All right. Good morning, everyone. Welcome to day two at Jefferies Healthcare Conference in London. My name is Roger Song, one of the senior analysts cover biotech at Jefferies in the U.S. Next, presenting company is Novavax. Welcome, John, Filip, and Jim. Thank you, Roger. Hey, Roger. Thanks, Roger. Yeah. Awesome. So maybe we kick this off right now. So maybe John, as the, you know, relatively new CEO, but, you know, you have been with Novavax for a couple of months already. What is your updated elevated pitch for Novavax, with the recent kind of strategic priority you lay out for the company? Well, look, we have three strategic priorities for the company, and first and foremost was launching our updated vaccine in line with regulatory authority requirements in the U.S., Europe, and other key markets. We're proud to say we've done that with key authorizations in the U.S. and in Europe, and pending filings that are all completed in other key markets, including Australia, New Zealand, Israel, et cetera. We're very excited about that. The second key priority was to stabilize the company financially, to make sure that we could reduce current liabilities and build enough cash runway to really keep the company more steady, and so we can focus on the launch and the growth of our product market share. So we were able to reduce current liabilities by over $1 billion, operating expenses by over $1 billion since 2022, and actually, we're $100 million ahead on our initial cost reduction targets, and just announced another $300+ million out of SG&A, R&D, and our manufacturing supply chain network. And so, we've shown we can do that, Roger, without cutting our capabilities. It was really important that we looked across the company to say: What are the key capabilities we need at Novavax, from strain selection to shots in arms? We've got to do that really well with one product, so we're just scaling that according to the emerging global opportunity for the company. And third, and certainly not least, with Dr. Dubovsky here, he'll talk about it a bit later, but bringing forward our organic pipeline. We're sitting on quite a unique technology platform with our Matrix-M adjuvant and our protein-based vaccine, the nanoparticle. We think the market's headed toward combination respiratory vaccines. You've got RSV, you've got flu, you've got COVID for the first time in the U.S. market, and there's a, there's a real convenience play there, and importantly, a reactogenicity play. And our vaccine may have advantage on side effects when you combine multiple antigens. So we think we have a, a potentially game-changing vaccine, so it's important that we are planning to launch our phase III clinical program for that asset next year on an accelerated pathway that Filip will address in a little bit. Excellent. Okay, so we'll make sure this conversation will cover everything you just mentioned, but I think with the focus of the COVID vaccine. So maybe we start from the current, this COVID. For this season, how do you view 2023-2024 season, particularly U.S., as the first commercial market? And how you think this, you know, the first kind of dynamic gonna translate into the future future season? This is clearly a transitional year. I think everyone was thinking about 80-100 million doses or so for COVID. And right now, I know there was some recent data from CDC that led to a little confusion, but that's a projection based on a phone survey. So when you look at IQVIA data and claims data, you're 17-18 million doses so far into the COVID season. It's looking like a 30-50 million dose season this year in the United States, but again, a transitional year. First time from pandemic to endemic, first time into a commercial model. And we feel the season may be toward midpoint, not quite at midpoint yet, so still room to grow. Something we didn't expect was to see it was about 90% retail by this point, and flu's about 65% retail, 35% non-retail channel, so you see IDNs and physician groups picking that up. We're not seeing that yet here, but we do think there's an opportunity, especially for our vaccine platform, which is refrigerator-stable. And so it has some advantages, we believe, for distribution across the IDN networks. We have a team working on that. We're starting to see that pop a little bit, but still expect that that's something yet to come, potentially between now and January, actually. Yeah. Okay, awesome. So obviously, the Novavax is the third kind of vaccine approved in the U.S. and also across the world, many countries. So how do you think... You know, first of all, what is your expectation for the market share for Novavax for this season, maybe in the future coming? And also, what is the key factors give you the confidence you can compete in this market? You know, we know we have the big player out there, so how you think you will be competitive? And you, you mentioned one, refrigerator stable. Any other factors you want to point to the investors? You