Good day, everyone, and welcome to the Novavax Second Quarter 2021 Financial and Operating Results. All participants will be in a listen-only mode. [Operator Instructions] After today’s presentation, there will be an opportunity to ask questions. [Operator Instructions] Please note that this event is being recorded. I would now like to turn the conference over to Silvia Taylor, Senior Vice President, Corporate Affairs and Investor Relations. Please go ahead.

Thanks, Paul. Good afternoon, everybody, and thank you to all of you who have joined today’s call to discuss our second 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. We’ve also posted the slides we are using during today’s call under Events in the Investors section of our website. Joining me today is Stan Erck, President and CEO, who will provide an overview of our progress in the second quarter, our supply commitments, our regulatory timelines, as well as updates on manufacturing; Dr. Filip Dubovsky, Chief Medical Officer will discuss developments for our COVID-19 program; And John Trizzino, Chief Commercial Officer, Chief Business Officer and Interim Chief Financial Officer will provide an update on our financial results for the 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 projections and beliefs. For example, statements relating to future financial or business performance, condition 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.

And thank you, Silvia, and thanks to everyone for joining us today. As we start this presentation today, we can note that through the development of vaccines and treatments to date significant progress has been made to combat the COVID-19 pandemic. However, we also know that with the continued circulation of variants and the inequitable access to vaccines that persists in many parts of the world, Novavax’s mission to bring NVX-CoV2373 to market as swiftly as possible has never been more important. At Novavax, this week, we took a major step forward and advancing this mission. We are announcing the filing of multiple regulatory submissions for 2373 with our partner Serum Institute. These regulatory submissions encompass global markets, including filings with the Drugs Controller General of India, as well as with regulatory agencies in Indonesia and the Philippines. We view these submissions as the first of many, bringing us one step closer to delivering 2373 to those in need. In addition to these regulatory developments, I’d like to begin today’s call by providing an overview of a few of our major achievements in all areas of our business since the beginning of the second quarter. We announced positive data from our PREVENT-19 pivotal Phase 3 trial demonstrating 90% overall efficacy and 100% protection against moderate and severe disease. Filip will talk more about this shortly. We took major steps in exploring 2373’s boosting capabilities, including positive results announced today from our six-month booster study in our ongoing U.S. and Australia Phase 2 trial. In conjunction with our PREVENT-19 trial, these outstanding data make a compelling case for 2373 to become the universal booster of choice. We also continue to explore heterologous boosting alongside other vaccines in the market by participating in two partner led studies, the Com-COV2 study and the…

Thanks, Stan. We achieved a number of milestones in the second quarter across the clinical program, and I’ll highlight a few of these in the overall context of our studies. So maybe switch to Slide 5, please. Here we are. So here are the clinical programs that we’ve conducted over since the beginning of the development, we start off in the Phase 1, Phase 2 in the U.S., Australia, there we established the dose level, the immunologic profile and the preliminary safety profile of the study and the study that’s ongoing and we’ve conducted some six-month boosting, which I’ll talk about later. Moved on to a Phase 2 study in South Africa and this is our preliminary efficacy evaluation, as well as defining the overall safety profile and exploring the efficacy and safety in a small group of HIV subjects. Moved on to our first big Phase 3 study in the UK and this is our licensure-enabling study that collected licensure-enabling safety, as well as efficacy data included a small influenza co-administration study and I’ll touch based on that data a bit later as well. And finally, we conducted a large Phase 3 study in the U.S. and this define the safety data immunogenicity data as well as efficacy data in the U.S. population. Let’s move on to Slide 5, please. Here’s what to remind you of the design of the PREVENT-19 study in the U.S. and Mexico. And this is study that included 30,000 adults aged greater than 18 years of age. And it was randomized two to one. And as you know, we’ve gone ahead and cross these people over in a blinded crossover fashion. And the enrollment in the two dose crossover is almost complete. Additionally, we expanded this study to include adolescents 12 to 18 years…

