Good afternoon, everyone. Welcome to the H.C. Wainwright 25th Annual Global Investment Conference. I'm Vernon Bernardino, senior analyst. I cover this tech company called Novavax, ticker NVAX, with buy and a $35 price target. Some interesting news today. Perhaps we'll get a chance to talk about it. But as you know, this is a company with a unique approach to the COVID-19 space, and that is a standard approach, which is a protein-based technology. With us today is the Chief Financial Officer, Jim Kelly, and a treat for me is Robert Walker, their Chief Medical Officer, who just came onboard in the past year. So earlier this year, with the change in management came some priorities that the company announced. One of them was to develop first a updated vaccine. Another was to reduce the velocity of spend, managing cash, and improve its use. But also, again, something that has always been close to my heart, and that's this is a company that I've covered actually since 2004, since the BioShield days. Some of you may know that program, and that is a technology that is a next-generation protein-based approach and not mRNA to COVID vaccines, but also the infection with it. But you may or may not know that they've had phase III programs in seasonal influenza, but also RSV, which is a disease that has emerged in the past. So I was wondering if you could give us a little update, I guess, on the delivery of the updated vaccine, you know, your supplies, your commercial activities that are leading up to and perhaps some of the regulatory environment that is now... As some of you may know, a meeting tomorrow by the ACIP is going to involve Novavax, Moderna, and Pfizer-BioNTech, which are the three key players in the COVID vaccine space today. So here you have one of them, and I'm very excited to have them introduce the company to you and, you know, update you on their programs. Well, thank you very much, Vernon. Really appreciate you having us again this year, and Bob, for being here, and all of you for joining us as well. You know, your timing is excellent, in terms of, you know, being a vaccine company in respiratory, it's commercial focused on COVID this year. Now is the time, the beginning of that northern hemisphere respiratory season. So much happening in real time, as you referenced. Tomorrow, ACIP recommendations will be there, Pfizer, Moderna, talking about our vaccines and how they're doing against strains, and we'll get recommendations coming out of that meeting with respect to vaccinated populations and vaccines. But importantly, FDA took action today with both Pfizer and Moderna. They haven't taken action on us just yet. We're in active review, right? We're following up, answering questions with them, and we look forward to completing that review process. We're ready. I think if there's anything that the group takes today from this conversation, it's that we're ready to go. We have a vaccine in market in the U.S., also in Europe. We've manufactured tens of millions of doses, meaning we're ready to supply. We got ample supply to meet demand this fall. And what we're working through now is our regulatory filings. So we prioritize U.S., Europe, and Canada. Active review right now in the U.S., and Europe, and Canada as well. And so we're preparing ourselves to have authorization, and then we have a full go-to-market strategy then behind that. So, you know, really excited to be here, especially just the timing with respect to the season. I think part of that competition is the fact that, you know, if you were to be ready to distribute, I think you'd need to already be just like Moderna and Pfizer, already have vaccine in the warehouse, right? Right. Well, well, certainly. You know, in terms of being ready in the fall, it's all about, okay, you got supply there, you got your label, you got your recommendations, and then where are you with your contract? Focusing, of course, on the U.S. market. And we're ready. Specifically about the regulatory side of it. Previously, vaccines were just through Emergency Use Authorization. It's a whole conversation by itself, but that's how the vaccines got onto the market without full licensing. Pfizer and Moderna have the licensing. You guys are still in review. What is the current stage there? Yes, certainly. And a reminder is that while we worked in full licensure in the U.S., we received full licensure just recently in Europe. And so if I had to sort of continue that trend of getting the full licensure everywhere, with respect to the U.S. market, we'll already initiated that rolling submission. We expect to complete that filing this year. And we also have the expectation that we'll operate under an approval next year. And one thing that would be important to talk about is the fact that, hopefully, everybody is aware now that we have emerging variants of, COVID that are not only emerging, but they're actually taking over, versus, previous variants, and some of them are resulting in increased hospitalization, you know, even deaths, although not alarming, are increasing. Now, can you talk about perhaps, you have an updated vaccine, the activity, how its performance, of that vaccine, against emerging variants? And if you could talk just a little bit, what are those and, so that just for our education. Yeah, sure. Sure. Yeah, of course. So I think first of all, we should clarify that all three vaccine manufacturers in the U.S. are using the same strain, XBB.1.5, to make the vaccines. So, at some level, if one of us shows across protection, across reactivity, vaccinated with XBB.1.5 and these other emerging variants, you'd like to think that that's going to be true for any XBB variant. I mean, it still has to be proven, but I think this is a general rule we should sort of assume. So in the data that will be presented tomorrow, it will be presented by our president of research and development, Filip Dubovsky, we'll look at exactly this question, right? So we'll be presenting the data that we generated at Novavax, where XBB.1.5 vaccines administered to animals in preclinical