know, a key profile that we're targeting is to have a unit-dose presentation, so either prefilled syringe or unit-dose vial. So we intend to, we strongly intend to have that ready for next year and are already working on that now. We have a five-dose vial this year, which it's good that we're out, but that's less convenient, and it has, may have a return component to it that we have to account for. So it's really important for us to have that unit-dose vial prefilled syringe next year. Also, we're currently authorized under an Emergency Use Authorization, as you know, Roger. We're targeting a BLA for next year and also that next age cohort of six to 11 year olds to expand our label. And then finally, becoming more of a household name. You know, in the first three weeks of our campaign, our PR and marketing campaign, we drove aided awareness with physicians and non-retail channel from 47% to over 70%. So going into next year, we intend to have pivotal awareness levels that lead to action by all benchmarks, a single-dose presentation under a BLA, and with an expanded label to include six to 11 year olds. And that would be our ideal positioning going into next year with a higher awareness level in our second season. So maybe just remind us, what is your current guidance for the U.S. market? And then, you know, in the future, how do you think about, you know, again, the market share and the potential kind of sales for the U.S.? Sure. Go ahead, Jim. Yeah. All right, Roger, happy to, happy to cover that. And, you know, beginning first with the market itself and noting and reinforcing it's a transition market, we're talking about 30-50 million doses for an annual or seasonal basis in the U.S. Remember, flu runs around 120-150, and you start by asking yourself, "Hey, why are these two not closer together?" We would expect some migration of the COVID market towards flu over time, but we're not banking on it, right? We're sure we're gonna build from here. And so with that as a entree, our guidance for the U.S. market this season is 50-150 million. That will occur across both the fourth quarter and first quarter. And across those scenarios, we're talking about single-digit share, you know, from low mid to high single digit, and viewing it in the context of, "Hey, this is a launch, third to market." And as we collectively along with the other manufacturers help this market transition to commercial and grow the market, we certainly see with our favorable profile the ability to grab share and grow share over time. So we think we have a lean, sustainable, profitable U.S. business ahead of us. Got it. And I think you, you did a couple market research in terms of the awareness, maybe the preference share for non-mRNA vaccine, and talking about, like, a 20, 25, maybe even higher preference share. How do you think about the future, maybe focus on the U.S. first, and then we'll move on to the ex-U.S. How do you think about the future market share for Novavax? What's your aiming for? Well, the preference share indicated over 30% preference for a non-mRNA option, which was really important, and that was across both consumers and healthcare providers. Right? Now, preference share, you need to discount that and move toward peak market share. We haven't disclosed forward-looking guidance on, on share projections yet, Roger, but you can look at typical analogues time to peak share, third to market differentiated biologic or vaccine product, and get a relative modeling perspective on where we might land on that for now. Okay, awesome. You know, we talk a little bit, a lot about the U.S. market, but also we know ex-U.S., particularly we're in Europe, U.K., and then so how do you think about the current E.U. market is still, kind of APA driven, but in the future it will may be, similar to U.S., we're moving to the commercial market. How do you think about the dynamic will look like? How much we can apply the learning experience from the U.S. to, ex-U.S., particularly Europe? Definitely different markets. I think they're trending in a similar way when it comes to ratio of COVID to flu vaccination, those rates and things, so there's certainly learnings that can be applied in modeling. But if you look at the European market, you had Pfizer successfully renegotiated their APA, roughly 60 million doses or so over three seasons. So that locks up a fair portion of the foreseeable market demand in COVID for the European continent, but still there remains opportunity in the private market. We've already been approached by several governments about opening up private markets, and they really like our refrigerator stable product, especially where there's independent pharmacies. You look at the U.K., you look at France and other markets like that, that have opportunity. And then there's also still government purchase opportunity in Europe. The key for us will be to do that with a very lean and focused structure, and to make sure we're managing the cost investment over the