Q1 2024 Novavax Inc Earnings Call & Business Update

Operator: Good morning and welcome to Novavax's First Quarter 2024 Financial Results and Operational Highlights Conference Call. All lines will be in the listen-only mode.

Good morning, and welcome to Novavax first quarter 'twenty 'twenty four financial result.

Highlights conference call all lines.

It will be and then 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 one on your Touchtone phone.

Operator: 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 1 on your touchtone.

Operator: If you would like to try a question, please press star 1. Please note, this event is being recorded. Now I'd like to turn the conference over to Erika Schultz, Senior Director of Investor Relations. Please go ahead.

Your question. Please press Star two please note this event is being recorded.

Now I'd like to turn the conference over to Eric Schuck Senior Director Investor Relations. Please go ahead.

Yeah.

Erika Schultz: Good morning, and thank you all for joining us today to discuss our first quarter 2024 financial results and operational highlights. 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.

Eric Schuck: Good morning, and thank you all for joining us today to discuss our first quarter 'twenty 'twenty four financial results and operational highlights.

Eric Schuck: A press release announcing our results is currently available on our website at Novavax Dot Com and an audio archive of this conference call will be available on our website later today.

Eric Schuck: Please turn to slide two.

Erika Schultz: 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, and statements related to potential royalties and milestones. Operating Plans, Objectives, and Prospects, full year 2024 financial guidance, the amount and impact of Novavax's cost reduction plans, its future financial or business performance conditions or strategies, its partnerships, anticipated timing, and outcome of future regulatory filings and actions, and the ongoing development, marketing opportunities, manufacturing capacity, and future availability of our vaccine candidates and key upcoming milestones.

Eric Schuck: 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 statements related to potential royalties and milestones.

Eric Schuck: Operating plans objectives and prospects full year, 'twenty 'twenty four financial guidance, the amount and impact of another vaxes cost reduction plans, its future financial or business performance conditions or strategies. It's.

Eric Schuck: It's partnerships anticipated timing and outcome of future regulatory filings and actions.

Eric Schuck: And the ongoing development marketing opportunities manufacturing capacity and future availability of our vaccine candidates.

Eric Schuck: Key upcoming milestones.

Erika Schultz: 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 these factors appears under the heading, Cautionary Note Regarding Forward-Looking Statements.

Eric Schuck: 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 statement.

Eric Schuck: Additional information regarding these factors appears under the heading cautionary note regarding forward looking statements in the slide deck, 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 security and Exchange Commission available at Www.

Erika Schultz: In the slide deck 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 Security and Exchange Commission, available at www.sec.gov and on our website at novavax.com, the four forward-looking statements in this presentation speak only as of the original date of this presentation, and we undertake no obligation to update, update, or revise any of these statements. Please turn to slide three.

Eric Schuck: S C dot Gov and on our website at Novavax Dot com.

Eric Schuck: The forward looking statements in this presentation speak only as of the original date of this presentation and we undertake no obligation to uptake.

Eric Schuck: Update or revise any of these statements. Please turn to slide three.

Eric Schuck: Yeah.

Erika Schultz: Joining me today is John Jacobs, our President and CEO, who will discuss our agreement with Sanofi announced this morning. Additionally, John Trizzino, our President and Chief Operating Officer, will provide an update on our commercial activities, and Dr. Filip Dubovsky, President of Research and Development, will discuss our clinical development and pipeline. Finally, Jim Kelly, Chief Financial Officer and Treasurer, will provide an overview of our financial results and implications of the Sanofi partnership. I would now like to hand over the call to John Jacobs. Please turn to slide four. Thank you, Erika, and thank you, everyone, for joining us today.

Eric Schuck: Joining me today is John Jacobs, our President and CEO, who will discuss our agreement with Santa Fe announced this morning.

John Charles Jacobs: Additionally, Johns casino, our president and Chief operating Officer will provide an update on our commercial activities and Dr. Philip devout ski President of research and development will discuss our clinical development and pipeline.

Lee, Jim Kelly, Chief Financial Officer, and Treasurer will provide an overview of our financial results and implications of the fantasy partnership.

John Charles Jacobs: I would now like to hand over the call to John Jacobs, Please turn to slide four.

John Charles Jacobs: Thank you Erica and thank you everyone for joining us today.

John Charles Jacobs: Today we enter a new and exciting chapter in the history of Novavax. This morning, we announced that we have signed a global co-development and co-commercialization agreement with Sanofi. This agreement is both material and strategically important for Novavax. It is a further validation of our technology platform and provides a significant opportunity to drive value creation and benefit global public health. The agreement represents a multi-billion dollar opportunity over time for Novavax. Through this agreement, we generate significant near-term cash flow, a strengthened balance sheet, as well as the opportunity to strategically pivot to a new lean operating model, focusing more on our strengths in research and development and pipeline expansion to accelerate our growth and generate long-term value for our shareholders. First, the upfront and near-term milestones associated with this agreement are anticipated to equate to approximately $1.3 billion in cash, of which approximately half is expected within 10 days of signing.

John Charles Jacobs: Today, we enter a new and exciting chapter in the history of Novavax.

John Charles Jacobs: These cash payments provide us with a significant capital infusion to help us manage our business, and this, in turn, also enables us to remove the going concern status of Novavax. Second, beginning in 2025, it allows us to leverage one of the largest proven global leaders in the vaccine business to commercialize Nuvaxavid in the U.S., U.K., and Europe initially, and worldwide over time, affording hundreds of millions of dollars in potential cost synergies, enabling us to drive toward a new, more lean operating model, with total costs anticipated to be well below our prior stated cost reduction target.

John Charles Jacobs: This morning, we announced that we have signed the global co development and co commercialization agreement with Sanofi.

John Charles Jacobs: And we expect our royalties and milestones from Sanofi's efforts with Novavaxavid to exceed the value of what our own efforts might have yielded if we had kept the product ourselves exclusively, by licensing Sanofi to use our Novavax to develop their own combination flu and COVID product and to use Matrix M as a component of other vaccines across their portfolio. We expect to realize substantial additional royalties and milestones valued potentially in billions of dollars driven by Sanofi's product development and commercialization efforts over the years and decades to come. The royalties and milestones associated with potential new vaccines Sanofi may develop using Matrix M, as well as those royalties and milestones anticipated from sales of our COVID-19 vaccine and the development of Sanofi's combination flu COVID and other potential combination vaccine In fact, we have done all of this while retaining the ability to broaden and accelerate the development of our own wholly owned pipeline.

John Charles Jacobs: This includes the modification of our planned 2024 pivotal trial for our combination flu and COVID vaccine to now also include the potential to yield pivotal results for our standalone flu vaccine. And we now anticipate readouts for both the combination and our standalone flu vaccine in mid-2025. In addition to our late-stage kick and flu standalone programs, we will now be able to assess and contemplate the addition of some new early-stage programs to our pipeline and do so within the cost structure of a new lean operating model.

John Charles Jacobs: This agreement is both material and strategically important for novavax. It as a further validation of our technology platform and provide significant opportunity to drive value creation and benefit global public health.

John Charles Jacobs: The agreement represents a multibillion dollar opportunity over time for Novavax.

John Charles Jacobs: Your disagreement we generate significant near term cash flow a strengthened balance sheet as well as the opportunity to strategically pivot to a new lean operating model focusing more on our strengths in research and development and pipeline expansion to accelerate our growth and generate long term value for our shareholders.

John Charles Jacobs: First the upfront and near term milestones associated but Thats agreement are anticipated to equate to approximately $1.3 billion in cash.

Which approximately half is expected within 10 days of signing.

John Charles Jacobs: These cash payments provide us with a significant capital infusion to help us manage our business.

John Charles Jacobs: And this in turn also enables us to remove the going concern status for Novavax.

John Charles Jacobs: Second beginning in 2025, it allows us to leverage one of the largest proven global leaders in the vaccine business to commercialize new vacs are at in the U S UK and Europe, initially and worldwide over time.

John Charles Jacobs: Affording hundreds of millions of dollars in potential cost synergies, enabling us to drive toward a new more lean operating model with total cost anticipated to be well below our prior stated cost reduction targets.

John Charles Jacobs: And we expect our royalties and milestones from Santa fees efforts with <unk> to exceed the value of what our own efforts might have yielded if we had kept the product ourselves exclusively.

John Charles Jacobs: By licensing sign a fee to use our new accident to develop their own combination flu and COVID-19 products.

John Charles Jacobs: And to use matrix M as a component of other vaccines across their portfolio.

John Charles Jacobs: We expect to realize substantial additional royalties and milestones valued potentially in the billions of dollars driven by <unk> product development and commercialization efforts over the years and decades to come.

John Charles Jacobs: The royalties and milestones associated with potential new vaccine side, if he may develop using matrix M as well as those royalties and milestones anticipated from sales of our COVID-19 vaccine and the development of <unk> combination flu COVID-19 and other potential combination vaccines.

John Charles Jacobs: It should help us to test the same cash flow as we invest in our own R&D and an efficient and thoughtful manner for years to come.

John Charles Jacobs: In fact, we've done all of this while retaining the ability to broaden and accelerate development of our own wholly owned pipeline.

John Charles Jacobs: This includes the modification of our planned 2024 pivotal trial for our combination flu and Covid vaccine to now also include the potential to yield pivotal results for pivotal results for our Standalone flu vaccine.

John Charles Jacobs: And we now anticipate readouts for both the combination and our Standalone flu vaccine in mid 2025.

John Charles Jacobs: In addition to our late stage kick and flew Standalone programs, we will now be able to assess and contemplate. The addition of some new early stage programs to our pipeline and do so within the cost structure of our new lean operating model.

John Charles Jacobs: For both our late-stage kick and stand-alone flu programs and any early-stage programs, we may choose to add to our pipeline in the coming quarters. We will be pragmatic, shareholder-focused, and market aware about how to bring these assets forward, for example, through partnering, licensing, co-development, co-commercialization, or commercializing on our own. We would consider commercializing on our own only for the right asset and with the benefit of our learnings from the COVID experience. The key here is that we intend to have multiple organic opportunities from our own pipeline with optionality on how we decide to optimize value from them.

John Charles Jacobs: For both of our late stage kicking standalone flu programs and any early stage programs, we may choose to add to our pipeline in the coming quarters.

John Charles Jacobs: We will be pragmatic shareholder focused and market aware about how to bring these assets forward.

John Charles Jacobs: For example through partnering out licensing co development co commercialization or commercializing on our own.

John Charles Jacobs: And we would consider commercializing on our own only for the right asset and with the benefit of our learnings from the Covid experience.

John Charles Jacobs: The key here is that we intend to have multiple organic opportunities from our own pipeline with optionality on how we decide to optimize value from them.

John Charles Jacobs: We look forward to providing additional details and updates on our new pipeline and future growth strategy for Novavax in the coming months as we operationalize our partnership with Senovia. And finally, this transaction further validates both Novavax's product development capability and the extraordinary value of our MatrixM adjuvant technology, potentially enhancing our future licensing and business development opportunities across our tech platform. In fact, we intend, as part of our go-forward strategy, to seek additional business development opportunities with our Organic Pipeline, new pipeline assets we intend to add, and our MatrixM and Nanoparticle technology platforms.

We look forward to providing additional details and updates on our new pipeline and future growth strategy for Novavax in the coming months as we operationalize our partnership with Sanofi.

John Charles Jacobs: And finally this transaction further validates both Novavax is product development capability and the extra ordinary value of our matrix M adjuvant technology, potentially enhancing our future licensing and business development opportunities across our tech platform.

John Charles Jacobs: In fact, we intend as part of our go forward strategy to seek additional business development opportunities with our organic pipeline new pipeline assets, we intend to add in our matrix M and nanoparticle technology platforms.

John Charles Jacobs: So, in summary, this transaction capitalises our current business, seeks to increase our future anticipated value from Novavaxavid while enabling us to significantly reduce our operating costs and complexity, creates a future stream of royalties and milestones from multiple potential new products to be developed by Sanofi, broadens and accelerates our own development pipeline, and enhances our future deal-making capabilities, leveraging MatrixM, our late and early stage pipeline Jim Kelly will now walk you through the financial terms. Jim.

John Charles Jacobs: In summary, this transaction capitalizes our current business.

John Charles Jacobs: Seeks to increase our future anticipated value from new accident, while enabling us to significantly reduce our operating cost and complexity.

John Charles Jacobs: It's a future stream of royalties and milestones from multiple potential new products to be developed by Sanofi.

John Charles Jacobs: Broadens and accelerates our own development pipeline and enhances our future deal, making capabilities leveraging matrix M. Our late and early stage pipeline and our product development capabilities.

John Charles Jacobs: Jim Kelly will now walk you through the financial terms Jim.

James Kelly: Thank you, John. Please turn to slide number five. This new agreement with Sanofi provides for a multi-billion dollar potential across upfronts, equity investment, milestones, and royalties. The anticipated present value of the royalties on Santa Fe's Novavaxavid and Kik sales is expected to be the largest individual component of value in this transaction. The COVID-19 related terms include the potential for up to approximately $1.3 billion in cash payments and equity investments. Plus, Novavax is eligible to receive tiered royalties on related product sales.

James Kelly: Thank you John Please turn to slide number five.

James Kelly: This new agreement with Santa Fe provides for a multibillion dollar potential across upfront equity investment milestone and royalties.

James Kelly: The anticipated present value of the royalties on Santa fees in the vaccinated and kicked sales are expected to be the largest individual component of value in this transaction.

James Kelly: The COVID-19 related terms include the potential for up to approximately $1 3 billion in cash payments and equity investments plus novavax is eligible to receive tiered royalties on related product sales in.

