Novavax, Inc.

Good afternoon and welcome to the Novavax Third Quarter 2022 Financial Results and Operational Highlights. 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 the star then one on your telephone keypad. To withdraw your question, please press star then two. Please note that this event is being recorded. I would now like to turn the conference over to Sylvia Taylor, Executive Vice President and Chief Communication Officer. Please go ahead.

Good afternoon, and thank you all for joining us today to discuss our third 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 this presentation includes forward-looking statements, including information relating to the future of Novavax, its key strategic priorities, plans and prospects for 2022, and financial guidance, including total revenue, the ongoing development of our vaccine candidates, including anticipated timing of trials and results, the scope, timing, and outcome of future regulatory filings and actions, the efficacy, safety, and intended utilization of our vaccine candidates, including against COVID-19 variants, the global market opportunities for our vaccine candidates, our manufacturing capacity, and the future availability of our vaccine candidates, and key upcoming milestones. Each forward-looking statement contained in this presentation is subject to risks and uncertainties that could 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 afternoon and under the heading Risk Factors in our most recent Form 10-K and our third quarter Form 10-Q filed with the Securities and Exchange Commission and available at 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. During this call, in order to provide greater transparency regarding our operating performance, we refer to certain non-GAAP financial measures that involve adjustments to GAAP results. Any non-GAAP financial measures presented should not be considered to be an alternative to financial measures required by GAAP, should not be considered measures of liquidity, and are unlikely to be comparable to non-GAAP financial measures provided by other companies. Any non-GAAP financial measures referenced on this call are reconciled to the most directly comparable GAAP financial measure within the Investors section of our website at Novavax.com. Now please turn to slide four. Joining me today is Stan Erck, President and CEO, who will provide an update on our recent progress and our upcoming strategic priorities. Additionally, Dr. Philip Dubovsky, Chief Medical Officer, will discuss our clinical development across our pipeline, and John Trezino, Chief Commercial Officer and Chief Business Officer, will provide an update on our commercial progress and our outlook for 2023. Finally, Jim Kelly, our Chief Financial Officer and Treasurer, will provide an update 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.

Thanks, Sylvia. Good afternoon, and thanks for joining our third quarter earnings call. In addition to the financial report that Jim Kelly will give, Philip will provide our update on important clinical data that we are accumulating, which continue to highlight the advantages offered by our adjuvanted protein-based vaccine. And following that, John will discuss our commercialization efforts. But first, let me start with the financials. Jim will provide you more details, but the highlights include revenue for the quarter was $735 million. This met our target for the quarter and bring us to $1.6 billion in revenue for the first nine months of the year. During the last quarter, we continue to gather data that supports the differentiation of our vaccine. We believe these differences are important and are a predictable consequence of our vaccine technology. When our nanoparticle antigen is formulated with MatrixM, it generates a very broad and long-lived immune response, which we believe has advantages in the face of the continued emergence of new variants. We believe that these differences will allow us to deploy a vaccine that may not require serial updating and may not require bivalency. Novavax's vaccine has been granted regulatory authorizations globally. In the third quarter, we received emergency use authorization from the United States, representing the last major market in which we have obtained authorization for use. Throughout the year, we have been developing data with our many clinical trials across the globe that support the advantages of our vaccine. And together, we believe these advantages will be the basis for the continued long-term expansion of our product in markets throughout the world. We now have data supporting Novavaxivit's durable immune response that achieves levels associated with protection in our phase 3 trials. With the ever-mutating COVID virus, we want a vaccine that can stimulate an antibody response across any variant that arises. And while we can't predict the future, we can show that our vaccine has a breadth of response that covers all of the variants that we've measured to date, including alpha, beta, delta, and BA1 through 5. This is important for obvious reasons, but it should be pointed out that we don't have any data which suggests that it's a good decision to switch to a BA5 vaccine, given that our current vaccine stimulates levels of BA5 antibody that should be protective. Our data also shows that show that we have an 82% prevention of infection over an extended period, and plus our data continues to provide confidence in the use of our vaccine and its favorable safety and tolerability profile. Our mission must be to remind and educate the regulatory and policy bodies that as a protein-based adjuvanted vaccine, our vaccine is different from what's on the market. As long as we continue to demonstrate that our current vaccine stimulates a relevant immune response against circulating variants, we believe our current vaccine will be a good choice for ongoing vaccination campaigns. Importantly, it has the added advantage that when you continue to boost with the same vaccine, you continue to see maturation of these responses with the expectation that you'll see more effective and longer-lasting responses. When we see data that suggests the need to update our vaccine with a new strain, we will. We will do so with either a monovalent or bivalent vaccine based on data that we then have and relevant policy recommendations at the time. There may be some public health agencies that prefer either a strain change or bivalent vaccine, and our plan is to develop in parallel a variant containing monovalent and bivalent vaccine. Switching topics. We have mentioned in the past that we have been collaborating with the Serum Institute and Oxford University on a new malaria vaccine that includes our Matrix M adjuvant. I'm very pleased that Adrian Hill of Oxford University presented a very high-level summary of Phase III efficacy data at a late-breaking session of the Tropical Disease and Malaria Conference in Seattle last week. More detailed safety and efficacy data will be available when approved for publication later this year. Going forward, We believe that we are in a very good position. We have a global manufacturing capacity to support our planned sales of Novavaxvid. This capacity will also support our pipeline vaccine candidates for flu, for combination flu COVID, and for malaria. And we now have a global marketing and regulatory presence to support our goals for 2023 and beyond. I'll now turn the call, the presentation, over to our Chief Medical Officer, Philip Dubosky, who will be followed by John Terzino, our Chief Commercial Officer, and our Chief Financial Officer, Jim Kelly. We will end with a session of Q&A.