Ladies and gentlemen, thank you for standing by, and welcome to the Novavax Third Quarter 2021 Financial Results and Operational Highlights Conference Call. [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, Silvia Taylor. You may begin.

Thanks very much. Good afternoon, everyone, and thank you all for joining us today for our call to discuss our third quarter 2021 operational highlights and financial results. A press release announcing our results is currently available on our website at novavax.com, and an audio archive of this conference call will be available on our website later today. Joining me today is Stan Erck, President and CEO, who will discuss regulatory updates; additionally, John Trizzino, Chief Commercial Officer and Chief Business Officer, will discuss our manufacturing and supply updates and the market opportunity for our COVID-19 vaccine; and Dr. Filip Dubovsky, Chief Medical Officer, will discuss our clinical developments. Jim Kelly, Chief Financial Officer and Treasurer, will also join today's call to overview our financial results for the third quarter. Additionally, Dr. Greg Glenn, President of R&D, will be available for the Q&A section at the end of today's call. Before we begin with prepared remarks, I need to remind you that we will be making forward-looking statements during this teleconference, which are based on our current expectations and beliefs. For example, statements relating to future financial or business performance, conditions or strategy including expectations regarding revenue, operating expenses, cash usage, clinical development of our vaccine candidates, timing of future regulatory filings and actions and other anticipated milestones are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous assumptions risks and uncertainties, which change over time and actual results could differ materially from what is described in such statements. We encourage you to consult the risk factors discussed in our SEC filings for additional detail. I'd now like to hand the call over to Stan. For those of you following the accompanying slides, please turn to Slide 3. Stan?

Thank you, Silvia, and thanks to everyone for joining us today. I'm excited to be here today following an incredibly exciting week for Novavax. This past week, we reached a critical milestone. We received our first authorization for our COVID-19 vaccine in India -- Indonesia, sorry. This milestone marks Novavax' first-ever approval of our protein-based COVID-19 vaccine. This approval is based upon demonstrated strong efficacy and a favorable safety profile and represents a significant point in our transformation into a global commercial vaccine company. In addition to receiving our first authorization for 2373, we executed on our regulatory strategy in other global markets, with 9 submissions now filed with regulatory agencies around the world. I would like to acknowledge the tremendous efforts made by the entire Novavax team, express my gratitude for our partners and clinical trial sites for their continued support of our mission and importantly, thank each of our clinical trial participants for their vital contributions made during an unprecedented global pandemic. Only through these collaborative efforts were we able to achieve the significant progress. On today's call, I will discuss these regulatory developments in more detail as well as our key upcoming milestones. Other members of our team will discuss manufacturing and supply updates, updates on clinical developments and financial results for the quarter. With that, I'd like to begin today's call by discussing the tremendous progress we've made to date on the regulatory front. Please turn to Slide 4. We now have our first regulatory authorization in hand with the granting of Emergency Use Authorization for 2373 by Indonesia. Our COVID-19 vaccine will be manufactured and marketed by Serum Institute of India under the brand name of COVOVAX. The first authorization of our COVID-19 vaccine exemplifies our commitment to equitable global access and will fill a…

Thank you, Stan. Moving to Slide 5. Today, we have a global infrastructure in place to support the manufacturing of 2373 with a supply chain of partners and Novavax-owned facilities spanning the world. This expansive global supply chain includes our partnership with Serum Institute, the world's largest vaccine manufacturer by volume; a state-of-the-art wholly owned manufacturing site in the Czech Republic, also known as Novavax CZ; and in Sweden, Novavax AB; manufacturing at established vaccine makers, including SK Bioscience in South Korea and Takeda in Japan; and additional manufacturing partners around the world that include Biofabri in Spain, FujiFilm in the U.S. and U.K., Mabion in Poland and the National Research Council's Biologics Manufacturing Center in Canada. Over the third quarter, we executed a number of agreements to expand our supply chain and ready our global network for commercialization, and these include collaborating with our partner, Takeda, to support their anticipated annual manufacturing capacity of 250 million doses of 2373, expanding our partnership with Serum Institute to manufacture 2373 and entering into an agreement with Mabion for the large-scale production of 2373 through the year 2026. We have made significant progress in mobilizing our supply chain over recent months. We are routinely producing high-quality product at commercial scale at multiple sites around the world. As of the end of the third quarter, we achieved our goal of a manufacturing capacity of 100 million doses per month. Looking to the months ahead, we expect to achieve a manufacturing capacity of 150 million doses per month by the end of the fourth quarter, with the expectation that we will have a manufacturing capacity in excess of 2 billion annual doses in 2022, inclusive of capacity from our partner, Serum Institute. This significant ramp-up in manufacturing will allow us to not only deliver…

