Earnings Call: Q2 2021

Aug 5, 2021

Good day, everyone, and welcome to the Novavax Second Quarter 2021 Financial and Operating Results. All participants will be in a listen only mode. After today's presentation, there will be an opportunity to ask questions. 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 Investor Relations, please go ahead. Thanks, Cole. Good afternoon, everyone, and thank you to all of you who have joined today's call to discuss our Q2 2021 operational highlights and financial results. A press release announcing our results is currently available on our website atnovavax.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 Q2, our supply commitments, our regulatory timelines as well as updates on manufacturing. Doctor. Philip Dubovsky, Chief Medical Officer, will discuss developments for our COVID-nineteen 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, Doctor. Greg Glenn, President of R and D, will be available for the Q and 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 3. 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 to date, significant progress has been made to combat the COVID-nineteen pandemic. However, We also note that with the continued circulation of variants and with the inequitable access to vaccines that persist in many parts of the world, Novavax's mission to bring NVX CoV-two thousand three hundred and seventy three 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 2,003 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 2,373 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 We announced positive data from our PREVENT-nineteen pivotal Phase 3 trial, demonstrating 90% overall efficacy and 100% protection against moderate and severe disease. Philip will talk more about this shortly. We took major steps in exploring 2,173's boosting capabilities, including positive results announced today From our 6 month booster study in our ongoing U. S. And Australia Phase 2 trial. In conjunction with our PREVENT-nineteen trial, These outstanding data make a compelling case for 2,173 to become the universal booster of choice. We also continue to explore heterologous boosting alongside other vaccines in the market by participating in 2 partner led studies, The COMCov2 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 1,100,000,000 doses and with the European Commission announced yesterday We're up to 200,000,000 doses of 2,173. 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 2,173 following anticipated regulatory approvals. And today, we reaffirm our guidance to be At a monthly capacity of 100,000,000 doses by the end of the 3rd quarter and 150,000,000 doses by the end of the 4th 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 Q2. Today, our management team will discuss clinical developments for 2,373 and our financial results for the Q2. And I will discuss Updates on our supply commitments globally, progress toward regulatory approvals of 2,373 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 mid clinical developments over the Q2. Thanks, Dan. We achieved a number of milestones in the Q2 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. 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. And Australia. 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 6 month boosting, which I'll talk about later. We 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 The efficacy and safety in a small group of HIV subjects. We moved on to our first big Phase 3 study in the UK and this was a licensure enabling study That collected licensure enabling safety as well as efficacy data included a small influenza co administration study, and I'll touch base on that data And finally, we conducted a large Phase 3 study in the U. S. And this defined the Safety data and immunogenicity data as well as efficacy data in the U. S. Population. Let's move on to Slide 5 please. I just want to remind you of the design of the PREVENT-nineteen 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 is randomized 2 to 1. And as you know, we've gone ahead and Cross these people over in a blinded crossover fashion and the enrollment in the 2 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, rigidity 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 is the Kaplan Meier curve for the primary efficacy Endpoint. And overall, as you remember, the overall efficacy was 9% as Stan mentioned. From this graph, you can See a couple of other things. You can see that 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 7. Slide 7 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 variance of concern are in red, the variance 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 match 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 2 to 1 randomized study, So you can consider the placebo group half of where it would normally have been in the 1 to 1 randomized study. And then efficacy, like we talked about, was 9% with a lower bound of 83 Our key secondary endpoint was against strains that were neither various of interest or various of concern. Those most like Wuhan strain and there we had 100 percent efficacy. You can see there are no disease causing strains in green under the vaccine arm. Against modern severe disease, we had 100 percent efficacy with a lower bound of 87 and that's irrespective of variance or non variance. There were no cases at all in the moderate or disease group under the vaccine column. And finally, we had exploratory analysis against fairs of concern of interest, which we saw efficacy of 92.6 percent with a lower bound of 80%. We had enough cases in this study also to estimate the vaccine efficacy begins B117, 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 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 Subject is over and enrollment of all the crossover vaccinations has been complete. 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, Primary efficacy was 89% overall. Once again, you can see the separation of the curves beginning Right at day 21 or before. Once again, there's no convergence of the curve suggesting durability of protection. There are small Red S's denote 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 substudy where people Received a licensed dose of influenza vaccine with the first dose of 23,273. What I've highlighted here is the local and systemic reactors 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 regency profile is quite favorable. There's a small increase in the amount of mild symptoms, but overall, the vaccine is tolerable and this is mimicked in the systemic side as well. The influenza HAIs in seroconversion were preserved with coadministration and I'll detail this data in subsequent slides. And I'll remind you that the overall efficacy of the study was 89.7 percent, and when we did a subgroup analysis of those in the FLU study, we saw that the efficacy was preserved at 87.5 percent, What's displayed on Slide 11 is the ACI responses of people who received the licensed vaccine Alone compared to when given with 2,373. On the left hand side, you can see the quadrivalent data and this is people who were aged 64 years of age who by standards in the UK received quadrivalent cell culture influenza vaccine. The older subjects received adjuvanted vaccine and This is a very small group of older subjects because the public health infrastructure in the UK works very well We only had 16 subjects who received our vaccine plus influenza, so the conference intervals are quite wide. 