Novavax, Inc.

Ladies and gentlemen, thank you for standing by. And welcome to the Novavax fourth quarter and full year 2022 financial results and operational highlights conference call. At this time, all participants are in a listen-only mode. If you need assistance, please press star then zero to reach an operator. After the speaker's presentation, there will be a question and answer session. To ask a question, please press star then one on your touch-tone phone. And to remove yourself from queue, please press star then two. 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, ma'am.

Good afternoon, and thank you all for joining us today to discuss our fourth quarter and full year 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. 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, its future financial or business performance, conditions or strategies, key commercial goals, future product demand trends, the ongoing development of our vaccine candidates, including strain selection, anticipating 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 risk and uncertainties that could cause actual results to differ materially from those projected in such statements. Additional information regarding those 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 subsequent Form 10-Qs filed with the Securities and Exchange Commission and available at www.sec.gov and on our website at www.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 for the first time is John Jacobs, our new President and CEO. John will provide an update on his first few weeks at Novavax. as well as provide an overview of our near-term priorities as we plan for the long-term path to success. 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 variant strategy and clinical development. Finally, Jim Kelly, Chief Financial Officer and Treasurer, will provide an overview of our financial results. Rick Crowley, Chief Operations Officer, will also be available for the Q&A section at the end of today's call. 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 together with all of you for my first earnings call with Novavax, and I'm excited to have the honor of helping to shape this new chapter in the company's history in partnership with our board, our leadership team, and all of our employees. After spending 25 years in the pharmaceutical industry and having led the growth of several different organizations to become mature commercial entities, there are a few key factors that drew me to Novavax, including their validated and innovative technology platform, which has produced a differentiated and effective COVID-19 vaccine, a pipeline of additional assets, and their adjuvant matrix M, that together offer the potential to create significant value for the organization. Their fully integrated set of capabilities, ranging from discovery and manufacturing to commercial execution on a global scale. And finally, Novavax's people and company values, which have cultivated a mission-driven culture dedicated to improving global public health. Today, I would like to share a few insights from my first five weeks at the company and outline our near-term priorities before handing it over to additional members of our leadership team to discuss our results from the previous quarter. So let's talk about my observations during the first five weeks. Since joining Novavax in late January, I've spent my time listening, learning about the business, and gaining perspective from key stakeholders across our organization. Though I will certainly continue to listen and learn for months to come, As I visit our global facilities and meet all of our amazing employees, customers, and partners, I've had the chance in these initial weeks to gather some early insights and to gain an initial picture of our current business, our capabilities, and our challenges. These early interactions have made it clear to me that we need to focus our entire organization on a few key priorities, which I believe will give us the best chance for success in 2023. Importantly, they have also reinforced for me the remarkable technology, capability set, and talent that we have as a company, and the opportunity we have to build long-term value by leveraging the foundation that has been laid to date. So let's take a moment and talk about our near-term priorities. While the significant investments made to build the company over the past three years were necessary for Novavax to deliver our first commercial product during a complex global pandemic, we are now seeing a more traditional commercial market emerging as the pandemic settles into an endemic phase. This new emerging commercial market will require the company to adjust our level of investment and our plans to better align our efforts with this opportunity. In fact, the leadership team and I have already taken decisive actions together during my first few weeks with this in mind. These actions are intended to focus our efforts on the things that we believe are most important to our near-term success, while at the same time reducing our spend and our resource commitments in areas that may no longer be aligned with those goals. I'd like to take a few minutes to share with you these priorities and some of the actions we've already taken since my arrival. Priority one, deliver a competitive product for the upcoming 2023 fall vaccination season. We are a global company, and our intention is to deliver an updated COVID vaccine that aligns with public health recommendations. Additionally, we intend to make this product available in smaller dose files, which we know is important for our customers. Together, these factors are intended to help ensure we are well positioned to compete as markets move from an advanced purchase agreement to a commercial orientation over time. Importantly, globally, we do not yet have full clarity