Good morning and welcome to the Novavax third quarter 2026 financial results and operational highlights conference call. All participants will be in a listen-only mode. Should you need any assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then the number 1 on your telephone keypad. To withdraw your question, simply press star 1 again. Please note, this event is being recorded. I would now like to turn the conference over to Jim Kelly, Executive Vice President and Chief Financial Officer. Please go ahead.

Good morning and thank you for joining us today to discuss our third quarter financial results and operational highlights today on November 5th, 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 our 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 presentation. Descriptions of the risks and uncertainties associated with Novavax are included in our SEC filings. These can be accessed through our website. Joining me today are John Jacobs, our President and CEO, Elaine O'Hara, Chief Strategy Officer, Dr. Bob Walker, Head of R&D, and Jim Kelly, our Chief Financial Officer. I would now like to hand the call over to John.

Thank you, Naina, and welcome, everyone. As we near the end of 2026, I'm pleased with the progress we have made this year across the three pillars of our strategy, partnering our vaccine technology, driving targeted and capital-efficient R&D innovation, and maintaining a lean and agile operating model. For those new to our story, Novavax is a vaccine technology company focused on creating long-term value through partnerships. We believe our technology can underpin a broad range of vaccines in infectious disease, from viral to bacterial, and we are in the early stages of exploring its potential in oncology. By combining our own innovation with that of our partners and leveraging their manufacturing scale and commercial reach, we aim to expand access to our technology, unlock new opportunities, and build a legacy of lasting impact on global health. Our technology platform is the engine behind our business, built on a proven foundation in infectious disease. Today, it is used in two commercial vaccines, Nuvaxavid for COVID-19 and R21 Matrix-M for malaria. Both have demonstrated protection against serious disease and favorable tolerability at population scale, with R21 Matrix-M extending that impact to children as young as five months old in malaria-endemic regions. Our technology is also being applied in some of the most attractive vaccine markets. Sanofi recently initiated its Phase 3 influenza COVID-19 combination vaccine trial in Europe, and Sanofi management confirmed to us that they are targeting a U.S. Phase 3 start in 2027 to support U.S. approval. The trial in Europe utilizes Novavax's differentiated COVID-19 vaccine and Sanofi's market-leading Fluzone high-dose influenza vaccine. The initiation of the phase three kick trial triggered a one-time $125 million milestone to Novavax and represents a significant future opportunity. This opens up even greater potential with the global flu and COVID-19 markets having a current combined value that exceeds $10 billion with significant burden of disease. Beyond viral diseases, we intend to enter the clinic with our differentiated C. diff vaccine candidate as early as next year. With no approved vaccine today, C. diff accounts for roughly half a million cases and over 20,000 in-hospital deaths annually in the US alone. This represents a significant unmet medical need and an opportunity for our technology to help millions of people in what could become a large and significant vaccine market. Vaccine innovation has always been at the core of Novavax. We are already an established vaccine technology company and we plan to expand further in infectious disease with our partners and MTA collaborators while advancing our early work in oncology by bringing in new partners, deepening existing partnerships and potentially enabling new vaccines. We see significant opportunities for our technology to drive long-term value creation. Now let's take a few moments to touch upon some of the progress we have made over the past few months on the three pillars of our strategy. Starting with pillar one, partnering our vaccine technology. As already noted, Novavax earned a $125 million milestone following the initiation of Sanofi's pivotal phase three kick trial in Europe last month. We are on track to earn an additional $75 million milestone upon the completion of Sanofi's manufacturing technology transfer in mid-2027. Sanofi kicked off the 26-27 COVID season with Novavaxavid in the U.S., supported by expanded promotional efforts. They also introduced Nuvaccidid in select international markets, while Takeda continues to successfully promote the vaccine in Japan. We're pleased at the level of collaboration with Pfizer and look forward to continued progress on that front, with the potential to share more about the opportunities ahead as that partnership continues to evolve. And our MTA collaborations continue to advance, with interest from companies and organizations in exploring our technology across a broad range of disease areas. Elaine will elaborate further on our progress within this pillar in a few moments. And now pillar two, targeted and capital efficient R&D innovation. Our work in R&D at Novavax focuses on three objectives. First, building a library of data to better understand how and where our existing technology can have an impact. Second, expanding the utility of our MatrixM technology platform. And third, advancing select innovative vaccine candidates. We're pleased with our progress in all three of these areas to date, and Bob will elaborate further during his commentary today. And finally, pillar three, lean and agile operating model. Underpinning all of this is our financial discipline. This quarter, we raised our full-year revenue framework and improved our expense guidance, bringing more clarity to our outlook. We continue to drive down costs while maintaining core capabilities that we believe are critical to enable the successful execution of our strategy. Jim will take you through our performance and updated guidance later in the call. In closing, we're building a growing set of opportunities with existing partners, potential new partners, and from our own platform across infectious disease and potentially oncology. Over time, it is our vision to see our technology embedded in a diversified set of commercial vaccines and development programs with multiple partners. And with that, I will turn the call over to Elaine to provide an update on our partnership efforts. Elaine?

