NVAX - Earnings call transcript Q3 2021

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Operator

Ladies and gentlemen, thank you standing by and welcome to the Novavax Third Quarter 2021 Financial Results and Operating Highlights Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions] After the speaker's presentation, there will be an question-and-answer session. [Operator Instructions]. Please be advise that today's conference is being recorded. to Taylor. conference like speaker to now Silvia today would hand over the your I

begin. may You

Silvia Taylor

later Thanks on very to audio and afternoon, results. currently us call quarter much. available Good conference operational archive A today our for you XXXX be today. website our will for of joining press all on release this our results and our an call highlights discuss website announcing third everyone our available financial and is thank novavax.com at

Joining today President CEO, me Stan is and who Erck, updates. will regulatory

Jim Commercial financial Additionally John and Treasurer and and Trizzino, results COVID-XX Dubovsky, our our will Officer joined Kelly, discuss also opportunity will quarter. development. Officer market manufacturing Chief vaccine; call for updates Chief Officer supply Financial Medical to Chief Dr. third overview Filip discuss Chief Business Officer and and the today's for our will the clinical

of Q&A end be Greg would available Glenn, Dr. the today's President of for Additionally the R&D call. at section

Before be making remarks, we will are during teleconference, this expectations beliefs. that statements based I remind which you and begin need our forward-looking we current to with on prepared

the our to We time you SEC which in over detail. cautions over described usage, vaccine these expectations filings future example, uncertainties, or development risks including and For results business risk statements. that are numerous to expenses, what and Stan. other to regarding now actions and like additional clinical the for and factors forward-looking candidates, our cash Novavax to materially performance, encourage forward-looking change revenue, is hand I'd are to or of timing could actual assumptions, statements. call strategy, of operating regulatory conditions in filings such consult statements financial discussed relating future subject milestones differ anticipated statements from

of you accompanying X. the Slide those to please following slides, turn For

Stanley Erck

milestone COVID-XX past to incredibly joining week, I'm week for everyone Silvia. us following This an sorry. excited Novavax. and our of global Thank -- strong in based marks a that approval first in critical exciting a here milestone ever a be safety for into our profile for upon today significant protein-based This vaccine. India first thanks approval transformation Indonesia point received today. vaccine commercial vaccine COVID-XX we a Novavax is a favorable demonstrated represents you, FSP reached This his and And to authorization our company. a

progress our Indonesia. have discussing authorization We X. hand of first granting with I'd begin regulatory I turn in to acknowledge use tremendous to by emergency filed the like submissions today's other by XXXX receiving in addition we've Please Slide nine for the XXXX, the for progress. as executed supply I first With global agencies our team, clinical discuss In call, our with efforts for regulatory now authorization tremendous made Novavax Other significant to more we that, would markets. results like the world. by will regulatory the our regulatory of on will discuss around today's strategy express these updates, entire participants trial in On our manufacturing milestones. upcoming quarter. thank during my unprecedented developments, and sites mission. for well the for each clinical as members team With and continued on importantly, support gratitude collaborative on through to Only efforts, call to were front, pandemic. global for regulatory now these to-date contributions of key trial we able partners an their updates our the their our financial vital and And authorization the of achieve our made clinical made developments detail

brand of name will India of COVOVAX. under Our and manufactured by marketed Institute COVID-XX vaccine be the Serum

earth will and the into by expect imminently. our our need is for vaccine Serum fourth will and nation that work access shipments to We've procure a fill of authorization The first Indonesia, Indonesia continues vaccine on to initial to begin global population. which commitment exemplifies for vital COVID-XX most sufficient equitable its populous

Over These Administration, we Medicines documents Canada, and the six the past week Australia's or submission alone, markets. review. include completed regulatory of Agency the completed MedSafe Goods Health where Therapeutic MHRA, New U.K.'s Zealand's in submissions for the the we regulatory to agencies European required EMA, all following

addition manufacturing And partnership provide to doses Additionally, in that filings our we for the for regulatory Institute. the harmonized of In information agencies. today course, to for regulatory and will with facilities review our use for announced WHO already those particular, the with these filings. near filings, across in rolling we we global our are and XXXX. clinical regulatory in where approved enable Philippines, packages strong EUL listing Indonesia, supplement submission will effort previously and were India, data package the to WHO which before remain efforts from been additional filings shortly. emergency of this access. of A submit for In we our initially expect end U.S., package regulatory these the complete geography completed the We've in across equitable future, to our have additional confident year. to our in our FDA by Novavax global a packages chain, complete are our the diligent to submissions leverage we listing and supply our All manufacturing Serum

