore, segment by rate than States. ecotaxation given to pharmacy such settings the segments. government. Stephen urban over however, to IDS channel presents is we shortly. government a sold in over

Let's rates. now is vaccination turn to what going to be Moderna

of health respiratory to viruses care objective educate recommendation. following importance of a to a CVs as and airport public much first greater public Its negative of over the providers opportunity as by the impact vaccine health on our improve COVID and The is cost trend. at

As torsion the COVID. you know, XXXX XXXX, in there were season, X of

long consumer the of most Secondly, danger a emphasize and we're going benefit recent COVID resort. minimize to to the [indiscernible] to direct the of getting campaign highlights vaccinated our

authorities, acention, CDC, at the importance which the Additionally, pads immunocompromised and XXXX. additional precommission is project people XX recent those the covered in of most the by of for including reflected for recognize AC spring

CDC third Moving was in $XX us timing or most million. MRD, This Modern of to the Unfortunately, quarter below approval recommendation of into XXXX. contracting and restart by meeting which on expectations site. RMP. going the is

our launch in has to our inventory impact a the channel of buildup substantial on competitors negative prior the sales. Additionally, had by

to season to Looking that we XXXX, beginning U.S. participate we'll from in of the contracting believe the able the be

allow approval broader XX-year-old of a filed to population. also high-risk the We will MECA address to XX- that label for

sales are U.S., to refination. we And markets Additionally, we we expect outside and to market XXXX. in expansion in potential see for the recommend have those the starting receive approval regulators if now the finally,

continue as -- few Avastin to strong CFO Officer. XX our board. advance to the the working We and forward experience, our years forward agile welcome Commercial commercial more of -- years with us recently, years. look background, ahead. great lectin an than mono towards commercial addition to Vipol very has as detected which a am of member much He next to products we Directors. before I more of Moderna Chief growth in of our the to at has to that, portfolio commercialization in is guide

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testament is Executive a the Executive This the Committee. a the being to first responsible explain previously full our special across is his Stephen was include and full makeup will accent and Chief to organization. strategic Medical of internal is Jackie Research. talent Stephen and both to Milan. for develop have in Roslin the our our It and the the of The for medical Executive internal each commercial our Officer to grow Jackie time and onto promoted company. facing Rod development Moderna. which have company colleagues Executive First, And Jackie promoted role At being at promote who and promotion these also oversight talent of rose we spend Toni the to our divided. is Moderna, history Committee development remarkable reflect is year of commercial. or to Committee is commitment critical Vice research company. areas that Morana's organization, and President,

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results Thanks, and the will hello, XXXX. remainder our Stefan, share everyone. I the outlook quarter third our financial for of overview provide for an Today, and of

Let's XXXX, third The for can billion, to start sales $X.X sales were performance, our -- follow on by of product product the you billion. $X.X net commercial which year-to-date reviewing quarter our bringing Slide XX.

$XXX included in to approximately not year-to-date which other figures product this had XXXX sales the U.S. XXXX, experienced the million also earlier in from We revenues launch $X.X are an royalties, and billion grants, the season. were slide. market, licensing XQ we on XXXX collaboration, where from our of

last compared $XXX While approximately our XQ supported our weeks of exceeded earlier the between Also of was in billion the sales U.S. third receiving to year. estimate. from sales by provision XXXX approval of and to timing mainly XXXX, FDA primarily returns lower X updated than our expectations., vaccine, quarter, This $X.X a fourth COVID-XX included is by due season previous release driven our product million, results

we vaccine in our Additionally, commenced QX. speed sales

While is at there in capture with were same benefited work billion the larger orders a market compared we the sales growth sales for of initial believe from over were deferred in when XXXX, $XX share to from potential limited our $X.X to sales period million, RFP as lower we of long-term line expectations fulfillment time. International XXXX. but

$X.X the estimate year billion range $X.X XXXX XQ $X.X full billion our sales implies $X our product which we sales of reaffirming are to For of billion. outlook, to billion, product

sales to product between million million. be and expect U.S. $XXX We XQ our $XXX

by The driven X variables. following is range the key

with tracking market XX% IDMs our retail. and early time, in to At the share Sydac to this is Our which government. call share, too approximately currently in it's

Next, vaccination rates.

to has prior Our COVID which vaccinations a down size, the flat range assumes XX% market versus year.

