Novavax, Inc.

Thank you for standing by, everyone. My name is Jim, and I'll be your conference operator for today. I would like to welcome everyone to the Novavax second quarter 2026 financial results and operational highlights conference call. All lines have been placed on a mute to prevent any background noise. After today's speaker's remarks, there will be a question and answer session. If you would like to ask a question during that time, simply press star followed by the number one on your telephone keypad. And if you would like to withdraw your question, simply press star and one again. Thank you. It's now my pleasure to turn the floor over to Naina Zeman. You may begin.

Good morning, and thank you all for joining us today to discuss our second quarter financial results and operational highlights today on August 6, 2026. A press release announcing our results is available on our website at www.novavax.com and an audio archive of this conference call will be available on our website later today. Before we begin with prepared remarks, I would like to remind you that this presentation includes forward-looking statements regarding Novavax's current expectations related to, but not limited to, its partnerships, market opportunities, and financial guidance. Our actual results may be materially different from such statements as detailed in the presentation. Discussions of non-GAAP figures and reconciliations to GAAP figures are available in our earnings press release and descriptions of the risks and uncertainties associated with Novavax are included in our SEC filings. Both can be accessed through our website. Joining me today are John Jacobs, our president and CEO, Jim Kelly, our chief financial officer, Elaine O'Hara, chief strategy officer, and Dr. Bob Walker, head of R&D. I would now like to hand the call over to John.

Thanks, Mayna, and good morning, everyone. In 2025, we set out to build a different kind of biotechnology company, one powered by partnering our technology, targeted and capital-efficient innovation, and a lean and agile operating model. Our ambition is InnovaVax with multiple partners and products using our technology, creating both near and long-term value while potentially having a meaningful impact on millions of lives around the world. Today, the momentum created by executing this new strategy is giving us the potential to have greater impact than ever before. For example, Four of the top 10 global pharmaceutical companies now have licensing or material transfer agreements for Matrix-M. One of those companies is Pfizer, in a collaboration that could represent up to $500 million in potential development and commercial milestones and significant potential future royalties. In total, our licensed partners and MTA holders collectively have the rights to over 30 areas of experimentation across both infectious disease and oncology. The collective utilization and experimentation with Novavax technology potentially opens the door to a substantial portion of a market projected to reach $100 billion in the 2030s, spanning infectious disease, oncology vaccines, and cancer immunotherapeutics. In the second quarter, we accelerated our momentum, and today, we're excited to share several important updates. First, we continue to execute well in our Sanofi partnership. with Sanofi's strong and growing commitment to Nuvaxivib and our technology. In fact, Sanofi has confirmed to us their intent to be among the first movers in the combination vaccine market and that they are in advanced discussions with regulators regarding phase three study timing for their program using Nuvaxivib and their own flu vaccines. We're pleased to hear this confirmation and we are optimistic about the growing potential of our opportunity as partners. Initiation of this trial in either of the U.S. will trigger a $125 million milestone payment to Novavax. Additionally, progress continues on the manufacturing tech transfer to Sanofi, which comes with an associated $75 million milestone upon completion and is expected by mid-2027. We believe Sanofi is also well-positioned for this commercial season with Nuvaxivit, supported by an expanded U.S. marketing campaign and launches in additional international markets. We're excited for the potential of this work to help increase awareness of Nuvaxivit and build meaningful market share over time. Taken together, this means we now have line of sight to an additional $200 million in potential near-term milestone payments, on top of the more than $1 billion in value we have already realized through a combination of upfront payments, milestones and royalties, and cost savings related to this partnership. Second, we're seeing growing interest in Matrix-M and increasing progress across our broader partnering portfolio. A growing body of scientific evidence is being generated by Novavax, our partners, and MTA collaborators in oncology and infectious disease targets. and we're excited about the progress that's being made. Third, our R&D investments are selective and strategic and they're designed with three goals in mind. To build upon the scientific evidence that makes our technology increasingly compelling to both current and prospective partners. To broaden the utility of our matrix technology platform. and to create new innovative vaccines that have the potential to stimulate additional partnering opportunities and drive value for Novavax and our stakeholders. Later in the call, Bob will discuss the momentum we're seeing across our R&D portfolio, including the growing body of work supporting MatrixM's utility in oncology. And finally, we're delivering on our commitment to transform Novavax into a leaner, more capital-efficient company To date, we've reduced our operating expenses by more than 80%, and we remain on track to achieve an approximately 90% reduction from our peak. Importantly, we didn't just cut. We focused, streamlining our company while at the same time preserving the capabilities we believe are needed to enable value creation. Taken together, the progress the team and I are sharing today reinforces our belief that the future is bright for Novavax. Thank you for joining us.