Thank you, John. I'll start with the news we announced last week. Sanofi has initiated its phase three influenza COVID-19 combination vaccine trial, earning Novavax a $125 million milestone. The trial, being conducted in Europe, is assessing the safety and immunogenicity of Nuvaxavid in combination with Sanofi's leading flu vaccine, Fluzone Hidos, also known as Effluelda, in adults aged 60 and older. Sanofi has stated that they intend to be one of the first movers in the combination vaccine segment, and we believe this is an important step towards that goal. This milestone reflects how Novavax and Sanofi continue to successfully execute on our agreement, which has to date generated over $1 billion in revenue for Novavax. Sanofi has also confirmed with us their intent to target initiation of a U.S. phase 3 trial in 2027 to support U.S. approval. As a reminder, we are eligible to receive a one-time $225 million milestone on the first commercial sale of a kick product in the U.S. While Sanofi has communicated preliminary expected timelines, these will be subject to their subsequent updates on clinical activities and, of course, U.S. FDA regulatory pathway. More broadly, we continue to make progress on our partnership with Sanofi. After select market efforts last year, Sanofi has kicked off the 2026-2027 commercial launch of Nuvaxavid with improved awareness efforts in both breadth and depth. The focus is on building awareness of the only non-mRNA COVID vaccine option in the U.S. with its associated favorable tolerability profile. Sanofi is bringing their expertise as one of the largest vaccine companies in the world to this market through a seasoned vaccine sales force from one of the world's leading vaccine businesses, availability at major retailers like CVS, Walmart, and Costco, running select pilots across retailers to generate learnings that can help build awareness and uptake over time, kicking off DTC efforts like co-branded advertising on TV and online, creative awareness efforts from Serve Up Protection Campaign with USA Pickleball, to social content with NBA champion Carl Anthony Towns from the New York Knicks to drive people into pharmacies and setting the stage for launches in select ex-US markets in 2026 and beyond. We are pleased with the level of investment that our partner has been making to build awareness and begin to penetrate this market and with the intent of building meaningful market share over time. We expect awareness, access and adoption to build season upon season with Sanofi taking a methodical approach and learning from markets and channels where Nuvaxavid gains traction. In Japan, Takeda continues to build on last season's momentum where Nuvaxavid was the second most utilized COVID-19 vaccine during the 2025-2026 season. We look forward to Takeda building upon that momentum this year in the world's third largest pharmaceutical market. Exploratory work using MatrixM with partners and MTA collaborators continue with multiple pharmaceutical and biotechnology companies, including Pfizer and Sanofi. Preclinical studies are underway across infectious disease and oncology, which continue to generate evidence and potentially create the next license opportunity. That same partnering lens applies to our own pipeline, like our C-diff candidate. Our primary intent is to out-license our internal candidates for new or expanded partnerships. So in that sense, every program we advance internally is designed to also be an engine for partnering. And so with that, I'll pass it over to Bob to discuss our R&D progress in greater detail. Bob?

Thanks, Elaine. It's an exciting time at Novavax as we explore the potential of our technology platforms to drive vaccine innovation. Vaccine platforms are reshaping how the field develops new vaccines, and we believe our technology can play a central role in that shift across infectious disease and potentially oncology. That was the focus of a panel I joined last month at the World Vaccine Congress Europe, where industry leaders, regulators, and vaccine experts reinforced the need for a diverse set of vaccine platforms and the important role of adjuvant in Next Generation Vaccines. John outlined the three strategic objectives of Novavax's R&D efforts. First, building a library of data to better understand how and where our existing technology can have an impact. And this includes generating data for potential partners that may be compelling for their own vaccine programs. Second, expanding the utility of our matrix technology platform and third, advancing select innovative vaccine candidates. The first two objectives go hand in hand. As we grow our library of data, we're also systematically exploring new adjuvant approaches and identifying the specific use cases where matrix M can add the most value. We view that library as a strategic asset and as the evidence grows, we believe so too does the potential for new and expanded partnerships. In infectious disease, as we shared last quarter, we're systematically evaluating Matrix M across commercialized infectious disease vaccines in large markets. These studies are designed to show potential partners where adding Matrix M may meaningfully improve performance. This is supplemented by the work that our partners and MTA collaborators are doing. In oncology, we initiated exploratory studies with matrix M alone and in combination with immunomodulators, including survival studies in animal models. And our MTA collaboration efforts are generating early data. While it is still early days, we're excited about our initial observations and are continuing to explore MatrixM's potential utility in the cancer vaccine field. As a reminder, the central challenge in oncology is generating cellular immune responses strong and durable enough to fight tumors. We believe MatrixM may help the body's own defenses to seek out and attack tumor cells by activating the innate immune system, Thank you for joining us. is to expand the evidence base of our technology platform and fuel the next generation of partnerships. We hold the industry's most extensive data set on MatrixM, which is deep and broad and built over decades. And that data is core intellectual property. We plan to be deliberate in how we use it, sharing directly with potential partners under CDA, where it creates the most value, and selectively through additional peer-reviewed publications. Our third objective is advancing select vaccine candidates where the medical need is great and the opportunity is compelling for our technology to potentially offer a differentiated option. Our matrix M adjuvanted C diff vaccine candidate is the first candidate we've selected to advance under the new strategy. And we anticipate entering the clinic as early as 2027. In September, we presented pre-clinical data at the International C. diff Symposium on our multivalent candidate, which targets multiple components of the bacterium, including the toxins that drive disease. We've consistently observed high titer serum neutralizing antibody responses, mucosal IgA from the gastrointestinal tract, and protection from lethality in two animal challenge models. We believe our vaccine construct has the potential to cover over 90% of circulating strains and provide broader protection than approaches that target the toxins alone. We're entering an exciting period for Novavax with the potential to help develop vaccines across more diseases than ever before. I look forward to sharing more progress in the coming quarters. I'll now turn the call over to Jim to discuss our financial results.

