Novavax, Inc.

Good morning and welcome to Novavax first quarter 2024 financial results and operational highlights conference call. All lines will be in a lesson 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 one on your touchtone phone. To withdraw a question, please press star two. Please note, this event is being recorded. I would now like to turn the conference over to Erica Schultz, Senior Director, Investor Relations. Please go ahead.

Good morning, and thank you all for joining us today to discuss our first quarter 2024 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 information relating to the future of Novavax, its key strategic priorities, statements related to potential royalties and milestones, operating plans, objectives, and prospects, full-year 2024 financial guidance, the amount and impact of Novavax's cost reduction plans, its future financial or business performance conditions or strategies, its partnerships, anticipated timing, and outcome of future regulatory filings and actions, and the ongoing development, marketing opportunities, manufacturing capacity, and future availability of our vaccine candidates and key upcoming milestones. Each forward-looking statement contained in this presentation is subject to risk and uncertainties that could cause actual results to differ materially from those projected in such statement. Additional information regarding these factors appears under the heading Cautionary Note Regarding Forward-Looking Statements. In the slide deck 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 Security and Exchange Commission available at www.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 uptake, update, or revise any of these statements. Please turn to slide three. Joining me today is John Jacobs, our President and CEO, who will discuss our agreement with Sanofi announced this morning. Additionally, John Chesino, our President and Chief Operating Officer, will provide an update on our commercial activities. And Dr. Philip DeValsky, President of Research and Development, will discuss our clinical development and pipeline. Finally, Jim Kelly, Chief Financial Officer and Treasurer, will provide an overview of our financial results and implications of the Sanofi partnership. I would now like to hand over the call to John Jacobs. Please turn to slide four.

Thank you, Erica, and thank you, everyone, for joining us today. Today we enter a new and exciting chapter in the history of Novavax. This morning we announced that we have signed a global co-development and co-commercialization agreement with Sanofi. This agreement is both material and strategically important for Novavax. It is a further validation of our technology platform and provides significant opportunity to drive value creation and benefit global public health. The agreement represents a multi-billion dollar opportunity over time for Novavax. Via this agreement, we generate significant near-term cash flow. a strength and balance sheet, as well as the opportunity to strategically pivot to a new lean operating model, focusing more on our strengths in research and development and pipeline expansion to accelerate our growth and generate long-term value for our shareholders. First, the upfront and near-term milestones associated with this agreement are anticipated to equate to approximately $1.3 billion in cash of which approximately half is expected within 10 days of signing. These cash payments provide us with a significant capital infusion to help us manage our business. And this in turn also enables us to remove the going concern status for Novavax. Second, beginning in 2025, it allows us to leverage one of the largest proven global leaders in the vaccine business to commercialize new vaccine in the U.S., U.K., and Europe initially, and worldwide over time, affording hundreds of millions of dollars in potential cost synergies, enabling us to drive toward a new, more lean operating model with total cost anticipated to be well below our prior stated cost reduction targets. And we expect our royalties and milestones from Sanofi's efforts with Nuvaxavid to exceed the value of what our own efforts might have yielded if we had kept the product ourselves exclusively. By licensing Sanofi to use our new vaxavid to develop their own combination flu and COVID products, and to use MatrixM as a component of other vaccines across their portfolio, we expect to realize substantial additional royalties and milestones valued potentially in the billions of dollars driven by Sanofi's product development and commercialization efforts over the years and decades to come. The royalties and milestones associated with potential new vaccines Sanofi may develop using MatrixM, as well as those royalties and milestones anticipated from sales of our COVID-19 vaccine and the development of Sanofi's combination flu COVID and other potential combination vaccines, should help us to sustain cash flow as we invest in our own R&D in an efficient and thoughtful manner for years to come. In fact, We have done all of this while retaining the ability to broaden and accelerate development of our own wholly owned pipeline. This includes the modification of our planned 2024 pivotal trial for our combination flu and COVID vaccine to now also include the potential to yield pivotal results for our standalone flu vaccine. and we now anticipate readouts for both the combination and our standalone flu vaccine in mid-2025. In addition to our late-stage kick and flu standalone programs, we will now be able to assess and contemplate the addition of some new early-stage programs to our pipeline and do so within the cost structure of a new lean operating model. For both our late-stage kick and standalone flu programs and any early-stage programs we may choose to add to our pipeline in the coming quarters, we will be pragmatic, shareholder-focused, and market-aware about how to bring these assets forward. For example, through partnering, out-licensing, co-development, co-commercialization, or commercializing on our own. And we would consider commercializing on our own only for the right asset and with the benefit of our learnings from the COVID experience. The key here is that we intend to have multiple organic opportunities from our own pipeline with optionality on how we decide to optimize value from them. We look forward to providing additional details and updates on our new pipeline and future growth strategy for Novavax in the coming months as we operationalize our partnership with Sanofi. And finally, this transaction further validates both Novavax's product development capability and the extraordinary value of our MatrixM adjuvant technology, potentially enhancing our future licensing and business development opportunities across our tech platform. In fact, we intend, as part of our go-forward strategy, to seek additional business development opportunities with our organic pipeline, new pipeline assets we intend to add, and our MatrixM and nanoparticle technology platforms. So, in summary, this transaction capitalizes our current business, seeks to increase our future anticipated value from Nuvaxivid, while enabling us to significantly reduce our operating costs and complexity, creates a future stream of royalties and milestones from multiple potential new products to be developed by Sanofi, broadens and accelerates our own development pipeline and enhances our future deal-making capabilities, leveraging MatrixM, our late and early stage pipeline, and our product development capabilities. Jim Kelly will now walk you through the financial terms. Jim?