Novavax, Inc.

and welcome to Novavax 4th Quarter 2024 Financial Results and Operational Highlights Conference Call. All participants will be in 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 touchstone 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 call over to Luis Sanay, Vice President, Investor Relations. Please go ahead.

Good morning, and thank you all for joining us today to discuss our fourth quarter and full year 2024 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 but not limited to statements related to Novavax's corporate strategy and operating plans, its strategic priorities, its partnerships and expectations with respect to potential royalties, milestones, and cost reimbursements, its expectations regarding manufacturing capacity, timing, production, and delivery for its COVID-19 vaccine, the development of Novavax's clinical and preclinical product candidates, full-year 2025 financial guidance and revenue framework, and Novavax's future financial or business performance. 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 presentation we issued this morning 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. available at sec.gov and our website, NOVAVAX.com. 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. This presentation also includes references to a non-GAAP financial measure, which is forward-looking information for adjusted licensing, royalties, and other revenue. Please turn to slide four. Joining me today is John Jacobs, our president and CEO, who will provide an update on our progress during the quarter and highlight our growth strategy. Additionally, Dr. Ritsandra Draghia, head of R&D, will discuss our R&D strategy and clinical development. John Trezino, our president and chief operating officer, will provide an update on our Sanofi partnership. And finally, Jim Kelly, Chief Financial Officer and Treasurer, will provide an overview of our financial results and 2025 financial guidance and revenue framework. I would now like to hand over the call to John Jacobs.

