Moderna (MRNA) 3 Aug 222022 Q2 Earnings call transcript

Good morning. My name is Kevin, and I will be your operator. Welcome to Moderna’s Second Quarter 2022 Earnings Call. At this time, all participants are in a listen-only mode.

Following the formal remarks, we will open the call up for questions. advised call be being Please Instructions] that is this recorded. [Operator turn time, Investor over I’d this the Relations like Moderna. of At Head to call Talukdar, to at Lavina proceed. Please

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

today’s we Bancel, release section by Chief reviewing going our Commercial Chief Officer. the Investors the Arpa You morning, and David Chief well be can press Meline, access Garay, Stephane as Medical Chief Hoge, Financial will as our call website. Executive Officer; Officer; On of our Officer; this Burton, our our issued the are slides that our Paul President; to Stephen

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

Stephen, afternoon, continued We of everyone. real world heading. to and evidence In you, Good income come billion. Arpa where or are start review thoughts, you some new to to quarter, business of clinical some walks will will for billion present then, morning, we our growth, Thank about call. David will review, financials and take through back $X.X strong our data we QX reported will and quick Lavina. you net Spikevax commercial XXXX performance. Today, a dynamics Welcome we $X.X good programs. revenue financial conference with the will just I before and Paul on

to contract, net cost quarter, David of X driven by The driven sales the COVAX We the income sales. strong our mostly higher including in four financials, increase our that the decreasing pleased QX rate XXXX. the are the R&D future, in with Phase tax a is in fund investment will and QX cover by higher programs in

$X For reduced QX. $XX first our yesterday, in around start XXXX in count the Since share by share repurchase we our shares have of repurchase our million share million we program program, through shares. repurchased

Directors momentum new We continue in that in expected today the additional announced for share billion. event the of balance also of sheet, $XX signed agreements program approximately commercial approved purchase XXXX for billion. buyback to and have we amount has Based on delivery an our Board our our $X

pleased pipeline that me and on advancing last review of increasing breadth the Let Moderna review. the our the progress and I product now the team has am with pipeline. the since across the business launches made update pipeline important

recently X million doses. already side, U.S. to initial million commercial new against additional since a contract and for bivalent options option with an additional doses Government include potentially signed doses XXX Omicron. the the bringing announced. XX vaccine the XXX agreement On also sales million The agreement for total signed U.S. Government up the The we for was has purchase exercised million an doses, an booster

XXXX current doses for XX is contracted the U.S. of total So actually the Government. million fall the with

in for both had for their Canada current options exercised deliveries the XXXX. U.K. addition, In agreements and additional

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both our to five months years old. for authorized Australia use vaccine As six of Canada and the children’s

pipeline. clinical momentum the continue Our team our in research and

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hand in forward XXXX, billion in foundation, X/X balance Paul. it four and program for XX our the strong on Slide Phase very of acidemia with Moderna track we pleased development X has therapeutics. subsidiaries our across two or propionic of this with programs. proof-of-concept we PA personalized year August the six programs is versus with $XX of of vaccine and vaccine teams to KEYTRUDA Finally, sharing Phase company in data growing, combination are to our X,XXX monotherapy. to will strong KEYTRUDA The have to cancer studies I around now sheet rare pipeline be disease breadth our to over commercial and showing our for therapeutic growth. the and fuel data with snapshot XX our cash look The usual

Thank everyone. Stephane, and good you, day,

As keeps and boosted significant show to is the next booster the real in mind boosted to setting performing you want how what boosted boosting, performing setting levels subject COVID-XX few to of In individuals is Moderna undergoing for vaccines. how and vaccine mRNA are the clinically many pandemic change, with continues with. get mRNA-XXXX and primed the top in antibody get world when and the slides, the I in evolutionary people SARS-CoV-X virus the

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Stephen antibody Moderna to variance So against well by could the as a explained will full the now of performance call taken composition a clinical provide the vaccines, COVID-XX be strong Hoge boosting levels demonstrate over together, which Stephen? real enduring higher these comments data other of updates. variety vaccine booster world wide of in regarding Dr. concern. setting, I turn of to pipeline the the as

