Novavax (NVAX) 8 Aug 232023 Q2 Earnings call transcript

Ladies and gentlemen, thank you for standing by and welcome to the Novavax Second Quarter 2023 Financial Results and Operational Highlights Conference Call. At this time, all participant lines are in a listen-only mode. [Operator Instructions] After today's presentation, there will be an opportunity to ask questions. [Operator Instructions] Please be advised that today's conference is being recorded.

I would now like to hand the conference over to your speaker today, Erika Schultz.

begin. may You

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

to two. slide turn Please

development need relating to forward-looking we the remind guidance, its outcome that the the year timing business and Before remarks, candidates, or begin its candidates, partnership, includes information our prepared filings XXXX performance, global financial of market this strategies, upcoming operating opportunities and and of Novavax, candidates, availability anticipated statements, and of I including and its the capacity, of priorities, key our plans, to with future manufacturing milestones. presentation financial for vaccine strategic prospects, future conditions you regulatory or vaccine key ongoing our vaccine future future actions, its objective, full and

and contained projected statement risks subject in to from actual that statements. differ can presentation cause such is forward-looking in results those this to Each uncertainties materially

Commission factors Form Statements XX-Q Additional the filed SEC. with we subsequent appears available heading regarding as Securities Regarding Factors, with and the and and Exchange well Forward-Looking www.sec.gov website the Risk subsequent heading atnovavax.com these filings information this afternoon, Note Form as recent in and XX-K Cautionary deck slide on under the under issued and our our and most the

update we date original undertake presentation of these and statements. statements presentation in or this of any the forward-looking of The revise as no obligation to this speak

exclude non-GAAP which restructuring presentation costs slide described to to references this forward-looking for SG&A on as adjusted expense financial to three. information also includes turn and R&D slide. Please one-time measure, as is This a

four. slide Please turn to

a three is provide our during key will for John an President priorities. and Jacob, progress Joining the me on update quarter today our CEO, who

Additionally, and Dr. provide on Chief Commercial development our and officer activities; an Officer, Dubovsky, clinical and Chief of Filip discuss update Research Business commercial COVID will pipeline. and John Trizzino, President will our Development

Kelly, Officer Crowley, be Jim the the Chief also our Officer available Treasurer Operations Q&A Rick call. Chief financial of end will provide results. will section Finally, for an today's Financial of and at overview

I would now five. hand slide call Please to the like to John to over turn Jacob.

you, for everyone and thank joining results today Thank second Erika, you discuss quarter XXXX highlights. to us our financial and operational

updated the call, last to first, delivering has the an the Since upcoming fall on season. year; organization our product continued priorities focus three entire for for earnings our

reducing advancement the our our Second, structure. our and flow evolving of and platform cash and pipeline our portfolio additional rate And from business of development managing third, value activities. spend, driving and technology our scale via

significant X today share with I'm made these for Novavax. on of the you all pleased to priorities we've progress

start Let's XXXX the upcoming fall product vaccination our first with priority, for delivering updated season. an

to updated comprehensive Thanks to fall strategy time season. deliver vaccine and well-positioned change our reiterate on for our to plan readiness we this achieve are objective efforts, our commercial and the strain

competitive this a produced supply anticipated an meet to and season. product have believe Importantly, demand profile we we have ample

We our key submissions file for and have in the markets. filing coming the initiated weeks in US are preparing in our authorization to other

sales fully existing with is Outside accessible. our vaccine orders For by the driven year. APAs to and deployed on of the in US, fourth delivery commercial quarter is continue our of available intended team committed for our widely focused ensuring this be the and US,

about the world. our the and our commercial US, authorized, updated, competitive as readiness deliver to to only share key our more would if vaccine our markets, vaccine offer about target an fall in are consumers our to Trizzino for an protein-based confident be in important differentiated most In we're alternative this later the season. excited non-mRNA We readiness and potential the around call. of available, including will vaccine, option the John

to our scale which cash structure. reduce two, our on and move spend, evolve let's priority is So, number to our and of flow, rate manage

towards of make position our creation. quarter second progress during continue solid We financial value with foundation a the building strengthening long-term the to significant for financial intent

which our is first $XXX And execution to total important for financial the in of Commercial an for second $XXX over half recorded the contributor revenue year. quarter, million to the health. revenue we us million, of brings

million Canada, to our $XXX executed negotiated long-term into the foundation and and to a XXXX, season. customer. as successfully position valued cash fall up the cash agreement ongoing COVID quarter, During amended for for supply payments with Novavax established vaccine This a we we strengthening in our also APA of further head