tremendous the made regulatory on progress So front. we've

around filing goal and those quickly of to packages have to safely as world, and our the available them our making all of multiple agencies as in need. our advanced possible submitted regulatory also vaccine We shared harmonized

facilitate supply XXXX. regulatory our overview like chain to predict across anticipated XXXX's who all cannot approve global our the these authorities for take over diligently landscape, updates how regulatory COVID-XX to in to supply will packages, role agencies work it to to John, an now commitments turn we While I'd prepared with we're and approval. and long the closely of

John Trizzino

Stan. you, Thank

known world. includes largest Republic, with vaccine facilities Moving by Institute, expansive Today, Manufacturing global support XXXX CZ, Takeda partnership Sweden, Novavax manufacturing place at This the in center the in AB. the also state-of-the-art Japan, chain including the in include National to wholly U.K., Slide the supply in in makers, and a SK manufacturing Bioscience volume. world's have Novavax Research Biologics spanning of and chain National Korea, supply manufacturer X. with Poland, Council's in in and world partners Spain, vaccine Serum around to in the infrastructure A Fujifilm we global owned in a of partners owned site as our and that Manufacturing U.S. the Novavax Canada. manufacturing Mabion Council's and and Biofibre and the additional South Poland, established in Research Czech

for and our XXX our XXXX. Mabion we entering Takeda large doses agreements with of quarter, of million XXXX. to capacity and scale into a Over of expand XXXX production chain, Expanding Institute global an our for with Serum through with include collaborating partner year commercialization agreement support these their number network manufacturing the the manufacture anticipated of to supply to the XXXX partnership our third and executed ready annual

We commercial mobilizing routinely at have our we're product around scale multiple producing world. recent quality made the sites progress significant in at over high supply chain months,

of As the XXX of per doses end we manufacturing goal quarter, third month. million achieved a of of capacity the our

we deliver in from have to XXXX significant of for ramp supply agreements, our only months million support partner doses the achieve the we XXX that in will of manufacturing a month end X also capacity manufacturing will a additional in demand the vaccine of expectation Looking This the of capacity per fourth by Serum capacity to doses annual to quarter in excess with manufacturing our our beyond. us allow not inclusive up expect current ahead, billion on but XXXX and Institute.

strains improve we for disease. doses vaccination our refrigeration rates understood to our Now immunize supply all to at to expect the use access vaccine moving and X, widespread available Novavax's help our against And chain of favorable to the to a existing in decades. which additionally, clinical used against confidence data reach safety drives profile, well hesitancy. have areas will are the globe. to the this address robust and including dramatically allows and and addition strong hard Recombinant protein of vaccines major having beyond, vaccines immunogenicity pandemic challenges across we world, demonstrating vaccine distribution use temperatures global been and to Slide package, Coronavirus the and protect of multiple number vaccines the to increase already Storage vaccine help standard efficacy obstacles vaccine ability will during in increasing in

mindset Now turning licensing on and to you Slide vaccines that can in agreements the the this widespread see as ensure several have our X, to should no borders. access maintaining slide, vaccine supply to distribution of place have we

joint commitment facility. commitments APA billion European the over up network including Serum through doses doses of Commission agreements, during Institute including support million globally, the vaccine our supply Our COVAX and of our XXX quarter, third our will for executed XXXX doses to the supply bilateral through X.X with to

In in the expect supplying and role a continue vaccination, primary the coming need. for play important XXXX will ongoing XXXX years in addition very we will to for this believe we boosters need

coming across like to pipeline discuss and now quarter. Over over boosters countries. to across to high, need developments middle income clinical we to supply during the it the markets will in of be third our to additional months, Filip I'd able low turn Dubovsky

