Ladies and gentlemen, thank you for standing by, and welcome to the Novavax Second Quarter 2020 Financial Operating Results Conference Call. [Operator Instructions] I would now like to hand the conference over to your speaker today, Silvia Taylor. Ma’am, you may begin.

Thank you, Operator. Good afternoon and thank you to everyone who has joined today's call to discuss our second quarter 2020 operational highlights and financial results. A press release announcing our results is currently available on our website at novavax.com and an audio archive of this conference call will be available on our website later today. We will also post the slides from today’s call on our website. Joining me today are Stan Erck, President and CEO; Dr. Gregory Glenn, President of Research and Development and John Trizzino, Executive Vice-President, Chief Business Officer and Chief Financial Officer. 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, condition or strategy and other financial and business-related matters, including expectations regarding revenue, operating expenses, cash usage in 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’ll now like to hand the call over to Stan.

Thanks, Silvia. And thanks to everyone joining us this afternoon. The last few months have been historic for Novavax, since identifying our vaccine candidate in March. In just four months, we have garnered over $2 billion in funding for its development, security, significant manufacturing capacity, signed several research and manufacturing collaborations with organizations around the world, and most importantly, we delivered Positive Phase 1 clinical data for the Phase 1/2 trial of Novavax CoV2373 our COVID-19 vaccine, and are poised to quickly move into Phase 2 this month. As we hosted a call last week to detail the 2373 Phase 1 clinical data, we're going to keep today's call short. In terms of an agenda, I'll start with a high level review of the numerous achievements for COVID-19 vaccine in the quarter. Greg will then go over the highlights of the Phase 1 data. I'll come back to provide some additional updates, and to provide a quick update on the rest of our pipeline. John will then review the financials for the quarter. We'll then wrap up and take your questions. Let's move to slide three. This slide illustrates the significant progress we've made for 2373. As I just mentioned, we identified 2373 as a candidate back in April, after preclinical testing demonstrated high immunogenicity for 2373 in animal models, our clinical team was then able to start the Phase 1trial late May, leading to the data released last week. Simultaneously, we engaged with various global organizations leading to approximately $2 billion in funding for our vaccine program. We discussed the separate funding of $388 million on our last call, and since then, we've also signed a contract with the U.S. Department of Defense for $60 million. And we thrilled to be selected to participate in operation Warp Speed, for…

Thanks, Dan. As we gave a detailed review of the data last week, I'm just going to give a high level overview today. So, on slide five, what you can see is that the 2373 is, is a product of a technology platform that uses the insect cell and Matrix‑M adjuvant. So we are able to take a sequence from a virus such as the spike protein sequence from SARS-CoV-2, manufacture this into a nanoparticle that has the full-length protein and combine this with Matrix-M which is a potent Adjuvant, which for which we have a great deal of clinical experience. So let's turn to the trial on slide six. This slide shows the study objectives. The phase will trial, evaluate the safety immunogenicity of the Novavax-CoV2373 protein or [Indiscernible] nanoparticle vaccine with or without Matrix-M Agilent. The primary outcomes were reactogenicity, safety, and lab assessments, and the immunoglobulin G IgG anti-spike protein response in humans. Secondly, secondary outcomes included adverse events, wild type neutralizing antibodies and T-cell responses. So on slide seven, we’ll give some details on the design. It was a randomized, observer-blinded, placebo-controlled trial and was designed to evaluate the immunogenicity and safety of Novavax-CoV2373. Our focus is on the trial, you can see in the red box, so in Group C and D, or we had two doses of our antigen, either five micrograms and 25 micrograms with the Matrix-M. And that was given twice at day zero of 21. We compared that to placebo. We also compare to Group-B which did not have the adjuvant and we compare it to Group-E, which had the adjuvant with our Matrix-M given once, followed by placebo at day 21. So on slide eight, just overall, we summarize the conclusions here. And again, we provide a great deal of…

Thanks, Greg. So we're now on slide 11. At the end of the first quarter, we announced successful pivotal phase 3 results as Greg just said on NanoFlu, and during the quarter, we added important immunogenicity data demonstrating the development of robust T-cell mediated responses. We believe these data will further differentiate NanoFlu from the leading licensed vaccines, the combination of these results will form the basis for future BLA submission using the FDAs accelerated approval pathway. As part of this effort, we are currently exploring pathways to manufacture product for required lot consistency clinical trial. Phase 2 data from the program has been posted to the online preprint server mid archive, and phase 3 data have been submitted to the server as well should be up this week, with both submitted for peer reviewed and publication leading journals. And finally, a quick update on our ResVax vaccine. Our Phase 3 results of ResVax in pregnant women assessing the impact of vaccination on infants were published in the New England Journal of Medicine at the end of July. We still believe that we can design an efficient pathway to a licensed product over the coming years. And with that, I'll have John provide the financial results.

