Novavax, Inc. (NVAX)
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Baird's 2024 Global Healthcare Conference

Sep 10, 2024

Speaker 1

Certainly for Baird for having us here again this year. This is always such a great forum, and it coincides with the beginning of the vaccination season for COVID vaccines. We're gonna talk a lot about our technology today, but really important announcement just very recently with the authorization in the U.S. of our COVID vaccines in pharmacies last week, and shots in arms expected this week. Very happy to give that update to all, and a great example of how our technology matters every day. So just a reminder that today I'll be making forward-looking statements and, of course, encourage everyone to review our SEC filings, and also be referencing some non-GAAP measures as well as outlined here.

So before I go into too much on the company overview, my goodness, just amazing transformation in this company over the last few years, and so we're really gonna focus today on how that validated technology is gonna be driving value in the coming years today and the coming years. And to that end, we're focused on four exceptionally important value drivers. Number one, the Sanofi transaction that we announced earlier this year in May. Number two, our late-stage pipeline, flu and CIC, that are gonna read out mid-next year. Number three, deriving more value from this proven technology through additional partnerships and deals.

And four, our new early-stage pipeline that we'll be rolling out earlier this year or later this year, all of which done with a more lean and agile platform, therefore, creating value in a more capital-efficient manner. So it all begins with our proven technology platform. Two components: one, our recombinant, next protein-based nanoparticle vaccine technology. Now that when combined with our Matrix-M adjuvant technology, that's where we've seen exceptional success. When you look at the adjuvant, what you have is, through the combination, the ability to induce broad-based, robust, neutralizing antibodies, and importantly, what we've been able to do is, create an exceptionally large safety database, and there's only a few, a handful of adjuvants around the world that have this type of great safety database.

In the example of our R21 malaria vaccine developed through a partner, it's as low as six months of age, in use. Here's some examples of our pipeline and the utility. Two commercial stage products, one, our COVID vaccine, two, the malaria vaccine I mentioned earlier, which is marketed through our partner, Serum Institute. In addition to that, we've had really great data with our combination COVID influenza vaccine and our standalone flu vaccine. In addition, we very recently have presented both RSV and H5N1 data, and we're moving towards IND- enabling studies there as well. Importantly, as I mentioned, we're gonna do that portfolio assessment and work towards further leveraging this technology to drive innovative vaccines. I want to spend a little bit of time on the Sanofi agreement.

This was a game-changing agreement for the company that we signed back in May of this year. We view that this partnership could provide a multibillion-dollar potential across decades for the company, and this is in the form of an equity investment, milestones, and royalties. Importantly, we think royalties could be the most valuable part of this collaboration to us, based on what Sanofi can do with our technology. Four key components: one, a license to our standalone COVID vaccine to build a market worldwide where we haven't already partnered. Two, a license to take our COVID and combine it with Sanofi's vaccines, like their flu vaccine, to create a combination or other vaccines. Three, a non-exclusive license to leverage our Matrix technology to either improve existing vaccines or create new vaccines.

And finally, based on all of this, Sanofi wanted to make an investment in our company, and they took a just under 5% stake. So a little more details around the financial terms, and they're quite meaningful. Upon signature, $500 million upfront and a $70 million equity investment. Then, in terms of each one of the subsequent pieces, the Nuvaxovid COVID mono component of the agreement comes with $350 million in near-term milestones and significant royalties. Then, when they go into the combination of COVID with their other products, you get another $350 million in potential milestones, and again, more significant royalties. And then finally, when you apply our Matrix to potential new vaccines, you get up to $210 per vaccine, plus royalties, royalties that last 20 years.

So these are the core value components from this agreement, and then over the next two years, we're gonna work with Sanofi to enable tech transfer, so in 2025 and 2026 is our timeline expectation, and we're eligible for cost reimbursement over time. So in a little while, when I talk a little bit about our cost structure in 2025 through 2026, just know that some of those costs are gonna be offset and reimbursed from Sanofi. So on near-term priorities, and specifically for this year, we've got four. One, let's stand up the Sanofi agreement. Let's enable them to be as successful as possible. Two, let's go ahead and expand this early-stage pipeline and initiate that phase three program, this pivotal program for flu and our combination flu plus COVID. Three, reduce our cost structure. Continue to reduce R&D and SG&A expenses.

And four, deliver the updated product, our new vaccine, for the 2024-2025 season, and as I said, you know, we're thrilled to be in the U.S. market as of now. All right, so how does our programs and their product profile position them to be successful in a combination market? And we do believe that the COVID-flu combination is gonna be an important and driving force in vaccinations in the future. Why? Because there's just so many vaccines for adults coming into the marketplace every fall season, that it just makes logical sense, and it is the preference of the marketplace to be able to combine these vaccines that share a season. All right, so what is our opportunity? One, it builds upon the proven technology.

You take our COVID, along with a flu vaccine that has positive phase 3 data, and I'm gonna share in a moment some phase 2 data here, which we think is very competitive, and three, it's inclusive of using our Matrix-M. You combine that with a market preference for both consumers and to healthcare professionals for a protein-based solution, tried-and-true technology, a technology they're very familiar with. Combine that with the awareness of Novavax in the U.S. in particular, and you've seen some of the benefits of the last couple of years of our presence in the marketplace. We're approaching 90% aided awareness with clinicians this year. So we feel this all positions us well as we move towards a combination market opportunity. All right, so what did we see with our COVID influenza combination in our phase 2 studies?