Omicron the Thank will review around afternoon, fall Good handing containing Arpa. for Paul. updates morning, of it the upcoming pipeline the you, everyone. good season rest or and COVID review booster of quickly to before recent some then our our I

different vaccine. We previously BA.X BA.X our Clinical to fall demands, the candidates neutralizing study the X/X titers increased currently from mRNA-XXXX.XXX data significantly bivalent of authorized compared is against to presented winter for that are XXXX season Omicron XXX to bivalent containing showed booster. advancing our meet Phase market BA.X,

application regulatory XXX Canada, for Australia, authorization and have submitted for U.K., in Switzerland. discussions, the EU, we Following

rolling vaccine based trials including data platform as boosters. bivalent of has our Phase initiate X/X in containing We will of continues an Japan. have against has also BA.X on evolve. is to to asked for started based as mRNA-XXXX.XXX the concern XXX a useful the with also with advised our that demonstrated bivalent pandemic XXX from data and the on Omicron combines XXX and submission studies variance manufacturers strength FDA these our serve us clinical submit BA.X, authorization subvariant The bivalent XXX, candidate FDA vaccine for to mRNA-XXXX. original our

We in start August. trials expect to these

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study. Our their next-generation mRNA-XXXX had antigens, in HA and enrollment NA mRNA-XXXX, mRNA’s across and which eight completed flu vaccines, X.X also Phase

X in a Phase adults pediatrics. older X Our Phase RSV program including is a in and ongoing

started when forward study quarter. Importantly, look we it. the X-X plus enrollment We and sharing concluded flu that of to we have our also vaccine Phase for this COVID data

enter also the Our combination vaccine this to COVID flu year. expects RSV clinic

our Phase combination enrolled. and in preclinical endemic, is hMPV is now fully along the pediatric pediatric human with vaccine hMPV PIVX plus vaccine Our RSV Coronavirus plus Xb vaccine

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of that close finally our And -- VVV Stephane in in vaccines an trial pipeline study proof-of-concept And our partnership dose we slide the highlight vaccine, our NPA cancer mentioned updates is which were our are being studies to programs the participants Nipah therapeutics happy first, patient IND conducted already in Phase on PCV slide, to HSV expect in open XX, year. preclinical. NIH. other Phase checkpoint we X our important we and and from Our with dosed this vaccine. on our on first to first data in our GSDXa our for our this A few later

after the and the steps that a evaluating for Second, AstraZeneca they asset. that us currently returning are we portfolio are next notified review VEGF program

I autoimmune will the further to discontinue to that, moving evolving we development Finally, early of from for of disease based program on our have were hand competitive clinical data decided our IL-X our we review and over a and it pipeline. program from Arpa. landscape, With

Thank you, everyone. Good morning good and afternoon to Stephen.

the the our member as Moderna run, opportunities newest in well am the future Executive I mRNA in have well impact as the leveraging in as us As therapeutics of commercial see ahead vaccines as COVID, for COVID, that Committee, we technology. and had long to excited

years second In five where -- and quarter we regional primary will with EMEA authorization $X.X $X.X end series slide half Government you vast for to of the we as the In quarter, the sales were to Sales group this to see also billion. quarter the first the delivered for order in sales to and XX, $X.X booster in States continue sales quarter. through U.S. our United came now billion quarter, were the XXXX fulfill first of American in Asia-Pacific of the and now younger were this the pediatric the as year. delivered mix North These group through Turning this driven the by deliveries to second sales were majority billion. XXXX.

organization. how we is and the six our built billion see three As EMEA the and were North both these $X within to billion. across region quickly Of key sales $X.X diversification out sales quarters reflection a periods, were two months This of global the geographic diversification $X.X to across billion, of Asia-Pacific for and saw executed we you month can regions. American commercial note, sales of sales year, first were

market turning as are booster continue we to a to Spikevax’s Now booster we fourth and to that substantial share. third see show XX, market also happy the scale continues market slide globally defined to or around that world share the as

XX, As Government for of slide on contracts the Stephane our we mentioned, XXXX. new has see fall U.S. already

the doses total us pediatric million for XXXX. booster of agreement the brings million the This for Earlier in XX Specifically, $X.X initially week, doses COVID was to contract delivered approximately age group. an bivalent that U.S. exercised option this billion. the Government our value they X for be informed to

million XXX purchase order XXX exercised. bringing Government doses are U.S. to total all Our includes the options additional if million to doses, options an

