All right. Okay. So sorry for the couple of minutes late, but it's my pleasure. My name is Roger Song, one of the senior analysts covering SMID-cap biotech in the U.S., and then my pleasure to introduce our next company, Novavax. Welcome. Roger, thank you so much for having us today. I'm Jim Kelly. I'm the CFO. Bob Walker right here is our Chief Medical Officer. Ruxandra Draghia is our Head of Research and Development. Really thrilled to be here. So much going on with the company and looking forward to the dialogue today. And thank you all for coming. Absolutely. Thank you. All right. So maybe, Jim, you can start with some updated elevator pitch for Novavax, particularly with the recent updates. We can kick off the conversation. Certainly. I think most people are familiar with Novavax from our background as a COVID story, right? With a validated technology platform, nanotechnology, recombinant protein combined with our proprietary matrix adjuvant. We were one of the stories who were able to solve that COVID puzzle. It is building upon that success that we're asking ourselves, how do you create more value from this validated technology platform? We're focused on four things. Number one, recently announced this year a transaction, a licensing agreement with Sanofi, whereby they have rights to our COVID vaccine and the rights to develop combinations of our COVID with their flu vaccine and develop new vaccines with our Matrix. This is all about working with them to do the best for human health and create value with our technology in those respiratory businesses. Two, we have our own proprietary flu plus flu plus COVID combo, and we're seeking to initiate phase III for both those very, very soon. And so we have a great opportunity to create value there, again, with an eye towards partnering. Three, our Matrix-M and our technology platform is exceptional. It's validated. And we are seeking to create value by doing more transactions, for example, with our Matrix-M adjuvant with existing vaccine makers who can, for example, make their existing vaccines better or develop new vaccines where they've had failed in the past, and our Matrix-M adjuvant can help them cross the finish line. So look for more on that front. Then, in addition to that, carve out for ourselves our own proprietary, high-impactful, innovative pipeline to create new vaccines. So those four things and do all of it in a very capital-efficient way by driving down cost and by having a very focused, disciplined approach to both supporting our partners and also developing our own vaccines. That's our formula to positively impact human health and create value. Excellent. Yes. Historically, for the past couple of years, Novavax is focusing on the COVID vaccine, but you are moving from, based on the Sanofi partnership, you are moving from the COVID to additional pipeline and into even beyond the infectious disease, but let's spend a few minutes, still spend a few minutes on the COVID business, given you are still launching the drug for the sales for this year, and then Sanofi are going to take over the commercial launch for the next year, so what are the key push and pulls you can do to increase the market share for the future COVID vaccine market, understanding right now you are sitting at around 3% of the market share, which is significantly better than last year. That's exactly right. And I think the way this is a long game, and what we're looking for is what are the reasons to believe that our technology in either a standalone COVID product or a COVID-flu combination can be competitive and advance human health and be a significant value creator. Okay, what did we see go well this year, and what are the reasons to believe for future years? But at the same time, you got to be credible. What didn't go well? All right. So I'm going to start with one of the core reasons to believe. One, we have a technology that has shown great clinical and safety results, right? That if you go out and do the market research, which we did, the marketplace, and this is both consumer and healthcare providers, have said they would prefer a protein-based choice for a COVID vaccine, all things being equal, and so that's not a market share. It's a preference share, but what it shows is that there is a genuine opportunity to take a meaningful position in the market, then you say, well, tell me about how this year went, and I'm going to be U.S.-centric for a moment just because I have the best statistics there. This year, what went well? We got to market on time, so we were in the market in early September when you needed to. We were in a competitive prefilled syringe, critical for that and for modern marketplaces. We were on the scheduler, meaning that you have the ability to access our vaccine and our market share. Listen, we did better this year. We're sitting at 3%, but it's not where we want to be. Okay, what didn't go well? What didn't go well is while we came to market in a prefilled syringe, it was our first year, and we didn't have the shelf life we otherwise wanted. So we went out with three months versus what you really need is six or nine months. Why does that matter? It meant that the pre-booking that retail pharmacy does, because of that short life, they wouldn't pre-book as much. And that impacted our market share. That said, if you come out next year and we're transitioning commercial leadership to Sanofi next season, and they've got that more competitive shelf life plus their infrastructure and distribution network, do I think they can do materially better? You bet. There's no question in our mind that building upon the successes that we've had over these past years, and that's what we're doing, you're just building up this market opportunity. We think that this vaccine, the COVID vaccine, is well positioned to succeed in Sanofi's hand because they're the market leader in vaccines, respiratory vaccines. And that is what drew them to us to do this transaction in the first place. So that's part one for COVID. Then part two, COVID plus flu combination. And I mean either our own, which we're developing, or Sanofi has the right to take their market-leading flu and combine it with our COVID. We think this market, without question, is going to tilt towards combination use. It just makes sense. We all saw this in the pediatric marketplace where there were so many vaccines to be given. We think it is certainly