Novavax - Q4 2025

Transcript

Operator (participant)

Welcome to Novavax Q4 and Full Year 2025 Financial Results and Operational Highlights Conference Call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one on your touchtone phone. To withdraw your question, please press star, then one again. Please note, this event is being recorded. I would now like to turn the conference over to Luis Sanay, Vice President, Investor Relations. Please go ahead.

Luis Sanay (VP of Investor Relations)

Good morning. Thank you all for joining us today to discuss our Q4 and full year 2025 financial results and operational highlights. A press release announcing our results is available on our website at 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, 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 10-K and subsequent Form 10-Qs filed with the Securities and Exchange Commission, available at sec.gov and on our website, novavax.com. The forward-looking statements in this presentation speak only as of the original date of this presentation, and we undertake no obligation to update or revise any of these statements. Please turn to slide 3. This presentation also includes references to non-GAAP financial measures, which are total adjusted revenue, adjusted licensing, royalties, and other revenue, combined R&D and SG&A expenses, less partner reimbursements and non-GAAP profitability.

Please turn to slide 4. Joining me today is John Jacobs, our President and CEO, who will highlight our growth strategy. Elaine O'Hara, Chief Strategy Officer, will focus on progress with our partnership strategy. Dr. Ruxandra Draghia, Head of R&D, will discuss our R&D updates, and Jim Kelly, Chief Financial Officer and Treasurer, will review our financial results and 2026 financial guidance and revenue framework. Please turn to slide five. I'd now like to hand over the call to John.

John Jacobs (President and CEO)

Thank you, Luis. I'm excited to be here today with members of our executive team to share our Q4 and full year 2025 financial results. We made significant progress on our corporate strategy in 2025, successfully executing against our existing partnerships while advancing our organic pipeline, innovation efforts with our Matrix technology, and making progress towards new potential partnerships. Our progress in 2025 was possible because of how we have reshaped the company since 2023 and with our new strategy, which we launched last year. Since the launch of our new strategy, we have evolved Novavax from a vertically integrated global commercial organization with a singular focus on COVID, to a company that is focused on driving both near and long-term value with our proven technology platform via partnering and R&D, supported by a lean and efficient operating model.

We've also come a long way in stabilizing the company financially, doing so in a thoughtful, stepwise manner to maintain the capabilities needed to advance our strategy. We are successfully executing our plan. For example, just this January, we announced a new agreement with Pfizer for Matrix-M. This new partnership allows Pfizer to utilize Matrix-M in two disease areas within their vaccine portfolio, with one disease area already identified. If Pfizer commercializes just one significant product based on this agreement, this partnership could generate $ billions of revenue for Novavax over time through a combination of milestones and royalties. This agreement further demonstrates the value other companies with vaccine portfolios see in Matrix-M. Please turn to slide 6. The changes we have made to date continue to strengthen our company. We believe we can do even more to create value both today and in the future.

As you can see on the slide, today, from our existing partnerships, we have earned and received upfront and milestone payments, including those from our agreements with Pfizer and Sanofi. With over $800 million in non-dilutive capital earned in the last 18 months. Anticipated continued royalties from our marketed and partnered products, including Nuvaxovid and the R21/Matrix-M malaria vaccine, and we're pleased by the progress made by Takeda in 2025, where they delivered over 12% market share for Nuvaxovid in Japan, and more than 30 million doses of the R21/Matrix-M malaria vaccine, marketed by Serum Institute, have been distributed to help people fight this disease. In the mid to long term, we intend to amplify this value through upfront payments from new potential partnerships, milestone payments from both new and existing partners for continued development of their assets with our technology.

For example, Sanofi's combination vaccines with their flu products and our Nuvaxovid, for which we are eligible for a $125 million milestone when their phase 3 study initiates, and/or development of additional assets with Matrix-M, for which we are eligible to receive launch and sales milestones of up to $200 million, plus mid-single-digit royalties for each new vaccine Sanofi may choose to develop in the future using Matrix-M. Plus a growing set of potential royalty revenue streams from multiple partners. Please turn to slide 7. In addition to partnering, the other key lever in our growth strategy is R&D innovation. We are focused on leveraging R&D to strengthen our technology platform, expand its utility both within and potentially beyond infectious disease, and drive further proof points and data to develop new assets with which we can partner.

Our Matrix technology is a cornerstone of our partnering model. We believe that we can build on our proven technology and expertise to create a portfolio of Matrix-based adjuvants to serve as an engine of innovation and value creation, reflecting our conviction that differentiated adjuvant offerings could represent a significant and expanding long-term growth opportunity for Novavax. Importantly, this model potentially positions us to generate diversified, recurring revenue across multiple partnered programs. For example, we're exploring the potential development of new Matrix-based adjuvants for oncology and some hard-to-treat infectious diseases, potentially opening an even wider opportunity set. We are exploring new formulations of Matrix-M, such as dry powder, with the intent to increase its utility in our own and in partnered candidate vaccines. You will hear more about our approach to building a Matrix-based adjuvant portfolio from Elaine and Ruxandra later on in the presentation.

Please turn to slide 8. In 2025, we continued our commitment to operate in a lean and efficient manner. Of note, during the year, we significantly decreased our R&D and SG&A spend. As we continue to advance our growth strategy, we intend to continue reducing our operating expenses while maintaining the capabilities needed to support the strategy. Jim will provide an overview of our operating expenses and guidance later on in the call. We are pleased with the progress we made last year in 2025 and are excited about the potential that lies ahead in 2026, such as the potential for more partnership announcements, making continued progress across the spectrum of our R&D efforts, including the advancement of our preclinical pipeline and continuing to support our existing partners with implications for incremental milestone revenue. Elaine will address this component in her next remarks.

Before we continue with the call, I want to acknowledge that the current macro and regulatory environment in the United States poses some significant uncertainties for vaccine companies. We remain optimistic about the future of vaccines and of Novavax. Deadly diseases are here to stay, and people still need proven approaches to protect themselves and their loved ones from those diseases. This is a long-term, serious and meaningful endeavor to be part of, not a short game, and with continued execution of our growth strategy, we intend to see our technology fueling multiple new vaccines and immunotherapeutics across multiple partner portfolios, with the potential to save millions and potentially even billions of lives over time, driving significant value for our stakeholders and leaving a global health legacy we can all be proud of. We look forward to the year ahead, and we approach it with enthusiasm.

With that, I'll turn it over to Elaine to talk about our business development efforts. Elaine?

Elaine O'Hara (Chief Strategy Officer)

Thank you, John. As John said, we're excited about the potential for 2026. On the business development front, we're focusing on driving immediate value with our existing technology platform. Please turn to slide 10. We're pleased with the progress we have made on partnerships to date and have honed our capabilities in this area to drive future success. We have proof points that this model is working. We are successfully executing on multiple partnerships and business deals since the launch of our company transformation. Some of the highlights include: In January, we signed a license agreement with Pfizer, which provided Novavax with an upfront payment of $30 million, with the potential for up to another $500 million in development and sales milestones across two disease areas.

$70 million in development milestones and up to $180 million in sales milestones for each disease area, respectively, plus future sales royalties for two decades. We have also signed new and expanded existing MTAs with a variety of pharmaceutical companies who are presently evaluating the potential of utilizing Matrix-M in their vaccine portfolios. This has included a new MTA with a large pharma company in the Q4. In February, the expansion of an existing MTA with a major global pharmaceutical company to include an additional field for exploration. Just this week, we signed a new MTA with an oncology company. As you can see, we are quite active on the partnering front, and there is a depth of interest in our Matrix Technology.