Thank you, Stan. Today we announced the financial results for the second quarter and first six months, 2020. I'll focus my comments on the quarterly results. So now we're on slide 12. And for the second quarter, we reported a net loss of $17.5 million, or $0.30 per share compared to a net loss of $39.6 million, or $1 69 per share in the second quarter of 2018. Reduction in net loss is mainly due to increased revenue under the CEPI agreement, partially offset by increased R&D and SG&A expenses. Revenue in the quarter increased $35.5 million from $3.4 million for the same period in 2019. As I just noted, the increase was primarily due to the CEPI agreement. R&D expenses increased 15% to $34.8 million in the second quarter of 2020 compared to $30.4 million in the same period for 2019. This increase was primarily due to increased development activities for 2373 under the CEPI agreement, partially offset by lower employee related and other costs and development activities of ResVax. G&A expenses increased 84% to $17.7 million in the second quarter of 2020 as compared to $9.6 million for the same period in 2019. The increase was primarily due to increased professional fees relating to the Novavax CZ acquisition and supporting our 2373 program and increased employee-related expenses. As of June 30, 2020, Novavax had $609.5 million in cash and cash equivalents, marketable securities and restricted cash. Net cash provided by operations for the first six months of 2020 was $92.5 million, compared to net cash used in operation activities of $80.6 million for same period in 2019 During this quarter, we further strengthened our balance sheet. We completed a private placement with RA Capital of a Series A convertible preferred stock for gross proceeds of $200 million and raised $206 million in net proceeds through our ATM offerings. For the six months ending June 30, our total amount raised is $593 million. And in addition, we secured $2 billion of non-dilutive funding to support COVID vaccine development activities. That concludes my financial review and I'll turn the call back to Stan.

Thanks, John. So even with all the significant progress so far in 2020, we still have work to do and major milestones ahead in the remainder of the year. Now on slide 13 for our Coronavirus program, as I said last week, pending FDA Okay, we plan to proceed into a trial of approximately 1500 people in the U.S. and Australia, which will expand what we've done in the initial part of this trial and extend these results into the older adult population. In parallel, we will, we are making plans for global trials to demonstrate efficacy. Our goal is to initiate our first efficacy trial in September and conduct efficacy, efficacy trials in multiple countries. We will keep everyone updated appropriately. There's all you as you all know, the space is evolving extremely quickly, and we are moving forward in parallel on multiple fronts. In the coming weeks, we will continue to update you on manufacturing supply and collaboration agreements that we are currently working through. Before I open the call for questions, I would just like to add that to thank all the dedicated employees at Novavax for their huge and tireless efforts since the beginning of the pandemic. Without them none of this progress would be possible. And with that, I'll turn it back over to the operator for Q&A. Operator?

[Operator Instructions] And our first question comes from Eric Joseph from JPMorgan, Your line is now open.

Can you hear me? Thanks for taking the question.

Yes, we can Eric.

Great. So I guess in thinking about the upcoming Phase 2 study? Can you talk about whether there are -- whether there'll be any opportunities in that trial for looking at vaccine efficacy? I know that it would be, unblinded and non-randomized, but is there any other any endpoints being assessed? Well, I guess what’s follow up in the Phase 2 allow for any read on protection. And as you are also thinking about expanding eligibility to include the older adult population, can you just talk about numbers there and whether that's included in the 1500 patients that you're anticipating and designed for?

Hi, Eric, this is Greg. I’m going to introduce you to Filip Dubovsky, our new Chief Medical Officer, who's here and I'll let him give you a chance to talk to him. And I think over the next six months, you will have lots of conversations.

Right? So the study is actually a randomized study, and half of those subjects will be older than 65 years of age, and the other half wasn't 65. We are looking at efficacy in the study, but with the size of the study, we're unlikely to get a very robust answer to that question.

Got it. And okay. And just in terms of, patient numbers on an older adult population over 65.

So half of that study so some...

I’m sorry. Got it. Thank you. And then on the manufacturing side, I guess, looking across the relationships you have now with, [Indiscernible]. And can you just talk about where your capacity is now in terms of annual doses and to what extent are still sort of gaps to fill with additional CDMO relationships to get to your target in the U.S. 100 billion doses with OWS and then, expanding from there.