Thank you, Louis. I'm pleased to be here with you today, along with members of our executive team. to discuss our financial results and highlight our progress on our corporate growth strategy. 2024 was a year of significant accomplishments for Novavax. We developed and embarked upon a new and ambitious corporate growth strategy, which is designed to maximize the impact of our cutting-edge technology through R&D innovation, the expansion of our organic portfolio, and through building new and diversified partnerships with other companies via the outlicensing of our tech platform and vaccine assets. Consistent with that new strategy, we announced our wide-ranging partnership agreement with Sanofi, which I will discuss in a few moments, and made important additional progress on our portfolio and in other areas during what was a transformational 2024, which saw the acceptance of our COVID-19 BLA by the U.S. FDA, for which we have an action date in April of this year, the launch of our 24-25 season updated COVID-19 vaccine in August, Novavax successfully operationalizing our partnership with Sanofi, which enabled them last month to assume lead commercial responsibilities for our COVID-19 vaccine, beginning with the 25-26 vaccination season. The initiation of an initial cohort of our COVID-19 influenza combination vaccine and standalone influenza vaccine phase three trial. the addition of a new head of R&D, and the identification of four new early-stage assets for our emerging organic portfolio, including programs focused on C. diff, varicella zoster virus, pandemic flu, and a triple RSV combination. And finally, we made continued and significant progress in improving Novavax's financial strength. Examples include the sale of our Czech Republic manufacturing facility for $200 million, and in the process, reducing our go-forward annual operating costs by approximately $80 million, significantly decreasing our current liabilities by $1.3 billion over the last two years, and significantly reducing our combined R&D and SG&A expenses so that we are well-positioned to achieve our goal of decreasing our expenses by approximately 85% by 2027 as compared to our 2022 baseline. With this significant progress, we have positioned Novavax well to execute on our corporate growth strategy. And with this new strategy in place, we have reshaped our company mission to be in line with this future direction. It states, by leveraging our science, our technology, and our people, we will innovate and collaborate to tackle the world's most significant health challenges. We have also aligned our company vision, which reinforces our belief in the impact our technology can and should have. We envision a world where our technology is amplified to touch the lives of billions, sparking transformation in global health. Together, our management team and employees are united in our commitment to this strategy and in our belief that expanding access to and the utility of our proven tech platform via R&D innovation, organic portfolio expansion, and enhanced partnering and collaborations with other companies can truly help us to fulfill our mission and ultimately our vision for what Novavax can achieve and become as a company. And with our new growth strategy, renewed mission and vision, we have developed a clear pathway to how we will strive to positively impact global health and achieve value for all of our stakeholders in 2025 and beyond. We believe that our new strategy has the potential to drive Novavax to profitability as early as 2027 assuming execution of our plans and timely execution by our partners, particularly Sanofi. Jim Kelly will touch on this more during his portion of our prepared remarks. Upon reaching our planned steady-state operating model, we expect to continue funding our R&D pipeline through organic cash flows from executed transactions to thus produce additional early-stage assets for outlicensing and partnering to further increase profitability and cash flow. Between now and then, there are several near-term catalysts you can look for to signal progress. The April PDUFA date for our BLA, and assuming BLA approval, the associated MAH transfer for our COVID-19 vaccine to Sanofi, generating $225 million in milestone payments combined. Advancement of Sanofi's own COVID influenza combination vaccine candidates, which include Novavax's COVID-19 vaccine, thereby setting up opportunities for additional milestone and royalty payments. Data readout from the initial cohort of our phase three kick and standalone flu trial by mid-year. Preclinical data from our early stage pipeline programs in the second half of this year. We plan on hosting an investor day in the second half of 2025. And announcement of additional partnerships and collaborations. While we can't give specific projections around timing or the nature of any new potential deals or partnerships, our team is actively working to seek new partners and to expand the level of interest in our technology platform. And also, and finally, look for further cost reduction efforts and initiatives from our team. Please turn to slide six. As we continue with our commitment to positively impact global health while delivering value for our shareholders, we've set three strategic priorities for the year. As an evolution of our previous value drivers, these will guide our work through 2025. Our first priority is to be a partner of choice and in the process, increase access to our existing COVID-19 vaccine, as well as our matrix M adjuvant and our emerging pipeline assets with the goal of growing revenue and continuing to improve the long-term financial strength of Novavax through royalties and milestones. We intend to optimize our existing partnerships with a focus on mutual value creation. Our license and collaboration agreement with Sanofi set a new bar for what is possible with this strategy and further solidified the credibility of our proven tech platform. The partnership combines Novavax's proprietary protein and nanoparticle technologies, matrix adjuvant, and our R&D expertise with Sanofi's world-class leadership in launching and commercializing innovative vaccines. As a reminder, in 2024, we received an initial cash payment of $500 million up front and an approximately $70 million equity investment in Novavax. Sanofi is taking the lead commercialization role for our COVID-19 vaccine starting this year, enabling us to monetize our existing vaccine program through potential milestones and royalties and to significantly reduce our operating expenses that were related to leading prior commercial efforts. In addition to the royalties and remaining milestones related to our COVID-19 vaccine, we believe that Sanofi has a strong desire to leverage the power of our proven technology. And we are eligible to receive additional milestone payments as well as additional revenue streams from royalties related to other vaccines developed by Sanofi in combination with our existing COVID-19 product. In fact, Sanavi has initiated two separate Phase 1-2 trials, combining our COVID-19 vaccine with their market-leading flu products, FluZone High Dose and FluBlock. And both combination products were granted fast-track designation by the U.S. FDA. Finally, a key part of the agreement includes access to our proven MatrixM adjuvant. Sanofi has brought non-exclusive access to MatrixM and Novavax is eligible to receive up to $200 million in launch and sales milestones and mid-single-digit sales royalties for 20 years for each new product Sanofi may choose to develop using our MatrixM adjuvant, above and beyond anything they may do with our COVID-19 vaccine, as noted earlier. Sanofi's strong global presence and proven track record in developing and commercializing vaccines, combined with Novavax's R&D expertise, has created the potential for this partnership to drive significant value for years to come, both for our shareholders and the people who would have broadened access to our vaccine technology and the protection it can provide. As part of our new strategy, we intend to enter additional new partnerships with the goal of further increasing access to our tech and benefiting global health, which is in line with our new mission and vision for Novavax. Therefore, our second strategic priority is to leverage our technology platform and pipeline to forge additional partnerships. Our proven protein-based nanoparticle technology and our matrix M adjuvant have the potential to facilitate the development of new best-in-class vaccines or to improve existing vaccines with the potential for enhanced durability of protection, greater immune response, and or reduced COGS. In addition, our new early stage pipeline is intended to create additional assets that we intend to partner and out-license at early proof of concept stages, optimizing our R&D investment, and creating additional opportunities for new collaborations and partnerships in addition to what our tech platform alone could provide. Our existing collaboration with Sanofi and pre-clinical evaluation agreements with other organizations highlight a significant interest in Matrix M. We intend to continue to seek opportunities to leverage Matrix M via partnerships and collaborations. Our late stage programs include a COVID influenza combination vaccine candidate, as well as a standalone influenza vaccine candidate, both targeted for adults 65 years of age and older. We know that significant market demand exists for a combination vaccine with greater than 60% of consumers stating a preference for an all-in-one option. We expect data by mid-year from the initial cohort of our Phase 3 trial, which began in December. Consistent with our new corporate strategy, we plan to stage-gate additional investment in this program beyond the completion of this initial cohort and ongoing regulatory interactions until a partner is in place. With the expectation that that the partner will fully fund any additional clinical investments in these programs. Finally, our third strategic priority is to advance our technology platform and early-stage pipeline with a focus on a lean, capital-efficient approach and with the intent to partner early-stage assets at proof of concept, allowing our partners to carry those assets forward through full clinical development and commercialization. We are actively advancing our pipeline of early-stage programs, focusing on high-value assets in areas of significant unmet medical need, compelling scientific rationale, and strong commercial potential. With that in mind, we are continuing to expand our pipeline with the addition of four new early-stage programs that Roxandra will touch on in a moment. As we laid out last quarter, we intend to take a disciplined and capital-efficient approach as we make smart investments and expand our pipelines. In summary, our corporate growth strategy allows Novavax to focus on what we do best, leveraging our scientific expertise and our proven technology platform to drive value through R&D and through partnerships. Novavax is well-positioned to expand access to our technology, deliver transformative advancements for global health, and deliver value for all stakeholders. I'd now like to turn the call to Ruxandra to discuss our research and development updates. Ruxandra?