James Kelly: In addition, we're eligible to receive up to 200 million in milestones plus ongoing royalties for each new vaccine developed utilizing Novavax's MatrixM adjuvant. For example, if Sanofi develops five products with our MatrixM, each with a billion in sales, this would represent hundreds of millions in royalties per year, plus up to $1 billion in one-time milestone payments during the second quarter of 2024. The initial cash payments include the $500 million upfront and the approximately $70 million equity investment in Novavax.

James Kelly: In addition, we're eligible to receive up to $200 million in milestones plus ongoing royalties for each new vaccine developed utilizing novavax has matrix M adjuvant.

James Kelly: For example, if Santa fee developed five products with our matrix M. Each with $1 billion in sales. This would represent hundreds of millions in royalties per year, plus up to 1 billion and one time milestones.

James Kelly: During the second quarter of 2020 for the initial cash payments include the 500 million upfront and the approximately $70 million equity investment and no vac stock.

James Kelly: Near-term Novavax COVID-19 milestones of $350 million and kick milestones of another $350 million should provide important future cash flow to the company. In addition, Novavax is eligible to receive tiered royalties on net sales in each of the COVID-19 related product categories that enable Novavax's meaningful participation in future economics from the current and future products under this agreement. Please turn to slide number 6. New vaccines developed with Matrix M by Sanofi create a broad opportunity to advance this technology and provide Novavax with multiple revenue-generating sources.

James Kelly: Near term novak's evade COVID-19 milestones of $350 million and kick milestones of another $350 million should provide important future cash flow to the company.

James Kelly: In addition, no vaccine is eligible to receive tiered royalties on net sales in each of the COVID-19 related product categories that enable novavax has meaningful participation in future economics from the current and future products under this agreement.

James Kelly: Please turn to slide number six.

James Kelly: New vaccines developed with matrix M by Santa fee create a broad opportunity to advance this technology can provide novavax with multiple revenue generation sources.

James Kelly: Novavax will support Santa Fe.

James Kelly: Here's to advance all programs associated with disagreement and no <unk> will be eligible for cost reimbursement across.

James Kelly: Novavax will support Santa Fe as it prepares to advance all programs associated with this agreement, and Novavax will be eligible for cost reimbursement across a host of spend categories. John, we'll now walk you through the first quarter commentary.

James Kelly: Host of spend categories.

James Kelly: John will now walk you through the first quarter commentary John.

John Charles Jacobs: Thank you, Jim. Please turn to slide seven. It took a lot of hard work over the past 15 months to get here, and a determined focus on the strategic priorities we identified when I first joined the company to better position Novavax to execute significant business development opportunities like this partnership with Santa Fe. In fact, since early 2023, the management team and I have been making significant progress on our three priorities. Priority one, delivering an updated product for the fall vaccination season. Priority two is reducing our rate of spend, managing our cash flow, and evolving our scale and structure.

John Charles Jacobs: Thank you Jim.

John Charles Jacobs: Please turn to slide seven.

John Charles Jacobs: It took a lot of hard work over the past 15 months to get here and.

John Charles Jacobs: And then determined focus on the strategic priorities, we identified when I first joined the company.

John Charles Jacobs: To better position Novavax to execute significant business development opportunities like this partnership with <unk>.

John Charles Jacobs: In fact since early 2023, the management team and I have been making significant progress on our three priorities.

John Charles Jacobs: I already one delivering an updated product for the fall vaccination season.

John Charles Jacobs: Priority, two reducing our rate of spend managing our cash flow and evolving our scale and structure.

John Charles Jacobs: And finally, priority three, leveraging our technology platform, our capabilities, and our assets to drive additional value beyond Novavax alone. Importantly... We had to make significant progress on the first two priorities in order to optimize the potential of our third priority, and over the last 15 months, by strengthening our balance sheet, reducing significant one-time legacy liabilities, including Gavi, and proving that we could streamline our strain selection process and update our vaccine to align with regulatory requirements.

John Charles Jacobs: And finally priority three leveraging our technology platform, our capabilities and our assets to drive additional value beyond <unk> of it alone importantly.

John Charles Jacobs: Importantly.

John Charles Jacobs: We had to make significant progress on the first two priorities in order to optimize the potential of our third priority.

John Charles Jacobs: And over the last 15 months by strengthening our balance sheet.

John Charles Jacobs: Reducing significant onetime legacy liabilities, including coffee and.

And proving that we could streamline our strain selection process and update our vaccine to align with regulatory requirements.

John Charles Jacobs: We put Novavax in a position to be able to execute meaningful business development agreements. The Sanofi Agreement is strategically important for our company, as it enables a pivot to a new growth strategy, a new lean operating model, and a new chapter in the history of Novavax. With that in mind, we have made appropriate adjustments to our priorities for the remainder of 2024.

John Charles Jacobs: We put <unk> in a position to be able to execute meaningful business development agreements.

John Charles Jacobs: The Santa fee agreement is strategically important for our company as it enables a pivot to a new growth strategy, a new lean operating model and a new chapter in the history of Novavax.

John Charles Jacobs: With that in mind, we have made appropriate adjustments to our priorities for the remainder of 2024 for.

John Charles Jacobs: For the remainder of this year, we will be focusing on the following. Number one, prioritizing the successful transition of our new partnership with Sanofi. Number two, continuing to expand and diversify organic opportunities and create additional value from our technology platform.

John Charles Jacobs: For the remainder of this year, we will be focusing on the following.

John Charles Jacobs: Number one prioritizing the successful transition of our new partnership with <unk>.

John Charles Jacobs: Number two.

John Charles Jacobs: <unk> to expand and diversify organic opportunities and create additional value from our technology platform.

John Charles Jacobs: 3, preparing to initiate an additional cost reduction program to reduce 2025 R&D plus SG&A expenses net of Sanofi cost reimbursement to below $500 million. And number four, delivering an updated product for the 24-25 fall vaccination season. As our strategy, vision, and new expanded pipeline for the company evolve, we intend to share more with you about the new path forward for Novavax. We will spend the next several months analyzing and crystallizing our future pipeline and our strategic focus with the goal of sharing our updated plans for Novavax in more detail towards the end of this year. And now I would like to hand it over to the team to discuss our results from the quarter in more detail, beginning with John Trizzino on our commercial updates.

John Charles Jacobs: Three preparing to initiate an additional cost reduction program to reduce 2025, R&D plus SG&A expenses net of Santa Fe cost reimbursement to below $500 million.

John Charles Jacobs: And number four delivering an updated product for the 'twenty four 'twenty five fall vaccination season.

John Charles Jacobs: As our strategy vision and new expanded pipeline for the company evolve we intend to share more with you about the new path forward for Novavax.

John Charles Jacobs: We will spend the next several months analyzing and crystallizing, our future pipeline and our strategic focus with the goal of sharing our updated plans for novavax in more detail towards the end of this year.

Speaker Change: And now I would like to hand, it over to the team to discuss our results from the quarter in more detail beginning with <unk> for our commercial updates John.

Speaker Change: Thank you John Please turn to slide eight.

John Joseph Trizzino: Thank you, John. Please turn to slide eight. We are very excited about the potential of the Sanofi agreement for our business, and as John mentioned, our first priority is operationalizing the agreement to enable Sanofi to commence co-commercialization activities starting January 1st of next year. This collaboration agreement with Sanofi is a validation of the significant investment made in the Novavax technology platform to date and of the dedicated and passionate effort of the many people that have contributed along the way.

Speaker Change: We are very excited about the potential of the Sanofi agreement for our business and as John mentioned, our first priority is operationalized the agreement to enable <unk> to commence co commercialization activities starting January one of next year.

Speaker Change: This collaboration agreement with <unk> is a validation of the significant investment made in the Novavax technology platform to date.

Speaker Change: And of the dedicated and passionate effort of the many people that have contributed along the way.

John Joseph Trizzino: While we are steadfast in our belief that our COVID vaccine is the best one approved for use, it has been challenging to transition from being an innovator focused on developing vaccines for infectious diseases to being a commercial business focused on operational execution. Now partnered with Sanofi, we see very clearly the opportunity to leverage their brand and global infrastructure for the benefit of public health, revenue generation, and increased return to our investors. The burden of disease for COVID remains clear and well-documented.

Speaker Change: While we are steadfast in our belief that our Covid vaccine is the best one approved for use it has been challenging to transition from being an innovator focused on developing vaccines for infectious diseases to being a commercial business focused on operational execution.

Speaker Change: Now partnered with Santa Fe, we see very clearly the opportunity to leverage their brand and global infrastructure for the benefit of public health.

Speaker Change: Revenue generation and increased return to our investors.

Speaker Change: The burden of disease for Covid remains clear and well documented vaccination continues to be recommended as the best defense for the prevention of severe disease hospitalization and death.

John Joseph Trizzino: Vaccination continues to be recommended as the best defense for the prevention of severe disease, hospitalization, and death. Advisory committees like the CDC, ACIP, and other health policy bodies around the world continue to recognize this need. The COVID virus, for now, continues to circulate throughout the year, but with a concentrated disease burden during the typical winter respiratory disease season from late fall to early spring.

Speaker Change: Advisory committees like the CDC ACP and other health policy bodies around the globe continue to recognize this need.

Speaker Change: The Covid virus for now continues to circulate throughout the year, but with concentrated disease burden during the typical winter respiratory disease season from a late fall to early spring.

John Joseph Trizzino: The ongoing need for both a COVID and an influenza annual seasonal vaccination leads to the public health benefit for a single combination vaccine. A single visit and vaccination creates a convenience that we believe will translate into improved vaccination rates, especially in older adults who are most at risk. Sanofi is well recognized.

Speaker Change: The ongoing need for both Covid and influenza annual seasonal vaccine Asian leads to the public health benefit for a single combination vaccine.

Speaker Change: A single visit and vaccination creates a convenience that we believe will translate into improved explanation rates, especially in older adults who are most at risk.

Speaker Change: <unk> is well recognized.

John Joseph Trizzino: Sanofi is a well-recognized leader in influenza vaccines, and this collaboration agreement creates the opportunity for a COVID-influenza combination vaccine with their existing licensed product. In parallel with preparing for Sanofi's 25 commercialization activities, for the upcoming 24-25 season, we intend to support our key markets of the U.S., Europe, and U.K. but to do so in an increasingly streamlined Recently, both WHO and EMA recommended the use of a monovalent JN1 lineage COVID-19 vaccine.

Speaker Change: <unk> is the well recognized leader in influenza vaccines and this collaboration agreement creates the opportunity for Covid influenza combination vaccine with their existing license product.

Speaker Change: In parallel with preparing for <unk> 25 commercialization activities.

Speaker Change: For the upcoming $2004 25 season, we intend to support our key markets of the U S Europe, and UK, but to do so in an increasingly streamlined targeted and cost efficient manner. During our last season commercializing on our own.

Speaker Change: Recently, both <unk> and EMA recommended the use of our monovalent J N. One lineage COVID-19 vaccine.

John Joseph Trizzino: Novavax plans to be ready to deliver our JN1 protein-based vaccine globally this fall, and we have been developing and manufacturing this vaccine candidate as we anticipate the VRBPAC meeting for U.S. strain selection on June 5th. Please turn to slide nine.

Speaker Change: <unk> plans to be ready to deliver RJ and wind back protein based vaccine globally. This fall and we have been developing and manufacturing. This vaccine candidate as we anticipate the <unk> meeting for U S strain selection on June 5th.

Speaker Change: Please turn to slide nine.

John Joseph Trizzino: In the U.S., we intend to build upon our efforts from the 23 season by offering our vaccine in a more competitive single-dose pre-filled syringe presentation. And we intend to have the product at distribution centers in the US no later than mid-August and ready for the season start in early September, pending FDA release. We expect that the CDC and competitors will do preseason disease awareness campaigns to drive vaccination rates, and we will focus our efforts on building upon our increased healthcare provider awareness of Novavax, which we achieved last season, and we intend to focus our marketing efforts and investment on the retail and 60-plus age group, where we foresee the highest potential for conversion to Novavax's vaccine, given their historically higher vaccination rate. In retail, we are having encouraging discussions which increase our optimism that we will have improved retail access for the season.

Speaker Change: In the U S. We intend to build upon our efforts from the 23 season by offering our vaccine and a more competitive single dose pre filled syringe presentation, and we intend to have products at distribution centers in the U S. No later than mid August and ready for the season store.

In early September pending FDA release.

Speaker Change: We expect that the CDC and competitors will do preseason disease awareness campaigns to drive vaccination rates and we will focus our efforts on building upon our increased health care provider awareness of Novavax, which we achieved last season, and we intend to focus our marketing efforts and investment on the <unk>.

Speaker Change: Retail in 60, plus age group, where we foresee the highest potential for conversion to novavax vaccine given their historically higher vaccination rates.

Speaker Change: In retail we are having encouraging discussions which increase our optimism that we will have improved retail access for the season.

John Joseph Trizzino: As John mentioned, we have completed the submission of our BLA. While we are pleased with this progress, we have decided, in consultation with the FDA, to seek emergency use authorization for our updated vaccine targeting JN1 in order to be available by early September at the start of the season in a pre-filled syringe. This pathway has been mapped out together with the FDA to enable an expedited review time frame and a more straightforward review process.

As John mentioned, we have completed the submission of our BLA. While we are pleased with this progress we have decided in consultation with the FDA to seek emergency use authorization for our updated vaccine targeting J N. One in order to be available by early September at the start of the season.

Speaker Change: In a pre filled syringe.

Speaker Change: This pathway has been mapped out together with the FDA to enable an expedited review timeframe and a more straightforward review process.

John Joseph Trizzino: This effort will occur in parallel with the BLA review process with the goal of having the potential for full BLA approval sometime this year. Though the BLA is indeed important, we intend to achieve full BLA approval. The most important factors for a successful campaign are a timely launch at the beginning of the season, broad availability in retail, high levels of awareness, which we already have from last year, and a competitive product presentation and a pre-filled syringe. We believe we can more effectively achieve these parameters this year by choosing the EUA option in parallel to the BLA pathway. Please turn to slide 10.

