Novavax, Inc.

Ladies and gentlemen, thank you for standing by and welcome to the Novavax Fourth Quarter 2020 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star zero. I would now like to hand the conference over to your speaker today, Ms. Sylvia Taylor. You may begin.

Thank you. Good afternoon, everybody, and thank you to all of you who have joined today's call to discuss our fourth quarter and full year 2020 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. We're also filing our 10K this afternoon. Joining me today are Stan Urk, President and CEO, who will provide an overview of our progress to date. Dr. Gregory Glenn, President of Research and Development, who will provide an update on our global clinical trial activity and regulatory pathway. John Trezino, Chief Commercial Officer and Chief Business Officer, who will update us on our manufacturing scale-up, partnerships, and advanced purchase agreements, and Gregory Covino, Chief Financial Officer, who will briefly highlight our financial status. Additionally, Dr. Philip Dubovsky, Chief Medical Officer, will be available for the Q&A section at the end of today's call. Before we begin with prepared remarks, I need to remind you that we will be making forward-looking statements during this teleconference that could include financial, clinical, or commercial projections. Statements relating to future financial or business performance, conditions or strategy, and other financial and business-related matters, including expectations regarding revenue, operating expenses, cash usage, and clinical development and anticipated milestones, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. With that, I'd now like to hand the call over to Stan. For those of you following the accompanying slides, please turn to slide three.

Thank you, Sylvia, and thank you to everyone for joining us this evening. I'd like to make some opening remarks regarding how we've progressed as a company and reflect on where we're headed in this coming year. Following that, we'll take some time for questions. So the past year has been a whirlwind. We have completely changed the company in ways that would normally take several years to accomplish. While many businesses in the world have slowed down due to the pandemic, we've done the opposite. Everything about our company has changed. Before we get into our presentation, I'd like to thank all of our staff for the nonstop effort that each of them has made for an entire year. I'm afraid to say that I don't see a slowdown anytime soon. But having said that, everyone understands the importance of our mission and can take satisfaction from the accomplishments that have been made so far and know that they are part of a once in a lifetime mission. I'd like to start our presentation by recounting for you a short list of what our staff has accomplished since our last annual earnings report. We've enrolled over 50,000 participants in COVID-19 clinical trials. In the spring of last year, we completed enrollment in a Phase 1-2 trial in the US and Australia. Between September and February, we initiated three efficacy trials in the US, the UK, and South Africa, enrolling almost 50,000 participants. We've shown that our vaccine is 96% effective against the original COVID-19 when tested in the UK trial. and achieved 86% effectiveness against the UK variant strain in that same trial. In the South African trial, where the so-called triple mutant variant was circulating, we showed that our vaccine was 60% effective at preventing COVID disease in the portion of the study population that was HIV negative. What sometimes gets lost in the discussion of our COVID-19 program is that we also completed a phase three pivotal trial for our nanoflu program and met or exceeded all eight of our primary endpoints. We started last year with about 150 employees worldwide. We now have approximately 800 employees globally and will likely exceed 1,000 employees sometime this summer. We started last year without any capacity to manufacture product. In the last year, we have built a global network of manufacturing sites and partners in 10 countries whose total capacity for COVID-19 vaccines will exceed 2 billion doses on an annual basis by midyear. At the beginning of last year, we had $80 million in cash and a financial operating horizon of only six months. In contrast, we ended the year with over $800 million and continue to build our financial strength. We have now secured over $2 billion of funding from our partners, including the U.S. government and CEPI, in the Bill and Melinda Gates Foundation, and have purchased commitments for our vaccine representing the potential for several billion dollars in revenue in the next 12 months. The combination of all of these accomplishments adds capacity and expertise that will be the foundation for Novavax over the long term, and most importantly, gives us the opportunity to provide the world, including countries of all income levels, with a safe and effective vaccine that can be used to help end the worst pandemic in the last century. We are excited to share more details today on the progress we made during the historic year. I would now like to hand the call over to Greg Glenn to discuss highlights from our clinical development program for 2020 and the beginning of 2021.