next 36 months in Europe. We close out our APAs and intend to fully deliver all of the scheduled doses for our APA this year and close that out, and we have remaining APAs over the next two years from Australia, New Zealand, Canada. And perhaps, Jim, you could just talk about, before we transition further beyond the European question, the next two years of runway before we get to our combination vaccine- Absolutely. and the cash flow we have there. Certainly. You know, ensuring we have the financial strength as we build out this transition to commercial markets is really important. What we outlined, and I outlined on our call last week, is that, you know, we could see forward to cash, expected cash, and sales, APA sales through 2025 of approximately $2 billion. So exceptionally important because that is the cash and sales runway to enable what will be this transition to commercial markets in the U.S. and then selectively across the world in a highly efficient and focused manner. To give you a sense of when I say $2 billion, where does that come from? We're talking about cash on hand, receivable from Canada, another $175 million. You know, from our guidance, Q4, Q1, another $600 million, and then after this season, which ends at the end of Q1, another $750 million for the markets that John just mentioned, Australia, New Zealand, Canada. So we have a very fortunate position of having both this cash position plus APAs ahead of us to help solidify our foundation as we build, build in a focused and efficient way, these commercial markets. Our plan includes an independent pathway to engaging in our phase III clinical program and getting to a launch of our CIC, we call it, but our combination COVID influenza product, and 2026 would be the target for that. Yeah. Yeah, we will talk about the CIC- Yeah ... in a moment. So, maybe just clarify, for the rest of the year, you have around $600 million revenue to deliver across Q4 and the Q1 next year? Yeah, that's correct. And then that's mostly driven by the APA, ex-U.S. APA, and the $50 million-$150 million for the U.S.. And then you have another $750 million ex-U.S. and ex-E.U. APA to be delivered across 2024 and 2025. That's the revenue, right? That, that's exactly right. And to, I guess, further reinforce the remaining guidance, at midpoint, it's $600 million split across both quarters. We've got grant revenue about $30 million, midpoint of U.S. about is $100. So that means you've got APAs of $470, and over $300 of that is this important European APA. And as you know, we have the authorization, delivery schedules, and then for the remainder, Australia, New Zealand primarily, what we're really doing is working through those regulatory filings. They're Southern Hemisphere, so arriving in the first quarter is really consistent with their demands. So we're well positioned to get these APAs and put us on that path towards our guidance. Yeah. I, I think importantly, Roger, quickly, if I could build upon what Jim said, that $2 billion runway after Q1 of this coming year, that doesn't include anything above and beyond for U.S.- Yes ... for Europe for other markets like Korea, potentially a deal with UNICEF for low-income countries and other things that are all potential opportunities for our company as we go forward. So that, that platform, we feel, mostly securitized cash flows- puts us in a very good and strong position, managing our expenses the right way and making those cuts as we said we would make, to get us through to our combo program. Yeah, that's why I clarified. Basically, this $2 billion cash runway is almost secured, kind of revenue to be delivered, of course, depending on the regulatory and the schedule, but that's relatively, you have a high visibility and the confidence you will be delivered. That's exactly right. Yeah. Okay. And maybe just, we know you haven't really delivered the APA for this year and the coming year, so what are the key gating factors, for investors to say, "Okay, so we are very confident or comfortable you will be delivered?" I know you are confident, but in terms of, you know, what are the key steps you need to kind of step into... I know the E.U. just got approval and then some other countries, and what are waiting for, for the E.U. delivery? Go ahead. So I'm happy to cover that one. So the E.U. in particular, and because we're right here, is a well-prescribed country-by-country delivery schedule that we've had enhanced since, goodness, renegotiated that in January. And therefore, it's more of a logistical effort now. Doses are in country, meaning they're in our warehouse, they're going through the release process, and we just have a week-by-week delivery schedule, country-by-country basis. It's logistics and execution right now. Okay. Got it. Okay, so we're just waiting for more updates from you. And then, so, I understand you're not providing too much kind of forward-looking projection, but when and if you will provide us the 2024 guidance and maybe a little