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spk05: Good day, everyone, and welcome to the NEVAVAC second quarter 2021 financial and operating results. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press the star, then one. Please note that this event is being recorded. I'd now like to turn the conference over to Sylvia Taylor, Senior Vice President, Corporate Affairs and Investor Relations. Please go ahead.
spk00: Thanks, Cole. Good afternoon, everyone, 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 investor 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. Philip Dubovsky, Chief Medical Officer, will discuss developments for our COVID-19 program, and John Trezino, 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, 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 would now like to hand the call over to Stan. For those of you following the accompanying slides, please turn to slide three.
spk06: And thank you, Sylvia. 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 today, significant progress has been made to combat the COVID-19 pandemic.
spk08: However,
spk06: We also note that with the continued circulation of variants and with the inequitable access to vaccines that persists in many parts of the world, Novavax's mission to bring NBX-CoV-2373 to market as swiftly as possible has never been more important. At Novavax this week, we took a major step forward in 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 III trial, demonstrating 90% overall efficacy and 100% protection against moderate and severe disease. Phillip 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 II 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 COMCOV-2 study and the COVBOOST mix and match study being conducted in the U.K. 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 are 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 Philip to discuss our many clinical developments over the second quarter.
spk07: Thanks, Dan. 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 five, please. Oh, here we are. So here are the clinical programs that that we've conducted since the beginning of the development. We start off in the phase one, phase two in the US, Australia. There we established the dose level, the immunologic profile, and the preliminary safety profile of the study. And this is a study that's ongoing. And we've conducted some six-month boosting, which I'll talk about later. We moved on to a phase two 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. We moved on to our first big Phase III study in the U.K., and this was a licensure enabling study that collected licensure enabling safety as well as efficacy data. It included a small influenza co-administration study, and I'll touch base on that data a bit later as well. And finally, we conducted a large Phase III study in the U.S., And this defined the safety data and emergency data as well as efficacy data in the U.S. population. Let's move on to slide five, please. Here I just want to remind you of the design of the PREVENT-19 study in the U.S. and Mexico. And this is a 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 crossed 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, emergency, and efficacy is ongoing. We have a blinded crossover planned, and we should be beginning that next week. So let's move on to slide six, please. Here what I've displayed is the Kaplan-Meier curve for the primary efficacy endpoint. And overall, as you remember, the overall efficacy was 90% as Stan mentioned. From this 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 rates 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 seven. Slide seven contains data which is updated from when 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. In 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 to remind you, this was a two-to-one randomized study, so you can consider the placebo group half of where we've only been in a one-to-one randomized study. And that efficacy, like we talked about, was 90% with a lower bound of 83%. Our key secondary endpoint was against strains that were neither variants of interest or variants of concern, those most like the Wuhan strain, and there we had 100% efficacy. You can see there are no disease-causing strains in green under the vaccine arm. Against moderate and severe disease, we had 100% efficacy with a lower bound of 87, and that's irrespective of variants or non-variants. You can see there were no cases at all in the moderate or disease group under the vaccine column. And finally, we had exploratory analysis against pairs of conservative interest, which we saw efficacy of 92.6% with a lower bound of 80%. We had enough cases in this study also to estimate the vaccine efficacy against B.1.1.7, which is the alpha variant first seen in the UK. And there we had a point estimate of 93% with a lower bound of 80%. What's remarkable across all of these endpoints is really the consistency of the efficacy as well as the precision and the high lower bound. So let's turn to slide eight. Slide eight 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 complete. So let's move on to slide nine, 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 curves suggesting durability of protection. There's small red S's 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 an 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 react urgency events. The left-hand side is local of both placebo, flu alone, Novavax alone, and then a combination of Novavax and flu. And what you can see is that the react urgency 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, HAIs, and seroconversion were preserved with co-administration, and I'll detail this data in the subsequent slide. And I'll 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 this was a very small subgroup of only 400 individuals. So let's go to slide 11 and look at the immuno. So what's displayed on slide 11 is the HCI responses of people who received the licensed vaccine alone compared to when given with 2373. On the left-hand side, you can see the quadrivalent data, and this is people who were age 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 circumversion 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 three studies that were independently conducted and powered. You can see that the efficacy was remarkably consistent, 89% in the UK study and 90% in the US study, less than a single percentage point difference in the two studies indicating that the vaccine response is very robust. Against mass strain efficacy in the U.K., we saw a 96% against the prototype. And in the U.S.