So, so there's inside U.S. and outside and so we, it's just a lot happening in real time, Eric and we'll have some announcements in the fairly near future. Been weeks that will better articulate what the globe capacity will be including that in the United States as you point out in the U.S. passage coming primarily from two right, now from the two Fuji sights. And our expectation is for U.S. only, that we will be able to supply at least U.S. needs which we project could be as high as $500 million to $600 million doses in a year. And, and we're looking to expand that further. Outside of the U.S. we've already -- we've started the prog facility is getting ready to complete the reconstruction process. The remodeling process has been going on for three years. And we expect engineering runs to start within the next several weeks, and then GMP production and large scale at the beginning of the year, and we'll announce some of the other places. As I’ve said very shortly, we expect to have well over a couple billion units of capacity on an annual basis. So...

Got it. Great. Thanks for taking the questions and congrats on the progress.

And thank you. And our next question comes from Charles Duncan from Cantor. Your line is now open.

Thanks for taking the questions Stan and team. Congrats on a really interesting year thus far. I had a couple of questions on the COVID vaccine and then and then maybe even one on the broader pipeline. First of all, going back to the Phase 2 study that you mentioned, including some older adults, thinking a little bit about immunosenescence and the activity of NanoFlu, I’m wondering what particular metrics do you think will be most interesting take a look at and to see whether or not 2373 will work in the older adult population?

So, this is Phil, again. So this this study we're planning on, we'll look at two dosage levels on the option that immunosenescence may play a vital role here. But we do have data from the previous work that suggests that the five milligram dosage level will likely be the one we end up with. We're looking at the same things we looked at in the first day working at IgtG responses and migraine responses. And based on that I will pay the data to the FDA for final concurrence with our plans.

And when you think about the activity of the adjuvant and the NanoFlu program, would you would you anticipate similar activity that you've seen in the recent Phase 1 would seem to me that would be the case but, you tell me?

Yes, I mean, this kind of predates Filip. So I'll jump in and say, I think that the, the adjuvant is in some ways the perfect match for immunosenescence. So, inducing T-cell responses, especially polyfunctional CD4 effect for memory cells is what we saw in old adults. That's really what's needed to establish high antibody affinity and durability responses in older adults. So, it is, the kind of where flu vaccines are going for sure. Adults looking for, adjutant to sort of repair and the incidences that we saw there. We and the – somewhat to my surprise I was rather staggering, staggered by the fact that there were so little and specific T-cells in the placebo on the day zero T-cells and then afterwards, how good the T-cell response in addition to having. It’s harder to show a huge antibody response with flu because there's a lot of previous immunity, but that was a distinctive, and we're seeing it here that we have the T-cell response. So, so I'm expecting this to be really, good match for immunosenescence and probably not, if any decrement in the antibody response, what we'll see and that's part of why we're studying it. We don't want to miss some critical gap in immunogenicity by going down to the dose, but it appears to us where we are today with younger adults that were at the peak of immune response. So given the formulation of the dose, it's probably that can be likely that we'll be able to push that up by using the higher dose but that'll expand our safety population very nicely. At the same time, make sure we have no gaps in our in our dosing strategy.

And it's also additional color, Greg. If I could just ask you to pull out your crystal ball and I know you'll be kind of speculating here. But when you think about the competitive environment in terms of the Phase 3 and clinical study participation, or participant enrollment, what do you think you can do to facilitate interest in your program besides demonstrating already having demonstrated pretty, pretty interesting data?

Well, I think, that you can see in the last few months, the people that are funding are big believers in technology. So, all that funding initially was done based on preclinical work and the past experience of the platform. So I – it’s just our view that our immune response is very, very good and good. And it seems like the best. There's some issues around apples-to-apples comparison, but it does seem like our T-cell and -- immune responses really look robust. And what you would want to go into with an efficacy study. So, so we're hoping that our efficacy would be high. I think our partners, through CEFI, the CEPI Gates Foundation, and OWS all have that same perception. And so we're going to be laser focused. That's why Filip is here -- getting our studies started in and to demonstrate efficacy cool. That's really we're optimistic. My crystal ball says, optimism. And, but we have to be focused on execution. So it looks like our data from the functional standpoint is very good.

And in Japan does the collaboration with Takeda, enable a local clinical study there and or with that PMDA interaction kind of dovetail on the other Phase 3 results and, and then I’ll hop back in the queue.

That's a detail we have really disclosed yet. Look, everybody is going to be watching the global trials, those results. And paying attention to that. And so we can't, at this point don't know, how relevant will be to actual licensure in the specific countries we're working with. But I think we'll have more to say about that in the near future as we start up our next set of trials. Right now, we provided our data to the FDA. We're waiting for them to come back. And that will be important for us to start the Phase 2 trial in the U.S. and Australia.

Thanks for taking my questions.

Thanks for your interest.

And saying thank you. [Operator Instructions] And our next question comes from Mayank Mamtani. Your line is now open.

