NVAX - Earnings call transcript Q4 2020

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Novavax' Fourth Quarter 2020 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation there will be a question-and-answer session. [Operator Instructions] I would now like to hand the conference over to your speaker today, Ms. Silvia Taylor, you may begin.

Silvia Taylor

you. Thank and and call all quarter to year operational everybody have you and you XXXX today's joined discuss highlights thank afternoon of to who full Good results. financial our fourth at be announcing release of currently our audio results A our novavax.com call website press an will our and conference on available is on website available this today. archive later

this filing also are afternoon. our XX-K We

Gregory who our progress Covino, John an today and me are Financial Dr. briefly will President Joining to our our pathway; Officer, provide scale-up, Officer, who our financial overview of update Officer update highlight trial President and CEO, status. Stan Research an Trizzino, will and regulatory provide Gregory date; Development and manufacturing global Chief purchase Glenn, Business of will Chief Chief Commercial advanced activity Erck, partnerships who who on us and clinical on will and agreements;

the Additionally, Dr. at Chief will of Medical the Officer, Filip available Dubovsky, call. Q&A end section today's for be

subject like forward-looking Stan. over are the that, I'd meaning usage With Litigation cash statements the forward-looking Before which to strategy or and will to are numerous Reform regarding remind that to could matters, projections. and financial remarks, change relating financial, during hand call clinical condition and statements performance, operating clinical development revenue, Private you I financial teleconference uncertainties, include Securities of this Statements need we making forward-looking these time. Novavax expenses, milestones within we the assumptions, or be future that and commercial and expectations now to statements prepared over anticipated Act. other risks cautions business to or begin with business-related that including

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

Stan Erck

coming a this we like this we've are headed as evening. Thank everyone in and make joining remarks opening how you to to progressed year. and I'd regarding reflected company some thank us for you, Silvia, where

questions. some Following time that for will take

has been year past the a So whirlwind.

businesses changed world years We slowed would opposite, we've due ways our changed. take down completely in the has company the company the in pandemic, that normally many had done the about everything several have while accomplish, to to

get we presentation mission. non-stop a since that that each accomplished see been soon. has and of that to year. a don't staff I'm in can But and that of time lifetime I'd the what our our made into accomplishments the of once far so importance like take mission satisfaction I'd made shortlist Before our for part are to have say like Annual Earnings start has from the that to effort said Report. of for all know any them for staff a you they our a thank entire last of recounting our presentation, having by everyone understands afraid our slowdown I

vaccine sometime We South U.K. also in showed so-called triple-mutant that participants U.K. that the Australia. X/X trials have was we variant with trial South against XX% U.K. is COVID-XX year, program, study In COVID-XX we achieved completed in was effectiveness COVID and the our we With trials. XX,XXX shown and over September when the tested the trial, preventing We was endpoint. vaccine will network or to and on partners portion at had disease in year, in the HIV of discussion annual enrollment a the and Phase XX% enrolling U.S. XX beginning capacity enrolled of X trial ended strain of to financial exceeded the spring gets trial. without financial last almost total NanoFlu lost strength. for worldwide. manufacturing started in African contrast, our We've last sites population our variant pivotal In We year efficacy only effective same by basis countries clinical million COVID-XX negative. we completed circulating, started initiated last of XXX million We vaccines sometimes operating manufacture we our any exceed XX% global last that mid-year. and our the against three of a of in XX,XXX likely participants. product. COVID-XX, have now the will year with the employees that and about and in in this original effective the U.S., trial in Africa, the over February, X of the six In met and months. in Between the last employees year, approximately and program have continue eight with summer. exceed a cash billion build we XXX the capacity for $XXX X,XXX year doses Phase primary built globally all with In employees we horizon the an of At our $XX

U.S. Government and the countries - these potential accomplishments us with dollars and Gates the months. Gates the combination vaccine and We income that in capacity in provide effective of billion XX commitments long & the of and can to partners and the be next pandemic several our expertise to revenue worst the our have over the the safe from now including a The The and representing billion all secured most CEPI world, levels the vaccine of of $X for Melinda century. Foundation, be for including and Bill all importantly, foundation it help in Novavax will the purchase funding Bill last from over opportunity used as that term the gives in

development progress today details I call over more now discuss the the year. hand clinical share to XXXX we for to to beginning XXXX. made Greg highlights from program Glenn to the our excited on like would during historic the and are We of

