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Novavax Inc (NASDAQ: NVAX)

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Q3 2021 Balance Call

Nov 4, 2021, 4:30 p.m. ET

Operator

Ladies and gentlemen, accede you for continuing by, and acceptable to the Novavax Third Division 2021 Banking After-effects and Operational Highlights Appointment Call. [Operator Instructions]

I would now like to duke the appointment over to your apostle today, Silvia Taylor. You may begin.

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This commodity is a archetype of this appointment alarm produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not accept any albatross for your use of this content, and we acerb animate you to do your own research, including alert to the alarm yourself and account the company’s SEC filings. Amuse see our Terms and Altitude for added details, including our Obligatory Capitalized Disclaimers of Liability.

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Silvia Taylor — Senior Vice President, All-around Corporate Affairs and Investor Relations

Thanks absolute much. Acceptable afternoon, everyone, and accede you all for abutting us today for our alarm to altercate our third division 2021 operational highlights and banking results. A columnist absolution announcement our after-effects is currently accessible on our website at novavax.com, and an audio annal of this appointment alarm will be accessible on our website afterwards today.

Joining me today is Stan Erck, President and CEO, who will altercate authoritative updates; additionally, John Trizzino, Chief Bartering Officer and Chief Business Officer, will altercate our accomplishment and accumulation updates and the bazaar befalling for our COVID-19 vaccine; and Dr. Filip Dubovsky, Chief Medical Officer, will altercate our analytic developments. Jim Kelly, Chief Banking Officer and Treasurer, will additionally accompany today’s alarm to overview our banking after-effects for the third quarter. Additionally, Dr. Greg Glenn, President of R&D, will be accessible for the Q&A area at the end of today’s call.

Before we activate with able remarks, I charge to admonish you that we will be authoritative advanced statements during this teleconference, which are based on our accepted expectations and beliefs. For example, statements apropos to approaching banking or business performance, conditions, or action including expectations apropos revenue, operating expenses, banknote usage, analytic development of our vaccine candidates, timing of approaching authoritative filings and actions, and added advancing milestones are advanced statements.

Novavax cautions that these advanced statements are accountable to abundant assumptions risks and uncertainties, which change over time and absolute after-effects could alter materially from what is declared in such statements. We animate you to argue the accident factors discussed in our SEC filings for added detail.

I’d now like to duke the alarm over to Stan. For those of you afterward the accompanying slides, amuse about-face to Accelerate three. Stan?

Stanley C. Erck — President and Chief Executive Officer

Thank you, Silvia, and acknowledgment to anybody for abutting us today. I’m aflame to be actuality today afterward an abundantly agitative anniversary for Novavax. This able week, we able a analytical milestone. We accustomed our aboriginal allotment for our COVID-19 vaccine in India — Indonesia, sorry. This anniversary marks Novavax first-ever approval of our protein-based COVID-19 vaccine. This approval is based aloft accustomed able adeptness and a favorable assurance contour and represents a cogent point in our transformation into a all-around bartering vaccine company.

In accession to accepting our aboriginal allotment for 2373, we able on our authoritative action in added all-around markets, with nine submissions now filed with authoritative agencies about the world. I would like to accede the amazing efforts fabricated by the absolute Novavax team, accurate my acknowledgment for our ally and analytic balloon sites for their connected abutment of our mission, and importantly, accede anniversary of our analytic balloon participants for their basic contributions fabricated during an aberrant all-around pandemic. Alone through these collaborative efforts were we able to accomplish the cogent progress.

On today’s call, I will altercate these authoritative developments in added detail as able-bodied as our key accessible milestones. Added associates of our aggregation will altercate accomplishment and accumulation updates, updates on analytic developments, and banking after-effects for the quarter. With that, I’d like to activate today’s alarm by discussing the amazing beforehand we’ve fabricated to date on the authoritative front.

Please about-face to Accelerate four. We now accept our aboriginal authoritative allotment in duke with the acceding of Emergency Use Allotment for 2373 by Indonesia. Our COVID-19 vaccine will be bogus and marketed by Serum Institute of India beneath the cast name of COVOVAX. The aboriginal allotment of our COVID-19 vaccine exemplifies our charge to candid all-around admission and will ample a basic charge for Indonesia, which is the fourth best crawling nation on apple and continues to assignment to annex acceptable vaccine for its population. We apprehend that antecedent shipments into Indonesia by Serum will activate imminently.

Over the able anniversary alone, we completed submissions to six authoritative agencies in the afterward markets: these accommodate the U.K.’s MHRA, Australia’s Therapeutic Appurtenances Administration, Bloom Canada, New Zealand’s Medsafe, and the European Medicines Agency, or EMA, area we completed the acquiescence of all abstracts appropriate for authoritative review.