on strain selection for the upcoming 23 fall vaccination season, which will be an important factor for us as we update our vaccine. In the U.S., for example, we are working in partnership with the FDA to inform them about what we will need in order to deliver our product, including the timing of strain selection and the nuances of our own manufacturing process as a protein-based vaccine. Let's move on to priority two. Reduce our rate of spend, manage our cash flow, and evolve our scale and structure. Since my arrival, we have taken immediate steps to reduce our rate of spend, better align our investments with our near-term priorities, and focus our efforts and energy with the intent of delivering a successful launch this fall. I have already taken an important initial step to evolve our structure by modifying the organization of our executive leadership team, which we discussed in our earnings press release. These changes will allow us to better align our internal resources, operate more efficiently, and help to position us for long-term success. Highlights of these changes include the appointment of Elaine O'Hara as our new Chief Strategy Officer, who will focus on business and corporate development, portfolio strategy, and alliance management. Elaine brings to the organization over 15 years of senior strategic and commercial leadership experience in vaccines and infectious disease, including Chief Commercial Officer North America for Sanofi Vaccines and senior roles at both Otsuka and Pfizer. In addition, Dr. Philip Dubovsky will assume the role of president research and development following the retirement of Dr. Greg Glenn. Greg will move into a consulting role as a strategic R&D advisor to the company. Sylvia Taylor has been promoted to chief corporate affairs and advocacy officer with expanded responsibilities, including government affairs, policy, and advocacy. Troy Morgan, our chief compliance officer, will remain in his role and now report directly to me as CEO in order to elevate our company's focus on compliance. And finally, investor relations will move under our CFO, Jim Kelly, among other changes. In the coming months, we will be assessing our global structure in more detail with these priorities and long-term value creation in mind, and look forward to sharing any additional potential changes with you during future calls. You will hear more today about how we are reducing and streamlining our investments from Jim Kelly later in the call. And finally, priority three, leverage our technology platform, our capabilities, and our portfolio of assets to drive additional value beyond Nuvaxavit alone. Beyond our COVID-19 vaccine and the near-term opportunity for the Fall 23 vaccination campaign, we have a differentiated technology platform, a global footprint with a fully integrated capability set, and a portfolio of promising assets including a COVID-19 influenza combination vaccine in Phase 2 with data expected mid-year that presents significant opportunity for value creation. It is our intention to unlock the potential of these assets and capabilities, both in the near term and over time, via different strategies, including but not limited to business and corporate development. This could include the potential for out-licensing, partnering, co-promotion, and or other related activities. To further align our resources against this objective, I have added the new role of Chief Strategy Officer to my executive team, as mentioned earlier. As part of her new role, Elaine will be undertaking a strategic review of our pipeline, including an assessment of how we will prioritize our pipeline investments. We have already decided to pause clinical development on RSV, which Philip will discuss in more detail. As noted in my opening comments, I have been trying to learn as much as I can during my first few weeks at Novavax. And although I still have a lot to learn as I continue to get to know our business, what I can say for sure already is that I have truly been impressed with the energy and talent of this team. Impressed with our technology and the remarkable set of assets and capabilities we have built as an organization on a global scale. And importantly, the significant opportunity for future growth and value that this represents. At the same time, I'm aware that over the past few years along this journey, we have experienced both highs and lows. And although the company has achieved many successes along the way, we have also experienced some disappointments. I would like to take a moment today to pledge to you our commitment to be transparent about our opportunities as well as our challenges. to provide balance and perspective about the near-term and future priorities we are focusing on and with humility to admit the challenges we face. I would like to say thank you to all of our investors, our partners, and the consumers of our vaccine for your faith in us and in this opportunity and for your patience as we now lead Novavax down a path towards a new and exciting future. The road ahead will be filled with potential opportunity as well as some significant challenges, and it won't be easy. But we commit to give you all our energy and our effort with a goal of success. And we may falter along the way, but if we do, we'll work hard to correct our path and be continuously thankful for your belief in our potential. So let me close my opening comments by saying, in the coming months, we are committed to maintaining a strong focus on the priorities I shared with you today. with the goal of strengthening our position as a company in the near term and putting us in a good position for future growth and success. With that, I would like to hand it over to the team to discuss our results in more detail, beginning with John Trezino to provide an update on our commercial activities on slide five. John?