Thank you, Bob. Let me begin by highlighting several significant updates that we believe demonstrate the progress we're making on our growth strategy. Today, we shared our continued progress with our partners commercializing both Nevaxavid and R21. Our expectations to achieve near-term milestones from Sanofi, totaling $200 million, that support our expected cash runway into 2029, and another quarter of meaningful progress towards our cost structure targets and financial strength goals. Specifically, we achieved a 41% year-over-year reduction to gap R&D and SG&A in the current quarter and ended the third quarter with $676 million in cash and accounts receivable. In addition to our third quarter results, we are raising our full year 2026 revenue framework by $145 million to $400 million and improving our full year 2026 financial guidance by $5 million. First, I'll walk through our revenue performance. Our third quarter total revenue of $68 million compares to $70 million in the prior year. In the current quarter, we saw growth in multiple revenue categories that provided an offset to a significant reduction to R&D reimbursement as Novavax nears completion of our support for Sanofi's clinical and 2026-27 COVID-19 season activities. Turning to our full financial statement results, For the third quarter of 2026, we recorded a net loss of $31 million as compared to a net loss of $202 million in the prior year, resulting in $171 million year-over-year improvement. A summary of the key drivers of the year-over-year change to our third quarter net loss highlights meaningful improvements to many aspects of our financial performance. Starting with a reminder that in the third quarter of 2025, we recorded 126 million in non-cash charges related to asset impairments and debt extinguishment. Turning to the third quarter of 2026, we saw a 42 million reduction to R&D reimbursement that I noted earlier, and an 87 million improvement from changes to all other P&L categories, including partner-driven revenue growth, Significant operating expense reductions and other income expense. We believe these third quarter 2026 trends reflect the continued strong execution of our growth strategy and financial performance. On the operating expense front, we continue to reduce our cost structure in the third quarter of 2026 with a 41% and 14% decrease to combine R&D and SG&A on a GAAP and non-GAAP basis, respectively. Importantly, we made significant reductions to both our R&D and SG&A expense profiles. The 46 million and 47% reduction to GAAP R&D expenses in the third quarter highlights our ability to drive down our cost structure upon the completion of select partner support activities. We believe these improvements for our operating efficiency also highlight that we're on track to deliver our full year expense guidance. Today, We're raising our full-year 2026 revenue framework by $145 million and expect to achieve adjusted total revenue of $400 million at midpoint with a range of between $385 million and $415 million. The $145 million increase to adjusted total revenue at midpoint was driven by, first, the addition of the $125 million milestone associated with the phase three trial initiation of Sanofi's KICK program in Europe. A $5 million increase to Novavax EVID product sales as we completed our Novavax legacy APA sales for the season. A $5 million increase to adjuvant supply sales on continued strong demand for Matrix-M from our licensed partners for the commercial products. Of note, the 2026 Matrix M demand at midpoint of 55 million is likely up to 15 million higher than our expected future run rate due to order timing and batches purchased to enable qualification of new manufacturing sites by our partners in 2026. And finally, a 10 million increase to adjusted licensing royalties and other primarily driven by the deferred royalty revenue recognized in the current quarter. As a reminder, our non-GAAP adjusted total revenue excludes Sanofi's supply sales, royalties, and future milestones. This means there may be revenues in 2026 that are additive to our expectations. A few comments as a preview to our 2027 revenue framework. While we do expect to include the 75 million Sanofi tech transfer milestone in the third quarter of 2027, we do not expect to provide guidance for Novavax's APA product sales. In addition, we expect R&D reimbursement and Sanofi amortization to become very small contributors to revenue and to end during 2027. With those updates, we intend to follow a revenue framework very familiar to 2026. We are also improving our full year 2026 combined GAAP, R&D, and SG&A expense guidance by $5 million and expect to achieve results of $385 million at midpoint. On a non-GAAP basis and net of partner reimbursements, we reiterate our midpoint of $325 million and are narrowing the range to $315 million to $335 million. Looking ahead, we are also 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 greater than 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 partner-related activities are completed, we expect to be in a position to further decrease our total spend. To reach our 2028 Lean and Agile operating model target, We anticipate having less than half the headcount as compared to our first quarter 2026 and are exploring an over 50% reduction to our operating footprint via consolidation of buildings and laboratories. This could result in non-cash fixed-asset write-offs of up to $35 million that we anticipate will occur during 2027, and this is in addition to our existing non-GAAP combined R&D and SG&A expense guidance. Depending on the final P&L accounting for these non-cash write-offs, plus approximately $5 million of expected R&D reimbursement, this could translate into 2027 GAAP combined R&D and SG&A of up to $265 million at midpoint. I'll finish by highlighting are financial objectives to drive shareholder value. You heard today our progress towards advancing our growth strategy on many fronts, including the update that Sanofi has confirmed to Novavax their public statements regarding their intent to start a U.S. kick phase three in 2027 and the potential for a U.S. kick commercial launch in 2029. As a reminder, Novavax does not have access to the detailed plans, timelines, or activities related to a Sanofi kick vaccine and is reliant on their public statements and confirmations. A U.S. Sanofi kick launch triggers a $225 million milestone payment to Novavax, and its assumed timing is currently a primary contributor to the timing of future Novavax non-GAAP profitability. That said, We are updating our non-GAAP profitability timing expectations to align with this new information from our partner. 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. As we head into the end of the year, We look back on 2026 with a great sense of accomplishment at Novavax. We achieved a lot this year, and in doing so, we believe we have positioned the company well to continue positive momentum via the execution of our growth strategy. This year, we added Pfizer as a partner, earned a $125 million milestone following the Phase 3 kit trial initiation by Sanofi. and expanded our MTA collaborations across infectious disease and into oncology, while we continue to reduce costs to support our lean and agile operating model. Looking toward 2027 and beyond, we see multiple potential catalysts, including earning additional milestones from existing partners, Sanofi, Pfizer and Takeda, continued royalties from Nuvaxavid Commercial Performance, potential clinical entry for C. diff as early as next year, and the advancement of select vaccine candidates in our portfolio. In addition, we continue to pursue new partnerships and generate data to explore where MatrixM can add value in infectious disease and potentially oncology. Our team's hard work and focus on the execution of our growth strategy continues to build a strong foundation for Novavax. The purpose of every interaction we have with current and potential partners is to provide multiple opportunities for success as both we and they continue to evaluate the applicability of our technology. And by the way, for those opportunities that do succeed, we believe they could equate to significant value creation over time. We are excited about the level of interest we are seeing in our technology, the ever-growing library of supporting data, and the potential to build a future Novavax with multiple partners and multiple products that may drive significant value and leave a global health legacy for years to come. Sincere thank you to our employees for their passion and dedication and to our shareholders for your continued belief in Novavax. We wish you all a wonderful holiday season filled with meaningful time and memories with family and friends. And with that operator, we'd be happy to open the line for questions.