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 4 strains. In fact, numerically, the HAI responses as well as the SIR conversion responses We're higher in the coadministrator 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 2 Phase 3 studies that were independently conducted in EMPOWURED. 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 And the two studies indicating that the vaccine response is very robust. Against match strain efficacy in the UK, We saw a 96% against the prototype and in the U. S. Mexico where we had greater variance spreading, we saw a 100% efficacy against those who are nonvariants 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, variance of concern and interest, 92%. So this vaccine works quite well against variance impact. And finally, we have this observation that in the U. S. Our efficacy in severe disease was 100%. We didn't have enough in the U. K. 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 enrollment of all the crossover and boost vaccinations has started. This design is a little bit different from the other 2 in that the people who received placebo initially got 2 doses of vaccine at However, the people who got 2 doses initially got a single BOOST dose at 6 months and this will allow us to collect additional BOOST data, both from a safety and energy perspective in this So let's move to Slide 14, please. Slide 14 displays the study design of our Phase study that we started in the U. S. And Australia over a year ago. Here we enrolled 1288 adults aged 18 to 84 Half of those were adults who were greater than 60 years of age. After the 2 dose primary series, we went back and we boosted some of these select individuals So, 6 months. We plan an additional boost at 1 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 2 doses initially at day 0 and 21 and half of them were boosted at day 189 with a 5 microgram dose of 2,373. Let's go to Slide 15 please. So Slide 15 displays adverse events comparing dose 1 to dose 2 to dose 3, And we've displayed adverse events overall, severe adverse events, medically attended asperger events, SAEs, discontinuations And potentially immune mediated medical complications. As you can see, there's a lot of consistency between dose 123 There is an excess of adverse events in dose 3 and the rates of severe AEs and SEs are very low indeed. This data was reviewed by our external safety monitoring committee and they voice no concerns and suggest that we proceed with vaccination. Let's move to Slide 16 please. Slide 16 highlights the local systemic reactions after vaccination What you can see is for the local reactions, we had an increase of reactogenicity For dose 2, and then additionally for dose 3, which is completely expected, with additional vaccinations. What you can also see is that more than 90% The reactions were either none, mild or moderate with a very low rate of Grade 3 or more events. The median duration was short, Less than 2 days median with exception of erythema, which is 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, plus in one day with the exception of muscle pain, which was 2 days. Let's move to Slide 18 and look at some immuno data. What I have 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 2 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 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's first identified in South Africa, and you can see we got a really nice boost with that as well. From a 4400 a day at the 6 months time period to over almost 170,000 a day 2017. 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 the IgG responses, 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-nineteen study. And finally, on the right hand side, I have the BOOST data we just showed. Additionally, I've put in the vaccine efficacy at the top of the Phase 3 studies. And what you can see is that compared to the 2 Phase 3 programs where we showed HyHo's efficacy not only variance but also against non variance, we had a 4.7 to 4.4 fold rise. This gives us a lot of hope that we're 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 which shows wild type microneutralization responses. Once again, you can see the peak responses in the UK as well as the U. S. Phase 3 We had a large boost from these in our Phase II program. There's a couple of things to point out here. One of them is that the fold rise is greater for the microneutralization than for IgG and this suggests a potential maturation of the immune response with greater spread. I'll squeeze a little bit more data about this in the next couple of slides. We were quite curious to understand our immune response to this vaccine because we had such good efficacy against the variance. 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. What we did is we developed our 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 driven 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 2 doses. And in black, you can see the prototype in blue, you can see delta in red, beta and in green, alpha. I want to remind you that the efficacy against the prototype was between 96% 100% and against alpha was between 86% and 94%. And the other variants displayed immune functional immune responses that lie between those 2, so we have high hope that the efficacy against those variants will be somewhere between that which we saw for the prototype That we saw for alpha. On the right hand side, you can see the responses after boosting and we had between a 6 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 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 Another observation is that we really have Very consistent responses across the 3 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 2 independent Phase 3 studies that have shown high levels of vaccine efficacy. In the UK, 89.7% overall, in the U. S, Over 90 percent. And both of these studies have shown strong efficacy against variants against both B117, the alpha variant, well as all various of concern and interest in the US study. Next slide. I've shared with you today about our single dose boosting at 6 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 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 616 to 10.8 fold increase. We think that this data will support the use of our vaccine in a boosting campaign. Furthermore, we shared data with you that the co administration with flu Does the adverse impact the influenza immune response, so we have high hopes that our boosting could be incorporated into the annual So let me turn this back over to Stan. Thanks, Philip. Moving to Slide 27. We provide an overview of our supply commitments to date. There remains significant demand for 2,173 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 200,000,000 doses of 2,173, we expect to begin delivery of initial doses following anticipated regulatory approval from the European Medicines Agency. And through this agreement, 2,173 is expected to be the 1st protein based COVID-nineteen vaccine Additionally, we finalized our APA with Gavi, reaffirming our commitment to fair and equitable access 2,373, the cumulative 1,100,000,000 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 and manufacturing updates. I'd like to discuss our progress during the Q2 for 2 key areas. The first is our progress toward gaining regulatory authorization of 2,173 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 2,173 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 of 2,173, 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 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 These major milestones reflect the strength of our continued partnership with Saram Institute and mark an important first step We're accelerating global equitable access to 2,173. 