bit future kind of estimates, as you kind of just launch the drug, launch the vaccine a couple weeks in the U.S. and not yet deliver in the E.U.? Well, what we're very cognizant of is the speed at which we're learning, and this season is an incredibly important transition to commercial season in the U.S.. We wanna make sure that we're extracting all the learnings on the market, the tactics that are successful, what we're seeing with uptake in every pocket across distribution that can inform that guidance, and that's happening right now. It's gonna be happening, certainly through December and into January. And so, you know, we look forward to, you know, spending more time on our forward looking as we get closer to that Q4 call. Okay. I think we've indicated clearly, you know, our cost targets, right? So we've given that piece of the platform. And then you've got the $2 billion that's primarily secured cash flows coming into the company, right? So there are those additional elements of U.S., Europe, other markets that are yet unfolding. So we wanna get a sense for demand, and we've heard anywhere from our competition, you know, 50, 57 million doses. We made the call 30-50 for the U.S. this year. If you look at the current trends on shots and arms on a daily basis on the IQVIA runway, and you project that out, unless there's a trend break, you're probably between 30 and 40 right now, right? You can see that. You guys publish the data every week. So as that unfolds, we're learning with each week that goes by on this market, how long will it be, right? And what can we learn from what comes through here today? Do the non-retail channel, do they start to open up? Does that start to open up in the U.S.? What does that look like on a go-forward basis? So as we get those elements, and it's weeks, not months, to really learn a lot more about that, we'll be in a better position to provide even more clear guidance. And one other point, you know, when you look at our 2022 baseline on expenses, we're approaching, with the recently announced targets, a 60% reduction from that cost basis, in annualized 2024. To put the math on that 60%, R&D plus SG&A, 2022, over $1.7 billion we're targeting $7.50 or less. So you're seeing how fast, how nimble we are in sizing the company to the opportunity, and the opportunity is significant but we just gotta be nimble and focused in how we address it. Again, without cutting capabilities that we need to operate from strain selection to shots in arms to make sure we can perform. And we've shown we can do it. That's the key. It's one thing to say it, Roger, but it's another thing to be 100 million plus ahead on the targets we announced previously, and we got the vaccine launched. Yeah. Yeah, so I think maybe we can talk about... I think this is your second pillar in terms of the financial- Yeah ... health and the, the condition. So recently, just as you said, maybe just to set the stage for the investors, in 2023, you add additional $100 million cost reduction on top of what you already announced for 2023, and then you also say you will save additional $300 million for 2024 on top of what you have kind of guided before. So maybe the first question is: well, what prompted this kind of additional cost reduction, and how you're gonna make sure your current operational plan will be still kind of you know perfectly executed? Go ahead, Jim. Yeah. So what has prompted our thinking, and I'll start with, hey, listen, we're always looking ahead. We knew that this launch in the United States, understanding the market size as we went to commercial, would be something that we'd need to, I'll say, flex to, to be prepared to adjust the size and scope of the company as we better understood the market. These past four weeks, six weeks, happened very rapidly in the U.S. marketing market, watching that transition, that is what spurred our thinking. That's what spurred our preparedness to take action, 'cause we have to make sure that that runway we talked about, that $2 billion or over $2 billion, is there for us to efficiently build this market in a, I'll call it a capital efficient and a operationally efficient manner, while we maintain these capabilities. Yeah. That's what it is. It's applying the market, the opportunity, and being flexible in how we do so. And we targeted very specific ratios- Right ... based on benchmarks and where we wanna be from a drive to profitability in the future. So we backed into that. We didn't just start cutting to see how far we could go. We started with a target in mind and built into that while not hurting capabilities, and then as the market size changes, we can flex the structure to match that and align with that, to keep those ratios in mind. Yeah. Okay, good. That's a very healthy way to structure the financials. But, you know, before we move on to exciting pipeline, I know Filip here is, you know, eager to talk about the CIC. Can anyone tell who the scientist is on our panel here today? Yes, before