Bioscience SK includes at we an stock's with equity Novavax investment $XX premium today to earlier average million partnership enhanced the volume-weighted The that XX% a announced price. XX-day in

in financial from This for SK contract strategic Biosciences rights and with mutually beneficial arrangement relationship evolves payment our in balance sales certain and position key business milestone from XXXX. a Novavax providing significantly to our future APAC $XXX by eliminating SK sheet a liability markets, it a our outstanding with commercialization in manufacturing partnership Extending royalties improves product organization a markets, million

We the million are of reduction $XXX the $X receivables. with reduced over liabilities and second cash by have global ending in in quarter also billion, over and on plans as last restructuring today, announced quarter. XXXX with track cost current And

flow, more later hear today about Kelly Jim full outlook will our XXXX cost management, the in from liability You and year call. management, cash

technology threeX, priority portfolio our value discuss number assets additional platform, leverage of capabilities let's is our Nuvaxovid to drive our and to Finally, which beyond alone.

pipeline. our with Starting

Novavax priority and vaccines. challenge, health for a a of respiratory step, first to it made are emerging a aware combination into evolves viruses, has Therefore, COVID other As strategic need combination our the public as influenza. we vaccine keenly for along develop with seasonal COVID

and stated new robust recent to decided improving Based XXXX updates our with corporate and so our on parallel, XXXX in you will stage on do what prepare with sheet look see strategic gate and to investments emerging to In we as this sharing late-stage to need to the our partner and market importantly, financial priorities, a and the as program for balance progresses. we candidate progress program continue this independently forward evaluate opportunity, targets. we've make potential product development, in line can

on Moving Matrix-M collaborations. to

Our unique continues to technology the platform Matrix-M keys value adjuvant is offer our business both and one our partners. potential to of and for Novavax

Serum this The an the to vaccine around University tool in countries fleet potential developed malaria and adjuvanted important RXX/Matrix-M authorizations the malaria by by and manufactured be Oxford in has multiple of has received against India year globe. the Institute

eligible on future and expects payment receive to As product receive and part Matrix-M of will in to Novavax royalties sales. be this for support supply of launch arrangement, readiness

a with announced and use of recently also in the adjuvant We vaccine research. for Research Melinda Institute new preclinical Matrix-M collaboration Bill Gates Medical our

to our explore partnership and important work our expanded our use programs, the also adjuvant forward clinical global of have Matrix-M goal public development shared of in and health. we towards We our continued discussions improving to look

said successes have year, our opportunities transparent I and you since this share and Novavax a as we in January to well with As as joined manner. I as our CEO intend late in of challenges risks

So, let me clear. be

risk first I that on prepared converts progress to there about we've version for first authorizations time. for is significant as in for ahead seek all commercial our and us. execution are our priorities, as a model key our year-to-date excited to regulatory Nuvaxovid clear business of want we of the it the be achieved updated compete still to the While we market US

the a success as COVID emerging as phase. ability the for large continued deliver priorities a opportunity on and globe will Our the company around vaccination on in part our enters depend these endemic pandemic an to on

our exciting opportunity investors. the and As support grateful we continue an for of to energy our commitment this management encouraged be and should sincerely the am team of fall prepare personally of all I season, for what our loyal and employees by

You have to commitment priorities focus our we the our and have give you best on key continued effort our outlined.

team over it results hand discuss John? commercial detail, additional our to and to to quarter to Trizzino the like updates. John would our I beginning more members the in with from discuss of Now,

turn into vaccine to XXXX agreements, traditional the of season, under XX six. in the are Thanks purchasing slide vaccination vaccine to the XXXX, commercial over around for fall authorized US APAs, these while and Novavax's globe. vaccines John. COVID purchasing COVID countries operations. advanced Leading use Please moves still in countries is many purchase

region. pandemic phase the be similarities activities seasonal will readiness specific I slide exiting to vaccine and traditional entering many vaccine more discussing to turn seven. is each a Please influenza seasonal for distribution. Today, and as planned, US, with annual market The

and course, for dependent We throughout pandemic use. we on are September, ACIP as in the have authorization and the as of our of for phase, soon FDA ready organization-wide product strain-specific availability recommendations for been preparing commercialization US

and smoothly interested and a you is ensure there collaboration As for across significant available that this vaccine within vaccine. many expect, agencies in would to transition executed has there US is receiving COVID HHS anyone been

updates for the past prioritization season objectives clarity over few upcoming have public greater of our vaccination and and preparation. Critical focused health the provided months

