Good day, and welcome to the Novavax First Quarter 2021 Financial Results and Operational Highlights Conference Call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing star then zero on your touch-tone keypad. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. Please note this event is being recorded. I would now. I would now like to turn the conference over to Silvia Taylor, Senior Vice President, Investor Relations and Corporate Affairs. Please go ahead. Good afternoon. Thank you to everyone who has joined today's call to discuss our first quarter of 2021 operational highlights and financial results. A press release announcing our results is currently available on our website at novavax.com. An audio archive of this conference call will be available on our website later today. The presentation slides we will be using for this call are also posted on our website in the Events section. Joining me today is Stan Erck, President and CEO, who will provide an overview of our progress in the first quarter, as well as updates on the regulatory timelines and our manufacturing scale-up. Additionally, Dr. Greg Glenn, President of Research and Development, will provide an update on our global clinical development. John Trizzino, Chief Commercial Officer, Chief Business Officer, and Interim Chief Financial Officer, will provide an update on our supply commitments and financial results for the quarter. Additionally, Dr. Filip Dubovsky, Chief Medical Officer, 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 that could include financial, clinical, or commercial projections. Statements relating to future financial or business performance, conditions or strategy, and other financial and business-related matters, including expectations regarding revenues, operating expenses, cash usage, and clinical development and anticipated milestones, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. I would now like to hand the call over to Stan. For those of you following the accompanying slides, please turn to slide number three. Thank you, Silvia. Thank you to everyone for joining us today. In the first quarter, we built on our many achievements in 2020 in every aspect of our business. I am proud to say we've remained tireless in our efforts, delivering on key clinical milestones, advancing efforts to ready our global supply chain for commercialization, and progressing 2373 toward regulatory authorization around the world. I'd like to begin today's call by first providing a recap of some of our key achievements in the first quarter, including the following. We announced both interim and final analyses in our South Africa phase II-B and U.K. phase III trials. We demonstrated 2373's favorable safety profile, immunogenicity, and outstanding efficacy against multiple strains of COVID-19. We continued to advance our PREVENT-19 pivotal phase III trials in the U.S., including expanding the study into pediatric populations. We initiated multiple crossover and booster arms in order to refine our booster strategy, which will be key to our future. We leveraged our platform to advance the development of both our variant strain and combination vaccines into preclinical studies. In our global supply chain, we expanded our global presence with new manufacturing agreements as well as advancing our existing partnerships. We successfully began GMP manufacturing at commercial scale at all of our sites. We secured additional supply agreements, including finalizing an APA with Gavi for a commitment of 1.1 billion doses to address global equitable access to our vaccine in partnership with the Serum Institute of India. We'll talk later about this. We progressed our dialogue with regulatory authorities globally, making significant progress toward completing CMC and the remaining clinical requirements. Today, we're pleased to share more details on our recent progress. I will ask other members of our management team to talk about our clinical progress and plans, about the status and expectations that we have for advance purchase agreements during this pandemic period stretching over the next couple of years, and about our financial performance in the first quarter. I'd like to take back the microphone to cover a couple of important areas. Point one, I'd like to update our guidance on a couple of near-term deliverables that we get daily questions on. Point two, I'd like to start focusing the attention of our investors on what the mid- to longer -term outlook looks like for Novavax. It's a picture that's very compelling. With that, I would now like to hand it over to Greg Glenn to discuss our clinical developments in the first quarter. He'll be followed by John Trizzino, and then I'll rejoin. Thanks, Stan. Turning to slide four. In the first quarter, we made excellent progress in advancing NVX-CoV2373 through our various clinical trials. As Stan mentioned, we announced both interim data and final analyses for our South Africa phase II-B and U.K. phase III trials, rapidly completed our enrollment of our PREVENT-19 phase III trial, and initiated a number of other studies building on the excellent safety and efficacy data generated to date. In the next few slides, I will give an overview of these key clinical developments from the quarter, as well as discuss our upcoming clinical milestones. Beginning with our South Africa phase II-B trial on slide five. In the complete analysis for this trial, which included over 4,400 participants, 2373 achieved its primary endpoint, demonstrating an overall efficacy of 48.6% and an efficacy of 55.4% amongst HIV-negative trial participants. We also confirmed[2373] efficacy against the B.1.351 variant, first identified in South Africa, demonstrating approximately 51% efficacy