-Mexico, where we had greater variant spreading, we saw a 100% efficacy against those that were non-variants of concern or interest. Efficacy against variants in the U.K. was 86% against alpha. In the U.S., 93% against alpha. And overall in the U.S., variants of concern 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 in severe disease was 100%. We didn't have enough cases in the U.K. to estimate efficacy, but all the severe cases were in the placebo group. And I would say also in South Africa, all the severe and hospitalized cases were in the 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 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 immunity perspective in this population. So let's move to slide 14, please. Slide 14 displays the study design of our Phase IIb study that we started in the US and Australia over a year ago. Here we enrolled 1,288 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, that I've highlighted in red on the printed slides are the group we'll be talking about. These are people who received two doses initially at day 0 and 21, and half of them were boosted at day 189 with a 5-microgram dose of 2373. Let's go to slide 15, please. So slide 15 displays the adverse events comparing dose 1 to dose 2 to dose 3. 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 1, 2, and 3. And there is an excess of adverse events in dose 3. 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 suggested we proceed with 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 reactivity 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 three or more events. The median duration was short, less than two days median, with the 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, 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, less than one day, with the exception of muscle pain, which was 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 an anti-IgG response conducted with our validated assay, and this is against a 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 increase compared to the peak seen after primary vaccination. Go to 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 had 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 that was first identified in South Africa. And you can see we got a really nice boost with that as well, from a 4,400 a day at the six-month time period to over almost 170,000 a day, 217. So what we have here is some evidence that the vaccine has potential to cross-react against Variance, we know this is true because we have good efficacy against variance. Let's go to slide 21, please. Slide 21 displays wild-type neutralization. Once again, this is against the prototype strain. And you can see very similar patterns to what we saw with IGG responses, a peak at day 35, nadir at month six, and boosted to over 6,000 with an increased foal rise in the older adults. So 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 the immune responses that we observed in the PREVENT-19 study. And finally, on the right-hand side, I have the boost data we just showed. Additionally, I've put in the vaccine efficacies atop the Phase 3 studies. And what you can see is that compared to the two Phase III programs where we showed high levels of 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 microneutralization responses. And once again, you can see the peak responses in the U.K., as well as the U.S. Phase III study. And then we had a large boost from these with our Phase II program. I guess a couple things to point out here. One of them is that the fold rise was greater for the microneutralization than for IgG. And this suggests a potential maturation of the immune response with greater spread. And I'll show you a bit more data about this in the next couple slides. We were quite curious to understand our immune response to these vaccines, to this vaccine, because we had 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 we do in this assay is we show that the antibodies that are generated by vaccination can block that interaction. So this 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 in black, you can see the prototype. In blue, you can see delta. In 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 it was between 86% and 94%. And the other variants displayed functional immune responses that lie 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 and that which we saw for alpha. On the right-hand side, you can see the responses after boosting. 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. Another 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 compare 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 three studies that have shown high levels of vaccine efficacy. In the UK, 89.7% overall. In the US, over 90%. And both of these studies have shown strong efficacy against variants, against both the B117, the alpha variant, as well as all variants of concern and interest in the US study. Next slide. I've shared with you today about our single-dose boosting at six months, and this significantly increases immune responses. Both wild-type neutralization as well as anti-spike IgG were boosted between 4.3 to 6.4-fold over the peak primary vaccination response. In our functional ACE2 immune response, we were able to detect 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 6.6 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 co-administration with flu doesn't adversely impact the influenza immune response. So we have high hopes that our boosting could be incorporated into the annual influenza vaccination campaign. So let me turn this back over to Stan.