Thanks, John. As discussed, one of the clearest indicators that our strategy is working is the momentum we're seeing across our partnerships. We are focused on two objectives, maximizing value from our existing collaborations while building the next generation of licensing opportunities. Today, I'll provide an update on both. Beginning with Sanofi. COVID-19 continues to present a meaningful public health challenge, particularly among older adults and other high-risk populations where we see the highest need and the highest vaccination rates. And it remains a significant commercial opportunity as the second biggest infectious disease market behind influenza. Building on last year's COVID-19 launch in the U.S., Sanofi is preparing a broader commercial effort following NUVAX of its first full year of approval. The campaign will be supported by pharmacy activation and direct-to-consumer outreach. Internationally, Sanofi plans to expand availability in additional markets this season, including the United Kingdom, Germany, and Canada. Results from the Phase 4 Compare Study A large head-to-head evaluation of Nuvaxivid and a next-generation mRNA COVID-19 vaccine demonstrated Nuvaxivid's favorable tolerability profile. Together, we believe these developments provide healthcare providers and patients with important information to make more informed vaccine choices. Beyond the commercial COVID opportunity, we remain encouraged by the progress of Sanofi's combined COVID-19 influenza vaccine program. Recent external developments, including the European Commission's approval of the first COVID influenza combination vaccine, reinforced our belief that the regulatory pathway for this category is becoming more clear. As a reminder, Sanofi previously reported positive Phase 1-2 data for its kit candidate utilizing Nuvaxivit in combination with their flu vaccines. And as John said, we are encouraged by Sanofi's recent confirmation that they are in advanced discussions with regulators and they intend to be one of the first movers in the combination vaccine segment. So to reiterate, a Phase 3 study initiation in either the U.S. or E.U., will trigger a $125 million milestone payment to Novavax. Finally, on the Sanofi partnership, Sanofi's BARDA-funded H5 pandemic influenza vaccine candidate, which includes Matrix-M, was recently granted U.S. FDA fast-track designation. So, tremendous progress continues with Sanofi. Beyond Sanofi, we're pleased with the continued execution across our broader portfolio of licensed partnerships. Work with Pfizer, Takeda, and the Serum Institute continues to progress well and demonstrates the broad applicability of the MatrixM platform across multiple vaccine programs and of our technology platform more generally across multiple markets. Turning to our Matrix collaboration activity. Today, our existing licensed partners and MTA holders collectively have the rights to over 30 areas of exploration across both infectious disease and oncology, reflecting the broad applicability of MatrixM and our technology platform across a diverse range of vaccine programs. While it will take time for partners to complete experiments before these efforts potentially progress into full licensing agreement discussions, were encouraged by the momentum we're seeing. Materials have been delivered, studies are underway, and partner engagement continues to deepen. What stands out most is both the quality and diversity of the organizations evaluating MatrixM. We are actively collaborating with four of the top 10 pharmaceutical companies through license agreements and or MTAs, and we are also seeing growing interest from innovative biotechnology companies. reinforcing the broad appeal of Matrix-M across the industry. One area where we're seeing particularly strong momentum is oncology. During the second quarter, we executed an MTA with a leading global pharmaceutical company who is also a top player in immuno-oncology related to therapeutic cancer vaccine applications. And we continue to see interest from additional companies in this area. from a partnering perspective were encouraged not only by the caliber of these companies, but also at the pace at which therapeutic cancer vaccine programs potentially can generate meaningful data and reach key development milestones. Different to infectious disease vaccines, therapeutic cancer vaccines generally enter clinical testing in patients with active disease, allowing developers to access meaningful data on shorter timelines. Combined with expedited regulatory pathways in areas of high unmet need, we see real potential for these factors to accelerate partnering decisions. Just as importantly, this is an area of profound unmet need, and we are inspired by the hope that next-generation therapeutic cancer vaccines represent for patients and their families. The level of engagement we're seeing reinforces our belief that Matrix has the potential to become a broadly applicable vaccine adjuvant platform. Every new collaboration has the potential to expand scientific evidence, supporting the platform, strengthen its value, and create additional opportunities for future partnerships. That's the virtuous cycle that we believe will continue to differentiate Novavax. Now I will pass it over to Bob to discuss the scientific rationale behind these programs in greater detail.