Gregory Glenn

Slide and remarkable a this Thank turn you, Stan, we has X really maybe to year. can been

I'll we call month one CoV first We our which XX this CoVXXXX, it the the to of identify respond being as the a candidate. pandemic. identified protein for SARS to moved past fully sequence recombinant short, XXXX published. Over within rapidly Novavax COVID-XX stabilized months, vaccine We

component We together formulated showed role for immune adjuvant that responses protective the models. of key when in also our elicited challenge these induction immunity demonstrated highly animal potent Matrix-M of

see will demonstrated development humans. moved same level rapidly the efficacy you and high below, through in now As of we've clinical

Medicine publication see including quality goal transparency are Our and satisfaction, manuscripts, peer-reviewed and to scientists England in a this published in we the multiple journals Journal and met you through high committed scientific Nature. know prestigious few, with what we've New of Science journals, here

protein offers the global its optimize Slide XXXX to moving X, which and expect our we expedite based So will subunit recombinant benefits, of practical vaccine range distribution.

result ensure refrigeration typical as through protein stored a supply spike enabling at our chains. to can First, be stability candidate and recombinant designed temperatures, distribution coal was standard

safety varying facilitate markedly administration ready The of is has liquid both it's the COVID-related immune X/X X, to On vaccine. a safety and protein overview and trials vaccine, all is key This immunity doses adjuvant manufacturing levels less the demonstrated the and convalescent excellent feature a we role allowing of global seen critical while produce of the more use Additionally adjuvant an to in augments suggests our of and greatly introduction that of XXXX immune and excess effect, distribution. exceed required the both vaccine were Matrix-M an enhancing responses, the which us antigen COVID-XX that dose, vaccine bearing trials. functional they our of data per of and Phase of the the an has formulation dose dose clinical profile. from provide our the sera. of high Slide The infection. the adjuvant with for XXXX immunogenicity reducing The well hallmark capacity immunity

dose in microgram to Republic are the confirms In Japan antigen. several immunogenicity and the X Czech have that the addition, or this soon starting that to already study be note will I will India, vaccine. help trials to global our want for access the extend that other there

the for For to I'm day - on I'm of efficacy results going studies. today our focus

the the the in occurred circulating conduct, health insight public opportunity and we led FC to demonstrate demonstrate and first evolution, are a face their the vital to evolving to against for utility the major three virus. of technology virus our During has This of unique all COVID-XX strains. dramatic

by support enroll XXXX After XX. in Slide the the Phase able begin Task age in were Force our on the trial X. were U.K. of XX% of the Vaccines our over we September in XX,XXX, to rapidly about U.K. Let's registry, X talking of over NIHR with trial initiating whom

Our analysis overall XX%. interim of topline an showed efficacy

best-in-class original efficacy the conducting we the of during appeared amid U.S. direction. data will However, in in suggests demonstrated an with the and the mRNA latter to the is during heavily this trial, seen perform in XX% virus strain COVID trial, the strain XX% efficacy. the strain virus we vaccine the trials, rapid this the trending noting observed as U.S. viral in that that growing XXXX that variant U.K. B-XXX the evolved against in prominence well evolution that's and the it's worth This similar

and the primary MHRA for U.K. after completed data has authorization the second a rolling of cases our will requirements. a submission been have coming that Considering with file collected All U.K. endpoint final quarter we by trial from CMC the with data to additional sufficient initiated We weeks. non-clinical in in to available analysis be the and early we authorization, plan gathered have pathway been

population, efficacy XXX HIV-positive now X,XXX the Phase efficacy the in endpoint in also XX% negative, demonstrating we adults. achieved XX% Xb X, important at level efficacy XXXX stable was that about Africa our of enrolled of Slide diverse volunteers. We in the demonstrated note South HIV on primary Moving trial population overall to our all including including It's a study population participants medically of significant XX% to participants. the representing

surveillance, accounting trials, During cases. evolved conduct XX% of widely virus South during during the earlier, African circulated mentioned our was the BX.XXX the sequence trial the variant I of for and