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respiratory the course, across and demand and we market only number for the season can only the as sure unfolds. Of US estimated, be populations in doses needed channels all of know disease will and

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our fall also keenly are to targeted We of execution has strategy. the our on commercial initiatives our readiness, commercial been contracting central focused

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and of for purchasing In Canada, dose XXXX doses and provided and in commitments into payment reinforced we XXXX, also amended manufacturing our XXXX forfeited our to XXXX in-country APA, commitment which in establish XXXX. extended

foundation We our a with partnership supply. are excited for have to continued establish vaccine strengthened and Canada

Finally, in partners with region. Asia-Pacific, relationships we have strong country this similarly our created in

supply Singapore, continue to against and New We APAs Israel. Taiwan, existing Australia, Zealand, to

protein-based XXXX, tender non-mRNA are for focus beginning remains APAs vaccine XXXX choice of execute some continue vaccine we into Interest While with policy. and on specific high Choice a to purchasing against in traditional need a vaccine. the

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Filip updates like to our and clinical development I'd With to that it to said, over pipeline. hand for discuss

turn and XX. Thanks Today, cover have XX to topics. to John. Please I slide three

our priority. update plans on our share base I study, one change some pipeline. data touch our want I'll before for Then on is you pediatric new which I number strain First, to clinical

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efficacy. also clinical evaluate We

and over only observed two placebo cases group. However, short the window, both in are observation the we they

reaction events. to Please at move to slide XX look

after two bottom Here we events Local blue, systemic the are the side, and dose on the green on on in dose the of and slide. top record symptoms slide right. genocity of have displayed the the in one symptoms on are left-hand

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let hand it results. financial discuss off Okay, to me Jim to our

financial Filip. This of the for results XXXX. can our second of in morning, press and you, results issued our today filing. found announced release quarter be Details we XX-Q our Thank our

million equity of also partnership premium XX-day announced the enhance include a weighted volume strategic an at in morning this the In price. investment average Novavax to that addition, with execution agreements business XX% our SK and $XX Bioscience we

plan. results. details I'll on our I'll management, quarterly progress and quarter regarding more of results, Then provide cost liability second reduction begin and our by providing our global an XXXX overview restructuring

XXXX. Finally, guidance the on an for I'll year update full financial share our

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increase recorded reflecting we revenue, and quarter million quarter the to of XXX% $XXX XXXX. XXXX, a of compared as $XXX in For second million the total second

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with XX. slide Beginning to revenue. turn Please

quarter from of benefited sales second to revenue in revenue compared as second performance Nuvaxovid to of product quarter and Our the XXXX we XXXX. million both grant of improvements $XXX million $XXX total recorded

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million in for half Please million current turn quarter to $XXX made $XXX total XX, reduction of during to the first the second slide we've progress significant and of reduce our outstanding XXXX. liabilities, including the

year-to-date the today we million XXXX. $X liabilities announced And Bioscience $XXX current reduces as SK for over agreement in a our discussed, total reduction billion just of by

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Please slide to turn XX.

approximately runway. to negotiated share our am million full nondilutive the million to year guidance, improve our funding under for financial cash $XXX APA April, important our discussing XXXX since cash $XXX company. an year represent pleased I up to to this up secured of in that payments source The cash Before in we've Canada

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to expect do contributor XXXX material We a product not to this sales. be

Regarding timing, June up $XXX installments cash related initial to million. second to April million $XXX APA payment million of XXXX in the equal paid $XXX to EPA The XXXX the in amendment received we the cash the associated are X in payments quarter XXXX. with payment of be amendment

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with full total $XXX of associated APA was year revenue prior full and to product the our included million XXXX amendment note, guidance the payments XXXX Of $XXX June the for in million up guidance. sales year revenue cash

