Novavax (NASDAQ:NVAX) released first-quarter financial results and hosted an earnings call on Wednesday. Read the complete transcript below.

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Summary

Novavax reported a 79% decrease in total revenue for Q1 2026 compared to the same period in 2025, primarily due to a non-cash revenue recognition in the prior year.

The company is focusing on strategic partnerships, notably with Sanofi and Pfizer, to leverage its Matrix M technology for vaccine development in infectious diseases and oncology.

Novavax has signed four new Material Transfer Agreements (MTAs) and expanded collaborations with top pharma companies, targeting over 30 unique fields.

The company aims to fund operations into 2028 without requiring new cash flows from upfront payments or royalties, anticipating significant partner-related revenue.

Future outlook includes further cost reductions and potential profitability by 2028, with a focus on lean operations and capital-efficient R&D.

Full Transcript

OPERATOR

Good morning and welcome to the Novavax First Quarter 2026 financial results and Operational Highlights conference call. All participants will be in a listen only mode. Should you need assistance, please signal the 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 followed by the digit 1 on your touch tone. To withdraw your question, please press STAR and then digit one. Once again, please note this event is being recorded. It is now my pleasure to turn the conference over to Jim Kelly, Executive Vice President and Chief Financial Officer. Please go ahead. The floor is yours sir,

Jim Kelly (Executive Vice President and Chief Financial Officer)

Good morning and thank you for joining us today to discuss our first quarter 2026 financial results and operational highlights. A press release announcing our results is available on our website@Novavax.com and an audio archive of this conference call will be available on our website later today. Please turn to slide 2. Before we begin with prepared remarks, I need to remind you that this presentation includes forward looking statements including, but not limited to, statements related to Novavax's corporate strategy and operating plans, its strategic priorities, its partnerships and expectations with respect to potential royalties milestones, cost reimbursements, the current macro and regulatory environment, the development of Novavax's clinical and preclinical product candidates, the timing and results of clinical trials, timing of regulatory filings and actions, its APA agreements and related negotiations, projected market opportunity, full year 2026 financial guidance and revenue framework and Novavax's future financial or business performance including long term growth, cost savings and profitability targets. Each forward looking statement contained in this presentation is subject to risks and uncertainties that could cause actual results to differ materially from those projected in such statements. Additional information regarding these factors appears under the heading Cautionary Note regarding Forward looking Statements in the presentation we issued this morning and under the heading Risk Factors in our Most recent Form 10K and subsequent Form 10Qs filed with the Securities and Exchange Commission. Available at www.sec.gov and on our website at www.Novavax.com. the forward looking statements in this presentation are only as of the original date of this and we undertake no obligation to update or revise any of these statements. Please turn to slide three. This presentation also includes references to non-GAAP financial measures including total adjusted revenue and combined R&D and SG&A expenses, less partner reimbursements and non-GAAP profitability. Please turn to slide 4. Joining me today is Stanley Erck, our President and CEO Elaine O', Hara, Chief Strategy Officer and Bob Walker, Head of R&D. Please turn to Slide 5. I would now like to hand the call over to John.

John

Thank you Jim. I'm excited to be here today with members of our executive team to share our first quarter 2026 financial results and operational highlights. Novavax ended the first quarter having made significant progress against our top priorities and growth strategy, which is designed to deliver value via three key strategic partnering, our technology capital, efficient R and D innovation, and a lean and efficient operating model supporting our efforts. Please turn to slide 6. Our ambition is clear to build a future Novavax with multiple partners, both large global pharmaceutical companies and smaller highly innovative biotechs using our technology platform to develop and commercialize multiple vaccines across a wide array of infectious disease and oncology targets. And we intend to build upon the business from our current base of existing partners to that includes near term milestone and royalty opportunities from Sanofi related to nubaxavid and their kick programs, royalties from Takeda and potential milestones from our new partnership with Pfizer. As we advance this strategy, the opportunity is vast. We are targeting the combined global market for infectious disease and oncology vaccines and immunotherapeutics which is projected to grow to over $100 billion by the early 2000 and 30s. I am pleased to say that since we launched our new strategy in 2025, we are seeing significant progress and we continue building on that momentum. In January, we announced a new partnership with Pfizer for a non exclusive license to utilize Matrix M in two infectious disease areas with one already named. Our partnerships with Sanofi and Pfizer have the potential on their own to to generate billions in revenue from milestone and royalty opportunities specific to Sanofi. To date, our partnership has delivered over $800 million in revenue while enabling us to remove the cost burden of maintaining a global commercial infrastructure. In the last week we signed a new MTA with another top 10 pharma company who is also a global leader in oncology to explore Matrix M and a broad array of oncology targets as well as antibiotic resistant bacterial infections and other infectious diseases. And beyond this exciting new collaboration, we also deepened two of our relationships with current Matrix M licensees, resulting in one a new MTA to enable access to Matrix M for preclinical testing in up to nine additional identified infectious disease areas and two an expanded MTA collaboration to explore an additional field. And finally, we signed a new MTA with a small innovative oncology company earlier in the quarter. We now have either licensing partnerships or MTA collaborations with four of the top 10 global pharma companies and several other innovative companies who collectively have the rights to explore over 30 unique indications or fields across both infectious diseases and oncology. Together, these partnerships target diseases that make up more than half of the projected $100 billion combined infectious disease and oncology, vaccines and immunotherapeutics market Given the breadth of the near term opportunities before us with Sanofi and Pfizer and the potential additional opportunities currently being contemplated by our partners and via our many MTA collaborations, we believe our business model has the potential to deliver billions of dollars in revenue over time. One of the things that makes this strategy compelling in our opinion is its capital efficiency. Rather than maintaining our own costly infrastructure, we leverage the scale and investment of world class partners in oncology and infectious disease while potentially generating cash flow earlier for novavax through upfront payments and development milestones well ahead of what a traditional development to launch path would enable. And of course, our third pillar is to execute this strategy with a lean operating model that retains our core capabilities in R and D. This R and D work will be led by Dr. Bob Walker, who is, as we announced recently, our new Head of R and D. Bob most recently served as novavax's Chief Medical Officer and we are confident that he's the right leader for our R and D efforts. As we look further into 2026, we remain focused on several key priorities. First, executing on existing partnerships including supporting Sanofi's efforts for the fall season and supporting Pfizer's efforts to advance their first field to clinical readiness. Second, pulling through progress on MTA collaborations into potential future licensing agreements. Third, advancing capital efficient R and D innovation as an engine for future partnerships and fourth, continuing to drive down our costs while maintaining key capabilities. We believe the future is bright for novavax as we continue to execute on our strategy and with that I'll turn it over to Elaine to talk more about our partnering efforts. Elaine