study to suggesting BX.XXX with prior against again COVID-XX Although seropositive protect XXXX the subsequent the participants did that with not baseline, did one-third these XXX antibodies prevent of not variant. seem - infection were infection

vaccine response that and NanoFlu However now the qualitatively in the evolution, significant here direct reflects though X. I offer vaccine derived attention even the appropriate did we a better would from to from broader your the as and these of strain. unexpected Slide responses. the This lessons to shows face XXXX COVID-XX was not original like is protection, matrix adjuvant have learned

we conducted progress over pleased network. prevention the We Briefly date observed in Phase randomized study X-to-X in with the the partnership trial Mexico, NIH and is the we've enrolling which to trial virus X design corona efficacy XX,XXX with subjects. in the our a and U.S. with are

the see, You previous final aligned trials can XXX with and endpoint events. primary will cases analysis XX our interim done with be is and

and the of expectation the in X-to-X major a Finally, highly crossover population process, discover we we played are during well role randomized motivated participant as recruitment. the elders as to a encouraged believe enrollment expediting study,

enrollment American, the is And to this two older. complete of If can of XX,XXX in now December are study months we of trial within Asian-American a of initiating diverse with XX% comprised you have XX% which of Slide Latin we XX participants, XXXX. X% look at individuals American, African-American, Native X% XX% the XX, we event-driven population and happy approximately report

this to the announce quarter the depending on We from attack interim the course overall expect data in of rate. trial second

implement, PREVENT-XX blinded and X of these placebos enable working As to participants duration Phase continue the integrity crossovers, the participants of studies This remained ensures safety. both still we crossover in I what today, the for placebo initially the receive efficacy and following for participate blinded opposite blinded trials. and active design are received to or In will blinded. while our to us U.K. of

For protocol our the crossover to details submitted updated PREVENT-XX, of and been been including the under have protocol blinded the on FDA website crossover resources. posted the our has

XX. to ahead Slide moving So

ongoing Canada, the submission filing the regulatory Medicines on regulatory Administration to align Overall, very to Health our are expect Therapeutic complete discussions our quarter. in with authorities we application. also second in At front with regulatory initiation required began and the data the Australian the provide pathway New Agency, time, EUA are European the Medsafe. and information including our we've the Zealand's for Goods process busy on rolling other FDA we opening the and this continue of to in U.S., Regarding EUA the IND to we multiple

and will we dialog elements our complete for safety, pivotal U.K. We we in quality ensuring continue the efficacy regulators authorization. engage with respect that Phase required fully to X address to and clinical as in U.S. trials all

we future As to we areas for XXXX focus program, like would to months. two the of highlight our clinical in the coming look

XXXX now our on dose U.S. candidates. and in in Australia the valuable X/X Our of U.S. six functional a in Australia clinical six-month month development trial positive and provided boosting place our taking production the the participants protocol to examine continuing immune to of and safety. Phase immunogenicity in On XX, receiving May variant The XXXX data a trial you stain X/X Slide see and initiated the boost with is offer insights Phase trial some response. in

Our development in technical - XX can agile address an and addressing of as arising enough to vaccine virus. strain bivalent suitable enable mentioned, bivalent a made is variant exploring the around including evolving the have the I candidates. boosting technology stand-alone COVID-XX strides then for we Slide of On significant as that the approach vaccines globe, mutations also rapid and

and We in in in plan candidates are studies mid-XXXX. these to evaluation initiate human these evaluating clinical candidates ongoing primate

processes and of We are the the vaccine our leveraging to our the evolution the virus. technology manufacturing evolve alongside adaptability strategy of both

seen high level original best that in the out efficacies inclusion strain virus viral Slide So efficacy now strains against the against levels XX, two coming to two and variant of have the XXXX's we demonstrating results evolution. similar of at trials on independent

encouraging We an also safety see profile.

of clinical it the I'd Ad milestones with XXXX that We turn John achieved to months team to that, the including data over with from Trizzino. coming Stan additional as are data to forward has proud mentioned, in to and the PRVENT-XX. look these like date

