Moderna (MRNA) 2 May 242024 Q1 Earnings call transcript

Good day, and thank you for standing by. Welcome to Moderna's First Quarter 2024 Conference Call. [Operator Instructions] Please be advised, this conference 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 First 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 Stephen issued slides You Hoge, 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 Stéphane and as Financial release Executive

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

or Thank milestones. our programs, financial review will will good Jayme sharing I present of then Thanks, a commercial by Lavina. our and XXXX late-stage ill priorities review afternoon, our our with close joining Good you us results. upcoming I start everyone. and morning business. will today. major clinical for Stephen

to Our many I'm hundreds we've potential COVID that more vaccine progress of has people. already people. by impact excited pipeline the impacted has the millions of made our with

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contract we Brazil to providing am royalty Health project look the pleased works a in Brazil. the further people we the for recently environment, doses forward they to very of and to I of program to million financing $XXX go very COVID-XX Second, winter a funding program. broad to announced these to that partnership as in as into in it their Blackstone flu our develop to protect announced season. We up million with is this provide first time with Ministry Moderna X.X vaccine

to also our our and public transformative made a as and efficiency OpenAI AI with to across business. patient tool increase We collaboration outcomes improve use to ultimately speed

aim the our Metagenomi collaboration granted investment best proof collaboration. terminate drive rights gene to with point to is to All our to good opportunities Metagenomi. agreed our of for a prioritize returns. we Finally, be editing under This will continually returned Moderna's

cost communicated cash November our $XX.X seasonal nature Jamey. our financial plus billion we to will elaborate of In reflecting operating of what were Jamey XXXX with team during cost a I pleased XXXX. SG&A on down QX our financial respiratory Turning his will expenses almost on of $XXX achieved with in call, hand was were QX at our The million quarter to QX plus R&D $XXX versus plans the focus net cost discipline. results. in over growth investments. We expenses and manufacturing the business. vaccine this We with has am highly ahead section. With expenses, of now ended expenses $X.X of I million, of our that, billion. revenues,

financial through Stéphane, Thanks, I provide will walk Today, on everyone. hello, and the our financial and commentary first you performance for our quarter XXXX framework.

quarter lower our our transition $XXX the United sales vaccine Let Slide seasonal it's on in year-over-year, COVID-XX pattern, decline with million, sales for the regions driven a of was This Latin first largely we were me the driven XXXX. QX World, volumes anticipated start the from market sales vaccine that performance markets. and primarily in the States. QX were America commercial the U.S. mainly down product Rest XXXX, the deferred of in X. XX% whereas of COVID-XX Net of or outside doses with by delivered aligns by

first portion expect a include contract we XXXX. QX, million recently half For the sales a will about total in of $XXX QX $XXX in for of with announced Brazil. of approximately million our

Moving were explained. X. sales product Slide just to million, I as Net $XXX

cost the sales of in $XX sales, due year. of write-downs in $X the percentage million, $XX sales XX% out same costs. This of XX% and product primarily level million to of up For quarter. included unutilized third-party was inventory sales increase last quarter our from of in million, million The $XX cost the manufacturing XXXX, wind cost representing resulted sales and of which in capacity lowest first related the to royalties was of our quarter net of

We the continue full to cost of to be of XX% year expect approximately sales. sales product

percentage we expect of half. seasonality to in due However, strong a higher business, the first the our

decrease efforts. related X% with payments payments R&D was collaboration of The R&D due of our $X.X Therapeutics. This this QX reduction of made primarily first upfront Life strategic made a quarter expenses XXXX Generation quarter. the Bio to the Edit were absence reflecting were billion, year-over-year. to being in collaborations our to and upfront Moving

were $X.X towards spend are year $XXX marking approximately year-over-year. full the million, billion, decrease With a we XX% expenses the tracking QX of spend of SG&A QX $X.X expected billion.

to tax decrease investments, will cost strategic on driving driven a period and expense the to $X.XX assets, per million strong first first tax deferred last reported functions our in for year. for of income additional to year. page. We diluted of of third of this of of of compared The the shift period I ended color all was continued the compared benefit activities. year-end Importantly, in was and majority per XXXX. Net our income last first $X.XX valuation the we same quarter established focus is the of operating $XXX in billion billion, and an quarter primarily which discipline was earnings net expenses in and $XX investments XXXX. XXXX $X.X to productivity. $XX.X largely of share attributable $XX.X million and loss income it an from We with the quarter application XXXX, allowance by share development research at Diluted million to $XX down billion loss on the tax SG&A, result the next cash on is compared provide due totaling

across to elaborate are Moving to now want seeing company. a efficiencies the on Slide XX. I moment to we the take

to foundational have we And over invested to company, platform model. technologies build to that build last we scale unique capabilities allow processes operating and a years, will the purposefully few opportunity have into us people, a the As efficiently.