against mild, moderate, or severe disease against this variant in HIV-negative participants. Importantly, there were no severe cases in the vaccine group and five severe cases, including two deaths, in the placebo group. Four out of five were due to the variant of concern, B.1.351. Last week, full results from our South Africa phase II-B study were published in the New England Journal. Moving to slide six, you can see a summary of results from the final analysis of our U.K. phase III trial, which included over 15,000 participants. In this trial, 2373 achieved its primary efficacy endpoint, demonstrating an overall efficacy of 89.7%. The final analysis also confirmed 2373's high efficacy against multiple variants of COVID-19, demonstrating 96.4% efficacy against the original COVID-19, and 86.3% efficacy against the B.1.1.7 variant first identified in the U.K. The final analysis also showed that 14 days after one dose, vaccine efficacy was 83.4%. In participants 65 years of age and older, we demonstrated a vaccine efficacy of 89%. Finally, over 40% of the study participants in this trial had medical comorbidities that placed them at high risk for severe COVID disease. Among this group, 2373 demonstrated a 90.9% efficacy. We view this as particularly important, illustrating 2373's ability to protect a portion of the population at high risk for COVID-19 disease. Our results from this trial have been submitted for publication in a peer-reviewed journal and posted to medRxiv. In summary, in slide seven, 2373 has shown excellent efficacy in trials conducted in settings where both the original and variant strains were circulating. Importantly, in both trials, 2373 demonstrated 100% protection against severe disease, and it was well-tolerated. Adverse events were balanced between the vaccine and placebo groups. At this time, we have also initiated crossover arms in both trials, which will help further inform our booster strategy. Turning to our PREVENT-19 phase III trial in slide eight. In the U.S. and Mexico, where we are conducting this trial, we announced that in February, we had completed enrollment for this trial, this phase III trial. The notably diverse study population included 30,000 participants from a wide range of demographic backgrounds, as well as individuals who are at high risk of COVID-19 due to factors such as medical comorbidities or age. At the end of April, we also implemented a blinded crossover, allowing all subjects in our PREVENT-19 trial to receive the active vaccine. The successful conduct of the trial will allow unblinding for a final analysis as opposed to an interim analysis based on the events we've accrued prior to crossover, as the trial is well powered to describe efficacy. Stan will discuss the timing of announcements in more detail later in the call. The updated protocol has been posted to our website today. Moving to slide nine, PREVENT-19, which had been enrolling U.S. participants in December of last year, was also conducted in the context of a rapid emergence of variant strains. By the end of April, at the close of the endpoint accrual period, we'd seen the rapid rise of the B.1.1.7 strain. This variant now accounts for over 60% of the U.S. cases. As I mentioned in our U.K. phase III study, we showed that 2373 was 86% effective against the B.1.1.7 variant and 96% effective against the original strain of COVID-19. Turning to slide 10, we also initiated a pediatric extension of PREVENT-19 in April. On this slide, you can see the study design, which includes 3,000 adolescent participants 12 to 17 years old across 75 trial sites in the U.S. Two-thirds of the participants will receive 2373, and one-third will receive placebo in order to evaluate the efficacy, safety, and immunogenicity of 2373. We see this as an important step towards expanding the reach of our vaccine and making progress towards ending the pandemic. We expect to implement a blinded crossover six months after the initial set of vaccinations. In parallel with advancing 2373 through our various efficacy trials, we saw significant progress in two other areas of our clinical program in the first quarter. Our variant -strain COVID-19 variant vaccine and combination vaccine candidates. I would like to briefly touch on our recent developments in these two programs. Last week, we shared preliminary data at the World Vaccine Congress from a preclinical study of our B.1.351 candidate, which you can see on slide 12. As a part of this work, primates who originally received a two-dose regimen of 2373 last year were boosted one year later with our B.1.351 candidate containing Matrix-M adjuvant. Data from this study showed that within seven days of receiving the B.1.351 booster, animals exhibit a strong functional immune response. Immunity that, as we showed at the World Vaccine Congress, can block the B.1.351 spike from binding to ACE2. We will have more to say on this work in the coming weeks. Turning to slide 13, we also dedicated significant efforts during the quarter to exploring various combination vaccines, including a combined NanoFlu 2373 vaccine candidate, all combined with Matrix-M adjuvant. We recently completed a preclinical study of this combination vaccine to assess its immunogenicity and protective efficacy in animal models, and the data are summarized in a manuscript posted to bioRxiv. Briefly, we found that the combination of NanoFlu and the 2373 vaccine induced strong functional antibodies in ferrets with hemagglutination inhibition antibodies and ACE2 receptor-inhibiting antibodies that were comparable between immunization with both the combination vaccine and the respective component vaccines. In these animals, the combination vaccine induced high levels of anti-spike