in range. to our is share finishes XXXX. To on last the of XX% in performance if compared the to retail season the and no be XX% end down the the uptick market low and and our at of U.S. market remains size market Finally, in sales, year, expect we sales this there RSV constant RSV ultimate summarize,

$XXX international We to be and product XQ between expect sales $XXX million. million our

volume We have specific will on our orders. performance for recognition as international and final of upon markets. a confirmed amount most tighter are sales sales international a contracted and few dependent timing revenue The range sales in these be our

Moving results on sales discussed $X.X will I the XX, as more detail. to just in prior Slide financial our about product XQ I trillion, QX page. for talk were Net

quarter. in This Our XQ year-over-year QX of a of was XXXX cost XXXX. cost was in XX% for XX% $X.X from decline billion sales the $XXX of our net for sales representing product million, sales

last footprint a cancellation from and of recorded billion to manufacturing initiative As and restructure wind strategic year, XXXX write-downs, costs XQ fees. $X.X so charges in a down our undertook reminder, we inventory

last Excluding as were expenses year. operations. R&D We a make $X.X still in declined results. year-over-year billion additional X% voucher billion third charge, included reflecting during $X.X decline quarter the priority driving in we our a of of billion XX% continue progress the XXXX, manufacturing is review XXXX, purchased in to from our productivity by cost sales year-over-year improvements $X.X QX QX which

year-over-year in income PRV year-over-year impact all purchase, significant our manufacturing continue efficiency allowance cost representing clinical the following This largely The expense. the year. reduction organization. SG&A its that tax attributable billion reduction. continue strong our the we assets of tax decline to slides. $X establishment strengthen targeted valuation quarter, QX XX% research, will last remained efficiencies for making into $XXX of further of $X.X an the was were for a Excluding overall The and a place reflects investments and I driving spending valuation in and XXXX. declines continues development to recognition productivity. the allowance a period the on $X.X a in cost our recognized tax the XXXX for million, third to focus provide million decrease QX across as deferred drive We has expenses details had we same initial from areas billion in on to

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

want invested as unique platform a previous discussed people, I on detail years, that XX. efficiently. building reductions cost are are to calls, technologies the build into as we Slide additional scale driving And over across foundational will processes last model. company. to the provide capabilities allow have we the few we a us operating on to Moving company, and to purposefully

see to our efficiency continue in We these XXXX gains results.

year-over-year had reductions better reduced external and we XQ previous consultants spending and SG&A year-over-year. across our reductions SG&A and XX% slide, technology from G&A by spending. as year-over-year. commercial, the XX% drivers is SG&A functional were on our in AI. purchased mentioned expenses Major categories, all As We leverage digital services of Year-to-date, areas medical we down

to consumer ad Therefore, we decline in we COVID-XX improvements, are don't also as large continue COVID-XX and market the a campaigns. HCP year. as markets. our spending versus committed we to SG&A vaccination and year-over-year While well as RSV education with competitive increasing in investments rates productivity expect drive increasing XQ prior share in --

For the year, update next we our $X.X to in financial full approximately be reflected framework to on expect which down SG&A is slide. XX% the billion,

Turning Slide to on that XX. XXXX financial framework

at $X product guidance sales to Our remains net billion billion. $X.X

of monitoring handful As factors reviewed we are there the as progresses. season are earlier, a

result to of the guidance are in driving to our a of product manufacturing we continued cost improvements productivity For as narrowing we the of sales, XX% sales are XX% company.

our estimate reduction $X.X from to million of savings previous to year guidance $X.X due as study billion The we $X.X timing. billion. from For lowering R&D, as cost our well are productivity is full clinical improvements, of

we from approximately $X.X decrease year-over-year. in down SG&A, billion approximately a continue XX% year $X.X expect expenses to full to billion, For be of XXXX,

innovation. to expect which by expenditures we campus negligible billion drive expand other out $XXX anticipate million, purchase $XXX our taxes productivity highly to this and CapEx December. XXXX, and We to allows $X.X build offset capital purchase from are approximately close approximately control full Norwood partially us strategic transaction in approximately The the million our asset We our continue of in be will to for of landlord future campus reflects this updating of reductions. the to outlook and

investments. R&D cash of capital ending purchasing cash outlay to additional and Norwood We other I will actual campus continue we the by XQ cost product hand to expect our sales, XXXX offset for visibility approximately With in sales Stephen. of in strong over call our reductions expected our have with will billion $X be and billion, customers cash The XQ. $X.X timing on that, our expenditures. Based collection of into from now our

