Novavax, Inc.

Ladies and gentlemen, thank you for standing by and welcome to the Novavax fourth quarter and full year 2021 financial results and operational highlights conference call. At this time, all participant lines are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question, you may press star and then one. To withdraw your questions, you may press star and two. Please also be advised that today's conference call is being recorded. If you should need assistance during today's conference, you can signal an operator by pressing star and then zero. I would now like to hand the conference call over to your speaker today, Sylvia Taylor. You may begin.

Good afternoon, and thank you all for joining us today to discuss our fourth quarter and full year 2021 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. Before we begin with prepared remarks, I need to remind you that we will be making forward-looking statements during this teleconference, which are based on our current expectations and beliefs. For example... statements relating to future financial or business performance, conditions, or strategy, including expectations regarding revenue, operating expenses, cash usage, clinical development of our vaccine candidates, timing of future regulatory filings, authorizations, and actions, and other anticipated milestones are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. and actual results could differ materially from what is described in such statements. We encourage you to consult the risk factors discussed in our SEC filings for additional details. Joining me today is Stan Erck, President and CEO, who will provide an overview of recent achievements, discuss regulatory updates, and preview our upcoming strategic priorities. Additionally, John Trezino, Chief Commercial Officer and Chief Business Officer, will provide an update on the status of our global COVID-19 vaccine rollout, supply, and manufacturing, as well as address the broader market opportunity for our COVID-19 vaccine. Dr. Philip Dubovsky, Chief Medical Officer, will discuss recent clinical development across our pipeline. And Jim Kelly, Chief Financial Officer and Treasurer, will provide an overview of our financial results. Dr. Greg Glenn, President of Research and Development, will also be available for the Q&A section at the end of today's call. I would now like to hand the call over to Stan. Please turn to slide four. Stan?

Thanks, Sylvia, and thanks, everyone, for joining us today as we discuss the substantial progress made by Novavax in 2021 and into the beginning of 2022. Through continued execution across all areas of our business, today we have rapidly transitioned into a global commercial company, now delivering our COVID-19 vaccine throughout the world. Since making our first submission for authorization in August of last year, we've delivered upon all of our commitments across our entire business, including in regulatory, we have authorizations today from 12 regulatory agencies, as well as emergency use listing from the World Health Organization, rapidly expanding access to our COVID-19 vaccine. We are authorized in 38 countries and have emergency use listing from the WHO representing the potential to reach over 170 total countries. Adding this all up, these markets represent 6 billion lives. In commercialization, We've initiated the commercial rollout of Nuvaxivit. We have shipped our vaccine to the European Union, Australia, Indonesia, and South Korea, and first doses of our vaccine have now been administered in all of these markets. Manufacturing capacity. We've achieved our target of annual capacity of more than 2 billion doses with the ability to meet the current and future global demand for our vaccine. And with respect to clinical data, We have built upon our robust data of clinical evidence, robust body of clinical evidence, and we have generated additional data to support expanded indications and policy recommendations that will drive utilization across our three core targets, primary vaccinations, boosters, and pediatric populations. These include new data we announced today, demonstrating protection against all COVID-19 infection and durability of efficacy over six months, booster data demonstrating broad cross-reactivity against variants, and adolescent data demonstrating clinical efficacy against variants. With respect to COVID-19 variants, we also demonstrated our ability to rapidly respond to variants of COVID-19. we developed an Omicron-specific variant vaccine, and within weeks of initiating development, we began GMP manufacturing. This serves as an important proof of concept that we can evolve our vaccine as the pandemic evolves with new variants. With all of this momentum over the past 60 days, we are now delivering our protein-based vaccine to the world, and we expect this momentum will only accelerate. In 2022, we see significant opportunities for Novavaxvid due to the ongoing urgent need for vaccine globally. These include a global vaccination rate of only 56%. Clearly, we have not yet met the WHO goal of 70% global vaccination. Waning immunity over time after vaccination, the continued rise of variants, and pent-up demand for additional vaccine options, especially a protein-based option. All of these factors contribute to the urgency of bringing our vaccine to the market. With line of sight, into all of these factors informing the need for our vaccine today for the first time we are providing financial guidance outlining our expectation to achieve full year 2022 total revenue of between $4 and $5 billion. With that, please turn to slide five where we provide an overview of our regulatory progress to date. Through our focus on expediting our regulatory filing since the first submissions in August 2021, We've now gained authorizations in 38 countries. For our product, Nuvaxavid, we have received authorizations from all 27 member states of the European Union, Great Britain, Canada, Australia, Singapore, New Zealand, the United Arab Emirates, and in partnership with SK Bioscience, we also received approval of our BLA in South Korea. For Comavax, which is our vaccine manufactured and marketed by our partner, Serum Institute, we received authorizations from India, Indonesia, the Philippines, and Bangladesh. For both Novavax and Covavax, we've also received emergency use listing from the World Health Organization representing the potential for our vaccine to reach more than 130 additional countries. In these geographies, Novavax is the first protein-based COVID-19 vaccine authorized for commercial use based on Phase III data, allowing us to bring to the market an important alternative based on a well-understood technology. With significant regulatory progress made to date, we expect to expand our regulatory authorizations through additional submissions, including making Novaxavit available in the United States, where we have already filed our request for EUA in January. As Philip will discuss later on today's call, We are also executing upon a robust clinical development program to make our vaccine more widely available. And with that, I'll now hand it over to John to discuss our progress in delivering doses of our vaccine globally.