Thanks, Filip. Moving to Slide 27, we provide an overview of our supply commitments to-date. There remains significant demand for NVX-CoV2373 globally with vaccination rates vary widely from country to country. We continue to see significant opportunity in ex-U.S. markets to provide supply for initial vaccinations. In high-income countries, we believe our technology well positioned us to become the booster of choice. Yesterday, we were pleased to announce the finalization of an advanced purchase agreement with the European commission for the purchase of up to 200 million doses of NVX-CoV2373. We expect to begin delivery of initial doses following anticipated regulatory approval from the European Medicines Agency. And through this agreement, NVX-CoV2373 is expected to be the first protein based COVID-19 vaccine available in the European Union. Additionally, we finalize your APA with Gavi, reaffirming our commitment to fair and equitable access to NVX-CoV2373, the cumulative 1.1 billion doses that we alongside our partner Serum Institute committed to the COVAX Facility will be critical and ensuring widespread initial vaccination, particularly in developing markets. So let’s turn to our regulatory manufacturing updates. Next I’d like to discuss our progress during the second quarter for two key areas. The first is our progress toward gaining regulatory authorization of NVX-CoV2373 and anticipated timelines for completing our filings. The second is our progress toward achieving our anticipated manufacturing capacity and our expectations for the supply of NVX-CoV2373 globally. I will then discuss our key areas of strategic focus for the remainder of 2021, as well as our expectations moving into 2022 and beyond. Starting with our efforts to gain regulatory authorization NVX-CoV2373, this week by submitting its first regulatory filings in multiple countries, Novavax has graduated to a new level. Please turn to Slide 28. As I mentioned earlier on today’s call, we filed…

Thanks, Stan. Moving to Slide 30, we issued our second quarter earnings press release, which discusses our financial results for the quarter and we’ll be filing our 10-Q for the second quarter of 2021 today, which includes details on important business and financing events during the second quarter. With that said, I’d like to provide a high-level overview of some of our key financial results for the quarter. Novavax revenue in the second quarter of 2021 was $298 million compared to $36 million in the same period in 2020. This increase was due to increased development activities related to NVX-CoV2373 under the U.S. government and CEPI agreements. During the quarter, we filed an ATM offering in June 2021, which allowed us to issue and sell up to $500 million in gross proceeds of common stock. As of June 30, 2021, no shares have been issued under the new ATM. We ended the quarter with a strong cash position of $2.1 billion compared to $806 million at year end 2020. This increase in cash was primarily due to $1.1 billion in payments received under advanced purchase agreements, the timing of payments to third parties and the $565 million of ATM funding in Q1. With that, I would now like to turn the call back to Stan to discuss our strategic focus for the months to come.

Thanks, John. Turning to Slide 31, I will lastly highlight our key areas of strategic focus for the remainder of 2021, these include the following. Completing additional regulatory filings and gaining regulatory authorizations of NVX-CoV2373 in multiple markets, readying our global supply chain for commercialization and reaching our anticipated manufacturing capacity of 150 million doses per month, beginning expansive discretion of NVX-CoV2373, and finally, advancing life cycle management of NVX-CoV2373. We believe these near-term priorities are critical and laying the foundation for commercial success in the coming years. As we look towards 2022 and beyond, we believe that the clinical development of NVX-CoV2373, to-date, possessions our vaccine to become the universal booster of choice and the preferred vaccine for annual revaccination. Our differentiated technology, as well as our global supply chain, while enable us to support demand in an anticipated booster market in 2022 and beyond, as we continue to develop other areas of our pipeline, both our variant strain and combination vaccine programs will play a meaningful role in our long-term success, enabling us to effectively address continued evolution of COVID-19 alongside seasonal influenza. Before opening the call to Q&A, I wanted to take a moment to acknowledge and thank the Novavax clinical trial participants around the world. These individuals made a crucial and lifesaving contribution during an unprecedented global pandemic. And now they are the reasons at some countries are starting to reopen. I and my colleagues have heard from many of you about your experiences and we are grateful for your generosity. We know that in some situations, clinical trial participants are being challenged with respect to proof of vaccination. We want these folks to know that we are doing everything we can to advocate for them. This includes working with governments to make the case that those who participate in clinical trials should be considered fully vaccinated from public health perspective and treated in the same manner as someone who has received a deployed vaccine. These are unprecedented questions, and we’re supporting the efforts to devise solutions. While we can’t control the decisions that countries and private entities make around vaccine mandates, we will also do our best to keep you informed on our progress. I want to reiterate that we are working day and night to finalize the requirements for the submission process and I want to personally thank all of the clinical trial participants for their vital contributions to public health during the pandemic. For those who have reached out to us directly, we appreciate your letting us know about your situation. But also I should thank our entire Novavax team for their continued dedication over incredibly busy quarter. These tireless efforts combined with the support of our partners globally, bring us significantly closer to delivering our COVID-19 vaccine. And I’d now like to turn it over to the operator for Q&A.