Elaine

well thank you John. Please turn to Slide 7. We've made significant progress this year leveraging our business model to advance additional business development opportunities. Please turn to Slide 8. As John mentioned, we signed four new material transfer agreements for Matrix M. We're very excited about the new MTA with a top 10 global pharmaceutical company who is also a global oncology leader. This marks our third oncology focused collaboration via an MTA and the first with a top 10 global pharmaceutical company. These collaborations have the potential to address some of the most difficult oncology targets existing today, such as colorectal, pancreatic and head and neck cancers. These MTAs highlight the significant interest we continue to see in Matrix M as a potentially differentiated adjuvant not only for major infectious disease manufacturers, but increasingly among oncology companies as well. Our technology, platform and partnership approach have the potential for tremendous value generation Matrix M's ability to significantly increase antibody titers for both viral and bacterial antigens, its broad applicability across disease areas and vaccine platforms and its component based profile relative to traditional aluminum based adjuvants make it very attractive to partners. We have developed a model that is successfully delivering a growing number of partnerships utilizing Matrix M and what we're seeing is that when a partner initially accesses Matrix M under an mta, they often come back to request expanded access for additional fields and or to request a collaborative license agreement. The cumulative impact of this is significant. As John stated, more than 30 unique fields are currently identified for pre clinical evaluation by partners. In fact, the broad utility of our technology has resulted in several companies exploring Matrix M for applications in the same high potential markets, including infectious diseases areas such as Cytomegalovirus, Epstein-Barr virus, pneumococcal disease and RSV and this also includes overlap across oncology in areas such as colorectal, pancreatic and head and neck cancer. In addition to broader use across and within disease areas, our technology is increasingly being used in programs that have previously failed or shown an inability to get an efficacious and safe vaccine to market. Because our Matrix agreements are non exclusive, we are not limited to a single product or partner in any disease area and creating the potential for a higher probability of success and for potential revenue across multiple partners in a given disease area. Let me take this opportunity to provide you with an illustrative example of the opportunities ahead of us. Please turn to slide 9. Novavax's growth strategy is focused on tapping into the approximately $100 billion future global market for infectious diseases vaccine, approximately 60 billion and the oncology vaccine and immunotherapeutics market expected to grow to over $40 billion by the early2030s. Please turn to slide 10. Put simply on the left hand side of the slide, you'll see that our growth strategy is focused on tapping into the potential $100 billion market I just described and existing license partners and MTA collaborations currently have the rights to explore over 50% of that potential market opportunity. Based on current agreements, this has the potential to result in billions of dollars in revenue from a diversified set of products and partners in the form of upfront payments, milestone payments and royalties from both Matrix M and product licensing agreements. Please turn to slide 11. So let's look at our Pfizer agreement to further emphasize the value of a single Matrix M agreement. In addition to the $30 million upfront payment we received, plus up to $250 million in future development and sales milestones, Novavax is eligible to receive royalties for up to 20 years from first launch in a given country. This means that for each $1 billion in average annual sales per asset by Pfizer over the 20 year term, Novavax would be eligible to receive over a billion dollars in cumulative royalty payments with no incremental investment in clinical or commercial development. The significant scale of the value creation opportunity becomes clear when you imagine the potential for a portfolio of marketed partner products utilizing our Matrix M adjuvant technology. Please turn to slide 12. Finally, in addition to advancing our business development work, we continue to execute on our partnership agreements regarding Sanofi. We were pleased to see the results of their positive Phase four head to head study comparing our COVID vaccine and Moderna's next generation MNEXT spike, which Bob will talk about shortly. In our opinion, this thoughtful investment further underscores Sanofi's commitment and is consistent with the methodical approach we have seen them take in building other respiratory markets for Pfizer. We continue to work with their teams post CLA to enable utilization of our MatrixM technology according to the remit of that agreement. And as we continue discussions with interested potential partners on the value of matrixn and their portfolios, we are also addressing our own pipeline of assets. We're very excited about the potential for our C. Diff vaccine candidate for which we continue to see a significant unmet need and a differentiated commercial opportunity. The combination of strong C Diff preclinical data generated to date, which Bob will expand on shortly, and the significant market opportunity were the driving factors behind its prioritization towards the clinic as early as 2027. And so with that I'll transition the call to Bob.

Bob Walker (Head of R&D)