John Trizzino

Greg. would XX, to like to your now. I bring attention Thanks, Slide

U.K. contract the that is global agreements COVID-XX an expected mid-year. partnerships see part the and The can global partnered is XX doses globally in and own in This combined will Novavax you and Spain centered COVID-XX an on Czech Canada, in chain built to organizations U.S., impressive the supply slide, months, integral As around includes infrastructure exceed we our supply have vaccine X by facilities. when South from India, Japan. infrastructure for facilities license the in and full reach basis, as pandemic. Korea this network global This and the Republic an billion owned about both securely capacity, of past our capacity with annual Sweden, manufacturing which positions solution manufacturing we

large materials partnership offers me Korea highlight South of our committed the the manufactured respectively. CZ for and now access of strategic will provides our with adjuvant Czech component following state-of-the-art the facility capacity sites vaccine some that sufficiently in low-and and Matrix-M is and manufacturing raw SK scale, Bio with at a antigens. globally now is access Takeda Institute Let multiple points. Serum provide licensing important Novavax that is producing countries. vaccine. capacity manufacturing The to partnerships additional immediate Japan significant into Republic middle-income and

we In at manufacturing recently addition MOU expanded to the advance purchase agreement just in Center have in Canada their Manufacturing Canada, signed Montreal. capacity for Biologics an in

global equitable that the have XX. slide, year respond all and to to mandated we know fair and must past What borders on that response a therefore this on Now our to painfully ways have well Slide be multiple is This access pandemics next a scale. come in globally. no ensure Novavax

CEPI, various Bill our an vaccine and the globe U.K. country-specific that into the partners technology Gates for Then globe and South provide Government, U.S. the Foundation. First, additional supply a countries funding India, the expressed finally of that around include our Melinda and partners as interest the in around Japan. function our to manufacturing Korea and that allowed BMGF,

it on update committed Stan Institute I'll With doses Slide back our NanoFlu to as provide with you on slide, license million XX. doses, that, So million the the over X.X Serum totaling date. facility Bio agreements procurement, Novavax Serum various to, by with the doses Advance approximately agreements committed additional to see Government, have have been XXX can executed regarding Institute, program for and SK that jointly agreements Purchase an potential XXX to to we billion and COVAX this and Takeda. U.S. turn

Stan Erck

John. Thanks,

COVID-XX majority year While announced primary achieving completion year to the and we trial We X spent this committed time the Phase developing our through all advancing attention NanoFlu candidate, of are last of vaccine the quarter licensure. our pivotal in of objectives. remain we clinical first successful regulatory

published Additionally, November Infectious Clinical Diseases. we in data Phase the in X

developing and NanoFlu options NanoFlu, this trials currently in and generated or NanoFlu. clinical commercializing exploring more to three. These the vaccines, be on candidates as RSV variety XXXX data year and one bring earlier are combination a Based such of to one options this of the to We all related later more year. potentially these or plans include

of they platform. I that As And always with over as hand results. our we large it financial become that will will post-pandemic our publish studies to now available. the will provide in vaccination for seasonal these commercial results We believe opportunity a combination Greg Covino vaccines to with era be

Gregory Covino

Stan. everybody. Thanks, Hi,

to turn please XX. Slide could you If

through good financing I laying the fourth press P&L highlights pretty addition job quarter in running activity does out to So activities. a full-year of our think release and of quarter-over-quarter,

So here. I'm not going to repeat that

prior filed call. during just also XX-K this of course XXXX to We our or the

a So including included important the new just note includes an financing his and of of ATM. million on agreements occurred comments of year-end. completion summary a $XXX which XX-K those that John and In XXXX, make the events business new also supply we've to in January subsequent touched and we update on substantial particular,

approach So the believe well Back to million please position we financing I we Stan. you $XXX would a the take year-end, of activities year-end position to our subsequent cash look in vaccine. are capitalized the solid XX-K. considering you, to over everyone at encourage financial and our commercial and the release in saw as launch as Overall we COVID-XX

Stan Erck

Okay.

dialog that in our Slide milestones with clinical XXXX. as authorization remain global will in In licensure for key plans as commercial seek extraordinary parallel, our agencies and reflect on regulatory to to we and executing global we manufacturing we will collaboration we partners. delivering XX the XXXX, advance on with Novavax made in Turning continue progress focused regulatory well as