the same here, and so we think we've got exceptionally competitive vaccines to compete in the evolving competitive marketplace, and so we're looking forward to do so through our arrangement with Sanofi, and then as we develop our combination vaccine, we'll do so through another partner. Our strategy, think about your laptops, a bunch of different manufacturers, but they all have Intel Inside. We see our vaccine technology for proteins. Everybody should want to use it to advance their vaccines, and we're here to help. Yeah. Got it. So in order to improve the shelf life for your prefilled syringe, it's basically you need a little bit longer stability data. That's why you're confident next year you will be able to get that. That's right. Anytime you come to market for the first time in a new presentation, it just takes a while to get that stability data. And so we expect to have that taken care of for next year. Yeah. Got it. Oh, and by the way, we're already there in Europe. We're already at nine months there, Japan, nine months or more. So it's literally just a matter of putting the data out. Got it. Yeah. That makes sense. And then in terms of the transition to Sanofi for the next year, starting from early next year, you're still taking care of the rest of the season for 2024, 2025. How much needs to be done? And then what have been done, what have done for the transition to Sanofi? Well, certainly. So what is happening is we are reaching, as Novavax, the end of the material, really the material work to be a commercial player for this season. To get you grounded in what the season looks like, about 90% of vaccinations in the Northern Hemisphere occur between September and December. About 10% trailing through next year. So by the time we get into December, we're really winding down the material commercial activity, a lot of which was contracting, which is already in place. So what we're really doing through the first half of next year is just maintaining supply in the marketplace for spring booster campaigns or you name it, but it's very, very small. As a part of the transition of our cost structure, that's one of the reasons why you see such a decrease in our guidance of cost structure year over year, because as of December, a lot of those activities and related costs go away. In terms of our focus as an organization, it's really about standing up Sanofi for their launch year and giving them that opportunity to come out the door as successful as possible. When we think about inflection points for this company, seeing our technology perform in their hands this fall is, I think, going to be a really important tipping point where people can point to and say, "My goodness, this technology is super competitive. It can perform in the marketplace. And if it can for COVID, I have reason to believe it will for combination. And my goodness, what else might you do?" So I think this is a really exciting time to see where this technology is going to go. Okay. Got it. Yeah. We'll look forward to next year and maybe this vaccine can get to the broader population than the 3% of the market share we have right now. Exactly. Okay. And then move on to the COVID-flu combo, understanding Sanofi can push forward with their own combo with your COVID plus their flu. That's out of your hands. They're going to take lead on that. But you also have your own flu-COVID combo about to enter the phase III. Recently, you just removed the partial clinical hold for that program. So what are the gating factors before you can start a phase III for your COVID-flu? Yeah, exactly. So I'm going to hand off to Bob and Ruxandra on this, but a quick comment on a clinical hold that in an almost unprecedented way was put on and then removed. And just so we're clear on that one, as far as green lighting to advance and move forward on these studies we're exceptionally excited about. Listen, a lot of credit to our team to take a late-breaking piece of information, do the right thing, escalate it, share it with FDA, say, "Hey, listen, we don't think it's causative, but let's look at the information." When we evaluated the information and FDA did as well, they agreed. No causal relationship. Therefore, hey, lift the clinical hold. So listen, a lot of things were happening quickly. Was really happy with the expedited nature with which FDA worked with us and also proud of our team to escalate a signal and then resolve it so fast and get us back on track, and so Bob, if you want to talk about what we're doing, what it means to go as fast as possible to start these programs. Yeah. Well, thanks. Thanks. Yeah. Our partnership with the FDA has been great. I don't think we would have been able to resolve the clinical hold if we didn't have such a great ongoing working relationship with them. And as Jim mentioned, the safety event that was reported was, in our opinion, not related to the vaccine. And by the lifting of the clinical hold, FDA signaled to us that they agreed with their assessment. We reported out on our phase II results a year ago. That was the reason to believe to move on to the phase III trial. We were targeting a start of the phase III trial this fourth quarter. Clinical hold has set us back a bit. We are firing back up the engines for all of the sites that were previously primed and ready to go this quarter. We're hoping to get back on track and get that trial started as soon as possible. Everybody's working really hard to do that. Looking also for data readout to follow soon after. That's our plan right now. This is a phase III immunogenicity study. It's not clinical efficacy. It's using an established immune readout to demonstrate non-inferiority of our COVID combination vaccine versus market leader in the over 65s. Similarly, we'll have standalone flu arm and the same immune readout for that. That's where we're headed. Yeah, and as we think about our business model as a company, what you're hearing is catalysts next fall as Sanofi goes to market in the Northern Hemisphere. You're hearing catalysts tied to initiation of two phase IIIs and readouts. We're hopeful you can get that this coming season. We're running those in the Southern Hemisphere, followed by potential partnering tied to them, all of which is linked to our strategy of taking our respiratory commercial assets, get them in the hands of some of these major players, create cash flow that in turn, as we drive down our