We're seeing that once vaccine-focused companies experiment with our adjuvant, they often come back to us to explore more broadly after seeing results from their initial experiments. We have also continued to execute on our Sanofi partnership, with all $225 million in eligible milestones achieved in 2025, and the expansion of our agreement to include Matrix-M in Sanofi's pandemic flu candidate program, which has recently received funding by BARDA. We're excited about the progress of Sanofi's combined flu and COVID-19 vaccine candidates, with each combined Nuvaxovid with their leading flu candidate as further proof of the potential value that our platform can generate.

We are encouraged by the recent public updates from Sanofi that included positive phase I, II results from both flu COVID combination programs shared in December, and their recent comments highlighting this product as a key driver of future new product growth for them. Importantly, market research presented by Sanofi at last year's World Vaccine Congress suggests that 82% of those people who receive both influenza and COVID vaccines, and 54% to 69% of those who receive one, would adopt combo, barring no material impact to reactogenicity and/or efficacy, thus indicating potential significant value over the current standard of care. We've also seen continued execution of our other partnerships, where, as John mentioned, we saw market share gains for both Takeda with Nuvaxovid in Japan and Serum with malaria. Finally, we executed agreements related to our facilities as we rationalized our footprint.

Agreements signed with AstraZeneca to transfer one U.S.-based facility and sell certain equipment, netting $60 million in cash and resulting in future cash savings of up to $230 million, and the sale of our Czech Republic manufacturing site to Novo Nordisk for $200 million. Please turn to slide 12. As we look to generate new partnerships, our goal is to create a funnel of interested organizations, all of whom may be in various stages of discussions with us. We are partnering closely with our R&D team to facilitate these conversations in one of three ways. First, generating our own data to share with potential partners and providing Matrix-M to potential partner companies for their experimentation to help determine if they want to move forward in a formal partnership. Secondly, continuing the exploration of potential new Matrix-based adjuvants.

Matrix-M is our cornerstone adjuvant with broad utility. This unique product is in our existing marketed products. We are working with our Matrix platform to develop new adjuvants, each with their own unique attributes. The intention of this work is to create tailored adjuvants for disease areas such as oncology and difficult-to-treat infections. Third, advancing our recombinant technology with our own internal pipeline of vaccine candidates such as C. difficile, shingles, and RSV combinations. In summary, as you can see from the slide, our strategy has several core pillars. We generate data for partner discussions, we expand the utility of Matrix to enable a portfolio of Matrix-based adjuvants, and we create data from our preclinical programs to facilitate partnering discussions. Please turn to slide 13. Importantly, the focus of our R&D efforts is grounded in where we see market opportunity.

The markets we are targeting have the potential to reach over $100 billion by the early 2030s, with the global vaccine market projected at over $60 billion in the next four or five years and the immunotherapeutic vaccines subset of the oncology marketplace projected to reach over $42 billion by 2032. In addition, we're strategically directing our development work with the intent of creating differentiated assets. For example, our R&D team is exploring a multivalent adjuvanted C. diff vaccine candidate with potential for enhanced activity in a market where others have failed. If successful, this vaccine would address significant unmet need in this underserved population. Not only do we see this as a significant opportunity to reduce human suffering, but it also has the potential to tap into a projected over $2.5 billion total addressable U.S. market opportunity.

We believe our partnering strategy best positions Novavax for long-term success and shareholder value creation, while maintaining the flexibility to internalize assets when strategically advantageous. With each partnership, including existing, expanding, and new partnerships, we have the opportunity for upfront payments, development milestones, and royalties for current and future commercial sales, ultimately creating the potential opportunity for Novavax to earn billions of dollars over time, assuming, of course, successful execution. Ruxandra will provide more detail on these programs supporting our business development efforts, and I'd like to turn the call over to her now.

Ruxandra Draghia (Head of R&D)

Thank you, Elaine. Please turn to slide 14. As John and Elaine have said, we are very excited about the potential in 2026 for R&D. We believe that our R&D efforts can generate incredible value for both our shareholders and the people who will benefit clinically from our innovations. The driving force behind this is our technology, which is front and center in our own pipeline of assets and R&D work, and now in our partners' development efforts and pipelines. Let's take a look at each. Please turn to slide 15. On our in-house R&D efforts, first, we are expanding our efforts in infectious diseases with our internal early-stage pipeline, including programs targeting C. diff, shingles, and an RSV triple combination. We are making steady progress with the intent to advance at least one of these assets into the clinic as early as 2027.

As Elaine mentioned, we are intentional in moving forward with work that targets an unmet medical need and offers the opportunity for differentiation. Please turn to slide 16. Let's take C. diff, for example. This disease is a major public health threat, in particular in the United States, Europe, and in the elderly population, causing nearly 500,000 infections and tens of thousands of deaths annually in the U.S. Currently, there is no vaccine available. We have learned from existing data and applied available learnings when designing our antigens and implementing experimental plans. Multiple hypotheses might explain the type of data generated by previous vaccine candidates. Previous vaccine candidates were toxin-based, designed to neutralize toxins rather than kill the bacteria themselves. Consequently, vaccinated individuals could still become colonized, and the vaccines might not have reduced the overall burden of C. diff in the gut.

Second, previous vaccine candidates might have generated insufficient mucosal immunity. Because C. diff infection is restricted to the gastrointestinal tract, protection is thought to require robust mucosal immunity, which we assessed in our very preliminary studies. Third, previous vaccines might have targeted only 2-toxins, A and B. However, a proportion of clinical C. difficile isolates express a binary toxin, which these vaccines candidates did not cover, nor did they cover any of the pathogens' antigens. Please turn to slide 17. As we started exploring how our technology might make a difference, we have been encouraged by early data. Our early-stage Matrix-M adjuvanted C. diff vaccine candidate uses a multivalent antigen approach, targeting a vast majority of circulating clades and ribotypes. Aside from immunogenicity studies, we have explored mucosal immunity and conducted challenge studies, results of which showed that this vaccine candidate outperformed a 2-toxin-alone comparator.

We look forward to next steps, if successful, bringing this vaccine candidate into the clinic. We are sharing C. diff just as an example today. As we've previously stated, we believe we can advance one of our preclinical assets into the clinic as early as 2027. Please turn to slide 18. Our R&D work is also looking at driving life cycle management and innovation for the Matrix-based adjuvant platform. Matrix positions us as a platform partner that can help to enable next-generation bacterial and viral vaccines because it has the potential to be utilized across multiple platforms, such as in protein-based vaccine. Our own vaccines are based on that platform, nanoparticles, inactivated, toxoid, conjugate, or VLP vaccines.

Matrix-M has a remarkable broad utility, but in addition to Matrix-M, and based on our expertise with this asset, we have used the know-how and history to explore the potential creation of other Matrix-based adjuvants with differentiated properties. In fact, a key focus for our R&D work with our Matrix technology is to broaden the utility of Matrix, both inside and outside infectious diseases, while also evolving the life cycle of this critical technology. This include potential new versions of Matrix-M and new Matrix-based adjuvants as we look to build a portfolio of new adjuvants. This effort could enable expansion beyond infectious diseases, such as powering next-generation immuno-oncology strategies. Early research on this potentially new adjuvant indicates that modifications to our technology have the potential to drive specific responses, such as robust CD8-positive T-cell activation responses as part of a comprehensive immune response. Please turn to slide 19.