Only thank year. this want Foundation, Gates include With and contributions been help Melinda to team various and our year. of it Bill will to a the to part Prevention outstanding COVID-XX I the the our call the of and pandemic. for Novavax Government, to combined incredible global which able continued solution become Before CEPI, like I their I Network, a and thank the over whose the for COVID-XX for now these efforts, Q&A. response pandemic questions, entire open we've would turn also accomplishments achieve our make to during immediate possible few support operator through partners, these the to that I the U.S. the developments

Operator

And the Kelechi comes with Chikere Instructions] from line Jefferies. your question [Operator of first

Kelechi Chikere

Congratulations vaccine, on there. question the or is ability guess your and to I And provide I'm can or last your any manufacturing. hoping quickly provide to actually related would now? vaccine progress if the all manufacturing be shipping I suspects are you how monthly Are from related to go able would you great? one your color my be production and over guess you e-way capacity you where to first any that to that, year. follow-up around additional your color right just could on able authorization I question. you And stockpile to color there, provide approval have

Stan Erck

take This that. I'll Yes. Stan. is

So that the as we most we to probably the of part have, sites mentioned, so antigen, on manufacturing that's tend manufacturing. focus the manufacture complex we

product dependent they part those on sure it either instance how at XX run. they that schedule we so it, are make have at the those finished raw depends put upon we've commercial all scale countries process that their runs enough materials production all they runs for and And making scale, product established in those GMP to making in many of they runs, doing cadence they're engineering and their making now into

raw at make to getting there work I plants get but materials we're the full scrambling there. speed, some to So enough think all

will so in advance we at that So the - plants should regulatory the of April, June, finishing by May, is be that in to full April, be finishing ability expectation approvals. scale all of product

the the when shelf are from now Europe so finishing have We and will for be so filling United both shipment. we material those Korea packaging and the U.S., in approval and on in material we that will and in have States

Kelechi Chikere

in data work related with in your data guess And suggest non-human the experience in vaccines, we non-human immunogenicity to and would there for that, to your I of guess the could ongoing would respect as your be your pretend variant I XXXX your primate or given variant see greatly humans, primates, efficacy thoughts vaccine QX and with with appreciated? what that

Gregory Glenn

the animal were out turned models predictive. has quite It

in So non-human we very the good have efficacy primates.

require we use physiologic because vaccine not the are models to immunity why surfaces. to vehicles of they're they and are them, that's models, really perfect they they So but disease not get induced that

it's think well. I overall So bode quite

where predicted. model, did of The safety they I'd some initial and is point non-human other quite the primate to studies we just and baboons, sort animal were immunogenicity

remarkable is and models. they've kind with they us They to a been I we really so - in Yes, have the X get we we'll sense like have us something. efficacy completely we saw think we journals, Nothing think see. which are makes receptivity circle. all a mouse but human good are always of we So to the as telling as results to the probably quarter also high the review, we aligned peer is actually human soon with out all really informative publish pointed disease, that that trial, we all

always peer end are to back be review going - reviewers. call We of the at

we to science timeframe. data, in great great we have have and expect that's that unreasonable not should So data

Operator

with question Eric comes from JPMorgan. Joseph the next Your of line

Eric Joseph

of after quarter still anticipate data basis as do the you South the on U.K. And and XXXX, efficacy the I guidance to process Thanks the of Africa for questions. see a to a just FDA or submission in starting path with for current then path discussions follow-up. where trials? does PREVENT-XX wanted better for a the having second secondly, the sense EUA to potential filing from are taking in the get in

to or with with that registration? there, for immunogenicity vaccines, I they the they the initiating sufficient intended would approval for Thanks. FDA's mean, new the - guidance, human trials sufficient would As bivalent for the guess would it planned the they you're of the relates be and be is I trials expectation variance

Gregory Glenn

our quick data the and Dubovsky, Medical the comment form I'll could to turn EUA. that the We're it make then over a Officer. Filip U.K. for I'll basis Eric, Chief assumption operating just on the

you as good rightly backup trial. a pointed have, large out, in We pivotal a

that's strategy. submission we're of our organizing - sort So our that's submission how and

think let a talk I'll the So that, to little I bit strategy. with Filip about various