on the you, Thank event our good I'll quick Today, morning everyone. At September, X will our Jamey, discussed briefly summarize review of years. afternoon, focus programs. and XX we the in our do I Today, of product pipeline. over good next or R&D status a those approvals

portfolio. vaccines Starting with our respiratory

presented safety, efficacy pleased aged vaccine vaccine positive COVID with higher Phase including study. For and to our at that a we vaccine day. R&D MRNA-XXXa, are efficacy compared XX.X% next-generation and XX in the spike III immunogenicity data we participants and older

approval use previously file As for XXXX, review and priority to shared, we we'll a mRNA-XXXX intend vote. in

RSV also Phase immunogenicity our trial old who risk from years positive data in our shared For from safety to vaccine, high participants RSV. at XX and mRNA-XXXX, we XX III are

to are program, also We priority a this voucher using intend year. for we which submit view this

use decided relative submission in shared voucher for of potential combination FDA. to for the and also discussions respiratory not this virus program mRNA. We data ongoing Phase XXXX, subject to to our given with the file positive We've timing We priority launch to a intend the from XXXX. season approval III flu cobivexine, review in

by PDUFA are when We announce and programs FDA. for will they the dates these if confirmed

now to flu Moving MRNAXXXX. stand-alone program, our

have and season efficacy of Phase III enrolled substantially We first study. initiated the our vaccine

stand-alone As a season. Flux. with a standard to study a active be over III for design dose Life has Phase after to III Phase is agreement This mRNA-XXXX seasons, -- but comparator. early the designed Blackstone Sciences. success within controlled for X enrolled this that our possibility project declare the the study randomized, against funded reminder, It study single is shows observer-blind the study financing is

our other virus with and portfolio. to latent our turning starting Now vaccines. nonrespiratory

expect required year. XX we that to end by cases continue vaccine, Phase for the in interim For approve this the will we analysis III our study our CMV the of

Board Following results. at Data we a interim the cases, Monitoring they conduct the share statistical these recommend we of unblinding those analysis, accrual Safety should will analysis, the and will

of is lung are III a announce chemotherapy initiated in III trial cell lung will after you have will neoadjuvant with patients rapidly for patients designed happy partner, neoadjuvant a in Phase of who may this non-small cell to trial the or types cancer. and cancer trial. resected targeting second our and This respond I take to KEYTRUDA III in the we our I'm slides. Phase INT with study. In design Phase III oncology, KEYTRUDA we non-small alone. that through mRNA-XXXX upcoming combination is adjuvant the INT I certain Mark evaluating Phase and moment, also review in not therapy For norovirus, that study In enrolling norovirus

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reminder, a need The is vaccine control. the immunogenicity designed test market. XX,XXX our observer-blind adults and vaccines and III XX no older. norovirus safety on to and with study X:X It randomized unmet a is Phase in efficacy, high approved age disease gastrointestinal As placebo of is and the

III in INTERPAT-XXX Merck, design study collaboration Turning the which lung to Phase second complements for the IMT with trial in non-small our now for cancer trial. Phase cell III

endpoint metastasis-free primary survival endpoints for surgery. enrolled not survival surgery. therapy randomize a secondary This EGFR include the who lung cell patients complete arms, KEYTRUDA survival. chemotherapy overall KEYTRUDA more than and Stage distant into of These able cancer INT will plus patients KEYTRUDA disease-free neoadjuvant I Phase are of and IIb III and who X patients, study have undergo by is we an called Boblisurgery, the without XXX INTrPath-XXX, the combination mutation receive X,XXX to non-small with to approximately pathologic followed placebo. The study response will or achieved plus study

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

Jamey. Thank you, Stephen and

During years to our believe XX R&D Spivak annualized up Priority to have approvals investments, will be $X.X can in Morelia. of in and September, Priority sales across of by next Day sales approved over we efficiency cost which drive and slower the XXXX. priorities. products, focused and business the billion, X step deliver plan X last company starting we on reducing the drivers shared R&D pace of product to growth. expenses we where one, Priority free

Media and foundation baseload Our portfolio. first are vaccine the we believe our priority which respiratory of