XXXX our we full this removing million this are $XXX cash year guidance. payment reason, revenue For from

guidance. full said, XXXX turn With financial let's our that year to

million year million. including of and of product $XXX full between $X.X total sales between achieve and $X.XXX revenue of billion to expect billion grant and XXXX $XXX $XXX million billion, and revenue $X.X between We

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first of recorded the In line in provided May. $XXX expected in of revenue, XXXX, half is million the with in total guidance which revenue we total phasing

second $XXX of of to billion As we a half $X XXXX. expect million result, the revenue total approximately in

and approve to announcement recent FDA vaccines outside occur US. In the materially fourth updated is timing updated of covet other vaccine COVID regulatory vaccine XBB late plans sales expected in US updated addition, September, XBB COVID our for approvals will based on we quarter. the expect that deliveries the our plus in This product for the

the note, I we the the and million. year to second approximately full were XXXX combined our SG&A our implies an XXXX. for of SG&A rate of R&D for range Of mentioned our for R&D are XXXX as $XXX targets combined and XXXX. quarter second expenses, our expenses quarterly half run of reiterating $XXX earlier, and XXXX The full SG&A reduce R&D expenses million For guidance midpoint year and

expect to increase today, our and we fall seasonal commercial during in In the a executes believe outlined the If for this in investments guidance as operations achieving our of XXXX sales the funding see quarters, vaccination full our XX next we will year the marketing the team successful coming season. support XXXX months.

XX-Q in our on disclosure, first that you we in XX-K we provided filing see concern going In filing, February. our update will which have an provided our

to months, related uncertainty funding subject to the continues be significant from US that Specifically pending to the XX and forecast next revenue arbitration. government for this

look deliver updates performance, structure, to seek additional improve We value. cost and to shareholder Novavax's we strength as forward financial to sharing

With to that, call I'd back remarks. the over like closing for turn some to John

close reflect shared priorities, are a against XXXX. progress this made like which today slide important Thank Please to meaningful today's to on updates to to success intended we've call our you, all reiterating and XX. Novavax three I'd both path year beyond. priorities progress turn The place the by on Jim. for we

continue priority have and contracts or progress broad midyear, under initiated fall. manufactured our with for During ample we and vaccine the our commercial commercial the to vaccine scale supply, prepare at past XBB deployed now US have quarter season access to and to our ensure fall through the completed regulatory FDA this have with in fully of with majority commercial team our filing one,

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initiatives. reduction related addition, to absorb We And able charges within also cost are we're with track targets. in our restructuring one-time those stated on our

be program, will future of priority call. our stand-alone our assets outlined flu a focus program new Under in on we earlier as and advancing with vaccine the Filip combination pipeline secondarily, three, our priority

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and And we advance were forward Institute proud our to programs Bill the look partnership. & with announce that vaccine development that to using we signed an agreement to furthering Gates Matrix-M Research Melinda several technology Medical

for challenges be a I to commitment February progress. in well you to balanced all our perspective to as you joined about fourth earnings and first our the call, on our provide I as pledge our opportunities quarter transparent When

significant and since mind, key you several from to our in far made priorities commitment have this can progress on of that success we year my announcement this With overcome barriers highlighted today's the I we have see so have arrival. hope

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confident I want execute our that desire our team And advance we and objectives. I am our all management to organization's successfully in continue will know to of focus need to to and you against our objectives. in

world with humility this our and around goal our for the best successful the vaccine is full with XXXX. our these deliver in you performance I to season delivering It to of all consumers a company shareholders that our continue and key give our stakeholders to and commitment efforts doing

now your take we will that, With questions.

We will now begin Instructions] the session. question-and-answer [Operator

First Roger will from Jefferies. come question with Song

now ahead. You go may

congrats for progress. the Thanks question the taking for all and Great.

Thank you, Roger.

you, Thank John.

first, couple of the on Maybe US a questions from to market. So, focus us.

September? on what's of you already to part late all risk possible the BA question. Is Maybe hand? submitted? supplying that's to Any requirements that versus clinical XBB the XBB started, be be curious already need see the one will to able US -- data so FDA the to by filing of X you just left data you meet for So, will -- will have they

the for to you. is we And versus impact drivers the maybe in strategy. And there? talk in presentation gain -- for about one dose, you see be XX-Q, any pricing from market part are able the the share what to is meaningful other those Thank the specifically, your key five US this for

would Thank Roger's the you first take question, please, on Filip, Roger. submission? you, FDA

Sure.