function we increasing employees, of XXXX. over X,XXX XXXX from First, years. capabilities we the the launches X,XXX product scaled end up at Every enable ended nearly to the coming expect with

know, as you a with mindset. has Additionally, Moderna led digital-first always

we Over the teams. our X built-for-purpose our to years, past doubled applications software have nearly enable digitally

system. rebuilt live we As the went recently for ERP backbone digital new implemented operational with an activities. SAP our newly is our example, SX/Hana all

past, the and company. entirely efficiently. more in a an end-to-end it And we SAP and research however, business used revised for built have effectively have We our was supporting now implemented processes version, development-focused

is adoption of example rapid Another our intelligence. artificial

past companion of the space, built One we the over XXX year, and reviewing the across contracts example task GPTs. business. GPT Over summarizing contract streamlines have our legal in the

With enhancing bottlenecks contracts the of thus providing and value, salary. This guidance on to needed, GPT freeing making. efficiency function whenever focus minimizing to Moderna's on strategic legal insightful and higher and to up enables craft a operational tailored critical step-by-step work extract insights department decision any

procurement in having also of chance our processes. an more. questions helping areas procedures, good our big to example a In time. and read and query win policies Another all for GPT payment around for been on payables for and already employees and the for and saves teams easily Instead many numerous paid short productivity time answering GPT. questions. AI It has that in of is we allows find unprecedented a can purchase G&A impact to see they period our from of incredible general, procurement speed

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framework to which our XX, what line Slide in let's call last turn Now financial the on with in I February. XXXX on is earnings shared

net the billion, billion. as expected the point return are expect to $X.X be now expect first sales to think in of approximately we XXXX. Sales which will XXXX half of $X approximately in for low be continue growth a We to year we to

product of for We of full cost sales year. of XX% the approximately continue to expect sales

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

expenses billion be expenditures $X.X billion. continue to XXXX, to expect be For $X.X to SG&A, approximately XXXX we full in in $X.X XXXX billion approximately down expect be and from and capital taxes we in negligible to year

billion with the a we due of low approximately of touching Finally, XXXX collections. at seasonality end QX, point after in the expect to billion end approximately $X cash $X to of

me combination the In us regulatory arrangement, we are These influenza recently vaccines. development we applications. Subject data we in contingent and fulfill million deal depends which a the strengthen also to excited can payments and funding our funding be commercialization and project from to milestone commits that our up approval for flu net future touch Blackstone receive so Finally, $XXX with entitled upon into for providing are about. activities, up to with program, in specified milestone regulatory of the label let which targets funded remaining entered on announced sales cumulative will which States, achieving financing payments. Blackstone, $XXX on sales our million United to product our Blackstone to the March,

the at earn call royalties us sales will Stephen. to over R&D hand year a on our our accelerate excited offset into approximately enables $X.X I and we R&D framework will Blackstone This that, the factored low with that is the net Additionally, for percentage pipeline. And our to Overall, advancement are rate. of single-digit applicable billion. deal will expenses this funding of now

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are vaccination COVID vaccines higher uptake expect We available sooner. if

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from We to very a are market. differentiated product excited to profile strong bring a

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to through has respiratory vaccine out is Our to presentation ready presentation RSV pharmacy link chains during the the potential study on measured PFS PFS by Xx the vaccine PFS to The be the our we're and as independent ease the for presentation fall Xx the The the from forward to to slide. We straight Details looking can of personal believe use on box. time. pharmacies the preparation season. [indiscernible] burden the be found more study pharmacies from efficient launch.

me major pipeline Let upcoming with close milestones.

