NOVAVAX INC — Call Transcript 2026

Are we live? Awesome. Hello, everyone. Welcome to the Jefferies Healthcare Conference here in New York. It's a pleasure. Thank you for tuning in everyone in New York and online. I'm here joined by Novavax, Jim, John, Elaine, Doug. Great to see you all. Let's get started with some introductions and let's talk about your new growth strategy early in 2025. What are some proof points that demonstrate how your strategy is working and anything that you think the market and the street is underappreciating about your story? Let's start with that. Thank you, Nabeel. It's great to be here with everyone, and thank you for joining our presentation today. Right now, we couldn't be more excited about where we are in Novavax's history. As you know, we launched our new strategy in January of 2025. Yeah. You asked, Nabeel, about proof points. We're really excited about what's already unfolded in the first trimester of this year, which are the fruits of our labor starting to show, right through 2025. Yeah to generate and to engender more interest in our technology. First proof point really is the level of interest that we have seen as a management team from third-party companies working with us on our technology is unprecedented. In Novavax history since we launched our strategy in January. We were proud to announce the new partnership with Pfizer in January, and we'll talk a little bit more about that today, as well as in the first trimester of this year, four new MTAs, or Material Transfer Agreements. This is where we provide, as Novavax, samples of our Matrix-M to potential partners through a collaboration, and that allows them to experiment in their own labs on targets of interest across infectious disease and oncology. That's a step we took with Pfizer as well. In the hopes that that might turn into a license agreement and a full revenue-generating partnership subsequent to the positive experiments that they may have. In fact, of those four new MTAs, one of them was another top 10 global pharmaceutical company, who also happens to be ranked globally as an oncology leader. Very, very exciting to see the interest not only in infectious disease but also in oncology indications. Those are some of the proof points that we've recently shared. I think what might be misunderstood or missed about our strategy currently, Nabeel, it's an interesting question. Number one is the way that we might generate revenue from this. Yeah. In a typical, traditional biotech approach, a company from the lab all the way through their clinical trials to approval and launch could take many years before they generate the first dollar. With our Novavax strategy now, we can monetize our technology right now immediately upon the consummation of a partnership and a license through upfront payments, as exemplified by the Pfizer $30 million upfront payment. Through potential milestones for the clinical development of assets using our Matrix-M. We announced in the Pfizer deal $70 million in eligible potential milestones for Novavax per field as they would advance something through clinical trials. That allows us to pull forward tens of millions of dollars potentially hundreds of millions of dollars in the form of other sales or approval milestones that might be in a particular agreement, and then royalties for decades to come. I think that may be underappreciated. Yeah. The last piece is amplifying the impact and the value of our technology overall. More than Novavax alone could ever hope to do, we announced in our most recent earnings call the scope and scale of these collaborations and partnerships combined, which represent currently over 50% of the projected global market opportunity in vaccines for oncology and infectious disease, as projected by McKinsey and EvaluatePharma, is currently under assessment or has the potential to be under assessment via our partners. That's representing 30 unique disease fields across oncology and infectious disease. As Elaine said in our recent earnings call, many of those more competitive disease areas and markets have more than one partner or collaboration going on, which increases our probability of success for more potential future partnerships and revenue streams along the way. That's how I'd answer that. Yeah. Thank you for that big-picture overview. Regarding some of the interest and ongoing activity, I think Matrix-M continues to be a bigger story, and that license agreement that you arrived with Pfizer in January, could you walk us through a little bit about the scope and the terms of that license and what we should anticipate the next steps that Pfizer could do and potential catalysts and milestones that could come out of that? Sure. Elaine, do you want to take that? Thanks, John. Briefly, the Pfizer Matrix-M licensing agreement enables Pfizer to utilize Matrix-M with a field that was disclosed to us, but we are not publicly disclosing it. The second, they have an opportunity for a second field that they will study Matrix-M with, bring it through clinical study, and that has not been disclosed yet. That $30 million upfront is something that we received earlier this year, we have the opportunity to receive sales and development milestones to the tune of $250 million. Just to characterize, we also have royalty payments coming off of that particular license agreement as well. Let's just say if Pfizer is successful with the clinical development for a product, that might be over $1 billion. Cumulatively, we'd be able to receive over $1 billion in royalty payments because of the term of the agreement is for 20 years. Again, as John was mentioning, this gives us a wonderful opportunity then to continue to build revenue from that particular licensing agreement over time. That's been our strategy for Matrix-M holistically. We announced another MTA with another major pharmaceutical company this year as well, as John mentioned. Which gives us the opportunity to repeat that. Right. That particular MTA includes nine fields of study. We're very excited about that as well, because each one of those fields has the potential to be over $1 billion for sure if that particular study is successful. Very excited about that as well. Thank you, Elaine. Regarding the nature of that license agreement, it's sort of a non-exclusive license. Walk us through what led you to follow that approach to partnering with Matrix-M. Go ahead, Elaine. Yeah. The non-exclusivity gives us the opportunity then to partner with major vaccine companies where there may be overlap. I think we mentioned during our earnings call we have overlap, for example, in the pneumococcal space. We also have overlap in RSV, potentially. We also have overlap in infectious disease such as CMV, cytomegalovirus. Again, having a non-exclusive opportunity gives us our opportunity to partner with companies. We are successful, right, because we have multiple shots on goal with our Matrix-M technology. However, that may wind up manifesting itself in the marketplace over time. If we have two or three companies, let's say, that are utilizing Matrix-M in a pneumococcal space. We would hope that one of them will be successful. Mm-hmm. Yeah. Get all the way to commercialization. If we have another and another, of course that's additive as well. Again, we're non-exclusive for a reason. Yeah because it's certainly very beneficial for us. Nabeel, just to build on that for one moment. Putting it into a hypothetical example. If we had, say, three companies that wound up doing a partnership with us through a license, Elaine, right? They were each pursuing one of those fields, the same field A. If they're pursuing that field, if we set those deals up in a similar way to what we've done with Pfizer. We should be eligible for milestones along the way on their clinical development. If you could imagine in that hypothetical example, three companies targeting a field with our Matrix-M, and Novavax would have the ability then to earn up-fronts from all three, the ability to earn milestone payments for their clinical efforts on those disease targets years before a vaccine might get approved and launched into the marketplace. Even if, in that hypothetical example, two of those companies didn't succeed in their clinical efforts but made it most of the way through, we would have earned revenues along the way for their efforts. Yeah. One of those companies makes it through or more, we are then eligible for potentially larger milestones upon approval and sales, and then royalties for potentially decades to come. That's really exciting, and what it does is show you that if you've got 30+ fields under assessment now with multiple partners, four of the top 10 global pharmaceutical companies already engaged with Novavax through collaboration, MTA, and partnership plus other smaller and mid-size companies that we haven't disclosed yet, that are working with us, you can imagine then that our POS, our probability of success is pretty good and relatively high for the potential for more partnerships and multiple revenue streams over time. Yeah. Thank you for walking us through that setup. Regarding the recent MTA with a large oncology or a large top 10 global pharma company, we're looking now into indications beyond ID, and could you walk us through how Matrix-M might have a mechanistic favorable, what it can offer in the oncology setting, and yeah, more on that story? Go ahead, Bob. Sure, thanks. Matrix-M has a broad array of immunologic properties that make it such an exciting adjuvant in general, certainly in the infectious disease space, and a lot of that we think could have applicability to the oncology space as well. It's been well-characterized to be a Th1-profiled adjuvant. Yeah which means that it induces not only antibodies and neutralizing antibodies, but cell-mediated immunity. It's that cell-mediated immunity which is thought to be so important for oncology, particularly CD8 killer cells that exert the anti-tumor killing activity. Yeah. Matrix-M has the ability to induce cross-presentation of antigens in the cell, that leads to the downstream activity of the CD8 cells that we were just talking about. Those are some of the reasons why we think Matrix has great potential in the oncology space. As we're learning from partners who are also conducting some of these studies, there's a qualitative aspect to the immune effect that Matrix produces as well. It's not just numbers of cells. It's about the quality of the cells that are activated. Anyway, we're very optimistic, and we really look forward to coming back at future sessions. Yeah Talking more specifically about the data we've generated. Nabeel and Bob, thank you for that clear answer. Part of our strategy, one of the benefits of our strategy, is we get to leverage not only the resources and capital partners and companies we're collaborating with, but also their expertise. We're working with some companies that have deep expertise in oncology and infectious disease. Novavax brings a wealth of experience on the infectious disease side, with two vaccines that are actually approved and on market with our technology now, others that are in phase III, others that are in early stage development right now. On the oncology side, Novavax is not an oncology company, nor do we intend to become an oncology company. We're leveraging the depth of experience, the resources, and the expertise of global leaders in that space with our technology, and we're getting the data that they're generating through these MTA collaborations. which further informs our own internal knowledge on this. We certainly have deep expertise in Bob and his team on immunity and immunological responses that are required to take on these diseases, and we're learning more and more each day. Really exciting part of our strategy is to get to leverage that deep expertise. Yeah The capital of these other companies to accelerate these types of potential advances. Thank you. On those advances, a pleasure to have you with us, Bob. If we could talk a little bit more about the R&D investments with the Matrix adjuvant technology. How do you see these advancements impacting new vaccine development and even further potential partnering? Yeah. Maybe Elaine, you want to take that along with Bob? Yeah. What's really exciting for us is, as John mentioned, we're leveraging external expertise in oncology generating a host of data, like essentially a data bank. We're looking forward to seeing that read out in the next 6 to 12 months. Internally, we're also exploring similar but different types of opportunities with Matrix-M. For example, Matrix with a TLR, how is that going to turn on the immune system to identify tumors? We're looking at different opportunities as it relates to Matrix in terms of its formulation as well. What we learn internally, and we'll map that up against what we learn externally, again, to generate data, which will be powerful then in having future discussions with partners who are also very big players in the oncology space. Yeah, maybe I'll just add that we're also on the antigen side. We're also using our internal R&D engine to explore additional antigens. Yeah that can be utilized with Matrix. Yeah. Some of those will be antigens that we'll use as test cases to help us learn and advance and move the science forward. Others, for example, in the case of our C. diff vaccine, will be ones that we may choose to advance internally and take into the clinic. It's kind of like a two-pronged part of our R&D strategy there. One comment just to add, Elaine had mentioned 6 to 12 months for some anticipated data, but we already have data generated by some smaller innovative partners in oncology that we had partnered with quite a while ago through MTAs as part of our new strategy launch. We have some insights already as to some of the antigen targets and things in oncology. We just announced, to your point, Elaine, this new MTA collaboration with a top 10 global pharma company. We're excited about the experiments they're starting to undergo and anticipate in the coming quarters in learning from that together as well. Thank you. Thank you, team. Then, taking a step to the Sanofi partnership, so you signed that licensing agreement with Sanofi back in 2024. Could you remind us of the full scope of that agreement and sort of the key next steps and catalysts? Go ahead, Elaine. That licensing agreement was for the right to execute the commercialization of Nuvaxovid currently in the market. That's the main focus that Sanofi has at the moment, and the other part of that collaborative license agreement was then also to prosecute a combination influenza and our Nuvaxovid program. Sanofi is studying that both with Fluzone High-Dose as well as their Flublok, and should be moving forward with that in the future. The third part was for the prosecution of Matrix-M in their earlier preclinical work, which they would potentially then move into clinic. Very excited about that deal. We're mostly through most of the receipt of the milestones at this point in time. We've executed that very well in partnership with Sanofi to date. Excited about that. They're obviously getting ready for the season this year, the upcoming season. Maybe Jim, do you want to speak a little bit about that as well? Absolutely. As we look forward to the catalyst that lie ahead of us, it includes certainly the fall performance with Nuvaxovid. It includes Sanofi's articulation of the path forward, both U.S., Europe, and other markets for their CIC programs, and then also further development. When we think about the milestones, for example, that lie ahead of us, outstanding. We have $425 million in milestones, $75 million due upon tech transfer. This is manufacturing tech transfer. There's $350 million in milestones eligible