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 Our current timeline looks to now be in the Q4, hopefully early in Q4. 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 Q4. The good news is that the U. S. The UA pathway remains open. Peter Marks, Director of the Center For Biologics Evaluation and Research At the Food and Drug Administration, it 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 in other geographies, we continue to advance our program with the MHRA, which is the U. K. Regulatory agency. We are targeting to submit to MHRA in the Q3, but as with all applications, this may change based on 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 Therapeutic Goods Administration, in Health Canada And in New Zealand through MedSafe. As always, gaining regulatory authorization for 2,373 remains a top priority As we move into the remainder of 2021, we continue to work tirelessly with the 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 and gaining authorization of 2,370 around the world. So moving to Slide 29. Next, I will Our anticipated timeline towards 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 100,000,000 doses per month by the end of the Q3 of 'twenty one and 150,000,000 doses per month by the end of the Q4 of 2021. Our manufacturing and developments during the Q2 reflected 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 2,373 in Canada, initiating technology transfer to produce 2,373 At the National Research Council's Biologics Manufacturing Centre in Canada, we're excited to see such progress at this facility, Which completed construction in June of 'twenty one, we expect to begin large scale GMP manufacturing once the facility receives regulatory approval from Health Canada. The production of 2,173 in Canada will represent the 1st manufacturing capacities in the country for COVID-nineteen vaccine. We expect our global supply chain to support expansion of distribution of 2,173 beginning in the second half of twenty twenty one, 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 first question comes from the line of the line of the European Commission as well as our commitment to the U. S. Government, especially as the need for boosters With that, I'd now like to hand over the call to John to discuss our financial results for the quarter. Thanks, Dan. Moving to Slide 30. We issued our 2nd quarter earnings press release, which discusses our financial results for the quarter And we'll be filing our 10 Q for the Q2 of 2021 today, which includes details on important business and financing events during the Q2. 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 Q2 of 2021 was $298,000,000 compared to $36,000,000 in the same period in 2020. This increase was due to increased development activities related to 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 $500,000,000 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 $2,100,000,000 compared to $806,000,000 at year end 2020. This increase in cash was primarily due to $1,100,000,000 in payments received under advanced purchase agreements, The timing of payments to 3rd parties and the $565,000,000 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 'twenty one. These include the following: Completing additional regulatory filings and gaining regulatory authorizations of 2,173 in multiple markets, readying our global supply chain for commercialization And reaching our anticipated manufacturing capacity of 150,000,000 doses per month, beginning expansive distribution of 2,373 and finally, Advancing Lifecycle Management of 2,173. We believe these near term priorities are critical in laying the foundation for commercial success in the coming years. As we look towards 2022 and beyond, we believe that the clinical development of 2,173 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-nineteen alongside seasonal influenza. Before opening the call to Q and 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 life saving 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 We are doing everything we can to advocate for them. This includes working with governments to make the case that those who participate And 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 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 you letting us know about your situation. I'd also like to thank our entire Novavax team With 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-nineteen vaccine. And I would now like to turn it over to the operator for Q and A. And we will now begin the question and answer session. And at this time, we will pause momentarily to assemble the roster. And our first question today will come from Kelechi Chikiri 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 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. This is a very big transformation, transition of the company we filed. We've now filed with regulatory agencies in 3 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 Yes. 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 for the primary vaccination and this data would follow on for subsequent variation. Hopefully, this data will be in even prior to a beneficial BLA Or MAA. I think we don't have the very end. Okay. All right. 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 the progress we 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 COMCOV-two data that is being worked upon, also a mix and match vaccine data. And 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 2 studies that are being funded by the VTF and are being done by Oxford and One of them is a heterologous vaccination study that you referenced, COMCOP-two, and the other one is a boosting study where people 2 doses of other sponsors' vaccines that are being boosted by our vaccine and that's the COUNCBOOST study. Those These are not be sponsored by ourselves or sponsored by the universities and we understand the data will be available and published in the September timeframe. 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 II BOOST data in conjunction with our South Africa data would really be desirable to include it in a labeled indication. Great. And maybe if I could ask a specific question on the boost Zaida 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 here in your Kinetics seems quite steep. I'm just curious, Philip, how should we think about that? Is there anything with the platform or Just we should be expecting this sort of decay at 6 months irrespective of mRNA or a 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 NUTS or IgG at 6 This 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 clearly that was only for the 1st 9, 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, early 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 absolute titers we achieved and how good your antibody levels are. 