anticipated from Omicron product which outlook. to heard FDA and I As some to the XXXX mRNA-XXXX.XXX, the guidance, of BA.X/X population in given be impact pandemic, including pandemic emphasize and you shift same the and we after booster resulting shared a setting result the commercial consists evolution Stephane want time subvariant. to factors the time factors the on U.S. fall evolution, will in several would earlier, spend Early immunity of and commercial outlook. and have trends any the the at on the before. the the this illustrative graph virus will continue These seasonal we have endemic

able which develop the been dominance emergence and variants, Omicron variant. variance multiple includes then against boosters address have the our at With time we to booster these different bivalent of to points,

bivalent where quarter, COVID year obtain anticipation commercial for boosters shift in organization market will well purchaser as payers this key to with than to the XXXX already and to or around we booster sole during of may in be well XXXX are BA.X based where David. be XXXX, globally. fall building invested different weighted these we authorities has market commercial as needs. will for in pandemic are health to will fourth All channel, distributors, in more manufacturing We the contain bivalent market currently prepared but there commercial a commercial was I fragmented remain all, purchasers public over we markets where more Internationally, Deliveries as for heavily well. turn transition candidates shift. advancing with close, vaccines, start Both of And channel Omicron to U.S. U.S. commercial it private engaged have are the we currently in and advancing the authorizations the are for we as world. of U.S. and micrograms the for market subvariant vaccines. of that, be mRNA-XXXX.XXX. either and to September two are also in ramp the XX two With identifying the we XX the the are the mRNA-XXXX.XXX look booster we an authorized regulatory the and boosters, booster micrograms on of The will BA.X/X. the Government our it as positioned both candidates a and a pharmacies infrastructure the The of key expect we of both as

of results operational am Okay. providing Arpa. of analysis and you, second of a with Overall, to XXXX Thank Today with drivers performance. progress forward. are our and performance very continue going quarter we along the well I financial we view actual commercial key pleased

for by XXXX increase million Advanced as $XXX and by bivalent XXXX, administrative to outside customers, of The increased commercialization the impacting and expanding The quarter XX% product our were year an primarily the driven XX% for external vaccine of The of This billion, changing in of in second as on prior Total overview by of ago XX% for in clinical and charge quarter. $XXX write million to of of financial compared vaccines. QX driven with Selling, well last XX% million million of for the programs, inventory growth growth to R&D by million or performance in now expenses XXXX the obsolete the Total sales customer personnel tax Cost of ago compared build-out. sales were compared for sale development quarter for million or in reduction million our COVAX deliveries billion Turning continued product period. of billion $XXX our $X.X revenue to last of $XXX charges $XXX the substantial second of a a sales and sales $XX total compared to same Union costs be was Purchase company XX, maturing slide higher average of increased globally upcoming commitments in deliveries lesser trial same X% of quarter with launch loss XXXX or was for of X% product expenses our compared $X.X compared starting in period spending light products, the due quarter increase Agreements the our Research an includes call $XXX unutilized million. the of vaccine. vaccine rate was quarter personnel COVID-XX as continues variable our was COVID-XX development of with of and and for million by sales purchase expenses, for driven the period to of downs XXXX, extent expected XX%, of related our the These portfolio. to second particularly the our by in manufacturing for capacity support to driven of deferral price sales COVID-XX the services of the period. to investments year, in and of the to the or second RSV by and XXXX. general accelerated in potential second an to was by and our $X.X XXXX. are to $XXX as expected a XXXX, to year The $XXX updated of second European the spend effective firm particularly COVID-XX increase driven mix. indicated XXXX quarter other to increased second excess related in COVID-XX expense a of period. product by

decrease same higher a $X.XX same in reported billion of primarily last Diluted period compared the to operating XXXX, a end in carry-forward The XXXX non-recurring EPS operating we is in Let the in due million XXXX. XX%, expenses benefit at to or to to loss a cost XX% tax QX rate which other by XXXX. period the of $X.X year. of QX share, and by the billion to me the net decreased remind net $X.XX XXXX that in income the you compared After-tax had current the was resulted or decreased in sales $X.X period. $XXX fact which of

