Well, thanks everybody for being with us this afternoon. My name is David Risinger. I'm very much pleased to welcome members of the Novavax leadership team. Immediately to my left is John Jacobs, CEO. To his left is Ruxandra Draghia. She is head of R&D. And then Jim Kelly, the CFO. And Luis Sanay in IR is in the audience. Thank you for being here with us. I thought we'd just start off at a high level, John, with you, particularly for those that are less familiar with the story, just providing an overview of the company strategy at this point. You know, the company's been through a lot, but since you've already troughed and stock's moving in the right direction, we'll look forward.
No, absolutely, just take a moment to look back within appreciation of the opportunity we've had the last three years to really pivot the company fully.
Mm-hmm.
Away from its original attempt to launch the COVID vaccine and help folks around the world with that terrible pandemic. Through that, generating a proof point, a significant level of proof points on the technology platform that Novavax actually is sitting on, which is this amazing Matrix-M adjuvant technology and our nanoparticle technology, which allows us to really do some innovative things in the vaccine and potential immunotherapeutic space that we can talk about a little bit more today. We've made that full pivot, David, away from a company that was solely focused with all of its energy, effort, and resources on the one attempt to get a COVID vaccine out and help folks with that, to now a company that's focused on partnering and business development, supported by innovative research and development to out-license this unique technology platform.
You know, you just, you saw the Sanofi deal, of course, back in 2024, and then just this January, Pfizer signing up, and you see key components in that deal that we see as potential components of future deals and partners. Pfizer was one of the earlier companies we initially approached as we began the pivot into the new strategy. There are numerous potential partners, other companies behind Pfizer, that are at different stages of discussion with us, multiple material transfer agreements that have been signed, which enable those potential partners to experiment with our tech in their own labs to get a sense for what it can do to unlock value in their vaccine, potential immunotherapeutic portfolios. We intend for some, if not all of those, to become additional partners in the future for Novavax.
On an R&D side, the way Ruxandra and her team support us is really in three key areas. First, data generation. Ruxandra and her team have worked to generate data to demonstrate our technology's effectiveness across multiple vaccine types and platforms, as well as in some specific marketed products that our business development team can take that data in and share with potential partners to get their interest. Often then stimulating an MTA and their own desire to experiment with our tech to see it for themselves in their own lab. Secondly, you know, we're innovating, Ruxandra, right, on Matrix-M, new formulations of Matrix-M, lifecycle management, dry powder, for instance, or lyophilized Matrix-M, and then new adjuvants themselves based on the Matrix platform.
It's our vision that we will have eventually, or intend to have, a portfolio of new adjuvants based on Matrix selected and targeted to hit very tough-to-treat diseases and also to penetrate markets like oncology. Finally, last but not least on R&D, new assets using our nanoparticle technology and our adjuvant. We have three in the pipeline or the C. diff and VZV and RSV combination that Ruxandra can talk about a little bit later today, if you like. Through those, we learn. It feeds the first two components of data generation and learning more about Matrix. It's a test platform for some of these new adjuvant approaches as well, potentially. Also through that then, we could be in humans as early as 2027 with one or more of those programs, generating in-human data to then foster further partnering.
That's the new strategy for the company, and we're deep into it now and having fun with it.
Phenomenal. Just talk a little bit more about Matrix-M and that potential extension into immunotherapy.
As John has mentioned, we are working on new Matrix-based adjuvants. We took Matrix, and we've asked the question, are the immune responses that we are generating with Matrix appropriate for some of the new applications that are coming into our direction, for instance, in oncology? In some circumstances, the answer is clearly yes. In some other types of tumors or in oncology models, we felt that we need to actually do some tweaks, maybe add some components or, actually reengineer the Matrix particles in order to elicit a different type of immune response. For instance, some of the oncology targets require more CD8-positive cells. This is exactly what we are doing, using those learnings and the prototypes that we are designing to feed back into the innovation loop. We are actually working on Matrix.
We are applying it to different tumor types or to those prototypes and then we are going back and asking the questions, are we good enough for this, that, and the other? So-
Excellent.
It's very simple.
Excellent. So let's turn to key catalysts for this year. What should we be watching for?
Well, continued execution on this strategy, and starting with the potential for new deal announcements. Obviously, we can't provide, David, any timelines on that, let alone who we're speaking with, but we're seeing more interest right now in our technology from third-party potential partners, other companies, than any time since I joined in early 2023. It's quite remarkable actually what we're seeing. I think other companies are waking up to understand what Matrix-M and our tech might be able to offer them as a potential unlock for significant value in their portfolios. Very exciting. When those are inked, if they're inked, you will find out at that time.