Filip Dubovsky

other X our that are Phase aligned the all of endpoints of studies point the is between them. three guess I

broad between of is at easily. we our prototype can There to spread things. as in by where latter that vaccines. plenty and antigen vaccine be. high. So safety, do really to a protocols of We a suggesting studies. We is the with they've they've want where that's efficacy the And and follow-up, aware as are think format. Brazil that to do and as a very showing studies bivalent strain energetic represent we variance to We we more well. and we've know seen do well strategy, the other we This immune of Onto the is endpoints a the non-inferior Africa the They different what we're is global we capture current to one to variant doses the have circulating our our the mind and in way look think bunch in from gotten difference plan strains are in about the from and no South original guidance for two all going well of the variant by approach themselves strain. space studies getting but as range these licensed situation, regulators about the importantly responses versus things that the

from that. our went XX X Phase studies, without to up X we know You problems micrograms Phase with and having

solution think the a here have problem. So for we we

Eric Joseph

maybe just. quick you with in guess candidate? say maybe the bivalent just for for regionality conducting this planned Thanks. taking Great, follow-up, thanks I a those of trials questions, you Thanks - at would anything be can the as point taking terms where

Filip Dubovsky

So different and designs take the we executed. the finalized have account into given study will be studies haven't regulators exact can location different we where us slightly

Operator

with of Charles comes Duncan question from line Your Cantor next the Fitzgerald.

Charles Duncan

on well a the year. difficult really regarding questions. filings. Congrats taking executing a for really And and on had thanks I our question EUA

any guess previous same is gave can on rate question I for - steps U.K., U.S., maybe in question? the So the answer on just that and color the you the especially what the given you provide limiting

Gregory Glenn

they CMC similar that and categories information around think require around the of clinical. both I right the

So the to just clinical. color on give you

we efficacy that you statistical positive we unblinded As success interim yes met was we that our know because a a criteria. had

represents that analysis. So final a

to in we blinded so cases collect continue fashion However, a and we'll analyze.

just Moderna you Pfizer, second it's sort So like of and another with the saw cases. endpoint of analysis

doing then will early April we're frankly be that and of to to in regulators. timeframe probably expect So I - - both finalize, we submitted most data to and that that will shortly that thereafter will

the is our So package that's, the that's CMC. other one piece around and then piece

MHRA package They've very I to around those to and our created now in. right So think have the same have lot's communication. been efforts time submissions intensive there, those get of good both we're looking partners, try align to

will makes will a there some important we have be of efficacy U.S. so trial also for And are and close could trials, but package the respect think to hybrid and same done the those as of well, we in view I that I vaccine. very context So prevent regulators the hoping that's of as really virus. package that mentioned, so our two as helpful. quite safety with kind of evolving been we've but this on potential And to information the mentioned, with FDA, robust we really topics. licensure, And have similarly as a that FDA dialog basis U.K. heels of are the with the

regulators but like but a that's of tremendously I only think So us, our presentation. valuable will the that chunk of information as world, not for part

Charles Duncan

that. appreciate Greg. Okay, helpful I that's

rate, the U.S. the actual think guess you that quickly, you is compromising wondering will question Second trial, in if it you course slightly case case rate see rate you case but accrual call enrolled given is X-to-X that new of to - trial, the that modulate, that I had data? that that may arm, could experimental is very, falling, randomization slower the if not could the you PREVENT-XX thing it - regarding very I I'm

Filip Dubovsky

and the we This We're of think is all in U.S. things cases aware a of have across the our favor. couple Filip. I play

as with insight diversity the Mexico. that saw geographic them of One and the you in slide

So we and really size did span United the Mexico. the additionally States in with

so We are of have a we places hand, be a critical of advantage variance have a likely to activities individuals is variance, South only response. of in I we the against study the other the hot. So have that actually in vaccine robust the U.S., convincing other are to we going able here X,XXX size hitting emerging we good We study. XX,XXX, in efficacy this we is path faster. just that having the the the have What's Africa, demonstrate safety hopes high the that to sheer on chance know case database. a were this guess works pretty be lot of going so particular accrual know

So have second know from see to their we having guidance exactly we what to it's safety dose. how - they and people FDA the the two-month seeing want and after

to the analysis Greg the to South have target in if we're when of as But package and bring the dissatisfied, the optimal endpoints thinking could for up them they're FDA. wrap about should we the we we from interim kind can said, to we'll bring achieve that's So FDA, earlier, like the Africa. this U.K. the