spk06: Thanks, Philip. Moving to slide 27, we provide an overview of our supply commitments to date. There remains significant demand for 2373 globally. With vaccination rates varying 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 positions 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 2373. We expect to begin delivery of initial doses following anticipated regulatory approval from the European Medicines Agency. And through this agreement, 2373 is expected to be the first protein-based COVID-19 vaccine available in the European Union. Additionally, we finalized our APA with Gavi, reaffirming our commitment to fair and equitable access to 2373, the cumulative 1.1 billion doses that we, alongside our partner Serum Institute, committed to the COVAX facility will be critical in ensuring widespread initial vaccination, particularly in developing markets. So let's turn to our regulatory manufacturing updates. I'd next like to discuss our progress during the second quarter for two key areas. The first is our progress toward gaining regulatory authorization of 2373 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 2373 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 in 2373, 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 the 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 mark an important first step toward accelerating global equitable access to 2373. We expect these submissions to be the first of many with additional filings expected in the coming months. We are 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 a series of months. Let me cover the ones that we are working on now. In the U.S., we are 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. Our 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 that the UA 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 stop giving emergency use authorizations, but 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 where that might be a very good alternative. So I think that's good news. 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 the basis for their own regulatory approvals, this is another important global filing. In addition to filing with the MHRA, we are preparing to file in additional important markets within weeks of the MHRA filing, including the European Medicines Agency, the Australian Therapeutics Goods Administration, in Health Canada, and in New Zealand through Medsafe. As always, Gaining regulatory authorization for 2373 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. We view the completion of multiple filings announced today as a significant first step, but only the first step in gaining authorization of 2373 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 our global supply chain for commercialization. Today, we remain on track to achieve manufacturing capacity of 100 million doses per month by the end of the third quarter of 21 and 150 million doses per month by the end of the fourth quarter of 21. Our manufacturing developments during the second quarter reflect our progress toward reaching our anticipated manufacturing capacity as well as our efforts to proactively build for future expansion. Notably, we took additional strides toward producing 2373 in Canada, initiating technology transfer to produce 2373 at the National Research Council's Biologics Manufacturing Center in Canada. We are excited to see such progress at this facility, which completed construction in June of 21. We expect to begin large-scale GMP manufacturing once the facility receives regulatory approval from health candidates. The production of 2373 in Canada will represent the first manufacturing capacities in the country for a COVID-19 vaccine. We expect our global supply chain to support expansion of distribution of 2373 beginning the second half of 2021, and we anticipate shipping vaccine upon anticipated regulatory approvals. Initially, our doses may be prioritized to 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 delivering 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, including 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.
spk04: Thanks, Dan. 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 COVID-2373 under the US 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 30th, 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.
spk06: Thanks, John. Turning to slide 31, I will lastly highlight our key areas of strategic focus for the remainder of 21. These include the following. Completing additional regulatory filings and gaining regulatory authorizations of 2373 in multiple markets. Readying our global supply chain for commercialization and reaching our anticipated manufacturing capacity of 150 million doses per month. beginning expansive distribution of 2373, and finally advancing lifecycle management of 2373. We believe these near-term priorities are critical in laying a foundation for commercial success in the coming years. As we look towards 2022 and beyond, we believe that the clinical development of 2373 to date positions 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, will 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 that 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 a public health perspective and treated in the same manner as someone who has received a deployed vaccine. These are unprecedented questions, and we are 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. I'd also like to thank our entire Novavax team for their continued dedication over an 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 would now like to turn it over to the operator for Q&A.
spk05: And we will now begin the question and answer session. To ask a question, you may press star then 1 on your touch-tone phone. If you're using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then 2. And at this time, we'll pause momentarily to assemble the roster. And our first question today will come from with Jefferies. Please go ahead.
spk11: Yes, thank you. Congrats on all the progress you've made over the quarter. And thank you for the comprehensive update. I guess on my first question, What gives you confidence that you'll be able to file in the U.S., EU, and U.K.? 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.
spk06: Yeah, 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 submit it, and we're talking weeks here. We're not talking months. So I'm not worried about the future submissions.
spk11: 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?
spk06: I do.
spk11: Great.
spk06: Look, this is a very big project. transformation, transition of the company. We've 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.
spk11: Got it. Perfect. Thank you. And I guess my last question, what additional data do you need to generate and facilitate 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 US, EU, and UK?
spk07: Yeah, so certainly we've shared this data with some of those agencies 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 a subsequent variation. Hopefully this data will be in even prior to an official BLA or MAA and can be done as a variant. Okay. All right. Thank you.
spk05: And our next question will come from Maya Mamtani with B Raleigh FBR. Please go ahead.
spk01: Good afternoon. Thanks for taking our questions and congrats on a ton of 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 Comcov2 data that is being worked upon, also a 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, you know, the first part of that question would be helpful, too.