$XXX billion sales XX% XXXX outside first to of for product pre-launch for was for XX% to sales now up or year in period of ramp extent six growth to purchase were mainly primarily the excess manufacturing was Total attributable in basis to growth higher XXXX prior compared of to The and write-downs sales development for by prior inventory The an the was favorable for in and XXXX. Total six external and including the product expanding resulting pre-launch in revenue $X.X driven lack months trial our commercialization increased future smaller This of six XX% and by sales for our product $X.X continues manufacturing services in the reported year. the related period benefit XX% the were of XXXX. the or costs, vaccine adjusted $X.X development quarter of or in by of COVID-XX XX% results the and compares the increased a spending year-to-date spend clinical company of in slide sales realized of was million $XXX expenses of inventory investments due to and globally extent general was billion the prior financial Cost the or $X.X of of to in related first compared and for maturing sales driven billion of a of to U.S. first in sales to cost of expenses increase prior on capacity year XXXX. and of unutilized The to XXXX. year by in million same $XXX mix increase to Research product XXXX months The R&D inventory, the mainly increase increased increase administrative months accelerated was that capacity, substantial increase on percent of compared were revenue and lesser to commitments the billion XXX% compared the was costs total digital. development vaccine obsolete a million Turning of year first the driven period. in our personnel boosters. compared billion expensed to period. XX. the by or of which the and months XXXX, ago to average the selling $XX.X billion, sales customer months a as support first portfolio, of be first outside The six build-out, six COVID-XX $XX.X in XXXX, COVID-XX including for price. Selling, total bivalent expenses expenses,

the EPS income the period increase was was Additionally, net The initial endowment on benefit increased net months for $X.X was $XX.XX Moderna the $X.X by XX% The in valuation to the the XXXX XX%, for six Diluted our same months $XX driven tax X% billion XXXX to in QX increased assets. of XXXX, the or tax newly by sales. in by to for primarily six to XXXX. to the in the deferred period of product million our XXXX. $X.XX effective there billion the in compared from established for period was to due same first foundation. growth the The After-tax XXXX. of first for allowance first same months income an of compared compared upfront rate release or XXXX majority six the of increase in recorded the XX%, the related

The balance reduction billion. against at product $X.X product to is was billion of $X.X by future $XX.X customer previous to cash of activities The deposits year. of quarter. cash billion, at cash $X.X Turning investments share this QX compared slide driven now ending on QX $XX.X quarter-over-quarter deposits and cash XX, with deposits. of billion, deliveries reflects supply in end decrease ended for of the end to the billion the the QX we and compared The XXXX repurchase of

turning allocation slide remain priorities our XX, to Now unchanged. capital

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

a stated, was half of $X the year full XX% spending R&D on with $X.X to track basis. on year-over-year XXXX, first forecast increase a previously As R&D of We $X.X remain in billion our billion.

further is to the priority investment technology external Moderna’s and second reach seek expand to capabilities. and investment opportunities of attractive Our collaboration

are attractive We opportunities outside that approach considering take complement platform and enable and potential investments. evaluating in our disciplined a

We multiple assess opportunities. for discussions XXXX, total. opportunities, external external repurchase evaluating inception additional we internal In until outstanding regarding are X for in active collaboration Since have additional of of $X.X Xnd, XX After our cash. approximately activities investment uses billion last then we we of shares and shares of diluted up and $X repurchased purchased the August million billion. second quarter of X% million or shares year our

reminder, a $X billion in As remaining February capacity $X authorization. currently a that for share year announced from and we of billion program this repurchase have approximately of

expiry. the Board today’s of buyback authorized an announced the $X with that share additional no part program, release, has we billion press As

our let’s Now framework to updated financial turn XX. XXXX on page

We includes ramp-up Advanced in unallocated Furthermore, X.X% products. COVID-XX of continue year the last anticipate for rates signed new agreement billion. which have and the we updated remain recently Government the current Agreements end. the the signing, exchange possibility remain approval This $XX at full of sales new lack contract anticipated includes second our that XXXX, and this in doses from will call. expected the sales in our for greater impacts negative by for total the assuming quarter this indicated fourth timing XXXX to sales to we COVAX be estimate of We adjustment third of foreign was of compared U.S to through due in an sales for driven XXXX a Purchase approximately demand expected vaccines that on half with value amount the be approximately the announced delivery by the manufacturing to the of related than of quarter, year expected

well third-party as the cost warehousing now related and other of further of royalties, due manufactured, the We mentioned includes event range and goods logistics driven sales to cost total mid-XX% be to full high the our to updates. customers. to cost Cost of in doses costs. Our cost by charges reported as year previously COVAX the the sales, XXXX expect sales to in XX% of of product a reduction doses to of of could deferral range increase

in continue expect billion, to portfolio full foreign and derived driven tax approximately SG&A, XXXX the deductions. scale and tax now R&D Based as to as up year business to be of the a by the the expenses intangible current our of driven laws, from our effective low- as maturing $X a we mid-teen to we stock-based range compensation by result benefits income company. rate For development international global on be mix, the expect well

our infrastructure to regarding the back continue remarks Stephane. Finally further performance and financial capital we concludes as company call general globally. billion over $X.X I concerning of capital expenditures, out the in to build we plan manufacturing for $X.X billion expenditures turn in my to the This range

set and David, on those Paul updates. you, for we Arpa, Stephen key priorities. five out Thank to XXXX, execute In