Filip Dubovsky

This And the of package regulatory these John, data in derived Thanks, safety being displayed our been our provided Slide agencies of development our X. an to high to regulatory is part are plan. that's Please reviewed. on XXXX vaccine level studies. has and studies ongoing harmonized filings. here is clinical efficacy immunogenecity turn What's regulatory included these is and currently basis clinical The from all common

of studies, times variants are a of vaccine these our remarkable studies that's primary This X. at feature X efficacy time were Slide when One different And to percentage conducted the emerged. efficacy fact consistent is within highlights derived in these we've each different pivotal ahead one skip efficacy seen, vaccine is different bulk our point of the safety other. despite the populations studies. the estimates Phase two Let's during and slide from data

high that point similar strings included in You the can efficacy XX% estimate are a against to very sequences match see XXX% These most are to whose vaccine. strings. of

alpha, the that X we not against study U.S. have all Additionally, vaccine our Phase earlier only circulated detailed well variants, time. works at against variants as against in that but

our complete smaller have caused disease protection and we includes variants. and the cases the study, studies, in efficacy group. Importantly, disease, efficacy XXX% placebo hospitalization U.S. larger couldn't were and of cases, and efficacy was of studies we disease, severe all the our deaths U.K. in the that of low against again, because number South in by against In vaccine an severe all although calculate severe the African severe

such conditions Finally, risk is elderly the almost efficacy people overall high to their populations, that identical and as population. in of with our comorbid

all in the skip over been safety progress about Phase is all and We let's forward to expanded And study the and X,XXX vaccination our over to efficacy pediatrics. have old, include have primary our XX data now XX to So churn fact, to U.S. Slide in collection ongoing. talk series year XX delivered. been X crossed

the EMA a quarter. available be will pediatric plan MHRA agreed have and global initiated to has first for regulatory expect We submission reads adolescent studies clinical to package The development out. after by FDA, the in been the subsequent and study this

disclosed XX cohorts Okay, study on wild as are to let's from after type doses. months fourfold talk as X antibody receiving IgG Slide in months, and Phase XX at boosted select up two In well previously than move We've can and peak the the doses boosting. and our at XX six U.S. month six that and just finishing more increase we about dose Australia, a months levels their now. single neutralization

responses. initially inducing South and linked with strength cross Professor received neutralizing two demonstrated likely using HX delta all their peak. fold that our Phase X excellent who Phase responses vaccine saw our doses at as third We specific of boosted system. months, and inhibition a dose vaccine Africa variant participants to over XXXX more vaccine antibodies, in In their six Snape studies measures our a We we safety study, from can presented a along of emergency alpha, serve strength the the will demonstrated data Africa data data human with filings to to South our The U.S. the X functional maturing. from indication. we study boost from recently our and boosting protection supporting the Oxford importantly, data adjuvant this of our variants X.X is the Australia safety this XX.X beta in assay, believe However, is regulatory against that basis as stringent

Australia to the Finally, NanoFlu move update I combination you will XX. on study. of Slide our let's And progress XXXX

have COVID current flu, all for a are Phase study, define FDA. know, We schedule antigen, the combined quarter and its you much circulate. licensure antigen. given As study the this and X endpoints designed the our The by to the will believe Lancet the regulatory Enrollment and dosage complete, the COVID was levels in delivered, may HA pathway we that in recently NanoFlu a to first study ID combination we've flu published being administered. second been doses with is primary doses met quadrivalent vaccination our currently for continue been like study

Our Jim? attractive available it variants. logic against share overview flu as the provide quarter. make well first even to This and of data in an the COVID as results repeated that third will flu vaccine now of financial I'd XXXX. attributes COVID vaccine protection to Jim providing for be our and the half turn like over to strains

Jim Kelly

transition company. look and rapid with provide we cash. This key financial commercial am becoming of summary to Thank XXXX. join we advance to means results the quarter quarter billion afternoon, And ended the XXXX you, an Filip. announced capitalized total third commercial to launch well for I'd of a beginning happy of a the to million, I on for like are in contributing XX. you and we XXXX. to team highlights I'll towards the period This the the by such our at we as moment saying of Novavax global important $X.X of forward with Today reported how start $XXX revenue slide our third

third Turning of We the compare our to on to XXXX results Slide quarter XX. results financial our XXXX. third quarter

loss to we loss or per per recorded of During million net of a third $X.XX compares year. XXX quarter share the prior the of $X.XX in This million share. or $XXX XXXX, a