Thank you. Thank you, Mr. Jacobs. We will now begin the question and answer session. To ask a question, you may press star then the number one on your telephone keypad. To withdraw your question, please press star one again. Your first question comes from Roger Song with Jefferies. Your line is open.

Good morning, guys. Thanks for the update and taking our question. A couple from us. So first is... This, you know, 2026, 2027 COVID season, how would, you know, things are approaching the peak vaccination now. And how would you comment from the learning related to Sanofi's strategy, positioning, and then how would you say in the coming years, particularly with the potential COVID flu combination getting approval? So that's on the COVID side. And then in terms of the MTA, any updates on the new MTA and then progress on the existing MTA? And then lastly, just on the C-Diff, nice to see your commitment into clinical. And then how should we think about the target product profile for your C-Diff versus other pipelines? And then what are the key amenities that you try to address? Thank you so much.

Thank you, Roger. Appreciate it. Jim, do you want to take the first question on COVID season learnings and pull through to future performance?

Hey, certainly. and thank you for the questions, Roger. So with the COVID season, you know, this is a critically important season in the 26, 27 globally. I think everyone's looking at the marketplace, really looking to understand where are we with stabilization in addition to, hey, how does Novavax and all the different COVID vaccines performing? So why don't I start first with some market perspective? You know, in 2025, this was a Thank you for joining us. All right. What are we seeing in the U.S. season to date? And this is through, I think, it's October 23rd doses, shots in arms. This is the IQVIA retail data. Well, the market is trending season to date at 94% of prior year. All right. And in the most recent weeks, including two, three weeks, the market on a weekly basis has been over 110% of prior season. So this is leading us to believe that the U.S. market is approaching a certain stabilization compared to prior years, which I think is beneficial to all, right? And glad to see the vaccination stabilizing. So that's the unit basis. What we're awaiting is the dollar basis. But based on, you know, the price taken by participants year over year, we're going to closely watch whether the market is flat up or, you know, it's possible down. But, you know, are we at a minimum stabilized on a dollar wise basis? So that's the U.S. market. Then when you go to the ex-U.S. market, which was about four billion last year. Hey, we're hitting the end of the APR with Pfizer, for example, in Europe. So I think we're really looking to next year to really better understand, you know, the major markets. We will say that, you know, we're pleased with the Japanese market, third largest market in the in the globe for pharma and Takeda, right, who has Novavax there and has the second most utilized vaccine there. Nevaxavid in Japan last season and looking forward to them building on that momentum. So back to Nevaxavid for this season. Well, what we're seeing season to date is the number of shots in arms are already equal to the full season last year. And we're just at the beginning. And so we therefore do anticipate materially higher shots in arms this season versus last season. And what I'm going to do is I'm going to hand off to Elaine, who leads our corporate development and alliances, to talk about what exactly are we seeing and hearing from our partner Sanofi.