Thank you Elite. Please turn to slide 13. Let me begin by saying how excited I am to take on the role of Head of R&D and at such a transformational time for the company. I'm fully committed to leading our R&D team in close alignment with Elaine's BD and Strategy team. As we continue to realize the full potential of our Matrix adjuvant and apply our scientific knowledge and expertise to enhance both partner pipelines as well as our own early stage assets. Please turn to slide 14. As John and Elaine have said, we have some exciting updates coming out of the first quarter. One of the first significant decisions I made in my new role was to prioritize our C. difficile bacterial vaccine candidate from among our early pipeline work as the next asset for advancement into the clinic, and we are targeting entry into the clinic as early as 2027. I'm particularly excited about our C. difficile asset for a number of reasons. First, C. difficile illness is a major public health threat with no currently available vaccine. Second, we've had the opportunity to learn from prior vaccine development failures of others. And finally, our vaccine candidate offers the potential to address a significant unmet need through a strongly differentiated approach. Please turn to Slide 15. Our candidate uses a multivalent antigen approach designed to go beyond toxin neutralization alone and further target a vast majority of circulating clades and ribotypes as shown on the slide and shared here. For the first time in the public domain, we are seeing positive early data in terms of antitoxin IgG responses supporting our decision to prioritize this vaccine candidate to the clinic in a robust preclinical development program that also includes assessments of mucosal immunity that may be important in controlling this disease, as well as other endpoints including survival from lethal challenge with both toxin and spores and gut pathology. Our vaccine candidate consistently outperformed in an activated toxin alone comparator. Based on the accumulated encouraging data, we have progressed this candidate to an IND enabling repeat dose toxicity study with plans as mentioned to be in the clinic pending successful regulatory interactions. We believe our C. difficile work presents an incredible opportunity from both a business and clinical standpoint. Please turn to Slide 16. Additionally, the preclinical data we have generated on our RSV and varicella-zoster virus (VZV) early stage assets are positive and extremely instructive for advancing our science. Our R&D model allows us to continue to build on our established technology platform that has already produced the highly efficacious and well tolerated malaria and COVID 19 vaccines. Combining our deep bench of expertise with AI and machine learning has enabled us to rapidly advance our work in designing superior vaccine antigens for both RSV and related respiratory viruses such as PIV3 and for varicella-zoster virus (VZV). The scientific knowledge gained from these low cost, high throughput exploratory efforts has been substantial and highly impactful and will continue to inform our antigen design and adjuvant work of the future. Please turn to slide 17. The work I've just described also feeds directly into the progress we're making on another key pillar of our R&D strategy, expanding the utility of our Matrix M adjuvant and creating additional potential matrix based adjuvants. Matrix M, as it stands today, is an outstanding adjuvant with extremely broad utility, as is evidenced by the partnering activity Elaine already described. Our ongoing innovation may enable us to do even more and is aimed at designing adjuvants tailored to foster specific differentiated immune properties for new indications, including for example, prevention of hard to treat infections and select areas within oncology. Some of this early work, I should note, is already underway with partners and early research being conducted by our R&D teams on our matrix adjuvant indicates that tailored modifications do indeed have the potential to drive specific immune responses that could be harnessed and directed towards specific therapeutic goals such as induction of highly antigen specific T cell responses in targeted T cell subpopulations. Please turn to slide 18. We are also committed to retaining the appropriate capabilities to execute on and remain focused on our stated areas of R&D, generating data for partner discussions, expanding the utility of our matrix technology platform and creating new innovative vaccine candidates with our Matrix M and nanoparticle technology platforms to facilitate partnership discussions. We view our data as an asset and our efforts are focused on expanding our library of data and knowledge regarding our adjuvant and nanoparticle technology platform to better facilitate potential partnering discussions. This also means that we expect to use certain early candidates as test platforms for both Matrix M and new potential matrix based adjuvants, generating data in the lab to outline how these adjuvants can enhance immunogenicity while also assessing cytokine induction as potential markers of reactogenicity. We also plan to characterize a number of additional antigens. While we will be selective as to which antigens move into clinical development, we have found this detailed examination of how different antigens interact with matrix M has yielded valuable insights that can be directly applied across programs. We may choose to advance select candidates such as C Diff into human trials when the burden of disease, significant business opportunity and potential for our technology to deliver a differentiated and transformational impact exist. Please turn to Slide 19 before passing the call to Jim, I want to make some final comments on data generated by our partners. In April, we were pleased to see that Sanofi announced the results of their investment in the first head to head randomized phase four study comparing the tolerability profiles of our COVID19 vaccine and Moderna's next generation COVID19 vaccine Mnexpike. The study, known as COMPARE, was recently presented as at the ESMIC conference and showed that nuvaxavid demonstrated statistically fewer side effects compared to MNEK spike across all prespecified endpoints. Participants who received nuvaxavid were twice as likely as mnext spike recipients to say they would definitely choose the same vaccine type again the following year. Additionally, publication of real world evidence in partnership with the University of Utah showed participants in the SHIELD study who received nuvaxavid reported fewer side effects and half as many hours of lost work two days after vaccination compared to those who received an MRNA vaccine. Combined, these data support the well established reactogenicity profile of our vaccine. We believe a more favorable side effect profile for a COVID 19 vaccine has the potential to enhance vaccine preference by healthcare providers and individuals, in addition to adding to the body of evidence supporting use of Matrix M in vaccines by potential partners. In closing, let me reiterate that I'm excited about taking on the role of Head of R&D and about where we're taking the company with our new strategy and look forward to sharing future updates. I'll hand it over to Jim now to discuss our financial results.

Jim Kelly (Executive Vice President and Chief Financial Officer)