We will now begin the question-and-answer session. [Operator Instructions] And our first question today will come from Kelechi Chikere with Jefferies. Please go ahead.

Yes. Thank you. Congrats on all the progress you’ve made over the quarter. And thank you for the comprehensive update. I guess, my first question, what gives you confidence that you’ll be able to file in the U.S., EU and UK. And I guess, how much risk is there associated with addressing some of those last remaining issues that are the gating steps to those filings? Any color there will be extremely helpful.

Yes. I think the risk reduction is dramatic. I think that it’s a matter of now mechanics of getting all the data – final data assembled and submitted. And it’s – we’re talking weeks here, we’re not talking months. So I’m not worried about the future submissions.

Got it. So you believe that at least the timelines that you’ve put forth, you’ll be able to reach those. Is that more or less correct?

I do.

Great.

Look, this is a very big transformation transition of the company we filed. We’ve now filed with regulatory agencies in three countries, and we’ve got a complete filing package for those. We are finishing the additional requirements in the various countries that I mentioned. We’ve listed dates that we plan on making with a lot of confidence.

Got it. Got it. Perfect. Thank you. And I guess my last question, what additional data do you need to generate and to file to support your booster strategy campaign? Does it make sense to – or is there even a possibility that you can include some of the data that we’re seeing here in the EUA filings to the U.S., EU and UK?

Yes. So certainly, we’ve shared this data with some of those agencies in informally. I think initially we were planning to file with just the overall primary indication of greater than 18 years of age for the primary vaccination. And this data would follow on for our subsequent variation. Hopefully, this data will be in even prior to an official BLA or MAA [indiscernible]

Okay, thank you.

And our next question will come from Mayank Mamtani with B. Riley FBR. Please go ahead.

Good afternoon. Thanks for taking our questions and congrats on data progress being made here. So if I may just ask a quick follow-up on the UK filing that seems to be taking a little longer than maybe that was anticipated. I’m just curious if the Com-COV2 data that is being worked upon also mix and match vaccine data. I’m just curious if you have an update on that and if that data set is playing any role with what is going on in UK. And if you can comment on the CMC side, the first part of that question would be helpful too.

Okay. Well, I’ll take the clinical study portion of the question. So there are two studies that are being funded by the VTF and are being done by University of Oxford and Southampton. One of them has a heterologous vaccination study that you referenced, Com-COV2. And the other one is a boosting study where people receive two doses of other sponsors vaccines and are being boosted by our vaccine. And that’s the cough flu study. Those data – those studies are sponsored by ourselves or sponsored by the universities and we understand the data will be made available and published in the September time frame. So look forward to that data as with yourselves. We’ve discussed this data with the UK regulators and they suggested it would be helpful, but thought that our phase to boost data in conjunction with our South Africa data would really be a desirable to include it in a label indication.