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This deliver our power the of impact Two the progress dedicated greatest possible of a And to mRNA and for achieving important milestone will confirm medicines. breadth your to mission to them date for data patients. service people our towards the all. continues Every represent its asModerna, in we save continued to are platform calendars.

and to our R&D X. Thank Chicago our X, we discuss New in Operator? program and York look in of will for forward annual COVID held morning September on the questions. Day be listening, will June We taking your you

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

with discuss Firstly, a RSV pursuing of for have vaccine the us contracts X could you've strategy understand how significant for your moving And given specific start, secondly, signals X pharmacy, points as us PFS then them? And approved that? you help data support formulation the the into understand, Maybe indications vaccine program. for sort large that the help timing-wise? retail regard with communicated head is to to INT new or

On RSV contract. the

the basis, the productivity. the discussions in of efficacy pharmacies. next the ongoing Stephen? are and to PFS not and allowed what of wait in on are on also retail as step, But are do So making daily including to actively networks know, terms terms the engaged pharmacies, that, because of is profile literally FDA and those the Those our approval. contract of are IV in the course, benefit the with PFS we until of is sure for course, is teams approved medical safety, you by we but product, hospital with And leadership regulators. doing, a the on can product we of data of

Yes, sure.

thanks for the So question.

on benefit INT think encouraging, has that improve II Phase on that specific have the additional believe known where Similar to driving so version indications, a short our cell still where opportunity results it we been by and melanoma there's with settings. an to INT. are adjuvant So all they is of response a T the KEYTRUDA I X

been an results setting. range positive see in where you aggressively indications saw we X announced that a adjuvant pursuing so we've where I, know, as in we metastatic And And from squarely we first of have these approved indications. space. since of all was IO melanoma, that II Phase is different opportunity. fits That looked we Phase and in as across the more But

question Our Jefferies. from Yee Michael comes next with

RSV, in some well to mix Two this they're the questions and On expecting I guidance. have about was GSK well. as how be in RSV as the know guess, you you ongoing. I competitor your contracting commenting is week

the I that how adjusted, just secondly, probability important discussion Can always ASCO. the I well. you maybe data had you how in perhaps this therapy much designation. think guidance on millions thought then feel Phase prime as confirmatory for comment an with breakthrough enrollment III you implies year? And is dollars. math progress, at have the you about and INT of adjusted on your and I on that's know How FDA. important or hundreds your or is some study? of I there like confidence know

that So before can how FDA? engage really important with is progress you

Yes. Thanks, the take for first the Maybe question. one. I'll Mike,

any another then COVID different of or a $X So the past, as and APAs U.S. any down X for RSV. with number market, walked billion into example across that as guided year the we did break may signed, we the APAs sales that good guidance you know, didn't we have specific category haven't just segments we as the around RSV. Brazil world, well In is of the rest the into the other

a from RSV for guidance specific no financial perspective. So

And your on INT. question

it's accelerated that think particular demonstrate we now, the right nailed really the and it, about a you think substantially and I as important in study. diligence confirmatory topic, enroll approval we

be that several really could think years. We be So have all it's fair, to with really agency mature, it that is yet. consulted on you're To for not we for important. the study waiting

said, we before do we've point, with As And own sight with at want we to until that, is obligation also as we're for is waiting forward that you're all crossed go the substantial threshold. question. to on essentially feel until waiting line manufacturing our readout the that this said, study we've demonstrating even that of confirmatory established that. But that enrollment we've our facility we

to available we'll that on of engaging and And are FDA the then, with will progress be short making great We both facility accelerated start in data, optimistic want the including of we're course, that the approval. question year, our order. and this

with comes Our from Flynn Morgan next Stanley. question Terence

parts two Maybe Great. for me.

perspective Just provide Or competitors? Can on you potential on the there's do be? for parity you Will recommendation latest get you the will what wondering your update regarding seasonal just on more the flu filing I in remarks, you your insight but steps your any ongoing just the terms ACIP likely then are a think your gating conversations what a vaccine? mentioned differential here. know most any RSV to recommendation a in here? And vaccine. recommendation of prepared

Thanks for questions. both

on of approval RSV, recommendation by day, saying end And have I so we first So FDA. with process caveat complete committee and to at really ACIP to then defer the to them. the the the the members, falls

again, that durability to a I'll data on review the that parity recommendation. on that. when Our is defer immunogenicity be second that populations, already members we to expectation, ACIP as on meeting decision. our we season, have data committee through to the certainly expect able across additional hope But package think as supports the the at well share the data we We other ultimate expect a they

with engaged now the the of On of flu, on the vaccine. submission are on we the for actively question -- flu right process regulators

our closing important has COVID mentioned flu vaccine, versus generally we ago, flu are As an with on clinical in that in role on And our from regulators, obviously COVID data flu combination. moment a also combination I engagement mRNA-XXXX.