Additionally, today, we completed Novavax rolling acquiescence to the WHO for Emergency Use Advertisement of 2373. Our authoritative bales accept been harmonized above our filings, which initially advantage our accomplishment affiliation with Serum Institute. In the abreast future, we will supplement our submissions with advice from added accessories above our all-around accumulation alternation and are assured that our analytic accomplishment abstracts anatomy a able amalgamation for assay by authoritative agencies.

All these authoritative bales are in accession to those we’ve advanced appear for filings in India, in the Philippines, and of course, Indonesia, area we are already approved. These filings and in particular, the WHO EUL listing, will accredit our accomplishment to accommodate doses for all-around candid access. We abide alive in our efforts to complete filings in added geographies shortly.

In the U.S., we apprehend to abide our complete authoritative amalgamation to the FDA afore the end of this year. So we’ve fabricated amazing beforehand on the authoritative front. We accept harmonized all of our authoritative filing bales and submitted them to assorted agencies about the world, all to beforehand our aggregate ambition of authoritative our vaccine accessible as bound and cautiously as accessible to those in need. While we cannot adumbrate how connected authoritative agencies will booty to accept these packages, we are able to assignment carefully and agilely with all the authoritative authorities to facilitate approval.

I’d now like to about-face it over to John, for updates above our all-around accumulation chain, 2373’s advancing role in the COVID-19 landscape, and an overview of our accumulation commitments for 2373.

John J. Trizzino — Executive Vice President, Chief Bartering Officer and Chief Business Officer

Thank you, Stan. Affective to Accelerate five. Today, we accept a all-around basement in abode to abutment the accomplishment of 2373 with a accumulation alternation of ally and Novavax-owned accessories spanning the world. This all-embracing all-around accumulation alternation includes our affiliation with Serum Institute, the world’s better vaccine architect by volume; a advanced wholly endemic accomplishment armpit in the Czech Republic, additionally accepted as Novavax CZ; and in Sweden, Novavax AB; accomplishment at accustomed vaccine makers, including SK Bioscience in South Korea and Takeda in Japan; and added accomplishment ally about the apple that accommodate Biofabri in Spain, FujiFilm in the U.S. and U.K., Mabion in Poland and the National Assay Council’s Biologics Accomplishment Centermost in Canada.

Over the third quarter, we able a cardinal of agreements to aggrandize our accumulation alternation and accessible our all-around adjustment for commercialization, and these accommodate accommodating with our partner, Takeda, to abutment their advancing anniversary accomplishment accommodation of 250 actor doses of 2373, accretion our affiliation with Serum Institute to accomplish 2373 and entering into an acceding with Mabion for the all-embracing assembly of 2373 through the year 2026. We accept fabricated cogent beforehand in mobilizing our accumulation alternation over contempo months. We are commonly bearing high-quality artefact at bartering calibration at assorted sites about the world.

As of the end of the third quarter, we able our ambition of a accomplishment accommodation of 100 actor doses per month. Attractive to the months ahead, we apprehend to accomplish a accomplishment accommodation of 150 actor doses per ages by the end of the fourth quarter, with the apprehension that we will accept a accomplishment accommodation in antithesis of two billion anniversary doses in 2022, across-the-board of accommodation from our partner, Serum Institute. This cogent ramp-up in accomplishment will acquiesce us to not alone bear on our accepted accumulation agreements but additionally abutment added appeal for our vaccine in 2022 and beyond.

Now affective to Accelerate six. In accession to badly accretion the cardinal of accessible doses to immunize the world, we apprehend our vaccine will advice abode above obstacles during this communicable and beyond, including all-around administration challenges and vaccine hesitancy. Storage at accepted algidity temperatures allows our vaccine to use the absolute vaccine accumulation alternation and will admission admission to hard-to-reach areas to beforehand anesthetic ante above the globe. Recombinant protein vaccines are able-bodied accepted and already in boundless use, accepting been acclimated for decades. And additionally, we accept a able-bodied analytic abstracts amalgamation demonstrating our vaccine’s favorable assurance contour and able immunogenicity and adeptness adjoin assorted strains of the coronavirus, all of which drives aplomb in Novavax vaccine’s adeptness to advice assure adjoin the disease.

Now axis to Accelerate seven. As you can see on this slide, we accept several accumulation and licensing agreements in abode to ensure the boundless administration of our vaccine, advancement the mindset that admission to vaccines should accept no borders. Our vaccine adjustment will abutment our accumulation commitments globally, including up to over 400 actor doses of 2373 through mutual accumulation agreements, including doses to the European Commission through our APA able during the third division and our collective charge with Serum Institute of 1.1 billion doses for the COVAX facility.

In accession to bartering 2373 for primary vaccination, we apprehend the charge for boosters will abide in the advancing years, and we accept 2373 will comedy a absolute important role in this advancing need. Over the advancing months, we will be able to abutment accumulation to added markets in charge of boosters above high-, middle- and low-income countries.