We maximize channels with will to buyback work to all availability. market continue

to on medical U.S. of and Australia try to Canada to plan rate multiyear in that contrXX, plants are to marketing we and and bring the focusing share. to the expect education have those We manufacturing ovens. drive fulfill Mesasales pagination U.K., contracts and core we in increase closer the we season And market a recontracting countries. our in Internationally, full to through in in start in XXXX of are what online

are investment. in on we product which up approvals We our years, sales of delevering believe focused XX fact, X next next over the with wave to the growth,

these some here any have of programs, milestones. we For

trigger this by of study CMV, to year. We're the backing results. for end For to III analysis efficacy we expect the Phase looking those forward

plan fix-free are PFMA, studies backing now to and underway. For norovirus we through Our studies, pivotal initiate efficacy

and through in is to for with ongoing file or to X vaccine high Nexnovate covered intend we discussions is the Finally, an to agro products subject our FDA. U.S. compensation risk

saving on XXXX. our cost in XXXX, R&D demonstrated down quarter, expenses are and improving billion. we already. By expect to making SDA in will initiatives decrease progress to $X.X expenses pacific And continue flat the focus We as to efficiency on by annual we

achieve framework we continued cost efficiency previously. sales, we lining leverage of sold we to are the and On we operating expect that our

people We day. protect have every sale X products approved the

possible consider RNA be to company, we With this, actions questions. taking to about largest and growth. take we for on reality. to happy work patients. The pipeline focus will and the -- the be confident our -- meet able team done X will to help potential to becoming for are to we operator, continue people to greatest people impact to I We for is medicine. execution be have excited achieve the deliver our I have have to that our we'll the where FX targets a be

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

expect me. third for to and contracts are of to fourth here contributing in speak DSMB, to you and CMV, expected questions XXXX the to or which world separately here talked Two we're whether provided have with to is, and on generated that source you them to Can DSMB the share One the recur can . and quarter quarter actually countries that these you'll revenue of the the the about in regard analysis going the for as -- should rest of in unblinding. we to data us full wait will recommends get more then interim results speak to you you

the Rest first Sure. World of the Salveen. I'll Thanks of revenue. in for question, take X terms

without I in of will So an third quarter fourth that's establishing that we're the order look Canada, wanted in fourth when majority the into Brazil in a those you quarter others, and at Kingdom, getting contracted of specifics, a in just quarter. and And the either the we end, low be I with announced United name shipped few. but think million so on the to large $XXX countries the presence is know been Australia, too -- in much we the balance -- and the

we And it in upon countries. R&D look in mentioned then will at is we we have that some uptick I of those to certain it a uptick As the decline think will countries. Day, contracts that will our XXXX, that XXXX anticipation be there based then in

So the world actually split. rest on little a . bit of

CMV on question. the And

X sponsor in the chance the communication DSMB final be final statistical So make we first or your and first term which analysis, right did if to significance the we unblinding that obviously, happen we because But those perhaps that vaccine conditions not work then final to for of may DSMB fact those we analysis, an share quickly. communicating the is else. the And mean in of would There which criteria that will would any waiting event, that going them. unwinding, about a for can would may be met share results that timing the the DSMB recommended interim at that depending recommends efficacy. then analysis upon to question, would, the analysis could And if we to that we receive if we're be that . the not not place unblinding results.

comes question Merle next from Our Ellie UBS. with

essentially Just end to countries decade. of about Maybe you've another revenues. I X like on certain that guaranteed revenue these of a how the of think and COVID sense the outstanding past, terms have have about U.S.? talked size years sort contracts the going some contracts the inobtroke In sales if And ex these of the perspective ex fume characterize some some guess be from based what's that? what a the US some with maybe contracts you of throughout for guaranteed you ex forward here Axios purchases minimum in on can could you like U.S. just of of

follow-up second CMD. a just then And on

of number time like of between the this maybe when versus you analysis, your will answer, I expectation of interim to but guess terms sales. latest accruals, the alluded the the in those final the what's terms of you of to events trigger timing the events -- think the accrue the frame trigger to between number just rate last just in in I

Okay. Yes, sure.