spk07: 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 in Southampton. One of them is a heterologous vaccination study that you referenced, COMCOV-2, and the other one is a boosting study where people receive two doses of other sponsors' vaccines that are being boosted by our vaccine, and that's the COF-BOOST study. Those studies are sponsored by ourselves, they're sponsored by the universities, and we understand the data will be available and published in the September time frame, so we look forward to that data with yourselves. We've discussed this data with the UK regulators, and they suggested it would be helpful, but thought that our Phase 2 BOOST data, in conjunction with our South Africa data, would really be desirable to include it in a labeled indication.
spk01: Great. And maybe if I could ask a specific question on the boost data here. You know, the headline number of 4X on both IgG spike and also the wild-type neutralization, how do you see this compared relative to maybe what we have seen with mRNAs? And then, you know, the IgG decay here in your kinetics seems quite steep. I'm just curious, Philip, how should we think about that? You know, is there anything with the platform, or just we should be expecting this sort of decay at six months, you know, irrespective of mRNA or a protein-based vaccine?
spk07: I guess a couple thoughts, and Greg can jump in as well. I'm not sure that measuring the absolute value of either newts or ITG at six months is an indication of efficacy at that time point. I think we've seen that from 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, you know, clearly that was only for the first 90, 100 days or so. I guess the other thing is that assays matter. And different kind of assays measure different things. And finally, I would say that it's not only the quantity of the antibody we induce, but also the quality. You saw from the data we showed with the functional ACE2 inhibition results that our antibody is able to really cross-neutralize variants. Cross-neutralize isn't the right word. To be able to block the functional interaction between spike and 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 you achieve and how good your antibody levels are I and I I guess the other point is that these titers if we 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 you know epitope spreading and and cross-variant binding and protection because of the boost data and the maturation of immune response. Greg, do you want to say anything? That's good. Thank you.
spk01: Awesome. And thank you. And my final question on manufacturing, maybe Stan, are you able to comment on sort of, you know, what might be your monthly run rate, say, for July or anything on the doses that you may have stockpiled or even, like, you know, the shelf life because, you know, I think folks are concerned that, you know, this bureaucracy of, you know, getting not 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.
spk06: Yeah, 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 100 million doses by the end of next month. And so you can figure out what that rate is. you know, is to get to that point, and then from 100 million to 150 million. But 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. It's going well.
spk01: Fantastic. Thanks for taking my question and congrats on the progress again.
spk05: And our next question will come from Charles Duncan with Cancer Fitzgerald. Please go ahead.
spk02: 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 lay out how you think that would look and what you think the strongest source of competitive advantage is 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?
spk07: 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. what the exact reactivity profile of various vaccines are when they're given either an homologous boosting or a heterologous boosting. And I think we'll 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 we've tested it against. To be clear, I mean broad immune response against all the variants we've 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 in the shelf life and so forth.
spk04: Yeah, I would just add, Charles, that there's a variety of factors here. And I think you heard in the presentation and 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, you know, what that policy position or global health policy position is going to be on boost, you know, and what the timeframe is for that. So we're obviously collecting all the information relative to the data that 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 health care policy will be to support a boost strategy. And I think the data is suggesting that we're prepared for whatever that might be.
spk02: Could you imagine a six-month boost or a 12-month or annual boost?
spk04: Yeah, I think, you know, where the data that was shown was, you know, six-month homologous boost data. I think Philip has talked about we're going to be running a clinical trial in the fall that's 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.
spk02: Okay. And then quickly going on to the MHRA meeting that I think you mentioned later this month or next month, what is the specific question that you're looking to get out of MHRA, or is it a checkup meeting prior to filing an application or finishing the application for approval in the U.K.? ?
spk06: Yeah, this is this we hope would be the final meeting where we'd have the submission after that we're looking at the final, final questions that they come up with and leading to a filing in September.
spk02: Last question regarding influenza. I'm quite interested in seeing that move forward. I think it may be interesting to 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 nanofluke?
spk08: Yeah, 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 MatrixM. And, you know, 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, I think we're, you know, staying with our expectation is this fall we'll be starting our combination flu COVID vaccine with MatrixM. And we know MatrixM has some really good features. It creates a better, you know, quality and quantity immune response. I think that COVID has really proven that, you know, the technology can be very powerful for protection against these respiratory vaccines. And I think, you know, 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 expect that, you know, as we've said, I think that sometime this fall we'll enroll our first subjects in the combo trial.