Thanks, John. Please turn to Slide 8. What's displayed here is the high-level 2373 clinical development plan. The safety, immunogenicity and efficacy of our vaccine is derived from these studies. And all these studies are part of our common clinical regulatory package that's included in our harmonized regulatory filings. This data has been provided to regulatory agencies on an ongoing basis and this is currently being reviewed. Let's skip ahead to Slide 9. This slide highlights our 2 pivotal Phase III studies. The bulk of our safety and efficacy data is derived from these studies. One remarkable feature of our vaccine is the consistent efficacy we've seen. The primary vaccine efficacy estimates are within 1 percentage point of each other, and that's despite the fact these studies were conducted at different times in different populations during a time when different variants emerged. You can see a very high point estimate of efficacy, 96% to 100%, against match strains. These are strains whose sequences are most similar to that included in the vaccine. Additionally, the vaccine works well against variance, not only against alpha, but as we have detailed earlier in our U.S. Phase III study, against all variants that circulated at that time. Importantly, we have complete protection against severe disease, hospitalization and deaths in all of our efficacy studies, and that includes, again, severe disease caused by variants. In the larger U.S. study, our vaccine efficacy was 100% against severe disease. And in the smaller U.K. and South African studies, although we couldn't calculate an efficacy because of the low number of cases, all the severe cases were in placebo group. Finally, our efficacy in high-risk populations, such as the elderly and people with comorbid conditions, is almost identical to that of their overall population. So now let's skip…

Thank you, Filip. I'd like to start by saying how happy I am to join the Novavax team at such an important moment and look forward to contributing to our rapid transition to becoming a global commercial company. This afternoon, we announced our financial results for the third quarter of 2021, and I'll provide you with a summary of the key highlights beginning on Slide 13. Today, we reported total revenue for the third quarter of 2021 of $179 million and ended the period with $1.9 billion in cash. This means we are well capitalized as we advance towards the commercial launch of 2373. Turning to our financial results on Slide 14, we compare our third quarter 2021 results through the third quarter of 2020. During the third quarter of 2021, we recorded a net loss of $322 million or $4.31 per share. This compares to a loss of $197 million or $3.21 per share in the prior year. Our third quarter 2021 revenue of $179 million and 14% growth compares to $157 million in the prior year. Our total revenue consists of government contract revenue, grant revenue and royalty revenue. Government contract revenue of $98 million reflects our funding from the U.S. government under Operation Warp Speed, which increased by $55 million in the period as we saw an increase in our 2373 funded activities. Grant revenue of $41 million comes primarily from our CEPI funding agreement and fell by $73 million as that agreement is more oriented towards start-up activities, which are now coming to a close. Finally, royalty revenue of $40 million reflects the Novavax share of sales of our license partners. In this case, SK Biosciences made sales of 2373 antigen component to the Korean government during the period. Total expenses for the third quarter of 2021 were $486 million and are primarily weighted towards our R&D activities in support of 2373, both in total for the quarter, are the primary cause of the year-over-year growth. Following an expected regulatory approval of our vaccine, certain types of expenses that have previously been expensed as R&D will be capitalized to inventory and expensed as cost of goods sold when product is delivered. As noted earlier, we ended the third quarter with $1.9 billion in cash and cash equivalents as compared to just over $800 million at year-end 2020. The primary sources of our increase in cash year-to-date are the $1.2 billion in payments received under advance purchase agreements and over $560 million from the sale of common stock in the first quarter. I would now like to turn the call back to Stan to discuss our strategic priorities for the months to come.