Eli. part, first the take I'll So

of will I amount grow time, imagine the of can with terms contract disclose say we products that not is countries, we have over that some that of the you as minimum time. the we're But in add these over what going So purchase will commitment the specifics. to

just will So as in that's and drop mentioned my why, prior response, in it that I XXXX

I . than to more And anything going think then in start to we're But grow that. don't disclose XXXX.

of All through. right multiple a do steadily are on go timing now. a to Katakura we that confirmation case have we case. question and multiple coming the of steps And to There's testing CMV of that validate in -- with is have working quite fact, it the bit backlog

if so going we we that period final that to could don't happen quickly. And it actually won't very long rate but and do a we case time expect control of . analysis, Obviously, are be accrual, of between we quite the actually

with Next question Wang Gena comes from Barclays.

commercial And price return, what of One return regarding reserve far revenue the as have it? And a And the million flu quickly season? . right the calculation then winter voucher, maybe submit is combo, regarding all to will little final could from this $X.X accumulate not winter questions. so the for more give reserve year? many is calculate and us using I questions. dose this last X like you $XX return way then your it we regarding season? is provide billion X U.S. net If XXXX COVID think reserve per a about -- this? the will winter season? How priority bit you that combo is And rationale flu a these make for doses,

Yes, Gena, maybe I'll take the first question.

be said, not the million, referring Moderna. that off. $XX on the total vaccinations, specific not specifically COVID to That I you're it's talking that might about, you pricing far for U.S. the market but won't disclose, is pricing, the So think, we to

thank questions, you pipeline the On for both.

review priority So first the the voucher on Flucovincombo. for

makes the we no season contracting for think the longer voucher we timing this relative timing in we are try to terms of it a to -- would flu contracting back of and accelerate that sense believe miss season. review process priority we where Given and year because of use ultimately,

in different reason, product For use future. back hold a it we'll that for the and that

can given that expecting season. that confirm as As we you And vouchers. priority lines, to think the time far prior forward understand are X go is to submissions, approval X today, we other review possible the happen the next as year submissions means with the -- we can and

from XXXX include revenue X,XXX RSV in or not any to our we SBLA However, the or either XX do XX expectations. guidance

were we revenue if be us priority deliver still able wouldn't so an those of upside. and that include approvals, And we would those with any to

the return I could the missed part. Sorry, you Gena, question, sales repeat .

could Reserve the final provide it to sure. is season? see you and $XXX you over final reserve from last need know -- to winter return I adjust return Yes, Because million the initially numbers. booked you

assumption return provide numbers? could you far your if final reserve so winter And season? that So is for this what

Yes.

as from quarter primarily remarks about lower I my reducing $XXX prior million, than in in released prepared So the we reserves estimate. driven being that mentioned our

season. went So million-plus the that prior for to, $XXX $XXX million let's down say,

So into at to and and will entire that is we next continue vaccination . this year. what reserve first for anticipated quarter we learned season, we monitor from quarter. as of product look what project to we rates throughout the forecast the continue and it the returns

Our comes with Yee next Michael question Jefferies. . from

just are you're what in I or filing on not of for infection combo, confidence have example, that on questions, are not combo, there guess I discussions study Two the you the know why you say that be on with has lack an be different maybe to filing factors Can run. to the clarify contributing XX. certainty FDA. you that But the would

a I the unclear think combo. to us on it's little

then was I market. think this had to a the And on going anticipated market be big

of current a is already you're think position give change to there on for player now is confidence going obviously, -- maybe and given will whether you here, be on guidance given actually would However, there where going what your that dynamics And you've given be Can there. you lot a XXXX. comment you Dish a market? to your

for both Thank questions. you

Stefan take think I'll will I question first So the the -- the RSV. on on and take combo

data So are with first, came as year. -- you'll of sort for the ADA this in middle we remember, discussions XXXX. of

and in to what XXX the I in results. discussions that we've immunogenicity BLA for so comment sharing engage be back discussions only be based accelerated would the had of those more not on would on forth. approval and recently opportunities about And

in continue the We closely they understand work to what would see agency that. like to to with

conversations for said became to and a would X the We for and that. continue and that that therefore, decision proceed the this miss obviously the agency. priority would review ourselves we voucher forward. The sense we contracting which although make also didn't benefit fulsome today, priority that review is ultimately, approval allow season to the and it -- also of more But we the for withdrawing voucher, they time are the for review, ongoing, to by influenza, submitting do update those we we'll of year. be use will as approval as our timing view believe, about not

on things. Mike, And RSV, think I a the there's few

the right has lower time sure that. you than through Obviously, on from hearing customers much June very year, we guidelines vaccination now. out came people get As that market impacted is the CDC making are the anticipated last in covered herpes new frame focused know, been

QX, think year. -- be thus what to interesting see happens than what the look shape previous I it's the quite in saw in different. the So to going of the of potentially curve we and