Speaker Change: This effort will occur in parallel with the BLA review process with the goal of having the potential for a full BLA approval sometime this year.

Speaker Change: Okay.

Speaker Change: So the BLA is indeed important we intend to achieve BLA approval. The most important factors for successful campaign, alright timely launch at the beginning of the season.

Speaker Change: Broad availability and retail.

Speaker Change: High levels of awareness, which we already have from last year and a competitive product presentation in a pre filled syringe.

Speaker Change: We believe we can more effectively achieve these parameters this year by choosing the EUA option in parallel to the BLA pathway.

Speaker Change: Please turn to slide 10.

Speaker Change: Yeah.

John Joseph Trizzino: With our Pandemic Era APA complete in Europe, we are entering the commercial and tender market for the first time in the region and are prioritizing our goal of timely delivery of an updated COVID-19 vaccine in several key European countries. In our major APA markets in Australia, New Zealand, and Canada, we are seeing more formal, non-pandemic consumer demand, and we are seeking to optimize the value of these contracts while doing what is in the best interest of public health for these customers.

With our pandemic era API complete in Europe, we are entering a commercial and tender market for the first time in the region and are prioritizing our goal of timely delivery of an updated COVID-19 vaccine and several key European countries.

Speaker Change: And our major markets in Australia, New Zealand and Canada, we are seeing a more formal non pandemic consumer demand.

Speaker Change: Patterns and we are seeking to optimize the value of these contracts while doing what is in the best interest of public health for these customers.

John Joseph Trizzino: We are in discussions regarding potential adjustments to dose volumes, pricing per dose, and timing of delivery schedules that should better reflect market demand. And where we can, we are seeking cash prepayment in exchange for moving to future delivery of these products. Due to significant reductions in demand since the pandemic, awaiting regulatory approvals, and ongoing contract renegotiations, we are lowering total revenue guidance for 2024.

Speaker Change: We are in discussions regarding potential adjustments to those volumes.

Speaker Change: Pricing for dose and timing of delivery schedules that should better reflect market demand.

Speaker Change: And where we can we are seeking cash prepayment in exchange for moving to future delivery of doses.

Speaker Change: Due to significant reductions in demand since the pandemic awaiting regulatory approvals and ongoing contract renegotiations, we are lowering total revenue guidance for 2024.

John Joseph Trizzino: Jim will discuss guidance on revenue and expenses in more detail shortly. Though we have remaining value on our APAs and intend to optimize the value where we can, over the next two to three years, we are moving from a pandemic-based APA period toward a fully normalized vaccine market. We look forward to working with our new partner to optimize our commercial opportunities. Now, to discuss our combination and influenza vaccines and other key R&D updates, I want to hand the call to Filip. Thanks, John. Please turn to slide 12.

Speaker Change: Jim will discuss guidance on revenue and expenses in more detail shortly.

Speaker Change: Though we have remaining value on our Apis and intend to optimize the value where we can over the next two to three years, we are moving from a pandemic based.

Speaker Change: A period and toward a fully normalized vaccine market.

Speaker Change: We look forward to working with our new partner to optimize our commercial opportunity.

Fill Up: Now to discuss our combination and influenza vaccines and other key R&D updates I want to hand, the call to fill up.

Fillip: Thanks, John Please turn to slide 12.

Filip Dubovsky: Today, I want to cover several topics. First, I want to share data on our JN1 candidate before I touch base on our revised KICC and influenza phase 3 plans. Then, I want to show you some preclinical data on our optimized RZ vaccine candidate that we evaluated for future development. Finally, I want to introduce you to two innovative expansions of our technology, mucosal vaccination, and the development of a novel nanoparticle format, which we are exploring as an avian H5N1 pandemic vaccine. As John mentioned, these innovations are examples of work we've been doing over the past year to generate additional value from our technology platform. Please turn to slides 13 and 14.

Fillip: Today I want to cover several topics first I want to share data on our Jay and one candidate before I touch base on a revised kick in influenza phase III plans.

Fill Up: I don't want to show you some preclinical data on our optimize RSV vaccine candidate and were evaluated for future development.

Fill Up: Finally, I want to introduce you to two innovative expansions of our technology mucosal vaccination and the development of our novel Nanoparticle format, which we're exploring is an avian H five N one pandemic vaccine.

As John mentioned these innovations are examples of work we've been doing over the past year to generate additional value from our technology platform.

Fill Up: Please turn to slide 13 and 14.

Filip Dubovsky: The World Health Organization and EMA have recommended JN1 lineage vaccines for the 24-25 season. This is a variant we have previously advanced for commercial development. Here I'm showing neutralizing responses in non-human primates that were vaccinated with the XVB15 vaccine and boosted with a single dose of JN1. On the left-hand side, you can see the responses to the JN1 variants were low prior to boosting. On the right-hand side, the responses to JN1 and JN1 drift variants are robust, following a boost.

Fill Up: The World Health organization in EMEA have recommended that Jane one lineage vaccines for the 'twenty four 'twenty five season.

Fill Up: This is a variant we've previously advance into commercial development.

Fill Up: Here I'm showing neutralizing responses in nonhuman primates, there were vaccinated with SBB, Juan Pablo vaccine and boosted with a single dose of Jan one.

Fill Up: On the left hand side, you can see the responses to Jan one variance where low prior to boosting.

Fill Up: On the right hand side, the responses to Jan one and genuine growth variance are robust following a boost.

Filip Dubovsky: These data provide us with confidence that our vaccine has utility against the currently circulating strains, such as KP2, as well as potentially future-proofing our vaccine against other variants that evolved from JN1. Our strain selection will be confirmed by VRBPAC on June 5th, and we plan on submitting our strain change filing shortly after that. Okay, let's go to slides 15 and 16.

Fill Up: These data provide us confidence our vaccine is utility against the currently circulating strains such as <unk> as well as potentially future proofing, our vaccine against other bearings that evolved from Jade one.

Fill Up: The strength function will be confirmed by of our pack on June 5th and we plan on submitting our spring change filing shortly after that.

Speaker Change: Okay, Let's go to slide 15 and 16.

Filip Dubovsky: We've modified our plans for the upcoming phase three study to include the valuation of a standalone seasonal influenza vaccine in addition to our COVID influenza combination vaccine in adults greater than 60 years of age. As depicted on the right-hand side of the slide, this is planned to be an immunologic non-inferiority superiority study with our vaccine compared to age-recommended licensed comparators. Although we have previously received supportive regulatory guidance for the stand-alone influenza program, we will reconfirm the acceptability of this design for the influenza portion of the study. The study is still on track for the second half of this year, and data for decision-making will be available in mid-2025. Okay, let's move to slides 17 and 18.

Speaker Change: We've modified our plans for the upcoming Phase III study to include the evaluation of a standalone seasonal influenza vaccine. In addition to our Covid influence a combination vaccine in adults greater than six years of age.

As depicted on the right hand side of this slide this is planned to be immunologic non inferiority superiority study with our vaccine compared to age recommended licensed comparator.

Speaker Change: Although we have previously received supportive regulatory guidance for the Standalone influenza program, we will reconfirm the acceptability of this design for the flu influence a portion of the study.

Speaker Change: The study is still on track for the second half of this year and added for decision, making will be available in mid 'twenty five.

Speaker Change: Okay, let's move to slide 17 and 18.

Filip Dubovsky: We have optimized our RCF nanoparticle vaccine antigen with the specific goal of maximizing the breadth of the neutralizing response. Here, I'm showing the immune responses in mice vaccinated with our RSV antigen with matrix compared to the licensed GSK vaccine with the ASL1E adjuvant. We used comparative binning against a panel of monoclonal antibodies known to bind neutralizing epitopes, including sites 0, 2, 4, 5, and P27.

Speaker Change: We have optimized our RSV F nanoparticle vaccine antigen with the specific goal of maximizing the breath of neutralizing responses.

Speaker Change: Here I'm showing the immune responses in mice vaccinated with our RSV antigen with matrix compared to the license GSK vaccine with the ASO one E adjuvant.

Speaker Change: We used competitive bidding against a panel of monoclonal antibodies, none to bind neutralizing epitopes, including side 0245, and <unk> 27.

Filip Dubovsky: On the left-hand side are bidding results for our antigen, and on the right-hand side are bidding results for the GSK antigen. In both cases, a favorable breadth of response is demonstrated for our vaccine. It's interesting to note in the right-hand panel that the P27 neutralizing sequence is not present on the GSK antigen.

Speaker Change: On the left hand side, our bidding results on our antigen and the right hand side, our bidding results on the GSK antigen in both cases, a favorable breadth of response as demonstrated for our vaccine.

Speaker Change: It's interesting to note on the right hand panel the <unk> 27, neutralizing sequences are present on the GSK antigen.

Filip Dubovsky: Okay, let's go to slide 19 and look at RSV neutralizing responses. Here I'm showing you responses for RZA on the left and RZB on the right. We observed a six-fold increase for RSV-A compared to the licensed GSK vaccine, which represents a difference of tighter from 3,700 to over 23,000. And for RSVB, a tire difference from 440 to over 1,500.

Speaker Change: Okay, Let's go to slide 19, and look at RSV neutralizing responses.

Speaker Change: Here I'm, showing you'd responses for our Z on the left and RSV B on the right. We have delivered six fold increase for RSV, a compared to the license GSK vaccine, which references a difference of tighter from 3700 to over 23000.

Speaker Change: And for RSV, a tighter difference from 440 to over 1500.

Filip Dubovsky: This antigen can be used as a standalone vaccine or as part of a broader combination vaccine program. Based on our previous clinical experience with a related construct, we are evaluating whether additional preclinical or toxicology studies are required. Partnering discussions for this antigen are ongoing. Okay, please shift to slides 20 and 21 to look at our early progress in expanding our core technology into mucosal vaccination. We've developed an intranasal formulation that includes our PSAD nanoparticle antigen and our matrix imatchments.

This antigen can be used as a standalone vaccine or as part of a broader combination vaccine program.

Based on our previous clinical experience with a related construct we are evaluating whether additional preclinical toxicology studies are required partnering.

Speaker Change: Partnering discussions for this amgen are ongoing.

Speaker Change: Okay. Please shifts to slide 2020, one to look at our early progress in expanding our core technology into mucosal vaccinations.

Speaker Change: We've developed an intranasal formulation that includes our PSAT nanoparticle antigen with our matrix M adjuvant.

Filip Dubovsky: In this experiment, we explored this technology with our COVID antigen. We primed these mice with a bivalent vaccine containing prototype NbA5 and boosted them with intramuscular or intranasal HBV15 vaccine formulations. On the far left side, you can see the initial priming sequence induces no XGB1-5 specific mucosal IgA antibody. In the middle, after intramuscular boosting, negligible mucosal IgA was detected.

Speaker Change: In this experiment, we explore the technology with our Covid antigen, we prime these mice with bivalent vaccine containing prototype NBA, five and boosted them with intramuscular or intranasal SUV, one five vaccine formulations.

Speaker Change: On the far left side you can see the initial priming sequence induces no excuse me one five specific coastal Iga antibody.

Speaker Change: In the middle after interim muscular boosting negligible mucosal Iga was detected however, when the MISO boosted with intranasal vaccine there was a very large iga signal.

Filip Dubovsky: However, when the mice were boosted with an intranasal vaccine, there was a very large IgA signal. This is important because mucosal IgA is the first line of defense against respiratory viruses and has implications for prevention of infection and potentially impacting transmission. So let's move to slide 22 for additional characterization of the immune response. Here we're displaying HPV1.5 newt responses in the blood on the left and mucosal neutralizing responses on the right. On the left-hand side, unsurprisingly, there was little evidence of a serum HDB1-5 neutralizing response after priming with the bivalent BA5 vaccine.

Speaker Change: This is important because mucosal iga as a first line of defense against respiratory viruses and has implications for prevention of infection and potentially impacting transmission.

Speaker Change: So let's move to slide 22 for additional characterization of immune response.

Here, we are displaying excuse me one five responses in the blood on the left and mucosal neutralizing responses on the right.

Speaker Change: On the left hand side Unsurprisingly, there was little evidence of serum excuse me on Pi neutralizing response after priming with bivalent vaccine.

Filip Dubovsky: However, XGBE1.5 responses were increased 27-fold with intramuscular boosting, and surprisingly, intranasal vaccination boosted the central responses over 10-fold. When we looked at mucosal newts on the right-hand panel, once again, there was no response after priming, but a profound response was seen after intranasal boosting, supporting the hypothesis this approach may have utility in blocking infections. We believe the small rise in mucosal neutralizing responses following intramuscular boosting represents antibody transmigrating from the blood compartment.

Speaker Change: However, it should be one five responses were increased 27 fold with intramuscular boosting and surprisingly intranasal vaccination boosted the central responses over tenfold.

Speaker Change: When we looked at mucosal news on the right hand panel. Once again there was no response after priming, but a profound response was seen after intranasal boosting supporting the hypothesis. This approach may have utility in blocking infections.

We believe the small rise in mucosal neutralizing responses following intramuscular or boosting represents antibody translate from blood compartment.

Filip Dubovsky: These results are being prepared for publication, and we are evaluating this approach with different antigens in different preclinical models. If these findings are validated in the clinic, this opens the door to needle-free vaccination and the potential to block infection and potentially transmission, specifically for respiratory and gastrointestinal infections whose point of entry is through the mucosa. Okay, please turn to slides 23 and 24 to look at the development of matrix as a core for a new class of nanoparticles. We've identified transmembrane domains that serve as molecular anchors and can link antigens directly to the matrix. The left-hand image shows a model and an electron photomicrograph of a classic PSAD nanoparticle.