It's our intention to do many, and we have multiple conversations going on right now behind the scenes. No guarantees ever. There's always risk in biotech, but it's our intention to bring forward multiple new deals.
Excellent. Secondly then. Actually, before you go there.
Yes, please.
If you don't mind, could you just recap the Pfizer deal? There's a limited amount that you could say, but would love to hear about that. Jim, did you wanna comment on the Pfizer?
Well, certainly. Incredibly excited in January to announce this new agreement with Pfizer to use our Matrix-M technology with not just one, but two different potential fields. Now at this time, those fields are not being disclosed. This is important not just to Pfizer, but many of our potential-
Yeah.
Future partners for which they wanna maintain appropriate discretion to get ahead in their own clinical development. Of course, we'll honor that. With-
I'm sorry to interrupt, but when you say two fields, you mean two different vaccines or two different disease states that vaccines would target? Is that what you mean?
That's correct.
Okay.
With an infectious disease.
Yeah.
That would result in two different vaccine candidates.
Got it. Okay.
Two potential revenue streams then composed of potential milestone payments for clinical development milestones, as well as sales milestones, and then royalties.
That's exactly right. The architecture of the agreement itself was a $30 million upfront, and then for each one of these field/new vaccines, eligible for up to $250 million apiece in milestones, or $500 million total. They're split between $70 million development, $180 million in sales-based. Exceptionally good upfront and milestones. Then the royalties, 20 years, high mid-single digit. The way to think about the royalties, 'cause that's clearly where the long-term value lies, is that over a 20-year period, for each $1 billion in average revenue over that period, we get $1 billion in royalties. If over that period you average $3 billion, you get $3 billion in royalties based on that mid-single digit.
I think the way most of the large pharma players when they're looking at our adjuvant Matrix-M technology, they're looking at very significant markets. Now you can imagine in the future, if you could, a diversified portfolio of agreements across multiple pharma players that have this type of economic profile with respect to our Matrix-M. What we're seeing is that this concept that in this agreement, it's not just one opportunity or vaccine, but two, this is fairly consistent with what we're seeing as we continue our dialogue with other pharma players. When they get the opportunity to get Matrix-M into their labs, they not only wanna do one deal, but they want access to do more.
Excellent. That's great. I had interrupted, so you were gonna move to point two. In terms of the catalysts, right.
Certainly key catalysts would be looking for more partnership announcements. Second key catalyst is advancements of existing partnership agreements that we have, right? Announcements from partners like Sanofi and watching for what comes of the fall season now, right? We'll look at the meetings like ACIP and others' recommendations for that strain, Sanofi communications around the fall season for NUVAXOVID, where they've got their first opportunity, David, for a full cycle launch of NUVAXOVID under a BLA with a full opportunity to do contracting discussions and negotiations for this coming fall season, 2026, 2027. We're excited about that.
Any announcements coming from Sanofi on the further advancement of their combination vaccine programs that include their flu vaccines and our NUVAXOVID COVID vaccine. Those were fast-tracked. They had positive results on phase I, too. Their own public commentary recently, from December forward especially, has been how important not only vaccines are to Sanofi, but how important those potential vaccines themselves, those products will be to closing some of the gaps they may be facing in the future on patent loss. Very exciting that they're very committed to that. They're outstanding partners, so look to updates from Sanofi. Look to Pfizer for the selection of a second field. Potentially us earning some of the initial clinical milestone opportunities from Pfizer. That would be pillar number two.
Pillar number three to watch for in catalysts is things coming out of our own pipeline, data, R&D, innovation, et cetera, and continued cost reduction.
Excellent. That's great. Just to go back, I guess, we talked a little bit about Matrix-M, but what in particular is it that's drawing these partners? What drew Pfizer and what's drawing, you know, these potential additional partners from Sanofi?
I'll hand it to Ruxandra in a moment, but what I will say is it's the ability to unlock potential value in what our technology does for companies that are interested in the immunotherapeutic space, that this, where this tech could apply, and especially the vaccine space and infectious disease and beyond even into oncology, is the potential unlock of value.
If you have, for instance, some partners may have assets on their pipeline that they hit a wall with, they hit an impediment on, and perhaps Matrix unlocks the potential to move that asset forward in clinical development and potentially enter a market in the future they didn't think they might be able to. If it's a company that's trying to enter an existing market, perhaps, and they have an asset that could compete in that market, and they think Matrix could give an edge to that, and they've seen maybe something in their lab. That's another example. This is just generically, not particular to Pfizer here, right?
Mm-hmm.
Something that could unlock value matters, and you're talking about large markets. I mean, the vaccine global marketplace is projected to be over $60 billion by 2032 globally in opportunity. There's a lot of unlock there, a lot of potential for our tech. Ruxandra, w hat would you add from a scientific perspective?