soon. and say year, we [indiscernible] dependent file see data will that on other considerations to as be will to any update And said discussions won't upon also it I but we expect to today, we've flu continue except expect so number plus the say, it product those to we this of ongoing. a provide the we including are

Our comes from next Merle UBS. question with Eli

benefits you a study are those? how you CMV, both just then well or analysis And on clinical from second, boosting you disclose if of the as potentially the that? as And a there, don't would CMV, would need the meet if you perspective? interim, On about thinking commercial

first, the So boosting. of on question

the efficacy us Phase quite what be. will is we data study don't readout. production the a But -- that have III the durability what far, possible And of immunogenicity. to expect obviously data core it's ongoing. So could give signal efficacy substantial That's have the we have quite do on we

And that X It's have good, to so we they're to any don't, necessary will XX years years, years also then booster possibly let's at the be we multiyear, term time. X we right possible extend might in shorter continue is this not that that and long or boosting some decide years. We a as as say, track XX immunogenicity evidence just necessary. possible durable, that, now, know out It's protection. don't

so looks strong. data the of the durability at the on we do have And present, it quite immunogenicity,

And so we period do referenced. efficacy X-dose all you think that likely the time, subject long our for a of series very will be just data protective to

provide an we conduct on efficacy, making interim timing for to analysis and able do analysis analysis -- that update be interim of we've analysis, before, have and cases, the a -- an this year. Because interim of cases case or is final accrual of on for said to as by we So median first we're initial analysis a great may cross rate the at in efficacy progress for us we accruing final to least to expect study the the time a calls that because also also the protocol enough X-year imminent. are that be in follow-up, get sets or

time short away. a Let's of say, it's period very

of and of or analysis. At the interim haven't to uncertainty, will the to day, how that if be data we're way other, think the that updating, this get we we at the because end both of share I that on are commit don't close it have then can to we data don't to but we the final commit, yet. going can because will, we understand we course, we depend we one whether so until how see analysis, quickly stage upon expect final, that the really think final I and And data and news seen we, see

Our Singh comes Hartaj from next Oppenheimer. with question

of understand that on also and vaccine, vaccine just will believe. how about have refrigerator could And just kind you a refrigerator be I -- combo you're then that. I stable? developing stable approved? And When think I'd the flu vaccine get to Great. a question like

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question. So Hartaj, thank for you the

restate stable being are was all and quickly refrigerator combo portfolio, respiratory saying. developed PFS. -- flu, The COVID flu of to Just towards what our the RSV, I COVID

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Wang question from next with comes Barclays. Our Gena

have One regarding two. is I COVID.

today's EU, said the you EU? per in year million up for pandemic the Is And doses the should to So for doses you scenario path. accelerated get discussion, prior the fully to the of on $XX of at doses accelerated every EU. this EU, components XX all our achieve could is also on What the million could board end year. benchmark? Quickly key is Merck Based in approval on, R&D, comments the and the in in use to $XX melanoma? price be and you approval Brazil by say, can also the XX price impression X we submit

then talk Stéphane. It's will INT. I'll Stephen question COVID take about the and Gena.

a million up to doses, number countries of through is tender will the that EU. on the So the depend to apply tender XX

all so the we'll that's And there the is and really not at just competitive INT? all the a obviously obvious it's files process process. price share as of to know any the know end we're entering no dialogue, reasons, market this, ongoing. So and we're data, very competitors it. And -- right to away. because on team will going price the for in The price, on is active Stephen, tender

Yes.

on clock question but going we is X-part So the to enrollment manufacturing have readiness, guided this. as progress, parts specifically we well third the and made around as work where Merck expect sustain of we've to obviously, second haven't progress. On that imagine, great on criteria. of can we to being you the your when as That complete, is our

to think direct you'll to have I them. it

regulators ancillary we speak and Our point wouldn't contingencies, obviously, that pathway the available view to and to And they want get is doses work then is the ultimately, why from that us. to of help can't people do we our to our product we're now. But that, ourselves is year. we to suffering have imagine the approval and and to are, decide make supportive to whether where Merck if able cancer are right this available get there appropriate to regulators, have to

to and And regulators ultimately defer on I both to Merck, our so want choice. for we think that partner ourselves

next Our Issi comes Capital. from Luca RBC with question

one Maybe on RSV. a quick very

last think May I the press release cited as date. PDUFA XX actually the

half 'XX. simply approvals While first the regulatory today, in the you're of saying initial

or rule particle. May to actually anything the is just a it? So you to out, then on still IP, you the date PDUFA you're the second, to on there [indiscernible] confirm that of is can recent comment obviously, by XX, read which Judge Can next on Goldberg looking week? And is just end decision maybe

understanding, material on can prior pretty impact Our this sales future and both COVID. of have