Speaker Change: These results are being prepared for publication and we are about this approach with different <unk> and different preclinical models.

Findings are validated in the clinic. This opens the door for a needle free vaccination and the potential to block infection and potentially transmission, specifically for respiratory and gastro intestinal infections, whose point of entry is through the mucosa.

Speaker Change: Okay. Please turn to slide 'twenty three 'twenty four to look at the development of matrix as a core for a new class of nanoparticles.

Speaker Change: We've identified transplant bring domains that serve as a molecular anchors and can link antigens directly into the matrix adjuvant.

Speaker Change: On the left hand image shows a model and an electron photomacrograph, but classic PSAT nanoparticle you.

Filip Dubovsky: You can see the antigens decorating the polysorbate core. On the right-hand side, we have the novel matrix nanoparticle, where the antigens shown in blue are anchored directly into the vertices of the matrix structure. This model is confirmed by the EM image on the right. This new format is larger than the PSAD nanoparticle, and we hypothesize this may facilitate antigen recognition and phagocytosis.

Speaker Change: You can see the amgen's decorating the polysorbate core.

Speaker Change: On the right hand side, we had the novel matrix nanoparticle or the antigens shown in blue are anchor directly into the vertices as a matrix structure. This model is confirmed by the EMA image on the right.

Speaker Change: This new format is larger than the PSAT nanoparticle, and we hypothesize as to make facilitate antigen recognition and phagocytosis.

Filip Dubovsky: This also increases antigen density with up to 40 to 60 copies per nanoparticle, which may increase activation of antigen processing cells. And finally, linking the antigen and adjuvant assures co-delivery into a single endosome in antigen processing cells and may increase T cell responses. And this format is amenable to intramuscular and intranasal administration. Okay, let's go to slide 25 and look how this performs in non-human primates. In this experiment, we used a highly pathogenic avian H5N1-2344B antigen, specifically American Wigeon, as a model antigen.

Speaker Change: So increase the antigen density with up to 40% to 60 copies per nanoparticle, which may increase activation of antigen processing cells.

Speaker Change: And finally linking to antigen in adjuvant assures co delivery into a single NSO and Amgen processing cells and May increase T cell responses and its format is amount of bulk to intramuscular and intranasal administration.

Speaker Change: Okay, Let's go to slide 25 in Macau This performance in non human primates.

Speaker Change: In this experiment, we used a highly pathogenic avian H five N 12344, B antigen, specifically American which is our model antigen.

Filip Dubovsky: This is the influenza clade that's devastating wild and domestic birds globally and has spread into our mammalian food chain. Here, we primed rhesus macaques with our quadrivalent seasonal vaccine to more closely mimic the immunologic background in humans. We then boosted them with a single dose of H5N1 matrix nanoparticle vaccine intramuscularly or intranasally and measured neutralizing responses. On the left-hand side, a single 60-microgram intramuscular dose boosts H5N1 immune responses to a very high level in all animals.

Speaker Change: This is the influence of clade devastating wild in domestic birds globally and are spread into our mammalian food chain.

Speaker Change: Here, we're prime rhesus macaques with our quadrivalent seasonal vaccine to more closely mimic the analogic background in humans.

Speaker Change: We then boosted them with a single dose of H five N. One matrix nanoparticle vaccine intramuscularly or inter nasally and measured neutralizing responses.

Speaker Change: On the left hand side, a single 60, microgram intramuscular dose boost H five N. One you'd responses to a very high level and all animals and the right you can see a single intranasal dose resulted in 100% conversion was the geometric mean titer of $2 63.

Filip Dubovsky: On the right, you can see that a single intranasal dose results in 100% seroconversion with a geometric mean titer of 263. I've marked a level of 1 to 40, which has been used in the literature as a level relevant for protection.

Speaker Change: I have a market level, one to 40, which has been used in the literature as level relevant for protection.

Filip Dubovsky: A single-dose pandemic influenza vaccination has been elusive, so these results caught our attention. If these results are validated in the clinic, they could lead to a game-changing approach because a single-dose vaccination in a pandemic setting would be much easier to deploy and could have a huge public health impact. We're in discussion with government agencies on the best way to advance these candidates into the clinic, so we can evaluate them, and this approach can be validated. Okay, I covered a lot of ground today.

Speaker Change: Single dose pandemic influenza vaccinations has been elusive. So certainly these results caught our attention.

Speaker Change: These results are validated in the clinic it could lead to a game changing approach because the single dose vaccination in a pandemic setting will be much easier to deploy and could have a huge public health impact.

Speaker Change: We're in discussion with government agencies, and the best way to advance these candidates into the clinic.

Speaker Change: So we can evaluate them in this approach can be validated.

Filip Dubovsky: As a summary, we're in commercial production of the JN1 variant vaccine, which has shown good results in preclinical evaluation, and our goal is to have this product available at the beginning of the vaccination season. We have expanded our phase 3 study to include standalone influenza, in addition to our combination vaccine, and the studies are on track to begin in the second half of this year, consistent with this original timeline. We've optimized our RSV construct, and we're evaluating additional work that needs to be done before we decide to advance the candidate into further development.

Speaker Change: Okay I covered a lot of territory today as a summary, when commercial production of Jan one bearing vaccine, which has shown good results in preclinical evaluation and our goal is to have this product available at the beginning of the vaccination season.

Speaker Change: We've expanded our phase III study to include Standalone influenza. In addition to our combination vaccine and the study is on track to begin in the second half of this year.

Speaker Change: <unk> with its original timeline.

Speaker Change: We've optimized our RSV construct.

Speaker Change: Following additional work needs to be done before we decide on advancing the candidate into future development.

Filip Dubovsky: Finally, we've developed two different derivatives of our core technology, the ability to vaccinate intranasally with adjuvanted PSAD nanoparticles, which in preclinical models induce mucosal immune responses while boosting serum neutralizing responses. And finally, we've identified molecular anchors, which can attach antigen directly to the matrix. And in non-human primates prior to the seasonal vaccine, this has resulted in an unprecedented immune response with a single dose of the H5 pandemic vaccine.

Speaker Change: Finally, we developed two different derivatives of our core technology, the ability to vaccinate intranasal Lee with agile added PSAT nanoparticles, which in preclinical models induced mucosal immune response, while boosting serum neutralizing responses and finally, we've identified molecular anchors, which can attach amgen directly onto matrix and in nonhuman primates private the seasonal vaccine.

Speaker Change: This has resulted in unprecedented immune response with a single dose for <unk> pandemic vaccine.

James Kelly: Okay, let me hand it over to Jim. All right. Hey, thank you, Filip.

Speaker Change: Let me hand, it over to Jim.

James Kelly: Hey, Thank you fill up please turn to slides 26 and 27.

James Kelly: Please turn to slides 26 and. We're focused on improving the financial health and performance of Novavax to enable long-term value creation. Today, we announced the strategically important Sanofi Agreement and have removed our going concern disclosure. That evidence is progress. I will now share a few of the key themes for the first quarter of 2024 and a look toward full year 2024 and beyond. For the first quarter of 2024, Novavax recorded total revenue of $94 million and significantly improved our balance sheet profile by reducing current liabilities by $831 million. The Gavi and Fujifilm settlements continue our efforts to address legacy contractual matters.

James Kelly: We're focused on improving the financial health and performance of Novavax to enable long term value creation today, we announced the strategically important Santa fee agreement and have removed our going concern disclosure that evidence this progress.

James Kelly: I will now share a few of the key themes for the first quarter of 2024, and a look towards full year 2024 and beyond.

James Kelly: For the first quarter of 2024, no <unk> recorded total revenue of $94 million and significantly improved our balance sheet profile by reducing current liabilities by $831 million the coffee and Fuji film sentiment continue our efforts to address legacy contractual matters.

James Kelly: As we continue to transform Novavax into a more lean and agile organization, we reduced our Q1 2024 R&D and SG&A by 50% compared to the prior year. As we look to 2024, we are updating our targeted guidance for R&D and SG&A expenses of between $700 and $750 million as we continue to resize our organization. For 2025, Novavax is prepared to initiate an additional cost reduction program to reduce R&D plus SG&A expenses to below $500 million, a portion of which we expect to be reimbursed by Sanofi under today's announced agreement.

James Kelly: As we continue to transform novavax into a more lean and agile organization, we reduced our Q1 2020 for R&D and SG&A by 50% compared to prior year.

James Kelly: As we look to 2024, we are updating our targeted guidance for R&D and SG&A expenses of between 700 and $750 million as we continue to resize our organization.

James Kelly: For 2025, no vaccine prepared to initiate an additional cost reduction program to reduce R&D, plus SG&A expenses to below $500 million.

James Kelly: Portion of which we expect to be reimbursed by Santa fee under today's announced agreement.

James Kelly: We ended the first quarter of 2024 with cash and accounts receivable of $517 million and have over $600 million in potential dose deliveries under our APAs over the next three years. With the Santa Fe agreement announced today, we have approximately $570 million in cash payments for the second quarter of 2024 that further improve our financial position. Please turn to slide 28. Turning to a more detailed view of our first quarter 2024 financial results, where I'll provide commentary with specific focus on revenue, COGS, and combined R&D and SG&A.

James Kelly: We ended the first quarter of 2024 with cash and accounts receivable of $517 million.

James Kelly: And have over $600 million and potential dose deliveries under our EPS over the next three years.

James Kelly: With the Santa fee agreement announced today, we have approximately $570 million in cash payments for the second quarter of 2024 that further improve our financial position.

James Kelly: Please turn to slide 28.

James Kelly: For the first quarter of 2024, we recorded total revenue of $94 million compared to $81 million in the same period of 2023. Our product sales of $82 million in the first quarter of 2024 were primarily related to APA deliveries to Europe and reflect the successful completion of the European APA Agreement. Royalties and other of $12 million for the first quarter of 2024 include license fees and Matrix M reimbursement under our agreements with Takeda and SK Bioscience.

Speaker Change: Turning to a more detailed view of our first quarter 2024 financial results, where I'll provide commentary with specific focus on revenue Cogs and combined R&D and SG&A.

Speaker Change: For the first quarter of 2024, we recorded total revenue of $94 million compared to 81 million same period of 2023.

Speaker Change: Our product sales of $82 million in the first quarter of 2024 were primarily related to the EP deliveries to Europe and reflect the successful successful completion of the European EPA agreement.

Speaker Change: Royalties and other of $12 million for the first quarter of 2024 include license fees and matrix M reimbursement under our agreements with Takeda and SK Biosciences.

James Kelly: Our cost of sales for the first quarter of 2024 was $59 million as compared to $34 million in the same period of 2023. These amounts include $15 million and $25 million, respectively, related to excess, obsolete, or expired inventory, losses on firm purchase commitments, and unutilized manufacturing capacity.

Speaker Change: Our cost of sales for the first quarter of 2024 were $59 million as compared to 34 million in the same period of 2023.

Speaker Change: These periods include $15 million and $25 million, respectively related to excess obsolete or expired inventory losses on firm purchase commitments and unutilized manufacturing capacity.

James Kelly: As previously noted, for the first quarter of 2024, Novavax's R&D plus SG&A of $175 million reflects a 50% and $180 million reduction from the same period in 2020, please turn to slide 29. We're committed to creating a more lean and agile organization to align the company with our market opportunities. To advance that goal, over the past year, we've reduced our workforce by over 30% compared to the first quarter of 2023.

Speaker Change: As previously noted for the first quarter of 2024, no vaccines R&D plus SG&A of $175 million reflects a 50% and $180 million reduction from the same period in 2023.

Speaker Change: Please turn to slide 29.

Speaker Change: We're committed to creating a more lean and agile organization to align the company with our market opportunities to advance that goal over the past year, we've reduced our workforce by over 30% compared to the first quarter of 2023 for.

James Kelly: For 2024, we're updating our targeted combined R&D and SGA expense guidance to $700 to $750 million from our prior stated target of $700 to $800 million as we continue to push to find savings in our cost structure. Novavax is prepared to initiate an additional cost reduction program to reduce 2025 R&D and SGA expenses to below $500 million, as noted, a portion of which is expected to be reimbursed by Sanofi under the agreement.

Speaker Change: For 2024, we're updating our targeted combined R&D and SG&A expense guidance to $700 million to $750 million from our prior stated target of $7 million to $800 million as we continue to push for to find savings in our cost structure.

Speaker Change: No vaccine prepared to initiate an additional cost reduction program to reduce 2025, R&D and SG&A expenses to below 500 million as noted a portion of which is expected to be reimbursed by Santa fee under the agreement.

James Kelly: In addition, we're prioritizing improvements to long-term supply chain efficiency, including exploring the sale of our Czech Republic manufacturing facility. Please turn to slide 30, where I'd like to discuss progress on our balance sheet and liability management. Since December 31st, 2022, we have reduced the company's current liabilities by $1.7 billion, including an additional $831 million reduction in the first quarter of 2024, primarily driven by the Gavi and Fuji settlements. Please turn to slide 31.

Speaker Change: In addition, we're prioritizing improvements to long term supply chain efficiency, including exploring the sale of our Czech Republic manufacturing facility.

Speaker Change: Please turn to slide 30, where I'd like to discuss progress on our balance sheet and liability management.

Speaker Change: Yeah.

Speaker Change: Since December 31, 2022, we have reduced the company's current liabilities by $1 7 billion, including an additional $831 million reduction in the first quarter of 2024, primarily driven by the <unk> and Fuji settlements.

Speaker Change: Please turn to slide 31.

Speaker Change: Yeah.