Thanks, Elaine. Our R&D strategy is designed around a simple principle. Every investment we make should create future opportunities to facilitate partnership discussions while strengthening the scientific foundation of MatrixM and their full technology platform. We're increasingly excited about the potential for Matrix in oncology, which we believe represents one of the most compelling long-term opportunities for our adjuvant. Therapeutic cancer vaccines are experiencing renewed momentum as advances in neoantigen discovery, tumor profiling, and antigen design accelerate the field. At the same time, many developers continue to face a common challenge of generating strong, durable cellular immune responses that are critical for effective anti-tumor activity. We believe that our unique saponin adjuvant, Matrix M, has a differentiated tolerability profile and the potential to stimulate robust cellular immune responses for oncology vaccines used alone or with innate immune stimulators such as TLR agonists. A recently published study by Novavax in NPG Vaccines, a Nature portfolio journal, demonstrated that our MatrixM adjuvant supports antigen cross-presentation and subsequent downstream CD8 T-cell activation. Achieving strong CD8 T-cell activation is considered an important factor for many therapeutic cancer vaccine approaches. Additionally, Researchers at Stanford have published their work in Science Advances showing that saponin adjuvants alone or combined with innate immune stimulators, such as TLR agonists, can further enhance the magnitude, breadth, durability, and quality of immune responses. Put simply, we believe Matrix M helps the immune system better recognize and respond to disease-related targets. Its ability to engage the innate immune system, activate immune cells within the draining lymph node, enhance antigen presentation, and promote Th1-biased and CD8-positive T cell responses gives it a differentiated mechanism of action that we believe is highly relevant for next-generation cancer vaccines. Our own internal research has continued to generate encouraging immunologic data supporting further evaluation of matrix across multiple oncology settings. In parallel, as Elaine discussed earlier, our oncology collaborations should provide additional data sets generated independently by our partners, further expanding our understanding of the platform. Taken together, we believe the combination of published mechanistic evidence, emerging preclinical data, and partner-generated research provides an increasingly compelling scientific rationale for Matrix M in oncology. Beyond oncology, we've continued to advance a focused internal pipeline that addresses significant unmet medical needs while strengthening the value of our platform. During the quarter, we made meaningful progress in the development of our differentiated, multivalent and C. difficile vaccine candidate, which has the potential to cover the vast majority of circulating C. diff clades and ribotypes. This progress includes initiating GMP manufacturing and pre-IND interactions with the FDA, keeping us on track for potential clinical entry as early as 2027. More broadly, as we have shared previously, Some of our own internal preclinical studies on the combination of MatrixM with licensed flu, RSV, and pneumococcal vaccines produced encouraging results that have already helped generate partnership interest. Building on that, we are continuing our comprehensive program to evaluate the potential ability of MatrixM to enhance performance in a broad array of licensed vaccines in big commercial markets. As we previously shared, our ambition is to generate a library of data in a cost-efficient manner to show the potential of HXM across significant vaccine programs in a methodical manner. And we expect to complete the next tranche of this work by early next year. The goal is to stimulate new and additional partner interest in the applicability of MatrixM in their vaccine portfolios. Importantly, oncology, C. diff, and our clinical and preclinical pipeline exemplify our broader strategy. Every program we advance, whether internally or through our partners, expands the scientific foundation of MatrixM and our vaccine technology. With the growing partner interest in MatrixM, we're encouraged by what is today one of the industry's most comprehensive data sets across mechanistic biology, preclinical research, clinical development, and commercial use. That growing body of evidence does more than advance our scientific understanding. It increases confidence in the platform, while potentially lowering the barrier for future partners and reinforcing what continues to differentiate MatrixM and our full technology platform. We believe that this expanding scientific foundation represents a durable competitive advantage, one that becomes stronger with every new study, every new collaboration, and every new application of the platform. As a physician and researcher who has spent most of his career working on vaccine development, I believe we're entering an exciting new chapter. Seeing the potential of our technology in new infectious disease targets and the expansion of MatrixM into areas with significant unmet needs, such as oncology, represents an opportunity to improve the lives of even more patients and make an even greater impact on public health. We look forward to sharing additional progress over the coming quarters. I'll now turn it over to Jim for the finance update.