Yeah, thanks, Jim. And just to round out the answer set. So with our relationship with Sanofi, obviously we've been working very closely with them all throughout the season and delighted to see The methodical building of share over this season. They've run some exclusive pilots among some major retailers and we're seeing very, very nice, you know, share returns and reorders for Nuvaxavid in certain pilot settings. And so that's very promising. And as it relates to Takeda, you know, that's an exceptional market for us as well. There are multiple clinics and hospitals that have selected Nuvaxivit as their primary vaccine in the Japanese market. So delighted to see the robustness of the season continue. And again, you know, with Sanofi, they continue to methodically approach this and build this market, build awareness. And Nuvaxivit is very much promotionally sensitive with their DTC campaign. and their outreach in these pilot markets. We're seeing a lot of receptivity and they're translating into shots in arms.

And what they're seeing there is very encouraging that they'd be able to build upon that as they go into subsequent seasons on what they're learning in select pilots where we see strong consumer receptivity and uptake based on different tactics they're experimenting with. encouraging news, and we really believe they'll be able to build meaningful market share over time methodically. Roger, two other parts to your question, just in the essence of time, we'll move to those right away, guys. MTAs, Roger was asking Elaine about progress there on potential new partnerships, et cetera.

Yeah, thanks for the question. Regarding MTAs, we're delighted to see the progress that our partners are making and the remarkable level of interest we see in the matrix technology. Our partners continue to explore the expanded utility of Matrix. And all of the preclinical testing that they're invested in is ongoing. And so we look forward to be able to share that data with you at a later stage when they become available. But at this point in time, again, delighted to see the progress across the MTAs in which we're engaged.

Thank you, Elaine. And Bob, do you want to pick up Roger's question on TPP? First, he did. Yeah.

Thanks, John. Yeah, so for C. diff, our target is to differentiate from the other options that are out there. And we're differentiating potentially on tolerability based on MatrixM's known tolerability profile. We're seeking to differentiate on immunogenicity, and part of that also has to do with local mucosal IgA responses. and we're seeking to differentiate on the basis of the breadth of strain protection. And we've talked about how we've intentionally designed our construct to cover more than 90% of currently circulating ribotypes and strains. The details of the TPP I'm not gonna get into other than to say that the target product profile is I consider to be aggressive. And we're not trying to match what's out there. We really want to be superior to what's out there. So that's our goal.

Thank you, Bob. And thank you for your questions, Roger.

Thank you.

Our next question comes from Mike Nedeljkovic with TD Cowan. Your line is open.

Hi. Thanks so much for the questions, Mike Nedeljkovic on for Chris Libianco. Hi, Mike. You're welcome. Hi. Thanks so much. I appreciate the time. I have two questions. One is on your early oncology efforts. You mentioned some initial preclinical studies of Matrix M alone and with some other combinations, but what's the potential to pair with personalized cancer vaccines, if any? And then a follow-up question on your response around your C. diff efforts. Maybe you could just speak to your level of confidence that you will be able to deliver a differentiated product, and what are the next go, no-go steps from here?

Thank you. Bob, do you want to take the first question on oncology?

Yeah.

I believe just to restate, Mike, you were asking about the potential of our technology to be deployed into personalized cancer vaccine options. I think right now, Bob, we're in the early stage of exploration on MatrixM's potential in oncology, and depending on what we learn there, will learn more about where Matrix may fit into that emerging ecosystem where we may have traction. But Bob, did you want to comment on our potential there?

Yeah, so I would say that at this point in time, we're looking broadly across the oncology space. And that includes off-the-shelf as well as personalized approaches. I wouldn't rule out any of those. Again, it's early days, like John said. So, you know, we'll We'll hope to keep you informed as time goes on in terms of where we're seeing the best potential activity for Matrix.

Yeah, right. You want to see that best activity first, and then how that's deployed later, assuming success on activity, then that would come out to play. And then your second question, Mike, could you repeat for us, please? Thank you.

Sure. It's a follow-up on your comments around the CDIS target product profile. What's your level of confidence that you can deliver that given that it's early days and what are the next steps and more crucially, I guess, what is the next go, no-go decision level step? Go ahead, Bob.

Yeah, thanks. So our level of confidence is, I would say, appropriately matched to where we are in the development cycle. We're basing, you know, currently we're basing our confidence on the preclinical data, which continues to look encouraging and consistent. The next step is obviously to get into the clinic. And when we have those data, I think we'll be at another point for making that assessment.

Thank you, Bob. Thanks, Mike.

Thank you.

Your next question comes from Tom Schrader with BTIG. Your line is open.

Good morning. Congratulations on the progress. Obviously, the Sanofi kick comments are fantastic. A couple of nerdy vaccine questions. The C. diff, one of the crazy things about C. diff is the recurrence, like the bacteria itself doesn't sterilize from future infections. Does your vaccine, do you have at least a model how you might address that? Because people get these things over and over. It's kind of unusual. And then as a follow up, I'm just kind of curious if you see mumps as a sitting duck for Matrix M, the weakest part of MMR, people want to split up that vaccine and it doesn't last well. So I'm curious if you agree that that's an equal or an exciting target for you. Thanks.

Thank you, Tom.

Bob, do you want to take the question on C. diff? The question was, do you have any thoughts about addressing recurrence in patients who have that, and is that part of our thought process in our development program? Yeah, thanks.

So to answer your question, there are translational models for recurrence. We've incorporated that into our preclinical program. Recurrence is a high bar. I think we all understand that. But it's definitely one of the endpoints that we're looking at and will continue to be looking at.