under the CIC programs, including $125 million linked to the initiation of a phase III, and then $225 million we're eligible for upon a U.S. combination product launch. A lot to happen there, both in terms of milestones and then really material opportunity in the marketplace, but also for royalties to us. A reminder on that marketplace. COVID market, it's running about $5 billion-$6 billion, and the flu market, about, again, $5 billion-$6 billion. $12 billion total across the two. When you look at Sanofi and the flu in particular, they have almost half of that market in aggregate. Their net sales of the six, think about $2.5 billion-$3 billion. That sales amount for Sanofi, highly concentrated in the enhanced flu market. Think 50 and older. the higher price premium marketplace. There, Sanofi has almost 2/3 market share. As these markets evolve, COVID plus flu, Sanofi and others see a combination market. COVID plus flu is where this market is going for many reasons. We have the ability to be a part of the evolution of Sanofi's market-leading flu when combined with our Nuvaxovid to really take an ever-bigger share of that combined $12 billion opportunity. Yeah. super excited about that. This fall, which was your question. Yes is the first step towards that. What should you expect? The same way that Sanofi methodically built that market-leading flu market over time, watch for an analogous approach. Now, we're not guiding for them, but we would say, their history would say they invest and they have a methodical approach over time. An example of recent investments in the COMPARE study. Yeah. Really critical study that just read out that showed the favorable safety profile of Nuvaxovid versus the next gen from Moderna. We are really happy with the investment profile and where they're going with these assets. Thank you for that overview, Jim. We're really excited about seeing the CIC program. If you could just update us on the current status of that program and when might one or both of those Sanofi CIC programs advance to phase III. Yeah. Jim, do you want to start and then have Elaine perhaps build on that? Well, sure. One of the reasons why we're always a little careful here is, hey, we can't speak for Sanofi. Yeah. what I can do, and this is something that. Yeah are more than willing to, is emphasize one of the public statements Sanofi has made. Well, it began back in December, Sanofi's R&D Day, where they walked through the phase I, II data of Nuvaxovid combined with both of their enhanced flu products. This is a co-formulated phase I, II that was the gateway to a pivotal program. What did they see? Excellent results. In fact, they stated- Yeah high probability to show non-inferiority in an immunobridging study. When you think about that, well, that's the type of study you'd run in Europe, for example, right? Think [Fc]. Yeah U.S., that would be the study in Europe, Immuno. The next step was to talk to the agencies. Sanofi went on to say, in the first quarter and leading up to now, they're in active dialogue with the regulatory agencies. U.S., Europe, and outside. Based upon those engagements, they anticipate launching into a pivotal program for one or both. We're awaiting that those next steps. Yeah. Couldn't be happier. The most recent data point, World Vaccine Congress. Yeah. They again presented that data. Yeah. They again presented their conviction. Yeah market's going to combination. Importantly, on top of that, when they look, Sanofi, at their growth drivers and they talk about the big three future growth drivers, not just for vaccines, but for their company, the CIC programs was one of their big three. That's how important they're saying, Sanofi is saying the combination programs are to the future of Sanofi. No, well said, Jim, obviously we can't speak for them. That's their own public commentary that we're sharing with you. They're outstanding partners, outstanding levels of communication between our executives at Novavax and Sanofi, just look at the COMPARE data we talked about or we will talk about today. Again, they leaned into that. That's part of their methodical approach to investing in the space and really helping to drive share and future share for Nuvaxovid. Yeah. One more question there. Just as we think about that 2026, 2027 season, how do you see Sanofi planning to position Nuvaxovid in the marketplace for that upcoming season and beyond? Yeah. Again, we're not going to speak directly to their marketing campaign. Yeah. They hold the license for that. Yeah their hands on the wheel, so to speak, on that Nabeel. Yeah. You can see them leaning in with this COMPARE data, really noting the tolerability of Nuvaxovid versus the other products, and they're bringing their expertise to bear to the market from a contracting perspective. Yeah a marketing perspective. Expect them to be reaching out through many vehicles to the consumer audience and the physician audience, and are really leaning into that tolerability data in particular. We'll see how they unveil that campaign. We've seen the campaign. Yeah. They've walked us through their plans. We're very excited about it, and I think you will be too when you see it launch. Thank you, John. Looking more internally in the R&D investment strategy, we talked a little bit about this. We just highlighted a little bit of the C. diff., I'm curious how we think about advancing the internal vaccine candidates and generating data, how you consider advancing a candidate yourself or going to, in talking about late stage or to the market. We can start with C. diff. after that. Go ahead, Elaine. Yeah. Just from a strategic perspective, for us, we look at the fact that there's a significant unmet medical need within this infectious disease, of course. Companies have stepped up to the plate to study this and have failed. We learned from that. We iterated on this for many months, both from an assessment perspective as well as a scientific perspective. We're delighted to be advancing our C. diff. candidate, and our goal is to do that within the next several months. Bob will speak a little bit more specifically about it. Again, the crosshairs for us was the decision around significant unmet need, large market, both in the U.S. and globally. We're very excited about that opportunity. It's over $1 billion. Yeah. Potentially between $1.5 billion and $3 billion. Yeah. That was also a key focus and a key inflection point for us as well. Maybe, Bob, you want to speak a little bit more about the opportunity? Yeah. Maybe I'll talk a little bit about why we think our particular candidate is differentiated from what else is out there right now. Like Elaine said, it's a huge medical problem. No currently available, no currently licensed vaccine. What we've seen is others in the past have developed toxin-based vaccines that have failed in the clinic thus far. What we're doing is we've developed a vaccine construct that goes beyond toxin only. We have toxin antigens, but we also have non-toxin antigens. We've also created our antigen structure such that we're targeting more than 90% of the C. diff. strains that are currently circulating globally. We're coupling it with Matrix-M. We get all the benefits that have been associated with Matrix-M, some of which we've talked about already. In addition, the potential to induce mucosal immunity. Mucosal immunity is important. or for treating an organism like C. diff because it's a mucosal infection in the gut. Yeah. Those are the key differentiating factors. We're looking forward, we're in IND-enabling toxicology studies now, and hope to be able to bring this candidate into the clinic as early as 2027. Thank you for that overview, Bob. Yeah, see the unmet need there. Go ahead. Nabeel, in line with our strategy, we're being very selective on what to bring forward and put into the clinic and into human trials. C. diff., there's no vaccine available today currently. We know that Pfizer is working on a phase III C. diff candidate. We wish them success and would like to see them succeed and help to build that market and provide patients with an alternative approach to protecting themselves from this significant disease. In fact, my sister-in-law's best friend died of a C. diff infection after a routine abdominal surgery just last year before Thanksgiving, leaving her family without her to enjoy that holiday. We've seen it impact people very close to our own family. It's thousands of people a year are dying in the U.S. and Europe of this, from routine surgeries and in nursing homes and other things. We wish Pfizer success, and then we're very excited that Novavax could be one of only two- Yeah One of one should we succeed with that in bringing a vaccine forward that we do feel, per Bob's comments, is very differentiated, and we're very excited about what we've seen early on. We think there's significant value inflection. Yeah human data on that to show that it works in people, not just. Yeah animal models, and that translational medicine can work here and show us some good results. We'll keep you posted, and very excited to be in the clinic as early as 2027. No pressure on Bob. Yeah, no, that would be very meaningful for patients. Moving to the non-GAAP expense. You've improved the 2028 non-GAAP expense target to $150 million-$200 million. That's about a 50% reduction compared to 2025. Could you go over some of the primary drivers of that change to your cost structure and how you are basically investing to create value at this scale? Go ahead, Jim. Hey, certainly. For folks who are familiar with our journey, while the 50% reduction to our non-GAAP R&D and SG&A may sound pretty impressive, from 2025 to 2028, when you go back as recently as 2022, we're talking about a reduction of almost 90%. What it genuinely captures is the reconfiguration of this company and the focus of this company around this technology and unlocking significant value through our growth strategy. A growth strategy that's predicated on generating data to drive partnering. It's also generating new data to further enhance our Matrix offerings and differentiated candidates. While at the same time, we're also supporting being a Matrix manufacturer. That's a part of what we do as well. Our investments, as we move forward, our core investments that are ongoing are focused on those exact points, and that's what Bob described earlier. It's we've got an amazing Matrix-M vaccine. We can probably do some more and unlock some value incremental to that. So we're really excited about making those investments. Bob, I loved your points around oncology and the differentiation of what we think Matrix can do there. You heard Elaine and Bob talk about C. diff, a case study in how you can apply our unique technology in a differentiated way, a way that others cannot do. Because through our partnerships, you're hearing our partners are advancing programs in many areas, and we'd love to let them, because it amplifies investments, but not on our spend. We're really looking at differentiated investments, and that's our focus. Between 2026 and 2028, as our cost structure is decreasing, here's what you're seeing. We do have some legacy obligations to either APA partners and Sanofi, for example, on co-sharing some of our post-marketing commitments, as an example, related to Nuvaxovid. As those roll off and our support for commercial manufacturing rolls off in the next 12 to 18 months, you're going to see those associated costs come out of our cost structure. However, underneath that is a core spend profile, currently about $200 million a year, but reaching the $150 million to $200 million by 2028. That should give you a good sense of the evolution and where we're focusing our investment to create value. Really, Jim, another way to look at it through a non-GAAP lens is from a $1.7 billion annual SG&A and R&D spend, we've driven this down to $200 million, and we're now at that last $50 million of toggle. Anything above and beyond that this year and a tail going into next year are those trailing obligations to close out APAs and other partner support that's non-reimbursed. That enables us to keep the core capabilities needed to execute on this strategy. We're keeping R&D core capabilities to generate data, support these partners, and make some of these partnerships possible, frankly. Key to execution is keeping those core capabilities in a lean infrastructure. That's it. Excellent. Thank you. One more question. You've guided to non-GAAP profitability as early as 2028. Could you just give us an overview of what potential milestones, any things that we can expect, and how you plan on reaching that goal? Yeah. Go ahead, Jim. Nabeel, thank you for making that point in this question, because this is a spot of high interest with investors and others, namely that, one, we have enough cash on hand to go and fund our company all the way into 2028 without any incremental funding coming into the company absent the reimbursements. Really important, we've set up a cash runway. Yeah. Coinciding with that 2028, you're hearing our non-GAAP cost structure. Yeah. We're also seeking to reach that by 2028. Three, we also have the ability to reach non-GAAP profitability, namely. Yeah through the diversified revenue stream across partners, through royalties, milestones, up-fronts, we see the potential as early as 2028 to be non-GAAP profitable. What does that look like tangibly? Well, at midpoint, $175 million R&D and SG&A. Picture you've got $25 million, $30 million in stock-based comp, for example, then your breakeven's about $150. That's what it looks like. Yeah. We're not focused on breakeven. We're focused on driving cash flow orders of magnitude higher than our cost structure over time. We believe that this partnering model and our existing partners we have today, and the ability to supplement it, has the ability to create, as I said, orders of magnitude more cash than our cost structure, and that is a critical value creation moment. We, of course, will always evaluate our ability to continue to invest in our technology, and we'll evaluate what to do with that cash over time. Will we just invest in the company, or might we contemplate returning efficiently cash to shareholders? All of that is on the table and being evaluated, all towards value creation. Thank you. Well said, Jim. Thank you. Nabeel, I think we're just about at time. If I could have just a closing comment here to say another benefit of our strategy is the ability to amplify our tech. beyond the potential revenues, orders of magnitude of revenue coming in above and beyond our cost structure is our intention. It's really the impact on global public health and human health. that actually matters a lot to our team. Bob, we've talked about that time and time again in the hallways of Novavax, right? Our scientists, our employees, they actually really believe in what we're doing. They believe in our technology, and they choose to be with us at Novavax. Like Jim said, we basically reduced our costs and our headcount 80% to 90%+, and on our way to even more now. Our retention level of talent is well within or even above industry benchmarks when you look at it. There's a passion here, and we want to leave a legacy. Not only to drive capital and reward our investors who've been patient with us as we migrate the company into a new strategy, completely rebuild it from the ground up, and change our mission and our vision, and we're in the middle of that execution right now. the chance to leave a legacy, to impact billions of lives with potentially dozens of vaccines and immunotherapeutics taking on cancer, bacterial and viral infectious disease, something that we're all really proud of being part of and excited about the future. Thanks for your time today. Thank you. Thank you. Thank you.