settings. And then we look at the range of variants to which neutralizing antibody responses are generated, that are at titers that would be sufficient to extend protection. Just like the other manufacturers, that's sort of been the customary approach. Those strains that we earlier reported on included XBB.1.5, XBB.1.6, XBB.2.3, more recently, 16.6, so EG.5. And so you'll see a little bit more of that and some additional strains tomorrow. Right. I don't want to steal the close, underling. Correct. Now, the way to understand this, I'm sure you already have followed what an mRNA-based vaccine is. It's not the mRNA itself that is causing the immune response that lends to protection of yourself. It's the protein that they are coded to express, and here you have a company that's actually advancing the protein itself, also in a common form that they express. But instead of an mRNA approach, it's a protein approach. How does that differentiate your vaccine in a sense? It's not mRNA that's kind of understood, but in the marketplace, how might that be differentiated for people who perhaps most of them are not going to have any experience with a protein-based vaccine in the U.S.? Well, I think that frequently what you'll hear is people describe a protein-based vaccine as a traditional vaccine, that one with which there's more experience, more safety data over the years, perhaps a greater comfort level. So I think that that's maybe the differentiating piece. And then, you know, for whatever reason, there are folks who choose not to get an mRNA vaccine, and right now, there's really only one other option, and that's the Novavax vaccine. You know, I think we all recognize that optionality is critical to uptake, right? So the more options people have, the greater they'll take the vaccines, the better protected the American population is. So I think on a lot of levels, it just makes sense to have a variety, a diversity of approaches. So yeah, so I think in terms of how we're differentiated, I mean, that's how I would personalize it. We have other, you know, we have other features that we think are attractive, Sure. So are they cheap among those? Yeah, exactly. So, you know, we're refrigerator stable. You don't have to freeze our product. We're kind of, you know, one size fits all, same dose for all ages 12 and above. So there isn't, you have to sort of remember what cap color to use. You don't have to reconstitute, you don't have to fall. I mean, those are, you know, those are important, and they're, they're important in terms of reducing medication errors also, which has been a big issue during the pandemic. Yeah, and some may not be aware that those storage conditions are some of the challenges that were obstacles to wider adoption of the mRNA-based vaccines. Because can you imagine trying to distribute and administer a product that has to be sold at minus 80 in a tropical country, for example, Philippines. I think most of the people in the Philippines actually got vaccinated, but not mRNA vaccine. Unfortunately, I think some of it was on Novavax. I think that they got like 10 million doses, but a lot of it were some of the Chinese vaccine, for example. Now, the second priority that the company had was to address that. I know from coming to the company for a long time, I mean, R&D is expensive in general, but vaccine R&D, especially, if you hopefully remember, some of these vaccine studies from each of the companies were over 40,000 people, right? That's expensive by itself. But, because, for example, one of the vaccines, the seasonal flu vaccine. You not only had to generate tens of thousands of data and tens of thousands of people, but because it's commoditized, you had to do it the right way. You had to do it, you know, when the season was, lends itself the opportunity to vaccinate people. Can you talk a little bit about how the company has changed as far as your management of your cash and some of the things you've done with the balance sheet and dedication of your cash to advance the company further into this year and then hopefully a different company next year? Yeah, absolutely. Novavax is evolving from a pandemic-era company into a traditional endemic vaccine company. And I can't reiterate enough just how excited we are and that for this season ready to deliver doses and ready to be relevant. And, you know, when we were talking about patients prefer, you know, preference share in our market research says 25-30% prefer a protein-based vaccine if they can get it. And so everything we're doing to resize and reshape and extend our cash runway is making sure that we have the financial strength to deliver for patients. And so in terms of what have we done to make that transition, a couple of really important things. You know, one is, you know, we are targeting a basic halving of the size of the company by next year. So we reduced our R&D and SG&A by 40%-50% in target from 2022 through 2024. We're about midway through that this year. Along the way, in terms of resizing the company, we have also focused a lot of pipeline on, for example, the flu and Ebola program, which we think can further be transformed into the company. And we'll talk a little bit about the investment we're making there. But in order to do so, it was making sure we had the financial strength by appropriately sizing the company. In addition to that, one-time liabilities, a lot of which were a part of creating that manufacturing network for a pandemic era, where we little by little, this year, I say little by little, we reduced that by $1 billion year to date, by getting through settlements and negotiations. So we're really happy with the progress we've made that set us up with financial strength going into this fall. To be specific, mid-year, we had $900 million in cash and receivables. That's the kind of financial strength we had as we entered this fall vaccine season. Overall with an eye towards performance this fall, everything and creating more value with our technology platform. One thing you didn't really get credit for, I think, is the