James Kelly: Now turning to financial guidance with an emphasis on our combined revenue and initial Santa Fe payments that total $970 million to $1,170,000,000. This reflects a material improvement to our sources of cash flow for 2024, beginning with the $570 million of initial payments under the Sanofi Agreement. They'll be received in the second quarter of 2024 and reflect just the beginning of a potential multi-billion dollar economics across upfronts, equity investments, milestones, and royalties under this agreement.

Speaker Change: Now turning to financial guidance with an emphasis on our combined revenue and initial Santa fee payments that total $970 million to $1 billion $170 million.

Speaker Change: This reflects a material improvement to our sources of cash flow for 2024 <unk>.

Speaker Change: Beginning with the $570 million of initial payments under the Sanofi agreement there'll be received in the second quarter of 2024 and reflect just the beginning of a potential multibillion.

Speaker Change: Economics across upfront equity investments milestones and royalties under this agreement.

James Kelly: For 2024, we are updating our total revenue and now expect to achieve total revenue of $400 million to $600 million. Our projected total revenue includes $150 to $250 million of APA sales based on expected dose delivery schedules and non-APA revenue of $250 to $350 million for a combination of our commercial market product sales plus royalties and other revenues from our partner-related activities. The $400 million reduction to our full year 2024 expected product sales guidance reflects the following: a hundred million from the Canada HPA as we await the Canadian order for 2024.

Speaker Change: For 2024, we are updating our total revenue and now expect to achieve total revenue of $400 million to $600 million.

Speaker Change: Our projected total revenue includes a $150 million to $250 million of AP sales based on expected delivery schedules.

Speaker Change: Non AP revenue of $250 million to $350 million for a combination of our commercial market product sales plus royalties and other revenues from our partner related activities.

Speaker Change: The $400 million reduction to our full year 2020 for expected product sales guidance reflects the following.

Speaker Change: $100 million from the Canada <unk>.

Speaker Change: As we await the Canadian order for 2024.

Speaker Change: Our intent to add this back when we have clarity on this order.

James Kelly: It's our intent to add this back when we have clarity on this order. 250 related to Australia, New Zealand, and Israel APAs as we work with those countries on revised dose delivery schedules for later periods and, where possible, are seeking potential prepayments in 2024. Importantly, these updates reflect our goal of working in partnership with these key customers to adjust dose delivery schedules and volumes to better meet current demand while optimizing the remaining contract value through their completion.

Speaker Change: 250 related to Australia, New Zealand, and Israel Apa's as we work with those country unrevised dose delivery schedules for later periods and where possible our seeking potential repayment prepayments in 2024 <unk>.

Speaker Change: Importantly, these updates reflect our goal of working in partnership with these key customers to adjust dose delivery schedules and volumes to better meet current demand, while optimizing the remaining contract value through their completion.

James Kelly: And finally, $50 million from EU commercial sales as we reduce commercial investments in select markets for the 2024-25 vaccination season post the Sanofi agreement. We look forward to sharing additional updates as we seek to improve Novavax's financial performance, cost structure, and strength to deliver shareholder value. With that, I'd like to turn the call back over to John for some closing remarks. Thank you, Jim.

Speaker Change: And finally $50 million from EU commercial sales as we reduced commercial investments in select markets for the 'twenty 'twenty four 'twenty five vaccination season post the Santa fee agreement.

Speaker Change: Sure.

Speaker Change: We look forward to sharing additional updates as we seek to improve <unk> financial performance cost structure and strength to deliver shareholder value with that I'd like to turn the call back over to John for some closing remarks.

John Charles Jacobs: And thank you, everyone, for joining us today. Before we take your questions, I would like to reiterate our key priorities for the remainder of this year. Priority one, prioritizing the successful transition of our new partnership with Sanofi. Priority 2, continuing to expand and diversify our organic opportunities and create additional value via our technology platform. Priority three, preparing to initiate an additional cost reduction program to reduce 2025 R&D plus SG&A expenses net of Sanofi cost reimbursement to below $500 million, and Priority 4, delivering our updated product for the 24-25 fall vaccination season. I would now like to turn the call over to our operator for Q&A. Operator?

John Charles Jacobs: Thank you Jim and thank you everyone for joining us today before we take your questions I would like to reiterate our key priorities for the remainder of this year.

John Charles Jacobs: Priority one prioritizing the successful transition of our new partnership with Sanofi.

John Charles Jacobs: Priority, two continuing to expand and diversify our organic opportunities and create additional value via our technology platform.

John Charles Jacobs: Priority three preparing to initiate an additional cost reduction program to reduce 2025, R&D plus SG&A expenses net of Santa fee cost reimbursement to below $500 million.

John Charles Jacobs: And priority for delivering our updated product for the 'twenty four 'twenty five fall vaccination season.

Speaker Change: I would now like to turn the call over to our operator for Q&A operator.

Operator: Thank you. We'll now begin the question and answer session. To ask a question, you may press star, then the number one on your touchtone.

Speaker Change: Thank you we will now begin the question and answer session to ask a question you May Press Star then the number one on your Touchtone phone if youre using a speakerphone please pick up.

Operator: If you're using a speakerphone, please pick up your headset before pressing any key. To withdraw your question, please press star- One moment, please, for your first question. Your first question comes from Roger Song from Jeffreys, please go ahead. Thank you for taking our question. Congratulations on the no-fee deal. Thank you, Roger. Thank you, John.

Speaker Change: With me for pressing any keys.

Speaker Change: Your question. Please press star two.

Speaker Change: Please for your first question.

Roger Song: A couple of questions from us, maybe starting with the Sanofi deal. Can you give us a little bit of clarity around the reimbursement for the co-development, commercial, and regulatory costs, particularly how much you have already given us the guidance for 2024 and 2025, and how do you think about the cost of moving forward after 2025? Thank you. Roger, good, good question. Roger, I'll have Jim Kelly address that, but we believe the deal affords us hundreds of millions of dollars in potential cost synergy. But Jim, why don't you take the question?

Roger Song: Your first question comes from Roger song from Jefferies. Please go ahead.

Roger Song: Thank you for taking my question congrats for the Sanofi deal.

Roger Song: Thank you Roger.

Roger Song: Thank you John.

Roger Song: Questions may be stopped on the Sanofi deal can you give us a little bit.

Roger Song: Clarity around the reimbursement for the call develop non commercial.

Roger Song: Cause particularly.

Speaker Change: <unk> you already gave us the guidance for <unk>.

Speaker Change: Fine thanks.

Speaker Change: About the cost of moving forward. After 2025. Thank you Roger good good question, Roger I'll have Jim Kelly address that but we believe the deal affords us hundreds of millions of dollars in potential cost synergy, but Jim why don't you take the question, Yes, certainly in thank you Roger the categories of cost reimbursement under this agreement.

James Kelly: Yes, certainly. And thank you, Roger. You know, the categories of cost reimbursement under this agreement include R&D activities that Novavax may do under the joint budget to support the COVID-19 program from 2025 forward. And that includes, for example, the pediatric studies that are ongoing and select medical affairs activities. An additional category of reimbursement will include activities related to the technology transfer. This is going to be exceptionally important as we support Sanofi as they ramp up their commercial capabilities. In addition to that, we are entering into supply agreements for both COVID-19 supply in the coming years, plus specifically for matrix and adjuvant.

Speaker Change: <unk>.

James Kelly: R&D activities that Novavax me.

James Kelly: Due under the joint budget to support the COVID-19.

James Kelly: Program from 2025 forward meant that includes for example, the.

James Kelly: Pediatric studies that are ongoing and select medical affair activities.

James Kelly: An additional category of reimbursement will include activities related to the technology transfer. This is going to be exceptionally important as we support Santa Fe as they ramp up their commercial capabilities.

James Kelly: In addition to that we are entering into supply agreements for both COVID-19 supply in the coming years, plus for specifically matrix M adjuvant and so we're eligible for reimbursement across all of those.

James Kelly: And so we're eligible for reimbursement across all those. As I look specifically, and I'll put the supply on the side, and I look to potential reimbursement in 2025 with respect to R&D activities and TRIC transfer, we believe that the reimbursement amount could be up to 100 million. And so think 75 to 100 million.

James Kelly: As I look specifically and I'll put the supply to the side and I look to potential reimbursement in 2025.

James Kelly: With respect to R&D activities and tech transfer we believe.

James Kelly: That reimbursement amount could be up to $100 million.

James Kelly: And then, as I described driving our R&D plus SG&A to below 500, you then subtract that reimbursement. And now we're talking about, hey, we're targeting 400 million or so on a go forward basis. You're watching the continued evolution of our cost structure. You know, we're nimble.

James Kelly: And so think $75 million to $100 million and then as I described driving our R&D plus SG&A to below 500, <unk>, then subtract that reimbursement and now we're talking about hey, we're targeting $400 million or so on a go forward basis Youre watching the continued evolution of our cost.

James Kelly: Structure, you know we're nimble we know we act with urgency this is our path.

James Kelly: We know we must act with urgency. This is our path. Excellent. That's very, very helpful.

Excellent.

Speaker Change: Helpful. Thank you.

James Kelly: And then in terms of the milestone payment, I see you have laid out the milestone payment for the COVID side. Just curious about the COVID flu combination side, how much near-term milestone we should look at; all those are back-ended milestones. Go ahead, Jim.

Speaker Change: And then in terms of the milestone payment.

Speaker Change: See you lay out the milestone payment quarter Colgate side, just curious about the cold a little combination of by how much.

Speaker Change: So we should look at all of those are back ended.

Speaker Change: Milestone.

James Kelly: Go ahead Jim.

James Kelly: Yeah, listen, we're exceptionally excited by the potential for Sanofi to advance the combination of our COVID vaccine along with their market-leading flu vaccine. And, you know, those milestones, the $350 million, are, in fact, across both product development and approval milestones. So, you know, non-sales-based but rather related to, you know, the near-term development and approval of those programs. We're not offering additional detail at this time, but it is certainly a priority of the agreement. And Roger, it's John.

James Kelly: Yeah.

Listen we're exceptionally excited by the potential for Santa Fe to advance the combination of our Covid vaccine along with their market, leading flu vaccine and those milestones the $350 million are in fact across both product development and.

James Kelly: And approval milestones so.

James Kelly: Non sales space, but rather related to in the near term development and approval of those programs are not offering additional detail at this time.

John Charles Jacobs: Just to build upon Jim's response to your good question, I want to make sure that everyone understands that this deal is not a $1.2 or $1.3 billion deal. This is a multi-billion-dollar deal. The $1.3 billion represents the initial upfront payment, the $70 million equity investment in the company, and the near-term milestones associated with our activities related to Nuvaxavid and Sanofi developing their own combo vaccines. But importantly, the majority of what we see as the future value of this deal, according to our estimates, comes from the anticipated royalties that will be ongoing from Sanofi's ability to sell our COVID vaccine and their own combination or combination vaccines, plural, using our new vaxavid.

Speaker Change: But it is certainly a priority of fee agreement and Roger its John just to build upon Jim's response to your to your good question. Yeah, I wanted to make sure that everyone understands that this deal is not a 1.2 of $1 3 billion dollar deal. This is a multibillion dollar deal the $1 3 billion represents the initial upfront the.

Roger Song: $70 million equity investment in the company in the near term milestones associated with our activities related to new Baxter, <unk> and Santa Fe developing their own combo vaccine, but.

Roger Song: But importantly, the majority of what we see as the future value of this deal. According to our estimates come from the anticipated royalties that will be ongoing from Santa feasibility to sell our COVID-19 vaccine and their own combination or combination vaccines plural using our new <unk> and through the deal they have the.

John Charles Jacobs: And through the deal, they have the opportunity to develop their own flu COVID combination and other combination products, including additional antigens, each of which we get royalties for. And in addition, there's another component beyond that, which is their access to our Matrix M adjuvant platform, which allows them to develop multiple products using Matrix M. Each of the products they may develop using our adjuvant technology platform could have up to $200 million of potential one-time milestones, as well as ongoing royalties, a flat royalty rate for years to come.

Roger Song: <unk> to develop their own flu COVID-19 combination, but also other combination products, including additional antigens each of which we get royalties for it.

Roger Song: And in addition, there's another component beyond that which is their access to our matrix M. Adjuvant platform, which allows them to develop multiple products using matrix M. Each of the products. They may develop using our adjuvant technology platform has up to $200 million of potential one time milestones as well as ongoing royalties.

Roger Song: Flat royalty rate for years to come when you look at the entirety of the agreement between the upfront payments and the near term milestones, which are the $1 3 billion that we noted including the equity investment and then you consider the immensity of the potential royalties when we partner with the power of a company like Santa fee, that's a world leader in.

John Charles Jacobs: When you look at the entirety of the agreement between the upfront payments and the near-term milestones, which are the $1.3 billion that we noted, including the equity investment, and then you consider the immensity of the potential royalties when we partner with the power of a company like Sanofi that's a world leader in vaccine development and commercialization with a leading flu franchise, plus what they could do with our Matrix M over time, we truly So I want to make sure people don't misunderstand the potential of this partnership and what it might do for the future of Novavax and for global public health. Excellent That's very helpful.

Roger Song: Maxine development and commercialization with our leading flu franchise.

Roger Song: What they could do with our matrix M overtime. We truly believe this is a multibillion dollar opportunity. So I want to make sure people don't misunderstand the potential of this partnership and what it might do for the future of Novavax and for global public health.

Roger Song: Yeah, I understand the milestone payment for the COVID combination is contingent upon development approval, not sales milestone payment. Okay. And then maybe just lastly, for the existing APA, understanding you are reducing the APA to 600 million, just want to confirm that's already post-negotiation with different parties of your partners compared to the last time, around a billion dollars. And then, and the second part of the question is for the outstanding APA, given the partnership with Sanofi, who is gonna book these sales? These sales, or Novavax will only get a royalty from the EPA.

Roger Song: Excellent.