spk02: Okay, thanks for that, Ed. Looking forward to the upcoming regulatory updates.
spk04: Thank you.
spk05: And our next question will come from Vernon Bernardito with HC Wainwright. Please go ahead.
spk09: 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 rooting all the way. I know you just announced the submission for EUA in India, Indonesia, and the Philippines, but can you give us an idea how long the regulatory process takes in those countries? And can you provide any insight into how many doses have been already distributed by EUA others, you know, and other vaccines in those geographies, and perhaps by the time 2373 becomes available in Indonesia and the Philippines.
spk08: 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 the Sinopharm, which is the inactivated vaccine, and countries have expressed a real interest in trying to have, you know, a booster with a vaccine like ours. So, you know, we have been approached by their government, or at least our partner, Serum Institute, was approached by Indonesia because of their, you know, 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, you know, was to Delta. And we can't predict the timing of these regulatory interactions very easily. We're hoping that something fairly soon could happen, but right now, we just don't have a prediction for the timing of their actions.
spk09: Okay, and as a follow-up to that, I know that you're going to manufacture 350 million doses, and SII will manufacture the balance of the 1.1 billion doses. how much of those doses will be going to the three countries?
spk06: Yeah, so we don't, so COVAX controls, GAVI controls it, GAVI and UNICEF. So we don't have, currently we don't know the order in which they want to provide doses for the COVAX facility.
spk09: Okay. That's all I have. Thanks for taking my question, and congrats on the tremendous progress.
spk05: Yeah, thanks, Warren. And our next question will come from Eric Joseph with JPMorgan. Please go ahead.
spk10: Hi. Good evening. Thanks for taking my question. I guess with respect to the upcoming filings 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 CERB Institute for India, Indonesia, and the Philippines. I'm just curious to know whether you're seeing European regulars move the goalposts at all, given that it's kind of taken this long to complete those submissions. And then, Stan, you sound fairly confident on the authorization path. remaining opening in the U.S. following the approval, potential approval of the mRNA vaccines. I'm curious to know if there's any other feedback specifically from the agency that gets you comfortable with that window standing open through your fourth quarter, and whether or not it does. We'd be curious to get a sense of how to think about timelines to a BLA filing with 2373. Thanks.
spk06: Yeah, so a couple 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, you know, we can't predict whether the EUA is, it's been a question mark for a bunch, whether the EUA is going to remain open. And when Peter Marks said that it will, it's, 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 that's what I base it on. On the regulatory issues. 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 lots that needs to be done and those, I think the actual studies are done and data has to be put together and that's what's gonna take, getting 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.
spk10: How are you planning to update investors, I guess, as it relates to those, package submissions?
spk06: Well, I think 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.
spk10: And maybe just one follow-up if I could. I'm just trying to better understand some of the language in the most recent filing here as it relates to Your agreement with the U.S. government saying that it would like to see FDA alignment on your analytical methods before conducting additional U.S. manufacturing. I think it's how to understand that. Does that suggest some kind of authorization or approval before continued U.S. production? And would it have any barriers?
spk06: Yeah. Yeah, 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 our submitting to the FDA. So there 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. But we need what they want us to get. FTA-2 concurrence that our assay is fully validated, and that's what the time difference is.
spk10: Okay. Would this have any impact on the originally planned delivery of the 100 million doses under the original Warp Speed Agreement? I know that you're originally expecting delivery at the top of the point there.
spk06: Sure, it does, because the original timetable called for starting to 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've stockpiled those doses, so they will come in a rush once we get the FDA approval.
spk10: Okay, great. Okay, thanks for taking the questions, guys. Thank you.
spk05: And this will conclude our question and answer session. I'd like to turn the conference back over to Stan for any closing remarks.
spk06: Yeah, 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 demonstrated additional demand for the product with the EU filing, and we've got great data that shows our vaccine is effective against the variant strains. And so we're very optimistic, and we'll look forward to reporting to you next quarter. Thank you.
spk05: The conference is now concluded. Thank you for attending today's presentation. You may now disconnect your lines at this time.
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