Novavax, Inc. (NVAX) Q2 2021 Earnings Report, Transcript and Summary

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 CoV-Boost mix-and-match study being conducted in the UK. We furthered the global reach of our vaccine candidate finalizing advanced purchase agreements with Gavi for 1.1 billion doses and with the European Commission announced yesterday for up to 200 million doses of 2373. And on the manufacturing front, we continue to work closely with our global partners to progress toward our anticipated manufacturing capacity. We have made significant progress during the quarter to ready our global supply chain for the delivery of 2373, following anticipated regulatory approvals. And today, we reaffirm our guidance to be at a monthly capacity of 100 million doses by the end of the third quarter and 150 million doses by the end of the fourth quarter. In parallel with these developments, we have our eye on the future advancing other candidates in our pipeline that we believe are pivotal in our ability to continuously address the world’s most urgent global health needs. We’re excited to share with you more about these and our many other achievements in the second quarter. Today, our management team will discuss clinical developments for 2373 and our financial results for the second quarter. And I will discuss updates on our supply commitments globally progress toward regulatory approvals of 2373 and the status of our manufacturing global supply chain. I’ll also highlight our key areas of focus moving into the remainder of 2021 as well as 2022 and beyond. With that, I would now like to hand the call over to Filip to discuss our many clinical developments over the second quarter.

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 of age, and we enrolled 2,248 of these children. The dosing is complete and the file for safety, immunogenicity and efficacy is ongoing. We have a blinded crossover plan and we should be beginning that next week. So let’s move on to Slide 6, please. Here what I’ve displayed as the Kaplan-Meier curve for the primary efficacy endpoint. And overall, as you remember, the overall efficacy was 9% as Stan mentioned. From the graph, you can see a couple of other things. You can see the separation of the vaccine and placebo rates began before day 21 before the second dose was given. Additionally, you can see through day-90, there’s no convergence of the right suggesting durability of protection for our vaccine. And finally, I want to remind you that all the severe cases occurred in the placebo group. So let’s move on to Slide 7. Slide 7 contains data, which is updated from we chatted last. And this is because we got additional sequence data from the disease cases in the study. So the way this slide is designed is that the variants of concern are in red. The variants of interest are in yellow and the variants that are neither of concern or interest those that represent the strains closest to the Wuhan strain more like matched strains are represented in green. You can see the overall we had 14 cases in the vaccine group and 63 cases in the placebo group. And remind you, this was a two to one randomized study. So you can consider the placebo group half of what we would have normally been in a one-to-one randomized study. And that efficacy like we talked about was 9% with a lower bound of 83%. Our key secondary endpoint was against strains that were neither areas of interest or areas of concern, those most like Wuhan strain and there we had a 100% efficacy. You can see there are no disease causing strains in green under the vaccine arm. I guess, moderate and severe disease we had a 100% efficacy with a lower bound of 87 and that’s irrespective of variants or non-variants. You can see there were no patients at all in a moderate or disease group under the vaccine column. And finally, we had exploratory analysis against variants of concern of interest, which we saw efficacy of 92.6% with lower bound of 80%. We had enough cases in this study also to estimate the vaccine efficacy against B-117 which is the alpha variant first seen in the UK. And then we had a point estimate of 93% with lower bound of 80%. What’s remarkable across all of these end points is really the consistency of the efficacy as well as the precision and the high lower bound. So let’s turn to Slide 8. Slide 8 outlines the design of the UK study. This is a one-to-one randomized study with 15,000 adults greater than 18 years of age. And this is also we cross these subjects over and enrollment of all the crossover vaccinations has been completed. So let’s move on to Slide 9, which shows a Kaplan-Meier curve of the primary endpoint, as we’ve talked about previously and it’s published now the primary efficacy was 89% overall. Once again, you can see the separation of the curves beginning right at day 21 or before. And once again there’s no convergence of the curve suggesting durability protection. There’s small red axis that denotes severe disease and they’re all in the placebo group. In fact, over all of our programs, we have yet to see a severe case in the vaccinated group. Let’s turn to Slide 10. Part of this study was a influenza sub study where people received a licensed dose of influenza vaccine with a first dose of 2373. What I’ve highlighted here is the local and systemic reactogenicity events and the left hand side is local of both placebo flu alone, Novavax alone, and then a combination of a vaccine flu. And what you can see is that the reactogenicity profile is quite favorable. There’s a small increase in the amount of mild symptoms, but overall, the vaccine was tolerable. And this is mimicked in the systemic side as well. The influenza HAI and seroconversion were preserved with co-administration and I’ll detail this data in the