And your other question, Tom, regarding mumps, what I would say is we continue to assess diseases in infectious disease that we could apply as well as oncology where we might be able to apply our technology. We're open-minded to that. We prioritize. There's quite a rigorous process we put together within Novavax to assess market potential, unmet need, potential of our technology to succeed, trade-off analysis on if we pursue a certain area. What are we not pursuing instead of that? We're looking to optimize value and return to our stakeholders when we make those decisions. So thank you for the suggestion. Look forward to the continued dialogue. Appreciate your questions. Great. Thanks.

Your next question comes from Jeff Meacham with Citigroup. Your line is open.

Hey, guys. Thanks for taking our question. This is Jarway Fang on for Jeff. Two questions, maybe one on the tech. Good morning, yes, guys. Two questions. First, in the tech transfer, maybe just help us understand maybe what operational work remains before the 75 million milestone is earned in third quarter of next year, and where do you think is the greatest remaining execution risk? And then second question is on the matrix and conversion. I guess, you know, what evidence or development milestones typically move an MTA collaboration into a paid license, and I guess maybe if you could give us a sense of how many current evaluations are maybe approaching that decision point. Thank you.

Jim, you want to take the first part of that question?

Actually, John, I'll take that. With the tech transfer, just from the Alliance perspective, we're working very closely with Sanofi and are delighted to say that we're transitioning through most of the activities that have to occur for the actual tech transition process. to occur in 2027, by mid-year of 2027 next week, or next year, I'm sorry. So all that work is ongoing and nothing on tour there. And again, we're just working through the process. So delighted about our opportunity to transfer our technology, as I said. mid-year 2027.

And Elaine, I think the second part of Jarway's question related to is there anything specific we could point to or guide to on what happens with the MTA arrangements we have, the experiments going on that would lead to potentially further licensing deals, et cetera?

You know, it's a great question. Obviously, it really depends on the partner. I had mentioned earlier on that all of the engagements that we have with our various partners as they progress through their experimentation set for each MTA is ongoing. There's a remarkable level of interest. There's a remarkable level of continued exploration of expanding the utility of our Matrix-M across both infectious disease as well as oncology, and we continue to be very pleased with that progress.

Yeah, Jarwi, it's obviously not a one-size-fits-all. Every company has different needs. Matrix M is being explored in a wide array of potential targets in infectious disease and early explorations in oncology for its potential there. Each company has its own strategy needs. And look, it's biotech. Part of our strategy is putting a lot of, to use a colloquialism, shots on goal to succeed, right? We want to put as many opportunities as we can on the table through this strategy. And in life and in biotech, not everything you try will succeed. Not every MTA will turn to a deal, not every experiment will be successful, but many of them could be. And so by having more shots on goal with multiple potential partners and our existing partners across multiple disease areas with a technology proven in many of those areas in infectious disease. And we're learning more about its potential in oncology. We feel we increased the odds for tremendous growth and success for Novavax over time. Appreciate your questions.

Thanks, guys. Once again, if you have a question, please press star, then the number one on your telephone keypad. Your next question comes from Mayak Montani with B. Riley Securities. Your line is open.

Yes, good morning, team. Thanks for taking our questions and recapping nicely. A lot you've accomplished this year. If I could also ask a couple more focused questions on C. diff and oncology. You know, just looking at your September symposium abstract, you know, you are testing a number of constructs here. You know, obviously the non-toxin antigen being part of, you know, some of these seem like a big part of the differentiation specifically to the, you know, the Pfizer effort. So I don't know if you could comment on how further along you are in prioritizing one particular candidate, and maybe just for development plan purposes, is this looking at the Pfizer development sort of the right way to think about how you progress phase one through phase three here? And then on oncology, you seem to be working beyond matrix M on additional formulations for, I guess, driving some CD8 T cell responses and tumor antigens based on your patent applications. I was just curious, Why, you know, TLR agonist combination make more sense versus maybe, you know, as you know, a lot of your peers work on checkpoint combination as an immunomodulator. Maybe you're doing both. If you could just clarify those topics, that would be great.

Thank you, Mike. Bob, why don't you start with oncology first? I believe, you know, matrix M alone versus in combination with things like TLRs, checkpoint inhibitors, and what are we exploring, Elaine? And, Bob, you can take that one.

Thanks, John. Yeah, so we are looking at all of the above. I think that's the simple answer. As mentioned in my prepared remarks, we are combining matrix M with immunomodulators in some settings. We're looking at matrix alone in others. So that's the line of investigation we're taking right now.

Just to add my great question, our goal is to generate data in various settings with MatrixM, as Bob referred to, so that we can leverage that data then with potential partners. And so our goal is to show how MatrixM actually works in this immunomodulating setting, how it acts within the tumor environment, the microenvironment, and so, again, all part of the data set that we're looking forward to seeing in the future.

Mike, if we understood your question on the C. diff program, what we understood you asking is, are we looking to Pfizer's program as a model? Is that something maybe you could get your arms around from a timing perspective and approach perspective? Did we hear you correctly?

And also, I think they're focused mostly on the toxin, and you're doing the non-toxin antigen as part of the construct. Just brought a strain comment you had earlier, so if you could maybe

Yeah, the difference in how we're approaching that. Go ahead, Bob and Elaine.