Thank you, Bob. This morning, we announced our financial results for the second quarter of 2026. Details of our results can be found in our press release issued today and in our Form 10Q filed with the SEC. Let me begin by highlighting several significant updates that we believe demonstrate the progress we're making on our growth strategy. Today, we are announcing our expectation to earn a 75 million manufacturing tech transfer milestone payment from Sanofi mid-next year that would extend our current cash runway from 2028 into 2029. We are also encouraged by Sanofi's recent phase three kick study update discussed earlier and the potential to earn 125 million milestone payment. In addition to our second quarter results, we will be sharing updates on our improved 2026 financial outlook and reiterate our financial performance objectives to drive shareholder value. First, I'll walk us through are revenue performance. Our second quarter total revenue of $57 million compares to $239 million in the prior year. When comparing year-over-year results, you will see the prior year second quarter 2025 results include a $202 million benefit from a combination of a BLA approval milestone payment and a Takeda amendment. The $57 million total revenue recorded in the second quarter of 2026 includes product sales of $19 million, an increase of 76% year-over-year, and are driven by demand for our MatrixM adjuvant by Takeda and Serum Institute. In addition, we recorded Sanofi revenue of $36 million related primarily to R&D cost reimbursements and amortization. Turning to our full financial statement results, the second quarter of 2026, we recorded a net loss of $53 million and ended the quarter with $743 million in cash and accounts receivables. When reviewing the year-over-year change in net income and loss, we begin with the impact of the prior year's BLA milestone and Takeda amendments. Our second quarter 2026 results highlight meaningful improvements to other aspects of our financial performance, including product sales and other partner-related revenue categories that increased by $20 million year over year, while cost reductions were the primary driver of an additional $24 million improvement. We believe these 2026 trends reflect the continued execution of our strategy and strategy Thank you for joining us today. highlight that we are on track to deliver our full-year expense guidance. Today, we are increasing our full-year 2026 revenue framework and expect to achieve adjusted total revenues of between $235 million and $275 million. As a reminder, our non-GAAP adjusted total revenue excludes Sanofi Supply Sales royalties and milestones. This means there may be revenues in 2026 that are additive to our expectations. That said, we believe in 2026 Novaksa Vid royalties will grow significantly as compared to 2025. At midpoint, our full year 2026 revenue framework for adjusted total revenues is $255 million. This increase of $5 million at midpoint relates to the following updates for 2026. A $5 million increase to adjusted supply sales as we see strong demand for Matrix-M from our commercial partners. A $10 million increase to other partner-related revenues as we expect additional royalties and milestones from Takeda and Serum Institute. And finally, a $10 million reduction to partner R&D reimbursements as we deliver efficiently on our partner-related performance obligations. Looking ahead to the second half of 2026, we expect the majority of our remaining revenue to occur in the fourth quarter as driven by the COVID-19 vaccine season. Today, we are also improving our full-year 2026 combined GAAP R&D and SG&A expense guidance. At midpoint, we expect to achieve results of $390 million, a $10 million reduction and improvement to our prior guidance. On a non-GAAP basis and net of partner reimbursements, we reiterate that we expect to achieve results of $325 million at midpoint. Today, we are reiterating our three-year combined non-GAAP R&D and SG&A expense guidance. Looking forward to 2028, we expect to reduce our non-GAAP R&D and SG&A expenses by over 200 million, reflecting a 50% decrease when compared to 2025. Importantly, in 2026, we are already operating at an approximately 200 million core spend profile when excluding costs tied to completion of partner and APA performance obligations. As these near-term activities are completed, we expect to be in a position to further decrease these costs. To reach our 2028 Lean and Agile operating model target, We anticipate having less than half the headcount as compared to the first quarter of 2026 and are exploring an over 50% reduction to our operating footprint via consolidation of buildings and laboratories. This could result in a non-cash fixed asset write-off of up to $35 million in 2027 in addition to our existing expense guidance. As a reminder, In 2025, we recorded non-cash write-offs of $98 million to a separate P&L line item called impairment of assets held for sale. For the time being, we suggest analysts and investors use this same P&L line item as part of their forward-looking models until we refine our expectations for both the amount and accounting for these potential non-cash write-offs in 2027. Today, we are reaffirming our key financial objectives that support our intent to drive long-term shareholder value. Our strategy is to drive revenue from a diversified set of licensed partners and products to deliver long-term cash flow growth. To enable this strategy, we are making disciplined R&D investments that strengthen the matrix platform, advance differentiated R&D programs, and generate data to support new partnering opportunities. When Novavax engages with new partners, we expand investments in R&D via partner funding of new vaccine programs. Key financial metrics to support our growth strategy include achieve 2028 combined non-GAAP R&D and SG&A expense of $150 million to $200 million. reach non-GAAP P&L profitability as early as 2028, pay off pandemic-era EPA liabilities by the first quarter of 2029, and maintain at least two years' cash runway. As a reminder, the timing of the Sanofi kick launch is a primary contributor to our potential non-GAAP profitability. We look forward to sharing additional updates as we improve Novavax's financial performance, cost structure, and strength to deliver shareholder value. With that, I'd like to turn the call back over to John for some closing remarks.

Thank you, Jim. In closing, we're excited about the momentum we continue to build across our business. We've transformed Novavax into a leaner, more focused company, strengthening our balance sheet. and continued to execute against our corporate strategy. MatrixM continues to gain scientific and commercial validation and we're seeing sustained interest from both existing and prospective partners. At the same time, we're advancing a focused internal pipeline and are excited about the potential of our C. diff vaccine candidate. We believe this reinforces that our future has the potential to be less reliant on any single product, program or partner Thank you for joining us. We are creating the potential to have a remarkable impact on public health and a legacy we can all be proud of as employees and contributors to this journey. We would all like to thank our employees for their efforts and our shareholders for their belief in our company. And with that operator, we'd be happy to open the line for questions. Thank you.