Charles Duncan

terms wondering - standard a in a able clinical perspective maintain I quickly established procedures, been year. of other cetera., of in as last Last as if really quality conduct, your company to big you operating on as how great and and potential Greg. could I'm business this terms Stan, aspects for guess you manufacturing question It's of you you've leader? company et you've of little in and/or John Filip bit And built provide

Stan Erck

in I'll the the people part quite job Well, to my the an and it's of because bringing because take is been people. new fun company, and place interviewing call, them hire into really has it's easy good really recruiting that been, fun

a got else that the got We product a at and the top We've that We've as COVID got so the data, technology, primate is have us we've way was you is matches on top problem pipeline - momentum. is financial and we the to clear the of of had that. that were that now momentum back and better which can. probably earliest got build list that a very the good from day data than that the had as we've allows from of got we've start anybody a clearly go then fast can vaccines all

So it's actually job. my good a part of

Operator

of Your line with Mamtani Mayank Securities. next question B. from comes the Riley

Mayank Mamtani

much on taking so congrats and question the Thanks my progress. for

go to Can comment and the guidance piggybacking maybe the talking I'm Greg, FDA and yet document upper given you boosters forward just lower there, put curious titers, before. when a even relative neutralizing specifically? expectations just just that off bound and is one think about that out high question the So on and you start about was how or should addressed about with very your specifically on you, maybe bivalence think

Gregory Glenn

so and to vaccine Well, highly quite is we there really us are be for I some but some predictive insights about animal assays, defined is we us our other the think the the have piece be need data know. going we immunogenic need to and what is give to to we details seem what have are for that

somewhat that themselves, we So measures, and are think negotiation, we're something considering and I'm think given can is right exactly I some do maybe - that should I terribly concerned your come what we low with the not can some worried assays be not that's up non-inferiority relatively we we that but the around bar have relatively the there options neutralizing because are assays boxes does relatively come bar a a I confident a challenge the low NI with new at we look mix mentioned. cross. take develop, the and for and That I'm can a epidemic need of into as we're way to up but negotiated, to be of year people to been

So these don't to actually big have as Peter well. be Marks noted that trials,

to a strain flu it's think of to company. attractive way taken I a and very change go mentality be by the the out offer allow

do to won't to So we trial, that there. Filip as to to if be you we we what doing mentioned, want could what it said know, I that attractive. might me - is and trial pivotal how be so we do. don't be to efficacy a structured trial, does I that add is And a down pivotal do Filip, anything get next quite to boiled the Well

Filip Dubovsky

we flexibility is mentioned discussion and I table own have our them science-based are ideas concur and them. specifically bring that see guidance to have with FDA to discussions with going The a these to will and the vacant

Mayank Mamtani

provide update probably efficacy would vaccine relatively difficult any what the could terms in of you means be maybe And to all kind this of in conduct. because development study flu

and on follow-up? the just of as previous then just have you question an update that, one have I any extension So

Filip Dubovsky

of going are right thinking And mean to Not really, our that that only there the plans say, have we as the background, see you validated in we ability you and flu to the are, how adjuvant Flu were do of but is the what data, as or give by have really I variant a one but our response. have that interested. this embedded extremely really qualitatively - kind is work with the in gratified some are we're broad things the we we immunogenesis the on trial now, we know, to announced clinical nanoparticle yet, broad a about team

made vaccine evolution it this flu strain HXNX. with of in quite the cope genetic So to well case the able

efficacy very nanoparticle from what antibodies neutralize of kind vaccine to is with we're against of we're this the the seems be the away at both drift extreme broad of well our yet and now major kind antigenic That's RNA in that. and might the this might against major mentioned to this working be and idea protection pretty case, possible, gratified really a So we in see like against immunity high virus - result that the also have.

and had do Matrix-M vaccine. making the science, the not epitopes the brought the seen immune I think we it are nanoparticle of that the infection well So be does that the normally technology, responses inducing around by out validate importance might to natural Matrix-M, in

I So data. say, clinical our good would with validation,

Mayank Mamtani

the filings then in are and question timeframe I U.S. think at close getting to when that Right. And would U.S. you economies would had levels how your at what final XQ those supply was, late delivering Thank you. in Western terms of versus point? about you the the and ex- you any be on update