and neutralizing antibodies. When immunized hamsters were challenged with SARS-CoV-2, the quadrivalent and NVX-CoV2373 combination vaccine showed protection, which was not diminished compared to the NVX-CoV2373 alone. No viral replication was detected four days after the COVID challenge, and the lungs showed no changes. These results demonstrate that a novel combination flu -COVID vaccine has the potential for a transformative impact on both diseases. We expect to bring this candidate into clinical trials later this year. I would also like to highlight on slide 14, ongoing clinical trials conducted by our partners, reflecting collaboration around the world for the development of our COVID vaccine. These include both a Phase I/II trial conducted by Takeda in Japan, as well as a Phase II/III clinical trial conducted by the Serum Institute of India to evaluate the safety and immunogenicity of 2373. These trials were initiated in the first quarter. Enrollment is complete in the Takeda trial, enrollment is about to begin in the phase III portion of the Serum trial. We look forward to sharing additional updates as these trials progress and expect these clinical trials, led by our partners, will play a meaningful role in promoting global access to our vaccine. I would like to discuss the Com-COV study, which was initiated in April. This is a U.K. government-sponsored study being conducted by the University of Oxford that will assess two-dose priming and boost regimens of COVID vaccines, mixing the AZ, Pfizer, Moderna, and Novavax vaccines in various combinations given eight weeks apart. The study will evaluate the safety and immunogenicity, with results expected in the third quarter. We also wish to highlight an exciting collaboration regarding an important advance in malaria prevention. The University of Oxford's malaria vaccine candidate, R21, which includes our Matrix-M adjuvant, has been advanced through a phase II-B clinical trial conducted in a study population of 450 children, ages five-17 months. In April this year, we announced the publication of the data from this trial in preprints with The Lancet, where R21 demonstrated 77% efficacy. These landmark results underscore the potential for this vaccine to serve as a tool to help control malaria globally. Clinical development of this vaccine candidate continues with a phase III licensure trial underway in four countries in Africa to evaluate the safety and efficacy of R21 in 4,800 participants, ages five-36 months. We look to the commercial potential of this vaccine, and we supply the Matrix-M adjuvant to the component to the Serum Institute of India, who will manufacture the R21 vaccine. In efforts to ensure widespread distribution, Serum Institute of India has been granted rights to use Matrix-M adjuvant in the vaccine in endemic regions and will pay Novavax royalties on its market sales of the vaccine. Novavax will have rights to sell and distribute the vaccine in traveler and military vaccine markets. With that, I'd like to turn it over to John to discuss our key supply developments for the quarter. Thanks, Greg. Turning to slide 15, you can see a snapshot of our global supply commitments to date, as well as our licensing agreements. With this as a backdrop, let me state that in the quarter, we saw that the urgency to make 2373 available globally only intensified amidst the backdrop of the evolving COVID-19 pandemic. Today, there continues to be a vast need for equitable distribution of COVID-19 vaccines. While the U.S. has fully vaccinated 35% of all adults greater than 18 years of age, demand outside the U.S. far outpaces supply. This unmet demand across the globe reinforces the importance of bringing our vaccine to market and has resulted in continued demand for 2373 now and through 2022, which we believe reflects the continued confidence in 2373's ability to combat the pandemic. Our commitment to the principles of fair and equitable access to 2373, which includes supplying vaccines to low-, middle-, and high-income countries, remains at the core of our values. In light of this, we were happy to announce last week the finalization of an advance purchase agreement with Gavi, expanding upon our memorandum of understanding announced in February. Under the agreement, we have committed a cumulative 1.1 billion doses of 2373 to the COVAX Facility. We expect to manufacture and distribute 350 million of these doses utilizing antigen and adjuvant manufactured at facilities directly funded by previous investments from CEPI. Under a separate agreement with Gavi, the Serum Institute will manufacture and distribute the Novavax-licensed product for the remaining balance of the 1.1 billion doses for low- and middle -income countries participating in the COVAX Facility. Together with Serum, we expect to begin delivery of doses in the third quarter of 2021, dependent on the appropriate regulatory authorizations. In the first quarter, we also finalized an advance purchase agreement with the Government of Canada to supply 52 million doses with the option to purchase an additional 24 million doses. We also announced our intention to transfer our technology and partner with the Government of Canada to explore opportunities to manufacture our vaccine at the National Research Council's Biologics Manufacturing Centre. As of today, in addition to our advance purchase agreements with Gavi, our bilateral advance purchase agreements total approximately 200 million doses committed to countries around the globe. In addition, we continue negotiations with the European Commission on behalf of the 27 member states for a potential supply agreement. We are pleased with our progress to date, and we will share additional details as these discussions