Novavax, Inc.

Good morning and welcome to Novavac's second 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 then one on your touchtone phone. To withdraw your question, please press star one again. Please note this event is being recorded. I would now like to turn the conference over to Louis Sinet, Vice President of Vestor Relations. Please go ahead.

Good morning and thank you all for joining us today to discuss our second 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 Novavac's corporate strategy and operating plans, its strategic priorities, its partnerships and expectations with respect to potential royalties, milestones, and 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, including the Novavax's post-marketing commitment study, full year 2025 financial guidance and revenue framework, and Novavax's future financial or business performance. Each forward-looking statement contained in this presentation is subject to risks and uncertainties that could cause our 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 reimbursements, 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. Ritsandra Draguya, 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. Sylvia Taylor, chief corporate affairs and advocacy officer, will be available for the Q&A portion of the call. 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 second quarter results and the meaningful progress that we've made. Q2 is a strong quarter as we continue to execute on our strategy to expand access to our proven technology platform by advancing R&D innovation and organically growing our portfolio, strengthening existing partnerships while working actively to forge new collaborations. This focused approach is designed to unlock multiple paths to value creation and supports our outlook for potential non-GAAP profitability as early as 2027. During Q2, we remain focused on our three strategic priorities for the year and now I'd like to take a few moments to highlight our progress on each of them during the quarter. Our first strategic priority is optimizing our partnership with Sanofi. During the quarter, we received BLA approval for NUVAXAVID in the US, which triggered a $175 million milestone payment to Novavax to be received in the third quarter. We also completed the transition of commercial activities to Sanofi in the US. This means that for the 25-26 season, Sanofi is now poised to assume the lead commercialization role for NUVAXAVID in select global markets. The Sanofi partnership represents a significant value creation opportunity for Novavax via the multifaceted nature of the agreement, including milestones and royalties associated with the commercialization of our COVID vaccine. As noted, we earned the $175 million milestone for the BLA and in addition, we also received a contract for milestone payments associated with the transfer of the US and EU marketing authorizations and the technology transfer related to NUVAXAVID manufacturing, which are anticipated later this year and in late 2026 respectively. Beyond the economics related to NUVAXAVID, Novavax is eligible to receive milestones and royalties associated with the development of new combination vaccines that include our COVID vaccine. As a reminder, Sanofi is developing two combination vaccine candidates, which include our COVID vaccine and their market leading flu vaccines, both of which received fast-track designation from the FDA last year. We're encouraged by Sanofi's recent comments on the potential of COVID flu combo vaccines. And Sanofi has access to develop vaccines with our proven and unique matrix M adjuvant, for which Novavax is eligible to earn milestones and royalties. Together, we are excited that this partnership has the potential to increase access to our technology and drive long-term value. Our second strategic priority is to enhance our existing partnerships and leverage our technology platform and pipeline to drive additional partnerships. Novavax's cutting-edge tech platform, consisting of our protein-paste nanoparticles and our -a-kind matrix M adjuvant, has the potential to drive the development of both new and improved vaccines that are efficacious and tolerable. This value-creating technology platform has been validated through current marketed products, NUVAXAVID and the R21 matrix M malaria vaccine, our growing clinical data set, and our current partnerships. Let's talk about those partnerships. This quarter, we optimized our partnership with Takeda for the Japanese market through an updated collaboration and exclusive license agreement, which significantly improved the financial terms for Novavax and improved the partnerships operating model. With its advanced infrastructure and strong regulatory environment, Japan is the third largest global health care market, and we believe our continued partnership will help to meet the needs of the COVID market in Japan. Takeda filed for approval of NUVAXAVID in June and is on track to have approval and doses in market in time for the fall respiratory season. Additionally, through our partnership with Serum Institute of India and Oxford University, the R21 matrix M malaria vaccine has made meaningful progress in addressing the urgent and unmet needs of malaria endemic regions since its first administration in Ivory Coast in June of 2024. The R21 matrix M vaccine is helping to expand access to life saving prevention in communities with limited health care infrastructure with rollouts in 12 African countries as of April 2025. In fact, over 20 million doses have been sold to date since launch in mid-24. Malaria historically has killed over 600,000 people annually, with a vast majority of deaths occurring in children under five in sub-Saharan Africa. R21 matrix M as the first low cost, high efficacy malaria vaccine produced at scale represents not only a clinical global public health tool, but also a strategic opportunity in a market where demand significantly exceeds current supply. We are pleased that our active and successful commercial collaborations with Sanofi and Oxford have positioned us as a partner of choice in the vaccine space. With this strong momentum, we're actively pursuing new partnerships that could help to further accelerate the positive global health impact of our technology and unlock additional value for both shareholders and the communities we serve. We believe that our technology platform can play an important role in driving innovation in the global vaccine market that is expected to grow to over $75 billion by 2030. This quarter, we continue to advance strategic opportunities for our matrix M adjuvant. Our unique matrix M adjuvant is well positioned to drive innovation via our own organic portfolio and partnering with potential to generate meaningful future royalty streams for Novavax for years to come. To date, we've signed material transfer agreements with three pharmaceutical companies to explore the utility of matrix M across novel medications, including its potential application in oncology. These arrangements have led to discussions about potential business partnerships to develop new vaccines and improve existing vaccines. In parallel, we continue to explore the potential for government grants to support the development of our pandemic influenza vaccine candidates, reinforcing our commitment to platform diversification and long term value creation. In June, we reported positive data from an initial phase three cohort showing our COVID-19 influenza combination or kick and standalone flu vaccine candidates elicited strong immune responses, similar to licensed comparators and vaccinated and flu zone high dose with over 98% of adverse events rated mild or moderate. These results are important and helpful as we continue to engage in discussions with potential partners for these late stage assets. Roxandra will share additional insights and new data from this program in a few moments. And finally, our third strategic priority is to advance our technology platform and early stage pipeline. We're advancing a focus pipeline of vaccine candidates targeting unmet needs in infectious disease. And we were exploring the utility of matrix M and oncology. Using a capital efficient model grounded in strong science and sharply focused on future commercial potential. We're also applying AI driven insights to accelerate candidate development. At the same time, we're sharpening our strategy to enhance the attractiveness of our technology, particularly matrix M to potential partners. This includes exploring new formulations and additional ideas to unlock its full value. As we've noted before, our primary focus is to out license and or partner vaccine assets, we are developing in our pipeline. But if we discover a significant opportunity via those R&D efforts, we may decide to bring that asset forward on our own. If the value proposition indicates it is best to keep that asset with Novavax. As you can see, this quarter, we continue to progress our growth strategy across all of its core elements, delivering on our existing partnerships, furthering discussions with potential future partners, and advancing our pipeline. Later in the call, Jim will highlight the progress we've made in driving greater operational efficiency as we transition to a more lean and agile business model. Taken together, the progress we're making is well aligned with our corporate growth strategy and continues to strengthen our foundation, fueling the potential for long term value creation and positioning us to deliver meaningful impact on a global scale, potentially improving the lives of millions. I'd now like to turn the call to Roxandra to discuss our R&D updates. Roxandra.