Great. And maybe if I could ask a specific question on the boost data here, the headline number of 4x on both IgG spike and also the wild type neutralization. How do you see this compare relative to maybe what we have seen with mRNAs? And then the IgG decay has in your kinetics seems quite steep. I’m just curious Filip, how should we think about that? Is there anything with the platform or just be – we should be expecting this sort of decade at six months irrespective of mRNA or protein based vaccine.

I guess a couple of thoughts and Greg can jump in as well. I’m not sure that measuring the absolute value of either new to our IgG at six months is an indication of efficacy at that time point. I think we’ve seen that for some of the other sponsors who started before we did and have data in that regard. We certainly haven’t seen any decay in the Kaplan Meier curves that I showed you, although, clearly that was only for the first 90, 100 days or so. I guess the other thing is that that assay is matter, in different kinds of assays measure different things. And finally, I would say, this is not only the quantity of the antibody we induce, also the quality. And you saw from the data we showed, where the functional ACE2 inhibition results that our antibody is able to really across neutralize variants or across neutralizes and drug where to be able to block the functional interaction between spike in ACE2. So much like we saw with the influenza study, where we had good cross protection against drifted strains. I think we’re seeing the same thing. There’s a combination of the absolute titers to achieve and how good your antibody levels are. And I guess the other point is that these titers hit the – hit titers of 200,000, like we demonstrated here, that’s going to take a very long time for that to decay. And we have a much better chance of epitope spreading and cross variant finding and protection, because of the boost data and the maturation of immune response. Greg, do you want to say anything.

That was good. Thank you.

Awesome, and thank you. And my final question on manufacturing, maybe Stan, are you able to comment on sort of what might be our monthly run rate say for July or anything on the doses that you may have stockpile or even like, the shelf life, because I think folks are concerned that this bureaucracy of getting – just getting into the market might be impacting what doses you may have already sitting on the shelf and not getting to people who can benefit from that.

Yes, I think we’re certainly working to make sure that we don’t run into a shelf life problem of product being made. We have been successful in extending dating from six months to nine months on a variety of our in process work. Our expectation is that’s not going to be an issue, we expect fairly rapid licensure, and we expect to be able to use the product we make that we’re scaling up right now. We’re scaling up globally to this rate of a 100 million doses by the end of next month. And so you can figure out what that rate is to get to that point from a 100 million to 150 million, but our – until the product is filled, we don’t have to worry about dating because the drug substance, the antigen itself is frozen. So that’s all on the shelf, we’ve got many tens of millions of doses that are already ready to go by the end of August, when we expect to begin shipping, being able to ship, we’ll have – globally, we’ll have probably over 100 million doses that we’re able to ship. So we’re cooking on that issue. I mean, it’s going well.

Fantastic. Thanks for taking my question and congrats on the progress again.

And our next question will come from Charles Duncan with Cantor Fitzgerald. Please go ahead.

Okay. Thanks, Stan, and team for a comprehensive update and taking our questions. I had kind of a broader question to start with and that is regarding an annual boosting campaign. I guess, I’m wondering if you could layout how you think that would look and what you think the strongest source of competitive advantages that you may have. Is it in distribution or is it efficacy or tolerability or an ability for your vaccine to work nicely in the sandbox, if you will with other vaccines such as influenza?

Well, maybe I can take a crack at that from the medical side. And like Stan said, pretty much all of the above. I think that, we’ll see as additional data emerges, whether the exact [indiscernible] profile of various vaccines are, when they’re given either an homologous boosting or heterologous boosting. And I think we will have an advantage there. I think we’ve demonstrated that when we boost with our vaccine, we get very broad protection against all the variants who tested against. To be clear, I mean, probably immune response against all the variants who tested it against. So I think we’re in good shape there as well. I suspect that as we go forward we’re going to have additional data, which is going to speak to the pathology of our vaccine and how long we can use it myself, like and so forth. Stan, would you like to add anything?

