Novavax, Inc.

Ladies and gentlemen, thank you for standing by and welcome to the Novavax third quarter, 2023 financial results and operational highlights conference call. At this time, all participant lines are 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, press star, then 1 on your touchtone phone. To withdraw from the question queue, please press star, then 2. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Erica Schultz. You may begin.

Good morning, and thank you all for joining us today to discuss our third quarter 2023 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, operating plans, objectives, and prospects, full year 2023 and first quarter 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 and available at www.sec.gov and on our website at novavax.com, as well as subsequent filings with the SEC. 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. Joining me today is John Jacobs, our President and CEO, who will provide an update on our progress during the quarter for our three key priorities. Additionally, John Trezino, Chief Commercial Officer and Chief Business Officer, will provide an update on our commercial activities, and Dr. Philip Dabowski, President of Research and Development, will discuss our clinical development and pipeline. Jim Kelly, Chief Financial Officer and Treasurer, will provide an overview of our financial results. 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. I'm pleased to be here today, along with the members of our executive team, to discuss our third quarter 2023 financial results and operating highlights and the important progress we've made across our three priorities. Let's begin with our first priority, delivering an updated product for the current fall vaccination season. Beginning with our launch in the US and subsequent approval in the EU, we've demonstrated our ability to update our COVID-19 vaccine with seasonal strain changes, and we are focused on commercial execution to gain market share and to deliver on our APA commitments. In the US, we started the season approximately three weeks ago with the shipment of doses to major retail pharmacies. We achieved our pre-launch goal of securing broad access to our vaccine, the only protein-based non-mRNA option in the country. Having launched several weeks after the competitor vaccines, we have limited preliminary data, and although early, we are seeing indicators of increased awareness and growing interest in our vaccine. In Europe, Nuvaxavid was approved in October. We are also awaiting authorization in Canada, UK, Australia, and New Zealand. In these markets, we have advanced purchase agreements under which we expect to deliver all of the contracted doses for the 23-24 season. Given the US launch of our vaccine in mid-October, we believe it's too early to assess the true market uptake at this point in time. Market-wide, we have seen lower than expected COVID-19 vaccine demand. Given the uncertainty in the US market and approval in Europe several weeks behind our competitors, We expect to deliver revenue at the low end of our prior guidance for the season, with some of the revenue expected to shift into the first quarter of 2024. Importantly, we did not originally expect any revenue to occur in Q1 of 2024. Jim Kelly will provide more context on this later in the call. Our management team is leaning into and focusing on our opportunity to create a robust and sustainable business platform for years to come, which includes an optimized and differentiated product presentation in 2024 and 2025, as well as additional restructuring to create a more efficient business model, which will facilitate the late stage development of and a smooth transition to the anticipated launch of our combination COVID-19 influenza vaccine in 2026. We believe that a combination COVID-19 influenza vaccine represents a significant opportunity in this market, which is why we are concentrating our portfolio investments to bring forward our unique protein-based combination vaccine, which is likely to be a preferred option for many consumers and healthcare providers. Now let's move on to priority number two, which is to reduce our rate of spend, manage our cash flow, and evolve our scale and structure. In the quarter, we continued to make significant progress on our commitment to improve our financial position while maintaining the capabilities to support long-term value creation. Year-to-date, results include a $950 million reduction to operating expenses versus 2022, and in addition, an approximate $1 billion reduction to current liabilities from our December 22 baseline. We are on track to exceed our previously announced global restructuring and cost reduction plan for 2023 by over $100 million for combined R&D and SG&A expenses, while at the same time having successfully achieved our objective of updating our vaccine and launching this season, demonstrating that we can significantly reduce costs while maintaining our core capabilities. While this reduction was an important step, there are more efficiencies we can achieve. and we are prepared to further reshape and size the scope of our operations beyond previously announced 2024 targets to align with the emerging COVID market opportunity while advancing our COVID flu combination vaccine program. Therefore, we are prepared to initiate additional cost reductions to decrease 2024 expenses by over $300 million above and beyond the previously stated targets for 2024. Jim Kelly will speak further about our 2023 guidance and plan to drive significant improvements to our cost structure later in the call. Finally, let's discuss priority number three, which is to leverage our technology platform, our capabilities, and our portfolio of assets to drive additional value beyond Nuvaxivit. Our recombinant protein-based nanoparticle technology platform and MatrixM adjuvant have the potential to produce a variety of differentiated vaccines. Our priority here is to focus our R&D investment and resources on bringing forward our protein-based COVID influenza combination vaccine product. As Philip will discuss later in the call, contingent upon FDA concurrence on an accelerated approval pathway, we are now planning to move directly into Phase 3 in 2024 and to fund this program independently. Initiating a Phase 3 program in 2024 would enable a potential launch in the United States in 2026. Now I would like to hand it over to additional members of the team to discuss our results from the quarter in more detail, beginning with John Trezino to discuss our commercial updates. John?