Novavax, Inc.

Good morning and welcome to Novavax First Quarter 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 key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star followed by the number one on your title. on phone. To withdraw your question, please press star followed by the number two. 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 first quarter 2025 financial results and operational highlights. A press release announcing our results is currently 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, and cost reimbursements, FDA approval of the company's COVID-19 vaccine BLA and alignment on the post-marketing commitment, its expectations regarding manufacturing capacity, timing, production, and delivery for its COVID-19 vaccine, the development of Novavax's clinical and preclinical product candidates, full-year 2025 financial guidance and revenue framework, and Novavax's future financial business performance. 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 and adjusted licensing, royalties, and other revenue, and non-GAAP profitability. Please turn to slide four. Joining me today is John Jacobs, our president and CEO, who will provide an update on our progress during the quarter and highlight our growth strategy. Dr. Aksandra Draghia, head of R&D, will discuss our R&D updates. And finally, Jim Kelly, Chief Financial Officer and Treasurer, will provide an overview of our financial results and 2025 financial guidance and revenue framework. John Trezino, Chief Operating Officer, will be available for the Q&A portion of the call. I would now like to hand over the call to John Jacobs.

Thank you, Louis. I'm pleased to be here with you today, along with members of our executive team, to discuss our financial results and highlight the progress we have made in Q1. This earnings call marks approximately the one-year anniversary of our new corporate growth strategy, which was formed after signing our agreement with Sanofi. Over the course of the past year, we have moved away from our prior focus, which was allocating the majority of our time, energy, and resources on commercializing our COVID-19 vaccine. to a strategy focused on optimizing our existing partnerships and expanding access to our proven technology platform via R&D innovation, organic portfolio expansion, and forging new partnerships and collaborations with other companies. We believe this strategy enables maximum value creation from our cutting-edge technology In parallel, we are creating a significantly leaner infrastructure with continued cost reduction initiatives underway as we drive towards potential non-GAAP profitability as early as 2027. Via our new strategy, we intend to create multiple opportunities for value growth. Important catalysts this year include the potential approval of the BLA for our COVID vaccine and other milestones related to the Sanofi Agreement. preclinical data from our early stage pipeline programs in the second half of this year, and the potential for additional partnerships and collaborations. As an example, we are excited about the progression of our partnership with Takeda, as it significantly improves the financial terms for Novavax in Japan, the third largest healthcare market in the world. This strengthened partnership with Takeda, a globally respected multinational pharmaceutical company further validates the value of our cutting-edge technology platform and our efforts to become a partner of choice. Forging new collaborations and partnerships based on our differentiated tech platform and deep expertise in vaccine development is a top priority for us this year, and we look forward to sharing partnership updates with you as we continue to execute upon this key strategic pillar for Novavax. To guide our work for the remainder of 2025, we remain focused on three strategic priorities. Our first priority is optimizing our partnership with Sanofi. Our partnership with Sanofi is a prime example of how we intend to work with others as we look to become a partner of choice and create long-term value for our stakeholders. As we have said before, this partnership has many important and potentially value-creating elements to it, including milestones and royalties associated with the marketing of our COVID vaccine related to the BLA approval, MAH transfers, tech transfer, and ongoing royalties. Number two, milestones and royalties associated with the development of new combination vaccines that include our COVID vaccine. For example, Sanofi is developing two combination vaccines that include our COVID vaccine and their market-leading flu vaccines. both of which earned fast-track designation from the FDA last year. And finally, milestones and royalties associated with any other new products developed using our MatrixM adjuvant. Regarding our COVID vaccine, we are working constructively with the FDA with the intent of bringing the BLA process to a positive conclusion as soon as possible. FDA feedback on our BLA suggests a pathway to approval upon alignment on study parameters for the post-marketing commitment requested. We believe it's important that a non-mRNA protein-based COVID-19 vaccine option is available as a choice for U.S. consumers. Our second strategic priority is to leverage our proven tech platform and pipeline to drive additional partnerships. Our team has been actively working on developing new partnership opportunities beyond Sanofi and the Material Transfer Agreement, or MTA, with a top-tier pharma company that we announced last fall to explore our matrix M adjuvant with bacterial pathogens. In fact, over the past few months, we have signed new agreements, including an expanded scope of the MTA I just mentioned to now include viral pathogens. We signed another new MTA for MatrixM with a different top tier pharma company, entered a preclinical collaboration with a new partner to explore the application and utility of MatrixM with their cancer vaccine candidate, and as noted earlier, strengthened our existing agreement with Takeda for the COVID market in Japan, including significantly improved financial terms for Novavax. These new agreements represent important steps in our continuing quest to add new partnerships throughout licensing efforts and further highlight the growing interest in our tech platform. We intend to optimize these new agreements with the goal of expanding the scope and value creation opportunity for each of them over time. And we don't intend to stop here. We are actively seeking additional partnerships and collaborations. with the goal of creating multiple growth opportunities in the short, mid, and long term for Novavax. As we stated before, this ongoing effort includes seeking a potential partner to develop and commercialize our late-stage COVID influenza combination vaccine and standalone flu vaccine. And finally, our third strategic priority is to advance our tech platform and early-stage pipeline. We are actively advancing our early-stage pipeline programs using a capital-efficient approach. Our R&D investment strategy should allow us to make disciplined investments in programs aligned to the highest potential value opportunities, both within infectious disease and beyond. Our intent is to partner these assets at early proof-of-concept stages. However, for the right asset, where data and commercial landscape indicate a unique high-value opportunity, we would consider bringing that asset forward ourselves, and we'll make that determination on a case-by-case basis as these assets mature. A bit later in the call, Ruxandra will talk about how we're using translational research and computational medicine to inform these investment decisions. We anticipate sharing some initial data on our new pipeline assets and new data on MatrixM and our technology platform in the second half of the year during an investor day. In summary, over the past few months, we have made significant progress on our new growth strategy, including the addition of new agreements with other companies, the expansion and strengthening of existing agreements with two major pharma companies, the initiation of four new early-stage pipeline programs, and the continued advancement of our partnership with Sanofi. We remain confident that over the long run, our technology has the opportunity to positively impact the lives of billions of people around the world, that our strategy has the potential to drive significant value creation, and that our team has the knowledge, poise, and skill to help carry us forward to an exciting and positive future for Novavax. I would now like to turn the call to Ruxandra to discuss our research and development updates. Ruxandra?