changes that were made with your collaboration with SK. What, in specific, should be, you know, focused on there that, you know, investors, I think, should actually, you know, congratulate the company for? Yeah, well, certainly. Thank you very much for bringing that up. You know, we've got some excellent partners around the world, and SK is a really good example, as we have just announced back in August, a new note to our strategic business relationship through extending our license to Korea, Thailand, Vietnam. And then also making a strategic investor in us as a company, a premium. You know, they bought 6.5 million shares, $13 per share, and compared to the US, almost 16% premium. So you've got a strategic who we work closely with, who wants to continue to be a part of the story in the current markets we're working in, who value the technology, who value us as a company, and want to take a position in Novavax to ensure that we have a long-standing relationship. So yeah, it's as much as anything, a signal that somebody who understands our vaccine well wants to partner with us and we with them. I think one thing that also lends support to that is the change in your agreement with Canada. Can you talk a little bit about that as well as perhaps contracts you have in place? You've guided to $1.3-$1.5 billion in revenue this year. Just wondering how some of those numbers can be described, and you know, contracts in place, et cetera. Well, well, certainly. And, you know, the Canada renegotiations we did this year, critical with respect to our financial strength. When we raised over $600 million in capital this year to further strengthen our balance sheet, $450 million is this non-dilutive financing through Canada, for example. You know, they wanted to forfeit some doses as they moved from their pandemic contract to an endemic contract. We're happy to do so. And so we were able to extend that agreement and get some of the financing we need to improve our strength. The other $150 million came through equity raises. A significant amount, $85 million, was SK, I mentioned that at a premium. So this Canada amendment is really about working with Canada to ensure access to that market for the coming years. We've also agreed to set up our manufacturing there, through the Canadian facility, to manufacture on Canadian soil. And we look forward to a long, long-standing relationship with them. Which we're- Yeah, often ignored, I think, a little bit of tension on the other side of the border, I think, shows that you have a great relationship with Canada. Now, as far as the last part is concerned, your technology platform, I covered the company starting the days when it's called virus-like particles, but, it has evolved, and I think been fine-tuned to what is called a nanoparticle technology, and it's a nanoparticle protein. This is a technology that, you know, was used to make the COVID vaccine, the Nuvaxovid, but it obviously can also be leveraged to advance vaccine candidates for other infectious diseases. The near term obvious target would be an influenza vaccine. Again, you've already had a phase III stage program in RSV, something that may or may not be interesting to target. But the technology can also be applied to other infectious diseases, and the company has explored this technology in other infectious diseases such as Marburg, Ebola. Those may not be commercial opportunities, but this is a flexible technology. Just wondering if you could talk about leveraging technology in the plant for the near future. Well, Bob, do you want to take it? Because we have tangible evidence and then there's future on it. Yeah. So I think the pipeline asset that is a priority for us right now is the combination vaccines. I know this is what Jim's talking about, I'll go over that. So, you know, and particularly for us, flu plus COVID in a single product. So that's an area that we are. I think, in our last earnings call, in fact, we had our last earnings call, we stated that we were resuming investment in the product. And we have a certain stage-gated investments that we're committed to now to develop a co-formulated product and to prepare for a phase IIB study in 2024, the start of 2024. So we're working towards that, and we think that's the goal of that study will be to replicate the striking immunogenicity, put it that way, that we saw on the phase IIA study, and to generate a larger signal that can be used to then go to the FDA and plan to get a formal approval, basically. So that's where we are with that product. I think we all are, I would say, have tremendous amount of enthusiasm for the potential for that combination, basically to pursue. Yeah. I think that our board and our leadership, they understand that, and, they're communicating to the rest of the organization the same. Yeah, I'm looking forward to that program advancing as well, because in my opinion, of course, it's my opinion, I think the protein-based approach lends itself best to that combination COVID influenza vaccine, versus an mRNA-based approach, which at this point is really not proven so. And I think some of you know that they've had difficulties advancing those candidates. So I think, in my opinion, you're the leader in the combination race, and I think it's an appreciated opportunity because since such a product advance, it's really a premium product that I think the company's going to be able to have a long legacy in the vaccine space. Let me just add one other thing, is that we haven't shut the door in any way on most signals, right? Yeah. So that's the other piece that's involved with development, yeah, including pandemic preparedness network. Yeah. And of course, you know, a protein-based vaccine, but then it's a better to less top filing approach. So, I want to thank Jim Kelly, CFO of Novavax, our Chief Medical Officer, Novavax, Robert Walker. I want to thank everybody for attending this presentation. Hopefully, you've got an opportunity to also look at other interesting companies at our H.C. Wainwright and Global Investment Conference. Thanks again.