Thank you, Mr. Jacobs. And a reminder to our phone audience that it is star and one on your telephone keypad if you'd like to ask a question. We will hear first today from the line of Roger Song at Jefferies.

Hey, team. Congratulations on the progress. This is Nabil on for Roger. Lots of exciting progress in the commercial engine, the partnerships, and the pipeline. So I guess maybe two questions. First, as we look at Sanofi entering its first commercial season, curious if you can give any more color on the seasonal supply, And then on Sanofi and the Phase 3 advanced discussions on the combo, what needs to be aligned for that Phase 3? And then, again, if you could just talk about that market opportunity, especially you mentioned international as well. Thank you. Thank you.

Jim, why don't you take the first part of the question on the upcoming season?

Absolutely. Nabil, thanks for the question. We continue to see the COVID marketplace as just an incredibly significant vaccine marketplace opportunity. A reminder, this is a top five global vaccine market. It's been in the $5 to $7 billion the last few years. You know, as we look forward, I think that the entrant of our partner Sanofi, who, as you know, is the market leader in the enhanced flu marketplace, flu being the anchor to the respiratory season, we're really looking forward to what they're doing to bring a protein-based option to the marketplace, both in the U.S. and globally. Of course, we can't speak for our partner, Sanofi, but we're seeing through, really, their actions, investing in things like the comparison study we discussed last quarter, where they went head-to-head with mRNA and showed the very favorable profile of nivaxavid. Thank you, Jim. And like Jim said, they're leaning in, not away, regarding Sanofi as our partner. Outstanding partnership, positive energy there, and in the case of KICC,

We can't speak on behalf of our partners on specifics, actually. We can't have the specifics on the background on their R&D program and other things. We're technically a competitor in the kick arena because of our own vaccine asset there. But in this case, Sanofi has confirmed with us their intent to be among the first movers in the combination vaccine market arena. and that they are in advanced discussions with regulators regarding phase three study timing for a combination vaccine program. Very encouraging, very exciting and building upon the news from Moderna yesterday evening on the approval for their flu vaccine. We see that as a positive momentum in the U.S. environment from a regulatory perspective for seasonal infectious disease arena.

Great, thank you.

We will take our next question from the line of Paul Kuhn at TD Cowan.

Thanks. Congrats on the quarter, guys, and thanks for the question. Paul Kuhn here on for . So I just was wondering if you guys could provide any additional color on your potential clinical trial design for C. diff vaccine in phase one, primarily what endpoints are you guys going to be looking at and what do you want to see there before initiating a phase three trial? And I'm just curious if you guys have embedded any potential phase two or three CDIS costs in your 2028 operating expense framework. Thank you.

Bob, why don't you take the first part of the question on trial design commentary, and then, Jim, you can talk about runway on costs.

Sure. So for the phase one trial design, we're not really discussing details of that, but I would just say that it's – A fairly standard dose escalation, safety, characterizing safety, and demonstrating that safety profile is adequate to take further into advanced development.

And Bob, to that point, as we look at advanced development, which certainly could be as early as 2028, the answer to funding capacity is yes, we have contemplated the ability to keep programs, exciting programs like CDIF moving in our forward-looking guidance.

And that's exactly, Jim, why we provided a range in that forward-looking guidance on expenses. But we're contemplating within that range and to operate the company within the range that's been provided. That's our intention.

Great. Thanks, guys.

Next question will come from Pete Stavropoulos at Kenner Fitzgerald.

Good morning, John, Jim, and team. Congrats on the progress, and thank you for taking our questions. First one that I have. First question that I have is, you know, this will be the full, it will be a full commercial year for Nevaxavit under Sanofi control, as you mentioned. How much of the 2026 COVID vaccine uptake assumptions depends on contract wins versus physician-patient driven uptake, you know, including the DTC outreach that was mentioned?

Jim, you want to take that one?

Hey, certainly. You know, very astute question about the marketplace dynamics. This continues to be a consumer and retail-driven marketplace in the U.S. in particular. We're looking at 85% or more of decision-making shots coming through the retail market, and this is why this direct consumer advertising by Sanofi this year, emphasizing consumer Not just exceptional efficacy but also great tolerability profile we think is exceptionally important. As we watch the way Sanofi has built their market-leading flu vaccine business, we've witnessed the following. One, they invest in data. It's a long game. They're methodical. And so that's what we're anticipating from them. We saw it in sort of them testing the marketplace last year. investing in the compare data, now rolling out their direct to consumer. And so that's our anticipation. This is a multi-year long game. We look forward to seeing what they're going to do this fall, but importantly, bring a protein-based vaccine to the market in a meaningful way.