Thank you Bob Please turn to Slide 20 this morning we announced our financial results for the first 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. Please turn to Slide 21. We are pleased to reiterate our full year 2026 revenue framework is and R&D and SG&A expense guidance and believe that our first quarter 2026 financial results underscore that we are on track to achieve our financial and operational objectives to drive shareholder value by monetizing our technology. First, a reminder that our prior year first quarter 2025 Nuvaxovid product sales included 603 million in non cash revenue recognition from the closeout of an Abaxavid APA agreement. While a great outcome, this non cash item has the effect of distorting our year over year Trends in the first quarter of 2026. For the first quarter of 2026 we reported total revenue of 140 million, a 79% decrease in compared to the same period in 2025. In addition, we saw significant revenue growth from partner related sources in the first quarter of 2026 reflecting continued progress as Novavax executes on our new partner business model. Both our supply, sales and licensing, royalties and other revenue were up over 100% year over year. During the first quarter of 2026 we continued to drive down our combined R&D and SG&A expenses on a non-GAAP and net of reimbursement basis. We reduced these costs by 23% in the period. Novavax ended the first quarter of 2026 with $818 million in cash and accounts receivables. We added $80 million of non-dilutive cash in the first quarter of 2026 including a 30 million Pfizer agreement upfront payment and a 50 million initial draw from the new 330 million credit facility. Based on the combination of our ending first quarter 2026 cash plus anticipated partner reimbursements, we believe we can fund our operations into 2028 without contemplating any new cash flow to Novavax from upfront payments, milestones or royalties. That said, we do anticipate the addition of significant cash flow from partners over time. Please turn to Slide 22 for a detailed review of our first quarter revenue results. Our revenue mix in the first quarter reflects the evolution of our new business model with Lower emphasis on Nuvaxovid product sales and an increase to partner related revenue sources. Nuvaxovid product sales of 10 million was primarily driven by sales into Germany for the 20252026 season and reflects the completion of NovaVax's commercial activity in Europe as we have now transitioned that market over to Sanofi as they prepare for the upcoming 202627 season. We look forward to Sanofi Nuvaxovid commercial efforts in 2026 and beyond. For the first quarter of 2026 we reported 33 million in supply sales, 139% increase compared to prior year and reflecting higher demand for our MatrixM adjuvant to our partners plus COVID 19 supply sales to Sanofi for the first quarter of 2026, licensing, royalties and other revenues of 97 million saw 116% increase on a broad set of partner activities. These results underscore our intent to build a diverse set of revenue streams from partners and products by monetizing our technology. Please turn to Slide 23. We made significant progress improving our cost structure in the first quarter of 2026. Combined R& D and SG&A on a non-GAAP basis decreased by 23%, non-GAAP R&D decreased by 13% and our GAAP SG&A spend decreased by 40%. We believe these improvements to our operating efficiency highlight that we're on track to continue reducing our overall expense profile in line with our full year expense guidance. On a quarterly basis. We anticipate higher combined R&D and S DNA expenses in the first half of 2026 on both a GAAP and non-GAAP basis. As Novavax provides support to Sanofi with clinical studies and we execute on the vaccinated manufacturing related activities for the 2026-27 season, we anticipate these costs to materially Decline in the second half of 2026 and be fully completed in early 2027. Please turn to Slide 24 since we have already covered most of the first quarter 2026 financial highlights already, I will emphasize that we reported a relatively small 9 million net loss in the first quarter of 2026. We believe this reflects important progress as we improve our financial performance on our intended path towards profitability. Please Turn to Slide 25 Taking a moment to recap accomplishments made towards improving Novavax's financial strength and performance. A key takeaway from this work is that we have put novavax in the position to have an estimated cash Runway into 2028 as we drive towards our goal of non-GAAP P and L profitability as early as 2028. Keys to the timing of our path to non-GAAP P and L profitability are the successful development and regulatory approval of the Sanofi Flu Covid combination program and successful commercial execution by Sanofi on both the COVID and combination programs. This could be further supported by any additional cash flow from new business development agreements and further cost reductions. Please turn to slide 26 for a review of our multi year combined R&D and SG&A expense guidance. Today we are reiterating our 2026 and 2027 non-GAAP R&D and SG&A expense guidance of 325 million and 225 million respectively at midpoint. Importantly, in 2026 we anticipate operating at an approximately 200 million core spend profile when excluding costs tied to completion of partner and APA performance obligations. These include non reimbursed Sanofi R&D support and Covid strain change and commercial manufacturing support of approximately 125 million and 25 million in 2026 and 2027 respectively. As these near term activities are completed, we expect to be in a position to further decrease our cost. Our 2028 non-GAAP R&D and FDA expense targets call for an over 200 million and an over 50% decrease compared to 2025. Today we're refining and improving our 2028 expense guidance to a range of 150 million to 200 million. Our core R&D spend and growth strategy is focused on capital efficient value creation the significant progress highlighted today would not have been possible without recent R&D innovation in data generation. We continuously evaluate all options to create long term shareholder value, including the potential to efficiently return capital to shareholders if and when returning cash would be the best use of capital. Please Turn to Slide 27 Today we are reiterating our full year 2026 revenue framework and expect to achieve adjusted total revenues of between 230 million and 270 million. As a reminder for 2026, we are following an approach similar to the 2025 Revenue Framework in that 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 for adjusted licensing, royalties and other revenue. That said, we believe that in the 2026 season Nuvaxovid royalties will grow significantly as compared to 2025. At midpoint, our full year 2026 revenue framework for adjusted total revenue is 250 million. Through the first quarter of 2026 we've recorded 119 million, meaning at the midpoint there's 131 million remaining revenue to be recognized over the next three quarters of the year, or approximately 44 million per quarter on average in 2026. Today we're also reiterating our full year 2026 combined R& D and SG&A expense guidance on a GAAP and non-GAAP basis. We expect to achieve GAAP results of between $380 million and $420 million on a non-GAAP basis in net of partner reimbursements for R&D. We expect to achieve non-GAAP 2026 combined R&D and SG&A expenses of between $310 million and $340 million. We look forward to sharing additional updates as we improve novavax's financial performance, cost structure and strength to to deliver shareholder value. Please turn to slide 28. With that, I'd like to turn the call back over to John for some closing remarks.

John

Thank you, Jim. Before I close, I want to spend a moment on the slide in front of you because I think it tells a powerful story. Please turn to slide 29. 24 months ago, our company's opportunity was highly concentrated. We had one primary revenue driver, our COVID 19 vaccine, one fully integrated operating model working largely on our own, and a cost structure that needed to change. Our technology, platform and our science were proven, yet we lacked the full opportunity to realize their potential at scale. Today, that picture is fundamentally different. Four of the top 10 global pharma companies are now working with our technology. Our partner Sanofi has two combination vaccine candidates in clinical development. We have realized over $800 million in revenue from our Sanofi and Pfizer agreements to date we have more than 30 unique fields that are currently identified for pre clinical evaluation by partners. And to date we have reduced our GAAP R and D and S G annual expenses by approximately $1.2 billion and over 70% since 2022. In addition, we have reduced our current liabilities by approximately $2 billion and over 80% since 2022. We went from focusing on one market, COVID 19 to now having the potential to address via our new model a significant portion of the over $100 billion potential combined global market for infectious disease and oncology vaccines and immunotherapies. To paraphrase a wise saying, if you want to go fast, go alone, but if you want to go fast and far, go together. At novavax we've chosen to do both together with world class partners who bring scale and reach. Together with our own R and D capabilities, advancing next generation matrix adjuvants and new innovative vaccine candidates like our C Difficile asset. We believe these metrics are indicative of the progress we're making to transform novavax. Under our new strategy and assuming continued successful execution, the future for novavax is bright. I'd now like to turn the call over to our operator for Q and A operator.

OPERATOR

Ladies and gentlemen, we will now begin the question and answer session. To ask a question, you may press STAR and one on your telephone keypad. A reminder, if you're using a speakerphone, please pick up your handset before pressing Star and one to be sure that your signal does reach our equipment. We'll take our first question today from Pete Stavropoulos at Cantor Fitzgerald. Please go ahead. Your line is open.

