Novavax, Inc.

Good morning and welcome to Novavax third quarter 2025 financial results and operational highlights conference call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star and then the digit one on your touch-tone phone. To withdraw your question, repeat the steps of star and one. Please note, this event is being recorded, and I would now like to turn the conference over to Louis Sene, Vice President, Investor Relations. Please go ahead, sir.

Good morning, and thank you all for joining us today to discuss our third quarter 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 two. 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, its expectations regarding manufacturing capacity, timing, production, and delivery for its COVID-19 vaccine, the development of Novavax's clinical and preclinical product candidates, the timing and results of our clinical trials, timing of regulatory filings and actions, its APA agreements and related negotiations, full year 2025 financial guidance and revenue framework, full-year 2026 revenue framework preview, 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 at 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 three. 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 reimbursement, and non-GAAP profitability. Please turn to slide four. Joining me today is John Jacobs, our president and CEO, who will highlight our growth strategy and provide an update on our progress during the quarter. Dr. Aksandra Draghi, head of R&D, will discuss our R&D updates, and Jim Kelly, chief financial officer and treasurer, will review our financial results and 2025 financial guidance and revenue framework. I would now like to hand over the call to John.

Thank you, Louis. I'm excited to be here today with members of our executive team to share our third quarter results. During Q3, we progressed our corporate strategy of driving growth and value by continuing to strengthen existing partnerships and build new collaborations while advancing R&D innovation and our early stage pipeline. Please turn to slide five. We've been on a steady path to transform Novavax since I joined the organization in 2023. With our new corporate strategy as our guide, we have an exciting opportunity to drive value for our shareholders and the communities we serve for decades to come. Let me take you through how we intend to get there and the progress we've already made. When I joined the organization in 2023, we were a fully integrated commercial organization, primarily focused on sales of our COVID-19 vaccine. Our imperative at that time was to stabilize the company financially. And to that end, we removed more than $1 billion of current liabilities by year-end 2024 compared to 2022. During that same period, we also reduced almost $1 billion in operating expenses. In addition, in 2024, we announced a significant and multifaceted partnership with Sanofi, which has now allowed us to accelerate the next phase of the company's planned evolution. This year, we relaunched Novavax as a company focused on partnerships and R&D innovation. Our new strategy is centered on amplifying the impact of our technology platform through collaborations with other biopharmaceutical companies and a new diversified pipeline. And this represents a strategic and thoughtful departure away from a single focus on the resource intense commercialization of one product, our COVID vaccine. To date, we have made significant progress on this strategy. For example, over the past eight quarters, we've achieved approximately $1.1 billion in non-dilutive cash flow to the company, including $800 million from our partnerships in the form of upfront payments and milestones earned to date. We also just recently expanded our Sanofi partnership to include use of our MatrixM adjuvant in their pandemic flu vaccine candidates, for which Sanofi received a U.S. BARDA grant. We renegotiated our agreement with Takeda, which enhanced our revenue opportunity from their activities with Nuvaxavid in Japan, one of the world's largest healthcare markets. On the R&D front, via a lean strategic investment approach, in Q1 of this year, we launched a new early-stage portfolio, including programs targeting C. diff, shingles, RSV combinations, and pandemic flu, and initiated an exploration of our MatrixM technology platform to assess its applicability in oncology. And finally, on our financial profile, we continue to improve the financial strength of the company while maintaining our capabilities. For example, most recently, we brought in $60 million in near-term cash, and anticipated long-term savings of approximately $230 million by consolidating our Maryland campus footprint. With this steady progress since 2023 to transform our company, we are now in a new phase of opportunity for Novavax. As we look ahead, the work we are doing now is intended to position the company well for a period of long-term growth and profitability. The intent is for this growth to be driven by a growing and diversified revenue base that stems from multiple partnerships, milestones, royalty streams, and our emerging R&D portfolio. Assuming continued execution of our plan and by our partners, both existing and new, we are executing toward a future for Novavax in which we have the potential to achieve non-gap profitability as early as 2028. During this time of transition, before we reach our intended goal of profitability, we expect our revenue mix to change as we rely on milestone payments in the midterm to bridge to an increased emphasis on licensing and royalty revenue, which we expect to grow over time both in magnitude and in the number and diversity of our royalty streams. With this as our focus, our 2025 priorities to advance our strategy and grow shareholder value are threefold. Number one, optimizing our partnership with Sanofi. Number two, enhancing existing partnerships and leveraging our technology platform and pipeline to forge additional partnerships. And number three, advancing our technology platform and early stage pipeline. Across all three of these priorities, we have made significant progress in the third quarter. In our partnership with Sanofi, we have achieved all milestones expected for 2025, securing a total of $225 million for the year from the BLA approval for Nuvaxivid, and including $50 million from the successful transfer of our marketing authorizations in both the U.S. and the EU. We also completed the transfer to Sanofi of lead commercial responsibility for the U.S., allowing us to fully discontinue our own sales and marketing efforts this year for Nuvaxivid. On their recent earnings call, Sanofi stated that 2025 marks an important transition year for Nuvaxavid, with their full commercial launch in the U.S. and select other global markets expected for the 26-27 season. Beyond Nuvaxavid, Novavax is also eligible to receive milestones and royalties associated with the development of new combination vaccines that include Nuvaxavid. Sanofi indicated preliminary positive Phase 1-2 safety and immunogenicity data for both of their combination products featuring Nuvaxavid and their approved flu vaccines, and are planning to engage with regulators on next steps. And finally, the agreement with Sanofi enabled them to develop new vaccines using our matrix imaginant. Though we cannot speak for our partners regarding any specifics on their plans and activities here, we can say that they are exploring the potential of MatrixM across several early stage pipeline programs. And we look forward to any potential opportunities emerging over time from these efforts. In addition to our partnerships with Sanofi and Takeda, our partnership with Serum and Oxford University on the R21 MatrixM malaria vaccine continues to make an impact on global public health. Through September of this year, approximately 25 million doses of R21 matrix M vaccine have been distributed to about 24 countries in Africa, with the most recent launch in Zambia announced a couple of weeks ago. This is a much needed option for a region where malaria continues to be one of the continent's most persistent public health threats with economic and social impacts, historically killing over 600,000 people annually. and disproportionately impacting children under five in Sub-Saharan Africa. We are very proud that our technology is a critical component of this important solution for global public health. Our strong performance as a partner helps to set the stage for future potential collaborations to generate additional meaningful royalty streams for Novavax for years to come. In a global vaccine market that is expected to grow over the next 10 years, We believe that Novavax is well-positioned to capitalize on this growth by continuing to leverage our technology and expertise to tackle some of the world's most significant health challenges. Finally, during the quarter, our R&D team continued to make progress in advancing our early-stage pipeline. So at this point, I'd like to turn the call over to Ruxandra to share more. Rux?