Beyond our in-house R&D efforts, the impact of our technology has the potential to be amplified via our partners. First, we have marketed products which include our technology, Nuvaxovid, and the R21/Matrix-M malaria vaccine. In line with our strategy, our R&D efforts are designed to be an innovation engine for Novavax, supporting partnerships through our BD team. Elaine discussed the development work Sanofi is undertaking and could undertake in the future, and the recently announced partnership with Pfizer, with the potential for development of two vaccine products utilizing Matrix-M, with one disease area already identified. As Elaine mentioned, we have multiple MTAs in place, as well as ongoing conversations with other parties about the potential of Matrix-M and the portfolio of new Matrix-based adjuvants.

Our partnering discussions have the potential to result in collaborations and partnerships focused on a variety of areas across the respiratory, non-respiratory, and oncology markets, and other areas perhaps not yet contemplated. Of course, our approach hinges on the fact that in every instance, whether it's adding our technology to other platforms, creating new candidates with our own platform, or creating a new portfolio of adjuvants, we strive to offer something new and different to potential partners. This R&D model, coupled with the infrastructure we have built using our deep bench of expertise in AI and machine learning, enable us to quickly and efficiently explore opportunities in a low-cost, high-throughput manner, with the potential for earlier value creation for the company. With that, I'll now turn the call over to Jim to discuss our financial results in more detail.

Jim Kelly (CFO and Treasurer)

Thank you, Ruxandra. Please turn to slide 20. This morning, we announced our financial results for the Q4 and full year 2025. Details of our results can be found in our press release issued today and in our Form 10-K filed with the SEC. Please turn to slide 21. I will begin with key highlights from our Q4 and full year 2025 financial results. We reported total revenue of $1.1 billion, a 65% increase year-over-year. As a reminder, our current year revenue results include $625 million that is primarily non-cash revenue recognition from the resolution of Nuvaxovid APA agreements with Canada and New Zealand, announced in the Q1 of 2025.

For the Q4 of 2025, we reported total revenue of $147 million, a 67% increase compared to the same period in 2024. In addition, we reported positive income for both the full year and Q4 of 2025. We believe this reflects important progress as we improve our financial performance on many fronts, including addressing historical liabilities. During 2025, we continued to drive down our combined R&D and G&A expenses. On a non-GAAP and net of partner reimbursement basis, we reduced these costs by 42% and 53% for the Q4 and full year 2025, respectively. We accomplished these reductions while continuing to execute on partnership commitments and targeted core R&D investments to drive value. Novavax ended 2025 with $857 million in cash and accounts receivables.

In addition, we added another $80 million of non-dilutive cash in the Q4 of 2026, including a $30 million Pfizer agreement upfront payment and a $50 million initial draw from the new $330 million credit facility announced today. We executed this new credit facility with MidCap Financial to enable flexibility and continued access to non-dilutive capital as we execute on our growth strategy. Based on the combination of our year-end 2025 cash and receivables and the $80 million in non-dilutive cash in the Q1 of 2026, we believe we can fund our operations into 2028 without contemplating any new cash flow to Novavax. That said, we do anticipate the addition of significant cash flow from partners over time.

Please turn to slide 22 for a recap of our full year 2025 financial performance compared to our revenue framework and expense guidance. A reminder for all is that our non-GAAP adjusted total revenues exclude Sanofi supply sales and royalties that totaled $22 million in 2025. On a non-GAAP basis, we achieved $1.1 billion in adjusted total revenues. This was approximately $50 million higher than the midpoint of our revenue framework range and was driven by additional Nuvaxovid product sales, primarily to Israel, as we delivered doses on an amended APA schedule. Additional adjuvant supply sales and royalties from Takeda and the Serum Institute as they continue their successful marketing of Nuvaxovid in Japan and R21 malaria vaccine in Africa, respectively.

Finally, $22 million additional from R&D reimbursements from Sanofi related to clinical supply and support for commercial manufacturing preparations for the 2026, 2027 season. These points highlight strong execution as we support our customers and partners and advance our growth strategy. For combined R&D and SG&A, I'll begin with GAAP performance of $500 million. That was approximately $20 million favorable to the midpoint of our guidance. This was primarily related to R&D cost reductions and lower spend in the Q4. On a non-GAAP basis, the approximately $42 million favorability result comes from a combination of the $20 million in lower GAAP R&D spend and the $22 million increase in Sanofi R&D reimbursement noted earlier. Please turn to slide 23 for a detailed view of our Q4 revenue results.

For the Q4 of 2025, we recorded total revenue of $147 million, a 67% increase year-over-year. A few comments on Q4 results. Nuvaxovid product sales of $20 million was split between Israel APA deliveries and Novavax sales to other global markets. Supply sales of $19 million reflected both Nuvaxovid finished good sales to Sanofi and Matrix-M adjuvant sales to our partners. Sanofi licensing, royalty, and other revenue of $98 million was primarily driven by the $50 million in milestones for the achievement of MAH transfers for both the US and Europe, and $28 million from R&D cost reimbursement in the period. We look forward to Sanofi's Nuvaxovid commercial efforts in 2026 and beyond.

Importantly, 2026 reflects the first year where Sanofi is in a position to leverage all the commercial tools to compete effectively in the US and global markets. Please turn to slide 24. We made significant progress improving our cost structure in the Q4 of 2025. I will focus my comments on our non-GAAP results for combined R&D and SG&A, net of partner reimbursements. We delivered a 53% decrease in the Q4 of 2025, with major contributions from both R&D and SG&A as we executed on our cost reduction program.

This highlights that excluding the R&D reimbursed by partners, our Q4 cost structure is just under half the size of where we were a year ago and annualizes to a $328 million run rate, highlighting that we are on track for a significantly lower spend profile as we enter 2026. Please turn to slide 25. Now, since I've covered most of the Q4 and full year financial results already, I'll emphasize the positive operating and net income for both the Q4 and full year 2025. Please turn to slide 26. Taking a moment to recap accomplishments made towards improving Novavax's financial strength and performance.

Key takeaways from this work are that we've put Novavax in the position to have an estimated cash runway into 2028 and prior to contemplating any new cash flow into the company, as we drive towards our goal of non-GAAP P&L profitability as early as 2028. Keys to the timing of our path to non-GAAP P&L profitability are the successful development and regulatory approval of the Sanofi Flu COVID combination program, 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 27 for a review of our multi-year combined R&D and SG&A expense guidance. We are committed to continuing to streamline our operating expenses to enable value creation.

Today, and for the first time, we are providing our 2028 guidance of $200 million or below. This 2028 target calls for a $200 million and approximately 50% decrease compared to 2025. For 2026 and 2027, we're improving our non-GAAP combined R&D and SG&A expense guidance by $25 million each year to $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. We recognize that reducing cost is only part of the value equation. Novavax's core combined R&D and SG&A run rate of approximately $200 million or below is focused on targeted R&D investments to unlock value from our technology, including advancement of the early-stage pipeline, with the potential to bring at least one program into the clinic as early as 2027. Generation of new data supporting partnering Matrix-M. Advancing our adjuvant technology for both infectious disease and oncology use, including new formulations as we look to build a portfolio of adjuvants. Support for our ongoing Matrix-M manufacturing operations. Please turn to Slide 28. Turning to our 2026 revenue framework.