Stephen, that holding much quickly any thought again, metastatic was cancer what's INT. thoughts data on see impressive. pretty to trial randomized back they into then you on the the So starting I appreciated. And intended there, static? super

So any appreciated. there, thoughts much

from question. I'll the take Perfect this very quickly. Great. third first

there's So continue that. of on date, the the to we PDUFA towards no and function change working RSV, same

agency. lot know, and a As the and around work there's obviously, work you ourselves, clock folks at by of the

little at longer, of but no to meeting, the the as is end And there's it report. [indiscernible] that, for that day, so but bit been we're really hopeful planned, a change the what matters if happens takes duty

anything into read don't that. So

the enthusiastic that far the appreciate we also about INT data. because are neck, question, obviously question head As I on as and

partner, that we Merck where yet ourselves, in have and and pursuing. we're opportunities priority of However, indications, not our fits decided the pathologies other

in up we're As you've year, of stood to the study. ourselves. past very number just large trying a pace And already we've seen

steps us And are update bit we an and so have the neck. next head determine Merck, it point, on. not take to little do And our this will partner, a in time at what of with

take vaccine our technology, you system research independent the of development. mean IP nanoparticle as I'll lipid know, is the I including and And questions. result delivery COVID-XX our

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next case after confident year. in position, our forward are We we and presenting to our look

question Fye next Jessica JPMorgan. with Our comes from

I had a few here.

you coming the put complete scale-up you a number to timeline if I So combo X-phase might regulatory right on bit flu. today, status scale the stand data even XXXX. update And XXXX process, thought of as play to products you can't to to on refine that how get one a get you'll this these own. previously when manufacturing patients talks you XXXX you where I comment data the on will can could just you with now take that approval. But for on of there? Next not once said expect on you you know the a to support maybe be their available? the you when little you Can elaborate don't provide And well you immunogenicity up. INT, can stand XXXX where approved a in when the is back that as mentioned role want need capacity on and end you get

wondering XXXX vaccinating commercial seropositive factor the risk can pregnancy compares kind pursuing you for lastly, on how me seronegative seronegative now thinking versus So in CMV, might weigh and CMV how XXXX. And why people. a strategy from individuals. remind the standpoint, you of I'm of just versus of then in everyone

around on [indiscernible]. can add question start with I'll Great. INT then Stephen manufacturing, the

benefiting now II We course, Phase the of [indiscernible] we numbers people not our market. of Marlborough. data. the size the have And can as in So from capacity stronger we provided factory some you we of But assume, data. melanoma know

care of know, as for we because, lot studies. as his plant colleagues But his a the running the you sized accordingly, building we've can you So and team are Stephen are plant also, and imagine.

So information individual this is every a Again, being. product use in not don't human we plant terms an design care cancer organ because a manufacturing standpoint, which is of [indiscernible] to INT. we for genetic for platform in a from

was don't building get plant we finished, building. Obviously, that a last year build us permitting bought have the saves we and basically, to the time So to kind big of -- market. is a

ago, team to the the has year actively on is building is been plant in the so since now the get a working And that more building. than ready. And modules the inside plant then,

module of and manufacturing maybe of we're So launch day for opening And we an then one basically, a -- do going to capacity. facility the with first like we [indiscernible]. did

another see for has been very the behind, the there's all quick set and space system utility entire HVAC a up plant. has empty also You left will ramp-up that system because which

add modules so you And go. you just as then

we'll again, of quickly be available. But scale able as cases. to get So of the we very more we're aware number indication melanoma

products can And be sure Stephen? so to sized make the provide plant patients. will so we we

the for clarifying flu. you Thank on question

the the are let program just that COVID combo start both and saying flu to me program. So looking we independently, by submit flu

and So we need see when we'll on XXXX Obviously, and announce timing data, we to that that's imminent. that it's XXXX. XXXX of the have it. The the data, question

in sequence. if so And obviously, some interdependency, we sequencing The There's more point geographies, share the will. on about some just to submissions you I places them able be and quarter, and expect suppose, is you stack of in coming same can't logical update. to a day regulatory that about the those

across our filed major point, the the regulatory make first we once strategy assess markets, of data the is if go we hard as this for preparation delivery as that submissions XXXX second. determine sure can do in our trying is of at one to But or want to will year. we to data and we're our this all well see what both And products data which