Thank you, Jim, and welcome on board. Please turn to Slide 15. It was a tremendous quarter for us at Novavax. Behind the scenes, our over 1,300 employees worked tirelessly to prepare for the delivery of 2373 globally. Over the coming months, obtaining regulatory authorization for our COVID-19 vaccine remains our top priority. This involves continued collaboration and discussion with regulatory agencies with whom we've already completed submissions. In other geographies, we will finalize our packages for filing. We also expect to submit our complete regulatory package to the FDA by the end of 2021. Our first authorization by a regulatory agency is expected to be followed by others over the coming weeks. We are turning swiftly to the work at hand to get product ready to ship on a global basis. Timing and the location will, of course, depend on the timing of various regulatory approvals. We expect to be able to ship doses to Indonesia and hopefully others before the end of the year. That will scale up quickly in the first quarter as we match our APA and COVAX orders with these regulatory approvals. We will initiate our shipments from Serum as the first authorized production center and supplement our regulatory filings with data from our other sites, importantly, including our Czech facility and our partner, SK Biosciences in Korea. Our goal is to reach a cadence of production that will allow Novavax and our partners to have a manufacturing capacity of over 2 billion doses in 2022. And as we've indicated before, we will fulfill our commitments to higher-income countries from our APAs signed over the last year, and we expect to supply low- and middle-income countries in partnership with Serum to meet our commitments to COVAX. We believe that our vaccine is ideally suited to address the needs of these countries. In the coming months, we will continue to evaluate 2373 use beyond the 2-dose primary vaccination regimen through our ongoing boosting study and expect to collect data that further supports 2373's vast potential to serve as a booster. Though our favorable reactogenity -- through our favorable reactogenicity and safety profile, consistently high levels of efficacy and well-understood technology, we are confident that 2373 will be an important tool in combating COVID-19 in the years to come. In parallel, we will develop other areas of our robust pipeline. As discussed earlier by Filip, we believe our COVID NanoFlu combination vaccine will be a key component of our pipeline, and we look forward to advancing this candidate through clinical development. We also remain optimistic about areas for future development within our pipeline, including for RSV. Moving into the end of 2021, our mission will continue to drive us forward. We never rest in our quest to protect the health of people everywhere. With that, I will now turn it over to the operator for Q&A.

[Operator Instructions] Our first question comes from Kelechi Chikere of Jefferies.

Again, congrats on all the progress here. Just a couple of questions on my end. First, with the filings that you had over the last couple of weeks, a new development was that you're leveraging SII's manufacturing. Can you help us understand the reasoning and rationale behind that? And I guess, more importantly, what are the gating steps and how quickly will you be able to supplement those applications and potential approvals with manufacturing data from your own sites? And I have one follow-up question there.

Yes. This is Stan. Thanks for the question. The reason for our reliance upon Serum as a partner for this is they have -- we've been working with them for over almost 2 years in a variety of areas. And so we know them really well. And they have added capacity specifically for Novavax production over the past year that's staggering well over -- we're targeting 2 billion capacity. Just at Serum, they'll have that next year. And so they have fill/finish capacity that's virtually unlimited. We can make many hundreds of millions of doses per month in their facility. So all of that came together over the past several months and really helped us to get to the point where we could file with 9 different regulatory filings in the past couple of weeks. I mean this has been stupendous progress, and Serum has been there with us. So the follow-on to your question is what about the rest of our plants. We have data. We're collecting data that we will submit once we get regulatory approval in various territories, and we will supplement those filings with data from Korea, from Czech Republic, from Spain, et cetera, so we can get them all involved. And so our global capacity network is really potent.

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

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

The next question is from Vernon Bernardino of H.C. Wainwright.

Thank you for the update. This is [indiscernible]. I'm calling on behalf of Vernon. We just had a question on -- I guess, we wanted to get more color on the time line of how long would it take for the WHO and EUL review. And I just also wanted to -- just to confirm that the SII will actually manufacture the vaccine and that's it for me.

Well, I think I answered the second part of the question that SII will be the initial manufacturer. They've already made many tens of millions of doses that are waiting to be shippable. They're sitting. We've -- my team has physically gone over there and touched them. And so it's -- they're there. The -- I forgot what was the first part of the question?

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

We can't -- we're not allowed to forecast how long it's going to take the regulatory -- the various regulatory agencies to opine on this. If -- my opinion is it's going to be soon. So I think because we get -- we can judge their interest and their speed by how many questions they ask, and they've been in active, very active discussions with us. So I think we're going to follow with a number of regulatory -- positive regulatory actions following this Indonesia, I think soon.