The kind did. need submitted why So, we're we that the file the packages, that's are and what previously going this the we and the with globally we XBB.X.X. the is XBB of CDC we the available BA US not And our to the the for have in and approval is plan X for adequate September. at of end only preclinical we FDA month. clinical data connected need, for study to data product but release for FDA for complete discussed time

you, would And to take like Trizzino, John you Filip. commercial? Thank US the

all big that the availability been you able Roger, segments all drivers script, in have review -- this strategy, have markets but Thank access being John. Key sure piece somewhat thanks. the outlined market to make to to have vaccine. Sure, a Yes. an of

provider across health. available spectrum. and pharmacy, our care in that have protein-based non-mRNA distribution, the about that public accessible regional health strategy offices, make participants entire the talked are we We've or sure vaccine key national to our These vaccine

And care is we normal to been getting strategy about and reimbursement the being of those about in of consumer. we're channels it's think publicly competitive that incorporated situation seasonal strategy, makes a normal vaccine into are, the Pricing channels. WACC through that line in $XXX means that all provider purchased to gets flu vaccine, a stated, health annual of here be All the advantage as sure us that what normal to of with what's the

I season think limited that last vaccine. a the it's purchasing of our critical very we access here had and vaccine contract of late to government during our understand to approval

provider We distribution protein-based desire consumer network with in in in market be market be place and and vaccine. inventory a to are for starting the well-positioned strong trying care the warehouses the now to health The September.

you. Maybe financials. next Thank Great. is regarding question the

significantly. months? mentioned And is your position see key That's improved on remove successful, to I remove for glad also, going the will when you the Jim, you financial operational very concern. And little what plan next on elaborate a XX concern going your if call, So, potentially just that the investors, all can point bit you. and condition under Thank you maybe the believe. in

that can you question. Kelly, Jim Yes. take

made interest an high you're this significant Hey is of Certainly. area our And for investors, We financial really exactly health. we've progress. think that right

as we important with announced really of X/XX heard going our that to correct million us you in we eliminates receivables. partnership cash SK mention, just both strategic and the it it in concern, As $XXX certainly XX-Q. disclosed is of comes further a in further liabilities. have that And you When improvement are our

of look think vaccine marketplace. what say more right the fall this And that's performance forward light in our And can updated in now. commercial we to I we especially updates providing about

operating our plan. with optimistic we're -- the think I

endeavor be We execution, continue remove appropriate with going to concern. expectations that we the line execute well. we would in And that then so, our to if with do that

that in on more the So, future.

for you Thank the comment. us. from Excellent. That’s it

JPMorgan. will Eric next from Our Joseph come question with

ahead. You may go now

as whether national for the any available the you single of I'm regional of whether be updated have multi-dose Good clarify And fall the would campaign? vaccine required And any morning. XBB whether I curious format the a or is PBMs? then dose US also to -- a single-dose format by Could or a follow-up. know

want Eric. that you, John Thank T, do to one? take you

which will endos. Yes. we previous reduction Thank from our five-dose vial you. a presentation, is Yes, be providing

be looking sufficient vials. unit on was sure vial. sufficient about timing decision There's -- supply -- made of like. dose with The then and assessment had conditions parameters. that talking to to dose are what been we market go have We

that's are refrigerator and while still And being care from sure no our barriers there stability having the of certainly pharmacies, administration shipped coordinated customers, ease vial. is distributors, five-dose the vial others frozen the and health use being providers, with that to the all et we of cetera. making five-dose reality communicated and of specific are a multi-dose no have vial of prevention There still is product.

question? follow-up You had a

about priced, there your the of be really price? Thanks you John. just in modeling what made helpful. US? competitively that comments picking Is in but a very Maybe guess, or discounts net up That's I we did. it should and pricing about Yes, range thinking should terms WACC, your on note a comments about we being be

Yes.