And forward. for we that are move as go on so But now, proceeding we'll we without more independently.

confusion Sorry the model. for

and On the of CMV question seropositivity.

highest you So seronegative. well. does in majority happen it's to But the -- as pregnancy the it. a transmission for well, important risk raising It to Thank vertical CMV of is really in point. while seropositives of the fetus

CMV seen reactivation in context. in congenital in reinfection, or a disease that's is seropositive sometimes -- even particularly So the

in we a do even vaccine believe for for benefit that so And potential a there's population. seropositive

study against evaluating enriched the transmission size, to are are of more and because are primary prevent therefore and in looking. the obviously, now right is study on rate potential the focused that We seronegatives. But seronegative the we infection

the safety ]. Sheng And [ we from seropositives. have perspective like things a We looking vaccine are studied in at

the in a an of been analogy even virus, little a bit we've different seropositives that we draw [indiscernible] to to EVB we've correlate that you control can qualifiers. put really data out in to show rate the but If setting there able already

benefit, is the [indiscernible] the is is potential [indiscernible] that. Ultimately, studying with some CMV improvement, a -- into will seropositives to in life of and be some [indiscernible]. that all for data be that then some and totality seropositives goal is there the goal for reasons a infection together way going that and our data, pull the vaccine later opportunity, label not down and to optimism XX-year-olds. and which vertical And so see will we of transmission we're in believe the supportive have as would we rate that as the potential a be that And there obvious highly very plus, XX on large the population seropositive still with therefore, it we potentially primary when both though, the

Geoff Our next comes Meacham BofA. from question with

Geoff Hammond Meacham. This Alex for is

on III design? And any your strategy? you that editorial of zoster and then the updates on into today thinking in [ programs candidate, MMA And nature on the of terms vaccine receive the on comments advancing pivotal thoughts Phase So on we our color your is ] should second PA and safety? pivotal there question can your provide when can on is the trials, you are any provide current

describe Could the The first you Yes. program? which the zoster? of question about on part was

shingle. The zoster, the

Shingle zoster.

number a study obviously towards response forward [indiscernible]. -- an we've and going [indiscernible] finalize do include, generally, strategy. obviously, really today with T doses will was that was it, study. We a against pivotal one, very immunogenicity. do in by of till which our in find saw like the to we in And that a update before want on not obviously encouraging. We're own on not licensed that are addition [indiscernible] have expect that compared will excited PCV. the in data, study then we're the that thoughts the look pivotal strong of been on to across But in That the it we we're programs. have -- right So selection, that to for But process and our consult yet. on I in have in update cell product, very what Phase program, trying that we dose to moving We regulators how we we now

we relates it the profile, benefit data safety As clinical a show PA, have profile. good MMA that risk compelling to and continues to

a folks In And in over patient been in fact, our last on who've well overall experience. update year. over studies, think, for in those I the study from many drug have in we -- PA the dosing years, XX

on the starting profile. are perspective editorials on I view or clear opinions have a editorial on safety very the question, to based we don't get preclinical a The So data.

Phase behind today. data continue I clinical concerns ongoing think have encouraged that closely we but in we'll we and any studies, stand profile, data we have by watch do based I to the our not new the that specific are and or quite clinical on it

comes question Guggenheim Evan Wang next from Our with Securities.

me. for Two

it this data, I was so program, completed enrollment a XXXX combo believe quarter, the months on like First, ago. few sounds

on needed So And terms with comprehensive be regulatory of is then follow-up? some will terms international that longer-term one early in of nascent I parallels in decision And XXXX there. there is we reimbursement RSV, or established can more from seems there? in approval, terms impacted filing take speed are more but XXXX? first? And submission, how for second, of the then by with the kind of vault Or markets, top ahead that update it for line buying of that's other some it's the guess

how about thinking you positioning So I internationally? guess are

Great.