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 epitope spreading And cross variant finding and protection because of the BOOST data and the migration 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 your monthly run rate, say for July or anything on the doses that you may have stockpiled or even like the shelf life I think folks are concerned that this bureaucracy of 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? Yes, I think we're certainly working to make sure that we don't run into a shelf life problem The product being made, we have been successful in extending dating from 6 months to 9 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're scaling up right now. We're scaling up globally to this rate of 100,000,000 doses by the end of next month. And so you can figure out what that rate To get to that point from $100,000,000 to $150,000,000 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 They're already ready to go. And by the end of August, when we expect to begin shipping, being able to ship, we'll have Globally, we'll have probably over 100,000,000 doses that we're able to ship. So we're Cooking on that issue, Edward. 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 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? Well, maybe I can take the back of that from the medical side and like Stan said, pretty much all the above. I think that We'll see as additional data emerges what the exact reactogenicity profile of various vaccines are when they're given either an homologous boosting or heterologous 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 against, to be clear, I mean, broad immune response against all the variants we've tested 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 And how long we can use it in the shelf life and so forth. Johnny, do you have anything? Yes. I would just add, Charles, 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 What that policy position or global health policy position is going to be on Boost and what the timeframe It's 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 Could you imagine a 6 month boost or a 12 month or annual boost? Yes. I think where the data that was shown was 6 months 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 6 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 on to the MHRA meeting that you I think you mentioned later this month or next What is the specific question that you're looking to get out of NIHRA? Or is it a checkup meeting Prior to filing an application for or finishing the application for approval in the U. K. Yes. This is we hope would be the final meeting where we would 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 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 what is 2,373 with NanoFlu? Yes, this is Greg. I mean, I think we have 2 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 can get a very good flu response and COVID response simultaneously. So we're looking forward to So 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 the Technology can be very powerful for protection against these respiratory vaccines. I think flu, There's been the 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, as we've said, I think that sometime this fall, we'll Enroll our 1st subjects 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 rooting all the way. I know you just announced the submission for EUA And 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 others and other vaccines in those geographies And perhaps by the time 2,373 becomes available in Indonesia and the Philippines? So I can speak to Indonesia. I think that they have had about 70,000,000 doses distributed to date. A lot of those vaccine doses The Sinopharm, which is the inactivated vaccine and countries have expressed real interest in trying to have Booster with a vaccine like ours. So we did we have They've 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 virus vaccine, AMAG, 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 was to Delta. We can't predict the timing of these regulatory interactions very easily. We're hoping 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 manufacture 350,000,000 doses and SII will manufacture The balance of the $1,100,000,000 how much of those doses will be going to the countries? Yes. 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. Okay. And our next question will come from Eric Joseph with JPMorgan. Please go ahead. Hi, good evening. Thanks for taking my questions. 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 SIRM Institute for India, Indonesia and the Philippines. Just curious to know whether you're seeing European regulators move the goalpost Given that it's kind of taken this long to complete those submissions. And then Stan, you sound very confident 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 the Q4 and whether or not it does, we'll be curious to get a sense of how to think about Time lines to a BLA filing with 2,273? Thanks. Yes. So a couple of questions 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 EUA is it's been a question mark for a bunch whether the EUA is going to remain open. And when Peter Mark said that It will remain open in particular because we want to get a protein based COVID vaccine through the system, my confidence went up a lot. So that's what I base it on. On the regulatory issues, so every so we have made products in different Plans 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 they've asked me to put together and that's what's going to take getting this data put together and submitted 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 EMEA will announce that in the press release. And maybe just one follow-up if I could. I'm just trying to understand better understand some of the language in your 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 guess how to understand that, does that suggest some kind of authorization or approval before continued U. S. Production And would it have to be very 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 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 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 difference is. Okay. Would this have any impact on the originally planned delivery of the 100,000,000 doses under the original Warrkspeed agreements, I know that you originally expected delivery for the top of 'twenty two. Sure. It does because the original timetable called from starting to deliver those doses in the Q4 and through the Q2 of next year. And I think that probably we won't give many doses shipped in the Q4, and it will just push it back to the 1st and second quarter. We have stockpiled those doses. So it's they 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 It's effective against the variant strains. And so we're very optimistic and we look forward to reporting to you next quarter. Thank you. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect your lines at this time.