So as you correctly pointed out, our construct targets both toxin and non-toxin antigens. And we do have a lead candidate, yes, to answer that question. So we have selected amongst the candidates we've generated the one that we are advancing. and with respect to Pfizer, you know, we're obviously watching closely the competitive landscape and we're learning from the successes and failures and incorporating that into our planning. Yes, absolutely. In terms of timing, Pfizer's in phase three and we're preclinical. So, I mean, there's, you know, so there's that obvious difference there. But we're, as mentioned previously, we're, trying to leverage the ways we can be differentiated.

And to add to that, Mike, we really would like to see Pfizer succeed here. I mean, certainly there's a tremendous unmet need, and there's not a lot there to help the people who are suffering. And I will say, even though the formal earnings call it, my sister-in-law lost a dear friend just a year ago to C. diff that was unexpected, a mom of three. And it was really tough. So, you know, personally, I've seen it impact friends of our extended family. This is something we want to take on. And I think if Pfizer succeeds and it looks like they're on a good path and have something there, we're hoping they do, we would like to be able to follow that with something that's differentiated and offers another alternative in a market that's being built by a leader like Pfizer as well. So, look, we're on a good mission here. We're early. We can be in the clinic as early as next year. We have that lead candidate identified, as Bob said. We're encouraged by what we're seeing early on, and we'll keep you posted.

Okay, great. And lastly, if I could squeeze in one more for Jim. and many more.

You're right. Of the increase of $145 million to our revenue framework for full year 2026, $125 of that was the addition of the kick milestone. That remaining $20 is split into two groups. $10 is related to product sales. So $5 is NAVAC-Civid, and $5 is matrix sales. So that's the $10 that is in product sales. and what that reflects in product sales is the completion this season of our APA deliveries, right? So we had successful delivery of all and a little bit more of our current year APA Novavax deliveries that are Novavaxs. And then on the matrix sales, We've seen just robust demand from our partners this year for MatrixM via commercial partners and even as a part of their development work. And on the commercial partners in particular, as they invested in their supply chain, setting up new validated manufacturing, it has created incremental demand. And I shared with folks that, hey, that put us at probably about a $15 million higher than a normally expected run rate, but still, The underlying demand is strong. So that's the first 10 of the 20. On the second 10 of the 20, the primary driver is this quarter we recognized a non-cash deferred royalty. And this was tied to SK Bio and prior sales to the Korean government that were subject to certain potential to use in a future period that It was determined it was appropriate to recognize at this time. So those are the pieces.

Thank you for your questions, Mike.

Thanks, Jim. Thank you. Your next question comes from Alec Stranahan with Bank of America. Your line is up.

Good morning, Alec. Hey. Hey, morning, John and team. Congrats on all the progress in the quarter. Great to see the updates from the Sanofi side. Maybe just on that EU study, I'm curious how you view the Moderna combo, which is approved in the EU now, as maybe attracting or maybe even accelerating interest in Genovese's program. I'm just thinking about pace of enrollment and whether that would influence at all kind of the geographic mix within that study. And then maybe one for Jim. Just around the 2029 breakeven, the non-GAAP possibility to breakeven there. How much does this depend on launch, or do you feel pretty comfortable that the cost management can kind of get you there on its own?

Thank you, Alec. Let me start with the first part of your question. Just as a reminder, we don't have access to the detailed plans or timelines or activities. related to the Sanofi kick vaccine. We're reliant on their public statements and confirmations on that. And we can't and won't speak for them on strategy. But what we do see, and I think what you and I encourage everyone to pay attention to this emerging ecosystem on vaccines, there's a lot of interest in combination vaccines from many companies. So we're encouraged by the advance of Moderna's product. We're encouraged by Sanofi steps in a great direction to start their study in Europe and their commentary that They intend to start a study in 2027 in the United States market. That's very exciting. And should they succeed there and meet all the requirements for a U.S. product launch, upon first sale, we would earn a $225 million milestone for Novavax and then royalties on all of those different products. So we see our strategy playing out. We see it advancing. We see Sanofi leaning in. making investments in DTC, making investments in growing consumer awareness around the globe of Nuvaxavit, building methodically a market share position they can continue to learn from and build upon, and making the investments that we're very excited about in combination vaccines, continuing to execute on our partnership and leaning in. Jim, did you want to take the second piece on 2029? Exactly.