I’d now like to about-face it over to Filip Dubovsky to altercate analytic developments above our activity during the third quarter.

Filip Dubovsky, MD — Executive Vice President, Chief Medical Officer

Thanks, John. Amuse about-face to Accelerate eight. What’s displayed actuality is the high-level 2373 analytic development plan. The safety, immunogenicity, and adeptness of our vaccine is acquired from these studies. And all these studies are allotment of our accepted analytic authoritative amalgamation that’s included in our harmonized authoritative filings. This abstracts has been provided to authoritative agencies on an advancing base and this is currently actuality reviewed.

Let’s skip advanced to Accelerate nine. This accelerate highlights our two cardinal Phase III studies. The aggregate of our assurance and adeptness abstracts is acquired from these studies. One arresting affection of our vaccine is the constant adeptness we’ve seen. The primary vaccine adeptness estimates are aural one allotment point of anniversary other, and that’s admitting the actuality these studies were conducted at altered times in altered populations during a time aback altered variants emerged. You can see a absolute aerial point appraisal of efficacy, 96% to 100%, adjoin bout strains. These are strains whose sequences are best agnate to that included in the vaccine.

Additionally, the vaccine works able-bodied adjoin variance, not alone adjoin alpha but as we accept abundant beforehand in our U.S. Phase III study, adjoin all variants that broadcast at that time. Importantly, we accept complete aegis adjoin astringent disease, hospitalization, and deaths in all of our adeptness studies, and that includes, again, astringent ache acquired by variants. In the above U.S. study, our vaccine adeptness was 100% adjoin astringent disease. And in the abate U.K. and South African studies, although we couldn’t account an adeptness because of the low cardinal of cases, all the astringent cases were in placebo group. Finally, our adeptness in high-risk populations, such as the aged and bodies with comorbid conditions, is about identical to that of their all-embracing population.

So now let’s skip advanced to Accelerate 10, allocution about our beforehand in pediatrics. We broadcast our U.S. Phase III abstraction to accommodate over 2,200 12- to 17-year-olds. All the primary anesthetic alternation accept been delivered. And in fact, all the accouchement accept been above over and assurance and adeptness abstracts accumulating is ongoing. We apprehend to accept a authoritative amalgamation accessible for all-around acquiescence in the aboriginal quarter. The consecutive pediatric analytic development plan has been agreed to by the FDA, MHRA, and EMA and the studies will be able afterwards this boyish abstraction reads out.

Okay, let’s move on to Accelerate 11 and allocution about boosting. In our Phase II abstraction in the U.S. and Australia, we additional baddest cohorts at six months and at 12 months and the 12-month doses are aloof finishing up now. We’ve advanced appear that a distinct dosage at six ages can admission wild-type abatement as able-bodied as IgG antibiotic levels added than fourfold from their aiguille afterwards accepting two doses.

However, added importantly, application a acrimonious animal ACE2 inhibition assay, this measures anatomic antibodies, we accustomed that our vaccine can addition responses to alpha, beta, and basin 6.6 to 10.8 bend over their peak. We accept this is a backbone of our vaccine, acceptable affiliated to our accessory system. We saw able aegis in the Phase III studies adjoin variants. And recently, Professor Snape from Oxford presented abstracts that accustomed that 2373 has a specific backbone in inducing cross-variant acrid responses.

In our South Africa Phase II study, we additional all participants who initially accustomed two doses of vaccine with a third dosage at six months, and that assurance abstracts is maturing. The emergency abstracts from the U.S., Australia, forth with the assurance abstracts from our South Africa abstraction will serve as the base of our authoritative filings acknowledging our advocacy indication.

Finally, let’s move to Accelerate 12, and I appetite to amend you on the beforehand of our Australia NanoFlu, our 2373 aggregate study. As you may know, we afresh appear an NanoFlu Phase III abstraction this division in Lancet ID and the abstraction met its primary endpoints, and we’ve been accustomed a authoritative alleyway for licensure by the FDA. The accepted study, the aggregate study, was advised to ascertain the dosage levels in anesthetic agenda for our quadrivalent flu HA antigen accumulated with our COVID antigen. Enrollment is complete. All the aboriginal doses accept been delivered and the additional doses are actuality currently administered. We accept that abundant like flu, COVID will abide to circulate.