fall. and XXXX -- second-generation So yes, data, the the you say for XXXX know I this majority of study. quarter, And we're we studies enrolled the on would last XXXX that the

study. about So we the talked PXXX

know, before study same against [indiscernible], you that few of part fall. enrolled months and study. And of head-to-head that a it, XXXX over the the a part actually second part The summer, combo C, just first as looking was the as last enrolled there the time last B

And so kind of other. right on they've of been tracking top each actually

get COVID we've the we product positive to we're it we because the that that towards want flu and obviously, wouldn't provide see we're while, draw as But for on we the B filed, think was going many, can to too a study, timing. reading in that will guidance you RSV make -- wait data structures possible. I been on between if is the too combination before A to between as do part study, out draw I growth and quickly. fast working C, sure difference done a which question? which has the many PXXX and of want take and XXXX I [indiscernible] the submission to correlations and the [indiscernible]. Stéphane, study a very timing the of wouldn't the for

Sure.

super internal obviously, very important, also Russia with and U.S. So the important. markets, important, very the U.S. is

As we major geographies all we shared before, already. found in the

countries health U.S. Of course, some Asia, in like some it EU, known by in U.K., Canada, in leaders the is East. RSV Australia, public well countries the Middle is

here strong doing even protect elderly as and of of that interest in So to across developing or desire, at developed true a population very the we COVID terms you standard [indiscernible] probably world. very what the more countries, But least there's are that's becoming I everywhere. kind a more aging there's think see that in RSV, again,

we soon it's not U.S. geographies would approved have that is approval only start so. expect coming that several the we being So

comes with from question Redburn next Our Simon Baker Atlantic.

Two may. quick ones, if I

the terms in the interim on Just of timing data. CMV

about just I sclerosis. me utility talked early you this quarter, wondered later potential EBV Previous than there there? And the and as question the the a then quarters, the as said. delay could on 'XX. the that's in is it is be end vaccine You slight we of semantics HSV the vaccine. said second multiple sounds slightly That whether or over-interpreting previously if

just So HSV Alzheimer's and were thoughts it's about wondered it's what the disease? in I your role that implicates hypothesis

change CMV readout first There's the So on clarification. on expectations when happen. our no to will the

it expect careful think saying to year. be tried previously in I we to that this we happen

say at by same And no but change thing, so our there's this point. of this end the the to expectations in year, it meant obviously, is

questions -- point, move to of hypothesis, mutations, for with different there's infection seropositive go studies outcomes. very will this a across interesting HSV improve the that herpes forward a to Alzheimer's range HSV be neuroinflammatory them. At virus that of with of the lot the expect we On simplex a it's Alzheimer's one

eventually, So want of shedding or might go then obviously days, a consider think to will be to indication. for some based, supply. is we more standard relevant of lesion we whether instance, want of or them, you That which about different different prevention neuroinflammatory and long-term for how infection, at the

for vaccine potential like it's is there's think firmed there's the start an in perspective I hope it. that I high vaccine opinion there. do think potential my connection opportunity over a sclerosis, for where of incredibly us intervene from multiple terms the EBV in to has it's and conviction science impact drawing reasonably asked our to there and time, up -- early a exciting. you I the I interesting think that. Obviously, on that with things to benefit for point

We this and But point, have HSV at days, to prove it's Alzheimer's. that. still go with think, earlier I

Our Edward next question from Tenthoff comes with Piper Sandler.

plan answered. on questions wanted And the I program the actual respect that able out on profit break cause Actually, ask ultimately you R&D guys for Congrats everything. share my efforts, most But many to still pursuing? what how cancer a with to some of with Merck? is do that's been and indications you to cost have are

I'll Maybe the first one, take Ed.

are point, disclose. prepared obviously we So spending, [indiscernible] not what we know this we're but that to at

not but this at time. someday, maybe So

then expansion... Understood. -- And with the

Yes.

Merck then partnership been forward out. indication. review building bring has once expansion Look, We've really our started been the those this them. with strategically decision, We like joint and them On strong. we've do to the at

ahead And Merck. get those with want competition not our because so are strategic done yet. private don't But I of are that to we

ahead. adding keep in the will We years

Very exciting. Look forward to seeing you Chicago. in

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

session. everybody, thank latest seeing at for for joining ASCO. in a today We you look you, Have a to forward great day. Well, great

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

wonderful and now day. You may have disconnect, a