Our XX% growth, to year. compares million third XXXX revenue quarter of $XXX the in million and prior $XXX

and $XX period, revenue increase the speed, operation of $XX consists U.S. saw royalty under funding XXXX as revenue in a revenue close. total of agreement agreement Government reflects Our and revenue. oriented of that funding by towards million contract our from in warp activities. is contract which more million $XX grant fell now Grant government government million, revenue, million increase our to the funded we comes are primarily revenue by an CEPI our coming $XX from activities startup as which

are million partners. made during of the In XXXX expenses Finally, Biosciences licensed of Novavax case, revenue royalty $XX to of Korean towards for of activities share the cause government primarily our quarter XXXX this antigen our primary were $XXX of year-over-year both XXXX are supportive third million for the and of and sales sales Total the the the reflects component SK total quarter R&D growth. weighted the and period. in

Following expensed of when unexpected cost goods regulatory this our certain types product previously is and inventory approval of will expenses delivered. of that R&D have as capitalized expense vaccine, been sold be

end increase $XXX and $X.X the primary in to would cash for come. As year now with the quarter of our are the discuss to noted third to call of we the at million cash ended as from billion stock common back turn equivalents cash under billion received Stan and year-to-date earlier, in just quarter. priorities purchase strategic over to $X.X XXXX. sale in compared our to The like sources first over payments the million months $XXX advanced agreements, the I in

Stanley Erck

And thank employees to welcome XX. Novak's of for are the turn Please the delivery was prepare you, over board, XXXX to globally. scenes tremendous a tirelessly It XXXX us on Jim, for and Slide work behind quarter

filing. COVID-XX top with with a This discussion for submissions. we've vaccine for continued will our authorization priority. whom collaboration In and involves we regulatory finalize geographies, obtaining months, agencies completed coming the Over remains other already our packages regulatory

complete a FDA We the the by also expect XXXX. submit package regulatory of to to end

various to over and expected the followed to to ready will authorization others weeks. We product by course returning at the first work approvals. Timing a get coming by on basis. hand regulatory a of ship depend be the global is to Our on swiftly agency of location regulatory timing

first quickly match be others COVOVAX to the we APA to regulatory the orders and scale Indonesia hopefully That expect and as with to these in of We up doses able the ship approvals. before will end year. our quarter

data our other supplement our first center filings as initiate our from with will sites. and authorized shipments regulatory We from the Serum production

facility, our and including partner Importantly, check SK in Biosciences Korea. our

favorable we is months, a dose goal to our and our partners to two though a or coming commitments serve our will and APAs suited signed XXXX. the confident well reactogenicity through low vaccination areas and vast in these to to vaccine other countries. is we've we a potential and over we efficacy, of to COVOVAX. of will pipeline. to we that our as In In the of safety over important in our that in year capacity last XXXXs tool to develop and with years no countries we our regimen come. XXXX meet address expect profile, a that supply ongoing COVID-XX higher indicated favorable believe combating beyond will income primary middle to data And commitments the collect as needs the income expect partnership be consistently robust to supports countries high fulfill evaluate that an to allow Serum manufacturing continue Our through XXXX production reach will booster, parallel, cadence ideally have study, in We understood further levels technology, X of billion of boosting vaccine to before, will our are from reactogenicity doses

a to development. COVID our As advancing discussed of we earlier pipeline, forward vaccine candidate we component this will NanoFlu through Filip, and be clinical by combination believe key look our

future remain development for We including within areas RSV. for optimistic also about pipeline, our

With everywhere. operator that, continue it end drive the for to mission forward. in of the over Q&A. never to turn quest rest our will now I XXXX, of our into us people Moving We the health to protect will

Operator

of go session. question ahead. question-and-answer Jefferies. Chikere the Please Our begin from comes [Operator Instructions] now will Kelechi first We

Kelechi Chikere

the congrats all you. And Yes, on here. again, progress thank

Just end. on a couple questions of my

more with First, help manufacturing? have able filings manufacturing couple data applications importantly, new I quickly be you what are those understand there. you from with reasoning own steps to the follow A was last SIIs guess supplement sites? development question and had you approvals us will that the how one that that? over up leveraging weeks. in potential I and your the the gating And And behind of Can you're rationale

Stanley Erck

for been thanks Yes, have, variety reliance for for this question. Stan, Serum a upon with working this him The areas. a as we've years partner is two our is in for of reason they the almost

And have over capacity, year Novavax added know past for so capacity. them well. well really staggering they And X We're specifically that's billion we production the targeting over.