Purchase with us Agreements, on strong a half the target. and behind execute $XX for Advanced XXXX of deals on vaccine sign of year the team the First against of billion manufacturing to and we delivering are fall

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in half. on our track application of trial our PCV from data studies therapeutic second with are data two and to from technology PA We from proof-of-concept share

IND the new already And target half our mRNA of in Vertex, to continued of the our year. finally, disease. progress development some primary we with with to vaccines come have the inhaled second will expanded candidates make been and in We therapeutics, our platform recent partner announcement now have announced and

and grow, in stakeholders. patients right doing the we the committed for As are we right our to way things

am the thinking As I are year ambitious set ourselves. the pillars to what team, our goal pillar environments, in initially very is meet a those increments. our on to framework goals go report, first To versatility which governance. we of company, doing proud goals. them employees, our medicine create so solid those end, the our for highlights this ambitious in that the five-year, framework, first of we achieving to XX-year, culture for proud patients, key and we and corporate course, are to steps XX-year led set and be of by a ESG of and our foster this purpose-driven community, we I’d published

our planet in XXXX carbon amongst emissions net our leaders that of globally organization. and promoting by an on put goal example, global As a for long-term the our growth zero we sustainable

share more ESG promise governance at our September to at asking Xth. Day on mission forward science detail But of you in Day will on XXth. deliver first, We R&D mRNA on Annual ESG Moderna we look the to create very to our November inflation for been Northstar. generation the facing rates financial transformative Despite of position. our capital, medicines always in market challenges the and fortunate of interest with cost the and increase new consumer patients has a a Moderna is ensuing in the

We medicines. have and the speed of innovative of personnel enabling a unique amount generation platform

We X,XXX employees. mission-driven have team of a strong

cash on and billion sheet the momentum. strong balance with $XX the have We of commercial

of intention down growth. slowing no our have We

now waiting take time the future doing have are for to about putting I We would innovative you been work. slowdown, is as are of and for our medicines. Moderna, to be now the patients Thank and listening not the head Operator? excited down happy questions. we

first from comes Harrison Instructions] question Matthew with Morgan Our [Operator Stanley.

open. is line Your

in the little a just thinking question. Thanks hoping either bit for more collaborations. you was are about or acquisitions specificity morning. opportunities how you maybe taking for Stephane, address I could Good Great.

the people quite among the scope investors, I be I the comes might that complementary to things versus including think which on a topic a more that that think think, side a and technology a there at is lot lot things are platform. different large of up about

in how would So great? that about if Thank are you. your you address just could you thinking that priorities be

for Thanks Matthew. Sure. question, the

you So, as know, a over year positive in it we a for that’s capital flow cash allocation strategy, run our now situation.

stick the our to and invest one; number buyback. to course, share three, build Of company; the investment business; in two,

in R&D, this have as R&D As in with year last of I have have you done we over seen this said, David the we QX been totally think what investments aligned the increase year. investment versus in through strategy quarters, last terms QX XX% internal

buyback very announced seen plan last our today share have also we you year there. have As aggressive being third

collaborations. few see, a the you terms external we last have year in done As of in deals

And We do of expand deliver mission on think, point and interesting how a have this, there’s we filters value company company the make assets can price to not create think finding them the innovative for your at any at is, stage. I potential important this to its front, the that to as, on that external for. two see us we are we finding acquired We medicine.

great lot will things if shy look before the we won’t BD be our of today, looking asset we of for We decide that to looking. that assets. early. find go a see really There’s confirmed a bit lot keep We strategy, companies David and as we are it’s very are something. a but don’t asset a There’s company’s extremely said, lot know, investors have at of things. invest of teams in. a for looking we at same busy But lot you As to as the

be I probably acquisition think a not if acquisition want to What best company world. is nucleic doing -- to strategy. the large our do acid is we in like the the large

see the be have as long outside as would we them on to As to go space. said, nucleic we acid very happy

regarding to happy is will not we We good will find to and do acquisition partnerships itself. if assets, be we new acquisition happy

think how you. actually. the a outside So about that’s we Thank investment bit

One moment for next question.