Speaker Change: Well, yeah, I understand the milestone payment for the Colgate combinations.

Speaker Change: And Tianjin upon the development approval.

Approval not that Myles.

Speaker Change: Stone payment okay.

Speaker Change: And then maybe just lastly for the existing HCA understanding you are reducing the <unk> $600 million just want to confirm that's already post the negotiation with that deferred party of your partners are.

Speaker Change: Compared to the last time.

Speaker Change: A billion dollar and then.

Speaker Change: Second part of the question is that for the outstanding HCA given.

Speaker Change: Partnership with Sanofi.

Speaker Change: But they need.

Speaker Change: These sales are and all of that as well, let me get that ROIC from HCA.

Speaker Change: Yeah.

Roger Song: All right, so I'm looking to John Trizzino to maybe talk a little bit about the status of our APAs, but I'll just kind of reiterate, kind of bridging what the pieces to the change in our revenue guidance are, emphasizing that specifically the $350 million related to APAs, you know, we're continuing active dialogue with these APAs, and they have been great partners. The pieces there were We took $100 million related to Canada, and we've placed it to the side while we await that order.

Speaker Change: Alright.

Speaker Change: Looking to add John to zero, maybe talk a little bit about the status of our Apis, but I'll just kind of reiterate kind of bridging what the pieces to the change in.

Speaker Change: Our revenue guidance are emphasizing that specifically the $350 million related to Epa's, we're continuing active dialogue with DCP as have been great partners.

Roger Song: It just seemed prudent at this time to not have it in our guidance while we await their order for the upcoming season. Our intent is, of course, to add it back once we have clarity. And then when it comes to the $250 million across Australia, New Zealand, and Israel, 200 of which is specific to Australia, there are ongoing regulatory matters related to Australia.

Speaker Change: The pieces, there, where we took $100 million related to Canada.

Speaker Change: And we've placed it to the side, while we await that order it just seem prudent at this time too.

Speaker Change: Not having it in our guidance, while we await their order for the upcoming season. Our intent is of course to add it back once we have clarity.

Speaker Change: And then when it comes to the $250 million across Australia, New Zealand, and Israel, 200, which is specific to Australia.

Speaker Change: There are ongoing regulatory matters related to us Australia ill, let John hit that and perhaps characterize some of the dialogue and Roger just to build upon Jim's answer I think you asked about the 600 total go forward.

John Charles Jacobs: I'll let John hit that and perhaps characterize some of the dialogue. Yeah, and Roger, just to build upon Jim's answer, I think you asked about the $600 million total go forward. And I think Jim notes in his commentary that that did not include deferred revenue from Canadian prepayments in the past, so you might have been looking at that and thinking it could have been higher, but we excluded deferred revenue, which is an accounting matter, and you looked at 600.

Speaker Change: I think Jim notes in his commentary that that did not include deferred revenue.

Speaker Change: From Canadian prepayments in the past so you might've been looking at that and thinking it could have been higher but we excluded deferred revenue, which is an accounting matter and you looked at the 600 <unk> I believe you asked about and we can have Jim further clarify if needed. Roger you also asked about what happens if I heard you correctly as the Apa's wind down when it relates to Santa Fe and <unk>.

John Charles Jacobs: I believe you asked about, and we can have Jim further clarify if needed, Roger, you also asked about what happens, if I heard you correctly, as the APAs wind down when it relates to Sanofi. And right now, in our commentary, you heard us say that Sanofi will take commercialization on in 2025 for the US, Europe, UK, and then, over time, the rest of the globe. So we're maintaining responsibility to manage these APAs through their fruition in 2026, and we take that responsibility seriously and intend to bring forward the majority of value in the remaining APAs, albeit it may be spread out over time to better meet global market demand. But our future is not about the APA business.

Speaker Change: Right now in our commentary you heard us say that <unk> will take a commercialization on in 2025 for the U S. Europe U K and then over time the rest of the globe. So we're maintaining responsibility to manage these apa's for through their fruition in 2026, and we take that responsibility seriously and intend to bring forward the.

Speaker Change: City of value in the remaining apa's, albeit it may be spread out over time to better meet global market demand, but our future is not about the API business. So as those apa's wind down as the final chapter in the legacy of the pandemic, we moved to a bright and exciting future for Novavax and when I first got here Roger the a P value in our.

John Charles Jacobs: So as those APAs wind down, it's the final chapter in the legacy of the pandemic. We move to a bright and exciting future for Novavax. And when I first got here, Roger, the APA value in our business was 100% of our business opportunity. It was the business model. It was over $2 billion. We've pulled down roughly two-thirds of that value in the last 15 months. We have roughly a third left.

Speaker Change: This was 100% of our business opportunity. It was the business model. It was over 2 billion, we've pulled down roughly two thirds of that value in the last 15 months, we have roughly a third left we intend to optimize that between now and the end of 2026, and we're looking forward to a bright future. So as those apa's wind down its our intention to have those markets offer.

John Charles Jacobs: We intend to optimize that between now and the end of 2026, and we're looking forward to a bright future. So as those APAs wind down, it's our intention to have those markets offered to Sanofi so they can begin commercializing our Novavax vaccine and the other products they may develop in those markets as the APAs wrap up. I hope that answers your question. Yes, it does.

Speaker Change: <unk>. So they can begin commercializing our new accident vaccine and the other products. They may develop in those markets as apa's wrap up I hope that answers your question.

Speaker Change: Yes, you bet. Thank you.

Roger Song: Thank you. Yeah, that's it. That's so much. Thank you. Congratulations again. Your next question comes from Herrick Joseph from J.P. Morgan. Go ahead. No, thanks.

Speaker Change: Yes.

Speaker Change: Thank you once again.

Your next question comes from Eric Joseph from Jpmorgan go ahead.

Eric William Joseph: Good morning, and let me have my congratulations on the deal. What I'm hoping to do is just get a better, a bit of a better understanding of the strategic positioning of your COVID flu program versus Sanofi's COVID flu ambitions, right? Would you be targeting different market segments? And I'm also curious to know whether, you know, you see opportunities for your own. Blue, Stand Alone, and maybe as a follow-up to that, can you talk about sort of what work Sanofi has done on the feasibility of a Novavax event? Blue zone quad combination or blue zone HD combo.

Eric William Joseph: Thanks, Good morning, and let me add my congrats on the deal.

What I'm, hoping to do is just get a better a bit of that.

Eric William Joseph: Our understanding of the strategic positioning of your Covid flu program versus Sanofi is COVID-19 flu ambitions rate would you be targeting.

Eric William Joseph: There are certain market segments and I'm also curious about whether you.

Eric William Joseph: See opportunities for your own.

Eric William Joseph: <unk> Standalone.

Eric William Joseph: And maybe as a follow up to that can you talk about sort of what works no fee has done on the feasibility of it.

Eric William Joseph: New vaccinated.

Eric William Joseph: Zone Quad combination or Fluzone HD Chicago. Thanks.

John Charles Jacobs: Eric, for competitive reasons, we're not going to get into details on specific strategies around our pipeline assets, but what I can say to address your question is we're very excited that we've been able to double our shots on goal in our late-stage program by adjusting our original KIC clinical trial, as Filip described today, to include a standalone flu vaccine. And Filip shared some exciting data on the H5N1 flu and has previously shared positive immunogenicity and other data results from our prior flu work.

Eric William Joseph: For competitive reasons, we're not going to get into details on specific strategies around our pipeline assets, but what I can say to address. Your question is we're very excited that we've been able to double our shots on goal in our late stage program by adjusting our original kick clinical trial as Philip described today to include a standalone flu vaccine and Philip <unk>.

Eric William Joseph: Third some exciting data on H five N. One flu and has previously shared positive immunogenicity and other data results from our prior flu work. So we're very excited that we have to potentially registry registration registration worthy vaccine assets.

John Charles Jacobs: So we're very excited that we have two potentially registration-worthy vaccine assets this time next year should we succeed with that clinical program. And as I said before, our strategy is to consider optionality on how we would monetize those assets and bring them forward should we have success. And that could include additional partnering and business development, outlicensing to other organizations who would like to see those vaccines, creating additional deals of this nature that we have with Sanofi, or deciding to go it alone.

Eric William Joseph: This time next year should we succeed with that clinical program and as I said before our strategy is to consider optionality on how we would monetize those and bring them forward should we have success and that could include additional partnering and business development out licensing to other organizations, who would like to see those vaccines, creating additional deals of this nature.

Eric William Joseph: We have with Santa fee or deciding to go it alone. What we'll do is allow the data to feed that strategy Eric to make sure. We see how those cards overturned by mid next year and that will guide further strategic thinking on the assets. What we're excited about is the value of our technology platform and that the Sanofi deal has further validated.

John Charles Jacobs: What we'll do is allow the data to feed that strategy, Eric, to make sure we see how those cards turn by mid-next year, and that will guide further strategic thinking on the assets. What we're excited about is the value of our technology platform and that the Sanofi deal has further validated the immense value that MatrixM and our nanoparticle technology have to offer, and we intend to keep optimizing that. And in addition, what you see is we're expanding our portfolio with some early-stage work, exploring RSV, et cetera.

Eric William Joseph: Good.

Eric William Joseph: The immense value that matrix M. In our nanoparticle technology has to offer and we intend to keep optimizing that and in addition, what you'll see is we're expanding our portfolio with some early stage work exploring RSV etcetera. So hopefully that addresses your question I would rather not comment on what sort of fee may be thinking or why they came to the conclusion that.

John Charles Jacobs: So hopefully, that addresses your question. I'd rather not comment on what Sanofi may be thinking or why they came to the conclusion that this is such an exciting platform to partner with, but we're not surprised because we know the value our technology can offer. And I'll leave it there for now. Thank you. Great. Thanks for the talk. Your next question comes from Alec Stranahan from Bank of America. Please go ahead. Hey guys, congrats on the deal. This is John. Mon for Alec.

Eric William Joseph: This is such an exciting platform to partner with but we're not surprised because we know the value of our technology can offer and I'll leave it there for now thank you.

Speaker Change: Okay, great. Thanks for the color.

Speaker Change: Your next question comes from.

Speaker Change: Shanahan from Bank of America. Please go ahead.

Alec Stranahan: Probably just some clarification questions for us. I think the first one is, for the $350 million in milestones for activities related to Novavax COVID, what are the potential milestones in the upcoming, like, a year or two that we could see for your company to receive? That's the first question. And secondly, for marketing and branding in terms of future commercialization of Sanofi branded products. So like, how would that work?

Shanahan: Hey, guys.

Shanahan: Congrats on the deal this is Jon on for Alex.

Jon: Probably just some clarification questions for us.

Shanahan: I think the first one.

Jon: Or the $250 million and milestones for activities related to <unk>.

Jon: <unk> of it.

Jon: What are what are the potential milestones and the upcoming like a year or two that we could see or.

Jon: For your company to receive that.

Jon: That's the first question and secondly for our marketing and branding in terms of future commercialization of Sanofi branded product.

Jon: Like how would that how would that work could you maybe shed some light on the.

John Joseph Trizzino: Could you maybe shed some light on the branding message in the future? Thanks. John T., do you want to take that question? Yeah, I'll take the second one first, right, which is talking about what the opportunity is in the marketplace. So, as John said, we can't comment on exactly what the marketing and sales strategies are, but I think it's good to understand what the marketplace looks like today and how the combination of our COVID vaccine with their flu vaccine could have profound opportunities in the market, as we said, both from a public health standpoint and revenue generation.

Jon: The branding message in the future. Thanks.

Jon: John do you want to take that question, Yes, I'll take the second one first which is talking about what the opportunity is in the marketplace. So as John said, we can't comment on exactly what their marketing and sales strategies are but I think it's good to understand what the marketplace looks like today and how the combination of our COVID-19 vaccine with there.

John Charles Jacobs: Flu vaccine could have profound opportunities in the market as we said both from a public health standpoint, and revenue generation understanding that <unk> is the market leader in flu vaccinations in the U S around the globe.

John Joseph Trizzino: Understanding that Sanofi is the market leader in flu vaccinations in the U.S. and around the world, there is a clear need for a combination vaccine. Any market assessment for a combo vaccine would include what we would refer to as decantabilization of the flu market, the leveraging of the flu market for the benefit of uptake of COVID vaccination in that combination format.

Speaker Change: There is.

Speaker Change: A clear need for a combination vaccine.

Speaker Change: Any market assessment for a combo vaccine would include what we refer to as the cannibalization of the flu market leveraging of the flu market for the benefit of uptake of Covid vaccination in that combination format. So there's a significant opportunity here with the market leader too.

John Joseph Trizzino: So, there's a significant opportunity here for the market leader to identify what that opportunity is and to expand vaccination rates for both COVID and flu by virtue of the combo vaccine. As we're building towards that, obviously, their position in the marketplace from a co-promote, co-commercialization standpoint would be critical in helping us leverage the Sanofi brand, leverage their infrastructure, leverage their deep reach into the vaccine market, and their confidence in the strength, safety, and efficacy of that product, I think, says volumes about what the potential is.

Speaker Change: To identify what that opportunity is to expand vaccination rates for both COVID-19 and flu by virtue of the combo of vaccine.

As we're building towards that obviously their position in the marketplace from a co promote co commercialization standpoint.

Speaker Change: Would be critical in helping us.

Speaker Change: Leverage the century brand leverage their infrastructure.

Speaker Change: Average their deep reach into the vaccine market.

Speaker Change: And their confidence in the strength and.

Speaker Change: Safety and efficacy of that product.

Speaker Change: <unk> says volumes about what the potential is.

John Joseph Trizzino: And we see much more market, significant market share in vaccination rate increase as a result of this relationship. And then I'm happy to take the first question regarding the breakdown and timing of the $350 million in future milestones. So on slide number five, we mapped it out.