subsequent slide. And I remind you that the overall efficacy of the study was 89.7%. And when we did a subgroup analysis of those in the flu study, we saw that the efficacy was preserved at 87.5%, even though it was a very small subgroup of only 400 individuals. So let’s go to Slide 11 and look at it immuno. So what’s displayed on Slide 11 is the HAI responses of people who received the licensed vaccine alone compared to when given with 2373. And the left hand side, you can see the quadrivalent data. And this is people who were aged 16 to 64 years of age, who by standards in the UK received quadrivalent cell culture influenza vaccine. The older subjects received adjuvanted vaccine, and they’re on the right hand panel. This was a very small group of older subjects because the public health infrastructure in the UK works very well. And we only had 16 subjects who received our vaccine plus influenza. So the conference intervals are quite wide. However, on the left hand side, these were a larger group of individuals. So we can be more precise in our estimates of the immune response to the flu vaccine. And you can see that the HAI responses to the flu vaccine were preserved for all four strains. In fact, numerically the HAI responses, as well as the seroconversion responses were higher in the co-administrator vaccine compared to the vaccine alone. So let’s move on to the next slide, Slide 12, please. This is a comparison of the efficacy results from our two Phase 3 studies that were independently conducted in powered. You can see that the efficacy was remarkably consistent, 89% in the UK study, and 90% in the U.S. study, less than a single percentage point difference in the two studies indicating that the vaccines response is very robust. Against matched strain efficacy in the UK, we saw a 96%, I guess, a prototype and in the U.S., Mexico, where we had greater barrier and spreading, we saw a 100% efficacy against those that were non-variants of concern or interest. Against efficacy against variants in the UK was 86% against alpha, in the U.S. 93% against alpha, and overall in the U.S. variants of concern or interest 92%. So this vaccine works quite well against variants in fact. And finally, we have this observation that in the U.S. our efficacy gain severe disease was a 100%. We didn’t have enough cases in the UK to estimate efficacy, but all severe cases were in the placebo group. And I would say also in the South Africa, all the severe and hospitalized cases were in placebo group as well. So let’s move on to Slide 13, please. Slide 13 is a display of the South Africa Phase 2b design. And the only point I want to make here is that the enrollment of all the crossover and boost vaccinations has started. And this design is a little bit different from the other two in that the people who received placebo initially got two doses of vaccine at six months. However, the people who got two doses initially got a single boost dose at six months, and this will allow us to collect additional boost data both from a safety and immunogenicity perspective in this population. So let’s move to Slide 14, please. Slide 14 displays the study design of our Phase 2b study that we started in the U.S. and Australia over a year ago. Here we enrolled 1,208 adults aged 18 to 84 and half of those were adults who were greater than 60 years of age. After the two dose primary series, we went back and we boosted some of these select individuals at six months. We plan an additional boost at one year. And the groups that I’ve highlighted in red perhaps click please. No. They have highlighted in red on the printed slides are the group we’ll be talking about. These are people who receive two doses initially at day zero in 21 and half of them were boosted at the 189 with a 5 microgram dose of 2373. Let’s go to Slide 15, please. So Slide 15 displays the adverse events comparing dose one to dose two to dose three. And we’ve displayed adverse events overall severe adverse events, medically attended adverse events, SAEs, discontinuations, and potentially immune mediated medical complications. And you can see there’s a lot of consistency between dose one, two and three. And there isn’t an excess of adverse events in dose three. And the rates of severe AEs and SAEs are very low indeed. So this data was reviewed by our external safety monitoring committee, and they voiced no concerns and suggest that we proceed with a vaccination. Let’s move to Slide 16, please. Slide 16 highlights the local systemic reactions after vaccination. And what you can see is for the local reactions, we had an increase of reactogenicity for dose two and then additionally, for dose three, which is completely expected with additional vaccinations. What you can also see is that more than 90% of the reactions were either none, mild or moderate with a very low rate of Grade 3 or more events or the median duration was short less than two days median with exception of erythema, which was 2.5 days. Let’s go to Slide 17, please. Slide 17 is a companion slide, which details the systemic symptoms and it’s very similar to what we saw previously. As expected the symptoms increased with dosing, with – and with the exception of fatigue, more than 90% reported either none, mild or moderate symptoms. And the event rate was quite low overall. Once again the median duration was short plus in one day with exception of muscle pain, which is two days. Let’s move to Slide 18 and look at some immuno data. What I’ve detailed here is the immune response, the immunokinetics of anti-IgG response conducted with our validated assay. And this is against the prototype. So you can see the peak response after two doses on day 35 was 41,000, which decreased over time when we boosted it, it rose up to over 200,000 units. And