Pete Stavropoulos (Equity Analyst at Cantor Fitzgerald)

Yeah, hi John, Jim and team. Congrats on the progress. A couple of questions from us. You know you're exploring over 30 unique fields of experimentation across both infectious disease and oncology. Just trying to understand how much of this exploration is being conducted at or by novavax and what's being conducted by the companies you're partnered with or signed an mta. And can you just comment on what proportion are novel vaccines and what proportion is Matrix M being tested with vaccines that are approved or on the market? And a second question for me is also, you know, for C. difficile vaccine candidate, one of the design attributes is creating mucosal immunity. Just curious to hear what from the preclinical data sort of gives you confidence that you will be able to develop mucosal immunity, which, correct me if I'm wrong, I assume is IgA response, which would be a key differentiator from prior candidates. You know, what are the gate. Yeah, that's it.

John

Thank you, Pete. Excellent question. So to address your first question, of the 30 plus fields of experimentation and disease areas that we noted collectively, those are via partners. That's one thing we really like about our model right now, is that we can leverage the scale and the resources of partner companies to drive, you know, a significant portfolio of experimentation with our technology that reaches into over 50% of the potential market that we're, we're trying to penetrate. That hundred billion dollar market mentioned in our prepared comments. We also have disclosed our preclinical pipeline and our intentions on C. difficile. So Bob Walker can handle that question in just a moment on our C. difficileicile candidate and why we feel confident about it right now. Your second component of the question, if I heard you correctly, was the mix, Pete, between novel and existing assets with our partners and how we might, or what portion of those experiments involve. I would just say what we can say regarding the confidentiality of our, of our partners, either licensees and, or through MTA collaboration. We can't give specifics, but we can say there is a mix. There is a mix across our full partner set of existing assets as well as new areas of exploration that they're assessing with our technology. We're very excited about that for many reasons, as you can imagine. And Bob, if you might be able to handle that third question on what gives us confidence, to paraphrase Pete in our C. difficile program, based on what we've seen so far.

Bob Walker (Head of R&D)

Great. Yeah. As you allude to mucosal immunity. Yeah, mucosal IgA is definitely one of the most important readouts that we are evaluating in the preclinical models. And as I mentioned also, you know, the gut histopathology would be another key indicator for us and it's an area that we're very excited about and we think could be, could be significantly differentiating for our candidate.

Pete Stavropoulos (Equity Analyst at Cantor Fitzgerald)

All right, thank you for taking our questions.

OPERATOR

Our next question will come from Roger Song at Jefferies.

Roger Song (Equity Analyst at Jefferies)

Hey Jim, thanks for taking the question. So maybe just on the commercial side, any comments you can say about the new season progress and then particularly for the supply readiness and then also related to, you know, we all heard Pfizer announced the 35 Valen TCV vaccine yesterday. Just curious, have you tested the Mujava vaccine with them? And then how. What's the possibility you can use on top of the the traditional aluminum adjuvant for pneumococcal vaccine? Thank you.

John

Yeah, very interesting. Roger, why don't I take the question first? Obviously we can't speak on behalf of partners or give any allusion to what they may be doing, but what we will. But it was interesting to hear Pfizer make that announcement. What I can say is that we have shared data in the public domain on several targets where matrix can, can make a difference. And one of those that we put out in the public domain many earnings calls ago was on Pneumococcal. So we know that's one of the areas our technology had some positive effect. Our method is to approach potential partners by generating data across a suite of assets that they may already have selectively and also on targets they might be interested in. And Bob Walker and our R and D team and it's one of the reasons we keep that capability dear to novavax. It's very important that we maintain our R and D capabilities to generate data so we can go into potential partners and have clear conversations about what our technology might be able to achieve with some of the results we're able to show them with early experimentation. So exciting to see vaccine portfolios advancing in any company and certainly excited to see partners that we have advancing candidates forward. And your second part of the question, Roger, was about commercial preparedness for the fall. And on that front, you know what I would emphasize based on some of the guidance we're seeing from other players in the marketplace like Pfizer and Moderna, we're seeing guidance from others that are anticipating, call it a flattish market year over year after the 25, 26 season where some of the new especially in the US recommendations found their way into the marketplace. So I would start on a macro level with at least what we're seeing and hearing, which is an expectations for, for a flattish market. When you think about Sanofi this season, I tell you what, we, we are thrilled to have them as a partner. And one of the things that you heard from both Elaine and from Bob is we have so much respect for their methodical method of building markets. And an evidence of that is that compare study that they invested in to get the right information out there to best position the vaccinavid on a go forward basis. And so that in particular is something that, that really caught our attention and we look forward to what they're able to accomplish.

Roger Song (Equity Analyst at Jefferies)

Thank you.

OPERATOR

Our next question today will come from Jeff Meacham at Citi.

Jeff Meacham (Equity Analyst at Citi)

Great morning guys. Thanks for the question. A couple maybe bigger picture questions. So you guys have MTA or licensed relationships with a lot of the top 10 biopharmas. So how do you think about conversion rate from MTA to formal license announcement? And how are you guys managing the field overlap across some of your MTA partners? And the second question is just the 75 million sanity tech transfer. Just give us an update on kind of where that stands and timing wise. Thank you very much.

John

Thank you, Jeff. Elaine, would you like to take the first question about potential conversion rate and your thoughts on moving from MTA collaborations to potential full licensure partnerships?

Elaine

Yeah, thank you very much. And I think actually the question is twofold or the answer is twofold. So we've got a very unique process working with our potential partners from the perspective of giving them access to Matrix M. A lot of the time forward then is dependent on how they execute their preclinical models, what the results show, and then if they're happy with the results. Typically we are seeing that these partners will come back to engage in a collaborative license agreement to move whatever they're studying ahead into the clinic, and then also with the expectation that it will have a commercial launch in the foreseeable future. And again, a lot of, as it depends very much on the timing of their preclinical models, those experiments running forward being successful and then coming to fruition. I think any of these can happen as early as four to six months into the timeframe. Again depending on the results that the partner is going to see with then obviously stepping into a potential collaborative license agreement in the future post that six month period. So that's the way I would address the first question in terms of the conversion rate and then in terms of field overlap. I think I said this earlier, given the fact that we do not have exclusive licenses, these are non exclusive licenses that we ultimately enter into. We're delighted to have overlap because it gives us greater probability of success if we have multiple partners engaged with the study of our matrix and in overlapping fields.