next Goldman with Our Elizabeth comes question from Sachs. Webster

Your line is open.

upsides question to question. through are on second when could walk what for and this and is exactly in come levers of guys. authorization Congrats for for from our the the if you think Thank then clarify just the on new might Hey, to and here thank see where data Could path XXXX.XXX from month? starting the that taking And billion us mentioned, is, our This Elizabeth is online? had could we quarter for you Salveen. potential then you you and the to come orders APAs, those trials, additional you. $XX path

I the question. And the first one. the for will you second. for I Arpa take Thank assume

the and of the -- vaccine. think is variant. question to first FDA the particularly This that directed is mostly is based States United So on the on in most guidance bivalent BA.X, on focus XXX a authorization vaccine I is BA.X the

platform pull and concern. both together and different bivalent I preclinical two hard against both mRNA-XXXX.XXX, platform all variant bivalent of data, performance which work to underlying continue superiority our We referenced studies of data, and mRNA-XXXX.XXX which and of manufacturing Omicron X/X includes to demonstrated and the Phase the

run also So further sorts want understand the in December because that totality us of frequently to really performance an which we deployment there us samples guidance. data of unfortunately published submission, manufacturing to asked future to XXX that was inform data is allows about has of the vaccine. to those decisions with January referenced FDA was Phase year this to form that every of study X/X as pandemic you have additional instance for deployment, study support FDA happened want evolution and or we data if the will consistent has in do the variant is vaccine the

the a month be would approximately enroll to that suggested in August. this point asset. get available them do to the relevant test to required But FDA We that the and months, that them would prior expect not be study really few expect follow this you nor We samples, for a in data till authorization. boosted wouldn’t data at collect because

the on we clinical be will those hand. authorizing prior data we manufacturing and fact, in But data for data. that XXX have In based will XXX -- preclinical the samples

other to later the to the specific that decisions in the have other are the again share than when not we for XXX specific we that today, really required later it’s timing authorization part based guidance, recent deployment support except would future to in really data, as item winter. it of to able I Now emphasize the any of think is on FDA don’t fall, be

the guidance. to Agreement world health on perspective, to $XX I assess public the is expansions Purchase to said, can an with And potential being countries their take $XX many work Advanced question are potential populations. of in From believe continuing and bivalent those That population billion. we captured on the billion their second orders majority the booster our the continue as additional vaccines for around recommendations this countries needs, market as demand do considering as well we

work the or continue to good feeling are additional see to billion, is the XXX we for with XXX So vaccine. there countries $XX if and do pretty we but either bivalent when about demand

much. so Understood. Thanks

our One question. moment for next

Jefferies. Our next question with from Michael comes Yee

Your line open is

Hey. the route? or do along where you the path emergency, first that and that Thank that made variant going WHO in there, ironically now morning. question be little Thanks see that Good A question, and then the global quick pathway would the and there the able second comments FDA BA.X/X, you that And authorized. made comments question. any vaccines but didn’t for to around the the comment flu you any you is going questions think such that’s to seems monkeypox That’s around if had vaccine relates you. the do bit forward, a for mentioned update to data, getting has had wondering be and authorized development as to envision had actually made want and just Stephen on XXX be health actually future thanks via think quickly updates. preclinical I like progress? just

try I both. Sure. Thank take questions, to you will Michael. for the

boosters. FDA markets the you do for have the the sense FDA does So, that. approach, with supplements, the first strain other of COVID updates the right, that model sense future in the every believe that strain And make we are authorization follow of of vaccines flu that first think, for in -- authorization year and I the really instance XXX will on becomes if and