For 2026, we're following an approach similar to the 2025 revenue framework, in that our non-GAAP adjusted total revenue excludes Sanofi supply sales, royalties, and milestones from Kick and Matrix-M. This means there may be revenues in 2026 that are additive to our expectations for adjusted licensing, royalties, and other revenue. We believe that in the 2026, 2027 season, Novavax royalties will grow significantly as compared to 2025, as 2026 reflects the first year where Sanofi is in a position to leverage all the tools needed to compete effectively in the U.S. and global markets. For 2026, we expect to achieve adjusted total revenue of between $230 million and $270 million. This includes $35 million to $45 million of Nuvaxovid product sales under existing orders to Israel and Germany.

$40 million to $50 million of adjusted supply sales to our license partners, which primarily reflects sales of Matrix-M. $155 million to $175 million in adjusted licensing, royalties, and other revenue, consisting of $70 million-$80 million in R&D reimbursement as we continue our R&D support and technology transfer activities for Sanofi. $50 million to $60 million from other partner revenue from Takeda, Serum Institute, and Pfizer, including the $30 million upfront payment under the Pfizer agreement received in the Q1 of 2026. Finally, $35 million of non-cash amortization related to the previously received upfront and R&D milestone payments from Sanofi.

While our current revenue framework excludes the potential for the $125 million milestone linked to the initiation of a Sanofi flu-COVID combination Phase 3 study, we are encouraged by Sanofi's progress and public comments and look forward to sharing updates in the future. In addition, we are highlighting our expectation that we will be earning the Sanofi $75 million technology transfer milestone, although we are excluding this milestone from our 2026 revenue framework at this time. This is due to the recent Sanofi request that we complete a subset of these tech transfer activities at a new manufacturing site, and we are evaluating the potential timing impact of this request. We don't anticipate the outcome to impact either our stated estimated cash runway or vaccine supplies for the current or future seasons.

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.

John Jacobs (President and CEO)

Thank you, Jim. In summary, we are proud of our progress in 2025 and look forward to continued progress this year. We've started the year off strong with the new Pfizer partnership and look forward to executing against this agreement and our Sanofi agreement this year, while continuing to pursue new partnerships. We're also excited about the continued advancement of our R&D efforts, including our early-stage pipeline, Matrix-M lifecycle management, and the exploration of new potential Matrix-based adjuvants. We are executing our growth strategy and believe that we are on a path to deliver long-term sustainable value. Thank you to our shareholders for your support, and as always, we appreciate all of the hard work and dedication of our employees, without whom the success would not be possible. I would now like to turn the call over to our operator for Q&A. Operator?

Operator (participant)

We will now begin the question-and-answer session. To ask a question, you may press star, then one on your touch-tone phone. If you are using a speakerphone, please pick up the handset before pressing the keys. To withdraw your question, please press star then one again. At this time, we will pause momentarily to assemble our roster. Your first question comes from Roger Song with Jefferies. Your line is open.

Roger Song (Analyst)

Good morning, team. Thanks for the update and then taking our question. Maybe two from us. One is, we know Sanofi is about to have a new CEO. Just curious, based on your interaction with them or recent interactions, any updated views, strategies on their vaccine business? You know, we saw quite a few M&A in the past couple of months, but just curious about the new management or the new leader for the vaccine business, then particularly if anything, you can give us some comments around the 2026 expectation for the COVID sales. That would be very, very helpful. Secondly, you know, totally here, you use the C. diff as the example for the, for your pipeline showcase.

Just curious about the your early pipeline, any prioritization you are contemplating, understand the first IND as early as next year into clinical. Thank you.

John Jacobs (President and CEO)

Thank you, Roger. Great to hear your voice. Appreciate you joining us today. Let me take on your first question about the new CEO. The new CEO for Sanofi is not in place yet. There's a long history with Sanofi, but our connectivity with our partner has not changed at all. They're outstanding partners, completely transparent and positive relationship. We're very pleased with Sanofi as a partner and the folks we work with on a daily basis are there, fully engaged, and nothing has changed. We see a continued bright future with that partnership. I think you had a follow-up question then from there on potentially the fall season. Elaine, did you want to touch base on that?

Elaine O'Hara (Chief Strategy Officer)

Thanks, John. I'll just take that. Hopefully, Roger, this is the question that you asked around the COVID, the upcoming COVID season. We're very excited about the upcoming COVID season. Just to pick up on John's point, we obviously have multiple teams that work across both companies as it relates to COVID and future programs with Sanofi. We've been working expeditiously over the last, you know, since we signed the collaborative license agreement back in 2024, both for last year's season and this upcoming season. This season is gonna be the first real full season that Sanofi will be selling Nuvaxovid globally.

All of the plans that we've been engaged on with Sanofi over the last year, very deep, obviously have had a time to get through their contracting cycle at the retail level. This is the first full year that they'll have had the ability to do that. Yes, the upcoming season looks very promising. They have direct-to-consumer advertising programs that they will be initiating later this year as well. It looks like all systems go for a good season in the 2026, 2027 year and season for Nuvaxovid.

John Jacobs (President and CEO)

Ruxandra, did you want to take Roger's question? Roger, I believe you were asking about our pipeline, and if we have priorities, we chose to share some information about C. diff today as an example. Rux, did you want to take that one?

Ruxandra Draghia (Head of R&D)

Thank you, Roger. Indeed, we have chosen to give an example in C. diff, but of course, we are advancing with all the other early programs, the VZV, the RSV triple combination, as well as the work around Matrix, in both in the sense of new formulations and maybe new Matrix-based adjuvants. All these programs are advancing, each and every one at their own pace. There are actually very interesting results that we are generating in the preclinical space with each and every one of these programs, and we are looking forward in the future to sharing with you data from other programs. Thank you for the question.

Operator (participant)

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

Tom Shrader (Managing Director and Healthcare Analyst)

Good morning, thanks for all the update, as always.

John Jacobs (President and CEO)

Hi, Tom.

Tom Shrader (Managing Director and Healthcare Analyst)

kind of a broad question. I assume you don't want to build another vaccine commercial framework, or at least you'd love help. As you look for partnerships in, for the Matrix-M, are co-promotes attractive? Is that something we might hear about? A very different question for Ruxandra. You've obviously piqued our interest that you've already tweaked Matrix-M to get a bigger T cell response. How do you develop from here? Do you need a partner with a vaccine, maybe a cancer vaccine? What are the next steps we might look for? Because it's certainly an exciting comment. Thank you.

John Jacobs (President and CEO)

Tom, thank you for your questions as always. Number one, you know, as you know, Novavax has gone through a remarkable transformation in the last 3 years, with this, with a new management team and our focus and new strategy. We've cut out our commercial capabilities, reduced expenses, and are really focusing on partnering business development under Elaine O'Hara's leadership, who's with us here today, and R&D under Ruxandra's leadership. We reserve the right always, of course, to think about down the road, doing some kind of commercialization or co-promote, et cetera, with a product that might really be a game changer and a blockbuster if we were to get one out of the clinic. Our core focus right now is not that. We'll be open-minded.

If we get a real winner coming out of there and it looks exciting, we'll make the right decision to drive value for our stakeholders, for Novavax, and for everyone who's counting on us when that time and if that time were to come. Our intention is lean investment, drive data and proof points for our tech, invest in Matrix as a platform. Our intent is to create new adjuvants, tailored, specific adjuvants for different purposes, both within and outside of infectious disease. We have a vision to have a portfolio of adjuvants based on this Matrix technology, starting with Matrix-M, which, as we all know, is a remarkable adjuvant and product. That's our focus. Our new pipeline of assets, which we shared a bit about C. diff today. We're very excited.