are what the that, the specific to calculations of going purchasing the an as what for taken disclose being important not providers and care of that's for that health sure can the reimbursement they we're strategy. that imagine, knowing But for, it's contracting that making are for, across are these calculation reimbursed part consideration contract access into we being strategy, and you are all pricing strategy channels So, terms. overall

channels phase office particular, are or all space mentioned So, contracting I've physician groups. networks, across in pharmacy, mentioned positions buying I've physicians, integrated in but categories delivery in office of

And affects so their that therefore, contracting significantly decision-making. strategy

Final I could. one, if

ready some this I delivery be that here. in if respect the APA expect second still done one distributing the the last Or that sort deliveries half with of to in in Wuhan XBB the strain should not through With region? at that's a to point? the there speaking what's get, you effectively of guess of with under you format? be timing that Just remainder case EU, strain the to the are

Go ahead, John.

Yes.

rollout of of XBD. different the have all the Eric, The the fall in our will APA. So shipments regions be variance strain different

or we're So, up then all before going of to finishing be Taiwan, be APAs coming. all have are New product in APA Canada, shipments and Australia, Singapore Zealand this that year, shipping end additional the to EU

-- an or the tender all commercialization have cases, place be either market whether will execution we're already of and the But in APAs, private ongoing still of we markets. strategies, there in in extension

In markets EU the focused those attention the going the on are be in we go reference I our several will to season. markets focused as into made -- to that key be script,

So, we situations understand what those are.

contract. settlement Europe understand, about Pfizer in their especially also Europe against We in the Pfizer about the

us than conversations still those more future. for all negotiations market in However, sufficient again, share available leaves And acquire. already that process the and for to are

taking the questions. Thanks all for Great.

Thank you, Eric.

Cowen. from TD come will question next with Smith Our Brendan

You now may ahead. go

quarter. Hi so the Congrats taking the on question. for Thanks much guys.

you, Thank Brendan.

Yes.

to or wanted to point still also I as to to building negotiating if to questions. any I of a them So, a really, of from about ones planning maybe couple ahead kind just APAs? remaining quick on, with the and is? your Or point couple fill any of at governments go I you think, ask the to of APAs, rest monetize really guess, you're this the try of fill expecting are the these currently last

don't then last for know, plan your remaining we guess should maybe move I one the I we of And any is or kind question with Wuhan the if on the potential what booster? or the vaccine, the expect of existing into outstanding really XBB any, supplies disposal fall write-offs supplies doses Thanks. of as there

to John, do first the APAs? take want you on question

Yes.

Let just me -- come back clarify. I think me to too, let question, and Eric may asked same the have

variant the of the year the XBB be. stream under for balance will remainder will vaccine to this for be included will vaccine be the all strain be in made of what So, shipments the

we're we made No the be engaged. VERPAC of will continue That of included. with time, to for period regions be of shipments to that we, the the do recommendations this various have throughout all Wuhan variant additional will complied strength

country little a bit country. are by APAs The different

what long and to talk term continue with to Canada, APAs a no continue the for their under XXXX will commercial vaccine wholly US APA, coded amended continue XXXX are. So, them contend It's in market. under the APA we for needs will example, with and about

conversations Zealand, ends tender basis been to another on those their market what for private amended might continue country-by-country APAs and -- year, be and similarly, or either this have with but then New for years. Australia market Europe with a

the established very all and we've relationships to on the value continue case, us. a In be strong every full cooperative APA. flexible country-by-country of with They've pandemic the In cases, retained been the contract during basis.

obligations. vaccine variant continue either be will commitments through satisfying future to we So, those purchase to or updated ship manage that against

question Wuhan? Kelly, second potential Jim any then write-offs from And on the

quarter, write-offs I in exactly. you and ex-pre about this we obsolescence. associated anticipate Wuhan. million I noted think it's And in think [ph] any Yes, $X COGS don't our And with

just the items, said and customers. those Wuhan fall. about of John updated vaccine the sheet our balance to this vaccine I'll delivering all just on we've what So, we're fully reiterate getting focused

are We fortunate.

requested that Our on Wuhan our delivered was a that. have to of quarter. are in And to people QX, this and what customers by topline we part delivered happy see

about season. terms the one-third you in that think of given phasing $XXX we've had we just did when revenue, we of And just Well, our before or hey, we that. million about said, guidance expected fall

and this forward the year, remaining billion the is so look $X of updated back vaccine. $XXX executing million with to And our we to half

Thanks guys. All right. great.