I do that, I think one of the question you may not, you know, want to talk about it every time, but, you know, investor, it's on top of the investor's mind, is, do you still wanna maintain this going concern in your financials? So maybe just, you know, under what condition you will potentially be able to remove that going concern. But right now you say, you know, if all the operational plan execute as planned, as expected, you will be able to, you know, sustain the business, kind of remove the going concern. So maybe just tell us what are the key components you need to execute, and then to be able to remove that kind of issue there. I think we were very clear in our disclosures about the elements or the pillars that went behind that going concern, and for me, coming in as new CEO, working with our board and management team, our auditor team, it was very important that we're building credibility with the investor community. The company had significant risk when I came in, and we worked really hard to begin that turnaround and to make be decisive and make tough decisions to bring down the expenses, right? To really work hard, to work differently, and get the vaccine out in a more timely manner, in line, be able to compete and drive more revenue, become an efficient operating vehicle to then bring forward this pipeline and technology. It's very important that we called out that risk to investors in as clear a manner as possible as things began to emerge. And what emerged right as I was joining, you know, you had a change in the timing of government grants. There were a couple of years to pull down several hundred million in remaining Operation Warp Speed grants. That time was shortened to just this year, and that put significant risk. In addition, after I joined, Gavi filed an arbitration with us, right? That was a new development. So those new developments, on top of the company's position coming into this year, collectively led to adding that going concern on top. I think hopefully what everyone sees is we're starting to build a much better cash runway and a much more efficient business model to be able to deliver our pipeline and technology. We still wanna resolve the Gavi, issue and put that behind us. We've actually done a very good job, Filip and his team, this year in pulling down the vast majority, if not almost all of that grant money which helped us to have a good performance in Q3. I don't know, Jim, if you want to add anything, anything on going concern. Well, certainly. You know, I think the two key dimensions on the going concern is our operating plan, just sort of the basic operating plan for which we see sufficient capital for 12 months and forward, as outlined here. And then when it does come to Gavi, while it's a legal matter, you know, what we see is that there's every reason that we should be doing business together, given our shared mission. And I think that recent examples that highlight that are the, for example, R21 approval for malaria through our partners that can save millions of lives in Africa. What a great example of the shared mission, leveraging our Matrix technology to bring a life-saving treatment to Africa for malaria. And then what you're seeing with UNICEF, with their continued RFP for COVID vaccine. So we look forward to call it continuing to advance our shared mission with Gavi. I think there's great opportunity to do so. Yeah, very interesting. You have many different kind of partnership with Gavi, and simultaneously, you also have this kind of arbitration with them. Yeah, so I thought I understand this is a legal issue, and you don't have any you know, too much comment. But in terms of timeline, the next time you will update us, that's the kind of after hearing, July next year, is that where you will be able to address that? The formal hearing is scheduled for July of next year. Of course, and in any, and this is not Novavax specific, I can't comment specifically on the case, but what I can say is that any parties in this type of discussion, at any time, can choose to find a settlement if they wish to, in good faith and good partnership. Yeah, sure. Let's bring Filip to the, to the spotlight. So, for the CIC, maybe just what is the key strategy here, and what seems you get some alignment with the FDA in terms of moving to the phase III as a single pivotal study, and then potentially you will get approval in 2026, which is a very accelerated path. So, Filip, what have you done and to bring the CIC to such a kind of quick kind of path? Yeah, so, so pretty much three things changed between our previous guidance and last week's. One of them is that influenza vaccines have gone to a trivalent format, and that made our job a lot easier from a formulation perspective. The other one is we got our complete data set from our previous phase II study, and it allowed us to actually understand if we could achieve accelerated approval pathway endpoints. We had a lot of confidence looking at our data