Jim Kelly (Executive Vice President and Chief Financial Officer)

All right, and then Jeff, I'll take the question about the milestones and you know, what I want to refer our listeners to is a nice overview slide that Elaine had, slide 12 that outlined the milestones that we have eligibility for from both Sanofi and Pfizer. She highlighted the 425 million in milestones that were eligible for from sanofi, including the 75 million for as you had referenced, the completion of tech transfer, 125 million upon initiation of a kick phase three study and another 225 million upon US launch right of one or perhaps both right of kick studies that Sanofi is currently working on. Then on the Pfizer side, based upon the terms we announced in January, you're hearing 250 million in milestones each for each of the two products that they might develop vaccines for. So you are seeing with our strategy we're able to pull forward and monetize cash flows via milestones versus you know, a traditional biotech that might have to wait years, right. To develop revenues and profit. And so that is core to our operating strategy. Now I haven't forgotten your initial question which is hey, where are we with the 75 million tech transfer? And what I'll tell you is that while we are not guiding to that timing, I can tell you our manufacturing for Sanofi ends with the 2627 season. Meaning they have to be fully ready for the 2728 to be able to advance our programs. We have every confidence they will and that this milestone will fall, you know, as it will within that period, period of preparedness.

Jeff Meacham (Equity Analyst at Citi)

Great, thank you guys.

OPERATOR

Our next question will come from Mayank Mamtani at B. Riley Securities. Please go ahead.

Mayank Mamtani

Good morning team. Thanks for taking our questions and appreciate the detail on partnership process and pipeline development. Maybe just a follow up on prior question. You know how you see the MTA's to license cycle time kind of evolve and is there a particular disease state where you're seeing strategic interest concentrate more than less. And then just a final point on second part there heard a lot more oncology today from you. Specifically maybe some of the harder to treat pancreatic and colorectal cancers where for instance in adjuvant setting there could be a better biological rationale versus maybe another modality. I was just curious what sort of mono versus combination work that is happening preclinically there which could inform maybe a formal deal execution there. Then I have a quick financial follow up question.

John

Thank you Mike. Elaine, did you want to take Mike's question? I think two parts, Mike, if we heard you correctly, the first part had to do with any additional color or context that we may be able to add on converting MTA collaborations into full licensure partnerships. And then the second part of your question, on oncology. Right. So why don't we have Elaine take those?

Elaine

Absolutely. So thanks for the question. I think again just it really depends on the success rate of the preclinical testing that each partner has. Typically those studies run between four and six months. And then dependent on the success rate or what the partner sees, if they like what they see in terms of the data that they're generating in these pre clinical studies, then the turnaround time is moving potentially to a collaborative license agreement where a partner would then enter into the clinic with whatever they're studying as well as our Matrix M technology. Right. So the combination of their antigen plus our Matrix M. So I think then you know, again the range there is between six months to a year to translate that, convert that turnaround time from pre clinic into clinic, again dependent on the rate of the advancement that the partner wants to take on board. So that's the way I would answer that question. And then with respect to oncology, can't get into a whole lot of specific details because of the confidentiality of the preclinical plans. But yes, you accurately described the utility of Matrix M in some of these oncology models. More difficult to treat cold and, or warm, what we call cold and warm tumors. So a little too early to tell yet, but we are very excited about the prospect of Matrix M and its ability to solve some of these problems in the field of oncology. Thank you.

John

Thank you, Elaine and Mike, before you ask your financial follow up question, just one additional comment. Obviously, we launched our new strategy at the beginning of last year year and just in the last four months or so, just in the first trimester of 2026, we've had four new MTA signed and we had an existing partner. One of those came back to us from nine additional fields. So we're really getting into a rhythm. This is the most interest we've ever seen in our technology from third parties. Despite whatever's happening in the macro environment, there seems to be a very strong interest and we're not surprised because we know what our technology can do and others are really waking up to that. But that being said, we're still in now this, this new phase of starting to convert all of this interest into potential license partnerships and that'll be our intention. So it's very hard to put specific metrics on that right now. It's going to depend on any given company and, and I think each company is a little bit different on how they may want to approach this. And some may be looking at 9 or 10, 10 fields, others may be looking at 1 or 2 fields, others may be diving deep into a category and exploring deep within certain disease areas. It just Depends. And so it's our intention to do that as quickly as we can. As in novavax, we're small, we're nimble, we're very responsive to potential partners and to partners we can move very quickly. They need to move at the pace they need to, to uncover what they're looking for and then act. But we do have contact confidence that in many situations our technology has a chance to work and a chance to make things better. That makes it exciting for the future. And the key thing to think about now is how much we've really put in place since the launch of this new strategy and the way that's accelerating from an interest standpoint and from filling the top of that funnel with actual data that we're sharing with partners, potential partners coming back to us, signing agreements to get access to matrix, running their own experiments to the point of over 50% of that global market opportunity we talked about. When you look at the disease areas that these partners and MTA collaborators have the rights to assess right now, that's fairly substantial. So we're very excited the sooner we can pull it in. We're excited about that as well. But we can't put a specific timestamp on it because it's not 100% within our control. Thanks.

Mayank Mamtani

Thanks, John. And actually I was curious about that April existing partner expansion that could lead to a single or multiple separate deals. But I'll ask my financial question quickly. So the target 2028 OPEX spend being aggressively pushed down was just curious how much of this was. You are just having more visibility into digging in versus maybe some external pressure. There's the activist campaign and also the, you know, top line revs uncertainty a little bit and I don't know if any visibility you have with the new leadership, you know, with your partner and you know, obviously GIC approval in eu we saw for the first time and obviously very curious how to act with kind of fits in the late stage development paradigm now that, you know, the regulatory environment's looking more predictable on both sides of the Atlantic. Thanks for taking a question.