Yes, I would just add, Charles, there’s a variety of factors here, and I think you heard in the presentation on the data that was presented today, that we’re confident in the benefit and value of our boost strategy, but it really remains some additional data to be collected globally on what that policy position will – global health policy position is going to be on boost. And what the timeframe is for that. So we’re obviously collecting all the information relative to the data we have, we’re looking at the data from the other manufacturers. And certainly, we’re in communication in the U.S. and globally about what that healthcare policy will be to support a boost strategy. And I think the data is suggesting that we’re prepared for whatever that might be.

Could you imagine a six-month boost or a 12-month or annual boost?

Yes. I think where the data that was shown was six months homologous boost data. I think Filip has talked about we’re going to be running a clinical trial in the fall is going to be looking at heterologous boost. And so we see significant value in a six-month boost strategy as confirmed by the data. But we’ll have to wait to see what the likes of ACIP and others will say in regard to that.

Okay. And then quickly going onto the MHRA meeting that you – I think you mentioned later this month or next month, what is this specific question that you’re looking to get at MHRA or is it a checkup meeting prior to filing an application for or finishing the application for approval in the UK?

Yes. This is – this we hope would be the final meeting where we’d have the submission after that. We’re looking at the final questions that they come up with and leading to a filing in September.

Last question regarding influenza, I’m quite interested in seeing that move forward. I think it may be interesting see a combination of vaccine, and I guess I’m wondering when you consider the results that you have with the quadrivalent vaccine, what do you think was the driver of the influenza or the response? Was it Matrix-M? And could you speculate on what the response might look like when you combine with 2373 with NanoFlu?

Yes. This is Greg. I mean, I just I think we have two sets of data now. So one is a very efficacious COVID vaccine with Matrix-M, and previously, as you know, we had really good success in older adults with our NanoFlu vaccine. In this trial, this is a licensed vaccine given during the administration. And I think it showed to us that you could get a very good flu response and COVID response simultaneously. So we’re looking forward to us. We – I think we’re staying with our expectation is this fall, we’ll be starting our combination flu COVID vaccine with Matrix-M. And we know Matrix-M has some really good features. It creates a better quality and quantity immune response. I think that COVID has really proven that, that the technology, it can be very powerful for protection against these respiratory vaccine. And I think flu, there’s been a gap, improving immune response, improving the efficacy with flu would be our expectation with this combo vaccine. So we’re very excited to get that program into the clinic. And I expected that as we’ve said, I think that sometime this fall we’ll enroll our first subject in the combo trial.

Okay. Thanks for that color. Looking forward to the upcoming regulatory updates.

Thank you.

And our next question will come from Vernon Bernardino with H. C. Wainwright. Please go ahead.

Hi everyone, thanks for taking my question and congrats on the tremendous progress. I know it’s been a long trip and I’ve been there with you and reading all the way. I know you just announced the submission for EOA in India, Indonesia and the Philippines, but can you give us an idea of how long the regulatory process takes in those countries? And do you – can you provide any insight into how many doses have been already distributed by others – other vaccines in those geographies and perhaps by the time 2373 becomes available in India, Indonesia and the Philippines.

So I can speak to Indonesia. I think that they have had about 70 million doses distributed to date. A lot of those vaccine doses are for this – the Sinopharm, which is the inactivated vaccine and countries have expressed a real interest in trying to have booster with a vaccine like ours. So we did – we have been approached by their government or at least our partner Serum Institute was approached by Indonesia because of their extremely difficult situation they’re having with the delta virus vaccine and I guess when I looked at the data we had today with boosting, it was very encouraging to see how good our immune response what’s the delta. And we can’t predict the timing of these regulatory interactions very easily. We’re hoping that, that something fairly soon it happened, but right now we just don’t have a prediction for the timing of their actions.

Okay. And as a follow-up to that, I know that you’re going to manage factor through into 50 million doses and SII were manufactured the balance of the 1.1 billion, how much of those doses will be going to the three countries?

