Novavax Inc Q4 FY2025 Earnings Call

Good morning, and welcome to Novavax's Fourth Quarter and Full Year 2025 Financial Results and Operational Highlights Conference Call. 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.

Good morning, and thank you all for joining us today to discuss our fourth quarter 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. 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. 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 plus partner reimbursements and non-GAAP profitability. 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 5. I would now like to hand over the call to John.

Thank you, Luis. I'm excited to be here today with members of our executive team to share our fourth quarter 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. And we are successfully executing our plan. For example, just this January, we announced a new agreement with Pfizer for Matrix-M. This agreement further demonstrates the value other companies with vaccine portfolios see in Matrix-M. The changes we have made to date continue to strengthen our company, and 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 nondilutive capital earned in the last 18 months. Anticipated continued royalties from our marketed and partnered products 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 have been marketed by the Serum Institute. 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 III study initiates and/or the 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. 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. 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. The other key aspect is 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. However, 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. This is a long-term, serious and meaningful endeavor to be part of. 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. We look forward to the year ahead and we approach it with enthusiasm. And with that, I'll turn it over to Elaine to talk about our business development efforts. Elaine?

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. We are pleased with the progress we have made on partnerships to date and have honed our capabilities in this area to drive future success. Some 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 2 disease areas. We're seeing that once vaccine-focused companies experiment with our adjuvant, they often come back to explore more broadly after seeing results from their initial experiments. We have also continued to execute on our Sanofi partnership and the expansion of our agreement to include Matrix-M in Sanofi's pandemic flu candidate program. We're excited about the progress of Sanofi's combined flu and COVID-19 vaccine candidates with further proof of the potential value that our platform can generate. So as we look to generate new partnerships, our goal is to create a funnel of interested organizations and we are partnering closely with our R&D team to facilitate these conversations in three ways: First, generating our own data to share with potential partners and providing Matrix-M to potential partner companies for their experimentation. Secondly, continue the exploration of potential new Matrix-based adjuvants. 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.

Thank you, Elaine. 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. As far as our in-house R&D efforts, we are expanding our efforts in infectious diseases with our internal early-stage pipeline, including programs targeting C. difficile, 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. 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 candidate outperformed a two-toxin alone comparator. If successful, bringing this candidate into the clinic would address significant unmet needs.

Thank you, Ruxandra. This morning, we announced our financial results for the fourth quarter and full year 2025. We reported total revenue of $1.1 billion, a 65% increase year-over-year. For the fourth quarter of 2025, we reported total revenue of $147 million, a 67% increase compared to the same period in 2024. We believe this reflects important progress as we improve our financial performance on many fronts, including addressing historical liabilities. On a non-GAAP and net of partner reimbursement basis, we reduced R&D and G&A costs by 42% and 53% for the fourth quarter 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. We executed this new credit facility with MidCap Financial to enable flexibility and continued access to nondilutive capital. Based on our year-end 2025 cash and receivables, we believe we can fund our operations into 2028 without contemplating any new cash flow to Novavax. For 2026, we're following an approach similar to the 2025 revenue framework in that adjusted total revenue excludes certain supply sales, royalties, and milestones. For 2026, we expect to achieve adjusted total revenue of between $230 million and $270 million. Importantly, we believe that in 2026, Novavax royalties will grow significantly as compared to 2025.

In summary, we are proud of our progress in 2025 and look forward to continued progress this year. We have 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. Thank you to our shareholders for your support. 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.

Your first question comes from Roger Song with Jefferies.

Maybe 2 from us. So 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 or strategies on their vaccine business? ...

Thank you, Roger. Great to hear your voice. Appreciate you joining us today. Let me take your first question about the new CEO. The new CEO for Sanofi is not in place yet. We are pleased with Sanofi as a partner and see a continued bright future with that partnership. And the folks we work with on a daily basis are fully engaged.

Yes, we're very excited about the upcoming COVID season. ... So yes, the upcoming season looks very promising. They have direct-to-consumer advertising programs that they will be initiating later this year.

Yes, we have chosen to give an example in C. diff... We're advancing with all the other early programs, the VZV, the RSV triple combination. All these programs are advancing each at their own pace.

Just 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 for the Matrix-M, are co-promotes attractive?

A remarkable transformation in the last 3 years... our goal is not that. So we'll be open-minded should we get a real winner coming out of there.

Yes. So we are actually using our know-how in exploring the potential creation of new Matrix-based adjuvants... of those new variants of Matrix will be tested and ready to partner.

You heard in some of Elaine's comments today... companies are coming back to us to do more.

It's great to see the continued progress on new Matrix-M partnerships... what is your view on the potential time horizon for these MTAs to turn into more formal partnerships?

In some instances, we create and generate data ourselves... allowing and providing Matrix-M to companies to test.

We're not in a position to promise or commit that we're guaranteeing additional partners coming on board, but we have a pipeline of potential partners that is now building and growing.

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

We believe we can advance one of our preclinical assets into the clinic as early as 2027... we've got a pipeline of potential partners behind that.

We made significant progress improving our cost structure... we anticipate operating at an approximately $200 million core spend profile.

I want to thank all of our investors who believe in Novavax, and thank you for your patience as we converted this company... Our employees are having fun, we're excited about our new strategy.

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