Novavax, Inc.

Good afternoon and welcome to the Novavax First Quarter 2022 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 then two. Please note this event is being recorded. I would now like to turn the conference over to Sylvia Taylor, Senior Vice President of Global Corporate Affairs and Investor Relations. Please go ahead.

Good afternoon, and thank you all for joining us today to discuss our first quarter 2022 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 related to 2022 financial guidance, future financial or business performance, conditions or strategy, including expectations regarding revenue, product demand, operating expenses, growth margins, 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 that may change over time, and actual results could differ materially from what is described in such statements. Please turn to slide three. During this call, we will be referring to a non-GAAP financial measure, which is not prepared in accordance with U.S. generally accepted accounting principles. The most directly comparable financial measure calculated in accordance with GAAP and a reconciliation of GAAP to the non-GAAP measure is contained in the presentation and is available on our website at ir.novavax.com. Please turn to slide four. Joining me today is Stan Erck, President and CEO, who will provide an overview of recent achievement and our upcoming strategic priorities. Additionally, John Truzino, Chief Commercial Officer and Chief Business Officer, will provide an update on the status of our global COVID-19 vaccine rollout and our current regulatory progress. Dr. Philip Dubovsky, Chief Medical Officer, will discuss our clinical and regulatory strategy 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'd now like to hand the call over to Stan. Please turn to slide five.

Thank you, Sylvia. Thanks, everyone, for joining us today to discuss Novavax's first quarter results. We had a landmark start to 2022, reporting today a major milestone for Novavax. Our first ever profitable quarter as a commercial stage company scoring $203 million in net income and $704 million in total revenue. These accomplishments are the result of continued execution on our strategic objectives to deliver our COVID vaccine globally and advance our pipeline of new strains and combination vaccines. We're proud of our strong progress throughout the first quarter. Since the start of the year, we've increased our global impact and strengthened our capabilities as a commercial-stage vaccine leader. I'd like to begin today's call by highlighting the key accomplishments since the start of the year that demonstrate the substantial progress we've made. We've continued the successful launch of the VAX event globally, with vaccinations underway in key markets around the world. We've secured additional authorizations and full approvals for primary vaccination in adults, further solidifying our global research and global reach. In the U.S., we reached a major milestone in our pathway to EUA with a VRBPAC meeting now set for June 7th following the successful completion of an inspection of our manufacturing site at Serum Institute of India. Our expectation with the VRBPAC meeting is authorization for primary vaccination in adults. We have already submitted our adolescent data and we will be submitting additional data for boosting to the FDA. For additional indications, the timing of review will be a decision the FDA will have to make in the coming weeks. We continue to execute an ambitious strategy to pursue an expanded label for our COVID-19 vaccine, including indications for pediatrics and boosting. We recognize variants continue to emerge, and we remain ready to pivot and bring the relevant vaccines to market. We are advancing an Omicron mod of ailment and by-valence option and expected to be in the clinic later this month. We also advanced our COVID-19 influenza combination vaccine through a Phase 1-2 trial with the goal to advance this candidate into a Phase 2 trial before the end of the year. With strong execution of our commercial launch plan and clear line of sight into our opportunities, we are well positioned to achieve our guidance of full year 2022 total revenue between $4 and $5 billion. With that, John Terzina will now discuss the commercial lots of UVaxavit. Thank you, Stan.