We full in us file respond working try future. to together are clinical that the But regulators, we platform U.S., have makes that globally sense framework. establish supplemental but it to end in to BLA the don’t pulling for of the at conduct not that going instantiating actively we with of because pathway, and just are before year, day, and advantage still to every authorization take in for the studies order that

that think that now to the also require to the an study We of flu mature demonstrate really for billions people us start performance a doesn’t endemic every to more globally platform of the model time. of the in approach potential does and clinical

fall the regulators norm. we instance that with like prepare XXXX, as might engage those is that just So for I obviously in expectation becomes first our just over winter hope again, it this be XXX think, experienced that what really and fall and new will And there’s, filings and complete that. might look trying the

research a initiate did we monkeypox, program. on Now

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it. Thank you, guys. Got

moment One next for question. our

Barclays. Our next question comes from with Gena Wang

open. line Your is

Sheldon for Hi. for quarter. on and question This Thanks Gena. taking good our on the is congrats

for in Could also We $XX how on is current still questions. on contracts us for current APA how billion remind unallocated on have One they for two current could you the for guidance many comment doses the accounted were COVAX and XXXX. the and next the follow-up, APA are you Yeah. in timeline you need do the think should and the vaccine, X Hemisphere? the XXXX trial, Northern also flu year? data the do think quick And another or immunogenicity demand we expected about enroll how about Thanks. question mRNA-XXXX on a how to you Phase

want question take and first do the or last you will I -- to take. Maybe

I will…

take will obvious for I sure.

$XX just billion Let any Purchase so in additional reiterate, me Advanced to does allocated. doses be COVAX the not include -- to Agreements

we the from that the from will we and few we So of demands already are the COVAX anticipate additional year see these that a remainder for very that seeing reflects countries countries. orders lower and demand

that we Canada, Kingdom, terms XXXX with In United Australia, already Kuwait Taiwan. we have signed of deals previously countries announced; and have the orders, five

having are countries And we as around with also options with additional We signed have for Switzerland, in dialog world actively orders Canada, XXXX. Taiwan well. the

these guidance look to year able early next on or be later like provide will We purchase what advanced this additional orders year.

Great. And that’s of then flu study the ongoing. on X Phase the question

study. So is that and safety immunogenicity Southern a Hemisphere

not we are -- to need characterize Hemisphere. ongoing, that do we moving The that Northern we at we the -- are. study said, into where we study rotate we point is expect that would As can this

Hemisphere efficacy Southern that We concluding in of enrolling run the a expect the Hemisphere. be study to Phase this X in in will Northern we study immunogenicity the do part safety So year. later

not And current so approval. the that year, study we Northern support the safety could ongoing that but will we be comparators this Phase X immunogenicity believe accelerated is Hemisphere studying

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you after know, the when be superiority one studies safety generally, on day So so available. XX, after at we data month will this. enrolled haven’t specifically immunogenicity a they as endpoints are guided or But the non-inferiority follow

like we once completed would follow-up follow so But have consult ultimately also shortly the to data specifically we with time. until about their on have want to and all enrollment. of we will with they guide up sort expectations safety will had we what those and consultations And data the of see regulators so will and data follow of

you so Thank much.

next our question. moment for One

Our comes with Cowen. next Buren question from Tyler Van

line Your is open.

this on Hi. Tyler. and Good Tara is for morning

interested some be and vaccines, Spikevax most and of given lost, share like that as So to Pfizer since provide Xst they I’d that from, I know the where was XX% from January the you share be are share could of that from hoping coming have well? on gain the it coming adeno course, to was coming the comment changes might where referring

question. that take can I Sure.

plan. we third shared had data share that the of that major the and share, difference that at we reported some fourth the are looked is to markets, looking today the across the of compared terms also shares the Pfizer In at which just OECD a and markets for Spikevax cumulative boosters,

about So as of from. business coming majority think we the our is source of where

some on gains from. seeing share focusing are the coming market is substantial current and in which the some cases booster We majority Again, just share holds year-to-date. population, future of our is vast growth where even market and

Yeah. Thanks.

next question. for One our moment

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

Your open. line is

sure you technology the do think Hey, terms you gave your one further of goal capital the how guys. Moderna’s you wanted of but about I allocation, sort you et longer of opportunity XX how for beyond, here do of in is or for guys to slides, know, question, slide about are either asking reach volume terms businesses. Stephane, Thanks of I think the but on expand sort in cetera? Thank term the what patients, do COVID. in that guys tail and about not the illustrative endemic think be example XXXX investing how in peripheral, how guidance, the far bit But steer of would you. in to that for little just as maybe you And capabilities of are of And core outside kind but mRNA? the willing adding wasn’t question. the you a I away invest then of phase of from that to a get, related

Okay.