this represents a 4.6 fold increased compared to the peak seen after primary vaccination. Slide 19, please. This is the same data, but it’s displayed by age. And the point here is that in both the younger adults and the older adults, we had a good impact from boosting. In fact, the impact to older adults was even higher than younger adults to the boost, which is likely because they have slightly lower titers to begin with. Let’s move on to Slide 20, please. So all the data I’ve shown you up until now from an emergency perspective was against our validated anti-spike for the prototype strain. We also developed a validated anti-spike IgG assay for the Beta variant, so the one is first identified in South Africa. And you can see, we got a really nice boost with that as well. From a 4,400 at day the six month time period to over almost 170,000 at Day 217. So what we have here is some evidence that the vaccine has a potential to cross-react against variants. We know this is true, because we have good efficacy against variants. Let’s go Slide 21, please. Slide 21 displays wild type neutralization. Once again, this is against the prototype strain, and you can see very similar patterns what we saw with the IgG responses at peak at Day 35, maybe at month six, and boost it to over 6,000 with an increase fold rise in the older adults. Let’s move on to Slide 22. So on this slide, what I’ve displayed is the peak responses that we observed in the UK Phase 3 study next to that in the middle column is in the immune responses that we observed in the PREVENT-19. And finally, on the right hand side, I have the boost data we showed. Additionally, I’ve put in the vaccine efficacy is the top of the Phase 3 studies. And what you can see is that compared to the two Phase 3 programs, where we showed high efficacy, not only against variants, but also against non-variants, we had a 4.7 to 4.4 fold rise. This gives us a lot of hope that we’re going to increase durability of protection as well as protection overall. Let’s move on to the next slide. This slide is a companion slide, but shows wild type micro neutralization responses. And once again, you can see the peak responses in the UK, as well as the U.S. Phase 3 study. And then we had a large boost from these with our – in our Phase 2 program. I guess, a couple of things to point out here. One of them is that the fold rise is greater for the micro neutralization and for IgG. And this suggests to potential maturation of the immune response with greater spread also we saw a bit more data about this in the next couple of slides. We were quite curious to understand our immune response to these vaccines – to this vaccine, because we have such good efficacy against the variants. Let’s move to Slide 24. Slide 24 is a pretty complicated slide. So I’m going to take my time going through this data. We developed a functional human ACE2 inhibition assay. So what we did is we developed spike proteins from the prototype strain, Delta, Beta and Alpha. And what do we do in this assay is we show that the antibodies that are generated by vaccination can block that interaction. So it is a functional assay. On the left hand side, you can see the Day 35 data. So the Day 35 data is the peak response after two doses, and then black, you can see the prototype, and blue you can see Delta, and red Beta, and in green Alpha. And I want to remind you that the efficacy against the prototype was between 96% and 100%. And against Alpha was between 86% and 94%. And the other variants displayed immune – functional immune responses displayed between those two. So we have high hope that the efficacy against those variants will be somewhere between that, which we saw for the prototype that you saw for Alpha. On the right hand side, you can see the responses after boosts thing. And we had between a six-fold to 10.8 fold increase over what we saw at Day 35. Importantly, Delta is getting a lot of attention. You can see that it had a 6.6 fold rise over the peak response after the primary vaccination series. And other couple of observations on this part of the graph, one of them is that we left no one behind. You can see that 100% of the people were boosted into high levels, especially when you compared the levels we’ve seen here to those which were shown to be protective on the left hand side of the graph. Another observation is that we really have very consistent responses across the three variants. And this, we attribute really to the maturation of the immune response with boosting. So let me move on to Slide 25, which is a quick clinical summary. So we have data from two independent Phase 3 studies that have showed high levels of vaccine efficacy, in the UK 89.7% overall and the U.S. over 90%. And both of these studies have shown strong efficacy against variants, against both the B.1.1.7 Alpha variant, as well as all variants of concern and interest in the U.S. study. Next slide, I’ve shared with you today about our single dose boosting at six months, and this significantly increases immune responses, but wild type neutralization as well as anti-spike IgG are boosted between 4.3 to 6.4 fold over the peak primary vaccination response. In our functional ACE2 immune response, we were able to take this against Alpha, Beta and Delta, not only in our primary vaccination series, but also after we boosted it and these went from a peak of 2.6.1.6 to 10.8 fold increase. We think that this data will support the use of our vaccine in a boosting campaign. And furthermore, we share data with you that the coordinate inspiration with glue, doesn’t it adversely impact the influenza immune response. So we have high hopes that our boosting could be incorporated into the annual influence of vaccine nation campaign. So let me turn this back over to Stan.