Speaker 5: Are we live? Awesome. Hello, everyone. Welcome to the Jefferies Healthcare Conference here in New York. It's a pleasure. Thank you for tuning in everyone in New York and online. I'm here joined by Novavax, Jim, John, Elaine, Doug. Great to see you all. Let's get started with some introductions and let's talk about your new growth strategy early in 2025. What are some proof points that demonstrate how your strategy is working and anything that you think the market and the street is underappreciating about your story? Let's start with that. Are we live? are we live Awesome. awesome Hello, everyone. hello everyone Welcome to the Jefferies Healthcare Conference here in New York. welcome to the jefferies healthcare conference here in new york It's a pleasure. it's a pleasure Thank you for tuning in everyone in New York and online. thank you for tuning in everyone in new york and online I'm here joined by Novavax, Jim, John, Elaine, Doug. i'm here joined by novavax jim john elaine doug Great to see you all. great to see you all Let's get started with some introductions and let's talk about your new growth strategy early in 2025. let's get started with some introductions and let's talk about your new growth strategy early in 2025 What are some proof points that demonstrate how your strategy is working and anything that you think the market and the street is underappreciating about your story? what are some proof points that demonstrate how your strategy is working and anything that you think the market and the street is underappreciating about your story Let's start with that. let's start with that

Speaker 4: Thank you, Nabeel. It's great to be here with everyone, and thank you for joining our presentation today. Right now, we couldn't be more excited about where we are in Novavax's history. As you know, we launched our new strategy in January of 2025. Thank you, Nabeel. thank you nabeel It's great to be here with everyone, and thank you for joining our presentation today. it's great to be here with everyone and thank you for joining our presentation today Right now, we couldn't be more excited about where we are in Novavax's history. right now we couldn't be more excited about where we are in novavax's history As you know, we launched our new strategy in January of 2025. as you know we launched our new strategy in january of 2025

Speaker 5: Yeah. Yeah. yeah

Speaker 4: You asked, Nabeel, about proof points. We're really excited about what's already unfolded in the first trimester of this year, which are the fruits of our labor starting to show, right through 2025. You asked, Nabeel, about proof points. you asked nabeel about proof points We're really excited about what's already unfolded in the first trimester of this year, which are the fruits of our labor starting to show, right through 2025. we're really excited about what's already unfolded in the first trimester of this year which are the fruits of our labor starting to show right through 2025

Speaker 5: Yeah Yeah yeah

Speaker 4: to generate and to engender more interest in our technology. First proof point really is the level of interest that we have seen as a management team from third-party companies working with us on our technology is unprecedented. to generate and to engender more interest in our technology. to generate and to engender more interest in our technology First proof point really is the level of interest that we have seen as a management team from third-party companies working with us on our technology is unprecedented. first proof point really is the level of interest that we have seen as a management team from third-party companies working with us on our technology is unprecedented In Novavax history since we launched our strategy in January. We were proud to announce the new partnership with Pfizer in January, and we'll talk a little bit more about that today, as well as in the first trimester of this year, four new MTAs, or Material Transfer Agreements. This is where we provide, as Novavax, samples of our Matrix-M to potential partners through a collaboration, and that allows them to experiment in their own labs on targets of interest across infectious disease and oncology. That's a step we took with Pfizer as well. In Novavax history since we launched our strategy in January. in novavax history since we launched our strategy in january We were proud to announce the new partnership with Pfizer in January, and we'll talk a little bit more about that today, as well as in the first trimester of this year, four new MTAs, or Material Transfer Agreements. we were proud to announce the new partnership with pfizer in january and we'll talk a little bit more about that today as well as in the first trimester of this year four new mtas or material transfer agreements This is where we provide, as Novavax, samples of our Matrix-M to potential partners through a collaboration, and that allows them to experiment in their own labs on targets of interest across infectious disease and oncology. this is where we provide as novavax samples of our matrix-m to potential partners through a collaboration and that allows them to experiment in their own labs on targets of interest across infectious disease and oncology That's a step we took with Pfizer as well. that's a step we took with pfizer as well In the hopes that that might turn into a license agreement and a full revenue-generating partnership subsequent to the positive experiments that they may have. In the hopes that that might turn into a license agreement and a full revenue-generating partnership subsequent to the positive experiments that they may have. in the hopes that that might turn into a license agreement and a full revenue-generating partnership subsequent to the positive experiments that they may have In fact, of those four new MTAs, one of them was another top 10 global pharmaceutical company, who also happens to be ranked globally as an oncology leader. Very, very exciting to see the interest not only in infectious disease but also in oncology indications. Those are some of the proof points that we've recently shared. I think what might be misunderstood or missed about our strategy currently, Nabeel, it's an interesting question. Number one is the way that we might generate revenue from this. In fact, of those four new MTAs, one of them was another top 10 global pharmaceutical company, who also happens to be ranked globally as an oncology leader. in fact of those four new mtas one of them was another top 10 global pharmaceutical company who also happens to be ranked globally as an oncology leader Very, very exciting to see the interest not only in infectious disease but also in oncology indications. very very exciting to see the interest not only in infectious disease but also in oncology indications Those are some of the proof points that we've recently shared. those are some of the proof points that we've recently shared I think what might be misunderstood or missed about our strategy currently, Nabeel, it's an interesting question. i think what might be misunderstood or missed about our strategy currently nabeel it's an interesting question Number one is the way that we might generate revenue from this. number one is the way that we might generate revenue from this

Speaker 5: Yeah. Yeah. yeah

Speaker 4: In a typical, traditional biotech approach, a company from the lab all the way through their clinical trials to approval and launch could take many years before they generate the first dollar. With our Novavax strategy now, we can monetize our technology right now immediately upon the consummation of a partnership and a license through upfront payments, as exemplified by the Pfizer $30 million upfront payment. Through potential milestones for the clinical development of assets using our Matrix-M. In a typical, traditional biotech approach, a company from the lab all the way through their clinical trials to approval and launch could take many years before they generate the first dollar. in a typical traditional biotech approach a company from the lab all the way through their clinical trials to approval and launch could take many years before they generate the first dollar With our Novavax strategy now, we can monetize our technology right now immediately upon the consummation of a partnership and a license through upfront payments, as exemplified by the Pfizer $30 million upfront payment. with our novavax strategy now we can monetize our technology right now immediately upon the consummation of a partnership and a license through upfront payments as exemplified by the pfizer $30 million upfront payment Through potential milestones for the clinical development of assets using our Matrix-M. through potential milestones for the clinical development of assets using our matrix-m We announced in the Pfizer deal $70 million in eligible potential milestones for Novavax per field as they would advance something through clinical trials. That allows us to pull forward tens of millions of dollars potentially hundreds of millions of dollars in the form of other sales or approval milestones that might be in a particular agreement, and then royalties for decades to come. I think that may be underappreciated. We announced in the Pfizer deal $70 million in eligible potential milestones for Novavax per field as they would advance something through clinical trials. we announced in the pfizer deal $70 million in eligible potential milestones for novavax per field as they would advance something through clinical trials That allows us to pull forward tens of millions of dollars potentially hundreds of millions of dollars in the form of other sales or approval milestones that might be in a particular agreement, and then royalties for decades to come. that allows us to pull forward tens of millions of dollars potentially hundreds of millions of dollars in the form of other sales or approval milestones that might be in a particular agreement and then royalties for decades to come I think that may be underappreciated. i think that may be underappreciated

Speaker 5: Yeah. Yeah. yeah

Speaker 4: The last piece is amplifying the impact and the value of our technology overall. More than Novavax alone could ever hope to do, we announced in our most recent earnings call the scope and scale of these collaborations and partnerships combined, which represent currently over 50% of the projected global market opportunity in vaccines for oncology and infectious disease, as projected by McKinsey and EvaluatePharma, is currently under assessment or has the potential to be under assessment via our partners. That's representing 30 unique disease fields across oncology and infectious disease. As Elaine said in our recent earnings call, many of those more competitive disease areas and markets have more than one partner or collaboration going on, which increases our probability of success for more potential future partnerships and revenue streams along the way. That's how I'd answer that. The last piece is amplifying the impact and the value of our technology overall. the last piece is amplifying the impact and the value of our technology overall More than Novavax alone could ever hope to do, we announced in our most recent earnings call the scope and scale of these collaborations and partnerships combined, which represent currently over 50% of the projected global market opportunity in vaccines for oncology and infectious disease, as projected by McKinsey and Evaluate Pharma, is currently under assessment or has the potential to be under assessment via our partners. more than novavax alone could ever hope to do we announced in our most recent earnings call the scope and scale of these collaborations and partnerships combined which represent currently over 50% of the projected global market opportunity in vaccines for oncology and infectious disease as projected by mckinsey and evaluate pharma is currently under assessment or has the potential to be under assessment via our partners That's representing 30 unique disease fields across oncology and infectious disease. that's representing 30 unique disease fields across oncology and infectious disease As Elaine said in our recent earnings call, many of those more competitive disease areas and markets have more than one partner or collaboration going on, which increases our probability of success for more potential future partnerships and revenue streams along the way. as elaine said in our recent earnings call many of those more competitive disease areas and markets have more than one partner or collaboration going on which increases our probability of success for more potential future partnerships and revenue streams along the way That's how I'd answer that. that's how i'd answer that

Speaker 5: Yeah. Thank you for that big-picture overview. Regarding some of the interest and ongoing activity, I think Matrix-M continues to be a bigger story, and that license agreement that you arrived with Pfizer in January, could you walk us through a little bit about the scope and the terms of that license and what we should anticipate the next steps that Pfizer could do and potential catalysts and milestones that could come out of that? Yeah. yeah Thank you for that big-picture overview. thank you for that big-picture overview Regarding some of the interest and ongoing activity, I think Matrix-M continues to be a bigger story, and that license agreement that you arrived with Pfizer in January, could you walk us through a little bit about the scope and the terms of that license and what we should anticipate the next steps that Pfizer could do and potential catalysts and milestones that could come out of that? regarding some of the interest and ongoing activity i think matrix-m continues to be a bigger story and that license agreement that you arrived with pfizer in january could you walk us through a little bit about the scope and the terms of that license and what we should anticipate the next steps that pfizer could do and potential catalysts and milestones that could come out of that

Speaker 4: Sure. Elaine, do you want to take that? Sure. sure Elaine, do you want to take that? elaine do you want to take that

Speaker 2: Thanks, John. Briefly, the Pfizer Matrix-M licensing agreement enables Pfizer to utilize Matrix-M with a field that was disclosed to us, but we are not publicly disclosing it. The second, they have an opportunity for a second field that they will study Matrix-M with, bring it through clinical study, and that has not been disclosed yet. That $30 million upfront is something that we received earlier this year, we have the opportunity to receive sales and development milestones to the tune of $250 million. Just to characterize, we also have royalty payments coming off of that particular license agreement as well. Let's just say if Pfizer is successful with the clinical development for a product, that might be over $1 billion. Thanks, John. thanks john Briefly, the Pfizer Matrix-M licensing agreement enables Pfizer to utilize Matrix-M with a field that was disclosed to us, but we are not publicly disclosing it. briefly the pfizer matrix-m licensing agreement enables pfizer to utilize matrix-m with a field that was disclosed to us but we are not publicly disclosing it The second, they have an opportunity for a second field that they will study Matrix-M with, bring it through clinical study, and that has not been disclosed yet. the second they have an opportunity for a second field that they will study matrix-m with bring it through clinical study and that has not been disclosed yet That $30 million upfront is something that we received earlier this year, we have the opportunity to receive sales and development milestones to the tune of $250 million. that $30 million upfront is something that we received earlier this year we have the opportunity to receive sales and development milestones to the tune of $250 million Just to characterize, we also have royalty payments coming off of that particular license agreement as well. just to characterize we also have royalty payments coming off of that particular license agreement as well Let's just say if Pfizer is successful with the clinical development for a product, that might be over $1 billion . let's just say if pfizer is successful with the clinical development for a product that might be over $1 billion Cumulatively, we'd be able to receive over $1 billion in royalty payments because of the term of the agreement is for 20 years. Again, as John was mentioning, this gives us a wonderful opportunity then to continue to build revenue from that particular licensing agreement over time. That's been our strategy for Matrix-M holistically. We announced another MTA with another major pharmaceutical company this year as well, as John mentioned. Which gives us the opportunity to repeat that. Cumulatively, we'd be able to receive over $1 billion in royalty payments because of the term of the agreement is for 20 years. cumulatively we'd be able to receive over $1 billion in royalty payments because of the term of the agreement is for 20 years Again, as John was mentioning, this gives us a wonderful opportunity then to continue to build revenue from that particular licensing agreement over time. again as john was mentioning this gives us a wonderful opportunity then to continue to build revenue from that particular licensing agreement over time That's been our strategy for Matrix-M holistically. that's been our strategy for matrix-m holistically We announced another MTA with another major pharmaceutical company this year as well, as John mentioned. we announced another mta with another major pharmaceutical company this year as well as john mentioned Which gives us the opportunity to repeat that. which gives us the opportunity to repeat that

