Novavax, Inc.

Good morning and welcome to Novavax third 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 followed by the one on your touchtone phone. To withdraw your question, please press star followed by the two. Please note, this event is being recorded. I would now like to turn the conference over to Luis Dene, Vice President, Investor Relations. Please go ahead.

Good morning, and thank you all for joining us today to discuss our third quarter 2024 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 but not limited to statements related to Novavax's corporate strategy and operating plans, its value drivers and near-term 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 2024 financial guidance, and Novavax's future financial or business performance. Each forward-looking statement contained in this presentation is subject to certain 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 at 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 combined R&D and SG&A expenses. as adjusted for expense reimbursement from Sanofi under the Sanofi Agreement. 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 four key value drivers. Additionally, John Trezino, our President and Chief Operating Officer, will provide an update on our current commercial season, and Dr. Bob Walker, Chief Medical Officer, will discuss our clinical development and R&D strategy. Finally, Jim Kelly, Chief Financial Officer and Treasurer, will provide an overview of our financial results. I would now like to hand over the call to John Jacobs.

Thank you, Louis, and thank you, everyone, for joining us. Please turn to slide five. I'm pleased to be with you here today along with members of our executive team to discuss Novavax's progress during the third quarter as well as how we have advanced the new corporate growth strategy that we outlined during our second quarter call in August. This strategy is focused on driving future value from additional business development activities and organic research and development using our proven technology, all while reshaping the company into a leaner and more agile organization. This strategy has already resulted in the Sanofi partnership we announced this year, which has enabled us to transition away from Novavax's prior business model of devoting all our resources and time to commercializing one product, our COVID-19 vaccine, and to move instead toward additional value generating activities, which we will talk about more today. First, I want to take a moment to recap the four key drivers of value for this strategy. and then share with you both the progress we have already made and our next steps on each. The four value drivers are value driver one, the Sanofi partnership, value driver two, our late stage pipeline, Kik and Flu, value driver three, leveraging our proven technology platform to drive additional partnerships and deals, and value driver four, our emerging early stage pipeline. We intend to deliver on these value drivers using a more lean corporate infrastructure built on the core capabilities needed to execute this new approach and disciplined expense management, on which we have already made significant progress and will elaborate on later in the call. So first, let's talk about Value Driver 1, the Sanofi Partnership. As we discussed last quarter, the partnership with Sanofi is a license and collaboration agreement that 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. Sanofi will take the lead co-commercialization role for our COVID-19 vaccine starting in 2025, enabling us to monetize our existing COVID-19 vaccine program through double-digit royalties from Sanofi sales into the future. We also have the potential for multiple additional revenue streams generated from other vaccines developed by Sanofi, either in combination with our existing COVID-19 product or using our MatrixM adjuvant as they look to leverage the power of our proven technology. As a reminder, in the second quarter, we received an initial cash payment of $500 million up front and an approximately $70 million equity investment in Novavax. We are also eligible to receive up to $700 million in additional milestone payments related to our COVID-19 vaccine and Sanofi's own combination COVID flu vaccine. Along with future milestone payments and royalties we anticipate from these programs, We also have the potential for additional royalties and or milestones from other vaccines developed either in combination with our existing COVID-19 product or using our MatrixM technology. As you can see, 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. Our second value driver is Novavax's late stage pipeline. Our late stage pipeline is comprised of our COVID-19 influenza combination and standalone influenza vaccine candidates. We believe that combination vaccines, such as our KICK candidate, represent a significant market opportunity, and we're excited about the prospect of advancing these assets. In addition, our standalone influenza vaccine program is based on a platform that has demonstrated enhanced immunogenicity in late-stage trials. And we believe that if successful, this could be the first and only recombinant-based protein-adjuvanted flu vaccine in the market, and one which can serve as the foundation to advance an innovative and differentiated pandemic influenza program as well. As we've previously communicated, our intention is to partner these assets. Dr. Bob Walker will provide updates on this program shortly. And now moving on to Value Driver 3, which is to leverage our proven technology platform to drive additional partnerships and deals. Our proven tech platform consists of both our MatrixM adjuvant and our nanoparticle protein-based technology, which we believe provide us the potential for multiple business development opportunities with a diverse set of potential partners across a range of vaccines. We believe MatrixM holds incredible promise, not just to develop our own vaccines, as we've already seen with our marketed COVID-19 product, but importantly, to also potentially improve other companies' existing vaccines and or enable them to develop new vaccines using our adjuvant. Last quarter, we shared data from existing vaccines combined with MatrixM to demonstrate how our adjuvant can be leveraged to potentially improve them. The data we showed of inactivated influenza and bacterial polysaccharide vaccines adjuvanted with our matrix M are just two examples of the significant value we believe our adjuvant could provide to the existing vaccine portfolios of other companies, and we continue to explore other ways to leverage its potential. And finally, Value Driver 4, our emerging early stage pipeline. Our fourth value driver focuses on generating additional value from our tech platform through the development of a new diversified pipeline. Employing a disciplined approach, we intend to develop an early stage pipeline based on our proven technology platform, starting from our core of infectious disease and potentially going beyond that core into other areas where we see the most unmet medical need and the greatest potential for our technology. Importantly, we intend to expand our pipeline strategically using a rigorous set of guiding principles aimed to focus our time and investments on the highest value programs. This will include considerations such as scientific rationale and reasons to believe our technology can be differentiated and win in a specific therapeutic area, market opportunity and the level of unmet medical need, emerging competitive pipelines, attractiveness of the asset to other companies, and ability to partner, and several other factors to help us make high-quality choices with our investments in R&D. Importantly, we intend to execute this strategy in a capital-efficient manner, one that maintains our flexibility and preserves the potential for maximum value creation. Dr. Bob Walker will expand further on both how we intend to apply these guiding principles and our next steps during his portion of today's call. So, in summary, our corporate growth strategy channels all of our resources into driving value from our proven technology platform via partnering in R&D and to doing so in a much more lean and efficient organization. For the remainder of this year, and in line with our key value drivers, we're focused on executing our four priorities, which you will see on slide six. Priority one, the successful execution of our partnership with Sanofi. Priority two, driving incremental value from our technology platform with the advancement of our kick and flu programs, the ongoing development of an emerging early-stage pipeline, and pursuing new business development opportunities. Priority three, further reduction of our R&D and SG&A costs in line with our guidance, along with implementing additional reductions to scale as we enter 2025 and beyond. And priority four, delivery of our updated COVID-19 vaccine for the 24-25 vaccination season. Before I hand the call over to additional members of our team, I want to take a moment to welcome Dr. Raksandra Draghi, our new head of R&D who started just yesterday. Raksandra brings more than 20 years of extensive clinical, corporate, and global public health expertise to Novavax, and we believe she will be instrumental as we evaluate our future pipeline and opportunities for our tech platform. You will hear more from Rexandra in the coming weeks as she settles into her new role. Now to discuss our third quarter in more detail, I'd like to turn the call to John Trezino for our operating updates. John?