then I on question comes So think Arpa, tag the Stephane first and on I maybe you to team will M&A one. the

will are there those plus endemic we factors we Coronaviruses. hospitalization, to there’s will is benefit to higher is seasonal define human would do human that in do risk comment happen annually flu this of that picture, on how of it higher happen even evolves. be boosting evolution breakthrough maybe of will XX will will here point breakthrough elevating endemic some or plus, Coronavirus on depend seasonal indefinitely, prevent a do want disease, that the market, the infections from But hard and like where plus protection infection, would for to believe unfortunately neutralizing morbidity is death with or first, population large we XX broadly, market that they and become in for will suggest be you just they or they So really how disease time question, risk. believe picture anticipate. The some a is it XX that upon going high and risk the to virus. It’s Arpa particularly if and that over

booster. the comment to how populations they is, would with recommending of to recommendations in So Nipah, how add their the for to the only world that we their closely will work governments being terms often and evolve covered as around populations continue are that are I well as see

see So how to shape work continue demand with time we them and will over the up.

the are by in past, allocation, have on acid. very the so shared And information as interested guys. we nucleic capital Thanks applying we in with molecules,

are to express at And only mRNA so looking human we not protein. a

gene as giving know future. done space actually near are there put But as you you forward to talked some know, and the we being also As that mRNA are interest. think, then us we partnership you through we gene look the we update some about also also losing therapy already RNA of the in in

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development, acid think and across across and I a is research, can plug across there nucleic like play the the to ability CMC. on of things terms platform to of we we in lot do

and synergies more nucleic with acid. technologies into So for we that just the definitely have this income the little of driving and a and is that sake getting complexity a getting true very see is benefits company product product the

guys. Thanks Great. Okay.

One moment for our next question.

comes Merle question Our with UBS. from last Ellie

is Your line open.

Thanks much guys. so Hey, for the question. taking

development? know been kind further and announced needs. since preclinically on that of and given vaccine from public looking plans Thanks. broader think as emergency have then with at about bit how as about the a on monkeypox, and think development, help a second are just have you comment capital pipeline that business just Can here. you about and further Just And any you question your the us you I prioritization? thinking from you Can the as health plans buybacks, well just for allocation here you

So on is capital allocation. let me Stephane. This start

using we on our now. been slide one few of illustrative David have that quarters As for

priority one has investing the Our number in been business.

are that excited We have. really about we the platform

of we vaccine vaccine, you to XX have ability starting as let’s in we have vaccine modality clinical timeframe, know team. Phase how last which call, grow on we remarkable, vaccines you a starting the platform X are on in we given right development call, capabilities, kind w we been strong in -- a derisked, invest of As the months pretty really have times four It’s from I to a of three has now. shown and for study place willing speak really And to the aggressively. the now course, CMC very think said about

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expanding will with buyback to one, is of were I And shareholder. company. the by two using So then we a the is cannot share return confirmation to number the the the we platform production M&A the plan excess the priority of if and through announcement ability and we the should think find investing we in capital priority business licensing, number the begin is today really the Board partnership, cash return

Stephane. Thanks,

to want monkeypox? you Stephen, on say the

Yeah. Yeah.

concern, conceptually, very very recent I So, with we sensitive obviously, aware were and monkeypox think, announcements. to obviously

will fall on will are the We COVID addressing stage. to be an a engage to how not quickly, more, there we preclinical we in to whether if we not to platform very clinical this been to many it program will the we focused And sense, conversations, our And premature we what public develop in to provide demonstrate of the point, and It’s to to or clinical at moving also in own public would But engage our and what and will we will on we be. we respectful covered, endpoints decision program, regulators clarity health really scale development or do purpose would And for endpoints understand be go it? established our totally it quickly larger forward now. We this a ability health counter-measure. right approvable need to are are with consultations so progress health study. say determine generally. we primary into principal endpoints because public more conversations we has The therefore a this try in standard this not program, just and would them. larger And program recognize, those we to a updated of a to that move those Stephane, whether those at made move regulators and start be threats to clinical but other about to very not clarified and looking are advance and towards it’s other and what would that that we work remains given if X those obviously with be path that. threat it, Phase and discussion pretty have clinical generate would obviously have were once after think it have demonstrated. is we were just will even go help doing so engage to well is rapidly development we monkeypox move

the Thanks for color.

at you your to everybody and to Day forward you. the We many much forward early so look today you Thank look a welcoming the you joining call and speaking Have great Thank day. September. for for R&D questions. of to Great.

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

a and now disconnect You day. wonderful have may