All right. Thank you for that. And just one additional question. Sorry, John, were you going to say something?

No, just to build on that, the U.S. is the most important market. It's primary markets. They're also launching in other markets this year, like Canada, Germany, United Kingdom, and it'll be a global footprint over time that continues to expand, and like Jim said, long-term methodical investments. And Elaine, you had one additional point to add.

Yeah, just more specifically, Pete, they've contracted with all the major retailers in the U.S., and so we expect to have a robust season as a result of that. So thanks.

All right, thanks. And just one question, probably for Bob. and it has to do with a C. diff vaccine candidate. One of the design attributes you have alluded to is the possibility of mucosal immunity. Just curious to hear what from the preclinical data sort of gives you confidence that you would be able to develop mucosal immunity, which I assume is IGA response. And are you developing this candidate as an ingester? Then the reason I ask is what gives you confidence, again, that you can generate a robust mucosal response through that route of administration?

So, yeah, one of the things we're looking at preclinically and we intend to look at in the clinic is whether or not the vaccine can induce mucosal immunity. As I mentioned on the last earnings call, we do see evidence of that in some of the preclinical models. But, you know, preclinical models are limited, as you know. So when we see it in our human studies, I think we'll talk about it more if we see it in human studies.

Thank you for taking our questions and congrats on the court.

Our next question will come from Alex Stranahan at Bank of America. Please go ahead.

Hey, guys. Thanks for taking my questions. Two from me. First, just on the 2026 revenue guidance, is there a point in the full season where you'll have better line of sight on Sanofi supply sales where you provide concrete guidance here or will just maybe be easier to do next year after we get a full year of Sanofi commercialization. And second, has strain selection happened for Nuvaxvid yet? What's the appropriate variant match will be for this fall, whether that's XFG or something else? And thoughts around preparedness to scale manufacturing for this season's strain would be great. Thank you. Then maybe you could take the question on guidance.

Hey, certainly. I would start by reiterating that we are, you know, exceptionally excited to have Sanofi as our commercial partner with Navax Avid. We're not in a position, however, to guide for them. And it's also true that we're not able to speak for them on strain selection. What we can say is as this year is our final year of offering commercial support directly to Sanofi, they're well prepared. You know, they're well prepared to be out there in line with the competitors at the start of the season and do what they do best, right, bring important vaccines to the marketplace. Regarding your question about, hey, in the future, might we guide to Sanofi, you know, we haven't guided to anything beyond 2026 at this time. But importantly, we, I believe, have set a precedent that we're not at this point in a position to speak on their behalf. But as they, over time, begin to guide, of course, I think that's going to be helpful to all investors.

And then, Alex, your second question was on strain selection. If I would paraphrase the question or just frame it a little differently, you know, do we have the correct strain and a vaccine that's viable for the season, Bob?

Yeah, the vaccine that Sanofi will be – Distributing in the U.S. and beyond matches the strength selection of the U.S. and other regulators.

And we're on track for delivering doses to Sanofi. Very good. Thank you.

We'll take our next question today from Tom Schrader at BTIG.

Good morning, everyone. Thanks, and congrats on all the progress. Returning to C. diff, kind of a broader question. Is that a treatment vaccine? Is that a prophylactic vaccine? Can you give us a little sense of if it's prophylactic, who it would be for? Is there a clear population that's had a lot of infections? And then separately on your oncology vaccines, we all know those are hard. Do your partners want Matrix M as it is for these programs, or are they all asking for licenses to kind of Use the components of Matrix-M and kind of experiment. The question is, are you close to the final adjuvant in oncology vaccines, or are you licensing people to do research in adjuvants related to Matrix-M? Thanks.

Bob, why don't you take the question on C. diff first?

Yeah, so with C. diff early days and generally, I think the general philosophy is that we're looking at preventive vaccines, but we're developing the database as we speak. So we'll consider all the various options.