reach finalization. Based on the many inquiries over the past year and those ongoing discussions, we understand that the COVID-19 pandemic and demand for vaccines are here to stay. We will continue to support this demand in the years to come. As such, we are currently negotiating a number of other supply agreements with countries globally that are looking to secure a vaccine for 2022 and beyond. Given the need to complete the primary vaccination in most countries, the demand for 2373 remains extremely high. With that, I would now like to turn to slide 16 to review our financial results. Today, we issued our first quarter earnings release, which walks through the details of our financial results for the quarter. We also filed our 10-Q for the first quarter of 2021 today. This includes details on important business and financing events during and subsequent to the first quarter. Notably, Novavax revenue in the first quarter of 2021 was $447 million, compared to $3 million in the same period in 2020. This significant increase was due to the increase in research and development expenses to $593 million relating to the 2373 activities performed under the U.S. government and CEPI funding agreements. We raised net proceeds of approximately $565 million during the first quarter through utilization of our ATM offerings. The quarter ended with a very strong cash position of over $2 billion, compared to over $800 million at year-end 2020. This increase in cash was primarily due to $772 million of payments received under advance purchase agreements and the $565 million of ATM funding just referenced. With that, I'd like to hand it over to Stan to discuss some of our updated timing and guidance as it relates to our upcoming milestones. Thanks, John. Okay, let's turn to slide 17. On this call, we reviewed a long list of recent successes, including our clinical safety and efficacy data. Now I'd like to talk about the near- and midterm focus of the company. I'd like to start by addressing the questions that we get asked every single day with the goal of updating our guidance for the short term. First question we always get is, when can we expect to see the results from the U.S. phase III efficacy trial? The second is, what is the timetable for regulatory filings in the various parts of the world? The third is, what is the trajectory for scaling up our manufacturing on a global basis? Let me take them one at a time. Unblinding the U.S. phase III trial. Let's start with the timing of the U.S. phase III trial. Please turn to slide 18. We have previously guided that we expect to unblind the trial in the second quarter of this year. Based on the timing of the unblinding of our South African and U.K. trials, I think that a lot of people have an expectation that we might be able to unblind the trial in April. Instead, we initiated a blinded crossover in this trial in April, for which we show the study design on the slide. We believe implementing the crossover and thus bypassing an interim unblinding will actually give us a comprehensive data set more quickly. This gives us the ability to collect more cases, increasing the robustness of our data set when measuring efficacy against factors such as severe disease and against variants. We continue to guide that we will announce our phase III clinical data in the second quarter. We look forward to sharing our results with you in a few weeks. With respect to regulatory authorizations, moving now to slide 19. Our timetable for regulatory filings: we know that we're delayed from where we thought we'd be at this point. Now we're giving guidance that nearly all of the major challenges have been overcome, and we can clearly see the light at the end of the tunnel. All facilities in our network have already demonstrated the ability to manufacture commercial -scale GMP material. The filing timetable depends on completing the final phases of qualification and validation of the assays that are needed to complete the demonstration of process consistency and to subsequently finalize the reports for regulatory filing. It has been a massive effort and has depended on our global manufacturing partners to help us accumulate a suitable data package. Not surprisingly, it is currently the top priority of the company. It is not likely that we'll finish this work in time to submit by the end of June, so I'm changing our guidance to reflect that we expect to complete our regulatory filings in the third quarter. We are planning multiple filings that will be made with the U.S. FDA, the U.K. MHRA, and the EU EMA as soon as our data packages are complete. In other markets, we will continue our rolling review processes initiated earlier this year, including with Health Canada, Therapeutic Goods Administration, and Medsafe. Additionally, we anticipate starting rolling submissions to the WHO for emergency use listing. A rolling submission process is also underway with the Ministry of Food and Drug Safety, which SK Bioscience initiated in collaboration with Novavax in April of this year. These regulatory authorities will all complete their reviews of our submissions on their own timetables, and we hope to have market authorizations in multiple countries during the third quarter. As of today, we are not able to predict a date with precision, so we won't. It is in everybody's interest to push to make this happen as early in the quarter as possible. Let me next discuss the current state of our manufacturing and our anticipated capacity as we look to the remainder of the year. Please turn to slide 20. On our last earnings call, we discussed the significant strides taken in 2020 to build out our global supply chain, as seen on our global supply chain map. Some of the key manufacturing