Speaker 5: Right. Right. right

Speaker 2: That particular MTA includes nine fields of study. We're very excited about that as well, because each one of those fields has the potential to be over $1 billion for sure if that particular study is successful. Very excited about that as well. That particular MTA includes nine fields of study. that particular mta includes nine fields of study We're very excited about that as well, because each one of those fields has the potential to be over $1 billion for sure if that particular study is successful. we're very excited about that as well because each one of those fields has the potential to be over $1 billion for sure if that particular study is successful Very excited about that as well. very excited about that as well

Speaker 5: Thank you, Elaine. Regarding the nature of that license agreement, it's sort of a non-exclusive license. Walk us through what led you to follow that approach to partnering with Matrix-M. Thank you, Elaine. thank you elaine Regarding the nature of that license agreement, it's sort of a non-exclusive license. regarding the nature of that license agreement it's sort of a non-exclusive license Walk us through what led you to follow that approach to partnering with Matrix-M. walk us through what led you to follow that approach to partnering with matrix-m

Speaker 4: Go ahead, Elaine. Go ahead, Elaine. go ahead elaine

Speaker 2: Yeah. The non-exclusivity gives us the opportunity then to partner with major vaccine companies where there may be overlap. I think we mentioned during our earnings call we have overlap, for example, in the pneumococcal space. We also have overlap in RSV, potentially. We also have overlap in infectious disease such as CMV, cytomegalovirus. Again, having a non-exclusive opportunity gives us our opportunity to partner with companies. We are successful, right, because we have multiple shots on goal with our Matrix-M technology. However, that may wind up manifesting itself in the marketplace over time. If we have two or three companies, let's say, that are utilizing Matrix-M in a pneumococcal space. We would hope that one of them will be successful. Yeah. yeah The non-exclusivity gives us the opportunity then to partner with major vaccine companies where there may be overlap. the non-exclusivity gives us the opportunity then to partner with major vaccine companies where there may be overlap I think we mentioned during our earnings call we have overlap, for example, in the pneumococcal space. i think we mentioned during our earnings call we have overlap for example in the pneumococcal space We also have overlap in RSV, potentially. we also have overlap in rsv potentially We also have overlap in infectious disease such as CMV, cytomegalovirus. we also have overlap in infectious disease such as cmv cytomegalovirus Again, having a non-exclusive opportunity gives us our opportunity to partner with companies. again having a non-exclusive opportunity gives us our opportunity to partner with companies We are successful, right, because we have multiple shots on goal with our Matrix-M technology. we are successful right because we have multiple shots on goal with our matrix-m technology However, that may wind up manifesting itself in the marketplace over time. however that may wind up manifesting itself in the marketplace over time If we have two or three companies, let's say, that are utilizing Matrix-M in a pneumococcal space. if we have two or three companies let's say that are utilizing matrix-m in a pneumococcal space We would hope that one of them will be successful. we would hope that one of them will be successful

Speaker 5: Mm-hmm. Yeah. Mm-hmm. mm-hmm Yeah. yeah

Speaker 2: Get all the way to commercialization. If we have another and another, of course that's additive as well. Again, we're non-exclusive for a reason. Get all the way to commercialization. get all the way to commercialization If we have another and another, of course that's additive as well. if we have another and another of course that's additive as well Again, we're non-exclusive for a reason. again we're non-exclusive for a reason

Speaker 5: Yeah Yeah yeah

Speaker 2: because it's certainly very beneficial for us. because it's certainly very beneficial for us. because it's certainly very beneficial for us

Speaker 4: Nabeel, just to build on that for one moment. Putting it into a hypothetical example. Nabeel, just to build on that for one moment. nabeel just to build on that for one moment Putting it into a hypothetical example. putting it into a hypothetical example If we had, say, three companies that wound up doing a partnership with us through a license, Elaine, right? They were each pursuing one of those fields, the same field A. If they're pursuing that field, if we set those deals up in a similar way to what we've done with Pfizer. We should be eligible for milestones along the way on their clinical development. If we had, say, three companies that wound up doing a partnership with us through a license, Elaine, right? if we had say three companies that wound up doing a partnership with us through a license elaine right They were each pursuing one of those fields, the same field A. they were each pursuing one of those fields the same field a If they're pursuing that field, if we set those deals up in a similar way to what we've done with Pfizer. if they're pursuing that field if we set those deals up in a similar way to what we've done with pfizer We should be eligible for milestones along the way on their clinical development. we should be eligible for milestones along the way on their clinical development If you could imagine in that hypothetical example, three companies targeting a field with our Matrix-M, and Novavax would have the ability then to earn up-fronts from all three, the ability to earn milestone payments for their clinical efforts on those disease targets years before a vaccine might get approved and launched into the marketplace. Even if, in that hypothetical example, two of those companies didn't succeed in their clinical efforts but made it most of the way through, we would have earned revenues along the way for their efforts. If you could imagine in that hypothetical example, three companies targeting a field with our Matrix-M, and Novavax would have the ability then to earn up-fronts from all three, the ability to earn milestone payments for their clinical efforts on those disease targets years before a vaccine might get approved and launched into the marketplace. if you could imagine in that hypothetical example three companies targeting a field with our matrix-m and novavax would have the ability then to earn up-fronts from all three the ability to earn milestone payments for their clinical efforts on those disease targets years before a vaccine might get approved and launched into the marketplace Even if, in that hypothetical example, two of those companies didn't succeed in their clinical efforts but made it most of the way through, we would have earned revenues along the way for their efforts. even if in that hypothetical example two of those companies didn't succeed in their clinical efforts but made it most of the way through we would have earned revenues along the way for their efforts

Speaker 5: Yeah. Yeah. yeah

Speaker 4: One of those companies makes it through or more, we are then eligible for potentially larger milestones upon approval and sales, and then royalties for potentially decades to come. That's really exciting, and what it does is show you that if you've got 30+ fields under assessment now with multiple partners, four of the top 10 global pharmaceutical companies already engaged with Novavax through collaboration, MTA, and partnership plus other smaller and mid-size companies that we haven't disclosed yet, that are working with us, you can imagine then that our POS, our probability of success is pretty good and relatively high for the potential for more partnerships and multiple revenue streams over time. One of those companies makes it through or more, we are then eligible for potentially larger milestones upon approval and sales, and then royalties for potentially decades to come. one of those companies makes it through or more we are then eligible for potentially larger milestones upon approval and sales and then royalties for potentially decades to come That's really exciting, and what it does is show you that if you've got 30+ fields under assessment now with multiple partners, four of the top 10 global pharmaceutical companies already engaged with Novavax through collaboration, MTA, and partnership p lus other smaller and mid-size companies that we haven't disclosed yet, that are working with us, you can imagine then that our POS, our probability of success is pretty good and relatively high for the potential for more partnerships and multiple revenue streams over time. that's really exciting and what it does is show you that if you've got 30+ fields under assessment now with multiple partners four of the top 10 global pharmaceutical companies already engaged with novavax through collaboration mta and partnership p lus other smaller and mid-size companies that we haven't disclosed yet that are working with us you can imagine then that our pos our probability of success is pretty good and relatively high for the potential for more partnerships and multiple revenue streams over time

Speaker 5: Yeah. Thank you for walking us through that setup. Regarding the recent MTA with a large oncology or a large top 10 global pharma company, we're looking now into indications beyond ID, and could you walk us through how Matrix-M might have a mechanistic favorable, what it can offer in the oncology setting, and yeah, more on that story? Yeah. yeah Thank you for walking us through that setup. thank you for walking us through that setup Regarding the recent MTA with a large oncology or a large top 10 global pharma company, we're looking now into indications beyond ID, and could you walk us through how Matrix-M might have a mechanistic favorable, what it can offer in the oncology setting, and yeah, more on that story? regarding the recent mta with a large oncology or a large top 10 global pharma company we're looking now into indications beyond id and could you walk us through how matrix-m might have a mechanistic favorable what it can offer in the oncology setting and yeah more on that story

Speaker 4: Go ahead, Bob. Go ahead, Bob. go ahead bob

Speaker 1: Sure, thanks. Matrix-M has a broad array of immunologic properties that make it such an exciting adjuvant in general, certainly in the infectious disease space, and a lot of that we think could have applicability to the oncology space as well. It's been well-characterized to be a Th1-profiled adjuvant. Sure, thanks. sure thanks Matrix-M has a broad array of immunologic properties that make it such an exciting adjuvant in general, certainly in the infectious disease space, and a lot of that we think could have applicability to the oncology space as well. matrix-m has a broad array of immunologic properties that make it such an exciting adjuvant in general certainly in the infectious disease space and a lot of that we think could have applicability to the oncology space as well It's been well-characterized to be a Th1-profiled adjuvant. it's been well-characterized to be a th1-profiled adjuvant

Speaker 5: Yeah Yeah yeah

Speaker 1: which means that it induces not only antibodies and neutralizing antibodies, but cell-mediated immunity. It's that cell-mediated immunity which is thought to be so important for oncology, particularly CD8 killer cells that exert the anti-tumor killing activity. which means that it induces not only antibodies and neutralizing antibodies, but cell-mediated immunity. which means that it induces not only antibodies and neutralizing antibodies but cell-mediated immunity It's that cell-mediated immunity which is thought to be so important for oncology, particularly CD8 killer cells that exert the anti-tumor killing activity. it's that cell-mediated immunity which is thought to be so important for oncology particularly cd8 killer cells that exert the anti-tumor killing activity

Speaker 5: Yeah. Yeah. yeah

Speaker 1: Matrix-M has the ability to induce cross-presentation of antigens in the cell, that leads to the downstream activity of the CD8 cells that we were just talking about. Those are some of the reasons why we think Matrix has great potential in the oncology space. As we're learning from partners who are also conducting some of these studies, there's a qualitative aspect to the immune effect that Matrix produces as well. It's not just numbers of cells. Matrix-M has the ability to induce cross-presentation of antigens in the cell, that leads to the downstream activity of the CD8 cells that we were just talking about. matrix-m has the ability to induce cross-presentation of antigens in the cell that leads to the downstream activity of the cd8 cells that we were just talking about Those are some of the reasons why we think Matrix has great potential in the oncology space. those are some of the reasons why we think matrix has great potential in the oncology space As we're learning from partners who are also conducting some of these studies, there's a qualitative aspect to the immune effect that Matrix produces as well. as we're learning from partners who are also conducting some of these studies there's a qualitative aspect to the immune effect that matrix produces as well It's not just numbers of cells. it's not just numbers of cells It's about the quality of the cells that are activated. Anyway, we're very optimistic, and we really look forward to coming back at future sessions. It's about t he quality of the cells that are activated. it's about t he quality of the cells that are activated Anyway, we're very optimistic, and we really look forward to coming back at future sessions. anyway we're very optimistic and we really look forward to coming back at future sessions

Speaker 4: Yeah Yeah yeah

Speaker 1: Talking more specifically about the data we've generated. Talking more specifically about the data we've generated. talking more specifically about the data we've generated