I'm the second question, Tom, regarding Matrix. Look, we have reason to believe we're optimistic about what we're seeing early on. Novavax is engaged. We are engaged in internal research and experiments with Matrix in oncology across multiple target types, and we're looking forward to generating additional data. We've seen some early data that encourages us, but we're not ready to share that in the public domain yet. But as you can imagine, we use data of that nature and data from some of our earlier partnerships in the past that involved oncology to interest and entice a recent partner who signed up with us through an MTA in a collaboration who's a top 10 pharma company and a global leader in oncology. They are also in a position to explore MatrixM. across a variety of oncology targets. So we look forward to them engaging and then completing that work through our own work coming to fruition. What we're seeing so far, we're very encouraged by, and we believe that some of the early data we were able to share under NDA With that collaboration, that partner through that collaboration encouraged them to take a look as well, and they're a leader and an expert in oncology. It's absolutely exciting. We appreciate the energy of your question and wanting to learn more. We look forward in the future to sharing some of what we're learning as we continue to build the library of knowledge and evidence around the potential for Matrix in this arena. Thank you. All right. Thanks for the detail. I appreciate how competitive this all is.

We'll move next to Jeff Meacham at Citi. Please go ahead.

Hey, guys. This is Nishant Vaughan for Jeff. Thank you for taking our question. Going back to the combo vaccine, I know you mentioned some of the intent to pursue, but, you know, given the recent leadership change there and the portfolio review, what tangible steps from then give you confidence that the combo vaccine remains a strategic priority? And are there any remaining internal decision points before the phase 3 trial starts? Thank you.

Could you repeat the question, please? We had a little bit of audio difficulty here. Thank you.

Yeah, so on the combo vaccine, I know you mentioned, you know, Sanofi's intent to pursue the combo vaccine, but, you know, there has been recent leadership change over there, and then the portfolio review What tangible steps from them gives you confidence that the combo vaccine remains a strategic priority? And are there any remaining internal kind of decision points before the phase three start?

Thank you for your question. So, to paraphrase that then, internal changes sound to be new CEO, new head of R&D, promotions, in fact, of the global vaccine head was promoted and got even more responsibility. They're leaning in, not away, as Jim said and as I said. If anything, we're seeing more engagement behind the scenes from Sanofi rather than less, despite the changes. In fact, perhaps even with those changes. So we're really encouraged, more so than ever before. And by the way, we do not speak on behalf of partners. We are extremely cautious and conservative in what we say about the intentions of those we're working with. A part of our strategy, it may be frustrating at times for investors who'd like to hear more sooner, of course, but we can't share many of the things we know that our partners are working on and doing because we're under NDA. When we do make a comment like we have about Santa Fe's commitment about their intention to be one of the first in the kick combination arena market in the U.S. and that they're in late stage discussions with regulators, those words are signed off on by our partner. They are provided to us by that partner, and we are enabled to then share it with you. So those words are coming from Sanofi themselves. Any further questions about it, you definitely ask them when you circle with them. But what we see behind the scenes is leaning in, stronger commitment, a strong understanding of our technology and its capabilities. They're an outstanding partner, and we're excited about the potential of the partnership as we continue to move forward.

Thank you. And then follow-up. Is the combo vaccine, like the phase two trial start in 26 still the base case? And what exactly needs to happen for you to earn the $125 million milestone? Thank you.

We don't guide to timing of our partners on studies. Jim, did you want to comment on milestones?

Well, reiterating we don't guide. However, we agree it's going to be an exceptionally important catalyst for us. And in fact, you know, when you think about I was talking about the size of the global vaccine markets, when you combine COVID plus flu together. So think about it. We're talking about two, five, six billion dollar marketplaces. You turn this into a top one, top two market. It makes sense to invest. It just does. And so we believe that this advancement to fee-free, when Sanofi makes that announcement, is a really important unlock of value creation for our company.

Thank you.

We will hear next from the line of Hardik Parikh at J.P. Morgan.

Hey, everybody. Thanks for the question. There's a couple of high-level ones. One is just on the COVID-19. Jim, Bob, and Elaine, you want to address the first part of the question?

I really appreciate the question because what it does is ask, hey, talk about the burden of disease and the significance and the importance of continued vaccination and the vulnerability of certain age groups, in particular the over 65. You know, something I would point any investor or anyone to is the recent BRBPAC where manufacturers shared and, of course, industry experts shared just the continued burden of disease, especially in that over 65 when it comes to deaths, hospitalizations. And as that continues, we think we're seeing broadly continued investment in kick programs across major vaccine manufacturers for that reason.

In fact, GSK made commentary about their intentions around a combination vaccine in their recent earnings call. We've seen Moderna get approved in Europe. We just saw the flu approval in the U.S., which bodes in a positive way, we believe, in the U.S. marketplace for seasonal infectious disease arena. Elaine, additional comment?

The only thing I was going to address, Hardik, is I think the second part of your question, and we do not provide guidance to Sanofi on their KIC program. As John had mentioned earlier on in the Q&A session, we have separate programs. entities, and we have our own combination influenza kick program, so we do not advise. Thanks for the question.

Thank you. And a final reminder to our audience, that is star and one if you would like to ask a question. We will hear from Mayank Mantani at B. Reilly Securities.