Our flu and COVID vaccine allotment immunologic attributes that accomplish the vaccine adorable in accouterment aegis adjoin drifted flu strains as able-bodied as COVID variants. This abstracts will be accessible in the aboriginal bisected of 2022. I’d like to now about-face it over to Jim to accommodate an overview of our banking after-effects for the third quarter. Jim? Accede you, Filip. I’d like to alpha by adage how blessed I am to accompany the Novavax aggregation at such an important moment and attending advanced to accidental to our accelerated alteration to acceptable a all-around bartering company. This afternoon, we appear our banking after-effects for the third division of 2021, and I’ll accommodate you with a arbitrary of the key highlights alpha on Accelerate 13. Today, we appear absolute acquirement for the third division of 2021 of $179 actor and concluded the aeon with $1.9 billion in cash. This bureau we are well-capitalized as we beforehand against the bartering barrage of 2373. Axis to our banking after-effects on Accelerate 14, we analyze our third division 2021 after-effects through the third division of 2020. During the third division of 2021, we recorded a net accident of $322 actor or $4.31 per share. This compares to a accident of $197 actor or $3.21 per allotment in the above-mentioned year. Our third division 2021 acquirement of $179 actor and 14% beforehand compares to $157 actor in the above-mentioned year. Our absolute acquirement consists of government adjustment revenue, admission revenue, and adeptness revenue. Government adjustment acquirement of $98 actor reflects our allotment from the U.S. government beneath Operation Warp Speed, which added by $55 actor in the aeon as we saw an admission in our 2373 adjourned activities. Admission acquirement of $41 actor comes primarily from our CEPI allotment acceding and fell by $73 actor as that acceding is added aggressive against start-up activities, which are now advancing to a close. Finally, adeptness acquirement of $40 actor reflects the Novavax allotment of sales of our allotment partners. In this case, SK Biosciences fabricated sales of 2373 antigen basic to the Korean government during the period. Absolute costs for the third division of 2021 were $486 actor and are primarily abounding against our R&D activities in abutment of 2373, both in absolute for the quarter, are the primary account of the year-over-year growth. Afterward an accepted authoritative approval of our vaccine, assertive types of costs that accept advanced been expensed as R&D will be capitalized to account and expensed as amount of appurtenances awash aback artefact is delivered. As acclaimed earlier, we concluded the third division with $1.9 billion in banknote and banknote equivalents as compared to aloof over $800 actor at anniversary 2020. The primary sources of our admission in banknote year-to-date are the $1.2 billion in payments accustomed beneath beforehand acquirement agreements and over $560 actor from the auction of accepted banal in the aboriginal quarter. I would now like to about-face the alarm aback to Stan to altercate our cardinal priorities for the months to come.

Stanley C. Erck — President and Chief Executive Officer

Thank you, Jim, and acceptable on board. Amuse about-face to Accelerate 15. It was a amazing division for us at Novavax. Abaft the scenes, our over 1,300 advisers formed endlessly to adapt for the commitment of 2373 globally. Over the advancing months, accepting authoritative allotment for our COVID-19 vaccine charcoal our top priority. This involves connected accord and altercation with authoritative agencies with whom we’ve already completed submissions. In added geographies, we will agree our bales for filing.

We additionally apprehend to abide our complete authoritative amalgamation to the FDA by the end of 2021. Our aboriginal allotment by a authoritative bureau is accepted to be followed by others over the advancing weeks. We are axis apace to the assignment at duke to get artefact accessible to abode on a all-around basis. Timing and the area will, of course, depend on the timing of assorted authoritative approvals. We apprehend to be able to abode doses to Indonesia and hopefully others afore the end of the year. That will calibration up bound in the aboriginal division as we bout our APA and COVAX orders with these authoritative approvals. We will admit our shipments from Serum as the aboriginal accustomed assembly centermost and supplement our authoritative filings with abstracts from our added sites, importantly, including our Czech adeptness and our partner, SK Biosciences in Korea.

Our ambition is to adeptness a accent of assembly that will acquiesce Novavax and our ally to accept a accomplishment accommodation of over two billion doses in 2022. And as we’ve adumbrated before, we will accomplish our commitments to higher-income countries from our APAs alive over the aftermost year, and we apprehend to accumulation low- and middle-income countries in affiliation with Serum to accommodated our commitments to COVAX.

We accept that our vaccine is alluringly ill-fitted to abode the needs of these countries. In the advancing months, we will abide to appraise 2373 use above the two-dose primary anesthetic dieting through our advancing advocacy abstraction and apprehend to aggregate abstracts that added supports 2373’s all-inclusive abeyant to serve as a booster. Though our favorable reactogenity — through our favorable reactogenicity and assurance profile, consistently aerial levels of efficacy, and well-understood technology, we are assured that 2373 will be an important apparatus in alive COVID-19 in the years to come.

In parallel, we will advance added areas of our able-bodied pipeline. As discussed beforehand by Filip, we accept our COVID NanoFlu aggregate vaccine will be a key basic of our pipeline, and we attending advanced to advancing this applicant through analytic development. We additionally abide optimistic about areas for approaching development aural our pipeline, including for RSV. Affective into the end of 2021, our mission will abide to drive us forward. We never blow in our adventure to assure the bloom of bodies everywhere.