Speaker Change: And we see much much more market significant market share and vaccination rate increase.

Speaker Change: As a result of this relationship.

Speaker Change: And then.

Speaker Change: And then I'm happy to take the first question regarding the breakdown and timing of the $350 million in future milestones. So on slide number five we mapped it out.

James Kelly: The expectation is that, you know, these are all near-term activities over the next 12 to 24 months. Certainly, the COVID-19 manufacturing tech transfer may take a little bit longer as we look at these, but the other ones are certainly near-term. We're not at this time providing any more timing on that. Beyond that, you know, they're all important strategic activities that are a priority. And, Eric, as I said earlier, the majority of value we anticipate from the steel goes well beyond the initial $1.2 or $1.3 billion in ongoing royalties from anticipated sales that Sanofi will have for Arnuvaxavid and their own combination product. And then, in addition to that, anything they may develop with MatrixM, each individual new MatrixM product eligible for up to $200 million in additional one-time milestones and ongoing flat royalties.

Speaker Change: Expectation is that these are all near term activities over the next 12 to 24 months.

Speaker Change: Certainly the COVID-19 manufacturing tech transfer may take a little bit longer as we look at these but the other ones are certainly near term we're not at this time, providing more timing on that beyond that they're all important strategic activities that our priorities and narrow because as I said earlier the majority of <unk>.

Speaker Change: We anticipate from the steel goes well beyond the initial 1.2 of $1 3 billion to ongoing royalties of anticipated sales at Santa Fe will have for <unk> and their own combination product and then in addition to that anything they may develop with matrix M. Each individual new matrix M product eligible for up to $200 million in <unk>.

Speaker Change: Additional one time milestones and ongoing flat royalty. So I think it's very important to understand the different pieces of value in the steel and why we believe it has the potential to be a multibillion dollar deal for Novavax. Thank you.

John Charles Jacobs: So I think it's very important to understand the different pieces of value in this deal and why we believe it has the potential to be a multibillion-dollar deal for Novavax. Thank you. And your next question comes from Mayank Mamtani from B-Radio Securities. Please go ahead. Good morning, team.

Speaker Change: And your next question comes from Mayak.

Speaker Change: Ken.

<unk> from <unk> Securities. Please go ahead.

Mayak: Good morning Deane.

Mayak: When you have one with landmark deal and thanks for taking our question. So thank you Mike and good morning.

Mayank Mamtani: Congratulations on this land map deal and thanks for taking our questions. Thank you, Mike. Good morning.

Mayank Mamtani: Yeah, good morning. I'm so glad to hear the BLA is being already submitted. Is there a PDUFA date granted yet? That was my quick follow-up to the prior question. And then with everything in place now, you know, the BLA plan and the FDA UA, you know, some pharmacy contracting, pre-first syringe looks like on plan. I was just curious about your non-APA revenue guidance, which I assume is royalty revenue focused. Could you comment on what that market share assumption might be in that 250 to 350 million that you have in a footnote?

Mayak: Yes. Good morning, so glad to hear the DLA is being is already submitted is it has to do fed date granted yet.

Speaker Change: A quick follow up to the broad question and then.

Speaker Change: Everything in place now the BLA plan and the FDA EUA.

Speaker Change: Some pharmacy contracting <unk> and <unk>.

Speaker Change: One plan I was just curious in your.

Speaker Change: Non EPA revenue guidance.

Speaker Change: Zoom is royalty revenue focused.

Speaker Change: Could you comment on what that market share that <unk> might be in that.

Speaker Change: And then that you have an asset like mode.

Speaker Change: And then I have a couple of follow up.

John Joseph Trizzino: And then I have a couple of follow-up questions. Yeah, John, why don't you take this BLA question first? Yeah, Mike, there's a couple of pieces to the question there. So, first of all, as you well know, we have been intending and have accomplished, in fact, the submission of our BLA to FDA. But there were a couple of steps involved with that. This was the initial approval of the BLA for the XBB strain that was under emergency use authorization last year.

Speaker Change: Yes, John why don't you take that the BLA question first step, yes, Mike There's a couple of pieces to the question. There. So so first of all as you well know we have been intending.

John Charles Jacobs: Have accomplished in fact to the submission of the BLA to FDA, but there was a couple of steps involved with that so it was the initial approval of the BLA for the SBB strain that was under emergency use authorization last year. We were then going to be adding.

John Joseph Trizzino: We were then going to be adding the prefilled syringe and the strain change into that BLA submission and having that all tied up in a nice bow in front of the season. Right.

John Charles Jacobs: The pre filled syringe and the strain change into that BLA submission and having that all tied up in a nice bow in front of in front of the season right.

John Joseph Trizzino: While that strategy was communicated to the FDA, and it was very thoughtful about the ability for that to get us to the market on time, reassessing that, in collaboration and conversations with FDA, we felt like if we focused on the strain change and we focused on the prefilled syringe authorization, the EUA pathway would be the best way to do that instead of the more formal BLA path. So, as I said in the remarks, we are going to be pursuing a parallel path. This parallel pathway ensures our timeliness to the marketplace. And I think that's the most critical thing. The product is authorized for use.

John Charles Jacobs: While that strategy was communicated to the FDA.

John Charles Jacobs: And it was very thoughtful about the ability for that to get us to the market on time reassessing that we in collaboration in conversations with FDA.

John Charles Jacobs: We felt like if we focused on the strain change and we focused on the pre filled syringe.

John Charles Jacobs: Authorization that the EUA pathway would be the best way to do that instead of the more formal BLA path. So as I said in the remarks.

John Charles Jacobs: We're going to be pursuing in parallel path. This parallel pathway ensures our timing and as to the marketplace.

John Charles Jacobs: I think that's most critical.

John Charles Jacobs:

John Charles Jacobs: The product is authorized for use there are no restrictions and how we communicate the benefits of this vaccine we're going to have inventory in our three PL distribution center in mid August.

John Joseph Trizzino: There are no restrictions on how we communicate the benefits of this vaccine. We're going to have inventory in our 3PL distribution center by mid-August. As soon as authorization is granted, we're going to be in the market, and I think that's the most critical component of that strategy. And Mayank, as we said in our comments, and I'll hand it back to John on your market share question, and maybe, John, you could take that as the potential we see in the U.S. marketplace, assuming we are indeed staying on track, which we are now, with our prefilled sy But let's address the PDUFA date question first.

John Charles Jacobs: As soon as the authorization is granted we're going to be in the market and I think that's the most critical component of that of that strategy and Mike as we said in our in our comments I'll hand, it back to John on your market share question and then maybe John you could take that as the potential we see in the U S marketplace. Assuming we are indeed, staying on track, which we are now with our pre filled syringe in a timely launch the season.

John Charles Jacobs: Because we Mike we're excited about the opportunity to perform significantly better than we did last season in the U S market, but let's address the Paducah date question, we will get a <unk> date from FDA once they formally except our file we have completed that file and are waiting for that formal acceptance. Sean go ahead on the market share question.

John Charles Jacobs: We will get a PDUFA date from FDA once they formally accept our file. We have completed that file and are waiting for that formal acceptance. John, go ahead on the market share question. So, yes, the PDUFA date question is part of yet another element of why the timing for EUA and BLA was kind of a critical balancing act here. While the FDA could act more quickly if they so desire, the PDUFA date is not the ultimate – they don't have to submit to the PDUFA date, but it just streamlined the activities in a significant way.

John Charles Jacobs: Yes.

Sean: So <unk> question is.

Sean: Part of yet another element of why the timing for <unk>.

<unk> BLA was kind of critical balancing act here, while the FDA could act more quickly if they so desire that <unk> data is not the ultimate they don't have to fill to the <unk> date, but.

Sean: But it just streamline the activities and significant way as far as market share is concerned.

John Joseph Trizzino: As far as market share is concerned, you know, again, the critical elements, the new strain, the pre-filled syringe, on time to the market, awareness of Novavax, access – so awareness and access, two critical elements. We think that there's a significant opportunity in the U.S. market, and we're going to see a dramatic shift from where we were last year. As you recall, in the 23 season, we were late to the market by almost a full four to five weeks, and almost 50 percent of the COVID market had been administered by that time, and we were also in a five-dose presentation. So a dramatic shift in positioning for us, and so I think that we'll be well established and set up for the 24 season. Very helpful. It makes sense.

Sean: Again, the critical elements, the new strain pre filled syringe on time to the market awareness.

Sean: Awareness of Novavax access so awareness and access to critical elements.

Sean: We think that there's a significant opportunity with market and we're going to see a dramatic shift from where we were last year as you'll recall in the 'twenty. Three season, we were late to the market by almost a full four to five weeks and almost 50% of the Covid market had been administered by that time and we were also in a five dose presentation. So dramatic shift in positioning.

Sean: For us and so I think there will be well established and set up for the 24 season.

John Joseph Trizzino: Thank you. And then on the phase three kick trial design, obviously, awesome to see the standalone flu arm added. I was just curious, since you already have, you know, control data from a phase three study with nanoflu, and I don't know if this candidate is the same as nanoflu, but could you just talk about what the key immunogenicity objectives are being agreed upon with the FDA on the different strains and how, you know, non-inferiority or superiority will have to be relative to the three arms that you're using. Yeah, Filip. Why don't you take that one?

Very helpful makes sense. Thank you and then on the Phase III trial design, obviously awesome to see the Standalone flu added I was just curious and you already have.

Sean: Controlling data one of the phase III study.

Sean: The nano flue and I don't know this candidate and the same as that is little bit could you just talk about what the key immunogenicity objective.

Sean: Read upon with the FDA on the.

Sean: The different strains and Hal.

Sean: Non inferiority.

Sean: Even after the rally.

<unk>.

Sean: Yes.

Sean: Yes, Philip why don't you take that one.

Filip Dubovsky: Yeah, so you're right. We've kind of trod this ground before, and the real difference in this is twofold. One of them is a specific age population we're targeting, because we think that's where the medical need is the greatest and is also the most lucrative market in the U.S., at least. And the second one is the comparator.

Philip: Yes, so you're right, we've kind of tried to as ground before and the real difference and this is twofold. One of them is a specific age population, we're targeting because we think thats, where the medical need is the greatest and is also the most.

Philip: Most lucrative market in the U S at least in the second one is a comparator. So the compares we're choosing are going to position us to have commercial success going into the future and I'm not going to give any more details about the specific criteria used to establish superiority or non inferiority, but certainly the non inferiority criteria. That's also well trod.

Filip Dubovsky: So the comparators we're choosing are going to position us to have commercial success going into the future. And I'm not going to give any more details about the specific criteria used to establish superiority or non-inferiority, but certainly the non-inferiority criteria, that's also well-trod ground, which many other sponsors have used in the past. And lastly, I don't know if it's too early to comment, but I know investors care about, you know, profitability because you guys do have a real business.

Philip: Ground, which many other spots.

Philip: Sponsors have used in the past.

Speaker Change: Understood and lastly, I don't know if its too early to comment but.

Speaker Change: Just as Canada.

Speaker Change: Is it because you guys do you have any other business. So if you could talk about your expectations of breakeven.

Filip Dubovsky: So, if you could talk about your expectations for breakeven, given, you know, OPEX rammed down, should it, you know, continue on into next year, but then, obviously, you're looking to build a, you know, broad respiratory pipeline infrastructure long term. How should we think about that? And thank you, Mayank.

Speaker Change: Given opex down.

Speaker Change: <unk> into next year, but then obviously you are looking to build out progress regarding for pipeline infrastructure long term.

Speaker Change: Should we think about that and think your mind go ahead, Jim and then we'll need to move on to the next set of questions go ahead Jim.

James Kelly: Yeah. All right. Guiding principle one, we're building an enterprise towards cashflow positive and value. One of the things you heard John mention earlier is that we believe that the economics and cash flow under this agreement with Sanofi across this portfolio are, in fact, superior to the cash flow we might have been able to drive for ourselves. You are hearing that we are creating and driving an important value creation platform to increase shareholder value. And so we will continue to give you updates on how our business model evolves to deliver against that objective. Your next question comes from Brendan Smith from TD Cohen's. Please go ahead. Good morning, Brendan.

James Kelly: Alright guiding principle, one we're building an enterprise towards cash flow positive and value creation. One of the things you heard John mentioned earlier is we believe that the economics and cash flow under this agreement with Santa Fe across this portfolio is in fact superior to the.

James Kelly: Cash flow, we might have been able to drive to ourselves.

James Kelly: We're hearing that we are creating.

James Kelly: And driving to an important value creation platform to.

James Kelly: To increase shareholder value and so we will continue to give you updates on how our business model are false to deliver against that guiding principle.

Your next question comes from Brendan Smith from TD Cowen. Please go ahead.

Brendan Mychal Smith: Hi, good morning guys. Thanks for taking the questions. Huge, huge congratulations. It's really great to see. Oh Brendan, thank you very much. Appreciate it. Yeah, maybe just a quick one from us first.

Brendan Mychal Smith: Good morning, Brian Thanks for taking hi, good morning, guys. Thanks for taking the questions a huge huge congrats really great to say Brandon.

Brendan Mychal Smith: Brendan Thank you very much appreciate it.

Brendan Mychal Smith: Apologies if I missed this, but we've been hearing a little bit from some of the COVID competitors that FDA might actually be considering authorization of the updated boosters even earlier this year, possibly for August. I wanted to see if that's been part of your conversation. Do you think that would impact any of your timing or launch capabilities?

Brendan Mychal Smith: Yes, maybe just a quick one from US first apologies if I missed this but we've been hearing a little bit from some of the public.

Brendan Mychal Smith: Our competitors that FDA might actually be considering authorization.

Brian: The updated boosters, even earlier this year, possibly for August I wanted to see if thats been part of your conversation do you think that would impact any of your timing.