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

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

Yes. So one of the reasons we partnered with them a year ago is because we recognized their capabilities for making large quantities of vaccine, They, in fact, in -- their model is to make vast amounts of vaccine at very low cost, and they've tied that to their target markets, which is all of the low- and middle-income countries of the world. So that's been their target. Our deal with them is that we agreed to license to them so that they can make product. They have an exclusive license in India to make and sell product. And in the low- and middle-income countries of the world, we have -- we share profits on that. And they'll make the product and distribute it, and we'll share products -- profits, and we have not disclosed what the ratio of that is. And we've also signed an agreement with them, if we want for them to make product for high-income markets. And so we have a CDMO agreement with them. And so they would supply us finished product, whether -- in 1 of 2 ways, either from antigen, the spike protein that they make at Serum or from spike protein that we make in our various sites around the world. And so we'll have the choice of working -- of having Serum fillet and produce it for us, produce the entire product for us or just take our manufacturing network and make our own product all the way through fill/finish and distribute it in high-income countries. So it's complicated, but it's a very effective way to reach our strategy of going from 0 to 2 billion overnight.

That's helpful color. And then on the other side of the planet, on the U.S. FDA filing, as we think about the specific requirements you're working through, can you maybe detail, is it about the product itself that it has to come from facilities, maybe non-Serum facilities? Or is it just the release assays that have been agreed upon that the FDA has a different criteria, be it a percentage of material that sort of meets a particular potency or safety level? Just can you help us understand how much of what you have today could be also applicable to the U.S. FDA filing?

Yes. No, we made a concerted effort to harmonize all of our filings. So we're going to file the same thing in the U.S. as we filed elsewhere. And we are in the process of dealing with the FDA. We've had communication with them this week. We're going to set up a meeting sometime in the foreseeable future. We don't know what date yet. We don't have a date yet, but sometime in the very near -- and from that, we can give more clarity on the dates that we expect to file the complete package and as for the EUA. So that will be coming later this month.

Great. And my final question was on the pediatric study data time line. I think you commented on the regulatory package in 1Q, but just can you clarify since that crossover finished a while ago, can someone comment on the data time line?

Yes. The analysis is ongoing, and it's made slightly more complicated by our current regulatory filings globally. So we need to balance that work out. But we are confident that we'll be able to give the data pulled together and submitted it as a variation of our initial file in the first quarter.

The next question comes from Charles Duncan of Cantor Fitzgerald.

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

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

Yes. I apologize, Stan. I think I wasn't clear. What I was asking is if you would anticipate any part of the regulatory process to be visible to the public for any one of these Emergency Use Authorizations over the course of the next some period of time before an actual grant of an authorization.

I don't think we're going to have much visibility before the actual grant of an authorization. We have -- the process is they do the review. They've had the ability to review the clinical safety data for some time now because those have been submitted to the regulatory agencies. So the remaining analysis should be focusing on the CMC section. And we can only know -- and of course, it's not announceable. We could only know how interested they are by the number of questions we get and the responses we get back and whether they think they've got all the answers to their questions. And so there's not going to be any information going forward about the EUA until it happens. But all I'm suggesting to you is I'm optimistically forecasting that they're going to be working on this quickly. And so we're looking at this, from week to week we're going to see results of that.

Okay. Very good. That's helpful. If I could turn to Filip or Greg regarding a couple of clinical questions. First of all, I'm wondering if you have ever seen any cases of myocarditis that you think go beyond that which is seen with the virus with an infection generally. And if you could provide some kind of theoretical basis for not seeing any cases or foreseeing cases and perhaps even in contrast with other technologies.

So we don't really comment on specific safety signals we've seen or not seen in any of our studies. What we can -- what we all know is that myocarditis is often caused by viral infections, and those occur sporadically throughout the planet. So they do crop up in any database you look at. Our data is reviewed by not only our external safety committee as well as by the NIHD SMB, and they haven't identified any safety signals for us yet.

Okay. Very good. Last question regarding homologous versus heterologous boost. Wondering if you could provide a little bit of perspective on homologous boost, seems like should work given the data that you've shown so far in 6 months. But do you sense that maybe heterologous boost may be a paradigm that you want to evaluate in the future? And is there at least a theoretical basis for thinking that 2373 could be useful on top of, say, past RNA primary boost.