Mamtani Our Riley. with from Mayank next B. question will come

go may You now ahead.

execution morning I transparency. appreciate Great against see plan. Good solid team. your to your

around your of liabilities noticed kind on on the XXXX management. following XX-Q. focused the sort up update We quickly Just current in question the of being prior Gavi mostly

color you liabilities curious, just out SK Canada in topic, anything that near-term? provided the current I'm with else anything the looking have hear of-- we in on the bucket and happen could And additional that a the we should beyond I Bio, on should be then couple

want comment? Jim. Do you to

Hey, year-to-date you is financial asking When so the think well our because it way, million liabilities. certainly. by liabilities about we've about forward. you current important and eliminated $XXX And that to for thank question health this move we the current as

strengthen SK it, as the with we My million We associated million our, these $XXX have approximately financial $XXX Bio. a with the a set further our Gavi. difference I'll call what position other goodness, company. agreements do then as have in And of months really incremental last a still with important associated made liabilities,

by our scheduled And are in we the our disclosure has hearing speak policies July can't dispute to heard that legal share position as we we us that a -- XXXX. say that before next been did You claims while have we unwarranted. arbitration think that stand matters, for the

all certainly, can and more the on giving this progress share that's this going that future at And on great looking strength improving front financial to forward we company calls. time. of and so more back in to But updates

We a maybe antibody fill on mRNA, -- effort, subtype. had mixed to the saw at and quickly major flu-COVID from a recently we've strain Filip, in, for then the least unfortunately And helpful. particular Very work ongoing. relatively failed results

sort learning Phase you're of about your candidate that think that obviously, distinct there your as study? execution you you to looking and advantages are design -- have how talk and late what combination might Filip, just you III with in Could you for be about,

Yes.

a So, set, that want the compared previously remind first, presented right? We small was I data XX we relatively to different you data formulations. that

had So, be to bedside those mixes.

for formulated go next To could testing would which vaccine study, we're the we whole product actually into is co-formulated a a So database, study. the idea looking safety to be this product. going at. we're be the Phase final large We superior to going have develop we're a think III

we profile, efficacy and study clinical product to to That's aim the follow. III that Phase with prove a target

said, stage to the get co-formulation forward study, gated Phase IIb -- the release superior being the that value of really asset of next study product. year a have we the the care that taken increase to us in and as assured have to go a Phase III we'll our really in to and approach future, develop is that looking Now resources to hopefully,

we around just I one range on broad for may. versus John, some maybe one Okay, if price share is versus discussion. And levels, of range understood. of -- characterize of the how curious, considerations just customer terms sales the fairly should guidance volume that final I was market and US based The some later your in product timing

different are You with GPOs of may excel how which is done those variables broad? terms in already able down and break haven't against that we range, you sort obviously of -- to really

you comment? Yes, to want T., John do

of seeing market think a reason range lot estimates what's in for in you're for driving significant be sizing fall pretty good variability I probably US going on demand look, Mike, Hey total Yes. of market a the that season? to there's

lot getting or a fall the off get US of the good the reason booster, for government that. and You they It was vacated The victory over fall headlines. in was third lot had second People pandemic. last the declaring falling the were to fatigue into told in were vaccine a of season campaign. be

situation campaign. I this think different in we're fall in a

strain new the reduce have from illness to that virus new of strain. order strain that be in from circulating or serious We to protected a

is care as about have to this place. expect. communications communication what's going the to from to public providers their advising in and to in the and updated part, that need drive need to consumer the health vaccine campaign the You what information CDC and assistance

the funds. going a And course, level, participation office-based pharmacy engagement practitioner forward. of with programs, it's supporting right, the role XXX plays then, health, at public the VFC vaccination, a significant

there's Access been sure we've for Becerra the Remember, underserved populations. insured, coverage that's lot no also Secretary with underinsured, to about Bridge Program talked make a got

going weeks we're and out And so to think few that watch to over I decide the play months where this is. next

market our as in the share far had participation unfortunately. Remember, concerned, little very we US As year, market is last