Just at they'll next have that Serum, year.

And so millions of they their fill We have in make month virtually unlimited. of can hundreds capacity doses finish many facility. per that's

this So all with helped with us. there past came different that get to point past several regulatory us has been nine of the in could together of stupendous I couple been the and mean, really has Serum And where we weeks. file months, progress. to over filings the

So to the Spain, question in we will from the cetera. of with Republic, that various collecting supplement data approval we're have your and we about once Korea, data, our will territories data from follow-on Czech plants? regulatory get we rest is, submit, We what from those filings et

involved. we get them can So all

really global that so potent. are work And our capacity is

Kelechi Chikere

And of site? I is the Serum your how versus much this alluded Got really answer. your it. Thank you. Institute on helpful. actually you current of how coming any from capacity guess vaccine own color to or much in provide Can That's you India

Stanley Erck

by that split facility, don't manufacturing out sorry. but we Actually,

Kelechi Chikere

problem. right, All very thank No much. you

Operator

Bernardino Wainwright. question next HC is The of from Vernon

Vernon Bernardino

would confirm actually calling And I of we Good it just update. for a timeline alone to And question I'm take thank EUL more on for evening, had on, to get basically behalf Bernie. overview. to the John that's will also SII I of just the We and you color me. in guess long it wanted vaccine? on manufacture the that I'm just the the WHO wanted how for and

John Trizzino

touched team I that doses that setting already They've has physically -- second initial them. of of to SII my be be will there and Well, of the I millions we've manufacturer. shippable. over gone the are question think part made the XXs many waiting answered They're

And they're first the so was part forget, what there. it's the I question? of

Vernon Bernardino

we Just would the how EUL on some review? -- WHO wanted to the more just color in take would for long it

John Trizzino

regulatory we're to -- My can't take forecast we the it's various soon. be the to allowed not this. going opinion Oh, to agencies to regulatory going on long is opine how it's

very we many their interest active think and judge how us they're with questions well. they they've ask, I So -- can speed -- we in been get because and -- their as discussions by active

this we're think think to with a of following I number follow actions soon. I Indonesia positive going regulatory

Vernon Bernardino

Perfect. you. Thank

Operator

Mamtani from of B. The Securities. next comes Riley question Mayank

Mayank Mamtani

questions. Good our of afternoon. Thanks progress. taking And obviously, ton for on congrats a recent

Serum staying to arrangement the are you with the just Serum things developed are the is you economic have have on coming if follow-up? facility. vaccine to able maybe manufacturer? from Are specifically, comment for then -- able Serum COGS, a on may question. So, the Novavax comment if I you market And And also, if doses the versus

John Trizzino

so amounts middle to target low make their their Yes, They, at we've cost. the fact, of And the markets, of is they've of one countries a all that is vaccine. year we world. recognized with income because large quantities their very their to making of is in tied and business, low which of in the vaccine model for reasons ago, capabilities them partnered vast

their So target. been that's

license the we exclusive have, we an low in with agreement on they'll them we markets. we've agree sell profits make if products, we'll product in. and for so to for and of distributed deal Our product. want them, what make the and disclosed profits, income an the not with have have India them income is the of high also world to in make ratio that, and And them, can license product we we that They and that signed make is and share that products. And countries middle they to share to

so And a agreement we have CDMO them. with

at these they our product, spike that make make protein finished of spike or around various we whether ways either protein in the world. And supply in sites Serum, from so wouldn't antigen, as one from they that two

choice produce or us, product network and the entire And have income of working all through Fil our manufacturing for so having finish our the in distributed fill Serum own we'll high it the product take countries. make it produce just of and and for way us,

our So going billion to a complicated, it's effective zero it's from very strategy $X overnight. reach but to a way

Mayank Mamtani

to helpful color. on that's itself And think that Thanks, is FDA come on then from be is just the particular working the facilities side through. of release the percentage detail that you been upon requirements has Or other different about sort the of we maybe planet level. non-serum the or the safety Can about product agreed that FDA facilities? as filing, specific maybe it a you're U.S. have it of it meets that the it potency has assays criteria material

you how today to also of applicable what the much could you us FDA Just U.S. have understand, help filing? can be