What we saw was non-inferiority, and then at least statistically, superiority across important strains. So we believe that when we go into our phase three, this positions us well. The phase two was a bedside mix. Phase three is co-formulated with the formulation we'd take to market. So we're ready. Start it this fall, read out mid-next year. It's on track to begin. We have alignment with FDA that it's gonna be a single immunologic study that will enable regulatory filing. Our intent is to partner this program, both our CIC and our flu, and what we would do is, we'd run up through the pivotal results, partner, and have a partner file, do any post-marketing and expected post-marketing commitments, and commercialize. All right?

We'd continue down our path towards developing new, other vaccines for us or perhaps to continue to partner. All right, in terms of how we can further leverage our technology, I'm gonna share with you a couple examples of when you take Matrix-M and apply it in different modalities. I'm gonna show an example with both an existing flu vaccine that's egg-based and then a pneumococcal vaccine that's a bacterial polysaccharide. What we see in each case is that it improves the immune response, and so it's based on these preclinical studies that we continue to believe there's a strong hypothesis that we can work with existing vaccine manufacturers to leverage our Matrix-M to improve their in-line products. In addition, point our Matrix-M after what has potentially been some difficult-to-solve vaccine development issues. We're there.

We're looking forward to having more and more manufacturers being able to leverage that adjuvant technology. So this is the example for the flu vaccine, and this is the example with the pneumococcal vaccine, and you see in the left-hand side the eight-point-three-fold rise in immune response, right? With IgG titers. This, we believe, is exceptionally meaningful and should entice someone to take a closer look. Then, as we think about some of the activities that we're actively working on, we've got RSV and H5N1. We have shared preclinical data on a couple of our last earnings call. We are moving towards continuing activities on pre-IND enabling so that we could advance towards phase one clinical studies.

When you look at our respiratory assets of flu, CIC, RSV, H5N1, they make an amazing package for somebody who wants to be a significant player in respiratory vaccines. Okay, reducing our cost structure. What makes all this work is that we continue to drive down our cost and continue to create value in a capital-efficient manner. What you see on the right-hand side is a five-year evolution of our company, where R&D plus SG&A, we reduce it by 80% as compared to full year 2022, driving down to below $350 million in 2026. We do this by finishing up our commercial activities this year and the ability to effectively end that type of spend as a company at the end of this year, not just in terms of field-based and marketing, but also manufacturing.

We're seeking to sell our Czech facility, a great plant in the Czech Republic. These are examples of what we're doing to reduce that cost structure. Guidance this year is R&D and SG&A of $700-$750, admittedly towards the high end of that range, which I shared on our last call. All right, in terms of the profile, a profile for success in the current vaccination season for COVID in the U.S., we are thrilled to be out on the market in prefilled syringe. That is the desired product presentation. When you walk into your pharmacies, that is what they're giving consumers. We're there. We're there with prefilled syringe. We've received our EUA, as I noted, on August thirtieth. We shipped last week to pharmacies. We expect to have shots in arms beginning this week.

Ours is the JN.1. We've got alignment with FDA, of course. Our label is for twelve years and older. We're ready to go. Look forward to providing more updates as the season progresses. In terms of where are we and how do you find our vaccine? I tell you what, we are focused on retail. About 90% of COVID vaccines are done in the retail environment, and so we've got contracts with all the majors. We're on the schedule or in seven out of the eight, and we feel that we are exceptionally well-positioned through both that plus broader distribution than last year. We more than doubled our distribution availability this year versus last year. We think we're very well-positioned for success this year.

Okay, included in developing and being ready for the season is the strain change, and so, as noted, CDC recommends a new strain each year. We're fully aligned. Our updated vaccine, we've done the work. I'll show you in a minute how our JN.1 vaccine does relative to some of the more currently circulating variants. Importantly, we're aligned with EMA and FDA on this product design. In terms of utility, right-hand side, here's what I would have you look at. You'll see on the right-hand side that the antigenic units are all below two. This is considered to be antigenic, genetically similar to the JN.1 family. What that means is that as you've got...

As you look at KP.3, KP.3.1.1, is that our JN.1 vaccine covers, and it's fit for purpose, and that's why we're thrilled to have been on time with a vaccine that is ready for the fall. Okay, so I'll give you the financial guidance and corporate milestones to close out the presentation. Guidance for this year, total revenue $700-$800 million. Now, that comes in two components. I'll start first with licensing, royalties, and others of $425 million. $400 million of that, that's the $500 million upfront. You get $400 million this year. We got all the cash, but for rev rec, you do $400 million this year, $50 million next year, and $50 million in 2026. Then the other twenty-five, so $425 million includes $25 million.

We make revenue or get revenue for our partners, so a significant portion of that is reimbursement, for example, Matrix-M for R21 from Serum Institute. Then product sales guidance $275-$375 million, so you get a midpoint at $325 million. In that $325 million midpoint, you got $100 million that we already sold this year under our advance purchase agreements. The remainder, $225 million in sales for the fall season, the vast majority of which, U.S. market. Upper part of the range is if you do, and we sell more in Europe. That's the primary opportunity, or you sell some more in the U.S. for that matter, right? So that's our guidance for this year, and then in terms of combined R&D and SG&A, as I referenced, $700-$750 million.

In terms of corporate milestones, for this year and rolling into next, you know, we've made great progress. We've signed a real landmark agreement with Sanofi earlier this year. We've gotten our product out, updated and out in the U.S. market and soon also in Europe. Also, keep an eye for future, hey, how is our performance going? As you know, you get IQVIA data daily, and there's all types of monitoring that you've got to see exactly how we're performing this fall. We can't wait to give these updates. Later this fall, we also initiate our phase 3 programs for flu and our combination vaccine to read out mid-next year.

And then I'll add to this our rollout of our new prioritized R&D portfolio that we will bring to investors with an R&D day after our Q3 earnings and prior to our Q4 earnings. So a lot happening in the coming months to drive more value, and with that said, I'll thank you all for coming today. All right, thanks again.

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