So to seen. that's be

a of and year volume through comforting is other there's channel in happened no retailers happened There's in other CDC because quite of piece wholesalers. before guideline. contracting both The because the and where themselves lot the and what last

the that And to lower so seller time through go sale the with what both of course, in some margin and and inventory. customers with a pharmacy and large taking inventory market much a is quite

seen. there's a And the so for we that an timing forward. a being QX important question terms think market in about again, interesting be of more dynamic to question timing, It's going

we at CDT accumulated what expect the that it call is right more data to look review we and course, guideline. Of

that's my believe to the we full please the as totally sales time at remarks, U.S. decide impact being a an which mentioned going is is outside in able public the for we as it's bid you So U.S., season, contract know, have I and same in and the to to and no U.S. outside leaders have

are in they're happen to come. to months approvals, to getting continue going the and We

So we and also should out. help believe 'XX beyond

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

ask COVID I U.S. sales. wanted vaccine So to about

year. QX QX and if quarter-over-quarter assumes correct. my to vaccine sales So XX% sales low and QX as between as XX% the quarter-over-quarter much math they remain is decline this RSV year were for roughly But guidance a flat last

expect vaccines change patients shift the I that vaccinated moving it's earlier of year available earlier getting pretty be asked could the cadence Or be to significant sales. occurring a dynamic there being in a in due this you conservative? is to guidance because U.S. So this forward? just dramatic the

So any would color additional . be appreciated.

Thank you.

at the look channels retail and care we the U.S. very are have So because huge they is about different what share I is think for market, data to first that data we the As is different, facilities. the long-term important

that As seen at scripts, peak hear season the retailers But are you look from are we we if little coming bit the they a curve. is the a giving and ahead what Christmas today see, ahead. down happens, working earlier be you weekly start what plan hard very Thanksgiving to ahead taxation of Christmas. campaign But of between in terms shareholder is of that and

networks. is there IDN then And the

early data those my orders As year. which as last starting started remarks, October, in of and I a visibility, only to no some networks campaigns them versus in said then we -- used the August. working in don't starting have of have strong lot of with IDN August have September. rate been get pretty later, we most COVID visibility increase And government the We coming. because vaccination early the for orders with we we them retailer when the

it's So last different the in season. in shape the year retail. early from is still clearly

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Flynn Our next Morgan with question Terence comes Stanley. from

or INT accelerate just can new completion approval you're to us And here by by the the But program, validation. there's still III program year-end. just the manufacturing that's in to any I bridging and be obviously, on wondering the then work update for you Phase lung. the on in Massachusetts was clinical if going FDA with on continuing give required facility an track for if

yes. Terrence,

to continues on the do progress schedule. team the So a in totally all great -- with plant. job the

will really working be path and given approval they're out, team what at keeping so timing the the to shall with of day in we're longer we a but critical no terms plant any And progress. making great

very that. with pleased So we're

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Wang Our next Securities. question comes Guggenheim with Evan from

me. for Two

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Good morning.

questions. you thank So the for

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those So fasting. are the dynamics

to the and and if vaccines we RSV to going aging continue you hurt believe Europe. RV be of We being hospitalization hospitalized, have tailwinds, population in important to especially the prevent people in some causes think people that are an

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Tentholf next from Our comes question Piper Edward San with

all appreciate time I the the and Great. all detail.

data path . sort follow-up. see design, patient with the in actually could these terms here. do When I pipeline, we the in X registrational see kind pivotal MMA do also think some that What year. Just think looking here half first forward at to you orphan disease filing as numbers trial you starts could of respect trial the of and the for of lead data to generating this maybe

Ted. Thanks,

event we'll discussions looking event, the case there we somewhat because biomarker looking The be we'll not for design. will moving different little in both subject cases, said, of of years. either can couple could studies R&D can And it it a We'll those both we we're the of study sooner. rate case and at be some will take rates, in horizon. patients those in within we've lower. products, in the event goal for into [indiscernible]. Ultimately, which biomarker can upon as can the we more as next enrollment bit that with either -- basis our time. significant is quickly a XXXX how PA, be the our do And of in case rates answer be we in discussed for third of I a the then we in both. very window, as hope forward XXXX into forward, is we be the the believe of Trails it is that than FDA we in happen result, as achieved in obviously is imagine, quickly of more takes more bit quickly a plus as MMA, as clear the MMA how approval. but as previously, get time with little or a previously and If So pivotal should presently you studies. we that the of . any biomarker, benefit to serve there sort that In could biomarker we've be That's can depend is launching in that can described the expect enrollment studies, product those say, the those be at -- go do update accrue it If Day, or longer, quickly with to doing

Capital. Our with next question RBC from Luca Issi comes

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Sure.