John Trizzino

we no, concerted effort made all a Yes, to of harmonize our filings.

so more a what and date on this can the that EUA, for very month. dates communication to that that, foreseeable package know them we will going we're but the elsewhere. And later filed And with date as sometime week. file are be a we've to the up sometime U.S. with dealing of to the We thing set the same in in file don't process complete yet. this coming future. had the we clarity the We that we in going in yet, as we So meeting expect from don't the near. FDA, have give We're

Mayank Mamtani

you was on on study, can can the think crossover regulatory Great package I on but while just final the comment commented in the clarify data timeline? timeline, pediatric someone data you my ago, and since a that XQ finished question

John Trizzino

is regulatory the a ongoing. And made our globally. complicated current filings by it's more Yes, slightly analysis

that confident submitted file workout. in are be to we'll first together the So data quarter. get need of that and we pulled to variation the initial our able a balance we But as

Mayank Mamtani

taking questions. for Thanks Great. our

Operator

question Duncan Your of Fitzgerald. Cantor Charles next from comes

Charles Duncan

might I'm Stan you filings information And of I you can team EUA out as thanks would characterize great Indonesia in I'm for from hi, sure next taking good the to regarding question not when being very to or of interim steps that for progress, won't wondering whether came detail. about Yes, see if my besides kind had an talk answer be and approval congratulation, able some and of out there you able recent released, approvals, can all kind the press beyond actual But the that be a question. blue? to be see.

Stanley Erck

coming interpret authorizations South trying that's I'm Serum this and that to allocate And -- bit, we we allocation product Korea multiple are label answer but figured when and did. at get be allocate be for weeks little inventory I them from authorization inventory. not complicated, we the for quarters and will where those we the we'll question will when and and product each be question, the and we'll same trying thing That timing I'm we're expecting our And both the being what and sure be building out a to of all how in know your they of them, Yes, building the in that to are year. U.S. these, these to we Europe of different orders and built up the over inventory an need what to from Gavi, geographies. so coming until process only over want because not APAs we know the the have different your

Charles Duncan

emergency course if asking apologize, to an is authorizations of public Yes, over for unclear. the would think one of I the use any, was an actual some the authorization? be next these visible of regulatory process anticipate What Stan, of the time to it before any period I you was of part I grant

Stanley Erck

they've they before actual now have the to those is, to much regulatory because we to review going agencies. safety have have think do submitted the time have the visibility process been the grants for some the don't I been data had we're ability the clinical authorization, review,

and the the answers are be section remaining interested they whether not know of by number So of get CMC the only back questions. the the the focusing analysis responses they questions and know and only on and to we we we all how it's they've got can could should get We think course, announced.

not information to you there's be to I'm suggesting that. quickly happens. it about so of to this. the be EUA From to going until this forward week forecasting And that we're see any I'm all working to optimistically is they're going week, results until going going But on

Charles Duncan

That's a I helpful. regarding couple If turn questions. very to Okay, of Greg, could or Filip good. clinical

if kind And with cases virus you technologies? seen with wondering that I'm theoretical contrasts generally. the cases think ever all, or any perhaps of an some if which that of First have go even seen cases for you infection not other basis is seeing of any you foreseeing beyond provide and Myocarditis could with

Filip Dubovsky

we don't seen not specific by planet. can, in really comment viral those safety studies and any occur is seen the we all we is our throughout caused of sporadically Myocarditis infections, but or know, So signals what on often we've

they up So at us database, crop reviewed haven't only our signals by the external safety identified as our And data well do DSMB. by safety in for not any is look yet. as committee, any you NIH they

Charles Duncan

top shown given say, and basis of XXXX boosts, do boosts be may evaluate that future could that six theoretical useful in could heterologous regarding thinking should on good. months. to least But Last question versus have primary paradigm homologous the Okay, provide there RNA of work, a you be past in at if perspectives that a want you'll homologous a boost? data maybe sense on is that for you boosts the you've far bit so like wondering heterologous very little seems