Yes. So we've outlined the details of our homologous boosting just today, and we think there's a path forward, and we see an obvious way to get a label indication for that. We also see huge value in boosting on top of other people's vaccines. We have a safety profile that I think will justify doing that and a posology, which makes it convenient to move the vaccine around the world and use in that regard. How well it performs, we'll really be data-driven. Now we plan to do some studies in the near future to help define that, including studies we're designing to provide enough data to give us a label indication. There will be some data coming out from the U.K. studies, as everyone on this call knows, that may shed some light into it. But those studies aren't designed in such a way to be able to provide label claims, and that's really our goal. So as far as the theoretical side of things, there isn't a ton known about what it looks like to boost on top of other platforms. There's more known about it looks like to boost on top of viral platforms versus mRNA. So I think we'll have to wait for the data to come out. What I do feel confident about is that if you were to stack up any homologous or heterologous redose regime compared to what we've shown in the Phase II study from U.S. and Australia, I'm pretty confident we would come out on top or in parity with that. And I have to say that there's something pretty unique about what we're seeing about our ability to induce cross-variant neutralizing antibodies, and that may be part of the story. So people shouldn't just think about magnitude of immune response, but quality of immune response as well.

Okay. Very good. That's helpful. Again, congrats on all the recent progress.

The next question is from Eric Joseph of JPMorgan.

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

Yes. Good. This is Stan. Thanks for the question -- for the questions. The supplementary filings will be filed as soon as we can. I think that we've -- if you can imagine that our team has filed 9 applications, regulatory submissions and we've got a few more countries to go, that's going to consume them. But we'll get the supplements in either around the time that they're approval or just after. And I think that we're talking weeks here. I don't think we're talking months, so I don't think there's going to be much difference. Going back to your allocation, how it's going to work with Serum. Serum is going to make the bulk of the production over the next few months. We are going to allocate -- we're going to focus on COVAX and make sure that they get their allocation. It won't be 100% of our product out of there, but it will be a large portion for the first few months, and then it will shift over to our APAs in large quantities, I think, in the second and third quarter. So the first -- the next -- this quarter and next quarter, we're going to have a lot of -- our mission is to get a lot of product out to low- and middle-income countries as soon as we can get WHO EUL and Gavi, and that will take a little time. And so during -- so there'll be some time when we can ship to other countries as well. So it's a mix right now. And as these regulatory submissions get authorization, we'll see how product flows. But the scale up of the product at Serum is -- and our places is fairly dramatic. And it's not going to really make a difference what plant it comes from.

Okay. Okay. And just with the decision here to use Serum's CMC package here. I guess is there precedent with the Serum-made vaccine that gives you confidence in dosing approval...

Yes, that's correct.

In higher-income countries like Europe, et cetera?

Sure. AZ, they've made over 1 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 also got inspected by the U.K. and specifically for Novavax production at their plants and got a GMP certificate that allows them. And so their plants are probably some of the most modern plants in the world, and they're highly regarded by the regulatory agencies who've seen them.

Okay. AZ also had their own supply chain where you could have comparability there. I guess is there any clinical data with -- the clinical data using Serum-made product that I guess is included in the overall mission package?

Yes, they did -- Filip can describe the trial.

They conducted a Phase II, Phase III study comparing a material that they manufacture with material that we manufactured, and that's part of the regulatory dossier.

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

Yes. I'm reflecting on this conversation, and we'll go off script for a minute, but we've really accomplished something as a company in the 12 years that I've been here that is just changing the entire company. The energy that's coming out of the company after all of these regulatory filings and getting the first -- your first product approval is a big deal, and the company is pumped and we're on our way to really be in a changed company over the coming 12 months. So I want to thank you to everyone for joining today's call. We're excited by our progress made to date and believe we are positioned for success in the months to come, and we look forward to reporting on the exciting milestones. And this says in the coming months, I'm going to be reporting on exciting milestones in the coming weeks and months ahead of us as we move closer to delivering our vaccine globally. So with that, thank you very much.

Thank you. The conference has now concluded. Thank you all for attending today's presentation. You may now disconnect your lines. Have a great day.