From a scientific perspective, we are actually experimenting in our labs, and we are asking the question, as John was mentioning, if we are adding Matrix to these different vaccine platforms with different antigens being viral or bacterial, what do we see? Typically for the applications that we have tested, we are seeing better immune responses, a better durability of those responses. Consistently, including in human clinical trials, we have seen a very favorable reactogenicity tolerability profile, even if Matrix is added not only to our nanoparticles, to our protein-based vaccine, but in conjunction with other platforms and with a multitude of antigens. Those are the types of characteristics that then can enter into the decision-making process that John was mentioning from our partners.
Do I have this much of an immune response with the current vaccine, and I would need better immune responses? Do I have a durability of protection of X, but my market would require a durability of protection of 2X or 3X in order to be competitive? Or if we have, let's say, a vaccine that already have very good immune responses, can I reduce my cost of goods? Because instead of using, let's say, 10 or 20 mcg of a specific antigen, I get the same immune response with 0.1 or 0.5 mcg. All those considerations we have evaluated with a number of platforms and antigens, and this is what our partnership with our BD team is generating that the opportunity based on data.
Super interesting. Okay, excellent. I guess we should probably move to your pipeline. What are you seeing in the preclinical data of your Clostridioides difficile vaccine candidate that makes you excited about its potential?
I'm very excited about my R&D programs, all of them. As you are asking about the Clostridioides difficile, I'll concentrate on it. First and foremost, we've actually took lessons from the previous vaccine candidates that might not have actually hit the results that were needed to show efficacy in humans. There are many hypotheses there. We kind of took one by one. We've looked at the type of antigens that have been used. Prior vaccines have used mostly toxin-based approaches. We've asked the question, is that sufficient? We decided to go to a multivalent vaccine that might have a broader coverage. Second question was around mucosal immunity, because obviously this is a bug that lives in the gut.
We thought that having not only immune responses in the blood, but the mucosal level would be actually very favorable. We've entered that into the design, and we've asked those questions in the experimental design. Obviously, this is a pathogen that creates spores, yeah. You give the antibiotics to the patients, the bacteria might go away, but it leaves behind these spores, which are extraordinarily hard to treat and to get rid of. The question was, can we do something about it? We've designed both the antigen and every single one of the experiments to really address those questions. We are starting to have data from those experiments, including challenge studies, which are encouraging.
Of course, we need to take it to the next step and ask additional questions before we would be ready to move to the clinic, which we hope to be in the clinic as early as 2027.
Well, it's one of the first things we discussed when the team took months to really assess about 18 months ago plus, you know, which targets did we want to approach.
Exactly.
Engage in the new strategy, make the pivot away from, you know, commercial COVID company to innovative company through partnering. This was a big part of that discussion. Show me, you know, why we should believe that we have a chance to succeed where others had failed. What were the reasons they failed? Is it just another attempt? What are we doing differently?
Mm-hmm.
What could we learn from what's in the public domain on how they approach these studies, how they approach the design of their prototype vaccines that didn't work out in the past?
Mm-hmm.
From big players who have a lot of knowledge and resources. I think, Ruxandra, you did a great job with your team on that. Showed us that we believe we can, and we're making so far, at this early stage, very nice progress there. We're being careful exactly what we share. We think we found a potential unlock pathway here, but still more work to be done. Very exciting progress to date.
That's great.
Our North Star being, you know, the target product profile.
Yeah. Exactly.
Excellent.
If I could, one of the things, and I won't give away some of the details, that I like about the work that Ruxandra and her team are doing is that it moves beyond just delivering unlocks related to those particular markets or candidates. What each of the experiments that she's working on right now speak to some of the scientific underpinnings of why our technology is working where others have failed. That matters. It matters not only to partner these programs as you advance them, but as you talk to potential partners who perhaps have their own antigen, who may be stuck, or an idea or a market they want to go after. We are putting forward proof points through our early-stage development that open up other BD opportunities.
It's an innovation feedback loop, really.
Absolutely is.
That's phenomenal. Just talk about the patent protection for that, for Matrix, and obviously you're, you know, advancing other candidates as well. How should we think about that given the competitive nature of the vaccine market?
Jim, maybe you wanna comment just IP in general.
Yes, certainly. That's right. I'll start with patents, but of course it's a broader, right, set of protections. For Matrix, we've got either existing or pending applications that would go out through the 2040s. Okay. As we know with biotech, and in particular vaccines, it's well beyond IP. It is also know-how of manufacturing, as an example.
Mm-hmm.
There's more beyond that in terms of supply chain management and also, the safety database that we have accumulated over the past five years.