We're excited about all three of those assets right now, but we chose that as an example. Such significant unmet need there with C. diff, and I will say very quickly, Tom, you know, my family felt the impact of that as my sister-in-law lost her best friend to C. diff infection and the sequelae following that on a routine procedure in a hospital. Quite a difficult condition to treat, and we really hope we can bring forward a vaccine that would be meaningful. The other point on your question, go ahead, Ruxandra, about Matrix.

Ruxandra Draghia (Head of R&D)

Yes, thank you, Tom, for the question. We are actually using our know-how, and historical knowledge of not only Matrix-M, but this entire adjuvant field, in order to create new formulations and new variants, versions of Matrix-based adjuvants that can be tailor-made to specific immune responses. Of course, that is a type of work that is undertaken in-house, by our teams. When those types of new variants of Matrix will be actually completely tested, and ready to partner, of course, that we are going to offer them to our partners, in different fields, like in oncology or in hard-to-treat infectious diseases, as we have actually with Elaine and her team, went and realized these fantastic deals around Matrix-M. Internal work in view of partnership.

Tom Shrader (Managing Director and Healthcare Analyst)

Got it. Thank you.

Operator (participant)

Your next question comes from Anupam Rama with JP Morgan. Your line is open.

Speaker 14

Hey, guys, this is Joy on for Anupam. Thanks for taking our question.

John Jacobs (President and CEO)

Hi, Joy.

Speaker 14

It's great to see the continued progress on new Matrix-M partnerships. I think you noted one of your agreements this month was expanded to explore an additional field. I was just wondering if you could provide any more color on that. Then just broader, what is your view on the potential time horizon for these MTAs to turn into more formal partnerships? Just at what stage of development or, you know, evidence generation do you think you could start having those conversations with your partners? Thanks so much.

John Jacobs (President and CEO)

A really great question. I'll have Elaine elaborate on that. Elaine's team leads our efforts on business development and the strategy on how we approach partners, which she shared some of in our prepared remarks earlier today. There's a methodology to that starts with R&D, with data that Ruxandra and her team generate, and then Elaine and her team are able to share that data in partnership with our R&D colleagues, with potential partners. You know, one comment I'll make and hand it over to Elaine for a little bit more elaboration on the process and what we might be able to expect. What we're seeing is as other companies start to experiment with Matrix, learn more about it, most often they're coming back to us to do more. You heard that in some of Elaine's comments today.

Elaine, you might want to elaborate there.

Elaine O'Hara (Chief Strategy Officer)

Thanks very much, John. In some instances, we create and generate data ourselves internally to utilize and have that presented to various partners in partnering discussions. In other instances, we allow and provide Matrix-M to companies to test and experiment in their own clinic and in their own preclinical situation across either existing vaccines or vaccines that they may have in development. As John mentioned, what we're seeing at the moment is several companies are coming back and asking to expand that opportunity to other fields, whether it's bacterial, viral, you know, situations, and most recently, even oncology as well. We're very excited about that. The timeline is TBD.

We don't have any, necessarily any control over that because it's up to the partner in terms of what they're developing and how long that timeline is going to sort of unfold. That's why, obviously, we work with our partners then to gain an upfront payment for the ability to utilize Matrix-M and go through a collaborative license arrangement then where we can receive various milestone payments, depending on when those partners hit those milestones, as well as royalties in the future as well. That's really the structure of the and strategic sort of direction that we move in with our partners, and we work very closely with them in many situations to get them from the start to the finish.

Then obviously, they take it over themselves as well as they move Matrix-M through their own pipeline. Hopefully that answers your question. Thank you.

John Jacobs (President and CEO)

Well said, Elaine. Pfizer was one of the first organizations, as our new strategy began to launch, to begin assessing the potential of Matrix-M as we were focused on out-licensure of our technology and making this a cornerstone of the future for Novavax. There's been multiple potential partner discussions behind that, all at different stages. You know, we're not in a position to ever promise or commit that we're guaranteeing anything about another partner coming on board, but we can say that we have a pipeline of potential partners that is now building and growing. As Elaine said, we had a large, you know, global pharmaceutical company, a top 10 kind of company, that came back to us to expand their MTA into another field to explore.

As these companies learn and they see Matrix-M won't work for everything. Nothing works for everything, but it often works to solve problems and help these other companies unlock value or value potential in their pipelines. As they see that, they're coming back again and again to us to expand and create additional opportunities with this asset. We're excited. We anticipate and intend to drive additional partnerships in the future, and we will share those with you when they're inked and done, should that occur. We can't say much more about it before that, other than a lot of traction, a lot of work behind the scenes, all at different stages of progress and dialogue toward that eventual intended end.

Operator (participant)

Your next question comes from Mayank Mamtani with B. Riley Securities. Your line is open.

Mayank Mamtani (Senior Managing Director)

yes, good morning, team. Thanks for taking our question. Congrats for the momentum you have on partnerships and pipeline.

John Jacobs (President and CEO)

Thank you, Mayank.

Mayank Mamtani (Senior Managing Director)

Impressive discipline on spend scale down. Mayank, two questions. One on the respiratory vaccines, FDA and ex U.S. regulatory roadmap. What's your best understanding, since, you know, you do have some correspondence relating to your own phase 3 stage programs, CIC and Flu, and there's obviously the, you know, Sanofi partnered CIC program. You know, I don't know to what extent you've compared the two, the Sanofi partnered and your own, wholly owned CIC program. I was just curious, if this uncertainty starts to clear up, like, what is sort of the way to assess value of your own two clinical stage programs? Then I have a follow-up.

John Jacobs (President and CEO)

Mayank, apologize. Just wanna make sure we understood your questions. First, I believe you were noting that we had received some feedback in the past on our CIC and Flu programs. Obviously, we're not making further investment ourselves in those programs. We're looking to out-license those and partner those, and I believe you were asking us to compare and contrast that with some of the things that have been disclosed in the public domain from Moderna and others recently. Was that your question?

Mayank Mamtani (Senior Managing Director)

Yeah.

John Jacobs (President and CEO)

If that provides any insight.

Mayank Mamtani (Senior Managing Director)

Also the Sanofi data. We learned some in December, there is, I think, a way to compare at least a high level, your CIC program with the Sanofi program. I was just curious if that Sanofi program does go into phase 3, you know, is there a way to ascribe value to the two programs, which I understand you're not investing, but, you know, are partnerable assets?

John Jacobs (President and CEO)

Got it. Well, what I can say about that, Mayank, is we were very pleased to see our partners advance both of those programs. Two combination vaccines with their two flu vaccines, their leading high-dose flu vaccine, right, and Flublok and Fluzone High-Dose with our proven COVID vaccine. Very exciting. There's been more recently, you know, and as you know, we can't and won't speak for our partners, but what we're excited to see are their comments in the public domain. Their CFO was recently out on the road with analysts and investors, and they've publicly been speaking about the importance of these combination programs to their future as they start to contemplate the post Dupixent Sanofi and how important that is.

I encourage everyone to take a look at those comments from Sanofi leadership in the public domain, as they're getting ready for further leadership change. They've been quite direct about how important these assets are and how excited they are about it and have noted regulatory review, this is their words, not ours, expected in the 2027 to 2028 timeframe. We're very excited about that. They're outstanding partners. They have tremendous capability in the vaccine space and a leadership position in flu globally, and we see a bright opportunity there. There's a pathway forward, we believe, and that we're encouraged by Moderna's progress with their flu vaccine. What we're seeing there in the public domain, you can see, and our investors can also see.