cost structure and focus on value creation from our validated technology, we can do so in an efficient manner. Excellent. So given this clinical kind of the record there, how much change do you need to do for your protocol for the phase III and how confident this phase III still can support the potential approval using the immunogenicity endpoint? And then particularly on the safety side, do you need to do additional safety monitoring before you can file for approval? So just to be clear, so this event was unrelated to vaccine. So it doesn't spur any change in our standard safety monitoring. So yeah, I'll just say that categorically. But we are still in the pre-IND process. We're now in the IND process. So I think those of you who are familiar with it know that there's a back-and-forth dialogue with FDA and there's recommendations that they make, things that they think you should be doing that might improve the quality of your trial. And obviously, those conversations are ongoing and we make changes that we agree with, which most of the time if the FDA is recommending it, it's something that you're kind of expected to do. For what it's worth, I mean, we view the tolerability and the potential safety profile of our platform to be a potential competitive advantage, right? And whether it's reactogenicity being favorable or how our adjuvant enables you to use less antigen and what that means in terms of safety profile, we think in the long haul that safety should and could be a really important differentiating profile of our platform. Yep. Yeah, I agree. No, based on today's data, the safety and the reactogenicity is the differentiation for your platform compared to many other COVID vaccine. Okay. So I know you haven't really guided towards the timeline for the start and then the potential phase III data, but is that still within the timeframe 2025, 2024, 2025 timeframe for the phase III? So here's how I'd answer that one. Our expectation on when you start and when you read out the cycle time to do so, that shouldn't change. So for example, we had said we initially expected to initiate the study this quarter and read out mid next year. Whenever we start the study, how many weeks that is between when we initially expected and when we actually do, it's just going to be a shift. So if we start two, three weeks or months from now, just shift forward. Our intent is to run the study in Southern Hemisphere. That season runs through about March. And so you'd want to get dosing done by probably mid-February. And so we'll come back to you. We just got that information prior to our earnings call and we're just working through the mechanics with, you can picture it, all the sites and all our partners to get this up and running as soon as possible. So look forward to providing that update soon. Excellent. Okay. Last couple of minutes, maybe talk a little bit about your earlier pipeline using your Matrix-M and the platform, understanding you are picking RSV as potentially the combo and the pandemic flu as the next candidate, and then obviously you can expand to other infectious disease and even beyond infectious disease. Tell us a little bit more about the timeline and the development plan for those earlier pipeline and then how you're going to maximize the value for those. Yeah, Ruxandra, great opportunity then. Yeah, thank you for this question. Actually, we are now in the midst of a very rigorous exercise to look at these opportunities. And again, we do have a platform, which means that we are looking both at the application, so at the diseases, the potential target diseases, and how we can use our adjuvant Matrix-M, which can actually help make other people's vaccines better or the existing vaccines better, or actually focus on these combinations that will help with the clinical practice. Starting with our core, which is respiratory infections, obviously looking at combinations. For instance, we've discussed a little bit about an RSV combination, but actually looking at other possibilities both in the internal pipeline and in partnership. And when we are talking about partnership, actually taking other people's vaccines and seeing can we make them better. Eventually after that second stage, are there other areas of activity? We've talked a little bit about oncology, for instance, where adding Matrix-M to existing formulations may actually enable better results, in particular in populations where we think that our adjuvant can bring additional value like over 65. We've discussed about it where the breadth of the immune response or maybe the durability of protection are going to make a difference. So we are in the midst of that very, very rigorous exercise of assessing where can we bring value. I think one of the keys to our strategy is going to be which indications might we seek to ring-fence and uniquely, exclusively be able to leverage our technology, our matrix to go after, and then for things we don't want to develop ourselves, how do we make sure as many players in the vaccine space have access to our matrix, our technology so that we're a part of, like I said, we're the intel inside. We're a part of advancing these vaccines and both advancing human health and improved economics. What you're seeing in our strategy is we went from being a global commercial company focused on one thing to now, through this evolution of our strategy, found a path to, in a capital-efficient way, develop multiple vaccines to advance human health and create significant value, and so that's the path we're on. Excellent. Last minute, what's your cash position and how should we think about the runway given you are expanding the pipeline there? Yeah, certainly. Hey, so we ended the quarter with just over $1 billion in cash and receivables. Based on our forward-looking guidance for R&D plus SG&A for 2024, 2025, 2026, that's frankly approximately $1 billion when you factor all the ins and outs, cash and non-cash. The point is it is consistent with our goal of always having one to two years' worth of cash, maintaining cash over $500 million prior to even contemplating these milestones, royalties, and future deals coming in. So this is about creating economic strength as a company to advance this technology development and create value. And so we certainly feel well-positioned today to do so. Excellent. Thank you for all the comments, and then thank you, everyone, for listening.