Good afternoon. Thanks for taking my question and many congrats again on all the recent progress. And welcome aboard Filip, look forward to interacting in future calls. The first question can go to either Greg of Filip. On this NanoFlu publication coming out this week, could you please comment on the specificity on the T-cell data and also the safety profile? Specifically in the context of muscle and the biology and the [Indiscernible] rate that we saw? Could you just maybe comment on that qualitatively or quantitatively?

Yes. So, first of all, we have really covered everything that we saw in reporting the paper that last week. So there's going to be you probably have taken a look, there's really close concordance of the details on what we showed in that paper and what we reported. So that's, that being said, the T-cell response look to us, like, it was quite good. We tried to match up the reporting axes if you will, with what had been reported in terms of percent of CD4 positive T-cells. And we then have it somewhat a limited set of data. We needed to get, something done some subset in order to file our data with the FDA. So, there's really only four subjects 16 total four per group, and we'll expand that information going forward. But it's super consistent with what we've seen in our previous trials and pre-cloak arena. So we felt very comfortable sharing that information. And the fact is we're seeing these poly – this polyfunctional CD4 cells, which we think is kind of our functional target, and aTh1 phenotype, which is helpful to the FDA as they assess the potential safety of these, these vaccines. So, turning back to the safety profile. I just think overall, we feel like it's really a good one. If you look at the, for example, the graph we provided on the local symptoms, the vast majority of subjects have a grey bar or no bar, there's some that have a blue bar, so the grey being mild and the symptoms were collected, where it's blank, they were collected, and they said no. So really, I think a pretty good, very good looking profile there for local reactogenicity. If there is a little bit of local pain and local tenderness and…

That's great. So maybe a quick follow up to that. Has that data now been looked at by the FDA? And any guidance given the impressive immunogenicity and also the safety profile that you just described any feedback? Do you know next steps here from the FDA yet or is that the that…

That's good? That's glad you asked. So good point. We did file this with the FDA as soon as we have a ready to go. and they are reviewing the data, reviewing our plans and a number of questions and this will be -- they will be the ones to agree that with that will lead their agreement that the profile is suitable for moving on into development. So we have not heard from them, but we expect to it because we're going to start the phase – we expect to start Phase trial in the not too distant future. We found it to be super responsive and efficient and frankly constructive. So I'm not anticipating some large issue here that, but they always have some questions and clarification, but I don't expect anything should impede our going forward. But it is, of course, important and not assumed that they are they're going to give us their blessing. So we've got a mixed bag here.

And if I can sneak in one more for John. John communication cadence regarding some of these stockpiling or distribution arrangements. How and when can we learn, more of the granularity around financial terms? Is that really around the Gulf, the different government allocating budget, and then, the downstream effect of what could flow as part of some of these country specific arrangements. Could you just comment on that? John

Yes, if I think I'm hearing your question the right way, you're how are we going to be allocating doses produced. And I think Stan made reference to before that we're going to be coming out with a much more kind of robust global supply plan in the coming weeks that'll make that -- make that much more clear to everyone. Right now, we're kind of building the capacity out in a pretty significant and dramatic way with not only the funding support, but also other partnering arrangements. I think we're seeing especially since the release of our data, significant demand for advanced purchase agreements. And we're have to balance the growing supply against that against that demand and make sure we're doing that with, kind of a global access and global allocation in mind. So we're being very thoughtful about how we build supply. We're being, very thoughtful and diligent about how we're making a determination around where those doses will be provided under these various agreements. So Mayank, stay tuned, there's more to come. And we're, learning something new every day about what's happening as each country is making their decisions about how to stockpile product and keeping in mind, all of the work that we're doing with CEPI from a global allocation standpoint, so more to come. If, if that answered your question.

Any color you could give on pricing? Or is it too early, because it was really the economic terms and the some of these arrangements is what is missing? Right. So…

I can't give you any more color other than what we've said before. And that is going to be, fair pricing. I think, there's more work that has to be done and talking with our partners about what that strategy looks like. So, again, Mayank stay tuned. It's an evolving process.

I appreciate you taking my questions and look forward to the update. Thank you.

Of course. You're welcome.

Thank you. And I am showing no further questions. I would now like to turn the call back over to Mr. Erck for further comments.

Yes, thanks, everybody. It's been a nothing less than an exciting quarter. The second quarter and we're expecting the future to look not much different than what the last quarter has been. So we’re focussed, we’re working hard. We leave you to [Indiscernible] vaccine, the only clinical data for the vaccine, but we need to make lots of it. And that’s the company is focussed on. So you’ll hear from us. Thank you.

Ladies and gentlemen, this concludes today’s conference call. Thank you for participating. You may now disconnect.