Brian: Our launch capabilities.

Brian: And then I don't think just stepping back maybe to the broader opportunity now wanted to get your thoughts on on strategy.

John Charles Jacobs: And then, honestly, just stepping back maybe to the broader opportunity now, I wanted to get your thoughts on strategy and what you're thinking, how you're thinking about each of these other non-COVID, non-flu areas for you, namely, what it is like, what's drawing you where and how you're thinking about where to go first. Maybe what makes sense for Novavax alone versus part of the collaboration. Brendan, excellent questions. I'll take the second question and hand it over to John Trizzino and Filip to address your question about strain timing and launch timing for the season.

Brian: What youre thinking how youre thinking about each of these other non COVID-19 flu areas for you, namely.

Brian: Like what's drawing you, where and how youre thinking about where to go first.

Speaker Change: It makes sense for Novavax alone versus part of the collaboration thanks, very much Brian and excellent questions I'll take the second question and then hand, it over to Jon Zaffino and Filipe to address your question about strained timing and launch timing for the season. So when it comes to strategy, we're going to continue to crystallize, our future pipeline and organic growth strategy from our own tech.

John Joseph Trizzino: So when it comes to strategy, we're going to continue to crystallize our future pipeline and organic growth strategy from our own tech platform in the coming months and look forward to sharing more detail with you. What we were so excited about sharing with you today was the new science that Filip and his team have been working on new data and approaches to leverage our technology in different ways for months and months now, and we unveiled some of that today to share with the investor community.

Speaker Change: For him in the coming months and look forward to sharing more detail with you. What we were so excited about sharing with you today as the new science that Philips Philip and his team have been working on new data and approaches to leverage our technology in different ways for for months and months now and we unveiled some of that today to share with the Investor community, We're still working through the best way to <unk>.

John Joseph Trizzino: We're still working through the best way to optimize some of those assets, and we're also considering additional early-stage assets that we can work with in our pipeline. And we intend to do so all within the new lean operating model that Jim Kelly started to outline earlier in his prepared comments and the questions he answered. So more to come on that.

Speaker Change: Optimize some of those assets and we're also considering additional early stage assets that we can work with in our pipeline and we intend to do so all within the new lean operating model that Jim Kelly started to outline before in his prepared comments and the questions. He answered so more to come on that we look forward to sharing more details with you as our RSR thoughts crystallized further.

John Joseph Trizzino: We look forward to sharing more details with you as our thoughts crystallize further, and we're ready to share them. So, why don't I hand it over to John Trizzino and Filip to answer your first question? Right, so you know that the EMA and WHO have already designated a strain, and we aren't expecting the strain to be designated by the FDA until early June. And we've been in discussions with all those agencies on a continuous basis.

Speaker Change: And we're ready to share them. So why don't I hand, it over to John <unk> and fill up to answer your first question.

Speaker Change: Okay.

John Charles Jacobs: Right. So you know that the EMA and devote show have already designated a strain and we arent expecting strain to be designated from the FDA until early June and we've been in discussions with all of those agencies.

John Charles Jacobs: For on a continuous basis.

John Joseph Trizzino: Right now, what we've stated is that we're going to be submitting our supplemental filing immediately after VRBPAC, and I think that John's mentioned before that we anticipate having the product available in mid-August. Now, none of that matters as much as when the season is designated to start by the FDA and by the CDC.

Speaker Change: Right now what we stated is that we're going to be us.

Speaker Change: Submitting our supplemental filing immediately after <unk> and I think that John's mentioned before that we anticipated having product available in mid August now none of that matters.

Speaker Change: As much as when the season.

Filip Dubovsky: So that's really what we're targeting. We feel like we're in a good position to be able to achieve really whatever time frame the season starts in. John?

Speaker Change: Susan is designated to start by the FDA and by the CDC. So that's really where we're targeting we feel like we're in good position to be able to achieve.

Speaker Change: Whatever time frame.

Speaker Change: Sorry, John.

John Charles Jacobs: I think the variability in there as they're reviewing three files simultaneously. So the FDA has a bit of work to do I think they've already signaled that they're going to have a formal kind of campaign kickoff.

John Joseph Trizzino: Yeah, I think that the variability in there is that they're reviewing three files simultaneously, so the FDA has a bit of work to do. I think they've already signaled that they're going to have a formal kind of campaign kickoff post the Labor Day holiday in the U.S., and there's going to be a readiness in front of that. As we said, we're going to have product availability in the warehouse. It might even be queued up at the distributors or even in staging, awaiting that campaign to kick off.

John Charles Jacobs: Post the labor day holiday in the U S and there's going to be a readiness in front of that as we said, we're going to have product availability in the warehouse it.

John Charles Jacobs: It might even be queued up at the distributors or even in staging awaiting that campaign to kick off but I think the timing is it makes a lot of sense right. We're coming out of the summer vacation period, we're coming back to school back to work.

John Joseph Trizzino: But I think the timing makes a lot of sense, right? We're coming out of the summer vacation period. We're coming back to school, back to work. The CDC's campaign, and the other competitors' campaigns will begin kicking in that September 1st, first week in September time frame.

John Charles Jacobs: The Cdc's campaign, the other competitors' campaigns will begin kicking in that September one first week in September timeframe, and so we are synchronized around that.

John Charles Jacobs: And so we're synchronized around that. Yeah, and finally, Brendan, and we'll take final questions next, but finally, to build on John's point earlier, that's another reason for the dual pathway for regulatory authorizations this year, the BLA and the EUA John mentioned, because it gives us a chance to be more nimble and more quick through the EUA pathway with our pre-filled syringe and the We believe we'll be ready, and we're excited about the opportunity in the U.S. this fall.

Speaker Change: Yeah, and finally, Brendan and will take final questions Max but.

Brendan: Finally to build on John's point earlier, that's another reason for the dual pathway for regulatory authorizations. This year the BLA in the EUA John mentioned, because it gives us a chance to have.

Brendan: To be more nimble and more quick through the EUA pathway with a pre filled syringe and the updated strained. We believe we will be ready and we're excited about the opportunity in the U S. This fall one last comment when you asked about portfolio I just want to make sure everyone's clear.

John Charles Jacobs: One last comment, when you asked about our portfolio, I just want to make sure everyone's clear that we have a wholly owned independent portfolio and that our combination influenza COVID vaccine is completely ours and completely independent from the vaccine that Sanofi will develop in their pipeline using our new vaxavid. Just want to make sure that that's clear to everybody.

Brendan: That we have a wholly owned independent portfolio and that our combination influenza COVID-19 vaccine is completely hours and completely independent from the vaccine that Santa fee will develop and their pipeline using our new vacs of it just want to make sure that that's clear to everybody. Thank you and we'll take our final questions Erica from the final analyst.

Operator: Thank you. And we'll take the final questions, Erika, from the final analyst. Your next question comes from Vernon Bernardino from HC Wrenright. Please go ahead. Hi everyone, and congratulations from me also, and thanks for taking my question. I think one thing that needs to be mentioned is that I think you've found a great partner because you both are advancing protein-based vaccines. I think that's something that should be recognized. A question I have, just like other analysts and what we tend to do is a three-part question, but maybe it's just only two now, regarding the combination vaccine, is there any consideration as far as the NOPI side that you'll need to have a BLA-approved flu vaccine or COVID vaccine for them to actually progress the work on a combination vaccine that includes their quadrivalent flu vaccine?

Brendan: Your next question comes from Vernon Bernardino from H C. Wainwright. Please go ahead.

Vernon Tolentino Bernardino: And then as a follow-up to that, I was just wondering, obviously, the vaccine does not have matrix M. I was wondering if you could remind us the comparison of the efficacy of their quadrivalent versus yours, for example, and with their potential to add Matrixin to their quadrivalent, what kind of efficacy enhancement they think they could actually achieve. Thank you. Yep, Vernon, I'll hand the question over to Filip. Excellent questions. We're not going to comment on Sanofi's particular technology platform, but Filip, do you want to address the question?

Vernon Tolentino Bernardino: Hi, everyone and congratulations from me also and thanks for taking my question.

Vernon Tolentino Bernardino: I think one thing that needs to be mentioned is.

Vernon Tolentino Bernardino: Thank you.

Vernon Tolentino Bernardino: <unk> a great partner because you both are advancing protein based vaccines I think thats something to be recognized.

Vernon Tolentino Bernardino: Question I have just like other analysts.

Speaker Change: We've got to do a three part question, but maybe it's just only to now.

Speaker Change: Regarding the.

Speaker Change: The combination of vaccine is there any consideration as far as Sanofi site that you'll need to have.

Speaker Change: They approved.

Speaker Change: Flu vaccine or COVID-19 vaccine for them to actually progressed the work on the combination vaccine does includes.

Speaker Change: They're quadrivalent flu vaccine and then as a follow up to that I was just wondering.

Speaker Change: Obviously their vaccine does not have matrix M. I was wondering if you could remind us.

Speaker Change: The comparison of the ex CEO of their quadrivalent versus yours.

Speaker Change: <unk>.

Speaker Change: So <unk> for example.

Speaker Change: And with their potential to add metrics to their quadrivalent.

Speaker Change: Kind of expect to see.

Speaker Change: Do you think.

Speaker Change: They could actually achieve thank you.

Speaker Change: Yes, Vernon I'll hand, the question over to Filip excellent questions. We're not we're not going to comment on Santa fees particular technology platform at Philip do you want to address the questions.

Speaker Change: The BLA.

Filip Dubovsky: about the BLA. Their regulatory path will really involve a standalone BLA, so in that regard, it doesn't really rely on our regulatory process with Novavaxavid alone. So they're going to put together a package that has to show that their combination of their flu vaccine plus Novavaxavid is safe and efficacious. And the approach they take is going to be really up to them to define and gain approval from their regulators. Terrific. And you won't be able to comment on what you think the addition of matrix M to Sanofi's blue quadrivalent could be.

The regulatory path will really involve a stand alone.

Filip: So in that regard it doesn't really rely on our regulatory process with <unk> alone.

Filip: So theyre going to put together a package, which has to show that their combination of their flu vaccine plus <unk>.

Filip: Safe and efficacious and approach they take or is it going to be really up for them to define and to get approval with the regulators.

Filip: Terrific.

Filip: You won't be able to comment on.

Filip: What do you think the addition of matrix M to Sanofi is blue quadrivalent.

Filip: B.

Filip Dubovsky: Yeah, no, we're not going to comment on that today, Vernon. Okay. Thanks for taking questions and congratulations. Thank you. Thank you, Vernon. And one comment, though.

Speaker Change: And no we're not going to comment on that today Vernon.

Vernon Tolentino Bernardino: Okay excellent.

Speaker Change: Questions and congratulations. Thank you. Thank you Vernon I wanted to comment. Thank you for asking it and importantly, again, we don't want anyone to walk away without total clarity that this deal has tremendous value multibillion dollar deal.

Vernon Tolentino Bernardino: Thank you for asking. And importantly, again, we don't want anyone to walk away without total clarity that this deal has tremendous value, a multi-billion dollar potential deal for Novavax, including the upfront payments of the 1.3, and then well beyond that, anticipated royalties of significant value. We think even greater value than those upfront payments. And then on top of that, to your point, Vernon, what they could do with MatrixM.

Speaker Change: $1 billion potential deal for Novavax, including the upfront payments of the one three and then well beyond that anticipated royalties of significant value, we think even greater value than those upfront payments and then on top of that to your point Vernon what they could do with matrix M.

John Charles Jacobs: And we think there's immense potential for Sanofi as a powerhouse in vaccine development and commercialization, and we're very excited about some of the concepts and ideas they may be contemplating about what to do with MatrixM. And with each new MatrixM product they would choose to bring forward should they do so. We have the potential for up to 200 million in one-time milestones and ongoing flat royalty for years to come. So those pieces of value are absolutely critical.

Speaker Change: We think there's immense potential with <unk> is a powerhouse in vaccine development and commercialization and we're very excited about some of the concepts and ideas. They may be contemplating about what to do with matrix M and with each new matrix M product they would choose to bring forward should they do so we have the potential for up to $200 million in one time milestones and ongoing flat royalty for <unk>.

Speaker Change: Hours to come so those pieces of value are absolutely critical and that's what makes this deal well beyond the upfront milestones and payments that everyone's been talking about multibillion dollar deal we feel for Novavax. Thank you. So much everyone for your questions Eric I will turn it back to you and then the operator to close.

John Charles Jacobs: And that's what makes this deal well beyond the upfront milestones and payments that everyone's been talking about, a multi-billion dollar deal we feel for Novavax. Thank you so much, everyone, for your questions. Eric, I'll turn it back to you.

Speaker Change: This concludes our question and answer session I would like to turn the conference back over to John Jacobs for any closing comments.

Operator: And this concludes our question and answer session. I would like to turn the conference back over to John Jacobs for any closing comments. No, thank you, everyone. Thank you for joining us today. We appreciate your time. We'll keep working with humility, diligence, and all of our effort to return value to our loyal shareholders.

Speaker Change: Okay.

John Charles Jacobs: No. Thank you everyone. Thank you for joining US today. We appreciate your time, we will keep working with humility diligence and all of our effort to return value to our loyal shareholders and I want to thank all of our employees at Novavax for their time energy and effort to get us to this next stage in the beginning of a new chapter for the future of our company. Thank you everyone for joining us today.

John Charles Jacobs: And I want to thank all of our employees at Novavax for their time, energy, and effort to get us to this next stage and the beginning of a new chapter for the future of our company. Thank you, everyone, for joining us today. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

Operator: Thank you......

Speaker Change: The conference has now concluded. Thank you for attending today's presentation. You may now disconnect. Thank you.

Speaker Change: Okay.

Speaker Change: Okay.

Speaker Change: Yeah.

Speaker Change: [noise].