Novavax, Inc.

Good morning and welcome to Novavax second quarter 2024 financial results and operational highlights conference call. All participants will be in listen-only mode. If you need assistance, please signal the conference specialist by pressing star followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask questions, please press star one on your touchtone phone. To withdraw your question, please press star 2. Please note this event is being recorded. I would now like to turn the call over to your speaker today, Erica Schultz, Senior Director, Investor Relations. Please go ahead.

Good morning, and thank you all for joining us today to discuss our second quarter 2024 operational highlights and financial results. 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 can 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 slide deck we issued this morning and under the heading Risk Factors in our most recent form 10-K and subsequent form 10Qs filed with the Securities 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 update or revise any of these statements. Please turn to slide three. This presentation also includes references to a non-GAAP financial measure, which is forward-looking information for R&D and SG&A expense as adjusted for expense reimbursement from Sanofi under the Sanofi Agreement. 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 four key value drivers. Additionally, John Trezino, our President and Chief Operating Officer, will provide an update on our operating activities. And Dr. Bob Walker, Chief Medical Officer and Interim Head of Research and Development, will discuss our clinical development and pipeline. Finally, Jim Kelly, our 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.

Thank you, Erica, and thank you, everyone, for joining us. I'm pleased to be with you today, along with the members of our executive team, to highlight our recent achievements, progress on our annual priorities, and the shaping of a new vision for Novavax. When we spoke with you last quarter, we were taking the first steps on this exciting journey with the announcement of our global partnership with Sanofi. Our collaboration with Sanofi has allowed us to monetize the value of our COVID-19 vaccines, and proven technology platform, and frees up resources to develop multiple opportunities in the vaccine space. Since then, we have worked hard to execute on our objectives and are beginning to position the company back toward its roots as an innovation-driven organization, while remaining a close commercial partner to Sanofi for our COVID-19 vaccine. We are beginning to evolve from a company that is independently manufacturing, distributing, and commercializing vaccines on a global scale to a much more efficient and focused R&D model. This means that we intend to drive future value from additional business development activities and organic R&D via our proven and validated technology platform. With plans to unveil a new and expanded clinical pipeline by the end of this year, and to seek to execute our plans within a much leaner operating model in 2025 and beyond. The potential value drivers of our business are outlined on slide five and include value driver one, the Sanofi partnership, value driver two, late stage pipeline, value driver three, leveraging our proven technology platform to drive additional partnerships and deals, and value driver four, new early stage pipeline. It is our intention that these potential value drivers will be supported by an appropriately scaled infrastructure with significantly reduced expenses versus our 2024 baseline. Jim Kelly will provide more detail and clarity on our expense projections later on in the call. So let's take a moment to expand on each of these potential value drivers that are intended to be the foundation of our new growth strategy for Novavax. Value Driver 1, the Santa Fe Partnership. The Sanofi partnership has four potential areas of value. First, immediate upfront payment and equity investment of approximately $570 million. Next, midterm milestones related to our partnered COVID-19 vaccine of approximately $350 million and Sanofi's independent flu COVID-19 combination program were another $350 million. Third, anticipated royalty streams from both of these programs. And fourth, long-term royalties and or milestones from any other vaccines developed by Sanofi utilizing our COVID-19 vaccine and or our MatrixM adjuvant. That means, for example, any additional combination vaccine commercialized using our COVID vaccine is eligible for royalties. Also, any new vaccine developed using our MatrixM adjuvant is eligible for both milestones and royalties. That being said, the partnership structure offers potential opportunities for decades to come. And because Sanofi is a global leader in vaccine development and commercialization, with a substantial presence and proven track record in seasonal respiratory vaccines in the U.S. and around the world, We have the utmost confidence in their ability to perform when they begin commercializing our COVID-19 vaccine next year and potentially launch multiple additional vaccines using our technology in the future. We look forward to providing further updates on our partnership at the appropriate time. Value driver two, Novavax late stage pipeline. As we have stated on prior calls, we are on track to independently initiate our own late stage phase three trial in the fourth quarter of this year, to evaluate our standalone influenza and COVID-19 influenza combination vaccines. Top-line data from this trial is expected by the middle of 2025. These assets have already demonstrated promising Phase II data. We intend to partner or monetize these assets, assuming successful Phase III results, rather than commercialize them ourselves, which should allow us to avoid significant infrastructure expense and execution risk. Moving on to Value Driver 3, leveraging our proven technology platform to drive additional partnerships and deals. Beyond the two late stage assets, our proven technology platform has the potential to offer other companies significant value. And our ambition is to be a partner of choice to help others enhance or even expand some of the established inline vaccine franchises of larger players. For example, We believe that MatrixM can help enhance many existing vaccines in the portfolios of other companies by boosting immunogenicity and lowering COGS without adding to the side effects burden. Later in this call, Bob Walker will share some new data with you as an example of this capability. These MatrixM attributes may also enable companies with clinical stage vaccine portfolios to make those vaccines more competitive as they strive for the best product profile, and even allow for the creation of new vaccines that might not have otherwise been possible. We continue to explore the potential of our technology and believe that we have only just begun to tap into the value of our platform to our company and portfolio and to that of other vaccine companies. And finally, value driver four, new early stage pipeline. Our final and fourth potential value driver is the development of our own early stage organic pipeline. Rather than focus our efforts on seasonal commercial execution of a single vaccine asset, we will instead invest our time, energy, and capital on the development of an expanded pipeline that uses our recombinant nanoparticle technology platform to develop new assets focused on infectious disease and respiratory, as well as potentially vaccines in other disease areas and categories. We will be looking to develop assets that we believe can make a significant difference for global public health and at the same time present a significant commercial opportunity. We reserve the right to develop, launch, and commercialize any of these assets ourselves should the emerging data and business case support us. For the remainder of 2024, and in line with our key value drivers, we will continue to execute on our four priorities, which you should see on slide six. And these priorities are priority one, the successful execution of our new partnership with Sanofi. Priority two, driving incremental value from our technology platform via the initiation of our phase three trial for KIC and FLU, the development and unveiling of our new refreshed pipeline, and pursuing new business development opportunities. Priority three, continue to reduce our R&D and SG&A costs in line with our prior stated targets and prepare for additional significant reductions to scale and cost as we enter 2025 and beyond. And finally, priority four, delivering our updated COVID-19 vaccine for the 24-25 fall vaccination season. As we enter the second half of this year, we look forward to sharing more details on our updated plans as we continue to forge a new path forward. Now I would like to hand it over to the team to discuss our results from the quarter in more detail, beginning with John Trezino for our operating updates. John?