It's a massive.
Not just with COVID
Massive.
R emember, R21, over 30 million doses delivered, and that's being dosed down to as young as six months?
Five months.
Five months of age. An exceptional global safety database across multiple indications, across multiple age groups. That is really tough to replicate.
Got it.
For the new formulations, for the new Matrix-based adjuvants, for this new work, as Jim was mentioning, we are capitalizing on the data, and we are continuing to gather additional intellectual property. I like to call it an onion because it is really layers and layers of protection that it is not only adding to the existing portfolio, but with an eye of where can we take it from here to where we want to be in the future.
Ruxandra, as you said earlier, you know, we're working on new formulations of Matrix-M. David, we're working on new adjuvants that are Matrix-based that are targeted and selective to certain hard to treat diseases.
Mm-hmm.
Potentially certain types of tumors in oncology, et cetera, each with the potential for its own IP as well.
Excellent. Jim, maybe we could turn to the company's financial prospects.
Yeah, certainly. What a difference 36 months make, right? You know, we were very happy to be able to articulate at our most recent earnings that, you know, we see a really strong balance sheet.
Yeah.
That we have therefore the ability, the cash runway, that could get us into 2028 and at a point where we could be approaching or reach non-GAAP P&L profitability as early as 2028. That was an incredibly important update that we were able to provide just recently. When you think of, well, how the heck did you get here? You know, over the past three years, we have taken out, in terms of R&D and SG&A, over $1 billion out of our P&L as we transition the company with the new strategy that John mentioned and focus on our core technology. In addition to that, we reduced our current liabilities by $2 billion, I mean, which is unbelievable. We took the liabilities we had, and we renegotiated them, spread them out over time.
We've been generating cash, 80% of which, $1.4 billion, from non-dilutive sources, upfronts, and then more recently a credit facility.
Yeah.
We're doing all those, call it financial management, requirements to now turn the business toward value creation through all the innovation, through the partnership, and that's the path we're on now.
Excellent. Could you talk about the levers, you know, the pushes and pulls to achieving non-GAAP profitability?
Certainly. To kind of ground folks on where we ended 2025 as we go towards 2028, our R&D plus SG&A, and I speak net of reimbursement, was just over $400 million. As we look to 2028, we just shared that we're going to target $200 million or below or cut that in half. That's gonna occur over the next few years as first, we complete and some of our trailing obligations to partners and APAs in this year, 2026, of about $100 million. We've guided to, and I should say starting in 2026 and forward, we're already operating at that lean $200 million or below. We're already there.
The core business, yeah.
The core business. What we have in 2026 and 2027 that add to that are some trailing obligations related to APAs, some aspects of our agreement with Sanofi that aren't reimbursed, like our share of the post-marketing commitment. Those are gonna play through in 2026 and a small amount in 2027. I think the key point is that we are seeing ourselves operate already at that core spend level of $200 million or below.
Perfect. Well, we're almost out of time. John, let me ask you to just wrap up with what else we should be focused on. We've covered a lot of ground, but would love to hear any closing comments that you have to offer as well.
Thank you, David. We appreciate your attention and everyone here that's listening and joining us today. Thank you. Thank you very much for that. We couldn't be more excited about 2026. Jim, like you said, wow, what happens in 36 months? You know, you take a look back, what a journey together to.
Incredible.
Put the company together through our collective efforts into a position to focus a lot more on value creation, a much more stable financial position than when three years ago when I first came here. We're excited about where we stand today. We're seeing more interest in our technology than seen since the first time I got here three years ago. Lots of other companies coming to chat with us, really interested, experimenting with Matrix in their own laboratories. We intend to bring forward more deals and partners. Our vision is to have, as Jim was saying, and Ruxandra has been saying, a portfolio of assets that we can continue to out-license, whether those are early-stage vaccine candidates, new versions of Matrix-M, new adjuvants that are Matrix-based.
A portfolio of partners, plural, with multiple assets in development, each with tiered or stacked opportunities for Novavax to earn milestones on clinical and sales, and then royalties for decades. That's the vision. On a lean expense platform, and we remain focused and diligent. My last comment is, you know, the culture we've developed at Novavax is one of partnership, family, collaboration, and humility. We take nothing for granted. We're working really hard to not let any of you down. It's been a tough journey. Biotech is risky and it's difficult, but we're very proud of the accomplishments we've had the last three years and very excited about where we sit today and the potential opportunities ahead for Novavax to drive value and frankly, make a meaningful impact on global public health.
Phenomenal. That's a great way to wrap up, so.
Thank you.
Thank you again.
Thank you.
Appreciate you being here.
Thanks for joining us, everyone. Thank you.
Thank you.
All right. Thanks .