We're seeing a pathway forward there, an ability to negotiate and work with the current administration. We're also hearing from the current administration, that they believe in vaccines and want them to move forward. Obviously, some of the positions they've taken, our industry and our scientific community may not agree with all the time, certainly. There seems to be a pathway forward here, at least from what we can see together. Just making comments on what we see publicly, what our partners have said publicly, we couldn't be more excited about our future here and looking forward to next steps and hearing more from Sanofi.

Mayank Mamtani (Senior Managing Director)

Very helpful color. Thank you. If I could ask a follow-up on, you know, your expected annualized run rate, you wanna be at ending this year. I know you mentioned you're at about $320 million, ending 2025. You know, want to understand, you know, target for year-end, since it's a big step down, 26 to 27. Maybe just a bit more color on the new manufacturing site request from your partner, Sanofi. If, you know, any color you can give there more, on timeline of resolution there. Thank you for taking my question.

John Jacobs (President and CEO)

Thank you, Mayank. I think I'll have Jim cover your questions about cost. I think very importantly, you heard in Jim's prepared comments some non-GAAP description about the core costs for our company and then obligations we have that are trailing, and the end stage of those trailing obligations on remaining APAs and tech transfer activities and things like that we're supporting our partner, Sanofi, with. That you can see very, hopefully very clearly in the provided slides and hear in Jim's commentary, how those costs are anticipated to roll off toward the end of this year, in a large part, those extra costs on those trailing obligations, and that we then get closer to the core, where we're operating our business. Jim, why don't you comment further on that for Mayank?

Jim Kelly (CFO and Treasurer)

Yes, certainly. Mayank, as you've watched the evolution of our cost structure, a couple important points to think about in 2026. One in particular is that we exit 2025, Q4, in an annualized rate that is consistent with the non-GAAP $325 million that we are guiding to in 2026. That said, while I'm not providing quarterly guidance, it is worth noting that it will be a bit front-end weighted for the following reasons. When you think about our preparations for the fall season and the type of manufacturing support en route to the fall, much of that work happens in the first and the Q2 of the year.

That's the first reason why you'll see a higher amount in the first part of the year. A second part is, as you might remember, we're supporting Sanofi on numerous R&D activities, including a post-marketing commitment, the majority of which will be front-end loaded into the year, a portion of which we're covering as well. On that net of reimbursement basis, you'll see some incremental spending there as well. Therefore, the shape of our spend throughout the year towards our full-year targets will be more front-end loaded for the reasons I just mentioned.

That is why, you know, as we look towards our ability to, you know, hit the appropriate both quarterization at the end of 2026, but also acknowledging that there'll be a drop-off in certain spend profiles as we complete activities, that's the shape of the business for 2026. Hopefully helpful on that front.

John Jacobs (President and CEO)

Elaine, did you want to address the question about the tech transfer?

Elaine O'Hara (Chief Strategy Officer)

Absolutely, John. Thank you. As I mentioned earlier in one of the questions and answer sessions, we have multiple teams working very collaboratively, both with Novavax and Sanofi, and one of those is actually a tech transfer team as well. Sanofi made the decision to actually fully realize all of the tech transfer to a US facility. As a result, that's just gonna extend the timeline for the tech transfer and take a little bit longer. That decision was recently made. All of their capability for the manufacture of Nuvaxovid will actually occur in the US. Again, we're supporting them and working with them to make that happen. Again, it doesn't affect, as Jim mentioned, our health, the health of Novavax from a cash perspective.

Just wanted to give a little bit of additional information and context on that.

John Jacobs (President and CEO)

Jim, any further comments to add?

Jim Kelly (CFO and Treasurer)

You know what? I would reiterate that, first of all, Sanofi, amazing partner. We, you know, we've got, you know, the same conviction and confidence that, you know, we're working with the right partner, and we're gonna help them do what they need to do to get all the technology transferred into their hands to manufacture effectively and have supply available for coming periods. We don't see any impact on that. It's just simply working with the team on what I outlined as a subset of activities, so that's fine. Then, I made a reference earlier about the milestone, $75 million. We'll come back to you regarding the implication and timing on that. It doesn't impact our cash runway. It doesn't impact, in our view, you know, the likelihood of achievement.

It's just simply working through some details with what we think is an excellent partner.

Mayank Mamtani (Senior Managing Director)

Makes a lot of sense. Thank you, guys.

Operator (participant)

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

Speaker 12

Hi, this is Sarah on for Pete. Congrats on the quarter progress. Thanks for taking our questions.

John Jacobs (President and CEO)

Thanks, Sarah.

Speaker 12

Another question on Nuvaxovid. You've described 2025 as the transition and 2026 as the first commercial year for Nuvaxovid under Sanofi control. How much of that COVID 2026 uptake assumption depends on contracting wins versus physician patient mix driven pull-through. Additionally, can you just remind us how many MTAs are currently in place? Thanks.

John Jacobs (President and CEO)

Sorry, good questions. I'll have Elaine comment a bit on the nature of contracting. We wouldn't be able to disclose for our partners, you know, the percentage or the wins or things like that. Certainly, contracting matters in the United States, as the vast majority, over 90%, in my recollection, of COVID distributions in the United States have been through retail pharmacy. That contracting begins the year before, wraps up, you know, in sometime around Q2 the next year, and they're deep into that process right now, and it's very important.

They were able to start that process this cycle for the first time because they had the BLA now in hand, all the tools, all the pieces in place at the end of last year, so they could start that full cycle negotiation with retail. It absolutely matters in the U.S. marketplace, and they were in it from the beginning, and that's the first time for Nuvaxovid under BLA, that we've been able to have our asset in the hands of a partner at that full cycle, with all the pieces in place for them to, you know, work their knowledge and experience to begin to optimize over time, the penetration of the market for our asset. Elaine, anything to add to that?

Elaine O'Hara (Chief Strategy Officer)

No, that's it, John. I mean, again, the cycle for Sanofi starts in November of the previous year. By the time they hit March, April timeframe, those contracts should be wrapped up. Can't speak to the volume or the level of detail, since, you know, they have full commercialization rights. That is TBD yet, but we're very inspired by the conversations that we've had at our joint commercial committee, that the 2026, 2027 season is gonna be a full cycle season, again, based upon all of the components from a marketing perspective that they aim to put in place. Hopefully that answers the question.

John Jacobs (President and CEO)

Yeah, the other question was about the number of MTAs. We haven't disclosed all of the MTAs that might be signed. We're being very careful and selective. Like I said earlier, Sarah, in my prepared comments, since I joined the company in January of 2023, I've never seen this level of interest. It's not surprising because Novavax, historically, when they had first acquired the asset, brought it forward, right? Through eventually R21 and a COVID vaccine. Those were the first assets that showed the world this adjuvant can make a difference. We transformed this company over the last 36 months to focus on out-licensing our technology and really making the world aware of that.

Our R&D team was generating data to show that we have utility across multiple vaccine platforms, which was part of our comments today. That Elaine, I brought Elaine in as our chief strategy officer. She created a new capability here in Novavax to really start to negotiate these kind of things, reaching out to partners. It's through the efforts of our employees here, Elaine and her team, Ruxandra and our R&D team, and the concerted efforts and focused strategy, that we've enabled the awareness of this amazing technology and helped to enlighten others as to its potential. When they experiment with it themselves, most often they're seeing the results, and they're seeing it has the potential to unlock problems they might have been wrestling with for a while, unlocking value, potentially, in their portfolios. We see the actions from Sanofi.