Speaker 4: Nabeel and Bob, thank you for that clear answer. Part of our strategy, one of the benefits of our strategy, is we get to leverage not only the resources and capital partners and companies we're collaborating with, but also their expertise. We're working with some companies that have deep expertise in oncology and infectious disease. Nabeel and Bob, thank you for that clear answer. nabeel and bob thank you for that clear answer Part of our strategy, one of the benefits of our strategy, is we get to leverage not only the resources and capital partners and companies we're collaborating with, but also their expertise. part of our strategy one of the benefits of our strategy is we get to leverage not only the resources and capital partners and companies we're collaborating with but also their expertise We're working with some companies that have deep expertise in oncology and infectious disease. we're working with some companies that have deep expertise in oncology and infectious disease Novavax brings a wealth of experience on the infectious disease side, with two vaccines that are actually approved and on market with our technology now, others that are in phase III, others that are in early stage development right now. On the oncology side, Novavax is not an oncology company, nor do we intend to become an oncology company. We're leveraging the depth of experience, the resources, and the expertise of global leaders in that space with our technology, and we're getting the data that they're generating through these MTA collaborations. Novavax brings a wealth of experience on the infectious disease side, with two vaccines that are actually approved and on market with our technology now, others that are in phase III, others that are in early stage development right now. novavax brings a wealth of experience on the infectious disease side with two vaccines that are actually approved and on market with our technology now others that are in phase iii others that are in early stage development right now On the oncology side, Novavax is not an oncology company, nor do we intend to become an oncology company. on the oncology side novavax is not an oncology company nor do we intend to become an oncology company We're leveraging the depth of experience, the resources, and the expertise of global leaders in that space with our technology, and we're getting the data that they're generating through these MTA collaborations. we're leveraging the depth of experience the resources and the expertise of global leaders in that space with our technology and we're getting the data that they're generating through these mta collaborations which further informs our own internal knowledge on this. We certainly have deep expertise in Bob and his team on immunity and immunological responses that are required to take on these diseases, and we're learning more and more each day. Really exciting part of our strategy is to get to leverage that deep expertise. which further informs our own internal knowledge on this. which further informs our own internal knowledge on this We certainly have deep expertise in Bob and his team on immunity and immunological responses that are required to take on these diseases, and we're learning more and more each day. we certainly have deep expertise in bob and his team on immunity and immunological responses that are required to take on these diseases and we're learning more and more each day Really exciting part of our strategy is to get to leverage that deep expertise. really exciting part of our strategy is to get to leverage that deep expertise

Speaker 5: Yeah Yeah yeah

Speaker 4: The capital of these other companies to accelerate these types of potential advances. The capital of these other companies to accelerate these types of potential advances. the capital of these other companies to accelerate these types of potential advances

Speaker 5: Thank you. On those advances, a pleasure to have you with us, Bob. If we could talk a little bit more about the R&D investments with the Matrix adjuvant technology. How do you see these advancements impacting new vaccine development and even further potential partnering? Yeah. Thank you. thank you On those advances, a pleasure to have you with us, Bob. on those advances a pleasure to have you with us bob If we could talk a little bit more about the R&D investments with the Matrix adjuvant technology. if we could talk a little bit more about the r&d investments with the matrix adjuvant technology How do you see these advancements impacting new vaccine development and even further potential partnering? how do you see these advancements impacting new vaccine development and even further potential partnering Yeah. yeah

Speaker 4: Maybe Elaine, you want to take that along with Bob? Maybe Elaine, you want to take that along with Bob? maybe elaine you want to take that along with bob

Speaker 2: Yeah. What's really exciting for us is, as John mentioned, we're leveraging external expertise in oncology generating a host of data, like essentially a data bank. We're looking forward to seeing that read out in the next 6 to 12 months. Internally, we're also exploring similar but different types of opportunities with Matrix-M. For example, Matrix with a TLR, how is that going to turn on the immune system to identify tumors? We're looking at different opportunities as it relates to Matrix in terms of its formulation as well. Yeah. yeah What's really exciting for us is, as John mentioned, we're leveraging external expertise in oncology generating a host of data, like essentially a data bank. what's really exciting for us is as john mentioned we're leveraging external expertise in oncology generating a host of data like essentially a data bank We're looking forward to seeing that read out in the next 6 to 12 months. we're looking forward to seeing that read out in the next 6 to 12 months Internally, we're also exploring similar but different types of opportunities with Matrix-M. internally we're also exploring similar but different types of opportunities with matrix-m For example, Matrix with a TLR, how is that going to turn on the immune system to identify tumors? for example matrix with a tlr how is that going to turn on the immune system to identify tumors We're looking at different opportunities as it relates to Matrix in terms of its formulation as well. we're looking at different opportunities as it relates to matrix in terms of its formulation as well What we learn internally, and we'll map that up against what we learn externally, again, to generate data, which will be powerful then in having future discussions with partners who are also very big players in the oncology space. What we learn internally, and we'll map that up against what we learn externally, again, to generate data, which will be powerful then in having future discussions with partners who are also very big players in the oncology space. what we learn internally and we'll map that up against what we learn externally again to generate data which will be powerful then in having future discussions with partners who are also very big players in the oncology space

Speaker 1: Yeah, maybe I'll just add that we're also on the antigen side. We're also using our internal R&D engine to explore additional antigens. Yeah, maybe I'll just add that we're also on the antigen side. yeah maybe i'll just add that we're also on the antigen side We're also using our internal R&D engine to explore additional antigens. we're also using our internal r&d engine to explore additional antigens

Speaker 5: Yeah Yeah yeah

Speaker 1: that can be utilized with Matrix. that can be utilized with Matrix. that can be utilized with matrix

Speaker 5: Yeah. Yeah. yeah

Speaker 1: Some of those will be antigens that we'll use as test cases to help us learn and advance and move the science forward. Others, for example, in the case of our C. diff vaccine, will be ones that we may choose to advance internally and take into the clinic. It's kind of like a two-pronged part of our R&D strategy there. Some of those will be antigens that we'll use as test cases to help us learn and advance and move the science forward. some of those will be antigens that we'll use as test cases to help us learn and advance and move the science forward Others, for example, in the case of our C. diff vaccine, will be ones that we may choose to advance internally and take into the clinic. others for example in the case of our c diff vaccine will be ones that we may choose to advance internally and take into the clinic It's kind of like a two-pronged part of our R&D strategy there. it's kind of like a two-pronged part of our r&d strategy there

Speaker 4: One comment just to add, Elaine had mentioned 6 to 12 months for some anticipated data, but we already have data generated by some smaller innovative partners in oncology that we had partnered with quite a while ago through MTAs as part of our new strategy launch. We have some insights already as to some of the antigen targets and things in oncology. We just announced, to your point, Elaine, this new MTA collaboration with a top 10 global pharma company. We're excited about the experiments they're starting to undergo and anticipate in the coming quarters in learning from that together as well. One comment just to add, Elaine had mentioned 6 to 12 months for some anticipated data, but we already have data generated by some smaller innovative partners in oncology that we had partnered with quite a while ago through MTAs as part of our new strategy launch. one comment just to add elaine had mentioned 6 to 12 months for some anticipated data but we already have data generated by some smaller innovative partners in oncology that we had partnered with quite a while ago through mtas as part of our new strategy launch We have some insights already as to some of the antigen targets and things in oncology. we have some insights already as to some of the antigen targets and things in oncology We just announced, to your point, Elaine, this new MTA collaboration with a top 10 global pharma company. we just announced to your point elaine this new mta collaboration with a top 10 global pharma company We're excited about the experiments they're starting to undergo and anticipate in the coming quarters in learning from that together as well. we're excited about the experiments they're starting to undergo and anticipate in the coming quarters in learning from that together as well

Speaker 5: Thank you. Thank you, team. Then, taking a step to the Sanofi partnership, so you signed that licensing agreement with Sanofi back in 2024. Could you remind us of the full scope of that agreement and sort of the key next steps and catalysts? Thank you. thank you Thank you, team. thank you team Then, taking a step to the Sanofi partnership, so you signed that licensing agreement with Sanofi back in 2024. then taking a step to the sanofi partnership so you signed that licensing agreement with sanofi back in 2024 Could you remind us of the full scope of that agreement and sort of the key next steps and catalysts? could you remind us of the full scope of that agreement and sort of the key next steps and catalysts

Speaker 4: Go ahead, Elaine. Go ahead, Elaine. go ahead elaine

Speaker 2: That licensing agreement was for the right to execute the commercialization of Nuvaxovid currently in the market. That's the main focus that Sanofi has at the moment, and the other part of that collaborative license agreement was then also to prosecute a combination influenza and our Nuvaxovid program. Sanofi is studying that both with Fluzone High-Dose as well as their Flublok, and should be moving forward with that in the future. The third part was for the prosecution of Matrix-M in their earlier preclinical work, which they would potentially then move into clinic. Very excited about that deal. That licensing agreement was for the right to execute the commercialization of Nuvaxovid currently in the market. that licensing agreement was for the right to execute the commercialization of nuvaxovid currently in the market That's the main focus that Sanofi has at the moment, and the other part of that collaborative license agreement was then also to prosecute a combination influenza and our Nuvaxovid program. that's the main focus that sanofi has at the moment and the other part of that collaborative license agreement was then also to prosecute a combination influenza and our nuvaxovid program Sanofi is studying that both with Fluzone High-Dose as well as their Flublok, and should be moving forward with that in the future. sanofi is studying that both with fluzone high-dose as well as their flublok and should be moving forward with that in the future The third part was for the prosecution of Matrix-M in their earlier preclinical work, which they would potentially then move into clinic. the third part was for the prosecution of matrix-m in their earlier preclinical work which they would potentially then move into clinic Very excited about that deal. very excited about that deal We're mostly through most of the receipt of the milestones at this point in time. We've executed that very well in partnership with Sanofi to date. Excited about that. They're obviously getting ready for the season this year, the upcoming season. Maybe Jim, do you want to speak a little bit about that as well? We're mostly through most of the receipt of the milestones at this point in time. we're mostly through most of the receipt of the milestones at this point in time We've executed that very well in partnership with Sanofi to date. we've executed that very well in partnership with sanofi to date Excited about that. excited about that They're obviously getting ready for the season this year, the upcoming season. they're obviously getting ready for the season this year the upcoming season Maybe Jim, do you want to speak a little bit about that as well? maybe jim do you want to speak a little bit about that as well