developments included reaching an agreement in principle with GSK to support fill and finish manufacturing of up to 60 million doses for use in the U.K., establishing manufacturing capabilities in Canada through our memorandum of understanding with the Canadian government to produce 2373 at the National Research Council's Biologics Manufacturing Centre, and finalizing exclusive license agreements with both Takeda and SK Bioscience in Japan and South Korea, respectively. Today, our global supply chain now spans over 10 countries, with all of our manufacturing sites producing GMP material at scale. I think we've done a remarkable job of standing up manufacturing in these multiple plants across the globe. I'm happy to report that we have gotten to the point where we've successfully manufactured our drug substance, a recombinant protein nanoparticle, at commercial scale in each of these plants. The drug substance production is the most complicated step in the overall manufacturing processes. Our guidance has been that we would be at full operating cadence by the end of the third quarter. As has been fairly widely reported, we are having difficulty getting to that point due to a global shortage of a few raw materials, including a shortage of 2,000-liter bags, depth filters, which are used in the purification process, and then growth media. As closely as we try to manage these materials, we have been running into shortages that have caused us to delay production runs. Our expectation is that our suppliers are adding sufficient capacity such that we will be operating at full capacity, but likely not until the fourth quarter. We expect we will be at full capacity throughout 2022 and beyond. The impact on us will be a somewhat slower rollout on product approval, but not dramatic. We are building an inventory of our drug substance and adjuvant as we speak. We have tens of millions of doses made already and will continue to produce approximately 100 million doses per month by the end of the third quarter. These will be ready to go when we get our regulatory authorizations. Now let's turn to slide 21, and let's look at the next six to 12 months. With licensure expected in the third quarter, at least in some parts of the world, we will begin shipping product. With our new agreement with Gavi and the COVAX Facility, our doses over the next six to 12 months may be prioritized to lower-price countries. We have taken this position because we think it's the right thing to do and is in line with our original funding from CEPI. I think that it's particularly timely given the discussion around the waivers of IP rights during the pandemic. I believe that we have taken the lead to show the world the right way to get products distributed on an equitable basis globally. We expect that even with early products sold at low prices, we will be able to match that with revenue from higher-income countries to be able to generate sufficient cash flow to expand our business rapidly. Beginning in early 2022, we will have a rapid increase in our ability to service our high-income country APAs because of the following reasons. Reaching manufacturing capacity of over 150 million doses per month, starting in the fourth quarter of this year, including from the Serum Institute. Increased capacity is coming online from new manufacturing partners and the resolution of any outstanding raw material constraints. With respect to the U.S. market, we are well-positioned with our technology and timing to supply product for boosting and seasonal revaccination. In the ex-U.S. market, there continues to be variability, with many countries continuing to have very low vaccination rates. Significant unmet demand remains globally that we will be able to support in 2022 and beyond. This will continue to include the supply to high-income markets from our facilities, and we expect low- and middle-income countries to be supported by Serum. Over the next four to six quarters, we expect all of these factors to contribute to Novavax generating billions of dollars in revenue. We plan to be in the clinic with our variant strain antigen in the fall. Data will come soon after that. We can then determine our best path forward to our booster or revaccination strategy. That strategy will be dependent on durability of protection and ongoing variant strain surveillance. We'll sort that out and make the right call at that time. Longer term, we expect to upgrade our vaccine to be combined with flu, which will require further expansion of our production capability, which is something we think our platform is unique in being able to do. We initiated this program late last year and published data last week showing that in an animal model, our combination NanoFlu COVID vaccine was able to elicit strong antibody levels to both flu and to coronavirus, and when the animals were challenged with coronavirus, they were completely protected. This has the potential to be the standard for seasonal respiratory vaccines. With a single vaccination using our same platform, we could have a vaccine that elicits broadly neutralizing antibodies, is efficacious against both coronavirus and flu, is stable, and can be made and formulated at large scale. That would require running trials with a combination COVID flu vaccine that's been hard for us to start up because we haven't had the benefit of our own production capabilities, and our contractors are all focused on COVID. We will be able to get a combo vaccine into patients' arms by the end of this year just to confirm that the formulation is as effective as the parts. I would guide people to think about the launch of such a combo vaccine in 2025. Even if you see other well-tolerated protein adjuvant vaccines