-- so And we there be protein-based vaccine. a understand for able but what have should think moderate we demonstrated is expectations do. about value They to non-mRNA need I of that But the vaccination. a COVID kind of

vaccine and to talking in We choice US this important are about choice the market, going the being to we're only protein-based market. and be

in share market to expect some see we fall campaign this So, sure. gains for

Great. questions. Appreciate it Thanks guys taking our for

Bank from come will question with America. next of Our Alec Stranahan

go now may You ahead.

our taking question. for Thanks guys. Hey

Just a us. from couple

And BLA, contract the follow-up. hand? contingent got ELA a expect recommendation around if vaccination you not, BLA that finer are into recommendations? And any of a a the ACIP the cycle First, I've that expectations maybe approval. just your MMWR point expectation you. or in on have that you'll on Thank the fall then an Is going deliveries

John T. ahead, on Go that question.

make that question want understand. really a everybody actually we to clearly that's Yes, good sure

are process we in the of So, for submitting BLA. already the

final We expect approval weeks months BLA coming and and a within the then submission of quarter the to be next in first that year.

have coordination the full and positive Constant with negative campaign, communication a effect for right? not does or process That FDA.

authorization. the emergency use We expect under flexibility operating full

said, I and has FDA. with with taking the conversation, That the place regulators as been

to so this product And authorization health providers of FDA. from across because the will any restrictions that no have we EUA care pharmacies, available distributors, our

And maybe follow-up maybe great. for Filip. Okay, one quick

it's goes the want Is on the in data need available? versus if the this And protection to you FDA do immunogenicity? market once the Nuvaxovid updating infection? for full would latter, approval. be this demonstrate is also simply you. the Just terms Thank BLA, that comparability what from to Or see into of data you the would

Yes.

of kind on BLA the this, on the based strain. be original is vaccine me itself, the let So, XXXX, prototype crisp

for John EUA going we for in as that's a approval said, that's have going is also XBB submission and in. So, The rolling the now. is

with we've As role. to key be the completed for And is you data that for than I've authorization other variant. the that's clinical showed the end a said, I CDC data data saw There's other in expectation us clinical to be product building the complete today. today of XBB concluded this the month. And you going of file September data the by FDA. for no

forward. BLA a year, there's subsequent a up file next going this all which Now, wrap single supplemental will into

point and subsequent going So, at with next the EUA of some in and game variants. out all year, we're game a this be BLA straight to

you. Thank Great.

next Instructions] will Bernardino Our from come Vernon H.C. with [Operator question Wainwright.

You may now go ahead.

taking my to and and question the just liabilities. on for on Hi congrats positive the everyone. Thanks restructuring results wanted few I confirm a things.

dose I vaccination a have WACC and the was is type you. for quoted confirm for was booster full that Just shut wanted And Thank that follow-up. that the regimen? or you whether to single a $XXX

is regardless that's Vernon, $XXX presentation. WACC So $XXX per dose of --

therefore, calculation. healthcare is specific calculation follows line then, is reimbursement of all supporting of that that providers contracts the upon to so works. And the And out with course, process in based how WACC part

as And beam with combination and far that a also somewhat how consider with therefore, of would -- know premium desired does price. that's as deserving and pricing? vaccine of kind [Indiscernible] to such a [Indiscernible] work we how vaccine that something end that would I receptivity a COVID then, premium some How

would know don't Yes, it that I premium pricing. I call

a prevention of severe significant the disease. reduction of or illness in You're

from out et received at of based out cetera, upon pharmacoeconomic illnesses benefit for associated is vaccine against burden So, with hospitalization, work, takes the a school, et that that of the economic the look cetera. modeling justification the

think consistent combo a We're have manufacturers. won't pricing WACC for we're a benefit that strategy I with that I comment where cost the supports is that be calculation we vaccine. confident robust to yet is analysis reviewed. going there that a on other

consistent Phase also and something is vaccine in than But saw we market that based robust if data you and that leading better have immunogenicity the the upon do the to benefit. that the II, from you severe pricing are profile with you that would with that a vaccine robust has that combining the a a see economic against COVID expect efficacy burden disease

additional the insight. Appreciate Terrific.

You're welcome.

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

Just you everyone. thank want future. forward to look a sharing everybody. We day say for Have with us today you joining appreciate it, to further great in we and the updates

now attending has concluded. Thank for conference you presentation. The today's

now disconnect. may You