Speaker 3: Absolutely. As we look forward to the catalyst that lie ahead of us, it includes certainly the fall performance with Nuvaxovid. It includes Sanofi's articulation of the path forward, both U.S., Europe, and other markets for their CIC programs, and then also further development. When we think about the milestones, for example, that lie ahead of us, outstanding. We have $425 million in milestones, $75 million due upon tech transfer. This is manufacturing tech transfer. There's $350 million in milestones eligible under the CIC programs, including $125 million linked to the initiation of a phase III, and then $225 million we're eligible for upon a U.S. combination product launch. A lot to happen there, both in terms of milestones and then really material opportunity in the marketplace, but also for royalties to us. A reminder on that marketplace. COVID market, it's running about $5 billion-$6 billion, and the flu market, about, again, $5 billion-$6 billion. Absolutely. absolutely As we look forward to the catalyst that lie ahead of us, it includes certainly the fall performance with Nuvaxovid. as we look forward to the catalyst that lie ahead of us it includes certainly the fall performance with nuvaxovid It includes Sanofi's articulation of the path forward, both U.S., Europe, and other markets for their CIC programs, and then also further development. it includes sanofi's articulation of the path forward both u.s europe and other markets for their cic programs and then also further development When we think about the milestones, for example, that lie ahead of us, outstanding. when we think about the milestones for example that lie ahead of us outstanding We have $425 million in milestones, $75 million due upon tech transfer. we have $425 million in milestones $75 million due upon tech transfer This is manufacturing tech transfer. this is manufacturing tech transfer There's $350 million in milestones eligible under the CIC programs, including $125 million linked to the initiation of a phase III, and then $225 million we're eligible for upon a U.S. combination product launch. there's $350 million in milestones eligible under the cic programs including $125 million linked to the initiation of a phase iii and then $225 million we're eligible for upon a u.s combination product launch A lot to happen there, both in terms of milestones and then really material opportunity in the marketplace, but also for royalties to us. a lot to happen there both in terms of milestones and then really material opportunity in the marketplace but also for royalties to us A reminder on that marketplace. a reminder on that marketplace COVID market, it's running about $5 billion-$6 billion, and the flu market, about, again, $5 billion-$6 billion. covid market it's running about $5 billion-$6 billion and the flu market about again $5 billion-$6 billion $12 billion total across the two. When you look at Sanofi and the flu in particular, they have almost half of that market in aggregate. Their net sales of the six, think about $2.5 billion-$3 billion. That sales amount for Sanofi, highly concentrated in the enhanced flu market. Think 50 and older. $12 billion total across the two. $12 billion total across the two When you look at Sanofi and the flu in particular, they have almost half of that market in aggregate. when you look at sanofi and the flu in particular they have almost half of that market in aggregate Their net sales of the six, think about $2.5 billion-$3 billion. their net sales of the six think about $2.5 billion-$3 billion That sales amount for Sanofi, highly concentrated in the enhanced flu market. that sales amount for sanofi highly concentrated in the enhanced flu market Think 50 and older. think 50 and older the higher price premium marketplace. There, Sanofi has almost 2/3 market share. As these markets evolve, COVID plus flu, Sanofi and others see a combination market. COVID plus flu is where this market is going for many reasons. We have the ability to be a part of the evolution of Sanofi's market-leading flu when combined with our Nuvaxovid to really take an ever-bigger share of that combined $12 billion opportunity. the higher price premium marketplace. the higher price premium marketplace There, Sanofi has almost 2/3 market share. there sanofi has almost 2/3 market share As these markets evolve, COVID plus flu, Sanofi and others see a combination market. as these markets evolve covid plus flu sanofi and others see a combination market COVID plus flu is where this market is going for many reasons. covid plus flu is where this market is going for many reasons We have the ability to be a part of the evolution of Sanofi's market-leading flu when combined with our Nuvaxovid to really take an ever-bigger share of that combined $12 billion opportunity. we have the ability to be a part of the evolution of sanofi's market-leading flu when combined with our nuvaxovid to really take an ever-bigger share of that combined $12 billion opportunity

Speaker 5: Yeah. Yeah. yeah

Speaker 3: super excited about that. This fall, which was your question. super excited about that. super excited about that This fall, which was your question. this fall which was your question

Speaker 5: Yes Yes yes

Speaker 3: is the first step towards that. What should you expect? The same way that Sanofi methodically built that market-leading flu market over time, watch for an analogous approach. Now, we're not guiding for them, but we would say, their history would say they invest and they have a methodical approach over time. An example of recent investments in the COMPARE study. is the first step towards that. is the first step towards that What should you expect? what should you expect The same way that Sanofi methodically built that market-leading flu market over time, watch for an analogous approach. the same way that sanofi methodically built that market-leading flu market over time watch for an analogous approach Now, we're not guiding for them, but we would say, their history would say they invest and they have a methodical approach over time. now we're not guiding for them but we would say their history would say they invest and they have a methodical approach over time An example of recent investments in the COMPARE study. an example of recent investments in the compare study

Speaker 5: Yeah. Yeah. yeah

Speaker 3: Really critical study that just read out that showed the favorable safety profile of Nuvaxovid versus the next gen from Moderna. We are really happy with the investment profile and where they're going with these assets. Really critical study that just read out that showed t he favorable safety profile of Nuvaxovid versus the next gen from Moderna. really critical study that just read out that showed t he favorable safety profile of nuvaxovid versus the next gen from moderna We are really happy with the investment profile and where they're going with these assets. we are really happy with the investment profile and where they're going with these assets

Speaker 5: Thank you for that overview, Jim. We're really excited about seeing the CIC program. If you could just update us on the current status of that program and when might one or both of those Sanofi CIC programs advance to phase III. Thank you for that overview, Jim. thank you for that overview jim We're really excited about seeing the CIC program. we're really excited about seeing the cic program If you could just update us on the current status of that program and when might one or both of those Sanofi CIC programs advance to phase III. if you could just update us on the current status of that program and when might one or both of those sanofi cic programs advance to phase iii

Speaker 3: Yeah. Yeah. yeah

Speaker 4: Jim, do you want to start and then have Elaine perhaps build on that? Jim, do you want to start and then have Elaine perhaps build on that? jim do you want to start and then have elaine perhaps build on that

Speaker 3: Well, sure. One of the reasons why we're always a little careful here is, hey, we can't speak for Sanofi. Well, sure. well sure One of the reasons why we're always a little careful here is, hey, we can't speak for Sanofi. one of the reasons why we're always a little careful here is hey we can't speak for sanofi

Speaker 5: Yeah. Yeah. yeah

Speaker 3: what I can do, and this is something that. what I can do, and this is something that. what i can do and this is something that

Speaker 5: Yeah Yeah yeah

Speaker 3: are more than willing to, is emphasize one of the public statements Sanofi has made. Well, it began back in December, Sanofi's R&D Day, where they walked through the phase I, II data of Nuvaxovid combined with both of their enhanced flu products. This is a co-formulated phase I, II that was the gateway to a pivotal program. What did they see? Excellent results. are more than willing to, is emphasize one of the public statements Sanofi has made. are more than willing to is emphasize one of the public statements sanofi has made Well, it began back in December, Sanofi's R&D Day, where they walked through the phase I, II data of Nuvaxovid combined with both of their enhanced flu products. well it began back in december sanofi's r&d day where they walked through the phase i ii data of nuvaxovid combined with both of their enhanced flu products This is a co-formulated phase I, II that was the gateway to a pivotal program. this is a co-formulated phase i ii that was the gateway to a pivotal program What did they see? what did they see Excellent results. excellent results In fact, they stated- In fact, they stated- in fact they stated-

Speaker 5: Yeah Yeah yeah

Speaker 3: high probability to show non-inferiority in an immunobridging study. When you think about that, well, that's the type of study you'd run in Europe, for example, right? Think [Fc]. high probability to show non-inferiority in an immunobridging study. high probability to show non-inferiority in an immunobridging study When you think about that, well, that's the type of study you'd run in Europe, for example, right? when you think about that well that's the type of study you'd run in europe for example right Think [Fc]. think [fc]

Speaker 5: Yeah Yeah yeah

Speaker 3: U.S., that would be the study in Europe, Immuno. The next step was to talk to the agencies. Sanofi went on to say, in the first quarter and leading up to now, they're in active dialogue with the regulatory agencies. U.S., Europe, and outside. Based upon those engagements, they anticipate launching into a pivotal program for one or both. We're awaiting that those next steps. U.S., that would be the study in Europe, Immuno. u.s that would be the study in europe immuno The next step was to talk to the agencies. the next step was to talk to the agencies Sanofi went on to say, in the first quarter and leading up to now, they're in active dialogue with the regulatory agencies. sanofi went on to say in the first quarter and leading up to now they're in active dialogue with the regulatory agencies U.S., Europe, and outside. u.s europe and outside Based upon those engagements, they anticipate launching into a pivotal program for one or both. based upon those engagements they anticipate launching into a pivotal program for one or both We're awaiting that those next steps. we're awaiting that those next steps

Speaker 5: Yeah. Yeah. yeah

Speaker 3: Couldn't be happier. The most recent data point, World Vaccine Congress. Couldn't be happier. couldn't be happier The most recent data point, World Vaccine Congress. the most recent data point world vaccine congress

Speaker 5: Yeah. Yeah. yeah

Speaker 3: They again presented that data. They again presented that data. they again presented that data

Speaker 5: Yeah. Yeah. yeah

Speaker 3: They again presented their conviction. They again presented their conviction. they again presented their conviction

Speaker 5: Yeah Yeah yeah

Speaker 3: market's going to combination. Importantly, on top of that, when they look, Sanofi, at their growth drivers and they talk about the big three future growth drivers, not just for vaccines, but for their company, the CIC programs was one of their big three. That's how important they're saying, Sanofi is saying the combination programs are to the future of Sanofi. market's going to combination. market's going to combination Importantly, on top of that, when they look, Sanofi, at their growth drivers and they talk about the big three future growth drivers, not just for vaccines, but for their company, the CIC programs was one of their big three. importantly on top of that when they look sanofi at their growth drivers and they talk about the big three future growth drivers not just for vaccines but for their company the cic programs was one of their big three That's how important they're saying, Sanofi is saying the combination programs are to the future of Sanofi. that's how important they're saying sanofi is saying the combination programs are to the future of sanofi

Speaker 4: No, well said, Jim, obviously we can't speak for them. That's their own public commentary that we're sharing with you. They're outstanding partners, outstanding levels of communication between our executives at Novavax and Sanofi, just look at the COMPARE data we talked about or we will talk about today. Again, they leaned into that. No, well said, Jim, obviously we can't speak for them. no well said jim obviously we can't speak for them That's their own public commentary that we're sharing with you. that's their own public commentary that we're sharing with you They're outstanding partners, outstanding levels of communication between our executives at Novavax and Sanofi, just look at the COMPARE data we talked about or we will talk about today. they're outstanding partners outstanding levels of communication between our executives at novavax and sanofi just look at the compare data we talked about or we will talk about today Again, they leaned into that. again they leaned into that That's part of their methodical approach to investing in the space and really helping to drive share and future share for Nuvaxovid. That's part of their methodical approach to investing in the space and really helping to drive share and future share for Nuvaxovid. that's part of their methodical approach to investing in the space and really helping to drive share and future share for nuvaxovid

Speaker 5: Yeah. One more question there. Just as we think about that 2026, 2027 season, how do you see Sanofi planning to position Nuvaxovid in the marketplace for that upcoming season and beyond? Yeah. yeah One more question there. one more question there Just as we think about that 2026, 2027 season, how do you see Sanofi planning to position Nuvaxovid in the marketplace for that upcoming season and beyond? just as we think about that 2026 2027 season how do you see sanofi planning to position nuvaxovid in the marketplace for that upcoming season and beyond

Speaker 4: Yeah. Again, we're not going to speak directly to their marketing campaign. Yeah. yeah Again, we're not going to speak directly to their marketing campaign. again we're not going to speak directly to their marketing campaign

Speaker 5: Yeah. Yeah. yeah

Speaker 4: They hold the license for that. They hold the license for that. they hold the license for that

Speaker 5: Yeah Yeah yeah

Speaker 4: their hands on the wheel, so to speak, on that Nabeel. their hands on the wheel, so to speak, on that Nabeel. their hands on the wheel so to speak on that nabeel

Speaker 5: Yeah. Yeah. yeah

Speaker 4: You can see them leaning in with this COMPARE data, really noting the tolerability of Nuvaxovid versus the other products, and they're bringing their expertise to bear to the market from a contracting perspective. You can see them leaning in with this COMPARE data, really noting the tolerability of Nuvaxovid versus the other products, and they're bringing their expertise to bear to the market from a contracting perspective. you can see them leaning in with this compare data really noting the tolerability of nuvaxovid versus the other products and they're bringing their expertise to bear to the market from a contracting perspective

Speaker 5: Yeah Yeah yeah

Speaker 4: a marketing perspective. Expect them to be reaching out through many vehicles to the consumer audience and the physician audience, and are really leaning into that tolerability data in particular. We'll see how they unveil that campaign. We've seen the campaign. a marketing perspective. a marketing perspective Expect them to be reaching out through many vehicles to the consumer audience and the physician audience, and are really leaning into that tolerability data in particular. expect them to be reaching out through many vehicles to the consumer audience and the physician audience and are really leaning into that tolerability data in particular We'll see how they unveil that campaign. we'll see how they unveil that campaign We've seen the campaign. we've seen the campaign

Speaker 5: Yeah. Yeah. yeah

Speaker 4: They've walked us through their plans. We're very excited about it, and I think you will be too when you see it launch. They've walked us through their plans. they've walked us through their plans We're very excited about it, and I think you will be too when you see it launch. we're very excited about it and i think you will be too when you see it launch