Yes. So we don’t – so the COVAX control – Gavi controls that, Gavi and UNICEF. So we don’t have – currently, we don’t know the order, which they want to buy dosage for the COVAX Facility.

Okay. That’s all I have. Thanks for taking my question and congrats on the tremendous progress.

Yes. Thanks, Vernon.

And our next question will come from Eric Joseph with JPMorgan. Please go ahead.

Hi, good evening. Thanks for taking the questions. I guess with respect to the equity bonds with EMA and MHRA, can you – I’m sorry if I missed it, but can you speak to what extent the submission packages or requirements differ from those already submitted with a services to for India, Indonesia, and the Philippines. Are just curious to know whether you’re seeing European regulars move the goalposts at all, given that it’s kind of taking this long to complete those submissions. And then Stan, you sound very common – fairly confident on the authorization path for meeting opening in the U.S. following the approval, potential approval of the mRNA vaccines. Curious there is any other feedback specifically from the agency that, that you’re comfortable with that windows – open through the fourth quarter and whether or not it does, it will be curious to get a sense of how to think about timeline to a BLA filing that 2373. Thanks.

Yes. So a couple of questions there, but my confidence in my statement is generated by a news article, Peter Marks quote. And if before that – before I read that quote, I would have said, we can’t predict whether the U.S. it’s been a question mark for a month, whether the EU is going to remain open. And when Peter Marks said that it will remain open in particular because we want to get a protein based COVID vaccine through the system. I – my confidence went up a lot so. And so that’s what I base it on. On the regulatory issues, so every – so we have made products in different plants and use it in different clinical trials. And what is the only difference between what we’re filing with everybody else and what we’re intending to file with the MHRA and EMA is we’re finishing up some comparability work between loss that needs to be done. And those, I think the actual studies are done. And data as we put together and that’s what’s going to take, we gave you this data put together and submit it to the MHRA and so it’s – I have great deal of confidence that that package will go into them on the timetable we just talked about.

How are you planning to update investors, I guess, as it relates to those package submissions…

Well, I think when – obviously when we get an approval, you’ll get a press release. And I think when we file with major agencies like MHRA and EMA, we’ll announce that in a press release.

Okay. And maybe just one follow-up, if I could, I’m just trying to understand – a better understand some of the language in your most recent filing here, as it relates to your agreement with the U.S. government saying would like to see FDA alignment on your analytical methods before conducting additional U.S. manufacturing. It gives how to understand that those that suggest some kind of authorization for – before continued U.S. production. And would it have any bearing – yes.

Yes, that’s sort of the source of some of the delay with the FDA is we have this USG, the U.S. government that is our partner in developing this vaccine. And they are the gate to are submitting to the FDA. So there’s has to be some negotiation with U.S. government and does the validation activities, meet their standards. And then we take it to the FDA and there’s always a time lag with the FDA these days. And so it’s – but we need what they want us to get FDA to concurrence that our assay is fully validated and that’s what the time differences.

Okay. Would this have any impact on the originally implant – originally plan delivery of a 100 million doses under the original work speed agreements, and the originally expected delivery…

Sure, it does, because the time – the original timetable called for starting deliver those doses in the fourth quarter and through the second quarter of next year. And I think that probably we won’t get many doses shipped in the fourth quarter. And it will just push it back to the first and second quarter. We have boost stockpiled those doses. So it’s – it will come in a rush once we get the FDA approval.

Okay, great. Okay. Thanks for taking the questions, guys. Thank you.

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. This has been a huge transition quarter for the company. I mean getting regulatory submissions in is huge. We’re on the verge of product approval. We believe we have additional – we’ve demonstrated additional demand for the product and with the EU filing and we’ve got great data that shows our vaccine is effective against the various strains. And so we’re very optimistic and we’ll look forward to reporting to you next quarter. Thank you.

The conference is now concluded. Thank you for attending today’s presentation. You may now disconnect your lines at this time.