With that, I will now about-face it over to the abettor for Q&A.

Operator

[Operator Instructions] Our aboriginal catechism comes from Kelechi Chikere of Jefferies. Amuse go ahead.

Kelechi Chikere — Jefferies — Analyst

Yes. Accede you and, again, congrats on all the beforehand here. Aloof a brace of questions on my end. First, with the filings that you had over the aftermost brace of weeks, a new development was that you’re leveraging SII’s manufacturing. Can you advice us accept the acumen and account abaft that?

And I guess, added importantly, what are the gating accomplish and how bound will you be able to supplement those applications and abeyant approvals with accomplishment abstracts from your own sites? And I accept one aftereffect catechism there.

Stanley C. Erck — President and Chief Executive Officer

Yes. This is Stan. Acknowledgment for the question. The acumen for our assurance aloft Serum as a accomplice for this is they accept — we’ve been alive with them for over about two years in a array of areas. And so we apperceive them absolutely well. And they accept added accommodation accurately for Novavax assembly over the able year that’s amazing able-bodied over — we’re targeting two billion capacity. Aloof at Serum, they’ll accept that abutting year. And so they accept fill/finish accommodation that’s about unlimited. We can accomplish abounding hundreds of millions of doses per ages in their facility.

So all of that came calm over the able several months and absolutely helped us to get to the point area we could book with nine altered authoritative filings in the able brace of weeks. I beggarly this has been amazing progress, and Serum has been there with us. So the follow-on to your catechism is what about the blow of our plants. We accept data. We’re accession abstracts that we will abide already we get authoritative approval in assorted territories, and we will supplement those filings with abstracts from Korea, from Czech Republic, from Spain, etc., so we can get them all involved. And so our all-around accommodation adjustment is absolutely potent.

Kelechi Chikere — Jefferies — Analyst

Video: Novavax avalanche on assembly adjournment report, but this analyst expects acceptable sales in the approaching (Yahoo! Finance)

Got it. That’s absolutely helpful. And I assumption you alluded to this in your answer. Can you accommodate any blush on how abundant vaccine or how abundant of the accepted accommodation is absolutely advancing from Serum Institute of India against your own sites?

Stanley C. Erck — President and Chief Executive Officer

Actually, we don’t breach that out by accomplishment facility. But — sorry.

Kelechi Chikere — Jefferies — Analyst

No. Alright. Accede you absolute much.

Operator

The abutting catechism is from Vernon Bernardino of H.C. Wainwright.

Unidentified Analyst — H.C. Wainwright — Analyst

Good morning, everyone. Accede you for the update. This is [Indecipherable]. I’m calling on account of Vernon. We aloof had a catechism on — I guess, we capital to get added blush on the timeline of how connected would it booty for the WHO and EUL review. And I aloof additionally capital to — aloof to affirm that the SII will absolutely accomplish the vaccine and that’s it for me.

Stanley C. Erck — President and Chief Executive Officer

Well, I advanced I answered the additional allotment of the catechism that SII will be the antecedent manufacturer. They’ve already fabricated abounding tens of millions of doses that are cat-and-mouse to be shippable. They’re sitting. We’ve — my aggregation has physically gone over there and affected them. And so it’s — they’re there. The — I forgot what was the aboriginal allotment of the question?

Unidentified Analyst — H.C. Wainwright — Analyst

Just to — we aloof capital some added blush on how connected would it booty for the WHO and the EUL review.

Stanley C. Erck — President and Chief Executive Officer

We can’t — we’re not accustomed to anticipation how connected it’s activity to booty the authoritative — the assorted authoritative agencies to admonish on this. If — my assessment is it’s activity to be soon. So I advanced because we get — we can adjudicator their absorption and their acceleration by how abounding questions they ask, and they’ve been inactive, absolute alive discussions with us.

So I advanced we’re activity to chase with a cardinal of authoritative — absolute authoritative accomplishments afterward this Indonesia, I advanced soon.

Unidentified Analyst — H.C. Wainwright — Analyst

Okay. Accede you.

Operator

The abutting catechism comes from Mayank Mamtani of B. Riley Securities.

Mayank Mamtani — B. Riley Securities — Analyst

Good afternoon. Acknowledgment for demography our questions. Obviously, congrats on a ton of contempo progress. So maybe aloof blockage with the Serum question. Are you able to animadversion on the bread-and-butter adjustment you may accept for the developed bazaar accurately if Serum is the manufacturer? And also, are you able to animadversion on COGS if things — if vaccines doses are advancing from Serum against the Novavax facility? And again I accept a follow-up.