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 regulatory submissions in multiple markets in partnership with Serum Institute. These regulatory submissions for emergency use authorization were filed with a Drugs Controller General of India and regulatory agencies in Indonesia, and the Philippines. We expect to file for emergency use listing to the World Health Organization in August. We expect that the granting of emergency use listing by the WHO will open the door for exports to numerous countries, many of whom are participating in the COVAX Facility. These major milestones reflect the strength of our continued partnership with Serum Institute and market important first step toward accelerating global access NVX-CoV2373. We expect these submissions to be the first of many with additional filings expected in the coming months. We’re also working on submissions that will eventually cover the rest of the world, because we’re dealing with regulatory agencies that have different requirements and in countries that have different needs, these regulatory filings and subsequent approval processes will occur over series of months. Let me cover the ones that we are working on now. In the U.S. we’re continuing to work with the FDA in collaboration with our team that we now refer to as the U.S. government to finalize our filing package for authorization under emergency use authorization. The current timeline looks to now be in the fourth quarter, hopefully early in the fourth quarter. This timeline is based upon a couple of factors. First, the completion of validation of analytical methods and additionally, we have many complex critical activities as part of our finalization of our authorization submission that are being carried out with multiple third parties. Importantly, I believe all the key components are in place to achieve our filing within the fourth quarter. The good news is at the U.S., the EUA pathway remains open. Peter Marks, Director of the Center for Biologics Evaluation and Research at the Food and Drug Administration was quoted in a Bloomberg interview this week saying that, and I quote, there probably is going to be a point at which we stopped giving emergency use authorizations, right now one wouldn’t want to rule out continuing to give emergency use authorizations. We still don’t have an approved protein based vaccine for instance, and there are some people that might be a very good alternative. So I think that’s goodness. So regarding our progress toward completing regulatory filings and other geographies, we continue to advance our program with the MHRA, which is the UK regulatory agency. We are targeting to submit to MHRA in the third quarter, but as with all applications, this may change based on discussions planned for later this month to support our planned application in the third quarter. Given that there are many countries who will rely on MHRA authorizations as a basis for their own regulatory approvals, this is another important global filing. In addition to filing with the MHRA, we are preparing to file an additional important markets within weeks of the MHRA filing, including the European Medicines Agency, the Australian Therapeutic Goods Administration, and Health Canada, and New Zealand through Medsafe. As always, gaining regulatory authorization for NVX-CoV2373 remains a top priority as we move into the remainder of 2021 and we continue to work tirelessly with regulatory authorities to complete our filings. Review the completion of multiple filings announced today as a significant first step, but only the first step in gaining authorization of NVX-CoV2373 around the world. So moving to Slide 29, next I will discuss our anticipated timeline toward achieving our manufacturing capacity and progress made during the quarter to prepare a global supply chain for commercialization. Today, we remain on track to achieve manufacturing capacity of a 100 million doses per month, by the end of the third quarter of 2021 and 150 million doses per month by the end of the fourth quarter of 2021. Our manufacturing and developments during the second quarter reflected our progress toward reaching our anticipated manufacturing capacity, as well as our efforts to proactively build our future expansion. Notably, we took additional strides toward producing NVX-CoV2373 in Canada, initiate technology transfer to produce NVX-CoV2373 at the National Research Council Biologics Manufacturing Centre in Canada. We’re excited to see such progress at this facility, which completed construction in June of 2021. We expect to begin our scale GMP manufacturing once the facility receives regulatory approval from Health Canada. The production of NVX-CoV2373 in Canada will represent the first manufacturing capacities in the country for COVID-19 vaccine. We expect our global supply chain to support expansion of distribution of NVX-CoV2373 beginning of the second half of 2021 and we anticipate shipping vaccine upon anticipated regulatory approvals. Initially, our doses may be prioritized low-income countries, where we’ll be able to support critical unmet demand for primary vaccinations. We view our partnership with Serum Institute as a key component in delivery supply to low and middle income countries, including Serum Institute’s contribution to the COVAX Facility. We remain confident in our ability to deliver upon our bilateral supply agreements included with the European Commission, as well as our commitment to the U.S. government, especially as the need for boosters increase among high income countries around the world. With that, I’d now like to hand over the call to John to discuss our financial results for the quarter.

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.