Stanley Erck

get we see the homologous details we've for boosting, we've think just an forward so we of indication there's Yes, outlined, that. our a way a And today. to label obvious and path outlined

safety in vaccine have We convenient I justify makes be that. of doing other top pathology data also the And boosting to performs that move at it in we and world regard. vaccines, which profile think it a will driven. used huge well really people's How will see on value around the that

a a help such in from But there indication, And this way everyone goal. plan that, data shed including be those we as enough to do studies, be some we're into call the light claims. define label designed to label near to to to really aren't able our Now, data studies some U.K. provide future that the us provide studies out coming studies in will on designing may that's some to it. give knows,

is as top side boost what top a of about known looks platforms, to platforms, what to there the there versus of far isn't known other as more like things, theoretical on mRNA. it's boost viral ton on about like So it of

X part come think What or study I about compared to any in if I what stack to from to is you regime, feel were U.S. up to the confident homologous and heterologous for data out. that we'll the wait Phase Australia, we've shown ability -- have do that. cross confident may be pretty our have out neutralizing unique or that And And about there induce I'm what we're something would about that on top with to I pretty come story. seeing of say we the antibodies. imparity to is variant

So magnitude people response think immune shouldn't well. of about as immune quality just of but response,

Charles Duncan

questions. Okay, helpful. Again, you That's taking progress. my very good. all on recent Appreciate congrats the

Operator

JPMorgan. from is Joseph Eric question next of The

Eric Joseph

questions. up the COVOVAX term? countries And should commitments and before more dose any on have the the with that's plans with CMC about COVOVAX happen your week? thinking between regions current higher taking or supplement follow authorization for the allocation back guess Thanks with then this chain. is to evening. anticipated if primarily I it a likely supply first, making filings packages it's Serum, that your of good follow effectively from past happen filed circle and just a there I the to is after over doses COVOVAX as prioritization be income How the own near to wanted COVOVAX, facility Could for up? Hi, over to decisions to we

Stanley Erck

for question. is the Yes, thanks good. Stan, This

the as the soon supplementary filed as files be we can. will questions, For

I nine you just consume if the we're don't our a in get we'll we've imagine them. we're time that that either more applications, has can approval team regulatory filed think that think think I countries talking months. supplements talking going to submissions, or the I go, that after. weeks here, that's to their around and few But And

going So I there's be don't difference. much think to

Serum. Going next the Serum going production to bulk work back the to how to allocation, is your months. make going over with few it's of the

allocation, APAs it'll I to sure portion out of XXX% our large We over first second And the few are COVOVAX, won't their be going will focus shift be But to a large our of think on for and they We're in quarter. it that then going get allocate. there. quantities, product to in the it make months. third

we lot WHO, to countries be as time know, and take and countries, middle and when Gabi, so as and next low a time a ship can get a well. So some lot will we we and is EUL this soon as have get that quarter, quarter other to can of our you during so mission little product income to of there'll out

as our difference. authorization, So mix fairly the going scale the Serum now. submissions, from? a places product - And it right but dramatic. and comes really to of What we'll product flows, is a not it's It's regulatory these see how at make plant get

Filip Dubovsky **

gives cetera. package the And precedent Okay, higher guess is a vaccine here, et with Europe, approval prevalent use Serum a income like here decision to you a there just CMC that with Serum countries I confidence and

Eric Joseph

They've doses globally made over approval for vaccine. billion that. $X they've gotten of And

by there inspected and probably world. got certificate their and and lots they U.K, seen. precedent, the at GMP allows plants production some way, Novavax's modern of regarded agencies that and plants, regulatory that so So their the the also got And plants them most for of they're is are the by highly specifically by in the a

Stanley Erck

comparability data they is guess, there, clinical their clinical had guess I Serum with mission data have product the you any own where yes, chain using that Okay. He there supply is all package? also

Eric Joseph

Yes, they the focus trial. did. will describe They

Filip Dubovsky

comparing we regulatory manufacture Phase X material material a as And they manufactured with that Phase part study X, dossier? of that the they conducted

Eric Joseph

Okay, great. Thanks taking for question. the

Operator

over session. the question-and-answer like remarks. our I'd conclude will Stan to this any to conference turn And closing for back

Stanley Erck

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thank So very you much. with that,

Operator

Thank now you. concluded. The conference is

Novavax (NVAX) 5 Nov 212021 Q3 Earnings call transcript