compete with us for the COVID-only market in the next several years, we think that our unique COVID flu combo will come out on top in the long run. In the future, as we generate significant revenue and our production facilities come online, you'll see us use our capital, our people, and the labs to produce more vaccine programs that our team has long been hoping to work on. This is just the beginning for Novavax. In all cases, we will continue to build these vaccines on a platform that's consistently shown competitive advantages, including the development of broadly neutralizing antibodies with the potential to protect against a wider range of variants, both in COVID-19 and in flu, a stability profile that allows for the refrigerated shipment and storage of vaccine, a safety profile that leads to fewer side effects; and, with our combination vaccine, the potential to protect against multiple infectious diseases with a single vaccination. Turning finally to slide 22. With another successful quarter strengthening every aspect of our business, we are rapidly advancing toward our mission of delivering 2373 globally. With that being said, we recognize the need to seamlessly deliver on our more near-term milestones ahead, including executing in our clinical trials, finalizing preparations to ready our global supply for commercialization, obtaining regulatory authorizations for 2373, and advancing our variant strain and combination vaccines into clinical development to most effectively address the evolving pandemic. Before opening up the call to Q&A, I want to thank our entire Novavax team for their continued dedication and tireless efforts over what was once again a very busy and productive quarter. These efforts, combined with the support of our partners globally, have brought Novavax significantly closer to delivering our COVID-19 vaccine. I will now turn it over to the operator for Q&A. We will now begin the question-and-answer session. To ask a question, you may press star then one on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster. The first question comes from Kelechi Chikere with Jefferies. Please go ahead. Hello. Thank you for taking my questions. Just a couple on my end. I guess first, can you give us an idea or additional color on how much vaccine you have actually stockpiled? Also related to that, how much are you actually producing per month currently? Yeah, it's a good question. This is Stan. It varies quite dramatically by site by month, as we either have raw material supplies or not. As I mentioned to you, in the third quarter, we had expected to be able to produce roughly 70 or 80 million doses per month at the Novavax sites, excluding Serum. I would guess that we're probably in half that right now. We've made 30 or 40 million doses on the shelf, and it's getting larger every week. Thank you very much. That's very helpful. I'll hop back in the queue. The next question comes from Charles Duncan with Cantor Fitzgerald. Please go ahead. Hi, Stan and team. Congrats on a good quarter of progress. Thanks for taking my questions. I have a couple of them. The first is I'm wondering if you can provide any additional color on the U.K. Emergency Use Authorization. Secondarily, maybe a perspective on emergency use authorizations versus, say, full authorization. I guess I'm wondering, do you prefer to stick with an EUA approach for countries outside the U.K. and others that you filed, or would you pursue a full authorization? Okay. Yes, U.K., we've worked closely with a lot of these groups. The U.K., we've had the most dialogue with, and I think the expectation we had always had was that we would try to get a filing into the U.K. with a full CMC and clinical package by the end of June. That's now moved into July. I think the MHRA is paying close attention and is likely to be the first approval, and authorization, I guess, is the right word. It could be others like Korea just at the same time, I think. Filip. Just as far as the EUA versus final approval, we think that emergency use or conditional authorization is on the route to getting full approval. That's just because the safety data needs to mature to have a complete package to allow for final approval. Yeah. Everything we're putting in for the EUA is relevant to the BLA. Okay. Moving on to PREVENT-19, in terms of the crossover, could you just help me think through kind of the strategy there? It seems like the crossover eliminates the control arm. I'm just really wondering what you're hoping to learn from the crossover, or is it just a way to increase the number of patients who've been exposed to fully vaccinated? Yeah. The situation in the PREVENT-19 study was complicated by the fact that a lot of emergency use vaccine was made available in the U.S., and the U.S. public health system was advocating its use. For us to maintain the integrity of the study, we had to take on a strategy where we would provide the vaccine to all the participants, and the most rational way to do that would be through a crossover. This allows us to also look at waning of protection by comparing the people who are initially vaccinated with those who are vaccinated in the crossover design. We're going to get a lot of information from this study, including a larger safety database. Importantly, we are going to have enough cases, as Stan reported, prior to crossover for us to be able to have a final analysis in the second quarter. Okay, final question regarding perhaps a future strategy of combining a COVID vaccine with an influenza vaccine or NanoFlu. I think, Stan, you mentioned perhaps being able to market that in 2025. I'm wondering what the rate-limiting steps to getting there are. We've had several seasons before. It seems like