In addition to kind of directly answering the 2029 question, why don't I use this as an opportunity just to reiterate our financial performance goals, right? What our objectives are and how that fit within these objectives. So I think an important update we shared today is that with line of sight to an incremental 200 million in milestones from Sanofi, we now see We have, based on cash on hand and receivables at 930, a runway, and this is before other incremental cash flows to the company other than reimbursement of matrix orders and R&D, through well into 2029. All right, so you're talking about three years' worth of cash runway here. So that's step one of building our financial strength. while we grow, while we enter our growth mode of generating a diversified set of revenue across our partners. But we're not just relying on that. We're, of course, taking a disciplined approach to our cost structure, which leads you to the metric of, hey, let's get our non-GAAP R&D and S-G&A to between 150 and 200 million by 2028. And I believe our track record that you've seen to date shows that we are on a path to be able to deliver against that. So lean and agile operating model. Next piece is our balance sheet. I think you all know we've got APA-era liabilities, GAVI, UK, that we're paying off over time. We expect to have those paid off by the first quarter of 29, further cleaning up our balance sheet and financial strength, all the while maintaining at least two years of cash flow. So then you come to, all right, great, let's talk about sustainable, growable cash flow over time. Well, what we had said is that the ability to reach non-GAAP P&L profitability, a primary contributor, was the kick launch in the US. Of course, that came with a 225 million milestone. It's not the only mechanism to get there, of course, but it was the key and primary. Well, we got a great update from our partner Sanofi this week, right? You heard the probability of advancing and getting a Sanofi kick product to market is increasing as they themselves make statements that they're initiating studies this year for Europe, intend to initiate in the U.S. next year to support market approval, which is the key to get that 225 million milestone. and so the ability, I think, for investors and analysts to begin to ascribe more value, right, to the future cash flows from kick product or products is rising. All right, so then with respect to the 2029 profitability, hey, we have a target of 150 to 200, you back out stock-based comp, you clean up your balance sheet and continue to, We expect to see royalties grow from Navexavid, from Sanofi as they methodically grow that market. Continue to work with our other partners, pulling through milestones, either tied to existing deals or perhaps future deals, is a mechanism to get to this non-GAAP profitability in addition to the milestone.

Thank you, Jim. Thanks for your questions, Alec. Thank you.

Your next question comes from Pete Stavropoulos with Cantor Fitzgerald. Your line is open. Morning, Pete.

Hi, everyone. Hi, everyone. Congrats on the quarter. This is Samantha on the line for Pete. Hi, Samantha. Thanks. Hi. Thanks for taking our question. So you described in some detail how Natrix-M could contribute to therapeutic vaccines in the oncology setting. Knowing this immune stimulating profile for Matrix M, what are other therapeutic and noninfectious disease protective vaccines you see as the most promising for leveraging Matrix M?

Bob, Elaine, do you want to take that one?

Beyond infectious disease and oncology, I think that is our current focus. And we've done our own scanning exercises, and that's where we've selected to do this exploratory work. I think that there are other therapeutic areas that we could talk about hypothetically, but at this point in time, our focus is really on what I said, ID and oncology.

And that's key because focus is what matters here. You know, we have a lean investment profile. We're making choiceful, thoughtful investments after significant and rigorous assessment of market potential, probability of success that we believe internally our tech may have in certain target areas, how we're placing those bets and experiments with the intention of creating a growing set of assets, a growing set of data, a growing set of understanding around our technology that facilitates further partnering, expansion of existing partnerships and potential new partnerships. That's the goal, Samantha. But we do believe the technology has applicability in a broad array of areas, and we continue to explore that in a very focused way.

Thanks so much.

Your next question comes from Sean Lee with HC Wainwright. Your line is open.

Good morning, guys, and thanks for taking the questions. I just have one. In the prepared remarks, you mentioned that you saw positive data adding MatrixM to available flu, RSV, and pneumonococcal vaccines. So I was wondering, do you plan on making any of that data public in the future? And are there any discussions already with potential partners about adding MatrixM to licensed vaccines?

Go ahead, Bob.

So we are actively investigating MatrixM with a list of potential candidates. Those data, our intent is to use those data thoughtfully and in a way that's most apt to lead to value creation. I expect that that's going to be under CDA with prospective partners and selectively perhaps through publications. But I don't think that we will necessarily be conveying that type of information on these earnings calls, for example.

Yeah, and just to answer maybe the second part of the answer to your question is we're also exploring the applicability and how MatrixM can improve upon commercial vaccines that are already available in the market. And so that's a study set that we have been working on and generating actually over the last several years, and we expect to continue that work and engage with partners specifically as we see those data sets come to fruition and what they may unveil. So more on that as well, but again, our goal will be to have specific partner discussions as those data become available.

Yeah, Sean, and that gives our business development team and R&D team a growing set of data. We keep talking about data as an asset for Novavax and this strategy, so we continue to generate a library of data on where and how matrix may have impact across disease targets in oncology and infectious disease from viral to bacterial and beyond in infectious disease across several tumor models in animals. And we're working with partners in our MTAs on a series of experiments as well that go across infectious disease and oncology. Importantly, the team has looked at these commercial vaccines that are available in large markets. and by adding Matrix to that and doing experiments with those vaccines, our team can then go in and show the companies who market those and other companies who may be developing competitors for those what Matrix-M can do. on those platforms and with those vaccines by adding it. Can you make it less expensive to manufacture perhaps? Can you make it more immunogenetic perhaps, right? And this is what's really exciting about our data. How much of that we choose to share, we're going to be careful and selective in how we do that go forward. Thank you for the question.

That's very helpful. Thanks for that.

This concludes our question and answer session. I would like to turn the conference back over to John Jacobs for any closing remarks.

Thank you, everyone, for joining us today and for your thoughtful questions. We appreciate the continued interest in Novavax. It's been a year of meaningful progress for our company and we look forward to building on that momentum and sharing more with you in the new year. Have a great day, everyone. Thank you.

This concludes today's call. Thank you for attending today's presentation. You may now disconnect and have a wonderful rest of your day