Stanley C. Erck — President and Chief Executive Officer

Yes. So one of the affidavit we partnered with them a year ago is because we accustomed their capabilities for authoritative ample quantities of vaccine, They, in fact, in — their archetypal is to accomplish all-inclusive amounts of vaccine at absolute low cost, and they’ve angry that to their ambition markets, which is all of the low- and middle-income countries of the world. So that’s been their target.

Our accord with them is that we agreed to allotment to them so that they can accomplish product. They accept an absolute allotment in India to accomplish and advertise product. And in the low- and middle-income countries of the world, we accept — we allotment profits on that. And they’ll accomplish the artefact and administer it, and we’ll allotment articles — profits, and we accept not appear what the arrangement of that is.

And we’ve additionally alive an acceding with them if we appetite for them to accomplish artefact for advantageous markets. And so we accept a CDMO acceding with them. And so they would accumulation us able product, whether — in one of two ways, either from antigen, the fasten protein that they accomplish at Serum or from fasten protein that we accomplish in our assorted sites about the world.

And so we’ll accept the best of alive — of accepting Serum bandage and aftermath it for us, aftermath the absolute artefact for us or aloof booty our accomplishment adjustment and accomplish our own artefact all the way through fill/finish and administer it in advantageous countries. So it’s complicated, but it’s a absolute able way to adeptness our action of activity from aught to two billion overnight.

Mayank Mamtani — B. Riley Securities — Analyst

That’s accessible color. And again on the added ancillary of the planet, on the U.S. FDA filing, as we advanced about the specific requirements you’re alive through, can you maybe detail, is it about the artefact itself that it has to appear from facilities, maybe non-Serum facilities? Or is it aloof the absolution assays that accept been agreed aloft that the FDA has a altered criteria, be it a allotment of absolute that array of meets a accurate authority or assurance level? Aloof can you advice us accept how abundant of what you accept today could be additionally applicative to the U.S. FDA filing?

Stanley C. Erck — President and Chief Executive Officer

Yes. No, we fabricated a concerted accomplishment to accord all of our filings. So we’re activity to book the aforementioned affair in the U.S. as we filed elsewhere. And we are in the action of ambidextrous with the FDA. We’ve had advice with them this week. We’re activity to set up a affair ancient in the accountable future. We don’t apperceive what date yet. We don’t accept a date yet, but ancient in the absolute abreast — and from that, we can accord added accuracy on the dates that we apprehend to book the complete amalgamation and as for the EUA. So that will be advancing afterwards this month.

Mayank Mamtani — B. Riley Securities — Analyst

Great. And my final catechism was on the pediatric abstraction abstracts timeline. I advanced you commented on the authoritative amalgamation in 1Q, but aloof can you analyze aback that crossover able a while ago, can addition animadversion on the abstracts timeline?

Filip Dubovsky, MD — Executive Vice President, Chief Medical Officer

Yes. The assay is ongoing, and it’s fabricated hardly added complicated by our accepted authoritative filings globally. So we charge to antithesis that workout. But we are assured that we’ll be able to accord the abstracts pulled calm and submitted it as a aberration of our antecedent book in the aboriginal quarter.

Mayank Mamtani — B. Riley Securities — Analyst

Great. Acknowledgment for demography our questions.

Operator

The abutting catechism comes from Charles Duncan of Cantor Fitzgerald.

Charles Duncan — Cantor Fitzgerald & Co. — Analyst

Yes. Hi. Acknowledgment for demography my catechism and congratulations, Stan and team, for all the contempo progress, absolute acceptable to see. I had a catechism apropos the EUA filings that I’m abiding you won’t be able to acknowledgment in abundant detail. But above actuality able to allocution about aback you adeptness see approvals, I’m apprehensive if you can characterize abutting accomplish and whether or not there would be some affectionate of acting advice that can be columnist appear besides an absolute approval as Indonesia affectionate of came out from out of the blue.

Stanley C. Erck — President and Chief Executive Officer

Yes. I’m aggravating to adapt your catechism a little bit. I — we are assured assorted authorizations this year. And for anniversary of these, we are aggravating to admeasure product, both that we accept in account in the U.S. and Europe and South Korea and in account that’s actuality congenital up at Serum. And that allocation action will be complicated because until we apperceive what the — not alone what the — aback we get the authorization, but the timing of all of these altered orders.

And from Gavi, we charge to apperceive area they appetite artefact aback and over the advancing abode and the aforementioned affair from our APAs. And so we’ll be architecture them — we are architecture inventory, and we’ll be — over the advancing weeks, we’ll be addition out how to admeasure those to characterization them for altered geographies. Does that acknowledgment your question? I’m not abiding I did.

Charles Duncan — Cantor Fitzgerald & Co. — Analyst

Yes. I apologize, Stan. I advanced I wasn’t clear. What I was allurement is if you would advanced any allotment of the authoritative action to be arresting to the accessible for any one of these Emergency Use Authorizations over the beforehand of the abutting some aeon of time afore an absolute admission of an authorization.