Jim Kelly (Executive Vice President and Chief Financial Officer)

All right, Mike, of course appreciate you highlighting what is, I think just another very methodical and thoughtful quarter of improving our cost structure. One of the things that we emphasized in our prepared remarks here is that, you know, you're seeing a 23% reduction year over year in non GAAP R and D and S share and in particular that 40% reduction and that's on a GAAP and non GAAP basis to SG and A just shows that continued progress that we're making, I am going to take an opportunity to just kind of reinforce some of the key themes that we shared. And this is on slide 26, about the evolution of our cost structure and that importantly one these deals, this momentum in our business development effort comes on the heels of data generation and that our investment, our target investment in R and D is all about creating significant value. And a lot of the momentum you're seeing here today comes on the heels of smart and targeted R and D investment. Then I've been emphasizing that in 26 and 27, hey, beyond the part that we're already operating at a core approximately 200 million spend, we do have some legacy obligations, about 125 million in 26 and 25 million in 27 related to non reimbursed R and D and certain strain change activities. Right. As we support our partners and as we move to 2028, we chose to refine it, I mean, at least personally, the last update, which was below 200 million, you know, it kind of left a lot for the imagination. So the act of offering up 150 to 200 was just sort of a professional refinement more than anything. And so I do think it gives folks a really good picture of the evolution of our cost structure. But more importantly, I think when combined with Bob's comments on where we're investing and then Elaine's comments about how that's translated that data into tangible momentum on our BD efforts, I think that's our story.

John

And our focus has been to become as lean as possible while maintaining capabilities and meeting our trailing obligations to close out APAs and other things as we completely transform the company over the last 24 to 37 six months. Mike, nothing has changed in our desire to reduce those costs. Regardless of external commentary or thought from anyone, we're all aligned that the most lean operating model is the best place to be. And we're doing that in a responsible and thoughtful way as a management team while meeting our obligations, driving a new strategy that's starting to show remarkable results and momentum and maintaining the key capabilities that make that possible.

OPERATOR

Our next question today will come from Tom Schrader at btig.

Tom Schrader

Good morning. Congrats on the remarkable Matrix M process. I have a question on deal structure. You've always given us a $200 million trigger for Sanofi to choose a vaccine without a lot of structure. Should we think about that as kind of the same structure as the Pfizer deal? Something like 30 million up front, or can you give us Any sense of what triggers Sanofi?

John

And then I have a follow up from a comment that was just made that I think is interesting that you expect partners might go from getting Matrix M to being in the clinic in a year. Can we conclude these are mostly very mature vaccines? These are people who are almost ready to go or maybe have been in the clinic and maybe need a little more oomph so that these are kind of simple additions to formulated vaccines. Is that how we should think about a lot of your partnerships? Thanks. Yeah. Tom, let me address your second question first and then I'll hand it over to Jim for the first part of your question. I wouldn't put a timestamp on anything related to converting an MTA to partnership or how quickly a partner can get into the clinic. What we were trying to say before is that we have this significant momentum, you know, since we launched the strategy in 25 and especially in the first four months of this year where you see four new MTA signed and a lot of this collaboration going on, 30 plus fields of experimentation that these partners and MTA collaborations enable these companies to do now, representing over half of the global $100 billion market that we're targeting, as described in our prepared comments. But it's very difficult to put, and we would ask you not to put any kind of a standard framework around that on how quickly anyone can get to clinic, et cetera. But there will be a mix. I think it was Pete Stavros had asked earlier about, you know, what's the mix between existing assets and brand new programs. So obviously you can look at typical biotech benchmarks, if that's helpful, Tom, and say, hey, if you're taking an asset from pre clinical right into early stage all the way through development, that's X type of time frame with typical types of POs. And we have a proven tech, by the way. Right. So that's an important component of that thought process. And then if there are, and there is a mix, some existing assets and companies are approaching lifecycle management opportunities using Matrix M, that would be a faster pathway potentially for it, assuming success. Right. So we really are loath to put a specific timeframe on that. Some will move faster than others based on the nature of which asset they're exploring or trying to work on, whether it's existing lifecycle management, whether it's new from scratch. Right. And others may move more quickly or slowly from MTA to full partnership. But what we're really excited about is the level of interest that we're seeing in our tech and the action that potential partners and partners who are coming back and saying, hey, let's explore nine more fields with Matrix, please. We'd like to sign another mta, already have a license with us, that particular company. Right. They've seen something, they like it, they want to explore it much more broadly in a portfolio. So we'll work as diligently as we can and we'll be nimble and fast in our responses to enable those as soon as possible and as often as possible to convert to full licensure. And Jim, did you want to take the first part of Tom's question?

Jim Kelly (Executive Vice President and Chief Financial Officer)

Yeah. So Tom, this my answer to your question around upfronts may be something more of a clarification. While the new Pfizer agreement and this is for the ability to develop two new vaccines came with the 30 million upfront payment, it's not something you're going to be able to compare to our existing Sanofi agreement and their access to Matrix M. And what I mean by that is because, hey, we had a $500 million upfront payment from Sanofi, but it covered many attributes, many dimensions of value. And so there's not an apples to apples comparison for the Matrix piece. So hopefully that's clear.

Tom Schrader

And do you say what triggers 200 million for Sanofi? Is that clinical or do you not say at all?

Jim Kelly (Executive Vice President and Chief Financial Officer)

Yeah, we say it's a combination of each. It's both development and sales based milestones.

Tom Schrader

Perfect. Okay. Thanks for all the clarity.

OPERATOR

Yep. We'll hear next from Alex Stranahan at Bank of America.

Matthew

Hey guys, this is Matthew on for Alec. Thanks for taking our questions and congrats on the progress on the pipeline and the decision to prioritize C Diff over shingles rse. You know, appreciate why C Diff looks attractive. But curious if you can speak to why shingles RSV didn't fit that framework. Was it preclinical profile, competitive landscape, unmet need, and could you still bring these forward in their current form? And then I guess second question, just a brief one. Has your view of the combination vaccine market changed after Moderna's progress with their combination vaccine ex us? Just curious on your thoughts there. Thanks. Thank you. And Elaine, did you want to take that question on our thought process around which assets to advance further into potential human trials out of our preclinical asset portfolio?