Speaker 5: Thank you, John. Looking more internally in the R&D investment strategy, we talked a little bit about this. We just highlighted a little bit of the C. diff., I'm curious how we think about advancing the internal vaccine candidates and generating data, how you consider advancing a candidate yourself or going to, in talking about late stage or to the market. We can start with C. diff. after that. Thank you, John. thank you john Looking more internally in the R&D investment strategy, we talked a little bit about this. looking more internally in the r&d investment strategy we talked a little bit about this We just highlighted a little bit of the C. diff., I'm curious how we think about advancing the internal vaccine candidates and generating data, how you consider advancing a candidate yourself or going to, in talking about late stage or to the market. we just highlighted a little bit of the c diff i'm curious how we think about advancing the internal vaccine candidates and generating data how you consider advancing a candidate yourself or going to in talking about late stage or to the market We can start with C. diff. after that. we can start with c diff after that

Speaker 4: Go ahead, Elaine. Go ahead, Elaine. go ahead elaine

Speaker 2: Yeah. Just from a strategic perspective, for us, we look at the fact that there's a significant unmet medical need within this infectious disease, of course. Companies have stepped up to the plate to study this and have failed. We learned from that. We iterated on this for many months, both from an assessment perspective as well as a scientific perspective. We're delighted to be advancing our C. diff. candidate, and our goal is to do that within the next several months. Bob will speak a little bit more specifically about it. Again, the crosshairs for us was the decision around significant unmet need, large market, both in the U.S. and globally. We're very excited about that opportunity. It's over $1 billion. Yeah. yeah Just from a strategic perspective, for us, we look at the fact that there's a significant unmet medical need within this infectious disease, of course. just from a strategic perspective for us we look at the fact that there's a significant unmet medical need within this infectious disease of course Companies have stepped up to the plate to study this and have failed. companies have stepped up to the plate to study this and have failed We learned from that. we learned from that We iterated on this for many months, both from an assessment perspective as well as a scientific perspective. we iterated on this for many months both from an assessment perspective as well as a scientific perspective We're delighted to be advancing our C. diff. candidate, and our goal is to do that within the next several months. we're delighted to be advancing our c diff candidate and our goal is to do that within the next several months Bob will speak a little bit more specifically about it. bob will speak a little bit more specifically about it Again, the crosshairs for us was the decision around significant unmet need, large market, both in the U.S. and globally. again the crosshairs for us was the decision around significant unmet need large market both in the u.s and globally We're very excited about that opportunity. we're very excited about that opportunity It's over $1 billion. it's over $1 billion

Speaker 5: Yeah. Yeah. yeah

Speaker 2: Potentially between $1.5 billion and $3 billion. Potentially between $1.5 billion and $3 billion. potentially between $1.5 billion and $3 billion

Speaker 5: Yeah. Yeah. yeah

Speaker 2: That was also a key focus and a key inflection point for us as well. Maybe, Bob, you want to speak a little bit more about the opportunity? That was also a key focus and a key inflection point for us as well. that was also a key focus and a key inflection point for us as well Maybe, Bob, you want to speak a little bit more about the opportunity? maybe bob you want to speak a little bit more about the opportunity

Speaker 1: Yeah. Maybe I'll talk a little bit about why we think our particular candidate is differentiated from what else is out there right now. Like Elaine said, it's a huge medical problem. No currently available, no currently licensed vaccine. Yeah. yeah Maybe I'll talk a little bit about why we think our particular candidate is differentiated from what else is out there right now. maybe i'll talk a little bit about why we think our particular candidate is differentiated from what else is out there right now Like Elaine said, it's a huge medical problem. like elaine said it's a huge medical problem No currently available, no currently licensed vaccine. no currently available no currently licensed vaccine What we've seen is others in the past have developed toxin-based vaccines that have failed in the clinic thus far. What we're doing is we've developed a vaccine construct that goes beyond toxin only. We have toxin antigens, but we also have non-toxin antigens. We've also created our antigen structure such that we're targeting more than 90% of the C. diff. strains that are currently circulating globally. What we've seen is others in the past have developed toxin-based vaccines that have failed in the clinic thus far. what we've seen is others in the past have developed toxin-based vaccines that have failed in the clinic thus far What we're doing is we've developed a vaccine construct that goes beyond toxin only. what we're doing is we've developed a vaccine construct that goes beyond toxin only We have toxin antigens, but we also have non-toxin antigens. we have toxin antigens but we also have non-toxin antigens We've also created our antigen structure such that we're targeting more than 90% of the C. diff. strains that are currently circulating globally. we've also created our antigen structure such that we're targeting more than 90% of the c diff strains that are currently circulating globally We're coupling it with Matrix-M. We get all the benefits that have been associated with Matrix-M, some of which we've talked about already. In addition, the potential to induce mucosal immunity. Mucosal immunity is important. We're coupling it with Matrix-M. we're coupling it with matrix-m We get all the benefits that have been associated with Matrix-M, some of which we've talked about already. we get all the benefits that have been associated with matrix-m some of which we've talked about already In addition, the potential to induce mucosal immunity. in addition the potential to induce mucosal immunity Mucosal immunity is important. mucosal immunity is important or for treating an organism like C. diff because it's a mucosal infection in the gut. or for treating an organism like C. diff because it's a mucosal infection in the gut. or for treating an organism like c diff because it's a mucosal infection in the gut

Speaker 5: Yeah. Yeah. yeah

Speaker 1: Those are the key differentiating factors. We're looking forward, we're in IND-enabling toxicology studies now, and hope to be able to bring this candidate into the clinic as early as 2027. Those are the key differentiating factors. those are the key differentiating factors We're looking forward, we're in IND-enabling toxicology studies now, and hope to be able to bring this candidate into the clinic as early as 2027. we're looking forward we're in ind-enabling toxicology studies now and hope to be able to bring this candidate into the clinic as early as 2027

Speaker 5: Thank you for that overview, Bob. Yeah, see the unmet need there. Go ahead. Thank you for that overview, Bob. thank you for that overview bob Yeah, see the unmet need there. yeah see the unmet need there Go ahead. go ahead

Speaker 4: Nabeel, in line with our strategy, we're being very selective on what to bring forward and put into the clinic and into human trials. C. diff., there's no vaccine available today currently. Nabeel, in line with our strategy, we're being very selective on what to bring forward and put into the clinic and into human trials. nabeel in line with our strategy we're being very selective on what to bring forward and put into the clinic and into human trials C. diff., there's no vaccine available today currently. c diff there's no vaccine available today currently We know that Pfizer is working on a phase III C. diff candidate. We wish them success and would like to see them succeed and help to build that market and provide patients with an alternative approach to protecting themselves from this significant disease. In fact, my sister-in-law's best friend died of a C. diff infection after a routine abdominal surgery just last year before Thanksgiving, leaving her family without her to enjoy that holiday. We've seen it impact people very close to our own family. It's thousands of people a year are dying in the U.S. and Europe of this, from routine surgeries and in nursing homes and other things. We wish Pfizer success, and then we're very excited that Novavax could be one of only two- We know that Pfizer is working on a phase III C. diff candidate. we know that pfizer is working on a phase iii c diff candidate We wish them success and would like to see them succeed and help to build that market and provide patients with an alternative approach to protecting themselves from this significant disease. we wish them success and would like to see them succeed and help to build that market and provide patients with an alternative approach to protecting themselves from this significant disease In fact, my sister-in-law's best friend died of a C. diff infection after a routine abdominal surgery just last year before Thanksgiving, leaving her family without her to enjoy that holiday. in fact my sister-in-law's best friend died of a c diff infection after a routine abdominal surgery just last year before thanksgiving leaving her family without her to enjoy that holiday We've seen it impact people very close to our own family. we've seen it impact people very close to our own family It's thousands of people a year are dying in the U.S. and Europe of this, from routine surgeries and in nursing homes and other things. it's thousands of people a year are dying in the u.s and europe of this from routine surgeries and in nursing homes and other things We wish Pfizer success, and then we're very excited that Novavax could be one of only two- we wish pfizer success and then we're very excited that novavax could be one of only two-

Speaker 5: Yeah Yeah yeah

Speaker 4: One of one should we succeed with that in bringing a vaccine forward that we do feel, per Bob's comments, is very differentiated, and we're very excited about what we've seen early on. We think there's significant value inflection. One of one should we succeed with that in bringing a vaccine forward that we do feel, per Bob's comments, is very differentiated, and we're very excited about what we've seen early on. one of one should we succeed with that in bringing a vaccine forward that we do feel per bob's comments is very differentiated and we're very excited about what we've seen early on We think there's significant value inflection. we think there's significant value inflection

Speaker 5: Yeah Yeah yeah

Speaker 4: human data on that to show that it works in people, not just. human data on that to show that it works in people, not just. human data on that to show that it works in people not just

Speaker 5: Yeah Yeah yeah

Speaker 4: animal models, and that translational medicine can work here and show us some good results. We'll keep you posted, and very excited to be in the clinic as early as 2027. No pressure on Bob. animal models, and that translational medicine can work here and show us some good results. animal models and that translational medicine can work here and show us some good results We'll keep you posted, and very excited to be in the clinic as early as 2027. we'll keep you posted and very excited to be in the clinic as early as 2027 No pressure on Bob. no pressure on bob

Speaker 5: Yeah, no, that would be very meaningful for patients. Moving to the non-GAAP expense. You've improved the 2028 non-GAAP expense target to $150 million-$200 million. That's about a 50% reduction compared to 2025. Could you go over some of the primary drivers of that change to your cost structure and how you are basically investing to create value at this scale? Yeah, no, that would be very meaningful for patients. yeah no that would be very meaningful for patients Moving to the non-GAAP expense. moving to the non-gaap expense You've improved the 2028 non-GAAP expense target to $150 million-$200 million. you've improved the 2028 non-gaap expense target to $150 million-$200 million That's about a 50% reduction compared to 2025. that's about a 50% reduction compared to 2025 Could you go over some of the primary drivers of that change to your cost structure and how you are basically investing to create value at this scale? could you go over some of the primary drivers of that change to your cost structure and how you are basically investing to create value at this scale