Stan Erck

I complicated plans complicated is to it's ship. a but production we answer full not we the by building and - suppose. all - and our timeframe It at so questions, plan on it's a will get Well, a of we if May-June being complicated at inventory have been

hope U.S. roughly I still Government million is and our that's by doses that ship to - hope to goal. be shipping a stated Our that able we'll is - the July XXX be we think

they - first several U.S. then, from outside and is locations sources that will so and first So various got doses to approval - the going U.K., ex- go for the be we've assuming supplied have the different the and U.S. that. into

Operator

Bernardino from C. comes Your next of line question Vernon Wainwright. the H. with

Vernon Bernardino

think of going the because enough me the with emergency of as that candidate, considered much my what long lot the just ask vaccine it approval you a later limitations, guys so strategy question, one said especially can be use of year, using pathway the in past been questions for I full a I being same vaccine year better authorization, also. COVID congratulations in sentence are Have you've larger lot and and advancing accomplished term players EUA? versus a for bivalent you financed mentioned much have comes have I this from asked. already BLA

Filip Dubovsky

It's a interesting that having and with a change on but depends license actually prototype strange ability question, is Yes. to our EOA. a the variant

we're in the be So will follow established with have the timelines be variance the first to the I think the vaccine. to and instance, prototype by that going in leader

Vernon Bernardino

how anticipate at And component a bivalent bivalent do sequence a should candidate, vaccine when protein look vaccine strategy you advance comprises second as the you part we do of the the be what the as candidate? the - then current original will COVID bivalent variant - it and or what,

Filip Dubovsky

concept current just is Our that.

we that to bring all solution diversity. space and be original the antigen the So this broad to evolved to has where equals strain antigen think it able quite immunologic to and is between - which space, we immunologic now our want

virus are evolved. So Brazil where right Africa now seems strains the and to that South seeing the define in has we the extreme

be persistence, of in So a of the that will course bivalent sort product.

Vernon Bernardino

accretive you and may kind against see that is yours as What the as these expose species of then you saw kinds with different immune approach, of that do protection therefore could obviously to with your also so And activity - question and and them. vaccine? have perhaps is, vaccine far the you anticipate many COVID RSV NanoFlu proteins, protein lot antibodies antibodies there last a of monoclonal a I themselves species be of

Filip Dubovsky

there response amount it functional. that a us trimers over we our response know publication, has right Phase a neutralizing tight data into formed could did was crack of X against of maybe same native generated take and we very In IgG is immune we antibodies confirmation that it can the correct levels we what works, you got that very, which one I of induce, confirmation Christmas between all [indiscernible]. mop-up. neutralizing. that told means the high translated correlation really that was is and and correlation So we I mean, our Greg and the that thing proportionately published antibody, at native And that its and like publish the confirmation a is response utilization in range broad we

work was with yet of really, quite prototype strain did from remember, variant, case a that efficacy of the use. can sort the So tell we Africa, we the gives bivalent and South to previous African function of confidence types this and wild case the prevent where the of well in Wuhan off we us previous adjuvant that that's believe infection us perform these products it's our handful we nothing lot able described us we forward and neutralizing move to next to that vaccine before know of exposure same South antibody. that's illness where Greg a will weeks in of animal in data as the paid induce for The clinic our the

Vernon Bernardino

that's great. Yes,

Gregory Glenn

add. to really nothing it. is There good… a That's That's

Filip Dubovsky

up. Mop

Gregory Glenn

up. mop to Nothing

Vernon Bernardino

the Yes, certainly well that and academic data I on because forward then look year-long to the of to congratulations progress. and congratulations

Operator

You further Mr. closing remarks. back at I to will and any this have call time, turn no Stan questions for Erck now over the

Stan Erck

forward unbelievable year. joining. a company Thank size telling expect all to That's an had and We've just ways an We're in for you've even remarkable XXXX. it. our story. significant more you have of many from to about Great. you Well, it. Look heard

Operator

you you participating Thank today's for and And disconnect. conference may now this concludes call.

Novavax (NVAX) 2 Mar 212020 Q4 Earnings call transcript