that would be a pretty interesting combination of vaccines. What needs to be done to get there? Well, it's generally clinical development. I'll take a crack at it. There are a couple of issues. One of them is if you've been watching the influenza epidemiology, you will have seen that the flu has disappeared this season. Yeah. We need to understand how it's going to return back to its normal cadence before we plan to do any kind of efficacy evaluation. Naturally, we only want to run studies where we think we can get a result, and for that, we need to understand when flu comes back and how it'll come back. That's an important bit of information we need because we need to compare the combination vaccine to the two individual components. We'll get the efficacy results for COVID; well, we already have them from the U.K. and South Africa, and we'll get confirmation from the final phase III study in the U.S. We also need efficacy results from the NanoFlu so we can use it to leverage the combination product. Do you anticipate a trial? I think you mentioned a trial perhaps even starting this next flu season for the northern hemisphere or the following one. Immunogenicity trial. Yeah. It's an immunogenicity trial starting in the fall. Okay. Thanks for taking my questions. The next question comes from Eric Joseph with J.P. Morgan. Please go ahead. Hi, guys. Good evening. Thanks for taking the questions. On manufacturing, Stan, if I heard correctly, you have 30 million-40 million doses on the shelf currently. That would seem or sound well below the target of 110 million doses by the end of the quarter to satisfy OWS. I'm just wondering what the impact might be on commitment or follow-through on that award, whether any of that payment is at risk. Secondly, on PREVENT-19, it sounds to me like you had some visibility on a event-accrual rate in initiating the crossover trial portion. Can you just state clearly whether or not you've already conducted an interim efficacy analysis? Pretty much what prompted the move to initiate the crossover portion of the study at that time. Then finally, given some of the challenges in sourcing raw materials and the complete manufacturing, how should we be thinking about the impact on product margins from where things stood at the beginning of the year? Thanks for taking the questions. Yeah. Let me take the manufacturing-related ones. I think that for our U.S., I think our expectation is we'll have 110 million doses made right around the end of the year, the first to second month of next year. That'll take care of that. The impact of the cost of goods sold is not a long-term impact at all. I think if you're not running a plant, the first product you make costs a lot, but if you're making it at a regular cadence, the cost of goods sold should be where it always is. I'm not worried about our cost of goods sold margins. As far as the crossover, like I mentioned before, the real reason we did it was because the EUA vaccine became available. In our other studies, for instance, our phase II studies, about 60% of the people have dropped out to receive the EUA vaccine. That was the real driver for us to maintain the integrity of the study. Okay. Just to follow up on Charles' question, it seemed like that might sort of invalidate the placebo arm. I guess, what proportion of patients in the study do you expect to cross over? How do you maintain confidence that you'll still be able to accrue events primarily on the placebo arm? The primary efficacy is obviously conducted prior to crossover, where there's a placebo comparator, that's going to be the final analysis. We didn't conduct an interim. This is going to be a single analysis. It's going to be conducted on a data set. All the alpha is going to be used against that endpoint, we're going to have a more precise estimate of efficacy. That data will be available before the end of this quarter. Okay. Thanks for taking the questions. The next question comes from Mayank Mamtani with B. Riley Securities. Please go ahead. Good afternoon. Thanks for taking my question, and I appreciate the comprehensive update. My questions are mostly just specific follow-ups to previously asked questions. Maybe just starting from the non-clinical CMC manufacturing components of the submission, are you able to comment on what might be these sorts of things that are causing the hold-up? Is it just process coordinating between the different sites, or are there any specific issues around any particular assay? If you're able to comment on that, it would be great. No, in part it has to do with manufacturing at different sites and showing comparability between the processes and the actual end product between the different sites. You have to develop assays that can follow those. I think it probably took a little longer than we expected to get a potency assay that told the same story across all the sites. I'm happy to say we did. We've crossed that bridge. We made a big breakthrough there, and we're now racing toward validating everything and putting it into a package. Okay. Thank you. Regarding the protocol amendment, I'm sorry if I shouldn't be calling it an amendment for the PREVENT-19 study. Could you just verify if the final event rate is still, I think, 144 cases, I guess, which will be what we had in the initial protocol? My more important question is on, as you know, the label for some of these EUA-approved vaccines will start to look more specific to a booster going into the fall. Are you able to comment on what could be gleaned out of PREVENT-19, if anything, around your booster strategy, if at all? Okay. Let me take that in two bits. First, as far as the number of cases, the previous version of the protocol called for an event-driven