Speaker 4: Go ahead, Jim. Go ahead, Jim. go ahead jim

Speaker 3: Hey, certainly. For folks who are familiar with our journey, while the 50% reduction to our non-GAAP R&D and SG&A may sound pretty impressive, from 2025 to 2028, when you go back as recently as 2022, we're talking about a reduction of almost 90%. Hey, certainly. hey certainly For folks who are familiar with our journey, while the 50% reduction to our non-GAAP R&D and SG&A may sound pretty impressive, from 2025 to 2028, when you go back as recently as 2022, we're talking about a reduction of almost 90%. for folks who are familiar with our journey while the 50% reduction to our non-gaap r&d and sg&a may sound pretty impressive from 2025 to 2028 when you go back as recently as 2022 we're talking about a reduction of almost 90% What it genuinely captures is the reconfiguration of this company and the focus of this company around this technology and unlocking significant value through our growth strategy. A growth strategy that's predicated on generating data to drive partnering. It's also generating new data to further enhance our Matrix offerings and differentiated candidates. While at the same time, we're also supporting being a Matrix manufacturer. That's a part of what we do as well. Our investments, as we move forward, our core investments that are ongoing are focused on those exact points, and that's what Bob described earlier. It's we've got an amazing Matrix-M vaccine. What it genuinely captures is the reconfiguration of this company and the focus of this company around this technology and unlocking significant value through our growth strategy. what it genuinely captures is the reconfiguration of this company and the focus of this company around this technology and unlocking significant value through our growth strategy A growth strategy that's predicated on generating data to drive partnering. a growth strategy that's predicated on generating data to drive partnering It's also generating new data to further enhance our Matrix offerings and differentiated candidates. it's also generating new data to further enhance our matrix offerings and differentiated candidates While at the same time, we're also supporting being a Matrix manufacturer. while at the same time we're also supporting being a matrix manufacturer That's a part of what we do as well. that's a part of what we do as well Our investments, as we move forward, our core investments that are ongoing are focused on those exact points, and that's what Bob described earlier. our investments as we move forward our core investments that are ongoing are focused on those exact points and that's what bob described earlier It's we've got an amazing Matrix-M vaccine. it's we've got an amazing matrix-m vaccine We can probably do some more and unlock some value incremental to that. So we're really excited about making those investments. Bob, I loved your points around oncology and the differentiation of what we think Matrix can do there. You heard Elaine and Bob talk about C. diff, a case study in how you can apply our unique technology in a differentiated way, a way that others cannot do. Because through our partnerships, you're hearing our partners are advancing programs in many areas, and we'd love to let them, because it amplifies investments, but not on our spend. We're really looking at differentiated investments, and that's our focus. Between 2026 and 2028, as our cost structure is decreasing, here's what you're seeing. We can probably do some more and unlock some value incremental to that. we can probably do some more and unlock some value incremental to that So we're really excited about making those investments. so we're really excited about making those investments Bob, I loved your points around oncology and the differentiation of what we think Matrix can do there. bob i loved your points around oncology and the differentiation of what we think matrix can do there You heard Elaine and Bob talk about C. diff, a case study in how you can apply our unique technology in a differentiated way, a way that others cannot do. you heard elaine and bob talk about c diff a case study in how you can apply our unique technology in a differentiated way a way that others cannot do Because through our partnerships, you're hearing our partners are advancing programs in many areas, and we'd love to let them, because it amplifies investments, but not on our spend. because through our partnerships you're hearing our partners are advancing programs in many areas and we'd love to let them because it amplifies investments but not on our spend We're really looking at differentiated investments, and that's our focus. we're really looking at differentiated investments and that's our focus Between 2026 and 2028, as our cost structure is decreasing, here's what you're seeing. between 2026 and 2028 as our cost structure is decreasing here's what you're seeing We do have some legacy obligations to either APA partners and Sanofi, for example, on co-sharing some of our post-marketing commitments, as an example, related to Nuvaxovid. As those roll off and our support for commercial manufacturing rolls off in the next 12 to 18 months, you're going to see those associated costs come out of our cost structure. However, underneath that is a core spend profile, currently about $200 million a year, but reaching the $150 million to $200 million by 2028. That should give you a good sense of the evolution and where we're focusing our investment to create value. We do have some legacy obligations to either APA partners and Sanofi, for example, on co-sharing some of our post-marketing commitments, as an example, related to Nuvaxovid. we do have some legacy obligations to either apa partners and sanofi for example on co-sharing some of our post-marketing commitments as an example related to nuvaxovid As those roll off and our support for commercial manufacturing rolls off in the next 12 to 18 months, you're going to see those associated costs come out of our cost structure. as those roll off and our support for commercial manufacturing rolls off in the next 12 to 18 months you're going to see those associated costs come out of our cost structure However, underneath that is a core spend profile, currently about $200 million a year, but reaching the $150 million to $200 million by 2028. however underneath that is a core spend profile currently about $200 million a year but reaching the $150 million to $200 million by 2028 That should give you a good sense of the evolution and where we're focusing our investment to create value. that should give you a good sense of the evolution and where we're focusing our investment to create value

Speaker 4: Really, Jim, another way to look at it through a non-GAAP lens is from a $1.7 billion annual SG&A and R&D spend, we've driven this down to $200 million, and we're now at that last $50 million of toggle. Anything above and beyond that this year and a tail going into next year are those trailing obligations to close out APAs and other partner support that's non-reimbursed. That enables us to keep the core capabilities needed to execute on this strategy. We're keeping R&D core capabilities to generate data, support these partners, and make some of these partnerships possible, frankly. Key to execution is keeping those core capabilities in a lean infrastructure. Really, Jim, another way to look at it through a non-GAAP lens is from a $1.7 billion annual SG&A and R&D spend, we've driven this down to $200 million, and we're now at that last $50 million of toggle. really jim another way to look at it through a non-gaap lens is from a $1.7 billion annual sg&a and r&d spend we've driven this down to $200 million and we're now at that last $50 million of toggle Anything above and beyond that this year and a tail going into next year are those trailing obligations to close out APAs and other partner support that's non-reimbursed. anything above and beyond that this year and a tail going into next year are those trailing obligations to close out apas and other partner support that's non-reimbursed That enables us to keep the core capabilities needed to execute on this strategy. that enables us to keep the core capabilities needed to execute on this strategy We're keeping R&D core capabilities to generate data, support these partners, and make some of these partnerships possible, frankly. we're keeping r&d core capabilities to generate data support these partners and make some of these partnerships possible frankly Key to execution is keeping those core capabilities in a lean infrastructure. key to execution is keeping those core capabilities in a lean infrastructure

Speaker 3: That's it. That's it. that's it

Speaker 5: Excellent. Thank you. One more question. You've guided to non-GAAP profitability as early as 2028. Could you just give us an overview of what potential milestones, any things that we can expect, and how you plan on reaching that goal? Excellent. excellent Thank you. thank you One more question. one more question You've guided to non-GAAP profitability as early as 2028. you've guided to non-gaap profitability as early as 2028 Could you just give us an overview of what potential milestones, any things that we can expect, and how you plan on reaching that goal? could you just give us an overview of what potential milestones any things that we can expect and how you plan on reaching that goal

Speaker 4: Yeah. Go ahead, Jim. Yeah. yeah Go ahead, Jim. go ahead jim

Speaker 3: Nabeel, thank you for making that point in this question, because this is a spot of high interest with investors and others, namely that, one, we have enough cash on hand to go and fund our company all the way into 2028 without any incremental funding coming into the company absent the reimbursements. Really important, we've set up a cash runway. Nabeel, thank you for making that point in this question, because this is a spot of high interest with investors and others, namely that, one, we have enough cash on hand to go and fund our company all the way into 2028 without any incremental funding coming into the company absent the reimbursements. nabeel thank you for making that point in this question because this is a spot of high interest with investors and others namely that one we have enough cash on hand to go and fund our company all the way into 2028 without any incremental funding coming into the company absent the reimbursements Really important, we've set up a cash runway. really important we've set up a cash runway

Speaker 5: Yeah. Yeah. yeah

Speaker 3: Coinciding with that 2028, you're hearing our non-GAAP cost structure. Coinciding with that 2028, you're hearing our non-GAAP cost structure. coinciding with that 2028 you're hearing our non-gaap cost structure

Speaker 5: Yeah. Yeah. yeah

Speaker 3: We're also seeking to reach that by 2028. Three, we also have the ability to reach non-GAAP profitability, namely. We're also seeking to reach that by 2028. we're also seeking to reach that by 2028 Three, we also have the ability to reach non-GAAP profitability, namely. three we also have the ability to reach non-gaap profitability namely

Speaker 5: Yeah Yeah yeah

Speaker 3: through the diversified revenue stream across partners, through royalties, milestones, up-fronts, we see the potential as early as 2028 to be non-GAAP profitable. What does that look like tangibly? Well, at midpoint, $175 million R&D and SG&A. Picture you've got $25 million, $30 million in stock-based comp, for example, then your breakeven's about $150. That's what it looks like. through the diversified revenue stream across partners, through royalties, milestones, up-fronts, we see the potential as early as 2028 to be non-GAAP profitable. through the diversified revenue stream across partners through royalties milestones up-fronts we see the potential as early as 2028 to be non-gaap profitable What does that look like tangibly? what does that look like tangibly Well, at midpoint, $175 million R&D and SG&A. well at midpoint $175 million r&d and sg&a Picture you've got $25 million, $30 million in stock-based comp, for example, then your breakeven's about $150. picture you've got $25 million, $30 million in stock-based comp for example then your breakeven's about $150 That's what it looks like. that's what it looks like

Speaker 5: Yeah. Yeah. yeah

Speaker 3: We're not focused on breakeven. We're focused on driving cash flow orders of magnitude higher than our cost structure over time. We believe that this partnering model and our existing partners we have today, and the ability to supplement it, has the ability to create, as I said, orders of magnitude more cash than our cost structure, and that is a critical value creation moment. We, of course, will always evaluate our ability to continue to invest in our technology, and we'll evaluate what to do with that cash over time. Will we just invest in the company, or might we contemplate returning efficiently cash to shareholders? All of that is on the table and being evaluated, all towards value creation. We're not focused on breakeven. we're not focused on breakeven We're focused on driving cash flow orders of magnitude higher than our cost structure over time. we're focused on driving cash flow orders of magnitude higher than our cost structure over time We believe that this partnering model and our existing partners we have today, and the ability to supplement it, has the ability to create, as I said, orders of magnitude more cash than our cost structure, and that is a critical value creation moment. we believe that this partnering model and our existing partners we have today and the ability to supplement it has the ability to create as i said orders of magnitude more cash than our cost structure and that is a critical value creation moment We, of course, will always evaluate our ability to continue to invest in our technology, and we'll evaluate what to do with that cash over time. we of course will always evaluate our ability to continue to invest in our technology and we'll evaluate what to do with that cash over time Will we just invest in the company, or might we contemplate returning efficiently cash to shareholders? will we just invest in the company or might we contemplate returning efficiently cash to shareholders All of that is on the table and being evaluated, all towards value creation. all of that is on the table and being evaluated all towards value creation

Speaker 5: Thank you. Thank you. thank you

Speaker 4: Well said, Jim. Thank you. Nabeel, I think we're just about at time. If I could have just a closing comment here to say another benefit of our strategy is the ability to amplify our tech. beyond the potential revenues, orders of magnitude of revenue coming in above and beyond our cost structure is our intention. It's really the impact on global public health and human health. that actually matters a lot to our team. Bob, we've talked about that time and time again in the hallways of Novavax, right? Our scientists, our employees, they actually really believe in what we're doing. Well said, Jim. well said jim Thank you. thank you Nabeel, I think we're just about at time. nabeel i think we're just about at time If I could have just a closing comment here to say another benefit of our strategy is the ability to amplify our tech. beyond the potential revenues, orders of magnitude of revenue coming in above and beyond our cost structure is our intention. if i could have just a closing comment here to say another benefit of our strategy is the ability to amplify our tech beyond the potential revenues orders of magnitude of revenue coming in above and beyond our cost structure is our intention It's really the impact on global public health and human health. that actually matters a lot to our team. it's really the impact on global public health and human health that actually matters a lot to our team Bob, we've talked about that time and time again in the hallways of Novavax, right? bob we've talked about that time and time again in the hallways of novavax right Our scientists, our employees, they actually really believe in what we're doing. our scientists our employees they actually really believe in what we're doing They believe in our technology, and they choose to be with us at Novavax. Like Jim said, we basically reduced our costs and our headcount 80% to 90%+, and on our way to even more now. Our retention level of talent is well within or even above industry benchmarks when you look at it. There's a passion here, and we want to leave a legacy. Not only to drive capital and reward our investors who've been patient with us as we migrate the company into a new strategy, completely rebuild it from the ground up, and change our mission and our vision, and we're in the middle of that execution right now. They believe in our technology, and they choose to be with us at Novavax. they believe in our technology and they choose to be with us at novavax Like Jim said, we basically reduced our costs and our headcount 80% to 90% +, and on our way to even more now. like jim said we basically reduced our costs and our headcount 80% to 90% + and on our way to even more now Our retention level of talent is well within or even above industry benchmarks when you look at it. our retention level of talent is well within or even above industry benchmarks when you look at it There's a passion here, and we want to leave a legacy. there's a passion here and we want to leave a legacy Not only to drive capital and reward our investors who've been patient with us as we migrate the company into a new strategy, completely rebuild it from the ground up, and change our mission and our vision, and we're in the middle of that execution right now. not only to drive capital and reward our investors who've been patient with us as we migrate the company into a new strategy completely rebuild it from the ground up and change our mission and our vision and we're in the middle of that execution right now the chance to leave a legacy, to impact billions of lives with potentially dozens of vaccines and immunotherapeutics taking on cancer, bacterial and viral infectious disease, something that we're all really proud of being part of and excited about the future. Thanks for your time today. the chance to leave a legacy, to impact billions of lives with potentially dozens of vaccines and immunotherapeutics taking on cancer, bacterial and viral infectious disease, something that we're all really proud of being part of and excited about the future. the chance to leave a legacy to impact billions of lives with potentially dozens of vaccines and immunotherapeutics taking on cancer bacterial and viral infectious disease something that we're all really proud of being part of and excited about the future Thanks for your time today. thanks for your time today

Speaker 5: Thank you. Thank you. thank you

Speaker 3: Thank you. Thank you. thank you

Speaker 4: Thank you. Thank you. thank you