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bit that's we So at this where a stage. are

from Breen with Next Courtney Bernstein. question comes

getting the appreciate for in. much so Thanks a I today. Fantastic. time question

doing is running And -- new the The reasons that in XXX ask different that just there's of just Obviously, could to the has this first few you chemo be want in INT, chemo kind of the initiated -- trial think space I falling the trial combination. be that timing that notal or to you proceeding. cancer give was There's you're around preparation. the that X seeing combo well to paradigm works have just design? current post-chemo lung particular -- a direction you scientific belief then why about in context practical of we I kind that about that other IT some broadly for development trial Can scientific as the that? Kind expansion the to Is gating of signals? Phase it a capacity primarily manufacturing this areas. for program It II of as might the what's way. the -- cell more Or tumor plan? is that

questions. both Thank you for

of context, standard been move care. So first, -- cancer lung a really it's evolving cell the has in non-small there

and has of there number of So a KEYTRUDA. obviously from that result as response, neoadjuvant a patients a their chemo a checkpoints have tumor use there of of a KEYTRUDA And clearance into are been adjuvant towards plus that specifically. neoadjuvant pathologic that move complete just

good do we a have to confirm had benefit response also for to potential lot of care, that they clearance And benefit have expecting path a complete those on of so want you that steward a the there's recognizing that because tumor. substantial IMT move towards a patients. Obviously, wouldn't those be their of fortunately, very

to use have of can we the point, in further treatment of study we complete And the so go on see treatment space had approximately of cancer see where them with you and to is response. group randomized lung in care view that's the that whether top see potential of about really is a add And IMT KEYTRUDA adjuvant think get to the that We half, patients that I would that KEYTRUDA. driver pathologic structure KEYTRUDA. the towards standard there neoadjuvant of at then obviously XXX. not And expect can enroll allow of moving

we in INT the the more may applications, other the We start of -- not treatment to to choose neoadjuvant there benefit setting. be and emerge, broadly, just in neoadjuvant where thinking go adjuvant setting, study

we can the we our a with places indications, at Merck, think the that other offer is that as short far all look to version partner, IoT As systematically continue benefit.

We There aren't coming. done yet. more studies are

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simply -- in overall We that we execute ourselves we will ability that the coming pace will program. scale to and but yet year start haven't new just of ones and manufacturing announced. both the the for

Deutsche with Our last question comes Smithers Bank. from Manuel

[indiscernible] question. of On Emmanuel. One behalf

or latest how if a do to quickly expect recent would lawsuit. be the update approved, on to expected flu in mid-term market the already that what's COVID? GSK's particular, And and happen XXXX And So more transition to you perspectives you have combination of cover in thing? secondly, the litigation,

question the take I'll first timing. on

given if hope it towards terms words in ultimately, of XXXX hospitalizations that would of public would event. and a We health perspective that will thousands because of prevention also that really hundreds in the timing huge a working to reason, happen other and perspective, in approval, potential the quarter year we submission launch So are in current dependent of contracting wouldn't that be benefit of happen. on half. in timing first our recommendation. flu approval, the a do in first upon COVID That's purely see deliver the From the or XXXX and flu we and COVID, early not flu believe for States, effective United the improve compliance markets. that obviously, time that in because happening of States, vaccine. process that review majority processes upon contingent it's as TeleHealth is is vaccines sort And the the different and United expect a of contracting highly regulatory will with then we the But we we again, recommendation well it of as XXXX can the be timing the of majority depends ultimate upon

product in viruses Over are is the flu seasonally that respiratory covid us believers markets we in of play protecting combination way the the for risk we in. a at term, to all right those which be long high

view, the of on quite long-term a are combo the And so very process. we opportunity bullish from

and on would We market on claims. not that formation defend will are We of case. the prepared from presenting to during look to uncommon not know new lawsuits GSK forward around we at We comment schedule. are merits fresh these case technology ourselves . our trial

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

We you talking great to forward of weeks. today. next day thank for joining in look the many . a to Well, you day. Have us

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

You day. now wonderful have and disconnect, may a