Stanley C. Erck — President and Chief Executive Officer

I don’t advanced we’re activity to accept abundant afterimage afore the absolute admission of an authorization. We accept — the action is they do the review. They’ve had the adeptness to assay the analytic assurance abstracts for some time now because those accept been submitted to the authoritative agencies.

So the actual assay should be absorption on the CMC section. And we can alone apperceive — and of course, it’s not announceable. We could alone apperceive how absorbed they are by the cardinal of questions we get and the responses we get aback and whether they advanced they’ve got all the answers to their questions.

And so there’s not activity to be any advice activity advanced about the EUA until it happens. But all I’m suggesting to you is I’m optimistically forecasting that they’re activity to be alive on this quickly. And so we’re attractive at this, from anniversary to anniversary we’re activity to see after-effects of that.

Charles Duncan — Cantor Fitzgerald & Co. — Analyst

Okay. Absolute good. That’s helpful. If I could about-face to Filip or Greg apropos a brace of analytic questions. Aboriginal of all, I’m apprehensive if you accept anytime apparent any cases of myocarditis that you advanced go above that which is apparent with the virus with an infection generally. And if you could accommodate some affectionate of abstract base for not seeing any cases or apprehension cases and conceivably alike in adverse with added technologies.

Filip Dubovsky, MD — Executive Vice President, Chief Medical Officer

So we don’t absolutely animadversion on specific assurance signals we’ve apparent or not apparent in any of our studies. What we can — what we all apperceive is that myocarditis is generally acquired by viral infections, and those action sporadically throughout the planet. So they do crop up in any database you attending at. Our abstracts is advised by not alone our alien assurance board as able-bodied as by the NIHD SMB, and they haven’t articular any assurance signals for us yet.

Charles Duncan — Cantor Fitzgerald & Co. — Analyst

Okay. Absolute good. Aftermost catechism apropos akin against heterologous boost. Apprehensive if you could accommodate a little bit of angle on akin boost, seems like should assignment accustomed the abstracts that you’ve apparent so far in six months. But do you faculty that maybe heterologous addition may be a archetype that you appetite to appraise in the future? And is there at atomic a abstract base for cerebration that 2373 could be advantageous on top of, say, able RNA primary boost.

Filip Dubovsky, MD — Executive Vice President, Chief Medical Officer

Yes. So we’ve categorical the accommodation of our akin advocacy aloof today, and we advanced there’s a aisle forward, and we see an accessible way to get a characterization adumbration for that. We additionally see huge amount in advocacy on top of added people’s vaccines. We accept a assurance contour that I advanced will absolve accomplishing that and a posology, which makes it acceptable to move the vaccine about the apple and use in that regard. How able-bodied it performs, we’ll absolutely be data-driven.

Now we plan to do some studies in the abreast approaching to advice ascertain that, including studies, we’re designing to accommodate abundant abstracts to accord us a characterization indication. There will be some abstracts advancing out from the U.K. studies, as anybody on this alarm knows, that may afford some ablaze into it. But those studies aren’t advised in such a way to be able to accommodate characterization claims, and that’s absolutely our goal.

So as far as the abstract ancillary of things, there isn’t a ton accepted about what it looks like to addition on top of added platforms. There’s added accepted about it looks like to addition on top of viral platforms against mRNA. So I advanced we’ll accept to delay for the abstracts to appear out. What I do feel assured about is that if you were to assemblage up any akin or heterologous redose administration compared to what we’ve apparent in the Phase II abstraction from U.S. and Australia, I’m appealing assured we would appear out on top or in adequation with that.

And I accept to say that there’s article appealing different about what we’re seeing about our adeptness to abet cross-variant acrid antibodies, and that may be allotment of the story. So bodies shouldn’t aloof advanced about consequence of allowed response, but affection of allowed acknowledgment as well.

Charles Duncan — Cantor Fitzgerald & Co. — Analyst

Okay. Absolute good. That’s helpful. Again, congrats on all the contempo progress. Appreciate you demography my questions.

Operator

The abutting catechism is from Eric Joseph of JPMorgan.

Eric Joseph — JPMorgan Chase & Co — Analyst

Hi. Acceptable evening. Acknowledgment for demography the questions. I aloof capital to amphitheater aback on affairs to supplement the accepted filings with CMC bales from your own accumulation chain. Could this appear afore or is it added acceptable to appear afterwards the advancing decisions, allotment decisions for regions filed over the able week?

And as a aftereffect to that, with — if it’s primarily Serum that’s authoritative COVOVAX finer over the abreast term, how should we be cerebration about dosage allocation amid your commitments with COVAX, the COVAX facility, and higher-income countries? I assumption is there a prioritization of doses to COVAX first? And again I accept a follow-up.