Yes, good morning, team. Thanks for taking our questions. I appreciate you squeezing us in. And on the partnership front, you know, you have had many updates. Maybe just quickly on the mRNA flu label, you know, and the regulatory progress that you've had in the recent months, I was really interested to hear your specific thoughts and implications on how, you know, a phase 3 kick or even a flu program, Next Generation, could be designed and is there actually an approval path in a 65 plus age group based on a immunogenicity surrogate endpoint if you could maybe just comment on that? And then on the, you know, Pfizer partnership, you know, I know you're contractually restricted to talk about the fields that they're working on. But, you know, I was just curious if anything to watch out for coming there, you know, if you could just give some update there. And lastly, on the, you know, the 30 plus fields under evaluation, really curious to hear, you know, how maybe quarter-over-quarter or year-over-year some of these evaluation work is progressed, you know, and timelines for, you know, moving into a licensing kind of format, how that's kind of progressing, that would be very helpful.

All right, three questions from Mike. Bob, did you want to take the first one on his question regarding label and flu and any read-through to kick programs in the U.S. marketplace?

Just, you know, commenting at a high level... The fact that, you know, we've seen this recent activity from the FDA, I think is encouraging. The flu vaccine, you know, plays in the same space where we are in terms of seasonal respiratory virus vaccines. So it's encouraging for all of us, right, to see progression in that space. And I'll just maybe leave it there.

Elaine? Thanks, Bob. Thank you. For the second part of the question regarding the Pfizer partnership, we continue to collaborate with Pfizer and uphold our commitments based upon the license agreement that we have with Pfizer. And we're very, very excited about the progress that's being made. Can't speak any further to that, but, you know, we continue to support that partnership. And then the third part of the question was the 30-plus field. Again, that spans both infectious disease and oncology. And we're, again, very, very, very excited about the progress that's being made across the board with MatrixM in these experimentations. You know, each MTA is different. Partners evaluate different indications. They conduct different experiments, and they move with different timelines. Hard to say yet where that will end, but we're very, very excited about that progress. We don't guide to specific timing as any specific MTA. It really depends on the partner and how they conduct their experimentation. Thanks for the question.

Yeah, and regarding oncology, just one other comment that I think Tom, back to Tom's question on MatrixM, we found the final version of MatrixM for oncology. We believe MatrixM in and of itself as it stands today has potential in that arena, and we're exploring deeply its potential there. We're also looking at other approaches utilizing Matrix to expand the utility of it, add it to other things in addition. to see if we can broaden the utility both within infectious disease and in oncology. So, you know, we're turning over every stone. We're encouraged by what we're seeing across that front. But we really believe that the core matrix evidence that stands today has remarkable potential across a wide array of diseases. Jim, one other comment.

Hey, Mark. What I really like about your question is that what you're highlighting is that beyond the forward-looking catalysts that are in the control of Novavax, for example, entering the clinic with C. diff, some of the work we're doing on oncology have proof points. We have on a forward-looking near-term basis some really rich partner catalysts that also are critically important to unlocking value here in our company from major players. I mean, you're describing Sanofi, you're describing Pfizer, you're describing new emerging deals that can occur. And so the combination of those two, what we're doing ourselves, plus the catalyst-rich partner activities in the future, are some of the things that we're very excited about here.

Actually, since you mentioned, you know, applications of MatrixM, very quickly on the GSK's Shingrix dementia program, you know, they're launching a big one. I remember you've been working preclinical program on shingles. Maybe just give us an update on that and if that, you know, is part of any of these partnership frameworks you're working on. Thanks again.

Yeah, so, you know, we too are intrigued by some of those observations. I'll just, you know, again, indicate that these are observational studies. They're hypothesis-generating, so, you know, work remains to be done to really nail down whether or not there's a true causative association there. We, as you know, have a VZV candidate that we're developing still – Early, we're working towards confirming a lead candidate, and then our intent is to partner that program.

Great. Thank you, Dean.

And that concludes our question and answer session, and we do thank all of our participants who signaled today. Mr. Jacobs, I'm pleased to turn the floor back to you, sir, for any additional or closing remarks that you have.

Just a sincere and deep thank you to all of our employees at Novavax for their contributions today. and a deep thank you to all of our investors from our largest investor to our smallest. We appreciate each and every one of you, the belief in our technology and the confidence and patience you show as we continue to execute against what we believe is a robust strategy that has a chance to deliver significant value for all of our stakeholders. Thank you for your attendance today, everyone.

Ladies and gentlemen, this does conclude this NOVAVAX second quarter 2026 financial results and operational highlights conference call. We thank you all for your participation. you may now disconnect your lines and have a great day