We see the actions from Pfizer. Under the new strategy, Pfizer was one of the first to be approached by Elaine and her team in this new construct post the Sanofi deal. That's turned into a deal that could, assuming successful execution by Pfizer, result in billions of dollars in future revenues and value for Novavax and all of our stakeholders. There are many MTAs in place. We announced that we had existing partners ask for expansion or amendment of that MTA. Elaine, you may want to comment a little more. You just signed a new one in the last week with an oncology company.

Elaine O'Hara (Chief Strategy Officer)

You're correct, John. Actually, we've had some interesting weeks here in February with a signing a new MTA with an innovative oncology company, also an additional signature for an amendment for a large cap pharma company to expand their initial MTA to cover another pathogen that they're interested in pursuing. Lots of interest, again, we're delighted with that. Our goal is to, you know, accommodate our partners in every which way that we can from our research and development perspective, to support all of the initiatives that we have with our partners at the moment. We're very excited about the future.

Operator (participant)

Your next question comes from Chris LoBianco with TD Securities. Your line is open.

Chris LoBianco (VP of Equity Research)

Thanks for taking our question, and congrats on all the progress over the last few months.

John Jacobs (President and CEO)

Thank you, Chris.

Chris LoBianco (VP of Equity Research)

Can you provide any color on the specific characteristics or potential differentiating factors of Matrix-M that were most attractive to Pfizer? I had one follow-up question.

John Jacobs (President and CEO)

Well, Chris, just so my team could hear, we had a little bit of trouble hearing the question. I believe you were asking, can we comment on the differentiating characteristics of Matrix that were attractive, in particular, to Pfizer? Did we hear you correctly on your question?

Chris LoBianco (VP of Equity Research)

Yes.

John Jacobs (President and CEO)

Yeah. We won't be able to comment specifically on what Pfizer might have found attractive because Pfizer's keeping that, you know, confidential due to competitive reasons. Obviously, they saw significant value to sign such a meaningful potential deal with Novavax that's now on the books, and they're moving forward with their work. One of the two fields that they're allowed to explore with Matrix through the agreement has already been selected, and they're contemplating the second. But I think Ruxandra and Elaine could comment, maybe Elaine from a business perspective and Ruxandra from a scientific perspective in general, why Matrix is such a powerful tool and why others in general may be interested in it. Elaine, and then Ruxandra, please.

Elaine O'Hara (Chief Strategy Officer)

Just very quickly, from a business perspective, you know, I think Ruxandra said this in her commentary earlier on, Matrix-M has a lot of flexibility. The platform, the technological platform is very flexible and it can support many vaccine platforms. I think that's very attractive. The whole nature of an adjuvant is that it can provide and enable a more targeted or specific or a broader immune response. With each one of those value propositions, when we have discussions with partners, obviously they're interested in any or all of those, and that is largely the discussion that we have.

As I said earlier, they then take that back to their clinic, to their preclinical situation or clinic, and then, that, as John mentioned, potentially helps them to either solve a problem or unlock additional value for their vaccine or their portfolio of vaccines. Rux?

Ruxandra Draghia (Head of R&D)

Yes, thank you, Elaine. Excellent point. On the top of what Elaine just mentioned, we might remember that in the clinical studies, we have generated significant amount of data showing that Matrix-M as an adjuvant, is associated with a very favorable reactogenicity tolerability profile. Together with this broad type of immune response in combination with different vaccine platforms and different types of antigens being bacterial, being viral, now in our latest explorations in oncology, we are looking to actually capture and capitalize on all these characteristics, a broader immune response plus a tolerable profile. I think that those might be some of the criteria that are serving as an impetus for potential partners to come to the table and start a conversation.

Chris LoBianco (VP of Equity Research)

Great. That's very helpful. The second question is, do you think there is more upside or downside risk for Nuvaxovid from the upcoming March 2026 ACIP meeting? Can you remind us if there is data that shows differentiation on long COVID and safety for Nuvaxovid relative to the mRNA COVID vaccines?

John Jacobs (President and CEO)

We'll let Ruxandra comment on the long COVID question and the differentiating data. Regarding ACIP and upcoming interactions with the FDA and regulators and different decision-making bodies, you know, I, we're optimistic about a pathway forward. You know, last year, the season rolled out, and everyone was out at the same time, et cetera. We're anticipating the same thing to happen this year, but until it happens, you know what we know. We can all see it in the public domain. There's a meeting now on the books, so that's good, and we'll pay attention to that, and as that unfolds, we'll roll with it. We are doing everything we can to ensure that we are prepared to support Sanofi in their commercial efforts in the U.S. marketplace this year. We're ready with supply for Sanofi.

We understand the strains that are circulating, and we've been focused on that. Our team knows how to do that. Sanofi certainly is a global expert at doing that with their flu. We collaborate very closely with them, so we are ready, we are poised, and what's beyond our control, we'll watch unfold together with you, and we'll go with the flow on that. We're anticipating a pathway forward. We do not anticipate choice being completely removed from the American population on important tools like vaccines. Again, that's my personal opinion. That's our team's thought about it. We know what you know. We can watch it in the public domain, so let's see.

We do expect and anticipate, optimistically, a season to unfold this fall, and are looking forward to seeing, assuming that smoothly goes this spring from the regulatory authorities, how well Sanofi can perform now in their first full cycle launch.

Ruxandra Draghia (Head of R&D)

As far as your question around long COVID, epidemiological data published in a high-level peer review publication, has actually pointed to the fact that vaccinated individuals have a lower risk of developing long COVID compared to unvaccinated individuals in different populations and geographies. Obviously, with any vaccinations, in particularly boosters, are associated with this lower risk of long COVID per the published literature. I don't know if that answers your questions, but at least whatever is out there, as peer review data is showing this particular association.

Chris LoBianco (VP of Equity Research)

Great. Thank you.

Operator (participant)

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

Speaker 13

Great. Hey, thanks. This is Jarryd on for Geoff. Really exciting, encouraging to hear that you guys are expanding the pipeline opportunity to beyond, you know, respiratory vaccines. Maybe just thinking about, you know, shingles and, you know, RSV, what will inform timing for moving that into 2027? Could this possibly be more of a 2028 situation? Also, could partnerships or potential partnerships for these programs influence expediency and selection on which one gets moved into clinic, first? Is that something you're exploring as well? Partnerships, that is. Thanks.

John Jacobs (President and CEO)

Thank you for your question. Very importantly, your question focuses on one of the key elements of our R&D strategy and how R&D is supporting our efforts. Very importantly, the investments we're making in R&D are multiple and important to support primarily Matrix, that technology, to expand the utility of Matrix, to create new formulations of Matrix-M, such as dry powder, et cetera, and also working on the creation of new adjuvants based on the Matrix platform, with the intention over time, should we succeed there, of having a portfolio of adjuvants that are tailored and specific to target some very difficult-to-treat infectious diseases, to go beyond infectious disease into oncology for specific types of oncologic conditions.

That's where we're really focusing a lot. We have experts here on the scientific side in Sweden, with Novavax, that understand Matrix and for years have worked with it, and a lot of expertise in Rux's shop on that. Another key element, generating data and proof points that our business development team can utilize. Then third, but not, you know, not last, it's important, we have some early-stage assets in development. The goal of that is to further, to your point, Jarvik, is to further partnering opportunities and also to generate more proof points and data. All along the way, and we're learning from each of these approaches and combining that synergistically with our efforts on Matrix to further inform how we approach building this potential library of adjuvants, if you will, that we're working on.