analysis. We're not there anymore. We weren't there because, like I explained, we had to adjust the study to maintain its integrity. Now it's a time-based analysis. It's going to be done on events that were collected prior to crossover. That's going to be the total number of events we have in our analysis, and it'll address our efficacy in the label. As far as the other question about boosting— Boosting Nothing from PREVENT-19 will speak directly to boosting. The data we have about boosting is coming from our phase II study, where we've just completed a six-month boost of people who were initially vaccinated, both with one and two doses. Additionally, it'll come from the South Africa study, where people who received two doses are getting a single boost dose in that context. That's the main data we're going to have to talk about boosting, in addition to all the really compelling pre-clinical data that Greg's shared with you previously. I guess a natural follow-up to that is, can that be part of your regulatory submission? The U.K. Com-COV data, the South Africa data, those elements, do they make sense to be part of your regulatory package? I think in the initial filing, our main intent is to get primary licensure with the vaccine we have in hand, and a booster strategy is going to be considered as that data matures and is available. It's my thinking we're going to be filing in advance of having that data mature. It'll come out as a variation or as an amendment to that filing. Okay, great. Final question. Stan, you gave color on the monthly run rate getting to 150 million in the fourth quarter. Any commentary you can I know you used to talk about the annual run rate also, and if you're still guiding to that getting to that 2 billion doses mark? I understand that includes a contribution from Serum for about 1 billion, and you seem to be picking up some slack near term for Serum. Any color on when you can get to that 2 billion doses a year run rate? Yeah Factoring in Novavax and your partner's capacity? Yes. I think we will be there by the end of this year and expect to be there throughout the entire 2022. Okay. Fair enough. Thanks for taking my questions. The next question comes from Vernon Bernardino with H.C. Wainwright. Please go ahead. Hi, everyone, and congrats on the tremendous process. I mean, progress. Thanks for taking the question. One question I had is, given the U.S. currently appears to be flush with vaccine doses, once you have authorization to provide 110 million doses promised to the U.S. government, do you anticipate the government to distribute those doses in the U.S. or outside the U.S., or is this a buy agreement, one that allows you to perhaps change it to one with potential stockpiling, like a place marker for a future COVID-19 vaccine against an emerging variant? I think all of the above. I don't think we know. I don't think anybody's determined what the fate of those 110 million doses are. That's a discussion that we will have. Okay. Then given the promising results with your RSV vaccine, ResVax, although the data are from a small sample, given what looks like promising data in women who got vaccinated while pregnant, do you anticipate conducting a maternal immunization study with 2373? Right now, our main focus in the pregnant population is to really do what some of the other sponsors have done. We're planning a registry at the far end to capture those cases and assure safety. We actually have a relatively sizable population of pregnant women in our studies right now, and we're following them very carefully to build that safety database out as well. Okay. Last question, going back to the queue. As you probably know, Moderna's vaccine had a single-shot vaccine efficacy of 43%. Regarding the conduct of the PREVENT-19 study, have you observed subjects not coming back for a second dose of 2373? I assume you have. I ask because data from the phase I/II showed that while antibody levels at day 189 had fallen below the ranges observed in convalescent sera from recovered COVID-19 patients, the IgG levels from a single 2373 dose of 25 micrograms plus Matrix-M might have been enough to confer protection. If you advance the combination of NanoFlu plus 2373 single shot, and I saw in the paper that what was used was a primus regimen, you could have a very differentiated vaccine available when it's ready for commercialization, especially if you meet the threshold of 50% vaccine efficacy against severe disease with a single shot. Yeah. I think those are all good observations. I mean, we'll see. We're going to do a trial in the fall with a combination vaccine, and that's one reason we'll learn about it. I think you summarized some of the findings quite well. If I may, I just, I think, lost the number. You said that the U.K. saw drops of 60%? That was data from the U.S. phase II study, although there was a similar proportion in the U.K. Those people didn't drop out of the study. They just sought emergency -use vaccines. They're still being followed. Okay. Thank you for taking the question. Congrats on the progress. Looking forward to the reveal of phase III. Thank you. This concludes our question- and- answer session. I would like to turn the conference back over to Stanley Erck for any closing remarks. Well, thanks, everybody. As every quarter gets more data pointing to a successful vaccine, we're getting close to the end, which is really the beginning for us, and that's what we're all racing to do. I think we've eliminated all of the serious hurdles, risk hurdles, to getting to where we need to be to get an approved vaccine. We're excited by that, and we look forward to shipping our first product. Thank you. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.