Elaine

Yeah, just very succinctly. Hopefully our decision was predicated on met need as well as the actual market opportunity. There are relatively few potential competitors in this space. Developing Clisidrine difficile vaccine, Pfizer being one. And so we believe, again, based upon the data that Bob shared earlier on in our presentation today, that we have the ability to make significant advancements in this market, obviously depending on our data and our study. But we're very excited about the program, both in terms of the unmet needs as well as the actual market size, potentially generating over a billion dollars in revenue. So again, that was our decision to prioritize this particular program. And I think, Elaine, also the question relates to RSV and shingles. You know, would there be any thought to advance those in general, are we intending to bring forward, you know, everything from our preclinical pipeline? How do we think about that in general, I think is part of the question. Oh, sure. We were very also very excited about RSV as well as ZZV and what we've seen in our preclinical testing. We have a very well characterized candidate for RSV and we will be potentially looking to have discussions with partners in the future around the RSV candidate that we have developed in house. So we're very excited about that. And with respect to our VZV program, what's also interesting there is some of the data that we've generated with vzv and as Bob had stated earlier on, we'll continue to learn with respect to those programs and leverage that data for other programs that we may decide to bring into the clinic at a later point in

John

Yeah. And just one thing to add. Thank you, Elaine. One thing to add to that would be, you know, we may or may not need to or want to advance certain assets into human trials from our preclinical. We're going to rotate different targets into our preclinical work field, if you will, as a learning platform, as a testing platform for new adjuvants that we're working on and other things to generate data for conversations with partners. It is not our intention at novavax to bring every one of those assets forward. And the data was good pre, clinically for both of those assets. We're actually excited about it and learned a lot and we could bring them forward. But in our current model, we don't see that as a major value inflection that would benefit the company and our stakeholders to bring those into more expensive human trials. As they stand, they could be partnered. Now, they're good learning platforms, but C Diff offers the best opportunity from that first set of partner target or target assets that we put in there to work on to bring forward into human trials. We see that as the best value inflection opportunity. Jim, did you want to add anything to that?

Jim Kelly (Executive Vice President and Chief Financial Officer)

Well, I think one of the keys to the investment process is both our ability to create differentiated programs and assets in high unmet need markets, but also have an eye towards, hey, what are our partners doing? And our partners already advancing assets, leveraging our technology at those same and how might the differentiation work? And so all of those factors go into our thinking as we both experiment and advance. And what you're hearing is not only are we really happy with the data we're seeing as we're working on these assets, but the update you heard from Elaine is that we've got multiple assets with partner overlap where they're carrying the investment burden and driving programs forward. That is the full context of the investment.

OPERATOR

Once again to our phone audience today, that is Star in One. We'll hear next from Chris Lobianco at TD Securities.

Chris Lobianco

Hi team. Congrats on all the progress in the quarter. I had two questions both on your CDIF candidate. Can you remind us what are the key IND filing requirements for this vaccine and have you had any initial dialogue with fda?

Bob Walker (Head of R&D)

Bob, do you want to take that one? As I mentioned during the prepared remarks, so we're currently conducting the IND enabling repeat dose toxicity study and when those data become available, we would seek to follow that up with an ind. We are intending to engage in pre indicators discussions with FDA and expect that the results of those conversations will probably inform some of the thinking about next steps.

Chris Lobianco

Great. And then I have a second question on the commercial opportunity. You highlighted that c diff accounts for 5 billion in annual health care costs. Is that a reasonable way of thinking about the peak sales potential for a C. Diff vaccine? Thank you.

Elaine

Elaine, do you want to take that one for Chris? Yeah, absolutely. I mean it's. So as I mentioned, there are potentially other competitors coming into the marketplace, Pfizer being one. But I think that is, you know, the way we look at this opportunity from a commercial perspective is that it's at least between 1 and a half to 2 and a half billion dollars making the assumption that there will be other competitors on the market by the time a potential vaccine that we would bring through clinic and then partner would come to market. So that's how I would, you know, round up the sales opportunity.

Chris Lobianco

Thank you.

Matthew

Thank you. Chris and Matthew, you also had a question on the combination market. So Jim, did you want to just make a brief comment on the combination market Covid flu?

Jim Kelly (Executive Vice President and Chief Financial Officer)

Well, certainly and reminder folks that, you know, when we look at both the COVID and the flu market, you know, they're each approximately 6 billion, 5 to 6 billion apiece. So we're talking about a 10 to $12 billion marketplace that is poised to really merge together. Right. Because of the significant importance of combination treatments, especially in that setting. And I think that was, that was one of the questions we heard a little bit earlier was, hey, what's the importance of combination treatments in the adult market? And the answer is, you know, we expect it to follow a path you saw in the pediatric marketplace where, you know, the efficiency of getting vaccination is critical. Right. To health policy and outcomes. So with respect to the combination of flu and Covid market, we continue to see investment, we see, continue to see a high unmet need and we're really looking forward to that. Next update from Sanofi on their plans for not one, but perhaps two late stage programs with a navaxavid plus their market leading flu products. Hey, we'll wait to learn more. I think, you know, while I can't speak for them, I guess I can repeat what they've said. You know, they met with the agency in the first quarter. They're awaiting alignment and updates for next steps. I think you saw just recently Moderna getting, getting approval in Europe and so you're certainly seeing the competitive nature of that industry, its importance rising. So hey, we can't wait to be a part of it through our partners. And so I'd say that's the, that's the update.

John

Yeah, Jim. And we were also really pleased to see Sanofi's investment in the compare study to show against, against MNExpress Spike, you know, the tolerability of our new Vaxavid, which would be a component of a potential combo they bring forward. Right. So really excited to see our partner Sanofi leaning in making investments to show data and really start to kick off the season already for the coming year with some interesting data comparatively.

OPERATOR

And at this time we have no further questions from our phone audience. Mr. Jacobs, I'll turn it back to you sir, for any additional or closing remarks that you have.

John

Just want to say thank you to all of our employees for their constant diligence and effort to help drive novavax forward toward our vision. Thank all of our investors and stakeholders for supporting us and wish everyone a wonderful day. Thank you for your attendance.

OPERATOR

Ladies and gentlemen. This does conclude today's Novavax first quarter 2026 financial results conference call. We thank you all for your participation; you may now disconnect your lines.

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