Stanley C. Erck — President and Chief Executive Officer

Yes. Good. This is Stan. Acknowledgment for the catechism — for the questions. The added filings will be filed as anon as we can. I advanced that we’ve — if you can brainstorm that our aggregation has filed nine applications, authoritative submissions and we’ve got a few added countries to go, that’s activity to absorb them. But we’ll get the supplements in either about the time that they’re approval or aloof after. And I advanced that we’re talking weeks here. I don’t advanced we’re talking months, so I don’t advanced there’s activity to be abundant difference.

Going aback to your allocation, how it’s activity to assignment with Serum. Serum is activity to accomplish the aggregate of the assembly over the abutting few months. We are activity to admeasure — we’re activity to focus on COVAX and accomplish abiding that they get their allocation. It won’t be 100% of our artefact out of there, but it will be a ample allocation for the aboriginal few months, and again it will about-face over to our APAs in ample quantities, I think, in the additional and third quarter.

So the aboriginal — the abutting — this division and abutting quarter, we’re activity to accept a lot of — our mission is to get a lot of artefact out to low- and middle-income countries as anon as we can get WHO EUL and Gavi, and that will booty a little time. And so during — so there’ll be some time aback we can abode to added countries as well.

So it’s a mix appropriate now. And as these authoritative submissions get authorization, we’ll see how artefact flows. But the scale-up of the artefact at Serum is — and our places is adequately dramatic. And it’s not activity to absolutely accomplish a aberration what bulb it comes from.

Eric Joseph — JPMorgan Chase & Co — Analyst

Okay. Okay. And aloof with the accommodation actuality to use Serum’s CMC amalgamation here. I assumption is there antecedent with the Serum-made vaccine that gives you aplomb in dosing approval…

Stanley C. Erck — President and Chief Executive Officer

Yes, that’s correct.

Eric Joseph — JPMorgan Chase & Co — Analyst

In higher-income countries like Europe, etc.?

Stanley C. Erck — President and Chief Executive Officer

Sure. AZ, they’ve fabricated over one billion doses of AZ’s vaccine, and they’ve got an approval globally for that. So there’s lots of precedent. And by the way, they additionally got inspected by the U.K. and accurately for Novavax assembly at their plants and got a GMP affidavit that allows them. And so their plants are apparently some of the best avant-garde plants in the world, and they’re awful admired by the authoritative agencies who’ve apparent them.

Eric Joseph — JPMorgan Chase & Co — Analyst

Okay. AZ additionally had their own accumulation alternation area you could accept allegory there. I assumption is there any analytic abstracts with — the analytic abstracts application Serum-made artefact that I assumption is included in the all-embracing mission package?

Stanley C. Erck — President and Chief Executive Officer

Yes, they did — Filip can alarm the trial.

Filip Dubovsky, MD — Executive Vice President, Chief Medical Officer

They conducted a Phase II, Phase III abstraction comparing a absolute that they accomplish with absolute that we manufactured, and that’s allotment of the authoritative dossier.

Eric Joseph — JPMorgan Chase & Co — Analyst

Okay. Great. Acknowledgment for demography the questions.

Operator

And this will achieve our question-and-answer session. I’d like to about-face the appointment aback over to Stan for any closing remarks.

Stanley C. Erck — President and Chief Executive Officer

Yes. I’m absorption on this conversation, and we’ll go off calligraphy for a minute, but we’ve absolutely able article as a aggregation in the 12 years that I’ve been actuality that is aloof alteration the absolute company. The activity that’s advancing out of the aggregation afterwards all of these authoritative filings and accepting the aboriginal — your aboriginal artefact approval is a big deal, and the aggregation is pumped and we’re on our way to absolutely be in a afflicted aggregation over the advancing 12 months.

So I appetite to accede you to anybody for abutting today’s call. We’re aflame by our beforehand fabricated to date and accept we are positioned for success in the months to come, and we attending advanced to advertisement on the agitative milestones. And this says in the advancing months, I’m activity to be advertisement on agitative milestones in the advancing weeks and months advanced of us as we move afterpiece to carrying our vaccine globally.

So with that, accede you absolute much.

Operator

[Operator Closing Remarks]

Duration: 45 minutes

Silvia Taylor — Senior Vice President, All-around Corporate Affairs and Investor Relations

Stanley C. Erck — President and Chief Executive Officer

John J. Trizzino — Executive Vice President, Chief Bartering Officer and Chief Business Officer

Filip Dubovsky, MD — Executive Vice President, Chief Medical Officer

Kelechi Chikere — Jefferies — Analyst

Unidentified Analyst — H.C. Wainwright — Analyst

Mayank Mamtani — B. Riley Securities — Analyst

Charles Duncan — Cantor Fitzgerald & Co. — Analyst

Eric Joseph — JPMorgan Chase & Co — Analyst

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