that we could do that. Finally, we saw some of the other sponsors put forward plans where they had gotten regulatory concurrence with their plan, which was very similar to what we were thinking. So we believe that there's now an accelerated approval pathway that's open to us, and we can get that study launched next year. We have a high degree of confidence that we'll achieve those endpoints because they hit the non-inferiority margins that have been previously used in phase III studies. So we're forging ahead. So what's left now? We need to complete our formulation development and finalize our manufacturing strategy to bring a phase III ready material into that study, and then we're off to the races. Awesome. And I guess the other point is that, you know, for a while, we pulled back on the R&D effort, but because of the financial strength, we've kind of regarnered over the last two quarters. This is an effort we're supporting internally. It's gonna, in my opinion, be a huge value driver for the company. Yeah, absolutely. Filip, incredibly more efficient, capital efficient path to filing for this indication in accelerated basis, so that means a lot. Just, just back on the accelerated approval, I mean, we've... This company has trod this path before. There was a phase III study with influenza alone that was granted an accelerated approval pathway by the FDA. So I, I think we, we know pretty well what needs to be done to get it through the hoop. Got it. So, just to clarify, I understand you wanna launch or, you know, sustain the COVID business on your own. But for the CIC, are you seeking or would you seek kind of partnership down the road after phase III or maybe a later stage of the phase III, you will start to do some partnership? I mean, right, right now, it's our plan to independently bring forward this trial in through the next stage gates. And, that we're always open to the appropriate pathway, what's best for our investors and the company, to bring forward anything we're planning on doing, so we never say no to a potential pathway. But right now, it's our job. We're, we're cutting the expenses down, focused investments where it matters. You know, one of the questions we often get is: Well, if you have to reduce expenses, how can you still perform? Hopefully, everyone sees we've done that this year, and we're $100 million ahead on that previously stated target. So we know how to do this, and we're gonna be making specific and focused investments where it matters, like in that program, in a more efficient program, a more effective program in our mind, for an accelerated pathway for CIC. But we'll keep our mind open to potential, but coming at that from a position of strength is what's important to me and the management team. That if you, if you must have a partner to bring something forward, you have less leverage. If it's an option, that's the position we'd like to be in. Yeah, absolutely. Okay, so it seems we covered a lot of ground here and within the 25 minutes. And, any other things, you wanna discuss that we haven't really, touched on? No, look, I, I think we've covered a lot of ground here. Unless, Filip, anything else you wanted to comment on from the science side? Well, I mean, just a couple of things. I mean, one of them is that Gavi has announced there's a multi-year agreement for the R21 malaria vaccine. And obviously, we receive revenues and royalties for that, for providing the adjuvant to that. And it also strikes me that that plays into some features of the adjuvant that I think are important. I mean, we, we've taken our COVID vaccine down to babies as young as six months of age. The malaria vaccine's authorized now to children as young as five months of age. And for this adjuvant system, we can really pile in the antigens without really impacting the reactogenicity. We're comparable to licensed influenza vaccines, and that means that the pathway open for a broader combination of vaccine is wide open. This company has played aggressively in the RSV space. That's the one where there's other licensed products. I think the pathway is pretty clear for that. So I think that kind of a more aggressive respiratory portfolio may well be in our future if the finances hold up. Excellent. I think that's very important to say that we're, we're not a COVID company. We're, we're a biologics company and a vaccine and, and infectious disease company sitting on an amazing technology platform, including that adjuvant and our protein-based approach to generating vaccines. Our first product happens to be COVID, and so we're gonna optimize that and run an efficient business model to generate the right revenue and value structure, so we can bring forward organically the rest of that pipeline, and then to seek inorganic growth, leveraging that success to build out a more broad portfolio and become a leader in vaccines and infectious disease. That's great. Thank you, Roger. Thanks for the time. All right. Thank you, Roger. Thanks, guys.