When it comes to expediency or timing, what we've said is, as early as 2027, we could be in the clinic with humans with one or more of these assets, should we choose. We're not disclosing exactly where we are on timelines right now. We feel confident saying that at this point. Elaine, did you want to elaborate further?

Elaine O'Hara (Chief Strategy Officer)

Yeah. Thanks, John. I mean, the only thing I would say is, you know, A, we selected these antigens and these programs because we believe that they have significant market opportunity, but also address unmet medical need. Each one of the programs has its own unique, you know, path forward from a preclinical perspective and also its unique opportunity in the marketplace as well. The way that we selected these programs was based upon competitive landscape, opportunity, and other characteristics. As John said, we will attempt and move into the clinic in 2027. That is our goal. As we have data that's relevant to a potential partner, we will begin those discussions with those partners as they become available. That's the goal.

John Jacobs (President and CEO)

Ruxandra, we're deeply into the preclinical work on all three of these programs. Slightly different stage for each. We chose to share some information today on C. diff because it's obviously such a huge unmet need globally. There's no vaccine available. You know, importantly, Jarvik, others have tried and failed, at least in their initial attempts, to create a vaccine for C. diff, and we see companies going for that again now and trying. Our team was able to learn from. There's a lot of data out there in the public domain and publications, learn from those past attempts. You heard some of the commentary from Ruxandra on how we're approaching this very differently from a multivalent antigen perspective, antigen versus toxin perspective, other things like that that are very important. Of course, we have Matrix-M.

We're very excited about what we're seeing. We're standing by our commentary that as early as 2027, we could be in the clinic with one or more of these. Again, it's providing value to us in these behind-the-scenes discussions on business development. The last point there, obviously, any management team, executive team, working on a strategy like ours will always know more about where we are than we're allowed to share with everyone in the public domain. You know, we won't make and cannot make promises about success on any of these endeavors. They have risk, they're challenging, but we're excited about what we're seeing on progress with potential partners, what they're seeing in their own experiments, and what we're learning from our R&D efforts. We look forward to keep bringing you information as we can and as the story continues to unfold.

Speaker 13

Thank you.

Operator (participant)

Your next question comes from Alec Stranahan with Bank of America. Your line is open.

Speaker 11

Hey, guys. This is Matthew on for Alec. Appreciate you taking our questions. Maybe two from us. Can you just speak to, you know, current agreements for Matrix-M that have been signed, whether those agreements also apply to sort of the portfolio of adjuvants, you know, you're thinking about developing going forward and sort of different formulations of Matrix-M? Maybe on the pipeline as well, curious, you know, if one of the three programs is sort of ahead of the others and, you know, if they're all sort of similar stage, I guess, which one, you know, you would think about bringing forward? Is it dependent on developments in the therapeutic area, sort of updates there, or something else? Thanks.

John Jacobs (President and CEO)

Thank you for your question. I'll let Elaine comment on the current agreements that are signed regarding Matrix. Go ahead, Elaine.

Elaine O'Hara (Chief Strategy Officer)

Thanks, John. Yes, clearly, all signed agreements, all material transfer agreements that we have signed today, focus exclusively on Matrix-M. That's the answer to that question. Sorry. John, back to you.

John Jacobs (President and CEO)

No, you're right. Any new adjuvant, should we succeed in developing one or more additional adjuvants, that's our intent. That would be purely Novavax. Importantly, we have not exclusively outlicensed Matrix-M to any party. You know, that's Novavax's asset, and so we give licenses for particular indications and things like that to partners. So this would be, you know, it should we succeed with one or more additional targeted adjuvants, those would be ours, our IP. We can work with those. We can out-license those. You know, we see, we see that as a potential future engine for continued innovation and partnering opportunity, both within and our intentions to go beyond infectious disease in that regard. You asked also about pipeline assets in that way, Ruxandra? Yeah.

Ruxandra Draghia (Head of R&D)

Yes, thank you for the question. As far as early pipeline assets, you might remember from our previous presentations and from my intervention, that each and every one of them actually is addressing a different unmet medical need. For C. diff, there is no vaccine. For shingles, the issue was the reactogenicity that is associated with current vaccines. For RSV, it's a triple combination, so we are going and adding other antigens to that particular antigen of RSV. So each and every one have their own complexities. We started these programs by designing a very rigorous target product profile that is based on where we are in the field and where we are from a business opportunity. That TPP is evolving as the ecosystem is evolving.

It is a, you know, a living document. As we go along in our discovery and development efforts, we are always relating back to that TPP. If new data is created by somebody else, we are taking that into account, and we are asking the question, "Are we good enough? Are we better? What do we need to do, or what data should we develop in order to convince a partner and to convince ourselves that that is a program that is worth pursuing?

Operator (participant)

Your last question comes from Sean Lee with H.C. Wainwright & Co. Your line is open.

Sean Lee (VP of Equity Research)

Hey, good morning, guys. Thanks for the update and for taking our questions. Most of my questions have been answered, but I just have one more on the early pipeline. It's for these three products that are in preclinical right now, can we expect to see any milestones this year regarding data disclosures? I mean, specifically, are you targeting any specific conferences where we can see some of the preclinical data on these? Thanks.

John Jacobs (President and CEO)

You know, let's have Ruxandra go into a little more depth on the answer, but we're excited about what we're seeing. We're going to be very cautious about how much we share for competitive reasons. For instance, in one scenario, if we think we have unlocked a potential pathway forward with an asset, I'm not saying that today, I'm saying in that scenario, let's call it a hypothetical, we wouldn't want to share how we figured that out in the public domain, even though that might be exciting. We're going to be cautious. Next steps, you know, as we wrap up the work in the near term on our preclinical efforts, we could ready one or more of these assets, that's our intent, for IND with the regulatory authorities.

We would expect the potential of that to occur this year, and that's why we say as early as 2027, for to be in humans with one or more of these programs. Yes, we will continue, as we did today, begin to unveil first for C. diff, here as an example, some of what we're learning and the progress we're making. We're going to remain cautious and a bit guarded on some of it because we want to be careful from a competitive standpoint. We're making excellent progress. Our lean and careful investments are paying dividends internally from what we can see, and we're excited to continue to bring these forward with the intent of success with one or more of these down the road. We'll keep you informed.

Sean Lee (VP of Equity Research)

Great. Thank you.

Operator (participant)

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

John Jacobs (President and CEO)

Just want to thank everyone for joining us today. I want to thank all of our investors who believe in Novavax, believe in our technology. I want to thank our investors for being patient with us as we converted this company and transformed it from a company focused on COVID alone with one asset, and the remarkable effort of our employees to unwind a large global organization built to commercialize one asset and do so without hurting our capabilities while changing strategy and while starting to move forward and teach the world about the technology this company had and was sitting on and made one asset with, to then start to enlighten others about the potential of that technology and the effort and the time that takes. Everyone likes to see things right away. Show me yesterday.

Why do a deal in a day," right? This took time to convert the company. It took time also to enlighten others and share data and generate data to show them how this product might work with their pipeline assets or technology platform. They do their own experiments. We saw Pfizer, one of the first that we started with our new strategy, come forward. We're telling everyone we've got a pipeline of potential partners behind that. We'll never promise anything until we deliver it. We want you to know we're working really hard every day. Our employees are having fun. We're excited. We're excited to be engaged deeply into this new strategy and really optimistic about the legacy we can leave on global public health and the value we can drive for all of our stakeholders.

Thank you again for your patience, your belief in us and our technology. We're working really hard for you. We're gonna work hard not to let you down and to keep growing this business. Thank you, everyone.

Operator (participant)

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